Surgical instrument for treating female urinary incontinence

• US 5,899,909 A
• Filed: 02/25/1997
• Issued: 05/04/1999
• Est. Priority Date: 08/30/1994
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Medscand Medical AB (The Cooper Cos., Inc.)
• Inventors: Ulmsten, Ulf, Claren, Jan
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): BUI, VY Q
• Application Number:
  US08/804,680
• Time in Patent Office: 798 Days
• Field of Search: 606/118, 606/119, 606/138, 606/139, 606/140, 606/141, 606/148, 606/222, 606/223, 606/224, 606/225, 606/226, 606/227, 606/228
• US Class Current: 606/119
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• 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 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle lateral opening for attaching suture to suture anchor A61B2017/0414
• CPC Class Codes: A61B 2017/06033 using adhesives glue applicators A61B17/00491; for connecting prosthetic parts A61F2002/30448
• CPC Class Codes: A61B 2017/06038 soldered or brazed or welded for connecting prosthetic parts A61F2002/30451, A61F2220/0058
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

A surgical instrument and a method for treating female urinary incontinence. The instrument comprises a shank having a handle at one end thereof, and two curved needle-like elements which are connected at one end thereof each with one end of a tape intended to be implanted into the body. These elements can be connected one at a time with the shank at the other end thereof to form a curved end portion of the shank and are intended to be passed into the body via the vagina, each element being dimensioned to extend from the inside of the vaginal wall over the back of the pubic bone to the outside of the abdominal wall. When practicing the method the tape is passed into the body via the vagina first at one end and then at the other end at one side and the other, respectively, of the urethra to form a loop around the urethra, located between urethra and the vaginal wall. The tape is extended over the pubis and through the abdominal wall and is tightened. Then, the tape ends are cut at the abdominal wall, and the tape is left implanted in the body.

Claims

1. Surgical instrument for treating female urinary incontinence, comprising

a shank,

a handle at one end of said shank,

a tape to be permanently implanted into the body as a loop around urethra,

two curved needle-like elements which are each connected at one end thereof to one end and the other of said tape, and

means on said shank and each of said elements for exchangeable connection of the elements one at a time to the shank at the other end thereof to form at said other end an extension of the shank as a curved end portion thereof dimensioned to extend from the inside surface of the vaginal wall over the back of the pubic bone to the outside of the abdominal wall.

2. Instrument as in claim 1 wherein said means comprises screw coupling means.

3. Instrument as in claim 2 wherein said screw coupling means comprises a shaft rotatably mounted in said shank, an operating knob at one end of the shaft said knob being available at said one end of the shank, threads on the shaft at the other end thereof and on each of said elements for screw interengagement between the shaft and the element to be connected to the shank.

4. Instrument as in claim 1 further comprising a sleeve portion on said shank at said other end thereof to receive therein an end portion of the needle-like element to be connected to the shank.

5. Instrument as in claim 1 wherein the handle comprises two wings projecting diametrically from the shank.

6. Instrument as in claim 5 further comprising mutually cooperating means on said shank and said needle-like elements for positioning the element to be connected to the shank at right angles to the plane of the wings.

7. Instrument as in claim 1 wherein said shank is intended for use several times and consists of a material that can be autoclaved, and wherein said needle-like elements are intended for a single use.

8. Instrument as in claim 1 wherein said tape is attached to said elements by the tape ends being glued to the elements.

9. Instrument as in claim 1 wherein said tape is attached to said elements by the tape ends being welded to the elements.

10. Instrument as in claim 1 wherein said elements are made of plastics material and wherein said tape is attached to said elements by the tape ends being baked into the plastics material of the elements.

11. Instrument as in claim 1 wherein said tape is attached to said elements by the tape ends being mechanically clamped on said elements.

12. Instrument as in claim 1 wherein each of said needle-like elements forms an eye said tape at each end thereof being passed through said eye in one and the other of said elements, respectively.

13. Instrument as in claim 1 wherein said needle-like elements are curved over substantially a quarter of a circle.

14. Instrument as in claim 1 wherein each of said needle-like elements tapers towards the other, free end thereof.

15. Instrument as in claim 14 wherein each of said needle-like elements is pointed at said other end thereof.

16. Instrument as in claim 14 wherein each of said needle-like elements is blunt at said other end thereof.

17. Instrument as in claim 1 wherein said tape is perforated for growth of fibroblasts thereinto.

18. Instrument as in claim 17 wherein said tape is coated with a fibroblast stimulating material.

19. Instrument as in claim 18 wherein said tape is made of polypropylene.

20. Instrument as in claim 17 wherein said tape comprises a netting.

21. Instrument as in claim 20, further comprising a thin plastic sheath enclosing said tape.

22. Instrument as in claim 21 wherein said sheath is made of polyethylene.

23. Instrument as in claim 21 wherein said sheath has a perforation line at the longitudinal center thereof.

24. Instrument as in claim 21 wherein said sheath comprises two halves having adjacent ends overlapping each other.

25. Instrument as in claim 21 wherein each of said needle-like elements comprises a non-circular end portion fitting into a non-circular socket at said other end of the shank.

26. Instrument as in claim 25 wherein said non-circular end portion of the needle-like element joins the rest of the element by a conical portion tapering towards a shoulder on the needle-like element.

27. Instrument as in claim 26 wherein the netting and the sheath are connected to the needle-like element at said conical portion.

28. Instrument as in claim 27 further comprising a shrink hose covering said netting and said sheath at the site of attachement thereof.

29. Instrument as in claim 28 wherein one end of the shrink hose abuts said shoulder and is substantially flush with the surface of the needle-like element at said shoulder.

30. Instrument as in claim 29 wherein the netting and the sheath project from the shrink hose at the other end thereof.

31. Instrument as in claim 21 wherein a visible marking is provided on the sheath at the longitudinal center thereof.

32. Method for treating female urinary incontinence comprising the steps of

passing a tape into the body via the vagina first at one end thereof and then at the other end thereof at one side and the other, respectively, of urethra to form a loop around urethra, located between urethra and the vaginal wall,

extending said tape over the pubic bone and through the abdominal wall, the ends of the tape being available outside the abdominal wall,

tightening said strap at said ends, and

leaving the tape implanted in the body.