Transobturator surgical articles and methods

• US 7,988,615 B2
• Filed: 10/05/2005
• Issued: 08/02/2011
• Est. Priority Date: 03/07/2002
• Status: Active Grant

• Current Assignee: ENDO Operations Limited (Endo, Inc.)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Mellier, Georges, Neisz, Johann J., Watschke, Brian P., Anderson, Kimberly A.
• Primary Examiner(s): Gilbert; Samuel G
• Application Number:
  US11/245,364
• Publication Number:
  US 20060063968A1
• Time in Patent Office: 2,127 Days
• Field of Search: 600 29- 32, 600/37, 128/897, 128/898
• US Class Current: 600/30
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/0417 T-fasteners
• 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 2017/06076 helically or spirally coiled
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/30708 Means for distinguishing between left-sided and right-sided devices, Sets comprising both left-sided and right-sided prosthetic parts
• CPC Class Codes: A61F 2250/0084 Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts

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

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.