Method and apparatus for passing suture

Abstract

To provide system, methods and apparatus for enhancing advancement and retention of a suture through tissue.SOLUTION: A device is disclosed that pierces and holds tissue and then passes a suture through the tissue. The device has a shuttle that can removably attach to a suture and jaws opened and closed rotatably with respect to each other. A method for using the device to repeatedly pass the suture through the tissue without removing the suture or device from the target site is also disclosed.SELECTED DRAWING: Figure 6b

Description

[Technical Field]

[0001] This application claims the benefit of priority to U.S. Patent Application Publication No. 2013 / 0139999, filed April 17, 2013, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to systems, methods and devices for improving the advancement and retention of sutures through tissue. [Background technology]

[0003] Previous suturing devices have had elongated shafts and low-profile distal gripping mechanisms that facilitate use through a cannula 226 in less invasive procedures. These devices generally include opposing jaws that grip onto the tissue to be sutured. An end portion of the suture is pre-positioned and secured to the distal end of one of the jaw members. Beyond the gripping action, the mechanism for passing the suture between the jaws and through the tissue incorporates a bendable needle. The bendable needle is advanced distally within the jaw members, thereby coming into contact with the suture portion.

[0004] The needle engages and advances the suture, securing it. This distal advancement of the bendable needle causes the needle's leading end to closely engage the ramp 44 of the jaw member, which deflects the bendable needle toward the opposing jaw. Bending the needle requires a high force, leading to excessive strain on the needle's components. Crushing and breakage of the bendable needle are a concern.

[0005] Additionally, the bendable needle may continue to advance after being biased away from the jaws, potentially into unintended anatomy. Such needle extension is a safety concern. Even after the device has completed passing the suture through the tissue, the end portion of the suture must be removed by retracting the entire device from the cannula.

[0006] It would be advantageous to have a device that allows for the attachment and detachment of sutures without having to remove the device from the surgical site.

[0007] It would be advantageous to have a device that can repeatedly pass sutures through tissue (without detaching) without having to remove the device from the surgical site. It would also be advantageous for the mechanism for shuttling the suture (either the needle or shuttle) to be contained entirely within the device, improving the accuracy of suture placement during surgery and improving the security of the needle or shuttle position during surgery. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Provisional Patent Application No. 61 / 812,805 Summary of the Invention [Means for solving the problem]

[0009] Disclosed are devices and methods for passing sutures through soft tissue, such as a suture passer capable of performing multiple suture passes without retracting the suture passer from the target site during a rotator cuff reconstruction procedure.

[0010] The suture passing device can be made without a mechanical pivot link. The suture passing device does not have a hinge on the jaw structure. The jaw structure can open and close with a hingeless motion.

[0011] The sutures may be placed on the lateral sides of the jaw structure.

[0012] The shuttle that holds and moves the suture is captured and held within the jaws, eg, made with a design that has no loose parts that can detach from the device during use.

[0013] The jaws and / or shaft of the device, or the compressive covering, may be made of a resilient metal, such as, for example, Nitinol or other materials disclosed herein.

[0014] The device can repeatedly pass sutures through tissue without the need to remove the device from the surgical site or to attach or detach the sutures from the device. The mechanism for shuttling the suture (e.g., needle and / or shuttle) can be contained partially or completely within the device to improve the accuracy of suture placement during surgery and improve the security of the needle or shuttle position during surgery. [Brief explanation of the drawings]

[0015] [Figure 1a] FIG. 10 is a perspective view of a variation of the suture passing device. [Figure 1b] FIG. 10 is a top view of a variation of the suture passing device. [Figure 1c] FIG. 10 is a side view of a variation of the suture passing device. [Figure 2a] FIG. 10 is a perspective view of a shuttle variation in a linear configuration. [Figure 2b] FIG. 10 is an enlarged view of a variation of the shuttle in a linear configuration. [Figure 2c] FIG. 2c is a close-up view of a variation of the shuttle of FIGS. 2a and 2b in a curved configuration. [Figure 3a] FIG. 10 is a partially transparent enlarged perspective view of the distal end of a variation of the suture passing device with a single suture attached. [Figure 3b] FIG. 3b is an enlarged view of a portion of FIG. 3a. [Figure 4a] FIG. 10 is an enlarged side perspective view of the distal end of a variation of the suture passing device in a closed configuration. [Figure 4b] FIG. 10 is an enlarged side perspective view of the distal end of a variation of the suture passing device in a closed configuration. [Figure 4c] FIG. 4b is an enlarged view of the end of FIGS. 4a and 4b. [Figure 4d] FIG. 4b is an enlarged perspective view of the distal end of the device of FIG. 4a in a closed configuration. [Figure 5] 1b is a variation of cross section AA of FIG. 1a of a device with a single suture attached. [Figure 6a] 10 illustrates an example of a method for using a variation of the suture passing device to create a stitch in tissue. [Figure 6b]10 illustrates an example of a method for using a variation of the suture passing device to create a stitch in tissue. [Figure 6c] 10 illustrates an example of a method for using a variation of the suture passing device to create a stitch in tissue. [Figure 6d] 10 illustrates an example of a method for using a variation of the suture passing device to create a stitch in tissue. [Figure 7a] FIG. 10 is a side perspective view and close-up view of a variation of the device with an exploded view of the shuttle. [Figure 7b] FIG. 1 is a close-up view of the proximal end of the device. [Figure 7c] FIG. 7b is an enlarged view of a variant of the shuttle of FIG. 7a. [Figure 7d] FIG. 7b is an enlarged view of the distal end of a variation of the device shown in FIG. 7a. [Figure 8a] 10 illustrates a modified example of the shuttle. [Figure 8b] 10 illustrates an enlarged view of a variation of the distal end of the device. [Figure 9a] 1A-1C are side perspective views of various devices in an open configuration. [Figure 10a] 1A-1C are partially transparent side perspective views of various devices in an open configuration. [Figure 9b] 9b-9c are side perspective views of various methods of closing the jaws of the device of FIG. 9a. [Figure 11a] 9b-9c are side cross-sectional views of various methods of closing the jaws of the device of FIG. 9a. [Figure 9c] FIG. 9b is an enlarged view of the distal end of the device of FIG. 9b. [Figure 11b] FIG. 9c is a transparent view of the distal side of the device of FIG. 9b. [Figure 10b] FIG. 10b is a partially transparent view of an enlargement of the distal end of the mandible of FIG. 10a. [Figure 12a] FIG. 10 is a side view of a modified shuttle. [Figure 12b] FIG. 10 is a top view of a modified shuttle; [Figure 12c] FIG. 10 is a bottom view of a modified shuttle; [Figure 13a]10 illustrates a modified example of the shuttle. [Figure 13b] 10 illustrates a modified example of the shuttle. [Figure 14a] 10 shows the upper end of a modified shuttle. [Figure 14b] FIG. 10 is a top perspective view of a modified shuttle; [Figure 14c] FIG. 10 is a bottom perspective view of a modified shuttle; [Figure 15a] FIG. 10 is a side perspective view of a modified shuttle; [Figure 15b] FIG. 10 is a bottom perspective view of a modified shuttle; [Figure 15c] FIG. 10 is a side and bottom perspective view of a variation of the shuttle. [Figure 16a] FIG. 10 is a top perspective view of a modified shuttle; [Figure 16b] FIG. 10 is a side perspective view of a modified shuttle; [Figure 17a] 12a to 12c illustrate a variation of the shuttle-involving device; [Figure 17b] 17b illustrates a variation of the device of FIG. 17a with a pusher. [Figure 17c] 17b illustrates a variation of the device of FIG. 17a with two thrusters of different configurations. [Figure 17d] 17b illustrates a variation of the device of FIG. 17a with two thrusters of different configurations. [Figure 18a] FIG. 10 is a side perspective view of a variation of the distal end of the device. [Figure 18b] FIG. 10 is a side view of a variation of the distal end of the device. [Figure 19a] FIG. 10 is a side perspective view of a variation of the distal end of the device. [Figure 19b] FIG. 10 is a side view of a variation of the distal end of the device. [Figure 20a] FIG. 10 is a side perspective view of a variation of the distal end of the device. [Figure 20b] FIG. 10 is a side view of a variation of the distal end of the device. [Figure 21a] FIG. 10 is a side perspective view of a variation of the distal end of the device. [Figure 21b]FIG. 10 is a side view of a variation of the distal end of the device. [Figure 22a] 10 illustrates variations in the distal end of the device. [Figure 22b] 10 illustrates a variation of the mandible at the distal end of the device. [Figure 22c] FIG. 22b is a side view of the device of FIG. 22a with a shuttle. [Figure 23a] 10 is a variation of the distal end of the device in an open configuration. [Figure 23b] A variation of the distal end of the device in the closed configuration, the device of Figure 23b, has a shuttle. [Figure 24a] FIG. 10 is a side perspective view of a modified example of the device. [Figure 24b] FIG. 10 is a side view of a modified example of the device. [Figure 24c] FIG. 10 is an end view of the distal end of a variation of the device. [Figure 25a] Bottom and side perspective views of the distal end of a variation of the device with the jaws in an open configuration and the shuttle and thruster in various positions, partially transparent (upper jaw is transparent), enlarged and partially cut away longitudinal cross sections. [Figure 25b] Bottom and side perspective views of the distal end of a variation of the device with the jaws in an open configuration and the shuttle and thruster in various positions, partially transparent (upper jaw is transparent), enlarged and partially cut away longitudinal cross sections. [Figure 25c] Bottom and side perspective views of the distal end of a variation of the device with the jaws in an open configuration and the shuttle and thruster in various positions, partially transparent (upper jaw is transparent), enlarged and partially cut away longitudinal cross sections. [Figure 25d] Bottom and side perspective views of the distal end of a variation of the device with the jaws in an open configuration and the shuttle and thruster in various positions, partially transparent (upper jaw is transparent), enlarged and partially cut away longitudinal cross sections. [Figure 25e]Bottom and side perspective views of the distal end of a variation of the device with the jaws in an open configuration and the shuttle and thruster in various positions, partially transparent (upper jaw is transparent), enlarged and partially cut away longitudinal cross sections. [Figure 25f] 25f are bottom and side perspective views of the distal end of a variation of the device with the jaws in an open configuration and the shuttle and thruster in various positions, partially transparent (upper jaw is transparent), enlarged and partially cut-away longitudinal cross-sections. The compression cover is not shown in FIG. 25f for clarity of illustration. [Figure 26a] FIG. 10 is a side perspective view of a variation of the distal end of the device with the jaws in a closed configuration having a shuttle in the upper jaw and not engaged with the lower jaw. [Figure 26b] 26b is a longitudinal cross-sectional view of the device of FIG. 26a with shuttles in the upper and lower jaws, and in FIG. 26b the pushers are not shown for clarity of illustration. [Figure 26c] FIG. 26b is a side perspective view of the device of FIG. 26a with shuttles in the upper and lower jaws; [Figure 26d] FIG. 26c is a partial cutaway view. [Figure 27] FIG. 10 is an enlarged, partial cutaway view of the distal end of a variation of the device having a shuttle in the lower jaw and an upper thruster extending from the upper jaw and partially retracting into the lower jaw. [Figure 28] FIG. 13c is an enlarged end perspective view of a variation of the device with shuttle and suture of FIG. 13a or 13b. [Figure 29] FIG. 14B is an enlarged end perspective view of a variation of the shuttle and suture device of FIGS. 14a to 14c. [Figure 30a] FIG. 10 is a cutaway view of the right rear of a variation of the device. [Figure 30b] FIG. 10 is a left cutaway view of a variation of the device. [Figure 31] FIG. 10 is a partially cut-away, partially transparent view of the proximal end of a variation of the device. [Figure 32a] FIG. 10 is a left perspective view of a variant of the propeller drive gear of the device. [Figure 32b] FIG. 10 is a right perspective view of a variant of the propeller drive gear of the device. DETAILED DESCRIPTION OF THE INVENTION

