Adjustable tension incontinence sling assemblies

• US 9,375,302 B2
• Filed: 01/13/2014
• Issued: 06/28/2016
• Est. Priority Date: 06/22/2006
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Ogdahl, Jason W., Roll, Jessica L., Lund, Robert E., Chapman, Kelly Ann, Jimenez, Jose W., Heys, Amanda J.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US14/153,717
• Publication Number:
  US 20140128664A1
• Time in Patent Office: 897 Days
• Field of Search: 600 29- 32, 600/37, 128/834, 128/885
• US Class Current: 1/1
• 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 having a central support portion adapted to be positioned to support any one of the urethra or anus and first and second sling end portions 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 or band, a tensioning device coupled to a suture or band free end, a tissue anchor coupled to one or more of a suture free end and a sling end, a mesh fold, a suture tube, and a sling sheath in various combinations.

Claims

1. A system for providing support to body tissue to alleviate incontinence in a patient, the system comprising:

an elongated incontinence sling having a central support portion adapted to be positioned to support urethra or anus, a first sling end portion extending from a first end of the central support portion to a first sling end, and a second sling end portion extending from a second end of the central support portion to a second sling end;

a first tension adjustment suture coupled to the first sling end portion between the central support portion and the first sling end, the first tension adjustment suture extending along the first sling end portion and away from the first sling end portion to a first suture free end; and

first tensioning means comprising an opening coupled to the first suture free end, the first tensioning means adapted to be implanted subcutaneously to bear against a tissue layer at a right-side pelvic location on a right side of the patient while the opening maintains the first suture free end in alignment with a location at which the first suture free end passes through the right-side tissue layer, the first tensioning means adapted to allow or cause the first tension adjustment suture to be drawn toward the right-side tissue layer and right-side pelvic location to apply tension through the first tension adjustment suture to the central support portion and reduce a distance between the first tensioning means and the central support portion;

a second tension adjustment suture coupled to the second sling end portion between the central support portion and the second sling end, the second adjustment suture extending along the second sling end portion and away from the second sling end portion to a second suture free end; and

second tensioning means comprising a second opening coupled to the second suture free end, the second tensioning means adapted to be implanted subcutaneously to bear against a tissue layer at a left-side pelvic location on a left side of the patient and spaced from the right-side pelvic location while the second opening maintains the second suture free end in alignment with a location at which the second suture free end passes through the left-side tissue layer, the second tensioning means adapted to allow or cause the second tension adjustment suture to be drawn toward the left-side tissue layer and left-side pelvic location to apply tension through the second tension adjustment suture to the central support portion and reduce a distance between the second tensioning means and the central support portion in a manner independent of the distance between the first tensioning means and the central support portion.

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

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

4. The system of claim 1, wherein the first tensioning means is coupled to the first suture free end for drawing the first tension adjustment suture toward the tissue layer at the right side pelvic location on the right side of the patient to apply tension through the first sling end portion to the central support portion.

5. The system of claim 4, further comprising:

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

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

6. The system of claim 4, further comprising a tissue anchor coupled to the first sling end adapted to be passed through body tissue to anchor the first sling end against a tissue layer at a second right-side location to stabilize the first sling end and facilitate adjustment of sling tension.

7. The system of claim 6, further comprising a second tissue anchor coupled to the second sling end adapted to be passed through body tissue to anchor the second sling end against a tissue layer at a second left-side location to stabilize the second sling end and facilitate adjustment of sling tension.

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

9. The system of claim 8, wherein the first tension adjustment suture is passed through a plurality of mesh pores extending through at least part of a length of the first sling end portion from a point adjacent the central support portion to a point adjacent the first sling end.

10. The system of claim 1, wherein the first tension adjustment suture is passed through a plurality of mesh pores extending through at least part of a length of a first sling end portion from a point adjacent the central support portion to a point adjacent the first sling end.

11. The system of claim 1, wherein the first tensioning means comprises a tissue anchor having a bore receiving a portion of the first tension adjustment suture, the tissue anchor adapted to be manipulated to anchor against the tissue layer at the right side pelvic location on the right side of the patient and to maintain tension in the central support portion applied to the urethra or anus.

12. The system of claim 1, wherein the second tensioning means comprises a tissue anchor having a bore receiving a portion of the second tension adjustment suture, the tissue anchor adapted to be manipulated to anchor against the tissue layer at the left side pelvic location on the left side of the patient and to maintain tension in the central support portion applied to the urethra or anus.

13. The system of claim 1, further comprising:

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

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

14. A method of providing support to body tissue to alleviate incontinence comprising:

providing an elongated incontinence sling as recited at claim 1;

implanting the incontinence sling disposing the central support portion in operative relation to the one of the urethra or anus; and

actuating the first tensioning means to change tension in the central support portion applied to the urethra or anus.

15. The method of claim 14 comprising implanting the incontinence sling disposing the central support portion in operative relation to the urethra.

16. The method of claim 14 comprising implanting the incontinence sling disposing the central support portion in operative relation to the anus.

17. The system of claim 1 wherein the first tensioning means comprises a surface adapted to bear against the tissue layer at the right-side pelvic location while the surface is oriented to face the central support portion, and the opening comprises a bore that passes through the surface, the first tension adjustment suture passing through the bore, and the second tensioning means comprises a second surface adapted to bear against the tissue layer at the left-side pelvic location while the second surface is oriented to face the central support portion, and the second opening comprises a second bore that passes through the second surface, the second tension adjustment suture passing through the second bore.

18. The system of claim 1 wherein the first tensioning means comprises a tissue anchor comprising a first end comprising a surface adapted to bear against the tissue layer, and a second end that is narrowed relative to the first end, wherein the opening extends between the first end and the second end, and wherein the opening is adapted to grip the first suture free end with a force sufficient to maintain sling tension.

19. The system of claim 18 wherein the second tensioning means comprises a second tissue anchor comprising a first end comprising a surface adapted to bear against the tissue layer, and a second end that is narrowed relative to the first end, wherein the opening extends between the first end and the second end, and wherein the opening is adapted to grip the second suture free end with a force sufficient to maintain sling tension.