阅读说明：本技术 用于使缝合线穿过的方法和设备 (Method and apparatus for passing suture ) 是由 范东·S·盖瑞 克鲁默·F·约翰 赫内芙乐德·H·史考特 纽厄尔·B·马修 克劳森·W·卢克 于 2014-04-17 设计创作，主要内容包括：公开一种装置,其能够刺穿并且保持组织,然后使缝合线穿过组织。该装置可具有：梭子,其能够可拆卸地装配到缝合线；以及钳口,其能够相对于彼此可转动地打开和闭合。还公开一种使用该装置反复地使缝合线穿过组织而不从目标部位移除缝合线或装置的方法。(A device is disclosed that is capable of piercing and holding tissue and then passing a suture through the tissue. The apparatus may have: a shuttle detachably mountable to the suture; and jaws that are rotatably openable and closable relative to each other. Also disclosed is a method of using the device to repeatedly pass a suture through tissue without removing the suture or device from the target site.)

1. A suture management device comprising:

a first jaw and a second jaw, wherein the first jaw has a first jaw tip and the second jaw has a second jaw tip, wherein the device has an open state and a closed state, the first jaw tip being closer to the second jaw tip when the device is in the closed state than when the device is in the open state, wherein the first jaw has a first jaw track, wherein the first jaw track extends along an outer surface of the first jaw such that at least a portion of the first jaw track faces away from the device, wherein the second jaw has a second jaw track, wherein the second jaw track extends along an outer surface of the second jaw such that at least a portion of the second jaw track faces away from the device; and

A suture retainer slidable in the first jaw track and slidable in the second jaw track.

2. The device of claim 1, further comprising a displaceable opening element, wherein the displaceable opening element is displaceable to an opening element first position and an opening element second position, wherein the device is in an open state when the displaceable opening element is in the opening element first position, wherein the device is in a closed state when the displaceable opening element is in the opening element second position, wherein the displaceable opening element is displaceable against the first jaw opening element surface.

3. The device of claim 2, wherein the first jaw opening element surface has a first jaw opening element surface position, wherein the displaceable opening element has a displaceable opening element surface position, wherein the first jaw opening element surface position is proximal to the displaceable opening element surface position when the device is in a closed state.

4. The device of claim 3, wherein the first jaw opening element surface position is distal to the displaceable opening element surface position when the device is in an open state.

5. The device of claim 2, wherein the displaceable opening element is displaceable against a second jaw opening element surface.

6. The device of claim 1, further comprising a displaceable closure element, wherein the displaceable closure element is displaceable to a closure element first position and a closure element second position, wherein when the displaceable closure element is in the closure element first position, the device is in an open state, wherein when the displaceable closure element is in the closure element second position, the device is in a closed state, wherein the displaceable closure element is displaceable against the first jaw closure element surface.

7. The device of claim 6, wherein a first jaw closure element surface has a first jaw closure element surface position, wherein the first jaw closure element surface position is located inside the displaceable closure element when the device is in a closed state.

8. The device of claim 7, wherein the first jaw closure element surface location is outside of the displaceable closure element when the device is in an open state.

9. The device of claim 6, wherein the displaceable closure element is displaceable against a second jaw opening element surface.

10. The device of claim 1, wherein the suture retainer has a suture retainer first longitudinal end and a suture retainer second longitudinal end, wherein when the device is in a closed state and the suture retainer is fully advanced into the first jaw track, a suture retainer second longitudinal end first portion is located in the first jaw track and a suture retainer second longitudinal end second portion is located in the second jaw track.

11. The device of claim 1, wherein the suture retainer has a suture retainer first longitudinal end and a suture retainer second longitudinal end, wherein the suture retainer first longitudinal end has a first shape when the suture retainer first longitudinal end is in the first jaw track and the suture retainer first longitudinal end has a second shape when the suture retainer first longitudinal end is in the second jaw track.

12. The device of claim 1, wherein the first jaw is angled relative to the second jaw when the device is in an open state.

13. A suture management device comprising:

A first jaw and a second jaw, wherein the first jaw has a first jaw tip and the second jaw has a second jaw tip, wherein the device has an open state and a closed state, wherein the first jaw tip is closer to the second jaw tip when the device is in the closed state than when the device is in the open state, wherein the first jaw has a first jaw track and the second jaw has a second jaw track, wherein the first jaw track extends along an outer surface of the first jaw and the second jaw track extends along an outer surface of the second jaw such that at least a portion of the first jaw track faces away from at least a portion of the second jaw track; and

A suture retainer slidable in the first jaw track and slidable in the second jaw track.

14. The device of claim 13, further comprising a movable opening element, wherein the movable opening element is movable to an opening element first position and an opening element second position, wherein the device is in an open state when the movable opening element is in the opening element first position, wherein the device is in a closed state when the movable opening element is in the opening element second position, wherein the movable opening element is movable against a first jaw opening element surface having a first jaw opening element surface position, wherein the first jaw opening element surface position is farther from the device proximal end when the device is in the open state than when the device is in the closed state.

15. The device of claim 13, further comprising a movable closure element, wherein the movable closure element is movable to a closure element first position and a closure element second position, wherein the device is in an open state when the movable closure member is in the closure member first position, wherein the device is in a closed state when the movable closure member is in the closure member second position, wherein the movable closure element is movable against a first jaw closure element surface having a first jaw closure element surface position, wherein the first jaw closure element surface location is inside the movable closure element when the device is in a closed state, wherein the first jaw closure element surface location is outside of the movable closure element when the device is in an open state.

16. The device of claim 13, further comprising a movable opening element and a movable closing element, wherein the movable closing element has a movable closing element distal end, wherein the movable opening element is movable to an opening element first position and an opening element second position, wherein the device is in an open state when the movable opening element is in the opening element first position, wherein the device is in a closed state when the movable opening element is in the opening element second position, wherein the movable opening element is movable against a first jaw opening element surface having a first jaw opening element surface position, wherein the first jaw opening element surface position is farther from the movable closing element distal end when the device is in the open state than when the device is in the closed state, wherein the movable closure element is movable to a closure element first position and a closure element second position, wherein the device is in an open state when the movable closure member is in the closure member first position, wherein the device is in a closed state when the movable closure member is in the closure member second position, wherein the movable closure element is movable against a first jaw closure element surface having a first jaw closure element surface position, wherein the first jaw closure element surface location is inside the movable closure element when the device is in a closed state, wherein the first jaw closure element surface location is outside the movable closure element when the device is in an open state, wherein the first jaw opening element surface faces a device longitudinal axis, wherein the first jaw closing element surface faces away from the device longitudinal axis.

17. A suture management device comprising:

A first jaw and a second jaw, wherein the first jaw has a first jaw tip and the second jaw has a second jaw tip, wherein the device has an open state and a closed state, wherein the first jaw tip is closer to the second jaw tip when the device is in the closed state than when the device is in the open state, wherein the first jaw has a first jaw track and the second jaw has a second jaw track, wherein the suture retainer has an extension and a suture retainer longitudinal axis, wherein when the suture retainer is in the first jaw track, the extension extends away from the suture retainer longitudinal axis and away from a surface of the first jaw that faces an opening of the first jaw track, wherein when the suture retainer is in the second jaw track, the extension extends away from the suture retainer longitudinal axis and away from a surface of the second jaw facing an opening of the second jaw track; and

A suture retainer slidable in the first jaw track and slidable in the second jaw track.

18. The device of claim 17, wherein the extension is configured to limit movement of the suture retainer when the suture retainer is positioned in the first jaw track or the second jaw track.

19. The device of claim 17, further comprising at least one of an opening element movable against a first jaw opening element surface facing toward the device longitudinal axis and a closing element movable against a first jaw closing element surface facing away from the device longitudinal axis.

20. The device of claim 17, wherein the first jaw rail extends along an outer surface of the first jaw and the second jaw rail extends along an outer surface of the second jaw, wherein the first jaw rail has a first jaw rail longitudinal axis having a straight portion and a curved portion, wherein the second jaw rail has a second jaw rail longitudinal axis having a straight portion and a curved portion, wherein the straight portion of the first jaw rail longitudinal axis and the straight portion of the second jaw rail longitudinal axis are angled relative to the device longitudinal axis when the device is in an open state and/or when the device is in a closed state.

Technical Field

The present invention relates to systems, methods, and devices for enhancing the advancement and retention of sutures through tissue.

Background

Previous suturing devices have had elongated rods and unobtrusive distal clamping mechanisms to facilitate use through the cannula 226 during minimally invasive surgery. These devices typically include opposing jaws for clamping onto the tissue to be stapled. The ends of the suture are pre-positioned and secured to the distal end of one of the jaw members. After the clamping action, the mechanism for passing the suture between the jaws and through the tissue comprises a bendable needle. The bendable needle is advanced distally within the jaw member to contact a length of suture.

The needle engages and holds the suture to carry it forward. Distal advancement of the bendable needle also causes the forward end of the needle to approach and engage the ramp 44 in the jaw member, deflecting the bendable needle in the direction of the opposing jaw. The bending of the needle requires a large force and causes excessive strain on the needle component. Breakage and failure of the bendable needle is a problem.

