IP Library Granted Patent US 7,351,197
Granted Patent B2
US 7,351,197 · App. 10/840,646 · Granted Apr 1, 2008

Method and apparatus for cystocele repair

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Quick Facts
Patent No.
US 7,351,197
App. No.
10/840,646
Granted
Apr 1, 2008
Kind
B2
Abstract

A method for cystocele repair comprising the steps of: establishing four pathways in tissue around a bladder of a patient, introducing a strap into each of said pathways, and positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced.

Claims (102)

1. A method for cystocele repair comprising the steps of:

(a) establishing four pathways in tissue around a bladder of a patient;

(b) introducing a strap into each of said pathways; and

(c) positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced;

wherein the step of establishing four pathways in tissue around a bladder of a patient comprises the steps of:

(a-1) making an incision in said vagina of said patient;

(a-2) making an incision on a left side of said patient where a left adductor longus tendon of said patient inserts into a left portion of a pubic ramus bone of said patient, lateral to an edge of said pubic ramus bone;

(a-3) making an incision on a right side of said patient where a right adductor longus tendon of said patient inserts into a right portion of said pubic ramus bone of said patient, lateral to said edge of said pubic ramus bone;

(a-4) making an incision on said left side of said patient where a left inferior edge of the pubic ramus bone of said patient ends at a bottom of a left obturator foramen of said patient; and

(a-5) making an incision on said right side of said patient where a right inferior edge of said pubic ramus bone of said patient ends at a bottom of a right obturator foramen of said patient.

2. The method recited in claim 1 wherein the step of introducing a strap into each of said pathways comprises the steps of:

(b-1) inserting a needle into each of said respective incisions made in steps (a-2), (a-3), (a-4), and (a-5), said respective incisions a respective entry incision for each respective needle;

(b-2) advancing each needle through said obturator foramen on a respective side;

(b-3) further advancing each said needle towards said vaginal incision made in step (a-1) until a tip of said needle extends through said vaginal incision.

(b-4) attaching a connector fixed to a first end of each respective said strap to said tip of each respective said needle;

(b-5) withdrawing said tip of each respective said needle back through said vaginal incision, toward a respective entry incision of each said needle, such that said connector and said strap are drawn into said vaginal incision towards said respective entry incision of each said needle; and

(b-6) withdrawing each said needle, each said connector, and each said first end of said strap from said respective entry incisions.

3. The method recited in claim 1 wherein the step of positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced comprises the steps of:

(c-1) positioning a leading edge of said support member below the bladder neck;

(c-2) positioning a trailing edge of the support member at a distal end of said vaginal incision or towards a vaginal apex; and

(c-3) removing a sheath located around each said strap.

4. A method for cystocele repair comprising the steps of:

(a) establishing four pathways in tissue around a bladder of a patient;

(b) atraumatically dilating said pathways;

(c) introducing a strap into each of said pathways while said pathways are atraumatically dilated; and

(d) positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced;

wherein the step of establishing four pathways in tissue around a bladder of a patient comprises the steps of:

(a-1) making an incision in said vagina of said patient;

(a-2) making an incision on a left side of said patient where a left adductor longus tendon of said patient inserts into a left portion of a pubic ramus bone of said patient, lateral to an edge of said pubic ramus bone;

(a-3) making an incision on a right side of said patient where a right adductor longus tendon of said patient inserts into a right portion of said pubic ramus bone of said patient, lateral to said edge of said pubic ramus bone;

(a-4) making an incision on said left side of said patient where a left inferior edge of said pubic ramus bone of said patient ends at a bottom of a left obturator foramen of said patient; and (a-5) making an incision on said right side of said patient where a right inferior edge of said pubic ramus bone of said patient ends at a bottom of a right obturator foramen of said patient.

5. The method recited in claim 4 wherein the step of atraumatically dilating said pathways comprises the steps of:

(b-1) inserting a needle into each of said respective incisions made in steps (a-2), (a-3), (a-4), and (a-5), said respective incisions a respective entry incision for each respective needle; and

(b-2) advancing each said needle through said obturator foramen on a respective side towards said vaginal incision made in step (a-1) until a tip of said needle extends through said vaginal incision.

6. The method recited in claim 4 wherein the step of introducing a strap into each of said pathways while said pathways are atraumatically dilated comprises the steps of:

(c-1) attaching a connector fixed to a first end of each respective said strap to said tip of each respective said needle;

(c-2) withdrawing said tip of each respective said needle back through said vaginal incision, toward a respective entry incision of each said needle, such that said connector and said strap are drawn into said vaginal incision towards said respective entry incision of each said needle; and

(c-3) withdrawing each said needle, each said connector, and each said first end of said strap from said respective entry incisions.

7. The method recited in claim 4 wherein the step of positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced comprises the steps of:

(d-1) positioning a leading edge of said support member below the bladder neck;

(d-2) positioning a trailing edge of the support member at a distal end of said vaginal incision or towards a vaginal apex; and

(d-3) removing a sheath located around each said strap.

