Ligament attachment method and apparatus

• US RE34,293 E
• Filed: 05/29/1990
• Issued: 06/22/1993
• Est. Priority Date: 02/17/1987
• Status: Expired due to Term

• Current Assignee: Zimmer Technology Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Goble E. Marlowe, Somers W. Karl
• Inventors: Goble, E. Marlowe, Somers, W. Karl
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US07/529,319
• Time in Patent Office: 1,120 Days
• Field of Search: 623/13, 623/16, 606/72, 606/73, 606/80, 606/88, 606/96, 606/97
• US Class Current: 623/13.14
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2002/0864 Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
• CPC Class Codes: A61F 2002/087 Anchor integrated into tendons, e.g. bone blocks, integrated rings
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3085 with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

The invention provides a system for surgically implanting an allograft or prosthetic ligament as a replacement for a patient'"'"'s cruciate ligaments. In a practice of the system, as a replacement for an anterior cruciate ligament, the patient'"'"'s leg is bent and maintained at approximately a ninety degree (90°) angle, a single incision is made medial to the tibial tuberosity, From this incision, under fluoroscopic and arthroscopic control, a guidewire is driven through the tibia and across the cruciate ligament junctions with the proximal tibia and distal femur ends and into the femur cortex. Succesively larger drills are then turned along the guidewire to form a ligament tunnel, with, as a last step in the tunnel formation process, the preparation of the femur cortex end of the tunnel to receive a femoral connector of the implanted ligament, which connector is arranged in one embodiment to be outwardly flared and in another embodiment to be turned into the appropriately prepared femur end of the ligament tunnel to lock therein. The invention, in addition to the embodiment of the ligament femur end connectors, further includes a tibial surface ligament tibial end connector for both securing the ligament end to the bone and the setting ligament tensioning, of which ligament connectors can be manufactured from a biodegradable material for absorption by the body.

Claims

1. A surgical system for implanting a human knee joint ligament, particularly a cruciate ligament comprising, under fluoroscopic control and with the patient'"'"'s leg bent and maintained appropriately, at single incision to the tibial tuberosity, urging a guidewire through the bone surface and passing through the cruciate ligament junctions to the proximal tibia and distal fem ur, the guidewire further urged into the fem ur cortex, which guidewire is to receive and guide therealong successively larger drills to form a ligament tunnel of a diameter to accommodate a selected allograft or prosthetic ligament, and the end of which ligament tunnel within said fem ur cortex is further prepared to receive a ligament fem ur attachment connector fitted and secured therein;

an allograft or prosthetic ligament for implant in said ligament tunnel that includes on one end the femoral attachment connector and is arranged for insertion into said ligament tunnel, the femoral attachment connector arranged for perm anent installation in said fem ur cortex at said ligament tunnel end; and

securing a tibial attachment end of said ligament at the open tibia end of said ligament tunnel.

2. A surgical system as recited in claim 1, wherein for replacement of an anterior cruciate ligament, the patient'"'"'s leg is bent and maintained at approximately a ninety degree (90°

) angle and the incision is made medial to the tibia tuverosity down to a point on the bone surface that is approximately two (2) centimeters distant from the medial tibial plateau; and

the guidewire is inserted into the tibia at that point to travel through the joint to cross the intercondylar notch area and engage the fem ur posterior and lateral femoral condyle at a point within said intercondyalr notch area that is approximately four (4) millimeters anterior to the junction of the fem ur posterior cortex and the intercondylar seam, the guidewire entering the fem ur to pass through the cancellous bone that surrounds the medullary channel is passed through the medullary channel and into the fem ur anterior lateral cortex.

3. A surgical system as recited in claim 1, wherein the ligament tunnel end within the fem ur cortex is drilled by turning a flaring drill means therein so as to form an open inverted cone shaped section.

4. A surgical system as recited in claim 3, wherein the ligament femoral attachment connector is an expansion cone formed as an open cylinder having a proximal end connected to an end of a prosthetic ligament that includes an open center longitudinal passage therethrough, which expansion cone is longitudinally slotted at spaced apart intervals around its distal end from said prosthetic ligament and includes a continuous groove formed around the cylinder inner circumference;

and an arrangement for expanding said expansion cone into a skirt at its longitudinally slotted end to conform to the inverted cone shape section formed at the ligament fem ur cortex end.