[0016] 1a to 1c illustrate a suture passing device 188 that can be used to pass a suture 70 through soft or hard tissue 74 while creating one or more complete stitches, without removing the device 188 or the suture 70 from the target site.

[0017] The suture passing device 188 has an ergonomic handle 104, a sliding tube actuator 6, and a distal end 2. The ergonomic handle 104 can be used to control the distal end 2. The ergonomic handle 104 has a side knob 10. The ergonomic handle 104 has a top knob 12. The top knob 12 and / or the side knob 10 can individually or together advance and / or retract the upper and / or lower pushers 86 and / or 76.

[0018] The sliding tube actuator 6 has an outer compression cover 34 and an inner rod (not shown for closure of the outer compression cover 34). The inner rod is fixedly attached to the handle 104 and the proximal end of the jaw structure 28. The outer compression cover 34 may be radially outward of the inner rod. The outer compression cover 34 can be actuated by the handle 104 to translate distally and proximally relative to the handle 104, for example, when the trigger 8 is squeezed or released.

[0019] 2a and 2b illustrate an apparatus 188 having a sliding ribbon shuttle 14 or needle held within the apparatus 188. The shuttle 14 has an elongated shuttle rail 16. The shuttle rail 16 has a number of slits 20 along one or both sides of the shuttle rail 16. The slits 20 may be of regular or irregular length along the rail 16. can be arranged at intervals of

[0020] The shuttle 14 has a suture holder 18 extending laterally from the rail 16. The shuttle 14, e.g., the suture holder 18, extends from a lateral groove 72 on the side of the arm structure. The suture holder 18 extends from the left and / or right side of the device 188. The distal end 2 of the device 188 is reversible so 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 holder 18 has a generally planar isosceles tetragon configuration. The suture holder 18 has a suture retention notch 100. The notch 100 has an inner bore 17a, an outer bore 17b connected to the inner bore 17a, and a first cleat 97a located between the inner bore 17a and the outer bore 17b. The notch 100 can have a second cleat 97b on the side of the outer bore away from the inner bore. Notch 100 is configured to secure suture 70. For example, suture 70 is compressed and friction-fit within inner cleat 97a.

[0021] The suture holder 18 has a front leading edge and a rear leading edge. The edges may be angled at a right angle or a non-right angle relative to the longitudinal axis of the rail 16. One or both edges may be sharpened to cut tissue 74, such as soft tissue 74. The edges cut tissue 74, thereby allowing the suture holder 18 to pull the suture 70 through the tissue 74 immediately behind each edge.

[0022] The shuttle 14 may be made from a flexible polymer such as PEEK, a resilient metal such as Nitinol, a material disclosed herein, or a combination thereof. The shuttle 14 may be made from a molded polymer. The shuttle 14 may be pre-curved to reduce resistance when bending, for example, in a trajectory.

[0023] FIG. 2c illustrates that the rail 16 is curved at the location of the slit 20 and / or the rail 16 is pre-curved.

[0024] 3a and 3b illustrate that the suture passing device 188 captures or removably attaches the suture 70 to the internal and / or external cleats 97a and / or 97b of the suture holder 18. The suture 70 is loaded or held to the side of the jaw structure 28 by rotating the jaws out of plane. The device 188 creates passages of multiple sutures 70 through the tissue 74 without withdrawing or reloading the suture passing device 188. The jaw structure 28 is resiliently deformable to open at the proximal end of the jaw structure 28 without a hinge. The jaws open and / or close without a mechanical pivot or connection in the jaw structure 28.

[0025] 4a illustrates a suture passer device 188 having a jaw structure 28 with a top jaw 30 and a bottom jaw 38. The entire jaw structure 28 may be a single molded, cast, or cut piece of material, such as nitinol, other resilient metals or polymers, other materials described herein, or combinations thereof. The jaw structure 28 is configured to be in an open configuration (as shown in FIG. 4d) when in an unbiased configuration (i.e., when no external force is applied).

[0026] Jaw structure 28 has a jaw structure longitudinal axis 42. Each jaw also has a respective jaw longitudinal axis along the jaw.

[0027] The internal conduit of the compression cover 34 is sized and shaped to fit over the jaw structure 28 with minimal clearance when the jaw structure 28 is in a closed configuration. When the compression cover is translated distally 138 relative to the jaw structure 28 as shown by the arrow, the compression cover 34 can press the top and bottom jaws 38 toward the jaw structure longitudinal axis 42. The jaw structure 28 is shown in FIGS. 4a-4c. The shuttle is compressed into a fully closed configuration as shown in FIG. 3c. In this manner, when an actuation lever such as trigger 8 is actuated, the conduit or compression cover 34 can advance to cam the jaws closed. The jaws have previously penetrated the tissue, establishing a continuous trajectory for the shuttle to pass through the tissue.

[0028] A compression cover 34 is attached to the release ball 32 which is located between the first and second jaws.

[0029] 4b illustrates that the release ball 32 is rotatably or fixedly mounted on a ball axle 52 that passes laterally through the release ball 32. The ball axle 52 can extend outward from a lateral side of the ball 32. The ball axle 52 is slidably received by axle groove 50 formed in a distal arm 54 or extension 138 of the compression cover 34. When the jaw structure 28 is in the closed configuration, the ball axle 52 abuts and provides an interference fit against the proximal end of the axle groove 50 to, for example, prevent overextension of the compression cover 34 on the jaw structure 28. When the jaw structure 28 is in the open configuration, the ball axle 52 abuts and provides an interference fit against the distal end 2 of the axle groove 50 to, for example, prevent overrotation of the jaws and / or pull the ball 32 over a ramp 44 within the jaw structure 28.

