Adjustable tension incontinence sling assemblies

• US 20110124954A1
• Filed: 06/22/2007
• Published: 05/26/2011
• Est. Priority Date: 06/22/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Lund, Robert E., Heys, Amanda J., Chapman, Kelly Ann, Jimenez, José W., Roll, Jessica L., Ogdahl, Jason W.
• Granted Patent: US 8,628,463 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension

Abstract

Systems for providing support to body tissue to alleviate incontinence are disclosed that comprise an elongated incontinence sling (20) having a central support portion (40) adapted to be positioned to support any one of the urethra or anus (58, 67) and first and second sling end portions (42, 44) extending from the central support portion through body tissue and a tension adjustment mechanism acting on or within one or both of the sling end portions. The sling tension adjustment mechanism comprises one or more of a sling tensioning suture (312, 314) or band, and a tensioning device (310) coupled to a suture or band free end.

Claims

1. A system for providing support to body tissue to alleviate incontinence comprising:

an elongated incontinence sling having a central support portion adapted to be positioned to support any one of the urethra or anus having first and second sling end portions extending from the central support portion through body tissue;

a tension adjustment suture coupled to at least one of the sling end portions between the central support portion and the sling end and the central support portion and extending along the sling end portion past the sling end to a suture free end; and

tensioning means coupled to the suture free end adapted to be manipulated to release or apply tension through the sling end portion to the central support portion.

2. The system of claim 1, wherein the tension adjustment suture is looped through the mesh pores to form a fold in the mesh that may be tightened or loosened by application or release of tension through the suture.

3. The system of claim 1, further comprising:

an elongated tube having a tube lumen extending between tube first and second ends, and wherein;

the tension adjustment suture is extended through the tube lumen.

4. The system of claim 1, further comprising:

an elongated sheath having a sheath lumen extending between sheath first and second ends, and wherein;

the tension adjustment suture and the sling end portion are extended through the sheath lumen.

5. The system of claim 4,wherein the elongated sheath has an exterior sheath surface configured or treated to increase frictional engagement with surrounding tissue.

6. The system of claim 1, wherein the tensioning means comprises means coupled to the tension adjustment suture free end for rotating the tension adjustment suture to release or apply tension through the sling end portion to the central support portion.

7. The system of claim 1, wherein the tensioning means is adapted to be implanted subcutaneously to bear against a tissue layer and comprises tension adjustment means coupled to the tension adjustment suture free end for drawing the tension adjustment suture toward the tissue layer to apply tension through the sling end portion to the central support portion.

8. The system of claim 7, further comprising:

an elongated external adjustment instrument having a shaft extending between a handle and an engaging end shaped to be percutaneously advanced through the skin; and

the tensioning means comprises means engageable by the engaging end of the external adjustment instrument for operating the tension adjustment means to increase or decrease the sling tension.

9. The system of claim 7, further comprising at least one tissue anchor coupled to at least one sling end adapted to be passed through body tissue to anchor the sling end against a tissue layer to stabilize the sling end and facilitate adjustment of sling tension.

10. The system of claim 1, wherein the tensioning means comprises means coupled to the tension adjustment suture free end for axially pulling the tension adjustment suture to release or apply tension through the sling end portion to the central support portion.

11. The system of claim 10, wherein the tensioning means is adapted to be implanted subcutaneously to bear against a tissue layer.

12. The system of claim 11, further comprising at least one tissue anchor coupled to at least one sling end adapted to be passed through body tissue to anchor the sling end against a tissue layer to stabilize the sling end and facilitate adjustment of sling tension.

15. The system of claim 1, further comprising at least one tissue anchor coupled to at least one sling end adapted to be passed through body tissue to anchor the sling end against a tissue layer to stabilize the sling end and facilitate adjustment of sling tension.

17. The system of claim 1, further comprising a tissue anchor having a bore receiving the portion of the tension adjustment suture extending through body tissue, the tissue anchor adapted to be manipulated to anchor against a tissue layer and to maintain tension in the central support portion applied to the urethra or anus.

18. The system of claim 1, wherein:

a first tension adjustment suture having first suture free ends extends through a plurality of suture pores extending through at least part of the length of the first sling end portion from a point adjacent the central support portion and a point adjacent the first sling end;

a second tension adjustment suture having second suture free ends extends through a plurality of suture pores extending through at least part of the length of the second sling end portion from a point adjacent the central support portion and a point adjacent the second sling end

the tensioning means is adapted to be implanted subcutaneously to bear against a tissue layer and comprises tension adjustment means coupled to the first and second tension adjustment suture free ends for drawing the tension adjustment sutures toward the tissue layer to apply tension through the sling end portion to the central support portion.

19. The system of claim 18, further comprising:

an elongated external adjustment instrument having a shaft extending between a handle and an engaging end shaped to be percutaneously advanced through the skin; and

the tensioning means comprises means engageable by the engaging end of the external adjustment instrument for operating the tension adjustment means to increase or decrease sling tension.

13-14. -14. (canceled)

16. (canceled)

20. A system for providing support to body tissue to alleviate incontinence comprising:

an elongated incontinence sling having a central support portion adapted to be positioned to support any one of the urethra or anus having first and second sling end portions extending from the central support portion through body tissue; and

a tension adjustment torque band coupled to at least one of the sling end portions between the central support portion and the sling end and the central support portion and extending along the sling end portion past the sling end to a torque band free end; and

tensioning means coupled to the torque band free end adapted to be manipulated to release or apply tension through the sling end portion to the central support portion.

21. The system of claim 20, wherein:

the tension adjustment torque band is coupled to the sling at a plurality of points along the sling end portion; and

the tensioning means is adapted to be rotated to twist the tension adjustment torque band and the sling end portion.

22. A system for providing support to body tissue to alleviate incontinence comprising:

an elongated incontinence sling having a central support portion adapted to be positioned to support any one of the urethra or anus and a sling end portion extending from one end of the central support portion through body tissue to a first sling end, the sling end portion adapted to be passed through and engage a tissue layer;

a tension adjustment suture coupled to a further end of the central support portion and having a suture free end, the tension adjustment suture adapted to be passed through a tissue layer; and

tensioning means coupled to the suture free end adapted to be implanted subcutaneously to bear against a tissue layer for drawing the tension adjustment suture toward the tissue layer to apply tension through the suture to the central support portion.

23. The system of claim 22, further comprising:

an elongated external adjustment instrument having a shaft extending between a handle and an engaging end shaped to be percutaneously advanced through the skin; and

the tensioning means comprises means engageable by the engaging end of the external adjustment instrument for operating the tensioning means to increase or decrease sling tension.

24. (canceled)