Soft tissue repair assembly and associated method

• US 7,749,250 B2
• Filed: 02/03/2006
• Issued: 07/06/2010
• Est. Priority Date: 02/03/2006
• Status: Active Grant

• Current Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Walters, Troy M., Stone, Kevin T., Holst, Andrew
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): Dornbusch; Dianne
• Application Number:
  US11/347,661
• Publication Number:
  US 20070185532A1
• Time in Patent Office: 1,614 Days
• Field of Search: 606/74, 606/213, 606/215, 606/216, 606/232, 606/233, 241/29.D, 289/2, 289/17, 285/235, 623/13.15, 623/13.11
• US Class Current: 606/232
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus

Abstract

A soft tissue repair assembly. The assembly includes a flexible member having first and second ends, and a strand passing through the flexible member. The strand has first and second strand ends extending through the flexible member, such that pulling at least one of the first and second strand ends changes the flexible member from a first shape suitable for insertion through soft tissue to a second shape suitable for securely lodging the soft tissue repair assembly relative to soft tissue.

Claims

1. A soft tissue repair assembly comprising:

an implantable integral deformable and flexible member defining an internal longitudinal bore and having first and second ends;

a first flexible strand passing through the flexible member, the first strand forming a closed loop, the closed loop passing at least partially through the longitudinal bore and having first and second loop ends extending outside the bore of the flexible member;

a second flexible strand separate from the first flexible strand, the second flexible strand coupled to the first and second loop ends of the first strand, the second strand extending substantially outside the flexible member, the second strand having first and second strand ends, such that pulling at least one of the first and second strand ends deforms the flexible member from a first shape suitable for insertion through soft tissue to a second shape suitable for securely lodging the soft tissue repair assembly relative to the soft tissue; and

an inserter having a shaft extending along a longitudinal axis with a solid cross-section and a groove perpendicular to the longitudinal axis of the shaft, the groove formed on an outer surface of the shaft, the groove supporting the flexible member outside the shaft, such that the flexible member is folded in a U-shape over the groove with the second flexible strand coupled thereon.

2. The soft tissue repair assembly of claim 1, wherein the first and second loop ends of the first flexible strand extend through first and second wall openings defined through a wall of the flexible member.

3. The soft tissue repair assembly of claim 1, wherein the flexible member comprises braided material.

4. The soft tissue repair assembly of claim 1, wherein the flexible member comprises woven material.

5. The soft tissue repair assembly of claim 1, further comprising a protective sleeve over the flexible member.

6. The soft tissue repair assembly of claim 1, further comprising a separate elongated tubular conduit for vascularization, the conduit including an outer surface, a longitudinal inner bore and a plurality of perforations through the outer surface.

7. The soft tissue repair assembly of claim 6, wherein the second flexible strand passes through the tubular conduit.

8. The soft tissue assembly of claim 1, wherein relative to the soft tissue includes in soft tissue, adjacent the soft tissue or on an outer surface of the soft tissue.

9. A soft tissue repair assembly comprising:

an implantable integral deformable and flexible member in the form of a tube having first and second ends and defining an internal longitudinal bore between the first and second ends;

a first continuous flexible strand having first and second ends, the first and second ends forming respective first and second loop ends, the first strand passing once through the longitudinal bore forming a loop around the longitudinal bore, the first and second loop ends extending outside the bore of the tube through first and second openings away from the first and second ends of the tube; and

a second flexible strand separate from the first flexible strand, the second flexible strand coupled to the first and second loop ends of the first strand, the second strand extending substantially outside the tube, the second strand having first and second strand ends, such that pulling at least one of the first and second strand ends deforms the tube from a first shape suitable for insertion through soft tissue to a second shape suitable for securely lodging the soft tissue repair assembly relative to the soft tissue, wherein the first shape is circular and the second shape is an eight-like shape; and

an inserter wherein the inserter includes a shaft with a solid cross-section and a longitudinal axis, the shaft defining a groove on an outer surface of the shaft, the groove being perpendicular to the longitudinal axis of the shaft, wherein the flexible member is supported on the groove outside the shaft.

