Orthopedic suture passer and method

[0001] This application claims the benefit of U.S. Provisional Application No. 61/568,137, filed Dec. 7, 2011, U.S. Provisional Application No. 61/505,992, filed Jul. 8, 2011, U.S. Provisional Application No. 61/506,000, filed Jul. 8, 2011, U.S. Provisional Application No. 61/506,004, filed Jul. 8, 2011, all of which are herein incorporated by reference.

[0002] The invention relates to devices and methods to pass a suture through material such as, for example, body tissues of a surgical patient and in particular for passing a suture through a bone tunnel in an orthopedic surgical procedure.

[0003] Various conditions affecting a patient may require surgical intervention involving passing a suture for example to repair a tear, repair an incision, pass grafts, attach grafts, and anchor implants. Various suture passers have been proposed. There is a need for an improved suture passer.

[0004] The present invention provides a suture passer and method to pass a suture through material during a surgical intervention.

[0005] In one aspect of the invention, a suture passer includes a suture retriever and a suture. The suture retriever includes a receiver operable to receive and retain the suture and the suture includes a portion receivable and retained by the receiver. The suture may be received and maintained by way of a stopper, adhesion, hook and loop engagement, wedging, grasping, or other suitable mechanism. For example, the receiver may include an opening and the suture may include a stopper insertable into the opening. The opening may include a hole, slot, groove, notch, or other opening. The opening may extend through a portion of the receiver to define a passage through the portion of the receiver. The stopper may include a hook, barb, pledget, knot, plug, toggle, or other stopper. The receiver may receive the stopper by resilient deformation of the stopper or receiver, by changing orientation of the stopper from a receivable orientation to a retention orientation, or by other reception mechanism. In another example, the retriever includes a movable first member mounted for movement relative to a second member and movable between a first position in which the suture is receivable between the members and a second position in which the suture is grasped by the members.

[0006] The portion of the suture receivable by the receiver may be an end of the suture, a bight of the suture, or any other portion of the suture.

[0007] In another aspect of the invention, a suture passer includes a suture retriever and a suture and the suture retriever further includes a guide for guiding the suture into engagement with the suture receiver.

[0008] In another aspect of the invention, a suture passer includes a suture retriever and a suture and the suture retriever further includes a guide for guiding a cutter to form an opening in material through which the suture is passed. The guide may include a notch, groove, eye, tube, slot, rail, or other suitable guiding member able to guide a cutter. The cutter may include a wire, drill, blade, or other suitable cutter. For example, the guide may include a tube able to receive a drill and guide it to intersect a receiver. The guide may also be able to receive the suture and guide it into engagement with the receiver. The suture passer may further include a suture inserter able to engage the suture and the guide and useable to move the suture into engagement with the receiver. For example, the suture may have insufficient columnar rigidity to allow it to be pushed into engagement with the retriever by itself. A suture inserter may be used to help advance the suture. A suture inserter may include rods, wires, tubes, or other suitable members.

[0028] The following illustrative examples depict instruments and techniques to pass a suture through a material. Instruments and techniques according to the present invention may be used to pass a suture through any material, at surgical sites anywhere in a patient's body, and for any purpose. Instruments and techniques according to the present invention are particularly useful to pass a suture through a bone tunnel in an orthopedic procedure. For example, it is often desirable to pass a suture through a bone tunnel which in turn is used to pass a graft into the tunnel or attach a graft in the tunnel. While suture passers in accordance with the present invention may be used with any material at any location, and in particular with any bone adjacent any joint within a patient's body, the illustrative examples are shown in use with a small bone joint such as in a hand or foot to form a tunnel in and pass a graft into a metacarpal or metatarsal bone. In particular, the illustrative examples are shown in use with a phalanx bone of the foot. The terms “suture” and “suture strand” are used herein to mean any strand or flexible member, natural or synthetic, able to be passed through material and useful in a surgical procedure. The term “material” is used herein to mean implants, grafts, fabric, tendon, ligament, fascia, skin, muscle, bone, and any other material through which it is desirable to pass a suture. The term “transverse” is used herein to mean crossing as in non-parallel. The term “bight” is used herein to mean a bend or loop formed in the intermediate portion of a suture.

