KNOTLESS SUTURE ANCHOR HAVING DISCRETE POLYMER COMPONENTS AND RELATED METHODS

• US 20080319478A1
• Filed: 04/21/2008
• Published: 12/25/2008
• Est. Priority Date: 04/25/2007
• Status: Active Grant

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Foerster, Seth A., Aldridge, David
• Granted Patent: US 8,137,381 B2
• Time in Patent Office: Days
• 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 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor

Abstract

A knotless bone anchor and method for securing soft tissue, such as tendons, to bone, includes a plurality of discrete components. In one variation of the invention, the bone anchor includes a proximal toggle component, an intermediate plug component, and a distal sleeve component. Suture is looped around the plug component and once the anchor is actuated, the suture is compressed between the plug and the sleeve components. Advantageously, one or more of the components may be made of a biocompatible polymer. The polymeric components may be detachably joined to a drive shaft using a plurality of sacrificial fills. The sacrificial fills are broken or severed during deployment of the anchor. Related instruments and methods are also described.

Claims

11. A driver instrument for inserting a suture anchor into a bone tunnel comprising:

a handle;

an elongate drive shaft extending from said handle, said shaft having a distal end section comprising a wall and a first set of holes extending through said wall;

an elongate die shaft in slideable arrangement with said elongate shaft, said die shaft comprising a distal abutment surface; and

a first anchor component detachably connected to said drive shaft by a first set of sacrificial fills extending into said first set of holes, said sacrificial fills having a size such that upon relative movement between said drive shaft and said die shaft, said abutment surface applies a force to said first anchor component in a direction opposite to the movement of said drive shaft thereby causing the first set of fills to break from said first anchor component.

12. The driver instrument of claim 11 further comprising a second anchor component distal to said first anchor component, said second anchor component connected to said drive shaft by a second set of sacrificial fills extending into a second set of holes in said distal section of said drive shaft wherein said second set of sacrificial fills being adapted to break from said second anchor component subsequent to said first set of sacrificial fills upon relative movement between said drive shaft and said die shaft.

13. The driver instrument of claim 12 further comprising a third anchor component distal to said second anchor component, said third anchor component connected to said drive shaft by a third set of sacrificial fills extending into a third set of holes in said distal section of said drive shaft wherein said third set of sacrificial fills being adapted to break from said third anchor component subsequent to said second set of sacrificial fills upon relative movement between said drive shaft and said die shaft.

14. The driver instrument of claim 13 wherein said first anchor component has an oval shape, and wherein said first anchor component has a first low profile orientation for insertion and a second large profile orientation when affixing said anchor in bone.

15. The driver instrument of claim 13 wherein said second anchor component has one shape selected from the group consisting of a plug, bullet, cylinder, and ball.

16. The driver instrument of claim 15 wherein said second anchor component is made of PEEK.

17. The driver instrument of claim 12 wherein said second component comprises a suture guide.

18. The driver instrument of claim 17 wherein said suture guide comprises an exteriorly disposed groove extending around a distal end surface of said second anchor component.

19. The driver instrument of claim 17 wherein said suture guide is an eyelet.

20. The driver instrument of claim 12 wherein at least one hole of said first set of holes has a circular cross section.

21. The driver instrument of claim 12 wherein said drive shaft is made of a different material than that of said first component.

22. A method for securing a soft tissue to a bone body comprising:

placing a stitch in the soft tissue to obtain at least one free suture end;

threading a bone anchor with said at least one free suture end;

inserting the anchor into a bone tunnel, said anchor detachably connected to a distal end of an elongate drive member by at least one sacrificial fill;

actuating a first component of the anchor to affix the anchor in the bone tunnel;

tensioning the suture until the tissue is held under tension in a desired location subsequent to said actuating step;

locking said suture; and

detaching said anchor from said drive member by severing said sacrificial fill.

23. The method of claim 22 wherein said actuating step is carried out by toggling said first component.

24. The method of claim 22 wherein said bone tunnel extends through a cortical layer of bone and into a subcortical layer of bone, said method further comprising a step of undercutting a subcortical tissue mass.

