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Publication numberUS20040260298 A1
Publication typeApplication
Application numberUS 10/869,808
Publication date23 Dec 2004
Filing date16 Jun 2004
Priority date18 Jun 2003
Also published asUS7255700, US20040260296, WO2004112650A2, WO2004112650A3
Publication number10869808, 869808, US 2004/0260298 A1, US 2004/260298 A1, US 20040260298 A1, US 20040260298A1, US 2004260298 A1, US 2004260298A1, US-A1-20040260298, US-A1-2004260298, US2004/0260298A1, US2004/260298A1, US20040260298 A1, US20040260298A1, US2004260298 A1, US2004260298A1
InventorsRyan Kaiser, Kevin Stone, Jason Meridew
Original AssigneeKaiser Ryan A., Stone Kevin T., Meridew Jason D.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Device and method of fastening a graft to a bone
US 20040260298 A1
Abstract
A fixation device for attaching elongate flexible members to tissue. The device includes a plate defining a plurality of openings for receiving respective flexible members, and a plurality of fasteners corresponding to the plurality of openings. Each fastener passes through the corresponding opening and is received into the tissue, such that tightening the fastener against the plate compresses the respective flexible member between the plate and the fastener.
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Claims(44)
What is claimed is:
1. A fixation device for attaching elongate flexible members to tissue, the device comprising:
a plate defining a plurality of openings for receiving respective flexible members; and
a plurality of fasteners corresponding to the plurality of openings, each fastener passing through the corresponding opening and received into the tissue, such that tightening the fastener against the plate compresses the respective flexible member between the plate and the fastener.
2. The device of claim 1, wherein the fasteners comprise resorbable materials.
3. The device of claim 2, wherein the plate comprises resorbable materials.
4. The device of claim 1, wherein the fasteners and the plate comprise biocompatible materials selected from the group consisting of metal, ceramic, polymer, LactoSorb®, bone, and combinations thereof.
5. The device of claim 1, further comprising a divider coupled to the plate for separating individual flexible members.
6. The device of claim 1, further comprising at least one anchoring pin for attaching a portion of at least one of the flexible members to a bone.
7. The device of claim 6, further comprising a holder orienting the anchoring pin and the portion of said flexible member mediolaterally relative to the bone.
8. The device of claim 7, wherein the holder is saddle-shaped.
9. The device of claim 7, wherein the holder includes first and second parallel bores for receiving respectively the anchoring pin and the portion of said flexible member.
10. A fixation method, the method comprising:
attaching a first end of a first elongate flexible member to a first bone;
pulling the first elongate flexible member through a tunnel of a second bone;
passing a second end of the first elongate flexible member through a first opening of a plate;
tensioning the first elongate flexible member;
inserting a first fastener through the first opening of the plate into the second bone; and
compressing the first elongate flexible member between the plate and the first fastener.
11. The method of claim 10, further comprising:
attaching a first end of a second elongate flexible member to the first bone;
pulling the second elongate flexible member through the tunnel of the second bone;
passing a second end of the second elongate flexible member through a second opening of the plate;
tensioning the second elongate flexible member;
inserting a second fastener through the second opening of the plate into the second bone; and
compressing the second elongate flexible member between the plate and the second fastener.
12. The method of claim 11, wherein the first bone is a femur and the second bone is at tibia of a knee joint.
13. The method of claim 12, further comprising tensioning the first elongate flexible member in extension and the second elongate flexible member in flexion.
14. The method of claim 12, further comprising orienting the first and second elongate flexible members mediolaterally relative to the femur.
15. The method of claim 14, wherein orienting comprises holding the first and second elongate flexible members parallel to an anchoring pin in the mediolateral direction of the femur.
16. The method of claim 10, wherein the first elongate flexible member is a graft or a suture.
17. The method of claim 11, wherein the second elongate flexible member is a graft or a suture.
18. A fixation device comprising:
a plate defining an opening for receiving two ends of an elongate flexible member that passes through tissue; and
a plug insertable in the tissue through the opening for locking the ends of the elongate flexible member between the plate and the plug when the plate is placed on an outer surface of the tissue.
