Apparatus for treating stress and urge incontinence

• US 8,195,296 B2
• Filed: 05/05/2006
• Issued: 06/05/2012
• Est. Priority Date: 03/03/2006
• Status: Active Grant

• Current Assignee: ENDO USA Incorporated
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Longhini, Ross A., Gross, Yosef
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): PATEL, NATASHA
• Application Number:
  US11/418,790
• Publication Number:
  US 20070260288A1
• Time in Patent Office: 2,223 Days
• Field of Search: 607 39- 41
• US Class Current: 607/41
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Apparatus is provided, including an implantable mechanical support, shaped to support a portion of a urethra of a patient. One or more electrodes are coupled to the mechanical support, so as to contact tissue of the patient when the mechanical support is implanted in the patient. A control unit drives the electrodes to apply a current to the tissue. A method for treating a patient is also provided, including implanting a mechanical support in a position that supports a urethra of a patient. In response to increased pelvic pressure of the patient, a substance stored in a portion of the mechanical support that is not under the urethra is moved to a portion of the mechanical support that is under the urethra. Other embodiments are also described.

Claims

1. A method, comprising:

providing an implantable member comprising mesh and at least one electrode;

making at least one incision in a patient;

implanting the member in contact with pelvic tissue of the patient comprising passing the implantable member through the at least one incision;

driving a current through the at least one electrode into the pelvic tissue of the patient; and

implanting a control unit in the patient comprising passing the control unit through the at least one incision, wherein driving a current through the at least one electrode comprises driving a current through the at least one electrode using the control unit.

2. The method according to claim 1, wherein the mesh forms a sling.

3. The method according to claim 1, comprising inducing relaxation of a pelvic muscle of the patient responsive to driving a current.

4. The method according to claim 1, comprising treating a condition of the patient responsive to driving a current through the at least one electrode, wherein the condition of the patient is selected from the group consisting of:

urge incontinence, bladder dysfunction, mixed incontinence, overactive bladder, interstitial cystitis, and fecal incontinence.

5. The method according to claim 1, comprising treating incontinence of the patient responsive to driving a current through the at least one electrode.

6. The method of claim 5, wherein treating incontinence of the patient responsive to driving a current through the at least one electrode comprises contracting the urinary sphincter of the patient.

7. The method according to claim 1, comprising inducing relaxation of a bladder muscle of the patient without contracting a pelvic muscle of the patient responsive to driving a current through the at least one electrode.

8. The method according to claim 1, comprising treating incontinence responsive to driving a current.

9. The method according to claim 8, comprising generating a signal indicative of imminent incontinence of the patient.

10. The method of claim 1, further comprising treating urge incontinence of the patient responsive to driving a current.

11. The method of claim 1, wherein the at least one electrode is coupled to the mesh.

12. The method of claim 1, further comprising mechanically supporting a pelvic structure of the patient using the mesh.

13. The method according to claim 12, comprising treating incontinence responsive to mechanically supporting a pelvic structure of the patient using the mesh.

14. The method according to claim 12, comprising treating cystocele responsive to mechanically supporting a pelvic structure of the patient using the mesh.

15. The method according to claim 12, comprising treating pelvic organ prolapse responsive to mechanically supporting a pelvic structure of the patient using the mesh.

16. The method according to claim 12, wherein mechanically supporting a pelvic structure of the patient comprises accessing the pelvic structure via an approach selected from the group consisting of:

a suprapubic approach, a transvaginal approach, a retropubic approach, and a transobturator approach.

17. The method of claim 12, wherein mechanically supporting comprises anchoring the member to structure of the patient other than the pelvic structure.

18. The method according to claim 12, wherein:

mechanically supporting a pelvic structure of the patient comprises mechanically supporting a portion of the urethra of the patient with the mesh;

the at least one electrode comprises a plurality of electrodes; and

driving a current comprises driving the current from the plurality of electrodes which are aligned around less than 180 degrees of the urethra.

19. The method according to claim 18, comprising:

at a pre-implantation time prior to a first time of mechanically supporting the portion of the urethra, identifying the patient as not suffering from urge incontinence; and

at a post-implantation time subsequent to the first time of mechanically supporting the portion of the urethra, identifying the patient as suffering from urge incontinence, wherein driving the current comprises;

not driving the current on each of any 30 consecutive days prior to the post-implantation time; and

driving the current on each of at least 30 consecutive days following the post-implantation time.

20. The method according to claim 18, wherein driving a current comprises starting to drive a current on each of at least 30 consecutive days at a time greater than 60 days from a first time of mechanically supporting the portion of the urethra.

21. The method according to claim 20, comprising treating at least one condition responsive to driving a current, wherein the at least one condition including a condition that is not stress incontinence.

