Transobturator surgical articles and methods

• US 7,070,556 B2
• Filed: 11/27/2002
• Issued: 07/04/2006
• Est. Priority Date: 03/07/2002
• Status: Expired due to Term

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Neisz, Johann J., Anderson, Kimberly A., Mellier, Georges, Watschke, Brian R.
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US10/306,179
• Publication Number:
  US 20030171644A1
• Time in Patent Office: 1,315 Days
• Field of Search: 600/30, 600/37, 128/898, 128/DIG.25, 606/73, 606/75, 606/139, 606/232, 606/223, 606/144, 606/118, 606/119, 606/185, 606/147, 606/148, 606/191, 606/225, 112/169
• 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

Abstract

Described is a surgical instrument and method for treating female urinary stress incontinence. The instrument includes a first curved needle-like element defining in part a curved shaft having a distal end and a proximal, a mesh for implanting into the lower abdomen of a female to provide support to the urethra; a second curved needle element having a proximal end and a distal end, and a coupler for simultaneous attachment to the distal end of the first needle and the distal end of the second needle.

Claims

1. A surgical assembly for treating 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 substantially helical needle portion having substantial structure in three dimensions and a distal end, 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;

a second surgical instrument for use on a left side of a patient, the second surgical instrument comprising a handle portion and a substantially helical needle portion having substantial structure in three dimensions and a distal end, 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; and

a sling assembly including a mesh material.

2. The assembly of claim 1 wherein the sling assembly comprises a synthetic material.

3. The assembly of claim 1 wherein the sling assembly comprises a knitted polypropylene material.

4. The assembly of claim 1 wherein the sling assembly comprises a sheath.

5. The assembly of claim 1 wherein at least a portion of the sling assembly comprises a non-synthetic material.

6. The assembly of claim 1 wherein the mesh material comprises a woven or knitted material.

7. The assembly of claim 1 wherein the mesh material comprises interlinked fibers that form multiple junctions.

8. The assembly of claim 1 wherein the needle portions of the first and second surgical instruments have structure near the distal ends for associating the first and second surgical instruments with the sling assembly.

9. The assembly of claim 1 wherein the needle portions of the first and second surgical instruments further comprise substantially straight spacer portions along an elongate axis of the handles.

10. The assembly of claim 1 wherein the substantially helical needle portions of the first and second surgical instruments are variable spiral portions.

11. The assembly of claim 1 wherein the needle portions of the first and second surgical instruments include a substantially circular cross sectional shape with a diameter of less than about 4 mm.

12. The surgical assembly of claim 1 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.

13. The assembly of claim 1 wherein the handle portions of the first and second surgical instruments are detachable from the substantially helical needle portions.

14. The assembly of claim 1 wherein the handle portions of the first and second surgical instruments consist of a single handle adapted to removably attach to the substantially helical needle portions of the first and second surgical instruments.

15. A surgical assembly for treating 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 a substantially straight portion projecting from the handle and a variable spiral portion with a distal end, the variable spiral portion being sized and shaped to extend between an incision substantially adjacent the obturator foramen on the patient'"'"'s right side and a vaginal incision;

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 a substantially straight portion projecting from the handle and a variable spiral portion with a distal end, the variable spiral portion being sized and shaped to extend between an incision substantially adjacent the obturator foramen on the patient'"'"'s left side and a vaginal incision; and

a sling assembly including a mesh material.

16. The assembly of claim 15 wherein the variable spiral portions of the first and second surgical instruments have a tissue clearance depth of greater than about 1.5 inches and less than about 2.5 inches.

17. The assembly of claim 15 wherein the variable spiral portions of the first and second surgical instruments have a maximum width of greater than about 1.25 inches and less than about 3 inches.

18. A surgical assembly for treating incontinence comprising:

a first substantially helical needle having a leading end, a trailing end and substantial structure in three dimensions, the needle having a portion that is sized and shaped to extend between an incision substantially adjacent the obturator foramen on a patient'"'"'s right side and a vaginal incision;

a second substantially helical needle having a leading end, a trailing end and substantial structure in three dimensions, the needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent the obturator foraxnen on the patient'"'"'s left side and a vaginal incision;

a handle removably attachable to the trailing ends of the first and second substantially helical needles; and

a sling assembly including a mesh material.

19. The surgical assembly of claim 18 wherein the handle is removably attachable to the leading ends of the first and second substantially helical needles.

20. A method of treating incontinence in a patient comprising the steps of:

creating a vaginal incision,

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

providing an elongate, substantially helical surgical instrument comprising first and second ends, with at least one of the ends having a securement surfaces,

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

passing the instrument between the incisions,

then snap fitting the instrument to 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.

21. A method of treating incontinence in a patient comprising the steps of:

creating a vaginal incision,

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

providing a substantially helical, elongate surgical instrument comprising first and second ends, the instrument having substantial structure in three dimensions,

providing an implant for treating the incontinence,

passing the instrument 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.

22. A method according to claim 21 wherein the step of passing the implant through tissue includes the step of passing the implant along a substantially three dimensional path.

23. A method according to claim 21 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 the instrument between the incisions includes the step of rotating the instrument about the axis of the handle portion.

24. A method of treating incontinence in a patient 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 a substantially straight portion projecting from the handle portion and a variable spiral portion with a distal end,

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

25. A method according to claim 24 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 end of the needle.

26. A method of treating incontinence in a patient comprising the steps of:

creating a vaginal incision,

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

providing a substantially helical, elongate surgical instrument comprising a pair of ends,

providing an assembly having an implant for treating incontinence,

initially passing one end of the instrument 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 one end of the instrument emerges from the incision substantially adjacent the patient'"'"'s obturator foramen, leaving the other end of the needle projecting from the vaginal incision,

then associating the end of the instrument that projects from the vaginal incision with the assembly, and

then moving the instrument 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.