阅读说明：本技术 左心耳(laa)夹持设备及夹持laa的方法 (Left Atrial Appendage (LAA) clamping device and method for clamping LAA ) 是由 德里克·迪·德维尔 马修·A.·帕尔默 理查德·卡特利奇 小托马斯·O.·贝尔斯 肖恩·M. 于 2019-01-25 设计创作，主要内容包括：一种外部LAA分离夹子包含夹子组件和偏置组件,所述夹子组件包含相对的第一夹杆和第二夹杆,其中每个夹杆具有组织接触面以及第一偏置面和第二偏置面；所述偏置组件连接所述第一夹杆和所述第二夹杆以在穿过所述组织接触面的杆平面中对准所述第一夹杆和所述第二夹杆。所述偏置组件包含连接至所述第一夹杆的所述第一偏置面和所述第二夹杆的所述第一偏置面的至少一个第一偏置弹簧和连接至所述第一夹杆的所述第二偏置面和所述第二夹杆的所述第二偏置面的至少一个第二偏置弹簧。所述第一偏置弹簧和所述第二偏置弹簧被配置成允许所述第一夹杆和所述第二夹杆在所述杆平面上的移动。(An external LAA detachment clamp includes a clamp assembly including first and second opposed clamp bars, wherein each clamp bar has a tissue contacting surface and first and second offset surfaces; the biasing assembly connects the first and second clamping bars to align the first and second clamping bars in a bar plane passing through the tissue contacting surface. The biasing assembly includes at least one first biasing spring coupled to the first biasing surface of the first clamping bar and the first biasing surface of the second clamping bar and at least one second biasing spring coupled to the second biasing surface of the first clamping bar and the second biasing surface of the second clamping bar. The first and second biasing springs are configured to allow movement of the first and second clamping bars in the bar plane.)

1. An external Left Atrial Appendage (LAA) detachment clip, comprising:

a clip assembly comprising opposing first and second clip bars, wherein each clip bar has:

a tissue contacting surface; and

a first offset surface and a second offset surface;

a biasing assembly connecting the first and second clamping bars to align the first and second clamping bars in a bar plane passing through the tissue contacting surface; the biasing component includes:

at least one first biasing spring connected to the first biasing surface of the first clamping bar and the first biasing surface of the second clamping bar; and

At least one second biasing spring coupled to the second biasing surface of the first clamping bar and the second biasing surface of the second clamping bar; and is

The at least one first biasing spring and the at least one second biasing spring are configured to allow movement of the first clamping bar and the second clamping bar in the bar plane.

2. The clip of claim 1, wherein:

the first clamping bar has a first proximal end and a first distal end;

the second clamping bar has a second proximal end and a second distal end;

the at least one first biasing spring is connected to:

a first offset surface of the first clamping bar located intermediate the first proximal end and the first distal end; and

a second offset surface of the second clamping bar located intermediate the second proximal end and the second distal end; and is

The at least one second biasing spring is connected to:

a second offset surface of the second clamping bar located intermediate the first proximal end and the first distal end; and

an intermediate position of the second offset surface of the second clamping bar between the second proximal end and the second distal end.

3. The clip of claim 1, wherein:

the first offset surface of the first clamping bar is a first upper side;

the second offset surface of the first clamping bar is a first lower side;

the first offset surface of the second clamping bar is a second upper side;

the second offset surface of the second clamping bar is a second lower side;

the tissue contacting surface of the first clamping bar comprises a first LAA contacting surface having a first longitudinal centerline;

the tissue contacting surface of the second clamping bar comprises a second LAA contacting surface having a second longitudinal centerline; and is

The rod plane passes through the first longitudinal centerline and the second longitudinal centerline.

4. The clip of claim 1, wherein:

the clip is sized to fit a laparoscopic port having an inner diameter; and is

The clip assembly and the biasing assembly collectively have a maximum outer width that is no greater than the inner diameter of the port.

5. The clip of claim 1, wherein:

the first and second clamping bars have a maximum longitudinal length;

the at least one first biasing spring has a longitudinal length shorter than the maximum longitudinal length; and is

The at least one second biasing spring has a longitudinal length that is shorter than the maximum longitudinal length.

6. The clip of claim 1, wherein:

the clip is sized to fit a laparoscopic port having an inner diameter;

the clip assembly and the biasing assembly collectively having a maximum outer width that is no greater than the inner diameter of the port;

the first and second clamping bars have a maximum longitudinal length;

the at least one first biasing spring has a longitudinal length shorter than the maximum longitudinal length; and is

The at least one second biasing spring has a longitudinal length that is shorter than the maximum longitudinal length.

7. The clip of claim 1, wherein the biasing assembly is configured to allow rocking of the first and second clamping bars on the bar plane.

8. The clip of claim 1, wherein the biasing assembly is configured to allow rocking of the first clip bar in the bar plane independent of rocking of the second clip bar in the bar plane.

9. The clip of claim 1, wherein:

the first offset surface of the first clamping bar is a first upper side;

The first offset surface of the second clamping bar is a second upper side;

the first upper side and the second upper side together define an outer upper boundary; and is

The first biasing spring is retained in the outer upper boundary.

10. The clip of claim 1, wherein:

the second offset surface of the first clamping bar is a first lower side;

the second offset surface of the second clamping bar is a second lower side;

the first and second undersides collectively defining an outer lower boundary; and is

The second biasing spring is retained in the outer lower boundary.

11. The clip of claim 1, wherein:

the first clamping bar has a first longitudinal axis;

the second clamping bar has a second longitudinal axis; and is

The at least one first biasing spring and the at least one second biasing spring balance forces such that the first clamping bar and the second clamping bar do not substantially rotate about the respective first longitudinal axis and second longitudinal axis when the first bar and the second bar move in the bar plane.

12. The clip of claim 1, wherein:

the first clamping bar has a first longitudinal axis;

the second clamping bar has a second longitudinal axis; and is

The at least one first biasing spring and the at least one second biasing spring balance forces such that the first clamping bar and the second clamping bar have substantially no torque when the first bar and the second bar move in the bar plane.

13. The clip of claim 1, wherein the first clip bar has a first proximal end and the second clip bar has a second proximal end, and wherein the clip further comprises a transfer device removably connected to the first proximal end and the second proximal end and configured to move the first clip bar and the second clip bar in the bar plane.

14. The clip of claim 1, wherein the first clip bar has a first proximal end and the second clip bar has a second proximal end, and wherein the clip further comprises a transfer device removably connected to the first proximal end and the second proximal end and configured to independently move the first clip bar and the second clip bar in the bar plane.

15. The clip of claim 1, wherein:

the first clamping bar has a first proximal end with a first proximal end opening;

The second clamping bar has a second proximal end having a second proximal end opening; and is

The clip further includes a transfer device removably connected to the first proximal end and the second proximal end through the first proximal opening and the second proximal opening, and configured to move the first clip bar and the second clip bar in the bar plane.

16. The clip of claim 1, wherein:

the first clamping bar has a first proximal end with a first proximal end opening;

the second clamping bar has a second proximal end having a second proximal end opening; and is

The clip further includes a transfer device removably connected to only the first proximal end and the second proximal end through the first proximal opening and the second proximal opening, and configured to move the first clip bar and the second clip bar in the bar plane.

Technical Field

The present systems, devices and methods generally belong to the field of surgical methods to externally occlude fluid passageways of hollow tissue structures. In particular, the present disclosure relates to devices, systems, and methods that externally clamp the Left Atrial Appendage (LAA) of the heart to separate the LAA from the left atrium of the heart to effectively occlude a fluid passageway between the LAA and the left atrium.

Disclosure of Invention

Currently, the most common type of arrhythmia in the united states is Atrial Fibrillation (AF), which is characterized by chaotic and rapid electrical activity in the upper chamber of the heart. There are many causes and risk factors that lead to the development of atrial fibrillation, including hypertension, acute and chronic rheumatic heart disease, and hyperthyroidism. Due to this abnormal heart rhythm, the contraction of the atrial fibers is asynchronous (uncoordinated or inconsistent) such that atrial pumping may cease completely. Thus, one of the most dangerous situations occurring during atrial fibrillation is the interruption or cessation of blood flow in the atria, which may lead to thrombus (blood clots) formation, placing the patient at high risk of heart attack or embolic stroke. Due to the anatomical location and physiological properties of the LAA, blood clots caused by atrial fibrillation are mostly from the LAA. The LAA is a pedicled finger pocket connected to the left atrial sidewall between the mitral valve and the root of the left pulmonary vein. Thus, LAA is the primary site of unwanted pooling and accumulation of extravasated blood when the heart is not contracting at a normal and coordinated rate to force blood into the ventricles. Thus, blood clots may easily form and accumulate in the LAA, grow on their own basis, and diffuse out of the LAA and into the atria. Thus, since LAAs are prone to thrombosis, inhibiting or eliminating blood clots formed in the LAAs of patients with atrial fibrillation will greatly reduce the incidence of stroke in those patients.

Drug therapies such as blood thinners, anticoagulants, and antiplatelet drugs are known and are commonly used to reduce the risk of blood clot formation. However, these drugs are often associated with harmful and painful side effects and complications, including massive bleeding, headache, dizziness, fatigue, and contraindications, making it difficult for patients to comply and tolerate. Therefore, there is a great interest in developing alternatives that improve the efficacy, limit any risks and chronic side effects and improve the quality of life of patients.

Thus, another method of reducing or completely eliminating blood clot formation in the LAA is to effectively close or substantially restrict blood flow between the LAA and the left atrium by transthoracic, thoracotomy, thoracoscopy, or percutaneous surgical intervention. The exact role of LAA as part of the cardiovascular system is not fully understood. It is believed that LAA may be suitable for use as a kind of decompression chamber during left ventricular systole and during other periods when left atrial pressure is high. However, the LAA does not seem to perform the necessary functions and is physiologically considered to be of no importance for the anatomy and function of the heart. Thus, complete removal (i.e., removal) of the LAA from the heart or fluid communication with the LAA by surgical resection is a promising and viable method of drastically reducing the risk of clot formation in the LAA.

Each of the existing surgical methods has its associated benefits and disadvantages. For example, complete removal of LAA eliminates all the risks of future clot formation therein. However, there is still a risk of transferring and releasing an already existing blood clot into the blood during surgery. In addition, removal of the LAA can cause a large wound on the heart, which must be carefully controlled, skillfully clamped, and sutured with absolute precision to avoid significant bleeding. In addition, the removal of LAA is clearly a major anatomical change and therefore care should be taken, as the hemodynamic and hormonal effects of LAA are still the subject of ongoing research and understanding.

Other surgical methods aim to seal, occlude or occlude the fluid passageway between the LAA and the left atrium without removing any anatomical structures. For example, the surgeon may effectively close the passage by surgically suturing or stapling the LAA (e.g., via direct intra-atrial suturing or external ligation), such that the LAA is simply a blind pocket that separates from the left atrium. In another example, a percutaneous delivery device (such as a vascular catheter) may be used to implant the biocompatible barrier device from within the left atrium at the access site of the LAA and anchor it within the passageway. An example of such a device is WATCHMAN sold by Boston scientific Corporation ^TMLeft atrial appendage occluder. Although some of these procedures can be performed using minimally invasive techniques (e.g., thoracotomy, thoracoscopy), there is still a considerable risk because the heart tissue is punctured or the interior of the heart is invaded. Furthermore, theseThe effectiveness of the procedure depends on the precise placement of the staples, sutures, implants or other occluding devices, thus requiring the surgeon's super-precision. In addition, any foreign device left in the chamber of the heart may become a site for thrombus formation in the future, as some biocompatible materials eventually break down and/or promote clot formation. Therefore, there is an urgent need to develop different surgical methods for occluding or isolating the LAA that do not require actual destruction of the heart tissue.

One example of such a procedure is the permanent surgical application of a separate clip to the exterior surface of the LAA. Specifically, a separate clamp is placed around the base of the LAA, applying sufficient tightening or clamping pressure to effectively close the internal fluid passageway between the LAA and the atrium without ever penetrating the heart. Thus, the likelihood of uncontrolled bleeding or other trauma to the heart is greatly reduced. Also, because no elements are introduced into the cardiovascular system to separate the clip, the risk of inadvertently creating a site that promotes clot formation in the future is minimal. Still, there are several inherent limitations in existing breakaway clip designs and the systems, procedures and delivery devices currently used to apply breakaway clips.

In view of background considerations, current detachment clips for isolating LAAs typically consist of a pair of elongated, opposing clamping members urged together by one or more spring members. Prior to applying the detachment clamp to the LAA, the delivery device engages the detachment clamp and applies a force against the spring-biased closing force of the spring member to separate the clamping members from one another and form an interior space therebetween. During application, the LAA is positioned within the interior space of the split clamp to be received between the opposing clamping members. Once the surgeon determines that the detachment clip is at the desired location relative to the LAA, the delivery device of the clip releases the reaction force applied to the spring member and disengages from the detachment clip. As a result, the clamping members return to their inwardly spring-biased state, tightly surrounding the LAA in a gripping manner and creating a clamping action against the outer surface of the LAA. One example of such a device is sold by the Atricure corporation

A left atrial appendage separation system.

Currently, separation clamps are designed to be either open or closed loop. A closed loop type separating clip typically consists of a pair of parallel, opposed clamping members connected at their two ends by a spring member to form a loop. In contrast, open-disconnect clips include a pair of opposed clamping members connected to one another at only one end by a spring or spring-biased hinged member that urges the clamping members to pivot toward one another to produce the necessary clamping action.

Accordingly, to ensure the effectiveness and safety of the split-clip method to isolate the LAA, the split clip must be accurately positioned with sufficient pressure relative to the LAA and other parts of the heart to adequately and permanently occlude blood flow into and out of the LAA without severing or otherwise damaging the LAA or any other surrounding tissue. Thus, the surgeon must be skilled in controlling the placement of the separate clips and in determining that the clips are sufficiently closed and secured in place, which is a significant achievement. Once the detachment clip is in place on the LAA, the inserted tissue may dry out or otherwise contract and change, requiring a different, greater clamping force to maintain the LAA in a proper seal.

Another limitation of existing split clamp designs, particularly closed loop designs, is that the distance of the internal opening between the opposing clamping members is limited by the spring biasing force exerted by the spring member, which depends on the extent to which the spring member is able to flex. Thus, when the LAA of the patient is relatively large, the surgeon may have difficulty applying the detachment clip.

Open LAA separation clips are sometimes preferred over closed clips because they only require lateral access to the LAA and, therefore, can be positioned in less invasive procedures when access to the heart is restricted. One drawback of open clips, however, is that it is often difficult for the surgeon to determine when the clip has been fully positioned across the entire width of the LAA. The distal end of the LAA is generally not visible to the surgeon due to the use of a lateral approach to placing the clip. This requires the surgeon to estimate the distal position of the clip and release the clip when the surgeon believes the clip has spanned the entire LAA. If the surgeon's estimates are inaccurate and the open clamp is positioned only partially across the LAA when released into the clamped configuration, the LAA only achieves partial separation. Such embodiments would likely lead to complications requiring further surgery to correct the partial separation.

Accordingly, there is a need in the art for an applicator device for an open LAA detachment clip that provides a positive indication to the surgeon that the clip has been positioned completely across the LAA before it is released into the clamped implant configuration.

Furthermore, as described above, the LAA must be properly oriented and held in a stable position in order for the LAA to enter the interior space of the separation clip during application of the separation clip. Thus, instruments separate from the clip delivery device (such as a surgical grasper) are typically used to manipulate the LAA into position. In fact, in the occlusion, detachment and occlusion procedures of the LAA, it is necessary to use a separate instrument specifically for orienting the LAA into the correct position. Thus, during a split clip procedure, the surgeon must simultaneously operate the clip delivery device and the stabilization instrument (or directly stabilize the heart) to occupy both hands of the surgeon. This limits the surgeon's movement and freedom, and may also lead to fatigue. Importantly, if not carefully performed, in simple manipulation of the LAA, only a minor mistake tears or punctures the LAA, which may result in a direct risk of life-threatening major bleeding. Accordingly, there is a need in the art for a detachment clip and transfer device system that simplifies and improves the accuracy of the interaction between the detachment clip and the transfer LAA, and minimizes or eliminates the need for and/or involvement of a separate grasping or jogging device for the LAA.

Furthermore, there is a need in the art for a breakaway clip whose shape, material properties, tolerances, and surface area features can improve the face-to-face interaction between the clamping member of the clip and both the LAA and the left atrium after the clip is in place, and can enhance the gripping force of the breakaway clip around the LAA without causing any damage to the tissue, not only during the surgical procedure, but also throughout the life of the implanted clip.

Accordingly, there is a need to overcome the problems of the prior art systems, designs and processes as discussed above.

The described systems, devices and methods provide devices, systems and methods for gripping the outer surface of the left atrial appendage to fluidly separate the interior of the LAA from the left atrium, which overcome the above-described disadvantages of known devices and methods of this general type. More specifically, the described systems, devices and methods provide an LAA detachment clamp that is structurally characterized by: during surgical application of the detached clip, which acts on itself in this manner, and in some cases, in cooperation with the method of application, according to physical principles, naturally and instinctively motivates, encourages, and/or propels the LAA into the opening inside the clip, these features being referred to herein as "self-motivation. Such self-energizing detachment clips advantageously minimizes or eliminates the need for a stabilizing instrument for manipulating the LAA relative to the detachment clip that is independent of the clip delivery apparatus, thereby resulting in a one-handed and non-contact procedure.

The described systems, devices, and methods further provide a closed loop breakaway clip that provides the surgeon with greater precision and control over the degree of applied clamping pressure, and is free of the traditional limitations that result from the use of spring members to connect the terminal ends of opposing clamping members of the clip.

The described systems, devices, and methods further provide a tissue intersection sensor for a jaw-based surgical instrument that provides a surgeon with greater precision and control over the placement of the distal ends of the jaws when they are occluded or blocked by the surgical environment. The sensors of the surgical instrument facilitate placement and deployment of a separation device, such as an LAA separation clip. The split clip applier and system generates a positive visual and/or audible indication when the clip is placed completely across the anatomy to be occluded prior to releasing the clip into its clamped configuration.

In one embodiment, a delivery device includes a shaft having a proximal end and a distal end, a handle housing one or more controls connected to the proximal end of the shaft, and an applicator head connected to the distal end of the shaft. The applicator head includes two opposed jaws adapted to receive open separation clips. The jaws are pivoted between a closed position and an open position by a pivot assembly at or near the proximal end of the applicator head attached to the shaft. The pivoting action of the jaws is controlled by one or more controls on the handle. There is one retaining member or cup-shaped member at the tip of each jaw. The cup-shaped members are adapted to contact or come into close proximity with each other when the jaws are closed. When in the closed position, the jaws are configured to allow sufficient space to install a breakaway clip therebetween. To enable the jaws to closely conform to the clip, and to enable the cup-shaped members to closely approximate when the jaws are closed, a middle portion of each jaw may contain a flexible spring-like member.

In a "passive" embodiment of the transmission device, the applicator head is equipped with two different types of fiber optic lines. The first type is a "collector-type" fiber optic line. This type of fiber optic line is designed to collect ambient light illuminating the line along the entire length of the line and direct the light away through both ends of the line. The second type of fiber optic line used in the passive embodiments is a transmitter type fiber optic line. This type of fiber optic line is designed to collect light at one end thereof and transmit it so that it is output at the opposite end.

In a passive embodiment of the transfer device, a first of the opposing jaws of the applicator head is equipped with a length of collector-type fiber optic line arranged such that during use of the device as much of the length of line as possible is exposed to ambient light. This positioning may be achieved by wrapping or winding the wire around the jaws or by gluing or otherwise attaching the wire to the surface of the jaws. One or both ends of the collector wire are received or captured by a cup-shaped member disposed at the tip of the first jaw. The cup is configured such that the captured end of the collector wire is positioned directly facing the cup member of the second opposing jaw. The collector wire functions to capture as much ambient light as possible and direct it to exit at the tip of the first opposing jaw and be directed toward the second opposing jaw.

The second opposing jaw in the passive embodiment is fitted with a transmitter-type fiber optic line. One end of the wire is retained by a cup-shaped member on the second opposing jaw. This end of the transmitter profile is positioned so that it is in close proximity to one end of the collector profile in the first opposed jaw when the opposed jaws are in the closed position. The other end of the conveyor line travels along the second opposing jaw to a position where it can be retained but still be visible to the user of the apparatus. To enhance the visibility of the light emitted by the other end of this line, a lens, prism or other light enhancing device may be provided at the termination point. Alternatively, the other end of the transmitter profile may terminate at an electronic light sensor (such as a photocell, phototransistor, or photodiode) that triggers an electronic audible or visual indicator, such as an LED or horn, when light is sensed.

The second "active" exemplary embodiment of the transfer apparatus employs only transmission-type fiber optic lines on two opposing jaws. The wire in the first opposing jaw extends between the cup-shaped member at the tip and a source of light, such as an LED, laser, or infrared emitter. The configuration of the wires in the second opposing jaw is the same as in the passive embodiment. This exemplary embodiment does not rely on ambient light collected by the line on the first jaw, but on actively generated light. The active embodiments may alternatively include other variations and modifications. For example, light of the type generated and transmitted by the fiber optic line may have a frequency or color selected to maximize transmission through bodily fluids (such as blood) to ensure proper indication in the event that blood contaminates the end of the fiber optic line. The frequency of the light may be selected such that its wavelength is different from the wavelength generated by conventional light sources used in thoracoscopy procedures, thereby avoiding false positive indications. Furthermore, the generated light may be encoded by a known pulse frequency to ensure that the light received at the second opposing jaw is indeed generated light and not ambient light. Such exemplary configurations use electronic sensors that avoid false indications by only triggering an indication when the light received at the sensor is at the desired pulse frequency.

The applicator device may be used with open breakaway clips having a variety of different designs, whether known in the art or indicated herein. A breakaway clip is placed between two opposing jaws with the open end of the clip distally in the direction of the tip of the jaws. Each of the parallel clamping members of the split clamp is releasably secured to the jaw immediately adjacent thereto. In this manner, the separating clip is forced open when a control on the handle of the device is actuated to separate the opposing jaws. When the control is actuated to allow the opposing jaws to close, the spring in the split clip urges the jaws to close around the clip as it closes.

The breakaway clip can be releasably secured to the jaws in a number of different ways. One exemplary embodiment uses a suture extending from the clamping member on the clip and wrapped around a release cable disposed on each of the opposing jaws. When the operator believes the clip is properly positioned, the release cable is pulled out and removed from the applicator head, thereby releasing the breakaway clip from the device. Once the release cable is pulled out, the clip is permanently applied. In alternative exemplary embodiments, the fiber optic line may serve the same function as the release cable. That is, the suture is wrapped around the fiber optic wire and when the clip is properly positioned, the fiber optic wire is pulled out, thereby releasing the clip.

In operation, whether an active or passive device is used, the surgeon begins to apply the clip by actuating the appropriate controls on the handle to open the jaws and clip. The open end of the clip is then positioned across the LAA using a side approach. When the surgeon deems the clip to have been inserted sufficiently to fully straddle the LAA when closed, the handle controls are actuated to allow the clip to close, thereby clamping the LAA. If the surgeon correctly estimates the insertion distance of the clip, the tips of the opposing jaws will be very close to each other and no structure (such as a LAA) will be present therebetween. Such an orientation allows light generated at a first opposing jaw to be collected by a fiber optic cable in a second opposing jaw and trigger an audible or visual indicator at the other end of the wire in the second jaw. Upon receipt of such feedback, the surgeon is informed that sufficient placement may have been achieved and can release the clip from the applicator head, thereby permanently applying the clip across the LAA. On the other hand, if the surgeon does not receive a visual or audible indication while releasing the handle control and closing the clip and jaws around the LAA, the surgeon will be alerted that something (perhaps the LAA or other structure) is blocking light from reaching the second opposing jaw. The surgeon may then reopen the clip and attempt to properly position the clip until an audible or visual indication is received.

Although the exemplary embodiments described above rely on light being transmitted from a fiber optic network, those skilled in the art will appreciate that similar embodiments may be implemented using media other than light. For example, radio frequency waves, hall effect sensors, ultrasonic waves, conductive sensors, capacitive sensors, and the like may be used as alternative sensing measures.

The systems, devices, and methods described herein are also not limited to applicators or separation devices. Any device in which the jaw assembly must clear the structure before being actuated can benefit from the disclosed sensor. Such devices include, but are not limited to, stapling devices, graspers or clamping devices, electrocautery or ultrasonic sealers, and the like. In alternative exemplary embodiments, the fiber optic network need not be exclusively disposed on the opposing jaws. The fiber optic network may be fully or partially embedded in the clip itself. In such exemplary embodiments, the fiber optic network may be adapted to be easily detached from the clip for removal when the applicator device is retracted.

Although the end of the fiber optic line is aligned with the end of the fastener and lies in a plane above the fastener in the embodiment of the invention shown in the drawings, in alternative exemplary embodiments the fiber optic line end may be aligned inwardly, or extend beyond the end of the fastener. Similarly, in alternative embodiments, the ends of the fiber optic strands may be located above, below, or through the middle of the fastener. Any combination of these relative orientations may also be used.

In some exemplary embodiments, the retaining member, which is a cup-shaped member, may have structural features that guide their alignment when the jaws are closed. The flexible members in the jaws allow the cup-shaped members to contact each other, or come into close proximity to each other, even when the tissue clamped in the fastener partially opens the fastener.

As discussed above, the indicator light may be located at any location where it is visible to an operator of the device. This includes, but is not limited to, handles, jaws, shafts, or combinations thereof in which multiple indicators are used. The indicator itself may be visible (such as a light), audible (such as a horn or buzzer), or tactile.

Some exemplary embodiments of the described systems, devices, and methods may be equipped with a locking mechanism that prevents release of the fastener until a positive indication of proper placement is received.

In some exemplary embodiments, the end of the fiber optic line may include a feature, such as a cup or dome, to exclude fluids when the features are in contact with each other.

The limitations of known devices are overcome using an exemplary applicator for open separation of the clip that provides the surgeon with a positive indication that the distal end of the clip has fully traversed the anatomy to be occluded prior to releasing the clip into its clamped configuration, thereby ensuring complete separation upon clamping.

With the above and other objects in view, there is provided an external Left Atrial Appendage (LAA) detachment clip that includes a clip assembly and a biasing assembly. The clip assembly includes first and second opposing clip levers, each clip lever having a tissue contacting surface and first and second offset surfaces. A biasing assembly connects the first and second clamping bars to align the first and second clamping bars in a bar plane passing through the tissue contacting surface. The biasing assembly includes at least one first biasing spring coupled to the first biasing surface of the first clamping bar and the first biasing surface of the second clamping bar and at least one second biasing spring coupled to the second biasing surface of the first clamping bar and the second biasing surface of the second clamping bar. The at least one first biasing spring and the at least one second biasing spring are configured to allow movement of the first clamping bar and the second clamping bar in the bar plane.

According to another feature, the first clamping bar has a first proximal end and a first distal end and the second clamping bar has a second proximal end and a second distal end. At least one first biasing spring is coupled to the first clamping bar intermediate the first biasing surface between the first proximal end and the first distal end and the second clamping bar intermediate the first biasing surface between the second proximal end and the second distal end. At least one second biasing spring is coupled to the first clamping bar intermediate the second biasing surface between the first proximal end and the first distal end and the second clamping bar intermediate the second biasing surface between the second proximal end and the second distal end.

According to a further feature, the first offset surface of the first clamping bar is a first upper side, the second offset surface of the first clamping bar is a first lower side, the first offset surface of the second clamping bar is a second upper side, and the second offset surface of the second clamping bar is a second lower side. The tissue contacting surface of the first clamping bar comprises a first LAA contacting surface having a first longitudinal centerline and the tissue contacting surface of the second clamping bar comprises a second LAA contacting surface having a second longitudinal centerline. The rod plane passes through the first longitudinal centerline and the second longitudinal centerline.

According to an added feature, the clip is sized to fit a laparoscopic port having an inner diameter, and the clip assembly and the biasing assembly together have a maximum outer width that is no greater than the inner diameter of the port.

According to an additional feature, the first clamping bar and the second clamping bar have a maximum longitudinal length, the at least one first biasing spring has a longitudinal length shorter than the maximum longitudinal length, and the at least one second biasing spring has a longitudinal length shorter than the maximum longitudinal length.

