Apparatus and method for treating female urinary incontinence

• US 20060058578A1
• Filed: 04/11/2003
• Published: 03/16/2006
• Est. Priority Date: 04/11/2002
• Status: Abandoned Application

• Current Assignee: Gyne Ideas Limited
• Original Assignee: Gyne Ideas Limited
• Inventors: Browning, James
• Application Number:
  US10/510,488
• Publication Number:
  US 20060058578A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

The present invention provides a surgical implant and method for supporting the urethra, the implant comprising: comprising at least one fixing zone that can be fixed in the fibrofatty tissue of the retropubic space. In use the implant supports the urethra such that increased intra-abdominal pressure is transmitted to the sub urethral pressure space to promote occlusion of the urethra at periods of increased intra-abdominal pressure. The implant of the present invention has uses including treating urinary incontinence and uterovaginal prolapse.

Claims

1. A surgical implant for supporting the urethra, the implant including at least two fixing zones and a supporting zone, the supporting zone being interposed between the fixing zones and the fixing zones each having at least one retaining means for anchoring the fixing zones in the tissues of the retropubic space without penetrating the rectus sheath such that in use the supporting zone passes under the urethra.

3. A surgical implant as claimed in claim 1 wherein the supporting zone comprises mesh.

4. A surgical implant as claimed in claim 1 wherein the retaining means are moveable from an inserting position to a retaining position.

5. A surgical implant as claimed in claim 4 wherein the retaining means comprise at least one projection which can project from the implant into the tissues of the retropubic space in at least one plane, the projection being moveable from a collapsed position to an extended position.

6. A surgical implant as claimed in claim 1 wherein the retaining means comprise glue.

7. A surgical implant as claimed in claim 6 wherein the glue comprises cyanoacrylate glue.

8. A surgical implant as claimed in claim 1 wherein at least one fixing zone comprises a pointed end at a first end, a base portion at a second end, wherein longitudinal edges extend between the pointed end and the base and wherein the longitudinal edges are notched to provide a row of projections extending outward from the longitudinal edges.

9. A surgical implant as claimed in claim 1 further comprising plastics material.

10. A surgical implant as claimed in claim 1 further comprising absorbable material.

11. A surgical implant as claimed in claim 1 wherein material of the supporting zone is more quickly absorbed by a body than material of the fixing zones.

12. A surgical implant as claimed in claim 1 further comprising at least one resilient zone, wherein the resilient zone provides for resilient extension of the implant along its longitudinal axis.

13. A surgical implant as claimed in claim 12 wherein the resilient zone is interposed between the fixing zone and the supporting zone.

14. A surgical implant as claimed in claim 1 wherein an unextended length of the implant is in the range 6 cm to 22 cm.

16. A surgical implant as claimed in claim 1 wherein a width of the implant is in the range 0.3 cm to 1.7 cm.

17. A surgical implant as claimed in claim 1 wherein a thickness of the implant is in the range 100 μ

m to 600 μ

m.

18. A surgical implant as claimed in claim 1 wherein at least one of the fixing zones comprises pores which extend through the fixing zone material.

19. A surgical implant as claimed in claim 1 wherein at least one of the fixing zones comprises pits that indent at least one surface of the fixing zone, but do not extend through the fixing zone.

20. A surgical implant as claimed in claim 1 wherein at least one of the fixing zones comprise slits that extend through the fixing zone material.

21. A surgical implant as claimed in claim 1 wherein at least one microgroove is provided on at least one fixing zone.

22. A surgical implant as claimed in claim 21 wherein a microgroove is in the range 0.5 μ

m to 7 μ

in width and in the range 0.25 μ

m to 7 μ

m in depth.

23. A surgical implant as claimed in claim 1 wherein the supporting zone comprises a marker to aid in identifying a suitable location of the supporting zone under the urethra.

24. A surgical implant as claimed in claim 1 wherein each fixing zone comprises at least one aperture adapted to receive a tool for insertion of the implant into a body.

2. A surgical implant for supporting the urethra comprising an anchor strip, the anchor strip comprising at least one fixing zone having at least one retaining means wherein in use a first portion of the anchor strip is retained in tissues of the retropubic space above the endopelvic fascia and a second portion of the anchor strip extends into a urethral pressure compartment below the endopelvic fascia and thereby supports, but does not pass under, the urethra.

15. A surgical implant as claimed in claim 2 wherein an unextended length of the implant is in the range 4 cm to 8 cm.

25. (canceled)

26. (canceled)

27. A tool for inserting a surgical implant, the tool comprising an elongate shaft including a semi-blunt point at a first end and holding means to for releasably mounting the surgical implant on the shaft.

28. A tool as claimed in claim 27 wherein the holding means comprise a recess extending from the semi-blunt point of the elongate shaft, the recess capable of receiving a portion of the surgical implant.

29. A tool as claimed in claim 28 wherein the recess is angled to twist a surgical implant received by the recess along its longitudinal length.

30. A tool as claimed in claim 28 wherein the recess is offset such that a first portion forming a wall of the recess is longer than a second portion forming an opposite wall of the recess.

31. A tool as claimed in claim 27 wherein the holding means comprise an abutment located toward the first end of the elongate shaft, wherein the semi-blunt point of the elongate shaft is capable of being passed through the surgical implant and the abutment is capable of hindering movement of the surgical implant down the length of the shaft toward the second end of the elongate shaft.

32. A method of supporting a urethra comprising:

introducing a surgical implant into at least one incision made on an upper wall of the vagina;

inserting a first end of the surgical implant behind a first side of the urethra;

locating a first fixing zone of the surgical implant into tissues of the retropubic space fascia without penetrating the rectus sheath;

inserting a second end of the surgical implant behind a second side of the urethra; and

locating a second fixing zone of the surgical implant into the tissues of the retropubic space without penetrating the rectus sheath, such that the supporting zone passes under the urethra.

34. A method as claimed in claim 32 further comprising moving the retaining means from an inserting position to a retaining position.

33. A method of transmitting intra-abdominal pressure to the urethra comprising:

introducing a first anchor strip into at least one incision made on an upper wall of the vagina;

inserting a first portion of the first anchor strip behind a first side of the urethra;

locating a first portion including a fixing zone of the first anchor strip into tissues of the retropubic space above the endopelvic fascia without penetrating the rectus sheath;

locating a second portion of the first anchor strip alongside the urethra in the suburethral pressure compartment below the endopelvic fascia;

inserting a second anchor strip behind a second side of the urethra;

locating a first portion including a fixing zone of the second anchor strip into the tissues of the retropubic space above the endopelvic fascia without penetrating the rectus sheath; and

locating a second portion of the second anchor strip alongside the urethra in the suburethral pressure compartment below the endopelvic fascia.

35. (canceled)