ADJUSTABLE TISSUE SUPPORT MEMBER

• US 20090137862A1
• Filed: 11/12/2008
• Published: 05/28/2009
• Est. Priority Date: 11/13/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Evans, Doug, Holsten, Henry
• Granted Patent: US 8,206,280 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

The present disclosure relates to implants having two arms and a support portion configured to support a body tissue, such as a urethra. The implants are anchored in soft tissue with tissue anchors having a plurality of barbs. The tissue anchors contain an aperture through which a portion of arm is maintained. A locking member is disposed within at least one of the arms to facilitate fixation of the arm to at least one of the anchors.

Claims

1. A tissue support system comprising an implantable tissue support member, wherein said implantable tissue support member comprises:

a tissue support portion having a length and a width;

a first arm disposed at one end of the tissue support portion, and a second arm disposed at an opposite end of the tissue support portion,

a first tissue anchor connected to the first arm; and

a second tissue anchor connected to the second arm, wherein the second soft tissue anchor is slideable along a length of said second arm.

2. The tissue support system according to claim 1, wherein the first tissue anchor is fixed to the end of the first arm.

3. The tissue support system according to claim 1, wherein at least one of the first and second arms have a lumen defined by a tubular mesh construction.

4. The tissue support system according to claim 1, wherein said second tissue anchor comprises a head configured to penetrate tissue, and a base.

5. The tissue support system according to claim 4, wherein said base contains an aperture configured to receive said second arm.

6. The tissue support system according to claim 5, wherein the aperture is normal to the longitudinal axis of the anchor.

7. The tissue support system according to claim 6, wherein the base is configured to receive a locking pin, wherein said locking pin fixes the anchor to a desired position on the second arm.

8. The tissue support system according to claim 1, wherein said first and second soft tissue anchors are configured to penetrate tissue when urged in a first direction, and resist movement in a direction substantially opposite to the first direction.

9. The tissue support system according to claim 1 further comprising an introducer needle, wherein said introducer needle comprises:

a proximal end and a distal end;

a handle attached to the proximal end;

a collet at the distal end, wherein the collet is configured to releasably secure a tissue anchor; and

a manually operable actuator on the handle, wherein the actuator maintains the soft tissue anchor in the collet when actuator is in a first position, and releases the soft tissue anchor from the collet when the actuator is moved to a second position.

10. A tissue support system comprising an implantable tissue support member, wherein said implantable tissue support member comprises:

a tissue support portion having a first end and a second end;

a first arm having a first end and a second end, wherein the first end is joined to the first end of the tissue support portion;

a second arm having a first end and a second end, wherein the first end is joined to the second end of the tissue support portion;

a first tissue anchor fixed to the second end of the first arm; and

a second tissue anchor having an aperture therein, wherein the aperture is configured to at least partially enclose a portion of the second arm.

11. The tissue support system according to claim 10, wherein the second arm is constructed from mesh.

12. The tissue support system according to claim 11, wherein the second arm has a lumen formed by a tubular knit construction of the mesh.

13. The tissue support system according to claim 10, wherein the aperture is configured to resist unconstrained movement of the second arm therethrough.

14. The tissue support system according to claim 12, wherein the lumen has a locking member disposed therein, wherein said locking member is disposed in the lumen between the second tissue anchor and the second end of the second arm.

15. The tissue support system according to claim 14, wherein the locking member is configured to be urged in the direction of the second anchor, and resist movement in the direction of the second end of the second arm.

16. The tissue support system according to claim 14, further comprising a stylet configured for introduction into lumen from the second end of the second arm, wherein said stylet is further configured to urge the locking member in the direction of the second anchor.

17. The tissue support system according to claim 10, further comprising an introducer needle configured to releasably secure a tissue anchor.

18. The tissue support system according to claim 17, wherein the introducer needle comprises a shaft and a handle.

19. The tissue support system according to claim 18, wherein the shaft has a curved portion.

20. The tissue support system according to claim 19, wherein the shaft has a substantially helical shape.

21. The tissue support system according to claim 18, wherein the introducer needle comprises a collet at the distal end of the shaft.

22. The tissue support system according to claim 18, wherein the handle comprises a manually operable mechanism for releasing the anchor from the distal end of the shaft.

23. The tissue support system according to claim 10, wherein the tissue support portion comprises orientating indicia.

24. The tissue support system according to claim 23, wherein the orientating indicia comprises a colored feature in the center of the tissue support portion.

25. A method for providing support to body tissue, comprising

making an incision in the vaginal wall;

inserting an introducer needle having a first tissue anchor at the distal end thereof into the incision in the direction of the obturator membrane, wherein the first introducer needle is connected to an implant;

ejecting the first tissue anchor from the introducer needle;

withdrawing the introducer needle from the incision, and inserting a second tissue anchor in the distal end thereof, wherein the second tissue anchor is connected to an implant;

re-inserting the introducer needle into the incision in the direction of the contralateral obturator membrane;

ejecting the second tissue anchor from the introducer needle; and

applying traction to the implant until the desired amount of tissue support is obtained.

26. The method according to claim 25, further comprising locking the implant to the second tissue anchor.

27. The method according to claim 26, wherein the implant is locked to the second tissue anchor by inserting a locking pin through the implant and into the second tissue anchor.

28. The method according to claim 26, wherein the implant is locked to the second tissue anchor by facilitating a frictional fit between the anchor and the implant.

29. The method according to claim 25, wherein the implant comprises a lumen that passes through an aperture in the second tissue anchor.

30. The method of claim 29, wherein a locking feature is disposed in the lumen, and further wherein said locking feature is capable of being urged in a first direction through said lumen, but resists movement in the opposite direction.

31. The method according to claim 25, wherein the tissue is the urethra.

32. The method according to claim 25, wherein the tissue is the bladder.

33. The method according to claim 26, wherein the implant is locked to the second tissue anchor immediately after traction is applied to the implant.

34. The method according to claim 26, wherein the implant is locked to the second tissue anchor from 12-72 hours after traction is applied to the implant.

35. The method according to claim 25, wherein

an anchor stop disposed in the lumen of at least one of the first and second arms;

first and second tissue anchors; and

a stylet configured to urge said anchor stop in at least a first direction within the lumen of at least one of said first and second arms.

36. A medical device configured for implantation in tissue comprising:

a lumen formed from a flexible material;

at least one tissue anchor having at least one aperture therein, said at least one aperture configured to receive said lumen formed from a flexible material; and

an anchor stop disposed in said lumen, wherein said anchor stop is configured to resist movement when urged in one direction within said lumen.