阅读说明：本技术 医疗装置部署系统的电子控制 (Electronic control of a medical device deployment system ) 是由 里德·N·里兹克 丹尼尔·J·福斯特 阿杰伊·古普塔 于 2020-02-18 设计创作，主要内容包括：一种部署系统的实施例可以包括导管,其具有远端和近端。致动器可以设置在所述导管的远端并且可以可操作地连接到电连接器,所述电连接器沿着所述导管从所述近端纵向延伸至所述致动器。所述电连接器可以被配置用于将信号传输至所述致动器。一个或多个连接件可以联接至所述致动器以及至设置在所述导管的所述远端处的可部署医疗装置。(An embodiment of a deployment system may include a catheter having a distal end and a proximal end. An actuator may be disposed at a distal end of the catheter and may be operably connected to an electrical connector extending longitudinally along the catheter from the proximal end to the actuator. The electrical connector may be configured to transmit a signal to the actuator. One or more connectors may be coupled to the actuator and to a deployable medical device disposed at the distal end of the catheter.)

1. A deployment system, comprising:

a catheter having a distal end and a proximal end;

an actuator disposed at a distal end of the catheter; and

one or more connectors coupled to the actuator and to a deployable medical device disposed at a distal end of the catheter.

2. The system of claim 1, wherein a diameter of a proximal end of the catheter is smaller than a diameter of a distal end of the catheter.

3. The system of claims 1-2, further comprising an electrical connector extending longitudinally along the catheter from the proximal end to the actuator, the electrical connector configured for transmitting a signal to the actuator, and further comprising a control box operably connected to the electrical connector at the proximal end of the catheter to send a signal to the actuator.

4. The system of claim 3, further comprising a sensor for detecting actuation of the one or more connectors from the actuator such that the control box receives feedback to coordinate deployment of the medical device.

5. The system of claim 3, wherein the deployable medical device is positionable by the actuator in response to the signal received from the control box.

6. The system of claim 3, wherein the electrical connector comprises an electrical wire, a printed cable, or a thermal wire, or a combination thereof.

7. The system of claim 5, wherein the deployable medical device is positionable by an actuator via linear movement, rotational movement, inchworm actuation, rack-and-pinion actuation, clutching mechanisms, or complex displacements, or combinations thereof.

8. The system of claims 1-7, further comprising a support assembly longitudinally extendable along the conduit to support the conduit.

9. The system of claims 1-8, further comprising a control box in wireless communication with the actuator.

10. The system of claims 1-9, wherein the actuator comprises an electrical actuator, an electrostatic piezoelectric actuator, a thermal actuator, a magnetic actuator, a shape memory material actuator, a micro-actuator, or an electroactive polymer, or a combination thereof.

11. A method for deploying a device, comprising:

positioning a distal end of a catheter at a desired location;

positioning the device at a desired location by an actuator disposed at a distal end of the catheter, the actuator being operably connected to an electrical connector extending longitudinally from a proximal end of the catheter to the actuator;

transmitting, by the electrical connector, a signal to the actuator for positioning the device; and

disengaging one or more connectors to disconnect the actuator and the device.

12. The method of claim 11, wherein a diameter of a proximal end of the catheter is smaller than a diameter of a distal end of the catheter.

13. The method of claims 11-12, further comprising sending the signal to the actuator through a control box operably connected to the electrical connector at the proximal end of the catheter.

14. The method of claim 13, further comprising positioning the actuator in response to receiving the signal from the control box.

15. The method of claim 14, further comprising disengaging the device from the one or more connectors after positioning the device.

Technical Field

The present invention relates generally to medical device deployment systems, and more particularly to electronic control and methods of medical device deployment systems.

Background

Medical devices, such as implants or other interventional, endoscopic surgical or urological devices, may be deployed within a patient or otherwise controlled by a cable mechanically actuated at a proximal end of the deployment system, e.g., outside the patient. To accommodate several cables for actuating the medical device, the catheter may have a large diameter along its entire length, which may pose several challenges to the medical professional. For example, mechanical deployment systems may be difficult to navigate within a complex or narrow body lumen, e.g., a blood vessel, artery, etc., to accurately manipulate multiple cables extending along the entire length of the catheter to control the medical device. Medical professionals may be limited in actuation control at the proximal end of the deployment system, which may result in undesirable and/or limited repeatable positioning and deployment of the medical device.

With respect to these and other considerations, the improvements of the present invention may be useful.

Disclosure of Invention

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

According to one embodiment of the present invention, a deployment system may include a catheter having a distal end and a proximal end. The actuator may be disposed at the distal end of the catheter and may be operatively connected to an electrical connector extending longitudinally along the catheter from the proximal end to the actuator. The electrical connector may be configured to transmit a signal to the actuator. One or more connectors may be coupled to the actuator and to a deployable medical device disposed at the distal end of the catheter.