[0029] FIG. 1 depicts an illustrative example of a suture passer 100. The suture passer 100 includes a suture retriever 110 and a suture 150. The retriever 110 includes a receiver 112 able to receive and retain a portion of the suture 150. In the illustrative example of FIG. 1, the receiver 112 includes a foot 114 positionable on one side of a material through which the suture is to be passed. The foot 114 has a proximal end 116, a distal end 118, a front surface 115, a back surface 117 and a longitudinal axis 120 extending between the proximal and distal ends. The foot has an opening 122 defining a passage through a portion of the receiver for receiving the suture 150 and a sharp tip 124 able to engage the material and aid in maintaining the foot 114 in a desired location. In the illustrative example of FIG. 1, the retriever 110 further includes a handle 130 having a proximal end 132, a distal end 134, and a longitudinal axis 136 extending between the proximal and distal ends. The receiver 112 may be mounted directly to the distal end 134 of the handle. In the illustrative example of FIG. 1, the receiver 112 is offset from the handle. An extension 140 having a proximal end 142, a distal end 144, and a longitudinal extension axis 146 extends away from the distal end 134 of the handle transverse to the handle axis 136. The foot 114 is mounted to the distal end 144 of the extension 140 and extends away from the extension 140 transverse to the extension axis 146.

[0030] The suture 150 includes a proximal end 152 and a distal end 154. The distal end includes a stopper 156. In the illustrative example of FIG. 1 the stopper 156 includes a hook 158 formed on the distal end 154. For example, the distal end may be bent, molded, heat set, or otherwise formed into a hook shape. The hook 158 includes a shank 160, a bend 162, and a barb 164. The hook 158 is receivable in the opening 122. As the hook 158 is advanced through the opening 122, the barb 164 and shank 160 engage the sides of the opening 122 and the barb 164 moves toward the shank 160. This movement changes the orientation of the hook to a receivable orientation in which the barb-shank maximum dimension is smaller than the opening 122 maximum dimension and the hook passes through the opening. Once the hook 158 is through the opening 122, the barb 164 springs away from the shank 160 and the hook orientation changes to a retention orientation. Pulling the hook 158 back toward the opening causes the barb 164 to engage the back surface 117 of the foot and resist withdrawal. The bend of the hook 158 is such that relatively small movement of the barb 164 is necessary for insertion of the hook through the opening 122 but relatively large movement of the barb 164, in the opposite direction, is necessary for removal. The hook 158 may be withdrawn by forcing the barb to straighten or by clipping the hook 158 off of the suture 150.

[0031] The proximal end of the suture may be unmodified or it may include a loop, knot, hook, barb, or other feature for engaging another material.

[0032] In use, the receiver 112 is positioned behind material through which the suture 150 is to be passed. The distal end 154 of the suture is advanced through the material and the stopper 156 is engaged with the receiver 112. The receiver 112 is then withdrawn from behind the material to advance the suture further and retrieve it partially or fully through the material. The suture 150 may be used to connect the material to another material. For example the suture 150 may be used to attach soft tissue to bone. The suture 150 may be used to retrieve something through the material. For example, the suture 150 may be used to retrieve a graft through a bone tunnel. In the illustrative example of FIG. 1, the foot 114 may be positioned adjacent a bone with the opening 122 aligned with a tunnel formed in the bone and the tip 124 engaged with the bone. The distal end 154 of the suture 150 may be advanced through the bone tunnel and opening 122 until the hook 158 engages the foot 114. The proximal end 152 of the suture may be secured to a graft such as by tying, stitching, looping, knotting, hooking, or other securing mechanism. The foot may then be withdrawn away from the bone tunnel to retrieve the distal 154 end of the suture and pull the graft with it. Further pulling of the suture advances the graft into the bone tunnel.