[0030] 4c illustrates that the bottom track 66 terminates distally at the bottom track port 62. The top track 64 terminates distally at the top track port 60. The top track port 60 aligns with and abuts (as shown) or contacts the bottom track port 62 when the jaw structure 28 is in the closed configuration such that the first jaw end 46 intermates with the second jaw end 48. The tracks of the top jaw 78 and the bottom jaw 38 form a continuous path when the jaw structure 28 is in the closed configuration. The first jaw end 46 intermates with and abuts or contacts the second jaw end 48 when the jaw structure 28 is in the closed configuration.

[0031] 4d illustrates that the compressive cover 34 translates proximally 126 relative to the structure 28, as indicated by the arrow. The ball axle 52 slides into the distal end 2 of the axle groove 50. The axle groove 50 then pulls the ball axle 52, and thus the release ball 32, proximally. The release ball 32 then presses against the inner surface ramp 44 of the first and / or second jaw. The first and / or second jaw ends 46 and 48 rotate away from the opposing jaw ends. The jaw structure 28 is then in the open configuration, as shown.

[0032] The proximal ends of the jaws may be rigid or flexible, for example, to bend around the opening in the compressive cover 34 when the jaws are in the open configuration. All of the jaws or only the proximal ends of the jaws may be made from nitinol, for example, the distal ends of the jaws are made from stainless steel.

[0033] 5 illustrates that a lateral groove 72 extends laterally from one of the tracks. The rail 16 of the shuttle 14 is taller than the height of the lateral groove 72. The rail 16 is too large to pass through the lateral groove 72. The suture holder 18 extends laterally from the rail 16 through the lateral groove 72. The suture holder 18 holds the suture 70 laterally spaced away from the jaw.

[0034] FIG. 6 a illustrates the upper jaw 78 and lower jaw 80 closing, as indicated by the arrows, to compress tissue 74, such as soft tissue 74 in the rotator cuff or other joint. The upper jaw end 206 and / or lower jaw end 198 penetrate the tissue 74. The upper jaw end 206 and lower jaw end 198 interdigitate with or are adjacent to the tissue 74. The hole created by the contact or interdigitation of the upper jaw end 206 and / or lower jaw end 198 may be a hole in the tissue 74 through which the shuttle 14 and / or suture 70 can pass. A compression cover can further compress the first jaw distally 138 toward the second jaw, for example, forcing the jaw end to penetrate the tissue 74.

[0035] The lower pusher 76 can be advanced distally, as indicated by the arrow, controlled by the handle 104. The lower pusher 76 can push or urge the shuttle 14 through the track to move and carry the suture 70 distally on the shuttle 14.

[0036] 6b illustrates that the lower pusher 76 continues to be pushed by the handle 104. The lower pusher 76 pushes the shuttle 14 through the tissue 74. The leading blade 22 of the suture holder 18 cuts the tissue 74, allowing the suture holder 18 to pull the suture through the cutting surface made in the tissue 74 by the leading blade 22 and / or the perforation made in the tissue 74 by the edges of the jaws. The pusher and shuttle 14 move along the longitudinal axis of the jaws.

[0037] The shuttle 14 is then fully seated in the track of the upper jaw 78. The lower thruster 76 is then retracted from the track of the upper and / or lower jaw 80, and / or the lower thruster 76 is left in place but the resistance force is removed, allowing the lower thruster 76 to slide freely in the track.

[0038] 6c illustrates that the compressive cover is translated proximally 126 (e.g., by releasing or squeezing trigger 8), as indicated by arrow 83. Ball shaft 52 is pulled proximally, forcing release ball 32 against the interior surfaces of top and / or bottom jaws 38. Release ball 32 thus resiliently pries top and / or bottom jaws 38 open, and the jaws are then loosened (i.e., rotated open, as indicated by arrow 82) and disengaged from tissue 74.

[0039] The device 188 is moved from a position adjacent (eg, lateral) to the position where the distal end 2 of the device 188 first passed through the tissue 74 .

[0040] FIG. 6d illustrates the jaws being closed, penetrating the tissue 74 adjacent to the first passage of the suture 70 through the tissue 74. The upper pusher 86 is then pushed distally by the handle 104, as indicated by the arrow. The upper pusher 86 can push or urge the shuttle 14 along a trajectory in a direction opposite to the direction shown in FIGS. 6a and 6b. The trailing end 24 of the suture holder 18 cuts the tissue 74 as the suture holder 18 passes through the tissue 74, carrying the suture 70 through the tissue 74. In this manner, a dip stitch of the suture 70 through the tissue 74 is created.

[0041] As shown in FIG. 6a, the shuttle 14 is placed in position. The upper thruster 86 is then retracted from the track of the upper and / or lower jaw 80, and / or the upper thruster 86 is left in place but the resisting force is removed, allowing the upper thruster 86 to slide freely in the track. The jaws are reopened and repositioned, and the device 188 creates another stitch, repeating the method shown in FIGS. 6a through 6d. When the stitch is completed or a second stitch is to be created, the jaws are reopened and removed from the target site.

[0042] 7a illustrates device 188 having a base 102 and a handle 104 extending from base 102. Device 188 has a rotatable lever 106 rotatably attached to base 102 or handle 104. Device 188 has a compression cover 34 translatably attached to base 102 and extending distally therefrom.

[0043] The distal end 2 of the device 188 has upper and lower jaws 80. The upper jaw 78 is rotatable relative to the lower jaw 80 and vice versa.

[0044] A compression cover 34 is slidably attached to one or both jaws. Lever 106 is attached to compression cover 34. For example, squeezing and rotating lever 106 toward handle 104 can push the compression cover distally 138 against the jaws. The compression cover slides distally over the jaws, rotating upper jaw 78 toward lower jaw 80 and closing the jaws. Lever 106 is spring loaded to rotate away from handle 104, retracting compression cover 126 proximally and returning the jaws to the open configuration when external pressure or squeezing is no longer applied to lever 106.

[0045] FIG. 7b illustrates that the pusher shafts or buttons extend distally from the base 102 or handle 104. As indicated by the arrows, the pusher shafts or buttons translate relative to the base 102 and / or handle 104. The pusher shafts are configured to push and / or pull one or both of the pushers. Pushing or pulling the pusher shafts can translate the pushers. A single pusher shaft or button can be switched between both pushers.

[0046] A propeller toggle, such as a side paddle 112, extends from a lateral side of the base 102. The side paddle 112 is located on the top or bottom of the base 102 or the handle 104. As indicated by the arrow, the side paddle 112 can rotate 110 relative to the base 102. The side paddle 112 is configured to orient a propeller shaft or button for translating the upper propeller 86 or the lower propeller 76 according to the position of the side paddle 112.

[0047] The device 188 includes a lock 120 for the lever 106. The lock 120 for the lever 106 extends laterally from the base 102. As indicated by the arrow, the lock 120 can rotate 118 relative to the base 102. The lock 120 is configured to position or secure the lever 106 in a closed position or at a particular angular position relative to the base 102. For example, the lock for the lever 106 can close and secure the lever 106 to position the jaws in a closed configuration.

[0048] 7c illustrates that the shuttle 14 has rails 16, which are cylindrical tubes or sleeves. The rails 16 may be made of nylon, other materials disclosed herein, or combinations thereof. The rails 16 have longitudinal ends that are rounded (e.g., hemispherical) or flattened.

[0049] The shuttle 14 has a suture holder 18 that extends laterally from the rail 16 and may be a wire loop 98. The wire loop 98 comprises a wire. The wire loop 98 may extend in a flat surface. The end of the wire is removably or permanently attached and secured to the rail 16, for example, by a port or groove in the lateral side of the rail 16. While the suture 70 is held by the suture 70 passer, the suture 70 may extend through and remain in the area defined by the perimeter of the wire loop 98.

[0050] FIG. 7d illustrates that the lower jaw 80 (as shown) and / or the upper jaw 78 have one or more loading notches or docks 96. The loading docks 96 can expose a suture holder 18, such as a wire loop 98, for attachment and detachment of the suture 70. The suture holder 18 extends into the loading notch. For example, the wire loop 98 extends through the lateral groove 72 and into the retention notch 100, and the shuttle 14 is in position to attach and / or detach the suture 70 to and / or from the shuttle 14. For example, when the suture holder 18 is aligned with the loading dock 96, the shuttle 14 can be positioned most proximally of the shuttle 14 on the bottom track 66. The lateral grooves 72 terminate at the loading dock 96, providing an interference fit between the walls of the loading dock 96 and the shuttle 14 and / or the suture holder 18, e.g., to prevent further translation of the shuttle 14 proximally along the jaws.

[0051] The lower jaw 80 and / or upper jaw 78 may have a septum 90 covering the intermediate distal surface at the distal end 2 of the lower jaw 80 (as shown) and / or upper jaw 78. The septum 90 may be configured to seal around all or a portion of the shuttle 14 as the shuttle 14 passes through the septum 90. For example, the septum 90 may be made of a fabric or a solid panel of a polymer such as polyurethane or polyester.