In addition, after deflecting in a direction away from the extension of the jaws, the bendable needle continues to advance and may enter unintended anatomical structures. Extending the needle in this manner is a safety issue. Even after the device has completed passing the suture through the tissue, the ends of the suture must be retrieved by withdrawing the entire device out of the cannula.

An apparatus that is capable of loading and unloading sutures without requiring removal from the surgical site would be advantageous.

An apparatus that enables repeated passage (rather than loading and unloading) of a suture through tissue without requiring removal from the surgical site would be advantageous. It would also be advantageous for the suture shuttle mechanism (needle or shuttle) to be fully contained within the device during surgery to improve the accuracy of suture positioning and to improve the safety of the needle or shuttle position during surgery.

Disclosure of Invention

An apparatus and method for passing a suture through soft tissue is disclosed. The suture passing device may be used for multiple passes of suture without withdrawing the suture passing device from the target site, for example, during a rotator cuff repair procedure.

The suture passing device may be configured without a mechanical pivot link. The suture passing device may be free of hinges in the jaw structure. The jaw structure is capable of opening and closing by a hingeless action.

The suture may be mounted on the side of the jaw structure.

The shuttle for holding and moving the suture can be captured and held within the jaws, e.g., the device is designed without a loose piece that can be separated from the device during use.

The jaws and/or shuttle or gland of the device may be made of a resilient metal such as Nitinol (Nitinol) or other materials disclosed herein.

The device allows for repeated passage of the suture through the tissue without removing the device from the operative portion and without loading and unloading the suture at the device. Suture shuttle mechanisms (e.g., needles and/or shuttles) may be partially or fully contained within the device during surgery to improve the accuracy of suture positioning and to improve the safety of needle or shuttle position during surgery.

Drawings

Fig. 1a, 1b and 1c are perspective, top and side views, respectively, of a variation of a suture passing device.

Figures 2a and 2b are a perspective and a close-up view, respectively, of a variant of the shuttle in a rectilinear condition.

Figure 2c is a close-up view of the shuttle variant of figures 2a and 2b in a bent state.

Fig. 3a is a close-up perspective partial view of the distal end of a variation of a suture passthrough device fitted with a length of suture.

Fig. 3b is a close-up view of a portion of fig. 3 a.

Fig. 4a and 4b are a proximal perspective view and a side view, respectively, of the distal end of a variation of the suture passing device in a closed state.

Fig. 4c is a close-up view of the distal end of fig. 4a and 4 b.

Fig. 4d is a proximal perspective view of the distal end of the device of fig. 4a in a closed state.

Fig. 5 is a variation of section a-a of fig. 1a of the device fitted with a length of suture.

Fig. 6a to 6d show a variant of the method of producing stitches in a piece of tissue using a variant of the suture passing device.

Figures 7a and 7b are a close-up perspective side view of a variation of the device with an exploded view of the shuttle and a close-up view of the proximal end of the device, respectively.

FIG. 7c is a close-up view of a variation of the shuttle of FIG. 7 a.

Fig. 7d is a close-up view of the distal end of the device variation shown in fig. 7 a.

Figure 8a shows a variant of the shuttle.

Fig. 8b shows a close-up view of a variation of the distal end of the device.

Fig. 9a and 10a are a side perspective view and a partial perspective side perspective view, respectively, of a variation of the device in an open state.

Fig. 9b and 11a are a side perspective view and a side cross-sectional view, respectively, of a variation of the method for closing the jaws of the device of fig. 9 a.

Fig. 9c and 11b are a close-up view and a side perspective view, respectively, of the distal end of the device of fig. 9 b.

FIG. 10b is a close-up partial perspective view of the distal end of the lower jaw of FIG. 10 a.

figures 12a to 12c are side, top and bottom views, respectively, of a variation of the shuttle.

Fig. 13a and 13b show a variant of the shuttle.

Figures 14a to 14c are top, front and bottom perspective views, respectively, of a variation of the shuttle.

Figures 15a to 15c are side, bottom and side-bottom perspective views of a variation of the shuttle.

Figures 16a and 16b are top and side perspective views of a variation of the shuttle.

Figure 17a shows a variant of the device with the shuttle of figures 12a to 12 c.

Figure 17b shows a variant of the device of figure 17a with a propeller.

Figures 17c and 17d show a variant of the device of figure 17a with two impellers in different states.

FIGS. 18a and 18b are side elevation and side elevation views, respectively, of a variation of the distal end of the device

Fig. 19a and 19b are side perspective and side elevation views, respectively, of a variation of the distal end of the device.

Fig. 20a and 20b are side perspective and side elevation views, respectively, of a variation of the distal end of the device.

Fig. 21a and 21b are a side perspective view and a side view, respectively, of a variation of the distal end of the device.

Fig. 22a and 22b are a variation of the distal and distal lower jaws, respectively, of the device.

Figure 22c is a side view of the device of figure 22a with a shuttle.

Figures 23a and 23b are a variation of the distal end of the device in the open and closed states, respectively, of the device of figure 23b with a shuttle.

Fig. 24a to 24c are side, side and distal views, respectively, of a variant of the device.

Figures 25a to 25f are respectively a bottom-side perspective view, a partial perspective view (with the upper jaw in perspective), a longitudinal section view, a partial cut-away close-up view and a partial cut-away view of the distal end of a variant of the device with the jaws in an open condition, the shuttle and pusher in various positions, and for the sake of clarity the gland is not shown in figure 25 f.

FIG. 26a is a side perspective view of a variation of the distal end of the device with the jaws closed and the upper jaw having a shuttle therein and not engaged with the lower jaw.

Fig. 26b and 26c are a longitudinal cross-sectional view and a side perspective view, respectively, of the device of fig. 26a with the shuttle in the upper and lower jaws. For the sake of clarity, fig. 26b does not show the pusher.

Fig. 26d is a partial cutaway view of fig. 26 c.

FIG. 27 is a close-up partial cut-away view of the distal end of a variation of the device with the shuttle in the lower jaw and the upper pusher extending out of the upper jaw and partially into the lower jaw.

FIG. 28 is a close-up end perspective view of a variation of the shuttle and suture device of FIG. 13a or 13 b.

FIG. 29 is a close-up end perspective view of a variation of the shuttle and suture assembly of FIGS. 14a through 14 c.

Fig. 30a and 30b are a rear right view and a cut-away left view, respectively, of a variant of the device.

Figure 31 is a partially cut-away and partially perspective view of the proximal end of a variation of the device.

Fig. 32a and 32b are left and right side perspective views of a variation of the propeller drive gear of the device.

Detailed Description

Fig. 1 a-1 c illustrate a suture passing device 188 that can be used to pass a suture 70 through soft or hard tissue 74 without removing the device 188 or the suture 70 from the target site while creating one or more complete stitches.

The suture passing device 188 may have an ergonomic handle 104, a sliding tube effector 6, and a distal end 2. An ergonomic handle 104 may be used to control the distal end 2. The ergonomic handle 104 may have a side button 10. The ergonomic handle 104 may have a top button 12. The top button 12 and/or the side buttons 10 may advance and/or retract the upper pusher 86 and/or the lower pusher 76, either individually or together.

The sliding tube actuator 6 may have an outer gland 34 and an inner rod (not shown as being obscured by the outer gland 34). An inner rod may be fixedly assembled to the handle 104 and the proximal end of the jaw structure 28. The outer gland 34 may extend radially beyond the inner stem. The outer gland 34 may be actuated by the handle 104, for example, when the trigger 8 is squeezed or released, the outer gland 34 is displaced distally and proximally relative to the handle 104.

Fig. 2a and 2b show that the device 188 may have a sliding band shuttle 14 or a needle held within the device 188. The shuttle 14 may have an elongated shuttle cross member 16. The shuttle crossbar 16 may have a plurality of slits 20 along one or both sides of the shuttle crossbar 16. The slots 20 are positioned at regular or irregular length intervals along the beam 16.

The shuttle 14 may have a suture holder 18 extending laterally from the cross beam 16. The shuttle 14, such as the suture holder 18, may extend out of the lateral side slot 72 of the arm structure. The suture retainer 18 may extend from the left and/or right side of the device 188. The distal end 2 of the device 188 is reversible such that the suture holder 18 can be switched from one side of the device 188 to the other side of the device 188. The suture retainer 18 can have a generally flat isosceles trapezoidal shape. The suture retainer 18 may have a suture retaining notch 100. The recess 100 may have an inner bore 17a, an outer bore 17b connected to the inner bore 17a, and a first clip 97a located between the inner bore 17a and the outer bore 17 b. The recess 100 may have a second wire clamp 97b on the side of the outer bore remote from the inner bore. The notches 100 may be used to secure the suture 70. For example, the suture 70 may be pressed into and friction fit within the inner clip 97 a.

The suture retainer 18 can have a leading guide edge and a trailing guide edge. The edge may be inclined at right or non-right angles relative to the longitudinal axis of the beam 16. One or both edges may be sharpened to traumatize tissue 74, for example, to cut through soft tissue 74. The edges cut through the tissue 74, allowing the suture retainer 18 to pull the suture 70 through the tissue 74 proximate the back of the corresponding edge.

The shuttle 14 may be made of a flexible polymer such as PEEK, a resilient metal such as nitinol, the materials disclosed herein, or combinations thereof. The shuttle 14 may be made of a molded polymer. The shuttle 14 may be pre-curved, for example, to reduce drag when following a trajectory curve.

