Bladder neck suspension procedure

• US 5,860,425 A
• Filed: 01/26/1996
• Issued: 01/19/1999
• Est. Priority Date: 12/03/1991
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Technology Incorporated (Boston Scientific Corporation)
• Inventors: Benderev, Theodore V., Legome, Mark J., Naves, Neil H.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/592,497
• Time in Patent Office: 1,089 Days
• Field of Search: 128/895, 128/898, 128/885-887, 128/DIG. 25, 600/29, 600/30, 606/232, 623/12, 623/14, 623/16
• US Class Current: 128/898
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1796 for holes for sutures or flexible wires
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 46/30 : for surgery through the lower body openings, e.g. urology, gynaecology

Abstract

The surgical treatment of stress urinary incontinence is disclosed. The disclosed methods include: 1) a technique of probe passage to avoid injuring the bladder and to provide a more accurate and reproducible capture of the pubocervical fascia lateral to the bladder neck and urethra, 2) anchor fixation of the suspending sutures to the pubic bone to decrease the risk of suture pull through from above and to decrease post-operative pain and 3) a simple and reproducible technique to set a limited tension of the suspending sutures. A description of these methods and results of procedures with some of these methods are disclosed. Novel drill guides, suture passers, suture tensioners, and various related tools and devices for use in the surgical method are also disclosed.

Claims

1. A method of suspending a bladder neck, comprising the steps of:

(a) securing a first suture to a first bone anchor;

(b) positioning said first anchor in a bone without exposing the bone by way of an open surgical procedure;

(c) advancing said first suture through a tissue generally adjacent to the bladder neck;

(d) providing a first suture support;

(e) securing said first suture to said first suture support;

(f) positioning said first suture support against the tissue generally adjacent to the bladder neck to increase the effective contact area between said first suture and the tissue; and

(g) suspending the bladder neck with said first suture.

2. The method of claim 1, wherein said first suture is secured to said anchor before said first anchor is positioned in the bone.

3. The method of claim 1, wherein said first suture is advanced through the tissue generally adjacent to the bladder neck before said first suture is secured to said first anchor.

4. The method of claim 1, wherein said first suture is advanced through the tissue generally adjacent to the bladder neck before said first anchor is positioned in the bone.

5. The method of claim 1, wherein the step of positioning said first suture support against the tissue generally adjacent to the bladder neck comprises positioning said first suture support against a vaginal wall.

6. The method of claim 1, wherein said step of securing said first suture to said first suture support comprises securing said first suture to a mesh.

7. The method of claim 1, further comprising repeating steps (a) through (c), step (e), and step (g) on an opposite side of the bladder neck using a second suture and a second bone anchor, wherein said first suture is secured to a first end of said first suture support and said second suture is secured to a second end of said first suture support to form a bladder neck suspension sling.

8. The method of claim 1, wherein the step of positioning said first anchor is accomplished percutaneously.

9. The method of claim 1, wherein the step of positioning said first anchor comprises positioning said first anchor in a generally anterior surface of a pubic bone.

10. The method of claim 9, wherein the step of positioning said first anchor comprises positioning said first anchor approximately 2 centimeters lateral to a symphysis pubis.

11. The method of claim 10, wherein the step of positioning said first anchor comprises positioning said first anchor in a pubic tubercle.

12. The method of claim 1, wherein the suspending step (g) comprises tying said first suture to suspend the bladder neck.

13. The method of claim 12, further comprising repeating steps (a) through (g) on an opposite side of the bladder neck using a second suture, second bone anchor, and second suture support.

14. A method of suspending a bladder neck in a patient, said method comprising the steps of:

(a) securing a first suture to a first bone anchor, said first suture having a first end and a second end;

(b) positioning said first anchor in a pubic bone;

(c) grasping said first suture with a probe, said probe being able to pierce tissue;

(d) advancing said probe and the first end of said first suture behind the pubic bone and through an endopelvic fascia generally adjacent to a urethra at a first point;

(e) releasing said first suture within a vaginal cavity;

(f) withdrawing said probe through the endopelvic fascia;

(g) advancing said probe through the endopelvic fascia at a second point, said second point also being generally adjacent to the urethra;

(h) grasping said first suture within the vaginal cavity with said probe;

(i) withdrawing said probe and said first end of said first suture through the endopelvic fascia;

(j) releasing said first suture from said probe; and

(k) tying the first and second ends of said first suture to suspend the bladder neck.

15. The method of claim 14, further comprising providing a suture support, securing said first suture to said suture support, and positioning said suture support against the endopelvic fascia to increase the effective contact area between said first suture and the endopelvic fascia.

16. The method of claim 14, wherein said steps of advancing said probe and withdrawing said probe through the endopelvic fascia comprise advancing said probe and withdrawing said probe through a pubocervical fascia.

17. The method of claim 14, further comprising repeating steps (a) through (k) on an opposite side of the bladder neck using a second suture and a second bone anchor.

18. A method of suspending a bladder neck from a bone while minimizing invasion of tissue generally adjacent to the bone, comprising the steps of:

locating an anchoring site on the bone without exposing the bone in an open surgical procedure;

advancing an anchor into the bone through the tissue generally adjacent to the bone;

securing the anchor within the bone; and

thereafter

suspending the bladder neck using the anchor.

19. The method of claim 18, wherein the step of locating an anchoring site on the bone comprises locating an anchoring site on a pubic bone.