[0033] FIGS. 2-9 depict an illustrative example of a suture passer 200 similar to that of FIG. 1 and including a suture retriever 300 and a suture 400. In the illustrative example of FIGS. 2-9, the suture retriever 300 includes a handle 310, a receiver 320, and a guide 380. The handle 310 includes a proximal end 312, a distal end 314, and a longitudinal axis 316 extending between the proximal and distal ends. The receiver 320 includes a foot 324 positionable on one side of a material through which the suture is to be passed. The foot 324 has a proximal end 326, a distal end 328, a front surface 325, a back surface 327 and a longitudinal axis 330 extending between the proximal and distal ends. The foot 324 has an opening 332 having an opening axis and able to receiving the suture 400. The opening 332 includes an enlarged counterbore 333. The foot further includes a sharp tip 334 able to engage the material and aid in maintaining the foot 324 in a desired location. The receiver 320 is offset from the handle 310. An extension 340 having a proximal end 342, a distal end 344, and a longitudinal extension axis 346 extends away from the distal end 314 of the handle transverse to the handle axis 316. The foot 324 is mounted to the distal end 344 of the extension 340 and extends away from the extension 340 transverse to the extension axis 346.

[0034] The guide 380 includes a tube 382 having an inner surface 384, an outer surface 386, a proximal end 388, and a distal end 390. The inner surface 384 defines an inner diameter and a longitudinal axis 392. The tube 382 is mounted to the distal end 314 of the handle 310 with the tube axis 392 transverse to the handle axis 316 and coaxial with the opening 332 in the foot 324. The handle 310 axis 316 forms an angle 317 with the tube axis 392. The angle 317 facilitates manipulating the retriever 300 while maintaining a line of sight for the user and to prevent interference with tissues surrounding the surgical site. The angle 317 may have any suitable value. Preferably the angle 317 is in the range of 90 to 270 degrees. The handle 310 may also be mounted at any location around the circumference of the tube 382. In the illustrative embodiment of FIGS. 2-9, the handle is coplanar with the foot 324. The tube 382 includes a slot 394 through the sidewall of the tube from the inner surface 384 to the outer surface 386 and extending from the proximal end 388 to the distal end 390. The guide 380 and foot 324 define a space 396 between them for receiving a bone.

[0035] The suture 400 includes a proximal end 402 and a distal end 404. The distal end includes a stopper 406. In the illustrative example of FIGS. 2-9 the stopper 406 includes a pledget 408. The pledget 408 is mounted to the suture 400 such as by adhering, welding, crimping, molding or other suitable mounting method. The pledget 408 may also be formed as a unitary part of the suture. The pledget is resilient to allow it to bend or compress to fit through the opening 332. It may also be toggled to one side such as for example by bending the suture adjacent the pledget 408 to fit through the opening 332. In the illustrative example of FIGS. 2-9, the pledget 408 includes radially extending tabs 410, 412 that bend from substantially perpendicular to the suture 400 to substantially parallel to the suture 400 to reduce the radial dimension of the pledget 408 and allow it to pass through the opening in a receivable orientation. Once the pledget 408 is through the opening 332, the tabs 410, 412 spring back to their initial position and resume a retention orientation. The proximal end of the suture 400 includes a loop 420. The loop may be formed by tying a knot in a bight of a single or multiple strand suture 400, tying the ends of multiple strands together, splitting a monofilament strand, molding, or other suitable loop formation method. In the illustrative example of FIGS. 2-9, the loop is formed by molding a loop on a monofilament strand.

[0036] FIG. 10 illustrates a drill assembly 500 useable with the suture passer 200. The drill assembly 500 includes a drill tube 510 and an obturator 560. The drill tube 510 includes a tubular body 512 having a proximal end 514, a distal end 516, an inner surface 518, and an outer surface 520. The inner surface 518 defines an inner diameter and a longitudinal axis 522 extending between the proximal and distal ends. In the illustrative embodiment of FIG. 10, a connector 524 is mounted to the drill tube 510 near the proximal end 514. In the illustrative example of FIG. 10, the connector 524 is a female Luer-type fitting. A stop 528 extends radially outwardly from the body 512.

