阅读说明：本技术 自动心脏瓣膜缝制 (Automatic heart valve sewing ) 是由 C·利姆萨克恩 N·罗伯森 J·科罗纳 M·怀特 J·奎瓦斯 D·埃斯特尔 M·马什尼 于 2019-01-11 设计创作，主要内容包括：可用于缝合植入物的系统包括：第一自动化夹具,该第一自动化夹具可包括铰接臂和目标装置保持器；和第二自动化夹具,该第二自动化夹具被配置以作为缝制机械进行操作,以将材料缝制到植入物上。第二自动化夹具使用曲形针形成线迹,而不必在该过程中将针释放。第二自动化夹具还可包括线迹打环器,该线迹打环器与曲形针协调移动以执行单缝合线迹或单线程线迹。(A system useful for suturing an implant comprising: a first automated clamp, which may include an articulated arm and a target device holder; and a second automated clamp configured to operate as a sewing machine to sew the material onto the implant. A second automated jig uses a curved needle to form the stitch without having to release the needle in the process. The second automated clamp may further comprise a stitch looper that moves in coordination with the curved needle to perform a single stitch or a single thread stitch.)

1. A method of suturing an implant device, the method comprising:

disposing the implant device on a holder component of a first automated jig;

directing the first automated jig to position the implant device in a first position;

directing a second automated jig to perform a first stitch on the implant device by passing a curved needle into and out of material sutured to the implant device;

directing the first automated clamp to position the implant device in a second position; and

directing the second automated jig to perform a second stitch on the implant device by passing the curved needle into and out of material sewn to the implant device, the second automated jig including a stitch looper that moves in coordination with the curved needle to form the first stitch and the second stitch.

2. The method of claim 1, wherein the implant device is a prosthetic heart valve.

3. The method of any of claims 1-2, further comprising directing the first automated clamp to circumferentially rotate the implant device into position.

4. The method of any one of claims 1-3, further comprising loading a pre-programmed suture program script using one or more processors configured to at least partially control the first and second automated clamps.

5. The method of any one of claims 1 to 4, wherein the second automated clamp performs the first stitch using the curved needle such that the first stitch is a single stitch.

6. A method according to any one of claims 1 to 5 wherein the curved needle passes into and out of the material along a fixed path of the curved needle.

7. A method as claimed in any one of claims 1 to 6, in which the stitch looper comprises two or more teeth to secure portions of the suture as the curved needle is withdrawn through an insertion point formed during the formation of the first stitch.

8. The method of claim 7, wherein the stitch looper is configured to rotate to form a loop with the portion of the suture to form the first stitch.

9. The method of claim 8, wherein the curved needle passes through the loop formed by the stitch looper to form the first stitch.

10. The method according to any one of claims 1 to 9, wherein for each of the first and second stitches, the curved needle passes through the fabric of the implant device at two different locations.

11. A suturing system, comprising:

a first automated clamp comprising a plurality of motorized actuator devices and a suturing target holder, the first automated clamp configured to rotate the target suturing device when mounted to the suturing target holder;

a second automated clamp comprising a curved needle and a stitch looper having a plurality of teeth, the second automated clamp configured to move the curved needle in a fixed path, and the stitch looper configured to secure a portion of a suture and form a loop using the portion of the suture as the curved needle moves in the fixed path; and

the first and second automated clamps are disposed relative to each other and configured such that the first automated clamp is capable of moving the target suturing device in three dimensions to position the suturing device in the path of the curved needle to implement a predetermined suturing pattern on the target suturing device.

12. The suturing system of claim 11, wherein the target suturing device is a heart valve.

13. The suturing system of claim 11 or 12, wherein the first automated clamp comprises a first controller configured to direct the first automated clamp how to position the target suturing device.

14. The suturing system of any one of claims 11 to 13, wherein the second automated clamp comprises a second controller configured to direct the second automated clamp when to move the curved needle to implement the suturing pattern.

15. The suturing system of any one of claims 11-14, wherein the second automated clamp comprises a tensioning device capable of maintaining a suture thread in a state of constant tension while implementing the suturing pattern.

16. The suturing system of any one of claims 11-15, wherein the first automated clamp is configured to move the target suturing device in at least four directions.

17. The suturing system of any one of claims 11-16, wherein the first automated clamp comprises an articulated arm.

18. The suturing system of any one of claims 11 to 17, wherein the second automated clamp is configured such that the curved needle is used to implement the suturing pattern in a single suture stitch.

19. The suturing system of any one of claims 11 to 18, wherein movement of the curved needle is locked with movement of the stitch looper.

20. The suturing system of any one of claims 11-19, wherein the stitch looper moves along a second fixed path that includes rotating the stitch looper to form the loop with the portion of the suture.

Background

Medical devices, prosthetic implants, prosthetic heart valves, and the like may require sewing, processing, inspection, and the like of certain portions and/or components thereof. The accuracy and/or efficiency with which such devices perform suturing or other operations can be important. In addition, certain heart valve suturing procedures or other procedures can be time consuming and difficult.

Disclosure of Invention

This summary is intended to provide some examples, and is not intended to limit the scope of the invention in any way. For example, any feature included in an example of this summary is not a claim unless the claim explicitly defines the feature. Furthermore, the features, steps, concepts and the like described in the examples of the inventive content as well as elsewhere in the disclosure can be combined in various ways. The description herein relates to devices, apparatus, systems, assemblies, methods, combinations, etc. that may be used to manufacture and process heart valves and/or associated or related components, devices, apparatuses, etc. Among other features, elements of these or these may utilize or include logic that may receive as input a set of parameters, which may be graphically displayed to a user after the parameters have been received as input, and/or may be analyzed and may be new data generated and/or graphically displayed.

In some embodiments, the present disclosure relates to methods of manufacturing a target device or component, for example, methods of manufacturing or suturing a prosthetic implant device (e.g., a prosthetic human implant device, a prosthetic heart valve, a prosthetic human heart valve, etc.). The method comprises the following steps: directing (e.g., providing input, programming, running a program, pressing a button, clicking an icon, etc. to cause) an automated clamp to position a target device (e.g., a prosthetic implant device, etc.) in a first position; executing a first operation or program on a target device; direct (e.g., provide input, program, run a program, press a button, click an icon, etc. to cause) the automated fixture to position the target device in the second position; and executing the second operation or program on the target device. The method may include disposing the target device on the holder member.

The method may further include forming a stitch on the target device using a needle and a stitch looper (stitch looper) such that the stitch is formed without the needle releasing the suture or thread. The needle may be a curved needle that moves in a reciprocating manner in combination with a stitch looper that moves in a reciprocating manner in coordination with the curved needle to form stitches on the target device.