In various of the foregoing and other embodiments of the invention, the diameter of the proximal end of the catheter may be smaller than the diameter of the distal end of the catheter. The control box may be operably connected to an electrical connector at the proximal end of the catheter to send signals to the actuator. The deployable medical device may be positioned by the actuator in response to receiving the signal from the control box. The deployable medical device may be disengaged from the one or more connectors after positioning. The support assembly may extend longitudinally along the conduit to support the conduit. The electrical connectors may comprise electrical wires, electronic wires, printed cables or hot wires or a combination thereof. The connection to the actuator and/or the implant may be wireless. The control box may be in wireless communication with the actuator. A sensor may be included to detect actuation of one or more links from the actuator. The control box may receive feedback to coordinate the deployment of the medical device. The deployable medical devices may be positioned by the actuator by linear movement, rotational movement, inchworm-like actuation, rack-and-pinion actuation, clutching mechanisms, or complex displacements, or combinations thereof. The actuator may comprise an electrical actuator, an electrostatic piezoelectric actuator, a thermal actuator, a magnetic actuator, a shape memory material actuator, a micro-actuator, or an electroactive polymer, or a combination thereof.

According to one embodiment of the invention, a method for deploying a medical device may include positioning a distal end of a catheter at a desired location. The medical device may be positioned at a desired location by an actuator disposed at the distal end of the catheter. The actuator may be operably connected to an electrical connector extending longitudinally from the proximal end of the catheter to the actuator. Signals may be transmitted by the electrical connector to the actuator for positioning the device. One or more of the connectors may be disengaged to disconnect the actuator from the device.

In various of the foregoing and other embodiments of the invention, the diameter of the proximal end of the catheter may be smaller than the diameter of the distal end of the catheter. The signal may be sent to the actuator by a control box operatively connected to an electrical connector at the proximal end of the catheter. The medical device may be positioned by the actuator in response to receiving the signal from the control box. The medical device may be disengaged from the one or more connectors after positioning the medical device. The conduit may be supported by a support assembly that may extend longitudinally along the conduit. The electrical connectors may comprise electrical wires, electronic wires, printed cables or hot wires or a combination thereof. The medical device may be positioned by the actuator by linear movement, rotational movement, inchworm-like actuation, rack-and-pinion actuation, clutching mechanisms, or complex displacements or combinations thereof. The actuator may comprise an electrical actuator, an electrostatic piezoelectric actuator, a thermal actuator, a magnetic actuator or a shape memory material actuator, a micro-actuator or an electroactive polymer or a combination thereof. Actuation of one or more connectors from the actuator can be detected by the sensor such that the control box receives feedback to coordinate deployment of the medical device.

Drawings

Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every drawing, nor is every component of each embodiment shown as is necessary to allow those of ordinary skill in the art to understand the invention.

In the drawings:

FIGS. 1A-1B illustrate an embodiment of a deployment system according to the present invention;

figures 2A to 2C illustrate an embodiment of a connection mechanism between a medical device and a catheter of a deployment system according to the present invention;

figures 3A-3B illustrate an embodiment of an implant deployment system according to the present invention; and

fig. 4A-4B illustrate a method for deploying a medical device according to the present invention.

Detailed Description

The present invention is not limited to the specific embodiments described herein. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," or "includes" and/or "including," when used herein, specify the presence of stated features, regions, steps, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and/or groups thereof.

As used herein, the term "distal" refers to the end that is furthest from the medical professional when introducing the medical device into a patient, while the term "proximal" refers to the end that is closest to the medical professional when introducing the medical device into a patient. With respect to the opening, the central axis refers to a line bisecting a center point of the opening, which extends longitudinally along the length of the opening when the opening comprises, for example, a tubular frame, a strut, or a bore.

Embodiments of deployment systems and methods according to the invention may be configured to be electronically controlled to improve the deployment of medical devices. Wires and/or printed wires or cables may control high force and/or high displacement actuators placed immediately proximal to or distal to the medical device for manipulation, e.g., to approximate the intended location of a medical procedure and site for deployment within a patient's body. The actuator may be coupled to one or more connectors for positioning the medical device in a desired position during a medical procedure, including but not limited to pushing, pulling, deploying, repositioning, and/or otherwise controlling the medical device. By reducing and/or eliminating the number of mechanical wires or cables that must extend all the way out of the patient's body in order to manipulate the various elements of a medical device with multiple degrees of freedom, a catheter with a smaller profile according to the present invention may be included in a deployable system that has more flexibility for medical procedures and may provide improved overall control of the medical device. Smaller systems may reduce inadvertent and/or accidental contact with tissue. Existing systems may be large and less flexible for extending through tortuous anatomy, such as the aortic arch, the ventricle, at the ostia of vessels and branches, the femoral artery, and/or the transvavilar arch. In some patients, the system extends through organ and/or tissue anatomy that may be diseased or otherwise sensitive or damaged, such as calcified vessels, aneurysms, and/or dissections. The systems and methods of the present invention can reduce, minimize, and/or eliminate adverse events, such as inadvertent contact with sensitive or diseased tissue, which can damage the tissue, resulting in spasticity, bleeding, hematoma, infection, pseudoaneurysm, cardiac tamponade, nerve damage, dissection, puncture, or other types of damage.

