Surgical device forming a surgical prosthesis

• US 7,713,188 B2
• Filed: 12/22/2006
• Issued: 05/11/2010
• Est. Priority Date: 12/26/2005
• Status: Expired due to Fees

• Current Assignee: Analytic Biosurgical Solutions- ABISS
• Original Assignee: La Societe Evergin SA
• Inventors: Bouffier, Bernard
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US11/615,144
• Publication Number:
  US 20070162120A1
• Time in Patent Office: 1,236 Days
• Field of Search: 600/29, 600/30, 600/37
• US Class Current: 600/37
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

The surgical device is for supporting a mammalian organ in need of support, and in particular for treating urinary incontinence. The device has at least one first support element of elongate shape for exerting a supporting action on the organ; and at least one first traction filiform element, to be fastened to the support element. One end of the traction element constituting at least one first anchor system, activated by traction exerted on the first traction element thereby simplifying the surgical procedure.

Claims

1. A surgical device forming a surgical prosthesis, for supporting a mammalian organ in need of support, the device comprising:

a) at least one elongated support element having a first end and a second end for exerting a supporting action on said organ the support element being made, at least in part, out of a material that is substantially non-extendable, flexible, and deformable;

b) a first filiform traction element having a distal end and a proximal end, the proximal end of the first traction element can be fastened to the first end of said support element, said distal end of the first traction element having a first fixing system, the first fixing system integral with the distal end of the first traction element and comprising a plurality of folds in the distal end of the first traction element and the proximal end of the first traction element having perforated the folds to form the first fixing system, such that when traction is exerted on the proximal end of the first traction element, the first fixing system deploys to provide an umbrella effect so as to define an area that is sufficient for anchoring; and

c) a second filiform traction element, having a distal end and a proximal end, the proximal end of the second traction element can be fastened to the second end of the support element and the distal end of the second traction element having a second fixing system for anchoring.

2. A device according to claim 1, wherein the folds are perforated by a needle-forming element attached to the proximal end of the first traction element.

3. A device according to claim 1, wherein the first traction element is made, at least in part, out of the same material used for making the support element.

4. A device according to claim 1, wherein the second fixing system is formed in the same way as the first fixing system.

5. A device according to claim 1, wherein either the first traction element, or the second traction element, or each traction element, is made of the same material used to make the support element and the material is an organic polymer compatible with being implanted in mammalian tissue, the organic polymer is polyethylene, polypropylene, or nylon.

6. A device according to claim 1, wherein the first support element is a strip of width that is sufficient to achieve support of the organ to be supported.

7. A device according to claim 1, wherein the first traction element or she second traction element, or both of them, comprises a strip of a width that is narrower than a width of the support element.

8. A device according to claim 1, wherein at least one fastener element is provided at each end of the support element, for fastening to the proximal end of the first and second traction element.

9. A device according to claim 8, wherein the fastener element comprises a slot made in the material of the support element, said slot being disposed substantially parallel to longitudinal edges of the support element.

10. A device according to claim 1, wherein the first and second traction element and the support element are each formed by a woven or non-woven strip made from yarns of organic polymer material;

the first and second traction element and the support element are fastened together using at least one fastener element by pressing the first and second traction element against a facing surface of the support element, causing respective surfaces to be fastened together by natural interpenetration.

11. The device of claim 1 wherein the proximal end of the second traction element is integral with the second end of the support element.

12. The device of claim 1 wherein the folds in the distal end of the first traction element are formed by coiling the distal end of the first traction element.

13. The device of claim 1 wherein the folds in the distal end of the first traction element are formed by serpentine folds in the distal end of the first traction element.

14. A support and fixing kit comprising at least one surgical device for forming a surgical prosthesis as defined in claim 1;

together with a first and second introducer device, each in the form of a penetration trocar, the trocar having a pusher element for pushing the distal end of the traction element with the fixing system, folded inside the penetration trocar.