19. The fixation device of claim 18, wherein the plate is selected from the group consisting of circular plate, oval plate, two-lobed plate and rectangular plate.
20. The fixation device of claim 19, wherein the opening is selected from the group consisting of circular opening, oval opening, two-lobed opening, rectangular opening and cruciate opening.
21. The fixation device of claim 18, wherein the plate defines a second opening.
22. The fixation device of claim 21, wherein the plug is two-pronged.
23. The fixation device of claim 18, wherein the plate has a profile selected from the group consisting of contoured, flat, and stepped.
24. The fixation device of claim 18, wherein the plug further comprises a head supported on the plate and a body insertable into the tissue through the opening of the plate.
25. The graft fixation device of claim 24, wherein the head has a shape selected from the group consisting of circular, lobed, rounded, rectangular and square.
26. The graft fixation device of claim 25, wherein the body is has a shape selected from the group consisting of point-ended, stepped, threaded, straight, barbed, tapered, cannulated and two-pronged.
27. The graft fixation device of claim 18, wherein the plate and the plug are made of biocompatible materials.
28. The graft fixation device of claim 18, in combination with an installation tool.
29. The combination of claim 28, wherein the installation tool includes a pusher for installing the plug.
30. The combination of claim 28, wherein the installation tool includes a cutter for cutting the flexible member.
31. The combination of claim 28, wherein the installation tool includes a lock for holding the elongate flexible member.
32. The combination of claim 28, wherein the installation tool includes a groove for receiving the elongate flexible member.
33. The combination of claim 28, wherein the installation tool is adapted to hold the plate.
34. A fixation method for an elongate flexible member having two ends, the method comprising:
passing the flexible member through a tissue such that the ends of the flexible member exit through an outer tissue surface;
passing the ends of the flexible member through an opening of a plate;
placing the plate on the tissue surface;
inserting a portion of a plug into the tissue through the opening of the plate; and
compressing the flexible member between the plug and the plate.
35. The method of claim 34, further comprising coating portions of the flexible member with resorbable material.
36. The method of claim 35, wherein coating comprises increasing a contact area between the flexible member and the plate and plug.
37. The method of claim 34, wherein the tissue is a rotator cuff.
38. The method of claim 37, wherein the flexible member is a suture.
39. The method of claim 34, wherein the tissue comprises acromioclavicular joint tissue.
40. A fixation method for an elongate flexible member, the method comprising:
drilling first and second holes in a first bone;
inserting the flexible member through the first and second holes of the first bone such that first and second ends of the flexible member exit through an outer surface of the first bone;
passing the flexible member through first and second openings of a plate, the first and second openings corresponding to the first and second holes of the first bone;
placing the plate on the outer surface of the first bone;
fastening one of the first or second ends of the flexible member to one of the first bone or a second bone;
tensioning the flexible member; and
fastening the other of the first or second ends of the flexible member to the other of the first and second bones.
41. The method of claim 40, wherein fastening one of the first and second ends of the flexible member to the first bone comprises:
inserting a portion of a first plug-into the first bone through the first opening of the plate; and
compressing the flexible member between the first plug and the plate.
42. The method of claim 41, further comprising:
inserting a portion of a second plug into the first bone through the second opening of the plate; and
compressing the flexible member between the second plug and the plate.
43. The method of claim 42, further comprising looping the flexible member around a third bone.
44. The method of claim 43, wherein the first bone is clavicle, the second bone is an acromion, and the third bone is a coracoid.
Description
    CROSS-REFERENCE TO RELATED APPLICATIONS
  • [0001]
    This application is a continuation-in-part of U.S. patent application Ser. No. 10/464,037, filed on Jun. 18, 2003. The disclosure of the above application is incorporated herein by reference.
  • INTRODUCTION
  • [0002]
    Ligaments are strong fibrous soft tissue connecting the articular ends of bones to bind them together and to facilitate or limit motion. Injuries to ligaments are common, and patients who are physically active are generally more susceptible to such ligament injuries. The anterior cruciate ligament (ACL) of the knee joint is a ligament frequently injured by such patients. ACL injuries cause instability in the knee joint which, when left untreated, may lead to degenerative arthritis. Because of this condition, ACL reconstruction may be required. Generally during ACL reconstruction, a substitute soft tissue ligament or graft is attached to the femur (femoral fixation) and/or to the tibia (tibial fixation) to facilitate regrowth and permanent attachment.