Fig. 2c shows that the beam 16 may be bent at the location of the slit 20, and/or the beam 16 may be pre-bent.

Fig. 3a and 3b illustrate that the suture passthrough device 188 can capture or releasably fit the suture 70 into the inner and/or outer clips 97a, 97b of the suture retainer 18. Suture 70 may be loaded or held alongside jaw 28, out of the plane of rotation of the jaw. Device 188 may pass suture 70 through tissue 74 multiple times without having to remove or reload the suture through device 188. The jaw structure 28 may be resiliently deformed open at the proximal end of the jaw structure 28 without a hinge. The jaws may open and/or close without mechanical pivots or linkages in the jaw structure 28.

Fig. 4a illustrates that the suture passing device 188 may have a jaw structure 28, the jaw structure 28 having a top jaw 30 and a bottom jaw 38. The entire jaw structure 28 may be a unitary piece of material such as an element of molded, cast, or cut nitinol, other resilient metal or polymer, any other material listed herein, or a combination thereof. The jaw structure 28 may be configured to be in an open state (as shown in fig. 4 d) when in an unbiased state (i.e., when no external force is applied).

The jaw structure 28 can have a jaw structure longitudinal axis 42. Each jaw may also have a respective jaw longitudinal axis along the jaw.

The internal passage of the gland 34 is sized and shaped so that the gland 34 can fit onto the jaw structure 28 with minimal clearance when the jaw structure 28 is in the closed state. When the gland is displaced distally 138 relative to the jaw structure 28, the gland 34 can press the top jaw 30 and the bottom jaw 38 toward the jaw structure longitudinal axis 42, as indicated by the arrows. The jaw structure 28 may be fully compressed into a closed state as shown in fig. 4 a-4 c. Thus, when a lever, such as trigger 8, is actuated, the channel or gland 34 can advance to close the jaw cam (cam). The jaws can pre-penetrate tissue and establish a continuous track for the shuttle to pass through the tissue.

A gland 34 may be fitted to the opening ball 32 between the first and second jaws.

Fig. 4b shows that the opening ball 32 may be rotatably or fixedly mounted to the ball axle 52, the ball axle 52 passing transversely through the opening ball 32. The ball axle 52 may extend from a lateral side of the ball 32. The ball shaft 52 may be slidably received by a shaft slot 50 formed through the distal end arm 54 or an extension 138 of the gland 34. When the jaw structure 28 is in the closed state, the ball shaft 52 may abut and interferingly fit against the proximal end of the shaft slot 50, for example, to prevent the gland 34 from extending excessively out of the jaw structure 28. When the jaw structure 28 is in the open state, the ball shaft 52 may be mounted against and in an interference fit with the distal end 2 of the shaft slot 50, for example, to prevent over-rotation of the jaws and/or to prevent pulling of the ball 32 over the ramp 44 inside the jaw structure 28.

Fig. 4c shows that the lower track 66 may terminate distally at the lower track port 62. The upper track 64 may terminate distally at the upper track port 60. When the jaw structure 28 is in the closed state, with the first jaw tip 46 interdigitated with the second jaw tip 48, the upper rail port 60 may be aligned with and adjacent (as shown) or in contact with the lower rail port 62. The tracks of the upper jaw 78 and the bottom jaw 38 may form a continuous path when the jaw structure 28 is in the closed state. The first jaw tip 46 can be forked and adjacent to or in contact with the second jaw tip 48 when the jaw structure 28 is in the closed state.

Fig. 4d shows that the gland 34 can be displaced proximally 126 relative to the jaw structure 28 as indicated by the arrow. The ball shaft 52 can be slid to the distal end 2 of the shaft slot 50. The shaft slot 50 may then pull the ball shaft 52 and thus the opening ball 32 proximally. The opening ball 32 may then press against the inner surface ramp 44 of the first jaw and/or the second jaw. The first jaw tip 46 and/or the second jaw tip 48 are then rotated away from the opposing jaw tip. The jaw structure 28 may then be in the open state as shown.

The proximal end of the jaws may be rigid or flexible, for example, to bend around the opening of the gland 34 when the jaws are in an open state. The entire jaw or only the proximal end of the jaw may be made of nitinol, for example the distal end of the jaw is made of stainless steel.

Fig. 5 shows that the side slots 72 may extend laterally from one side of the rail. The cross beam 16 of the shuttle 14 may be higher than the height of the side slots 72. The cross beam 16 may be long enough to pass through the side slots 72. Suture retainers 18 can extend laterally from crossbar 16 through side slots 72. The suture retainer 18 can retain a suture 70 laterally apart from the jaws.

Fig. 6a shows that the upper jaw 78 and the lower jaw 80 can be closed as shown by the arrows and pressed through tissue 74, such as soft tissue 74 in the rotator cuff or other joint. Upper jaw tip 206 and/or lower jaw tip 198 may pierce tissue 74. The upper jaw tip 206 and the lower jaw tip 198 may be interdigitated with or adjacent to the tissue 74. The hole created by the contact or interdigitation of the upper jaw tip 206 and/or the lower jaw tip 198 can be a hole in the tissue 74 through which the shuttle 14 and/or suture 70 passes. The gland can be pushed toward the distal end 138 to further press the first jaw toward the second jaw, for example, to force the jaw tips to pierce tissue 74.

The lower pusher 76 may be controlled by the handle 104 to advance distally as indicated by the arrow. The lower pusher 76 can force or push the shuttle 14 through the track to move distally and the shuttle 14 carries the suture 70.

Fig. 6b shows that the lower pusher 76 can be pushed continuously by the handle 104. The lower pusher 76 can push the shuttle 14 through the tissue 74. The leading edge 22 of the suture retainer 18 may cut through the tissue 74 and the suture retainer 18 may pull the suture through the incision made in the tissue 74 by the leading edge 22 and/or through the perforation made in the tissue 74 by the tip of the jaws. The pusher and shuttle 14 can move along the longitudinal axis of the jaws.

The shuttle 14 can then be positioned entirely within the track of the upper jaw 78. The lower pusher 76 may then be withdrawn from the track of the upper and/or lower jaws 80, and/or the lower pusher 76 may be left in place, but the resistance may be removed to allow the lower pusher 76 to slide freely in the track.

fig. 6c shows that the gland can then be displaced towards the proximal end 126 as indicated by arrow 83 (e.g., by releasing or squeezing the trigger 8). The ball shaft 52 can be pulled proximally so that the opening ball 32 rests against the inner surface of the top and/or bottom jaws 38. Whereby the opening ball 32 can resiliently open the top and/or bottom jaws 38. The jaws may then be released (i.e., rotated open as indicated by arrow 82) and moved away from the tissue 74.

The device 188 may then be transferred to a position adjacent (e.g., transverse) to the distal end 2 of the device 188 where the suture is initially threaded through the tissue 74. Fig. 6d shows that the jaws can then be closed, piercing tissue 74 adjacent the first passage of suture 70. The upper pusher 86 may then be pushed distally by the handle 104 as indicated by the arrow. The upper pusher 86 can push the shuttle 14 along the track in the opposite direction as shown in fig. 6a and 6 b. The trailing edge 24 of the suture retainer 18 then cuts the tissue 74 as the suture retainer 18 is passed through the tissue 74, carrying the suture 70 through the tissue 74. A plain stitch (stitch) of suture 70 may then be created through tissue 74.

The shuttle 14 may then be in the starting position as shown in figure 6 a. The upper pusher 86 can then be withdrawn from the track of the upper and/or lower jaws 80 and/or the upper pusher 86 can be left in place, but the resistance can be removed so that the upper pusher 86 can slide freely in the track. The jaws may be opened and reset again and the device 188 may repeat the method shown in fig. 6 a-6 d to produce another stitch. When the stitch is completed or turned to a second stitch, the jaws may be opened and removed from the target site.

Fig. 7a shows that the device 188 may have a base 102, and the handle 104 extends from the base 102. The device 188 may have a rotatable lever 106 rotatably mounted to the base 102 or the handle 104. The device 188 may have a gland 34 displaceably mounted to the base 102 and extending distally from the base 102.

The distal end 2 of the device 188 may have upper and lower jaws 80. The upper jaw 78 may be rotatable relative to the lower jaw 80 and vice versa.

The gland 34 may be slidably mounted to one or both jaws. The rotating rod 106 may be assembled to the gland 34. For example, pinching lever 106 or rotating lever 106 toward handle 104 may push the gland distally 138 relative to the jaws. The gland can slide distally over the jaws, rotating the upper jaw 78 toward the lower jaw 80 and closing the jaws. The lever 106 may be spring loaded such that when external or pinching force is no longer applied to the lever 106, the lever 106 rotates away from the handle 104, proximally retracting the gland 126, and returning the jaws to an open state.

Fig. 7b shows the pusher rod or button extending distally from the base 102 or handle 104. The pusher bar or button may be displaced relative to the base 102 and/or the handle 104 as indicated by the arrow. The pusher bar may be configured to push and/or pull one or both of the pushers. Pressing or pulling the pusher rod may displace the pusher. A single pusher bar or button may be toggled between the two pushers.

