Expandable prosthesis for a tissue repair system

• US 9,463,009 B2
• Filed: 07/18/2012
• Issued: 10/11/2016
• Est. Priority Date: 07/18/2012
• Status: Active Grant

• Current Assignee: Jmea Corporation
• Original Assignee: Jmea Corporation
• Inventors: Sack, James A., Yeh, Jack Y.
• Primary Examiner(s): Lawson, Matthew
• Assistant Examiner(s): SIPP, AMY R.
• Application Number:
  US13/552,130
• Publication Number:
  US 20140025125A1
• Time in Patent Office: 1,546 Days
• Field of Search: 606/300, 606/301, 606/313, 606/314, 606/319, 606/320, 606/326, 606/327, 606/328, 606/232, 411/54, 411/54.1, 411/359, 411/448, 411/4, 411/5, 411/40, 411/41
• 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 17/0466 Suture bridges
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/844 with expandable anchors or anchors having movable parts
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00464 for use with different instruments with hole for different instruments A61B2017/22072
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 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 lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/042 : plastically deformed during insertion
• CPC Class Codes: A61B 2017/0424 : the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/0427 : having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0438 : slotted, i.e. having a longitudinal slot for enhancing their elasticity
• CPC Class Codes: A61B 2017/044 : with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0646 : for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2090/037 : with a frangible part, e.g. by reduced diameter

Abstract

A prosthesis for use with a tissue repair system is capable of expanding during implantation into the tissue. The prosthesis can include a driving portion and a base portion. The driving portion helps drive the prosthesis into a tissue during a first stage of implantation. The base portion is configured to expand or splay open during a second stage of implantation. The prosthesis may include a hole for receiving a portion of a suture thread.

Claims

1. A prosthesis assembly configured for implantation into tissue, comprising:

a prosthesis comprising a driving portion and a base portion;

the driving portion including a driving tip portion, a central portion, and a wedge portion, wherein the driving tip portion is shaped and dimensioned to penetrate bone to create a first bore;

the base portion including a forward portion and a rearward portion, the forward portion being associated with the driving portion;

the base portion comprising a first longitudinal portion that extends along the length of the base portion and a second longitudinal portion that extends along the length of the base portion;

the first longitudinal portion and the second longitudinal portion being attached at the rearward portion, and the first longitudinal portion and the second longitudinal portion being separable at the forward portion;

the first longitudinal portion being associated with a first surface of the wedge portion, and the second longitudinal portion being associated with a second surface of the wedge portion;

the prosthesis including a longitudinal cavity that is between the first longitudinal portion and the second longitudinal portion, that is aligned with a longitudinal axis of the prosthesis, and that extends through the prosthesis at least from the forward portion of the base portion to the rearward portion of the base portion;

wherein the longitudinal cavity has a first length;

a tube having an end portion disposed adjacent to the rearward portion of the base portion, wherein the tube has a second length;

a pin disposed in the longitudinal cavity and the tube, wherein the pin has a third length;

wherein the pin contacts the driving portion and extends from the driving portion through the longitudinal cavity and beyond the rearward portion through the tube;

wherein the third length of the pin is at least as long as the combined length of the first length of the longitudinal cavity and the second length of the tube; and

wherein during implantation of the prosthesis;

the driving portion and the base portion of the prosthesis move in a forward direction from a pre-implantation position to a final implantation position, with no rearward direction movement,

the end portion of the tube applies a force in the forward direction to the rearward portion of the base portion,

the first longitudinal portion and the second longitudinal portion are configured to engage the wedge portion and spread apart from one another,

the first longitudinal portion is shaped and dimensioned to penetrate the bone to create a second bore, wherein a direction of extension of the second bore differs from that of the first bore created by the driving tip portion, and

the second longitudinal portion is shaped and dimensioned to penetrate the bone to create a third bore, wherein a direction of extension of the third bore differs from that of the first bore created by the driving tip portion and the second bore created by the first longitudinal portion.