  • [0003]
    There are several known methods for performing ACL reconstruction, and there are also several tibial or femoral fixation devices that may be used with these methods, some of which are reviewed in U.S. Pat. No. 6,482,232. Nevertheless, new methods and devices that reduce soft tissue damage, are easy to install, prevent slippage of the graft, promote healing and increase strength are still needed.
  • SUMMARY
  • [0004]
    The present teachings provide a fixation device for attaching elongate flexible members to tissue. The device includes a plate defining a plurality of openings for receiving respective flexible members, and a plurality of fasteners corresponding to the plurality of openings. Each fastener passes through the corresponding opening and is received into the tissue, such that tightening the fastener against the plate compresses the respective flexible member between the plate and the fastener.
  • [0005]
    The present teachings also provide a fixation method. The method includes attaching a first end of a first flexible member to a first bone, pulling the first flexible member through a tunnel of a second bone, passing a second end of the first flexible member through a first opening of a plate, tensioning the first flexible member, inserting a first fastener through the first opening of the plate into the second bone, and compressing the first flexible member between the plate and the first fastener. A second flexible member can be similarly attached through a second opening of the plate.
  • [0006]
    The present teachingsbbbb provide a fixation device that includes a plate and a plug. The plate has an opening for receiving two ends of an elongate flexible member that passes through tissue. The plug is insertable in the tissue through the opening for locking the ends of the elongate flexible member between the plate and the plug when the plate is placed on an outer surface of the tissue.
  • [0007]
    The present teachings also provide a fixation method for an elongate flexible member having two ends. The method includes passing the flexible member through a tissue such that the ends of the flexible member exit through an outer tissue surface, passing the ends of the flexible member through an opening of a plate, placing the plate on the tissue surface, inserting a portion of plug into the tissue through the opening of the plate, and compressing the flexible member between the plug and the plate.
  • [0008]
    Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0009]
    The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
  • [0010]
    [0010]FIG. 1 is a diagram of a knee prepared for ACL reconstruction of a fixation device according to the present teachings;
  • [0011]
    [0011]FIG. 2 is a perspective view of a fixation device according to the present teachings;
  • [0012]
    [0012]FIG. 3 is a side view of a fastener of a fixation device according to the present teachings;
  • [0013]
    [0013]FIG. 4 is a top view of a first member of a fixation device according to the present teachings;
  • [0014]
    [0014]FIG. 5 is a sectional view of the first member taken along line 5-5 of FIG. 4;
  • [0015]
    [0015]FIG. 6 a top view of an embodiment of a second member of the fixation device according to the present teachings;
  • [0016]
    [0016]FIG. 7 is sectional view of the second member taken along line 7-7 of FIG. 6;
  • [0017]
    [0017]FIGS. 8A-9J are illustrative side profiles of the first member of the fixation device according to the present teachings;
  • [0018]
    [0018]FIG. 9 is a top view of a first member of the fixation device according to the present teachings;
  • [0019]
    [0019]FIG. 10 is a perspective elevated view of a first member of the fixation device according to the present teachings;
  • [0020]
    [0020]FIG. 11 is a perspective view of a first member of the fixation device according to the present teachings;
  • [0021]
    [0021]FIGS. 12 and 12A are perspective views of illustrative first members of the fixation device according to the present teachings;
  • [0022]
    [0022]FIG. 13 is a perspective view of an embodiment of the second member of the fixation device of the present teachings;
  • [0023]
    [0023]FIG. 14 is a side view of an embodiment of the fastener of the fixation device of the present teachings;
  • [0024]
    [0024]FIG. 15 is a perspective view of an embodiment of the fastener of the fixation device of the present teachings;
  • [0025]
    [0025]FIGS. 16A and 16B are perspective views of illustrative fasteners of the fixation device according to the present teachings;
  • [0026]
    [0026]FIG. 16C is an exploded side view of a fastener of the fixation device according to the present teachings;
  • [0027]
    [0027]FIG. 17 is a perspective view of a plate for a fixation device according to the present teachings;