In some embodiments, a method of suturing an implant device comprises: the target device or implant device (e.g., prosthetic heart valve, etc.) is disposed on the retainer component of the first automated clamp and the first automated clamp is directed (e.g., provided with input, programmed, run a program, pressed a button, clicked on an icon, etc.) to position the target device or implant device in the first position.

In some embodiments, the method further comprises directing (e.g., providing input, programming, running a program, pressing a button, clicking an icon, etc. to cause) a second automated clamp to perform a first stitch on the implant device by passing the curved needle into and out of the material sutured to the target device or implant device.

The method may also include directing (e.g., providing input, programming, running a program, pressing a button, clicking on an icon, etc. to cause) the first automated clamp to position the target device or implant device in the second position (and optionally, the third, fourth, fifth, and/or other additional positions).

In some embodiments, the method further comprises directing (e.g., providing input, programming, running a program, pressing a button, clicking an icon, etc. to cause) a second automated clamp to perform a second stitch on the implant device by passing the curved needle into and out of the material sutured to the target device or implant device.

The second automated clamp may include a stitch looper that moves in coordination with the curved needle to form the first and second stitches.

The method may further include directing the first automated clamp to circumferentially rotate the implant device into position.

In some embodiments, the method includes loading a pre-programmed suture program script using one or more processors configured to control the first automated gripper and the second automated gripper.

The second automated clamp may use a curved needle to perform the first stitch such that the first stitch is a single stitch (single stitch tack). The curved needle may be configured to pass into and out of a material along a fixed path of the curved needle. For each of the first and second stitches, the curved needle may pass through the material at two different locations.

The stitch looper may include two or more teeth to secure portions of the suture as the curved needle is withdrawn through an insertion point formed during the formation of the first stitch. The stitch looper may be configured to rotate to form a loop with the portion of suture to form a first stitch. The curved needle may be passed through an eyelet formed by a stitch looper to form a first stitch.

In some embodiments, the suturing system comprises one or more automated clamps. For example, the system includes at least a first automated clamp. The first automated clamp may include a plurality of motorized actuator devices and a suturing target holder. The first automated clamp is configured to move or rotate a target suturing device (e.g., a heart valve, etc.), for example, when mounting the target suturing device to a suturing target holder.

In some embodiments, the system further comprises at least a second automated clamp. In some embodiments, the second automated clamp includes a curved needle and may be configured to move the curved needle in a fixed path.

In some embodiments, the second automated clamp further comprises a stitch looper. The stitch looper may have one or more teeth. The stitch looper (e.g., the teeth of the stitch looper) may be configured to secure a portion of the suture and form a loop using the portion of the suture as the curved needle moves in a fixed path. In some embodiments, the stitch looper is moved along a second fixed path that includes rotating the stitch looper to form a loop using the portion of suture. The movement of the curved needle may be locked or synchronized with the movement of the stitch looper.

In some embodiments, the first automated clamp and the second automated clamp of the system are disposed relative to each other and configured such that the first automated clamp can move the target suturing device in three dimensions to position the target suturing device in the path of the curved needle. The system and its components or clamps may be configured to implement a predetermined suturing pattern on a target suturing device.

In some embodiments, the first automated clamp includes a first controller configured to direct the first automated clamp how to position the target suturing device. In some embodiments, the second automated clamp includes a second controller configured to direct the second automated clamp when to move the curved needle to implement the suture pattern.

The second automated clamp may include a tensioning device that may maintain the suture in a constant tension state while the suture pattern is being implemented.

In some embodiments, the first automated clamp is configured to move the target suturing device in at least four directions. The first automated clamp may comprise an articulated arm.

The system, e.g., a second automated clamp of the system, may be configured such that the curved needle is used to implement a suture pattern in a single suture trace.

Other steps, features, components, etc. not specifically mentioned in these examples but described elsewhere herein or otherwise known may also be included and/or used with the examples described herein.

Drawings

Various embodiments are depicted in the drawings for illustrative purposes, and should in no way be construed as limiting the scope of any invention disclosed herein. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between reference members.

Fig. 1 illustrates an example of an implantable prosthetic valve device.

Fig. 2 illustrates a perspective view of an example of another prosthetic heart valve.

Fig. 3A illustrates a frame of a support stent for an exemplary surgical valve.

Fig. 3B illustrates the frame of fig. 3A covered with fabric.

Fig. 4 illustrates an example of an operator performing an operation on an implant device.

Fig. 5 illustrates a close-up view of a sutured heart valve implant device using manual holding and suturing.

Fig. 6 illustrates a close-up view of a fabric that may be incorporated with an implant device.

FIG. 7 illustrates a block diagram showing an exemplary suturing system.

FIG. 8A illustrates a perspective view of an exemplary suturing system.

Fig. 8B, 8C, 8D, 8E, 8F, 8G, and 8H illustrate an exemplary process for suturing an implant device using the exemplary suturing system of fig. 8A.

Fig. 8I, 8J, 8K, 8L, 8M, 8N, and 8O illustrate another exemplary process for suturing an implant device using the exemplary suturing system of fig. 8A.

FIG. 9 illustrates a block diagram of an exemplary control system for controlling an automated suturing clamp.

Fig. 10 illustrates an exemplary distal articulating arm of an automated suture clip coupled to a holder component.

Detailed Description

Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and modifications and equivalents thereof. Thus, the scope of claims that may be generated thereby is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of that method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Further, one or more steps disclosed with respect to one method may be incorporated into other methods disclosed herein. Various operations may be described as multiple discrete operations in turn, in a manner that is helpful in understanding certain embodiments. However, the order of description should not be construed as to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages may be achieved by any particular implementation. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein. Features described with respect to one exemplary embodiment may also be incorporated into other embodiments disclosed herein, even if not specifically described with respect to that embodiment.

Prosthetic heart valve implants, as well as a variety of other types of prosthetic implant devices and other types of devices, can include various sutured components and/or portions. For example, a sealing portion, skirt, or the like may be sutured to the frame of the prosthetic heart valve to help prevent blood from leaking around the outer edge or circumference of the prosthetic heart valve. In some cases, it may be relatively difficult and/or cumbersome to perform the suture by a human operator. For example, where small stitches are to be made with high precision, the complexity and/or associated operator burden may result in damage and/or undesirably low product quality. Furthermore, some heart valve implant devices may require hundreds of sutures, which can involve a significant labor intensive and error prone suturing procedure. Accordingly, it may be desirable to add automation in the suturing of implants to improve quality, manufacturing speed, and/or help prevent problems associated with human operators.

Certain embodiments disclosed herein provide heart valve suturing systems, devices, and/or methods for performing a suturing procedure involving physical manipulation and/or positioning of one or more automated, mechanically articulated clamps, components, and/or subassemblies. Such articulating clamp(s) or component(s) may be configured to hold or secure a prosthetic human heart valve implant device, or other sutured object or implant device, having one or more components or portions that may advantageously be sutured together. The various embodiments presented herein relating to heart valve suturing may be applied to heart valves having any type of suture and/or structural configuration or pattern. Examples of heart valve structures and heart valve suturing techniques that may be applicable to certain embodiments presented herein are disclosed in WIPO publication No. WO 2015/070249 (the entire contents of which are expressly incorporated herein by reference).

