Transobturator surgical articles and methods

• US 20030212305A1
• Filed: 03/03/2003
• Published: 11/13/2003
• Est. Priority Date: 03/07/2002
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Neisz, Johann J., Watschke, Brian P., Anderson, Kimberly A., Mellier, Georges
• Granted Patent: US 6,911,003 B2
• Time in Patent Office: Days
• US Class Current: 600/29
• 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 for sutures A61B2017/06171
• 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
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

Surgical articles, implants and components suitable for a transobturator surgical procedure are described.

Claims

1. A surgical instrument for implanting an implantable material to treat incontinence, the instrument comprising:

a handle portion,

a second portion having substantial structure in three dimensions and a distal region, the second portion including a needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent the patient'"'"'s obturator foramen and a vaginal incision; and

the needle portion having structure in the distal region for associating the instrument with an implantable material for treating the incontinence.

2. A surgical instrument according to claim 1 wherein the needle portion includes a portion that is substantially helically shaped.

3. A surgical instrument according to claim 2 wherein the substantially helically shaped portion comprises a variable helix shape.

4. A surgical instrument according to claim 1 wherein the handle portion is elongate along a handle axis, the second portion includes a substantially straight spacer portion along the handle axis, and a variable spiral portion extending from the spacer portion.

5. A surgical instrument according to claim 4 wherein the variable spiral portion has a tissue clearance depth of greater than about 0.5 inches and less than about 2.5 inches.

6. A surgical instrument according to claim 4 wherein the variable spiral portion has a maximum width of greater than about 1.25 inches and less than about 3 inches.

7. A surgical instrument according to claim 1 wherein structure for associating the instrument with an implantable material comprises an eyelet.

8. A surgical instrument according to claim 1 wherein the handle portion is elongate defining a mid plane, and the distal end includes a distal tip situated substantially near an extension of the mid plane that is spaced from the handle portion.

9. A surgical instrument according to claim 1 wherein the needle portion includes a substantially circular cross sectional shape with a diameter less than about 4 mm.

10. A surgical instrument for treating incontinence, the instrument comprising:

first and second ends, the instrument having a needle portion on the first end;

the second end having a handle, at least the needle portion having a securement surface for snap fitting the instrument to another surgical component used to treat the incontinence, the snap fit providing a substantially permanent attachment between the instrument and the other surgical component.

11. A surgical instrument for treating incontinence according to claim 10 wherein the other surgical component comprises a dilator of a sling assembly for treating incontinence.

12. A surgical instrument for treating incontinence according to claim 11 wherein the instrument and the dilator have complementary engagement surfaces for resisting separation of the instrument from the dilator once they are snap fitted together.

13. A surgical instrument for implanting an implantable material to treat incontinence, the instrument comprising:

a handle portion,

a second portion having an extension portion projecting from the handle portion and a variable spiral portion with a distal region, the variable spiral portion being sized and shaped to extend between an incision substantially adjacent the patient'"'"'s obturator foramen and a vaginal incision; and

the second portion having structure near the distal region capable of associating the instrument with an implantable material.

14. A surgical instrument according to claim 13 wherein the variable spiral portion has a tissue clearance depth of greater than about 0.5 inches and less than about 2.5 inches.

15. A surgical instrument according to claim 13 wherein the variable spiral portion has a maximum width of greater than about 1.25 inches and less than about 3 inches.

16. A surgical assembly for treating incontinence comprising:

a surgical instrument having a handle portion,

a needle portion having substantial structure in three dimensions and a distal region, the needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent a patient'"'"'s obturator foramen and a vaginal incision;

an implantable material and a sheath situated about the implantable synthetic material; and

the needle portion having structure in the distal region that is sized and shaped to associate the instrument with the implantable material.

17. A surgical assembly according to claim 16 further including a dilator wherein the dilator has an overall length of less than about 0.7 inches.

18. A surgical assembly according to claim 16 wherein the structure of the needle portion in the distal region for associating the instrument with the implantable synthetic material comprises an eyelet.

19. A surgical assembly according to claim 16 further including a dilator with engagement surfaces for connecting the dilator to the instrument, the dilator operatively associated with the sheath and implantable material;

wherein the structure of the needle portion near the distal region comprises surfaces complementary with the engagement surfaces of the dilator for resisting separation of the instrument from the dilator once they are engaged.

20. A surgical assembly according to claim 16 wherein the needle portion is sized and shaped for a predetermined side of a patient, and the handle portion includes indicia indicating the predetermined side of the patient.

21. A surgical assembly for inserting a implantable material to treat incontinence comprising:

a first surgical instrument for use on a right side of a patient, the first surgical instrument comprising a handle portion and a needle portion having substantial structure in three dimensions and a distal region, the needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent the obturator foramen on the patient'"'"'s right side and a vaginal incision; and

a second surgical instrument for use on a left side of a patient, the second surgical instrument comprising a handle portion and a needle portion having substantial structure in three dimensions and a distal region, the needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent the obturator foramen on the patient'"'"'s left side and a vaginal incision.

22. A surgical assembly according to claim 21 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

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.

23. Am assembly according to claim 21 further including

an implantable material formed from knitted polypropylene, and

a sheath situated about the implantable material.

24. A surgical assembly according to claim 21 wherein the first and second surgical instruments include an eyelet for receiving a suture to tie the surgical instrument to the implantable material.

