Method and apparatus for coupling soft tissue to a bone

• US 9,572,655 B2
• Filed: 09/22/2014
• Issued: 02/21/2017
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Denham, Gregory J., Stone, Kevin T.
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US14/492,590
• Publication Number:
  US 20150012094A1
• Time in Patent Office: 883 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00845 of moving parts with respect to each other
• CPC Class Codes: A61B 2017/00858 high friction or non-slip
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 : with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/0618 : elastic, e.g. stretchable
• CPC Class Codes: A61B 2017/06185 : hollow or tubular
• CPC Class Codes: A61F 2/08 : Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0805 : Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 : Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0823 : Modular anchors comprising a plurality of separate parts
• CPC Class Codes: A61F 2002/0852 : Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
• CPC Class Codes: A61F 2002/0858 : Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• 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 2002/0888 : Anchor in or on a blind hole or on the bone surface without formation of a tunnel
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D04C 1/12 : Cords, lines, or tows
• CPC Class Codes: D10B 2509/00 : Medical; Hygiene
• CPC Class Codes: D10B 2509/04 : Sutures

Abstract

A method and apparatus for coupling a soft tissue implant into a locking cavity formed within a bone is disclosed. The apparatus includes a member to pull the soft tissue implant into a femoral tunnel. The member includes a suture having first and second ends which are passed through first and second openings associated with the longitudinal passage to form a pair of loops. A collapsible tube is positioned about the suture. Application of tension onto the suture construction causes retraction of the soft tissue implant into the femoral tunnel and the collapse of the tube to form an anchor.

Claims

1. A method for placing an ACL in a femoral tunnel formed in a femur in a patient, the method comprising:

delivering a fixation member through a femoral tunnel to a location outside the femur proximate a first opening in an outer surface of the femur, wherein a suture coupled to the fixation member includes a first free end that passes through the fixation member and through a first longitudinal passage in the suture to form a first adjustable loop that extends back through the femoral tunnel alongside a segment of the first free end of the suture with a portion of the first adjustable loop additionally extending outside the femoral tunnel through a second opening in the outer surface of the femur and into a tibial tunnel, and wherein the suture includes a second free end that passes through the fixation member and through a second longitudinal passage in the suture to form a second adjustable loop that extends back through the femoral tunnel alongside a segment of the second free end of the suture with a portion of the second adjustable loop additionally extending outside the femoral tunnel through the second opening in the outer surface of the femur and into the tibial tunnel, the first longitudinal passage separate from the second longitudinal passage in the suture;

coupling a leading end of an ACL to the first adjustable loop and the second adjustable loop outside the femoral tunnel; and

pulling on the first free end and the second free end of the suture so as to;

advance the segment of the first free end and the segment of the second free end through the femoral tunnel in a direction toward the second opening in the outer surface of the femur, force the fixation member against bone around the first opening in the outer surface of the femur, reduce the size of the first adjustable loop and the size of the second adjustable loop, and pull the leading end of the ACL into the femoral tunnel through the second opening in the outer surface of the femur.

2. The method of claim 1, wherein said delivering leaves the portion of the first adjustable loop and the portion of the second adjustable loop traversing the tibial tunnel, and wherein said coupling occurs while the portion of the first adjustable loop and the portion of the second adjustable loop are traversing the tibial tunnel.

3. The method of claim 1, wherein the first longitudinal passage and the second longitudinal passage in the suture maintain construct maintain positioning relative to the fixation member during said pulling on the first free end and the second free end of the suture.

4. The method of claim 1, wherein the leading end of the ACL is provided by a folded portion of the ACL.

5. The method of claim 1, wherein said pulling on the first free end and the second free end of the suture substantially fills the femoral tunnel with a portion of the ACL.

6. The method of claim 1, wherein the ACL is an artificial ACL.

7. The method of claim 1 further comprising fixing the ACL to the tibia after the leading end of the ACL is pulled to a desired location in the femoral tunnel.

8. The method of claim 7 further comprising, after said fixing, pulling on the first free end and the second free end of the suture to place a desired load on the ACL.

9. The method of claim 8, wherein the first adjustable loop and the second adjustable loop are self-locking to resist a decrease in the desired load.

10. The method of claim 8 further comprising measuring the desired load with a force gauge.

11. The method of claim 1, wherein said delivering locates the first longitudinal passage and the second longitudinal passage adjacent the first opening in the outer surface of the femur.

12. The method of claim 1, wherein the first opening in the outer surface of the femur and a first longitudinal section of the femoral tunnel have a first diameter, and wherein the second opening in the outer surface of the femur and a second longitudinal section of the femora tunnel have a second diameter that is larger than said first diameter.