According to still another feature, the clip is sized to fit a laparoscopic port having an inner diameter, and the clip assembly and the biasing assembly together have a maximum outer width that is no greater than the inner diameter of the port. The first and second clamping bars have a maximum longitudinal length, the at least one first biasing spring has a longitudinal length shorter than the maximum longitudinal length, and the at least one second biasing spring has a longitudinal length shorter than the maximum longitudinal length.

According to still further features the biasing assembly is configured to allow rocking of the first clamping bar and the second clamping bar in the bar plane.

According to a further feature, the biasing assembly is configured to allow rocking of the first clamping bar in the bar plane independently of rocking of the second clamping bar in the bar plane.

According to a further feature, the first biasing surface of the first clamping bar is a first upper side, the first biasing surface of the second clamping bar is a second upper side, the first upper side and the second upper side together define an outer upper boundary, and the first biasing spring is retained in the outer upper boundary.

According to yet another feature, the second biasing surface of the first clamping bar is a first lower side, the second biasing surface of the second clamping bar is a second lower side, the first and second lower sides together define an outer lower boundary, and the second biasing spring is retained in the outer lower boundary.

According to still further features the first clamping bar has a first longitudinal axis, the second clamping bar has a second longitudinal axis, and the at least one first biasing spring and the at least one second biasing spring balance forces such that the first clamping bar and the second clamping bar do not substantially rotate about the respective first longitudinal axis and second longitudinal axis when the first bar and the second bar move in the bar plane.

According to a further added feature, the first clamping bar has a first longitudinal axis, the second clamping bar has a second longitudinal axis, and the at least one first biasing spring and the at least one second biasing spring balance the forces such that when the first bar and the second bar move in the bar plane, the first clamping bar and the second clamping bar have substantially no torque.

According to still additional features, the first clamping bar has a first proximal end and the second clamping bar has a second proximal end. The clip further includes a transfer device removably connected to the first proximal end and the second proximal end and configured to move the first clip bar and the second clip bar in the bar plane.

According to still another feature, the first clamping bar has a first proximal end and the second clamping bar has a second proximal end. The clip further includes a transfer device removably connected to the first proximal end and the second proximal end and configured to independently move the first clip bar and the second clip bar in the bar plane.

According to still further features the first clamping bar has a first proximal end with a first proximal opening and the second clamping bar has a second proximal end with a second proximal opening. The clip further includes a transfer device removably connected to the first proximal end and the second proximal end through the first proximal opening and the second proximal opening, and the transfer device is configured to move the first clip bar and the second clip bar in the bar plane.

According to a concomitant feature, the first clamping bar has a first proximal end with a first proximal opening, the second clamping bar has a second proximal end with a second proximal opening. The clip further includes a transfer device removably connected to only the first proximal end and the second proximal end through the first proximal opening and the second proximal opening, and the transfer device is configured to move the first clip bar and the second clip bar in the bar plane.

With the above and other objects in view, there is provided an externally implantable Left Atrial Appendage (LAA) detachment clip comprising a clip assembly and a biasing assembly. The clip assembly includes a first clip bar having a first LAA contacting surface, a first pivot axis, a first end, and a second end opposite the first end, and a second clip bar having a second LAA contacting surface, a second pivot axis substantially parallel to the first pivot axis, a first end, and a second end opposite the first end of the second clip bar. The biasing assembly connects the first clamping bar and the second clamping bar and includes at least one first biasing spring connected to a first end of the first clamping bar and a first end of the second clamping bar and at least one second biasing spring connected to a second end of the first clamping bar and a second end of the second clamping bar, and the connection of the at least one first biasing spring and the at least one second biasing spring is configured to allow rotation of the first clamping bar about the first axis of rotation and rotation of the second clamping bar about the second axis of rotation.

According to another feature, the first LAA contacting surface has a first given roughness and the first clamping bar comprises a first friction reducing surface adjacent the first LAA contacting surface, the first friction reducing surface having a surface roughness that is substantially smoother than the first given roughness. The second LAA contact surface has a second given roughness and the second clamping bar includes a second friction reducing surface adjacent the second LAA contact surface, the second friction reducing surface having a surface roughness that is substantially smoother than the second given roughness.

According to a further feature, the first and second friction reducing surfaces are substantially smooth.

According to an additional feature, the first and second friction reducing surfaces comprise a hydrophilic coating.

According to an additional feature, the first given roughness is a texture.

According to still another feature, the second given roughness is a texture.

According to still further features at least one of the first LAA contacting surface and the second LAA contacting surface has a given roughness and at least one of the first clamping bar and the second clamping bar includes a friction reducing surface adjacent to the at least one of the first LAA contacting surface and the second LAA contacting surface having the given roughness, the friction reducing surface being substantially smooth.

According to a further additional feature, the friction reducing surface comprises a hydrophilic coating.

According to a further feature, the first clamping bar comprises a first power surface adjacent the first LAA contacting surface, the first power surface having a self-activator, and the second clamping bar comprises a second power surface adjacent the second LAA contacting surface, the second power surface having a self-activator.

According to yet another feature, the connection of the at least one first biasing spring and the at least one second biasing spring is configured to allow rotation of the first clamping bar about the first axis of rotation and rotation of the second clamping bar about the second axis of rotation such that the first power face faces the second power face in the first direction and the first LAA contact face faces the second LAA contact face in the second direction.

According to still further features the second direction is at an angle to the first direction.

According to a further added feature, the connection of the at least one first biasing spring and the at least one second biasing spring is configured to allow rotation of the first clamping bar about the first rotational axis and rotation of the second clamping bar about the second rotational axis such that the first LAA contact face is parallel to the second LAA contact face in a first direction and the first LAA contact face is parallel to the second LAA contact face in a second direction at an angle to the first direction.

According to still additional features, the angle is substantially 90 degrees.

According to still another feature, the first LAA contact surface has a given shape and the second LAA contact surface has a shape that mirrors the given shape.

According to a concomitant feature, the first and second clamp bars, the at least one first and second biasing springs defining an opening sized to receive the LAA therein, the biasing assembly configured to bias rotation of the first and second clamp bars to bring the LAA into contact with the first and second LAA contact surfaces on opposite sides thereof with an inwardly-directed force sufficient to substantially exclude blood flow from the interior of the LAA.

Although the systems, devices, and methods are shown and described herein as embodied in devices, systems, and methods that clamp around the exterior surface of the LAA to effectively occlude the interior of the LAA and the left atrium, it is not intended to be limited to the details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. Additionally, well-known elements of the example embodiments will not be described in detail or will be omitted so as not to obscure the relevant details of the systems, apparatuses and methods.

Additional advantages and other features of the systems, apparatus and methods will be set forth in the detailed description which follows, and in part will be obvious from the detailed description, or may be learned by practice of the exemplary embodiments. Still other advantages of the systems, apparatus and methods may be realized by means of the instrumentalities, methods or combinations particularly pointed out in the claims.

Other features which are considered as characteristic of the systems, devices and methods are set forth in the appended claims. As required, detailed embodiments of systems, devices, and methods are disclosed herein. However, it is to be understood that the disclosed embodiments are merely exemplary of systems, apparatuses, and methods that may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the systems, apparatus, and methods in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting but rather to provide an understandable description of the system, device, and method. While the specification concludes with claims defining the systems, apparatus, and methods of the present invention that are regarded as novel, it is believed that the systems, apparatus, and methods will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward.

Drawings

The accompanying figures, in which like reference numerals refer to identical or functionally-similar elements throughout the separate views and which are not necessarily to scale, are incorporated in and form a part of the specification, together with the detailed description below, to illustrate further various embodiments and to explain various principles and advantages all in accordance with the systems, apparatuses, and methods. Advantages of embodiments of the systems, devices, and methods will become apparent from the following detailed description of exemplary embodiments of the systems, devices, and methods, which description should be considered in conjunction with the accompanying drawings, in which:

Fig. 1 is a perspective view of an exemplary embodiment of a left atrial appendage surgical implant clip in an extended, open orientation;

FIG. 2 is an enlarged elevational view of the distal end of the clip of FIG. 1;

FIG. 3 is a top view of the clip of FIG. 1;

FIG. 4 is a side elevational view of the clip of FIG. 1;

FIG. 5 is a perspective view of the clip of FIG. 1 in a neutral contracted pre-implant orientation;

FIG. 6 is an enlarged elevational view of the distal end of the clip of FIG. 5;

FIG. 7 is a top view of the clip of FIG. 5;

FIG. 8 is a perspective view of the clip of FIG. 1 in a mid-collapsed and partially rotated pre-implantation orientation;

FIG. 9 is a perspective view of the clip of FIG. 1 in a contracted and fully rotated implantation orientation;

FIG. 10 is an enlarged elevational view of the distal end of the clip of FIG. 9;

FIG. 11 is a side elevational view of the clip of FIG. 9;

FIG. 12 is a top view of the clip of FIG. 9;

FIG. 13 is a partial top view of another exemplary embodiment of a left atrial appendage surgical implant clip mounted in an extended, open orientation on a distal end of a portion of an implant control assembly of a control handle;

FIG. 14 is an enlarged, right side elevational view of a portion of the clip and control assembly of FIG. 13;

FIG. 15 is a partial perspective view of the clip and control assembly of FIG. 13;

FIG. 16 is an enlarged, partial, horizontal cross-sectional view of the clamp and control assembly of FIG. 13;

FIG. 17 is a partial perspective view of a portion of the rod biasing subassembly and a portion of the control assembly of FIG. 13;

FIG. 18 is a distal end elevational view of the clip and control assembly of FIG. 13;

FIG. 19 is an enlarged, fragmentary perspective view of a portion of the clip and control assembly of FIG. 13 with the clip lever in a retracted, partially rotated pre-implantation orientation;

FIG. 20 is a partial top plan view of the clip and control assembly of FIG. 13 with the clip lever in a retracted-intermediate, non-rotated pre-implantation orientation;

FIG. 21 is a partial perspective view of the clip and control assembly of FIG. 20;

FIG. 22 is an enlarged, right side elevational view of a portion of the clip and control assembly of FIG. 20;

FIG. 23 is a partial perspective view of the clip and control assembly of FIG. 19 with the clip lever in a retracted-intermediate and partially rotated pre-implantation orientation;

FIG. 24 is an enlarged, partial right side elevational view of the clip and control assembly of FIG. 13 with the clip lever in a retracted, fully rotated implantation orientation;

FIG. 25 is a partial top view of the clip and control assembly of FIG. 24;

FIG. 26 is a partial distal elevational view of the clip and control assembly of FIG. 24;

FIG. 27 is a partial perspective view of the clip and control assembly of FIG. 24;

FIG. 28 is a partial horizontal cross-sectional view of the clip and control assembly of FIG. 24;

FIG. 29 is an enlarged elevational view of the distal end of the clip of FIG. 5 with the web;

FIG. 30 is an enlarged elevational view of the distal end of the clip of FIG. 5 with the web portion;

FIG. 31 is an enlarged, fragmentary diagrammatic sectional view of a further exemplary embodiment of a left atrial appendage surgical implant clip;

figure 32 is a perspective view of yet another exemplary embodiment of a left atrial appendage surgical implant clip in a retracted and rotated orientation;

FIG. 33 is an enlarged elevational view of the distal end of the clip of FIG. 32;

FIG. 34 is a side elevational view of the clip of FIG. 32;

FIG. 35 is a top view of the clip of FIG. 32;

FIG. 36 is an enlarged partial perspective view of the distal end of the clip of FIG. 32;

FIG. 37 is a bottom view of the clip of FIG. 32;

FIG. 38 is a perspective and partial longitudinal cross-sectional view of the clip of FIG. 32;

FIG. 39 is a perspective view of a biasing member of the clip of FIG. 32;

FIG. 40 is an enlarged partial perspective and partial longitudinal cross-sectional view of the distal end of the clip of FIG. 32;

FIG. 41 is an enlarged partial perspective and partial longitudinal cross-sectional view of the distal end of the clip of FIG. 32;

FIG. 42 is a partial top view of the clip of FIG. 32 positioned in an exemplary embodiment of a clip application head of the clip delivery apparatus;

FIG. 43 is a perspective view of yet another exemplary embodiment of a left atrial appendage surgical implant clip in a retracted and rotated orientation;

FIG. 44 is a perspective view of a biasing member of the clip of FIG. 43;

FIG. 45 is a perspective and partial longitudinal cross-sectional view of the clip of FIG. 43 having tissue in contact with an exemplary embodiment of the surface roughening;

FIG. 46 is a perspective and partial longitudinal cross-sectional view of the clip of FIG. 43 having tissue in contact with another exemplary embodiment of the surface roughening;

FIG. 47 is an enlarged partial perspective view of a portion of the clip of FIG. 46;

FIG. 48 is a partial perspective view of an exemplary embodiment of a two-part mold for making a spring member portion of the biasing member of the clip of FIG. 43;

FIG. 49 is a partial hidden line perspective view of the mold of FIG. 49;

FIG. 50 is a partial perspective view of a portion of the mold and spring member portion of FIG. 48;

FIG. 51 is a partial hidden line perspective view of the mold portion and spring member portion of FIG. 50;

FIG. 52 is a partial pictorial illustration of a human heart having a left atrial appendage;

figure 53 is a top or bottom view of an exemplary embodiment of another left atrial appendage surgical implant clip in a closed orientation;

FIG. 54 is a side elevational view of the clip of FIG. 53;

FIG. 55 is a perspective view of the clip of FIG. 53;

FIG. 56 is an enlarged open end elevational view of the clip of FIG. 53;

FIG. 57 is a top or bottom view of the clip of FIG. 53 in an intermediate expanded orientation with an exploded partial illustration of the clip contacting end of the exemplary embodiment of the clip transporting apparatus;

FIG. 58 is a side elevational view of the clip of FIG. 57;

FIG. 59 is a perspective view of the clip of FIG. 57;

FIG. 60 is an enlarged open end elevational view of the clip of FIG. 57;

FIG. 61 is a top or bottom view of the clip of FIG. 53 in an expanded orientation;

FIG. 62 is a side elevational view of the clip of FIG. 61;

FIG. 63 is a perspective view of the clip of FIG. 61;

FIG. 64 is an enlarged open end elevational view of the clip of FIG. 61;

FIG. 65 is a top or bottom view of the clip of FIG. 53 mounted on a fragment of an exemplary embodiment of a clip transport apparatus with the clip and transport apparatus in a closing orientation;

FIG. 66 is a top or bottom view of the clip and clip delivery apparatus of FIG. 65 in a first expanded orientation;

FIG. 67 is a top or bottom view of the clip and clip transfer apparatus of FIG. 65 in a second expanded orientation;

FIG. 68 is a top or bottom view of the clip and clip delivery apparatus of FIG. 65 in a third expanded orientation;

FIG. 69 is a top or bottom view of the exemplary embodiment of the clip of FIG. 53 in a proximal side opening direction;

FIG. 70 is a side elevational view of the clip of FIG. 69;

FIG. 71 is a perspective view of the clip of FIG. 69;

FIG. 72 is an enlarged open end elevational view of the clip of FIG. 69;

FIG. 73 is a top or bottom view of the clip of FIG. 53 in a distal open medial expansion direction with an exploded partial illustration of the clip contacting end of the clip delivery device of FIG. 57 in the distal open medial expansion direction;

FIG. 74 is a side elevational view of the clip of FIG. 73;

FIG. 75 is a perspective view of the clip of FIG. 73;

FIG. 76 is an enlarged open end elevational view of the clip of FIG. 73;

FIG. 77 is an enlarged open end elevational view of the clip of FIG. 60 with a diagrammatic representation of an exemplary embodiment of a clip cover;

FIG. 78 is a top view of the clip of FIG. 53 in a medial expansion direction with the distal side open with an exemplary embodiment of a clip lever cover;

FIG. 79 is a side elevational view of the clip and cover of FIG. 78;

FIG. 80 is a perspective view of the clip and cover of FIG. 78;

FIG. 81 is an open end elevational view of the clip and cover of FIG. 78;

FIG. 82 is a partial enlarged portion of the clip and cover of FIG. 80;

FIG. 83 is a partial perspective view of the distal end of an exemplary embodiment of a visual marker in an extended direction;

FIG. 84 is a perspective view of the indicia of FIG. 84 in the direction of articulation;

FIG. 85 is a perspective view of an exemplary embodiment of a visual marking device;

fig. 86 is a side elevational view of an exemplary embodiment of a delivery apparatus for opening and closing a clip engaging end that is removably attached to a left atrial appendage surgical implant clip in a fully closed clip orientation;

FIG. 87 is a side elevational view of the delivery device of FIG. 86 in a distal clip closing direction;

FIG. 88 is a side elevational view of the transfer device of FIG. 86 in a direction parallel to the opening of the center clip;

FIG. 89 is a side elevational view of the delivery device of FIG. 86 in the direction of distal extension of the open clip;

FIG. 90 is a diagrammatic illustration of a mechanism for opening and closing the clip engaging ends of an exemplary embodiment of the transfer device;

fig. 91 is a partial perspective view of an exemplary embodiment of the distal end of the delivery device for opening and closing the clip contacting end, wherein the clip contacting end is removably attached to the left atrial appendage surgical implant clip in a fully open clip orientation, a portion of the shaft is removed, the pivot pin is removed, and the biasing device of the clip is removed;

FIG. 92 is an enlarged partial perspective and horizontal cross-sectional view of the clevis portion of the transfer device and clip of FIG. 91 with the locking wire removed;

FIG. 93 is a partial perspective view of the conveyor and clip of FIG. 91 with the upper portion of the clevis and shaft removed in a fully closed orientation of the clip;

FIG. 94 is a partial side elevational view of the transfer device and clip of FIG. 93;

FIG. 95 is a partial top view of the transfer device and clip of FIG. 93;

FIG. 96 is a partial perspective view of the conveyor and clip of FIG. 91 with the upper portion of the clevis and shaft removed in a distal clip closing direction;

FIG. 97 is a partial side elevational view of the transfer device and clip of FIG. 96;

FIG. 98 is a partial top view of the transfer device and clip of FIG. 96;

FIG. 99 is a partial perspective view of the conveyor and clip of FIG. 91 with the upper clevis half and shaft removed in a fully open clip direction;

FIG. 100 is a partial side elevational view of the transfer device and clip of FIG. 99;

FIG. 101 is a partial top view of the transfer device and clip of FIG. 99;

FIG. 102 is a partial perspective view of the delivery device and clip of FIG. 99 with the upper jaw removed in a fully open direction of the clip;

FIG. 103 is a partial top view of the transfer device and clip of FIG. 102;

FIG. 104 is a perspective view of the clip of FIG. 91 in a fully closed orientation;

FIG. 105 is a side elevational view of the clip of FIG. 104;

FIG. 106 is a top view of the clip of FIG. 104;

FIG. 107 is an enlarged partial perspective view of the clip of FIG. 104;

FIG. 108 is a side elevational view of the clip of FIG. 104 with an exemplary embodiment of a convertible band;

FIG. 109 is a perspective view of the clip of FIG. 108 in a fully open orientation with the switchable band extending between the levers;

FIG. 110 is a distal end elevational view of the clip of FIG. 109;

FIG. 111 is a top view of the clip of FIG. 109;

FIG. 112 is a perspective distal end side view of an exemplary embodiment of an end effector jaw with a closure sensor for mounting a tissue occlusion clip having jaws in an opening direction with the sensor in a jaw open sensing state and the clip loaded within the jaws in the opening direction with the clevis, shaft and handle not shown;

FIG. 113 is a perspective view of the end effector jaws and clip of FIG. 112, viewed from the distal end;

FIG. 114 is a perspective view of the end effector jaws and clip of FIG. 112 from the proximal side;

FIG. 115 is a distal end elevational view of the end effector jaws and clip of FIG. 112;

FIG. 116 is a top view of the end effector jaws and clip of FIG. 112;

FIG. 117 is a bottom view of the end effector jaws and clip of FIG. 112;

FIG. 118 is a perspective view of the end effector jaws and clip of FIG. 112 from the proximal side, with the jaws in a closing orientation, the clip in a tissue occluding condition, and the sensor in a jaw closure sensing condition;

FIG. 119 is a perspective view of the end effector jaws and clip of FIG. 118, viewed from the distal side;

FIG. 120 is a right side elevational view of the end effector jaw and clip of FIG. 118;

FIG. 121 is a top view of the end effector jaws and clip of FIG. 118;

FIG. 122 is a bottom view of the end effector jaws and clips of FIG. 118;

FIG. 123 is a perspective view of the end effector jaws and clip of FIG. 118, viewed from above the distal end;

FIG. 124 is an enlarged, partial, bottom view of the distal end portion of the end effector jaw and clip of FIG. 118;

FIG. 125 is a partial perspective view of an exemplary embodiment of an end effector having a shaft, a clevis and jaws, the jaws having a closed end sensor for mounting a tissue occlusion clip, wherein the jaws are in an open orientation, the sensor is in a jaw open sensing state, the clip has a protective fabric sleeve loaded within the jaws in the open orientation, the clevis is hinged at a hinge point at a distal end of the shaft, and a handle is not shown;

FIG. 126 is a perspective view of the end effector, clip, clevis and shaft of FIG. 125 from above the distal end;

FIG. 127 is a bottom perspective view of the end effector, clip and clevis of FIG. 125 with the jaws in a closed orientation, the clip in a tissue occluding condition, and the sensor in a jaw closed sensing condition; and is

FIG. 128 is a top perspective view of the end effector, clip, clevis and shaft of FIG. 125 from the top left.

Detailed Description

As required, detailed embodiments of systems, devices, and methods are disclosed herein. However, it is to be understood that the disclosed embodiments are merely exemplary of systems, apparatuses, and methods that may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the systems, apparatus, and methods in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting but rather to provide an understandable description of the system, device, and method. While the specification concludes with claims defining the features of the systems, devices, and methods that are regarded as novel, it is believed that the systems, devices, and methods will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward.

In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration embodiments which may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of embodiments is defined by the appended claims and their equivalents.

Alternate embodiments may be devised without departing from the spirit or scope of the invention. Additionally, well-known elements of the exemplary embodiments of the systems, devices and methods will not be described in detail or will be omitted so as not to obscure the relevant details of the systems, devices and methods.

Before the systems, devices, and methods are disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element prefaced by the word "comprising … …" does not exclude the presence of other similar elements in a process, method, article, or apparatus comprising the element. The terms including and/or having, as used herein, are defined as comprising (i.e., open language). The terms "a" or "an," as used herein, are defined as one or more than one. The term "plurality", as used herein, is defined as two or more than two. The term another, as used herein, is defined as at least a second or more. The description may use the term "embodiment" to refer to one or more of the same or different embodiments.

The terms "coupled" and "connected," along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Rather, in particular embodiments, "connected" may be used to indicate that two or more elements are in direct physical or electrical contact with each other. "coupled" may mean that two or more elements are in direct physical or electrical contact (e.g., directly coupled). However, "coupled" may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other (e.g., indirectly coupled).

For the purposes of this description, a phrase in the form "A/B" or "A and/or B" or "at least one of A and B" means (A), (B), or (A and B), where A and B are variables that indicate a particular object or property. The phrase, when used, is intended to and is defined herein as a selection of a or B, or both a and B, similar to the phrase "and/or". Where more than two variables are present in such phrases, the phrase is defined herein to include only one of the variables, any combination of any variables, and all of these variables, e.g., "at least one of A, B and C" means (a), (B), (C), (a and B), (a and C), (B and C), or (A, B and C).

Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any substantial such relationship or order between such entities or actions. The description may use perspective-based descriptions such as up/down, back/front, top/bottom, and proximal/distal. Such descriptions are merely used to facilitate the discussion and are not intended to limit the application of the disclosed embodiments. Various operations may be described as multiple discrete operations in turn, in a manner that is helpful in understanding the embodiments, however, the order of description should not be construed as to imply that these operations are order dependent.

As used herein, the terms "about" or "approximately" apply to all numerical values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In various instances, these terms may include numbers that are rounded to the nearest significant figure. As used herein, the term "substantially" means that when the various portions are compared to each other, the portions being compared are dimensionally equal or very close together, such that one skilled in the art would recognize the same. As used herein, is not limited to a single dimension in general, and specifically includes a range of values of the compared portion. Ranges of values, including both above and below (e.g., "+/-" or above/below), include variations that are reasonable tolerances for the components as would be known to a person skilled in the art.

It will be appreciated that embodiments of the systems, apparatus, and methods described herein may be comprised of one or more conventional processors and unique stored program instructions that control the one or more processors to implement, in conjunction with certain non-processor circuits and other elements, some, most, or all of the functions of the devices, systems, and methods described herein. The non-processor circuits may include, but are not limited to, signal drivers, clock circuits, power source circuits, and user input and output elements. Alternatively, some or all functions could be implemented by a state machine that has no stored program instructions, or in one or more Application Specific Integrated Circuits (ASICs) or Field Programmable Gate Arrays (FPGAs), in which each function or some combinations of certain of the functions are implemented as custom logic. Of course, combinations of these methods may also be used. Thus, methods and means for these functions have been described herein.

As used herein, the terms "program," "software application," and the like are defined as a sequence of instructions designed for execution on a computer system or programmable device. A "program," "software," "application," "computer program," or "software application" may include a subroutine, a function, a procedure, an object method, an object implementation, an executable application, a subroutine, a servlet, a source code, an object code, any computer language logic, a shared library/dynamic load library and/or other sequence of instructions designed for execution on a computer system.

Various embodiments of systems, apparatuses, and methods are described herein. In various embodiments, the features are similar. Therefore, in order to avoid redundancy, a repeated description of these similar features will not be given in some cases. It should be understood, however, that the description of the first occurring feature applies to similar features described later, and therefore, each respective description is incorporated herein without being repeated.

Exemplary embodiments are now described. Referring now in detail to the drawings, and first in particular to fig. 1-12, there is depicted a first exemplary embodiment of an externally implantable, spring-biased left atrial appendage detachment clip 100. The breakaway clip 100 includes a clip assembly 102 and a biasing assembly 104. The clip assembly 102 is comprised of two opposing clip bars, referred to herein as a first clip bar 110 and a second clip bar 120. In the present exemplary embodiment, each of the first and second clamping bars 110, 120 is substantially in the form of a hexagonal rectangular column, the details of which will be discussed in further detail below. Also in the exemplary embodiment, first clamping bar 110 and second clamping bar 120 are mirror images of each other. The body of each clamping bar 110, 120 is composed of any suitable biocompatible material, such as titanium, stainless steel, chromium cobalt alloy, nickel titanium alloy, ceramic, polyetheretherketone, liquid crystal polymer, polymethylmethacrylate, and epoxy. In addition, each clip lever body 110, 120 is formed so that there are no sharp edges or corners in the clip 100 that could potentially cause tissue damage in the body. Thus, in exemplary embodiments thereof, each edge and corner of the clamp bar body is rounded, curved or beveled to form a substantially smooth exterior. For the interior of each clamp bar body, it may be formed hollow, partially hollow, or completely solid.

As described above, each of the first and second clamping bars 110 and 120 has six sides. Specifically, each clamping bar 110, 120 includes a first side 112, 122, a second side 114, 124, a third side 116, 126, a fourth side 118, 128, and two opposing ends 119a-b, 129 a-b. To orient the viewer with respect to the relative positions of these enumerated sides, the x-y axes have been used for each of a number of illustrations of embodiments of the breakaway clip of the present invention, and directions (such as inward, outward, upward and downward) are used with respect to these illustrations and are for illustration and explanation purposes only. Focusing first on the configuration of the breakaway clip 100 depicted in fig. 1-4, fig. 1-4 depict the breakaway clip 100 in an expanded state, wherein the diameter of the internal opening of the breakaway clip 100 extends to form a wider or enlarged internal opening 172 (diameter B) in the free-standing state of the clip 100. In this expanded configuration, the first sides 112, 122 of each of the clamping bars 110, 120 face inward (along the x-axis) toward the interior opening 172 such that the first sides 112, 122 are positioned face-to-face and substantially directly opposite one another. The second side 114, 124 of each clip bar 110, 120 is positioned at a substantially 90 degree angle relative to the first side 112, 122 of the respective clip bar 110, 120 and faces in an upward direction along the y-axis. Further, the fourth side 118, 128 of each clamping bar 110, 120 is also positioned at a substantially 90 degree angle relative to the first side 112, 122 of the respective clamping bar 110, 120, but toward an opposite direction of the first side 112, 122, i.e., downward along the y-axis. The third side 116, 126 of each clip lever 110, 120 forms a common edge with the respective second side 114, 124, forms a common edge with the respective fourth side 118, 128, and is positioned relative to the respective first side 112, 122 such that it points outwardly away from the interior opening 172 of the split clip 100 along the x-axis. Finally, each pair of ends 119a-b, 129a-b of each clamping bar 110, 120 includes two opposing ends thereof, wherein each end 119a-b, 129a-b faces in a direction perpendicular to the x-axis and the y-axis (i.e., along the z-axis).

