Urethral support system

• US 8,167,785 B2
• Filed: 02/28/2008
• Issued: 05/01/2012
• Est. Priority Date: 10/12/2000
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US12/072,901
• Publication Number:
  US 20080200751A1
• Time in Patent Office: 1,524 Days
• Field of Search: 600 29- 32, 600/37, 128/DIG.25
• US Class Current: 600/30
• 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 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 2250/0004 adjustable

Abstract

A supplementary urethral support stabilization system and method for supporting the urethra is described.

Claims

1. A method for stabilizing a urethral support member under the urethra of a patient requiring urethral support, the method comprising the steps:

introducing a urethral support stabilization system through an incision in the vaginal wall, the system comprising a first stabilizer and a second stabilizer, each of the first stabilizer and second stabilizer joined to a urethral support member, and a first elongate member and a second elongate member, each of the first elongate member and the second elongate member having a first end connectable to one of the first or the second stabilizers, and a second free end;

inserting the second free end of the first elongate member in a para-urethral space on one side of the urethra, through the subcutaneous tissue and through the skin, the second free end exiting at a first location on the skin surface;

positioning said first stabilizer in the soft tissue of the patient;

inserting the second free end of the second elongate member in a para-urethral space on the other side of the urethra, through the subcutaneous tissue and through the skin, the second free end of the second elongate member exiting at a second location on the skin surface;

positioning said second stabilizer in the soft tissue of the patient;

applying tension to at least one of said first and second elongate members to advance or withdraw the first or second stabilizer in the soft tissues of the patient thereby stabilizing the urethral support member under the urethra; and

providing a tensioner to the surface of said skin, said tensioner adapted to pinch, cleat, or clamp to said first elongate member.

2. The method of claim 1 further comprising the steps of, reversibly joining the second end of said first elongate member at said first location to said tensioner.

3. The method of claim 2 further comprising adjusting the tension on the urethral support member by adjustment of the tensioner.

4. The method according to claim 1 wherein said stabilizers are positioned in the soft tissue of the retropubic space.

5. The method according to claim 1 further comprising inserting the second end of said first elongate member through the rectus sheath.

6. The method according to claim 1 wherein said stabilizers are positioned in the soft tissue of the perineum.

7. The method according to claim 1 wherein said stabilizers are positioned in the pre-pubic soft tissue.

8. The method according to claim 1 further comprising applying tension to the second end of said first elongate member at said first location, said tension sufficient to permit a remnant of said second end to retract under the skin after cutting said second end, then,

cutting said second end of said first elongate member wherein the remnant of said first end retracts under the skin.

9. The method according to claim 1 wherein said stabilizers are positioned in soft tissues without penetrating the rectus sheath.

10. The method according to claim 1 wherein positioning the first stabilizer in the soft tissue of the patient includes positioning a flat tab having a plurality of radii arranged along the sides of the first stabilizer in the soft tissue of the patient.

11. The method according to claim 1 further comprising connecting at least one of the first elongate member and second elongate member to one of the first stabilizer and second stabilizer.

12. The method according to claim 1 further comprising post-operatively adjusting the urethral support member immediately after or at any time up to one week following introducing the urethral support stabilization system in the patient.

37. The method of claim 10, wherein positioning the first stabilizer in the soft tissue of the patient includes inserting a rounded terminal end of the first stabilizer in the soft tissue of the patient.

13. A supplementary stabilization system for supporting the urethra, comprising:

a first elongate thread member and a second elongate thread member, each thread member comprising an absorbable, flexible material comprising a length extending from a first end to a second end;

a first stabilizer and a second stabilizer;

said first stabilizer joined to said first end of said first thread member;

said second stabilizer joined to said first end of said second thread member;

a support member comprising a length shorter than each of said first thread member and second thread member, a first end and a second end, the first end of said support member joined to said first stabilizer, the second end of said support member joined to said second stabilizer; and

a tensioner that is adapted to pinch, cleat, or clamp to said first elongate thread member and said second elongate thread member.

14. The system of claim 13 wherein the second end of said first thread member and said second thread member is free.

15. The system of claim 13 wherein said first and second thread members are non-porous.

16. The system of claim 15 wherein said first and second thread members lack spaces for cellular integration.

17. The system of claim 13 wherein each of said first thread member and said second thread member comprise a width that is in the range of about 0.8% to 20% of the width of said urethral support member.

18. The system of claim 13 wherein each of said first and second thread members comprise a width no greater than 2.0 mm.

19. The system of claim 13 wherein each of said first thread member and said second thread member comprise a length that is longer than said urethral support member.

20. The system of claim 13 wherein the second end of said first thread member and said second end of said second thread member is reversibly joined to said tensioner.

21. The system of claim 20 wherein said tensioner comprises a plurality of holes.

22. The system of claim 20 wherein joining said first and second thread member comprises an adhesive.

23. The system of claim 20 wherein said tensioner comprises a rotary device.

24. A method for stabilizing a suburethral sling for the treatment of urinary incontinence in a patient, the method steps, comprising:

introducing a first stabilization system and a second stabilization system into the patient'"'"'s soft tissue, the first stabilization system comprising a stabilizer and an elongate member comprising a first end, and a second end, the first end of the elongate member joined to the stabilizer;

introducing said suburethral sling into said patient tissues, said suburethral sling joined to said stabilizer;

adjusting the position of the suburethral sling by applying tension to the second end of the elongate member of the first stabilization system, wherein the applied tension reversibly positions said stabilizer in said patient soft tissue; and

joining the second end of the first elongate member to a tensioner positioned on the patient'"'"'s skin.

25. The method of claim 24 wherein introducing a first stabilization system into the patient'"'"'s soft tissue includes introducing an elongate member that is absorbable into the patient'"'"'s soft tissue.

26. The method of claim 24 wherein introducing a first stabilization system into the patient'"'"'s soft tissue includes introducing a flat tab comprising a plurality of beads positioned along at least one side of the tab into the patient'"'"'s soft tissue.

27. The method of claim 24 wherein applying tension to the second end of the stabilization system comprises manual application.

28. The method of claim 24 further comprising introducing a second elongate member into the patient'"'"'s soft tissue, the patient'"'"'s soft tissues located between the stabilizer and the surface of the patient'"'"'s skin, the second elongate member comprising a first end, and a second end, the first end of the second elongate member joined to a second stabilizer;

and

adjusting the position of the suburethral sling by applying tension to the second end of the second elongate member to reversibly position the second stabilizer.

29. The method of claim 24 wherein said joining comprises tying said second end to said tensioner.

30. The method of claim 24 wherein said joining comprises pinching said second end to said tensioner.

31. The method of claim 24 wherein said joining comprises clamping said second end to said tensioner.

32. The method of claim 24 wherein said joining comprises adhering said second end to said tensioner.

33. The method of claim 24 wherein said patient skin surface comprises the abdominal skin.

34. The method of claim 24 wherein said patient skin surface comprises the perineal skin.

35. The method of claim 24 wherein said patient skin surface comprises the pre-pubic skin.

36. The method of claim 24 wherein said patient skin surface comprises the skin of the medial thigh.