Device for correcting stress urinary incontinence

• US 5,256,133 A
• Filed: 01/31/1991
• Issued: 10/26/1993
• Est. Priority Date: 09/05/1990
• Status: Expired due to Fees

• Current Assignee: Robert M. Spitz
• Original Assignee: Robert M. Spitz
• Inventors: Spitz, Robert M.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): REICHLE, KARIN M
• Application Number:
  US07/648,654
• Time in Patent Office: 999 Days
• Field of Search: 600/29, 600/30, 128/DIG. 25, 606/139, 606/184, 606/188, 606/228, 606/232
• US Class Current: 600/29
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

Female stress urinary incontinence is corrected by implanting a correcting device which supports the urethrovesical junction from the abdominal fascia. A trocar/cannula assembly is inserted upwardly through the vaginal wall immediately adjacent or proximate the urethrovesical junction, through the space of Retzius, and through the abdominal fascia. The trocar is then removed from the cannula after which the correcting device is loaded into the cannula and pushed upwardly through it and to an implanted position using a push rod. Thereafter the push rod and cannula are removed to complete the procedure.

Claims

1. Device for correcting stress urinary incontinence comprising implant means for supporting an associated portion of the vaginal wall in elevated position relative to the abdominal fascia to correct stress urinary incontinence including an axially elongate connecting member having a first end portion, retaining means for securing said first end portion of the connecting member proximate the abdominal fascia to support said implant means and including at least one resilient flexible retaining member having a deployed position wherein it projects laterally outwardly from said connecting member and an inserting position wherein it is disposed laterally inwardly of said deployed position in the direction of said connecting member, said at least one retaining member being resiliently self-biased toward said deployed position, and supporting means attached to said connecting member in axially spaced relation to said at least one retaining means for supporting said portion of the vaginal wall in said elevated position.

2. Device for correcting stress urinary incontinence as set forth in claim 1 including a plurality of retaining members angularly spaced about the axis of said connecting member.

3. Device for correcting stress urinary incontinence as set forth in claim 2 wherein said connecting member comprises a stem and each of said retaining members is connected in cantilever position to said stem and generally disposed within a common radial plane of said stem in said deployed position.

4. Device for correcting stress urinary incontinence as set forth in claim 3 wherein said retaining members are equiangularly spaced about said axis.

5. Device for correcting stress urinary incontinence as set forth in claim 1 wherein said at least one retaining member is deflectable in one direction to said inserting position and including limiting means for preventing deflection of said at least one retaining member in a direction opposite said one direction.

6. Device for correcting stress urinary incontinence as set forth in claim 5 wherein said limiting means comprises an enlarged head on said first end portion of said connecting member.

7. Device for connecting stress urinary incontinence as set forth in claim 1 wherein said supporting means comprises a support member attached in cantilever position to said connecting member and extending generally radially outwardly therefrom.

8. Device for correcting stress urinary incontinence as set forth in claim 7 wherein said supporting means includes a generally U-shaped reverse bend portion integrally connected to said support member and having two legs disposed to opposite sides of said connecting member.

9. Device for correcting stress urinary incontinence as set forth in claim 1 wherein said supporting means comprises another end portion of said connecting member.

10. Device for correcting stress urinary incontinence as set forth in claim 9 wherein said connecting member comprises a helical member.

11. Device for correcting stress urinary incontinence as set forth in claim 10 wherein said other end portion is frustoconical.

12. Device for correcting stress urinary incontinence as set forth in claim 1 wherein said connecting member comprises a helical member.

13. Device for correcting stress urinary incontinence as set forth in claim 12 wherein said at least one retaining member in said deployed position extends tangentially from said first end portion of said helical member.

14. Device for correcting stress urinary incontinence as set forth in claim 13 wherein said connecting member comprises a helicoid.

15. Device for correcting stress urinary incontinence as set forth in claim 12 wherein said supporting means comprises an annular ring integrally connected to an end portion of said helical member and having a major dimension greater than the major radial dimension of said helical member.