2. The prosthesis assembly according to claim 1, wherein the first surface of the wedge portion and the second surface of the wedge portion are joined along an edge of the wedge portion.

3. The prosthesis assembly according to claim 1, wherein the base portion includes a longitudinal slot that divides the first longitudinal portion from the second longitudinal portion and extends from the forward portion of the base portion toward the rearward portion of the base portion to allow passage of a suture thread from the driving portion, through the longitudinal slot, and beyond the rearward portion of the base portion;

and

wherein the longitudinal slot is laterally offset from the longitudinal axis of the prosthesis.

4. The prosthesis assembly according to claim 1, wherein during implantation of the prosthesis, the pin applies a second force to the driving portion in the forward direction.

5. The prosthesis assembly according to claim 1, wherein the base portion comprises a third longitudinal portion that extends along the length of the base portion and wherein the first longitudinal portion, the second longitudinal portion, and the third longitudinal portion are joined at the rearward portion of the base portion and wherein the first longitudinal portion, the second longitudinal portion, and the third longitudinal portion are separated at the forward portion.

6. The prosthesis assembly according to claim 5, wherein the first longitudinal portion, the second longitudinal portion, and the third longitudinal portion are configured to spread apart from one another during the implantation of the prosthesis.

7. The prosthesis assembly according to claim 1, wherein the central portion includes a hole for receiving a suture thread.

8. The prosthesis assembly according to claim 7, further comprising a suture thread received by the hole of the central portion of the driving portion.

9. The prosthesis assembly according to claim 8, wherein the base portion defines a longitudinal slot dividing the first longitudinal portion and the second longitudinal portion, and wherein the suture thread extends within the longitudinal slot toward the rearward portion of the base portion.

10. The prosthesis assembly according to claim 1, wherein the prosthesis is configured to be manufactured as a single monolithic piece.

11. The prosthesis assembly according to claim 1, wherein the wedge portion and the base portion are configured to separate from one another under a predetermined force.

12. The prosthesis assembly according to claim 1, wherein the driving tip portion has a tapered forward surface configured to penetrate bone.

13. The prosthesis assembly according to claim 12, wherein the driving tip portion has an approximately conical geometry that is approximately symmetrical about the longitudinal axis of the prosthesis.

14. The prosthesis assembly according to claim 1, wherein before the implantation of the prosthesis, at the forward portion of the base portion, the first longitudinal portion is connected to the driving portion by a first connection portion and the second longitudinal portion is connected to the driving portion by a second connection portion;

and

wherein during the implantation of the prosthesis;

the first connection portion separates from the driving portion and provides the first longitudinal portion with a first pointed distal end that is configured to penetrate bone, and

the second connection portion separates from the driving portion and provides the second longitudinal portion with a second pointed distal end that is configured to penetrate bone.

15. The prosthesis assembly according to claim 1, wherein before the implantation of the prosthesis:

at the forward portion of the base portion, the first longitudinal portion is connected to the driving portion by a first connection portion and the second longitudinal portion is connected to the driving portion by a second connection portion, and

the first connection portion and the second connection portion are rearward of the driving tip portion of the driving portion;

wherein after the implantation of the prosthesis;

the first connection portion is separated from the driving portion and is disposed forward of the driving tip portion of the driving portion, and

the second connection portion is separated from the driving portion and is disposed forward of the driving tip portion of the driving portion.

16. The prosthesis assembly according to claim 1, wherein in a driving position during the implantation of the prosthesis, a distal tip of the driving portion is located distal to a first distal end of the first longitudinal portion and to a second distal end of the second longitudinal portion, and

wherein in an inserted position after the implantation of the prosthesis, the distal tip of the driving portion is located proximal to the first distal end of the first longitudinal portion and to the second distal end of the second longitudinal portion.

