Treating urinary incontinence

• US 6,689,047 B2
• Filed: 11/14/2001
• Issued: 02/10/2004
• Est. Priority Date: 11/15/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Gellman, Barry N.
• Primary Examiner(s): Winakur; Eric F.
• Assistant Examiner(s): Veniaminov; Nikita R
• Application Number:
  US09/992,359
• Publication Number:
  US 20020058959A1
• Time in Patent Office: 818 Days
• Field of Search: 600/29-30,37 606/148,167,144-146,139,198,196,205-209,119,118,138,140,141,222-228,72-75 128/DIG. 25 60/119 28/897,898 604/515
• 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 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A surgical device for use in a minimally invasive procedure to treat urinary incontinence can include a dilator coupled to a curved needle at one end and a sling at the opposite end. Urinary incontinence can be treated minimally invasively. One treatment includes positioning the sling on an anterior portion of the urethra to provide proper coaptation to the urethra.

Claims

1. A surgical device for treating urinary incontinence, comprising:

a curved needle including a distal end and a proximal end;

a dilator including a distal end and a proximal end, wherein the distal end of the dilator is coupled to the proximal end of the curved needle;

a sling including a distal end and a proximal end, wherein the distal end of the sling is coupled to the proximal end of the dilator.

2. The surgical device of claim 1 wherein the curved needle includes a curvature sufficient to allow the needle to enter a body through a vaginal cavity, pass to a side of a urethra, continue over an anterior side of the urethra, and exit the body on an opposite side of the urethra.

3. The surgical device of claim 1 wherein the dilator is substantially flat and triangular in shape.

4. The surgical device of claim 1 wherein the dilator is substantially rectangular and tapered at the distal end.

5. The surgical device of claim 1 wherein the dilator comprises a marking to indicate a location of the sling in a body.

6. The surgical device of claim 1 wherein the sling comprises a material selected from the group consisting of a natural material, a synthetic material, and a combination of a natural material and a synthetic material.

7. The surgical device of claim 1 wherein the sling is about 1 centimeter to about 3 centimeters in width.

8. The surgical device of claim 1 further comprising a tether coupling the curved needle to the dilator, wherein the tether is selected from the group consisting of a wire, a suture, and a portion of the sling.

9. The surgical device of claim 1 wherein the sling includes a first portion, a middle portion, and a second portion, the first portion of the sling being smaller in width than the middle portion of the sling.

10. The surgical device of claim 9 wherein the first portion of the sling couples the sling to the dilator.

11. The surgical device of claim 9 wherein the first portion of the sling couples the dilator to the needle.

12. The surgical device of claim 1 further comprising a pouch attached to the dilator.

13. The surgical device of claim 1 further comprising a pouch releasably attached to the sling.

14. The surgical device of claim 1 further comprising a stiffener to maintain the sling in a generally planar orientation as the sling is passed through a body.

15. A surgical device for treating urinary incontinence comprising:

a sling including a distal end and a proximal end;

a first tether including a distal end and a proximal end, wherein the proximal end of the first tether is coupled to the distal end of the sling;

a second tether including a distal end and a proximal end, wherein the distal end of the second tether is coupled to the proximal end of the sling;

a curved needle coupled to the distal end of the first tether; and

a dilator disposed along the first tether between the curved needle and the distal end of the sling.

16. A method of treating urinary incontinence, comprising:

a) introducing a sling into a body; and

b) positioning the sling on an anterior side of a urethra to coapt the urethra against a vaginal wall.

17. The method of claim 16 wherein the positioning step comprises positioning the sling to surround less than 360°

of the circumference of the urethra.

18. The method of claim 16 wherein the introducing step comprises introducing the sling into the body via a vaginal cavity and through the vaginal wall.

19. The method of claim 16 further comprising the step of separating the anterior of the urethra from surrounding tissue.

20. The method of claim 19 wherein the separating step comprises using hyrodissection or balloon dissection.

21. The method of claim 16 wherein the introducing step comprises:

introducing a surgical device into the body via a vaginal cavity and through a vaginal wall to pass to one side of the urethra, passing the surgical device about the anterior side of the urethra, and removing at least a portion of the surgical device from the body on the other side of the urethra back into the vaginal cavity, wherein the surgical device comprises;

a curved needle including a distal end and a proximal end;

a dilator including a distal end and a proximal end, wherein the distal end of the dilator is coupled to the proximal end of the curved needle; and

a sling including a distal end and a proximal end, wherein the distal end of the sling is coupled to the proximal end of the dilator.

22. A method of treating urinary incontinence comprising the steps of:

a) introducing a surgical device into a body via a vaginal cavity, the surgical device comprising;

a sling including a distal end and a proximal end;

a first tether including a distal end and a proximal end, wherein the proximal end of the first tether is coupled to a distal end of the sling;

a second tether including a distal end and a proximal end, wherein the distal end of the second tether is coupled to a proximal end of the sling;

a curved needle coupled to the distal end of the first tether; and

a dilator disposed along the first tether between the curved needle and the distal end of the sling;

b) passing the curved needle into the body via the vaginal cavity, through a vaginal wall to one side of a urethra, over an anterior portion of the urethra, and out of the body on the other side of the urethra into the vaginal cavity creating a path for the first tether, the dilator, the sling, and the second tether to follow;

c) advancing the dilator along the path to position the sling about the urethra and leaving at least a portion of the second tether in the vaginal cavity;

d) removing the dilator and at least a portion of the first tether from the body into the vaginal cavity and positioning the sling about the anterior portion of the urethra to coapt the urethra against an anterior portion of the vaginal wall; and

e) securing the first tether and second tether to an interior wall of the vaginal cavity.

23. The method of claim 22 further comprising separating the anterior portion of the urethra from surrounding tissue.