Fig. 1 illustrates an implantable prosthetic human valve device 110 in accordance with one or more embodiments. The features of valve 110 described herein can be applied to other valves, including other valves described elsewhere herein. The valve 110 can be, for example, a transcatheter heart valve (TFIV), a balloon expandable heart valve, and/or a mechanically expandable heart valve. The valve 110 in the illustrated embodiment can generally include a frame or stent 112, a leaflet structure 193 supported by the frame 112, and a sealing member or skirt 116 secured (e.g., sutured) to an outer surface of the leaflet structure 193. In some embodiments, the valve 110 is configured to be implanted in the annulus of a natural heart valve (e.g., an aortic valve) of a human. However, the valve 110 can additionally or alternatively be adapted for implantation in other native valves of the heart, or in various other vasculature, catheters, or orifices of the body, or in implanted grafts, docking stents, docking stations, rings, etc., in the body. The lower end 180 of the valve 110 according to the orientation shown represents the inflow end, while the upper end 182 of the valve 110 according to the orientation shown represents the outflow end.

The valve 110 and frame 112 can be configured to be radially collapsible into a collapsed or crimped (crimped) state or configuration for introduction into the body using a delivery catheter, and can also be configured to be radially expandable into an expanded state or configuration for implantation of the valve at a desired location in the body (e.g., a native aortic valve). In certain embodiments, the frame 112 comprises a plastic, polymer, shape memory material, or metallic expandable material that allows the valve 110 to be crimped to a smaller profile for delivery and expansion of the valve. In some embodiments, an expansion device, such as a balloon of a balloon catheter or a tool for mechanical expansion, may be used to expand or assist in expanding the valve. In some embodiments, the valve 110 is a self-expanding valve, wherein the frame is made of a self-expanding material, such as a shape memory material or a metal (e.g., nitinol). Self-expanding valves can be crimped to a smaller profile and can be held in the crimped state by a restraining device, such as a sheath covering the valve. When the valve is positioned at or near the target site, the restraining device may be removed or retracted to allow the valve to self-expand to its expanded functional size or to a deployed configuration.

The sealing portion or skirt 116 may comprise a single piece (single piece) or multiple pieces or material (e.g., cloth, polymer, etc.) having opposite ends that are secured to one another to form the annular shape shown in fig. 1 or extend around the circumference of the valve. In certain embodiments, the upper edge of the sealing portion or skirt 116 has an undulating shape that generally follows the shape of the struts of the frame 112. In this manner, the upper edge portion of the sealing portion or skirt 116 may be tightly secured to the respective strut by the stitching 156. The sealing portion or skirt 116 may be placed on the outside of the frame 112 or on the inside of the frame 112 (as shown), and the upper edge portion of the sealing portion or skirt 116 may be wrapped around the upper surface of the frame struts and secured in place with sutures. The stitching 156 provides a durable attachment of the sealing portion or skirt 116 to the frame 112.

In some embodiments, the leaflet structure 193 can include three leaflets (as shown in fig. 1), which can be configured to collapse in a tricuspid arrangement. While a three-leaflet embodiment is illustrated, it should be understood that a valve implant sutured according to embodiments disclosed herein may have any number of leaflets, such as, for example, two or four. The leaflets 193 can be formed of individual flaps (flaps) of material or tissue, or all three leaflets can be derived from a single material. The lower edge of the leaflet structure 193 can have a variety of shapes. In some embodiments, the lower edge of the leaflet structure 193 can have an undulating, curvilinear, and/or scalloped shape that can be sutured to the frame 112. The leaflets 193 can be secured to one another at adjacent sides thereof to form commissures (comissurs) 184 of the leaflet structure where the edges of the leaflets meet together. Any suitable technique and/or mechanism can be used to secure the leaflet structure 193 to the frame 112. For example, the commissures 184 of the leaflet structure can be aligned with the support posts 118 and secured thereto, e.g., using sutures, adhesives, clamping portions, pleats, and/or other attachment means. In certain embodiments, the attachment points of the leaflets 193 to the post 118 can be reinforced, for example, with strips (rods, bars) comprising a more rigid material or stainless steel.

Fig. 2 illustrates a perspective view of a prosthetic human heart valve 210 according to one or more embodiments. The heart valve 210 can include a peripheral sealing ring structure 291, the peripheral sealing ring structure 291 being configured to provide support for nesting the heart valve 210 in a heart valve cavity and/or for placement on or attachment to an annulus or other structure of the heart. The valve 210 can further include a frame member 292, such as a metal frame, which can provide support for a plurality of flexible leaflets 293 and can define three upstanding commissure posts 294, wherein the leaflets 293 can be supported between the commissure posts 294. In certain embodiments, as shown in fig. 2, the sealing ring 291 may be attached at the periphery of the frame member 294 at the inflow end of the valve 210, with the commissure posts 294 protruding in the outflow direction.

The leaflets 293 can be formed of separate flaps of material or tissue, or all three leaflets can be derived from a single material. The leaflets 293 can be secured and supported by the commissure posts 294, as well as along the arcuate tips of the frame members between the commissure posts.

Fig. 3A illustrates a frame 392 of a support stent for a surgical heart valve, such as the valve 210 of fig. 2. The frame 392 may include a plurality of tips curved toward the axial inflow end alternating with a plurality of commissures 322 projecting toward the axial outflow end, the support stent 392 defining an undulating outflow edge. The support stent 392 may include a wire (wireform)320 having three upstanding commissures 322, the commissures 322 alternating with three points 324 generally circumferentially. A stiffening band 326 may be disposed inside or outside the wire form 320. The inflow edge of the strip 326 may conform to, or at least partially conform to, the tip 324 of the wire 320 and may be curved in the outflow direction between the regions of the wire commissures 322, for example, as shown in fig. 3A. In some embodiments, the support stent 392 provides a support structure for the unidirectional prosthetic heart valve of fig. 2 (e.g., valve 210).

Fig. 3B illustrates the frame of fig. 3A covered with fabric 340, wherein the fabric 340 may be stitched in one or more portions to secure the fabric 340 as a covering for the frame 392. The fabric-covered support stent 342 may be generally tubular and may include a plurality of tips 344 curved toward the axial inflow end alternating with a plurality of commissures 346 protruding toward the axial outflow end. The support stent 342 may include an undulating outflow edge around which the fabric 340 is fixedly held. In some embodiments, seam 350 is sewn adjacent inflow edge 352, securing fabric 340 around the support stent. The seam 350 is illustrated as being slightly above the inflow edge 352 in the axial direction for clarity, but it may be located directly at the inflow edge or even inside the support stent. In certain embodiments, one or more seams may be located in other locations along the fabric. The sutures supporting the stent 342 may be implemented or added in a variety of ways. Further, although some stitches are illustrated in fig. 3B, the support stent 342 and/or the valve implant 210 of fig. 2 may include any type or number of stitches or sutures. For example, the support stent 342 and/or one or more other components of the associated implant device can also have leaflets and/or other materials sutured thereto.