17. A prosthesis assembly for tissue repair, comprising:

a prosthesis comprising a driving portion and a base portion;

the driving portion including a driving tip portion, a central portion, and a wedge portion, wherein the driving tip portion is shaped and dimensioned to penetrate bone in a longitudinal implantation direction;

the wedge portion having a wedge surface downwardly inclined in a rearward direction opposite to the longitudinal implantation direction and having a projection projecting above the wedge surface;

the base portion including a forward portion and a rearward portion, the forward portion being disposed adjacent to the wedge portion;

the base portion being configured to expand by separating into a first longitudinal portion and a second longitudinal portion when the forward portion is engaged by the wedge portion;

wherein the forward portion is connected to the wedge portion prior to implantation into a tissue and wherein the forward portion and the wedge portion are configured to separate during an implantation process;

wherein the prosthesis includes a longitudinal cavity that is between the first longitudinal portion and the second longitudinal portion, that is aligned with a longitudinal axis of the prosthesis, and that extends through the prosthesis at least from the forward portion of the base portion to the rearward portion of the base portion;

a tube;

a pin;

wherein the tube has an end portion disposed adjacent to the rearward portion of the base portion;

wherein the pin is disposed in the longitudinal cavity and the tube;

wherein the pin contacts the driving portion and extends from the driving portion through the longitudinal cavity and beyond the rearward portion through the tube;

wherein the length of the pin is at least as long as the combined lengths of the longitudinal cavity and the tube; and

wherein during the implantation process;

the driving portion and the base portion of the prosthesis move in a forward direction from a pre-implantation position to a final implantation position, with no rearward direction movement,

the pin applies a first force to the driving portion in the longitudinal implantation direction, and the end portion of the tube applies a second force in the longitudinal implantation direction to the rearward portion of the base portion

each of the first longitudinal portion and the second longitudinal portion is configured to engage the wedge portion and spread in a direction lateral to the longitudinal implantation direction,

the projection of the wedge surface of the wedge portion engaging an interior surface of the first longitudinal portion,

the first longitudinal portion is shaped and dimensioned to penetrate the bone to create a second bore, wherein a direction of extension of the second bore differs from the longitudinal implantation direction, wherein the first longitudinal portion penetrates the bone to a first point at which a first forward distal end of the first longitudinal portion is forward of the driving tip portion of the driving portion, and

the second longitudinal portion is shaped and dimensioned to penetrate the bone to create a third bore, wherein a direction of extension of the third bore differs from the longitudinal implantation direction and the direction of extension of the second bore, wherein the second longitudinal portion penetrates the bone to a second point at which a second forward distal end of the second longitudinal portion is forward of the driving tip portion of the driving portion.

18. The prosthesis assembly according to claim 17, wherein the forward portion and the wedge portion are configured to remain connected during a first stage of implantation and wherein the forward portion and the wedge portion are configured to separate during a second stage of implantation.

19. The prosthesis assembly according to claim 17, wherein the first longitudinal portion extends along the length of the base portion and the second longitudinal portion extends along the length of the base portion, the first longitudinal portion and the second longitudinal portion being attached at the rearward portion, and the first longitudinal portion and the second longitudinal portion being separated at the forward portion;

and

wherein the first longitudinal portion and the second longitudinal portion are shaped and dimensioned to penetrate bone at the forward portion.

20. The prosthesis assembly according to claim 19, wherein the first and second longitudinal portions are adjacent and separated by a longitudinal slot.

21. The prosthesis assembly according to claim 19, wherein the base portion includes the first and second longitudinal portions and at least one additional separated longitudinal portion, which are permanently attached at the rearward portion of the base portion, and wherein the longitudinal portions are separated at the forward portion of the base portion.

22. The prosthesis assembly according to claim 19, wherein the forward portion of the base portion and the wedge portion are configured to separate when a predetermined force is applied to the rearward portion of the base portion.

23. The prosthesis assembly according to claim 19, wherein the first longitudinal portion and the second longitudinal portion are configured to separate from one another when the forward portion and the wedge portion are separated.

24. The prosthesis assembly according to claim 17, wherein the base portion includes a plurality of projecting portions projecting lateral to an implantation direction.

25. The prosthesis assembly according to claim 17, wherein the central portion includes a hole for receiving a suture thread.