10. The soft tissue repair assembly of claim 9, wherein the flexible member comprises woven material.

11. The soft tissue repair assembly of claim 9, wherein the flexible member comprises braided material.

12. The soft tissue repair assembly of claim 9, further comprising a separate elongated tubular conduit for vascularization preloaded on the inserter, the conduit including an outer surface, a longitudinal inner bore and a plurality of perforations through the outer surface.

13. A soft tissue repair assembly comprising:

an implantable integral deformable and flexible member forming a tube having first and second ends and defining an internal longitudinal bore between the first and second ends;

a continuous flexible strand having first and second strand ends, the strand passing once through longitudinal bore such that the first strand end exits the first end of the tube and passes through a first hole of the tube through the tube and the second strand end exits the second end of the tube and passes through a second hole of the tube through the tube, the first and second holes intermediate the first and second ends of the tube, such that pulling the first and second strand ends deforms the tube from a first shape suitable for insertion through soft tissue to a second shape suitable for securely lodging the soft tissue repair assembly relative to the soft tissue, wherein first shape is substantially linear and the deformed second shape is a pretzel-like shape including curved portions; and

an inserter including a shaft having a needle, the needle defining a longitudinal bore into which the tubular member is preloaded, the inserter including a flexible and retractable pusher, wherein the pusher includes a curved end that is straightened when the pusher is retracted under one of the tubular members the pusher operable to push the tubular members out of the needle.

14. A soft tissue repair assembly comprising:

a first inserter, the first inserter including a shaft with a solid cross-section and a longitudinal axis, the shaft defining a groove on an outer surface of the shaft, the groove perpendicular to the longitudinal axis of the shaft;

a first integral deformable and flexible tubular member, the first tubular member preloaded on the first inserter in a first shape, wherein the first shape is a substantially folded U-shape, the first tubular member supported on the groove outside the shaft, the first tubular member comprising woven fabric and having first and second open ends defining an internal longitudinal bore extending between the first and second ends of the first tubular member;

a first flexible strand forming a continuous loop, the continuous loop inserted within the longitudinal bore of the first tubular member such that first and second loop ends extend through the first and second ends of the first tubular member; and

a second flexible strand separate from the first flexible strand, the second flexible strand passing through the first and second loop ends of the first flexible strand, the second flexible strand operable by pulling to deform the shape of the first tubular member from the first shape to a second shape after implantation, the second shape being a U-shape bulkier than the first shape and suitable for securely lodging the first tubular member relative to soft tissue.

15. The soft tissue repair assembly of claim 14, further comprising:

a second integral deformable and flexible tubular member, the second tubular member deformable from a first shape for insertion through tissue to a second shape after implantation, the second tubular member comprising woven fabric and having first and second open ends defining an internal longitudinal bore extending between the first and second ends of the second tubular member;

a third flexible strand forming a continuous loop, the continuous loop inserted within the longitudinal bore of the second tubular member such that first and second loop ends of the third flexible strand extend through the first and second ends of the second tubular member; and

wherein the second flexible strand passes through the first and second loop ends of the second flexible strand for deforming both the first and second tubular members.

16. The soft tissue repair assembly of claim 14, further comprising a second inserter.

17. A soft tissue repair assembly comprising:

a plurality of integral deformable and flexible tubular members, each tubular member formed of woven fabric and having first and second open ends defining a corresponding internal longitudinal bore extending between the first and second ends of each tubular member;

a plurality of flexible strands, each flexible strand forming a separate continuous loop, each continuous loop inserted within the longitudinal bore of a corresponding tubular member such that first and second loop ends extend through the first and second ends of the corresponding tubular member;

an additional flexible strand member separate from the plurality of flexible strands, the additional flexible strand member passing through the first and second loop ends of the each flexible strand, the additional flexible strand member operable by pulling to deform the shape of each tubular member from a first shape to a second shape after implantation, wherein the second shape is a bulkier shape than the first shape and suitable for securely lodging the flexible member relative to soft tissue; and

an inserter including a shaft having a needle, the needle defining a longitudinal bore into which the plurality tubular members are preloaded, the inserter including a flexible and retractable pusher, wherein the pusher includes a curved end that is straightened when the pusher is retracted under one of the tubular members, the pusher operable to push each of the tubular members out of the needle sequentially.