Adjustable Tension Incontinence Sling Assemblies

• US 20100261950A1
• Filed: 06/22/2007
• Published: 10/14/2010
• 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: Roll, Jessica Lynn, Dockendorf now Chapman, Kelly Ann, Ogdahl, Jason Westrum, Lund, Robert E.
• Granted Patent: US 8,460,169 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 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 is attached to and extends through an adjustment spacing between sling intermediate ends within at least one sling end portion. The adjustment spacing is lengthened to decrease sling tension and shortened to increase sling tension

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 mechanism acting on or within one or both of the sling end portions, wherein the sling tension adjustment mechanism is attached to and extends through an adjustment spacing between sling intermediate ends within the sling end portion intermediate the sling end and the sling central portion and comprises spacing adjustment means for changing the adjustment spacing; and

external adjustment actuator means for actuating the sling tension adjustment mechanism to change the adjustment spacing between the sling intermediate ends and thereby change tension in the sling central portion applied to the urethra or anus.

2. The system of claim 1, wherein the external adjustment actuator means extends through the patient'"'"'s skin for adjustment.

3. 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 the body tissue to stabilize the sling end and facilitate adjustment of sling tension.

4. The system of claim 1, wherein:

the tension adjustment mechanism comprises a portion of a suture extending across the adjustment spacing between the sling intermediate ends within the sling end portion intermediate the sling end and the sling central portion to form the spacing adjustment means; and

the external adjustment actuator means comprises a portion of the suture extending from the spacing adjustment means between the sling intermediate ends and adapted to be extended through a skin incision for manipulation to change the adjustment spacing between the sling intermediate ends and thereby change tension in the sling central portion applied to the urethra or anus.

5. The system of claim 1, wherein:

the sling tension adjustment mechanism comprises a portion of a suture extending the across the adjustment spacing between the sling intermediate ends within the sling end portion intermediate the sling end and the sling central portion to form the spacing adjustment means; and

the external adjustment actuator means comprises;

a portion of the suture extending from the spacing adjustment means between the sling intermediate ends and adapted to be extended through a tissue pathway through body tissue; and

a tissue anchor having a bore receiving the portion of the suture extending through body tissue, the tissue anchor adapted to be manipulated to anchor against the body tissue and to the change the adjustment spacing between the sling intermediate ends and thereby change tension in the sling central portion applied to the urethra or anus.

6. The system of claim 5, wherein the sling further comprises 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 the body tissue to stabilize the sling end and facilitate adjustment of sling tension.

7. The system of claim 1, wherein:

the external adjustment actuator comprises a transmitter adapted to be brought into proximity to or applied against the skin and operated to generate a spacing adjustment command that is communicated transcutaneously through the skin and body tissue to the adjustment mechanism; and

the adjustment mechanism comprises means responsive to the transcutaneously communicated commands for operating the spacing adjustment means to increase or decrease the adjustment spacing.

8. The system of claim 7, wherein:

the external adjustment actuator comprises a RF signal transmitter that is employed to generate a RF sling adjustment command transmitted through the patient'"'"'s skin; and

the adjustment mechanism comprises a RF receiver for receiving the transmitted commands, and the spacing adjustment means is responsive to the received RF signal to increase or decrease the adjustment spacing.

9. The system of claim 7, wherein:

the external adjustment actuator comprises is a magnetic field generator or permanent magnet that is employed to generate a magnetic field representing a sling adjustment command that passes transcutaneously through the patient'"'"'s skin; and

the spacing adjustment means comprises a magnetic field responsive element that responds to the magnetic field by increasing or decreasing the adjustment spacing.

10. The system of claim 7, wherein:

the external adjustment actuator comprises an external thermal heater or cooler adapted to be applied to the patient'"'"'s skin; and

the spacing adjustment means comprises a temperature responsive element responsive to heat or cold applied transcutaneously through the patient'"'"'s skin to heat or cool the adjustment mechanism to thereby increase or decrease the adjustment spacing.

11. The system of claim 7, wherein:

the external adjustment actuator comprises an external light source adapted to be applied to the patient'"'"'s skin and to generated a light wavelength that is transmittable through skin and body tissue; and

the spacing adjustment means comprises light responsive elements responsive to the wavelength of light generated by the external adjustment actuator and transmitted transcutaneously to the sling tension adjustment mechanism to thereby increase or decrease the adjustment spacing.

12. The system of claim 1, wherein:

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

the adjustment mechanism comprises means engageable by the engaging end the external adjustment actuator for operating the spacing adjustment means to increase or decrease the adjustment spacing.

13. The system of claim 12, wherein:

the engageable means comprises;

a housing coupled to one sling intermediate end; and

a rotatable bobbin supported by the housing having a receptacle shaped to receive the engaging end of the elongated instrument to enable rotation of the bobbin; and

the spacing adjustment means comprises a strand coupled to the other sling intermediate end and extending around the bobbin that is adapted to be wound onto the bobbin to decrease the adjustment spacing or to be unwound from the bobbin to increase the adjustment spacing.

14. The system of claim 12, wherein:

the engageable means comprises;

a housing having a chamber bounded by a fixed detent ring of tabs extending into the chamber; and

a rotatable bobbin supported by the housing within the chamber having a receptacle shaped to receive the engaging end of the elongated instrument to enable rotation of the bobbin and an array of flexible tabs extending radially outward of the bobbin in engagement with the tabs of the fixed detent ring; and

the spacing adjustment means comprises a first strand coupled to the first sling intermediate end and extending around the bobbin in a first direction and a second strand coupled to the second sling intermediate end and extending around the bobbin in an opposite direction,

whereby the first and second strands are wound onto the bobbin by rotation of the bobbin in a first direction to shorten the adjustment spacing and the first and second strands are unwound from the bobbin by rotation of the bobbin in a second direction to shorten the adjustment spacing.