  • [0028]
    [0028]FIG. 18 is a perspective view of a plate with a divider for a fixation device according to the present teachings;
  • [0029]
    [0029]FIG. 19 is a perspective view of a graft holder according to the present teachings;
  • [0030]
    [0030]FIG. 20 is a perspective view of a graft holder according to the present teachings;
  • [0031]
    [0031]FIG. 21 is an exploded view of a fixation device according to the present teachings;
  • [0032]
    [0032]FIG. 22A is a perspective view of an installation tool for a fixation device according to the present teachings;
  • [0033]
    [0033]FIG. 22B is a sectional view of an installation tool for a fixation device according to the present teachings;
  • [0034]
    [0034]FIGS. 23A to 23F are plan views of exemplary plates for a fixation device according to the present teachings;
  • [0035]
    [0035]FIGS. 24A to 24C are side views of exemplary plates for a fixation device according to the present teachings;
  • [0036]
    [0036]FIGS. 25A to 25C are plan views of exemplary plugs for a fixation device according to the present teachings;
  • [0037]
    [0037]FIGS. 26A to 26H are side views of exemplary plugs for a fixation device according to the present teachings;
  • [0038]
    [0038]FIGS. 27A and 27B illustrate environmental views of the fixation device according to the present teachings, before and after assembly respectively;
  • [0039]
    [0039]FIG. 28A is an environmental exploded view of a fixation device according to the present teachings;
  • [0040]
    [0040]FIG. 28B an environmental assembled view of a fixation device according to the present teachings;
  • [0041]
    [0041]FIG. 29 is environmental view of a fixation device according to the present teachings; and
  • [0042]
    [0042]FIGS. 30A to 30D are exemplary plates for a fixation device according to the present teachings, each plate shown in plan and side views.
  • DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS
  • [0043]
    The following description of various embodiments is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. For example, the fixation devices and fixation methods described herein can be used for rotator cuff reconstruction, for acromioclavicular (AC) reconstruction, for anterior cruciate ligament reconstruction (ACL) and generally for fastening tendons, grafts, or sutures to tissue, including sift tissue and bone.
  • [0044]
    [0044]FIG. 1 is a simplified view of a knee prepared for ACL reconstruction and tibial fixation according to an embodiment of the present invention. A ligament or graft 50 extends from a femoral bone 52 and passes through a tunnel 54 that is bored into a tibial bone 56. The graft 50 may be bundled into several separate graft strands 58, such as four, for example. One example of a representative procedure to prepare the bore is set forth in U.S. Pat. No. 5,931,869, the entire contents of which are incorporated herein by reference. The graft 50 may be a natural graft harvested from the patient or from a donor using techniques that are known in the art. The graft 50 may also be synthetic, made from a polymer or other biocompatible material.
  • [0045]
    [0045]FIG. 2 shows an embodiment of a fixation device or implant 100 that may be used to fasten the graft strands 58 into the tibial tunnel 54 during an ACL or similar procedure. The fixation device 100 may include a first member 102, a second member 104 and a fastener 106. The fastener 106 may include a body 108 having a first portion 110, which may be threaded or include concentric locking ribs 127, as shown in FIG. 16, and a second portion 112, which may also be threaded, or may be blank and act as a plug in the tunnel 54. Referring to FIGS. 14 and 15, at least the second portion 112 of the fastener 106 may be cannulated and may include a plurality of holes 113 to allow for graft passage. The fastener 106 can also be cannulated for injecting calcium sulfate or various biologic materials into the repair site. Referring to FIGS. 16A, and 16B, the fastener 106 can have a tip 133 that is shaped like a trumpet or rounded or otherwise shaped. Referring to FIG. 16C, the fastener 106 can include a second portion 112 which is modularly connected with the first portion 110 by a Morse taper or other type of connection. The second portion 112 can be made of allograft, compressed autograft, hydroxylapatite (HA), or other biocompatible materials, and combinations thereof.
  • [0046]
    The fastener 106 may also include a head 114, which may be tapered and/or segmented. In one embodiment, as shown in FIG. 3, the head 114 may include a top portion 116, which can be removed using a tool, such as a wrench or a socket, after attaching the fastener 106 to the tibial bone 56, to reduce the length of the fastener 106 after installation.
