Granted Patent
B2
US 12,295,732 · App. 17/290,389 · Granted May 13, 2025
Devices, systems, and methods for monitoring bladder function
Inventors:
Marc D. Beer (Sudbury, MA); Samantha J. Pulliam (Boston, MA); Jessica L. McKinney (Boston, MA)
Assignee:
Axena Health, Inc.
A61B5/202A61B5/067A61B5/07A61B5/205A61B5/6856A61B5/7435A61B5/7475A61B2562/028A61B2562/043A61M2025/0166
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Abstract
Featured are urodynamic catheters, intravaginal devices, and intrarectal devices, systems and kits thereof, and methods of using the devices, systems, and kits to observe pelvic floor movements in order to monitor bladder function in order to diagnose, treat, or prevent urinary incontinence disorders, such as urge incontinence and stress incontinence.
Claims (19)
1. A method of evaluating a bladder function of a subject comprising performing one or more urodynamic measurements with a system comprising a urodynamic catheter comprising multiple lumens and a plurality of positional sensors located along a length of the catheter and an intravaginal or intrarectal device comprising a plurality of positional sensors located along a length of the device, and wherein each of the urodynamic catheter and the intravaginal or intrarectal device comprises a transmitter and/or receiver that communicates positional data comprising sensor angle and time to an electronic device;
wherein each of the urodynamic catheter and the intravaginal or intrarectal device transmits the positional data to the electronic device to monitor a bladder function of the subject, wherein the electronic device processes the positional data to detect, diarize, and discriminate between a bladder function comprising one or more of voiding, urge, knack, cough, Valsalva, reflex levator response, pelvic floor muscle contraction, filling, emptying, capacity, sensation, compliance, and leaking.
2. The method of claim 1 , wherein the one or more urodynamic measurements measures one or more of position, movement, pressure, and flow.
3. The method of claim 2 , wherein the pressure comprises one or more of intraabdominal pressure, detrusor pressure, and intravesicular pressure.
4. The method of claim 1 , wherein the positional sensors are MEMS accelerometers.
5. The method of claim 1 , wherein the catheter comprises from 2 to 50 sensors.
6. The method of claim 1 , wherein the intravaginal or intrarectal device comprises a plurality of positional sensors located along a length thereof.
7. The method of claim 1 , wherein the positional sensors of the intravaginal device or intrarectal device are MEMS accelerometers.
8. The method of claim 1 , wherein:
(a) the intravaginal comprises a substantially ring-shaped main body having an outer edge configured to contact a vaginal wall or vaginal fornix and a tether connected to the main body; or
b) the intrarectal device comprises a substantially ring-shaped main body having an outer edge configured to contact a rectum and a tether connected to the main body.
9. The method of claim 1 , wherein the transmitter or receiver:
(a) is a radio frequency transmitter or receiver;
(b) is configured to wirelessly communicate the data to the electronic device; or
(c) is configured for use with a Bluetooth, ISM (industrial, scientific and medical) band radio, and/or Wi-Fi enabled electronic device.
10. The method of claim 1 , wherein the electronic device comprises a display.
11. The method of claim 10 , wherein the display is a graphical user interface.
12. The method of claim 11 , wherein the graphical user interface comprises a touch user interface.
13. The method of claim 1 , wherein the electronic device is a computer, tablet, smartphone, or smart watch.
Assignments (3)
SECURITY INTEREST
Recorded Dec 23, 2025
From: AXENA HEALTH, INC.
To: ANKURA TRUST COMPANY, LLC, ADMINISTRATIVE AND COLLATERAL AGENT
Reel/Frame 073305/0470 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 18, 2023
From: RENOVIA INC.
To: AXENA HEALTH, INC.
Reel/Frame 064632/0786 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 5, 2021
From: BEER, MARC D.; PULLIAM, SAMANTHA J.; MCKINNEY, JESSICA L.
To: RENOVIA INC.
Reel/Frame 056146/0346 →
Continuity (2)
Provisional Application
62752987
· Oct 30, 2018
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