SUBURETHRAL HAMMOCK

• US 20100130814A1
• Filed: 07/31/2007
• Published: 05/27/2010
• Est. Priority Date: 08/02/2006
• Status: Active Grant

• Current Assignee: Cousin Biotech
• Original Assignee: Cousin Biotech
• Inventors: Dubernard, Pierre
• Granted Patent: US 9,861,460 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• 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: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/30537 adjustable
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

The invention concerns an implantable prosthesis (1) for the treatment of incontinence, comprising a retaining means (2) having a support element (3) designed to be placed under the urethra (U) and to prevent any uncontrolled intraurethral flow, said prosthesis being characterized in that it comprises an atraumatic suspension means (4) provided with at least one bearing element (5) arranged so as to overlap part of the pubic bone (OP) and to rest on the latter, and at least one sling (6, 7) connecting said bearing element (5) to the retaining means (2), said sling (6, 7) being designed to hold the support element (3) at a substantially constant distance from the public bone (OP), called the retaining distance (d_o), a means (20) for reversibly adjusting the retaining distance (d_o), thus making it possible to reversibly vary said retaining distance (d_o). The prosthesis is used to treat incontinence.

Claims

1. Implantable prosthesis (1) for the treatment of incontinence, comprising a retaining means (2) having a support element (3) designed to be placed under the urethra (U) in order to prevent the latter moving away in the direction of the lower pelvis, and to prevent any uncontrolled intraurethral flow, said prosthesis further comprises:

an atraumatic suspension means (4) provided with at least one bearing element (5) arranged so as to overlap part of the pubic bone (OP) and to rest on the latter, and at least one sling (6, 7) connecting said bearing element (5) to the retaining means (2), said sling (6, 7) being designed to hold the support element (3) at a substantially constant distance from the pubic bone (OP), called the retaining distance (d_o)

a means (20) for reversibly adjusting the retaining distance (d_o), thus making it possible to reversibly vary said retaining distance (d_o).

2. Prosthesis of claim 1 in which said means (20) for reversibly adjusting the retaining distance (d_o) has an element (21) to adjust the length of one or the other of the slings (6, 7).

3. Prosthesis of claim 1 in which said suspension means (4) comprises at least one anterior sling (6) and one posterior sling (7) arranged to connect the bearing element (5) to the retaining means (2) by respectively passing in front of, and behind, the pubic bone (OP).

4. Prosthesis of claim 3 in which said suspension means (4) comprises at least two suspension harnesses (10, 11), each comprising an anterior sling (6), a bearing element (5) and a posterior sling (7).

5. Prosthesis of claim 4 in which said one and/or the other of the harnesses (10, 11) is, prior to implantation, divided into a first strand (10A, 11A) and a second strand (10B, 11B), having a captive extremity attached to the retaining means (2) and a free extremity.

6. Prosthesis of claim 4 in which said one and/or the other of the harnesses is formed on the basis of a PTFE band, or on the basis of a composite material comprising an implantable textile insert, such as polypropylene or polyester, and an elastomer coating or matrix, such as silicon.

7. Prosthesis of claim 4 in which said retaining means (2) has a left area (3G) and a right area (3D) situated to both sides of an imaginary center line (L) substantially parallel to the main extension direction (XX′

) of the urethra and in that the suspension means (4) has a left harness (10) and a right harness (11), said left and right harnesses being respectively attached to the retaining means (2) in its left area and in its right area.

8. Prosthesis of claim 1 in which said retaining means (2) comprises a framing element (30) joined to the slings (6, 7).

9. Prosthesis of claim 8 in which said framing element (30) is formed by a crosspiece (31) whose center is substantially in register with the center line (L) and whose branches (32, 33, 34, 35) are each connected to the extremity of a harness (10, 11).

10. Prosthesis of claim 8 in which said framing element (30) and one/or the other of the harnesses (10, 11) consists of a single piece.

11. Prosthesis of claim 1 in which said retaining means (2) comprises lateral holding elements (12, 13) designed to its be placed on each side of the urethra.

12. Prosthesis of claim 11 in which said lateral holding elements (12, 13) and the support element (3) consist of a single piece.

13. Prosthesis of claim 1 in which said support element (3) is formed, at least partially and preferably totally, by a flexible plate (40).

14. Prosthesis of claim 8 in which said framing element (30), is flexible and said support element (3) is formed by a flexible plate (40) and said framing element is connected to the flexible plate (40).

15. Prosthesis of claim 13 in which the depth (D1) of the flexible plate (40) considered along the main extension direction (XX′

) of the urethra is greater than, or equal to, its'"'"' width along a transversal lateral direction (YY′

) to the said main extension direction (XX′

) of the urethra.