[0037] The obturator 560 includes an elongated body 562 having a proximal end 564, a distal end 566, and a longitudinal axis 568 extending between the proximal and distal ends. In the illustrative embodiment of FIG. 10, a connector 570 is mounted to the obturator 560 intermediate the proximal and distal ends. In the illustrative example of FIG. 10, the connector 570 is a male Luer-type fitting. The obturator 560 is receivable in the drill tube 510 by inserting the distal end 566 of the obturator 560 into the proximal end 514 of the drill tube 510 and advancing the obturator until the connectors engage. The obturator 560 and drill tube 510 are locked together by rotating the connectors relative to one another. The drill tube 510 and obturator 560 have drilling tips 526, 572 that align when the obturator is inserted into the drill tube and locked. For example, the drilling tips 526, 572 may be formed by assembling the obturator 560 and drill tube 510, locking them together, and then grinding the cutting tips on the drill tube 510 and obturator 560 simultaneously. In the illustrative example of FIG. 10, when the drill tube 510 and obturator 560 are assembled, the drilling tips 526, 572 form a diamond drill tip having primary bevels 580 formed on opposed first and second sides and secondary bevels 582 to provide relief and improve cutting. The outer diameter of the drill tube 510 and the counterbore 333 of the opening 332 are sized so that the drill tube 510 may be received in the counterbore 333.

[0038] FIGS. 11-20 illustrate the illustrative suture passer 200 of FIGS. 2-9 and the illustrative drill assembly of FIG. 10 in use to form a bone tunnel and load a graft into the tunnel. In FIG. 11, the suture retriever 300 has been positioned adjacent a bone 600 with the foot 324 on one side of the bone with the opening 332 aligned with a desired exit location for a bone tunnel and the guide axis 392 aligned with the desired tunnel axis. By viewing through the tube 382 along the axis 392, the location of the tunnel entrance can be visualized. The retriever 300 is shown positioned adjacent a phalanx bone with the extension 340 in the joint space and the guide positioned to form a tunnel from dorsal to plantar through the proximal phalanx. The guide may be positioned at any location around the joint to create bone tunnels at any desired location in the phalanx or the metatarsus. For example, the guide may be positioned to create tunnels for repairing or replacing a proper collateral ligament, accessory plantar ligament, plantar plate, or other structure in or around the joint.

[0039] In FIG. 12, the drill assembly 500 has been guided via the inner surface 384 of the guide tube 382 to form a tunnel through the bone 600. Stop 528 abuts the proximal end 388 of the guide 380 to limit the drilling depth. In the illustrative examples of FIGS. 2-10, the stop 528 abuts the proximal end 388 when the drill tube 510 is received in the counterbore 333. Alternatively, the opening in the foot may be sized to engage the tip of the drill to limit the depth or a depth stop may be omitted.

[0040] In FIG. 13, the obturator 560 has been removed leaving the drill tube 510 in place. Optionally, the drill tube 510 could be removed or a one-piece drill could be substituted for the drill assembly 500. However, by leaving the drill tube 510 in place, the drill tube 510 locks the retriever 300 in place on the bone, provides guidance for the suture, and provides a smooth passage for the suture.

[0041] In FIG. 14, the suture 400 has been inserted until the stopper 406 engages the receiver 320. In the example of FIG. 14, the pledget 408 has been forced through the opening 332 in the foot 324.

[0042] In FIG. 15, the drill tube 510 has been removed leaving the suture 400 in place.

[0043] In FIG. 16, the suture 400 has been pulled through the slot 394 to free the proximal end 402 from the guide tube 382. The slot 394 simplifies withdrawing the retriever 300 from the surgical site. However, the slot 394 may be omitted and the proximal end 402 of the suture threaded through the guide tube 382 as the retriever 300 is withdrawn.

[0044] In FIG. 17, the retriever 300 has been withdrawn from the surgical site taking the distal end 404 of the suture 400 with it and thereby further advancing the suture 400 into the bone tunnel. The suture 400 may be left attached to the retriever 300 or it may be separated from the retriever by pulling the distal end 404 back through the foot or cutting off the distal end 404 of the suture.

[0045] In FIG. 18, the distal end 404 of the suture 400 has been cut off to free it from the retriever 300 and the retriever 300 removed.