Embodiments of the deployment systems and methods may be configured for any number of medical devices for implantation within a patient's body, including but not limited to cardiovascular, gastrointestinal, pulmonary, urinary tract, and/or vascular devices, where wires or other electrical connectors may instead provide signals to manipulate various elements in multiple degrees of freedom of the medical device to deploy and position as desired at a desired location within the patient's body.

Referring now to fig. 1A-1B, embodiments of a deployment system 100, 100' according to the present invention are shown. As shown in fig. 1A, the system 100 may include a catheter 105 having a proximal end 110 and a distal end 115. Conduit 105 may be a hollow tube 107 having an outer surface 107a and an inner surface 107b and extending a length "L" along longitudinal axis 140_C". Conduit 105 may be formed from a flexible material such that length L_CAnd distal end 115 may be navigated in a body lumen (which may have a changing curvature) to reach a desired deployment location within a patient.

In an embodiment, diameter "D" of proximal end 110_A"may be less than the diameter" D of distal end 115_B". For example, proximal end 110 may be sized between about 2 and 10Fr and distal end 115 may be up to about 30 Fr. In other embodiments, the proximal end 110 and the distal end 115 of the catheter 105 may be substantially identical, e.g., D_AMay be substantially equal to D_B. As shown in FIG. 1B, for example, another embodiment of a deployment system 100' may include a deployment system havingA proximal 110 ' and a distal 115 ' catheter 105 ', wherein the proximal 110 ' has a diameter "D '_A"may equal diameter" D "of distal end 115'_B". Additional components described herein may be included in the deployment system 100, 100'.

The distal ends 115, 115 'of the catheters 105, 105' may have a proximal portion 145 and a distal portion 150. As shown in FIG. 1A, distal end 115 may extend from diameter D at proximal portion 145_AGradually transitioning to a diameter D at the distal portion 150_BAnd/or may extend in a stepped portion such that the distal end 115 may form a frustoconical shape. In other embodiments, proximal portion 145 and distal portion 150 may have substantially the same diameter, for example, as shown in fig. 1B.

The proximal portion 145 of the distal end of the catheter may include a reinforced region 155 for supporting the actuator 130. The stiffened region 155 can be a substantially inflexible portion of the catheter 105, 105 'to minimize collapse, kinking, and/or contraction of the catheter 105, 105' at the stiffened region 155 when navigating within a patient. In some embodiments, the reinforced area 155 can be a reinforced portion of the hollow tube 107. The reinforced region 155 can be formed of a different material and/or include additional elements to have greater strength at the reinforced region 155 than other portions of the conduits 105, 105'. In some embodiments, stiffened region 155 may include additional attachments of actuator 130 to hollow tube 107. A reinforced region 155 may be included so that the catheter can withstand "reaction" forces and/or torques applied during deployment of the selected medical device. In some embodiments, as shown in FIG. 1A, the reinforced region 155 may correspond to the diameter D from the proximal end 110_ADiameter D to distal end 115_BAligned with the diameter transition.

The length L of the conduits 105, 105' throughout the conduits 105, 105_CThere may be a uniform wall thickness of the hollow tube 107, however in some embodiments the wall thickness may taper from a thicker wall thickness at the proximal end 110, 110 'of the catheter 105, 105' to a thinner wall thickness at the distal end 115, 115 'of the catheter 105, 105'. Conduits 105, 105 'compared to existing conveying systems by removing the bulkier mechanical cables'Along the length L of the conduit 105, 105_CCan be uniformly thin.

During a medical procedure, the proximal end 110, 110 'may remain outside the patient to allow a medical professional to control the distal end 115, 115' at a desired internal location for the procedure. The catheter 105, 105 'may be inserted into a patient, with the distal end 115, 115' positionable at a desired location to deploy a medical device. For example, an implant may be deployed to repair a heart valve, an occlusion device may be positioned to redirect and/or prevent fluid flow in a body lumen, or any other number of grafts, stents, or other medical devices may be temporarily or permanently inserted into a patient by the system 100, 100' to improve patient health. In some embodiments, the systems 100, 100' may be used to actuate accessories such as biopsy forceps, graspers, snares, needles, or other instruments used in various applications (such as endoscopic and/or pulmonary applications).