Suturing of prosthetic heart valve devices and/or other implant devices (such as those described above) can be performed in a variety of ways. For example, certain hand-held procedures for suturing prosthetic human implant devices may be performed in which an operator holds, secures, and/or sutures the implant device with both hands. Fig. 4 illustrates an operator 405 operating on a prosthetic human implant device 410. For example, the operator 405 may suture the outer frame of the device 410 to the inner skirt or cloth as described above, wherein the implant device 410 is a transcatheter heart valve device. Alternatively, the implant device 410 may be a surgical valve device or other type of implant device. The implant device 410 may be the same as or similar to one of the valves shown herein, or may be a different type of valve or implant device.

As shown in the illustration of fig. 4, in some procedures, the operator 405 may require both hands of the operator to perform the associated suturing operation. For example, the first hand 406 may be used to hold and/or secure the implant device 410, while the second hand 407 may be used to manually operate a suture needle or the like.

In order for the operator 405 to effectively perform the associated suturing operation on the implant device 410, it may be necessary or desirable to somehow magnify or otherwise enhance the view of the implant device 410. For example, as shown, the operator may further utilize a magnification system 460, such as a microscope, which magnification system 460 may include an eyepiece member 461 and one or more lenses and/or refractive elements 463. In some embodiments, the magnification system 460 is designed such that the operator 405 may have a line of sight 409 of a first angle, wherein the magnification system 460 is configured to at least partially reflect light therein at a downward angle 408 to focus on an underlying target focal plane.

FIG. 5 illustrates a close-up view of the prosthetic human implant device sutured using manual retention and suturing as described above. As shown, for a handheld suture solution, a first hand 506 may be required to hold a target implant device 510, while a second hand 507 may be required to manipulate a suture needle 509, and so on. According to certain procedures, an operator may need to hold one or more hands at a substantially constant focus of the microscope for an extended period of time. Further, the operator may need to squeeze, push, pull, or otherwise apply manual force on one or more portions of the target implant device 510 and/or the suture needle 509.

Fig. 6 illustrates a close-up view of a fabric associated with an implant device according to one or more embodiments. Such fabrics may include braided strands forming ribs (ribs) with relatively small gaps between the ribs. For example, each rib in the area of the fabric to be sewn can have a thickness t of about 0.2mm or less. For certain processes, it may be necessary or desirable to position and stitch such fabrics within the precision of one rib. Therefore, precise positioning and focusing of the suturing members and the target is desired.

To address the above-mentioned problems and meet the demand for heart valves and other implants, automation of sewing operations can be beneficial in manufacturing, e.g., reducing touch time, human error, cost, etc.

Certain embodiments disclosed herein provide systems and processes for suturing components and/or devices (e.g., prosthetic implant devices) using multiple access systems and/or suturing systems for suturing implant devices. Such systems may be configured to articulate a component or device (e.g., an implant device, such as a prosthetic heart valve device, etc.), where precise positioning of the component or device may require a necessary or desired suturing operation. In addition, the system may be further configured to reposition the component or device for a subsequent operation (e.g., a subsequent stapling operation).

Suturing an implant device or heart valve may require suturing accuracy to within millimeters, half millimeters, or less, but suture locations may be easily missed between ribs or wires, particularly when performing a double-handed suturing procedure. Embodiments of the present disclosure may facilitate improved accuracy and may help reduce or eliminate human error.

Positioning accuracy may be improved with respect to embodiments of the present disclosure through the use of a system incorporating one or more cameras, sensors, articulated arms, automated clamps, and the like, and/or combinations of more than one of these, to properly locate and identify a desired location (e.g., a suture location, etc.) with respect to frame-to-skirt suturing, such as with a transcatheter heart valve or other target device. Quality control feedback to further improve manufacturing quality may also be implemented, for example, using sensors, imaging, and/or feedback mechanisms.

Embodiments disclosed herein provide systems, devices, methods, etc., for performing one or more operations (e.g., a suturing operation, an inspection operation, or inspection operation, and/or other operations) of a prosthetic implant device (e.g., a prosthetic heart valve) and/or other types of devices or components for a human. The system herein may be a fully or largely automated system. A fully or largely automated system may include one or more automated fixtures. For example, a first automated clamp (which may be the same as or similar to the automated clamps or automated suture clamps described and illustrated herein) may be used to articulate and move an implant device to various desired positions for processing operations or steps (e.g., suturing, treatment, application, etc.), while a second automated clamp or device may be used to perform processing operations or steps at various desired positions The formula is programmed. Suture tension management may also be used to maintain and apply proper tension.

In certain embodiments, a fully (or mostly) automated sewing procedure for one or more sewing operations may include two subsystems or automated clamps, where one subsystem or automated clamp is configured to sew patterns by movement of a translating needle, while the other subsystem or automated clamp is coordinated or synchronized therewith, and may utilize a multi-axis articulated arm (e.g., five-axis robotic arm) to grip and move a target implant as desired for sewing. Various types of needles may be used within the sewing subsystem or automated fixture. Further, the sewing subsystem or automated clamp may include a suture tensioning device configured to maintain the suture or thread attached to the needle in a constant tension to avoid problems with slack in the suture or thread (e.g., risk of entanglement, etc.). The implant holding subsystem or automated clamp may include a holder that does not damage the implant and may be configured to accurately map the path of the implant holding device and the implant held thereby.

Fig. 7 illustrates a block diagram of an exemplary suturing system 700, while fig. 8A illustrates a perspective view of an exemplary version of the system 700. One or more components of the system 700 can be used to suture a heart valve device or other implant device as described herein. The depiction of system 700 in fig. 7 and 8A is intended to be exemplary and not limiting, and thus various components illustrated in fig. 7 and 8A may be omitted from system 700 and other components not illustrated in fig. 7 and 8A may be added to system 700. These are not drawn to scale and the components may be of various sizes. For example, in certain embodiments, the needle is configured to be smaller than shown in fig. 8A to make the suture and puncture smaller and more accurate.

As depicted in fig. 7, the system 700 may include one or more power inputs, a first automated gripper 710 (e.g., such as a sewing machine), a second automated gripper 720 (e.g., such as a multi-axis robot or a five-axis robot), a feedback microcontroller unit (MCU), and the like. In some embodiments, the power input is an outlet power (e.g., 110 volts) that can be configured to power one or both of the automated clamps (e.g., one or both of an articulated arm and a sewing machine clamp), although other power inputs are possible.

