Methods and systems for treatment of prolapse

• US 9,283,064 B2
• Filed: 06/18/2015
• Issued: 03/15/2016
• Est. Priority Date: 07/26/2005
• Status: Active Grant

• Current Assignee: ENDO USA Incorporated
• 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:
  US14/743,259
• Publication Number:
  US 20150282920A1
• Time in Patent Office: 271 Days
• US Class Current: 1/1
• 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 an incision,

contacting the support portion with posterior vaginal tissue,

producing a tissue path that passes between a position of the tissue support portion and a region of an 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 an ischial spine and a distance 3 centimeters anterior to the ischial spine,

wherein the tissue path passes below the arcus tendineus through an iliococcygeus muscle, wraps around the arcus tendineus to a location above the arcus tendineus, through an obturator internus muscle, and back to a region of the pelvic floor, and

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.

4. The method of claim 1, wherein a distal end of the extension portion is sutured to the pelvic floor.

5. The method of claim 1, wherein the tissue path does not extend to an external incision.

6. The method of claim 1, wherein the extension portion is passed through an external incision.

7. The method of claim 1, wherein an incision is a perirectal incision.

8. A pelvic implant assembly comprising an implant and an insertion tool,

the implant comprising

a tissue support portion,

elongate extension portions extending from the tissue support portion, and

a dilator located at a distal end of each elongate extension portion, the dilator comprising a curve having a radius of curvature in the range of from 0.5-1.5 centimeters, a sharp tip at a distal end, and an opening at a proximal end, the opening designed and adapted to fit and removably engage a distal end of the insertion tool.

9. The pelvic implant assembly of claim 8, wherein the implant is a mesh strip.

10. The pelvic implant assembly of claim 8, wherein the implant has a length sufficient to extend from a region of an arcus tendineus on a first side of a patient to a region of an arcus tendineus on a second side of the patient.

11. The pelvic implant assembly of claim 8, wherein the tissue support portion has a width greater than a width of the extension portions.

12. The pelvic implant assembly of claim 8, wherein the implant includes a removable sheath that can cover one of the extension portions.

13. The pelvic implant assembly of claim 8, wherein the insertion tool comprises a handle and a longitudinally extending shaft, wherein a proximal end of the extending shaft extends from the handle and a distal end of the extending shaft comprises a radius of curvature.

14. The pelvic implant assembly of claim 13, wherein the dilator has a radius of curvature that matches the radius of curvature of the insertion tool.

15. The pelvic implant assembly of claim 13, wherein the insertion tool is configured to push the dilator through tissue.

16. The pelvic implant assembly of claim 8, wherein the insertion tool comprises a substantially straight shaft.

17. The pelvic implant assembly of claim 8, wherein the insertion tool comprises a curved distal end, the curved portion comprising a radius of curvature in the range of from 0.5-1.5 centimeters.

18. A pelvic implant assembly comprising an implant and a first and second insertion tools,

the implant comprising

a tissue support portion,

a first elongate extension portion extending from an end of the tissue support portion and a second elongate extension portion extending from an opposite end of the tissue support portion, and

a first dilator located at a distal end of the first extension portion and a second dilator located at a distal end of the second extension portion, each dilator comprising a sharp tip at a distal end and an opening at a proximal end, the opening designed and adapted to engage a distal end of the first and second insertion tools;

and wherein

each insertion tool comprises a shaft, a handle, and a curved distal end, the curved distal end comprising a radius of curvature in the range of from 0.5-1.5 centimeters, and the curved distal end being capable of engaging one of the dilators and pushing the dilator through tissue.

19. The pelvic implant assembly of claim 18 comprising a first suture extending along a length of the first extension portion and a second suture extending along a length of the second extension portion.