Absorbable pubovaginal sling system and method

• US 6,881,184 B2
• Filed: 07/16/2002
• Issued: 04/19/2005
• Est. Priority Date: 07/16/2002
• Status: Expired due to Fees

• Current Assignee: Stephen M. Zappala
• Original Assignee: Stephen M. Zappala
• Inventors: Zappala, Stephen M.
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US10/196,462
• Publication Number:
  US 20040015044A1
• Time in Patent Office: 1,008 Days
• Field of Search: 600 29- 32, 128/DIG.25, 128/898, 606228-233
• 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 a patient'"'"'s urinary incontinence that is adapted to be implanted 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;

one or more monofilament sutures that is adapted to be connected to said sling proximate a bladder neck and transposed to a suprapubic position and is configured to extend through said patient'"'"'s subcutaneous tissue and outer layer of skin; and

one or more means for fixing said suture at a desired tension, wherein said means for fixing is adapted to be seated on the outside of the patient'"'"'s body against the patient'"'"'s abdomen, wherein said means for fixing engages said sutures, and wherein said means for fixing comprises a means for releasably adjusting said tension of said sutures from the outside of the patient'"'"'s body.

2. 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.

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

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

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

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

7. The sling system of claim 6, wherein said sling is adapted to be absorbed in about 90 days.

8. The sling system of claim 1, wherein said means for fixing comprises one or more apertures through which said suture is passed and secured at an adjustable tension.

9. The sling system of claim 1, wherein said means for fixing comprises one or more apertures whereby said tension of said suture is releasably adjusted by opening said aperture of said means for fixing to stretch and tighten, or loosen, the tension of suture and then closing said aperture of the means for fixing to secure the suture at said readjusted tension.

10. 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.

11. The method of claim 10, 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.

12. The method of claim 10, wherein said step of transposing is accomplished in part using a percutaneous, incision-free needle.

13. The method of claim 10, 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.

14. The method of claim 10, wherein said monofilament suture is looped and comprises one or both prolene and nylon.

15. The method of claim 10, wherein said sling and suture are prefabricated and do not require physician reconstitution.

16. The method of claim 10, wherein said sling is fibrogenic and is adapted to be absorbed in about 90 days.