Apparatus and method for treating female urinary incontinence

• US 6,960,160 B2
• Filed: 10/12/2001
• Issued: 11/01/2005
• Est. Priority Date: 10/12/2000
• Status: Expired due to Term

• Current Assignee: Coloplast A/S
• Original Assignee: Gyneideas Limited
• Inventors: Browning, James
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/398,992
• Publication Number:
  US 20030191360A1
• Time in Patent Office: 1,481 Days
• Field of Search: 600 29- 31, 600/37, 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 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 The implant has uses including treating urinary incontinence and uterovaginal prolapse.

Claims

1. A method of supporting a urethra comprising the steps of,

introducing a surgical implant comprising first and second soft tissue anchors and a suburethral support portion therebetween into at least one incision made on an upper wall of a vagina,

inserting the first soft tissue anchor on a first side of the urethra behind a pubic bone, and

inserting the second soft tissue anchor on a second side of the urethra behind the pubic bone, such that the suburethral support portion is suspended from the first and second soft tissue anchors and supports the urethra,

wherein each of the first and second soft tissue anchors is positioned in fibro-fatty soft tissue which comprise a retropubic space without penetrating the rectus sheath.

2. The method as recited in claim 1, wherein the surgical implant comprises a water soluble dye.

3. The method as recited in claim 1, wherein:

A at least one of the first and second soft tissue anchors comprises a central portion and retaining means wherein the retaining means comprise 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 within the retropubic space.

4. The method as recited in claim 1, further comprising:

positioning at least one of the first and second soft tissue anchors as high as possible in the fibro-fatty soft tissue of the retropubic space.

5. The method as recited in claim 1, further comprising:

providing at least one of the first and second soft tissue anchors with portions to grip the fibro-fatty tissue of the retropubic space at multiple layers.

6. The method as recited in claim 1, wherein the suburethral support section comprises polymer tape.

7. A method of supporting a urethra, comprising:

introducing a surgical implant into at least one incision made in an upper wall of a vagina, the surgical implant comprising first and second ends and a suburethral support section therebetween;

inserting the first end of the surgical implant on a first side of the urethra and positioning the first end into fibro-fatty tissue of a retropubic space without penetrating a rectus sheath; and

inserting the second end of the surgical implant on a second side of the urethra and positioning the second end into the fibro-fatty tissue of the retropubic space without penetrating the rectus sheath such that the suburethral support section is positioned under the urethra and provides support thereto.

8. The method as recited in claim 7, wherein the suburethral support section comprises polymer tape.

9. The method as recited in claim 7, wherein the suburethral support section comprises water soluble dye.

10. The method as recited in claim 7, wherein:

at least one of the first and second ends comprises bioabsorbable material.

11. A method of supporting a urethra, comprising:

making at least one incision in an upper wall of a vagina;

inserting a first end of a surgical implant into the at least one incision;

placing the first end of the surgical implant on a first side of the urethra and positioning the first end into fibro-fatty tissue of a retropubic space without penetrating through a rectus sheath;

inserting a second end of the surgical implant into the at least one incision;

placing the second end of the surgical implant on a second side of the urethra and positioning the second end into the fibro-fatty tissue of the retropubic space without penetrating through the rectus sheath; and

positioning a suburethral support section of the surgical implant under the urethra to provide support thereto.

12. A method of supporting a urethra, comprising:

mechanically coupling, with a surgical implant, a first tissue portion of a retropubic space on a first side of the urethra to a second tissue portion of the retropubic space on a second side of the urethra, wherein the urethra is positioned between the first and second tissue portions; and

orienting a portion of the surgical implant underneath the urethra to provide support thereto,

wherein a rectus sheath is not penetrated.

13. The method as recited in claim 12, wherein each of the first and second tissue portions comprises fibro-fatty soft tissue.

14. The method as recited in claim 12, wherein no portion of the surgical implant penetrates the rectus sheath.

15. The method as recited in claim 12, further comprising:

locating the first and second tissue portions as high as possible in the retropubic space.

16. The method as recited in claim 12, further comprising:

causing a portion of the surgical implant to grip at least one of the first and second tissue portions.

17. The method as recited in claim 16, wherein no portion of the surgical implant penetrates the rectus sheath.

18. The method as recited in claim 15, further comprising:

causing a portion of the surgical implant to grip at least one of the first and second tissue portions.

19. The method as recited in claim 18, wherein no portion of the surgical implant penetrates the rectus sheath.

20. A method of supporting a urethra, comprising:

mechanically coupling, with a surgical implant, a first tissue portion of a retropubic space on a first side of the urethra to a second tissue portion of the retropubic space on a second side of the urethra, wherein the urethra is positioned between the first and second tissue portions; and

orienting a portion of the surgical implant underneath the urethra to provide support thereto,

wherein the surgical implant is coupled to the rectus sheath in an orientation such that the rectus sheath does not significantly contribute to the mechanical coupling of the first tissue portion to the second tissue portion.

21. The method as recited in claim 20, wherein the rectus sheath is not penetrated.

22. The method as recited in claim 20, wherein no portion of the surgical implant extends through the rectus sheath.

23. A method of supporting a urethra, comprising:

positioning a surgical implant in a retropubic space to mechanically couple a first tissue portion of the retropubic space on a first side of the urethra to a second tissue portion of the retropubic space on a second side of the urethra, wherein the urethra is positioned between the first and second tissue portions; and

positioning a portion of the surgical implant underneath the urethra to provide support thereto,

wherein substantially all of the mechanical coupling is provided by interaction of the first and second tissue portions with respective portions of the surgical implant.

24. The method as recited in claim 23, wherein each of the first and second tissue portions comprises fibro-fatty soft tissue of the retropubic space.

25. The method as recited in claim 23, wherein the rectus sheath is not penetrated.

26. The method as recited in claim 23, further comprising:

orienting the surgical implant in the retropubic space without extending a portion of the surgical implant extending through the rectus sheath.

27. A method of supporting a urethra, comprising:

positioning a surgical implant in a retropubic space to mechanically couple a first tissue portion of the retropubic space on a first side of the urethra to a second tissue portion of the retropubic space on a second side of the urethra, wherein the urethra is positioned between the first and second tissue portions; and

positioning a portion of the surgical implant underneath the urethra to provide support thereto,

wherein the surgical implant is substantially held in place by interaction of the first and second tissue portions with respective portions of the surgical implant.

28. The method as recited in claim 27, wherein at least one of the first and second tissue portions comprises fibro-fatty soft tissue of the retropubic space.

29. The method as recited in claim 28, wherein the rectus sheath is not penetrated.

30. The method as recited in claim 28, further comprising:

orienting the surgical implant in the retropubic space without extending a portion of the surgical implant through the rectus sheath.