  • [0047]
    Referring to FIG. 4, the first member 102 includes a central opening 120 and a plurality of recesses or openings 122 that radiate from the central opening 120 and are separated by radial projections 124. In the embodiment shown in FIG. 4, the first member 102 includes four recesses 122 separated by four radial projections 124. The recesses 122 may be arranged to define a symmetric pattern, such as, for example, a cross, a four-petal cloverleaf, etc., although the recesses may also be arranged asymmetrically. The number of recesses 122 may be chosen to correspond to a maximum desirable number of graft strands 58. For example, the first member 102 may have four recesses 122, all of which may receive graft strands 58 in some applications, while in other applications only two recesses 122 may receive graft strands 58. The shape and the size of the recesses 122 may be determined to accommodate the size of the graft 50 and the size of the resulting graft strands 58.
  • [0048]
    In reference to FIGS. 2 and 5, the first member 102 has first and second faces 126, 128. The first face 126 may include a plurality of protuberances 131, such as, for example, cleats or wedge-shaped protuberances, collectively wedges for short, 130. The second face 128 may also include a plurality of protuberances 131 or wedges 132. Each wedge 130, 132 may define an angle a, which may be selected such that the corresponding faces 126, 128 provide good grip without causing damage or tear to any bone or soft tissue surface that the wedge 130 may come into contact in use. The wedge angle a may be an obtuse angle, such as, for example, 96°. The wedges 130, 132 may be blunt and short rather than sharp and long. It will be appreciated that the protuberances 131 of the first member 102 may be other than wedge-shaped and may have, for example, circular or rectangular cross-sections.
  • [0049]
    As shown in FIG. 4, the radial projections 124 of the first member 102 may include segments 134, which may be threaded or otherwise shaped to engage the threaded portion 110 of the fastener 106 to enable the first member 102 to move up or down along the fastener 106 in a controllable and stable manner. In the embodiment shown in FIG. 11, the radial projections 124 include slots 125 that snap onto the locking ribs 127 of the first portion 110 of the fastener 106.
  • [0050]
    Referring to FIGS. 8A-8J, the first member 102 may have a variety of side profiles, including: flat (rectangular), FIG. 8G; tapered, FIGS. 8H and 8F; curved, FIGS. 8E and 8C; L-shaped, FIG. 8A; U-shaped, FIGS. 8B and 8D; having internal threads or ribs, FIG. 8I, having upper inclination, FIG. 8J; etc, or combinations thereof.
  • [0051]
    Referring to FIGS. 6 and 7, the second member 104 includes an opening 140 and has first and second faces 142, 144. The first face 142 of the second member 104 may include plurality of protuberances 131 or wedges 146 similar to those of the first member 102. The second face 144 of the second member may include a countersunk portion 148 sized to receive a lower portion 150 of the head 114 of the fastener 106. The inner surface 152 of the opening 140 may be undulated or threaded such that second member 104 can move along the threaded portion 110 of the fastener 106 in a controllable manner while in engagement with the fastener 106. The second member 104 may be pre-assembled onto the fastener 106 before the fastener 106 is inserted into the central opening 120 of the first member 102 and before the fixation device 100 is attached to the tibial bone 56.
  • [0052]
    In one embodiment, the second member 104 may be an integral portion of the fastener 106. In another embodiment, the second member 104 may be eliminated and its function may be assumed by the lower portion 150 of the head of the fastener.
  • [0053]
    The fixation device 100 may be implanted into the tibial bone 56 as follows. A step drill or other similar tool may be used to drill the tibial tunnel 54 to an appropriate length and size to receive the fixation device 100 as an implant. The step drill may create a counterbore 160 at a distal end 162 of the tunnel 54. The graft 50 may then be pulled in the tibial tunnel 54 through a proximal end 164 of the tibial tunnel 54 and out of the distal end 162. The graft 50 may be passed through the central opening 120 of the first member 102, which may be pulled up the graft 50 to be received into the counterbore 160 at the distal end 162 of the tibial tunnel 54. The graft strands 58 may be inserted into the individual recesses 122 of the first member 102 and made to lay flat and radially separated on the first face 126 of the first member 102. The fastener 106, having the second member 104 assembled thereon, may be threaded through the central opening 120 of the first member 102. When the fastener 106 is fully inserted into the tunnel 54, the graft strands 58 may be compressed against the tibial tunnel 54 and may also be securely compressed or clamped between the opposing surfaces 126 and 142 of the first and second members 102, 104.