16. Prosthesis of claim 13 in which said flexible plate (40) has an anterior edge and a posterior edge and the width of anterior edge of the flexible plate (40) is substantially less than, or equal to, the width of its posterior edge.

17. Prosthesis of claim 2 in which said means (20) for adjusting the retaining distance (d_o) is designed to allow continuous modification of the retaining distance (d_o).

18. Prosthesis of claim 17 in which said element (21) to adjust the length comprises a tightening loop (26) wrapped around a sling (6, 7) and arranged to enable continuous adjustment of the length of the said sling.

19. Prosthesis of claim 1 in which said means (20) for adjusting retaining distance (d_o) is designed to permit a discrete modification of the retaining distance (d_o).

20. Prosthesis of claim 5 and including an element (21) to adjust the length comprising several male fixing elements (22) distributed along the first strand (10A, 11A) as well as one or more matching female fixing elements (23) associated with the second strand (10B, 11B) in such a way that the length of the corresponding strand can be adjusted according to fixing element pair (22, 23) chosen.

21. Prosthesis of claim 1 in which said suspension means (4) comprises a peri-symphyseal suspension means designed to suspend the retaining means (2) to the symphysis pubica (SP).

22. Prosthesis of claim 1 in which said prosthesis further comprises an inflatable means of compression (50) positioned at the level of the support element (3) between the retaining means (2) and the urethra (U), and fitted in such a way that, when inflated, it exerts a compression on the urethra against the tissues above the latter.

23. Prosthesis of claim 1 in which said retaining means (2) has a subvesical extension (60) designed to bear up against the bladder.

24. Surgical instrument (8) to be used for implanting a prosthesis (1) for the treatment of incontinence comprising a retaining means (2) having a support element (3), an atraumatic suspension means (4) provided with a bearing element (5) arranged to overlap a part of the pubic bone (OP) and rest on the latter, as well as at least one sling (6, 7) connecting the bearing element (5) to the retaining means (2) in order to hold the support element (3) at a retaining distance (d_o) substantially constant from the pubic bone (OP), said surgical instrument being provided with an introduction element (81) designed to be inserted in the tissues situated in the retropubic space in order to therein open a passageway intended for one or the other of the slings (6, 7) said introduction element (81) comprising at least a proximal portion (81A) arranged to penetrate the tissues, a distal portion (81B) connected to a gripping means (82) and an intermediate section (81C) connecting the proximal portion to the distal portion and having an external lateral surface (83) in contact with the tissues traversed, said surgical instrument (80) characterized in that the intermediate selection (81C) comprises at least a lateral orifice (84) connecting its external lateral surface (83) to a collecting duct (85) so as to be able to collect liquid contained in the bladder when the introduction element accidentally perforates the latter.

25. Surgical instrument of claim 24 characterized in that it comprises several lateral orifices (84) tiered along the introduction element (81).

26. A surgical method for treating incontinence, said surgical method comprising:

an engagement step (a) during which is engaged, under the urethra (U), a retaining means (2) with a support element (3) designed to prevent the urethra moving away in the direction of the lower pelvis, and to prevent any uncontrolled intra-urethral flow,

an atraumatic bone suspension step (b) during which the retaining means is suspended to the pubic bone (OP), using an atraumatic suspension means (4) so that the support element (3) be kept at a distance substantially constant from the pubic bone (OP) called the retaining distance (d_o).

27. The surgical method of claim 26 wherein the suspension step (b) constitutes a suspension step to the symphysis pubica (SP).

28. The surgical method of claim 26 wherein the atraumatic suspension step (b) comprises a peri-osseous penetration sub-step (b1) during which a bearing element (5) is placed astride a portion of the pubic bone and the retaining means (2) is connected to said bearing element (5) using at least one anterior sling (6) passing in front of the pubic bone and at least a posterior sling (7) passing behind the said pubic bone in the retropubic space.

29. The surgical method of claim 26 further comprising a suspension tension adjustment step (c) during which the retaining distance (d_o) is adjusted in vivo so as to adjust the suspension stress (F) exerted by the support element (3) on the urethra (U).

30. The surgical method of claim 29 wherein the atraumatic suspension means (4) is provided with at least one bearing element (5) arranged so as to overlap part of the pubic bone (OP) and to rest on the latter, and at least one sling (6, 7) connecting said bearing element (5) to the retaining means (2), and wherein the suspension tension adjustment step (c) consists in a sub-step (c1) for adjusting the length of the slings.

31. The surgical method of claim 26 further comprising a vesical suspension step (e) during which a subvesical extension (60) is introduced under the bladder (V) so as to jointly support the urethra and the said bladder.