A pusher toggle switch, such as a side paddle 112, may extend from a lateral side of the base 102. The side flaps 112 may be located on the top or bottom of the base 102 or on the handle 104. The side blade 112 may rotate relative to the base 102 as indicated by arrow 110. The side paddles 112 may be configured to turn the pusher bar or button in a particular direction to displace the upper pusher 86 or the lower pusher 76 depending on the position of the side paddles 112.

The device 188 may have a lock 120 of the lever 106. The lock 120 of the lever 106 may extend laterally from the base 102. The lock 120 may rotate relative to the base 102 as indicated by arrow 118. The lock 120 may be configured to hold the rod 106 in a fixed relationship or at a particular angular position relative to the base 102. For example, a lock on the lever 106 may hold the lever 106 closed, thereby closing the jaws.

Fig. 7c shows that the shuttle 14 may have a cross beam 16, which cross beam 16 may be a cylindrical tube or sleeve. The beam 16 may be made of nylon, other materials disclosed herein, or combinations thereof. The cross beam 16 may have rounded (e.g., hemispherical) or flat longitudinal ends.

The shuttle 14 may have a suture retainer 18, and the suture retainer 18 may be a wire loop 98 extending laterally from the cross beam 16. The wire loop 98 may have a wire. The wire loop 98 may extend in a plane. The ends of the wires may be anchored, for example, by ports or slots transverse to the cross beam 16, such as being removably or fixedly mounted to the cross beam 16. The suture 70 may extend through or remain in the area defined by the perimeter of the wire loop 98 while being held by the suture 70 through the device.

Fig. 7d illustrates that the lower jaw 80 (as shown) and/or the upper jaw 78 may have one or more loading slots or notches 96. Loading slot 96 can expose suture retainer 18, such as wire loop 98, for loading/unloading suture 70. The suture retainer 18 can extend into the loading slot. For example, wire loop 98 can extend through side slot 72 and into retaining slot 100 with shuttle 14 in a position to load and/or unload suture 70 onto shuttle 14. For example, when the suture retainer 18 is aligned with the loading slot 96, the shuttle 14 can be in the proximal-most position of the shuttle 14 on the lower track 66. The side slots 72 can terminate at the loading slot 96, e.g., walls of the loading slot 96 can be mounted with an interference fit against the shuttle 14 and/or the suture holder 18 to prevent further proximal displacement of the shuttle 14 along the jaws.

The lower jaw 80 and/or the upper jaw 78 can have a spacer 90, and the spacer 90 can cover an intermediate end surface of the distal end 2 of the lower jaw 80 (as shown) and/or the upper jaw 78. The diaphragm 90 can be a flexible material that can be configured to seal around all or part of the shuttle 14 as the shuttle 4 passes through the diaphragm 90. For example, the spacer 90 may be made of a textile or a solid sheet of a polymer such as polyurethane or polyester.

The partition 90 may have a partition track port 92. The diaphragm rail ports 92 may be aligned with the ends of the upper rail 66 and/or the lower rail 64.

The partition 90 may have a partition groove 94. The spacer slot 94 may be aligned with the side slot 72 of the lower track 66 and/or the upper track 264.

The barrier 90 can be configured to wipe or scrape debris and biological fluids, such as tissue 74, from the shuttle 14 as the shuttle 14 passes through the barrier 90, for example, to prevent or reduce debris and fluids from entering the upper and/or lower tracks 66.

Fig. 8a shows that shuttle 14 can have a cross beam 16, that cross beam 16 can have a cylinder, and that suture holder 18 can be as shown in fig. 2b and 2 c. The retaining slot 100 may have an angled wire grip 97. The retaining slot 100 may extend to the side of the beam 16.

Fig. 8b shows that the shuttle 14 can be positioned such that the retention slot 100 of the suture retainer 18 can be in the loading slot 96 when the suture 70 is fitted or removed from the retention slot 100. Suture 70 may be pressed into (e.g., for assembly) or pulled out of (e.g., for removal, separation, or repositioning) retaining slot 100. A longitudinally opposed pair of first clips 97 can laterally friction fit or interference fit mount the suture 70 into the retention slot 100. A longitudinally opposed pair of second clips 97 may have a friction or interference fit therebetween to mount the suture 70 in the retention slot 100 (i.e., the suture 70 may be radially secured between a pair of first clips 97 on lateral sides of the suture 70 and a pair of second clips 97 on the interior side of the suture 70).

Suture 70 may be radially secured between a pair of longitudinally opposed clips 97, which clips 97 may dig into and compress or pierce the outer surface of suture 70.

The shuttle 14 may be mounted with an interference fit or otherwise blocked from movement by the lower jaw 80 proximate to where the retention slot 100 is exposed in the loading slot 96.

Figures 9a, 10a and 10b illustrate that the device 188 may be in an open state where the upper jaw 78 is rotated away from the lower jaw 80. The upper jaw 78 may have an upper jaw longitudinal axis. The lower jaw 80 may have a lower jaw longitudinal axis 132. The lower jaw longitudinal axis 132 (as shown) or the upper jaw longitudinal axis 124 may be parallel and/or collinear with the gland longitudinal axis. The upper jaw longitudinal axis 124 and the lower jaw longitudinal axis 132 may intersect at a jaw angle 128. The jaw angle 128 may be about 30 ° to about 45 °, more narrowly about 30 ° to about 40 °, when the jaws are in an open state.

Gland 34 may be displaced proximally away from the jaws and retracted as indicated by arrow 126. The upper jaw 78 may have a slotted slide pin 130 that may extend laterally from one or both lateral sides of the proximal end of the upper jaw 78.

The distal end 2 of the gland 34 may have one or more angled slots 134 on one or both lateral sides of the gland 34. The chute 134 can narrow as the chute 134 extends proximally (i.e., widen as the chute 134 extends distally). The angled slot 134 may be at a non-zero angle (i.e., non-aligned) with respect to the longitudinal axis of the gland 34.

The slot slide pin 130 may be configured to extend through the angled slot 134. The slot slide pin 130 can slide within the angled slot 134. The slot slide pin 130 can be friction fit mounted at the narrower proximal end of the angled slot 134, e.g., friction fit mounting the jaws in a closed state, and provide tactile feedback to the user of the jaw angle 128.

Fig. 10a shows that the upper rail can pass through the hinge tube 149 where it extends over the distal opening of the gland 34 and into the upper jaw. Hinge tube 149 may be made of nitinol, for example. The hinge tube 149 may flex as the upper jaw is rotated. Hinge tube 149 may be the entire length of the entire upper track or may be a separate length of tube fitted at one or each end to the remainder of the upper track.

Figures 9b and 11a illustrate that the gland 34 can be extended or advanced distally relative to the jaws as indicated by arrow 138. The gland 34 may force the jaws to rotate toward one another to a closed state. For example, the upper jaw 78 may be rotated as indicated by arrow 136 while the lower jaw 80 remains in a rotationally fixed position relative to the gland 34, or vice versa, or both jaws may be rotated relative to the gland 34. In this way, a lever such as trigger 8 can be actuated to advance the outer tube or gland 34 to cam the jaws closed.

The jaw angle 128 may be about 0 ° to about 3 °, more narrowly about 0 ° to about 2 °, such as about 0 °, when the jaws are in a closed state.

Fig. 9c and 11b show that the upper jaw tip 206 can be pressed into and through the diaphragm track port 92. The upper track 264 may form a lumen 152 continuous with the lower track 148 through which, for example, the shuttle 14 may slide.

The side slots 72 of the upper jaw 78 may be aligned with the side slots 72 of the lower jaw 80. The suture retainer 18 may extend through the side slot 72 and retain the suture 70 in the side slot 72. As the shuttle 14 is displaced back and forth between the upper jaw 78 and the lower jaw 80, the suture retainer 18 can displace the suture 70 back and forth between the upper jaw 78 and the lower jaw 80 in the side slot 72.

Fig. 12 a-12 c show that the shuttle 14 includes a crossbar 16, such as a shuttle spine 160 and a side arm or finger of the shuttle 14 extending laterally and/or inwardly from the shuttle spine 160. As shown, the shuttle fingers 156 may extend laterally, downwardly and inwardly relative to the shuttle spine 160. The shuttle 14 may have slots 20 or shuttle cross slots 158 between the shuttle fingers 156. The shuttle fingers 156 are flexible or rigid.

the shuttle 14 may have a shuttle longitudinal axis 157. The shuttle longitudinal axis 157 may be flat or curved, for example, having a shuttle radius of curvature 154 of about 3mm to about 5mm, more narrowly about 3mm to about 4mm, for example about 3.5 mm.

The shuttle spine 160 may be flexible or rigid. The shuttle 14 may be made from a single piece of material (e.g., metal), such as by bending and laser cutting a sheet of material.

The suture retainer 18 can be one, two or more circular, oval, or elongated longitudinal grooves in the shuttle spine 160. For example, the suture 70 may extend through one or both of the suture retainers 18. The suture 70 can be fused to the shuttle 14 adjacent the suture retainer 18. A removable or fixed frame may fit into a slot in the shuttle 14 and the suture 70 may fit into the removable frame. For example, the detachable framework may be an arcuate line with a first end fitting into a first groove in the shuttle spine 160 and a second end fitting into an adjacent second groove in the shuttle spine 160.