22. A method, comprising:

providing an implantable member comprising mesh and a plurality of electrodes;

making at least one incision in a patient;

implanting the member in contact with pelvic tissue of the patient comprising passing the implantable member through the at least one incision;

mechanically supporting a pelvic structure of the patient using the mesh comprising mechanically supporting a portion of the urethra of the patient with the mesh, wherein the electrodes are aligned around less than 180 degrees of the urethra; and

driving a current through at least one of the plurality of electrodes into the pelvic tissue of the patient, comprising starting to drive a current on each of at least 30 consecutive days at a time greater than 60 days from a first time of mechanically supporting the portion of the urethra.

23. The method according to claim 22, comprising treating at least one condition responsive to driving a current, wherein the at least one condition including a condition that is not stress incontinence.

24. The method according to claim 22, comprising treating incontinence responsive to mechanically supporting a pelvic structure of the patient using the mesh.

25. The method according to claim 22, comprising treating cystocele responsive to mechanically supporting a pelvic structure of the patient using the mesh.

26. The method according to claim 22, comprising treating pelvic organ prolapse responsive to mechanically supporting a pelvic structure of the patient using the mesh.

27. The method according to claim 22, wherein the mesh forms a sling.

28. The method according to claim 22, wherein mechanically supporting a pelvic structure of the patient comprises accessing the pelvic structure via an approach selected from the group consisting of:

a suprapubic approach, a transvaginal approach, a retropubic approach, and a transobturator approach.

29. The method according to claim 22, comprising inducing relaxation of a pelvic muscle of the patient responsive to driving a current.

30. The method according to claim 22, comprising treating a condition of the patient responsive to driving a current, wherein the condition of the patient is selected from the group consisting of:

urge incontinence, bladder dysfunction, mixed incontinence, overactive bladder, interstitial cystitis, and fecal incontinence.

31. The method according to claim 22, comprising treating incontinence of the patient responsive to driving a current through the at least one electrode.

32. The method according to claim 22, comprising inducing relaxation of a bladder muscle of the patient without contracting a pelvic muscle of the patient responsive to driving a current.

33. The method according to claim 22, comprising implanting a control unit in the patient comprising passing the control unit through the at least one incision, wherein driving a current through at least one of the plurality of electrode comprises driving a current through at least one of the plurality of electrodes using the control unit.

34. A method, comprising:

providing an implantable member comprising mesh and a plurality of electrodes;

making at least one incision in a patient;

implanting the member in contact with pelvic tissue of the patient comprising passing the implantable member through the at least one incision;

mechanically supporting a pelvic structure of the patient using the mesh comprising mechanically supporting a portion of the urethra of the patient with the mesh, wherein the electrodes are aligned around less than 180 degrees of the urethra; and

driving a current through at least one of the plurality of electrodes into the pelvic tissue of the patient;

wherein;

at a pre-implantation time prior to a first time of mechanically supporting the portion of the urethra, identifying the patient as not suffering from urge incontinence; and

at a post-implantation time subsequent to the first time of mechanically supporting the portion of the urethra, identifying the patient as suffering from urge incontinence, wherein driving the current comprises;

not driving the current on each of any 30 consecutive days prior to the post-implantation time; and

driving the current on each of at least 30 consecutive days following the post-implantation time.

35. The method according to claim 34, comprising treating at least one condition responsive to driving a current, wherein the at least one condition including a condition that is not stress incontinence.

36. The method according to claim 34, comprising treating incontinence responsive to mechanically supporting a pelvic structure of the patient using the mesh.

37. The method according to claim 34, comprising treating cystocele responsive to mechanically supporting a pelvic structure of the patient using the mesh.

38. The method according to claim 34, comprising treating pelvic organ prolapse responsive to mechanically supporting a pelvic structure of the patient using the mesh.

39. The method according to claim 34, wherein the mesh forms a sling.

40. The method according to claim 34, wherein mechanically supporting a pelvic structure of the patient comprises accessing the pelvic structure via an approach selected from the group consisting of:

a suprapubic approach, a transvaginal approach, a retropubic approach, and a transobturator approach.

41. The method according to claim 34, comprising inducing relaxation of a pelvic muscle of the patient responsive to driving a current.

42. The method according to claim 34, comprising treating a condition of the patient responsive to driving a current, wherein the condition of the patient is selected from the group consisting of:

urge incontinence, bladder dysfunction, mixed incontinence, overactive bladder, interstitial cystitis, and fecal incontinence.

43. The method according to claim 34, comprising treating incontinence of the patient responsive to driving a current through the at least one electrode.

44. The method according to claim 34, comprising inducing relaxation of a bladder muscle of the patient without contracting a pelvic muscle of the patient responsive to driving a current.

45. The method according to claim 34, comprising implanting a control unit in the patient comprising passing the control unit through the at least one incision, wherein driving a current through at least one of the plurality of electrode comprises driving a current through at least one of the plurality of electrodes using the control unit.