[0052] The bulkhead 90 has a bulkhead rail port 92. The rail port 92 may be aligned with the ends of the bottom track 66 and / or the top track 64.

[0053] The septum 90 has a septum groove 94. The septum groove 94 may be aligned with the lateral grooves 72 of the bottom track 66 and / or the top track 264.

[0054] For example, to prevent or minimize tissue debris and fluids from entering the top and / or bottom tracks 66, the septum 90 is configured to wipe or wipe away tissue debris, such as tissue 74 and bodily fluids, from the shuttle 14 as the shuttle 14 passes through the septum 90.

[0055] Figure 8a illustrates a shuttle 14 having a rail 16 with a cylinder and a suture holder 18 as described in Figures 2b and 2c. The retention notch 100 has an angled cleat 97. The retention notch 100 extends into the rail 16.

[0056] 8b illustrates that when suture 70 is to be attached or removed from retention notch 100, shuttle 14 is positioned so that retention notch 100 of suture holder 18 is in loading dock 96. Suture 70 is pressed into retention notch 100 (e.g., to attach) or pulled from retention notch 100 (e.g., to remove, detach, or relocate). A pair of longitudinally opposed first cleats 97 laterally friction-fit or interference-fit with suture 70 at retention notch 100. A pair of longitudinally opposed second cleats 97 medially friction-fit or interference-fit with suture 70 at retention notch 100 (i.e., suture 70 can be radially secured between a pair of first cleats 97 on the sides of suture 70 and a pair of second cleats 97 on the medial side of suture 70).

[0057] The suture 70 is radially secured between a pair of longitudinally opposed cleats 97 which may dig, compress or puncture the outer surface of the suture 70 .

[0058] The shuttle 14 is interference-fit by the lower jaw 80 or is otherwise prevented from moving near a position where the retention notch 100 is exposed to the loading dock 96 .

[0059] 9a, 10a, and 10b illustrate the device 188 in an open configuration, with the upper jaw 78 positioned to rotate away from the lower jaw 80. The upper jaw 78 has a longitudinal upper jaw axis. The lower jaw 80 has a longitudinal lower jaw axis 132. The longitudinal lower jaw axis 132 (as shown) or the longitudinal upper jaw axis 124 is parallel to and / or collinear with the compressive cover longitudinal axis. The longitudinal upper jaw axis 124 and the longitudinal lower jaw axis 132 intersect at a jaw angle 128. When the jaws are in the open configuration, the jaw angle 128 is from about 30° to about 45°, more narrowly from about 30° to about 40°.

[0060] The compressive cover 34 is translated and retracted proximally, away from the jaws, as indicated by arrow 126. The upper jaw 78 has a groove slide pin 130 that can extend laterally from one or both lateral sides of the proximal end of the upper jaw 78.

[0061] The distal end 2 of the compressive cover 34 has one or more ramp grooves 134 on one or both lateral sides of the compressive cover 34. The ramp grooves 134 narrow as they extend proximally (i.e., widen as they extend distally). The ramp grooves 134 are at a non-zero angle (i.e., not in a straight line) with respect to the longitudinal axis of the compressive cover 34.

[0062] The groove slide pin 130 is configured to extend through the ramp groove 134. The groove slide pin 130 slides within the ramp groove 134. The groove slide pin 130 frictionally fits with the proximal end of the narrower ramp groove 134, for example, frictionally fits with the jaw in the closed configuration, providing tactile feedback to the user regarding the jaw angle 128.

[0063] 10a illustrates that the upper track passes through a hinge tube 149 to extend beyond the opening at the end of the compression cover 34 and into the upper jaw. The hinge tube 149 is made, for example, from Nitinol. The hinge tube 149 flexes when the upper jaw rotates. The hinge tube 149 may be an integral length throughout the upper track, or it may be a separate length of tubing attached to one or each remaining end of the upper track.

[0064] 9b and 11a illustrate that the compression cover 34 extends or advances distally relative to the jaws, as indicated by arrow 138. The compression cover 34 can urge the jaws to rotate toward each other into a closed configuration. For example, the lower jaw 80 can remain in a fixed position relative to the compression cover 34 while the upper jaw 78 rotates, as indicated by arrow 136, or vice versa, or the jaws can both rotate relative to the compression cover 34. In this manner, a lever, such as trigger 8, can act to advance the outer tube or compression cover 34, causing the jaws to cam closed.

[0065] When the jaws are in a closed configuration, the jaw angle 128 is from about 0° to about 3°, more narrowly from about 0° to about 2°, for example about 0°.

[0066] 9c and 11b illustrate that the upper jaw end 206 is pressed through and into the bulkhead rail port 92. The top or upper portion 264 forms a continuous lumen 152 in which the bottom or lower track 148, for example, the shuttle 14, can slide.

[0067] The grooves 72 in the upper jaw 78 can be aligned with the grooves 72 in the lower jaw 80. The suture holder 18 extends through the grooves 72 and holds the suture 70 in the grooves 72. As the shuttle 14 translates back and forth between the upper jaw 78 and the lower jaw 80, the suture holder 18 can translate the suture 70 back and forth between the upper jaw 78 and the lower jaw 80 in the grooves 72.

[0068] 12a-12c illustrate that the shuttle 14 is a rail 16, such as a shuttle needle 160, with lateral arms or fingers of the shuttle 14 extending laterally and / or medially from the shuttle needle 160. The shuttle fingers 156 extend laterally, downwardly, and centrally relative to the shuttle needle 160 as shown. The shuttle 14 has slits 20 or shuttle lateral grooves 158 between the shuttle fingers 156. The shuttle fingers 156 may be flexible or fixed.

[0069] The shuttle 14 has a shuttle longitudinal axis 157. The longitudinal axis 157 may be flat or curved and has a shuttle curve radius 154 of from about 3 mm to about 5 mm, more narrowly from about 3 mm to about 4 mm, for example about 3.5 mm.

[0070] The shuttle needle 160 may be flexible or rigid. The shuttle 14 may be fabricated from a single panel of material (e.g., metal), for example, by bending and laser cutting the panel.

[0071] The suture holder 18 may be one, two, or more circular, oval, or elongated flutes in the shuttle needle 160. For example, the suture 70 may be attached to one or both of the suture holders. 18. Suture 70 is fused to shuttle 14 adjacent suture holder 18. A detachable or fixed frame is attached to grooves in shuttle 14, and suture 70 is attached to the detachable frame. For example, the detachable frame may be an arc-shaped wire that is attached at a first end to a first groove in shuttle needle 160 and at a second end to an adjacent second groove in shuttle needle 160.

[0072] 13a illustrates that the suture holder 18 is an arcuate shape that is integral with the shuttle needle 160. For example, the shuttle 14 may be made from a single panel of material (e.g., metal). The lateral sides of the suture holder 18 may be cut off, leaving the longitudinal ends integral with the shuttle needle 160. The suture holder 18 is then bent or otherwise deformed away from the plane of the shuttle needle 160, e.g., to form an arcuate shape away from the plane of the shuttle needle 160.

[0073] The suture 70 has a suture loop 162 at the end of the suture 70. The suture loop 162 extends around and completely or partially circumscribes the suture holder 18. The remainder of the suture 70 is integral with or removably attached to the suture loop 162. The suture loop 162 may be circular or oval in shape.

[0074] 13b illustrates that the shuttle 14 has one or more shuttle notches 166 or cutouts. For example, the shuttle 14 has two shuttle notches 166 on each side of the shuttle. The shuttle notches 166 may be spaced longitudinally and disposed along the shuttle 14. The shuttle notches 166 are curved. The sides of the shuttle 14 other than the notches are straight.

[0075] The radius of the curve of the shuttle notch 166 is from about 1 mm to about 2 mm.

[0076] 14a to 14c illustrate that one or both longitudinal ends of the shuttle 14 are curved or sharpened shuttle tips 164. For example, the shuttle tips 164 may have a deflected chisel tip or a needle tip.

[0077] The shuttle holder has a holder leader 170 extending away from the shuttle needle 160. The end of the holder leader 170 remote from the shuttle needle 160 is a closed wire loop 98 configured to be attached to the suture 70. A loop neck 172, such as a double clamp, can secure a first end of a leader wire at an intermediate position on the holder leader 170, as shown. The second end of the holder leader 170 extends through the shuttle groove 174 and terminates in a leader anchor 168, e.g., a folded or crimped ball or disk having a diameter greater than the width of the shuttle groove 174, slidably attaching the suture holder 18 to the shuttle groove 174. The suture holder 18 is slidably captured in the shuttle groove 174 by the leader anchor 168.

