Adjustable surgical implant and method for treating urinary incontinence

• US 8,273,011 B2
• Filed: 06/01/2011
• Issued: 09/25/2012
• 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:
  US13/150,010
• Publication Number:
  US 20110237874A1
• Time in Patent Office: 482 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, the method including introducing a surgical implant through an incision made on an upper wall of a patient'"'"'s vagina. The surgical implant includes a suburethral support, first and second suspending members, and first and second polymer tissue anchors. Each tissue anchor is 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. The first tissue anchor is inserted into tissue on a first side of a urethra of the patient without penetrating an abdominal wall. A position of the suburethral support is adjusted relative to the patient'"'"'s urethra by pulling the second suspending member through the patient'"'"'s vagina to adjust the distance between the suburethral support and the second anchor. And the distance between the suburethral support and the second anchor is fixed.

Claims

1. A method of treating urinary incontinence, comprising:

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

a suburethral support;

first and second suspending members; and

first and second polymer tissue anchors, each tissue anchor 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 by pulling the second suspending member 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.

2. The method of claim 1, wherein pulling the second suspending member through the patient'"'"'s vagina to adjust the distance between the suburethral support and the second anchor includes shortening a length of the second suspending member between the suburethral support and the second anchor.

3. The method of claim 1, wherein pulling the second suspending member through the patient'"'"'s vagina to adjust the distance between the suburethral support and the second anchor 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, wherein introducing a surgical implant includes introducing a surgical implant having first and second suspending members comprising a suture.

7. 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 at least one of 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;

releasing the first anchor from the introducer tool and removing the introducer tool from the patient after inserting the first tissue anchor;

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; and

releasing the second anchor from the introducer tool and removing the introducer tool from the patient after inserting the second tissue anchor.

8. The method of claim 7, 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.

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

10. A method for treating urinary incontinence, comprising:

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

a suburethral support having first and second opposite end portions; and

first and second unitary molded polymer soft tissue anchors, each tissue anchor coupled with a respective one of the first and second end portions of the suburethral support, and wherein a distance between the suburethral support and the second anchor is adjustable;

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

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

adjusting the distance between the second end portion of the suburethral support and the second anchor through the patient'"'"'s vagina; and

fixing the distance between the suburethral support and the second anchor.

11. The method of claim 10 wherein adjusting the distance between the second end portion of the suburethral support and the second anchor includes shortening a distance between the suburethral support and the second anchor.

12. The method of claim 10 wherein adjusting the distance between the second end portion of the suburethral support and the second anchor includes increasing a distance between the suburethral support and the second anchor.

13. The method of claim 10 wherein adjusting the distance between the second end portion of the suburethral support and the second anchor includes pulling a portion of the surgical implant through an aperture in the surgical implant.

14. The method of claim 13 wherein fixing the distance between the suburethral support and the second anchor includes positioning an element with respect to the aperture in the surgical implant to trap a portion of the surgical implant between an edge of the aperture and the element.

15. The method of claim 10 wherein the distance between the suburethral support and the second anchor is fixed by limiting an effective length of a portion of the surgical implant between the suburethral support and the second anchor.

16. The method of claim 10 wherein the distance between the suburethral support and the second anchor is fixed by positioning an element of the implant to secure the suburethral support along a length of the implant from the second anchor.

17. A method for treating urinary incontinence, comprising:

inserting a first tissue anchor of a surgical implant through a vaginal incision into soft tissue on a first side of a urethra of a patient without penetrating an abdominal wall of the patient, the first tissue anchor being coupled to a first suspending member that extends from a first end portion of a suburethral support;

inserting a second tissue anchor of the surgical implant into soft tissue on a second side of a urethra of the patient without penetrating an abdominal wall, the second soft tissue anchor being coupled to a second suspending member that extends from a second end of the suburethral support, the second end of the suburethral support being opposite the first end of the suburethral support and the second suspending member defining an effective length between the second end of the suburethral support and the second tissue anchor; and

adjusting the effective length between the second end of the suburethral support and the second tissue anchor by pulling the second suspending member through the patient'"'"'s vagina to adjust the distance between the suburethral support and the second anchor.

18. The method of claim 17 and further comprising limiting the effective length between the second end of the suburethral support and the second anchor by trapping the second suspending member with a trapping element.

19. The method of claim 17 and further comprising setting the effective length between the second end of the suburethral support and the second anchor by trapping the second suspending member with a trapping element.

20. The method of claim 17 and further comprising trapping the second suspending member with an element to secure the suburethral support at the effective length.