20. The method of claim 18, wherein the locating step is accomplished percutaneously.

21. The method of claim 20, wherein the locating step is accomplished using a bone anchor implantation device, said bone anchor implantation device comprising a housing, at least one probe mounted to the housing, and a guide channel extending through the housing, the locating step comprising advancing the at least one probe of the bone anchor implantation device through the tissue generally adjacent to the bone to contact the bone so that the guide channel is placed over the bone within which the anchor is to be secured.

22. The method of claim 21, wherein the step of advancing an anchor further comprises advancing a drill into the bone through the guide channel of the bone anchor implantation device to provide a recess in the bone and advancing the anchor into the recess.

23. The method of claim 18, further comprising the step of selecting an anchor having a suture secured thereto.

24. The method of claim 23, further comprising the step of securing said suture to tissue generally adjacent to the bladder neck.

25. A method of suspending a bladder neck, comprising the steps of:

(a) securing a first suture to a first bone anchor;

(b) locating an anchoring site on a bone without exposing the bone;

(c) positioning said first anchor in the bone;

(d) advancing said first suture through a tissue generally adjacent to the bladder neck;

(e) providing a first suture support;

(f) securing said first suture to said first suture support;

(g) positioning said first suture support against the tissue generally adjacent to the bladder neck to increase the effective contact area between said first suture and the tissue; and

(h) suspending the bladder neck with said first suture.

26. The method of claim 25, wherein the suspending step (h) comprises tying said first suture to suspend the bladder neck.

27. The method of claim 26, further comprising repeating steps (a) through (h) on an opposite side of the bladder neck using a second suture, second bone anchor, and second suture support.

28. A method of suspending a bladder neck from a bone while minimizing invasion of tissue generally adjacent to the bone, comprising the steps of:

locating an anchoring site on the bone without exposing the bone;

advancing an anchor into the bone through the tissue generally adjacent to the bone;

securing the anchor within the bone; and

thereafter

suspending the bladder neck using the anchor.

29. The method of claim 28, wherein the step of locating an anchoring site on the bone comprises locating an anchoring site on a pubic bone.

30. The method of claim 28, wherein the locating step is accomplished percutaneously.

31. The method of claim 28, further comprising the step of selecting an anchor having a suture secured thereto.

32. The method of claim 31, further comprising the step of securing said suture to tissue generally adjacent to the bladder neck.

33. A method of suspending a bladder neck comprising the steps of:

securing a suture to a bone anchor;

positioning said anchor in a bone without exposing the bone by way of an open surgical procedure;

positioning a suture support secured to said suture against the tissue generally adjacent to the bladder neck to increase the effective contact area between said suture and the tissue; and

suspending the bladder neck with said suture.

34. The method of claim 33, wherein said step of positioning a suture support comprises positioning a suture support comprising a web of biocompatible material having a plurality of apertures therein for facilitating tissue ingrowth.

35. The method of claim 34, wherein said step of positioning a suture support comprises positioning a mesh made of a biocompatible material.

36. The method of claim 35, wherein said step of positioning a suture support comprises positioning a mesh made of a material selected from the group consisting of metal and plastic.

37. The method of claim 35, wherein said step of positioning a suture support comprises positioning a mesh having said suture integrally molded thereto.

38. The method of claim 33, wherein said step of positioning a suture support comprises positioning a suture support comprising an outer ring and a plurality of inner spokes.

39. The method of claim 38, wherein said step of positioning a suture support comprises positioning a suture support made of a material selected from the group consisting of metal and plastic.

40. The method of claim 38, wherein said step of positioning a suture support comprises positioning a suture support having said suture integrally molded thereto.

41. The method of claim 33, wherein said step of positioning a suture support comprises positioning a suture support comprising a plurality of spokes radiating from a central hub.

42. The method of claim 41, wherein said step of positioning a suture support comprises positioning a suture support made of a material selected from the group consisting of metal and plastic.

43. The method of claim 41, wherein said step of positioning a suture support comprises positioning a suture support having said suture integrally molded thereto.

44. The method of claim 33, wherein said step of positioning a suture support comprises:

positioning a suture support comprising a biocompatible plate having two surfaces, said biocompatible plate sized for use in bladder neck suspension procedures and adapted for distributing a biasing force exerted on a suture over a larger surface area of soft tissue, said suture support also comprising a suture tab centrally connected to one surface of said plate and defining a loop with said plate.

45. The method of claim 44, wherein said step of positioning a suture support comprises positioning a suture support made of a material selected from the group consisting of plastic and metal.

46. A method of suspending a bladder neck comprising the steps of:

securing a suture to a bone anchor;

positioning said anchor in a bone without exposing the bone;

positioning a suture support secured to said suture against the tissue generally adjacent to the bladder neck to increase the effective contact area between said suture and the tissue; and

suspending the bladder neck with said suture.

47. The method of claim 46, wherein said step of positioning a suture support comprises positioning a suture support comprising a web of biocompatible material having a plurality of apertures therein for facilitating tissue ingrowth.

48. The method of claim 47, wherein said step of positioning a suture support comprises positioning a mesh made of a biocompatible material.

49. The method of claim 46, wherein said step of positioning a suture support comprises positioning a suture support comprising an outer ring and a plurality of inner spokes.

50. The method of claim 46, wherein said step of positioning a suture support comprises positioning a suture support comprising a plurality of spokes radiating from a central hub.

51. The method of claim 46, wherein said step of positioning a suture support comprises:

positioning a suture support comprising a biocompatible plate having two surfaces, said biocompatible plate sized for use in bladder neck suspension procedures and adapted for distributing a biasing force exerted on a suture over a larger surface area of soft tissue, said suture support also comprising a suture tab centrally connected to one surface of said plate and defining a loop with said plate.