Method for treating prolapse and incontinence

Patent metadata

Field	Value
Publication number	US-9414902-B2
Application number	US-93983210-A
Country	US
Kind code	B2
Filing date	Nov 4, 2010
Priority date	Nov 4, 2009
Publication date	Aug 16, 2016
Grant date	Aug 16, 2016

Abstract

A system and method of treating vaginal prolapse and incontinence comprises a kit. The kit includes a mesh graft configured for attachment to the anterior and posterior vaginal walls to thereby treat the vaginal prolapse. A graft delivery device is also provided for introducing and placing the mesh graft to a location deep within the peritoneal cavity and for attaching the graft thereto. A leg assembly is provided and coupled to an end of the mesh graft and cooperates with the graft delivery device to anchor and affix the mesh graft to the desired anatomical structures. The method according to the present invention contemplates a laparoscopic graft placement utilizing the components of the kit.

First claim

I claim:

1. A method of treating vaginal prolapse in a patient, comprising the steps of:
a. forming an abdominal access to the vagina;
b. denuding a peritoneum over an anterior and posterior vaginal wall fascia;
c. inserting at least one mesh graft and leg assembly through the abdominal access to the vagina, the leg assembly including a sheath and a dilator, the mesh graft including a first arm member, a second arm member, and a mesh extension, the mesh extension having a width smaller than widths of the first and second arm members;
d. attaching the first arm member of the mesh graft to the anterior vaginal wall fascia;
e. attaching the second arm member of the mesh graft to the posterior vaginal wall fascia;
f. creating a tunnel in the peritoneum between a first incision and a second incision;
g. passing the leg assembly through the tunnel;
h. anchoring the mesh extension of the mesh graft to a soft tissue near a sacral promontory, the anchoring includes (1) passing a bullet needle coupled to the mesh extension through the soft tissue, (2) passing the leg assembly through the soft tissue, (3) positioning the mesh extension in the soft tissue, (4) retracting the bullet needle and leg assembly out of the abdominal access through which the at least one mesh graft and leg assembly was inserted, and (5) removing the bullet needle and leg assembly; and
i. adjusting a tension of the mesh graft.

2. The method of claim 1 wherein the access is a laparoscopic portal entry.

3. The method of claim 1 wherein the access is a traditional incision.

4. The method of claim 1 wherein the mesh graft is attached to the anterior and posterior vaginal wall fascia by a suture.

5. The method of claim 4 wherein the suture is attached to the mesh graft by knot-free bidirectional fixation.

6. The method of claim 1 wherein a vaginal apex is affixed to the mesh graft at a location where the mesh extension and the first arm member connect such that the mesh extension is disposed between the vaginal apex and the soft tissue near the sacral promontory.

7. The method of claim 1 wherein the first incision is located either:
a. near a sacral promontory,
b. near an S1 vertebra, or
c. near an S2 vertebra.

8. The method of claim 1 wherein the second incision is located near a posterior cul-de-sac.

9. The method of claim 1 wherein adjusting the tension of the mesh graft comprises altering a position of the mesh extension in the soft tissue including pulling a suture coupled to the mesh extension and then pulling the dilator as the dilator is removed from the abdominal access.

10. The method of claim 1 , wherein the first arm member has a rectangular shape with reduced corners, and the second arm member has a tapered portion that tapers away from the mesh extension.

11. A method, comprising:
inserting a graft into a pelvic region of a patient through an abdominal incision, the graft including a first arm member, a second arm member, and a mesh extension, the mesh extension having a width smaller than widths of the first arm member and the second arm member, a leg assembly coupled to and extending from the mesh extension of the graft, the leg assembly having a sheath, a dilator, and a bullet needle;
coupling the mesh extension of the graft to soft tissue near a sacral promontory of the patient using a suturing device having a needle carrier and a needle catch, wherein the coupling the mesh extension of the graft to the soft tissue includes passing the bullet needle through the soft tissue by rotating the needle carrier of the suturing device and capturing the bullet needle in the needle catch of the suturing device;
retracting the leg assembly out of the abdominal incision through which the graft was inserted;
coupling the first arm member of the graft to an anterior vaginal wall of the patient; and
coupling the second arm member of the graft to a posterior vaginal wall of the patient.

12. The method of claim 11 , wherein the suturing device includes an outer housing, the outer housing defining a first opening and a second opening, wherein the coupling of the mesh extension of the graft to the soft tissue includes pivoting the needle carrier about an axis such that the needle carrier pivots out of the first opening and delivers the bullet needle into the needle catch via the second opening.

13. The method of claim 11 , further comprising:
inserting a paddle into the vagina of the patient; and
applying a force to the vagina via the paddle.

14. The method of claim 11 , further comprising:
inserting a paddle into the vagina of the patient, the paddle having a flat end and a handle end;
applying a force to the vagina via the paddle.

15. A method, comprising:
inserting a graft into a pelvic region of a patient through an abdominal incision, the graft having a mesh extension, a first arm member, and a second arm member, the mesh extension having a width smaller than widths of the first arm member and the second arm member;
coupling the mesh extension of the graft to soft tissue near a sacral promontory of the patient by passing a bullet needle coupled to the graft through the soft tissue by rotating a needle carrier out of an outer structure of a suturing device and capturing the bullet needle in a needle catch disposed within the outer structure of the suturing device;
retracting the suturing device and the bullet needle from the abdominal incision through which the graft was inserted;
coupling the first arm member of the graft to an anterior vaginal wall of the patient; and
coupling the second arm member of the graft to a posterior vaginal wall of the patient.

16. The method of claim 15 , further comprising:
inserting a paddle into the vagina of the patient; and
applying a force to the vagina via the paddle.

17. The method of claim 15 , further comprising:
inserting a paddle into the vagina of the patient, the paddle having a flat end and a handle end;
applying a force to the vagina via the paddle.

Assignees

• Miller Dennis
• Boston Scient Scimed Inc

Inventors

• Miller Dennis

Classifications

• A61F2/0045 Primary

  Support slings · CPC title

• A61F2/0063

  Implantable repair or support meshes, e.g. hernia meshes · CPC title

• A61F2230/006

  Y-shaped · CPC title