Apparatus and method for treating urinary incontinence

• US 9,113,992 B2
• Filed: 09/03/2014
• Issued: 08/25/2015
• Est. Priority Date: 10/12/2000
• Status: Expired due to Fees

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US14/476,484
• Publication Number:
  US 20150025302A1
• Time in Patent Office: 356 Days
• Field of Search: 600 29- 32, 600/37, 128/DIG.25, 606139-144, 606151-158, 606232-233
• US Class Current: 1/1
• 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 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 2017/0417 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 surgical implant for treating female urinary incontinence includes a suburethral support, first and second soft tissue anchors, and first and second elongated members connecting the first and second soft tissue anchors to first and second ends of the suburethral support. The first soft tissue anchor includes a central portion, a plurality of projections extending from the central portion, and a plurality of deflection-limiting features. The plurality of projections extends from the central portion, each of the projections being inclined away from a longitudinal axis of the first soft tissue anchor and configured to be deflected inwardly toward the longitudinal axis during delivery. The plurality of deflection-limiting features is configured to limit deflection of the plurality of projections outwardly away from the longitudinal axis beyond a desired angle.

Claims

1. A surgical implant for treating female urinary incontinence, the surgical implant comprising:

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

a first soft tissue anchor defining a longitudinal axis and including;

a central portion having a proximal end, a distal end, and a central lumen extending through the central portion from the proximal end to the distal end;

a plurality of projections extending from the central portion, each of the projections being inclined away from the longitudinal axis of the first soft tissue anchor and configured to be deflected inwardly toward the longitudinal axis during delivery; and

a plurality of deflection-limiting features configured to limit deflection of the plurality of projections outwardly away from the longitudinal axis beyond a desired angle;

a second soft tissue anchor;

a first elongated member coupled to, and extending between, the first soft tissue anchor and the first end of the suburethral support, the first elongated member connecting the first soft tissue anchor to the suburethral support; and

a second elongated member coupled to and extending between the second soft tissue anchor and the second end of the suburethral support, the second elongated member connecting the second soft tissue anchor to the suburethral support.

2. The surgical implant of claim 1, wherein the distal end of the first soft tissue anchor is substantially flat.

3. The surgical implant of claim 1, wherein the plurality of projections includes four winged sections spaced symmetrically around the central portion.

4. The surgical implant of claim 1, wherein the first soft tissue anchor is made from a polymer.

5. The surgical implant of claim 4, wherein the first soft tissue anchor is made from polypropylene.

6. The surgical implant of claim 1, wherein the first elongated member is made from a polymer.

7. The surgical implant of claim 6, wherein the first elongated member includes a mono-filament.

8. The surgical implant of claim 1, wherein the first end of the suburethral support is tapered.

9. The surgical implant of claim 1, wherein the suburethral support is made from flat polymer tape.

10. The surgical implant of claim 1, wherein each of the plurality of deflection-limiting features is configured to resist deflection of the plurality of projections outwardly away from the longitudinal axis beyond a perpendicular angle.

11. The surgical implant of claim 1, wherein the first soft tissue anchor further includes:

a tube received over the central portion for coupling the first elongated member to the first soft tissue anchor.

12. A surgical implant for treating female urinary incontinence, comprising:

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

a first soft tissue anchor including;

a central portion having a proximal end, a distal end, and a lumen extending through the central portion from the proximal end to the distal end and defining a longitudinal axis, the distal end having the shape of a truncated cone; and

a plurality of flexible sections, each of the plurality of flexible sections projecting at an incline away from the longitudinal axis in a proximal direction and being configured to flex inwardly toward the longitudinal axis; and

a plurality of deflection-limiting features configured to limit deflection of the plurality of flexible sections outwardly away from the longitudinal axis beyond a desired point;

a first elongated member coupled to, and extending between, the first soft tissue anchor and the first end of the suburethral support, the first elongated member connecting the first soft tissue anchor to the suburethral support;

a second soft tissue anchor; and

a second elongated member coupled to, and extending between, the second soft tissue anchor and the second end of the suburethral support, the second elongated member connecting the second soft tissue anchor to the suburethral support.

13. The surgical implant of claim 12, wherein the plurality of flexible sections consists of four winged sections symmetrically spaced around the single longitudinal location.

14. The surgical implant of claim 12, wherein each of the first and second ends of the suburethral support is tapered.

15. The surgical implant of claim 12, wherein the suburethral support is made from flat polymer tape.

16. A method for supporting the urethra of a patient to treat urinary incontinence, the method comprising:

introducing a surgical implant through a vaginal incision, the surgical implant including a suburethral support, and first and second soft tissue anchors connected to first and second opposite ends of the suburethral support by first and second elongated members, wherein the first soft tissue anchor has a central portion having a proximal end, a distal end, and a bore extending through the central portion from the proximal end to the distal end, and a plurality of flex wings, the flex wings projecting outwardly from a longitudinal axis of the anchor when the flex wings are in a resting state; and

a plurality of deflection-limiting features;

inserting the first soft tissue anchor into soft tissue on a first side of the urethra, including causing the plurality of flex wings of the first soft tissue anchor to be deflected inwardly toward the longitudinal axis of the first soft tissue anchor during insertion;

anchoring the first soft tissue anchor into soft tissue on the second side of the urethra, including causing the plurality of flex wings to be deflected outwardly away from the longitudinal axis during anchoring;

wherein the outward deflection of the plurality of flex wings of the first soft tissue anchor is limited to a predefined limit by the plurality of deflection-limiting features;

inserting the second soft tissue anchor into soft tissue on a second side of the urethra;

anchoring the second soft tissue anchor into soft tissue on the second side of the urethra; and

positioning the suburethral support below the urethra of the patient.

17. The method of claim 16, wherein the plurality of deflection-limiting features prevent the plurality of flex wings from moving beyond a point substantially perpendicular to the longitudinal axis.

18. The method of claim 16, wherein the plurality of flex wings define an inwardly deflected state during insertion of the first soft tissue anchor through soft tissue and return to a resting state after passing through the first soft tissue.