ABSORBABLE PUBOVAGINAL SLING SYSTEM AND METHOD

• US 20040015044A1
• Filed: 07/16/2002
• Published: 01/22/2004
• Est. Priority Date: 07/16/2002
• Status: Active Grant

• Current Assignee: Stephen M. Zappala
• Original Assignee: Stephen M. Zappala
• Inventors: Zappala, Stephen M.
• Granted Patent: US 6,881,184 B2
• Time in Patent Office: Days
• US Class Current: 600/29
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

An absorbable pubovaginal sling system for surgical management of urinary incontinence, generally comprising: a latex-free, synthetic sling made entirely of absorbable materials of which at least one of the materials is adapted to stimulate fibroblast interposition; and a looped monofilament suture that is adapted to be transposed to the suprapubic position, supported by an external adjustable tension device, and connected to said sling.

Claims

1. An absorbable pubovaginal sling system for surgical management of urinary incontinence that is adapted to promote increased rigidity of the anterior vaginal wall and improved integrity of the sphincteric mechanism, comprising:

one or more latex-free, synthetic slings made entirely of absorbable materials of which at least one of said materials is adapted to stimulate fibroblast interposition; and

one or more monofilament sutures that is adapted to be transposed to a suprapubic position.

2. The sling system of claim 1, further comprising an external adjustable tension device that is connected to said suture and is adapted to support said sling.

3. The sling system of claim 1, wherein one or more of said absorbable materials is selected from a group consisting of chromic gut, polyglactin, polydioxanone, and combinations thereof.

4. The sling system of claim 1, wherein said monofilament suture is looped and comprises one or both prolene and nylon.

5. The sling system of claim 1, wherein said sling and suture are prefabricated and do not require physician reconstitution.

6. The sling system of claim 1, wherein said sling is either braided or woven with a plurality of fenestrations to allow ingrowth of fibroblasts.

7. The sling system of claim 1, wherein said sling is fibrogenic and is adapted to be absorbed at a slow rate.

8. The sling system of claim 7, wherein said sling is adapted to be absorbed in about 90 days.

9. The sling system of claim 1, wherein said suture is adapted to pass through a patient'"'"'s subcutaneous tissue and skin to connect to an external adjusting device.

10. The sling system of claim 9, wherein said external adjusting device comprises one or more apertures through which said suture is passed and secured at an adjustable tension.

11. The sling system of claim 10, wherein said tension of said suture is readjusted by opening said aperture of said device to stretch and tighten the suture and then closing said aperture of the device to secure the suture at said readjusted tension.

12. An absorbable pubovaginal sling system for surgical management of urinary incontinence in a patient that is adapted to promote increased rigidity of the anterior vaginal wall and improved integrity of the sphincteric mechanism, comprising:

one or more latex-free, synthetic slings made entirely of absorbable materials of which at least one of the materials is adapted to stimulate fibroblast interposition;

one or more monofilament sutures that is adapted to be transposed to a suprapubic position; and

one or more external adjustable tension devices that is adapted to support said sling by passing the suture through the patient'"'"'s subcutaneous tissue and out through the patient'"'"'s skin;

threading said suture through said tension device;

tightening the tension of said suture until a desired level of tension support is achieved; and

at least temporarily fixing said suture at said desired level of tension support with said tension device.

13. A pubovaginal sling system for surgical management of urinary incontinence in a patient, comprising:

one or more slings;

one or more monofilament sutures that is connected to said sling; and

one or more external adjustable tension devices that is adapted to support said sling by passing the suture through the patient'"'"'s subcutaneous tissue and out through the patient'"'"'s skin;

threading said suture through said tension device;

tightening the tension of said suture until a desired level of tension support is achieved; and

at least temporarily fixing said suture at said desired level of tension support with said tension device.

14. A method for surgically managing urinary incontinence in a patient, comprising the steps of,

providing one or more pubovaginal slings;

providing one or more monofilament sutures that is connected to said sling and is adapted to be transposed to a suprapubic position;

providing one or more external adjustable tension devices;

passing said suture connected to said sling pubovaginally around each side of the patient'"'"'s bladder neck;

transposing said suture to a suprapubic position through the patient'"'"'s subcutaneous tissue and out through the patient'"'"'s skin;

threading said suture through said tension device;

tightening the tension of said suture until a desired level of tension support is achieved; and

at least temporarily fixing said suture at said desired level of tension support with said tension device.

15. The method of claim 14, further comprising the step of, releasing one limb of said looped suture to disengage said suture from said sling, once fibroblast interposition and collagen deposition is at least partially achieved.

16. The method of claim 14, wherein said step of transposing is accomplished in part using a percutaneous, incision-free needle.

17. The method of claim 14, wherein said sling is absorbable, synthetic, latex-free and comprises one or more absorbable materials selected from a group consisting of chromic gut, polyglactin, polydioxanone, and combinations thereof.

18. The method of claim 14, wherein said monofilament suture is looped and comprises one or both prolene and nylon.

19. The method of claim 14, wherein said sling and suture are prefabricated and do not require physician reconstitution.

20. The method of claim 14, wherein said sling is fibrogenic and is adapted to be absorbed in about 90 days.