FIG. 13a shows that the suture retainer 18 can be arcuate in shape integral with the shuttle spine 160. For example, the shuttle 14 may be made from a single piece of material (e.g., metal). The lateral sides of the suture retainer 18 can be cut and the longitudinal ends can remain integral with the shuttle spine 160. The suture retainer 18 can then be bent or deformed out of the plane of the shuttle spine 160, such as forming an arc out of the plane of the shuttle spine 160.

Suture 70 may have a suture loop 162 at the end of suture 70. The suture loop 162 may extend around and completely or partially surround the suture retainer 18. The remainder of suture 70 may be integral with suture loop 162 or may be removably fitted to suture loop 162. The suture loop 162 may be circular or oval.

FIG. 13b shows that the shuttle 14 may have one or more shuttle notches 166 or cut-outs. For example, the shuttle 14 may have two shuttle notches 166 at each lateral location of the shuttle. The shuttle notches 166 may be equally spaced longitudinally and distributed along the shuttle 14. The shuttle notch 166 may be curved. The sides of shuttle 14 other than the notch may be straight.

The radius of curvature of the shuttle notch 166 may be about 1mm to about 2 mm.

Fig. 14a to 14c show that one or both longitudinal ends of the shuttle 14 may be curved or sharp shuttle tips 164. For example, the shuttle tip 164 may have an angled chisel tip or needle tip.

The shuttle holder may have a holder forward end 170 extending outwardly from the shuttle spine 160. The end of the retainer leading end 170 distal to the shuttle spine 160 may be a closed wire loop 98 for fitting the suture 70. As shown, a neck 172 of a loop, such as a double clamp, may secure a first end of the front end wire to a midpoint of the retainer front end 170. A second end of the retainer front end 170 may extend through the shuttle longitudinal slot 174 and terminate at a front anchor 168, such as a pleated or forged sphere or a disk having a diameter greater than the width of the shuttle longitudinal slot 174, for example, for slidably fitting the suture retainer 18 to the shuttle longitudinal slot 174. The suture retainer 18 can be slidably captured by the leading anchor 168 into the shuttle longitudinal slot 174.

The retainer front end 170 may be displaceably and/or rotatably fixed in the shuttle longitudinal slot 174, or may slide and/or rotate in the shuttle longitudinal slot 174. For example, the wire loop 98 can extend over a first end of the shuttle spine 160 when the shuttle 14 is displaced in a first direction (e.g., from the upper jaw 78 to the lower jaw 80), while the keeper front end 170 can passively rotate and displace when the shuttle 14 is subsequently displaced in a second direction (e.g., from the lower jaw 80 to the upper jaw 78).

The retainer front end 170 may be flexible or rigid. For example, the retainer front end 170 may be made of stainless steel, other materials disclosed herein, or combinations thereof.

The suture 70 may be threaded and/or tied to the wire loop 98. The wire loop 98 may be at a height away from the shuttle spine 160. The wire loop 98 may extend proximally or distally beyond the end of the shuttle tip 164. For example, the suture 70 may be fitted to the wire loop 98 distal to the sharp edge point to minimize the risk of cutting or damaging the suture 70.

Fig. 15a and 15b show that the suture 70 can be directly fitted or fused to the shuttle spine 160 at a suture fitting 176 in the middle of the longitudinal and lateral portions of the shuttle 14. The suture 70 may be braided.

For example, the entire shuttle 14 may be made of plastic and may be molded, formed or added to a plastic suture. The suture may be thermoformed to the shuttle 14. The suture 70 may extend through the shuttle 14, for example, at a suture anchor 178. The suture anchor 178 may be the end of the suture 70 that extends through and is fitted to the shuttle 14.

Fig. 16a and 6b show that the leading end or wire loop 98 may extend partially or fully into a plane perpendicular to the plane of the shuttle spine 160. The first end of the wire loop 98 may have a leading first anchor 184. The second end of the wire loop 98 may have a leading second anchor 186. The shuttle spine 160 may have a shuttle longitudinal first slot 180 and a shuttle longitudinal second slot 182. The shuttle longitudinal slot 174 may be elongated or circular. The wire loop 98 may be made of nitinol and/or steel, for example, and may be tied to a suture.

The wire loop 98 may extend through the shuttle longitudinal slot 174. The leading first and second anchors may be on the underside (e.g., concave side or radially inward) of the shuttle spine 160. The wire loop 98 may be outboard (e.g., concave side or radially outboard) of the shuttle spine 160. One or both of the front anchors 168 may not be secured or integrated (e.g., fused or welded) to the shuttle spine 160. One or both of the front anchors 168 may not be slidably fitted to the longitudinal slot. The wire loop 98 may be fixed or longitudinally slidable relative to the shuttle spine 160.

The wire loop 98 may have a longitudinally symmetric or asymmetric (as shown) shape. For example, the wire loop 98 can be arcuate (similar to the shape shown for the suture retainer 18 in fig. 13a and 13 b) or can depend asymmetrically toward one of the ends of the longitudinal shuttle (as shown).

Figure 17a shows that the device 188 can place the shuttle 14 in a position straddling the upper jaw 78 and the lower jaw 80. The jaws may have a jaw transverse protuberance 190. The shuttle finger 156 can be crimped around the jaw transverse protuberance 190, for example to slidably fit the shuttle to the jaws. When the jaws are in a closed state, the jaw lateral ridges 190 at the ends of the upper jaw 78 or top jaw 30 and the bottom jaw or lower jaw 80 can be aligned, for example, so that the shuttle 14 can slide along the continuous ridge between the upper jaw 78 and the lower jaw 80.

FIG. 17b shows that the device 188 can have the lower pusher 76 slidably fit over the jaw lateral ridges 190 on the lower jaw 80. The lower pushers 76 may abut the shuttles 14.

Figure 17c shows that the device 188 can have the upper pusher 86 slidably fit over the jaw transverse ridges 190 on the upper jaw 78. The upper pusher 86 and/or the lower pusher 76 may be shaped similar to the shuttle 14. The shuttle 14 can be pushed onto the straight section of the lower jaw 80. The shuttle 14 may be deformed into a straight state when on a straight section of the jaws, and the shuttle 14 may be deformed into a curved state when on a curved section of the jaws.

The pusher generally has a similar shape to the shuttle 14, with fingers, longitudinal grooves, ridges and transverse grooves between the fingers. More than one pusher may be used simultaneously on one device 188 (e.g., if the pusher in fig. 17 b-17 d is a shuttle 14 and if additional pushers are used), for example, for delivering multiple sutures 70 to the same target site.

FIG. 17d shows that the shuttle 14 can be advanced to the upper jaw 78 by the lower pusher 76 as shown. The lower pusher 76 can then be retracted back onto the lower jaw 80.

Fig. 18a and 18b show that the upper jaw and/or the lower jaw 80 may have a jaw ridge 208, respectively. Jaw ridge 208 may extend centrally from the remainder of the jaw toward (as shown) or away from the jaw control extension longitudinal axis. For example, the jaw ridges may extend distally from the remainder of the jaws to the distal end 2 of the jaws, where the jaws extend from the jaw longitudinal extensions 191, 202 to a jaw central extension that is proximal to and curved in the middle of the respective jaw tip.

As described elsewhere herein, the jaws may have a jaw transverse ridge 190 or cross beam 16. The jaws may have a T-shaped cross-section.

The shuttle 14 may have shuttle fingers 156, and each shuttle finger 156 may have a shuttle downward extension 196. Each shuttle finger 156 may have a shuttle lateral extension 192 that extends laterally from the respective shuttle spine 160. The shuttle finger 156 may have shuttle downward extensions 196, each shuttle downward extension 196 extending downward (e.g., longitudinally of the jaw structure) from a lateral end of the lateral extension. The shuttle finger 156 may have a shuttle inward extension 194 extending inward from a shuttle downward extension 196. The shuttle spine 160 and/or the lateral extension, downward extension, and inward extension may be slidably curled around the jaw lateral protuberance 190.

The upper jaw tip 206 and/or the lower jaw tip 198 may have a blunt tip, a beveled tip (e.g., a needle tip), a chisel tip (e.g., beveled on opposite sides as shown in fig. 18a and 18 b), a conical tip, a spotter (spratte) tip, a diamond tip, a Tuohy (Tuohy) tip, or combinations thereof (e.g., the upper jaw tip 206 may have a first tip shape and the lower jaw tip 198 may have a second tip shape). The bevel distal to the jaw tip may have the same angle and length as the bevel proximal to the jaw tip, or a smaller angle and a longer length than it.

the upper jaw tip 206 may have a tip gap 290 or contact the lower jaw tip 198 when the jaws are in a closed state.

Fig. 19a and 19b show that the jaw ridges 208 in one or both jaws may terminate before the respective jaw tip or jaw center extension.

The bevel proximal to the jaw tip may have a smaller angle and a longer length than the bevel distal to the jaw tip.

Fig. 20a and 20b show that jaw ridge 208 of upper jaw 78 may extend along a straight section of upper jaw 78 and may terminate at or proximal of upper jaw central extension 204 or upper jaw tip 206. The jaw lateral ridges 190 of the upper jaw 78 may extend to the distal tip of the upper jaw 78.

