Method and apparatus for treating pelvic organ prolapses in female patients

• US 7,131,944 B2
• Filed: 02/28/2003
• Issued: 11/07/2006
• Est. Priority Date: 03/01/2002
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Jacquetin, Bernard
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/377,260
• Publication Number:
  US 20030220538A1
• Time in Patent Office: 1,348 Days
• Field of Search: 600 29- 32, 600/37, 128/DIG.25, 128/885, 128/887, 606151-158, 623/3.1, 623/3.29, 623/11.11, 623 2364- 2365, 623/23.72, 623924-926, 602 4- 6
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes

Abstract

An anterior implant adapted to treat central and lateral cystoceles present in a female patient includes laterally extending stabilizing straps for supporting the implant between the patient'"'"'s bladder and vagina independently of the patient'"'"'s arcus tendineous fascia pelvis. Rectocele and hysterocele repairs can be carried out using a single posterior implant which, like the anterior implant, is provided with laterally extending stabilizing straps for supporting the implant between the patient'"'"'s rectum and vagina.

Claims

1. An implant for treating central and lateral cystoceles present in a female patient, comprising a body having a pair of opposed ends, one of said ends having a concave shape selected so as to form an unobstructed recess which avoids contact with the patient'"'"'s bladder neck, a central longitudinal axis passing through said pair of opposed ends, an inboard area located between said opposed ends, said inboard area containing said longitudinal axis and having a size and shape selected so as to repair a central cystocele, at least one outboard area positioned on at least one side of said inboard area, said at least one outboard area having a size and shape selected so as to repair a lateral cystocele, and stabilizing means for laterally stabilizing said body on both sides thereof independently of the patient'"'"'s arcus tendineous fascia pelvis, said stabilizing means including at least one pair of straps extending laterally outward from opposite sides of said body, each of said straps being long enough to pass through a respective one of the patient'"'"'s obturator foramens and out a corresponding skin incision formed in the patient'"'"'s perineum proximal thereto, said at least one pair of straps including a first strap which extends laterally outward from one side of said body and a second strap which extends laterally outward from the other side of said body, said at least one outboard area including a first outboard area on one side of said inboard area and a second outboard area on an opposite side of said inboard area, said body including a first section proximal to said one end of said body, said first section having a first outer edge bordering at least a portion of said first outboard area and a second outer edge bordering at least a portion of said second outboard area, and said body including a second section proximal to the other end of said body, said second section having a wide portion which is proximal to said first section of said body, and a narrow portion which is proximal to said other end of said body, said narrow portion of said second section being sized and shaped so as to permit attachment of said second section to the patient'"'"'s utero-sacral ligaments.

2. An implant according to claim 1, wherein said one end of said body is sized and shaped so as to permit attachment of said first section to the patient'"'"'s pubococcygeous muscle.

3. An implant according to claim 2, wherein said first strap is positioned intermediate opposed ends of said first outer edge of said first section and said second strap is positioned intermediate opposed ends of said second outer edge of said first section.

4. An implant according to claim 2, wherein said at least one pair of straps includes a third strap which extends laterally outward from said one side of said body along said first outer edge of said first section and a fourth strap which extends laterally outward from said other side of said body along said second outer edge of said first section.

5. An implant according to claim 4, wherein said first and second straps are located proximal to said one end of said body and said third and fourth straps are located distal to said one end of said body.

6. An implant according to claim 1, wherein said first section has a first width at a location proximal to said one end of said body and a second width at a location proximal to said second section, said second width being greater than said first width.

7. A procedure for treating a cystocele present in a female patient comprising the steps of:

making a first skin incision in the patient'"'"'s perineum proximal to one of the obturator foramens;

making a second skin incision in the patient'"'"'s perineum proximal to the other obturator foramen;

providing an anterior implant with at least a pair of laterally extending straps;

inserting said anterior implant into the patient'"'"'s pelvic area through the patient'"'"'s vaginal opening and an anterior incision in the vaginal wall;

passing one of said straps through said one obturator foramen and out said first skin incision;

passing another of said straps through said other obturator foramen and out said second skin incision; and

pulling on said one strap and said another strap until said anterior implant is properly positioned between the patient'"'"'s bladder and vagina to repair the cystocele.

8. A procedure according to claim 7, further comprising the step of attaching said anterior implant to a posterior implant adapted to treat a rectocele and/or a hysterocele.

9. A procedure according to claim 8, wherein said anterior and posterior implants are attached to each other after their introduction into the patient'"'"'s body.

