Method of tensioning a suspended tissue mass

• US 5,836,315 A
• Filed: 08/27/1996
• Issued: 11/17/1998
• Est. Priority Date: 12/03/1991
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Technology Incorporated (Boston Scientific Corporation)
• Inventors: Benderev, Theodore V., Legome, Mark J., Naves, Neil H.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/703,900
• Time in Patent Office: 812 Days
• Field of Search: 128/830, 128/834-836, 128/897, 128/DIG. 25, 600/29-31, 600/37, 606/60, 606/72, 606/74-78, 606/139, 606/144, 606/145, 606/147-150, 606/220, 606/222-227, 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1796 for holes for sutures or flexible wires
• 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 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2090/062 : penetration depth
• CPC Class Codes: A61B 46/30 : for surgery through the lower body openings, e.g. urology, gynaecology

Abstract

The surgical treatment of stress urinary incontinence is described. The methods include: 1) a technique of probe passage to avoid injuring the bladder and to provide a more accurate and reproducible capture of the pubocervical fascia lateral to the bladder neck and urethra, 2) anchor fixation of the suspending sutures to the pubic bone to decrease the risk of suture pull through from above and to decrease post-operative pain and 3) a simple and reproducible technique to set a limited tension of the suspending sutures. A description of these methods and results of procedures with some of these methods are included. Novel drill guides, suture passers, suture tensioners, and various related tools and devices for use in the surgical method are also discussed.

Claims

1. A method of suspending a first tissue mass from a second tissue mass with a preselected tension, comprising the steps of:

providing a suture, said suture having at least a first portion, a second portion, and a third portion, the first portion of said suture being between the second and third portions of said suture;

positioning the first portion of said suture around the first tissue mass;

securing at least one of the second and third portions of said suture to the second tissue mass;

positioning a suture tensioner having a preselected cross-sectional area between said suture and either of the first or second tissue masses;

tying the second and third portions of said suture; and

thereafter

removing the suture tensioner to produce an amount of slack in said suture corresponding to the cross-sectional area of the suture tensioner.

2. The method of claim 1, wherein said positioning the first portion of said suture step comprises positioning said suture around a bladder neck.

3. The method of claim 1, wherein said securing step comprises securing said suture to a pubic bone.

4. The method of claim 3, wherein said securing step comprises securing said suture in an anchor and positioning the anchor in the pubic bone.

5. A method of suspending a tissue mass with a preselected tension, comprising the steps of:

securing at least one suture to a bone such that a first and second suture ends extend therefrom;

advancing at least one of said first and second ends of the suture around the tissue mass;

positioning a suture tensioner having a preselected cross-sectional area between the suture and the bone;

tying said first and second suture ends; and

thereafter

removing the suture tensioner to produce an amount of slack in the suture corresponding to the cross-sectional area of the suture tensioner.

6. The method of claim 5, wherein said advancing step comprises advancing at least one of said first and second ends of the suture around a bladder neck.

7. The method of claim 5, therein said securing step comprises securing said suture to an anchor and positioning the anchor in the bone.

8. The method of claim 7, wherein the step of positioning a suture tensioner comprises positioning the suture tensioner between the suture and a pubic bone, wherein the suture is secured to an anchor positioned in the pubic bone.

9. A method of suspending a bladder neck with a preselected tension, comprising the steps of:

providing a first suture, said suture having at least a first portion, a second portion, and a third portion, the first portion of said suture being between the second and third portions of said suture;

securing the first portion of said suture to tissue generally adjacent the bladder neck;

securing at least one of the second and third portions of said suture to a first anchor;

positioning the anchor in a bone;

positioning a suture tensioner having a preselected cross-sectional area between the suture and either the bone or the tissue generally adjacent the bladder neck;

tying the second and third portions of said suture; and

thereafter

removing the suture tensioner to produce an amount of slack in said suture corresponding to the cross-sectional area of the suture tensioner.

10. The method of claim 9, further comprising repeating each of the steps of claim 9 on a second side of the bladder neck using a second suture and a second anchor to form a bladder neck suspension sling with a preselected tension.

11. The method of claim 9, wherein the step of positioning a suture tensioner comprises positioning the suture tensioner between the suture and the bone.

12. The method of claim 9, wherein said suture is secured to the anchor before the anchor is positioned in the bone.

13. The method of claim 9, wherein said suture is secured to tissue generally adjacent to the bladder neck before said suture is secured to the anchor.

14. The method of claim 9, wherein said suture is secured to tissue generally adjacent to the bladder neck before the anchor is positioned in the bone.

15. The method of claim 9, wherein the step of positioning the anchor in a bone is accomplished without exposing the bone by way of an open surgical procedure.

16. The method of claim 15, wherein the step of positioning the anchor in a bone is accomplished percutaneously.

17. The method of claim 9, wherein the step of positioning the anchor in a bone comprises positioning the anchor in a pubic bone.

18. The method of claim 17, wherein the step of positioning the anchor in a bone comprises positioning the anchor in a generally anterior surface of the pubic bone.

19. The method of claim 18, wherein the step of positioning the anchor in a bone comprises positioning the anchor in a superior portion of the generally anterior surface of the pubic bone.

20. The method of claim 18, wherein the step of positioning the anchor in a bone comprises positioning the anchor in the pubic bone approximately 2 centimeters lateral to a symphysis pubis.

21. The method of claim 20, wherein the step of positioning the anchor in a bone comprises positioning the anchor in a pubic tubercle.

22. The method of claim 9, wherein the step of positioning the anchor in a bone is accomplished without exposing the bone.