Apparatus and method for treating urinary stress incontinence

• US 20030028180A1
• Filed: 08/01/2001
• Published: 02/06/2003
• Est. Priority Date: 08/01/2001
• Status: Active Grant

• Current Assignee: Nicholas Franco
• Original Assignee: Nicholas Franco
• Inventors: Franco, Nicholas
• Granted Patent: US 6,607,525 B2
• Time in Patent Office: Days
• US Class Current: 606/14
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy

Abstract

An apparatus and method for treating female stress-induced incontinence and other similar diseases associated with weakening of the pelvic floor muscles. A guiding catheter with temperature sensor(s) is positioned in patient'"'"'s urethra. An inflatable balloon carried by a forward end of the catheter is inflated to sit in a neck of a bladder. Measuring indicia on the exterior of the catheter is indicative of a distance between the bladder neck and external meatus. A vagina probe member provided with a laser output in a forward portion thereof is then positioned in place such that the laser output is at about a level of the bladder neck, as facilitated by the guiding catheter. The laser output is operationally connected to a medical laser generating and monitoring device that delivers a laser beam to selected areas in the pelvic floor to cause denaturing and recoiling of the tissue collagen in the area surrounding the urethra. A cooling medium is circulated through the probe member to cool the immediately adjacent tissue. If temperature inside the urethra reaches a dangerous level, supply of the laser energy through the probe is terminated.

Claims

1. An apparatus for treating a pelvic floor, comprising:

a hollow probe member having a forward portion and a handle portion, said forward portion being operationally connected with a means for delivering a laser energy to selected areas of pelvic floor muscles and to a means for cooling tissue surrounding said selected areas.

2. The apparatus of claim 1, further comprising a guiding catheter sized and shaped for positioning in urethra of a patient, said guiding catheter being provided with a temperature sensing means for monitoring temperature inside the urethra when the means for delivering the laser energy are activated.

3. The apparatus of claim 1, wherein said probe member is sized and shaped for positioning in a vagina of a patient such that the forward portion extends to an area corresponding to a neck of a bladder.

4. The apparatus of claim 3, wherein said forward portion is provided with a measuring indicia on an exterior surface thereof to facilitate positioning of the probe member in a desired location.

5. The apparatus of claim 1, wherein said means for operationally connecting the probe member with a means for delivering the laser energy comprises a laser generating and monitoring device having an output port formed in the forward portion of the probe member.

6. The apparatus of claim 1, wherein said means for operationally connecting the probe member to a cooling means comprises a pump for delivering a cooling medium to said forward portion and a heat-conductive cover mounted over a window formed in said forward portion for transmitting cooling temperature to the tissue surrounding the selected area.

7. The apparatus of claim 2, wherein said temperature sensing means is operationally connected to the means for delivering the laser energy, so as to de-activate the means for delivering the laser energy when the temperature inside the urethra exceeds a pre-determined limit.

8. The apparatus of claim 2, wherein said guiding catheter comprises an elongated body carrying an inflatable balloon adjacent to a forward tip thereof, said balloon is adapted to sit in a neck of a bladder when inflated.

9. The apparatus of claim 8, wherein said body is provided with measuring indicia on an exterior surface thereof to measure the distance to the neck of the bladder and facilitate correct positioning of the probe member.

10. The apparatus of claim 1, further comprising a video monitoring means for providing a continuous data on the temperature inside the urethra and the laser energy being delivered to the probe member.

11. An apparatus for treating female stress induced incontinence, comprising:

a hollow probe member having a forward portion and a handle portion, said forward portion adapted for positioning in vagina of a patient, said probe member being operationally connected with a means for delivering a laser energy to selected areas of pelvic floor muscles and to a means for cooling tissue surrounding said selected areas; and

a guiding catheter sized and shaped for positioning in urethra of a patient, said guiding catheter being provided with a temperature sensing means for monitoring temperature inside the urethra when the means for delivering the laser energy are activated, said guiding means being provided with a measuring indicia on an exterior surface thereof to measure the distance to the neck of the bladder from an entry point of said guiding catheter into external meatus to facilitate correct positioning of the probe member.

12. The apparatus of claim 11, wherein said forward portion is provided with a measuring indicia on an exterior surface thereof to facilitate positioning of the forward portion of the probe member at a level corresponding to a neck of a bladder.

13. The apparatus of claim 11, wherein said means for operationally connecting the probe member with a means for delivering the laser energy comprises a laser generating and monitoring device having an output port formed in the forward portion of the probe member.

14. The apparatus of claim 11, wherein said means for operationally connecting the probe member to a cooling means comprises a pump for delivering a cooling medium to said forward portion and a heat-conductive cover mounted over a window formed in said forward portion for cooling the tissue surrounding the selected area.

15. The apparatus of claim 11, wherein said temperature sensing means is operationally connected to the means for delivering the laser energy, so as to de-activate the means for delivering the laser energy when the temperature inside the urethra exceeds a pre-determined limit.

16. The apparatus of claim 11, wherein said guiding catheter comprises an elongated body carrying an inflatable balloon adjacent to a forward tip thereof, said balloon is adapted to sit in a neck of a bladder when inflated and facilitate determination of a distance from the external meatus to the neck of the bladder.

17. A method of treating female stress-induced incontinence, comprising the steps of:

providing a vaginal probe member having a laser output in a forward portion thereof;

providing a guiding catheter sized and shaped for positioning in urethra of a patient;

positioning said guiding catheter in urethra of the patient such that a forward end of the guiding catheter extends to a neck of a bladder of the patient;

noting a distance between the forward end of the guiding catheter and external meatus;

positioning the probe member such that a forward portion of the probe member extends to a level corresponding to the neck of the bladder;

delivering laser energy to selected areas surrounding urethra at the level of the bladder neck to cause denaturing of tissue collagen and recoiling of the tissue.

18. The method of claim 17, further comprising the step of providing said guiding catheter with a temperature-sensing means operationally connected to a temperature monitoring device and to a laser energy generating means.

19. The method of claim 18, wherein said temperature monitoring device de-activates the laser energy generating means when an excessive temperature is detected in the urethra.

20. The method of claim 17, wherein said probe member is provided with a means for cooling tissue surrounding said selected areas when the laser energy is being delivered to the selected areas.

21. The method of claim 17, wherein said guiding catheter comprises an elongated body carrying an inflatable balloon adjacent to the forward end thereof, said balloon is adapted to sit in a neck of a bladder when inflated and facilitate determination of a distance from the external meatus to the neck of the bladder.

22. The method of claim 17, wherein said the laser output port of the probe member is operationally connected to a laser generating and monitoring device.

23. The method of claim 17, wherein said forward portion is provided with a measuring indicia on an exterior surface thereof to facilitate positioning of the probe member in a desired location.

24. The method of claim 23, wherein said guiding catheter is provided with measuring indicia adjacent to the forward end thereof, said indicia facilitating determination of the distance between the forward end of the guiding catheter and the external meatus.