IP Library Granted Patent US 7,901,346
Granted Patent B2
US 7,901,346 · App. 11/243,802 · Granted Mar 8, 2011

Method for supporting vaginal cuff

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Quick Facts
Patent No.
US 7,901,346
App. No.
11/243,802
Granted
Mar 8, 2011
Kind
B2
Abstract

Described are methods and devices useful for supporting posterior vaginal tissue for various purposes such as treating or preventing vaginal prolapse or enterocele, especially in a patient not having a uterus, the devices including implants designed to contact the vaginal cuff and connect to sacral anatomy such as the sacrum or the uterosacral ligaments.

Claims (77)

1. A method of supporting vaginal tissue in a patient having a uterus removed, the method comprising

providing a surgical implant comprising a support portion and two extension portions, the support portion comprising an anterior lobe and a posterior lobe,

attaching the support portion to vaginal or cervical tissue remaining upon removal of a uterus, cervix, or both, including attaching the anterior lobe to pubocervical fascia, and attaching the posterior lobe to rectovaginal fascia and to a component of sacral anatomy,

passing a first extension portions through a tissue path leading to a first external incision at a perirectal region, and

passing a second extension portions through a tissue path leading to a second external incision at a perirectal region.

2. The method of claim 1 , wherein the component of sacral anatomy is a uterosacral ligament.

3. The method of claim 1 , wherein the component of sacral anatomy is a sacrum.

4. The method of claim 1 wherein the surgical implant comprises a central support portion and two extension portions extending from the central support portion,

the central support portion comprises:

an anterior lobe extending laterally from the extension portions, and

a posterior lobe extending laterally from the extension portions in a direction opposite of the anterior lobe, and

the method comprises:

attaching the anterior lobe to pubocervical fascia,

attaching the posterior lobe to rectovaginal fascia and to a component of sacral anatomy selected from the group consisting of a uterosacral ligament and a sacrum.

5. The method of claim 4 , wherein the posterior lobe comprises two posterior lobe extensions and the method comprises attaching the posterior lobe extensions to sacral anatomy selected from the group consisting of a uterosacral ligament and a sacrum.

6. The method of claim 5 , wherein the sacral anatomy is a sacrum.

7. The method of claim 5 , wherein the sacral anatomy is a uterosacral ligament, and the method comprises trimming the posterior lobe extension before attaching the uterosacral ligament to the lobe extension.

8. The method of claim 1 , wherein the method comprises removing the uterus.

9. The method of claim 1 , comprising introducing the implant transvaginally.

10. The method of claim 1 , wherein the method prophylactically prevents a condition selected from vaginal vault prolapse and enterocele.

11. The method of claim 1 , comprising

providing a surgical implant comprising a central support portion and two extension portions extending from the central support portion,

performing a hysterectomy to remove a uterus and leave tissue of a vaginal cuff or cervix,

attaching the central support portion to the vaginal cuff or cervix,

attaching the central support portion to sacral anatomy selected from the group consisting of a uterosacral ligament and a sacrum,

leading the extension portions of the surgical implant through tissue paths to an external incision, and

suturing the vaginal cuff or cervix to close a vaginal vault.

12. The method of claim 1 wherein the method comprises supporting vaginal tissue in a patient who has previously had a hysterectomy.

13. The method of claim 1 wherein the implant comprises a connector at an end of each extension portion, the connector capable of connecting to a tip of a needle, the method comprising

inserting a needle through an external perirectal region incision on a first side of a patient and passing the needle through a first tissue path extending to a vaginal region,

connecting a connector of an extension portion with the needle,

retracting the needle through the first tissue path and through the external incision on the first side of the patient to place the extension portion in the first tissue path,

inserting a needle through an external perirectal region incision on a second side of the patient and passing the needle through a second tissue path extending to the vaginal region,

connecting a connector of an extension portion with the needle,

retracting the needle through the second tissue path and through the external incision on the second side of the patient to place the extension portion in the second tissue path.

14. The method of claim 1 wherein the implant comprises

one or more suture extending along a length of one or more extension portion, and

one or more sheath extending along a length of one or more extension portion.

15. A transvaginal method of supporting vaginal tissue in a patient having a uterus removed, the method comprising

providing a surgical implant comprising a central support portion and two extension portions extending longitudinally from the central support portion, the central support portion comprising

an anterior lobe extending laterally from the extension portions, and

a posterior lobe extending laterally from the extension portions in a direction opposite of the anterior lobe, the posterior lobe comprising two lobe extensions,

transvaginally attaching the surgical implant to vaginal or cervical tissue remaining after removal of a uterus, cervix, or both, including attaching the anterior lobe to pubocervical fascia, and attaching the posterior lobe to rectovaginal fascia and to a component of sacral anatomy, and

transvaginally attaching the surgical implant to a component of sacral anatomy.