5. A surgical system as recited in claim 4, wherein the arrangement for expanding the expansion cone consists of a cylindrical expansion anchor that is center holed on one end and receives an end of a rod that is releasably secured therein so as to be capable of breaking away when a certain pulling force is exerted thereon, which rod is telescoped through said prosthetic ligament open center longitudinal passage, the opposite rod end extending beyond said prosthetic ligament end for receiving a pulling force thereon to move said expansion anchor into said expansion cone so as to flare said expansion cone outwardly into a skirt at said longitudinal slots, a circumferential edge formed around said expansion anchor to travel into the continuous groove of the inner circumference of the expansion cone, locking therein.

6. A surgical system as recited in claim 5, wherein the expansion anchor tapers inwardly from a central ring to a lesser diameter section and then outwardly to the end wherein the expansion anchor is center holed forming a circumferential edge that is the same diameter as the expansion anchor center portion;

and the expansion anchor center hole is tapped to receive a threaded end of the rod, which rod and expansion anchor center hole threads are such as to disengage when a certain tension stress is applied therebetween.

7. A surgical system as recited in claim 3, wherein, to provide for securing the prosthetic ligament tibial attachment end to the tibia, a flattened cone shaped disk is provided having a lesser diameter end wherefrom the cone shaped disk outer surface slopes uniformly outwardly to a greater diameter end, which lesser diameter end is for alignment with and installation in the tibia end of the ligament tunnel, the cone shaped disk having a center opening therethrough that is tapped to be turned over a threaded tibial end of said prosthetic ligament, turning of which cone shaped disk on said prosthetic ligament threaded end to move said lesser diameter cone shaped disk end into engagement with the bone around said ligament tunnel tibial end for setting prosthetic ligament tensioning.

8. A surgical system as recited in claim 1, wherein the ligament tunnel closed end within the fem ur cortex is tapped to form threads in the surrounding bone.

9. A surgical system as recited in claim 8, wherein, for a prosthetic ligament, the ligament femoral attachment connector includes thread means formed on the prosthetic ligament fem ur end for turning into the threads formed in the ligament tunnel at the fem ur cortex end.

10. A surgical system as recited in claim 8, further includes, for securing the prosthetic ligament tibial attachment end to the tibial end of the ligament tunnel, a flattened cone shaped disk having a lesser diameter end wherefrom the cone shaped disk slopes uniformly outwardly to a greater diameter end, which lesser diameter end is for alignment with and installation in the tibia end of the ligament tunnel, the cone shaped disk having a center opening therethrough that is tapped to be turned over a threaded tibial end of said prosthetic ligament, turning of which cone shaped disk on said prosthetic ligament to move said lesser diameter cone shaped disk end into engagement with the bone around said ligament tunnel tibial end for setting prosthetic ligament tensioning.

11. A surgical system as recited in claim 8, wherein, for an allograft R ligament, the fem ur attachment connector is a cylinder that includes threads formed along the length of its outer circumference, which threads are for turning into the threads formed in the fem ur cortex end of the ligament tunnel, which fem ur attachment connector is holed longitudinally from end to end at radial spaced apart intervals to accommodate a suture that is threaded therethrough and through spaced points at the end of the allograft ligament, the cylinder further including a center longitudinal sided driver hole formed in one end thereof;

and a tool that is sided to fit within the cylinder center longitudinal sided driver hole, wherearound the allograft ligament is arranged for turning said cylinder into the threaded fem ur cortex end of the ligament tunnel, the tool opposite end to extend out from the tibia end of said ligament tunnel for turning.

12. A surgical system as recited in claim 11, wherein the one end of the fem ur attachment connector is dished inwardly at the allograft ligament connection end, a circumferential lip extending from the cylinder end above that dished out portion to accommodate the end of said allograft ligament drawn therepast, against the dished surface of the cylinder, by tightening the sutures that have been passed at intervals through the allograft ligament end and threaded through through the cylinder radial longitudinal holes.