13. A method for placing an ACL in a tibial tunnel formed in a tibia and a femoral tunnel formed in a femur in a patient, the method comprising:

locating a fixation member outside the femur proximate a first opening in an outer surface of the femur, the first opening in the outer surface of the femur providing access to a femoral tunnel that extends through a portion of the femur to a second opening in the outer surface of the femur, the second opening in the outer surface of the femur proximate a first opening in an outer surface of the tibia, wherein a first adjustable loop and a second adjustable loop of a suture coupled to the fixation member extend back through the femoral tunnel with a portion of the first adjustable loop and a portion of the second adjustable loop additionally extending;

through the second opening in the outer surface of the femur, through the first opening in the outer surface of the tibia, and through a portion of the tibia, via the tibial tunnel, toward a second opening in the outer surface of the tibia, the first adjustable loop and the second adjustable loop coupled to a leading end of an ACL in the tibial tunnel, the suture also including a first free end with a suture segment that extends back through the femoral tunnel alongside the first adjustable loop and a second free end with a suture segment that extends back through the femoral tunnel alongside the second adjustable loop, wherein formation of the first adjustable loop includes passing the first free end of the suture through a first longitudinal passage in the suture and formation of the second adjustable loop includes passing the second free end of the suture through a second longitudinal passage in the suture, the first longitudinal passage separate from the second longitudinal passage in the suture; and

pulling on the first free end and the second free end of the suture, wherein said pulling;

advances the suture segment of the first free end and the suture segment of the second free end through the femoral tunnel in a direction toward the second opening in the outer surface of the femur, reduces the size of the first adjustable loop and the size of the second adjustable loop, pulls the leading end of the ACL out of the tibial tunnel through the first opening in the outer surface of the tibia, and pulls the leading end of the ACL into the femoral tunnel through the second opening in the outer surface of the femur.

14. The method of claim 13, wherein the first free end and the second free end of the suture pass through the fixation member.

15. The method of claim 13, wherein the first longitudinal passage and the second longitudinal passage in the suture maintain positioning relative to the fixation member during said pulling on the first free end and the second free end of the suture.

16. The method of claim 13 further comprising fixing the ACL to the tibia after the leading end of the ACL is pulled to a desired location in the femoral tunnel.

17. The method of claim 16 further comprising, after said fixing, pulling on the free end of the suture to place a desired load on the ACL.

18. A method for placing an ACL in a tibial tunnel formed in a tibia and a femoral tunnel formed in a femur in a patient, the femoral tunnel including a first opening and a second opening in an outer surface of the femur, the tibial tunnel including a first opening and a second opening in an outer surface of the tibia, the second opening in the outer surface of the femur proximate the first opening in the outer surface of the tibia, the method comprising:

delivering a fixation member through the femoral tunnel to a location outside the femur proximate the first opening in the outer surface of the femur, wherein a suture coupled to the fixation member includes a first free end that passes through the fixation member and through a first longitudinal passage in the suture to form a first adjustable loop that extends back through the femoral tunnel alongside a segment of the first free end of the suture, the suture also including a second free end that passes through the fixation member and through a second longitudinal passage in the suture to form a second adjustable loop that extends back through the femoral tunnel alongside a segment of the second free end of the suture, the first longitudinal passage separate from the second longitudinal passage in the suture, the first adjustable loop and the second adjustable loop further extending;

out of the femoral tunnel through the second opening in the outer surface of the femur, into the tibial tunnel through the first opening in the outer surface of the tibia, and out of the tibial tunnel through the second opening in the outer surface of the tibia;

coupling a leading end of an ACL to a portion of the first adjustable loop and a portion of the second adjustable loop that are protruding from the second opening in the outer surface of the tibia; and

pulling on the first free end and the second free end of the suture so as to;

advance the segment of the first free end and the segment of the second free end through the femoral tunnel in a direction toward the second opening in the outer surface of the femur, force the fixation member against bone around the first opening in the outer surface of the femur, reduce the size of the first adjustable loop and the size of the second adjustable loop, pull the leading end of the ACL into the tibial tunnel through the second opening in the outer surface of the tibia, pull the leading end of the ACL out of the tibial tunnel through the first opening in the outer surface of the tibia, and pull the leading end of the ACL into the femoral tunnel through the second opening in the outer surface of the femur.

19. The method of claim 18, wherein the first longitudinal passage and the second longitudinal passage in the suture maintain positioning relative to the fixation member during said pulling on the first free end and the second free end of the suture.

20. The method of claim 18 further comprising fixing the ACL to the tibia after the leading end of the ACL is pulled to a desired location in the femoral tunnel.