Jaw ridge 208 of lower jaw 80 may extend to the distal tip of lower jaw 80.

The jaw lateral ridges 190 of the lower jaw 80 may extend along a straight section of the lower jaw 80 and may terminate at or proximal to a lower jaw central extension 200 or lower jaw tip 198.

The lower jaw tip 198 may be positioned adjacent to and overlap the upper jaw tip 206 when the jaws are in a closed state. The upper jaw tip 206 and the lower jaw tip 198 may overlap along a tip interface 211. For example, distal end 2 of jaw ridge 208 of lower jaw 80 may overlap and slide against the proximal side of lower jaw tip 206. The upper jaw tip 206 can contact the lower jaw tip 198 at a tip interface 211, or there can be a gap between the upper jaw tip 206 and the lower jaw tip 198 at the tip interface 211.

The tip interface 211 can have a tip interface axis 214 relative to the jaw structure longitudinal axis 42. The tip interface axis 214 may intersect the jaw structure longitudinal axis 42 at a tip interface angle 212 of approximately 90 °.

At the tip interface 211, the upper jaw tip 206 can be distal to the lower jaw tip 198.

The distal end of the lateral jaw ridge 190 of the upper jaw 78 may or may not contact the distal end of the lateral jaw ridge 190 of the lower jaw 80 when the jaws are in the closed state.

Fig. 21a and 21b illustrate that the tip interface 211 can have a tip interface axis 214 relative to the longitudinal axis 42 of the jaw structure. At the tip interface 211, the lower jaw tip 198 may be distal to the upper jaw tip 206. The tip interface angle 212 may be about 30 ° to about 60 °, more narrowly about 30 ° to about 45 °, for example about 35 °.

Fig. 22a to 22c show that either the lower jaw tip 198 (as shown) or the distal end 2 of the upper jaw tip 206 may have a tip seat 216. The tip seat 216 is shaped to receive the shape of the opposing jaw tip. For example, the tip seat 216 may be triangular (e.g., A-shaped or V-shaped)

Tip seat 216 may surround the lateral and distal sides of upper jaw tip 206 when the jaws are in a closed state. When the jaws are in a closed position, the tip seat 216 may or may not contact the upper jaw tip 206 (i.e., there may be a gap).

The jaw lateral protuberance 190 of the jaw (bottom jaw 38, as shown) having a tip seat 216 may extend to the end of the lower jaw tip 198 and the tip seat 216. The jaw lateral protuberance 190 of the jaw (upper jaw 78, as shown) opposite the tip seat 216 may narrow to a point at the end of the corresponding jaw tip. The narrowed jaw lateral protuberance 190 can be received within the tip seat 216.

Fig. 23a and 23b show that the upper jaw 78 and/or the lower jaw 80 may have a circular or oval cross-section. The upper jaw 78 and/or the lower jaw 80 may be made of a solid or hollow column, for example, having a diameter of about 0.030 inches to about 0.100 inches, for example, about 0.060 inches.

The ends of the upper jaw tip and/or the lower jaw tip 198 may have a conical shape. The end of the lower jaw tip 198 may have a tip seat 216, and the tip seat 216 may have a shape that is the inverse or inverse of the conical shape, such as a size and shape suitable to receive the upper jaw tip 206.

Shuttle 14 may have a circular or elliptical cross-section.

The pusher may have a pusher spine similar to the shuttle fingers 156 and shuttle spine 160

Portion 218 extends a pusher finger 219. The pusher fingers 219 may be triangular.

Fig. 24a to 24c show that the distal end 2 of the device 188 may be inserted into a cannula 226 for deployment, e.g., percutaneously, through the cannula 226 inserted into the patient's body at a target site. The casing 226 may have a casing inner diameter 228. The casing inner diameter 228 may be about 4mm to about 8mm, such as 7mm, or 6.86mm (0.270 inch) or 15 French gauge (5mm (0.197 inch)).

Shuttle 14 may have a shuttle height 220. Shuttle height 220 may be about 0.020 inches to 0.060 inches, for example about 0.041 inches.

The gland 34 may be fitted to or integrated with one or more jaw control extensions 40. For example, the jaw control extension 40 may extend from the lateral distal end 2 of the gland 34. The jaw control extension 40 may be slidably mounted to or in contact with the jaws, directly or indirectly. The jaw control extension 40 can push the jaws away from each other when the jaw control extension 40 is proximally displaced relative to the jaws, and the jaw control extension 40 can push the jaws toward each other when the jaw control extension 40 is distally displaced relative to the jaws.

One or more upper cam pins 222 may extend laterally from one or both lateral sides of the proximal end of the upper jaw 78. One or more lower cam pins 232 may extend laterally from one or both lateral sides of the proximal end of the lower jaw 80 at the same or different longitudinal positions as the upper cam pins 222.

Jaw control extension 40 may have one or more upper cam slots 230 and one or more lower cam slots 224. The upper cam groove 230 and/or the lower cam groove 224 may be straight, curved, angled (as shown), or a combination thereof. The cam pins may be located within and pass through the corresponding cam slots. The cam pin may slide in the cam groove.

When jaw control extension 40 is displaced distally relative to the jaws, the camming pins can slide proximally within the corresponding camming slots and rotate the jaws away from each other. When jaw control extension 40 is proximally displaced relative to the jaws, the camming pin can slide distally within the camming slot and rotate the jaws toward one another.

The jaws may have a jaw extension length 234. The jaw extension length 234 may be the length from the distal end 2 of the jaw control extension 40 to the proximal side of the jaw tip. The jaw is in a closed state

The jaw extension length 234 may be about 5mm to about 30mm, such as about 16mm and 15.95 mm.

The jaws may have a straight jaw gap 236 along a straight section of the jaws. The straight jaw gap 236 may be about 1mm to about 3.5mm, such as about 1.1mm or about 3.2 mm. For example, the cannula inner diameter 228 can be 5mm and the straight jaw gap 236 can be about 1.1 mm.

The jaws may be discrete or may be integral to the jaw body. The jaws, which are integrated in the jaw body, can be rotationally deformed away from each other when moved to the open state.

Fig. 25 a-25 f illustrate that upper jaw tip 206 and/or lower jaw tip 198 can have a suture retainer slot 238. Suture retainer slot 238 can extend centrally along an outer surface of the corresponding jaw tip. Suture retainer slot 238 can extend from an outer surface of the jaw tip to a corresponding track. The suture retainer 18 can be entered through the suture retainer slot 238 or can extend out of the suture retainer slot 238. The suture 70 (not shown) may be fitted to the suture retainer 18 within or external to the suture retainer slot 238 or integrated with the suture retainer 18

The upper track 264 can terminate distally at the upper jaw tip shuttle port 240. The lower track 148 may terminate distally at a lower jaw tip shuttle port 256. Shuttles 14 may extend out of or into each shuttle 14 port and through each shuttle 14 port. During use, as the jaws are rotated to a closed position, a sharp shuttle tip 164 extending beyond the shuttle port can penetrate, cut and dissect tissue 74.

The upper jaw 78 and/or the lower jaw 80 may have jaw stops 242. Jaw stop 242 can be a feature, shape, or configuration configured to abut and block distal displacement of gland 34 relative to the jaws. For example, the distal end of gland 34 can abut jaw stop 242 when the jaws are in a closed state.

The radially inner surface of the jaws may have a radially inner ramp 250.

The upper jaw 78 and/or the lower jaw 80 may have jaw slides 244. Jaw slide 244 may be a radially outer surface of the jaws between jaw stop 242 and gland 34 when gland 34 is in a proximally retracted position 126 relative to the jaws and/or the jaws are in an open state. In a distal longitudinal direction, a radius of jaw slide 244 from jaw structure longitudinal axis 42 can increase (e.g., the greater the longitudinal dimension of jaw slide 244, the greater the radial dimension of jaw slide 244). When the gland is pressed

Upon displacement distally 138 relative to the jaws, the radially distal inner edge of gland 34 can slide along jaw slide 244 and press jaw slide 244 toward jaw structure longitudinal axis 42. The radial pressure transferred from the gland 34 to the jaw slide 244 creates a torque in the corresponding jaw that rotates the corresponding jaw toward the jaw structure longitudinal shaft 42 and the opposing jaw.

The device 188 may have a jaw control extension 40. The jaw control extension 40 can extend along a jaw structure longitudinal axis 42. The jaw control extension 40 may extend proximally of the jaw tip between the jaws. The jaw control extension 40 may terminate in a jaw control extension head 254.

The jaw control extension head 254 may have one or two lobes or cams. Each lobe may extend from a longitudinal axis of the jaw control extension 40 toward the jaws. The lobe may act similar to the opening ball shown in fig. 4a, 4d and elsewhere herein. The upper jaw 78 and the lower jaw 80 may have upper and inner jaw inward ramps 250, respectively. The internal ramp can be a radially inner surface of the jaw proximal to the tip of the jaw and distal to the head 254 of the jaw control extension when the jaw control extension 254 is in a proximally retracted position relative to the jaw. In a distal longitudinal direction, the radius of the radially inner ramp 250 from the jaw structure longitudinal axis 42 can increase (e.g., the greater the longitudinal dimension of the radially inner ramp 250, the greater the radial dimension of the radially inner ramp 250). As the jaw control extension 40 is proximally displaced or withdrawn relative to the jaws, the lobes may slide against the radially inner ramp 250 of the jaws and press the jaws apart from each other into an open state.

