Methods and systems for treatment of prolapse

• US 9,060,839 B2
• Filed: 09/13/2013
• Issued: 06/23/2015
• Est. Priority Date: 07/26/2005
• Status: Active Grant

• Current Assignee: ENDO Operations Limited (Endo, Inc.)
• 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:
  US14/025,988
• Publication Number:
  US 20140179990A1
• Time in Patent Office: 648 Days
• Field of Search: 600 29- 32, 600/37, 623/23.64, 623/23.66, 128/885, 128/DIG.25
• 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,

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 the arcus tendineus and between an ischial spine and a distance 3 centimeters anterior to the ischial spine, wherein the tissue path does not extend to an external incision,

wherein the tissue path passes above the arcus tendineus through an obturator internus muscle, and wraps around the arcus tendineus, 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 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 comprising

providing an implant assembly comprising the implant comprising the tissue support portion, the extension portion and a second extension portion, and a first and second insertion tool attached at a distal end of each extension portion, the first and second insertion tools 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 the posterior 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 the first tissue path in the region of the 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 comprising 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 does not extend to an external incision.

5. The method of claim 1 comprising

providing an implant assembly comprising the implant comprising the tissue support portion, the first extension portion and a second extension portion, 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 the posterior 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 the first tissue path in the region of the 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.

6. The method of claim 1 comprising

providing an implant assembly comprising the implant comprising the tissue support portion, the first extension portion and a second extension portion, 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 first of the curved dilators,

creating a vaginal incision,

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

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

transvaginally manipulating the first curved dilator to lead the distal end of the first extension portion through the tissue path on a first side of a patient,

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

transvaginally manipulating the second curved dilator to lead the distal end of the second extension portion through a second tissue path on an opposite side of the patient in a region of an arcus tendineus comprising a region from 2 centimeters above the arcus tendineus to the arcus tendineus and between an ischial spine and a distance 3 centimeters anterior to the ischial spine, wherein the second tissue path passes above an arcus tendineus through an obturator internus muscle, and wraps around the arcus tendineus, and wherein the tissue path does not extend to an external incision.

7. The method of claim 1 wherein the implant comprises

the tissue support portion,

a second elongate extension portion extending from the tissue support portion, and

two dilators, one each attached at an end of the two elongate extension portions.

8. The method of claim 7 wherein the dilators are curved dilators.

9. The method or claim 8 comprising providing an insertion tool comprising

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

the distal end being adapted to engage at least one of the dilators.

10. The method of claim 8 comprising engaging the insertion tool distal end with one of the two dilators and pushing the dilator along the tissue path.

11. 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,

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 the arcus tendineus and between an ischial spine and a distance 3 centimeters anterior to the ischial spine, and through an obturator internus muscle, wraps around the arcus tendineus, and passes through a levator ani muscle back into a pelvic region, wherein the tissue path does not extend to an external incision, and

extending the extension portion through the tissue path.

12. 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,

contacting the support portion with posterior vaginal tissue,

producing a tissue path 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, and

extending the extension portion through the tissue path,

wherein the tissue path passes above the arcus tendineus to exit a pelvic region through an obturator internus muscle, wraps around the arcus tendineus, and passes through a levator ani muscle back into the pelvic region.

13. 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,

contacting the support portion with posterior vaginal tissue,

producing a tissue path 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, and

extending the extension portion through the tissue path,

wherein the tissue path passes above the arcus tendineus through an obturator internus muscle, wraps around the arcus tendineus, passes through a levator ani muscle back into the pelvic region, and continues through a buttock and through an external incision in a perirectal region.