IP Library Granted Patent US 7,988,615
Granted Patent B2
US 7,988,615 · App. 11/245,364 · Granted Aug 2, 2011

Transobturator surgical articles and methods

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Quick Facts
Patent No.
US 7,988,615
App. No.
11/245,364
Granted
Aug 2, 2011
Kind
B2
Abstract

A surgical instrument for treating incontinence includes a handle portion elongate along a handle axis and a needle portion connected to the handle portion. The needle portion has a spacer portion along the handle axis, and has a distal end. The needle portion includes a substantially helical portion that is a variable spiral portion, extending from the straight spacer portion. The variable spiral portion is sized and shaped to extend from an incision substantially adjacent the patient's obturator foramen through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus. The needle portion has a structure near the distal end that associates the instrument with an implantable material configured to treat incontinence.

Claims (62)

1. A surgical instrument for treating a pelvic disorder, the instrument comprising:

a handle portion elongate along a handle axis; and

a needle portion connected to said handle portion, and having a spacer portion along the handle axis and a distal end, the needle portion having a helical portion that extends from the spacer portion, wherein the helical portion is sized and shaped to extend from an incision substantially adjacent an obturator foramen of a patient, through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision below the patient's urethra, wherein said needle is configured to be interfaceable with an implantable material that treats the pelvic disorder.

2. The instrument of claim 1 , wherein the needle portion has a structure near the distal end that associates the instrument with an implantable material configured to treat incontinence.

3. The instrument of claim 1 , wherein the structure comprises an eyelet.

4. The instrument of claim 1 , wherein the handle portion is elongate defining a mid plane, and the distal end of the needle portion includes a distal tip situated substantially near an extension of the mid plane that is spaced from the handle portion.

5. The instrument of claim 1 , wherein the needle portion includes a substantially circular cross-sectional shape with a diameter less than about 4 mm.

6. A surgical assembly for treating a pelvic disorder comprising:

a surgical instrument having a handle portion;

a needle portion connected to said handle portion, said needle portion having a distal end and having a first portion that is sized and shaped to extend between an incision substantially adjacent an obturator foramen of a patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision in a position below the patient's urethra;

an implantable material;

the needle portion having structure near the distal end to associate the surgical instrument with the implantable material; and

a dilator with an engagement surface to connect the dilator to the surgical instrument, the dilator operatively associated with the implantable material, wherein the structure of the needle portion near the distal end that associates the surgical instrument with the implantable material includes a surface complementary with the engagement surface of the dilator.

7. A surgical assembly for treating a pelvic disorder comprising:

a surgical instrument having a handle portion;

a needle portion connected to said handle portion, said needle portion having a distal end and having a first portion that is sized and shaped to extend between an incision substantially adjacent an obturator foramen of a patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision in a position below the patient's urethra;

an implantable material; and

the needle portion having structure near the distal end to associate the surgical instrument with the implantable material;

wherein the needle portion is sized and shaped for a predetermined side of the patient, and the instrument includes indicia indicating the predetermined side of the patient.

8. A surgical assembly for treating a pelvic disorder comprising:

a surgical instrument having a handle portion;

a needle portion connected to said handle portion, said needle portion having a distal end and having a first portion that is sized and shaped to extend between an incision substantially adjacent an obturator foramen of a patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision in a position below the patient's urethra;

an implantable material; and

the needle portion having structure near the distal end to associate the surgical instrument with the implantable material; and

a sheath.

9. A surgical assembly for treating a pelvic disorder comprising:

a surgical instrument having a handle portion;

a needle portion connected to said handle portion, said needle portion having a distal end and having a first portion that is sized and shaped to extend between an incision substantially adjacent an obturator foramen of a patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision in a position below the patient's urethra;

an implantable material; and

the needle portion having structure near the distal end to associate the surgical instrument with the implantable material,

the surgical assembly further comprising a dilator having an overall length of less than about 0.7 inches, and the dilator and the needle portion comprise engagement surfaces for associating the dilator with the needle portion.