As best shown in fig. 2, in the present exemplary embodiment, the first sides 112, 122 of each clamp bar 110, 120 define a substantially flat rectangular surface with a slightly rounded upper edge 182 leading to the adjacent second side 114, 124 and a further rounded lower edge 180 leading to the adjacent fourth side 118, 128. In contrast, the third sides 116, 126 of each clamping bar 110, 120 are not substantially flat rectangular surfaces. Rather, as best shown in fig. 3, the third sides 116, 126 exhibit a curve or curve that arches in an inward direction along the x-axis (i.e., toward the interior opening 172 of the clip 100) to form a concavity, with the degree or sharpness of the curve or curve increasing near the center of the third sides 116, 126. Thus, the first side 112, 122 may be characterized as a "flat side" of the clamping bar 110, 120, and the third side 116, 126 may be characterized as a "concave side" of the clamping bar 110, 120. Certain advantages of the concave shape of the third sides 116, 126 are described in further detail below.

With respect to the biasing assembly 104 of the split clamp 100, it functions to bridge the clamp bars 110, 120 to one another to form a complete clamp assembly 100 for capturing the LAA and to determine the relative position of the first and second clamp bars 110, 120 with respect to one another. Specifically, throughout implantation of the distraction clip 100, the biasing assembly 104 continuously applies a spring-biasing force to the first and second clamping bars 110, 120, to push either one of the clamping bars 110, 120 towards the other clamping bar 110, 120, or both clip levers 110, 120 are simultaneously urged in an inward direction along the x-axis, from initial capture of the LAA in the clip's expanded capture state (as shown in fig. 1-4), to continuous, but still reversible, installation in the clip's intermediate capture state (as shown in fig. 5-7), to final capture of the LAA in the clip's implanted and closed state (as depicted in the process from formation in fig. 8 to formation in fig. 9-12), wherein the detached clip 100 has been released from the clip delivery apparatus, not shown, to provide the final peristaltic and tensioning movement of the LAA into its final position within the clip interior opening 172.

In the exemplary embodiment depicted in fig. 1-12, the biasing assembly 104 is comprised of oppositely positioned spring members 150, wherein each spring member 150 is located on one of the two ends 119, 129 of the split clip 100. As shown in the exemplary embodiment, each spring member 150 comprises a set of springs, including an outer (or upper) spring 152 and an inner (or lower) spring 154. However, in alternative exemplary embodiments, each spring member 150 contains only one spring. Each of the springs 152, 154 is substantially semi-circular or "horseshoe" shaped, wherein the radius of curvature of the inner spring 154 is less than the radius of curvature of the outer spring 152 (as used herein, the term "radius" broadly refers to a path of curvature that is circular or non-circular (i.e., not perfectly circular)). Each spring member 150 is attached to a pair of adjacent clamping bar ends (either pair 119a, 129a or pair 119b, 129b) at one of the two distal ends of the split clamp 100, thereby connecting the clamping bars 110 and 120 together to create the boundary defined by the split clamp 100. Specifically, each of the two ends 158 of the inner spring 154 is rotationally connected to the respective clamping bar end 119a, 129a at the attachment point 164 in a longitudinally fixed manner such that the spring 154 is not moved. The attachment point 164 is located at a position of the clamping bar ends 119a, 129a that is closer to the first side 112, 122 than the third side 116, 126 of the respective clamping bar 110, 120. Similarly, each of the two ends 156 of the outer spring 152 is also rotationally connected to the respective clamping bar end 119a, 129a in a longitudinally fixed manner at attachment point 162. Relative to the attachment point 164, the attachment point 162 is closer to the third side 116, 126 than the first side 112, 122 of the respective clamping bar 110, 120. Thus, when anchored to the two clamp bars 110, 120 in this manner, the outer spring 152 and the inner spring 154 are positioned together in a substantially coaxial manner and extend in the y-axis direction from the clamp bars 110, 120. Likewise, at the other, opposite, distal end of the separator clip 100, the outer spring 152 and the inner spring 154 of the second spring member 150 are fixedly connected, in a coaxial manner, rotationally and longitudinally to the adjacent pair of clip lever ends 119b, 129 b. These dual attachment points 162, 164 of each clamp bar end 119a-b, 129a-b add considerable stability to the biasing assembly 104 and the overall clamp structure.

Due to the inward flipping of the outer spring 152 and the inner spring 154, in the present exemplary embodiment, the spring member 150 inherently and continuously applies a spring biasing force that urges the first and second clamping bars 110, 120 toward each other. The magnitude of the spring biasing force exerted by the spring member 150 at any given time depends on the internal spring constant k of each spring 152, 154 and the distance each spring 152, 154 extends relative to its point of equilibrium, according to Hooke's Law. It should be noted that if the material of the springs 152, 154 is superelastic, such as in the case of a nickel titanium (Ni-Ti) alloy (e.g., nitinol), the spring force does not follow hooke's law, and instead, the force is approximately constant rather than increasing linearly with displacement. In such cases, when reference is made herein to a spring constant, that spring constant will be replaced by the particular properties of the material.

Each of the outer spring 152 and the inner spring 154 is composed of a suitable biocompatible material having a desired spring constant k, wherein each of the springs 152, 154 may be composed of the same material. Alternatively, if it is beneficial for the springs 152, 154 to have differences in their respective material properties, the different materials may comprise the various springs 152, 154. Examples of such materials include, but are not limited to, chromium cobalt alloys, stainless steel, titanium alloys, and superelastic alloys (such as Ni-Ti). Additionally, the composition and shape of the outer spring 152 may be different than the inner spring 154 if it is beneficial to have a variable stiffness between the outer spring 152 and the inner spring 154.

Further, as described above, there is some rotational freedom at each connection between the upper and lower springs 152, 154 and the clamping bars 110, 120 at the attachment points 162, 164. This degree of rotation allows each of the clamp bars 110, 120 to rotate upward along the y-axis relative to the spring member 150 such that, for example, when a substantially downward moving pressure is applied from the outside to an outer portion of the clamp bars 110, 120 (e.g., at the outer edge 184 of the second sides 114, 124) or a substantially upward moving pressure is applied from the outside to an inner portion of the clamp bars 110, 120 (e.g., at the outer edge 180), the torsional force causes each clamp bar 110, 120 to rotate or pivot relative to the spring member 150 in either a clockwise or counterclockwise direction (depending on the curvature of the outer spring 152 and the inner spring 154) (about the z-axis as shown in fig. 8), which causes a significant transition in the configuration of the split clamp 100 as depicted in the transition of fig. 5-8-9. As explained in more detail below, this rotational or pivotal capability of the clamp bars 110, 120 facilitates maneuvering the LAA further into the clamp interior 172 and enhances the grip force exerted by the detachment clamp 100 when applied to the LAA.

Accordingly, the connection between each end 156, 158 of the springs 152, 154 and their respective clamp bar 110, 120 may comprise any suitable rotatable connection that retains the spring member 150 while pivoting the clamp bars 110, 120 at a desired degree of rotation relative to the spring member 150. For example, in one exemplary embodiment, each attachment point 162, 164 includes a hole, slot, or channel (not shown) that has been drilled into the respective clamping bar end 119a-b, 129a-b in the longitudinal direction of the clamping bar 110, 120 a partial distance or depth (which may be a blind hole) and matingly receives a portion of its respective spring end 156, 158. The holes, slots, or channels of the spring ends 156, 158 and/or the clamping bar ends 119a-b, 129a-b that receive the spring ends 156, 158 may be shaped or configured in such a way that the interaction between the holes, slots, or channels and the spring ends 156, 158 inserted therein creates a torsional effect. In one exemplary embodiment, each attachment point 162, 164 may consist of an elongated hole extending part way into the clamp bar body, having a diameter greater than the diameter of the springs 152, 154, and terminating in an inner floor (floor) in which the spring ends 156, 158 are secured. For example, the inner floor may include a second hole (which may also be a blind hole) having a diameter slightly smaller than the diameter of the respective spring end 156, 158 such that the spring end 156, 158 is secured into the second hole by a press fit. In another example, an inner bottom layer of the bore may open into an enlarged second aperture or window to receive the respective spring end 156, 158, wherein the spring end 156, 158 is configured to have a curled or bent distal end such that upon insertion of the spring end 156, 158 into the body of the respective clamp bar 110, 120, the distal end is cooperatively placed or hooked in the second aperture or window (examples of which are described in further detail below). Alternatively, when the spring ends 156, 158 are inserted into the bore, friction between the second aperture or window and the distal ends of the spring ends 156, 158 may actively force or deform the distal ends into a curled or bent configuration to secure the spring ends 156, 158 at a fixed position (examples of which are described in further detail below).

With the described configuration of the detachment clip 100, an exemplary embodiment of a procedure for implanting the clip 100 to isolate the LAA from the left atrium of the heart, thereby effectively occluding the internal fluid passageway between the LAA and the left atrium, is described. As depicted in fig. 9-12, in the stand-alone or rest state of the breakaway clip 100, the first and second clip levers 110 and 120 are positioned in close proximity to each other, or in face-to-face contact with each other, due to the spring biasing force applied by the biasing assembly 104. Accordingly, in this stand-alone or at rest condition, there is a relatively minimal interior opening 172, the width of which is depicted by arrow a, between the opposing clamping bars 110, 120. Thus, to stably engage the LAA and encompass its entire circumference during implantation of the distraction clip 100, the clip bars 110, 120 are separated from one another in a controlled manner to widen the interior opening 172 between the clip bars 110, 120 and place the distraction clip 100 in an expanded state (as depicted in fig. 1-4). Accordingly, a clip delivery device (not presently shown) is used to engage the separate clip 100 prior to placement in the patient and throughout the implantation process to securely deliver the clip 100 to the surgical site of the LAA and to change the relative positions of the clip levers 110, 120 during the implantation process. Thus, an exemplary clip delivery device compatible for use with a breakaway clip 100 is configured to temporarily engage and hold the clip 100 in place during an implantation procedure, and to disengage from the clip 100 once the implantation procedure is complete. In addition, the clip delivery device is configured to apply a counter force to the spring biasing force of the biasing assembly 104 to precisely control the placement of the clip levers 110, 120 relative to each other and to control the amount of compressive force applied to the LAA by the separation clip 100 during implantation. In one exemplary embodiment of such a suitable clip delivery apparatus, its primary components include a control handle, an elongate shaft, and a LAA clip applicator head. In use, the control handle is oriented in a proximal direction (e.g., in the direction of the surgeon) for manipulation by the surgeon. Further, the shaft forms an intermediate connection between the control handle and the clip application head such that the control handle is located at the proximal end of the shaft and the clip application head is located at the distal end of the shaft (the distal end being furthest from the surgeon). The clip applicator is configured to selectively engage and retain both the first clip bar 110 and the second clip bar 120, and controllably separate the clip bars 110, 120 into an expanded state, such as depicted in fig. 1, by applying an adjustable reaction force to the spring biasing force of the clip's biasing assembly 104 to form an extended interior opening 172 of the clip 100, the width of which is defined by arrow B. With this capability, the clip application head can be configured to displace only one of the clip bars 110, 120 in an opposite direction from the other of the clip bars 110, 120, or the clip application head can be configured to displace both the first clip bar 110 and the second clip bar 120 in opposite directions from one another to achieve the desired separation. The control handle, shaft, and clip application head are operably connected such that the surgeon uses one or more controls present on the control handle to actuate operation of the clip application head that causes movement of the clip levers 110, 120. Accordingly, as a first step in the implantation procedure, the detachment clip 100 removably engages the clip application head (using, for example, a series of cords (e.g., surgical sutures) to bind the clip 100 thereto) and prepares the clip 100 for its application to the LAA by widening the clip's internal opening 172 to the desired enlarged diameter B by placing the clip 100 in an expanded state as depicted in fig. 1-4 prior to advancing the detachment clip 100 to the patient's chest.

Next, using the clip delivery device, the surgeon delivers the breakaway clip 100 (in its expanded state) into the chest cavity and to the location of the LAA. At this point, it is noted that a variety of surgical methods for obtaining access to the LAA may be employed, and the present exemplary detachment procedure is not intended to be limited to any particular technique for accessing the LAA. For example, the LAA may be accessed by a conventional open chest procedure or open heart surgery, in which the surgeon makes a large incision in the middle of the chest and sternum to gain direct access to the heart. Alternatively, a left thoracotomy may be performed to make a small incision in the intercostal space between two adjacent ribs, so that the clip delivery device is inserted through the chest wall. In another alternative, thoracoscopic surgery can be performed, with several smaller incisions (called "ports") made in the chest wall to allow for the insertion of multiple instruments (e.g., cameras) including the clip transfer device. Once the detachment clip 100 is within the proper range of the LAA, the surgeon carefully advances the LAA into the central opening 172 of the expansion clip 100 (in the direction of the dashed arrow in fig. 1 and 2) such that the base portion of the LAA is located between the first side 112 of the first clip bar 110 and the first side 122 of the second clip bar 120, and the fourth side 118 of the first clip bar 110 and the fourth side 128 of the second clip bar 120 are at rest as optimally as possible, in face-to-face contact with the topography of the outer surface of the heart on either side of the LAA (or a portion of one surface of the fourth sides 118, 128, such as a pad, in face-to-face contact with the heart). At this stage, the initial acquisition of the LAA is complete.

It should be appreciated that in the case of access to the LAA through a less invasive surgical procedure (e.g., thoracotomy or thoracoscopy) in which a small incision is made, alternative exemplary embodiments of the clip delivery apparatus may be configured to allow the delivery of the detached clip 100 to the site of the LAA while the clip 100 is in its unexpanded form to facilitate manipulation of the clip 100 through the small incision. In such embodiments, the breakaway clip 100 is placed in its expanded state after the clip is advanced into the chest cavity.

In the next step, the surgeon actuates the clip delivery apparatus to controllably close the detachment clip 100 about the base portion of the LAA to the extent that the clamping force exerted on the LAA by the first sides 112, 122 of the clip levers 110, 120 is sufficient to effectively inhibit blood flow into and out of the interior of the LAA, referred to herein as "LAA detachment". Fig. 5 to 7 show the configuration of the separator clip 100 in an intermediate capture state. As best shown in FIG. 6, the first clamping bar 110 and the second clamping bar 120 are now positioned proximate to each other such that the interior opening 172 has a reduced diameter, as indicated by arrow C. For the present exemplary embodiment, two possible mechanisms (one referred to herein as "passive" and the other as "active") are contemplated for achieving this closure of the breakaway clip 100. The "passive" mechanism includes the surgeon actuating controls on the clip delivery apparatus to relieve or mitigate at a controlled rate the amount of reactive force exerted by the spring biasing force of the clip application head relative to the spring member 150, as described above, to place the clip 100 in its expanded state. Relieving the reaction force allows one or both of the clamping bars 110, 120 to return to its inherent, resting spring-biased state, allowing one or both of the clamping bars 110, 120 to move in an inward direction of the dashed-line arrow depicted in fig. 6 (e.g., along the x-axis) toward the opposing clamping bar 110, 120, which, as described in detail below, creates a momentum that then causes one or both of the clamping bars 110, 120 to rotate to a final implant position (e.g., as shown in fig. 9 and 10). For an "active" mechanism, the method includes not only the surgeon causing the release of the reaction force, but also further actuating the clip application head to apply some direct pressure to one or both of the clip levers 110, 120 (and/or one or both of the spring members 150) to provide additional force to one or both of the clip levers 110, 120 in the direction of the dashed arrows in fig. 6, for example.

During this stage of the implantation procedure, the detachment clip 100 is now in a position where the surgeon can determine whether the current neutral position is optimal and can effectively close blood flow into and out of the interior of the LAA. If the surgeon does not see the current position to separate the clip 100, the surgeon may actuate the clip delivery device to controllably disengage the clip 100 from the LAA by returning the clip 100 to an expanded or slightly expanded state, and then from the initial attempt, re-engage and close the clip 100 at a different location or using a different amount of clamping force about the LAA. By using the clip transfer apparatus, the process can be repeated as many times as necessary to achieve satisfactory placement.

When the surgeon has determined that the distraction clip 100 is in the desired LAA distraction position, the surgeon actuates the clip delivery apparatus to place the distraction clip 100 into a final implant state, which is depicted in FIGS. 9-12. This final implanted state achieves a peristaltic and tensioning motion that brings the LAA further and firmly into the interior opening 127 of the detachment clip 100, thereby enhancing the long-term strength and stability of the grip of the clip on the LAA during the useful life of the permanent clip implant. As depicted in fig. 8, this final implanted state of the split clip 100 is characterized by each of the first and second clip levers 110 and 120 being rotated substantially 90 degrees relative to each spring member 150. As shown in fig. 9-12, this converted configuration results in the first side 112, 122 of each clip bar 110, 120 facing in an upward direction along the y-axis, the second side 114, 124 of each clip bar 110, 120 facing in an outward direction along the x-axis, the third side 116, 126 of each clip bar 110, 120 facing in a downward direction along the y-axis, such that each of the third sides 116, 126 now contains the surface of the clip 100 against the heart topography surrounding the base portion of the LAA, and the fourth sides 118, 128 of each clip bar 110, 120 facing each other in an inward direction along the x-axis, such that each of the fourth sides 118, 128 is compressed into face-to-face contact with the outer surface of the LAA. In this configuration, the fourth sides 118, 128 are separated by a distance a, where the distance a is dependent on the spring-biasing force of the spring member 150 and the thickness of the LAA.

As described above, to produce a 90 degree rotation, a torsional force must be applied to each of the clamp bars 110, 120 to cause angular displacement of the clamp bars 110, 120 relative to the spring member 150. For the present exemplary embodiment, multiple sources of this torque are contemplated. In one example, as described above, actuation of the clip delivery apparatus by the surgeon to relieve the magnitude of the reaction force applied by the clip application head causes the inherent spring biasing force of the spring member 150 to be the dominant force, causing the spring member 150 to curl inward to the greatest extent possible, with the resulting face-to-face interaction between the interior region of the first side 112, 122, 180 of the clip lever 110, 120 and the inserted LAA automatically forcing the clip lever 110, 120 to rotate in a clockwise or counterclockwise direction (see dashed arrow in fig. 8), depending on the curvature of the spring member 150. In an alternative exemplary configuration, a more aggressive approach is used in which the surgeon actuates the clip application head by directly contacting each clip lever 110, 120 and/or each spring member 150 with the clip application head to forcibly rotate each of the clip levers 110, 120 90 degrees in the desired direction. Accordingly, the clip delivery device (including the clip application head) is configured to accommodate the expanded intermediate capture of the split clip 100 and the final implant conditions so that it can force or follow the relative positions of the clip bars 110, 120 throughout the implant process. Further, it should be noted that regardless of the mechanism used to rotate the clamping bars 110, 120, during the 90 degree rotation, the spring member 150 must contract to an extent to ensure that the optimal gap (i.e., distance a) between the first clamping bar 110 and the second clamping bar 120 remains substantially constant, which gap effectively retains and seals off the LAA captured therein.

Accordingly, the 90 degree rotation of the clamp bars 110, 120 creates a looping type motion in which the LAA is further "tucked" into the interior opening 172 of the detachment clamp 100, resulting in a tighter and more stable grip that eliminates any residual pockets or void spaces of the LAA formed at the junction between the left atrium and the base portion of the LAA during the intermediate capture phase in the implantation process. In fact, this 90 degree "wrap" of the clip levers 110, 120 effectively positions the detachment clip 100 one or more millimeters down the LAA, as opposed to other possible approaches. The elimination of any void space at the junction is important to ensure that no blood clots are formed therein.

Although this is the final stage of implantation, the surgeon may continue to adjust the position of the split clip 100 by reversing the closing of the clip 100, returning the clip 100 to its expanded state, and repeating the closing and rotating steps described above. In other words, after the clip delivery apparatus positions the clip levers 110, 120 relative to each other in the final implant state, the surgeon still has the ability to completely reverse the split clip implantation process. Once the surgeon is satisfied with the placement, the clip applier head of the clip delivery device is permanently disengaged from the breakaway clip 100. For example, if one or more sutures are used to temporarily attach the breakaway clip 100 to the clip application head, the sutures will be severed at this stage.

A further benefit of the 90 degree rotation of the clamping bar 110, 120, in addition to the wrap-around effect, is the final placement of the third side 116, 126 of the clamping bar 110, 120. As described above (and depicted in fig. 9-11), at the end of rotation and during the remaining useful life of the clip implant, the third side 116, 126 contains a portion of the detachment clip 100 that rests on the non-planar and irregular topography of the heart surrounding the base portion of the LAA. Thus, upon implantation, the "concave side" of clip 100 will be permanently against the surface of the heart. The concavity more precisely conforms to the natural curvature of the heart than a flat surface, allowing the clip 100 to comfortably rest in a perfectly fixed, unobstructed and protected position relative to the curved surface of the heart. Furthermore, if clip 100 has a straight surface rather than the concave surface described and shown, the distance between the atrial surface and the clip surface will be greater at the distal end of clip 100 when placed against a non-planar surface of the left atrium, possibly resulting in a condition known as "dog ear" in which the small pocket of the LAA remains in communication with the atrium. Such capsules exhibit sites suitable for clot growth that may lead to embolism. Thus, the curved shape of the third sides 116, 126 advantageously eliminates this situation.

Another notable feature of the breakaway clip 100 according to the exemplary embodiment of fig. 1-12 is the fourth side 118, 128 of the clip lever 110, 120. As described above, the fourth side 118, 128 is a separate clip 100 surface that is in permanent face-to-face contact with the LAA once the clip 100 is fully implanted. Thus, to facilitate a healthy and durable interaction between the detachment clip 100 and the LAA, the LAA interface 140 may be applied to all or a portion of the surface of one or both of the fourth sides 118, 128, or may be integrally formed therewith. In an exemplary gripping configuration, the LAA contact surface 140 provides a smooth and non-abrasive, but also non-significantly sliding contact surface so that the gripping force of the detachment clip 100 on the LAA does not diminish over time. Thus, in such a gripping configuration, the LAA-contacting surface 140 is composed of any suitable biocompatible material that is relatively non-smooth. For example, the LAA-contacting surface 140 may be composed of a soft, padded material, such as plain-woven polyester, silicone rubber, PTFE, expanded PTFE, urethane, or other elastic material that increases traction on the LAA to resist the detachment clip 100 from sliding and exiting the LAA. In another grasping example, the LAA-contacting face 140 of one or both of the fourth sides 118, 128 includes a slightly raised surface texture that does not cause damage to the LAA tissue when placed in contact with the LAA tissue.

The above description provides a description of an exemplary clip lever body of the clip assembly 102 that separates the clips 100. However, various improvements to the clip assembly 102 may be applied to or formed integrally with the clip lever body to improve aspects of the clip function. For example, in the exemplary embodiment disclosed in fig. 1-12, a "self-activator" or traction element 130 is applied on a portion of each of the first sides 112, 122 of the clamping bars 110, 120 or substantially the entire surface as depicted. As described in detail above, the first sides 112, 122 of the clip bars 110, 120 are surfaces that separate the clip 100, which initially capture and manipulate the LAA into the interior opening 127 between the clip bars 110, 120 during application of the clip 100. The self-energizing or traction element 130 is comprised of any structural component that moves with the surgeon and/or the outside of the clip delivery device, or with the pulsatile motion of the LAA (or more generally the heart), or both, during application of the detached clip 100 to naturally encourage the LAA to travel carefully into the interior opening 172 of the clip 100 and then inhibit escape of the LAA from the clip 100. Thus, unlike prior art devices and methods, the self-energizing or traction element 130 uses components of the distraction clip device itself to maneuver the LAA into the desired location with fewer stand-alone instruments (e.g., surgical graspers) or without instruments. Several exemplary embodiments of the self-actuator 130 or traction element are described below that operate according to these principles. In an alternative exemplary embodiment, the element 130 is a coating of a lubricious material, such as a hydrophilic coating. With a lubricious coating, the opposing surfaces of the detachment clip 100 can, for example, easily slide over the LAA during application of the clip.

Depicted in the exemplary embodiment of fig. 1-12 is a self-energizing or traction element 130 that includes one or more resilient fingers 132 (or appendages) that extend in a direction to separate the interior opening 127 of the clip 100. More precisely, as best shown in fig. 2, when the detachment clip 100 is in its expanded state, the fingers 132 are oriented at a positive angle (i.e., θ >0 °) relative to the x-axis, and thus in the same direction in which the LAA is received in the interior 127 of the clip 100 (see dashed arrows in fig. 2). Thus, when the LAA is received between the first and second clamp bars 110, 120 of the split clamp 100, the fingers 132 contact the LAA and combine with the pulsatile movement of the LAA and/or the back and forth movement of the clamp delivery device by the surgeon to naturally push the LAA into the clamp 100 in the direction of the dashed arrow in FIG. 2, while also inhibiting movement of the LAA away from the clamp 100 in the direction opposite the dashed arrow. Notably, in the exemplary embodiment of fig. 1-12, the self-energizing or traction elements 130 extend onto the edges 180, 182 of each of the first sides 112, 122 to maintain the ground floor rounded edges discussed above.

In another exemplary embodiment, the self-energizing or traction elements 130 may be in the form of a plurality of tiny, not shown foot structures configured to react with the forward moving pulse when subjected to vibratory forces, similar theretoThe manner in which the toy operates. These feet may be nano-or micro-sized and may be applied along the entire or only a portion of the surface of the first sides 112, 122 of the separation clip 100. During implantation, the pulsatile motion of the LAA may be sufficient to cause the necessary vibration of the clip 100 when in contact with the LAA. Alternatively, it may be necessary to transmit external vibratory forces to the detachment clip 100 in order to fully activate the foot to cause internal LAA excitation. In such exemplary embodiments, the clip transport apparatus is internally equipped with a small motor that generates vibrations within the clip application head that are then directly delivered to the clip 100. Once the foot is activated, as the LAA enters the interior opening 172 of the clip 100, the face-to-face contact that occurs between the foot and the LAA will cause the LAA to be continually brought into the interior opening 172 of the clip due to the forward pulse momentum of the foot.

In another exemplary embodiment of the breakaway clip 100, not shown, the self-energizing or traction element 130 may be composed of other small particles that, when closely packed together, form a one-way friction material due to the van der waals forces generated, and thus, when oriented in a direction in which the LAA will be received into the interior opening 172 of the clip of the breakaway clip 100, the particles encourage or direct the LAA further into the interior opening 172 when in face-to-face contact with the LAA during implantation. Although composed of synthetic materials, these particles can be modeled after the naturally occurring example. For example, the tiny microscopic hairs or fibers found on the footpads of geckos (i.e., bristles and spatule) exhibit frictional adhesion characteristics that can be effectively imitated for the present purpose. Another naturally occurring example is the toothed structure found on sharkskin. Other techniques include nanotube clusters (composed of arrays of carbon nanotubes) and other minute unidirectional microstructures (e.g., a plurality of slanted mountains of triangular or pyramidal structures).

In another exemplary embodiment of the detachment clip 100, not shown, the self-energizing or traction element 130 may consist of a series of rollers that generate a conveyorized driving force that guides the LAA into the clip's interior opening 172 during implantation due to a slip torque generated by friction between the pulsating LAA and the rollers when in face-to-face contact with the LAA. The rollers may be placed in a variety of configurations. For example, the rollers may be arranged along a single elongated axis. In alternative configurations, the axis may be segmented into a plurality of short axes that are placed in a line or in parallel lines to form multiple rows. In various exemplary embodiments, the roller may be freely rotatable in any direction, or restricted to rotate in only one direction. In the one-way embodiment, application of the clip 100 to the LAA is enhanced by the roller preventing the LAA from moving back out of the clip 100. In contrast, in the free-wheeling embodiment of the roller, if the clip 100 needs to be repositioned, the roller reduces the risk of applying excessive traction to the LAA.