The first automated clamp 710 may include a controller (e.g., a microcontroller), one or more actuators, a wire or suture feed system, programming, a needle holder or needle gripper, circuitry, a constant tension member, arduino, a gripper motor, one or more sensors, wiring (wiring), and/or other components. The second automated clamp 720 may include a controller (e.g., a microcontroller), one or more actuators, a clamping clamp, programming, circuitry, one or more sensors, CM-700, wiring, and/or other components. First automated gripper 710 and second automated gripper 720 may be integrated and synchronized to perform a sewing function, where first automated gripper 710 (e.g., a sewing machine) performs a sewing operation on a target implantable device that is held and moved into a desired position by second automated gripper 720 (e.g., a multi-axis manipulator).

In some embodiments, the system 700, e.g., one or more automated clamps, includes one or more controllers (e.g., microcontrollers) configured to direct one or more components of the automated clamps and/or other components according to the suturing process. The controller(s) may include one or more hardware and/or software components designed to generate and/or provide clamp control signals (e.g., suture clamp control signals) and/or data associated with one or more steps of a suturing process. For example, the controller(s) may comprise a computing device including one or more processors, and one or more data storage devices or components, which may include volatile and/or non-volatile data storage media. In some embodiments, the data store is configured to store process script data (e.g., suture process script data) that may include data indicating the positioning of one or more components and/or clamps of the system 700 for various steps and/or stages of a suture process. A process that includes multiple steps may be represented, at least in part, by a digital or other data set representing positioning information for one or more components of the automated fixture and/or one or more additional components of system 700 for each respective step or stage of the process. For example, a suturing process that includes multiple suturing steps can be represented at least in part by a digital data set or other data set representing positioning information for one or more components and/or clamps of the system of system 700 for each respective step or stage of the suturing process.

The automated fixture 710 may include a needle 740. Various needles may be used. Non-corrosive curved needles including one or more of nitinol, dullin, cobalt chrome, ABS plastic, PEEK plastic, strong plastic with polycarbonate groups may be used. The needles 740 may be curved in a semicircular shape or a curvilinear shape that does not form a complete circle. For example, in certain embodiments, the needle has a curvilinear shape forming an arc of between 70 and 220 degrees of rotation or between 100 and 190 degrees of rotation of the circle.

Automated clamp 710 may include a needle holder or needle clamping mechanism configured to hold a needle during a sewing process. The needle holder may comprise a drill chuck tool holder, may use vacuum pressure, may comprise a mechanical holder, or the like. The automated clamp 710 may also include a tensioning device 730, such as a system for holding a spool of line that is easily adjustable, and can maintain the line in constant tension. The tensioning device may comprise a spring system; a bolt and spring system; a bolt, nut and spring system; a bobby tensiometer; a PID controller; and so on.

Automated clamp 720 may include a holder or holder assembly (e.g., a clamp or clamp) configured to hold the target implant while the sewing occurs. For example, the holder can be a multi-pronged holder (e.g., a two-pronged holder or a three-pronged holder) configured to hold the implant while suturing occurs. Optionally, the gripper may be an inside-bellows gripper (inside-below gripper), a fork gripper (panned gripper), a 3D print gripper, a cage gripper (captured gripper), or other type of gripper. In some embodiments, a suture target holder assembly configured to hold or secure a suture target (e.g., a prosthetic implant device) may be similar to the target holder assembly shown in fig. 10.

The automated fixture 720 may also include various sensors. For example, the clamp may include sensors to detect the position and rotation of the valve clamp during sewing and the forces involved in the process. For example, the automated clamp 720 may also include a clamp force sensor configured to transmit the force exerted by the clamp on the implant. The automated clamp 720 may also include a gyroscope sensor that may be configured to measure the rotation of the second automated clamp or its articulated arm. The automated clamp 720 may also include an accelerometer sensor that may be configured to measure the position of the end effector of the automated clamp or its articulated arm.

While it is possible to perform a suturing operation with multiple sutures or wires, in certain embodiments, automated clamp 720 is configured to perform a single suture or wire suturing operation to reduce the amount of suture or wire used and the volume of the implant. The automated fixture 710 may be configured as a modified hemming-like machine (hemming-likemachine) with curved needles, which may eliminate the process of transferring needles after each pass through the material to allow for a single line operation. One method of doing this is to use a machine that can sew or apply sutures or threads, similar to a hemming machine or blind stitch hemming machine, where the machine has been specifically adjusted and sized for use with the implant and coordinated with an automated clamp that automatically moves the implant as needed during the sewing. Examples of programs using such machines are illustrated in FIGS. 8B-8O. The curved needle may include an eyelet near the sharp or penetrating end of the needle (or between the end and another point along the needle, e.g., the middle of the needle) through which the suture or thread passes, and the curved needle may guide the suture or thread into and then out of the material (e.g., cover, seal, leaflet, or other material) that is sutured to the stent or frame as the curved needle is rotated. The automated fixture 720 may also include such components: a loop is formed in the suture or thread and pulled to engage the rest of the suture to form a stitch along the device. The automated clamp 710 is configured to move, rotate, etc., the target implant as the automated clamp 720 is sewn (e.g., moving a curved needle along a fixed path) to produce a desired suture pattern. Movement of the target implant occurs in three dimensions. The automated clamps can be programmed, coordinated, and synchronized to work together to accomplish various desired suture patterns on various implants.

Fig. 8B-8H illustrate an exemplary process of forming stitches in a target device or stitch target having fabric or other material 716 (e.g., skirt 116 described with respect to fig. 1) to be secured to support structure 712 (frame 112 described with respect to fig. 1). For simplicity and clarity, these figures illustrate the process using a side cross-sectional view of the material or fabric 716 and the support structure 712. As shown in fig. 8B, the process uses a needle 740 and a stitch looper 745 in an automated clamp (e.g., automated clamp 710, automated sewing clamp, etc.), wherein the movement of the needle 740 and the movement of the stitch looper are coordinated and/or locked together using a common motor, a common gear, etc. The needle 740 may be a curved needle or a straight needle. Needle 740 holds suture 743 threaded through the eye of needle 740. The stitch looper 745 includes two or more teeth configured to retain a portion of the suture 743 and form a loop with the portion of the suture 743 during suturing. The needle 740 may be configured to pass between the teeth of the looper 745 to form a stitch on the material or fabric 716.