The system 100, 100 'may include an electrical connector 120 that extends along the length of the catheter 105, 105', e.g., from the proximal end 110, 110 'to the distal end 115, 115'. The electrical connector 120 may be operatively connected to a control box 170 disposed at the proximal end 110, 110'. The control box 170 may be configured to provide signals to the actuator 130 at the distal end 115, 115 'of the system 100, 100' through the electrical connector 120.

The electrical signal controlling the deployment of the medical device 135 may allow for improved repeatability and accuracy by providing more controlled positioning and deployment of the medical device through the actuator 130 at 115, 115 'of the catheter 105, 105' to place it at a desired location within the patient. In some embodiments, such control of the procedure may reduce procedure time and/or allow for better and/or safer tracking of the system 100, 100' to the intended delivery location of the patient.

The electrical connector 120 may be operably connected to the actuator 130 to receive electrical signals to actuate and deploy the medical device 135 to a desired location within the patient. In some embodiments, the control box 170 may be connected to the electrical connector 120 via a cable 171 and may be connected to the respective connection assembly 125a at the proximal end 110, 110' of the conduit and 175a at the control box 170 by the connection assemblies 125b and 175b as a male snap connection. In some embodiments, the control box 170 may be wirelessly connected to the electrical connector 120. In some embodiments, the control box 170 may be wirelessly connected to the actuator 130 to communicate operation, release, or other manipulation of the device 135 (e.g., bluetooth, rfid, etc.). In some embodiments, control box 170 may be designed individually for medical devices to be deployed, and in other embodiments, control box 170 may be an off-the-shelf design configured to deploy a plurality of different medical devices.

The electrical connector 120 may be along the length L from the connection assembly 125a_CAnd extends longitudinally substantially parallel to the longitudinal axis 140 of the catheter 105, 105 ' to the actuator 130 at the distal end 115, 115 ', the connection assembly 125a for connection with the control box 170 at the proximal end 110, 110 '. The electrical connector 120 may be disposed along the outer surface 107a of the conduit 105, 105 ', along the inner surface 107b of the conduit 105, 105', in the hollow tube 107 of the conduit 105, 105 ', and/or embedded in the hollow tube 107 of the conduit 105, 105'. In some embodiments, the electrical connector 120 may be within the wall of the hollow tube 107. The electrical connector may be one or more wires including, but not limited to, electrical wires, electronic wires, printed cables, or hot wires, or a combination thereof. The electrical connector 120 may include insulated wires, fine gauge wires, and/or printed electronics for transmitting voltage and current to the actuator 130. In view of the tortuous anatomy that may be encountered when the system 100, 100 'is delivered to the intended location of a medical procedure, the electrical connector 120 may be formed straight and/or serpentine to establish slack in the connector to allow the conduit 105, 105' to bend, thereby minimizing the risk of damaging and/or breaking the electrical connector 120 under large displacements, strains, and/or stresses. In some embodiments, the electrical connectors may be attached to the catheter outer surface 107a and/or inner surface 107b by a flexible glue and/or other adhesive that allows flexibility to accommodate the changing curvature of the catheter 105, 105' during delivery to the intended location of the medical procedure. The electrical connector 120 may additionally and/or alternativelyInsulation and/or coatings are included to protect electrical integrity during normal use and/or sterilization of the system 100, 100 ', which may not alter the flexibility of the electrical connector 120 and/or the attachment to the conduit 105, 105'.

The electrical connector 120 may replace a larger mechanical cable to perform the manipulation of the individual elements in existing systems such that the diameter D of the proximal end 110 of the catheter 105_AMay be smaller to improve delivery into and through the patient, as shown in fig. 1A. In some embodiments, catheter 105 'may have a constant diameter thickness such that proximal diameter D'_AIs approximately equal to distal diameter D'_BAs shown in fig. 1B.

Diameter D of proximal end 110_ACan extend substantially the length L_C. When the catheter 105 has a variable diameter, the reduced proximal and mid-catheter diameters may limit the "pushability" of the catheter 105 such that the catheter 105 may kink or collapse, or both. The kink and/or collapse may be the larger diameter D of distal end 115_BTo accommodate larger medical devices 135. It should also be appreciated that a catheter 105 ' having a constant diameter at the proximal end 110 ' and distal end 115 ' may also kink and/or collapse.

A support assembly 165 may be included in the system 100, 100 'and may be disposed in the catheter 105, 105' and extend along the catheter 105, 105 'to the distal end 115, 115'. Support assembly 165 may be included to extend along its length L_CThe reinforcing and/or supporting conduits 105, 105' may be formed as straight and/or helical rods. Support member 165 may be formed as a wire and may be any material, including but not limited to a composition, having sufficient strength to apply a force to proximal portion 145 of distal end 115, 115 'of catheter 105, 105' or to reinforcement area 155. In embodiments, support member 165 may be formed to have a uniform diameter, however in some embodiments, support member 165 may also be a variable diameter to enhance flexibility.

