IP Library Granted Patent US 9,060,839
Granted Patent B2
US 9,060,839 · App. 14/025,988 · Granted Jun 23, 2015

Methods and systems for treatment of prolapse

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Quick Facts
Patent No.
US 9,060,839
App. No.
14/025,988
Granted
Jun 23, 2015
Kind
B2
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 (60)

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.

Assignments (14)
SECURITY INTEREST Recorded Jul 22, 2024
From: ENDO BIOLOGICS LIMITED; ENDO OPERATIONS LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 068469/0001 →
SECURITY INTEREST Recorded Jul 19, 2024
From: ENDO BIOLOGICS LIMITED; ENDO OPERATIONS LIMITED
To: GOLDMAN SACHS BANK USA
Reel/Frame 068461/0692 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2024
From: ENDO USA, INC.
To: ENDO OPERATIONS LIMITED
Reel/Frame 067245/0492 →
RELEASE OF SECURITY INTEREST Recorded Apr 26, 2024
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: ACTIENT PHARMACEUTICALS LLC; ASTORA WOMEN’S HEALTH HOLDINGS, LLC; ASTORA WOMEN’S HEALTH LLC; AUXILIUM PHARMACEUTICALS, LLC; AUXILIUM US HOLDINGS, LLC; BIOSPECIFICS TECHNOLOGIES CORP.; BIOSPECIFICS TECHNOLOGIES LLC; DAVA INTERNATIONAL, LLC; DAVA PHARMACEUTICALS, LLC; ENDO GENERIC HOLDINGS, INC. (FORMERLY KNOWN AS PAR PHARMACEUTICALS COMPANIES, INC.); ENDO PHARMACEUTICALS INC.; ENDO PHARMACEUTICALS SOLUTIONS INC. (FORMERLY KNOWN AS INDEVUS PHARMACEUTICALS, INC.); GENERICS BIDCO I, LLC; GENERICS INTERNATIONAL (US), INC.; PAR PHARMACEUTICAL, INC.; PAR STERILE PRODUCTS, LLC (FORMERLY KNOWN AS JHP PHARMACEUTICALS, LLC); QUARTZ SPECIALTY PHARMACEUTICALS, LLC; SLATE PHARMACEUTICALS, LLC; VINTAGE PHARMACEUTICALS, LLC
Reel/Frame 067240/0001 →
RELEASE OF SECURITY INTEREST Recorded Apr 25, 2024
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: ACTIENT PHARMACEUTICALS LLC; ASTORA WOMEN’S HEALTH LLC; AUXILIUM PHARMACEUTICALS, LLC; AUXILIUM US HOLDINGS, LLC; BIOSPECIFICS TECHNOLOGIES CORP.; BIOSPECIFICS TECHNOLOGIES LLC; DAVA INTERNATIONAL, LLC; DAVA PHARMACEUTICALS, LLC; ENDO PHARMACEUTICALS INC.; ENDO PHARMACEUTICALS SOLUTIONS INC. (FORMERLY KNOWN AS INDEVUS PHARMACEUTICALS, INC.); GENERICS BIDCO I, LLC; GENERICS INTERNATIONAL (US), INC.; PAR PHARMACEUTICAL, INC.; PAR PHARMACEUTICAL COMPANIES, INC.; PAR STERILE PRODUCTS, LLC (FORMERLY KNOWN AS JHP PHARMACEUTICALS, LLC); QUARTZ SPECIALTY PHARMACEUTICALS, LLC; SLATE PHARMACEUTICALS, LLC; VINTAGE PHARMACEUTICALS, LLC
Reel/Frame 067239/0491 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 23, 2024
From: ASTORA WOMEN’S HEALTH, LLC
To: ENDO USA, INC.
Reel/Frame 067202/0768 →
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded Sep 17, 2021
From: ASTORA WOMEN'S HEALTH LLC; ENDO PHARMACEUTICALS SOLUTIONS INC.; ENDO PHARMACEUTICALS INC.; PAR PHARMACEUTICAL, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 057538/0978 →
SECURITY INTEREST Recorded Jun 8, 2017
From: ASTORA WOMEN'S HEALTH, LLC
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 042743/0278 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA NAME PREVIOUSLY RECORDED AT REEL: 037300 FRAME: 0728. ASSIGNOR(S) HEREBY CONFIRMS THE CHANGE OF NAME. Recorded Apr 21, 2017
From: AMS RESEARCH CORPORATION
To: AMS RESEARCH, LLC
Reel/Frame 042308/0630 →
CHANGE OF NAME Recorded Jan 18, 2016
From: APHRODITE WOMEN'S HEALTH, LLC
To: ASTORA WOMEN'S HEALTH, LLC
Reel/Frame 037551/0749 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2016
From: AMS RESEARCH, LLC
To: APHRODITE WOMEN'S HEALTH, LLC
Reel/Frame 037551/0626 →
CHANGE OF NAME Recorded Dec 15, 2015
From: AMS RESEARCH CORPATION
To: AMS RESEARCH, LLC
Reel/Frame 037300/0728 →
RELEASE OF SECURITY INTEREST Recorded Aug 6, 2015
From: DEUTSCHE BANK AG NEW YORK BRANCH
To: AMERICAN MEDICAL SYSTEMS, LLC; AMS RESEARCH, LLC; LASERSCOPE
Reel/Frame 036285/0146 →
GRANT OF SECURITY INTEREST IN PATENTS Recorded Mar 20, 2014
From: ENDO PHARMACEUTICALS SOLUTIONS, INC.; ENDO PHARMACEUTICALS, INC.; AMS RESEARCH CORPORATION; AMERICAN MEDICAL SYSTEMS, INC.; LASERSCOPE
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 032491/0440 →