25. The method of claim 22 wherein said soft tissue is the rotator cuff.

26. The method of claim 22 wherein said anchor comprises a second plug component, and a suture guide disposed about an exterior surface of said plug component.

27. A bone tunnel preparation instrument for preparing a bone tunnel for insertion of an anchor, said instrument comprising:

a handle and a trigger;

an elongate member extending from said handle, said elongate member comprising a distal end section, a distal tip, and a lateral window proximal of said distal tip;

a punch member situated within said window and comprising a cutting leading edge, said punch member being operatively connected to said trigger such that upon actuation of said trigger, said leading edge protrudes from said window to the extent that the trigger is actuated thereby modifying and cutting bone in the vicinity of the window.

1. A knotless suture anchor for securing soft tissue to bone comprising:

a first component adapted to affix the anchor in a bone tunnel;

a second component distal to said first component, said second component comprising a suture guide, and a proximal abutment surface adapted to abut a distal surface of said first component;

a third component distal to said second component, said third component comprising a cavity and a proximal opening, said cavity being adapted to accept said second component and to compress said suture when the second component is within the cavity of the third component thereby locking the suture in place and wherein said second component is made of a polymer.

2. The anchor of claim 1 wherein said first component has a first position and a second position different than said first position, said second position having a larger radial profile than said first position.

3. The anchor of claim 2 wherein said first component has an annular shape.

4. The anchor of claim 1 wherein said second component comprises a body and exterior surface, and said suture guide comprises a groove disposed about the exterior surface, and a portion of said groove extends across a distal surface of said second component.

5. The anchor of claim 1 wherein each of said first, second, and third components are separate members.

6. The anchor of claim 1 wherein said polymer is PEEK.

7. The anchor of claim 1 wherein each of said first, second and third components are made of an injection molded polymer.

8. The anchor of claim 7 wherein each of said first, second, and third components are detachably formed onto a driver shaft prior to deployment of the anchor, and a first axial space is present between the first and second components and a second axial space is present between the second and third components.

9. The anchor of claim 1 wherein said third component has a sleeve or tubular shape.

10. The anchor of claim 7 wherein each of the components is insert molded onto a drive shaft.

28. The instrument of claim 27 wherein said punch member further comprises a trailing cutting edge.

29. The instrument of claim 27 wherein said punch member is rotatably connected to said distal end section via a cross member and said cutting leading edge has a sweeping movement as the trigger is actuated remains constant.

30. The instrument of claim 27 wherein said punch comprises a tissue capture area comprising a space for holding tissue as the punch is manipulated through tissue.

36. A kit comprising:

an anchor as recited in claim 1;

an elongate member having a distal section upon which said anchor is detachably connected; and

a handheld tunnel preparation instrument comprising a handle, an elongate shaft, and an actuatable punch housed within said distal end section of said elongate shaft.

29-1. The instrument of claim 28, further comprising a tubular die shaft extending along the exterior of said elongate member, said die shaft comprising a distal stop surface situated proximal of said lateral window, and wherein a distance between said cutting leading edge and a stop.

31. A suture anchor for affixing tissue to bone comprising:

a toggle member that is movable from a low profile insertion position to a large profile position wherein said large profile position provides said suture anchor a large diameter section that affixes said anchor in a bone tunnel;

a plug member comprising an external surface such that a suture may be looped around said plug; and

a sleeve member having an internal lumen that may receive said plug and compress a suture between said plug and said sleeve to lock said suture in place and wherein each of said toggle member, plug and sleeve member are discrete components.

32. The suture anchor of claim 31 wherein said plug member is detachably connected to a shaft member by at least one plug sacrificial fill.

33. The suture anchor of claim 31 wherein said sleeve member is detachably connected to a shaft member by at least one sleeve sacrificial fill

34. The suture anchor of claim 31 wherein said toggle member is detachably connected to a shaft member by at least one toggle sacrificial fill.

35. The suture anchor of claim 31 wherein said toggle member comprises a disc shape.