Adjustable tension incontinence sling assemblies

• US 8,628,463 B2
• Filed: 06/22/2007
• Issued: 01/14/2014
• Est. Priority Date: 06/22/2006
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Ogdahl, Jason W., Roll, Jessica L., Lund, Robert E., Chapman, Kelly Ann, Heys, Amanda J., Jimenez, Jos W.
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/308,598
• Publication Number:
  US 20110124954A1
• Time in Patent Office: 2,398 Days
• Field of Search: 600/30, 600/29
• 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, the system comprising:

an elongated incontinence sling comprising;

first and second longitudinal edges;

a central support portion positionable to support the urethra or anus and comprising a first end and a second end;

a first sling end portion extending from the first end of the central support portion, the first sling end portion comprising a first sling end extending between the first and second longitudinal edges and spaced from the central support portion;

a second sling end portion extending from the second end of the central support portion, the second sling end portion comprising a second sling end extending between the first and second longitudinal edges and spaced from the central support portion;

at least one tension adjustment suture coupled to at least a portion of a length of the first sling end portion, the tension adjustment suture extending between a proximal location along a length of the first sling end portion to a distal location along a length of the first sling end portion, the distal location being located distal to the proximal location, wherein the tension adjustment suture includes a suture free end extending from the first sling end portion at the distal location, wherein the tension adjustment suture does not extend into the central support portion; and

a tensioner coupled to the suture free end, wherein the tensioner is manipulatable to release or apply tension through the first sling end portion to the central support portion.

2. The system of claim 1, wherein the first and second sling end portions comprise a plurality of mesh pores, and wherein the tension adjustment suture is looped through the mesh pores to form a fold within the first sling end portion that may be tightened or loosened by application or release of tension through the suture.

3. The system of claim 1, further comprising:

at least one elongated tube having a tube lumen extending between tube first and second ends, wherein the at least one tension adjustment suture extends through the tube lumen.

4. The system of claim 1, further comprising:

at least one elongated sheath having a sheath lumen extending between sheath first and second ends, wherein the at least one tension adjustment suture and at least one of the sling end portions extend through the sheath lumen.

5. The system of claim 4, wherein each 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 tensioner is coupled to the suture free end for rotating the free end to release or apply tension through the first or second sling end portion to the central support portion.

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

8. The system of claim 7, further comprising:

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

wherein the tensioner is engageable by the engaging end of the external adjustment instrument for operating the tension adjustment means to increase or decrease the tension.

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

10. The system of claim 1, wherein the tensioner is coupled to the suture free end and is capable of axially pulling the tension adjustment suture to release or apply tension through the first sling end portion to the central support portion.

11. The system of claim 10, wherein the tensioner is subcutaneously implantable to bear against a tissue layer.

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

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

14. The system of claim 1, further comprising a tissue anchor having a bore that receives tension adjustment suture, wherein the tissue anchor is manipulatable to anchor against a tissue layer and to maintain tension in the central support portion applied to the urethra or anus.

15. The system of claim 1, comprising

a second tension adjustment suture coupled to at least a portion of a length of the second sling end portion, the second tension adjustment suture extending between a proximal location along a length of the second sling end portion to a distal location along a length of the second sling end portion, the distal location being distal to the proximal location, wherein the second tension adjustment suture includes a second suture free end extending from the second end portion at the distal location, wherein the second tension adjustment suture does not extend into the central support portion;

and;

a second tensioner subcutaneously implantable to bear against a tissue layer and coupled to the second suture free end and capable of drawing the second tension adjustment suture toward the tissue layer to apply tension through the second sling end portion to the central support portion.

16. The system of claim 15, further comprising:

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

wherein the second tensioner is engageable by the engaging end of the second external adjustment instrument for operating the second tensioner to increase or decrease sling tension.

17. The system of claim 1, further comprising an adjustment suture coupled to the central support portion, wherein the adjustment suture is capable of manual tension adjustment.

18. The system of claim 1, wherein the tensioner comprises a housing and a bobbin, wherein the housing receives the tension adjustment suture and the tension adjustment suture is rotatable around the bobbin to increase or decrease sling tension.

19. The system of claim 1, wherein the at least one tension adjustment suture comprises two suture free ends.

20. The system of claim 1, wherein the tensioner is capable of releasing or applying tension through the first sling end portion to the central support portion by increasing or decreasing a length of the first sling end portion.