13. A surgical system as recited in claim 11, wherein the center longitudinal hole is hexagonally sided to accommodate, as the tool, a straight hexagonally sided shaft for sliding into said cylinder center longitudinal hole and accommodating the allograft ligament arranged therearound.

14. A surgical system as recited in claim 1, wherein the respective fem ur cortex and tibial attachment connectors of the prosthetic and allograft ligaments are formed of a biodegradable material for absorption by the body.

15. A surgical system as recited in claim 1, wherein the biodegradable material is polylactic acid.

24. A surgical system for installing an allograft ligament as recited in claim 2, wherein the one end of the allograft ligament connector is dished inwardly and includes a circumferential lip that extends above said dished portion to accommodate the end of said allograft ligament drawn therein by tightening the sutures that have been passed therethrough and through the cylinder radial longitudinal holes.

16. A surgical system for a prosthetic ligament implant as a replacement for a knee ligament, particularly a cruciate ligament, the ligament for installation in a ligament tunnel formed to have a closed end in either the femoral or tibial cortex, said ligament tunnel extending across the knee joint and is open at the distal bone surface from the ligament tunnel closed end, which ligament tunnel closed end is prepared to receive and connect in binding engagement to an end of said prosthetic ligament comprising, a femoral attachment connector end means secured to one end of said prosthetic ligament to be permanently secured in said prepared ligament tunnel cortex end;

and a tibial attachment connector means that is secured to said prosthetic ligament other end for maintaining and adjusting the prosthetic ligament tensioning at the ligament tunnel entrance which tibial attachment connector means consists of a flattened cone shaped disked that has a lesser diameter end wherefrom the cone shaped disk outer surface slopes uniformly outwardly to a greater diameter end, which lesser diameter end is for alignment with and installation in the open end of said ligament tunnel, the cone shaped disk having a center opening therethrough that is tapped to be turned over a threaded end of said prosthetic ligament, turning of which cone shaped disk on said prosthetic ligament threaded end to move said lesser diameter cone shaped disk end into engagement with the bone around said ligament tunnel open end.

17. A surgical system for a prosthetic ligament implant as recited in claim 16, wherein the ligament tunnel closed end is formed to have an open inverted cone shaped section and the femoral attachment connector means is an expansion cone that is formed as an open cylinder, is longitudinally open therethrough and has a proximal end that is secured to an end of the prosthetic ligament, which prosthetic ligament includes an open center longitudinal passage therethrough, and the expansion cone is longitudinally slotted at spaced apart intervals around its distal end from its coupling to said prosthetic ligament end and includes a continuous groove formed around the cylinder inner circumference at approximately the center thereof;

and means for expanding said expansion come into a skirt at its longitudinally slotted end.

18. A surgical system as recited in claim 17, wherein the means for expanding the expansion cone consists of an expansion anchor means that is cylindrical in shape and is center holed on one end to receive an end of a rod releasably secured, which coupling is such so as to be capable of breaking apart when a certain pulling force is exerted thereon, which rod is telescoped in sliding arrangement through said prosthetic ligament open center longitudinal passage the opposite rod end extending beyond said prosthetic ligament end;

and said expansion anchor means to travel on the end of said rod into said expansion cone a circumferential edge of said expansion anchor means to travel into the continuous groove that is formed around the inner circum ference of said expansion cone to flare said expansion cone outwardly into a skirt at said longitudinal slots and locking therein.

19. A surgical system as recited in claim 18, wherein the expansion anchor tapers inwardly from a central ring to a lesser diameter section and then outwardly to the end wherein the expansion anchor in center holded forming a circumferential edge that is the same diameter as the expansion anchor center portion;

and the expansion anchor center hole is tapped to receive a threaded end of the rod, which rod and expansion anchor center hole threads are such as to disengage when a certain tension stress is applied therebetween.

20. A surgical system for a prosthetic ligament implant as recited in claim 16, wherein the ligament tunnel closed end is tapped to form threads in the surrounding bone and the end means of the prosthetic ligament for perm anent atttachment in that ligament tunnel closed end includes thread means formed therearound for turning into the threads formed in said closed end of the ligament tunnel.

21. A surgical system for a prosthetic ligament as recited in claim 16, wherein the respective prosthetic ligament attachment connector means are formed of a biodegradable material for absorption by the body.

