Sling system for treating incontinence

• US 20020022841A1
• Filed: 10/11/2001
• Published: 02/21/2002
• Est. Priority Date: 03/18/1997
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Kovac, S. Robert
• Granted Patent: US 6,641,524 B2
• Time in Patent Office: Days
• US Class Current: 606/60
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes

Abstract

A pubic bone-mounted urethra stabilization and support system and method therefor for the long term cure of recurrent female urinary incontinence. The system comprises, a pair of anchors affixed to the posterior/inferior pubic bone, sutures attach to the anchors and a mesh sling passing behind and about the urethra and the adjacent endopelvic fascia and having ends attached to the anchors by the anchor-mounted sutures. The method includes the steps of accessing said urethra with the endopelvic fascia therebehind and the pubic bone, properly locating and attaching the anchors to the pubic bone, properly locating the sling about the urethra and adjacent endopubic fascia and suturing and tensioning the ends of the sling to the anchors, causing said sling to restore, support and stabilize functional urethral continence anatomy and prevent urethral descent under intraabdominal pressure.

Claims

1. A method of treating urinary incontinence in a patient comprising:

preparing said patient for surgery;

creating an incision allowing access to the urethra;

introducing a mesh material through said incision and moving said mesh to a position that traverses the urethra;

adjusting the position and tension of said mesh material relative to said urethra through manipulation of at least one suture interlaced within a weave of said mesh material;

securing said mesh material into place in a manner to effectively treat the urinary incontinence; and

,

closing said incision.

2. A method according to claim 1, wherein said incision is created in the vagina of a female patient.

3. A method according to claim 1, wherein said suture is interlaced into said mesh material just prior to the adjusting of the position and tension of the mesh material.

4. A method according to claim 1, wherein the adjusting of the position and tension of the mesh material is performed by placing upward tension on said mesh material.

5. A method according to claim 1, wherein the manipulation of at least one suture is performed with a suture that is interlaced along substantially the length of one side of said mesh material.

6. A method according to claim 1, wherein the securing of said mesh material includes the manipulation of sutures located proximal to the urethra and distal from ends of the mesh material.

7. A method according to claim 1, wherein the securing of said mesh material includes connecting ends of said mesh material to bone anchors located in a pubic bone of said patient.

8. A method of treating urinary incontinence in a patient comprising:

identifying a region on the patient for making an incision;

creating an incision allowing access to the urethra;

observing the tissue revealed by said incision

introducing a mesh material through said incision and moving said mesh to a position that traverses the urethra;

manipulating said mesh material using at least one suture interlaced within said mesh material until opposite ends of said mesh material extend upwardly toward an abdomen of said patient;

checking the condition of said urethra in order to confirm proper manipulation of said mesh material; and

,

repairing said incision.

9. A method according to claim 8, wherein the introduction of said mesh material is performed through the vagina of a female patient.

10. A method according to claim 8, wherein the manipulation of said mesh material is performed through the abdomen of said patient.

11. A method according to claim 8, wherein said suture is interlaced into said mesh material just prior to the manipulation of the mesh material.

12. A method according to claim 8, wherein the manipulating of said mesh material is performed by placing upward tension on said mesh material.

13. A method according to claim 8, wherein the manipulation of said mesh material using at least one suture is performed with a suture that is interlaced along substantially the length of one side of said mesh material.

14. A method according to claim 8, wherein the securing of said mesh material includes the manipulation of sutures located proximal to the urethra and distal from ends of the mesh material.

15. A method according to claim 8, wherein the checking of the condition of the urethra includes cystoscopic observation of the urethra.

17. A device as set forth in claim 16, wherein said suture is integrated with said mesh material along substantially the length of one side of said mesh material.

18. A device as set forth in claim 17, wherein said suture is integrated along substantially the width of said mesh material.

19. A device as set forth in claim 16, wherein said suture is a permanent suture.

20. A device as set forth in claim 16, wherein a suture is integrated into opposite ends of said mesh material.

16. A device for use in treating urinary incontinence in a patient comprising:

a mesh material;

said mesh being flexible;

said mesh being biocompatible with human tissue;

said mesh material being substantially rectangular in shape;

a suture integrated with said mesh material at the time of fixation of said mesh material in a patient; and

,

said suture being sufficiently integrated with said mesh material so as to distribute tension loads exerted on said mesh material by said suture during positioning of said mesh material in a patient.

21. A kit containing tools for treating urinary incontinence in a patient comprising:

a mesh material;

said mesh material having opposed edges;

at least one suture for integrating into said mesh material at a region inwardly of said opposed edges;

said at least one suture having an end of sufficient length so as to be interlaced along said mesh material; and

,

said mesh material and said at least one suture being biocompatible with patient tissue.

22. A kit as set forth in claim 21, wherein said mesh material is a woven mesh material.

23. A kit as set forth in claim 21, wherein said mesh material is rectangular in shape.

24. A kit as set forth in claim 23, wherein said end of said at least one suture is of sufficient length to be interlaced along substantially the length of one side of said mesh material.