While the breakaway clip 100 according to the exemplary embodiment of fig. 1-12 has benefits, the shape of the biasing assembly 104 has some requirements. First, in order to arrange the separator clip 100, a compatible clip delivery device must include a rigid outer frame that can surround a sufficient portion of the separator clip 100 to exert control over the movement of one or both of the clip bars 110, 120. Second, the biasing assembly 104 limits the distance the clamping bars 110, 120 can be separated from each other due to the inwardly turned configuration of the spring member 150. Third, the rigid outer frame of the clip transfer apparatus limits the extent to which the separator clip 100 can be opened, regardless of the extent to which the separator clip 100 itself can be opened. Fourth, the biasing assembly 104 requires an increasing reactive force to separate the clamping bars 110, 120 to expand the breakaway clip 100. Fifth, while the clamp bars 110, 120 limit the two directions of movement of the LAA when it is captured in the split clamp 100, the other two opposing sides of the LAA, including the distal end where the spring member 150 is located, are not accommodated by or closed in the plane of the LAA contact face of the clamp 100, which may deleteriously result in the distal side of the LAA tissue leaking out of or not being effectively clamped by the clamp 100 at the location of the spring member 150.

To improve or substantially prevent the LAA from escaping from the area of the spring members 150 of the detachment clip 100, a retractable barrier structure may be applied to one or both spring members 150 (each of which may have one or both springs 152, 154) to resist the LAA from escaping outwardly from the spring members 150 in the longitudinal direction. Depicted in fig. 29 and 30 are two exemplary embodiments of a web (which may be a stretchable, taut, or a portion having different stretchability) applied to a portion of the body of the spring member 150 such that the web covers a portion of the opening span formed by, for example, the arcs of the springs 152, 154. Thus, the web functions to substantially prevent the LAA from seeping outward from the detachment clip 100 in the area of the spring member 150. In the embodiment shown in fig. 29, the web is in the form of a shoe 190 that slides over the top of the springs 152, 154 and extends down a portion of the body of the springs 152, 154, conforming to the shape of the outer spring 152 when the two springs 152, 154 are substantially co-planar. In another embodiment, fig. 30 depicts an embodiment of a web in the form of a band 192 positioned around a middle region of the body of the springs 152, 154. The web in this example is comprised of a resilient material that provides sufficient resilience to hold the retractable web securely to the spring member 150, while providing the necessary retraction capability required so that the retractable web does not unduly restrict the spring member 150 from transitioning to its expanded state.

Certain protective measures may also be taken to prevent the outer surface of the spring member 150 from causing trauma to the surrounding body tissue and causing tissue ingrowth. For example, the outer surface of the spring member 150 may be coated in whole or in part with a suitable lubricant. In another example, the spring member 150 may be fully or partially enclosed by a flexible blunting member (such as the telescoping web described above) composed of a material with suitable properties. Such materials may include, but are not limited to, silicone, ePTFE, urethane, and the like. In an exemplary embodiment, the flexible blunting member is comprised of an elongated tubular member that securely surrounds one or both of the springs 152, 154. Further, the tubular member may be comprised of a series of circular or annular tubular sections. Alternatively, the tubular member may be comprised of a central lumen surrounded by a plurality of lumens.

It should be understood that although the description in fig. 1-12 and the corresponding description above with respect to the first exemplary embodiment of the detachment clip 100 indicate that each of the spring members 150 includes two coaxial "horseshoe" springs 152, 154, the spring members 150 are not limited to this particular type, shape, or configuration, and may be in the form of any spring-like structure that provides the necessary degree of spring biasing force to the opposing clip bars 110, 120 to bias one or both of the clip bars 110, 120 toward the opposing clip bars 110, 120, and with sufficient force to cause the detachment clip 100 to capture the LAA and remain securely implanted. For example, each spring member 150 may consist of only a single "horseshoe" spring. Further possible exemplary embodiments of spring-biased breakaway clips are depicted in fig. 32-50 and described in more detail below. Fig. 31 shows a partial view of an exemplary embodiment of a spring-biased separator clip 100a in an expanded state (i.e., in the configuration depicted in fig. 1-4), with only the left side of the separator clip 110a depicted. In this embodiment, the clip 100a includes a first clip lever 110a and a second clip lever 120a positioned relative to each other and connected to each other by a spring member 150a in the manner described above with respect to the embodiment shown in fig. 1-12, except that each spring member 150a includes a single non-specific spring structure terminating at a spring end 160, 162 and forming a rotatable and horizontally fixed connection with each clip lever 110a, 120a at each end 160, 162. More specifically, in a central region of the respective end 164, 166 of each clamping bar 110a, 120a there is an aperture 164a, 166a opening into a cylindrical passage 168 that extends partially into the clamping bar body (substantially along its centerline) and matingly receives one of the respective spring ends 160, 162 therein. Further, each channel 168 terminates in a floor 170. To rotationally fix the spring ends 160, 162 relative to the clamp bars 110a, 120a, the spring ends 160, 162, when advanced into their respective channels 168, traverse a 90-degree helical groove or track (not shown) that wraps along at least a portion of the inner surface of the channel 168. A T-bend or curl 160a, 162a is formed at the tip of each spring end 160, 162 such that the spring ends 160, 162 are oriented to engage the helical groove. In addition, the shape of each channel 168 may be further modified such that, for example, the inner diameter of the channel 168 varies one or more times along the length of the channel 168. For example, in the embodiment of FIG. 31, the inner diameter of the channel 168 decreases slightly as the bottom layer 170 is approached. Thus, as a result of the interaction between the curved or coiled spring ends 160, 162 and the internal shape and helical groove or track of the channel 168, a balance of forces is achieved by placing the spring biasing force on the center of the clamp bars 110a, 120a, and creating a torsional effect that horizontally secures each spring member 150a in place and allows the clamp bars 110a, 120a to freely rotate about the spring members 150a to the final implanted state of the clamp 100a (i.e., in the configuration shown in fig. 9-12).

Referring now to fig. 13-28, a second exemplary embodiment of an externally implantable left atrial appendage detachment clip 200 is shown, including a clip assembly 202 and a biasing assembly 204. The breakaway clip 200 has several benefits. First, to arrange the breakaway clip 200, it is not necessary to have a rigid outer head surrounding the frame of the breakaway clip 200. Second, the biasing assembly 204 does not limit the distance that the clamping bars 210, 220 can be separated from each other, which means that there is no limit to the extent to which the breakaway clamp 200 can be opened. Third, the biasing assembly 204 provides little or no force to the clamping bars 210, 220 when the breakaway clamp 200 is opened or closed. Fourth, when captured in the breakaway clip 200, the clip levers 210, 220 and control cords 252, 262 restrict all four possible directions of LAA movement. The clip 200 may be referred to as cord tensioned.

The clip assembly 102 includes two opposing clip levers: a distal clamping bar 210 and a proximal clamping bar 220. In the exemplary embodiment shown in fig. 13-28, the clamping bars 210, 220 are substantially in the form of rectangular posts and are mirror images of each other. Each of the clamping bars 210, 220 has a first side 212, 222 including a self-actuator 230, a second side 214, 224, a third side 216, 226, a fourth side 218, 228 including a LAA contact surface 240, and opposing fifth and sixth ends 219a, 219b, 229a, 229 b.

The biasing assembly 204 includes a first or distal rod biasing subassembly 250 and a second or proximal rod biasing subassembly 260.

The distal rod biasing subassembly 250 includes a distal control cord 252, a first distal anchor 254, and a distal tensioning device 256. The distal control cord 252 terminates at a first distal anchor 254 and begins at the proximal handle of the clip delivery device 300. The terminating end of the distal control cord 252 and the first distal anchor 254 are movably located within a first anchor lumen 217a defined by the distal clamp bar 210. The distal control cord 252 extends from the first anchor lumen 217a through the passageway 215a and, in the present exemplary embodiment, exits the distal clamping bar 210 at the fourth side 218, as shown in fig. 14. In an alternative embodiment, the distal control cord 252 may exit the distal clamp bar 210 at the fifth side 219a, which will be described in further detail below. The distal control cord 252 then extends across the gap 270 formed by the opposing surfaces of the two control rods 210, 220. (As defined herein, gap 270 is not limited to the space between the two opposing self-actuators 230, as the two control clip levers 210, 220 rotate to also present the fourth sides 218, 228 facing each other late in the implantation process, as shown in FIGS. 24-28 and described in further detail below. thus, gap 270 is broadly defined as two opposing sides of the inner portion 272 of the distraction clip 200 that are included at any time during the distraction clip implantation process.) gap 270 is shown in an extended open position in FIG. 13. In an exemplary embodiment, the extended open position may be a maximum extended position. However, the extended open position shown may also be an intermediate extended position. Because the distance of gap 270 is controlled by transfer device 300, the only limitation of the gap distance is the length of distal control cord 252 and proximal control cord 262 and the length of extension shaft 320, as will be described in further detail below. Thus, the breakaway clip 200 provides the ability to open the clip levers 210, 220 to a greater extent than shown in the figures.

After crossing gap 270, distal control cord 252 enters fourth side 228 of proximal clip lever 220 and passes through channel 227 defined by proximal clip lever 220. In the exemplary embodiment shown, the channel 227 exits the proximal clamping bar 220 at an exit 225 defined by the second side 224 of the proximal clamping bar 220. The distal control cord 252 exits the proximal clamping bar 220 at the second side 224, wherein the outlet 225 is a cord capture assembly 280, which will be described in further detail below with reference to fig. 19. The distal control cord 252 then enters the proximal base 310 of the delivery system 300; proximal base 310 is shown in phantom in fig. 13-20. The distal control cord 252 extends through or at the proximal base 310 and is guided into a cord control device, not shown, located in the proximal handle of the delivery device 300. The cord control device controls distal (outward) and proximal (inward) movement of the distal control cord 252 relative to the delivery device 300.

In an alternative, exemplary embodiment, not shown, the channel 227 exits the proximal clamp bar 220 at an outlet 225 defined by a fifth end 229a of the proximal clamp bar 220. A beneficial difference in exit at fifth end 229a is that distal control cord 252 performs two bends between first distal anchor 254 and proximal base 310, and proximal control cord 262 also performs two bends between second distal anchor 264 and proximal base 310. Thus, the forces exerted on both the distal tensioning device 256 and the proximal tensioning device 266 are balanced. A cord capture assembly 280 is located at the outlet 225 of the second side 224. The distal control cord 252 then enters the proximal base 310 of the delivery system 300, as described above. The distal control cord 252 extends through or at the proximal base 310 and is guided into a cord control device, not shown, located in the proximal handle of the delivery device 300. The cord control device controls distal (outward) and proximal (inward) movement of the distal control cord 252 relative to the delivery device 300.

In another alternative, exemplary embodiment not shown, the channel 227 is coaxial with the proximal clamping bar movement shaft 350, and the proximal clamping bar movement shaft 350 is hollow. In this configuration, the outlet 225 is an open hollow end of the proximal clamping bar motion shaft 350 opposite the proximal clamping bar rotation receiver 352. Thus, the distal control cord 252 exits the proximal clamp bar 220 at the outlet 225 and moves entirely through the longitudinal extent of the proximal clamp bar motion shaft 350, which is removably attached to the fifth end 229a of the proximal clamp bar 220. Other features of the distal control cord 252 are described with respect to other embodiments herein and therefore will not be repeated here.

The distal tensioning device 256 provides the distal control cord 252 terminating end with the ability to be unsecured at least over a distance 274 defined by the first anchor lumen 217a and the first distal anchor 254 (see, e.g., fig. 16). In an exemplary embodiment, the distal tensioning device 256 is a spring having opposing anchor points, a first anchor point of the spring being located at the first distal anchor 254, and a second anchor point of the spring being located at a wall within the anchor cavity 217a of the distal clamping bar 210. These anchor points define the distance 274 that the distal tensioning device 256 provides to the distal control cord 252 when the spring is the distal tensioning device 256. Where the first distal anchor 254 is a ball and the distal tensioning device 256 is a spring, the end of the spring connecting the first distal anchor 254 is in the form of a circle self-centred on the ball. Another exemplary embodiment of a distal tensioning device that is substantially constant over the stroke length includes a "negative" spring, which in an exemplary embodiment is a spring made of stainless steel, superelastic alloy, or an elastomeric spring.

The distal tensioning device 256 allows movement of the first distal anchor 254 based on a predefined force limit that depends on the type of bias used. In other words, if the biasing device is a spring, the motion of the spring and the force required will follow Hooke's Law. The spring may be unloaded within the anchoring cavity 271a or it may be preloaded. In the latter case, a given amount of force must be overcome before the distal tensioning device 256 will allow the first distal anchor 254 to move further within the anchoring cavity 217 a. If the force applied to the distal control cord 252 is less than the given amount of force, the first distal anchor 254 will not move from its preloaded position. Once the force applied is greater than the given magnitude, the first distal anchor 254 will move upward within the anchor cavity 217a to its limit of travel. By using a preloaded spring, the amount of tension will be more constant over the range of motion of the tensioning device compared to an un-preloaded spring. In the case of a negative spring, the force applied will be substantially constant over the range of displacement of the spring, thereby producing a certain amount of compression of the tissue, regardless of the tissue thickness between the clamping members.

As with the distal rod biasing subassembly 250, the proximal rod biasing subassembly 260 includes a proximal control cord 262, a second distal anchor 264, and a proximal tensioning device 266. The proximal control cord 262 terminates at a second distal anchor 264 and begins at the proximal handle of the clip delivery device 300. The terminating end of the proximal control cord 262 and the second distal anchor 264 are movably positioned within the second anchor lumen 217b defined by the distal clamping bar 210, as shown in FIG. 16. The proximal control cord 262 extends from the second anchor lumen 217b through the passageway 215b and, in the present exemplary embodiment, exits the distal clamping bar 210 at the fourth side 218, as shown in fig. 18. In an alternative embodiment, the proximal control cord 262 may exit the distal clamp bar 210 at the fifth side 219 a. The proximal control cord 262 then extends across a gap 270 formed by the opposing surfaces of the two control rods 210, 220. After crossing gap 270, proximal control cord 262 enters fourth side 228 of proximal clip lever 220 and passes through channel 227 defined by proximal clip lever 220. The channel 227 enters the body of the proximal clip bar 220 orthogonal to the fourth side 228, and then, in the exemplary embodiment shown, and particularly in fig. 16, turns parallel to the fourth side 228 to traverse the longitudinal extent of the proximal clip bar 220. In an exemplary embodiment, the channel 227 terminates at an exit 223 defined by the second side 224 of the proximal clamp bar 220 (see, e.g., fig. 19). (As described above, and not repeated here, outlet 223 may be defined by fifth end 229 a.) the proximal control cord 262 exits the proximal clamping bar 220 at the second side 224, wherein the outlet 223 is a cord capture assembly 280, which is described in further detail below with reference to FIG. 19. The proximal control cord 262 then enters the proximal base 310 of the delivery system 300. Proximal control cord 262 extends through, extends outside, extends near, or extends at proximal base 310, and is directed into a cord control device, not shown, located in the proximal handle of delivery device 300. The cord control device controls distal (outward) and proximal (inward) movement of the proximal control cord 262 relative to the delivery device 300.

The proximal tensioning device 266 provides the ability for the terminating end of the proximal control cord 262 to be movable and unsecured at least over the distance 275 defined by the second anchor lumen 217b and the second distal anchor 264 (see, e.g., fig. 16). In an exemplary embodiment, the proximal tensioning device 266 is a spring having opposing anchor points, a first anchor point of the spring being located at the second distal anchor 264, and a second anchor point of the spring being located at a wall within the anchor cavity 217b of the distal clamping bar 210. These anchor points define the distance 275 that the proximal tensioning device 266 provides to the proximal control cord 262 when the spring is the proximal tensioning device 266. Where the second distal anchor 264 is a ball and the proximal tensioning device 266 is a spring, the end of the spring connecting the second distal anchor 264 is in the form of a circle self-centred on the ball. The proximal tensioning device 266 allows movement of the second distal anchor 264 based on predefined force limits as described above (not repeated here).

Fig. 17 shows the distal control cord and the proximal control cord in shapes as the distal control cord 252 and the proximal control cord 262 take on various passages and cavities through the distal clamping bar 210 and the proximal clamping bar 220, and how they exit at the exits 223, 225, in this exemplary embodiment, starting from the second side 224. When passing through the exits 223, 225, the control cords 252, 262 are stacked, and they may be stacked in either direction. In other words, the exit 225 of the distal control cord 252 may be distal to the exit 223 of the proximal control cord 262, or it may be proximal to the exit 223. For embodiments in which control cords 252, 262 exit at the second side 224, the outlets 223, 225 are shown in fig. 19 at a cord capture assembly 280. The control cords 252, 262 exit the cord capture assembly 280 and are operably connected to the proximal base portion 310. In an exemplary embodiment, proximal base portion 310 has one or two control cord paths in which control cords 252, 262 are oriented, these paths being smooth and allowing free sliding movement of control cords 252, 262 therein. The control cords 252, 262 continue adjacent the handle of the delivery device 300, where a cord control assembly is provided that moves the control cords 252, 262 as necessary to perform the implantation procedure of the detachment clip 200, as described in further detail below.

Fig. 13-28 illustrate one exemplary embodiment of a distal portion of a delivery device 300 for detaching the clip 200. The exemplary distal portion includes a proximal base portion 310, an extension shaft 320, a distal base portion 330, a distal rod movement shaft 340, and a proximal rod movement shaft 350.

The proximal base portion 310 has a body through which the extension shaft 320 passes (the extension shaft may also pass adjacent to, from outside, or at the body of the proximal base portion 310). The extension shaft 320 is radially fixed to remain in one position relative to the main body of the proximal base portion 310, but is free to longitudinally extend distally and retract proximally relative to the main body. In an alternative, non-illustrated exemplary embodiment, the stabilization rod extends proximally from the distal base portion 330 and into the proximal base portion 310. In an exemplary embodiment, the stabilization rod is fixed to the distal base portion 330 and has a longitudinal extent into a hole (which may be a through hole or a blind hole) in the distal face of the proximal base portion 310, the hole having a cross-section substantially similar to the cross-section of the stabilization rod. In this manner, when a force is applied to the distal base portion 330, the force acting on the distal base portion (whether from the environment or transmitted from the handle of the delivery device 300) is not transferred only into the extent 328 of the extension shaft 320 between the proximal base portion 310 and the distal base portion 320.

The distal stem rotation device 322 is fixed at the distal end of the extension shaft 320 and is located in the distal base portion 330 (the distal stem rotation device 322 may be located near, outside, or at a location of the distal base portion 330). The distal rotational device anchor 332 connects the extension shaft 320 to the distal base portion 330 to allow free rotation of the distal stem rotational device 322 relative to the distal base portion 330 while preventing longitudinal movement of the distal stem rotational device 322 relative to the distal base portion 330. The distal rotating device anchor 332 is shown diagrammatically in phantom. In an exemplary embodiment, the distal rod rotation device 322, for example, is shown in fig. 13 and 14 as a helical gear. Thus, the helical gear rotates in the distal base portion 330, but does not move relative to the distal base portion 330 in the axial direction of the extension shaft 320. In an exemplary embodiment, the distal rotary device anchor 332 is a cylindrical blind hole having a given circumference, and the distal rod rotary device 322 has a protrusion having an outer shape corresponding to the given circumference. Thus, the distal rod rotation device 322 is free to rotate in the bore, but cannot move distally to further enter the bore.

The proximal rotational anchor 312 (shown diagrammatically in phantom in the proximal base portion 310) longitudinally fixes a proximal rod rotation device 326 (the proximal rod rotation device 326 may also be positioned adjacent to, outside of, or at a location of the proximal base portion 310) in the proximal base portion 310 relative to the axis of the extension shaft 320, but allows the proximal rod rotation device 326 to freely rotate with any rotation of the extension shaft 320. In an exemplary embodiment, the proximal rotational anchor 312 is configured to allow rotational movement of the proximal rod rotation device 326, but limit axial movement of the proximal rod rotation device 326 in the proximal base portion 310. For example, the anchor 312 may be a thrust bearing assembly in which the hub of the proximal rod rotation device 326 contains a thrust ring that engages an annular recess in the proximal rotation anchor 312. In an exemplary embodiment, the proximal shaft rotation device 326 is a bevel gear. Thus, the bevel gear rotates within the proximal base portion 310 in synchronization with any rotation of the extension shaft 320, but does not move along the axis of the extension shaft 320 relative to the proximal base portion 310. One exemplary embodiment of the attachment of the proximal stem rotation device 326 forms a distal extent 328 of the extension shaft 320 having a polygonal cross-section and providing the proximal stem rotation device 326 with a central cavity having a cross-section corresponding in shape to the polygonal cross-section of the extension shaft 320, the extent 328 of which is shown in fig. 14. Thus, the extension shaft 320 may move freely through the proximal shaft rotation device 326 along its rotational axis, but any rotation of the extension shaft 320 will result in a corresponding rotation of the proximal shaft rotation device 326.

As shown in fig. 15-19, rotation of the distal clamp bar 210 occurs with the distal bar displacement shaft 340. The distal rod movement shaft 340 has a base rotatably fixed on the fifth end 219 a. Opposite the base of the distal rod movement shaft 340 is a distal rod rotation receiver 342, which is connected to the distal rod rotation device 322 and rotates accordingly as the distal rod rotation device 322 rotates. In an exemplary embodiment, the distal rod rotation receiver 342 is a bevel gear. Thus, rotation of the bevel gear of the distal rod rotation device 322 results in a corresponding rotation of the distal clamp rod 210 about the axis of the distal rod movement shaft 340.

If the distal rod movement shaft 340 is permanently fixed to the distal clamp rod 210, the distal clamp rod 210 will not be disposed within the patient (at least not extending laterally from the fifth end 219 a). Thus, the distal rod movement shaft 340 is removably connected to the distal clamp rod 210. In a first exemplary embodiment, shown for example in fig. 13, 15, 16 and 20, this removable connection is formed by a blind shaft bore 213, wherein the base of a distal rod movement shaft 340 is slidably inserted. To retain the distal rod movement shaft 340 in the blind shaft bore 213, the staple channel 211 formed in the distal clamp rod 210 receives the grenade-type staple 360 therein. As long as the grenade-type nail 360 is located in the nail passage 211, the distal rod movement shaft 340 is rotationally and axially fixed in the blind shaft hole 213. When the grenade-type nail 360 is removed, the distal rod movement shaft 340 easily slides out of the blind shaft hole 213 with a small amount of outwardly directed force applied to the distal rod movement shaft 340. To deliver this force at the appropriate time, distal rod rotation receiver 342 is disposed in distal base portion 330 in a freely rotating manner, but is axially restrained in position relative to distal base portion 330. Thus, when the grenade-type nail 360 is pulled out of the nail passageway 211, any force applied to the delivery device 300 that acts to pull the distal rod movement shaft 340 outward will cause the distal rod movement shaft 340 to be removed from the blind shaft bore 213 and disconnect the distal clamp lever 210 from the delivery device 300 (except for the distal control cord 252, which disconnects as described below).

In a second exemplary embodiment, shown for example in fig. 18, 19, 21, 23 and 25 to 27, the removable connection is formed by threaded shaft bores 213, 221a, into which threaded bases 344, 354 of the distal rod moving shaft 340 and the proximal rod moving shaft 350, respectively, are threadedly inserted. When it is desired to remove the distal rod moving shaft 340 and the proximal rod moving shaft 350 from the distal clamp bar 210 and the proximal clamp bar 220, the distal rod moving shaft 340 and the proximal rod moving shaft 350 are properly rotated with respect to the distal clamp bar 210 and the proximal clamp bar 220, respectively. For example, once the control cords 252, 262 have been secured, the clamping bars 200, 220 will no longer rotate relative to each other; in that case, the extension shaft 320 is rotated in one direction to unscrew the distal rod movement shaft 340 and the proximal rod movement shaft 350. When the distal and proximal rod moving shafts 340, 350 are unscrewed from the respective threaded shaft holes 213, 221a, simple movement of the transfer device 300 away from the clip levers 210, 220 removes the distal and proximal rod moving shafts 340, 350 from the detachment clip 200 (except for the control cords 252, 262, the disconnection of which is described below).

As shown in fig. 15-19, rotation of the proximal clamp bar 220 occurs with the proximal bar displacement shaft 350. Proximal stem translation shaft 350 has a base rotationally fixed to fifth end 229 a. Opposite the base of the proximal stem translation shaft 350 is a proximal stem rotation receiver 352 that is connected to the proximal stem rotation device 326 and rotates accordingly as the proximal stem rotation device 326 rotates. In an exemplary embodiment, the proximal shaft rotation receiver 352 is a bevel gear. Thus, rotation of the bevel gear of the proximal rod rotation device 326 causes a corresponding rotation of the proximal clamp rod 220 about the axis of the proximal rod movement shaft 350.

If the proximal rod travel shaft 350 is permanently fixed to the proximal clamp rod 220, the proximal clamp rod 220 will not be disposed within the patient (at least not extending laterally from the fifth end 219 a). Thus, the proximal rod shift shaft 350 is removably connected to the proximal clamp rod 220. In a first exemplary embodiment, shown for example in fig. 13, 15, 16 and 20, this removable connection is formed by a blind shaft bore 221a, wherein the base of proximal rod moving shaft 350 is slidably inserted. To retain the proximal shaft moving shaft 350 in the blind shaft hole 221a, the staple passage 211 formed in the proximal clamp lever 220 receives the grenade-type staple 360 therein. As long as the grenade-type nail 360 is located in the nail passage 211, the proximal rod moving shaft 350 is rotationally and axially fixed in the blind shaft hole 221 a. When the grenade-type nail 360 is removed, the proximal shaft moving shaft 350 easily slides out of the blind shaft hole 221a with a small amount of outwardly directed force applied to the proximal shaft moving shaft 350. To deliver this force at the appropriate time, the proximal stem rotation receiver 352 is disposed in the proximal base portion 310 in a freely rotating manner, but is axially restrained in position relative to the proximal base portion 310. Thus, when the grenade-type nail 360 is pulled out of the nail passageway 211, any force applied to the delivery device 300 that acts to pull the proximal stem moving shaft 350 outward will cause the proximal stem moving shaft 350 to be removed from the blind shaft bore 221a and disconnect the proximal clamping bar 220 from the delivery device 300 (except for the proximal control cord 262, which disconnects as described below).

In a second exemplary embodiment, shown for example in fig. 18, 19, 21, 23 and 25 to 27, the removable connection is formed by a threaded shaft bore 223 into which a threaded base 344 of a proximal rod movement shaft 350 is threadedly inserted. The remainder of the proximal rod movement shaft 340 is identical to the distal rod movement shaft 340 described above and, therefore, will not be described again.

Cord capture assembly 280 is located at exits 223, 225 from which distal control cord 252 and proximal control cord 262 exit proximal clamping bar 220. The cord capture assembly 280 has a structure that allows for controlled free and unobstructed movement of the cords 252, 262 therethrough when the breakaway clip 200 is in its implantation process. When the clamping bars 210, 220 are in the implantation position and ready to be implanted, the control cords 252, 262 are fixed in position. In the exemplary embodiment shown in fig. 13, 15, 20, and 21, and particularly fig. 19 and 28, the cord capture assembly 280 is a spring-hinged door that remains open while the breakaway clip 200 is in the process of being implanted. When the breakaway clip 200 is ready for permanent implantation, the door's spring is released, clamping the door to the control cord lines 252, 262 and permanently holding them in place with the current pre-biasing force that has been applied to the distal and proximal tensioning devices 256, 266.

With the distal control cord 252 and proximal control cord 262 held in place, a cord cutter 314 located at the proximal base portion 310 (shown diagrammatically in phantom in fig. 13) severs the control cords 252, 262.

