Method for implanting an adjustable surgical implant for treating urinary incontinence

• US 8,118,728 B2
• Filed: 06/21/2011
• Issued: 02/21/2012
• Est. Priority Date: 10/12/2000
• Status: Expired due to Term

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US13/165,561
• Publication Number:
  US 20110237870A1
• Time in Patent Office: 245 Days
• Field of Search: 600 29- 31, 128/DIG.25, 128897-898, 606139-144, 606151-158, 606232-233
• US Class Current: 600/37
• 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 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• 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
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

A method of treating urinary incontinence of a patient by introducing a surgical implant through a vaginal incision. The surgical implant includes a suburethral support having first and second suspending members and first and second tissue anchors. The width of each suspending member is less than the width of the suburethral support. Each tissue anchor has a conical tip and is coupled with a respective one of the first and second suspending members. The first and second tissue anchors are inserted into tissue on first and second sides, respectively, of a urethra of the patient without penetrating an abdominal wall. A position of the suburethral support relative to the patient'"'"'s urethra is adjusted, including pulling the second suspending member through the patient'"'"'s vagina to adjust the distance between the suburethral support and the second anchor, after which the distance between the suburethral support and the second anchor is fixed.

Claims

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

introducing a surgical implant through an incision made on an upper wall of a patient'"'"'s vagina, the surgical implant including;

an elongate polymer suburethral support having a length and a width;

first and second elongate and porous polymer suspending members having a width extending from opposite ends of the suburethral support, wherein the width of each suspending member is less than the width of the suburethral support; and

first and second polymer tissue anchors, each tissue anchor having a conical tip and coupled with a respective one of the first and second suspending members, wherein a distance between the suburethral support and the second anchor is adjustable;

inserting the first tissue anchor into tissue on a first side of a urethra of the patient without penetrating an abdominal wall;

inserting the second tissue anchor into tissue on a second side of the urethra without penetrating the abdominal wall;

adjusting a position of the suburethral support relative to the patient'"'"'s urethra after inserting the first and second tissue anchors, including pulling the second suspending through the patient'"'"'s vagina to adjust the distance between the suburethral support and the second anchor; and

fixing the distance between the suburethral support and the second anchor after adjusting the position of the suburethral support.

2. The method of claim 1, wherein adjusting the position of the suburethral support includes pulling the second suspending member to shorten a length of the second suspending member between the suburethral support and the second anchor.

3. The method of claim 2, wherein adjusting the position of the suburethral support further includes increasing the length of the second suspending member between the suburethral support and the second anchor.

4. The method of claim 1, wherein adjusting the position of the suburethral support includes pulling the second suspending member through an aperture in the surgical implant.

5. The method of claim 4, wherein fixing the distance between the suburethral support and the second anchor includes fixing the length of the second suspending member by positioning an element with respect to the aperture in the surgical implant to trap the suspending member between an edge of the aperture and the element.

6. The method of claim 1, further comprising:

providing an introducer tool, including;

a handle; and

an elongate and curved body extending from the handle and having a distal end for releasably engaging the first and second tissue anchors of the surgical implant;

mounting the first tissue anchor on the distal end of the introducer tool body;

operating the introducer tool with the mounted first tissue anchor to insert the first tissue anchor through the incision and on the first side of the urethra without penetrating the abdominal wall, including manipulating the position of the curved body;

releasing the first anchor from the introducer tool and removing the introducer tool from the patient after inserting the first tissue anchor, including manipulating the position of the curved body to withdraw the distal end of the body;

mounting the second tissue anchor on the distal end of the introducer tool body;

operating the introducer tool with the mounted second tissue anchor to insert the second tissue anchor through the incision and on the second side of the urethra without penetrating the abdominal wall, including manipulating the position of the curved body; and

releasing the second anchor from the introducer tool and removing the introducer tool from the patient after inserting the second tissue anchor, including manipulating the position of the curved body to withdraw the distal end of the body.

7. The method of claim 6, further comprising inserting the first tissue anchor with the suburethral support positioned along an outer part of a curvature of the body of the introducer.

8. The method of claim 1, further comprising inserting the first tissue anchor on the first side of the urethra along a curved path.

9. The method of claim 1, wherein the suburethral support is suspended below a mid-urethra of the patient.