25. A kit as set forth in claim 24, wherein said one side of said mesh material is the width of said mesh material.

26. A kit as set forth in claim 21, wherein at least one suture is a permanent suture.

28. A method according to claim 27, wherein said incision is created in the vagina of a female patient.

29. A method according to claim 27, wherein the adjusting of the position of said mesh material is performed using a suture that is interlaced into said mesh material.

30. A method according to claim 29, wherein said suture is interlaced into said mesh material just prior to the adjusting of the position of said the mesh material

31. A method according to claim 27, wherein the adjusting of the position of the mesh material is performed by placing upward tension on said mesh material.

32. A method according to claim 29, wherein the adjusting of the position of said mesh material is performed using a suture that is interlaced along substantially the length of one side of said mesh material.

27. A method of treating urinary incontinence in a patient comprising:

identifying a region on a patient for performing surgery

creating an incision allowing access to the urethra;

introducing a mesh material through said incision and moving said mesh to a position that traverses the urethra;

observing the mesh material at said position; and

,

adjusting the position of said mesh material relative to said urethra using a suture that is attached to said mesh material in a manner so as to minimize undesirable cinching of said mesh material during permanent placement of said mesh material in said patient.

33. A method of treating urinary incontinence in a patient comprising:

identifying a patient suffering from urinary incontinence;

identifying a region on said patient for performing surgery;

creating an incision allowing access to a urethra;

introducing a mesh material through said incision and moving said mesh to a position that traverses the urethra; and

,

controlling tension of said mesh material relative to the urethra through manipulation of sutures that are attached to said mesh material at locations spaced from each distal end of said mesh material and on both sides of a central region of said mesh material; and

,

evaluating the state of said mesh material after controlling the tension.

34. A method as set forth in claim 33, wherein the controlling of tension is performed using permanent sutures.

35. A method as set forth in claim 33, wherein the creating of said incision is performed through the vagina of a female patient.

36. A method as set forth in claim 33, wherein the introducing of a mesh material is performed through the abdomen.

37. A method as set forth in claim 33, wherein the evaluating of the state of said mesh material is performed using cystoscopy.

38. A method as set forth in claim 33, wherein the controlling of the tension is performed so as to secure the mesh material relative to said urethra.

40. A method as set forth in claim 39, wherein the ensuring of urethral support is performed using sutures.

41. A method as set forth in claim 40, wherein the ensuring of urethral support is performed using permanent sutures.

42. A method as set forth in claim 39, wherein the exposing of said urethra is performed through the vagina of a female patient.

43. A method as set forth in claim 39, wherein the evaluating of the state of said mesh material is performed using cystoscopy.

44. A method as set forth in claim 33, wherein the ensuring of urethral support includes securing the mesh material relative to the urethra.

46. An assembly as set forth in claim 45, wherein said at least one suture is a permanent suture.

47. An assembly as set forth in claim 45, wherein said mesh material is a woven material.

48. An assembly as set forth in claim 45, wherein said assembly includes four sutures.

49. An assembly as set forth in claim 45, wherein said mesh material includes sites for receiving at least one suture.

39. A method of treating urinary incontinence in a patient comprising:

identifying a patient suffering from urinary incontinence;

exposing a urethra of said patient;

inserting a urethral support material into said patient;

manipulating said urethral support until said urethral support is located beneath said urethra at a position most effective for treating the incontinence; and

,

ensuring said urethral support is located at a position most effective for treating the incontinence by controlling the tension of regions of said urethral support that are in near proximity to said urethra; and

,

closing the exposure to said urethra.

45. An assembly for treating urinary incontinence in a patient comprising:

a substantially rectangular mesh material having two opposing ends;

said mesh material having sufficient length so as to traverse a urethra and extend with both ends towards an abdomen of said patient;

at least one suture to control the tension of said mesh material in a region proximal to said urethra; and

,

said at least one suture being located near a central region of said mesh material spaced from an opposing end of said mesh material;

said mesh material and said at least one suture being biocompatible with tissue.

50. A method of treating urinary incontinence in a patient comprising:

identifying a location on a patient for performing surgery;

creating an incision allowing access to the urethra;

introducing a mesh material through said incision and moving said mesh to a position that traverses the urethra;

manipulating said mesh material until opposite ends of said mesh material extend upwardly toward an abdomen of said patient;

ensuring against undue pressure of said mesh material relative to said urethra by controlling the tension of said mesh material at a region proximal to opposite sides of said urethra; and

,

closing said incision.

51. A method according to claim 50, wherein the ensuring against undue pressure includes controlling the tension of said mesh material using at least one suture.

52. A method according to claim 51, wherein the at least one suture is a permanent suture.

53. A method as set forth in claim 50, wherein the creating of said incision is performed through the vagina of a female patient.

54. A method as set forth in claim 50, including evaluating of the state of said mesh material after ensuring against undue pressure.

55. A method as set forth in claim 50, wherein the controlling of the tension is performed so as to secure the mesh material relative to said urethra.