8. An apparatus for repairing cystocele comprising:

a support member knitted with a first bar setting;

a plurality of straps continuously knitted with said support member, said plurality of straps knitted with a second bar setting; and

where at least one of said straps comprises a connector configured to mate with an end of a needle.

9. The apparatus recited in claim 8 wherein

said support member comprises a substantially rectangular member having two short sides and two long sides, a first end of said rectangular member at a first of said two short sides, a second end of said rectangular member at a second of said two short sides; and

said plurality of straps comprise:

a first strap continuously knitted with a first long side proximate said first end of said member;

a second strap continuously knitted with a second long side proximate said first end of said member;

a third strap continuously knitted with a first long side proximate a middle portion of said first long side; and

a fourth strap continuously knitted with a second long side proximate a middle portion of said second long side.

10. The apparatus recited in claim 8 wherein said first bar setting is:

Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2;

Bar 2: 1/0, 2/3, 2/3, 1/0; and

Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1.

11. The apparatus recited in claim 8 wherein said straps and said rectangular member is knitted of polypropylene monofilament material.

12. The apparatus recited in claim 8 wherein at least one of said straps comprises a tensioning suture.

13. The apparatus recited in claim 8 where at least one of said straps comprises a plastic sheath.

14. The apparatus recited in claim 13 where said sheath comprises identifying indicia.

15. A kit for repairing cystocele comprising:

a support apparatus comprising at least two straps, each of said straps comprising a connector configured to mate with a tip of a needle;

a first needle configured to extend from an incision on a right side of a patient where a right adductor longus tendon of said patient inserts into a right portion of a pubic ramus bone of said patient, lateral to an edge of said pubic ramus bone, through a right obturator foramen of said patient, to an incision in a vagina of said patient;

a second needle configured to extend from an incision on a left side of said patient where a left adductor longus tendon of said patient inserts into a left portion of said pubic ramus bone of said patient, lateral to an edge of said pubic ramus bone, through a left obturator foramen of said patient, to said incision in said vagina of said patient;

a third needle configured to extend from an incision on said right side of said patient where a right inferior edge of said pubic ramus bone of said patient ends at a bottom of said right obturator foramen of said patient, through said right obturator foramen of said patient, to said incision in said vagina of said patient; and

a fourth needle configured to extend from an incision on said left side of said patient where a left inferior edge of said pubic ramus bone of said patient ends at a bottom of said left obturator foramen of said patient, through said left obturator foramen of said patient, to said incision in said vagina of said patient.

16. The kit recited in claim 15 wherein said support apparatus comprises a biologic graft.

17. The kit recited in claim 16 wherein said biologic graft is pre-attached to said at least two straps.

18. The kit recited in claim 15 wherein said support apparatus comprises:

a pair of straps, each strap having a central portion and a connector at each end of said strap; and

a biologic graft connected to said central portion of each strap.

19. The kit recited in claim 15 wherein said support apparatus comprises a biologic graft fixed over a knitted support member.

20. The kit recited in claim 15 wherein said support apparatus comprises:

a substantially rectangular member having two short sides and two long sides, a first end of said rectangular member at a first of said two short sides, a second end of said rectangular member at a second of said two short sides;

a first strap connected to a first long side proximate said first end of said member;

a second strap connected to a second long side proximate said first end of said member;

a third strap connected to a first long side proximate a middle portion of said first long side; and

a fourth strap connected to a second long side proximate a middle portion of said second long side.

21. The kit recited in claim 15 wherein said support apparatus comprises:

a support member knitted with a first bar setting; and

a plurality of straps continuously knitted with said support member, said plurality of straps knitted with a second bar setting.

22. The kit recited in claim 21 wherein said support member comprises:

a substantially rectangular member having two short sides and two long sides, a first end of said rectangular member at a first of said two short sides, a second end of said rectangular member at a second of said two short sides; and

said plurality of straps comprise:

a first strap continuously knitted with a first long side proximate said first end of said member;

a second strap continuously knitted with a second long side proximate said first end of said member;

a third strap continuously knitted with a first long side proximate a middle portion of said first long side; and

a fourth strap continuously knitted with a second long side proximate a middle portion of said second long side.

23. The kit recited in claim 21 wherein said first bar setting is:

Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2;

Bar 2: 1/0, 2/3, 2/3, 1/0; and

Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1.

24. A surgical implant kit comprising:

a support apparatus comprising at least two straps, each of said straps comprising a connector configured to mate with a tip of a needle, each connector having an aperture configured to receive said tip of said needle, each aperture having a different shape; and

a least two needles, each needle having a tip having a shape configured to mate with said aperture of only one said at least two connectors.

25. A surgical implant kit comprising:

a support apparatus comprising at least two straps, each of said straps comprising a connector configured to mate with a tip of a needle, each connector having identifying indicia thereon; and

at least two needles.

26. A surgical implant kit comprising:

a support apparatus comprising at least two straps, each of said straps comprising a connector configured to mate with a tip of a needle, each connector having a color; and

at least two needles, each needle having a handle, each handle having a color matching a color of a corresponding connector.

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 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 →
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 →