As described above, the distal rod movement shaft 340 and the proximal rod movement shaft 350 are removably connected to the distal clamp bar 210 and the proximal clamp bar 220. In an exemplary embodiment in which grenade-type nails 360 are used, a nail remover 362 is connected to each of the grenade-type nails 360. Staple remover 362 is shown diagrammatically in FIG. 13 in dotted dashed lines. Before, after, or simultaneously with the cord cutter 314 cutting the control cords 252, 262, a control on the handle of the delivery system 300 is actuated, and a staple remover 362 acts to pull the grenade-type staples 360 out of each of the distal and proximal clamping bars 210, 220. The grenade-type pegs 360 may be retracted all the way to a handle separate from the proximal base portion 310, or they may be pulled into the proximal base portion 310 or into a corresponding recess of the proximal base portion 310 to facilitate evacuation from the patient as the delivery system is evacuated.

With the above configuration, the delivery system 300 enables all controls for performing implantation of the split clip 200, including movement of the distal clip bar 210 relative to the proximal clip bar 220, rotation of both the distal clip bar 210 and the proximal clip bar 220, and extension and withdrawal of the control cords 252, 262. In this regard, reference is made to the accompanying drawings, and in particular to fig. 13 and 20 to 24, with regard to the processes for implementing these controls.

In a first step, the detachment clip 200 is brought to the site of the LAA for LAA detachment in an open state (also referred to as expansion or extension), which is shown in fig. 13 to 18. The surgeon then places the LAA in the interior 272 of the split clip 200 in the direction shown by arrow a in fig. 15, and the fourth side 218, as best as possible, rests against the exterior surface of the heart on either side of the LAA. The pulsatile motion of the heart and the LAA actually ensures that the LAA cannot be positioned in the best possible orientation for separation without further stimulation into an improved position relative to the interior 272 of the separation clip 200. This is why the surgeon is required to use a separate actuator (e.g., a grasper or a blunt (Kittner) dissector) to manipulate the LAA with the surgeon's second hand, thereby requiring the surgeon to use both hands in the past procedure. As explained above, this manipulation is undesirable because damage to the vulnerable LAA can and does lead to catastrophic consequences. In the next step, in the present exemplary embodiment, the delivery device 300 is activated to close the split clip 200 around the LAA by moving the distal clip lever 210 toward the proximal clip lever 220. This movement occurs in two simultaneous actions. One action involves movement of the distal clamp bar 210 in a proximal direction. In particular and with reference to fig. 20, the delivery device 300 moves the extension shaft 320 in a proximal direction (indicated by arrow B). Since the proximal base portion 310, the proximal rotational anchor 312, and the proximal rod rotation device 326 are longitudinally fixed to the delivery device 300, they remain in place as the extension shaft 320 is moved proximally. The proximal clamp bar 220 also remains in place as long as it is attached to the proximal bar moving shaft 340. The distal rotational device anchor 332 allows the extension shaft 320 and the distal rod rotational device 322 to rotate, but proximal movement of the extension shaft 320 causes the assembly comprising the distal base portion 330, the distal rotational device anchor 332, the distal rod rotational device 322, and the distal rod movement shaft 340 to move proximally with corresponding movement of the extension shaft 320. Thus, this movement causes the distal clamp bar 210 to move from its expanded state (e.g., fig. 15) to a retracted or closed state, which is shown in fig. 20-22. The movement of the distal clamping bar 210 is equal to the movement of the extension shaft 320 as indicated by arrow C in fig. 20. As can be seen in these figures, neither the distal clamping bar 210 nor the proximal clamping bar 220 has been rotated. The second simultaneous action involves movement of distal control cord 252 and proximal control cord 262. Because control wires 252, 262 are placed across gap 270, control wires 252, 262 will bend or bunch if not move as distal clamping bar 210 moves toward proximal clamping bar 220. Thus, as movement of the distal clamping bar 210 occurs, the transfer device 300 loosely gathers in the control lines 252, 262. As shown in fig. 13, control cords 252, 262 exit distal clamp bar 224 and connect to proximal base portion 310. These control lines 252, 262 extend back to the handle of the transfer device 300. Loose removal may occur manually or automatically. In a manual procedure, when the surgeon moves the distal clamp bar 210 proximally by rotating the extension shaft 320 such that the delivery device 300 moves the distal clamp bar 210, the surgeon may grasp the proximal ends of the control cords 252, 262 and manually pull the control cords 252, 262 as closure of the breakaway clip 200 occurs. Alternatively, in one exemplary embodiment of the automatic mode, rotation of the extension shaft 320 may be associated with a transmission that is connected to a spindle connected to the proximal end of the control cord 252, 262 and that winds up and releases the control cord 252, 262 as rotation occurs. The transmission may be geared to match the longitudinal movement of the extension shaft 320 with the winding up and release of the control cord 252, 262. For example, for a 2cm proximal movement of the extension shaft 320 (i.e., a 2cm proximal movement of the distal clamp bar 214), the mandrel winds up a 2cm length of the control cord 252, 262. Similarly, for a 1cm distal movement of the extension shaft 320 (i.e., a 1cm distal movement of the distal clamp bar 214), the mandrel releases a 1cm length of the control cord 252, 262.

The detachment clip 200 is now at a location where the surgeon can determine whether the current intermediate implant location is optimal/desired. If the surgeon does not see the current state of LAA detachment, the surgeon causes the extension shaft 320 to extend and separate the clamping bars 210, 220, and then repeats the LAA detachment process steps. The self-actuators 230 of the clamping bars 210, 220 are automatically activated if the surgeon determines that the current state of LAA detachment is desired. The actuator finger 232 is oriented at an angle to a plane 234 defined by the closing movement of the distal and proximal clamp bars 210, 220. As particularly shown in fig. 22, the actuator finger 232 is oriented at a positive angle relative to the plane 234, which is defined as extending upwardly from the plane 234 relative to the view shown in fig. 22 and in a direction (arrow D) in which the LAA is intended to extend through the interior 272 of the detachment clip 200. Thus, in this configuration, the actuator finger 232 acts in the form of a ratchet, allowing movement of the LAA in the direction of arrow D, but inhibiting or restricting movement of the LAA in the direction opposite to arrow D. The importance of this configuration is that the activator finger 232 automatically functions to activate the LAA further into the interior 272 of the detachment clip 200 without the surgeon having to use a separate tool. It is well known that for vibrating part feeders (and toys such as hehbug and power soccer), vibration of the structural body causes directional movement throughout the body. Because the LAA essentially vibrates with the heartbeat, the LAA is naturally and automatically caused by the actuator fingers 232 to increasingly enter the interior 272, and is significantly prevented from exiting the interior 272 by the positive angle of the actuator fingers 232. This means that LAA separation is enhanced due to the presence of the self- actuators 230, 232. In addition to the heartbeat, the surgeon may manually vibrate the delivery device 300 by shaking the hand holding the delivery device 300 to encourage the LAA to further enter the interior 272.

The self-energizing action may be further enhanced by mounting a vibrator at the handle of the delivery device 300. When the vibrator is activated to vibrate the entire delivery device 300 (including the proximal base portion 310 and the shaft extending to or being part of the proximal base portion 310), the detachment clip 200 vibrates, which causes the actuator fingers to actively actuate the LAA more and more into the interior 272. One exemplary embodiment of the vibration is proportional to the separation distance between the actuator fingers 232 on one of the self-actuators 230. For example, if the plurality of fingers 232 on one of the rods 210, 220 has a pitch (spacing) of 1mm, a motion on the order of from about 0.1mm to about 2.0mm will cause a lateral displacement of the fingers relative to the surface of the LAA. If the fingers are spaced 0.1mm apart, vibration from about 0.01mm to about 0.2mm will effect such movement.

After the delivery device 300 has positioned the rods 210, 220 opposite one another during implantation to be in the initial captured state of the LAA shown in fig. 20-22, the surgeon still has the ability to reverse the split clip implantation procedure. When the surgeon determines that the detachment clip 200 is at the desired LAA detachment position, the surgeon activates the delivery device 300 to rotate the distal and proximal clip bars 210, 220 (see the process from fig. 22-23-24) to the final implantation position, as shown in fig. 24-28. The rotation of the clamping bars 210, 220 is caused by the rotation of the extension shaft 320. In the illustrated exemplary embodiment in which distal rod rotation device 322, proximal rod rotation device 326, distal rod rotation receiver 342, and proximal rod rotation receiver 352 are all beveled gears having the same number of teeth, rotation of extension shaft 320 results in direct and corresponding rotation of clamping rods 210, 220, with distal clamping rod 210 rotating clockwise in the views of fig. 21-24, and proximal clamping rod 220 rotating counterclockwise in the same views. Although the distal and proximal clamp bars 210, 220 may simply rotate, if they do not move further relative to each other, the separation distance 236 between the two self-actuators 230 will increase because the self-actuators 230 are located a distance from the rotational axis of the distal and proximal bar travel shafts 340, 350. Thus, to maintain the separation distance 236 substantially constant as the clamping bars 210, 220 are rotated (e.g., from the view of fig. 22 to the view of fig. 24), the two clamping bars 210, 220 move toward each other, which means that the extension shaft 320 moves proximally from the separation distance 238 of the bar rotation receivers 342, 352 shown in fig. 22 to the smaller separation distance 238 shown in fig. 24. Further movement of the distal clamping bar 210 toward the proximal clamping bar 220 also shortens the length of the control cords 252, 262. Thus, in the lever rotation step, the mandrel in the transfer apparatus 300 takes up any further slack in the control cords 252, 262 to keep them under tension.

Rotation of the clip levers 210, 220 into the final implant position effects peristaltic and tensioning movement of the LAA further into the interior 272 of the detachment clip 200. This peristaltic and tightening movement is beneficial because by ensuring that the clip sits closely against the outer wall of the atrium, a minimal amount of unclamped LAA is created, thereby minimizing the remaining pockets or "dog ears". Even with the distraction clip in the final implantation position, the surgeon still has the ability to partially or completely reverse the distraction clip implantation process.

In the final implanted position shown in fig. 24-28, the self-activator 230 is no longer abutting the portion of the LAA compressed between the clamping bars 210, 220. Conversely, with the fourth sides 218 of the clamping bars 210, 220 facing each other, the LAA-contacting surface 240 is the major surface that contacts the opposite compression side of the inserted LAA. It is desirable to leave all surfaces of the detachment clip 200 in contact with the LAA intact. Thus, the front edges of the self-actuators 230 adjacent to the rear edge of the LAA-contacting surface 240 have surfaces that provide a smooth transition, in particular they have the same height, and the self-actuators 230 continue the corresponding curve of the opposing LAA-contacting surface 240. Similarly, the edges and/or corners of the third sides 216, 226 facing the LAA-contacting surface 240 are curved and/or angled.

At the final implant position of the split clip 200, a clip release sequence may begin. First, control cords 252, 262 are pulled taut to pre-bias distal rod bias subassembly 250 and proximal rod bias subassembly 260 located in distal clamp bar 210. The pre-biasing may occur manually. For example, under manual operation, the surgeon may pull on control cords 252, 262 (or levers in the handle connected to control cords 252, 262) to move first and second distal anchors 254, 264. The amount of force applied to control cords 252, 262 may be displayed as a bar in a window of the handle, for example, when the first and second cords are aligned, the desired pre-biasing force occurs. Alternatively, the pre-biasing may occur automatically. For example, an electric motor controlled by a microcontroller may wind a mandrel around the control cords 252, 262 and measure the force exerted on the control cords 252, 262. The force measurement may be made by movement of a spring scale in the handle or by, for example, a switch or electronic transducer, and when this amount of force is detected, activation of the motor may be stopped. In a pre-biased state in which the distal rod biasing subassembly 250 and the proximal rod biasing subassembly 260 are in a spring configuration, such as shown in fig. 16, the first and second distal anchors 254, 264 may be pulled into a biased position, such as shown in fig. 28. At such locations, the expansion force of the captured LAA (e.g., due to expansion) may be absorbed by additional movement of the first and second distal anchors 254, 264, and the desiccation and/or contraction of the captured LAA may be explained by the expansion of the spring and the return movement of the first and second distal anchors 254, 264.

Thus, the configuration of the tensioning devices 256, 266 allows the detachment clip 200 to have the ability to compensate for variations in the force applied to the clip levers 210, 220 after the detachment clip 200 is applied to the LAA, for example, after the LAA tissue is dried and/or deformed. More specifically, during implantation, the surgeon secures the detachment clip 200 on opposite sides of the LAA. The surgeon or the delivery device 300 then pulls on the distal control cord 254 and the proximal control cord 264 such that the distal tensioning device 256 and the proximal tensioning device 266 compress the LAA to a desired degree. The control cords 254, 264 are then secured in the cord capture assembly 280 with the tensioning devices 256, 266 in a compressed state. In essence, this pre-biases the force applied to the LAA, and if tissue expands between the clamp bars 210, 220, the tensioning devices 256, 266 act to reduce the force on the expanded tissue. Similarly, if tissue contracts between the clamp bars 210, 220, the tensioning devices 256, 266 act to increase the force on the contracted tissue. In these ways, the tensioning devices 256, 266 will accommodate contraction or expansion of the LAA within the limits of their displacement range.

The control cords 252, 262 are now ready to be secured, thereby preventing further movement of the control cords 252, 262 from outside the breakaway clip 200. Therefore, in the next step, the cord cutter 314 cuts the control cords 252, 262. After or during the string cutting, the rod movement shafts 340, 350 are removed. In embodiments having a grenade-type nail 360, the nail remover 362 is actuated to remove the grenade-type nail 360, and the distal base portion 330 and the proximal base portion 310 are moved away from the implanted breakaway clip 200. Thus, the rod moving shafts 340, 350 are pulled out of the clamp rods 210, 220 to clear the detachment clamp 200 implanted on the LAA. Alternatively, in embodiments where the rod movement shafts 340, 350 are threaded into the clamp rods 210, 220, the extension shaft 320 is rotated to release the rod movement shafts 340, 350. Without further connection to the clamp bars 210, 220, the distal base portion 330 and the proximal base portion 310 fall off the implanted detachment clamp 200 to exit the detachment clamp 200 implanted on the LAA.

Referring now to fig. 32-42, a third exemplary embodiment of an external implantable left atrial appendage detachment clip 400 is shown that operates according to a spring-biased mechanism similar to the exemplary embodiment of fig. 1-12. In this embodiment, the breakaway clip 400 includes a clip assembly 402 and a biasing assembly 404. Further, the clip assembly 402 is comprised of two opposing clip bars, referred to herein as a first clip bar 410 and a second clip bar 420. Further, the biasing assembly 404 is comprised of a single closed-circuit biasing member 408 (which is shown separately in fig. 39) molded in two portions 408a, 408b (see fig. 48-51) to form, in general terms, two straight, parallel, co-planar elongate portions 406 that transition into two turnaround sections 450, each turnaround section 450 being positioned distally of the clip 400 relative to the other turnaround section and extending in an upward direction (along the y-axis) and substantially perpendicular to the plane of the elongate portions 406. As best shown in the bottom, separated and exposed views presented in fig. 37-39, each of the elongated portions 406 of the biasing member portions 408a, 408b sharply transitions to its respective turn section 450 at a curved section 452 that diverges outwardly (along the x-axis) from the elongated portion 406 and begins to rise in an upward direction (along the y-axis). The curved sections 452 lead or twist upwardly into oblong "racetrack" turnaround sections 450, wherein each turnaround section 450 is characterized by two inwardly facing curved portions 454 that are interconnected at the apex of the turnaround section 450 by a flat intermediate portion 456 (although the intermediate portion 456 has advantages in bending, as will be described below). This orientation and configuration of the turnaround sections 450, and the shape of each turnaround section 450, creates a preloaded spring bias force that biases the elongated sections 406 toward each other. Other advantageous aspects of the racetrack shape are that it has a larger opening and a lower height than the spring in the embodiment of fig. 1, for example. Also, the racetrack shape allows the clip 400 to have a lower opening load, but still have substantially the same clamping force applied to the surface of the LAA. The biasing member 408 is comprised of any suitable biocompatible material having a desired spring constant k. Examples of such materials include, but are not limited to, chromium cobalt alloys, stainless steel, titanium alloys, and superelastic alloys (such as Ni-Ti). If beneficial, the different materials may comprise different segments of the biasing member 408 such that there is a variation in stiffness along the length of the biasing member 408. The "racetrack" turn section 450 of this exemplary embodiment has a lower profile when compared to the "horseshoe" spring member 150 of the exemplary embodiment of the detachment clip 100 depicted in fig. 1-12, resulting in a less invasive clip structure and less open space from which LAA tissue may leak or escape. In further comparison, the "racetrack" turnaround portion 450 also has a wider span and longer distance, thereby increasing the amount of flex capacity available when the breakaway clip 400 is placed in its expanded state (which is described in detail below), thus allowing the breakaway clip 400 to assume a wider stance relative to the LAA during its initial capture. Further, since the bend section 452 can begin and end before the distal-most extent of the distal ends 419, 429 by providing a recessed pocket 472, the bend section 450 can be disposed above the first sides 412, 422 of the clamp bars 410, 420 and not a longitudinal distance from the distal ends 419, 429. Briefly, implantation of the detachment clip 400 substantially mimics the procedure described above with respect to the exemplary embodiment of fig. 1-12, wherein the user-controlled clip delivery device provides a counter force to the inherently provided spring biasing force of the biasing member 408 to place the detachment clip 400 in an initial expanded state to expand the internal opening of the detachment clip 400. Using the clip delivery device, the surgeon places the expanded clip 400 around the LAA to, in conjunction with controllably releasing the applied reactive force, cause the detachment clip 400 to urge the LAA into the internal opening of the clip, surrounding the base portion of the LAA during the intermediate capture state, and assuming a final implant state in which the inherent spring biasing force of the biasing member 408 biases one or both of the elongate portions 406 of the biasing member 408 toward the other to form a secure grip on the LAA. It should be noted that fig. 32-41 depict the breakaway clip 400 only in its freestanding (or at rest) state, wherein no external counter force to the inherent spring biasing force is applied to the clip 400. Fig. 42 depicts the breakaway clip 400 engaged by an exemplary embodiment of the clip application head 480 of a clip transfer apparatus, not shown, wherein the breakaway clip 400 has not yet expanded and remains in this resting state.

Furthermore, in contrast to other prior art detachment or occlusion devices of this type, it is believed that the shape and configuration of the biasing member 408 of the presently described embodiments advantageously requires a slower or more gradual lifting of the amount of reactive force required to place the detachment clip 400 in its expanded state, while still ensuring that, once applied, the detachment clip 400 provides a sufficient amount of gripping force required to occlude the fluid pathway of the LAA and permanently secure the detachment clip 400 in place.

Referring now to the clip assembly 402 of the separation clip 400, the bodies of the first clip rod 410 and the second clip rod 420 are composed of any one of one or more suitable biocompatible materials, such as titanium, stainless steel, chromium cobalt alloy, nickel titanium alloy, ceramic, polyetheretherketone, liquid crystal polymer, polymethylmethacrylate, and epoxy. Further, with the split clip embodiments described above, the bodies of the clip levers 410, 420 are formed to be absent or free of any sharp edges or corners that could potentially cause tissue damage in the patient. Each edge or corner of the clamp bar body is rounded, curved or beveled to form a smooth or blunted exterior. With respect to the configuration and profile of the first and second clamp bars 410, 420, each clamp bar 410, 420 is a mirror image of the other. Further, each clamping bar 410, 420 may be generally described as a hexagonal rectangular column. However, each clamping bar 410, 420 has several significant shape and structural features. Broadly speaking, each clamping bar 410, 420 includes a first side 412, 422, a second side 414, 424, a third side 416, 426, a fourth side 418, 428, and two opposing ends 419a-b, 429 a-b. To connect the clamping bars 410, 420 to the biasing member 408 to form the complete breakaway clip 400, each clamping bar 410, 420 is configured with a longitudinal cylindrical through-hole or channel 460 through a central region of the clamping bar body, wherein each of the two elongated portions 406 of the biasing member 408 traverses through the through-hole or channel 460 such that each clamping bar 410, 420 is freely rotatably mounted about a respective one of the elongated portions 406 of the biasing member 408. The through hole or channel 460 is best shown in fig. 37, which shows the underside of the breakaway clip 400 when the clip 400 is in its rest state (see also the cross-section of fig. 38). As shown, the recessed areas of the third sides 416, 426 of the clamp bars 410, 420 partially expose portions of the through-holes or channels 460 such that areas of the elongated portion 406 of the biasing member 408 are visible. In addition, fig. 38, 40 and 41 depict a breakaway clip 400 in which a longitudinal segment of the first clip lever 410 is omitted for clarity and illustration so that a cross-section of the first clip lever 410 can be viewed. From this cross-sectional view, the through-hole or passage 460 can be seen, through which the respective elongated portion 406 of the biasing member 408 passes. Thus, to accommodate the elongated portion 406 of the biasing member 408, the diameter of the through-hole or passage 460 is greater than the diameter of the elongated portion 406. To hold and stabilize the stabilization bars 410, 420 in place relative to the biasing member 408 such that the bars 410, 420 are not allowed to slide longitudinally along the z-axis on the elongated portion 406, each elongated member 406 contains a fixation strap 409 (e.g., at any intermediate longitudinal point or longitudinal midpoint of the bars 410, 420). In an exemplary embodiment, securing strap 409 is a crimp sleeve. When securing strap 409 is located at the longitudinal midpoint of clamping bars 410, 420, the two portions 408a, 408b of biasing member 408 may be made identically, as depicted in fig. 48-51. An exemplary embodiment of securing strap 409 has a diameter greater than the diameter of through-hole or channel 460 and is captured in widened notch 407 at a mid-point of through-hole or channel 460, respectively, with the ends of opposing portions 408a, 408b positioned such that securing strap 409 can secure both spring member portions 408a, 408b to clamp bars 410, 420. Longitudinal movement of the clamping bars 410, 420 is limited by longitudinal movement of the securing strap 409 either in the notch 407 (if there is a gap therein) or between the turnaround sections 450 of the biasing member 408 (where the gap in the notch 407 is greater than the curvature of the turnaround sections 450). Thus, with each clamping bar 410, 420 mounted about a respective elongated portion 406 of the biasing member 408, wherein the distance between the two parallel elongated portions 406 is less than the distance between the through hole or channel 460 and the third sides 416, 426, the clamping bars 410, 420 are likewise biased toward the other clamping bar 410, 420 due to the inherent spring biasing force of the biasing member 408.

As mentioned above, each clamping bar 410, 420 is mounted about the respective elongate portion 406 such that the clamping bars 410, 420 can freely rotate relative to the elongate portion in response to an external force applied to the clamping bars 410, 420, without requiring separation of the clamping bars 410, 420 by placing the separation clamp in its expanded state. This rotational freedom is possible due to the through hole or passage 460 of the clamp bar body, regardless of the pre-loaded spring biasing force generated by the biasing member 408. As described above in connection with the previously disclosed exemplary embodiments of the detachment clip and clip delivery apparatus and corresponding methods of implantation, rotation of the clip lever during the final stage of implantation of the detachment clip facilitates manipulation of the LAA further into the interior of the clip and enhances the gripping force exerted by the detachment clip as it is applied to the LAA. A description of an exemplary embodiment of an overall implantation procedure of detachment clip 400 is set forth in the following description. In a starting step, a clip transfer apparatus compatible for use with separating clips 400 is configured to temporarily engage and retain clips 400. An exemplary embodiment of a clip applicator head 480 of a suitable clip delivery apparatus for temporarily engaging a detached clip 400 is depicted in fig. 42, wherein the clip applicator head 480 is located at the distal end of a not shown elongate shaft that interconnects the clip applicator head 480 with a not shown control handle of the clip delivery apparatus. In this embodiment, the clip application head 480 is in the form of a C-shape comprising two oppositely positioned arms 486a, 486b interconnected by a bridge 488, wherein each of the clip levers 410, 420 is secured to an adjacent one of the clip application arms 486a and 486b by one or more cords 482, 484 (e.g., sutures), respectively, that encircle or pass through eyelets 490 formed in the lower portion of each of the clip lever ends 419a-b, 429 a-b. The importance of the location of the eyelet 490 is that the threads 482, 484 are isolated from any tissue located between the clamp bars 410, 420 and are not pinched or contacted by the LAA or the clamp bars 410, 420. The eyelets 490 are best shown in fig. 32, 33, 36 and 41, where each eyelet 490 includes an aperture through which one or more cords 482, 484 may pass. Further, the circumference at the entrance and exit of each eyelet 490 is beveled or rounded to avoid any sharp or sharp edges that may damage (e.g., break) the cords 482, 484 or cause any undue stress or tension to the cords when operating to control movement of the clamp bars 410, 420. Further, to allow for the presence of the eyelet 490 and provide sufficient clearance for the cords 482, 484, triangular cutouts 495 are formed on both distal ends of each of the third sides 416, 426 of the clamping bars 410, 420 proximate to the eyelet 490 (as best shown in fig. 34, 36, and 37). Referring back now to fig. 42, one or more cords 482 are wrapped around the respective eyelets 490 of each of the two clip bar ends 419a, 419b of the first clip bar 410 and tightened such that the first clip bar 410 is fixedly held against the adjacent clip application arm 486 a. To maintain the tautness of the cords 482, both ends of each cord 482 are attached or connected to the clip applier arm 486a at attachment points 485 by, for example, a suture crimping mechanism that secures the cords 482 at the attachment points 485, respectively. Accordingly, cord 482 may be advantageously characterized as "retaining" the cord. Conversely, with respect to the second clamp bar 420, one or more cords 484 similarly pass through or around the respective eyelets 490 of each of the two clamp bar ends 429a, 429b of the second clamp bar 420, but with some slack left so that an operator of the clamp delivery apparatus can selectively tighten or release the cord 484, when placing the distraction clamp 400 in its expanded condition, pull the second clamp bar 420 away from the stationary first clamp bar 410 in a direction toward the clamp application arm 486b with a force that counteracts the inherent spring biasing force of the clamp 400, and controllably release the applied counteracting force to allow the spring biasing force of the distraction clamp 400 to cause the second clamp bar 420 to adopt its biased position so that it is in close proximity to the stationary first clamp bar 410 when placing the distraction clamp 400 in its intermediate capture and final implanted condition. Thus, as depicted in fig. 42, each strand 484 is directed through the clip application arm 486b, out of the clip application arm 486b to extend through the clip delivery device in a proximal direction, and is operably connected to a control handle (not shown) of the clip delivery device such that the surgeon can selectively tension or release the strand 484 at the control handle. As such, the cord 484 may be advantageously characterized as a "tensioned" cord, thereby distinguishing the cord 484 from the "retention" function provided by the cord 482. With respect to this cord tensioning mechanism, it should be noted that the placement of the eyelet 490 relative to the clip application arms 486a-b advantageously places the reaction force (or tensioning force) from the cords 482, 484 in line with the inherent spring biasing force of the detachment clip 400, which increases the efficiency of the reaction force mechanism and prevents the cords 482, 484 from impeding or interfering with the rotational freedom of the clip levers 410, 420 and potentially becoming lodged in the interaction between the detachment clip 400 and the LAA tissue.

Thus, after the detached clip 400 has been removably engaged with the clip application head 480, the clip 400 is prepared for its application to the LAA by controllably transitioning the clip 400 to an expanded state to widen the interior opening of the clip 400 by displacing one or both of the clip bars 110, 120 in a direction opposite to the other of the clip bars 110, 120. In the above example of the cord tensioning mechanism of the clip applicator head 480, this expanded state may be achieved by tensioning the tensioning cord 484 to pull the second clip lever 420 in the direction of the adjacent clip application arm 486 b. Depending on the type of configuration of the clip delivery device, expansion of the detached clip 400 can be performed before or after the surgeon advances the clip delivery device into the patient's chest cavity by any of the surgical methods previously described. In this regard, it should be noted that the elongate shaft of the control device extends upwardly in the direction shown in fig. 42, which is 90 degrees to the longitudinal extent of the arms 486a, 486 b. In an alternative exemplary embodiment not shown, the elongate shaft may extend from the bridge 488 parallel to the clip applying arms 486a, 486b in a direction opposite to the direction in which the arms 486a, 486b extend. This parallel orientation results in a narrower conveyor apparatus than shown in fig. 42 when the range is 90 degree orientation.

