Bladder neck suspension procedure

• US 5,611,515 A
• Filed: 04/05/1993
• Issued: 03/18/1997
• Est. Priority Date: 12/03/1991
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Benderev, Theodore V., Legome, Mark J., Naves, Neil H.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/042,739
• Time in Patent Office: 1,443 Days
• Field of Search: 128/897, 128/898, 128/885-887, 128/DIG. 25, 600/29, 600/30, 606/232, 623/12, 623/14, 623/16
• 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 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• 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 46/30 : for surgery through the lower body openings, e.g. urology, gynaecology

Abstract

The surgical treatment of stress urinary incontinence is disclosed. The disclosed 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 disclosed. Novel drill guides, suture passers, suture tensioners, and various related tools and devices for use in the surgical method are also disclosed.

Claims

1. A method of suspending a bladder neck comprising the steps of:

securing a suture to a bone anchor;

positioning said anchor in a bone without exposing said bone by way of an open surgical procedure; and

suspending said bladder neck with said suture.

2. The method of claim 1, wherein said suture is secured to said anchor before said anchor is positioned in the bone.

3. The method of claim 1, wherein said suture is secured to said anchor after said anchor is positioned in the bone.

4. The method of claim 1, wherein the positioning step is accomplished percutaneously.

5. The method of claim 1, wherein the positioning step comprises positioning said anchor in a generally anterior surface of a pubic bone.

6. The method of claim 5, wherein the positioning step comprises positioning said anchor in the pubic bone approximately 2 centimeters lateral to a symphysis pubis.

7. A method of suspending a bladder neck in a patient, said method comprising the steps of:

securing a suture to a bone anchor, said suture having a first end and a second end;

positioning said anchor in a pubic bone;

grasping said suture with a probe, said probe being able to pierce tissue;

advancing said probe and the first end of said suture behind the pubic bone, and through an endopelvic fascia and anterior vaginal wall adjacent to a urethra at a first point;

releasing said suture within a vaginal cavity;

withdrawing said probe through the endopelvic fascia and vaginal wall;

advancing said probe through the endopelvic fascia and anterior vaginal wall at a second point, said second point being lateral to said first point;

grasping said suture within the vaginal cavity with said probe;

withdrawing the probe and the first end of said suture through the endopelvic fascia and vaginal wall;

advancing said probe and the first end of said suture through the endopelvic fascia and anterior vaginal wall at a third point, said third point being medial and distal to said second point;

releasing said suture within the vaginal cavity;

withdrawing said probe through the endopelvic fascia and vaginal wall;

advancing said probe through the endopelvic fascia and anterior vaginal wall at a fourth point, said fourth point being lateral to said third point;

grasping said suture within the vaginal cavity with said probe;

removing said probe and the first end of said suture from the patient;

releasing said suture from said probe;

applying tension to the first and second ends of said suture;

tying the first and second ends of said suture to suspend a first side of the bladder neck; and

repeating the foregoing steps on a second side of the bladder neck to form a bladder neck suspension sling.

8. The method of claim 7, wherein said probe comprises a handle, an elongate tubular probe guide extending in a distal direction from the handle, an elongate pointed probe axially movably disposed within the tubular probe guide, and a recess on the pointed probe and an opening on the tubular probe guide for receiving said suture, said grasping and releasing steps being accomplished by axially moving the pointed probe within the tubular probe guide to bring the recess on the pointed probe into and out of alignment with the opening on the tubular probe guide.

9. The method of claim 7, wherein the positioning step is accomplished using a bone anchor implantation device, said bone anchor implantation device comprising a housing, at least one probe mounted to the housing, and a guide channel extending through the housing, the positioning step comprising piercing tissue with said at least one probe of the bone anchor implantation device to contact bone so that the guide channel is placed over the pubic bone into which said anchor is to be positioned.

10. A minimally invasive method of suspending a bladder neck, comprising the steps of:

securing a suture to a bone anchor;

locating a generally anterior surface of a pubic bone;

positioning the anchor in the generally anterior surface of the pubic bone; and

suspending the bladder neck with the suture.

11. The method of claim 10, wherein the positioning step comprises positioning the anchor in a pubic tubercle.