Methods and systems for treatment of prolapse

• US 8,535,217 B2
• Filed: 07/25/2006
• Issued: 09/17/2013
• Est. Priority Date: 07/26/2005
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Davila, Guillermo H., Cox, James E., Anderson, Kimberly A.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US11/989,256
• Publication Number:
  US 20090192347A1
• Time in Patent Office: 2,611 Days
• Field of Search: 600 29- 32, 600/37, 128/885, 128/DIG.25, 128897-898, 623/23.64, 623/23.66
• US Class Current: 600/37
• 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 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• 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 2002/0072 Delivery tools therefor
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Described are implants, tools, and related methods, for use in pelvic surgery to treat conditions such as prolapse, including embodiments of methods that involve a tissue path above the arcus tendineus.

Claims

1. A method of supporting posterior vaginal tissue, the method comprising

providing an implant comprising a tissue support portion and an extension portion extending from the tissue support portion,

creating a vaginal incision,

transvaginally contacting the support portion with posterior vaginal tissue,

transvaginally producing a tissue path using an insertion tool at a distal end of the extension portion, the path being produced between the position of the tissue support portion and a region of the arcus tendineus, wherein the region of the arcus tendineus comprises a region from 2 centimeters above the arcus tendineus to 2 centimeters below the arcus tendineus and between the ischial spine and a distance 3 centimeters anterior to the ischial spine, wherein the insertion tool comprises a longitudinally extending shaft and a curved portion at a distal end of the shaft, the curved portion comprising a radius of curvature in the range of from 0.5 to 1.5 centimeters, and

transvaginally extending the extension portion through the tissue path.

2. The method of claim 1, comprising treating a condition selected from the group consisting of enterocele, rectocele, apical prolapse, and vault prolapse.

3. The method of claim 1 wherein the region of the arcus tendineus further includes the region between the arcus tendineus and 1 centimeter above the arcus tendineus, and between the ischial spine and a distance 1 centimeter anterior to the ischial spine.

6. The method of claim 1

wherein the step of providing an implant comprises providing an implant assembly comprising

the implant comprising the tissue support portion, the extension portion, and a second extension portion,

the insertion tool attached at the distal end of the extension portion, the insertion tool comprising a proximal handle, and

a second insertion tool attached at a distal end of the second extension portion, the second insertion tool comprising a second longitudinally extending shaft, a handle, and a second curved portion at a distal end of the second longitudinally extending shaft, the second curved portion comprising a radius of curvature in a range of from 0.5 to 1.5 centimeters,

and wherein the step of transvaginally producing a tissue path comprises:

inserting the curved portion with attached extension portion through the vaginal incision,

manipulating the handle of the insertion tool to lead the distal end of the extension portion through a first tissue path in the region of the arcus tendineus,

inserting the second curved portion with attached second extension portion through the vaginal incision, and

manipulating the handle of the second insertion tool to lead the distal end of the second extension portion through a second tissue path in a region of a second arcus tendineus.

4. A method of supporting posterior vaginal tissue, the method comprising:

providing an implant comprising a tissue support portion and an extension portion extending from the tissue support portion,

creating a vaginal incision,

transvaginally contacting the support portion with posterior vaginal tissue,

transvaginally producing a tissue path between the position of the tissue support portion and a region of the arcus tendineus, wherein the tissue path passes above the arcus tendineus to exit a pelvic region through the obturator intemus muscle, wraps around the arcus tendineus, and passes through the levator ani muscle back into the pelvic region, and

transvaginally extending the extension portion through the tissue path.

5. A method of supporting posterior vaginal tissue, the method comprising:

providing an implant comprising a tissue support portion and an extension portion extending from the tissue support portion,

creating a vaginal incision,

transvaginally contacting the support portion with posterior vaginal tissue,

transvaginally producing a tissue path between the position of the tissue support portion and a region of the arcus tendineus, wherein the tissue path passes above the arcus tendineus through the obturator intemus muscle, wraps around the arcus tendineus, passes through the levator ani muscle back into the pelvic region, continues through the buttock and through an external incision in a perirectal region, and

transvaginally extending the extension portion through the tissue path.

7. A pelvic implant assembly comprising

an implant comprising supportive portions comprising

a tissue support portion, and

elongate extension portions extending from the tissue support portion, and

an insertion tool at a distal end of at least one of the extension portions, the insertion tool comprising a longitudinally extending shaft having a longitudinal axis and a curved portion at a distal end of the shaft, the curved portion comprising a radius of curvature in the range of from 0.5 to 1.5 centimeters and being sized and shaped to be used in a transvaginal procedure to define a tissue path that exits the pelvic floor region in a region of the arcus tendineus, partially extends around an arcus tendineus, and re-enters the pelvic floor, wherein the region of the arcus tendineus comprises a region from 2 centimeters above the arcus tendineus to 2 centimeters below the arcus tendineus and between the ischial spine and a distance 3 centimeters anterior to the ischial spine.

8. The assembly of claim 7 wherein the curved portion has a length of from 3 to 5 centimeters.

9. The assembly of claim 8 wherein the curved portion is substantially a shape of a partial circle of from 90 to 270 degrees.

10. The assembly of claim 8 wherein the curved portion is substantially a shape of a partial circle of from 170 to 190 degrees.

11. The assembly of claim 7 wherein the insertion tool comprises

a handle having a longitudinal axis,

wherein the shaft has a proximal end and a distal end, the proximal end of the shaft attached at the distal end of the handle, the longitudinal axis of the shaft aligned with the longitudinal axis of the handle, and

the curved portion at the distal end of the shaft, the curved portion having a length of from 3 to 5 centimeters.

12. The assembly of claim 11 wherein the distal end of at least one of the extension portions engages a leading end of the curved portion.

13. The assembly of claim 11 wherein the tool is capable of being used to transvaginally place the curved portion in contact with tissue in a region of the arcus tendineus, and the handle can be manipulated with movement that includes rotation of the handle about a longitudinal axis through the shaft to cause the curved portion to produce a tissue path.