  • [0054]
    In the embodiment in which the second member 104 is eliminated, the graft strands 58 may be compressed between the first member 102 and the lower portion 150 of the head 114 of the fastener. The top portion 116 of the head 114 of the fastener 106 may be twisted off with a wrench or similar tool, such that it does not protrude outside the tibial tunnel 54 and such that the fixation device 100 may implanted substantially in its entirety into the tibial tunnel 54 in a break-away manner.
  • [0055]
    In operation, the fastener 106 may be substantially coaxial with the tunnel 54. The first and second members 102, 104, which may be substantially planar, may be perpendicular to the tunnel 54 when inserted into the tunnel 54.
  • [0056]
    Referring to FIGS. 5, 9, 11 and 12, the first member 102 has a boundary surface 129, which may have a shape that is circular, or non-circular, such as, for example oval, rectangular, polygonal, etc. Referring to FIG. 10, the boundary surface 129 may include one or more outer peripheral formations 166, including ridges or grooves or threads, to provide better grip of the first member 102 in the tunnel 54. In the embodiment of FIG. 9, the first member includes an outer tab 156 to prevent the first member 102 from rotating after implantation. In the embodiment of FIG. 11, the first member 102 may include one or more top spikes 158 mating with corresponding apertures 165 of the second member 104. The first member 102 may also include one or more bottom spikes 163, as shown in FIGS. 12 and 12A. Referring to FIGS. 9-12, the first member 102 may also include one or more substantially flat portions 164 for engagement with a tool holder that may be used to facilitate the installation of the first member.
  • [0057]
    Referring to FIG. 9, the first member 102 can include one or more holes 165′ for injection of calcium sulfate, growth promoting and/or other biologic materials to the repair site. Biologic materials can also be injected through the apertures 165 of the second member 104, as shown in FIG. 13, and through the fastener 106 when the fastener 106 is cannulated. In another aspect, as illustrated in FIG. 12A, the first member 102 can include engagement rings 169 defining a groove 167 therebetween and mating with corresponding ring formations of the second member 104 (not shown). The rings 169 can be defined by truncated conical surfaces or other ring-like elevated structures.
  • [0058]
    Each of the components of the fixation device 100 may comprise one or more resorbable materials, such as LactoSorb®, or other polymeric materials, or bone graft material or other biocompatible materials, including metals, such as titanium or titanium alloy, stainless steel, etc. The use of resorbable material combined with implantation of the fixation device 100 in the tunnel 54 of the tibial bone 56 may promote circumferential healing in the tunnel 54. The first and second members 102, 104 may act as a cortical layer fixation device, in contrast with standard devices utilizing interference screws which only contact cancellous bone.
  • [0059]
    The counterbore 160 at the distal end 162 of the tunnel 54 may provide a ledge on which the first and second members 102, 104 may securely rest, thereby dispensing with the need to anchor the fixation device 100 with spikes into the bone.
  • [0060]
    Whereas the fixation device 100 was described in connection with tibial bone fixation in an ACL procedure, it should be appreciated that the fixation device 100 may be readily used for securing grafts or ligaments in other types of bone and in other reconstruction procedures.
  • [0061]
    Referring to FIGS. 17 and 18, a plate 202 having multiple openings 220 is provided for use with fasteners such as the fasteners 106 of the fixation device 100 described above. The openings 220 can be variable in size and shape, and can have, for example, cruciate or cloverleaf shapes for receiving elongate flexible members 51, which may include individual grafts, grafts bundled into strands, ligaments, tendons, sutures, etc. The flexible members 51 can be made from natural or artificial materials that are biocompatible and can be resorbable. The plate 202 can be provided with a divider 201, which can be attached to the plate 202 integrally or modularly. The divider 201 provides individual channels 221 concentric with the openings 220 for receiving separate flexible members 51, such as grafts, for example. The plate 202 can be used in place of the first member 102, as described above, with a corresponding number of fasteners 106. Having two or more openings 220 allows more flexibility for tensioning independently two or more flexible members 51. For example, one flexible member 50 can be tensioned in flexion and another can be tensioned in extension. The order of tensioning can also be selected, such as anterior/posterior, semi tendonosis/gracilis.