15. The system of claim 12, wherein:

the engageable means comprises;

a housing having a chamber;

a dual cam assembly supported by the housing within the chamber comprising a first cam having a first receptacle shaped to receive the engaging end of the elongated instrument and a second cam having a second receptacle shaped to receive the engaging end of the elongated instrument;

a first cam follower mounted to the housing and bearing on the first cam; and

a second cam follower mounted to the housing and bearing on the second cam; and

the spacing adjustment means comprises a first tether coupled to the first sling intermediate end and extending around the first cam in a first direction and a second tether coupled to the second sling intermediate end and extending around the second cam in an opposite direction,

whereby the first tether is wound onto the first cam by rotation of the first cam in a first direction into engagement with the first cam follower to shorten the adjustment spacing and the second tether is unwound from the second cam by rotation of the second cam in the first direction into engagement with the second cam follower to shorten the adjustment spacing.

16. The system of claim 1, wherein:

the external adjustment actuator comprises a syringe having a syringe chamber adapted to be filled with fluid and a syringe needle having a needle bore extending from the syringe chamber to the needle tip, the syringe needle adapted to be percutaneously passed through the patient'"'"'s skin;

the tension adjustment mechanism comprises a housing enclosing a fluid retaining chamber having a port penetrable by the syringe needle tip enabling adding or withdrawing fluid from the fluid retaining chamber; and

the spacing adjustment means is coupled to the fluid retaining chamber,

whereby the adjustment spacing is adjusted by passing the syringe needle tip through the port and injecting or withdrawing fluid from the fluid retaining chamber to increase or decrease the adjustment spacing.

17. The system of claim 16, wherein:

the housing comprises a piston chamber, a piston within the chamber, and a piston rod extending from the piston chamber;

the housing is coupled to the first intermediate end; and

the piston rod is coupled to the second intermediate end,

whereby the piston is moved within the piston chamber to increase the adjustment spacing upon adding fluid through the port to the piston chamber and to decrease the adjustment spacing upon withdrawing fluid through the port to the piston chamber.

18. The system of claim 16, wherein:

the housing is formed of a flexible material in having opposed first and second spiral arms extending away from the port;

the first intermediate end is coupled to the first spiral arm; and

the second intermediate end is coupled to the second spiral arm,

whereby the arcuate arms straighten to increase the adjustment spacing upon adding fluid through the port.

19. The system of claim 1, further comprising

a fluid reservoir adapted to be subcutaneously implanted having a penetrable port and enclosing a reservoir chamber and further comprising a tube extending from the reservoir chamber to a tube end;

and wherein;

the external adjustment actuator comprises a syringe having a syringe chamber adapted to be filled with fluid and a syringe needle having a needle bore extending from the syringe chamber to the needle tip, the syringe needle adapted to be percutaneously passed through the patient'"'"'s skin and through the port into the reservoir chamber;

the tension adjustment mechanism comprises a housing enclosing a fluid retaining chamber coupled to the tube end; and

the spacing adjustment means is coupled to the fluid retaining chamber,

whereby the adjustment spacing is adjusted by passing the syringe needle tip through the port and injecting or withdrawing fluid from the reservoir chamber and the fluid retaining chamber to increase or decrease the adjustment spacing.

20. The system of claim 19, wherein:

the housing comprises a piston chamber, a piston within the chamber, and a piston rod extending from the piston chamber;

the housing is coupled to the first intermediate end; and

the piston rod is coupled to the second intermediate end,

whereby the piston is moved within the piston chamber to increase the adjustment spacing upon adding fluid through the port to the piston chamber and to decrease the adjustment spacing upon withdrawing fluid through the port to the piston chamber.

21. The system of claim 20, wherein the fluid retaining chamber comprises a single action hydraulic cylinder or a dual action hydraulic cylinder.

22. The system of claim 1, wherein:

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

the adjustment mechanism comprises a driven gear means engageable by the engaging end the gear drive for operating the spacing adjustment means to increase or decrease the adjustment spacing.

23. The system of claim 22, wherein:

the driven gear means comprises;

a housing coupled to the first sling intermediate end enclosing a gear chamber and a rod chamber;

a threaded rod extending through the rod chamber and attached at one end to the second sling intermediate end; and

a rotatable driven gear supported by the housing and in engagement with the threaded rod,

whereby the driven gear is rotatable by engagement with and rotation of the drive gear in a first direction to extend the threaded rod from the rod chamber to increase the adjustment spacing and is rotatable by engagement with and rotation of the drive gear in a second direction to draw the threaded rod into the rod chamber to decrease the adjustment spacing.

24. The system of claim 22, further comprising:

a gear drive adapted to be subcutaneously implanted having a receptacle, and an elongated drive shaft extending through a sheath lumen of a drive sheath to a drive shaft end, and wherein;

the external adjustment actuator comprises an elongated gear drive instrument having a shaft extending between a handle and an engaging end shaped to be percutaneously advanced through the skin into engagement with the receptacle; and

the adjustment mechanism comprises a driven gear means engageable by the drive shaft end for operating the spacing adjustment means to increase or decrease the adjustment spacing.

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

providing 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 mechanism acting on or within one or both of the sling end portions, wherein the sling tension adjustment mechanism is attached to and extends through an adjustment spacing between sling intermediate ends within the sling end portion intermediate the sling end and the sling central portion and comprises spacing adjustment means for changing the adjustment spacing;

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

actuating the sling tension adjustment mechanism to change the adjustment spacing between the sling intermediate ends and thereby change tension in the sling central portion applied to the urethra or anus.