Pubo-urethral support harness apparatus for percutaneous treatment of female stress urinary incontinence with urethal hypemobility

• US 6,221,005 B1
• Filed: 09/07/1999
• Issued: 04/24/2001
• Est. Priority Date: 02/17/1998
• Status: Expired due to Fees

• Current Assignee: Guillermo H. Davila, Norman I. Bruckner
• Original Assignee: Guillermo H. Davila, Norman I. Bruckner
• Inventors: Davila, Guillermo H., Bruckner, Norman I.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/390,901
• Time in Patent Office: 595 Days
• Field of Search: 600/29-31, 600/37, 606/151, 128/897-98, 128/DIG. 25
• US Class Current: 600/30
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An apparatus for treatment of female stress urinary incontinence with urethral hypermobility with a support harness adapted to fit over the superior edge of the pubic bone of a patient, left or right of the pubis symphysis, a sling adapted to rest against the anterior vaginal wall or submucosally at the level just below the urethrovesical junction, and vaginal shaft connecting the sling to the support harness and adapted to position the sling causing stabilization and support of the urethrovesical junction.

Claims

1. An apparatus for treatment of female stress urinary incontinence with urethral hypermobility (referred to as SUI) comprising:

support harnesses adapted to fit over the superior edge of the pubic bone of a patient, left and right of the pubis symphysis;

a sling adapted to rest against the anterior vaginal wall of a patient or submucosally at the level just below the urethrovesical junction;

shafts each integral with a support harness connecting the sling to the support harnesses and adapted to hold the position of the sling causing stabilization and support to the urethrovesical junction; and

coupling interfaces between the shafts and sling.

2. An apparatus for treatment of SUI as claimed in 1 wherein the shaft and the sling are in fixably adjustable relation.

3. An apparatus for treatment of SUI as claimed in 1 wherein the support harness and the shaft are in fixably adjustable relation.

4. An apparatus for treatment of SUI as claimed in 1 wherein the support harness, shaft and sling are constructed of material that is biologically compatible.

5. An apparatus for treatment of SUI as claimed in 1 wherein the support harness is constructed of material that is shapeable.

6. An apparatus for treatment of SUI as claimed in 1 wherein the support harness has an anterior end and the anterior end has an interior surface, the interior surface of the anterior end of the support harness is adapted to produce traction against the pubic bone.

7. An apparatus for treatment of SUI as claimed in 1 wherein the shaft is constructed of wire or synthetic thread.

8. An apparatus for treatment of SUI as claimed in 1 wherein the support harness is constructed of superelastic or thermomemory material.

9. An apparatus for treatment of SUI as claimed in 1 wherein the support harness is adapted to hook onto the pubic bone.

10. An apparatus for treatment of SUI as claimed in 1 wherein the support harness is adapted to clamp onto the pubic bone.

11. An apparatus for treatment of female stress urinary incontinence comprising of a single component adapted to form a support harness that fits over the superior edge of the pubic bone of a patient;

a sling adapted to engage, stabilize, and support the urethrovesical junction; and

shaft connecting the support harness and sling.

12. An apparatus for treatment of SUI as claimed in 11 wherein the apparatus is constructed of material that is biologically compatible.

13. An apparatus for treatment of SUI as claimed in 11 wherein the apparatus is constructed of material that is shapeable.

14. An apparatus for treatment of SUI as claimed in 11 wherein the support harness has an anterior end and the anterior end has an interior surface, the interior surface of the anterior end of the support harness to be is adapted to produce traction against the pubic bone.

15. An apparatus for treatment of SUI as claimed in 11. wherein the apparatus is constructed of superelastic or thermomemory material.

16. A method for the treatment of SUI comprising the steps of, but not necessarily in the order of:

(a) Placing patient in the lithotomy position;

(b) Penetrating the anterior vaginal wall at a location approximately 2 cm lateral to the urethrovesical junction with the sharp leading end of a directional cannula delivery unit containing a support harness-vaginal shaft assembly;

(c) Directing the cannula delivery unit in a cephalad direction along the posterior aspect of the pubic bone over the superior edge of the pubic bone;

(d) Advancing the harness end of the assembly through the cannula delivery unit, down the anterior aspect of the pubic bone until the tip comes to rest at a position approximately halfway down the anterior aspect of the pubic bone;

(e) Withdrawing the cannula delivery unit from the vagina exposing the tail of the vaginal shaft;

(f) Coupling one end of the sling onto the vaginal shaft end of the assembly;

(g) Adjusting the position of the sling against the anterior vaginal wall until the appropriate position is achieved;

(h) Securing the position of the sling and trimming excess vaginal shaft from the assembly;

(i) Repeat steps b-h on the opposite side of the urethrovesical junction using a second support harness-vaginal shaft assembly and the same sling.

