Methods and Systems for Treatment of Prolapse

• US 20090192347A1
• Filed: 07/25/2006
• Published: 07/30/2009
• 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., Anderson, Kimberly A., Cox, James E.
• Granted Patent: US 8,535,217 B2
• Time in Patent Office: Days
• 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 between the position of the tissue support portion and a region of the arcus tendineus,

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 includes the 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.

4. The method of claim 1 wherein the region of the arcus tendineus 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.

5. The method of claim 1 wherein the tissue path passes above the arcus tendineus to exit a pelvic region through the obturator internus muscle, wraps around the arcus tendineus, and passes through the levator ani muscle back into the pelvic region.

6. The method of claim 1 wherein the tissue path passes above the arcus tendineus through the obturator internus 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.

7. The method of claim 1 comprising

providing an implant assembly comprising an implant comprising a tissue support portion, two extension portions, and one insertion tool attached at a distal end of each extension portion, the insertion tool comprising a proximal handle and a curved needle at a distal portion,

creating a vaginal incision,

transvaginally placing the tissue support portion in contact with vaginal tissue,

inserting a first curved needle with attached first extension portion through the vaginal incision,

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

inserting a second curved needle 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 an arcus tendineus.

8. The method of claim 1 comprising

providing an implant assembly comprising an implant comprising a tissue support portion, two extension portions, and one needle attached to a distal end of each extension portion, each needle having a leading end and a trailing end, the distal end of each extension portion being attached to the trailing end of each needle,

creating a vaginal incision,

transvaginally placing the tissue support portion in contact with vaginal tissue,

inserting a first needle with attached end of first extension portion through the vaginal incision,

transvaginally manipulating the first needle to lead the distal end of the first extension portion through a first tissue path in a region of an arcus tendineus,

inserting a second needle with attached end of second extension portion through the vaginal incision, and

transvaginally manipulating the second needle to lead the distal end of the second extension portion through a second tissue path in a region of an arcus tendineus.

9. The method of claim 1 comprising

providing an implant assembly comprising an implant comprising a tissue support portion, two extension portions, and a curved dilator attached to a distal end of each extension portion,

providing a surgical tool comprising a handle, a shaft, and a curved distal end, the curved distal end capable of engaging a curved dilator,

creating a vaginal incision,

transvaginally placing the tissue support portion in contact with vaginal tissue,

engaging the curved distal end with a first dilator and inserting a first dilator with attached end of first extension portion through the vaginal incision,

transvaginally manipulating the first dilator to lead the distal end of the first extension portion through a first tissue path in a region of an arcus tendineus,

engaging the curved distal end with a second dilator and inserting the second dilator with attached end of second extension portion through the vaginal incision,

transvaginally manipulating the second dilator to lead the distal end of the second extension portion through a second tissue path in a region of an arcus tendineus.

10. A pelvic implant assembly comprising

an implant comprising supportive portions comprising

a tissue support portion, and

elongate extension portions extending from of the tissue support portion, and

an insertion tool at a distal end of an extension portion, the insertion tool comprising a curved portion 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.

11. The assembly of claim 10 wherein the curved portion has a radius of curvature in the range from 0.5 to 1.5 centimeters and a length of from 3 to 5 centimeters.

12. The assembly of claim 11 wherein the curved portion is substantially a shape of a partial circle of from 90 to 270 degrees.

13. The assembly of claim 11 wherein the curved portion is substantially a shape of a partial circle of from 170 to 190 degrees.

14. The assembly of claim 10 wherein the insertion tool comprises

a handle having a longitudinal axis,

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

a curved portion at the distal end of the shaft, the curved portion having a radius of curvature in the range from 0.5 to 1.5 centimeters and a length of from 3 to 5 centimeters.

15. The assembly of claim 14 wherein the distal end of the extension portion engages a leading end of the needle.

16. The assembly of claim 14 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.

17. The assembly of claim 10 wherein the insertion tool is a curved needle having a radius of curvature in the range from 0.5 to 1.5 centimeters and a length of from 3 to 5 centimeters, and wherein a distal end of the extension portion is attached at a trailing end of the needle.

18. A kit comprising the assembly of claim 17 and a surgical grasping tool capable of manipulating the curved needle transvaginally, the surgical grasping tool selected from a surgical forceps, a surgical needle-passer, and a surgical pliers.

19. The assembly of claim 10 wherein the insertion tool is a curved dilator.

20. A kit comprising the assembly of claim 19 and a tool comprising a proximal handle and a distal curved portion, the distal curved portion being capable of engaging the curved dilator.