  • [0062]
    Referring to FIGS. 19 and 20, to tension individual flexible members 51, such as grafts, properly, the flexible members 51 can be fixed to the femur 52 with an anchoring pin 300 using a holder 302 that helps orient the flexible members 51 in medial-lateral direction, rather than in the anterior-posterior direction at 90° to the anchoring pin 300, as would be the case were the flexible members 51 to be simply looped over the anchoring pin 300. In FIG. 19, the holder 302 is a saddle-shaped open device that allows both the anchoring pin 300 and the flexible member 51 to be oriented in the same direction, mediolaterally. In FIG. 20, the holder 302 is a sleeve-like device that includes a holding bore 304 for receiving the anchoring pin 300 and a holding bore 306 for receiving the flexible members 51, such that the holding bores 304, 306 are substantially parallel. The holder 300 can be made any biocompatible material, including metal, polymer, LactoSorb®, etc.
  • [0063]
    Referring to FIGS. 21-28, a fixation device 400, can include a washer-like plate 402 defining one or more openings 420, and a plug 406. The fixation device 400 can be used to fasten two or more flexible members 51, such as sutures or grafts, as illustrated in FIGS. 21, and 27, or a single flexible member 51 as shown in FIG. 28, without having to tie any knots. The flexible member 51 is strung through the opening 220 of the plate 402 and compressed in place with the plug 406, as illustrated in FIGS. 27A and 27B, creating about a 90° bend in the flexible member 51. The flexible member 51 can be coated with a resorbable material, such as LactoSorb®, to provide additional holding power, for example, by increasing the contact area between the flexible member 51 and the fixation device 400.
  • [0064]
    The plug 406 can be an interference anchor, having a head 408 and a body 410. The plug 406 can have a variety of profiles, with exemplary embodiments illustrated in FIGS. 26A to 26H. Exemplary plugs 406 can include bodies 410 that are point-ended (FIG. 26A), stepped (FIG. 26A), straight (FIG. 26B), threaded (FIG. 26B), tapered (FIG. 26E), barbed (FIGS. 26C and D), cannulated (FIG. 26F), and two-pronged (FIG. 26G) for plates 402 that have two openings 420 as illustrated in FIG. 23F. The plug 106 can also be modular including a sleeve 410′ that engages the head 408 and receives the body 410, as illustrated in FIG. 26H. The sleeve 410′ can be threaded, ribbed, barbed, etc. The head 408 of the plug 406 can have different shapes, including circular, arcuate, rounded, rectangular or square, etc., as illustrated in FIGS. 25A to 25C. The head 408 of the plug 406 can also have two arms for engaging the plate 402 as shown in FIG. 26D.
  • [0065]
    Similarly, the plate 402 can have various configurations, including, for example, oval plate 402 with oval opening 420 (FIG. 23A), circular plate 402 with circular opening 420 (FIG. 23B), two-lobed plate 402 with two-lobed opening 420 (FIG. 23C), rectangular plate 402 with rectangular opening 420 (FIG. 23D), circular plate 402 with cruciate opening 420 (FIG. 23E), and two-lobed plate 402 with two openings 420 (FIG. 23A). The profile of the plate 402 can be curved or contoured (FIG. 24A), flat (FIG. 24B), stepped (FIG. 24C), or otherwise shaped, such that plate 402 can conform and mate with an outer surface 57 of a tissue 59, as illustrated in FIG. 28B.