21. The method of claim 20 further comprising, after said fixing, pulling on the free end of the suture to place a desired load on the ACL.

22. A method for placing an ACL in a femoral tunnel formed in a femur in a patient, the method comprising:

delivering a fixation member through a femoral tunnel to a location outside the femur proximate a first opening in an outer surface of the femur, wherein a suture coupled to the fixation member includes a free end that passes through a portion of the fixation member and through a longitudinal passage in the suture to form an adjustable loop that extends back through the femoral tunnel alongside a segment of the free end of the suture, a portion of the adjustable loop additionally extending outside the femoral tunnel through a second opening in the outer surface of the femur and into a tibial tunnel;

coupling a leading end of an ACL to the adjustable loop outside the femoral tunnel; and

pulling on the free end of the suture so as to;

advance the free end segment through the femoral tunnel in a direction toward the second opening in the outer surface of the femur, force the fixation member against bone around the first opening in the outer surface of the femur, reduce the size of the adjustable loop, and pull the leading end of the ACL into the femoral tunnel through the second opening in the outer surface of the femur, wherein the longitudinal passage in the suture maintains positioning relative to the fixation member during said pulling on the free end of the suture.

23. The method of claim 22, wherein said delivering leaves the portion of the adjustable loop traversing the tibial tunnel, and wherein said coupling occurs while the portion of the adjustable loop is traversing the tibial tunnel.

24. A method for placing an ACL in a tibial tunnel formed in a tibia and a femoral tunnel formed in a femur in a patient, the method comprising:

locating a fixation member outside the femur proximate a first opening in an outer surface of the femur, the first opening in the outer surface of the femur providing access to a femoral tunnel that extends through a portion of the femur to a second opening in the outer surface of the femur, the second opening in the outer surface of the femur proximate a first opening in an outer surface of the tibia, wherein an adjustable loop of a suture coupled to the fixation member extends back through the femoral tunnel with a portion of the adjustable loop additionally extending;

through the second opening in the outer surface of the femur, through the first opening in the outer surface of the tibia, and through a portion of the tibia, via the tibial tunnel, toward a second opening in the outer surface of the tibia, the adjustable loop coupled to a leading end of an ACL in the tibial tunnel, the suture also including a free end with a suture segment that extends back through the femoral tunnel alongside the adjustable loop, wherein formation of the adjustable loop includes passing the free end of the suture through a longitudinal passage in the suture; and

pulling on the free end of the suture, wherein said pulling;

advances the suture segment through the femoral tunnel in a direction toward the second opening in the outer surface of the femur, reduces the size of the adjustable loop, pulls the leading end of the ACL out of the tibial tunnel through the first opening in the outer surface of the tibia, and pulls the leading end of the ACL into the femoral tunnel through the second opening in the outer surface of the femur, wherein the longitudinal passage in the suture maintains positioning relative to the fixation member during said pulling on the free end of the suture.

25. A method for placing an ACL in a tibial tunnel formed in a tibia and a femoral tunnel formed in a femur in a patient, the femoral tunnel including a first opening and a second opening in an outer surface of the femur, the tibial tunnel including a first opening and a second opening in an outer surface of the tibia, the second opening in the outer surface of the femur proximate the first opening in the outer surface of the tibia, the method comprising:

delivering a fixation member through the femoral tunnel to a location outside the femur proximate the first opening in the outer surface of the femur, wherein a suture coupled to the fixation member includes a free end that passes through a portion of the fixation member and through a longitudinal passage in the suture to form an adjustable loop that extends back through the femoral tunnel alongside a segment of the free end, the adjustable loop further extending;

out of the femoral tunnel through the second opening in the outer surface of the femur, into the tibial tunnel through the first opening in the outer surface of the tibia, and out of the tibial tunnel through the second opening in the outer surface of the tibia;

coupling a leading end of an ACL to a portion of the adjustable loop that is protruding from the second opening in the outer surface of the tibia; and

pulling on the free end of the suture so as to;

advance the free end segment through the femoral tunnel in a direction toward the second opening in the outer surface of the femur, force the fixation member against bone around the first opening in the outer surface of the femur, reduce the size of the adjustable loop, pull the leading end of the ACL into the tibial tunnel through the second opening in the outer surface of the tibia, pull the leading end of the ACL out of the tibial tunnel through the first opening in the outer surface of the tibia, and pull the leading end of the ACL into the femoral tunnel through the second opening in the outer surface of the femur, wherein the longitudinal passage in the suture maintains positioning relative to the fixation member during said pulling on the free end of the suture.