Fig. 8C illustrates the insertion of a needle 740 through the skirt 116 such that the suture passes through the skirt at the insertion point. Fig. 8D illustrates the stitch looper 745 being moved toward the needle 740 such that the stitch looper passes between a portion of the suture 743 and the needle 740. Fig. 8E illustrates needle 740 being withdrawn through the same insertion point. The suture 743 remains looped around the stitch looper 745 to maintain a portion of the suture 743 on a side of the material or fabric 716 opposite the withdrawn needle 740. Fig. 8F illustrates the rotation of the stitch looper to form a loop in suture 743. In addition, the material or fabric 716 moves relative to the needles 740 (e.g., by moving an automated clamp or other device). Fig. 8G illustrates the insertion of the needle 740 through the material or fabric 716 at a new insertion point due to the movement of the material or fabric 716 relative to the needle 740. The needle passes through the teeth of the stitch looper 745 and the loop formed by the suture 743. When the stitch looper 745 is withdrawn (e.g., moved upward in the figure), the portion of the suture 743 held by the stitch looper 745 slides out of the teeth of the stitch looper 745, causing the loop formed by the suture 743 to tighten around the portion of the suture 743 held by the needle 740. Fig. 8H illustrates a stitch 756 formed by this process. The process is repeated at the step shown in fig. 8C for stitches in the new location on the material 716.

Fig. 8I-8O illustrate another exemplary process of forming a stitch with a material or fabric 716 to be secured to a support structure 712 in a target device or stitch target. The process uses a curved needle 740 and a stitch looper 745 in an automated clamp (e.g., automated clamp 710, automated sewing clamp, etc.). An example of this process is looking down on the material or fabric so that the curvature of the needle in the illustration is not apparent. However, the curvature of the needles 740 allows the needles 740 to be inserted through two points of the material or fabric 716 on either side of the support structure without changing the angle of the material or fabric 716 and/or without pinching or binding the material or fabric 716.

Fig. 8I illustrates curved needle 740 passing through the eye of needle 740 to secure suture 743 at the distal end of needle 740. The stitch looper 745 includes a plurality of teeth configured to secure a portion of the suture 743 during the procedure. The stitch looper 745 is configured to retain a portion of the suture 743 as the needle 740 is withdrawn through the insertion point. The stitch looper 745 is also configured to form a loop in the suture 743 and position the loop formed by the suture such that the needle 740 passes through the formed loop, then creating a new insertion point for the next stitch.

Fig. 8J illustrates a needle 740 passing through the material or fabric 716 beneath the support structure 712 forming two insertion points. The two insertion points are configured to be at complementary target locations to form stitches that secure the material or fabric 716 to the support structure 712. Fig. 8K illustrates the movement of the stitch looper 745 toward the needle 740 to secure a portion of the suture. A stitch looper 745 passes between a portion of suture 743 and needle 740 to secure the portion of suture 745. Fig. 8L illustrates the needle 740 being withdrawn through the same insertion points that the needle 740 had just created, while the stitch looper 745 secures portions of the suture 743 so that portions of the suture 743 do not pass through those insertion points. Fig. 8M illustrates the movement of the stitch looper 745 towards the withdrawn needle in a manner that also rotates the stitch looper 745. This movement creates loops in suture 743. Fig. 8N illustrates the fabric 716 being moved so that when the needle 740 is advanced again, the needle 740 will create two new insertion points. As the needle 740 advances, the needle 740 passes through the loop formed by the suture 743 on the stitch looper 745. Fig. 8O illustrates the stitch looper 745 after the stitch looper 745 has been withdrawn and returned to its starting position. This movement of the stitch looper 745 causes the loop formed by the suture 743 to be removed from the stitch looper 745. In addition, advancement of needle 740 through the two new insertion points pulls the loop formed by suture 743 to tighten the loop around suture 743, forming stitch 756. This process is then repeated at the step shown in fig. 8J to form additional stitches.

Advantageously, the process described and illustrated in fig. 8B-8O may be used to form stitches in a fabric, wherein the needles used to form the stitches are never released during the process.

Referring to fig. 7 and 8A, system 700 can include a frame on which one or more automated fixtures (e.g., automated fixtures 710, automated fixtures 720, etc.) can each be mounted. In some embodiments, a frame with a measurement of 16 "x 12" may be used. The sides of the frame may be closed or the sides of the frame may be open so that the operator can see the process taking place and check the clamps for any errors. The automated jig 720 may be mounted to the front of the machine so that the automated jig 720 can exit the sewing area, pick up the target implant and rotate back into the sewing area.

In certain embodiments, one or more automated suturing fixtures comprise one or more motorized actuators (e.g., servo actuators) physically coupled to one another. By constructing an automated suturing clamp using one or more motor components (e.g., servo motor components), the system 700 can be relatively inexpensive and/or advantageously provide an enhanced range of motion as well as multiple axes of rotation. In certain embodiments, the one or more automated suture clamps include a plurality of actuator devices (e.g., servo-actuator devices) daisy chained together and implemented using software scripts to provide the functionality in cooperation for positioning the target implant device. For example, the actuator means or servo actuator means (e.g. servo motor means) may be mounted horizontally or vertically or at an angle, or configured to be mounted, and may be articulated in any direction.

In some embodiments, the second automated suturing clamp or assembly includes one or more components configured to articulate, operate, and/or position one or more motorized actuators to present a target device (e.g., a heart valve, implant, or other suturing target) in a desired or suitable position or display for convenient engagement or interaction therewith by another clamp performing at least a portion of a procedure (e.g., a suturing procedure). In certain embodiments, the automated suturing clamp includes a plurality of motorized actuators mounted, attached, or connected to one another in a desired configuration to provide a desired range of motion of the automated clamp (e.g., automated suturing clamp) for the purpose of articulating a target (e.g., a suturing target) associated with or held by the automated clamp. In certain embodiments, the target holder component or assembly may be associated with or connected to one or more motorized actuators. The motorized actuators may each include one or more rotating or otherwise articulated members driven by a motor or the like. An example of an automated suture jig and associated components is illustrated in greater detail in fig. 7 and 8A, and is described in greater detail herein in connection with fig. 7 and 8A.

In certain embodiments, the controller(s) provide one or more control signals to direct the positioning and/or operation of the clamp (or a motorized actuator of the clamp) based on a positioning script, a suturing process script, and/or user input provided by an operator. For example, the system 700 (or the system 1000 described herein with reference to fig. 9) may include a user input device (e.g., the user input device 1010 shown in fig. 9) that may be used by an operator to provide input that initiates or directs operation of the controller and/or automated suture clip assembly. For example, user input device 1010 may include any suitable user input interface, such as a mechanism for user input that incorporates a graphical user interface associated with an electronic display, where an operator may provide input through interaction with the interface. In some embodiments, the user input device comprises one or more physical switches, buttons, pedals, sensors, etc., wherein the user may provide input through engagement of such mechanism(s). In some implementations, voice commands and/or voice recognition software can be used to provide the input. One or more signals may be transmitted to advance from one step or stage of the current stitching operation to a subsequent step or stage, for example, inputs may be provided to the controller to advance the system through a script that moves the automated gripper and target to various positions in sequence. These can be coordinated so that the target always moves to a known, consistent path of the needle or a fixed path will not contact the frame of the implant or the location of the metal to avoid damage to the needle and other problems.