16. Device for correcting stress urinary incontinence as set forth in claim 12 wherein at least a portion of said helical member has a frustoconical configuration.

17. Device for correcting stress urinary incontinence as set forth in claim 1 wherein said supporting means comprises at least one resilient flexible support member having a deployed position wherein it projects laterally outwardly from said connecting member and an inserting position wherein it is disposed laterally inwardly of said deployed position in the direction of said connecting member, said at least one support member being resiliently self-biased toward its deployed position.

18. Device for correcting stress urinary incontinence as set forth in claim 17 wherein said connecting member comprises a stem and the members comprising said at least one support member and said at least one retaining member are supported in cantilever position on said stem and arranged in alternate series along said stem and to one and an opposite side of an axial plane of said stem.

19. Device for correcting stress urinary incontinence as set forth in claim 18 wherein said at least one support member and said at least one retaining member comprise elongate arms and said arms are coiled about said connecting members in said inserting position.

20. Device for correcting stress urinary incontinence as set forth in claim 1 wherein said device includes instrument means for implanting said implant means and said implant means is carried by and separable from said instrument means.

21. Device for correcting stress urinary incontinence as set forth in claim 20 wherein said instrument means includes means for releasable securing said at least one retaining member in said inserting position.

22. Device for correcting stress urinary incontinence as set forth in claim 21 wherein said means for releasably securing said at least one retaining member comprises means for pinning said at least one retaining member to said instrument means.

23. Device for correcting stress urinary incontinence as set forth in claim 21 wherein said instrument means includes a cannula having an elongate cannula body defining a main channel and said cannula body comprises said means for releasably securing said at least one retaining member in said implanting position.

24. Device for correcting stress urinary incontinence as set forth in claim 23 wherein said instrument means includes positioning means for advancing said implant means relative to said cannula and to an implanting position.

25. Device for correcting stress urinary incontinence as set forth in claim 24 wherein said positioning means comprises a push rod.

26. Device for correcting stress urinary incontinence as set forth in claim 25 wherein said push rod comprises an integral part of said implant means.

27. Device for correcting stress urinary incontinence as set forth in claim 26 wherein said device includes signaling means for indicating the position of said implant means relative to said cannula as said implant means is advanced by said push rod.

28. Device for correcting stress urinary incontinence as set forth in claim 27 wherein said signaling means comprises a projection on said cannula extending into said channel and a series of detent recesses defined by said push rod for cooperating with said projection.

29. Device for correcting stress urinary incontinence as set forth in claim 23 including guiding means for manually manipulating said cannula.

30. Device for correcting stress urinary incontinence as set forth in claim 29 wherein said guiding means comprises an appendage on said cannula.

31. Device for correcting stress urinary incontinence as set forth in claim 20 wherein said instrument means includes piercing means for penetrating the vaginal wall.

32. Device for correcting stress urinary incontinence as set forth in claim 31 wherein said instrument means includes a cannula defining a main channel having an axis and said piercing means comprises a trocar received within said main channel.

33. Device for correcting stress urinary incontinence as set forth in claim 32 wherein said trocar complements and substantially fills an associated portion of said main channel.

34. Device for correcting stress urinary incontinence as set forth in claim 33 wherein said instrument means includes means for loading said implant means into said main channel including a cannula extension defining a secondary channel communicating with said main channel, said secondary channel having an axis.

35. Device for correcting stress urinary incontinence as set forth in claim 34 wherein said cannula extension comprises an integral branch of said cannula.

36. Device for correcting stress urinary incontinence as set forth in claim 34 wherein the axis of secondary channel is inclined relative to the axis of said main channel.

37. Device for correcting stress urinary incontinence as set forth in claim 34 wherein said secondary channel is coaxially aligned with said main channel and said cannula extension is separable from said cannula.

38. Device for correcting stress urinary incontinence as set forth in claim 20 wherein said implant means comprises a helical member threadably engaged with said instrument means.