Support assembly 165 may be along the length L of conduit 105, 105_CExtend substantially parallel. Support assembly 165 may be substantially alongThe hollow tube 107 is centrally disposed and/or extends along the inner surface 107 b. In some embodiments, a support member 165 formed as a helix may extend along the inner surface 107b of the conduit 105, 105', which may be advantageous to enhance flexibility and/or torque applied to the actuator 130. In some embodiments, support member 165 may be a single rod, and/or may include multiple support members.

The actuator 130 may be disposed in the proximal portion 145 of the distal end 115, 115' of the catheter and may include a single actuator or any number "n" of actuators 130a, 130b, 130n to deploy the medical device 135. In some embodiments, the actuator 130 may be disposed in a distal portion 150 of the distal ends 115, 115'. The actuator 130 may be configured to provide sufficient force required to deploy a selected medical device 135, and may be individualized depending on the selected medical device 135. For example, depending on the anatomy of the intended location of the medical procedure, different forces may be required to deploy the medical device, e.g., linear, rotational, varying distances, etc. The actuator 130 may be an electrical actuator, an electrostatic piezoelectric actuator, a thermal actuator, a magnetic actuator, a shape memory material actuator, a micro-actuator, or an electroactive polymer, or a combination thereof, to deploy the medical device 135 at a desired location of a procedure. The actuator 130 may be configured for various movements to position the medical device 135, including but not limited to linear movement, rotational movement, inchworm actuation, rack-and-pinion actuation, clutching mechanisms, or complex displacements, or combinations thereof. The actuator 130 may be configured to support a wide range of operating parameters including, but not limited to, current, force, torque, and/or size, however in some embodiments actuators 130 having a narrower range of operating parameters may be used depending on the selected medical device and intended location for the medical procedure.

In some embodiments, the operating parameters of the actuator 130 may be insufficient to deploy the selected medical device 135 at the intended location of the medical procedure. The actuator 130 may then release the latch or other element with a lower energy and/or displacement force to release a mechanism, such as a linear spring, a rotational spring, a chemical reaction, or other energy source, that may generate sufficient force to deploy the selected medical device 135. For example, the spring may be held in a compressed position with stored energy. The actuator 130 may initiate movement to release the spring, allowing the spring to expand and thus apply a force to the selected medical device 135. The applied force may be sufficient to deploy the selected medical device 135 from the distal end 115, 115 'of the catheter 105, 105' as desired by a medical professional. In some embodiments, the system 100, 100' may include mechanically actuated cables or wires in addition to the electrical connectors 120 and actuators 130. This may be advantageous to overcome potential limitations in the force, torque, displacement, rotation, energy, etc. that may be applied by the actuator 130.

The actuator 130 may be configured to deploy, e.g., push, at least a portion of the medical device 135 away from the distal end 115, 115 'of the catheter tube 105, 105'. In some embodiments where the medical device 135 is formed of a shape memory material, such as nitinol, the actuator 130 may be configured to cause at least a portion of the medical device 135 to be extracted, unconstrained, or otherwise released to expand in the intended location of the procedure. In some embodiments, the actuator 130 may be configured to move and/or rotate at least a portion of the medical device 135. In some embodiments, the actuator 130 may be configured to reposition at least a portion of the medical device 135. In some embodiments, the actuator 130 may be configured to release a therapeutic drug or other agent from a reservoir or other compartment of the medical device 135 and/or the catheter 105, 105' (not shown). In some embodiments, therapeutic drugs or other agents may be pre-loaded in the catheter 105, 105' and/or the medical device 135.

The actuator 130 may be configured to deploy the medical device 135 from the linkage 160. One or more connectors 160 may be removably coupled to the actuator 130 and the medical device 135. The one or more connectors 160 may be sutures, strings, cables, sheaths, shape memory materials, screws, or any other material or geometry to retain the medical device 135 in the distal end 115, 115 'of the catheter 105, 105' until deployed at the desired location of the medical procedure. One or more of the connectors 160 may include a release element, such as a hook, knot, adhesive, electromechanical, electrochemical detachment mechanism, or other engagement mechanism, such that the medical device may be detached from the one or more connectors after deployment and satisfactory positioning at the intended location of the medical procedure is achieved.

