Urethral support for incontinence

• US 6,830,052 B2
• Filed: 10/03/2001
• Issued: 12/14/2004
• Est. Priority Date: 10/03/2001
• Status: Expired due to Term

• Current Assignee: Verathon Incorporated (Roper Technologies, Inc.)
• Original Assignee: Solarant Medical, Inc. (Endo International PLC)
• Inventors: Stiehr, David R., Carter, Garry L.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US09/971,051
• Publication Number:
  US 20030062052A1
• Time in Patent Office: 1,168 Days
• Field of Search: 128/846, 128/885, 128/886, 128/DIG.25, 600/29-31
• US Class Current: 128/885
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

The present invention provides methods, devices, and systems for supporting the urethra in a patient to treat urinary incontinence. Support of the urethra involves forming a loop under the urethra with a structure referred to as a urethral support and applying an upward force with the support to hold the urethra in a more desired position. The present invention utilizes the space of Retzius within which portions of the urethral support are positioned. Ingrowth by surrounding tissues to the urethral support material provide further stability and such ingrowth, combined with the position of the support, allow sufficient tension to be applied to support to hold the urethra in place. Placement of such a urethral support is achieved by minimally invasive techniques, such as with the use of laparoscopic instruments. Such techniques allows placement of the urethral support by accessing the space of Retzius through the vaginal wall without penetrating the abdominal wall. Such techniques also avoid perforations of nearby organs, such as the bladder, by utilizing specialized penetration devices.

Claims

1. A method for supporting a urethra in a body to treat urinary incontinence comprising the steps of:

providing a urethral support having a first end and a second end;

positioning the urethral support so that it forms a loop under the urethra wherein the first end and the second end are disposed within a space of Retzius, wherein the positioning step further comprises placing at least a portion of the urethral support between an endopelvic fascia layer and a mucosal layer under the urethra; and

leaving the urethral support implanted in the body so that the first end and second end remain within the body.

2. A method as in claim 1, further comprising creating a passageway through which at least a portion of the urethral support is positioned in the positioning step.

3. A method as in claim 2, wherein the step of creating a passageway includes penetrating through a vaginal wall and body tissue to a location within the space of Retzius.

4. A method as in claim 3, wherein the penetrating step comprises inserting a penetration device through the vaginal wall and body tissue.

5. A method as in claim 4, wherein the penetration device comprises a Veress-style needle.

6. A method as in claim 4, wherein inserting the penetration device further comprises contacting a depth stop against the vaginal wall.

7. A method as in claim 4, wherein a sheath is mounted on the penetration device and further comprising removing the penetration device leaving the sheath behind in the passageway.

8. A method as in claim 7, further comprising inserting a blunt dilator into the sheath.

9. A method as in claim 8, further comprising inserting a delivery catheter into the sheath.

10. A method as in claim 9, further comprising deploying the first or second end of the urethral support from the delivery catheter within the space of Retzius.

11. A method as in claim 3, wherein inserting the penetration device further comprises contacting a depth stop against the vaginal wall.

12. A method of minimally invasively positioning a sling for support of a urethra in a body to treat urinary incontinence comprising the steps of:

creating a first passageway through a vaginal wall and body tissue to a first location within a space of Retzius;

passing a first end of a sling through the first passageway;

positioning the first end within the space of Retzius

positioning the sling so that it forms a loop, under the urethra between an endopelvic fascia layer and a mucosal layer, and supports the urethra; and

leaving the first end implanted within the body.

13. A method as in claim 12, further comprising:

creating a second passageway through the vaginal wall and body tissue to a second location within the space of Retzius;

passing a second end of the sling through the second passageway; and

positioning the second end within the space of Retzius.

14. A method as in claim 12, further comprising adjusting the position of the sling to apply tension on the first or second ends.

15. A method as in claim 12, further comprising applying tension to the first or second ends to support the urethra.

16. A method for supporting a urethra in a body to treat urinary incontinence comprising the steps of:

providing a urethral support having a first end and a second end;

positioning the urethral support so that it forms a loop under the urethra wherein the first end and the second end are disposed within a space of Retzius;

creating a passageway through which at least a portion of the urethral support is positioned in the positioning step by penetrating through a vaginal wall and body tissue to a location within the space of Retzius, wherein penetrating comprises inserting a penetration device through the vaginal wall and body tissue, and wherein a sheath is mounted on the penetration device;

removing the penetration device leaving the sheath behind in the passageway; and

leaving the urethral support implanted in the body.

17. A method as in claim 16, further comprising inserting a blunt dilator into the sheath.

18. A method as in claim 17, further comprising inserting a delivery catheter into the sheath.

19. A method as in claim 18, further comprising deploying the first or second end of the urethral support from the delivery catheter within the space of Retzius.

20. A method as in claim 16, wherein the penetration device comprises a Veress-style needle.

21. A method as in claim 16, wherein inserting the penetration device further comprises contacting a depth stop against the vaginal wall.

22. A method for supporting a urethra in a body to treat urinary incontinence comprising the steps of:

providing a urethral support having a first end and a second end;

positioning the urethral support so that it forms a loop under the urethra wherein the first end and the second end are disposed within a space of Retzius;

creating a passageway through which at least a portion of the urethral support is positioned in the positioning step by penetrating through a vaginal wall and body tissue to a location within the space of Retzius, wherein penetrating comprises inserting a penetration device through the vaginal wall and body tissue, and wherein a sheath is mounted on the penetration device;

removing the penetration device leaving the sheath behind in the passageway; and

leaving the urethral support implanted in the body so that the first end and second end remain within the body.

23. A method as in claim 22, further comprising inserting a blunt dilator into the sheath.

24. A method as in claim 23, further comprising inserting a delivery catheter into the sheath.

25. A method as in claim 24, further comprising deploying the first or second end of the urethral support from the delivery catheter within the space of Retzius.

26. A method as in claim 22, wherein the penetration device comprises a Veress-style needle.