The configuration of the automated suture clip(s) may provide a weight and/or size for the automated suture clip(s) that is relatively small and convenient for use in applications designed to assist in the positioning and manipulation of relatively small devices, such as prosthetic human implant devices. The relatively small size of the system and automated clamp also allows for use in more compact working spaces, like those often used for suturing prosthetic heart valve implants, for example, the small size may be adapted and used even on relatively small tables or work tables, which allows for more efficient use of construction and work areas. In certain embodiments, the independent actuator device (e.g., independent servo actuator device) of the automated suture gripper(s) comprises a brushless potentiostat and/or a magnetic encoder device. In some embodiments, the actuator device is implemented using piezoelectric control using an analog voltage signal. In certain embodiments, one or more components of the automated suturing clamp(s) are controlled using pulse width modulated control signals, such as control signals at intervals of, for example, between 0 and 2 μ s. In certain embodiments, multiple motor components (e.g., multiple servo motor components) of the automated suture gripper(s) share one or more common leads with multiple signals, such as a three-lead connection. In certain embodiments, the automated suturing clamp(s) include four or five or more respective servo motor devices. The devices and clamps disclosed herein may be remotely controllable or partially remotely controllable.

A suture system according to the present disclosure may include one or more automated suture clips, such as automated suture clip 720 for articulating a suture target (e.g., a prosthetic human heart valve implant) to a desired suture location or other treatment location. Fig. 9 illustrates a block diagram of an example control system 1000 for controlling an automated stitching clamp 1070. An automated stitching gripper 1070 (which may represent any or all of the automated grippers described above) is configured to receive control signals from the controller module 1030. The controller module 1030 may include a combination of software and/or hardware components configured to generate control signals for directing, at least in part, the operation of the automated stitching clamp 1070 and/or one or more components thereof.

In certain embodiments, the controller 1030 comprises one or more processors and/or controller circuits configured to access the suture script information 1034 or other script or program information maintained by the controller in its data store or otherwise accessed by the controller 1030. The controller 1034 may include a positioning control circuit 1032 designed to interpret the suture script information or other script or program information, and to generate control signals for controlling the automated suture gripper 1070 and/or another automated gripper based at least in part on the suture script information or other script or program information.

The stitching script information 1034 or other script or program information may include sequential positioning information regarding one or more components of the automated stitching fixture(s) 1070 for one or more stitching processes or other processes for which the controller 1030 is designed to implement. For example, in some embodiments, the positioning control circuit 1032 is configured to provide location information for each step of the stitching process in sequence. Progression from one position step to another position step may be directed by controller 1030 based on a timer or user input or other mechanism.

The automated stitching clamp 1070 may include a plurality of motorized actuators 1071 communicatively coupled to the controller 1030. In certain embodiments, the motorized actuators are coupled to each other in a daisy-chained configuration, wherein two or more motorized actuators are coupled or wired together in sequence.

Each of the motorized actuators 1071 can include a motor, such as a DC, AC, or brushless DC motor. The motor may be a servo motor. In some embodiments, the motor 1072 is controlled using Pulse Code Modulation (PCM) as directed by the motor control circuit 1076. For example, motor control circuitry 1076 may apply a pulse application for a period of time, wherein the angular positioning of rotor component 1073 is determined at least in part by the length of the pulse. The amount of power applied to the motor 1072 may be proportional to the rotational distance of the rotor 1073.

In certain embodiments, the motorized actuator is a servo actuator device that includes one or more servo feedback components 1074, such as a position sensor (e.g., a digital encoder, a magnetic encoder, laser(s), etc.). The use of servo feedback component(s) 1074 may be desirable in order to achieve a desired level of confidence that the motorized actuator 1071 is positioned with acceptable accuracy as directed by the controller 1030. Servo feedback component(s) 1074 may provide analog signals indicative of the position and/or velocity of rotor 1073 to motor control circuit 1076, which may advantageously allow for relatively precise control of position, thereby more quickly obtaining a stable and precise rotor position. Due at least in part to the size of the material or cloth of the heart valve or other implant device that is sutured using the automated suturing jig 1070 in the implant suturing operation, it may be necessary or desirable to position the implant device relatively accurately. For example, the fabric or other material being seamed may include braided strands forming ribs with relatively small gaps between the ribs. In certain embodiments, the automated suture jig 1070 may be configured to articulate the targeted prosthetic human implant device to within 0.2mm or less of accuracy. Although servo motor arrangements and components are described, in some embodiments, one or more motorized actuators may include a stepper motor or other type of motor subsystem.

Motorized actuator 1071 may further include motor control circuitry 1076, the motor control circuitry 1076 may drive the motor 1072 according to control signals received from the controller 1030. In certain embodiments, the motor 1072, in conjunction with the servo feedback mechanism 1074 and/or the motor control circuit 1076, may advantageously be configured to hold the rotor 1073 and/or attached support member in a set position for a desired period of time. The motor 1072 can provide relatively smooth commutation and/or precise positioning of the associated rotor 1073. Motor 1072 may be relatively powerful with respect to its size and may draw (draw) power proportional to the mechanical loads present on rotor 1073 and/or associated support members.

In some embodiments, the servo feedback component 1074 includes a potentiometer coupled to a rotor 1073, the rotor 1073 can be an output device of the motorized actuator 1071. The rotor 1073 can be connected to a potentiometer coupled with a signal from the control circuit and control circuit 1076, wherein the potentiometer controls the angle of the rotor 1073 (and associated support member) throughout a range of rotation (e.g., between 0-180, or even further). In certain embodiments, the range of rotation of the rotor 1073 is limited by one or more mechanical stops built into the associated gear mechanism(s). A potentiometer (or other servo mechanism, such as an internal rotary encoder) may allow the control circuit 1076 to monitor the current angle of the motor or rotor. When the rotor 1073 is at the correct angle, the motor 1072 may freewheel until the next positioning signal is received from the controller 1030.

The automated suturing clamp 1070 may also include a suturing target holder device or assembly 1080 (although referred to herein as a suturing target holder or assembly, this may be another type of target holder device, holder, or assembly for holding a target device or component for other procedures). The suturing target holder 1080 may be physically coupled to one of the motorized actuators 1071, such as to a distally extending arm actuator device of a plurality of actuators. The suture target holder 1080 may be configured to hold or mount a prosthetic heart valve device or other prosthetic human implant device to which suturing is desired. Suturing target holder 1080 may have any suitable or desired shape, configuration, and/or size, and may be configured to hold or secure a target device or implant device in a variety of different ways. An exemplary embodiment of a suture target holder device or assembly is described below in conjunction with FIG. 10. However, it should be understood that such embodiments are provided by way of example only, and that other types of suture target holders may also be implemented in the disclosed systems.

