Implantable sling for the treatment of incontinence and method of using the same

• US 7,559,885 B2
• Filed: 02/14/2007
• Issued: 07/14/2009
• Est. Priority Date: 02/14/2006
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Rackley, Raymond, Vasavada, Sandip, Ellenson, Kapri, Rhee, Eugene, Merade, Bryon L., Nitti, Victor, Comiter, Craig
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US11/674,962
• Publication Number:
  US 20080009665A1
• Time in Patent Office: 881 Days
• Field of Search: 600/30, 600 29- 32, 128897-898, 128/DIG.25, 606/151
• US Class Current: 600/30
• 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 2017/06076 helically or spirally coiled
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0039 H-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped

Abstract

An implantable sling for the treatment of male or female incontinence and method of implementing the same. The sling comprises a urethral support portion and at least one anchoring portion extending therefrom. The anchoring portion is operatively positioned through the obturator foramen and about at least one ramus portion of the pelvis such that the support portion of the implant is operatively positioned at or distal to the bulbar urethra (male) or mid-urethral region (female) to treat urinary incontinence. In a preferred embodiment, the implant will have first and second anchoring portions extending from the support portion with each respective one of said anchoring portions being operative to be secured about dedicated ones of the patient'"'"'s pubic ramus. The implants may further be fabricated from tissues, synthetic materials or combinations thereof.

Claims

1. A method for treating urinary incontinence, comprising the steps of:

making a urethral incision exposing urethral tissue in a patient;

inserting an elongated implant into said urethral incision;

extending one end of said implant through an obturator foramen of said patient, around an ischial pubic ramus of said patient and back to said urethral incision;

extending an opposite end of said implant through the other obturator foramen of said patient, around the ischial pubic ramus of said other obturator foramen of said patient and back to said urethral incision;

positioning a center portion of said implant against said urethral tissue; and

securing said ends of said implant near said center portion of said implant so as to secure said ends around said ischial pubic ramus.

3. A method as set forth in claim 1, wherein said securing of said ends of said implant includes allowing said ends to be retained by tissue near an anterior surface of said ischial pubic ramus.

4. A method as set forth in claim 1, wherein said urethral incision is a perineal incision.

5. A method as set forth in claim 1, wherein said urethral incision is a vaginal incision.

6. A method as set forth in claim 1, wherein the extending of one end of said implant through an obturator foramen of said patient comprises:

attaching said one end to a tip of an inside-out transobturator tool; and

urging said inside-out transobturator tool through said obturator foramen and back toward said urethral incision.

7. A method as set forth in claim 1, further comprising:

making an incision above said obturator foramen of said patient prior to inserting said implant in said urethral incision;

inserting a first tool into said incision and urging said first tool through said obturator foramen into said urethral incision;

and wherein the extending of one end of said implant through an obturator foramen of said patient comprises;

attaching said one end to a tip of said first tool;

withdrawing said tool through said obturator foramen back toward said incision;

inserting a second tool into said urethral incision to transfer said one end from said first tool to said second tool; and

pulling said second tool back to said urethral incision and thereby pulling said one end of said implant back into said urethral incision.

8. A method as set forth in claim 7, wherein the inserting of said first tool includes inserting a transobturator helical tool.

9. A method as set forth in claim 7, wherein the inserting of said first tool includes inserting a transobturator hook tool.

10. A method as set forth in claim 7, wherein the inserting of said second tool includes inserting a curved tool.

11. A method as set forth in claim 10, wherein the inserting of said curved tool includes inserting a tool selected from the group consisting of a Stewart Crypt Hook, a suprapubic introducer, a transvaginal introducer, and a transperineal introducer.

12. A method as set forth in claim 1, wherein inserting an elongated implant includes inserting an implant having a central support portion and two opposing anchor portions, said anchor portions being narrower than said central support portion.

13. A method as set forth in claim 1, wherein inserting an elongated implant includes inserting an implant having a central support portion and at least two opposing anchor portions disposed on each side of said central support portion.

14. A method as set forth in claim 1, wherein inserting an elongated implant includes inserting an implant having a central support portion and at least two opposing anchor portions disposed on one side of said central support portion.

2. A method for treating urinary incontinence, comprising the steps of:

making a urethral incision exposing urethral tissue in a patient;

inserting an elongated implant into said urethral incision;

extending one end of said implant through an obturator foramen of said patient, around an ischial pubic ramus of said patient and back to said urethral incision;

extending an opposite end of said implant through the other obturator foramen of said patient, around the ischial pubic ramus of said other obturator foramen of said patient and back to said urethral incision;

positioning a center portion of said implant against said urethral tissue; and

securing said ends of said implant near said center portion of said implant so as to secure said ends around said ischial pubic ramus, wherein said securing said ends of said implant includes suturing said ends of said implant to said center portion of said implant.

15. A method for treating urinary incontinence comprising:

exposing urethral tissue in a patient;

extending opposite ends of an implant through an obturator foramen and wrapping said opposite ends around an ischial pubic ramus on either side of said patient;

positioning a center region of said implant against urethral tissue of said patient; and

securing said opposite ends of said implant near said center region of said implant.

17. A method as set forth in claim 15, wherein the securing of said opposite ends includes allowing native patient tissue to hold said opposite ends near said center region of said implant.

18. A method as set forth in claim 15, wherein the exposing of urethral tissue comprises making a perineal incision in said patient.

19. A method as set forth in claim 15, wherein the exposing of urethral tissue comprises making a vaginal incision in said patient.

20. A method as set forth in claim 15, wherein the extending and wrapping of said implant involves the use of an inside-out transobturator tool.

21. A method as set forth in claim 15, wherein the extending and the wrapping of said implant involves the use of a transobturator helical tool.

22. A method as set forth in claim 15, wherein the extending and the wrapping of said implant involves the use of a transobturator hook tool.

23. A method as set forth in claim 15, wherein the extending and the wrapping of said implant involves the use of a suprapubic tool.

24. A method as set forth in claim 15, wherein the extending and the wrapping of said implant involves the use of a transvaginal tool.

25. A method as set forth in claim 15, wherein the extending and the wrapping of said implant involves the use of a transperineal tool.

26. A method as set forth in claim 15, wherein the extending and the wrapping of said implant includes extending and wrapping an implant having a central support portion and two opposing anchor portions, said anchor portions being narrower than said central support portion.

27. A method as set forth in claim 15, wherein the extending and the wrapping of said implant includes extending and wrapping an implant having a central support portion and at least two opposing anchor portions disposed on each side of said central support portion.

28. A method as set forth in claim 15, wherein the extending and the wrapping of said implant includes extending and wrapping an implant having a central support portion and at least two opposing anchor portions disposed on one side of said central support portion.

16. A method for treating urinary incontinence comprising:

exposing urethral tissue in a patient;

extending opposite ends of an implant through an obturator foramen and wrapping said opposite ends around an ischial pubic ramus on either said of said patient;

positioning a center region of said implant against urethral tissue of said patient; and

securing said opposite ends of said implant near said center region of said implant,

wherein the securing of said opposite ends includes suturing said opposite ends to said center region of said implant.