The one or more connections 160 may be coupled to the actuator 130 and/or the medical device 135 using a variety of configurations, such as screws and bolts, pins, hooks, weld joints, adhesives, magnets, and/or interference fits (where force and/or actuated shape memory expansion or contraction may initiate release), and the like, or various combinations thereof. These couplings may be designed for individual actuators 130 and/or medical devices 135 and may be manufactured using micro-fabrication processes based on size, force, torque, thermal, magnetic, and/or additional design requirements. In other embodiments, the coupling may be an off-the-shelf design configured to accommodate a variety of different medical devices.

In some embodiments, the linking member 160 can have a predetermined length such that the medical device 135 can extend out of the distal end 115, 115 'of the catheter 105, 105' to a predetermined distance via the actuator 130 (see, e.g., fig. 4B). In some embodiments, the connector 160 may be formed from a shape memory material such that when the medical device 135 is in the distal end 115, 115 'of the catheter 105, 105', the connector 160 is in a compressed state. Upon deployment of the medical device 135 by the actuator 130, the connector 160 may not be compressed to allow positioning of the medical device at a distance from the distal end 115, 115 'of the catheter 105, 105'.

In some embodiments, as shown in fig. 2A-2C, the connection mechanism between the medical device and the catheter may be included in a deployment system. The deployable medical devices or implants 235, 235 'can include a connection 260 between the medical devices 235, 235' and a deployment system, such as an actuator and/or catheter. The connector 260 may include a first component, such as a medical device connector 260a, and a second component, such as a deployment system connector 260 b. First component 260a may be a tube or cap or any other shape configured to receive and/or mate with second component 260 b.

In some embodiments, the second assembly 260b may be coupled to an actuator, while in other embodiments, the second assembly 260b may be coupled to the interior of a catheter for deploying the medical devices 235, 235'. As shown in fig. 2A, the first and second components 260a, 260b may be initially coupled such that separation may only occur when the medical devices 235, 235' are placed in place as desired.

In an embodiment, the second component 260b may have an initial diameter "D_I", which may be greater than the inner diameter" D "of the first component 260a_C"slightly larger so that the first component 260a and the second component 260b are fixedly coupled by an interference fit. As shown in fig. 2B, the diameter of the second component 260B may be reduced to "D" when the medical device 235, 235' is deployed to a desired location_R", which may be less than the initial diameter D_IAnd the inner diameter D of the first component 260a_C. When the second component 260b is at the reduced diameter D_RAs such, first assembly 260a and second assembly 260b may be separated from one another, e.g., by retracting in a proximal direction indicated by arrow 210. This may separate or detach the medical device 235, 235' from the catheter, as shown in fig. 2B. Although the first and second members 260a and 260B of the connector 260 are illustrated as cylindrical members in fig. 2A through 2B, it should be understood that the connector may be configured in any shape that is detachably connected to each other.

The second component 260b may be configured such that the diameter may be adjusted in a known manner. The second component 260b may be formed of a compliant material. In some embodiments, the diameter may be adjusted by a mechanism operable via an actuator. For example, the second component 260b may be wound or twisted, e.g., by a motor, to bring the diameter from the initial diameter D_IReduced to a reduced diameter D_R. As the second component 260b is wound, the compliant material may compress, thereby reducing the diameter sufficiently to disengage from the first component 260 a. In some embodiments, the second component 260b may be scalable, e.g., may utilize a fluid to be at the initial diameter D_IAnd a reduced diameter D_RThe diameter is adjusted. For exampleFluid may flow into and/or out of the second assembly 260b to inflate and/or deflate, thereby adjusting the diameter as desired. In some embodiments, second component 260b may include a mechanism for expanding and/or contracting second component 260 b. For example, the plurality of arms may be connected to an actuator that is movable between an expanded or coupled position and a retracted or disengaged position.

Additionally and/or alternatively, as shown in fig. 2C, the medical device 235 'can include one or more connectors coupled between the actuator 230 and the medical device 235'. In some embodiments, the medical device 235' may be a medical device 135, 235. The connector 260 'may be removably coupled to the medical device 235' by the screw 215. The actuator 230 may include a micro-motor for rotating the screw 215 and/or the connector 260'. The screw 215 may be connected to a portion of the medical device 235 ', and in some embodiments may include a plurality of screws 215 coupled to a plurality of connectors 260'. In some embodiments, the screw 215 may be configured to attach to a patient, thereby securing the medical device 235' within the patient. In some embodiments, screw 215 may be any attachment mechanism including, but not limited to, a screw, a clip, a screw anchor, and/or a hook. The screw 215 may be adjusted by the connector 260 'to push, pull and/or rotate the medical device 235' for positioning within the patient prior to separation.