17. A method for the treatment of SUI, wherein the sling is placed submucosally, comprising the steps of, but not necessarily in the order of:

(a) Placing patient in the lithotomy position;

(b) Making a vertical suburethral incision along the vaginal mucosa of the anterior vaginal wall;

(c) Dissecting submucosal connective tissue laterally, off of the vaginal wall;

(d) Penetrating the anterior vaginal wall at a location approximately 2 cm lateral to the urethrovesical junction with the sharp leading end of a directional cannula delivery unit containing a support harness-vaginal shaft assembly;

(e) Directing the cannula delivery unit in a cephalad direction along the posterior aspect of the pubic bone over the superior edge of the pubic bone;

(f) Advancing the harness end of the assembly through the cannula delivery unit, down the anterior aspect of the pubic bone until the tip comes to rest at a position approximately halfway down the anterior aspect of the pubic bone;

(g) Withdrawing the cannula delivery unit from the vagina exposing the tail of the vaginal shaft;

(h) Coupling within the vaginal wall incision one end of the sling onto the vaginal shaft end of the assembly;

(i) Adjusting the position of the sling submucosally within the vaginal wall incision until the appropriate position is achieved;

(j) Securing the position of the sling and trimming excess vaginal shaft from the assembly;

(k) Repeat steps d-j on the opposite side of the urethrovesical junction using a second support harness-vaginal shaft assembly and the same sling;

(l) Closing vaginal mucosa incision.

18. A method for the treatment of SUI comprising the steps of, but not necessarily in the order of:

(a) Placing patient in the lithotomy position;

(b) Penetrating the abdominal wall at a location above the pubic symphysis and left of midline with the sharp leading end of a directional cannula delivery unit containing a support harness-vaginal shaft;

(c) Directing the cannula delivery unit in a downward direction along the posterior aspect of the pubic bone penetrating the anterior vaginal wall and coming to rest just below the superior edge of the pubic bone;

(d) Advancing the shaft end of the support harness-vaginal shaft assembly through the cannula delivery unit until the tip comes to rest in the vaginal cavity at a position approximately 2 cm lateral to the urethrovesical junction;

(e) Directing the cannula delivery unit over the superior edge of the pubic bone;

(f) Advancing the harness end of the support harness-vaginal shaft assembly up through the cannula delivery unit, down the anterior aspect of the pubic bone until the tip comes to rest halfway down the anterior aspect of the pubic bone;

(g) Withdrawing the cannula delivery unit from the vagina exposing the tail of the vaginal shaft;

(h) Coupling one end of the sling onto the vaginal shaft;

(i) Adjusting the position of the sling against the anterior vaginal wall until the appropriate position is achieved;

(j) Securing the position of the sling and trimming excess vaginal shaft from the assembly;

(k) Repeat steps b-i on the opposite side of the urethrovesical junction using a second support harness-vaginal shaft assembly and the same sling;

(l) Closing the abdominal wall cannula made incisions.

19. A method for the treatment of SUI, wherein the entry of the cannula delivery unit is through the abdominal wall and the sling is placed submucosally, comprising the steps of, but not necessarily in the order of:

(a) Placing patient in the lithotomy position;

(b) Making a vertical suburethral incision along the vaginal mucosa of the anterior vaginal wall;

(c) Dissecting submucosal connective tissue laterally off of the vaginal wall;

(d) Penetrating the abdominal wall at a location above the pubic symphysis and left of midline with the sharp leading end of a directional cannula delivery unit containing a support harness-vaginal shaft;

(e) Directing the cannula delivery unit in a downward direction along the posterior aspect of the pubic bone penetrating the anterior vaginal wall and coming to rest just below the superior edge of the pubic bone;

(f) Advancing the shaft end of the support harness-vaginal shaft assembly through the cannula delivery unit until the tip comes to rest in the vaginal cavity at a position approximately 2 cm lateral to the urethrovesical junction;

(g) Directing the cannula delivery unit over the superior edge of the pubic bone;

(h) Advancing the harness end of the support harness-vaginal shaft assembly up through the cannula delivery unit, down the anterior aspect of the pubic bone until the tip comes to rest halfway down the anterior aspect of the pubic bone;

(i) Withdrawing the cannula delivery unit from the vagina exposing the tail of the vaginal shaft;

(j) Coupling within the vaginal wall incision one end of the sling onto the vaginal shaft;

(k) Adjusting the position of the sling submucosally within the vaginal wall incision until the appropriate position is achieved;

(l) Securing the position of the sling and trimming excess vaginal shaft from the assembly;

(m) Repeat steps d-l on the opposite side of the urethrovesical junction using a second support harness-vaginal shaft assembly and the same sling;

(n) Closing vaginal mucosa incision;

(o) Closing the abdominal wall cannula made incisions.