Method and implant for curing cystocele

• US 20040249397A1
• Filed: 03/26/2004
• 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 7,494,495 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• 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 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 for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

The invention concerns an implant for the treatment of cystocele, haviong a thin and supple structure, characterised in that it comprises a support body (2) from which extend at least:

two anterior suspension straps (3) arranged on both sides of the sagittal plane (S),

two posterior suspension straps (4), arranged on both sides of the sagittal plane (S),

and two middle suspension straps (5) arranged on both sides of the sagittal plane (S) and between the anterior and posterior straps (3) and (4).

Application to the treatment of cystocele.

Claims

1. An implant, for the treatment of cystocele, having a thin and supple structure, characterised in that it comprises a support body (2) from which axtend at least:

two anterior suspension straps (3) on both sides of a sagittal plane (S),

two posterior suspension straps (4) on both sides of a sagittal plane (S),

and two middle suspension straps (5) on both sides of a sagittal plane (S) and between the anterior and the posterior straps (3) and (4).

2. An implant according to claim 1, characterised in that the longitudinal axes (A₃) of the anterior straps (3) form an angle (α

) exceeding 45°

.

3. An implant according to claim 2, characterised in that the longitudinal axes (A₃) of the anterior straps (3) form an angle (α

) between 100° and

180°

.

4. An implant according to claim 2, characterised in that angle (α

) is between 115° and

170°

.

5. An implant according to claim 1, characterised in that the longitudinal axes (A₄) of the posterior straps (4) form an angle (β

) that is not zero.

6. An implant according to claim 5, characterised in that the angle (β

) exceeds 10°

.

7. An implant according to claim 6, characterised in that the angle (β

) is between 10° and

75°

.

8. An implant according to claim 7, characterised in that angle (β

) is between 100° and

180°

.

9. An implant according to claim 1, characterised in that the longitudinal axis (A₅) of each middle suspension strap (5) forms, with the anterior part of the sagittal plane (S), an angle (γ

) of between 100° and

140°

, preferably between 110° and

130°

.

10. An implant according to claim 1, characterised in that the length of the anterior straps (3) exceeds 100 mm and, preferably 120 mm.

11. An implant according to claim 1, characterised in that the length of the posterior straps (4) exceeds 100 mm and, preferably exceeds or equals 120 mm.

12. An implant according to claim 1, characterised in that the length of the middle straps (5) exceeds 100 mm and, preferably exceeds or equals 120 mm.

13. An implant according to claim 1, characterised in that the whole shape of the support body (2) is substantially rectangular.

14. An implant according to claim 13, characterised in that the length (L₂) of the support body (2) is between 60 and 90 mm and the width is between 40 and 60 mm.

15. An implant according to claim 13, characterised in that the anterior straps (3) substantially extend from the posterior corners of the support body (2).

16. An implant according to claim 1, characterised in that the posterior straps (4) substantially extend from the posterior corners of the support body (2).

17. A device for the introduction of an implant (1) according to claim 1, characterised in that it comprises an introduction member (20) that has a supple structure and whose shape is similar to that of the implant (1) and that comprises:

a hollow body (21) defining a cavity for the reception of the body (2) of the implant (1),

tubular branches (22) extending from the hollow body (21) each defining a cavity for the reception of a suspension strap (3, 4, 5) of the implant (1),

means of traction (23) extending from the end of each of the branches (22) of the introduction member,

and means for cutting (25) at least the hollow body (21) of the introduction member (20).

18. An introduction device according to claim 17, characterised in that the means of traction (23) include a semi-rigid needle for each tubular branch (21).

19. An introduction device according to claim 17, characterised in that the means for cutting comprise at least one aperture (24) for the passage of a cutting instrument.

20. An introduction device according to claim 17, characterised in that it comprises an implant (1) according to any of claims 1 to 16 placed in the cavity of the hollow body (21) and the tubular branches (22).

21. An introduction device according to claim 20, characterised in that the implant (1) is free inside the introduction device (10).

22. An introduction device according to claim 17, characterised in that it also comprises an elongated perforator guide (10) or trocar, one end (12) of which is made to be introduced in the patient'"'"'s body and the other end is equipped with a handle (14).

23. An introduction device according to claim 22, characterised in that the shape of the perforator guide (10) is curved in one plane.

24. An introduction device according to claim 23, characterised in that the curved part (15) of the perforator (10) extends over an angular sector exceeding 140°

and, preferably under 180°

, and in a particularly preferred manner, between 150° and

170°

.

25. An introduction device according to claim 23, characterised in that the curved part (15) of the perforator guide (10) has a radius of curvature ®

of between 30 mm and 60 mm and, preferably, for the part of the perforator guide extending from the handle to the end made to be introduced in the patient'"'"'s body, of between 40 mm and 50 mm.

26. An introduction device according to claim 22, characterised in that the perforator guide (10) has a helicoid shape at the end opposite to the handle or distal end (17).

27. An introduction device according to claim 26, characterised in that the distal end (17) of the perforator guide (10) has the shape of a portion of helicoid spire extending over an angle of between 180°

and 350° and

, preferably, between 255° and

270°

.

28. An introduction device according to claim 27, characterised in that the spire (17) of the perforator guide (10) has a radius of curvature of between 20 mm and 40 mm, with a pitch between 15 mm and 25 mm.

29. An introduction device according to claim 22, characterised in that it also comprises a removable tubular casing (50) whose shape is complementary to that of the perforator guide (10), intended to be fit on the perforator guide (10) and remain in the patient'"'"'s body after the removal of the perforator guide (10) to define a tunnel for the passage of the means of traction (23) of the introduction member (20).

30. A procedure for the treatment of cystocele in women, characterised in that it consists essentially of:

using an implant (1) according to claim 1;

inserting the implant (1) in the body of the patient by placing;

each of the anterior suspension straps (3) in an obstructed hole,

each of the middle suspension straps (5) in a corresponding middle translevator region,

each of the posterior suspension straps (4) in a corresponding uterosacral region,

and the support body (2) in the anterior vaginal wall.

31. A procedure for the treatment of cystocele in women, characterised in that it consists essentially of:

using an implant (1) according to claim 1;

inserting the implant (1) in the body of the patient by placing;

each of the anterior suspension straps (3) in an obstructed hole,

each of the middle suspension straps (5) in an inferoposterior region of the corresponding obstructed hole,

each of the posterior suspension straps (4) in a corresponding uterosacral region,

and the support body (2) in the anterior vaginal wall.

32. Procedure for the treatment of cystocele in women according to claim 30, characterised in that it in particular consists of placing each of the posterior suspension straps through the corresponding uterosacral ligament.

33. Procedure for the treatment of cystocele in women according to claim 30, characterised in that it in particular consists of placing each of the posterior suspension straps (4) through the corresponding uterosacral ligament and in the corresponding transgluteal region.

34. Procedure for the treatment of cystocele in women according to claim 33, characterised in that it in particular consists of placing each of the posterior suspension straps (4) through the corresponding uterosacral ligament and through the corresponding sacrosciatic ligament.