Implant for treating rectocele and a device for putting said implant into place

• US 20040249473A1
• Filed: 03/29/2004
• Published: 12/09/2004
• Est. Priority Date: 03/28/2003
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Analytic Biosurgical Solutions- ABISS
• Inventors: Delorme, Emmanuel, Eglin, Georges, Beraud, Jean-Marc
• Granted Patent: US 7,588,598 B2
• Time in Patent Office: Days
• US Class Current: 623/23.64
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled
• CPC Class Codes: A61B 2017/06085 having a blunt tip
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

According to the invention, the implant for treating rectocele and/or prolapsus of the vaginal fornix presents a structure that is thin and flexible and includes a support body from which there extend at least:

two upper suspension stabilizers disposed on either side of a sagittal plane; and

two lower suspension stabilizers disposed on either side of the sagittal plane.

Claims

1. An implant for treating rectocele and/or prolapsus of the vaginal fornix, the implant presenting a structure that is thin and flexible,

and comprising a support body from which there extend at least:

two upper suspension stabilizers which are disposed on either side of a sagittal plane and have longitudinal axes forming between them an angle greater than 45°

; and

two lower suspension stabilizers disposed on either side of the sagittal plane.

2. An implant according to claim 1, wherein the longitudinal axes of the upper stabilizers form an angle lying in the range 100°

to 180°

.

3. An implant according to claim 1, wherein the angle lies in the range 115°

to 170°

.

4. An implant according to claim 1, wherein the free ends of the upper stabilizers and of the lower stabilizers are directed downwards.

5. An implant according to claim 4, wherein the longitudinal axes of the upper stabilizers form an angle greater than 180°

, and preferably greater than 200°

.

6. An implant according to claim 4, wherein the upper stabilizers are arcuate.

7. An implant according to claim 4, including two middle suspension stabilizers disposed on either side of the sagittal plane between the upper and lower stabilizers.

8. An implant according to claim 7, wherein the ends of the upper stabilizer and of the middle stabilizer situated on the same side of the sagittal plane converge substantially towards a common point.

9. An implant according to claim 1, wherein the longitudinal axes of the lower stabilizers form a non-zero angle between each other.

10. An implant according to claim 9, wherein the angle is greater than 10°

.

11. An implant according to claim 9, wherein the angle lies in the range 10°

to 75°

.

12. An implant according to claim 9, wherein the angle lies in the range 100°

to 180°

.

13. An implant according to claim 1, wherein the upper stabilizers present a length greater than 100 mm, and preferably greater than or equal to 120 mm.

14. An implant according to claim 1, wherein the lower stabilizers present a length greater than 100 mm, and preferably greater than or equal to 120 mm.

15. An implant according to claim 1, wherein the support body is substantially rectangular in general shape.

16. An implant according to claim 15, wherein the support body presents a length lying in the range 60 mm to 90 mm, and a width lying in the range 40 mm to 60 mm.

17. An implant according to claim 15, wherein the lower stabilizers extend substantially from the lower corners of the support body.

18. An implant according to claim 15, wherein the upper stabilizers extend substantially from the upper corners of the support body.

19. An implant according to claim 15, wherein the lower stabilizers extend from two long sides of the support body.

20. An implant according to claim 19, wherein each of the lower stabilizers extend at a distance from the top edge of the support body lying in the range 60% to 87% of the length of the support body.

21. An implant according to claim 15, wherein the upper stabilizers extend from two long sides of the support body.

22. An implant according to claim 1, wherein the implant body presents, in its upper region, at least two orifices for passing posterior stabilizers of an anterior prosthesis once the stabilizers have passed through the uterosacral ligaments.

23. An introduction device for inserting an implant according to claim 1, the device comprising an introducer presenting a flexible structure and of shape analogous to that of the implant, and comprising:

a hollow body defining a cavity for receiving the support body of the implant;

tubular straps extending from the hollow body and each defining a cavity for receiving a suspension stabilizer of the implant;

traction means extending from the end of each of the straps of the introducer; and

cut initiator means at least for the hollow body of the introducer.

24. An introduction device according to claim 23, wherein the traction means comprise a semirigid needle for each tubular strap.

25. An introduction device according to claim 23, wherein the cut initiator means comprise at least one opening for passing a cutting instrument.

26. An introduction device according to claim 23, including an implant according to claim 1, disposed in the cavity of the hollow body and in the tubular straps.

27. An introduction device according to claim 26, wherein the implant is loose inside the introduction device.

28. An introduction device according to claim 23, further comprising an elongate perforator guide or trocar having one end for insertion into the body of the patient and having an opposite end provided with a handle.

29. An introduction device according to claim 28, wherein the perforator guide is in the form of an arc in a plane.

30. An introduction device according to claim 29, wherein the arcuate portion of the perforator extends over an angular sector greater than 140°

, and preferably less than 180°

, and more particularly preferably lying in the range 150°

to 170°

.

31. An introduction device according to claim 29, wherein the arcuate portion of the perforator guide then presents a radius of curvature lying in the range 30 mm to 60 mm, and preferably, for the portion of the perforator guide extending from the handle to the end for insertion into the body of the patient, lying in the range 40 mm to 50 mm.

32. An introduction device according to claim 28, wherein the distal end of the perforator guide, i.e. its ends remote from the handle, presents a helical shape.

33. An introduction device according to claim 32, wherein the perforator guide is in the form of a portion of a helical turn extending over an angle lying in the range 180°

to 360°

, and preferably lying in the range 255°

to 270°

.

34. An introduction device according to claim 33, wherein the turn of the perforator guide presents a radius of curvature lying in the range 20 mm to 40 mm, with a pitch lying in the range 15 mm to 25 mm.

35. An introduction device according to claim 28, further comprising a removable tubular sleeve of shape complementary to that of the perforator guide and designed to be engaged on the perforator guide and to remain within the body of the patient after the perforator guide has been removed so as to define a tunnel for passing the traction means of the introducer.

36. A method of treating rectocele in a woman, the method consisting in particular in:

using an implant according to claim 1;

placing the implant in the body of the patient to be treated by placing;

the upper suspension stabilizers through the gluteal region;

the lower suspension stabilizers through the pubo-rectal region; and

the support body in the uterosacral region.

37. A method of treating rectocele in a woman, the mehtod consisting in particular in:

using an implant according to claim 1;

placing the implant in the body of the patient to be treated by placing;

the upper suspension stabilizers through the sacrosciatic region;

the lower suspension stabilizers through the pubo-rectal region; and

the support body in the uterosacral region.

38. A method of treating rectocele in a woman, the method consisting in particular in:

using an implant according to claim 7;

placing the implant in the body of the patient to be treated by placing;

the upper suspension stabilizers through the sacrosciatic region;

the middle suspension stabilizers through the pubo-rectal region;

the lower suspension stabilizers through the perineal region; and

the support body in the rectovaginal septum.

39. A method of treatment according to claim 38, wherein the upper portion of the implant is supported by the posterior stabilizers of an anterior prosthesis.