10. The surgical assembly of claim 9 , wherein the structure comprises an eyelet.

11. The surgical assembly of claim 9 , further comprising a dilator with an engagement surface to connect the dilator to the surgical instrument, the dilator operatively associated with the implantable material, wherein the structure of the needle portion near the distal end that associates the surgical instrument with the implantable material includes a surface complementary with the engagement surface of the dilator.

12. The surgical assembly of claim 9 , wherein the needle portion is sized and shaped for a predetermined side of the patient, and the instrument includes indicia indicating the predetermined side of the patient.

13. The surgical assembly of claim 9 wherein the surgical assembly further comprises a sheath.

14. The surgical instrument of claim 9 wherein the portion comprises a curve comprising an arclength in three dimensions.

15. The surgical instrument of claim 14 wherein the portion comprises a helical curve.

16. A surgical assembly for treating a pelvic disorder comprising:

a first surgical instrument that is used on a right side of a patient, wherein the first surgical instrument comprises a handle portion and a needle portion, the needle portion having a first portion that is sized and shaped to extend from an incision substantially adjacent an obturator foramen on the right side of the patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision in a position below the patient's urethra; and

a second surgical instrument that is used on a left side of a patient, wherein the second surgical instrument comprises a handle portion and a needle portion, the needle portion having a first portion that is sized and shaped to extend from an incision substantially adjacent an obturator foramen on the left side of the patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision in a position below the patient's urethra.

17. The surgical assembly of claim 16 , wherein the first surgical instrument includes indicia indicating the first surgical instrument is for use on the left side of the patient.

18. The surgical assembly of claim 16 , further comprising an implantable material.

19. The surgical assembly of claim 18 , wherein said implantable material includes a sheath situated about the implantable synthetic material.

20. The surgical assembly of claim 18 , further comprising first and second dilators to associate the first and second surgical instruments with the implantable material.

21. The surgical assembly of claim 16 , wherein the handle portion of the first surgical instrument includes indicia indicating the first surgical instrument is for use on the right side of the patient, and wherein the handle portion of the second surgical instrument includes indicia indicating the second surgical instrument is for use on the left side of the patient.

22. The surgical instrument of claim 16 wherein

the needle portion of the first instrument comprises a first portion comprising comprises a curve having an arclength in three dimensions, and

the needle portion of the second instrument comprises a first portion comprising comprises a curve having an arclength in three dimensions.

23. The surgical instrument of claim 22 wherein

the needle portion of the first instrument comprises a first portion comprising comprises a helical curve, and

the needle portion of the second instrument comprises a first portion comprising comprises a helical curve.

24. A surgical instrument for treating a pelvic disorder, comprising:

a needle sized and shaped to either: (a) initially extend through an incision substantially adjacent an obturator foramen of a patient and then through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision in a position below the patient's urethra; or (b) initially from an incision in a position below a patient's urethra extending through a region between the superior pubic ramus and the inferior pubic ramus and then through an incision substantially adjacent an obturator foramen of a patient.

25. The surgical instrument of claim 24 , wherein the needle includes a pair of ends and wherein each of said pair of ends has a surface to associate with either an implantable material or a removable handle.

26. The surgical instrument of claim 24 , wherein the needle is sized and shaped for use on either the patient's right side or left side.

27. A surgical instrument for treating a pelvic disorder, the instrument comprising:

first and second ends, the instrument having a portion that is sized and shaped to extend from an incision substantially adjacent an obturator foramen of a patient through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus to an incision below the patient's urethra;

one of the ends having a handle, at least the other end having a securement surface to secure the instrument to another surgical component used to treat the pelvic disorder, wherein the securement surface provides a secure attachment between the instrument and the other surgical component,

in combination with the other surgical component, wherein the other surgical component comprises a dilator of a sling assembly configured to treat a pelvic disorder.

28. The instrument of claim 27 , wherein the instrument and the dilator have complementary engagement surfaces to resist separation of the instrument from the dilator upon being snap fit together.

29. The surgical instrument of claim 27 wherein the portion comprises a curve comprising an arclength in three dimensions.

30. The surgical instrument of claim 29 wherein the portion comprises a helical curve.

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 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 →