[0046] In FIG. 19, a graft 610 has been engaged with the proximal end 402 of the suture 400 by threading it through the loop 420. Alternatively, a graft or any other material may be attached to the distal end for pulling in the opposite direction. In addition to being used to retrieve a graft, the suture 400 may be used as a definitive suture in a repair or reconstruction. Also, the suture 400 may be used to pull another graft retrieval strand such as, for example, a larger or more flexible strand.

[0047] In FIG. 20, the suture 400 has been pulled to advance it through the bone tunnel and pull the graft 610 along with it to position the graft 610 in the bone tunnel and the suture 400 has been removed.

[0048] FIG. 21 illustrates a suture inserter 710 having an elongated body 712 with a proximal end 714, a distal end 716, and a longitudinal axis 718. The suture inserter 710 may be used to advance the suture 400 into engagement with the receiver 320 by pushing the stopper 406. The suture inserter 710 or the suture inserter 710 in combination with the suture may have a higher columnar strength than the suture alone and facilitate advancing the suture 400. In the illustrative example, the suture inserter includes a longitudinal passage 720 for receiving the suture 400 with the stopper 406 adjacent the distal end 716.

[0049] FIG. 22 illustrates a suture 730 having two strands 732 joined to a stopper 734 having a proximal end 736 formed at an angle to the suture strands 732 so that the proximal end 736 will hook onto the retriever 320. The suture 730 is also shown with the suture inserter 710 of FIG. 21 useable to push the stopper 734. For use in passing a graft, the suture strands 732 may be tied to form a loop, stitched to the graft, wrapped around the graft, or otherwise connected to the graft. The suture ends may also be used directly to attach hard or soft tissue, implants, or other materials at a surgical site. The suture strands may also be used directly as a ligament or tendon replacement.

[0050] FIG. 23 illustrates a suture 740 having a loop 742 retained by swaging a ferrule 744 to retain the proximal end 746 of the suture 740.

[0051] FIG. 24 illustrates a suture 750 having a stopper 752 formed of a block of resilient material such as, for example, a closed cell foam.

[0052] FIG. 25 illustrates a suture 760 having a stopper 762 joined to a strand 764 at a pivot 766 so that the stopper 762 can toggle between a receiving position generally more parallel to the strand 764 and a retaining position generally more perpendicular to the strand 764.

[0053] FIG. 26 illustrates an alternative foot 770 to the foot 224 of FIG. 2. The foot 770 has first and second opposable jaws 772, 774. The first jaw 772 is mounted for rotation relative to the second jaw about a pivot 776. The jaws 772, 774 are moveable between a first closed, position (shown) in which the jaw faces are adjacent one another and a second, open position (not shown) in which the first jaw 772 is pivoted away from the second jaw 774 to create a space between the jaws 772, 774 for receiving a suture 778. The jaws may be closed on the suture 778 to retain the suture and allow it to be retrieved. Any suitable mechanism may be used to move the first jaw relative to the second jaw. For example, a control cable 779 may be mounted in the foot and moveable by a remote actuator to move the first jaw 772 between the first and second positions.

[0054] FIG. 27 illustrates an alternative foot 780 to the foot 224 of FIG. 2. The foot 780 has moveable member 782 mounted for movement relative to an opening 784 between a first position in which the opening is not blocked and a suture 786 may be received in the opening and a second position in which the member 782 and edge of the opening 784 grasp the suture. Any suitable mechanism may be used to move the member 782. For example, a control cable 788 may be mounted in the foot and moveable by a remote actuator to move the member 782 between the first and second positions.

[0055] The illustrative examples have shown the suture passer 200 in use to pass a suture used to pull a graft into a tunnel. However, a suture passed by the suture passer may be used in any way that sutures are known to be used. For example a suture may be used as a shuttle for pulling another suture, graft, or anything else from bottom to top rather than from top to bottom as depicted in the illustrative examples. Single strands, double strands, or any number of strands may be passed. Likewise one or more loops may be passed. Any of these may be used as a definitive suture in a repair or reconstruction, as a shuttle for pulling another material into a desired position, or for any other purpose.

[0056] Illustrative examples of instruments and methods have been shown in use to pass suture through material and to pass a graft through the material. The present invention is not limited to the specific instruments and methods depicted.