Fig. 10 illustrates a hinged arm 1878 and/or one or more actuators coupled to an exemplary retainer component 1880. In certain embodiments, to provide an interface for securing an implant device or other target form or device, the retainer component 1880 is fastened or secured to the distal articulating arm 1878 or end actuator of the automated suture clip. The retainer component or assembly 1880 may be designed or configured to hold or secure an implant device or other target device, or a portion thereof, so as to allow suturing thereof in accordance with any of the procedures or embodiments disclosed herein. The retainer component 1880 may be configured to secure or otherwise include a cylindrical form 1885, the cylindrical form 1885 may be sized or dimensioned to draw a target device or implant (e.g., a fabric-covered support stent for the surgical valve implant device 1818) thereon. For example, the valve implant device 1818 may include a plurality of commissure post portions 1892 as shown, the commissure post portions 1892 may be positioned such that they are oriented in a direction toward the retainer component 1880 such that the seam 1818 may be sewn over a location that will ultimately represent an inflow edge of the implant device 1818. The cylindrical form or component 1885 may be designed in a manner similar to a handheld implant device holder, and the cylindrical form or component 1885 may be used in certain embodiments to perform a suturing procedure without the assistance of an articulated arm 1878 and associated components. The cloth 1825 may be arranged around a rigid wireframe structure, with the seam of stitches 1818 being performed to substantially cover the wireframe with the cloth 1825. The seam 1818 may secure the cloth 1825 around the reinforcing strip, as illustrated and described in fig. 3A.

The retainer component 1880 may be designed for particular applications, such as for transcatheter heart valve suturing applications, or surgical heart valve suturing operations, or other implant suturing procedures. The valve can be used in animals (e.g., in humans). While a surgical valve configuration is illustrated in fig. 10, it should be understood that the retainer device 1880 and/or other components of fig. 10 may be designed or configured to support a suturing procedure and/or other procedures of a transcatheter heart valve or other device. For example, although the illustration of fig. 10 illustrates a cylindrical form 1885 designed to hold the implant device 1818 in a desired position, such a cylindrical form may not be necessary for a transcatheter heart valve. For example, instead of a cylindrical form 1885, the retainer 1880 may alternatively be configured to secure a rigid cylindrical wireframe of a transcatheter heart valve, embodiments of which have been illustrated and described above in connection with fig. 1.

The specific type of retainer for a program or application (e.g., for a suture assist application) may be determined on a process-by-process basis. That is, a particular adapter may be suitable or desirable for each of the individual procedures or procedures, or for individual types of valves or other targets. In certain embodiments, a single suturing procedure for an implant device can involve the use of a plurality of different types of retainer devices.

The stitching program may be performed after the stitching system has been programmed with a program, or script. One or more computer components, such as one or more processors and/or memory devices, may be utilized to store and execute program-guided scripts or programs so that the program scripts or programs may be played back to an operator as desired.

The program may include loading a stitching process script or program that may be pre-programmed. The desired script or program may be loaded in various ways, such as by providing input to the system or a computer of the system to load the desired script or program from storage or memory.

The procedure may involve triggering the positioning of an automated suturing clamp (or automated clamp) and/or performing a suturing operation or other operation or step.

Once the stitching operation or other operation or step is performed, the process may end if the associated stitching operation or other operation or step represents the final operation or step of the stitching procedure or other procedure. However, if a stitching operation or procedure or other operation or procedure steps still exist, the process may repeat the triggering, locating, or performing steps in which subsequent steps of the stitching process or procedure may be triggered, such that process 1700 may involve completion of the subsequent step(s).

Depending on the implementation, certain actions, events, or functions of any of the processes or algorithms described herein may be performed in a different order, may be added, merged, or omitted altogether. Thus, in some implementations, not all described acts or events are necessary for the practice of the process. Further, in some embodiments, acts or events may occur concurrently rather than sequentially. For example, multi-threaded processing, interrupt processing, and/or multiple processors or processor cores may be used.

As used herein, conditional language, such as "can," "might," "can," "e.g.," and the like, is understood in its ordinary sense and is generally intended to convey that certain embodiments do include certain features, elements and/or steps, while other embodiments do not include certain features, elements and/or steps, unless specifically stated otherwise or understood otherwise in the context of use. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment. The terms "comprising," "including," "having," and the like, are synonymous and are used in their ordinary sense and are used inclusively in an open-ended fashion, and do not exclude other elements, features, acts, operations, and the like. Furthermore, the term "or" is used in its inclusive sense (and not in its exclusive sense) such that, for example, when used in conjunction with a recited element, the term "or" means one, some, or all of the recited element. Unless otherwise expressly stated, connective language such as the phrase "X, Y and at least one of Z" should be understood along with the context of use to convey that an item, term, element, etc. may be X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to be present individually.

It should be appreciated that in the foregoing description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, the methods of the present disclosure should not be construed as reflecting the intent: any claim requires more features than are expressly recited in that claim. Furthermore, any components, features, or steps illustrated and/or described in a particular embodiment herein may be applicable to or used with any other embodiment(s). Moreover, no single component, feature, step, or group of components, features, or steps is essential or essential to each embodiment. Therefore, it is intended that the scope of the invention herein disclosed and claimed should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

The methods described herein include steps that are indicative of one or more embodiments of the presented methods. Other steps and methods may be conceived that are equivalent in function, logic, or effect to one or more steps, or portions thereof, of the program or method herein. Additionally, the order in which steps of a particular method occur may or may not strictly adhere to the order of the corresponding steps described. The components, features, steps, etc. described with respect to one embodiment herein may be combined or included in other embodiments described elsewhere herein.

The components, aspects, features, etc. of the systems, assemblies, devices, apparatuses, methods, etc. described herein may be implemented in hardware, software, or a combination of both. Where components, aspects, features, etc. of systems, components, apparatuses, devices, methods, etc. described herein are implemented in software, the software may be stored in an executable format on one or more non-transitory machine-readable media. Additionally, the software and associated steps of the above-described methods may be embodied in software as a set of data and instructions. A machine-readable medium includes any mechanism that provides (e.g., stores and/or transmits) information in a form readable by a machine (e.g., a computer). For example, a machine-readable medium includes Read Only Memory (ROM); random Access Memory (RAM); a magnetic disk storage medium; an optical storage medium; a flash memory device; DVD, electrical, optical, acoustical or other form of propagated signals (e.g., carrier waves, infrared signals, digital signals, EPROM, EEPROM, FLASH, magnetic or optical cards, or any type of media suitable for storing electronic instructions). Information representing units, systems, and/or methods stored on a machine-readable medium may be used in creating the units, systems, and/or methods described herein. Hardware for implementing the invention may include integrated circuits, microprocessors, FPGAs, digital signal controllers, stream processors, and/or other components.