Although not shown in the figures, when the breakaway clip 400 is in its expanded state, each of the four sides 412, 422, 414, 424, 416, 426, 418, and 428 of the clip 400 is rotated substantially 90 degrees from the position shown in fig. 33. Specifically, the first sides 412, 422 of each of the clamp bars 410, 420 face inward (along the x-axis) toward the interior of the clamp 400 such that the two first sides 412, 422 are positioned face-to-face and substantially directly opposite each other. The second side 414, 424 of each clamp bar 410, 420 is positioned at a substantially 90 degree angle relative to the first side 412, 422 of the respective clamp bar 410, 420 and faces in an upward direction along the y-axis. Further, the fourth side 418, 428 of each clamping bar 410, 420 is also positioned at a substantially 90 degree angle relative to the first side 412, 422 of the respective clamping bar 410, 420, but toward the opposite direction of the first side 412, 422, i.e., downward along the y-axis. Further, the third side 416, 426 of each clip lever 410, 420 forms a common edge with the respective second side 414, 424, forms a common edge with the respective fourth side 418, 428, and is positioned relative to the respective first side 412, 422 such that it is directed in a direction along the x-axis outwardly away from the interior of the split clip 400 (i.e., toward the clip application arms 486a, 486b when installed within the clip application head 480). Similar to the exemplary embodiment of fig. 1-12, the third sides 416, 426 each exhibit a curve or curve that is arched inward along the x-axis (i.e., toward the interior of the clip 400) to form a concave surface. Finally, each pair of ends 419a-b, 429a-b of each clamp bar 410, 420 comprises two opposing ends of the clamp 400, wherein each end 419a-b, 429a-b faces in a direction perpendicular to the x-axis and the y-axis (i.e., along the z-axis).

It should be noted that while the configuration of the biasing assembly 404 and the clip assembly 402 enables each clip lever 410, 420 to freely rotate relative to the biasing member 408, in order to control and effectively apply the detachment clip 400 to the LAA, the range of operation or degree of rotation should necessarily be limited to, for example, substantially 90 degrees. As such, in the exemplary embodiment of the breakaway clip 400, a shoulder 470 recessed into a pocket 472 (best shown in FIG. 36) is formed in a middle portion of each clip lever end 419a-b, 429 a-b. The back of pocket 472 enters through-hole or passage 460. Accordingly, the curved section 452 of each turnaround section 450 of the biasing member 408 is inserted into the pocket 472 and into the through-hole or passage 460 such that each turnaround section 450 is beneficially positioned substantially flush with the respective clamp bar ends 419a-b, 429 a-b. When the distraction clip 400 is placed in its expanded configuration with the second side 414, 424 of each clip lever 410, 420 facing in an upward direction at a substantially 90 degree angle relative to the y-axis, the geometry of the shoulder 470 not only accommodates the corresponding curved segment 452 of the turnaround segment 450, but also is in abutting contact with the curved segment 452 such that the clip levers 410, 420 are not permitted to rotate beyond that point (i.e., the second sides 414, 424 of each clip lever 410, 420 are not permitted to form θ >0 ° relative to the x-axis).

Turning now to the next step of the implantation method, once the surgeon delivers the split clip 400 (in its expanded state) into the chest cavity and to the location of the LAA, the surgeon carefully advances the LAA into the central opening (not shown) of the expanded split clip 400 (in the direction shown by the dashed arrow in fig. 33) such that the base portion of the LAA is located between the first side 412 of the first clamping bar 410 and the first side 422 of the second clamping bar 420, and the fourth side 418 of the first clamping bar 410 and the fourth side 428 of the second clamping bar 420 are stationary, as best as possible, in face-to-face contact with the topography of the outer surface of the heart on either side of the LAA. At this stage, the initial acquisition of the LAA is complete.

Thereafter, the surgeon actuates the clip delivery device to controllably close the detachment clip 400 about the base portion of the LAA to the extent that the clamping force exerted on the LAA by the first sides 412, 422 of the clip levers 410, 420 is sufficient to effectively inhibit blood flow into and out of the interior of the LAA. In the above-described exemplary embodiment of the cord tensioning mechanism of the clip applier head 480, this intermediate captured state mitigates or mitigates the magnitude of the reaction force exerted by the clip transport apparatus against the inherent spring biasing force of the biasing member 408 by releasing the tensioning cord 484. Relieving the reaction force allows one or both of the clamping bars 410, 420 to passively return to their inherent spring-biased condition, thereby allowing one or both of the clamping bars 410, 420 to move in an inward direction toward the opposing clamping bar 410, 420. At this stage of the implantation process, the surgeon may now evaluate the position of the split clip 400 to determine whether the current intermediate position is optimal and effective, or whether the clip 400 needs to be repositioned by repeating these initial steps.

When the surgeon has determined that the distraction clip 400 is at the desired location for LAA distraction, the surgeon actuates the clip delivery apparatus to place the distraction clip 400 in a final implant state, which is generally depicted in FIGS. 32-41. As further depicted in fig. 33, this final implanted state of the split clip 400 is characterized by each of the first and second clip levers 410 and 420 being rotated substantially 90 degrees relative to each of the turnaround sections 450 of the biasing member 408. As shown in fig. 32-41, this transition results in the first side 412, 422 of each clip lever 410, 420 facing in an upward direction along the y-axis, the second side 414, 424 of each clip lever 410, 420 facing in an outward direction along the x-axis, and the third side 416, 426 facing in a downward direction along the y-axis, such that each of the third sides 416, 426 now contains a clip surface that abuts the heart topography surrounding the base portion of the LAA, and the fourth sides 418, 428 facing each other in an inward direction along the x-axis, such that each of the fourth sides 418, 428 are pressed into face-to-face contact with the outer surface of the LAA. (it should be noted that the surfaces of the fourth sides 418, 428 shown in FIGS. 32-41 are depicted as contacting each other. however, this orientation is not applicable when tissue such as LAA is located therebetween

As described above, to produce a 90 degree rotation of the clamp rods 410, 420 relative to the turnaround section 450, a torsional force must be applied to each clamp rod 410, 420 to cause an angular displacement. For the present exemplary embodiment, the torque force is generated by the surgeon actuating a portion of the control handle to begin releasing the reaction force applied by the cord 484 of the clip delivery apparatus. As the force applied to the cord 484 is released, the clamp levers 410, 420 move toward each other. The first geometry of the first sides 412, 422 allows the clamping bars 410, 420 to be rotated from a horizontal orientation to a vertical orientation as desired. This first geometry is best depicted in fig. 33 and 36. In particular, the first sides 412, 422 are not coplanar with the third sides 416, 426. In contrast, first sides 412, 422 are angled from the horizontal, each surface being angled inward/downward, respectively, as the surface extends from corners 412a, 422a toward self-actuator 430 (or toward fourth sides 418, 428 when the self-actuator is not present). Although the clamping bars 410, 420 are not depicted in the horizontal direction, when the clamping bars 410, 420 eventually contact each other in close proximity, the two edges 412a, 422a are the first position of contact of the clamping bars 412, 420. Because the first sides 412, 422 are angled, the geometry of these surfaces is such that the first clamping bar 410 rotates counterclockwise and the second clamping bar 420 rotates clockwise in the desired direction to initiate the final LAA implantation movement. The second geometric feature facilitates this rotational movement of the clamp rods 410, 420. In particular, the geometry of the eyelet 490 relative to the elongated portion 406 residing in the through-hole allows the clamp bar 410 to be moved from a horizontal orientation (e.g., as shown in fig. 29 and 30) and rotated to an installation orientation such as that depicted in fig. 34-37. More specifically, the center point of the aperture 490 is located below the center point of the elongated portion 406, as indicated by distance D in fig. 33. When the tensioning cord 484 is pulled on the clamp lever 410, the clamp lever 410 pivots about the center point of the elongated portion 406 to move the clamp lever 410 through a 90 degree angle. The line 482 is secured in the arm 486a and passes through the eyelet 490 of the clamp lever 420. Accordingly, the pulling force exerted by the cord 484 on the clamp lever 410 also causes a corresponding 90 degree rotation of the clamp lever 420, which has the same two center points for the eyelet 490 and the elongated portion 406 passing through the clamp lever 420. The closing of the clip 400 causes the reverse motion to occur. Specifically, when the surgeon closes the clip 400 by allowing the clamp bars 410, 420 to approach together, the first contact with the LAA tissue disposed therebetween is through the first sides 412, 422 of each of the clamp bars 410, 420. As the force applied to the cord 484 continues to decrease, the clamp levers 410, 420 have no other way of rotating other than pivoting about the elongated portion 406 because the moment arm of the force applied about the axis of the elongated portion occurs at the eyelet 490. Thus, the clamp bars 410, 420 are rotated 90 degrees toward each other (clamp bar 410 counterclockwise and clamp bar 420 clockwise) and, at the same time, the self-activator grips 430 the LAA tissue and forces the LAA into the intervening space between the clamp bars 410, 420 in the direction of the dashed arrow in fig. 33.

The biasing assembly 404 also assists in rotating the clamping bars 410, 420 about and over the LAA tissue, and does so by including a rake or recess 458 in the middle portion 456 of the turnaround section 450, as shown in fig. 43 and 47. When the biasing member 408 is installed in the clip application head 480 and the two clip levers 410, 420 are pulled apart, the middle portion 456 is elongated such that the recess 458 is straightened (this is ideally depicted in fig. 32-42, but in practice, the recess 458 is not perfectly straight during use of the clip 400). As the recesses 458 straighten and shallowly, the curvature of the recesses 458 applies a force to each of the respective opposing turnaround sections that is clockwise for the clamping bar 420 and counterclockwise for the clamping bar 410, which is the exact force required to move the clamping bars 410, 420 from the horizontal installation position to the vertical installation position. These rotational forces supplement and increase the natural movement of the clamp bars 410, 420 caused by the geometry of the eyelet 490 and the pivot axis of the elongated portion 406, and are more effective with the fourth sides 418, 428 further away from each other due to LAA tissue being clamped therein. Further, the reduced curve protruding into the central opening of the turnaround section 450 positions the material of the recess 458 at the cassette location in the LAA tissue to further inhibit extrusion of the LAA tissue longitudinally through the central opening.

In addition to the circling effect, a further benefit of the 90 degree rotation of the clamp rods 410, 420 is that the LAA tissue surface can be advantageously exposed to a range of different surface types of the clamp rods 410, 420 as the split clamp 400 transitions through its expanded or initial capture, intermediate capture, and final implanted states during a single implantation procedure. More specifically, each surface area of the clamp bars 410, 420 that is in contact with the LAA may be cleverly configured to have a particular surface type that is well suited for the function of face-to-face interaction, and the time at which the interaction between the LAA and this characteristic surface area of the clamp 400 occurs. For example, for the above-described exemplary embodiment of the split clip 400, the LAA contacting surfaces thereof (i.e., the first sides 412, 422, the fourth sides 418, 428 and the common edge 432 therebetween) are configured to each have a different type of surface texture such that when the split clip 400 is advanced to its final implanted state with the clip levers 410, 420 advanced to substantially 90 degrees of rotation, the LAA experiences an increased degree of frictional contact with the clip levers 410, 420 due to the first sides 412, 422, the rounded common edge 432 and the fourth sides 418, 428 of each of the clip levers 410, 420 sequentially contacting the LAA. Thus, in conjunction with the rotational movement of the clamp bars 410, 420, this increased degree of friction helps to encourage and guide the LAA into the interior of the clamp 400, and then forms a secure grip around the LAA. Since the first side 412, 422 is the surface area of the clamping bar 410, 420 that initially makes facial contact with the LAA in the intermediate capture state of the clamp 400, and as rotation of the clamping bar 410, 420 begins during the final implant state, the first side 412, 422 may be molded or trimmed to be substantially flat and have an ultra-low friction surface that lightly engages the LAA and enters the rotation of the clamping bar 410, 420 substantially frictionless. As the rotation of each clip lever 410, 420 continues, the first side 412, 422 of the clip lever 410, 420 slides upward and away from the outer side of the LAA so that the LAA then contacts a rounded common edge 432 located between the first side 412, 422 and the fourth side 418, 428 of the clip lever 410, 420. Thus, as previously described, at this point in the implantation process, the sweeping movement of the inwardly traveling clamp bars 410, 420 is intended to encourage the LAA to further enter the internal opening of the clamp 400. As such, the friction may be increased by molding or trimming the rounded common edge 432 to have a rougher surface texture, or, as depicted in fig. 32-41, a "self-activator" or traction member 430 may be advantageously applied to the common edge 432 such that when movement of the clamp bars 410, 420 activates the LAA into the interior of the clamp 400, the LAA is immediately exposed to the resulting higher friction surface. Features of such a "self-energizing" or traction member are described in detail above with respect to member 130 in the exemplary embodiment of fig. 1-12. Alternatively, common edge 432 may also be substantially flattened to have an ultra-low friction surface. As previously described, when the rotation of the clamping bars 410, 420 is complete, the LAA is securely grasped at the oppositely positioned fourth sides 418, 428 of the clamping bars 410, 420 to place the clip 400 in its final implanted state. The fourth sides 418, 428 may have a substantially flat ultra-low friction face. Alternatively, to enhance the grip of the clip 400 on the LAA, the frictional force generated by the fourth sides 418, 428 of the clip levers 410, 420 may be further enhanced by applying a higher friction surface to one or both of the fourth sides 418, 428. Alternatively, the surface of one or both of the fourth sides 418, 428 of the clamping bars 410, 420 may be molded or finished to have a high friction surface. Fig. 45 depicts one exemplary embodiment of a specific surface texture that may be applied to or integrally formed with one or both of the fourth sides 418, 428 of the clamping bars 410, 420. For purposes of clarity and illustration, the first clamping bar 410 is omitted to better visualize the surface of the fourth side 428 of the second clamping bar 420. In this embodiment, the surface texture consists of small stripes or channel-like knurls 442 oriented at an angle that increase friction between the LAA and the fourth side 418, 428 of the clamp bar 410, 420 and prevent any movement of the LAA back out of the clamp 400. Further, fig. 46 illustrates another exemplary embodiment of a specific surface texture that increases frictional contact with the LAA when applied to or integrally formed with one or both of the fourth sides 418, 428. Again, the first clamping bar 410 is omitted from this view to better visualize the surface of the fourth side 428. In this embodiment, the surface texture consists of pyramidal knurls 444 oriented to increase friction and resist rearward movement of the LAA. Figure 47 shows the knurls 444 in more detail. Thus, by varying the type of surface between the LAA-contacting surfaces of the clip 400, it is possible to expose the LAA to different frictional surfaces at different but appropriate times in a single implantation procedure that facilitates the function of the clip 400. For example, in the embodiment just described, the face-to-face interaction between the LAA and clip 400 transitions from a "smooth" contact to a "grasping" contact through a single implantation procedure.

Although this 90 degree rotation of the clip levers 410, 420 is the final stage of implantation, the surgeon may continue to adjust the position of the split clip 400 by reversing the closing of the clip 100, returning the clip 400 to its expanded state, and repeating the closing and rotating steps as many times as necessary as described above. Once the surgeon is satisfied with the placement of the clip 400, the clip applier head 480 of the clip delivery device is permanently detached from the detached clip 400. For example, in the exemplary embodiment of a cord tensioning mechanism described above with the clip applicator head 480 of fig. 42, each clip applicator arm 486a-b may be configured with an internal cord disconnect mechanism 500 by which a surgeon may selectively sever the cords 482, 484. In one example, each clip application arm 486a-b can be configured with a slider (not shown) having one or more cutouts defined therein, the cutouts having edges (not shown) and being formed, for example, in a photolithographic process. The incision is positioned such that when disconnection of the cords 484, 482 is desired, the surgeon moves the slider to bring the edges of the incision into contact with the cords 482, 484.

Fig. 48 to 51 show an exemplary embodiment of forming two spring member portions 408a, 408 b. The spring member portions 408a, 408b are formed by two-part dies 510, 512. The two parts are hinged to each other. To manufacture the spring member portions 408a, 408b, the mold portions are flattened and a length of wire forming the spring member portions 408a, 408b is laid flat in the track of the mold. The first mold portion 510 has an elongated portion 506 and a portion of a transition section 452. Second mold portion 512 includes the remainder of transition section 452, turnaround section 450, and intermediate portion 456 having recess 458. The second mold portion 512 is rotated to the position shown in fig. 48 and 49 and the assembly is heated to set the wires of the spring member portions 408a, 408b into the shape shown in fig. 44, for example. Fig. 50 and 51 show the spring member portions 408a, 408b and the second mold portion 512 without the first mold portion 510.

An anterior view of the heart 10 in fig. 52 shows how the LAA 20 is positioned away from and against the outer surface 14 of the left atrium 12 to form a flap. In most cases, the flap formed by the LAA 20 against the outer surface 14 is flaccid, and the surgeon can manipulate the LAA 20 using a blunt Kittner dissector to erect the LAA. In such a position, the interior (e.g., 172, 272) of the detachment clip (e.g., clip 100, 200, 400) is positioned above the outermost point of the LAA 20 and the detachment clip slides down around all surfaces of the LAA 20, thus, the surgeon positions the detached side (e.g., 110, 120) of the clip at the base 22 of the LAA relative to the two opposing sides of the LAA. In some cases, however, the LAA 20 may have an adhesive force that holds the portion of the LAA facing the side 24 of the left atrium 12 to the outer surface 14 of the left atrium 12. In this case, the wings of the LAA 20 are fixed in one or more areas and therefore cannot be manipulated by the surgeon to keep the LAA 20 away from the outer surface 14 of the left atrium 12. More specifically, the right base of the LAA (left side in fig. 52) is open and accessible to the surgeon, but the opposite side-the left base (right side in fig. 52) -is covered by the left side of the LAA (the opposite side is present if the LAA grows in other directions). In the presence of adhesion, the LAA 20 may still be manipulated sufficiently to allow a rod-like device to be inserted between the LAA 20 and the outer surface 14 of the left atrium 12 and pass from below the LAA along the left side of the base 22 of the LAA 20 (from anterior to posterior) and penetrate to the other side of the LAA 20 (adjacent to the pulmonary artery). This means that if the detachment clip has a closed loop at the distal end of the clip (such as clips 100, 200, 400), the surgeon would be required to physically separate the left side of the LAA from the surface of the heart to use that particular clip. This separation is problematic for a number of reasons, one of which is that it can cause a tear in the left atrium, which can have fatal consequences. Thus, in such a case, it may be desirable to use a separate clip having an open distal end to access the LAA 20. The open separation clip allows the surgeon to penetrate between the left side of the LAA 20 and the left atrium 12 at one of the clip's clamping posts without peeling the adhesive portion of the LAA 20 from the outer surface 14 of the left atrium 12.

Fig. 53-82 illustrate a LAA detachment clip 600 having an open distal end. Fig. 53-56 illustrate the breakaway clip 600 in a resting or stable state, fig. 57-60 illustrate the breakaway clip 600 in an intermediate expanded or stretched state, and fig. 61-64 illustrate the breakaway clip 600 in a fully expanded or stretched state.

The breakaway clip 600 includes a first clip lever 610 and a second clip lever 620 that together define a central longitudinal axis 601 (see FIG. 61). In an exemplary embodiment, the clamping bars 610, 620 are hollow tubes (although the configuration of the clamping bars 610, 620 may be differently shaped). The length of the tube is between about 15mm and about 70mm, more specifically between about 25mm and about 60mm, and, in particular, between about 35mm and about 50 mm. In the depicted exemplary embodiment, the outer surface is smooth and cylindrical, although the outer surface may take other shapes and have other surface structures and/or treatments and/or textures as detailed herein. The tubes may be covered with a plastic (e.g., Polyetheretherketone (PEEK)) cover, or they may be made entirely of PEEK and integrate all of the features of the tubes 610, 620 and blocks 612, 622. In a desired embodiment, the connection between the biasing device 632 and the PEEK is rotationally grounded for stability of the breakaway clip 600. This may be accomplished by crimping or welding or by a biasing member geometry that engages a feature in the tube 610, 620 such as a curved section (e.g., a 90 degree L-shape or a full 180 degree hook). The biasing members may be attached to each other by crimping or welding using an intermediate member, or the two biasing members may be made of a single material using a more complex forming process. In an exemplary embodiment, first and second biasing anchors or biasing device connectors 612, 622 are attached to each of the clamping bars 610, 620, respectively. Each biased anchor 612, 622 may be secured to the respective clamping bar 610, 620 (e.g., by welding, brazing, soldering, or using an adhesive, or mechanically using nails or rivets), or the biased anchors 612, 622 may be integrally formed with the respective clamping bar 610, 620. In the depicted exemplary embodiment, each offset anchor 612, 622 may be welded to the clamping bar 610, 620 and have a racetrack cross-sectional shape, with the cut-out having an internal shape that substantially corresponds to the external shape of the clamping bar 610, 620 — this is true at least for shapes that exist at locations where the two portions are joined together. In an alternative embodiment, the clamping bars 610, 620 may have different outer surface shapes along the length of the clamping bars 610, 620 at locations where the biased anchors 612, 622 are not connected to the clamping bars 610, 620. For example, the outer shape of the clamping bars 610, 620 at/below the offset anchors 612, 622 may be circular or oval, and the outer shape of the clamping bars 610, 620 distal from the offset anchors 612, 622 may be hexagonal or octagonal.

The two clamping bars 610, 620 are connected to each other by a biasing device 630. The biasing device 630 is anchored to the first clamping bar 610 at a first biasing anchor 612 and to the second clamping bar 620 at a second biasing anchor 622. Although the biasing device 630 is shown and explained as being indirectly connected to the clamping bars 610, 620 through the biasing anchors 612, 622, in alternative embodiments, the biasing device 630 may be directly connected to the clamping bars 610, 620 or may be integrally formed with the clamping bars 610, 620. In operation, the biasing device 630 applies a force (e.g., a bias) to move the clamping bars 610, 620 toward each other. In the depicted exemplary embodiment, the biasing device 630 provides a force sufficient to cause the two clamping bars 610, 620 to touch and press them together with a positive force. Further, the rigid connection of the biasing member to the anchor (as in the exemplary embodiment shown) allows each rod to resist angles other than parallel. Thus, a given force (e.g., 0.75 pounds/3.34 newtons) is required to initiate separation of the clamping bars 610, 620 from one another. Further, even if activation only one end of the release lever requires force. The force used to separate the single ends of the rod may be greater than a simply calculable force based on the rod length and the point of force application of the force applied by the biasing member. For example, if the biasing member acts on the center of the rod length and only one end of the rod is to be opened, the force for opening only that end will be half the biasing member force. However, the rigid connection of the biasing member to the rod means that, in order to open one end, the biasing member is not only moved linearly away from the central axis in the normal direction, but also undergoes an angular change, thus requiring a greater force for deformation, which makes the force for separating the individual ends greater than a simple calculated amount. In another exemplary embodiment, the biasing device 630 has a steady state that holds the two clamping bars 610, 620 adjacent to each other, but applies no force to the two clamping bars 610, 620 when they are close to or in contact with each other. Similarly, a force (e.g., 0.75 pounds/3.34 newtons) is required to move the clamping bars 610, 620 in a direction away from where the clamping bars 610, 620 are adjacent or in contact with each other. In a further exemplary embodiment, the biasing device 630 has a steady state in which the clamping bars 610, 620 are separated from each other by a given distance (e.g., 1 mm). Thus, in a steady state, no force is applied to the two clamping bars 610, 620, but a force (e.g., 0.75 pounds/3.34 newtons) is required to move them in a direction away from the steady state separation. In this state, a force (e.g., 0.75 pounds/3.34 newtons) is required to move the clamping bars 610, 620 toward each other and bring the two clamping bars 610, 620 into contact.

The biasing device 630 may take any shape that results in a reaction force being applied to the clamping bars 610, 620 in a direction toward the central longitudinal axis 601 when the clamping bars 610, 620 are moved away from each other. In the exemplary embodiment depicted in fig. 53-64, the biasing device 630 is a set of two U-shaped spring clips 632. Alternatively, the biasing device 630 may be a single spring. The single spring may be one of the spring clips 632 located above the clamping bars 610, 620, one of the spring clips 632 located below the clamping bars 610, 620, or one of the spring clips 632 located in the same plane as the clamping bars 610, 620. It should be noted that such a configuration limits the movement of the clamping bars 610, 620 when the biasing device 630 is in the same plane as the clamping bars 610, 620. This limitation is not present when the biasing device 630 is located above or below or both above and below the clamping bars 610, 620. The proximal ends of the clamping bars 610, 620 may be angled and not prevented from movement by the biasing device 630 when the biasing device 630 is positioned above and/or below. This is important because it provides the user with the advantageous ability to manipulate the clamping bars 610, 620 individually or together in any manner. For example, the proximal ends of the clamping bars 610, 620 may be moved away from each other (which brings the distal ends closer to each other) or may be moved closer to each other (which brings the distal ends further away), or one of the clamping bars 610, 620 may be angled while the other clamping bar 620, 610 remains in line, allowing the distal end of one clamping bar 610, 620 to be brought closer to or further away from the other distal end of the other clamping bar 620, 610. Thus, it can be said that the biasing device 630 does not interfere with any desired movement of the clamping bars 610, 620. In this regard, the maximum width of displacement of the clamping bars 610, 620 relative to each other at their proximal closed ends will not be limited or disturbed by the biasing device 630.

Each of the biasing anchors 612, 622 has a set of blind or through holes 614, 624 in which respective ends 634 of spring clips 632 are secured. The spring clip 632 is preset (e.g., heat set if made of nitinol) to a steady state shape. In embodiments where the two clamping bars 610, 620 are forced together in a steady state, the spring clip 632 (when separated from the clamping bars 610, 620) has a different shape than that shown in fig. 53, 55, and 56. More specifically, each pair of ends 634 of the spring clip 632 are preset closer together than, for example, the shape depicted in fig. 53. In contrast, for embodiments in which the clamping bars 610, 620 are in contact with each other in the steady state but are not pressed together by force, the preset shape of the spring clip 632 is approximately the shape shown in fig. 53.

With the biasing device 630 connecting the clamp bars 610, 620 together, the breakaway clip 600 defines an open end 602 and a closed end 604. The open end 602 is said to be open because the area between the distal ends of the clamping bars 610, 620 is open so that the LAA (see, e.g., arrow a in fig. 59) enters between the two clamping bars 610, 620, and the closed end 604 is said to be closed because the area between the proximal ends of the clamping bars 610, 620 is prevented from entering from the ends (see, e.g., arrow a' in fig. 59) because the spring clip 632 traverses a distance from one clamping bar 610 to the other clamping bar 620 when separated from each other. The views in fig. 56, 60 and 64 are looking down on the open end 602 of the clip 600 in various expanded states of the clip 600.

Clip 600 has dimensions that are beneficial for use in thoracoscopic surgery because of its small cross-sectional area. The largest feature of the clip 600 that defines this cross-section is a biasing device 630 of a certain width. In the steady state orientation shown in fig. 53, for example, when the clip 600 is in a contracted state, the maximum cross-sectional diameter that defines the minimum port size into which the clip 600 can fit is the width W of the spring clip 632. In particular, for a clip 600 that is long enough to occlude a typical LAA, the minimum cross-sectional width W of the spring clip 632 is between about 8mm and about 9.9 mm. Thus, during the clip implantation procedure, the clip 600 can fit in a 10mm thoracoscopic port (30 French) for delivery to the LAA.

To maintain this minimum cross-section throughout the LAA clip implantation procedure, the delivery device 650 for the clip 630 is configured to grasp the clip bars 610, 620 from the respective internal cavities 616, 626. The distal clip contacting end 652 of the transfer device 650 is shown diagrammatically in fig. 57, in which the transfer device 650 has opened the clip 600 to an intermediate expanded position. Fig. 57-60 are various views of the clip 600 in this intermediate expanded position. These ends 652 are inserted into the clamp bars 610, 620 to temporarily secure and control the movement and delivery of the clamp 600. An exemplary embodiment of a transfer device 650 is shown in fig. 65-68. Various exemplary embodiments of mechanisms for opening and closing the clip contacting end 652 of the transfer device 650 are explained below.