[0078] The holder leader 170 may be translatably and / or rotatably fixed in the shuttle grooves 174, or may slide and / or rotate in the shuttle grooves 174. For example, when the shuttle 14 translates in a first direction (e.g., from the upper jaw 78 toward the lower jaw 80), the wire loop 98 extends beyond the first end of the shuttle needle 160, and when the shuttle 14 translates in a second direction (e.g., from the lower jaw 80 toward the upper jaw 78), the holder leader 170 passively rotates and translates.

[0079] Holder leader 170 can be rigid or flexible. For example, holder leader 170 can be made of stainless steel, other materials disclosed herein, or combinations thereof.

[0080] The suture 70 passes through and / or is tied to the wire loop 98. The wire loop 98 is at a height away from the shuttle needle 160. The wire loop 98 can extend proximally or distally beyond the end of the shuttle tip 164. For example, the suture 70 is attached to the wire loop 98 away from sharp edges to minimize the risk of cutting or damaging the suture 70.

[0081] 15a and 15b illustrate that the suture 70 is attached or fused directly to the shuttle needle 160 at the central suture attachments 176 on the longitudinal and lateral sides of the shuttle 14. The suture 70 may also be braided.

[0082] For example, the entire shuttle 14 may be made of plastic, molded or overmolded, or separately bonded to a plastic suture. The suture may be thermally formed to the shuttle 14. The suture 70 extends 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 attaches to the shuttle 14.

[0083] 16a and 16b illustrate that the leader or wire loop 98 extends partially or completely in a plane perpendicular to the plane of the shuttle needle 160. A first end of the wire loop 98 has a first leader anchor 184. A second end of the wire loop 98 has a second leader anchor 186. The shuttle needle 160 has a first shuttle flute 180 and a second shuttle flute 182. The shuttle flute 174 is elongated or circular. The wire loop 98 may be made of, for example, nitinol and / or steel and may be tied to a suture.

[0084] The wire loop 98 extends through the shuttle grooves 174. The first and second leader anchors are on the underside (e.g., the concave side or radially inner side) of the shuttle needle 160. The wire loop 98 is on the outside (e.g., the convex side or radially outer side) of the shuttle needle 160. One or both of the leader anchors 168 may or may not be fixed or integral to the shuttle needle 160 (e.g., melted or welded). One or both of the leader anchors 168 may or may not be slidably attached to the grooves. The wire loop 98 may be fixed or slide longitudinally relative to the shuttle needle 160.

[0085] Wire loop 98 may have a longitudinally symmetric or asymmetric (as shown) shape. For example, wire loop 98 may be arc-shaped (similar to the shape exhibited by suture holder 18 in FIGS. 13a and 13b) or may protrude asymmetrically toward one of the longitudinal shuttle ends (as shown).

[0086] 17a illustrates an apparatus 188 having a shuttle 14 in position across the upper jaw 78 and lower jaw 80. The jaws have jaw lateral ridges 190. Shuttle fingers 156 wrap around the jaw lateral ridges 190, e.g., to slidably attach the shuttle to the jaws. The jaw lateral ridges 190 at the ends of the upper 78 or uppermost jaw 30 and the bottom or lower jaw 80 align, e.g., when the jaws are in a closed configuration, so that the shuttle 14 can slide along the continuous ridge between the upper 78 and lower jaw 80.

[0087] 17b illustrates that the device 188 has a lower thruster 76 that is slidably mounted on a lateral jaw ridge 190 of the lower jaw 80. The lower thruster 76 can abut against the shuttle 14.

[0088] FIG. 17c shows a device 188 slidably mounted on a lateral ridge 190 of the jaw of the upper jaw 78. 1 illustrates an example of a lower jaw 80 having an upper thruster 86 that is configured to rotate in a straight line. The upper thruster 86 and / or lower thruster 76 are shaped like the shuttle 14. The shuttle 14 is forced into the straight section of the lower jaw 80. The shuttle 14 deforms to a straight configuration when forced into the straight section of the jaw and to a curved configuration when forced into the curved section of the jaw.

[0089] The pusher generally resembles shuttle 14 with fingers, longitudinal grooves, needles, and transverse grooves between the fingers. Multiple pushers may be used in parallel on a single device 188, for example, to deliver multiple sutures 70 to the same target site (e.g., when the pusher in Figures 17b through 17d is shuttle 14 and additional pushers are used).

[0090] 17d illustrates that the shuttle 14 is pushed by the lower thruster 76 onto the upper jaw 78, as shown. The lower thruster 76 can then retract onto the lower jaw 80.

[0091] 18a and 18b illustrate that the upper and / or lower jaws 80 each have a jaw needle 208. The jaw needle 208 extends centrally from the remainder of the jaw toward (as shown) or away from the longitudinal axis of the jaw control extension. For example, the jaw needle can extend from the remainder of the jaw to the distal end 2 of the jaw, where the jaw extends distally from the longitudinal extensions 191, 202 of the jaws, such that the jaws are closer to the mid-curved jaw extension at the center and at the respective jaw ends.

[0092] The jaws have jaw lateral ridges 190 or rails 16 as described herein. The jaws have a T-shaped cross section.

[0093] The shuttle 14 has shuttle fingers 156, each having a shuttle downward extension 196. The shuttle fingers 156 each have a shuttle lateral extension 192 extending laterally from a respective shuttle needle 160. The shuttle fingers 156 each have a shuttle downward extension 196 extending downward (e.g., toward the longitudinal axis of the jaw structure) from the lateral end of the lateral extension. The shuttle fingers 156 have a shuttle medial extension 194 extending inward from the shuttle downward extension 196. The shuttle needles 160 and / or the lateral, downward, and medial extensions slidably wrap around the lateral ridges 190 of the jaws.

[0094] The upper jaw end 206 and / or the lower jaw end 198 may have a rounded bevel (e.g., a needle tip), a chisel (e.g., beveled on opposing walls as shown in FIGS. 18a and 18b), a cone, a splotch, a diamond, a Tuohy needle, or a combination thereof (e.g., the upper jaw end 206 has a first end shape and the lower jaw end 198 has a second end shape). The bevels on the distal side of the jaws may have the same angle and length, or may have a smaller angle and a longer length than the bevels on the proximal side of the jaw ends.

[0095] The upper jaw end 206 has an end gap 290 or touches the lower end 198 when the jaws are in the closed configuration.

[0096] Figures 19a and 19b illustrate that the jaw needles 208 of one or both jaws terminate before the end or intermediate extension of the respective jaw.

[0097] The bevel on the proximal side of the jaw end may have a smaller angle and a longer length than the bevel on the distal side of the jaw end.

[0098] 20a and 20b illustrate an example in which the jaw needles 208 of the upper jaw 78 extend along the linear length of the upper jaw 78 and terminate at or proximal to the intermediate extension 204 or upper jaw end 206 of the upper jaw. A lateral jaw ridge 190 of the upper jaw 78 extends to the distal end of the upper jaw 78.

[0099] Jaw 208 of mandible 80 extends to the distal end of mandible 80 .

[0100] The lateral jaw ridge 190 of the mandible 80 extends along the linear length of the mandible 80 and terminates at or proximal to the intermediate extension 200 or mandibular tip 198 of the mandible.

[0101] When the jaws are in a closed configuration, the mandibular tip 198 is positioned proximally and can overlap the maxillary tip 206. The maxillary tip 206 and mandibular tip 198 overlap along an end junction 211. For example, the distal end 2 of the jaw needle 208 on the mandibular tip 80 can overlap and slide against the proximal side of the maxillary tip 206. The maxillary tip 206 can contact the mandibular tip 198 at the end junction 211, or there can be a gap between the maxillary tip 206 and the mandibular tip 198 at the end junction 211.

[0102] The end junction 211 has an end junction axis 214 relative to the jaw structure longitudinal axis 42. The end junction axis 214 intersects the jaw structure longitudinal axis 42 at an end junction angle 212 of approximately 90°.

[0103] The maxillary end 206 is distal to the mandibular end 198 at end junction 211 .

[0104] The distal ends of the lateral ridges 190 of the jaws of the upper jaw 78 may or may not contact the distal ends of the lateral ridges 190 of the jaws of the lower jaw 80 when the jaws are in the closed configuration.

[0105] 21a and 21b illustrate that end junction 211 has an end junction axis 214 relative to jaw structure longitudinal axis 42. Mandibular end 198 is distal to maxillary end 206 at end junction 211. End junction angle 212 is from about 30° to about 60°, more narrowly from about 30° to about 45°, for example, about 35°.

[0106] 22a-22c illustrate that the distal end 2 of the mandibular end 198 (as shown) or the upper jaw end 206 has an end seat 216. The end seat 216 is shaped to receive the shape of the opposing jaw end. For example, the end seat 216 may be triangular (e.g., A-shaped or V-shaped).