15. A surgical method for providing support to a mammalian organ in need of support, the method comprising:

a) applying local anesthetic in the vicinity of the organ to be supported on the future path of a prosthesis;

b) making an incision and dissecting tissue facing and on either side by the mammalian organ to be supported;

c) inserting a first introducer device, forming a trocar, in the passage created by said incision and tissue dissection, to one side of and away from the organ to be supported, and after, the introducer device forming a trocar is passed through a relatively tear-resistant support of said mammal, said trocar-forming introducer device of hollow tubular shape containing internally a first traction element, and a pusher element the first traction element having a proximal end and a distal end, the distal end having a first fixing system integral therewith, the first fixing system comprising a plurality of folds in the distal end of the first traction element and the proximal end of the first traction element having perforated the folds to form the first fixing system;

d) applying thrust to the pusher element so as to cause a distal end of a first traction element to move out from the introducer device until the first fixing system of the first traction element is released beyond said relatively tear-resistant support;

e) after releasing the first fixing system, applying traction in the vicinity of the proximal end of the first traction element, enabling the first fixing system to be positioned and deployed by being flattened out, thereby obtaining an “

umbrella”

positioning that presents a large anchoring area against said relatively tear-resistant support of said mammal;

f) withdrawing the penetration trocar leaving the first fixing system in place pressed against the tear-resistant support that can thus act as a fixing point since the size of the first fixing system greatly exceeds the size of the orifice caused by penetration of the trocar;

g) repeating above steps c), d), e), and f) on the other side of the organ so as to introduce a second traction element, identical to the first traction element;

h) securing the proximal end of the first traction element to a first fastener element at a first end of an elongate support element so as to apply a first traction movement on the proximal end of the traction element for pre-positioning purposes;

i) performing the same procedure as step h concerning the second traction element with a second fastener element provided at a second end of the elongate support element, until said elongate support element is put under tension in an appropriate position relative to said organ so as to provide the desired support of said organ; and

j) closing or suturing the incision with appropriate surgical closure means.

16. The surgical method of claim 15 for treating Incontinence in a female mammal.

17. The surgical method of claim 16, wherein the distal end of the first and second traction element bears against the tissue of the pelvic wall, in the portion situated between the urethra and the sides of the female mammal above the vaginal wall.

18. The surgical method of claim 15, for treating incontinence in a male mammal, the organ to be supported being the urethra, the support being performed in the vicinity of the urethral bulb.

19. The surgical method of claim 18, wherein the distal end of the first and second traction element bears against the tissues of the muscular membrane of the obturated foramen of the pelvis.

20. A surgical device forming a surgical prosthesis, for supporting a mammalian organ in need of support, the device comprising:

a) at least one elongated support element having a first end and a second end for exerting a supporting action on said organ, the support element being made, at least in part, out of a material that is substantially non-extendable, flexible, and deformable;

the support element is formed by a woven or non-woven strip made from yarns of organic polymer material compatible with being implanted in mammalian tissue;

b) a first filiform traction element having a distal end and a proximal end, the first traction element is formed by a woven or non-woven strip made from yarns of organic polymer material compatible with being implanted in mammalian tissue, the proximal end of the first traction element can be fastened to one end of the support element, by passing the proximal end of the first traction element through the support element, said distal end of the first traction element having a first fixing system, the first fixing system being integral with the distal end of the first traction element and comprising folds in the distal end of the first traction element, such that when traction is exerted on the proximal end of the traction element, the folds of the first fixing system deploy to provide an umbrella effect so as to define an area that is sufficient for fixing; and

c) a second filiform traction element, having a distal end and a proximal end, the second traction element is formed by a woven or non-woven strip made from yarns of organic polymer material compatible with being implanted in mammalian tissue, the proximal end of the second traction element can be fastened to the other end of the support element, by passing the proximal end of the second traction element through the support element, the distal end of the traction element having a second fixing system.

21. The device of claim 20, wherein the proximal end of the first and second traction element and the support element are fastened together by pressing the proximal end of the first and second traction element against a facing surface of either the support element or the first or second traction element, causing their respective surfaces to be fastened together by natural interpenetration.

22. A device according to claim 20, wherein the folds in the distal end of the first traction element are fastened together, by being perforated by a needle-forming element attached to the proximal end of the first traction element so as to form the fixing system.

23. A device according to claim 20, wherein the organic polymer material is selected from the group consisting of polyethylene, polypropylene, and nylon.

24. A device according to claim 20, wherein the second fixing system is formed from folds of said strip in the distal end of the second traction element.

25. A device according to claim 20, wherein the support element is a strip of width that is sufficient to achieve support of the organ to be supported.

26. A device according to claim 20, wherein the first traction element or the second traction element, or both of them, comprises a strip of a width that is narrower than a width of the support element.