26. The prosthesis assembly according to claim 25, further comprising a suture thread received by the hole of the central portion of the driving portion.

27. The prosthesis assembly according to claim 26, wherein the base portion defines a longitudinal slot dividing the first longitudinal portion and the second longitudinal portion, and wherein the suture thread extends within the longitudinal slot toward the rearward portion of the base portion.

28. The prosthesis assembly according to claim 17, wherein the wedge portion and the base portion are configured to separate from one another under a predetermined force.

29. The prosthesis assembly according to claim 17, wherein the longitudinal cavity extends forward of the forward portion of the base portion.

30. The prosthesis assembly according to claim 17, wherein the first longitudinal portion at the forward portion of the base portion has an interior surface that defines a track, and wherein the projection travels within the track during implantation and maintains axial alignment between the driving portion and the base portion.

31. The prosthesis assembly according to claim 17, wherein an interior face of the first longitudinal portion at the forward portion of the base portion defines a groove that has a size and shape corresponding to that of the projection and that receives the projection.

32. The prosthesis assembly according to claim 31, wherein the projection comprises a projecting feature having a rounded convex cross-sectional geometry and the groove of the interior face of the first longitudinal portion of the base portion has a concave geometry corresponding to the rounded convex cross-sectional geometry.

33. The prosthesis assembly according to claim 17, wherein the projection of the wedge surface of the wedge portion locks with the interior surface of the first longitudinal portion and prevents the first longitudinal portion from moving over the driving portion in the rearward direction in the expanded state.

34. The prosthesis assembly according to claim 33, wherein the projection comprises a plurality of barbed portions that incrementally locks into a plurality of notches in the interior surface of the first longitudinal portion of the base portion.

35. The prosthesis assembly according to claim 17, wherein the first and second longitudinal portions are adjacent and are separated by a longitudinal slot.

36. The prosthesis assembly according to claim 17, wherein the base portion includes the first and second longitudinal portions and at least one additional separated longitudinal portion, which are permanently attached at the rearward portion of the base portion, and wherein the longitudinal portions are separated at the forward portion of the base portion.

37. The prosthesis assembly according to claim 17, wherein the prosthesis is configured to be manufactured as a single monolithic piece.

38. The prosthesis assembly according to claim 17, wherein the driving tip portion has a tapered forward surface configured to penetrate bone.

39. The prosthesis assembly according to claim 38, wherein the driving tip portion has an approximately conical geometry that is approximately symmetrical about a central axis of the prosthesis.

40. The prosthesis assembly according to claim 17, wherein before the implantation process, at the forward portion of the base portion, the first longitudinal portion is connected to the driving portion by a first connection portion and the second longitudinal portion is connected to the driving portion by a second connection portion;

and

wherein during the implantation process;

the first connection portion separates from the driving portion and provides the first forward distal end of the first longitudinal portion with a first pointed end that is configured to penetrate bone, and

the second connection portion separates from the driving portion and provides the second forward distal end of the second longitudinal portion with a second pointed end that is configured to penetrate bone.

41. The prosthesis assembly according to claim 17, wherein before the implantation process:

at the forward portion of the base portion, the first longitudinal portion is connected to the driving portion by a first connection portion and the second longitudinal portion is connected to the driving portion by a second connection portion, and

the first connection portion and the second connection portion are rearward of the driving tip portion of the driving portion;

wherein after the implantation process;

the first connection portion is separated from the driving portion to provide the first forward distal end that is forward of the driving tip portion of the driving portion, and

the second connection portion is separated from the driving portion to provide the second forward distal end that is forward of the driving tip portion of the driving portion.

42. The prosthesis assembly according to claim 17, wherein in a driving position during the implantation process, a distal tip of the driving portion is located distal to the first forward distal end of the first longitudinal portion and to the second forward distal end of the second longitudinal portion, and

wherein in an inserted position after the implantation process, the distal tip of the driving portion is located proximal to the first forward distal end of the first longitudinal portion and to the second forward distal end of the second longitudinal portion.