It may be difficult for a medical professional to determine the force applied to the medical device 135, 235' by visualization alone. Additionally, some procedures may be difficult to visualize such that placement of the device may be compromised. Sensors or micro sensors, such as force, torque, linear displacement, rotational displacement, temperature, PH, flow, accelerometers, pressure, 3-D compass, gyroscopes, etc., may be included in the system 100, 100 ' to improve the deployment of the medical device 135, 235 ' by allowing a medical professional to receive feedback via the sensors, electrical connectors, and/or control box and from the system 100, 100 ' and adjust accordingly. For example, the sensor feedback may coordinate single or multiple actuations, e.g., to adjust intermediate deployment of the medical device and/or to adjust forces exerted on the device. The system 100, 100 'may receive sensor feedback, allowing a medical professional to manually adjust operating parameters, however the system 100, 100' may also be configured for the control box 170 to receive sensor feedback verifying deployment and allow the transmission of subsequent signals. If the sensor feedback indicates that the medical device is not properly positioned, an alarm may indicate that the medical professional may need manual adjustment, and/or the procedure may be continued or suspended.

For procedures that are difficult to visualize, such as procedures performed under fluoroscopy or other image guidance to the intended location of the procedure, sensor feedback may be advantageous to the medical professional. As described below with respect to fig. 3A-3B, for example, the sensor can detect the deployment distance and/or number of rotations of the anchor to secure the medical device 335 to tissue.

Referring now to fig. 3A-3B, an embodiment of a medical device is shown, for example, as medical device 335. As described above, the medical device may be any number of medical devices for deployment within a patient's body, including but not limited to temporary and/or permanent implants, and may be deployed in various body cavities and/or organs of a patient, including, for example, cardiovascular, gastrointestinal, urinary and/or other vasculature.

In some embodiments, each connector 160 may be removably attached to an element of medical device 335 for manipulation. For example, in some embodiments, the medical device 335 may include multiple elements with multiple degrees of freedom. Each linkage 160 may manipulate each element as desired to move medical device 335. The links 160 may be individually controlled and operated by the actuator or actuators 130, and the actuator or actuators 130 may receive signals for each link to manipulate each element in a selected sequence to deploy and position the medical device 335 as desired.

The illustrated medical device 335 may be deployed within a patient's heart valve, for example, as a transcatheter annuloplasty ring 300. The ring 300 may include a plurality of struts or arms 305 connected to form the ring 300 and movably coupled (e.g., hingedly coupled) to one another, such as by connectors 310. In some embodiments, connector 310 may be an actuatable sliding coupler. Each arm 305 can be hingedly coupled to an adjacent arm 305 at a connector 310 such that the ring 300 can be moved from a first compressed position to a second expanded position, as shown in fig. 3A. The link 160 may be connected at each connector 310 and attached to the actuator 130 to move the ring 300 from the first compressed position to the second expanded position.

Prior to deployment, the ring 300 may be in a first compressed position at the distal end 115 of the catheter 105. It should also be understood that a catheter 105 ' (where the proximal end 110 ' has a diameter substantially equal to the distal end 115 ') may be used to deploy the ring 300. Prior to deployment, the link 160 may be pinched or compressed between the actuator 130 and the ring 300. When the distal end 115, 115 'of the catheter 105, 105' is positioned at the desired location for the procedure, one or more signals may be sent from the control box 170 to the actuator 130 via the electrical connector 120. When the actuator 130 receives the signal, the actuator may actuate each link 160 according to the signal for deployment (e.g., as shown in fig. 1A-1B). In some embodiments, the connector 160 can extend a predetermined linear distance, e.g., substantially parallel to the longitudinal axis 140, without expanding the ring to the second expanded position, such that the ring 300 extends from the distal end 115, 115 'of the catheter 105, 105', but is still in the first compressed position. For example, the arms 305 may be held in a substantially closed position by the connector 310, and the actuator 130 may not actuate the link 160 to manipulate the connector 310 to expand the arms 305.

When the connector has been extended to the predetermined linear distance, the actuator 130 may receive additional and/or alternative signals from the control box 170 to actuate the ring 300 in a radial direction. For example, the ring 300 may be moved to the second expanded position by actuating the connector 160 to manipulate the actuator 130 of the connector 310 such that the adjacent arms 305 pivot or rotate outwardly to move the ring 300 to the second expanded position.