When the jaws are in the open state, gland 34 may be located at or proximally beyond the proximal end of jaw slide 244, and the jaw extension head may be located at or proximally beyond the proximal end of radially inner ramp 250.

Jaw control extension 40 can be mounted to control beam 248 or integrated with control beam 248. The control beam 248 may extend radially from one or both lateral sides of the jaw control extension 40, for example, in a plane at right angles to the plane defined by the opposing jaws or opposing extension head lobes 252.

The gland 34 may have a control beam groove 246. The control beam channel 246 may extend to the distal end of the gland 34. The control beam 248 may be fixed to the control beam slot 246 or may be longitudinally displaceable within the control beam slot 246. The control beam 248 may be interference fit mounted to, abut, or block the proximal end of the control beam slot 246, such as when the control beam 248 is in a proximal or distal longitudinal position relative to the jaws. The control beam 248 may move longitudinally in unison (i.e., in unison) with the gland 34 in the distal and/or longitudinal direction. Control beam 248 can move longitudinally in a distal and/or longitudinal direction in unison with jaw control extension 40.

Device 188 may have an upper socket arm 258 and a lower socket arm 270 radially inward of gland 34. Upper socket arm 258 and lower socket arm 270 may be a single integral element (e.g., a hollow cylinder) or separate elements. The upper socket arm 258 may be opposite the lower socket arm 270. The upper socket arm 258 may be displaceably secured to the lower socket arm 270 (i.e., mechanically assembled to displace in unison). The jaw control extension 40 may extend longitudinally between the upper and lower sleeved arms 258, 270 or within a hollow channel within a single sleeved arm (including the upper and lower sleeved arms 258, 270 as an integral element). The distal end of the socket arm may extend to the distal end of the gland 34 or proximally of the distal end of the gland 34 when the jaws are in the open state.

The proximal end of the upper jaw 78 may have a laterally elongated upper jaw support 262. The upper jaw support 262 can extend radially outward from a remainder of the proximal end of the upper jaw 78.

The distal end 2 of the upper socket arm 258 may have a laterally elongated upper jaw socket 260. Upper jaw socket 260 may be open centrally and have a diameter that is approximately equal to or slightly larger than the diameter of upper jaw support 262.

The upper jaw 78 hinge can have an upper jaw mount 262 and an upper jaw socket 260. The upper jaw 78 may rotate about a transverse axis of the upper jaw support 262. Upper jaw support 262 is rotatable within upper jaw socket 260.

The proximal end of the lower jaw 80 can have a laterally elongated lower jaw mount 266. A lower jaw mount 266 can extend radially outward from the remainder of the proximal end of the lower jaw 80.

The distal end 2 of the lower socket arm 270 may have a lower jaw socket 268 that is laterally elongated. Lower jaw socket 268 may be open centrally and have a diameter that is approximately equal to or slightly larger than the diameter of lower jaw mount 266.

The lower jaw 80 hinge can have a lower jaw mount 266 and a lower jaw socket 268. The lower jaw 80 can rotate about the transverse axis of the lower jaw mount 266. Lower jaw mount 266 can rotate within lower jaw socket 268.

The upper pusher 86 and/or the lower pusher 76 may have a full length or only the distal end 2, and the distal end 2 may have a hinge 286. The hinges 286 may rotate relative to each other about an axis perpendicular to the longitudinal axis of the respective pusher. The hinges 286 may be connected by discrete hinges, such as pins or snap connections, or may be transverse slots cut longitudinally coincident or alternating longitudinally on the pusher side similar to the shape of the shuttle transverse slots 158. The proximal end of one or both of the upper pusher 86 and the lower pusher 76 may have a continuous, non-segmented, flat, uniform strip of material.

The upper pusher 86 and/or the lower pusher 76 may each have a distal end that may have a shuttle seat 274. The shuttle seat 274 may be the inverse of the shape of the shuttle tip 164. For example, if the shuttle tip 164 has an angled end, the shuttle seat 274 may have a diagonal angle. If the shuttle tip 164 has a convex curved end, the shuttle seat 274 may have a concave curved end with the same radius of curvature as the shuttle tip 164.

Fig. 26a to 26d show that the gland 34 can be displaced distally relative to the jaws as indicated by the arrows. The gland 34 may transmit the displacement force to the control beam 248 via the edges of the control beam groove 246. Control beam 248 can transmit the displacement force to jaw control extension 40. The jaw control extension 40 may be distally displaced simultaneously with the gland 34 as indicated by the arrow. The gland 34 can be displaced 138 on the jaw slide 244 radially inward against the jaw slide 244. The jaw control extension head 254 may be moved distally relative to the jaws as indicated by arrow 280, e.g., to close the jaws without interference fit mounting or abutting the jaw control extension head 254. The upper jaw 78 and/or the lower jaw 80 may be rotated radially inward as indicated by the arrows.

When the jaws are in a closed state, gland 34 can be located at or adjacent to jaw stop 242 and the jaw extension head can be located at or proximally beyond the proximal end of radially inner ramp 250.

When the jaws are in the closed state, if the shuttle 14 is in the upper track 264, the upper pusher 86 can be displaced distally via the upper track 264. The distal end of the upper pusher 86 may abut the shuttle 14. The upper pusher 86 can then push the shuttle 14 out of the upper jaw tip shuttle port 240, via the upper track 264, and into the lower jaw tip shuttle port 256.

When the jaws are in the closed state, if the shuttle 14 is in the lower track 148, the lower pusher 76 can be displaced distally via the lower track 148. The distal end of the lower pusher 76 may abut the shuttle 14. The lower pusher 76 can then push the shuttle 14 out of the lower jaw tip shuttle port 256 and into the upper jaw tip shuttle port 240 via the lower track 148.

When the shuttle 14 is pushed from the upper track 264 toward the lower track 148 or vice versa, the shuttle 14 may be displaced along the path curve of the upper track 264 and the lower track 148 as indicated by arrow 282.

When the jaws are in the closed state, the shuttle 14 may be moved from the upper jaw 78 to the lower jaw 80, as indicated by the arrow, back to the upper jaw 78, and the action from the upper jaw 78 to the lower jaw 80 and optionally from the lower jaw 80 to the upper jaw 78 may be repeated one, two, or more times.

The device 188 may have a pusher lockout that may prevent the pusher and shuttle 14 from being displaced when the jaws are in the open state.

The device 188 can have a jaw lockout that can prevent the jaws from opening when one of the pushers extends out of the corresponding jaw tip shuttle port and/or when the shuttle 14 is in both the upper jaw 78 and the lower jaw 80.

Fig. 27 shows that the upper pusher 86 can be displaced distally relative to the jaws. The upper pusher 86 may be curvilinearly displaced along the upper track 264 as indicated by arrows 284 and 288. The distal end of the upper pusher 86 can exit out of and extend from the upper jaw tip shuttle port 240. A V-shaped (or a-shaped) or curved (e.g., U-shaped) shuttle seat 274 at the distal end of the upper pusher 86 may abut the V-shaped (or a-shaped) or curved (e.g., U-shaped) shuttle tip 164 at the end of the shuttle. The upper pusher 86 can push the shuttle 14 through the upper track 264, across the gap between the upper jaw tip shuttle port 240 and the lower jaw tip shuttle port 256, and into the lower track 148. Shuttle 14 may be displaced curvilinearly along the track as indicated by arrow 282.

The lower pusher 76 may have no or one lower pusher hinge (as shown) or may have multiple hinges similar to the upper pusher 86 in fig. 27.

Fig. 28 illustrates that the suture 70 can be tied or attached directly to the suture retainer 18, for example, as shown in fig. 13a and 13 b. Suture 70 may have a suture loop 162. The suture loop 162 may enclose the suture retainer 18.

Fig. 29 shows that the end of the upper jaw tip 206 can contact or have a tip gap 290 with the end of the lower jaw tip when the jaws are in a closed state. The tip gap 290 may be about 0 inches to about 0.020 inches, for example about 0.008 inches.

The shuttle 14 may have a shuttle width 292. The shuttle width 292 may be about 0.030 inches to about 0.100 inches, such as about 0.060 inches.

The shuttle 14 may be made of nickel titanium alloy (e.g., nitinol), stainless steel, other materials disclosed herein, or combinations thereof.

Fig. 30a, 30b, and 31 illustrate that a lever 106 or handle 104 can control the rotation and opening and closing of the jaws.

The handle 104 may have a handle pivot 302. The handle pivot 302 may be a rotatable pin joint in which the handle 104 may be rotatably mounted to the base 102. The handle 104 may rotate relative to the base 102 about a handle pivot 302.

Handle 104 may be mounted to socket arm and/or gland 34 (as shown). For example, the gland 34 may have radially and/or laterally extending cap pins 304. The cover pin 304 may be fitted to the jaw control extension 40. The handle 104 may have one or two drive ports 314 or rings 296 on opposite lateral sides of the gland 34. The cover pin 304 may extend through the drive ring 296.