In order to cooperate with the clip contacting end 652 of the transfer device 650, the clamping bars 610, 620 are either completely hollow, as shown, for example, in fig. 56, or the clamping bars 610, 620 have blind holes, not shown, that start from the closed end 604 of each of the clamping bars 610, 620 and pass from inside the clamping bars 610, 620 to an internal distance sufficient to allow for controlled separation between the two clamping bars 610, 620 and for rocking control of the clamping bars 610, 620 relative to each other, as described in further detail below. Where the transfer device 650 accesses and controls the clip 600 from the interior of the clip 600 rather than from the exterior of the clip 600, the transfer device 650 is sized to have a cross-sectional area that is less than the maximum cross-sectional diameter of the clip 600. This means that during use of the clip 600, the width of the port is minimized to the maximum cross-sectional diameter of the clip 600 rather than the diameter of the transfer device. It should be noted that in the exemplary embodiment of fig. 65-68, each arm located at and/or connected to the proximal end of a respective clip contacting end 652 is shown as being thicker than the width of each respective clip lever 610, 620. For use in thoracoscopic surgery where the port size is about 30 French, the size of the arms can vary, they can be slightly larger than the outer diameter of the clamping bars 610, 620 (e.g., but still have an overall outer diameter of less than 30 French), they can have the same diameter as each of the clamping bars 610, 620 (e.g., have an overall outer diameter of less than 30 French), and/or they can be narrower than each of the clamping bars 610, 620 (e.g., have an overall outer diameter of much less than 30 French).

As shown in the process of fig. 65-68, the clip 600 begins in a minimally compressed state and is expanded by the delivery device 650 to a size in which the open end 602 is large enough to slide the clip levers 610, 620 across the LAA and along the base of the opposite side of the LAA. To perform the implantation procedure of clip 600, clip contacting end 652 of delivery device 650 is inserted into holes/through- holes 614, 624 at the proximal end of clip levers 610, 620, and delivery device 600 is prepared for opening the clip from the minimum, port installation orientation position of clip 600 in which width W is minimized. A thoracoscopic port, not shown, is mounted in the patient to provide access to the patient's heart and the LAA. Under visualization (e.g., through another thoracoscopic port in which an appropriately sized camera is placed), the surgeon inserts the clip 600 through the thoracoscopic port and up to and adjacent to the LAA 20. In the case of a Kittner dissector (or another grasping/moving tool), the LAA is lifted (if there is no adhesion to prevent the lifting) or the path under the LAA20 is opened (if adhesion allows access to one of the clamping bars 610, 620 under the LAA). Before, during, or after this, the two clamping bars 610, 620 are separated from each other by a distance sufficient to encompass the base of the LAA 20. The surgeon extends the delivery device 650 to move the clip 600 along the base of the LAA20 by positioning the first clip lever 610 on one side of the base and the second clip lever 620 on the other side of the base. The surgeon manipulates the clip 600 to place the clip levers 610, 620 as low as possible around the LAA. When the desired implant position of the clip 600 is achieved, the surgeon causes the delivery apparatus 650 to spring the clip 600 back toward its steady state orientation to occlude the interior of the LAA20 from the interior of the left atrium 12 as completely as possible. In this state, the base of the LAA resides between the clamping bars 610, 620, wherein the clamping bars 610, 620 compress the LAA therebetween using the force applied by the outwardly-stretched biasing device 630. The surgeon determines whether clip 600 is in a successful implantation location (e.g., to visualize blood flow through left atrium 12 via transesophageal ultrasound (TEE) and/or by examining heart rate). If the location is not desired, the surgeon uses the delivery device 650 to re-expand the clip 600 and the surgeon repositions the clip 600 about the LAA 20. When the desired implant state of the clip 600 is present, the delivery device 650 is detached from the closed end 604 of the clip 600 and retracted away from the thoracoscopic port.

The connection between the clip contacting end 652 of the transfer device 650 and the clip levers 610, 620 may take a variety of forms. In an exemplary embodiment, the transfer device 650 is disengaged from the closed end 604 of the clip 600 by a release pin or wire that engages the at least one clip lever 610, 620 and the at least one clip contacting end 652 (e.g., similar to a grenade-type pin). When disengaged, the clip contacting end 652 is free to be removed from the clip levers 610, 620 and the delivery device 650 may be removed from the patient. Other exemplary embodiments of such release mechanisms include, grapples, detents, nooses, retaining fingers, ball detents, spreading features on the clip contact end 652 within the internal cavities 616, 626 of the clamping bars 610, 620, barbs, electrical ablation or cutting of the connection features between the clamping bars 610, 620 and the clip contact end 652, mechanical ablation or cutting of the connection features between the clamping bars 610, 620 and the clip contact end 652, to name a few.

In an exemplary embodiment, for the surfaces of the clamping bars 610, 620 that face each other and contact the LAA when the clip 600 is implanted, one or both of these surfaces have a self-energizing or traction member that retains the clamping bars on the LAA as described herein. There are textured features on one or more of the outer surfaces of the clamping bars 610, 620. For example, texturing may be surface finishing, knurling, or the like. Preferably, the texture may be longitudinal grooves and/or grooves that are angled with respect to the longitudinal extent of the clamping bars 610, 620. Such textured features facilitate sliding the clip 600 onto the LAA from one side of the LAA while preventing movement of the LAA away from between the opposing clamping bars 610, 620 when the LAA is clamped between the clamping bars 610, 620 during or after implantation.

In the embodiment of the clip 600 shown in the drawings, the motion of the clamping bars 610, 620 is substantially parallel, in other words, the clamping bars 610, 620 are parallel when close to each other, parallel when apart, and remain parallel when moved therebetween. The delivery device 650 may be configured to move the clamping bars 610, 620 in a non-parallel manner at any time during the implantation procedure. For example, as shown in fig. 69-72, at any time during movement from the parallel rest position shown in fig. 53-56 to the parallel expanded position shown in fig. 61-64, one of the clamping bars 610, 620 may be angled with respect to the other. Fig. 69 to 72 show the ends of the clamping bars 610, 620 at the open end 602 of the clamp 600 being closer to each other than the ends of the clamping bars 610, 620 at the closed end 604 of the clamp 600. In contrast, fig. 73-76 show the ends of the clamping bars 610, 620 at the closed end 604 of the clip 600 being closer to each other than the ends of the clamping bars 610, 620 at the open end 602 of the clip 600. These groups depict the clamping bars 610, 620 disposed at substantially similar angles relative to the central longitudinal axis. However, each of the first clamping bar 610 and the second clamping bar 620 may be independently moved in the shaking direction as needed. The transfer device 650 controls each of the clamping bars 610, 620 individually and each of the distal and proximal ends individually to position the clamping bars 610, 620 at any combination of angles during opening and closing of the clip 600. For example, if one side needs to be angled to avoid sticking, the clamping bar 610, 620 may be angled with the other clamping bar 620, 610 remaining in a parallel orientation. With such freedom of movement under the control of the transfer device 650, the clip 600 may approach the LAA20 at respective optimal angles on both sides of the LAA 20.

The offset anchors 612, 622 are shown herein as being located off-center of the clamping bars 610, 620. This exemplary orientation allows the distal leg of the spring clip 632 to be longer. It should be noted that with longer legs of the spring clip 632, less shortening of the available clip length occurs when the clip 600 is fully opened. Moreover, the longer length helps reduce stress in the spring clip 632 and allows for the use of a larger/stiffer spring clip 632.

In an exemplary embodiment, the clamping bars 610, 620 are made of PEEK. The clamping bars 610, 620 may also be made of, for example, stainless steel, aluminum, titanium, nickel titanium (Ni-Ti) alloys (e.g., nitinol), and polycarbonate.

In an exemplary embodiment, the biased anchors 612, 622 are made of any of, for example, stainless steel, aluminum, titanium, nickel-titanium (Ni-Ti) alloy (e.g., nitinol), and polycarbonate.

In an exemplary embodiment, the biasing device 630 is made of, for example, any of stainless steel, aluminum, titanium, nickel-titanium (Ni-Ti) alloy (e.g., nitinol), and polycarbonate.

In an exemplary embodiment, part or all of the clip 600 may be covered by a softening material (e.g., silicone or polyurethane) for atraumatic contact between the clip 600 and the heart and adjacent anatomical structures and to reduce compression between the surfaces of the clip 600. In the exemplary embodiment depicted in fig. 77, a protective shield 640 (shown diagrammatically in phantom) shields any or all of the clamp rods 610, 620, the biasing anchors 612, 622, and the spring clip 632 of the biasing device 630. The cover 640 is open at least at the proximal ends of the clamp bars 610, 620 for operation of the clamp 600 by the transfer apparatus 650. It should be noted that the portion of the spring clip 632 adjacent the clamping bars 610, 620 moves relative to the outer surface of the clamping bars 610, 620. This movement can be seen in the progression of the spring clip 632 in fig. 53, 57 and 61. When a structure such as these moves, there is a pinch or shear area between the spring clip 632 and the clip levers 610, 620. Thus, placing the cover 640 in this area reduces or removes any pinching or shearing hazard between the spring clip 632 and the clamping bars 610, 620. In an exemplary embodiment, the cover 640 may be a multi-lumen extrusion. The multi-lumen extrusion may cover the clip 600 or only the proximal ends of the spring clip 632 and clip levers 610, 620.

Fig. 78 to 82 show another exemplary embodiment of a cap 640. In this embodiment, the cover 640 has an interior 642 that surrounds the clamping bars 610, 620 at least on the interior/center, upper and lower surfaces (upper and lower referring to the orientation of the clip 600 in fig. 81) of the clamping bars 610, 620. Cover 640 has a medial cut 644 around biasing anchors 612, 622 (when present) such that the outer surface of cover 640 adjacent respective biasing anchors 612, 622 forms a substantially smooth transition with outer surface 613 of biasing anchors 612, 622. For example, the outer surface of cap 640 adjacent biasing anchors 612, 622 is substantially flush with outer surfaces 613, 623 of biasing anchors 612, 622. As previously described, when the biasing device 630 is in the form of spring clips 632 positioned above (and/or below) the clip levers 610, 620, a crush zone is formed at the distal end portion of each spring clip 632 adjacent the respective biasing anchor 612, 622. To minimize this crush zone, the cover 640 contains a guard 646, which is shown enlarged in fig. 82. The mesa 646 has a top surface that extends distally toward the biased anchors 612, 622 where the spring clip 632 is grounded. In the exemplary embodiment shown, the top surface is substantially the same as the upper surface of cover 640 from a top surface 646 to the distal end of cover 640 (at open end 602). The mesa 646 also includes vertical walls adjacent each spring clip 632, respectively, that define a shape to match the portions of the spring clip 632 adjacent the walls and biasing anchors 612, 622. This shape substantially corresponds to the shape of the interior/central plane of the spring clip 632 when the spring clip 632 is stretched to a substantially open state (e.g., such as the state shown in fig. 61) of the clip 600. In an exemplary embodiment, the wall may be shaped as a stop for opening the clip 600. As a stop, the wall prevents the spring clip 632 from flexing inwardly beyond a certain point toward the longitudinal axis 601. Because the spring clip 632 protrudes from the biased anchors 612, 622, the spring clip 632 may break at the clip-anchor connection if the spring clip 632 is bent too severely. Providing the wall as a stop prevents further bending of the spring clip 632 at the clip-anchor connection and, with continued bending, allows the spring clip 632 to bend/contract at an intermediate point at or near the proximal end of the wall. As in other exemplary embodiments, various surfaces of the cover 640 may have textured or self-energizing features, for example on interior opposing faces, to engage the LAA.

When the surgeon approaches the LAA 20 through the clip 600 and the clip levers 610, 620 pass along opposite sides of the LAA 20, the surgeon may not be able to view the distal side of the LAA 20. Thus, the surgeon may place the clip 600 on the LAA 20 in a direction in which the distal ends of the clip levers 610, 620 (at the open ends 620) do not pass completely distal of the LAA 20. To confirm that the distal end of the clip levers 610, 620 have passed the distal end of the LAA, a visual marker 660 is associated with at least one of the clip 600 and the delivery system 650. Generally, the indicia 660 is a structure located at the distal end (at the open end 602) of the clip 600 and capable of pivoting (or otherwise articulating, bending, folding) from one clamping bar 610, 620 to or toward the other clamping bar 620, 610, by which pivotal movement the surgeon will be able to see the end of the indicia 660 to indicate whether the distal open end 602 of the clip 660 is distal of or beyond the LAA 20. If the marker 660 is actuated but cannot be viewed by the surgeon on the other side of the LAA 20, the surgeon may conclude that the distal ends of the clamp bars 620, 610 are not secured to or beyond the distal side of the LAA 20, meaning that the surgeon needs to reposition the clamp 600 on the LAA 20. The indicia 660 may be part of the delivery device 650 or it may be part of the clip 600 (e.g., part of one of the clip levers 610, 620) or it may be a separate device completely distinct from the clip 600 and the delivery device 650.

An exemplary embodiment of the marker 660 is shown in fig. 83 and 84. At the end of shaft 662 is a finger 664 that is connected to shaft 662 by a pivotal connection 666. A finger controller, not shown, is attached to the finger 664 by a shaft 662 and selectively moves the finger 664 between an aligned position shown in fig. 83 and a pivoted position shown in fig. 84. In an exemplary embodiment where the indicia 660 is part of the clip 600, one of the clamping bars 610, 620 is a shaft 662 and the pivotal connection is at the distal end of the clamping bars 610, 620. When the clip levers 610, 620 are disposed on either side of the LAA during the clip implantation procedure, the surgeon actuates the finger controls and determines whether the fingers 664 can be viewed from the other side of the LAA opposite the side from which the fingers 664 emanate. If the finger 664 is visible, it is confirmed that the implant distance on the LAA 20 is sufficient.

Other exemplary embodiments include that the mark 660 is part of the transfer device 650. As indicated herein, at least one of the clamping bars 610, 620 may be hollow from the proximal end to the distal end. The shaft 662 and fingers 664 may be sized to fit within the inner lumen of the clamp rods 610, 620. When the clip 600 is secured to the LAA 20 by the clamping bars 610, 620 disposed on either side of the LAA, the shaft 662 may be inserted through the lumen such that the fingers 664 extend from the distal ends of the clamping bars 610, 620. The surgeon actuates the finger control and determines whether the finger 664 can be viewed from the side of the LAA 20 opposite the side from which the finger 664 emanates. If the finger 664 is visible, it is confirmed that the implant distance on the LAA 20 is sufficient. If the fingers 664 are not visible, the implant distance on the LAA 20 is insufficient and the clip 600 needs to be further repositioned on the LAA 20. The present exemplary embodiment in which the finger 664 is separated from the clip 600 can take various modifications. First, the shaft 662 may be one of the clip contacting ends 652 of the transfer device 650 itself, and the finger 664 may reside at the end of the clip contacting end 652. The fingers 664 extend further into the clamp bars 610, 620 by moving the transfer device 650. Alternatively, the shaft 662 may be its own instrument, such as the marking device 670 shown in fig. 85, separate from the delivery device 650. When the clip 600 is secured to the LAA 20 by the clamping bars 610, 620 disposed on either side of the LAA, the delivery device 650 is removed and the shaft 672 of the marking device 670 may be inserted through the lumen of one of the clamping bars 610, 620 such that the finger 674 extends from the distal end of the clamping bars 610, 620. As above, the surgeon actuates the finger control and determines whether the finger 674 can be viewed from the other side of the LAA 20 opposite the starting side of the finger 674. If the finger 674 is visible, it is confirmed that the implant distance on the LAA 20 is sufficient. If the finger 674 is not visible, the implant distance on the LAA 20 is not sufficient and the clip 600 needs to be further repositioned on the LAA 20 by reconnecting the delivery device 650 and moving the clip 600. Alternatively, the shaft 662 may be one of the clip contacting ends 652 of the transfer device 650 itself, and the finger 664 may be separate from the shaft 662 and reside within the internal cavities 616, 626 of the clip levers 610, 620. To actuate the fingers 664, the shaft 662 is advanced distally within the clamping bars 610, 620 until the fingers 664 clear the distal ends 602 of the clamping bars 610, 620, at which point the fingers 664 are free to rotate or otherwise articulate. Alternatively, the fingers may be made of a soft material (such as silicone or polyurethane), disposed on or around the clamping bar, and actuated by or around the clamping bar 610, 620. The soft fingers are atraumatic and may rest on the clamp bars 610, 620 after implantation or may remain attached to the delivery device 650 and removed after the delivery device 650 is detached from the clamp 600.

An exemplary embodiment of a mechanism for opening and closing the clip contacting end 652 of the transfer device 650 is shown in fig. 86-89. The progression of fig. 86 to 89 shows the opening phase of the clip 600. In the closed configuration shown in fig. 86, the clip 600 is advanced to the LAA. When adjacent to the LAA, the surgeon squeezes the handle 860, which is pivotally attached at the fulcrum 862. Clip contacting end 652 is attached to the distal end of each handle 860, respectively, by a multi-axis pivot assembly 870. In the present exemplary embodiment of multi-axis pivot assembly 870, each handle 860 has two connecting rods 872. Each distal connecting rod 872 is inserted into a hole located at the distal end of each handle 860. The distal rod 872 forms a pivot with the bore. Instead, each proximal connecting rod 872 is inserted into a slot 864 located at the distal end of the handle 860 and near the aperture. Each slot 864 extends a distance orthogonal (up and down for fig. 86) to the longitudinal extent (left and right for fig. 86) of the clip contacting end 652. In the exemplary embodiment, each connecting rod 872 extends orthogonally through a respective distal aperture or proximal slot 874. The length of the slot 874 is longer than the diameter of the connecting rod 872. Thus, the proximal connecting rod 872 slides a distance along and within the slot 874. Two connecting rods 872 of each of the multi-axis pivot assemblies 870 are secured to the plate 876. The distal end of plate 876 is secured to the proximal end of clip contacting end 652. Thus, the clip 600 and polyaxial pivot assembly 870 are able to pivot at a pivot angle about the distal connecting rod 872 in the distal bore. This pivot angle then forms and defines a rear opening angle at which the clip 600 can be opened on the proximal side of the clip 600, which is shown in the view of fig. 87.

In the orientation of fig. 86-89, the distal aperture is completely hidden behind plate 876, while proximal slot 874 is slightly visible in fig. 87-89. The configuration of the handle 860 and multi-axis pivot assembly 870 allows the levers 610, 620 to open in the particular manner shown in the progression of fig. 86-89. Specifically, as the handles 860 begin to move toward each other, the force automatically slides the proximal connecting rod 872 outward to the outer end of the proximal slot 874. This means that the proximal side of the clip 600 is open before the distal side of the clip 600 is open, the orientation of which is shown in fig. 87. As the handles 860 are moved closer to each other, the clamp bars 610, 620 move further apart and the force automatically slides the proximal connecting bar 872 within the proximal slot 874. Thus, the levers 610, 620 move to a parallel orientation in an intermediate closed state of the two handles 860, which state is shown in fig. 88. Finally, as the handles 860 are moved closer to each other to reach the fully open position of the clip 600, the rods 610, 620 move further apart and the force automatically holds the proximal connecting rod 872 at the outer end of the proximal slot 874, at which point the rods 610, 620 move to an angled orientation with the distal ends of the rods 610, 620 being further apart than the proximal ends of the rods 610, 620; this latter orientation is shown in fig. 89. During relative movement of the handles 860, the progression is reversed, i.e., the clips are moved to a parallel orientation, then to an orientation in which the distal ends of the rods 610, 620 are brought closer together and into contact with each other before the opposing proximal ends of the rods 610, 620 are brought into contact with each other in the clip-mounting orientation.

This progression is desirable because the distal ends of the rods 610, 620 first contact each other when the clip 600 is closed on the LAA. Such an orientation has benefits, one of which is that the LAA closes from the distal side toward the proximal side when the surgeon installs the clip 600. This closing direction ensures that the LAA is fully captured in the jaws before the jaws begin to apply clamping pressure. The operator can visually confirm the entire surroundings of the ear because there is sufficient space in the jaws for the ear to reside when the jaws form the intermediate step of the closed loop shown in fig. 87. This further helps to prevent the closing pressure from forcing the tissue out of the open end, which is known as "watermelon seeding". This closing direction ensures that the LAA is completely closed during clip implantation even if the surgeon cannot observe the entire span of the LAA. As will be described in further detail below, the clip 600 may be formed with a distal-side closure for informing (or insuring to) the surgeon that the distal end is beyond the LAA, in which state complete closure of the LAA is assured.

Fig. 90 illustrates another exemplary embodiment of a multi-axis pivot assembly 880. In this view, only one side of the open structure or assembly of the clip is depicted. The other side is not depicted for clarity. This polyaxial pivot assembly 880 allows the clip 600 to open in the progression shown in fig. 86-90 when the clip connecting end 652 is inserted into the clip 600.

The configuration of the handle 860 of the delivery device 650 shown in fig. 86-89 is one that can be used in open surgical procedures. In such procedures, the pericardial sac is open to the surgeon, and thus, handles 860 may be near the fulcrum and may be spaced apart from each other (e.g., in the form of forceps) because the surgeon has a relatively large area in which to manipulate delivery device 650. In contrast, fig. 91-103 illustrate a scaled-down delivery device 900 that may be configured for use in less invasive surgical procedures (e.g., thoracotomy or thoracoscopy). The delivery device 900 has an end effector 910 configured to open and close the left atrial appendage separation clip 600 in a size that can be used laparoscopically, but the exemplary configuration of the end effector 910 shown in fig. 91-103 has a fixed clevis 912 that includes a neck 914 and a side flange 916. Thus, the end effector is used in open chest surgery. To convert the end effector 910 into an end effector for use in laparoscopic surgery, the fixed bending of clevis 912 is replaced by an articulation device or joint (which may be passive or active) not shown. Similar to the shaft 902, the articulating device has a diameter sufficient for use in a laparoscopic port. Accordingly, the shaft 902 of the transfer device 900 (and the articulating device) has an outer diameter of no greater than about 10mm (30 French). Both the fixed clevis and the articulated variant are described by way of an exemplary embodiment of a fixed end effector 910 shown in fig. 91-103. Fig. 91-103 also depict another exemplary embodiment of a left atrial appendage detachment clip 1000 having some features that differ from clip 600. Nonetheless, all of the features of clip 600 can be used with clip 1000, and all of the features of clip 1000 can be used with clip 600.

A pair of jaws 920 are pivotally connected to the distal end of clevis 912. Each jaw 920 has a pivot hole about a jaw pivot axis, which is not shown for clarity. The jaw pivot shaft is fixed to each of the side flanges 916 of clevis 912. Thus, jaws 920 can pivot about a jaw pivot axis relative to clevis 912. Each of the jaws 920 has a distal end connected to a respective clip connection end 652. In the embodiment shown in fig. 91-103, the clip connecting end 652 includes a pivotable support peg 930. In contrast to the multi-axis pivot assembly described above, the support staples 930 provide multi-axis movement with a single staple pivot 932. The free "swinging" movement of the support staples 930 to allow the bars 610, 620, 1010, 1020 to be angled relative to each other is accomplished by angling one edge 934 of the support staple 930 disposed in the slot 922 of the jaw 920 relative to the longitudinal extent of the support staple 930 (which is parallel or collinear with the longitudinal extent of each bar 610, 620, 1010, 1020). As such, when the support staples 930 are connected to the jaws 920 at respective pivots 932, the support staples 930 can move at a larger angle relative to the distal ends of the jaws 920 (the angle is shown in the enlarged view of fig. 92) rather than move slightly in the slots 922 of the jaws 920. In this cross-section, each of the support pins 930 is disposed at a maximum angle relative to the slot 922 at a location where the edge 934 rests against and lies along a sidewall of the slot 922 relative to the edge 934. Thus, in the view of fig. 92, the support peg 930 at the top of the figure cannot rotate in a further clockwise direction about the pivot 932, but can rotate counterclockwise at least until the side wall 936 of the upper support peg 930 encounters the inner wall 924 of the slot 922. Similarly, the support pins 930 at the bottom of fig. 92 cannot rotate in a further counterclockwise direction about the pivot 932, but can rotate clockwise, at least until the side walls 936 of the lower support pins 930 in fig. 92 encounter the inner walls 924 of the slots 922. This free rotation capability of the support pins 930 allows the clip 1000 to assume each of the orientations shown in fig. 86-89.

The shafts 1010, 1020 of the clip 1000 are provided with blind bores 1012, 1022 extending inwardly from the proximal ends of the shafts 1010, 1020 (in another exemplary embodiment, the blind bores could instead extend all the way to the distal ends of the shafts 1010, 1020). The distal ends 938 of the support pins 930 extend into the holes 1012, 1022 to anchor the rods 1010, 1020, respectively, therein (temporarily, until the clip is ready for release for implantation). In the exemplary embodiment, distal end 938 and apertures 1012, 1022 are cylindrical. In an alternative exemplary embodiment, the outer surfaces of the holes 1012, 1022 and the distal end 938 have a polygonal cross-sectional shape that prevents the rods 1012, 1022 from rotating about the distal end 938.

To secure the rods 1012, 1022 to the distal ends 938 (both rotationally and longitudinally) of the support pins 930, the support pins 930 have transverse guides 931. The transverse guide 931 defines an entrance or starting point for a locking lumen 933 tunneled at an angle from the outer edge of the transverse guide 931 through the proximal first side walls of the rods 1012, 1022 and through part or all of the distal end 938 of the support pin 930. In an alternative exemplary configuration, the locking lumen 933 can continue to tunnel through all or a portion of a second sidewall opposite the first sidewall (this continuation is not shown). First and second rod lock tubes 940, 942 extend from a proximal control end, not shown, of the delivery device 900, through the shaft 902, through the clevis 912, and along the jaws 920 to enter and be secured in a lateral opening of the transverse guide 931, which defines the beginning of the lock lumen 933. These rod locking tubes 940, 942 serve as guides for locking wires, not shown, that extend through the rod locking tubes 940, 942 when in a locking orientation, through the locking lumen 933 of the transverse guide 931, into and through the locking lumen 933 of the distal end 938. In such a configuration, the locking wire prevents the rods 1012, 1022 from moving rotationally or longitudinally relative to the support pin 930. To unlock the levers 1012, 1022 from the support pins 930, and thus the clip 1000 from the entire delivery device 900, an actuator, not shown, located at the proximal handle of the delivery device 900 is actuated to retract the locking wires so that the distal ends of the locking wires move proximally out of the locking lumens 933 at least to the extent where the distal ends of the locking wires exceed the portions of the locking lumens 933 in the distal ends 938 and in the levers 1012, 1022. Thus, when the distal end of the locking wire is at least in the portion of the locking lumen 933 in the lateral guide 931, proximal movement of the delivery device 900 will allow the clip 1000 attached to the LAA to slide easily and smoothly off the distal end 938 for implantation onto the LAA.

In another exemplary embodiment, the locking wires securing the rods 1012, 1022 to the transfer device 900 may be thermally, mechanically, or otherwise deformed in the clamping bars 1012, 1022 to provide resistance to removal of the locking wires, thereby allowing the locking wires to retain the clamping bars 1012, 1022 on the support pins 930. Pulling the locking wires beyond the yield force of the mechanical resistance between the clip levers 1012, 1022 and the locking wires can release the clip levers 1012, 1022 from the support pins 930, allowing the clips to be freely released from the delivery device 900.