[0107] The end seat 216 surrounds the lateral and distal sides of the upper jaw end 206 when the jaws are in the closed configuration. The end seat 216 may or may not contact (i.e., there is a gap) the upper jaw end 206 when the jaws are in the closed configuration.

[0108] The lateral ridges 190 of the jaw with the end seat (bottom jaw 38 as shown) extend to the end of the lower jaw end 198 and end seat 216. The lateral ridges 190 of the jaw opposite end seat 216 (upper jaw 78 as shown) narrow to the end of the respective jaw end. The narrowed lateral ridges 190 of the jaw are received within end seat 216.

[0109] 23a and 23b illustrate that the upper portion 78 and / or lower jaw 80 have a circular or oval cross section. The upper portion 78 and / or lower jaw 80 are made from a solid or hollow rod having a diameter of about 0.030 inches to about 0.100 inches, for example, about 0.060 inches.

[0110] The end of the upper and / or lower jaw end 198 has a conical shape. The end of the lower jaw end 198 has an end seat 216, which may be an inverted or concave cone sized and shaped to receive the upper jaw end 206, for example.

[0111] The shuttle 14 has a circular or elliptical cross section.

[0112] The pusher has pusher fingers 219 extending from a pusher needle 218 similar to shuttle fingers 156 and shuttle needle 160. Pusher fingers 219 are triangular in shape.

[0113] 24a through 24c illustrate that the distal end 2 of the device 188 is inserted into a cannula 226, for example, for percutaneous deployment through the cannula 226 at a target site in a patient. The cannula 226 has an inner cannula diameter 228. The inner cannula diameter 228 is from about 4 mm to about 8 mm, such as 7 mm, or 6.86 mm (0.270 inches), or 15 French size (5 mm (0.197 inches)).

[0114] The shuttle 14 has a shuttle height 220. The shuttle height 220 is between about 0.020 inches and 0.060 inches, for example, about 0.041 inches.

[0115] The compression cover 34 may be attached to or integral with one or more jaw control extensions 40. For example, the jaw control extensions 40 extend from the lateral ends 2 of the compression cover 34. The jaw control extensions 40 are slidably attached to or contact the jaws, directly or indirectly. The jaw control extensions 40 push the jaws away from each other when the jaw control extensions 40 translate proximally relative to the jaws, and push the jaws toward each other when the jaw control extensions 40 translate distally relative to the jaws.

[0116] One or more upper cam pins 222 extend laterally from one or both sides of the proximal end of upper jaw 78. One or more lower cam pins 232 extend laterally from one or both sides of the proximal end of lower jaw 80 at the same or different vertical positions as upper cam pins 222.

[0117] The jaw control extension 40 has one or more upper cam grooves 230 and one or more lower cam grooves 224. The upper cam grooves 230 and / or lower cam grooves 224 may be straight, curved, angled (as shown), or a combination thereof. A cam pin is disposed within and through each cam groove. The cam pin can slide within the cam groove.

[0118] When the jaw control extensions 40 translate distally relative to the jaws, the cam pins slide proximally within their respective cam grooves, causing the jaws to rotate away from each other. When the jaw control extensions 40 translate proximally relative to the jaws, the cam pins slide distally within their cam grooves, causing the jaws to rotate toward each other.

[0119] The jaws have a jaw extension length 234. The jaw extension length 234 is the length from the distal end 2 of the jaw control extension 40 to the proximal side of the jaw end. The jaw extension length 234 is from about 5 mm to about 30 mm, for example, about 16 mm and 15.95 mm, when the jaws are in a closed configuration.

[0120] The jaws have a linear jaw gap 236 along their linear length. The linear jaw gap 236 is about 1 mm to about 3.5 mm, e.g., about 1.1 mm or about 3.2 mm. For example, the cannula inner diameter 228 is 5 mm and the linear jaw gap 236 is about 1.1 mm.

[0121] The jaws may be separate or integral with the jaw body, and when integral with the jaw body, the jaws may be rotatably deformed away from each other when moving to the open configuration.

[0122] 25a through 25f illustrate that the upper jaw end 206 and / or the lower jaw end 198 have suture holder grooves 238. The suture holder grooves 238 are located on the respective jaw ends. The suture holder grooves 238 extend centrally along the outer surface of the jaw end to their respective tracks. The suture holders 18 are accessible by extending through or from the suture holder grooves 238. The sutures 70 (not shown) are attached to or integral with the suture holders 18 within or outside the suture holder grooves 238.

[0123] The track 264 terminates distally at the maxillary end shuttle port 240. The lower track 148 terminates distally at the mandibular end shuttle port 256. A shuttle 14 extends from / to and through each shuttle 14 port. In use, a sharp shuttle tip 164 extending from the shuttle port can pierce, cut, and incise tissue 74 when the jaws are rotated to the closed configuration.

[0124] The upper jaw 78 and / or the lower jaw 80 includes a jaw stop 242. The jaw stop 242 is a feature, shape, or configuration that can abut and stop distal translation of the compressive cover 34 relative to the jaws. For example, the distal end of the compressive cover 34 abuts the jaw stop 242 when the jaws are in a closed configuration.

[0125] The radially inner surface of the jaw has a radially inner bevel 250 .

[0126] The upper jaw 78 and / or the lower jaw 80 has a jaw slide 244. When the compression cover 34 is in the proximally retracted position 126 relative to the jaws and / or the jaws are in the open configuration, the jaw slide 244 is the radially outer surface of the jaw between the jaw stop 242 and the compression cover 34. The radius of the jaw slide 244 increases in a distal longitudinal direction from the jaw structure longitudinal axis 42 (e.g., the larger the longitudinal dimension of the jaw slide 244, the larger the radial dimension of the jaw slide 244). When the compression cover translates distally 138 relative to the jaws, the radially inner distal end of the compression cover 34 slides along the jaw slide 244, urging the jaw slide 244 toward the jaw structure longitudinal axis 42. The radial compressive force applied from the compression cover 34 to the jaw slide 244 creates a torque in each jaw, rotating it toward the jaw structure longitudinal axis 42 and the opposing jaw.

[0127] The device 188 has a jaw control extension 40. The jaw control extension 40 extends along a jaw structure longitudinal axis 42. The jaw control extension 40 extends between the jaws proximal to the jaw end. The jaw control extension 40 terminates in a jaw control extension head 254.

[0128] The jaw control extension head 254 has one or two lobes or cams. Each lobe extends from the longitudinal axis of the jaw control extension 40 toward the jaw. The lobes can act similar to the open roller balls shown in FIGS. 4a, 4d and elsewhere herein. The upper jaw 78 and lower jaw 80 each have an upper and inner jaw radial internal bevel 250. When the jaw control extension head 254 is in a proximally retracted position relative to the jaw, the internal bevel is the radially inner surface of the jaw proximal to the jaw end and distal to the jaw control extension head 254. The radius of the radial internal bevel 250 increases in the distal longitudinal direction from the jaw structure longitudinal axis 42 (e.g., the greater the longitudinal dimension of the radial internal bevel 250, the greater the radial dimension of the radial internal bevel 250). When the jaw control extension 40 is translated proximally or retracted relative to the jaws, the lugs slide against the internal ramps 250 of the jaws, urging the jaws apart into an open configuration.

[0129] When the jaws are in the open configuration, the compression cover 34 is located on the jaw slide 244 or proximally beyond its proximal end, and the jaw extension head is located on the radial inner slope 250 or proximally beyond its proximal end.

[0130] The control extension 40 is attached to or integral with the control rail 248. The rules 248 extend radially from one or both sides of the jaw control extension 40, for example, in a plane perpendicular to the plane defined by the ledges 252 of the opposing jaws or opposing extension heads.

[0131] The compression cover 34 has a control rail groove 246. The control rail groove 246 extends to the distal end of the compression cover 34. A control rail 248 is fixed to or longitudinally translates within the control rail groove 246. The control rail 248 may, for example, be an interference fit, abut, or rest against the proximal end of the control rail groove 246 when the control rail 248 is in a proximal or distal longitudinal position relative to the jaws. The control rail 248 may move distally and / or longitudinally simultaneously (i.e., in unison) with the compression cover 34. The control rail 248 may move distally and / or longitudinally simultaneously with the jaw control extension 40.

[0132] The device 188 has an upper socket arm 258 and a lower socket arm 270 radially within the compression cover 34. The upper socket arm 258 and the lower socket arm 270 may be a single, integral element (e.g., a hollow cylinder) or separate elements. The upper socket arm 258 is opposite the lower socket arm 270. The upper socket arm 258 is translatably fixed to the lower socket arm 270 (i.e., mechanically attached for simultaneous translation). The jaw control extension 40 extends longitudinally between the upper and lower socket arms 258 and 270 or within a hollow conduit within the integral socket arm (which includes the upper and lower socket arms 258 and 270 as integral elements). The distal ends of the socket arms extend to or are proximal to the distal end of the compression cover 34 when the jaws are in the open configuration.

