Apparatus for the measurement of urethral angle change and vesical pressure

• US 6,056,699 A
• Filed: 05/02/1997
• Issued: 05/02/2000
• Est. Priority Date: 05/05/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Influence Medical Technologies Ltd.
• Inventors: Sohn, Ze'ev, Zimet, Nahman
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): CARTER, RYAN CHRISTOPHER
• Application Number:
  US08/850,164
• Time in Patent Office: 1,096 Days
• Field of Search: 600/547, 600/561, 600/29-31, 600/38-40, 607/105
• US Class Current: 600/561
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure

Abstract

Apparatus for diagnosing urinary stress incontinence of a subject, including a substantially rigid, disposable probe insertable into the urethra of the subject, generally along a longitudinal axis of the urethra. A reusable sensor unit, is removably coupled to the probe, for sensing physiological parameters of the subject. The apparatus preferably includes a fluid pressure sensor, contained in the sensor unit, in pressure communication with a distal end of the probe. The probe includes a flexible diaphragm in fluid communication with the distal end. The diaphragm provides the pressure communication between the pressure sensor and the distal end while substantially preventing fluid communication between the distal end and the pressure sensor.

Claims

1. Apparatus for diagnosing urinary stress incontinence of a subject, comprising:

a substantially rigid, disposable probe insertable into the urethra of the subject, generally along a longitudinal axis of the urethra; and

a reusable sensor unit, removably coupled to the probe, for sensing physiological parameters of the subject.

2. Apparatus according to claim 1, and comprising a fluid pressure sensor in pressure communication with a distal end of the probe.

3. Apparatus according to claim 2, wherein the pressure sensor is contained in the sensor unit, and wherein the probe comprises a flexible diaphragm in fluid communication with the distal end, which diaphragm provides the pressure communication between the pressure sensor and the distal end while substantially preventing fluid communication between the distal end and the pressure sensor.

4. Apparatus according to claim 3, wherein the probe contains first and second lumens communicating with the distal end thereof, the first lumen communicating at its proximal end with the diaphragm, and the second lumen communicating at its proximal end with a fluid port.

5. Apparatus according to claim 1, and comprising at least one spatial angle sensor coupled to said probe, so as to sense a change in an angular orientation thereof.

6. Apparatus according to claim 5, wherein the at least one angle sensor comprises a magnet which floats on a liquid, and at least one Hall effect device located in propinquity with the magnet, wherein the change in angular orientation causes a corresponding movement of the magnet, which movement is detected by the at least one Hall effect device, thereby to sense the change.

7. Apparatus according to claim 5, wherein the at least one angle sensor comprises a resistive element partially immersed in a conductive fluid, wherein an amount of the element that is immersed changes in relation to the change in angular orientation, causing a resistive change responsive to the change in angular orientation.

8. Apparatus according to claim 5, wherein the at least one angle sensor comprises a chip accelerometer.

9. Apparatus according to claim 1, and comprising a leakage detector attached to the probe, which detects the flow of a fluid along the probe.

10. Apparatus according to claim 9, wherein the leakage detector comprises an electrical conductivity sensor which detects presence of urine by sensing a change in conductivity due to urine contacting the sensor.

11. Apparatus according to claim 10, wherein the conductivity sensor comprises at least two conductive contacts on an outer surface of the probe.

12. Apparatus according to claim 1, and comprising a flexible sleeve, fixed to the probe, which sleeve is extended over the sensor unit to prevent transfer of contaminants between the probe and the sensor unit.

13. Apparatus according to claim 1, and comprising a central processing unit (CPU) in communication with the sensor unit, for processing data received therefrom.

14. Apparatus according to claim 13, wherein the CPU is in wired communication with the sensor unit.

15. Apparatus according to claim 13, and comprising a wireless transmitter, for transmitting data from the sensor unit to the CPU.

16. Apparatus according to claim 13, and comprising a monitor in electrical communication with the CPU which displays information provided by the CPU.

17. Apparatus according to claim 13, and comprising a rectal pressure sensor in communication with the CPU, which receives and processes data therefrom.

18. A method for diagnosing urinary stress incontinence of a subject, the method comprising:

coupling a sensor unit to a probe;

inserting the probe into the urethra of the subject, generally along a longitudinal axis thereof;

receiving signals from the sensor unit responsive to a change in pressure within the subject'"'"'s bladder.

19. A method according to claim 18, wherein coupling the sensor unit to the probe comprises bringing a flexible diaphragm, in fluid communication with a distal end of the probe, into pressure communication with the sensor unit.

20. A method according to claim 19, and comprising filling the bladder with fluid through a lumen in the probe, such that the fluid exerts a pressure on the diaphragm, wherein receiving signals from the sensor unit comprises measuring the pressure exerted on the diaphragm.

21. A method according to claim 18, wherein receiving signals from the sensor unit comprises receiving signals responsive to an angular orientation of the probe, and comprising measuring a change in the angular orientation responsive to the change in pressure.

22. A method according to claim 21, and comprising increasing an abdominal pressure of the subject, thereby causing the angular orientation to change.

23. A method according to claim 18, wherein receiving signals from the sensor unit comprises receiving signals responsive to leakage of urine from the bladder of the subject through the urethra.

24. A method according to claim 23, wherein receiving signals from the sensor unit comprises receiving signals responsive to an angular orientation of the probe and measuring a change in the angular orientation responsive to the change in pressure.

25. A method according to claim 24, and comprising analyzing the data to determine whether the urinary stress incontinence is related to urethral hypermobility or to ISD.

26. A method according to claim 24, and comprising inserting a probe into the subject'"'"'s rectum and receiving signals therefrom responsive to a rectal pressure.