Surgical instrument and method for treating female urinary incontinence

• US 6,273,852 B1
• Filed: 03/09/2000
• Issued: 08/14/2001
• Est. Priority Date: 06/09/1999
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Luscombe, Brian H., Chen, Chao-Chen, Lehe, Jorn
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/521,801
• Time in Patent Office: 523 Days
• Field of Search: 600/29, 600/30, 600/37, 601/19, 128/DIG.25, 288/97, 288/98, 604/515
• US Class Current: 600/30
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06047 located at the middle of the needle
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A is a surgical instrument and method for treating female urinary stress incontinence. The instrument includes a curved needle-like element defining in part a curved shaft having a distal end and a proximal end. The diameter of the needle decreases from the proximal end to the distal end, and the needle terminates in a blunt tip. A tape attaches to the needle for implanting into the lower abdomen of a female to provide support to the urethra. The tape may be made from synthetic and natural materials. The needle and tape may also be modified to allow the surgeon to attach and detach the tape during the surgical operation.

Claims

1. A surgical instrument for treating female urinary stress incontinence comprising:

a) a tape for implanting into the lower abdomen of a female to provide support to the urethra; and

b) a needle element defining in part a curved shaft having a distal end and a proximal end, and a diameter that decreasingly varies from the proximal end to the distal end, and means for attaching to the tape.

2. The surgical instrument of claim 1 wherein the distal end of the needle has a diameter from about 3 mm to about 5 mm.

3. The surgical instrument of claim 1 wherein the proximal end of the needle has a diameter from about 5 mm to about 6 mm.

4. The surgical instrument of claim 1 wherein the tape comprises connecting means and the needle comprises attaching means for detachably accepting the connecting means.

5. The surgical instrument of claim 1 wherein the attaching means is located at the distal end.

6. The surgical instrument of claim 4 wherein the connecting means is a tab element and the attaching means is a slot.

7. The surgical instrument of claim 1 wherein the distal end defines a blunt tip.

8. The surgical instrument of claim 7 wherein the blunt tip has a radius of about 0.6 mm.

9. A surgical instrument for treating female urinary stress incontinence comprising i) a tape for implanting into the lower abdomen of a female to provide support to the urethra, the tape defining a first end and a second end of a synthetic material and the tape further comprising a natural material;

and ii). a needle element defining in part a curved shaft having a distal end and a proximal end, and means for attaching to the tape, and a diameter that decreasingly varies from the proximal end to the distal end.

10. The surgical instrument of claim 9 wherein the natural material is selected from the group consisting of autologous, allograft, xenograft and a tissue engineered matrix.

11. The surgical instrument of claim 9 further comprising a curved needle-like element defining in part a curved shaft having a distal end and a proximal end, and means for attaching to the tape.

12. The surgical instrument of claim 11 wherein the curved needle element further defines a diameter that decreasingly varies from the proximal end to the distal end.

13. The surgical instrument of claim 9 wherein the distal end of the needle has a diameter from about 3 mm to about 5 mm.

14. The surgical instrument of claim 9 wherein the distal end of the needle has a diameter from about 5 mm to about 6 mm.

15. The surgical instrument of claim 9 wherein the tape comprises connecting means and the needle comprises attaching means for detachably accepting the attaching means.

16. The surgical instrument of claim 15 wherein the attaching means is located at the distal end.

17. The surgical instrument of claim 15 wherein the connecting means is a tab element and the attaching means is a slot.

18. The surgical instrument of claim 9 wherein the distal end defines a blunt tip.

19. The surgical instrument of claim 18 wherein the blunt tip has a radius of about 0.6 mm.

20. A surgical instrument for treating female urinary stress incontinence comprising:

a) a tape for implanting into the lower abdomen of a female to provide support to the urethra having connecting means; and

b) a needle element defining in part a curved shaft having a distal end and a proximal end and attaching means for detachably accepting the connecting means.

21. The surgical instrument of claim 20 wherein the attaching means is located at the distal end.

22. The surgical instrument of claim 20 wherein the connecting means is a tab element and the attaching means is a slot.

23. The surgical instrument of claim 20 wherein the distal end defines a blunt tip.

24. The surgical instrument of claim 23 wherein the blunt tip has a radius of about 0.6 mm.

25. The surgical instrument of claim 20 wherein the curved shaft defines a diameter that decreasingly varies from the proximal end to the distal end.

26. The surgical instrument of claim 25 wherein the distal end of the needle has a diameter from about 3 mm to about 5 mm.

27. The surgical instrument of claim 25 wherein the proximal end of the needle has a diameter from about 5 mm to about 6 mm.

28. A method for treating female urinary incontinence comprising the steps of:

a) providing a first and second needle element, each defining a curved shaft having a distal end and a proximal end, and a diameter that decreasingly varies from the proximal end to the distal end and a tape attached to both needle elements;

b) passing the first needle and tape into the body via the vagina and on one side of the urethra and extending the tape over the pubic bone and through the abdomen wall;

c) passing the second needle and tape into the body via the vagina and on the opposite side of the urethra than the first needle and extending the tape over the pubic bone and through the abdomen wall, creating a supporting sling below the urethra; and

d) leaving the tape implanted in the body.

29. A method for treating female urinary incontinence comprising the steps of:

a) providing a needle element defining in part a curved shaft having a distal end and a proximal end and a tape attached thereto; and

b) passing the needle and tape into the body via the vagina to form a sling around the urethra; and

c) leaving the tape implanted in the body.

30. A method for treating female urinary incontinence comprising the steps of:

a) providing a needle element defining in part a curved shaft;

b) attaching a tape to the needle;

c) passing the needle and tape into the body;

d) attaching the tape to the needle and passing the needle and tape into the body to form a sling around the urethra the and

e) leaving the tape implanted in the body.