22. A surgical system for a prosthetic ligament as recited in claim 21, wherein the biodegradable material is polylactic acid.

23. A surgical system for installing an allograft ligament implant as a replacement for a knee ligament, particularly a cruciate ligament, the ligament for installation in a straight ligament tunnel formed to have a closed end in either the femoral or tibial cortex, which ligament tunnel extends across the knee joint and is open at the distal bone surface from the ligament tunnel closed end, the ligament tunnel closed end to be tapped to form threads in the surrounding bone comprising, as an allograft ligament connector, a cylinder that has threads formed over its length around its outer circumference, which threads are for turning into the threads formed in the threaded closed end of the ligament tunnel, which cylinder is holed longitudinally from end to end at radial spaced apart intervals to accommodate a suture that is threaded therethrough and through spaced points at the end of the allograft ligament, said cylinder further including a center longitudinal sided driver hole formed in one end thereof;

sided tool means appropriate for removable fitting into said center longitudinal sided driver hole for turning said cylinder into said ligament tunnel threaded said tool means opposite end to extend from the open end of said ligament tunnel; and

the unattached allograft ligament end is bent into engagement with the bone at said ligament tunnel open end to receive connector means for securing said ligament end to said bone surface.

25. A surgical system as recited in claim 23, wherein the cylinder center longitudinal hole is hexagonally sided to accommodate, as the tool means, a straight hexagonally sided shaft for sliding into said cylinder center longitudinal hole and accommodating the allograft ligament arranged therearound.

26. A surgical system as recited in claim 23, wherein the allograft ligament connector is formed of a biodegradable material for absorption by the body.

27. A surgical system as recited in claim 25, wherein the biodegradable material is polylactic acid. .Iadd.

28. A surgical system for replacement of an anterior cruciate ligament comprising, with the pateint'"'"'s knee bent appropriately, from a single skin incision at the proximal tibial, means for forming a bone tunnel passes through the proximal tibia. through the cruciate ligament junctions, and into the endosteal bone within distal fem ur;

a graft ligament, either natural or prosthetic, that includes a mounting means installed onto its femoral end, said ligament adapted to be arthroscopically installed into said distal fem ur bony tunnel;

means for endosteally securing said mounting means in said distal fem ur tunnel; and

means for securing, under tension, the other end of said graft ligament at or adjacent to the proximal tibial cortex tunnel end. .Iaddend. .Iadd.

29. A surgical system as recited in claim 28, wherein the system is practiced under fluoroscopic visualization control. .Iaddend. .Iadd.30. A surgical system as recited in claim 28, wherein the mounting means is introduced to the intra articular opening of the femoral tunnel through the tibial tunnel or through an adjacent soft tissue portal formed into

31. Iaddend. .Iadd.33. A surgical method as recited in claim 31, wherein the ligament tunnel is drilled from a single incision at the anterior medial

30. the knee joint. .Iaddend. .Iadd.31. A surgical method for performing ligament surgery comprising the steps of bending the tibia to a predetermined angle with respect to the fem ur, forming a straight ligament tunnel through the tibia and into the fem ur, via a single proximal tibia incision, and securing ends of a natural of prosthetic ligament, respectively, to the tibia and endosteally within the distal fem ur portion of said tunnel. .Iaddend. .Iadd.32. A surgical method as recited in claim 31, wherein the natural or prosthetic ligament end is endosteally fixed within the distal fem ur by use of an attachment device connected to the ligament end which provides for ligament fixati0n within the distal fem ur portion of the tunnel;

setting the ligament tension at the open end of the tibial ligament tunnel; and

securing said ligament tibial end at or adjacent to said open ligament tunnel tibial end.

32. tibia. .Iaddend. .Iadd.34. A surgical method as recited in claim 31, wherein the ligament femoral end is secured within the distal femoral tunnel portion between the distal fem ur posterior and anterior cortexes. .Iaddend. .Iadd.35. A surgical method as recited in claim 31, wherein the ligament femoral end includes an attachment device that is introduced into the ligament tunnel through the open tibial tunnel end or through an adjacent soft tissue portal into the knee joint. .Iaddend.