[0133] The proximal end of the upper jaw 78 has a transversely elongated upper jaw bearing 262. The upper jaw bearing 262 extends radially outward from the remainder of the proximal end of the upper jaw 78.

[0134] The distal end 2 of the upper socket arm 258 has a transversely elongated upper jaw socket 260. The upper jaw socket 260 is open in the middle and has a diameter approximately equal to or slightly larger than the diameter of the upper jaw bearing 262.

[0135] The hinge of the upper jaw 78 includes an upper jaw bearing 262 and an upper jaw socket 260. The upper jaw 78 rotates about the left-right axis of the upper jaw bearing 262. The upper jaw bearing 262 rotates in the upper jaw socket 260.

[0136] The distal end of mandible 80 has a transversely elongated mandible bearing 266. Mandible bearing 266 extends radially outward from the remainder of the proximal end of mandible 80.

[0137] The distal end 2 of the lower socket arm 270 has a laterally elongated mandibular socket 268. The mandibular socket 268 is open in the middle and has a diameter approximately equal to or slightly larger than the diameter of the mandibular bearing 266.

[0138] The hinge of the lower jaw 80 includes a lower jaw bearing 266 and a lower jaw socket 268. The lower jaw 80 rotates about the left-right axis of the lower jaw bearing 266. The lower jaw bearing 266 rotates in the lower jaw socket 268.

[0139] The upper 86 and / or lower thrusters 76 have an entire length or only an end 2 with articulated portions 286. The articulated portions 286 can rotate relative to one another about axes perpendicular to the longitudinal axis of each thruster. The articulated portions 286 are connected by separate hinges (e.g., pin or snap connections) or are longitudinally coincident or longitudinally alternating side grooves cut into the sides of the thrusters similar in shape to the shuttle side grooves 158. The proximal ends of either or both of the upper and lower thrusters 86 and 76 comprise a continuous, undivided, flat, uniform ribbon of material.

[0140] The upper and lower thrusters 86, 76 each have a distal end with a shuttle seat 274. The shuttle seat 274 is the inverse of the shape of the shuttle end 164. For example, if the shuttle end 164 has an angled end, the shuttle seat 274 will have a diagonal. If the shuttle end 164 has a convex curved end, the shuttle seat 274 will have a concave curved end with the same radius of curvature as the shuttle end 164.

[0141] 26a through 26d illustrate that the compression cover 34 translates distally relative to the jaws, as indicated by the arrows. The compression cover 34 provides a translational force to the control rail 248 through the end of the control rail groove 246. The control rail 248 provides a translational force to the jaw control extension 40. The jaw control extension 40 can translate distally in parallel with the compression cover 34, as indicated by the arrows. The compression cover 34 translates 138 over the jaw slide 244 and presses radially onto the jaw slide 244, as indicated by arrow 280. The jaw control extension head 254 moves distally relative to the jaws, for example, to close the jaws without an interference fit or abutment against the jaw control extension head 254. The upper jaw 78 and / or lower jaw 80 rotate radially, as indicated by the arrows.

[0142] When the jaws are in a closed configuration, the compression cover 34 is positioned at or adjacent to the jaw stop 242 and the jaw extension head is positioned at or proximally beyond the proximal end of the radial internal slope 250.

[0143] When the jaws are in a closed configuration, if the shuttle 14 is in the upper track 264, the upper thruster 86 can translate distally in the upper track 264. The distal end of the upper thruster 86 abuts the shuttle 14. The upper thruster 86 then pushes the shuttle 14 through the upper track 264 from the maxillary end shuttle port 240 to the mandibular end shuttle port 256.

[0144] When the jaws are in a closed configuration, if the shuttle 14 is in the lower track 148, the lower thruster 76 can translate distally in the lower track 148. The distal end of the lower thruster 76 abuts the shuttle 14. The lower thruster 76 then pushes the shuttle 14 through the lower track 148 from the mandibular end shuttle port 256 to the maxillary end shuttle port 240.

[0145] When the shuttle 14 is pushed from the upper track 264 to the lower track 148 or vice versa, the shuttle 14 follows the path of the upper track 264 and the lower track 148, translating 282 in a curve, as shown by the arrows.

[0146] When the jaws are in a closed configuration, the shuttle 14 moves, as indicated by the arrows, from the upper jaw 78 to the lower jaw 80, back to the upper jaw 78, repeats the movement from the upper jaw 78 to the lower jaw 80, and can optionally move from the lower jaw 80 to the upper jaw 78 once, twice, or more times.

[0147] The device 188 has a thruster guard that prevents translation of the thrusters and shuttle 14 when the jaws are in the open configuration.

[0148] The device 188 has jaw protection that prevents the jaws from opening when either of the thrusters extend from the respective jaw end shuttle ports and / or when the shuttle 14 is parallel to the upper and lower jaws 78, 80.

[0149] 27 illustrates the distal translation of the upper thruster 86 relative to the jaws. As indicated by arrows 284 and 288, the upper thruster 86 moves in a curvilinear fashion along the upper track 264. The distal end of the upper thruster 86 emerges from and extends from the maxillary end 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 thruster 86 abuts the V-shaped (or A-shaped) or curved (e.g., U-shaped) shuttle end 164 at the end of the shuttle. The upper thruster 86 pushes the shuttle 14 through the upper track 264 across the gap between the maxillary end shuttle port 240 and the mandibular end shuttle port 256 and into the lower track 148. The shuttle 14 translates 282 along the track in a curved manner, as indicated by the arrow.

[0150] The lower thruster 76 may or may not have an articulated lower thruster section (as shown), or may have multiple articulated sections similar to the upper thruster 86 of FIG.

[0151] Figure 28 illustrates that a suture 70 may be knotted or directly attached to the suture holder 18, for example as shown in Figures 13a and 13b. The suture 70 has a suture loop 162. The suture loop 162 circumscribes the suture holder 18.

[0152] 29 illustrates that when the jaws are in a closed configuration, the edge of the upper jaw end 206 meets or has an edge gap 290 to the edge of the lower jaw end. The edge gap 290 is from about 0 inches to about 0.020 inches, for example, about 0.008 inches.

[0153] The shuttle 14 has a shuttle width 292. The shuttle width 292 is from about 0.030 inches to about 0.100 inches, for example, about 0.060 inches.

[0154] The shuttle 14 may be made from a nickel titanium alloy (eg, Nitinol), stainless steel, other materials disclosed herein, or combinations thereof.

[0155] Figures 30a, 30b and 31 illustrate that a lever 106 or handle 104 controls the rotation and opening and closing of the jaws.

[0156] The handle 104 has a handle pivot 302. The handle pivot 302 is a rotatable pin joint that rotatably attaches the handle 104 to the base 102. The handle 104 rotates about the handle pivot 302 relative to the base 102.

[0157] The handle 104 is attached to the socket arm and / or compression cover 34 (as shown). For example, the compression cover 34 has radially and / or laterally extending cover pins 304. The cover pins 304 are attached to the jaw control extensions 40. The handle 104 has one or two delivery ports 314 or loops 296 on opposite sides of the compression cover 34. The cover pins 304 can extend through the delivery loops 296.

[0158] The other of the socket arms (as shown) and the compression cover 34 that is not attached to the handle 104 are attached to the base 102 .

[0159] Squeezing and rotating the handle 104 toward the base 102 extends 138 the compression cover 34 and jaw control extension 40 relative to the jaws or retracts 126 the forehead proximally relative to the compression cover 34 and jaw control extension 40. When the handle 104 is rotated, the jaws can move to an open configuration. For example, when the bottom of the handle 104 is rotated proximally toward the base 102, the delivery loop 296 rotates distally toward the jaws, pushing the cover pin 304 and compression cover 34 distally. The delivery loop 296 can translate the compression cover 34 and / or jaw control extension 40 distally, for example, to push the jaws closed.

[0160] The proximal end of the upper socket arm 258 and the proximal end of the lower socket arm 270 may be a unitary element or may be fixedly attached by a socket arm fixator 300 .

[0161] The distal end of the upper pusher 86 is attached to or integral with the upper pusher 86 shaft and / or upper pusher button 210a. The distal end of the lower pusher 76 is attached to or integral with the lower pusher shaft and / or lower pusher button 210b. The distal ends of the upper pusher button 210a and the lower pusher button 210b are one above the other or side by side (e.g., side to side as shown). The device 188 is configured such that pressing (e.g., translating distally) the upper pusher button 210a advances the upper pusher 86 distally, and pressing (e.g., translating distally) the lower pusher button 210b advances the upper pusher 86 distally. Pressing the upper pusher button 210a retracts the lower pusher 76 and / or the lower pusher button 210b proximally. Pressing lower pusher button 210b retracts upper pusher 86 and / or upper pusher button 210 proximally.