The signals may continue to be sent to the actuator in the desired sequence to expand and/or position the ring 300 at the right or left atrium to repair the tricuspid or mitral valve. The signals may be pre-programmed for deployment of the ring 300, may be sent based on sensor feedback regarding the positioning of the ring, and/or a medical professional may manually input instructions to send the signals into place based on visualization and/or other feedback. The ring 300 can be positioned near the valve 315 for attachment, e.g., via the screw anchors 320, and signals can be sent to the actuators 130 to adjust the connectors 160 individually and/or in groups to align with the valve 315. When aligned, anchors 320 can be attached to the annulus tissue surrounding valve 315 while connecting element 160 remains attached to connecting element 310. When the ring 300 is attached to the annulus tissue, a signal may be sent from the control box 170 to the actuator 130 to manipulate the link 160 to move the ring 300 from the second expanded position to the third repair position. For example, due to disease, the mitral or tricuspid valve 315 may be wider such that the valve may not close completely during the beating of the heart. The ring 300 can be contracted to pull the surrounding annulus tissue into the valve 315, thereby providing a complete closure. The linkage 160 may be actuated to position the ring 300 as desired by a signal from the control box, for example, by hingedly opening and/or closing the arms 305 to close the valve 315. When the ring 300 has been positioned as desired, the anchors 320 may be fully implanted to secure the annulus tissue. The connector 160 may be disconnected from the connector 310 to disconnect the ring 300 from the catheter 105, 105' and the catheter may be retracted from the patient.

Referring now to fig. 4A-4B, an embodiment of a process for deploying a medical device from a catheter is shown. The medical device 135 may be retained in the distal end 115, 115 ' of the catheter 105, 105 ' by one or more connectors 160, and it should be understood that the described procedures may be applied to any of the medical devices 135, 235 ', 335 described herein. To perform a medical procedure, the distal end 115, 115 'of the catheter 105, 105' may be inserted into the patient at an access point, which may vary depending on the procedure and the device used for deployment. The medical professional may continue to extend the catheter 105, 105' into the patient until the desired location of the procedure is approached. A medical professional may adjust the distal ends 115, 115 'of the catheters 105, 105' so that the distal portion 150 faces the desired deployment location of the medical device. The proximal end 110, 110' of the catheter and the control box 170 may remain outside the patient, e.g., outside the access point.

When the distal portion 150 of the distal end 115, 115 ' is in place, a signal may be sent from the control box 170 to the actuator 130 at the proximal portion 145 of the distal end 115, 115 ' of the catheter 105, 105 ' via the electrical connector 120. The signal may initiate an action by the actuator 130 such that the connector 160 coupled to the actuator 130 and the medical device 135 may cause the medical device 135 to extend distally out of the distal end 115, 115' of the catheter, as shown in fig. 4A. In some embodiments, the cable or wire actuation system may retract the distal ends 115, 115 'of the catheters 105, 105' to at least partially enable deployment of the medical device 135. The actuator 130 and/or the linkage 160 may initiate an operation to complete the deployment of the medical device 135. The signal may control the actuator 130 such that the linkage extends the medical device 135 linearly, radially, rotationally, or in any other type of movement, or a combination thereof. In some embodiments, the actuator 130 may first extend the medical device 135 in only a linear direction to exit the catheter 105, 105 'and then continue more complex movements through the linkage 160 once the medical device is disengaged from the catheter 105, 105'.

As shown in FIG. 4B, after the medical device 135 has been extended from the catheter 105, 105', the connector 160 can expand the medical device 135, e.g., by being greater than the diameter D of the distal end of the catheter_B. The medical device may be in a compressed state to allow for travel through the patient to the desired location of the procedure prior to placement or attachment to the surrounding tissue, which requires subsequent expansion or allows for self-expansion. The actuator may receive a signal from the control box 170 to perform the expansion after extending the device 135 from the catheter 105, 105' or the device 135 may be self-expanding.

The medical professional can verify the placement of the device 135 and can send additional signals to the actuator 130 to make fine adjustments for final positioning within the patient. Depending on the type of medical device 135, the connector 160 may be attached to the surrounding tissue before it is detached by additional actuation, however in some embodiments, the medical device 135 may be self-locating and/or aligned and/or need not be attached to the tissue.

When the medical device 135 is in place, the connector 160 can be detached from the device 135. The connector 160 may have a mechanism for detachment, such as a hook, screw, adhesive, clip, or other attachment, including as described above. After detachment, the catheter 105, 105' may be removed from the patient.

Numerous specific details have been set forth herein to provide a thorough understanding of the embodiments. However, it will be understood by those skilled in the art that the embodiments may be practiced without these specific details. In other instances, well-known operations, components and circuits have not been described in detail so as not to obscure the embodiments. It can be appreciated that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments.

Some embodiments may be described using the expression "coupled" and "connected" along with their derivatives. These terms are not intended as synonyms for each other. For example, some embodiments may be described using the terms "connected" and/or "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. The term "coupled," however, 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.

It should be noted that the methods described herein need not be performed in the compliance described or in any particular order. Further, various activities described with respect to the methods identified herein can be executed in serial or parallel fashion.

Although specific embodiments have been illustrated and described herein, it should be appreciated that any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. It is to be understood that the above description is intended to be illustrative, and not restrictive. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description. Accordingly, the scope of the various embodiments includes any other applications in which the above compositions, structures, and methods are used.

Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.