Method and apparatus for treating pelvic organ prolapses in female patients

• US 20030220538A1
• Filed: 02/28/2003
• Published: 11/27/2003
• Est. Priority Date: 03/01/2002
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Jacquetin, Bernard
• Granted Patent: US 7,131,944 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 central longitudinal axis, an inboard area through which said central longitudinal axis passes, said inboard area being sized and shaped 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 being sized and shaped 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.

2. An implant according to claim 1, 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.

3. An implant according to claim 2, 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.

4. An implant according to claim 3, 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.

5. An implant according to claim 4, wherein said body includes a generally dome-shaped 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.

6. An implant according to claim 5, wherein said first strap extends laterally outward from said first outer edge of said dome-shaped section and said second strap extends laterally outward from said second outer edge of said dome-shaped section.

7. An implant according to claim 6, 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.

8. An implant according to claim 7, wherein said body includes a generally funnel-shaped section having a wide portion which merges into said dome-shaped section at a wide end thereof and a narrow portion which extends away from said wide end of said dome-shaped section, said narrow portion being sized and shaped so as to permit attachment of said funnel-shaped section to the patient'"'"'s utero-sacral ligaments.

9. An implant according to claim 8, wherein an end of said dome-shaped section opposite said wide end thereof includes a concave edge which merges into said first and second outer edges of said dome-shaped section, said concave edge being sized and shaped so as to, avoid contact with the patient'"'"'s bladder neck while permitting attachment of said dome-shaped section to the patient'"'"'s pubococcygeous muscle.

10. An implant according to claim 9, wherein said first strap is positioned intermediate opposed ends of said first outer edge of said dome-shaped section and said second strap is positioned intermediate opposed ends of said second outer edge of said dome-shaped section.

11. An implant according to claim 9, 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 dome-shaped section and a fourth strap which extends laterally outward from said other side of said body along said second outer edge of said dome-shaped section.

12. An implant according to claim 11, wherein said first and second straps are located proximal to said concave edge of said dome-shaped section and said third and fourth straps are located proximal to said wide end of said dome-shaped section.

13. An implant according to claim 2, 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.

14. An implant according to claim 1, wherein said body is formed monolithically with another implant adapted to treat a rectocele and/or a hysterocele.

15. An implant for treating a rectocele and a hysterocele present in a female patient, comprising a body having a central longitudinal axis, a generally triangular-shaped section through which said central longitudinal axis passes, said triangular-shaped section being sized and shaped so as to repair a rectocele and having a first edge extending along one side of said central longitudinal axis and a second edge extending along an opposite side of said central longitudinal axis, a first strap attached to said first edge proximal to a wide end of said triangular-shaped section and extending laterally outward therefrom, and a second strap attached to said second edge proximal to said wide end of said triangular-shaped section and extending laterally outward therefrom, said first and second straps cooperating with an intermediate portion of said body to form a generally arcuate tape-like segment sized and shaped so as to perform a vaginal vault suspension.

16. An implant according to claim 15, wherein said body includes attaching means for attaching said implant to another implant adapted to treat a cystocele.

17. An implant according to claim 16, wherein said attaching means includes a generally rectangular-shaped section which merges into said triangular-shaped section at said wide end thereof, said rectangular-shaped section having a dimension, as measured along said central longitudinal axis of said body, sufficient to permit said rectangular-shaped section to be folded over the patient'"'"'s vaginal cuff.

18. An implant according to claim 15, wherein said first and second straps are long enough for attachment to the patient'"'"'s sacrospinous ligaments.

19. An implant according to claim 15, wherein said first and second straps are long enough to extend through and beyond the patient'"'"'s sacrospinous ligaments.

20. An implant according to claim 15, wherein said body is made from a single sheet of a bio-compatible mesh material, whereby said first and second straps are formed monolithically with said triangular-shaped section.

21. An implant according to claim 15, wherein said body is formed monolithically with another implant adapted to treat a cystocele.

22. An implant according to claim 15, wherein said first and second straps extend toward and beyond said wide end of said triangular-shaped section forming an acute angle with said central longitudinal axis.

23. 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.

24. A procedure according to claim 23, further comprising the step of attaching said anterior implant to a posterior implant adapted to treat a rectocele and/or a hysterocele.

25. A procedure according to claim 24, wherein said anterior and posterior implants are attached to each other after their introduction into the patient'"'"'s body.

26. A procedure according to claim 24, wherein said anterior and posterior implants are attached to each other prior to their introduction into the patient'"'"'s body.

27. 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.

28. A procedure according to claim 27, further comprising the step of attaching said posterior implant to an anterior implant adapted to repair a cystocele.

29. A procedure according to claim 28, wherein said anterior and posterior implants are attached to each other after their introduction into the patient'"'"'s body.

30. A procedure according to claim 28, wherein said anterior and posterior implants are attached to each other prior to their introduction into the patient'"'"'s body.

31. A procedure according to claim 27, wherein said one strap extends through and beyond its associated sacrospinous ligament and said other strap extends through and beyond its associated sacrospinous ligament.