Opening and closing the jaws 920, and thus opening and closing the clip 1000, is explained in accordance with the progression of fig. 93-101. A jaw control line 944 extends from the proximal handle of the delivery device 900 through the shaft 902 about the pulley 904 and is secured at a distal wire end to a jaw control loop 946. Pulley 904 is connected to clevis 912 by a pulley shaft (not shown) and rotates about the pulley shaft to allow jaw control line 944 to move about pulley 904. A ring 946 at the end of the jaw control wire 944 surrounds the jaw control nail 948, which is only diagrammatically shown in phantom in fig. 92, and is secured to the jaw control nail 948 by, for example, press-fitting, welding, soldering, or brazing. The jaw control nail 948 is sized and shaped to slide within the pivot control slot 926 of each jaw 920. The jaw control staples 948 are also sized and shaped to slide within the side flanges 916 with the staple guide slots 913 that are present on each side of the clevis 912, as shown in fig. 91 (the staple guide slots 913 are not shown in fig. 93-101 since the upper half of the clevis 912 is removed from these illustrations for clarity). Staple guide slots 913 are oriented parallel to central longitudinal axis 1002 of clip 1000, and in this exemplary embodiment are collinear, as shown in fig. 91. The opposite ends of the jaw control staple 948 each slide within the staple guide slots 913 of the side flanges 916 and, in the present exemplary embodiment, do not extend out from the staple guide slots 913 beyond the outside of the flanges 916 to keep the size of the clevis 912 as small as possible. Thus, movement of the jaw control wire 944 in a proximal or distal direction causes the jaw control staple 948 to move proximally or distally, respectively, along the central longitudinal axis 1002. This movement (corresponding to the movement of jaw control ring 946) can be observed by placement of jaw control ring 946 in fig. 94, 97, and 100. In contrast to staple guide slot 913 in clevis 912, pivot control slot 926 of jaw 920 is oriented at an angle β to central longitudinal axis 1002, as shown in FIG. 95. Thus, with clevis 912 fixed to shaft 902 and jaws 920 pivotally connected to clevis 912 by a jaw pivot shaft, when jaw control staple 948 is located at the distal end of staple guide slot 913, as shown in fig. 93-95, clip 1000 is in a fully closed orientation. In contrast, when the jaw control staples 948 are located at the proximal ends of the staple guide slots 913, as shown in fig. 99-101, the clip 1000 is in a fully open orientation. Movement of the jaw control staples 948 from the distal ends of the staple guide slots 913 toward the proximal ends of the staple guide slots 913 will cause the clip 1000 to open in a selective manner from fully closed, to partially closed (proximal open but distal closed), to partially open (rods separated and possibly parallel to each other), to fully open (rods separated and angled to each other, the distal end of the clip 1000 being opened further than the proximal end).

With this exemplary configuration, an exemplary procedure for implanting the clip 1000 on the LAA in an open chest procedure may be performed. In describing this procedure, the terminology relating to LAA will be simplified. The LAA has a medial long axis immediately adjacent the heart and is referred to as the proximal cardiac side. This side of the LAA will be simplified and referred to herein as the medial side. The transverse axis of the LAA is called the free axis and the corresponding side is called the free wall. This side of the LAA will be simplified and referred to herein as the outer side.

The end effector 910 is maneuvered to the LAA. The surgeon may move the end effector 910 to the LAA in the closing direction of fig. 93-95 or in the fully open direction shown in fig. 99-101. In the latter orientation, the surgeon does not need to open the clip 1000 prior to manipulating the clip 1000 around the LAA. In the former orientation, the surgeon opens the clip 1000 (e.g., in the direction shown in fig. 99-101) by actuating the jaw opening assembly at the handle of the delivery device 900, which pulls the jaw control line 944 to open the jaws 920 and thus move the levers 1010, 1020 away from each other. If the inside of the LAA can be manipulated away from the left atrium, the surgeon uses the manipulator to lift the LAA, placing rod 1010 inside the LAA, and rod 1020 outside the LAA. In examples where the one or more adhesive forces resist movement of the LAA, the surgeon then slides one of the rods 1010, 1020 (e.g., rod 1010) under the medial side of the LAA so that the rod 1010 can be placed at the base of the LAA on the medial side while the rod 1020 is placed at the base of the LAA on the lateral side of the LAA. When the levers 1010, 1020 are placed at the base of the LAA, the surgeon actuates the closure of the clip 1000, which moves the jaw control wire 944, and in turn the jaw control staple 948, distally. The movement of the jaw control staples 948 causes the jaws 930 to close as shown in fig. 96-98. Because the support staples 930 are pivoted to the outermost open orientation pivot (as shown in fig. 92), this closing of the jaws 920 brings the distal ends of the levers 1010, 1010 into proximity and initial contact with one another, a condition shown in fig. 96-98. Desirably, when closed, the distal ends of the rods 1010, 1020 are positioned beyond the distal extent of the base of the LAA, and thus, the clip 1000 completely spans the base of the LAA and is enclosed within the interior space 960 of the clip 1000. The surgeon causes further closure of clip 1000 by continuing to actuate delivery device 900, which moves jaw control staple 948 to the distal end of staple guide slot 913. This state is depicted in fig. 93 to 95. At this stage, the surgeon has closed the clip 1000 on the base of the LAA, and can determine, for example, by the TEE whether implantation of the clip 1000 is satisfactory. If the implantation is not satisfactory, the surgeon opens the clip 1000 and repositions the clip 1000 on the base of the LAA. If the implantation is satisfactory, the surgeon actuates the clip release assembly of the delivery device 900, which causes the locking wire to retract from the locking lumen 933, as explained herein. When the locking wires have been retracted from the rods 1010, 1020, a slight movement of the delivery device 900 will allow the clip 1000 to slide off the support pins 930, and thus the end effector 910.

Fig. 104-108 show a clip 1000 with a biasing device 1030 on both the top and bottom of the bars 1010, 1020. In this exemplary embodiment, a first biasing anchor or biasing device connector 1014 and a second biasing anchor or biasing device connector 1024 are integrally formed with the rods 1010, 1020. Biasing device 1030 is secured to rods 1010, 1020 by first and second biasing anchors 1014, 1024. In an exemplary embodiment, the ends of the upper and lower biasing devices 1030 are press fit or attached to biasing anchors 1014, 1024 in the form of ports facing the proximal ends of the rods 1010, 1020. As shown in fig. 107, the biased anchors 1014, 1024 are formed by a front portion and a rear portion, with the biasing device 1030 extending through, between, and across the front and rear portions, and then into the rear portion. The biasing device 1030 may be secured to the rods 1010, 1020 in one or both of the front and rear. The span between the front and rear of the offset anchors 1014, 1024 defines a connecting space in which the band anchor 1040 is attached to the portions of the upper and lower offset devices 1030 that span the front and rear in this example. Thus, in this configuration, the strap anchors 1040 may be in the form of C-shaped clips that may be temporarily or permanently attached to portions of the upper and lower biasing devices 1030. A strap capture channel 1011 is formed in the outer surface of the bars 1010, 1020. The strap capture passageway 1011 has a proximal strap anchoring aperture 1013, an intermediate strap locking passageway 1015, a distal strap passageway 1017, and a distal strap passageway 1019. The proximal strap anchoring bore 1013 transitions to the intermediate strap locking pathway 1015 and has a width greater than the intermediate strap locking pathway 1015. The distal strap passage 1017 continues the strap capture passage 1011 from the intermediate strap locking passage 1015 and, in the exemplary embodiment, has approximately the same width as the proximal strap anchoring hole 1013. Thus, the intermediate strap locking passageway 1015 is narrower than the portions of the strap capturing passageway 1011 immediately adjacent the proximal and distal ends thereof. The distal band passage 1017 continues into a distal band passage 1019 that is angled, particularly approximately orthogonal, to the distal band passage 1017 to form an approximately 90 degree bend inward from the outer surface and extends completely to the inner surface of the rods 1010, 1020.

In another exemplary embodiment of the biasing device 1030, the inward (clip closing) force applied to the clamping bar is increased. In such embodiments, the profile of spring 1030 is modified such that the end legs cross each other, forming part of the "fig. 8" shape. Such a configuration provides a preload force between the clamp bars that is proportional to the degree to which the end legs cross. To maintain torsional balance between the upper and lower springs 1030 in such a configuration, one spring has a left-right leg cross with the left leg up, and the other spring has a right-left leg cross with the right leg up. Placing the spring in this mirror image can cancel any torque generated on the clamping bar that would otherwise cause the clamping bar to twist. To move the point of force equilibrium to the center of the longitudinal axis of the clamping bar, the legs of the spring 1030 may be further angled relative to the U-shaped portion to provide a biasing force to one or the other end of the clamping bar.

Extending through the band capture via 1011 is a switchable band 1050, depicted in fig. 108-111. Band 1050 is referred to as switchable because it is used to transition clip 1000 from a closed end clip (in which both the proximal and distal ends are closed to form a loop) to an open end band (in which only the proximal end is closed and forms an approximate U-shape), as described in further detail below. From one end to the other, strap 1050 has a first enlarged strap end 1052, a first reduced strap locking portion 1054, an intermediate strap portion 1056, a second reduced strap locking portion 1054, and a second enlarged strap end 1052. The proximal band anchor hole 1013 is configured and shaped to retain the first enlarged band end 1052. The first reduced belt locking portion 1054 is configured and shaped to retain the first reduced belt locking portion 1054. The distal end strap path 1017 and the end strap path 1019 are configured and shaped to retain the intermediate strap portion 1056 to bend the strap 1050 around the corner formed by the junction of the distal end strap path 1017 and the end strap path 1019. The belt capture path 1021 is a mirror image of the belt capture path 1011 and therefore will not be described further. The belt capture path 1021 holds the second reduced belt locking portion 1054 and the second enlarged belt end 1052 in the same manner that the belt capture path 1011 holds the first reduced belt locking portion 1054 and the first enlarged belt end 1052. Alternatively, the strap anchor 1040 may have protrusions such as barbs and teeth that extend toward the strap 1050 and pierce or squeeze the strap when installed. This has the following benefits: the ribbon 1050 may have a uniform diameter throughout for ease of fabrication and installation.

The belt 1050 is made of a material that is at least partially elastic. Thus, as the transfer device 900 expands the clip 100, at least the intermediate strap portion 1056 stretches to accommodate the enlarged span between the distal ends of the clip 1000. When present, both ends of the clip 1000 are closed, for example, as shown in fig. 109. When implanted on the LAA, the band 1050 can apply an inward bias to the distal ends of the clamping bars 1010, 1020. In this orientation, the clip 1000 forms a complete loop around the LAA. If the LAA is not insertable in this closed state, the tape 1050 may be severed between the two rods 1010, 1020 and, if stretched, the two cut ends of the tape 1050 will spring into the distal tape path 1017 and the tip tape path 1019.

The clips described herein provide a clip assembly (e.g., 610, 620, 1010, 1020) and a biasing assembly (e.g., 632, 1030). The clip assembly includes opposing first and second clip bars (e.g., 610, 620, 1010, 1020). Each of the clamp bars has a tissue contacting surface, which in an exemplary embodiment is the side facing the LAA. Each of the clamping bars has a first offset surface and a second offset surface. A biasing assembly connects the first and second clamping bars to align the first and second clamping bars in a bar plane passing through the tissue contacting surface. The biasing assembly includes one or more first biasing springs (e.g., 632, 1030) coupled to one side of the first biasing surface of the first clamping bar and another side of the first biasing surface of the second clamping bar. The biasing assembly also includes one or more second biasing springs (e.g., 632, 1030) coupled to one side of the second biasing surface of the first clamping bar and another side of the second biasing surface of the second clamping bar. In this manner, the first and second biasing springs allow the first and second clamping bars to move in the bar plane, e.g., in a rocking motion as shown in the progression of, e.g., fig. 86-89 and 91, 93, 96, and 99. Another way to describe this is that the biasing assembly is configured to allow rocking of the first and second clamping bars in the bar plane. The rocking motion of the first clamping bar in the bar plane may be independent of the rocking motion of the second clamping bar in the bar plane.

The first and second biasing springs balance the forces due to the position of the biasing assembly such that the first and second clamping bars do not substantially rotate about their respective longitudinal axes when the first and second bars move in the bar plane. The first and second biasing springs balance the forces such that the first and second clamping bars have substantially no torque when the first and second bars move in the bar plane.

The first clamping bar has a first proximal end and a first distal end, and the second clamping bar has a second proximal end and a second distal end. In an exemplary embodiment, the first biasing spring is coupled to the first clamping bar intermediate the first biasing surface between the first proximal end and the first distal end and the second clamping bar intermediate the first biasing surface between the second proximal end and the second distal end. Similarly, the second biasing spring is coupled to the first clamping bar at a position intermediate the second biasing surface of the first clamping bar between the first proximal end and the first distal end, and at a position intermediate the second biasing surface of the second clamping bar between the second proximal end and the second distal end.

The first offset surface of the first clamping bar may be a first upper side, the second offset surface of the first clamping bar may be a first lower side, the first offset surface of the second clamping bar may be a second upper side, and the second offset surface of the second clamping bar may be a second lower side. The tissue contacting surface of the first clamp bar can be a first LAA contacting surface having a first longitudinal centerline, the tissue contacting surface of the second clamp bar can be a second LAA contacting surface having a second longitudinal centerline, and the bar plane passes through the first longitudinal centerline and the second longitudinal centerline.

The clips described herein are sized, for example, to fit a laparoscopic port having an inner diameter. In this regard, the clip assembly and the biasing assembly collectively have a maximum outer width that is no greater than the inner diameter of the port.

The first and second clamping bars have a maximum longitudinal length and the first and second biasing springs have a longitudinal length that is shorter than the maximum longitudinal length, for example, as shown in fig. 88 and 106. As shown in these illustrations (e.g., fig. 86-89), the first and second upper sides of the lever collectively define an outer upper boundary, wherein the first biasing spring is substantially retained in the outer upper boundary. Likewise, the first and second undersides collectively define an outer lower boundary, wherein the second biasing spring is substantially retained in the outer lower boundary. As shown in fig. 86-89, for example, a transfer device (860, 862, 870) is removably connected to the first and second proximal ends of the clamp bar and moves the first and second clamp bars in the bar plane. The first clamping bar and the second clamping bar move independently in the bar plane. As shown in fig. 86-89 and 92, the delivery device is removably connected to the proximal end and the proximal end through the first proximal opening and the second proximal opening. In an exemplary embodiment, the delivery device is removably connected to only the first and second proximal ends through the first and second proximal openings.

Fig. 112-128 illustrate an exemplary embodiment of a surgical instrument having an end effector with various aspects of tissue intersection sensors for a jaw-based surgical instrument that provide a surgeon with greater precision and control over placement of the distal ends of the jaws when they are occluded or blocked by a surgical environment (e.g., view or tissue), and with embodiments of the jaws for holding and deploying tissue-blocking clips (e.g., LAA detachment clips). The sensor is particularly beneficial for LAA detachment clips having a closed proximal end and an open distal end. This is because the sensor provides the surgeon with information that the LAA-separating clip completely traverses the length of the LAA, and that upon closure, no tissue is ejected from the distal end of the LAA-separating clip that would not be contained in the clip when the clip is finally implanted (tissue ejection is a similar action to a toothpaste tube, where at least a portion of the LAA is squeezed out of the distal end of the clip during closure).

Fig. 112-124 illustrate a surgical end effector (e.g., applicator head) in an exemplary embodiment of a jaw 1100 having an exemplary embodiment of a LAA-separating clip 1200 loaded therein. Fig. 112-116 illustrate jaw 1100 and clip 1200 in an open orientation, and fig. 117-124 illustrate jaw 1100 and clip 1200 in a closed orientation. The distal end of the split clip applier 1300 is shown diagrammatically in phantom in fig. 116 and is connected to the proximal end of the jaws at a pivot assembly 1310. Pivot assembly 1310 includes a clevis 1312 pivotally attached to jaw 1100 and to the distal end of shaft 1314 (either fixedly or by a hinge). Other proximal components of the applicator 1300 include a handle, not shown. As can be seen, the opposing first and second jaws 1110, 1120 are independently connected to a pivot assembly 1310, allowing them to pivot relative to each other. The pivot assembly 1310 is actuated by a control on the handle, not shown.

Each jaw 1110, 1120 includes a proximal jaw base 1112, 1122, a distal cup member 1114, 1124, and a soft middle jaw member 1116, 1126 connecting the proximal jaw base 1112, 1122 to the cup member 1114, 1124, respectively. Attached to each of the jaws 1110, 1120 is a portion of a fiber optic assembly that includes a first optical fiber 1130 on the jaw 1110 and a second optical fiber 1132 on the jaw 1120 (the optical fibers are equivalently referred to as, for example, cables, wires, tubes, and/or lines). In an exemplary passive embodiment of the fiber optic assembly, the first optical fiber 1130 is a collector-type optical fiber and the second optical fiber 1132 is a transmission-type optical fiber, each of which is attached to a top surface of the first jaw 1110 and the second jaw 1120, respectively. In alternative exemplary embodiments, the optical fibers 1130, 1132 may be guided through channels in the jaws 1110, 1120 or attached to any surface of the jaws 1110, 1120. In one particular exemplary embodiment, the collector type wire is coiled around the first jaw 1120 to maximize the length of exposure to ambient light and, thus, increase the amount of light output by the wire.

The distal or proximal ends of collector wire 1130 and transmission wire 1132 are received by cup-shaped members 1114, 1124, respectively, and are arranged so that they approach each other when jaws 1110, 1120 are closed. In certain advantageous embodiments, the distal ends of the optical fibers 1130, 1132 have distal surfaces that are parallel to each other, coaxially aligned with each other, and in close proximity to or contact each other when the jaws are closed. This optimal relative condition is best shown in fig. 121 and 123, which show a top view and a front perspective view, respectively, of the end effector in a closed position or condition. It should be noted that the cup-shaped members 1114, 1124 and the distal ends of the optical fibers 1130, 1132 need not be in direct contact to allow light to be transmitted from one side of the jaws to the other. Depending on the type of wire used for the optical fibers 1130, 1132, light may still be transmitted even if there is a gap between the distal ends, which may be between about 1mm and about 3mm, or even larger. In the illustrated embodiment, the optical fibers 1130, 1132 are guided and terminated along respective top surfaces of the cup members 1114, 1124, and the distal ends of the optical fibers 1130, 1132 terminate at opposing symmetrical locations on the inner surfaces of the two cup members 1114, 1124. In alternative embodiments, the optical fibers 1130, 1132 are guided through apertures in the middle of the cup members 1114, 1124 or along the bottom surfaces of the cup members 1114, 1124. In further exemplary embodiments, multiple sets of separately guided fiber optic lines may be used (e.g., through both the top and bottom surfaces of the jaws or in any combination of pathways).

Proximal jaw bases 1112, 1122 contain control paths 1113, 1123 that guide clip release control lines 1140 from the handles to intermediate jaw members 1116, 1126 (and then to the distal cup members 1114, 1124), respectively. The proximal jaw base 1112, 1122 also contains a clip securing aperture 1111, 1121. The clamping members 1222, 1224 of the clip 1200 are removably secured to the respective proximal jaw bases 1112, 1122 by a proximal clip release apparatus 1410. In an exemplary embodiment, the proximal clip release device 1410 for the jaw bases 1112, 1122 is a suture that is wrapped around the clamping members 1222, 1224, passed through an upper portion of the clip securing apertures 1111, 1121, passed around the clip release wire 1400 and outward (along and perpendicular to the apertures 1111, 1121), and passed back through a lower portion of the clip securing apertures 1111, 1121 to be secured to the other end of the suture 1410, such as by tying one or more knots. This suture 1410 is shown, for example, in fig. 125-128. Thus, when the clip release control wire 1400 is pulled distally such that the distal end of the clip release control wire 1400 is retracted proximally beyond the clip securing apertures 1111, 1121, the proximal clip release apparatus 1410 no longer retains the clamping members 1222, 1224 at the proximal jaw bases 1112, 1122. As shown in fig. 112-128, the clip release control lines 1400 on each side of the jaws 1110, 1120 terminate at line end lead blocks 1430 attached to each of the cup-shaped members 1114, 1124, respectively. The wire end lead block 1430 retains the end of the clip release control wire until the placement of the clip 1200 is desired. Retention of the clip release control line 1400 at the wire end lead block 1430 can occur in a variety of ways, for example, by press fitting or by way of a friction fit.

In contrast to the relatively stiff proximal jaw bases 1112, 1122, the intermediate jaw members 1116, 1126 are relatively flexible, which flexibility allows the respective cup-shaped members 1114, 1124 to move inwardly and outwardly relative to the proximal jaw bases 1112, 1122 as the jaws 1100 are moved between their open and closed positions. As with proximal jaw bases 1112, 1122, intermediate jaw members 1116, 1126 each have a clip securing aperture 1117, 1127. Clamping members 1222, 1224 of clip 1200 are removably secured to respective intermediate jaw members 1116, 1126 by a distal clip release apparatus 1440. In an exemplary embodiment, the distal clip release device 1440 is a suture that is wrapped around the clamping members 1222, 1224, passes through an upper portion of the clip securing apertures 1117, 1127, surrounds the clip release wire 1400 and passes outward (along and perpendicular to the apertures 1117, 1127), and passes back through a lower portion of the clip securing apertures 1117, 1127 to be secured to the other end of the suture 1440, such as by tying one or more knots. The distal suture 1440 is shown, for example, in fig. 125-128. Thus, when the clip release control line 1400 is pulled distally to retract the distal end proximally beyond the clip securing apertures 1117, 1127, the clip release device 1440 no longer retains the clamping members 1222, 1224 at the middle jaw members 1116, 1126.

As shown enlarged in fig. 124, distal cup members 1114, 1124 have a top 1115, 1125, a distal wall 1118, 1128 substantially perpendicular to top 1115, 1125 at the distal end of cup members 1114, 1124, and a side wall 1119, 1129 substantially perpendicular to both top 1115, 1125 and distal wall 1118, 1128. These three walls of each of the cup members 1114, 1124 form respective cups in which the distal ends of the clamping members 1222, 1224 of the clip 1200 remain when attached to the jaw 1100.

Fig. 125-128 illustrate the attachment of the LAA detachment clip 1200 to the applicator head by, for example, wrapping sutures 1410, 1440 about the clip release control wire 1400. To disengage the clip 1200 from the jaw 1100, the clip release control wire 1400 is pulled proximally, away from the wire end lead block 1430, by, for example, a pull tab in the handle. The clip release control wire 1400 is then removed from most or all of the jaws 1100 to release the sutures 1410, 1440 and separate the clip 1200 from the jaws 1100.

In an exemplary embodiment, the ends of the optical fibers 1130, 1132 are disposed at slightly proximal or distal ends of the respective ends of the parallel clamping members 1222, 1224 of the split clip 1200. The position of the fiber relative to the tip of the clamping member determines how much overlap is required between the end of the clip and the tissue being detected. For example, it may be desirable for the length of the clip to extend distally beyond the optical fiber, thereby creating a greater overlap safety margin. In an exemplary embodiment, the optical fibers 1130, 1132 extend inwardly beyond respective inner surfaces of the clamping members 1222, 1224 of the clip 1200 to accommodate the distance between the clamping members 122, 1224 when tissue is disposed therebetween. Thickness is typically about 3mm +/-1mm, but the distance can accommodate 4mm to 6mm), which is typical for the thickness of a clamped LAA. With such inward extensions, the two ends of the optical fibers 1130, 1132 are substantially orthogonal.

In an exemplary embodiment of an applicator for a separate clip having a distal tip sensor, the applicator comprises a handle housing one or more controls, an applicator head, an elongate shaft having a proximal end and a distal end, wherein the proximal end is coupled to the handle and the distal end is coupled to the applicator head. The applicator head includes first and second elongated jaw members each having a proximal end and a distal end, and the proximal ends of the first and second elongated jaw members are pivotally connected. The pivotal connections may be to each other or to the clevis separately. The first and second elongated jaw members each include a cup-shaped member at a distal end thereof. A flexible member connects the distal end of the jaw member to the proximal end of the cup-shaped member. In an exemplary passive optical embodiment, a first fiber optic line is disposed on the first elongated jaw member, the first fiber optic line having two ends and a length, and collecting light along its length and outputting the collected light through its ends. At least one of the ends of the first fiber optic line is disposed at or in the cup-shaped member of the first elongate jaw member. A second fiber optic line is disposed on the second elongate jaw member, the second fiber optic line having two ends and being adapted to collect light at one end and output the collected light at the other end. The collection end of the second fiber optic line is disposed at or in the cup-shaped member of the second elongate jaw member. The output end of the second fiber optic line is located at the proximal end of the cup-shaped member from the second elongated jaw member, either in a position that is visible to an operator of the applicator or a light sensor advanced into a clevis, shaft or handle to automatically detect light and indicate to the user that the jaws and/or cup-shaped member are aligned and unobstructed. The first and second elongated jaw members are operably pivotable between a closed position and an open position by actuation of a control on the handle. When the first and second elongated jaw members are pivoted to the closed position, at least one end of the first fiber optic line and the collection end of the second fiber optic line are placed in close proximity. When the first and second elongate jaw members are pivoted to the closed position, light collected by the first fiber optic line is transmitted to the second fiber optic line and output at an output end of the second fiber optic line. In an exemplary configuration, the collection fiber is green, so light incident along the outer surface of the fiber enters the fiber and is directed along its axis. Because of the color of the material, the light collected and transmitted will be green. In contrast, the transmission fiber is clear, so when the two fibers are brought together, green light exits the end of the green fiber and enters the clear fiber when the ends are aligned and not blocked by tissue. This light is transmitted through the clear fiber and exits the proximal end of the fiber so that it can be seen by the operator/surgeon. If the operator sees a green light coming out of the clear fibers, it can be determined that nothing is blocking the opposite transmission ends of the fibers and, therefore, that the fastener has fully extended beyond the unclamped tissue. Alternatively, both fibres may be clear and run along the delivery device, or may even run all the way to the handle of the delivery device. Light of any given frequency may be input to the transmission fiber, which may be stable or pulsed in a particular pattern. When the optical fibers are sufficiently aligned at the distal end of the end effector, the receiving fibers bring the transmitted light back to the shaft/handle where the detector is placed. The detector observes the light and determines whether the light is a known transmitted signal. When a positive determination of transmitted light is confirmed, this indicates that the fastener is properly implanted across tissue, and a user interface, e.g., an LED and/or audible and/or tactile feedback alerts its user.

As indicated in the exemplary embodiments herein, the cross-section of the clamping bar 110, 120, 210, 220, 410, 420 of fig. 1-51 is substantially rectangular. These are merely exemplary embodiments. The cross-section of the clamping bar 110, 120, 210, 220, 410, 420 may also be circular, oblong or polygonal. Accordingly, narrative statements using first, second, third and fourth as four sides are exemplary only and should not be considered limiting. In embodiments where the cross-section is circular or oblong, the enumerated segments may be first, second, third and fourth quadrants, portions or sides.

LAA contact pads are described herein as being made from a variety of materials. In alternative exemplary embodiments, the clamping bars 210, 220 may be completely surrounded by a woven sleeve that provides a non-slip surface and promotes tissue ingrowth, e.g., which may be made of woven

And (4) preparing. Another alternative to a fabric pad is a smooth or textured surface or a surface covered by an elastomeric (e.g., polyurethane or polydimethylsiloxane) smooth or textured pad, which may be equipped with a self-energizing material as described above or have features that otherwise enhance traction to the LAA.

The word "cord" is used herein with respect to, for example, control cords 252, 262. The meaning of the word is broad and is not limited to a particular material or cross-section. Cord refers to any longitudinally extending material that may incorporate the structures and functions described herein. As defined herein, the term cord is not limited to a single cord; the cord may also be a plurality of cords. Thus, one cord and multiple cords may be used interchangeably. The cord is also not limited to a particular type of material. The material may be made of natural fibers, synthetic or synthetic fibers, plastics and/or metals, to name a few. The cord is not limited to a particular configuration. The material may be made of stranded strands, stranded strands with a central core, or single stranded wires or wires, to name a few. One exemplary embodiment described herein is a surgical suture. However, even though examples of surgical sutures are mentioned or used herein, the embodiments described herein are not limited to surgical sutures.

In various examples herein, a hole is referred to as a "blind" hole. With this representation, in an exemplary alternative embodiment, some of the holes may be through holes.

It should be noted that various individual features of the inventive process and system may be described in only one exemplary embodiment herein. The particular choice described herein in relation to a single exemplary embodiment should not be taken as limiting the particular features only applicable to the embodiment in which they are described. All of the features described herein may be equally applied to, appended to, or interchanged with any or all of the other exemplary embodiments described herein in any combination or grouping or arrangement. In particular, the use of a single reference number to illustrate, define or describe a particular feature herein does not imply that such feature is not associated with or equivalent to another feature in another figure or description. Furthermore, where two or more reference numerals are used in a figure or drawing, this should not be construed as being limited to only those embodiments or features which are equally applicable to similar features or where no reference numeral is used or another reference numeral is omitted.

The foregoing description and drawings illustrate the principles, exemplary embodiments and modes of operation of systems, apparatuses and methods. However, the systems, devices, and methods should not be construed as limited to the particular embodiments discussed above. Other variations of the embodiments discussed above will be understood by those skilled in the art and should be considered as illustrative and not restrictive. It is therefore to be understood that changes may be made in these embodiments by those skilled in the art without departing from the scope of the systems, apparatus and methods as defined in the following claims.