Other socket arms (as shown) and the gland 34 that are not mounted to the handle 104 may be mounted to the base 102.

Pinching and rotating the handle 104 toward the base 102 may extend 138 the gland 34 and the jaw control extension 40 distally relative to the jaws or retract 126 the jaws proximally relative to the gland 34 and the jaw control extension 40. When the handle 104 is turned, the jaws may move toward an open state. For example, as the bottom of the handle 104 is rotated proximally toward the base 102, the drive ring 296 may rotate distally toward the jaws, pushing the cover pin 304 and the gland 34 distally. The drive ring 296 may force the gland 34 and/or the jaw control extension 40 to displace distally, e.g., close the jaws.

The proximal ends of upper socket arm 258 and lower socket arm 270 may be an integral element or may be fixedly mounted by socket arm support 300.

The proximal end of the upper pusher 86 may be fitted to or integral with the upper pusher 86 shaft and/or the upper pusher button 210 a. The proximal end of the lower pusher 76 may be fitted to or integral with the lower pusher rod and/or lower pusher button 210 b. The proximal and distal ends 2 of the upper and lower pusher buttons 210a, 210b may be above or below each other or side-by-side (e.g., left and right, as shown). The device 188 can be configured such that pressing (e.g., distally displacing) the upper pusher button 210a can advance the upper pusher 86 distally, while pressing (e.g., distally displacing) the lower pusher button 210b can advance the upper pusher 86 distally. Pressing the upper pusher button 210 may cause the lower pusher 76 and/or the lower pusher button 210b to retract proximally. Pressing the lower pusher button 210b may cause the upper pusher 86 and/or the upper pusher button 210 to retract proximally.

The inner sides of the distal end 2 of the upper and lower pusher buttons 210b may have an upper pusher button gear 310 and a lower pusher button gear 306, respectively. The upper pusher button gear 310 may face the lower pusher button gear 306.

The pusher toggle button 294 can be rotatably mounted to the base 102. The pusher toggle button 294 may be integral with the pusher toggle button gear 308 or rotatably secured to the pusher toggle button gear 308. The pusher toggle gear 308 is rotatably engaged and interdigitated with the upper pusher button gear 310 on a first side and the lower pusher button gear 306 on an opposite side of the upper pusher button gear 310.

When the upper pusher button is displaced distally 284, the upper pusher button gear 310 may rotate the pusher toggle gear, e.g., also rotate the top of the pusher toggle 294 to a position indicating that the upper pusher button 210a has been displaced distally 284. The top surface or perimeter of the top of the pusher toggle 294 can have an indicator, such as an arrow, that can indicate whether and how far the upper pusher 86 or lower pusher 76 has been displaced, such as indicating the position of the shuttle 14 in the upper track 264, lower track 148, extending out of one track, or extending across both tracks at the same time. The pusher toggle gear may simultaneously displace the lower pusher button gear 306 proximally. For example, when the upper pusher 86 is displaced distally, the lower pusher 76 may be simultaneously displaced proximally at the same speed.

When the lower pusher button 210b is distally displaced, the lower pusher button gear 306 may rotate the pusher toggle gear, e.g., also rotate the top of the pusher toggle button 294 to a position indicating that the upper pusher button 210a has been distally 284. The pusher toggle gear may simultaneously proximally displace the upper pusher button gear 310. For example, when the lower pusher 76 is displaced distally, the upper pusher 86 may be simultaneously displaced proximally at the same speed.

The pusher toggle button 294 can be rotated to displace the upper pusher 86 and the lower pusher 76 by transmitting a torque applied to the pusher toggle button 294 to the upper pusher button gear 310 and/or the lower pusher button gear 306 via the pusher toggle button gear 308, with or without pressing the proximal end of the pusher button.

Fig. 32a and 32b show that the pusher toggle button 294 can be rotated to displace the upper pusher 86 and the lower pusher 76 by transmitting a torque applied to the pusher toggle button 294 to the upper pusher button gear 310 and/or the lower pusher button gear 306 via the pusher toggle button gear 308, with or without pressing the proximal end of the pusher button.

The diameter of the pusher toggle 294 may be less than the width of the base 102 as shown in fig. 30a, 30b, and 31, or greater than the width and height of the base 102 and equal to or greater than the dimensions of the handle 104 and the gland 34 as shown in fig. 32a and 32 b.

In one variation of the method of use, the distal end 2 of the device 188 including the jaws may be inserted into a percutaneous cannula 226 when the jaws are in a closed state. When the distal end 2 of the device 188 exits the distal end 2 of the cannula 226 at the target site, the handle 104 may be released to rotate away from the base 102. Rotation of the handle away from the base 102 may move the jaws toward an open state. The distal end 2 of the device 188 may then be further positioned such that the target site is between the upper jaw distal tip 206 and the lower jaw distal tip 198. The handle 104 may then be grasped to rotate the handle 104 toward the base 102. Rotating the handle toward the base 102 may move the jaws to a closed state, squeezing the tissue 74 at the target site together. The shuttle 14 can be completely hidden into the jaws in which the shuttle 14 is loaded, or the shuttle tip 164 can extend beyond the jaws in which the shuttle is currently loaded. When the shuttle 14 is displaced, the shuttle tip 164 can penetrate the tissue 74 as or after the jaws are closed.

After the jaws are closed, either the upper pusher button 210a or the lower pusher button 210b (e.g., corresponding to the track on which the shuttle 14 is currently positioned) can be pressed, advancing the corresponding pusher distally. The corresponding pusher can press shuttle 14 distally via a gap between upper jaw 78 and lower jaw 80, if such a gap exists or, alternatively, directly from one jaw to the other. The shuttle 14 can pull the suture 70 to follow the path of the shuttle 14 or to follow a path adjacent the shuttle 14. When the corresponding pusher button is sufficiently depressed, the device 188 may emit an audible and/or tactile response (e.g., from the button or a snap or detent device in the pusher and track), and the pusher toggle 294 may have an indicator (e.g., a line or arrow) that the shuttle 14 has been sufficiently displaced across the jaws.

The handle 104 may then be rotated away from the base 102. For example, the handle 104 may be released and spring-driven to return to a position rotated away from the base 102. Turning the handle can shift the drive ring 296 proximally. The drive ring 296 may pull and displace the gland 34 and jaw control extension 40 proximally, opening the jaws.

The device 188 may then be repositioned such that the jaw tip is completely removed, for example if suturing is complete, or moved to adjacent the previous position for a new stitch. The handle 104 may then be squeezed, closing the jaws. The pusher button of the track on which the shuttle 14 is located can then be pressed. Shuttle 14 can then be moved to the opposite jaw, as described above, to pull suture 70 through tissue 74 and form a stitch.

The above process may be repeated as necessary to produce the desired stitch length and location.

Any or all of the elements of device 188 and/or other devices 188 or apparatus described herein may be made, for example, from the following materials: single or multiple stainless steel alloys, nickel titanium alloys (e.g., nitinol), cobalt chromium alloys (e.g., of elgold specialty metals, elgold, illinois, usaOf the metal company of capone, wyoming, U.S. Pa) Nickel-cobalt alloys (e.g., available from the Matricaria industrial trade company of Westebaud, Connecticut, USA)) Molybdenum, molybdenumAlloys (e.g., molybdenum TZM alloys), tungsten-rhenium alloys, polymers, such as polyethylene terephthalate (PET)/polyester (e.g., e.i. dupont, wilmington, tera, usa)) Polypropylene (PET), Polytetrafluoroethylene (PTFE), expanded PTFE (eptfe), Polyetherketone (PEK), Polyetheretherketone (PEEK), Polyetherketoneketone (PEKK) (also known as polyaryletherketoneketone), nylon, polyether block copolyamide polymers (e.g., from atorvastatin corporation, paris, france)) Aliphatic polyether urethanes (e.g., available from Thermedics Polymer products of Wilmington, Mass.)) Polyvinyl chloride (PVC), polyurethane, thermoplastics, Fluorinated Ethylene Propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), polylactic acid (PLA), Polycaprolactone (PCL), Polyethylacrylate (PEA), Polydioxanone (PDS), and pseudo-poly receptor tyrosine-based amino acids, extruded collagen, silicone, zinc, echogenic radio-opaque materials, biomaterials (e.g., cadaveric tissue 74, collagen, allograft, autograft, xenograft, bone cement, bone meal, osteogenic powder, bone beads), any other material listed herein, or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel titanium alloy, tantalum, and gold.

The shuttle 14 in the present disclosure may be fitted to the suture 70. Thus, the suture 70 can be fitted to the shuttle 14 and can follow the movement of the shuttle 14. Similarly, the suture 70 can be assembled and disassembled on the shuttle 14, for example, before the desired suture is completed and disassembled after completion.

it will be apparent to those skilled in the art that various changes and modifications may be made, and equivalents employed, without departing from the spirit and scope of the invention. The elements shown in variation are examples of particular variations and may be used on other variations within the present disclosure. Any element described herein as singular may be plural (i.e., plural as "a," "an," and "the" may be plural). Any element (species) of an element of a genus (genus) may have the characteristics or elements of any other element of the genus. The above-described compositions, elements or complete assemblies and methods, as well as elements for implementing the invention and aspects of the invention, may be combined and modified with respect to each other in any combination.