BLADDER EVENT DETECTION FOR DIAGNOSIS OF URINARY INCONTINENCE OR TREATMENT OF LOWER URINARY TRACT DYSFUNCTION

• US 20160354028A1
• Filed: 04/29/2016
• Published: 12/08/2016
• Est. Priority Date: 04/29/2015
• Status: Active Grant

• Current Assignee: Case Western Reserve University, Cleveland Clinic Foundation, US Department of Veterans Affairs (Government of the United States of America)
• Original Assignee: Case Western Reserve University, Cleveland Clinic Foundation, US Department of Veterans Affairs (Government of the United States of America)
• Inventors: Bhunia, Swarup, Karam, Robert, Majerus, Steve, Bourbeau, Dennis, Zhu, Hui, Damaser, Margot S.
• Granted Patent: US 10,478,113 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/6874 Bladder
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

The present disclosure relates generally to using detected bladder events for the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction. A system includes a sensing device comprising a pressure sensor to directly detect a pressure within a bladder. The sensing device is adapted to be located within the bladder. The system also includes a signal processing device to: receive a signal indicating the detected pressure within the bladder; detect a bladder event based the detected pressure within the signal; and characterize the bladder event as a bladder contraction event or a non-contraction event. The characterization of the bladder event can be used in the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction.

Claims

1. A system comprising:

a sensing device comprising a pressure sensor to directly detect a pressure within a bladder, wherein the sensing device is adapted to be located within the bladder; and

a signal processing device to;

receive a signal indicating the detected pressure within the bladder;

detect a bladder event based the detected pressure within the signal; and

characterize the bladder event as a contraction event or a non-contraction event.

2. The system of claim 1, wherein the signal processing device determines whether the bladder event characterized as the contraction event corresponds to a voiding contraction or a non-voiding contraction.

3. The system of claim 2, wherein the signal processing device signals a neuromodulation device to deliver a stimulation to prevent voiding when the bladder event characterized as the contraction event corresponds to the voiding contraction.

4. The system of claim 3, wherein one or more parameters of the stimulation are configured based on the detected pressure.

5. The system of claim 2, wherein the signal processing device determines whether the bladder event characterized as the contraction corresponds to the voiding contraction or the non-voiding contraction based on a thresholding procedure,

6. The system of claim 5, wherein the thresholding procedure is based on a tunable parameter that is adjustable for different subjects.

7. The system of claim 3, wherein the signal processing device signals a neuromodulation device to deliver a stimulation to prevent leakage when the bladder event characterized as the contraction event corresponds to the non-voiding contraction.

8. The system of claim 1, further comprising an external sensing device,

wherein the external sensing device further comprises a three-axis accelerometer located on the torso of a subject to detect an acceleration of the body,

wherein the signal indicating the detected pressure correlates to a signal from the three-axis accelerometer, and

wherein the signal processing device characterizes the bladder event as the non-contraction event based on the signal from the three-axis accelerometer.

9. The system of claim 1, wherein the signal processing device is implantable within the subject or external to the subject.

10. The system of claim 1, wherein the signal processing device is an application-specific integrated circuit (ASIC), an embedded circuit running software, a custom programmable hardware, or software on a hardware computing device.

11. The system of claim 1, wherein the sensing device is adapted to be located within a wall of the bladder.

12. A method comprising:

receiving, by a signal processing device comprising a processor, a signal indicating a pressure detected within a bladder from a sensing device, comprising a pressure sensor, located within the bladder;

detecting, by the signal processing device, a bladder event based on the detected pressure within the signal; and

characterizing, by the system, the bladder event as a contraction event or a non-contraction event.

13. The method of claim 12, wherein the signal processing device excludes the bladder event characterized a non-contraction event from further processing.

14. The method of claim 12, further comprising signaling, by the signal processing device, a bladder prosthesis device to deliver a stimulation to block voiding or to prevent leakage when the bladder event is characterized as the contraction event,

wherein one or more parameters of the stimulation are configured based on the detected pressure.

15. The method of claim 12, wherein the signal processing device determines whether the bladder event characterized as the contraction corresponds to a voiding contraction or a non-voiding contraction based on a thresholding procedure.

16. The method of claim 15, wherein the thresholding procedure is based on a tunable parameter that is adjustable for different subjects.

17. The method of claim 12, wherein the bladder event is characterized as the non-contraction event based on a signal from an external sensor correlated to the signal from the pressure sensor.

18. The system of claim 12, further comprising processing, by the signal processing device, the signal with at least one of a digital filtering procedure and a multi-level wavelet approximation to condition the signal.

19. A sensor device implantable within a bladder wall, the sensor device comprising:

a pressure sensor to detect a pressure within a bladder;

a battery rechargeable by a radio frequency (RF) signal; and

an inductive antenna to receive the RF signal for recharging and to transmit a signal comprising the detected pressure,

wherein the sensor device is configured to transmit the signal to a signal processing device to detect and categorize one or more bladder events within the signal.

20. The sensor device of claim 19, further comprising a drift removal component to remove drift from the pressure detected by the pressure sensor.