  • [0066]
    Referring to FIGS. 21, 27, and 28, in operation, the flexible member 51 is passed through the tissue 59, and then strung through the plate 402. The plate 402 can be positioned on the outer surface 57 of the tissue 59 with the flexible member 51 looped, but not knotted, around the tissue 59, and the ends 61 of the flexible member 51 coming out of the opening 420, as shown in FIG. 28B. The plug 406 can be then inserted into the opening 420 compressing the flexible member 51 to lock the flexible member 51 against the plate 402. The body 410 of the plug 406 enters the tissue 59. In one aspect, the plate 402 can have a countersunk portion 403 for receiving the head 408 of the plug 206, or a portion thereof.
  • [0067]
    Referring to FIGS. 22A and 22B, an installation tool 450 can be used with the fixation device 400 to attach a flexible member 51 into tissue. The installation tool 450 can include a tube 460 having a bore 462 that is sized to receive the plug 406, and a pusher 452 for installing the plug 402. The installation tool 450 can also include a cutter 454 for cutting the flexible member 51 and a lock 458 for holding the flexible member 51. The plate 402 with the flexible member 51 strung through the opening 420 can be pre-loaded at one end of the installation tool 450 in front of the pusher 452. During installation and tensioning, the ends of the flexible member 51 can be received in a cut-out 464 of the tube 460 and secured with the lock 458. The installation tool 450 can be operated to cause the pusher 452 to move the plug 406 relative to the plate 402, such that the plug 406 is inserted through the plate 402 and into the tissue.
  • [0068]
    The plate 402 and plug 406 of the fixation device 400 can be conveniently made from resorbable materials, such as LactoSorb®, or other polymeric materials, or bone graft material or other biocompatible materials, including ceramics and metals, such as titanium or titanium alloy, stainless steel, etc. It will be appreciated that the fixation device 400 can be used as a versatile suture lock that is easy to use, avoids knot-tying, and saves time during the surgical procedure. Further, as the suture 50 is held between the plate 402 and the head 408 of the plug 406, the load of the suture 50 is distributed, and the suture 50 is prevented from pulling through without knot-tying.
  • [0069]
    The fixation device 400 can also be used for fastening any type of ligaments, grafts or sutures, and can be used, for example, for rotator cuff repair for the shoulder, for acromioclavicular (AC) joint reconstruction, for tibial graft fixation, for ACL reconstruction, and generally for fastening tendons or grafts and sutures to tissue, including soft tissue and bone. Referring to FIG. 29, for example, an exemplary fixation for an AC reconstruction is illustrated. A flexible member or tendon 51 is passed through holes 76 drilled through the clavicle 70, looped around the coracoid 74 and fixed to the acromion 72. The tendon 51 can be secured to the clavicle 70 using one of the plates 402 that define at least two openings, such as two holes 420, as illustrated in FIGS. 30A, 30B and 30D, or a one hole 420 and one slot 421, as illustrated in FIG. 30C. It will be appreciated that the openings of the plate 402 can be smooth, threaded, ribbed, notched and can have various shapes including the shapes illustrated in FIG. 23. Similarly the side profile of the plates 402 can be flat, curved, stepped, etc. as illustrated in FIGS. 24, and 30A to 30D. Screws or plugs 406, such as the plugs 406 illustrated in FIG. 26, can be used to secure the tendon 51 to the plate 402 and the clavicle 70, and to the acromion 72 (with or without another plate 402). The tendon 51 can be tensioned after one of its ends 61 is fastened with a first plug 406 and before the other end 61 is also fastened with a second plug 406 on the clavicle 70 or on the acrominon 72
  • [0070]
    While particular embodiments have been described in the specification and illustrated in the drawings, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention as defined in the claims. In addition, many modifications may be made to adapt a particular situation or material to the present teachings without departing from the essential scope thereof. Therefore, it is intended that the present teachings are not to be limited to the particular embodiments illustrated by the drawings and described in the specification, but that the present teachings will include any embodiments falling within the foregoing description and the appended claims.
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Classifications
U.S. Classification606/232, 623/13.13, 606/910, 606/329, 606/916, 606/286, 606/908, 606/298, 606/86.00B, 623/13.12, 606/909, 606/301, 623/13.17, 623/13.11, 606/304, 606/323
International ClassificationA61F2/08
Cooperative ClassificationA61F2/0811, A61F2002/0864, A61F2002/0829, A61F2002/0882
European ClassificationA61F2/08F
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