Apparatus and method for treating female urinary incontinence

• US 20030191360A1
• Filed: 04/11/2003
• Published: 10/09/2003
• Est. Priority Date: 10/12/2000
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Gyne Ideas Limited
• Inventors: Browning, James
• Granted Patent: US 6,960,160 B2
• Time in Patent Office: Days
• US Class Current: 600/29
• 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

The present invention provides a surgical implant and method for supporting the urethra (118), the implant comprising: a suburethral support (10) suspended between two soft tissue anchors (30) that do not penetrate the lower abdominal wall and are attached at either side of the suburethral support (10). The soft tissue anchors (30) retain each anchor in soft tissue, suspending each side of the suburethral support (10). The suburethral support (10) passes under the urethra (118) to support the urethra (118). The implant has uses including treating urinary incontinence and uterovaginal prolapse.

Claims

1. A surgical implant for supporting the urethra, the implant comprising:

a suburethral support suspended between at least two soft tissue anchors attached at either side of the suburethral support, each soft tissue anchor having retaining means for retaining each anchor in tissue and suspending means for suspending each side of the suburethral support from a soft tissue anchor such that, in use, the suburethral support passes under the urethra and the soft tissue anchor anchors the implant and does not penetrate the lower abdominal wall.

2. A surgical implant as claimed in claim 1 wherein the soft tissue anchor comprises a central portion and the retaining means includes at least one wing section, the wing section being mounted on a first end of the central portion by resilient hinge means such that the wing section is moveable between an open, resting position and a deflected position such that in use, when the soft tissue anchor device is inserted into the tissue the wing section is pushed or held towards the central portion in the deflected position to permit entry of the soft tissue anchor into the tissue and through the rectus sheath, wherein the wing section returns to its open or resting position and prevents the soft tissue anchor being removed from the rectus sheath.

3. A surgical implant as claimed in claim 2 wherein the central portion of the soft tissue anchor comprises a hollow passage through which an introducing tool may be inserted.

4. A surgical implant as claimed in claims 2 or 3 wherein the soft tissue anchor comprises a plurality of wing sections.

5. A surgical implant as claimed in claim 1 wherein the soft tissue anchor is capable of anchoring in the retropubic area without penetrating the rectus sheath.

6. A surgical implant as claimed in claim 1 or 5 wherein the soft tissue anchor comprises a central portion and the retaining means includes a plurality of projections, the projections, extending radially from the central portion along a length of the central portion allowing fixation at a plurality of layers.

7. A surgical implant as claimed in claim 1 wherein the soft tissue anchor comprises a substantially flat head the bottom surface nearest the suspending means of the flat head providing the retaining means, which in use, anchors the implant in the rectus sheath.

8. A surgical implant as claimed in claim 1 wherein the soft tissue anchor comprises a sharp point allowing it to pierce or penetrate the rectus sheath, and the retaining means comprises a surface or protrusion directed rearwardly with respect to the sharp point to maintain the anchor within the rectus sheath.

9. A surgical implant as claimed in any preceding claim wherein the soft tissue anchor is comprised of plastics material.

10. A surgical implant as claimed in any preceding claim wherein the soft tissue anchor is comprised of polypropylene.

11. A surgical implant as claimed in any preceding claim wherein the soft tissue anchor is integral with the suspending means.

12. A surgical implant as claimed in any preceding claim wherein the suburethral support is comprised of flat polymer tape.

13. A surgical implant as claimed in any preceding claim wherein the suburethral support has dimensions of length 15-35 mm, width 5-15 mm and thickness 50-350 μ

m.

14. A surgical implant as claimed in any preceding claim wherein the length of the suspending means is adjustable.

15. A surgical implant as claimed in any preceding claim wherein the suspending means comprise a plastics strip, 3-5 mm in width.

16. A surgical implant as claimed in any preceding claim wherein the suspending means comprises a plastics material which comprises pores which extend through the plastics material from a first surface of the plastics material to a second opposite surface of the plastics material said pores ranging in width across the surface of the plastics material from 50 μ

m to 200 μ

m.

17. A surgical implant as claimed in any preceding claim wherein the plastics material which comprises the suspending means comprises pits, that indent but do not extend through the plastics material, on at least one of the surfaces of the plastics material, the pits ranging in width from 50 μ

m to 200 μ

m.

18. A surgical implant as claimed in any preceding claim wherein the suspending means is provided with a plurality of microgrooves of width between 0.5-7 μ

m and of depth 0.25-7 μ

m on at least one surface of the plastics strip.

19. A surgical implant as claimed in claim 18 wherein the plurality of microgrooves are aligned such that they are substantially parallel with each other.

20. A method of supporting the urethra comprising the steps of, introducing a surgical implant in any of the preceding claims into an incision made on the upper wall of the vagina, inserting a soft tissue anchor on a first side of the urethra behind the pubic bone, inserting a second soft tissue anchor on a second side of the urethra behind the pubic bone, such that the suburethral support is suspended from the soft tissue anchor and supports the urethra.

21. Use of a method of supporting the urethra as claimed in claim 20 in treating urinary incontinence or uterovaginal prolapse.

22. A method as claimed in claim 20 wherein the soft tissue anchors are inserted in the rectus sheath.

23. A method as claimed in claim 20 wherein the soft tissue anchors are inserted in the fibro-fatty soft tissue which comprise the retropubic space and do not penetrate the rectus sheath.

24. A surgical implant as claimed in any of claims 1 to 19 wherein at least a part of the surgical implant of the present invention is coated or impregnated with a water soluble dye.

25. A soft tissue anchor comprising a central portion and retaining means wherein the retaining means includes a plurality of projections, the projections extending radially from the central portion along a substantial portion of the length of the central portion allowing fixation of the anchor at a plurality of layers.

26. Use of a soft tissue anchor as claimed in claim 25 in plastic surgery, cosmetic surgery, hernia repair, facelifts and the like.

27. Use of a plastics material as claimed herein in implants to encourage cell through growth or ingrowth.