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

• US 6,068,591 A
• Filed: 02/17/1998
• Issued: 05/30/2000
• Est. Priority Date: 02/17/1998
• Status: Expired due to Fees

• Current Assignee: Davila, Guillermo H., Norman I. Bruckner
• Original Assignee: Davila, Guillermo H., Norman I. Bruckner
• Inventors: Davila, Guillermo H., Bruckner, Norman I.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/024,701
• Time in Patent Office: 833 Days
• Field of Search: 600/29-30, 128/DIG. 25, 128/884, 128/885, 128/830, 606/139, 606/141, 606/151, 606/216
• 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

Abstract

An apparatus for treatment of female stress urinary incontinence (SUI) 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 stay adapted to rest against the anterior vaginal wall at the level of the urethrovesical junction, and vaginal shaft connecting the stay to the support harness and adapted to elevate the stay causing elevation of the anterior vaginal wall.

Claims

1. An apparatus for treatment of female stress urinary incontinence (SUI) comprising:

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 stay adapted to rest against the anterior vaginal wall of a patient at the level of the urethrovesical junction;

a shaft connecting the stay to the support harness and adapted to elevate the stay causing elevation of the anterior vaginal wall; and

coupling interfaces between the support harness and shaft, and shaft and stay.

2. An apparatus for treatment of SUI as claimed in 1 wherein the shaft and the stay 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 stay 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 metal 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 stay adapted to engage and elevate the anterior vaginal wall at the level of the urethrovesical junction; and

shaft connecting the support harness and stay.

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) Assembling a stay and vaginal shaft into an assembled apparatus and loading the assembled apparatus into a cannula delivery unit having a sharp closed leading end;

(c) Penetrating the vaginal wall with the sharp closed leading end of the cannula delivery unit;

(d) Directing the cannula delivery unit in a cephalad direction with the leading end adjacent to the posterior aspect of the pubic bone;

(e) Making a small suprapubic incision lateral to the midline on the same side as the placement of the cannula delivery unit;

(f) Delivering the cannula delivery unit through the incision;

(g) Removing the cannula delivery unit suprapubically, confirming that the stay is correctly and firmly positioned against the anterior vaginal wall;

(h) Raising the stay-vaginal shaft through the suprapubic incision to an appropriate tension;

(i) Attaching the stay-vaginal shaft to a support harness forming a PUSH apparatus, at the suprapubic incision site;

(j) Directing the PUSH apparatus over the pubic bone;

(k) Adjusting the position of the vaginal shaft in the support harness to achieve the appropriate anterior vaginal wall elevation;

(l) Closing the suprapubic incision and, if required, trimming excess shaft length before closing; and

(m) Repeating steps (b)-(l) on the opposite side of the urethrovesical junction using a second PUSH apparatus.

17. 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) Forming a vaginal wall stay from the vaginal end of an assembly having a vaginal end and a leading end;

(c) Loading the assembly into a cannula delivery unit having a sharp closed leading end;

(d) Penetrating the vaginal wall with the sharp closed leading end of the cannula delivery unit;

(e) Directing the cannula delivery unit in a cephalad direction with the leading end adjacent to the posterior aspect of the pubic bone;

(f) Making a small suprapubic incision lateral to the midline on the same side as the placement of the cannula delivery unit;

(g) Delivering the cannula delivery unit through the incision;

(h) Removing the cannula delivery unit suprapubically;

(i) Positioning the stay firmly against the vaginal wall;

(j) Raising the assembly through the suprapubic incision to an appropriate vaginal wall elevation;

(k) Maintaining the appropriate vaginal wall elevation, directing the leading end of the assembly over the superior edge of the pubic bone;

(l) Closing the suprapubic incision;

(m) Repeating steps (b)-(l) on the opposite side of the urethrovesical junction using a second assembly.

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 anterior vaginal wall with a directional cannula delivery unit containing an assembly having a support harness end and vaginal shaft;

(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 support harness end of the assembly through the cannula delivery unit down the anterior aspect of the pubic bone until the cannula delivery unit rests at a position approximately halfway down the anterior aspect of the pubic bone;

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

(f) Coupling a stay on the vaginal shaft;

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

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

(i) Repeat steps (b)-(h) on the opposite side of the urethrovesical junction using a second assembly.