IMPLANTS, TOOLS, AND METHODS FOR TREATMENT OF PELVIC CONDITIONS

• US 20120253106A1
• Filed: 03/28/2012
• Published: 10/04/2012
• Est. Priority Date: 03/28/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Khamis, Chaouki A., Roll, Jessica L., Moosai, Shiva P.
• Granted Patent: US 9,089,393 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2/0031 for constricting the lumen; Support slings for the urethra
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

Described are various embodiments of surgical procedures, systems, implants, devices, tools, and methods, useful for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to supportive tissue and adjusting the implant.

Claims

1. A pelvic implant useful to treat a pelvic condition, the implant comprising

a tissue support portion and two opposing extension portions,

a suture passing through an extension portion between a midline of the implant and a distal end of the extension portion, the suture being passed through the mesh such that pulling a loose end of the suture causes a length of the extension portion to decrease.

2. A pelvic implant as recited at claim 1 comprising a second suture passing through a second extension portion, between a midline of the implant and a distal end of the second extension portion, the second suture being passed through the mesh such that pulling a loose end of the second suture causes a length of the extension portion to decrease.

3. A pelvic implant as recited at claim 2 comprising supportive portions consisting of a central support portion and two extension portions.

4. A pelvic implant as recited at claim 2 comprising a self-fixating tip at an end of each extension portion, the implant having a length to allow the self-fixating tips to be placed at tissue of opposing obturator foramen of a patient, with the central support portion supporting tissue of a urethra or anus.

5. A pelvic implant as recited at claim 1 wherein the suture passes through the mesh exactly two times.

6. A pelvic implant as recited at claim 1 wherein the suture passes through the mesh exactly four times, loose ends of the suture extend from a front side of the mesh, and upon pulling the loose ends a loop forms on a back side of the mesh between locations of the suture passing through the mesh.

7. A combination comprising a pelvic implant and a suture passer, the combination useful to treat a pelvic condition,

the implant comprising a tissue support portion and two opposing mesh extension portions,

the suture passer comprising a proximal end, a shaft, and a shaft distal end, the shaft distal end comprising a suture passer and a mesh holder, wherein the mesh holder is capable of engaging mesh and holding the mesh between jaws of the suture passer, and the suture passer is capable of passing a suture through the mesh held between the jaws.

8. A combination as recited at claim 7 wherein the implant comprises supportive portions consisting of a central support portion and two extension portions.

9. A combination as recited at claim 8 wherein the implant comprises a self-fixating tip at an end of each extension portion, the implant having a length to allow the self-fixating tips to be placed at tissue of opposing obturator foramen of a patient, with the central support portion supporting tissue of a urethra or anus.

10. A combination as recited at claim 9 further comprising one or more insertion tool capable of engaging one or more of the self-fixating tips, passing the one or more self-fixating tips through a medial incision in the patient, and placing the one or more self-fixating tips at the opposing obturator foramen.

11. A method of treating a pelvic condition, the method comprising

providing a pelvic implant useful to treat a pelvic condition, the implant comprising

a tissue support portion, a first extension portion, and a second extension portion,

a suture passing through an extension portion between a midline of the implant and a distal end of the extension portion, the suture being passed through the mesh such that pulling a loose end of the suture causes a length of the extension portion to decrease,

placing the implant in a patient to support tissue,

adjusting a length of the extension portion by tightening the suture.

12. A method as recited at claim 11 wherein the implant comprises a second suture passing through a second extension portion, between a midline of the implant and a distal end of the second extension portion, the second suture being passed through the mesh such that pulling a loose end of the second suture causes a length of the second extension portion to decrease, the method comprising adjusting a length of second extension portion by tightening the second suture.

13. A method as recited at claim 12 comprising adjusting the length of the first extension portion and the length of the second extension portion together to prevent supported tissue from being moved in a left or a right direction within the patient.

14. A method as recited at claim 13 wherein the pelvic condition is selected from the group consisting of:

fecal incontinence and urinary incontinence.

15. A method as recited at claim 14 for treating urinary incontinence, the method comprising:

creating a medial incision in the patient,

placing the tissue support portion to contact tissue to support the urethra,

placing a distal end of the first extension portion in a tissue path extending toward a first obturator foramen of the patient, and

placing a distal end of the second extension portion in a tissue path extending toward a second obturator foramen of the patient.

16. A method of treating a pelvic condition, the method comprising

providing an implant comprising a tissue support portion, a first mesh extension portion, and a second mesh extension portion,

providing a suture passer comprising a proximal end, a shaft, and a shaft distal end, the shaft distal end comprising a suture passer and a mesh holder, wherein the mesh holder is capable of engaging mesh and holding the mesh between jaws of the suture passer, and the suture passer is capable of passing a suture through the mesh held between the jaws,

placing the implant in a patient to support tissue,

using the suture passer to place a suture at an extension portion, and adjusting a length of the extension portion by tightening the suture.

17. A method as recited at claim 16 comprising using the suture passer to place a second suture at a second extension portion, and adjusting a length of the second extension portion by tightening the second suture.

18. A method as recited at claim 17 comprising adjusting the length of the first extension portion and the length of the second extension portion together to prevent supported tissue from being moved in a left or a right direction within the patient.

19. A method as recited at claim 18 wherein the pelvic condition is selected from the group consisting of fecal incontinence and urinary incontinence.

20. A method as recited at claim 19 for treating urinary incontinence, the method comprising:

creating a medial incision in the patient,

placing the tissue support portion to contact tissue to support the urethra,

placing a distal end of the first extension portion in a tissue path extending toward a first obturator foramen of the patient, and

placing a distal end of the second extension portion in a tissue path extending toward a second obturator foramen of the patient.