Medical sling procedures and anchor insertion methods and devices

• US 6,334,446 B1
• Filed: 04/07/1999
• Issued: 01/01/2002
• Est. Priority Date: 11/13/1992
• Status: Expired due to Fees

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Beyar, Mordechay
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/287,867
• Time in Patent Office: 1,000 Days
• Field of Search: 128/898, 600/37, 606/139, 606/73, 606/75, 606/232
• US Class Current: 128/898
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0493 Protective devices for suturing, i.e. for protecting the patient's organs or the operator
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 17/863 with thread interrupted or changing its form along shank, other than constant taper
• CPC Class Codes: A61B 17/869 characterised by an open form, e.g. wire helix
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/2904 curved, but rigid
• CPC Class Codes: A61F 2/0045 : Support slings
• CPC Class Codes: Y10S 606/916 : Tool for installing or removing orthopedic fastener

Abstract

A procedure for treating urinary stress incontinence by using bone anchors, whether screw or staple type, with or without suture, inserted pervaginally for use with a sling material for supporting the bladder neck and/or proximal uretha.

Claims

1. A method of treating a female patient for urinary stress incontinence, comprising:

per vaginally inserting a bone anchor to enter the posterior wall of the pubic bone, said bone anchor comprising suture thread secured thereto; and

,

using said suture thread and a sling, made of a biocompatible texturized fabric impregnated with an absorbable gelatinous substance, to treat the incontinence.

2. The method as claimed in claim 1, wherein said bone anchor is a staple type bone anchor, and comprises suture thread attached thereto;

and

further comprising using said suture thread and a sling to adjust the anatomy of the patient.

3. A method as claimed in claim 2, wherein said suture thread and said sling are used to adjust the position of the bladder neck of the patient.

4. A method as claimed in claim 2, wherein said suture thread and said sling are used to adjust the position of the urethra of the patient.

5. A method of treating a female patient for urinary stress incontinence, comprising:

per vaginally inserting a bone anchor;

employing a pulling force on said bone anchor perpendicularly against the pubic bone of the patient to enter the posterior wall of the pubic bone by use of a bone anchor inserter; and

using suture thread and a sling made of a biocompatible texturized fabric impregnated with an absorbable gelatinous substance to adjust the anatomic position of the bladder neck and the urethra of the patient.

6. A method as claimed in claim 5, wherein said anchor comprises a bone screw, said bone screw comprising suture thread secured thereto.

7. A method as claimed in claim 5, wherein said anchor comprises a staple type bone anchor, said bone anchor comprising suture thread secured thereto.

8. A method as claimed in claim 5, wherein said bone anchor inserter comprises a nonlinear bone anchor inserter.

9. A method as claimed in claim 8, wherein said non-linear bone anchor inserter comprises a retractable shield.

10. A method as claimed in claim 5, further comprising creating a submucosal tunnel below the bladder neck.

11. A method as claimed in claim 10, wherein said submucosal tunnel is created using a dilator.

12. A method as claimed in claim 10, further comprising passing said sling through said submucosal tunnel.

13. A method as claimed in claim 12, further comprising tying said sling to the pubic bone.

14. A method as claimed in claim 13, further comprising checking and adjusting, if necessary, the tension of said sling.

15. A method as claimed in claim 14, wherein said tension of said sling is checked using a right angle dissector.

16. A method as claimed in claim 5, further comprising creating a U shaped incision in the vaginal mucosa.

17. A method as claimed in claim 5, wherein said sutures pass though tissue to create a tunnel, and further comprising the step of dilating said tunnel.

18. A method as claimed in claim 17, wherein said tunnel is dilated using a dilator.

19. A method as claimed in claim 18, further comprising passing said sling through said tunnel.

20. A method as claimed in claim 19, further comprising tying said sling to the pubic bone.

21. A method as claimed in claim 20, further comprising checking and adjusting, if necessary, the tension of said sling.

22. A method as claimed in claim 21, wherein said tension of said sling is checked using a right angle dissector.

23. A method of treatment for female urinary stress incontinence comprising:

providing a sling material and staple type bone anchors; and

,

positioning said sling material below a portion of at least one of a bladder neck and urethra, said sling material being positioned as a hammock and being pervaginally suspended to the posterior surface of the pubic bone using said staple type bone anchors, said staple type bone anchors being inserted pervaginally.