Apparatus and method for treating female urinary incontinence

• US 8,007,430 B2
• Filed: 07/16/2010
• Issued: 08/30/2011
• 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:
  US12/837,601
• Publication Number:
  US 20100280308A1
• Time in Patent Office: 410 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
• 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

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

Claims

1. A method for providing support to a urethra in a patient comprising the steps of:

introducing through an incision in the vaginal wall, a surgical implant comprising at least two soft tissue anchors and a suburethral support having a first end attached to one of the at least two soft tissue anchors and a second end attached to the other of the at least two soft tissue anchors, wherein the suburethral support is suspended from the soft tissue anchors;

positioning the suburethral support under the urethra;

introducing one of the at least two soft tissue anchors on one side of the urethra;

introducing the other of the at least two soft tissue anchors on the other side of the urethra; and

positioning each of the soft tissue anchors in tissue comprising soft tissue without penetrating the rectus sheath.

2. The method according to claim 1 wherein each of the soft tissue anchors comprises a suspending element integral with the soft tissue anchor.

3. The method according to claim 1 wherein positioning the suburethral support includes positioning the suburethral support under the mid-urethra.

4. The method according to claim 1 and further including detaching the suburethral support from at least one of the at least two soft tissue anchors.

5. The method according to claim 1 and further including repositioning within the soft tissue to adjust the position of the suburethral support.

6. The method according to claim 1 further comprising introducing a tool into the soft tissue for accessing and placing one or more of the soft tissue anchors in soft tissue, wherein the tool comprises a housing for receiving the one or more soft tissue anchors.

7. The method according to claim 1 wherein the method provides support to the urethra for treating incontinence.

8. The method according to claim 1 wherein the method provides support to the urethra for treating a uterovaginal prolapse.

9. The method according to claim 1 wherein positioning the soft tissue anchors includes positioning the anchors in fibro-fatty tissue.

10. The method according to claim 9 wherein positioning the soft tissue anchors comprises positioning a plurality of projections extending from the soft tissue anchors into the soft tissue.

11. The method according to claim 1 wherein the suburethral support comprises a length in the range of about 15-35 mm and a width in the range of about 5-15 mm, and wherein the width and length are dimensioned to pass under the mid-urethra of the patient.

12. The method according to claim 1 wherein the suburethral support comprises a sling.

13. The method according to claim 1 further comprising:

introducing an introducing tool to assist insertion of the at least two soft tissue anchors in soft tissue; and

retracting the introducing tool without penetrating the rectus sheath after positioning said at least two soft tissue anchors in soft tissue.

14. The method according to claim 13 wherein said introducing tool is introduced and retracted through the incision in the vaginal wall.

15. The method of claim 1 and further including attaching the suburethral support to at least one of the two soft tissue anchors.

16. The method of claim 15 and further including detaching the suburethral support from at least one of the two soft tissue anchors.

17. A method of treating incontinence in a patient, the method comprising:

forming a vaginal incision;

inserting an anchor into the vaginal incision and directing the anchor to a location behind a pubic bone of the patient;

anchoring the anchor into tissue without penetrating an abdominal wall of the patient; and

supporting a urethra of the patient by suspending a suburethral support from the anchor.

18. The method of claim 17, wherein the suburethral support includes a first end connected to a first anchor and a second end opposed to the first end and connected to a second anchor, and inserting an anchor into the vaginal incision and directing the anchor to a location behind a pubic bone of the patient comprises:

positioning the suburethral support centrally under the urethra;

introducing the first anchor on one side of the urethra and

introducing the second anchor on an other side of the urethra.

19. The method of claim 18, wherein anchoring the anchor into tissue without penetrating an abdominal wall of the patient comprises positioning the anchors in soft tissue without penetrating the rectus sheath.

20. The method of claim 18, wherein each of the anchors comprises a suspending element integral with the soft tissue anchor and coupled with the suburethral support.