28. A support and fixing kit comprising ac least one surgical device for forming a surgical prosthesis as defined in claim 20;

together with a first and second introducer device, each in the form of a penetration trocar, the trocar having a pusher element for pushing the distal end of the traction element with the fixing system, folded inside the penetration trocar.

27. A surgical device forming a surgical prosthesis, for supporting a mammalian organ in need of support, the device comprising:

a) at least one elongated support element having a first end and a second end for exerting a supporting action on said organ, the support element being made, at least in part, out of a material that is substantially non-extendable, flexible, and deformable; and

a first slot made in the material at first end and a second slot made in the material at the second end of the support element;

b) a first filiform traction element having a distal end and a proximal end, the proximal end of the first traction element can be fastened to one end of the support element, by passing the proximal end of the first traction element through the first slot, said distal end of the first traction element having a first fixing system, the first fixing system being integral with the distal end of the first traction element and comprising folds in the distal end of the first traction element, such that when traction is exerted on the proximal end of the traction element, the folds of the first fixing system deploy to provide an umbrella effect so as to define an area that is sufficient for fixing;

c) a second filiform traction element, having a distal end and a proximal end, the proximal end of the second traction element can be fastened to the second end of the support element by passing the proximal end of the traction through the second slot, the distal end of the traction element having a second fixing system; and

d) the first traction element, second traction element and the support element are each formed by a woven or nonwoven strip made from yarns of organic polymer material, the proximal end of the first and second traction element and the support element are fastened together by pressing the proximal end of the first and second traction element against a strip facing surface of either the support element or the first or second traction element, causing their respective surfaces to be fastened together by natural interpenetration.

29. A surgical method for providing support to a mammalian organ in need of support, the method comprising:

a) applying local anesthetic in the vicinity of the organ to be supported on the future path of a prosthesis;

b) making an incision and dissecting tissue facing and on either side by the mammalian organ to be supported;

c) inserting a first introducer device, forming a trocar, in the passage created by said incision and tissue dissection, to one side of and away from the organ to be supported, and after, the introducer device forming a trocar is passed through a relatively tear-resistant support of said mammal, said trocar-forming introducer device of hollow tubular shape containing internally a first traction element, and a pusher element;

the first traction element having a proximal end and a distal end, the distal end having a first fixing system integral therewith and comprising a plurality of folds in the distal end of the first traction element;

d) applying thrust to the pusher element so as to cause a distal end of a first traction element to move out from the introducer device until the first fixing system of the first traction element is released beyond said relatively tear-resistant support;

e) after releasing the first fixing system, applying traction in the vicinity of the proximal end of the first traction element, enabling the first fixing system to be positioned and the folds to be deployed by being flattened out, thereby obtaining an “

umbrella”

positioning that presents a large anchoring area against said relatively tear-resistant support of said mammal;

f) withdrawing the penetration trocar leaving the fixing system in place pressed against the tear-resistant support that can thus act as a fixing point since the size of the fixing system greatly exceeds the size of the orifice caused by penetration of the trocar;

g) repeating above steps c), d), e), and f) on the other side of the organ so as to introduce a second traction element, identical to the first traction element;

h) securing the proximal end of the first traction element to a first fastener element at a firs;

end of an elongate support element so as to apply a first traction movement on the proximal end of the traction element for pre-positioning purposes;

i) performing the same procedure as step h concerning the second traction element with a second fastener element provided at a second end of the elongate support element, until said elongate support element is put under tension in an appropriate position relative to said organ so as to provide the desired support of said organ, the first traction element, second traction element, and the support element are formed by a woven or non-woven strip made from yarns of organic polymer material, the proximal end of the first and second traction element and the support element are fastened together by pressing the proximal end of the first and second traction element against a strip facing surface of either the support element or the first or second traction element, causing their respective surfaces to be fastened together by natural interpenetration; and

j) closing or suturing the incision with appropriate surgical closure means.

30. The surgical method of claim 29, for treating incontinence in a female mammal.

31. The surgical method of claim 29, wherein the distal end of the first and second traction element bears against the tissue of the pelvic wall, in the portion situated between the urethra and the sides of the female mammal above the vaginal wall.

32. The surgical method of claim 29, for treating incontinence in a male mammal, the organ to be supported being the urethra, the support being performed in the vicinity of the urethral bulb.

33. The surgical method of claim 32, wherein the distal end of the first and second traction element bears against the tissues of the muscular membrane of the obturated foramen of the pelvis.