16. The method of claim 15 , comprising

attaching the central support portion of the surgical implant to the vaginal or cervical tissue,

attaching the central support portion to sacral anatomy selected from the group consisting of a uterosacral ligament and a sacrum,

leading the extension portions of the surgical implant through tissue pathways to an external incision, and

suturing the vaginal or cervical tissue to close a vaginal vault.

17. The method of claim 16 , comprising

establishing a first pathway in tissue on a first side of a vagina, the pathway extending between an external perirectal region to a region of an ischial spine of the patient;

establishing a second pathway in tissue on a contra-lateral side of the vagina, the pathway extending between an external perirectal region to a region of an ischial spine of the patient;

using a tunneler device or needle to introduce an extension portion through the first and second pathways.

18. The method of claim 15 wherein the method comprises supporting vaginal tissue in a patient who has previously had a hysterectomy.

19. The method of claim 15 wherein the sacral anatomy is a uterosacral ligament and the method comprises trimming the posterior lobe extension before attaching the uterosacral ligament to the lobe extension.

20. The method of claim 15 wherein the implant comprises

one or more suture extending along a length of one or more extension portion, and

one or more sheath extending along a length of one or more extension portion.

21. The method of claim 15 wherein the implant comprises a connector at an end of each extension portion, the connector being capable of connecting to a tip of a needle, the method comprising

inserting a needle through an external perirectal region incision on a first side of a patient and passing the needle through a first tissue path extending to a vaginal region,

connecting a connector of an extension portion with the needle,

retracting the needle through the first tissue path and through the external incision on the first side of the patient to place the extension portion in the first tissue path,

inserting a needle through an external perirectal region incision on a second side of the patient and passing the needle through a second tissue path extending to the vaginal region,

connecting a connector of an extension portion with the needle,

retracting the needle through the second tissue path and through the external incision on the second side of the patient to place the extension portion in the second tissue path.

22. A transvaginal method of supporting vaginal tissue in a patient having a uterus removed, the method comprising

providing a surgical implant comprising a central support portion and two extension portions extending longitudinally from the central support portion, the central support portion comprising

an anterior lobe extending laterally from the extension portions, and

a posterior lobe extending laterally from the extension portions in a direction opposite of the anterior lobe, the posterior lobe comprising two lobe extensions,

transvaginally attaching the surgical implant to vaginal or cervical tissue remaining after removal of a uterus, cervix, or both, and

transvaginally attaching the surgical implant to a component of sacral anatomy, wherein the implant comprises a connector at an end of each extension portion, the connector being capable of connecting to a tip of a needle, the method further comprising

inserting a needle through an external perirectal region incision on a first side of a patient and passing the needle through a first tissue path extending to a vaginal region,

connecting a connector of an extension portion with the needle,

retracting the needle through the first tissue path and through the external incision on the first side of the patient to place the extension portion in the first tissue path,

inserting a needle through an external perirectal region incision on a second side of the patient and passing the needle through a second tissue path extending to the vaginal region,

connecting a connector of an extension portion with the needle,

retracting the needle through the second tissue path and through the external incision on the second side of the patient to place the extension portion in the second tissue path.

Assignments (16)
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 ASSIGNOR NAME PREVIOUSLY RECORDED AT REEL: 037300 FRAME: 0318. ASSIGNOR(S) HEREBY CONFIRMS THE CHANGE OF NAME. Recorded Sep 6, 2016
From: AMS RESEARCH CORPORATION
To: AMS RESEARCH, LLC
Reel/Frame 039919/0017 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 11, 2016
From: AMS RESEARCH, LLC
To: APHRODITE WOMEN'S HEALTH, LLC
Reel/Frame 037473/0260 →
CHANGE OF NAME Recorded Jan 11, 2016
From: APHRODITE WOMEN'S HEALTH, LLC
To: ASTORA WOMEN'S HEALTH, LLC
Reel/Frame 037473/0354 →
CHANGE OF NAME Recorded Dec 15, 2015
From: AMS RESEARCH CORPATION
To: AMS RESEARCH, LLC
Reel/Frame 037300/0318 →
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 →
RELEASE OF PATENT SECURITY INTEREST Recorded Mar 3, 2014
From: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
To: AMS RESEARCH CORPORATION
Reel/Frame 032380/0053 →
SECURITY AGREEMENT Recorded Jul 22, 2011
From: AMS RESEARCH CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
Reel/Frame 026632/0535 →