25. A surgical assembly according to claim 21 further including an implantable material that includes polypropylene.

27. A universal surgical instrument for treating incontinence comprising:

a needle sized and shaped to either a) initially extend through an incision substantially adjacent a patient'"'"'s obturator foramen and then through a vaginal incision, or b) initially extend through a vaginal incision and subsequently through an incision substantially adjacent a patient'"'"'s obturator foramen.

28. A surgical instrument according to claim 27 wherein the needle comprises a pair of ends having surfaces capable of affording association with either an implantable sling material or a removable handle.

29. A surgical assembly according to claim 27 wherein the needle is sized and shaped for use on either the patient'"'"'s right side or left side.

30. A method of treating incontinence comprising the steps of:

creating a vaginal incision,

creating an incision substantially adjacent the patient'"'"'s obturator foramen,

providing an elongate surgical instrument comprising first and second regions, with at least one of the regions having a securement surface,

providing a sling assembly having an implantable sling for treating the incontinence, the sling assembly having a surface complementary to the securement surface,

passing the end region having the securement surface between the incisions,

then associating the instrument at the securement surface with the sling assembly to provide a substantially permanent attachment between the instrument and the assembly,

then passing the implantable material through tissue from the vaginal incision toward the incision substantially adjacent the patient'"'"'s obturator foramen.

31. A method of treating incontinence comprising the steps of:

creating a vaginal incision,

creating an incision substantially adjacent the patient'"'"'s obturator foramen,

providing an elongate surgical instrument comprising first and second regions, the instrument having substantial structure in three dimensions,

providing an implant for treating the incontinence,

passing a portion of one of the regions between the incisions,

then associating the implant with the instrument, and

passing the implant through tissue and through the patient'"'"'s obturator foramen with the instrument.

32. A method according to claim 31 wherein the step of providing an elongate surgical instrument includes the step of providing an instrument with a portion that is substantially helically shaped, and the step of passing the implant through tissue includes the step of passing the implant along a substantially three dimensional path.

33. A method according to claim 31 wherein the step of providing an elongate surgical instrument includes the step of providing an instrument with an elongate handle portion having an axis, and

the step of passing a portion of one of the regions between the incisions includes the step of rolling the instrument about the axis of the handle portion.

34. A method of treating incontinence comprising the steps of:

creating a vaginal incision,

creating an incision substantially adjacent the patient'"'"'s obturator foramen,

providing an elongate surgical instrument comprising a handle portion, a needle portion having an extension portion projecting from the handle portion and a variable spiral portion with a distal region,

providing an implant for treating the incontinence,

passing at least a portion of the variable spiral portion between the incisions by initially passing the distal end through the incision substantially adjacent the patient'"'"'s obturator foramen and then through the vaginal incision,

then associating the implant with a portion of the instrument that has emerged from the vaginal incision, and

then moving the distal region of the instrument with the implant associated therewith from the vaginal incision toward the patient'"'"'s obturator foramen to pass the implant through tissue.

35. A method according to claim 34 wherein the step of associating the implant with a portion of the instrument that has emerged from the vaginal incision includes the step of using a suture to tie the implant to an eyelet in the distal region of the needle.

36. A method of treating incontinence comprising the steps of:

creating a vaginal incision,

creating an incision substantially adjacent the patient'"'"'s obturator foramen,

providing an elongate surgical instrument having first and second regions,

providing an assembly having an implant for treating incontinence,

initially passing the first region initially through the vaginal incision toward the incision substantially adjacent the patient'"'"'s obturator foramen in a path through the patient'"'"'s obturator foramen until the first region emerges from the incision substantially adjacent the patient'"'"'s obturator foramen, leaving the second region projecting from the vaginal incision,

then associating the first region with the assembly, and

then moving the first region out of the patient'"'"'s body to pass the implant through tissue from the vaginal incision toward the incision substantially adjacent the patient'"'"'s obturator foramen to place the implant in a therapeutically effective position.

37. A surgical instrument for treating incontinence, the instrument comprising:

a handle portion,

a second portion having an extension portion projecting from the handle portion and a variable spiral portion with a distal region, the variable spiral portion being sized and shaped to extend between an incision substantially adjacent the patient'"'"'s obturator foramen through the obturator foramen and a vaginal incision; and

the needle portion having structure near the distal region associating the instrument with an implantable material for treating the incontinence.

38. A surgical instrument for treating incontinence, the instrument comprising:

a handle portion; and

a second portion having a medial structure and a helical structure, the medial structure being associated with the handle portion and the helical structure having a distal region, the distal region having structure associating the instrument with an implantable material for treating the incontinence, the helical structure having a longitudinal axis, the handle portion lying substantially along the longitudinal axis.

39. A surgical tool for treating incontinence, the tool comprising:

a handle portion,

a second portion having a medial structure and a needle structure, the medial structure being associated with the handle portion and the needle structure having a distal region, the distal region having structure associating the instrument with an implantable material for treating the incontinence; and

a dilator for association with the implantable material for treating the incontinence and the needle structure, the dilator with having a diameter no greater than the needle.

40. A surgical instrument comprising:

a handle portion,

a second portion having a medial structure and a helical structure, the medial structure being associated with the handle portion and the helical structure having a distal tip, the helical structure having a visual indicator, the visual indicator being indicative of a distance from the visual indicator to the distal tip.

41. A surgical instrument comprising:

a handle portion,

a second portion having a medial structure and a helical structure, the medial structure being associated with the handle portion and the helical structure having a distal tip, the handle having a visual indicator, the visual indicator being indicative of a location of the distal tip.