10. A procedure according to claim 8, wherein said anterior and posterior implants are attached to each other prior to their introduction into the patient'"'"'s body.

11. A procedure for treating a rectocele and a hysterocele present in a female patient, comprising the steps of:

providing a posterior implant with a pair of laterally extending straps;

inserting said posterior implant into the patient'"'"'s pelvic area through the patient'"'"'s vaginal opening and a posterior incision in the vaginal wall;

placing said posterior implant between the patient'"'"'s rectum and vagina to repair the rectocele;

attaching one of said straps to one of the patient'"'"'s sacrospinous ligaments; and

attaching the other of said straps to the patient'"'"'s other sacrospinous ligament, thereby repairing the patient'"'"'s hysterocele.

12. A procedure according to claim 11, further comprising the step of attaching said posterior implant to an antenor implant adapted to repair a cystocele.

13. A procedure according to claim 12, wherein said anterior and posterior implants are attached to each other after their introduction into the patient'"'"'s body.

14. A procedure according to claim 12, wherein said anterior and posterior implants are attached to each other prior to their introduction into the patient'"'"'s body.

15. A procedure according to claim 11, wherein said one strap extends through and beyond its associated sacrospinous ligament and said other strap extends through and beyond its associated sacrospinous ligament.

16. An implant for treating central and lateral cystoceles present in a female patient, comprising a body including a first end having a concave shape selected so as to form an unobstructed recess which avoids contact with the patient'"'"'s bladder neck, a second end opposite said first end, a first section proximal to said first end of said body, said first section having a narrow portion which is proximal to said first end and a wide portion which is distal to said first end, a second section proximal to said second end of said body, said second section having a narrow portion which is proximal to said second end, and a wide portion which is distal to said second end, a central longitudinal axis passing through said first and second ends of said body, an inboard area located between said first and second ends of said body, said inboard area containing said longitudinal axis and having a size and shape selected so as to repair a central cystocele, at least one outboard area positioned on at least one side of said inboard area, said at least one outboard area having a size and shape selected so as to repair a lateral cystocele, and stabilizing means for laterally stabilizing said body on both sides thereof independently of the patient'"'"'s arcus tendineous fascia pelvis.

17. An implant according to claim 16, wherein said stabilizing means includes at least one pair of straps extending laterally outward from opposite sides of said body, each of said straps being long enough to pass through a respective one of the patient'"'"'s obturator foramens and out a corresponding skin incision formed in the patient'"'"'s perineum proximal thereto.

18. An implant according to claim 17, wherein said at least one pair of straps includes a first strap which extends laterally outward from one side of said body and a second strap which extends laterally outward from the other side of said body.

19. An implant according to claim 18, wherein said at least one outboard area includes a first outboard area on one side of said inboard area and a second outboard area on an opposite side of said inboard area.

20. An implant according to claim 19, wherein said first section includes a first outer edge bordering at least a portion of said first outboard area and a second outer edge bordering at least a portion of said second outboard area.

21. An implant according to claim 20, wherein said first strap extends laterally outward from said first outer edge and said second strap extends laterally outward from said second outer edge.

22. An implant according to claim 21, wherein said first outer edge has a generally convex shape which substantially matches the shape of the arcus tendineous fascia pelvis on one side of the patient'"'"'s body and said second outer edge has a generally convex shape which substantially matches the shape of the arcus tendineous fascia pelvis on the other side of the patient'"'"'s body.

23. An implant according to claim 20, wherein said narrow portion of said second section has a size and shape selected so as to permit attachment of said second section to the patient'"'"'s utero-sacral ligaments.

24. An implant according to claim 23, wherein said first end of said body has a size and shape selected so as to permit attachment of said first section to the patient'"'"'s pubococcygeous muscle.

25. An implant according to claim 24, wherein said first strap is positioned intermediate opposed ends of said first outer edge of said first section and said second strap is positioned intermediate opposed ends of said second outer edge of said first section.

26. An implant according to claim 25, wherein said at least one pair of straps includes a third strap which extends laterally outward from said one side of said body along said first outer edge of said first section and a fourth strap which extends laterally outward from said other side of said body along said second outer edge of said first section.

27. An implant according to claim 26, wherein said first and second straps are located proximal to said first end of said body and said third and fourth straps are located distal to said first end of said body.

28. An implant according to claim 17, wherein said body is made from a single sheet of a biocompatible mesh material, whereby said at least one pair of straps is formed monolithically with said body.

29. An implant according to claim 16, wherein said body is formed monolithically with another implant adapted to treat a rectocele and/or a hysterocele.