[0162] At the medial side of the ends 2 of the upper and lower pusher buttons 210b are respectively an upper pusher button gear 310 and a lower pusher button gear 306. The upper pusher button gear 310 faces the lower pusher button gear 306.

[0163] The pusher toggle knob 294 is rotatably mounted to the base 102. The pusher toggle knob 294 is integral with or rotationally fixed to a pusher toggle knob gear 308. The pusher toggle knob gear 308 rotatably mates and interfits with an upper pusher button gear 310 on a first side and a lower pusher button gear 306 on an opposite side of the upper pusher button gear 310.

[0164] When the upper pusher button translates distally 284, the upper pusher button gear 310 rotates the pusher toggle gear, for example, to rotate the top of the pusher toggle knob 294 to a position indicating that the upper pusher button 210a has translated distally 284. The top surface or upper periphery of the pusher toggle knob 294 has an indicator, such as an arrow, indicating whether the upper pusher 86 or the lower pusher 76 has translated and how far, e.g., indicating the position of the shuttle 14 extending from either track in the upper track 264, the lower track 148, or across both tracks simultaneously. The pusher toggle gear simultaneously translates the lower pusher button gear 306 proximally. For example, if the upper pusher 86 translates distally, the lower pusher 76 can simultaneously translate proximally at the same rate.

[0165] When the lower pusher button 210b translates distally, the lower pusher button gear 306 rotates the pusher toggle gear, for example, can rotate the top of the pusher toggle knob 294 to a position indicating that the upper pusher button 210a has translated distally 284. The pusher toggle gear simultaneously translates the upper pusher button gear 310 proximally. For example, when the lower pusher 76 translates distally, the upper pusher 86 can simultaneously translate proximally at the same rate.

[0166] The thruster toggle knob 294 can rotate to translate the upper thruster 86 and the lower thruster 76 by transmitting torque applied to the thruster toggle knob 294 through the thruster toggle knob gear 308 to the upper thruster button gear 310 and / or the lower thruster button gear 306, with or without depression of the distal end of the thruster button.

[0167] 32a and 32b show that the pusher toggle knob 294 rotates to translate the upper pusher 86 and the lower pusher 76 by transmitting torque applied to the pusher toggle knob 294 through the pusher toggle knob gear 308 to the upper pusher button gear 310 and / or the lower pusher button gear 306, with or without depression of the distal end of the pusher button. This is an example of what can be done.

[0168] The diameter of the pusher toggle knob 294 may be smaller than the width of the base 102 as shown in FIGS. 30a, 30b, and 31, or may be larger than the width and height of the base 102 as shown in FIGS. 32a and 32b, and may be the same size as or larger than the handle 104 and compression cover 34.

[0169] In a variation of the method of use, the distal end 2 of the device 188, including the jaws, is inserted through the percutaneous cannula 226 with the jaws in a closed configuration. When the distal end 2 of the device 188 exits the cannula 226 at the target site, the handle 104 is released to rotate it away from the base 102. Rotating the handle away from the base 102 moves the jaws to an open configuration. The distal end 2 of the device 188 is then positioned further away so that the target site is between the upper jaw distal end 206 and the lower jaw distal end 198. The handle 104 is squeezed to rotate the handle 104 toward the base 102. Rotating the handle toward the base 102 moves the jaws to a closed configuration, clamping tissue 74 together at the target site. The shuttle 14 either fully enters the jaw to which it is attached, or the shuttle end 164 extends out of the jaw to which it is currently attached. The shuttle tip 164 can penetrate the tissue 74 as the jaws close or after the jaws close when the shuttle 14 translates.

[0170] After the jaws close, the upper 210a or lower pusher button 210b (e.g., whichever shuttle 14 is currently in) is pressed, advancing the respective pusher distally. Each pusher can push the shuttle 14 distally through the gap between the upper and lower jaws 78 and 80, if a gap exists, or directly from one jaw to the other. The shuttle 14 pulls the suture 70 to follow the path of the shuttle 14 or a path adjacent to the shuttle 14. When the respective pusher button is fully depressed, the device 188 emits an audible and / or tactile response (e.g., from a snap or detent in the button or pusher and track), and the pusher toggle knob 294 has an indicator (e.g., a line or arrow) that shows that the shuttle 14 has fully translated across the jaws.

[0171] The handle 104 is then rotated away from the base 102. For example, the handle 104 is released and spring loaded to return to the rotated position away from the base 102. Rotating the handle can translate the delivery loop 296 proximally. The delivery loop 296 pulls and translates the compression cover 34 and jaw control extension 40 proximally, opening the jaws.

[0172] The device 188 is then moved to another location, for example, by removing the jaw end entirely if the stitch is completed, or moved adjacent to the previous location to create a new stitch. The handle 14 is then squeezed to close the jaws. The pusher button on the track in which the shuttle 14 is positioned is then pressed. As described above, the shuttle 14 moves toward the opposing jaw, pulling the suture 70 through the tissue 74 to form the stitch.

[0173] The above method is repeated as necessary to create the desired stitch length and location.

[0174] Device 188 and / or any or all elements of other devices 188 or devices described herein may be made of, for example, a single or composite stainless steel alloy, a nickel titanium alloy (e.g., Nitinol), a cobalt chromium alloy (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Illinois; CONICHROME® from Carpenter Metals, Wyomissing, Pennsylvania), a nickel cobalt alloy (e.g., Magel® from Westport, Connecticut), or a titanium alloy (e.g., Nitinol® from ... Other examples of suitable materials include polymers such as MP35N® from Ian Industrial Trading Company, molybdenum alloys (e.g., molybdenum TZN alloy), tungsten-rhenium alloys, polymers such as polyethylene terephthalate (PET) / polyester (e.g., DACRON® from EI DuPont de Nemours and Company, Wilmington, Delaware), polypropylene (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), polyether ketone ketone (PEKK) (also polyaryl ether ketone ketone), nylon, polyether block copolyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., Thermedics Polymer, Wilmington, Massachusetts), and the like. The implant may be made from any or a combination of materials including absorbable or resorbable polymers such as TECOFLEX® (Products), polyvinyl chloride (PVC), polyurethane, thermoplastics, fluorinated ethylene propylene (FEP), such as polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudopolyaminotyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, biocompatible materials (e.g., cadaveric tissue 74, collagen, allograft, autograft, xenograft, bone cement, ground bone, osteogenic powder, bone beads), and other materials described herein. Examples of radiopaque materials include barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum, and gold.

[0175] Throughout this disclosure, the shuttle 14 is attached to a suture 70. Thus, the suture 70 is attached to the shuttle 14 and is capable of tracking the movement of the shuttle 14. Similarly, the suture 70 may be attached to or detached from the shuttle 14, for example, before and after the desired stitch or suture is completed.

[0176] It will be apparent to those skilled in the art that various changes and modifications may be made to the present disclosure and equivalents employed without departing from the spirit and scope of the present invention. Elements denoted by a variant are exemplary of a particular variant and may be used in other variants within the scope of the present disclosure. Elements described in the singular herein may be pluralized (i.e., "one" may refer to one or more). Elements of a species within a genus may possess features or elements of other species within that genus. The above-described configurations, elements or complete assemblies, and methods and elements thereof for carrying out the present invention, and variations of aspects of the present invention, may be combined and modified with each other in any combination.

Claims

1. a jaw structure having a longitudinal axis, the jaw structure including a first jaw portion and a second jaw portion; an opening element between the first jaw and the second jaw, the opening element configured to generate an outward force against the first jaw when the opening element translates in a direction along a longitudinal axis of the jaw structure; and a closure element configured to compress the first jaw toward the second jaw when the closure element translates relative to the jaw structure.

2. The device of claim 1 , wherein the opening element includes a ball positioned in contact with the first jaw.

3. The device of claim 2 , wherein the closure element comprises a compressible cover slidable along a longitudinal axis of the jaw structure.

4. a jaw structure having a longitudinal axis and a side surface, the jaw structure having a groove through the side surface at least the length of the jaw structure; and a suture holder extending laterally from said channel.

5. The device of claim 4 , wherein the suture holder has a first end finish surface in a first longitudinal direction and a second end finish surface in a second longitudinal direction.

6. The device of claim 5 , wherein the first end of the longitudinal suture holder is sufficiently traumatic to cut soft tissue.

7. The device of claim 6 , wherein the second end of the longitudinal suture holder is sufficiently traumatic to cut soft tissue.

8. 5. The device of claim 4, wherein the suture holder is mounted on a flexible rail, the rail being slidably mounted to the jaw structure, the jaw structure having a first jaw and a second jaw, the rail being slidable along a longitudinal axis of the first jaw.

9. a jaw structure including a first jaw and a second jaw, the first jaw having a first jaw end 46 and the second jaw having a second jaw end, the first jaw end 46 configured to intermate with the second jaw end, and an end point of the first jaw and an end point of the second jaw end being sharpened; and a suture holder;

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