Granted Patent
B2
US 12,220,345 · App. 16/759,060 · Granted Feb 11, 2025
Devices, systems, and methods for training pelvic floor muscles
Assignee:
Axena Health, Inc.
A61F6/08A61B5/0004A61B5/1107A61B5/14539A61B5/14546A61B5/227A61B5/391A61B5/4294A61B5/4337A61B5/6847A61B5/6857A61B5/7435A61B5/7475A61N1/0524A61N1/403A61B5/0002A61B2560/0487A61B2562/0219A61B2562/063
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Abstract
Featured are intravaginal devices and methods of using the devices to observe the state of an individual's pelvic floor muscles in order to diagnose, treat, or prevent pelvic floor disorders (e.g., pelvic organ prolapse and incontinence) and their accompanying symptoms and methods of using the devices to treat or prevent vaginal disorders (e.g., skin laxity) in a subject using an energy transmitter (e.g., a radiofrequency transmitter).
Claims (32)
1. An intravaginal device
comprising 2, 3, 4, 5, 6, 7, 9, or 10 accelerometers disposed along a length of the device, wherein each of the accelerometers are separated by a distance of about 1.6 cm.
2. The intravaginal device of claim 1 , wherein:
(a) the device is connected to an external power source;
(b) the device further comprises a microcontroller for receiving and storing data from the accelerometers;
(c) the device further comprises a wired transmitter and/or receiver for communicating data to an electronic device, optionally, wherein the transmitter and/or receiver can wirelessly communicate the data to the electronic device;
(d) the device further comprises a transmitter and/or receiver located in an external housing connected to the intravaginal device by a detachable cable;
(e) the device further comprises a power source connected to the accelerometers;
(f) the device further comprises one or more sensors selected from the group consisting of an accelerometer, gyroscope, micro-electro-mechanical systems (MEMS) sensor, G-sensor, tilt sensor, rotation sensor, a light detecting sensor, such as a light detecting and ranging (LiDAR) sensor, and electrical impedance myography (EIM) sensor;
(g) a length of the device is about 3 cm to about 50 cm;
(h) an angle formed by a line drawn between the position of at least two of the accelerometers in the device tether and the horizon defines a vaginal angle; and/or
(i) the device comprises a flexible, biocompatible material.
3. The intravaginal device of claim 2 , wherein:
(i) the electronic device comprises a display;
(ii) the transmitter and receiver are configured for use with a Bluetooth and/or Wi-Fi enabled electronic device;
(iii) the electronic device is a computer, tablet, smartphone, or smart watch; and/or
(iv) the intravaginal device is configured to send data to and receive data from the electronic device.
4. The intravaginal device of claim 2 , wherein:
(i) the intravaginal device comprises a combination of sensors of differing types; and/or
(ii) the intravaginal device further comprises at least one additional sensor within the device selected from the group consisting of a pressure sensor, a muscle quality sensor, a muscle strength sensor, a pH sensor, a humidity sensor, a temperature sensor, a hormone sensor, and a toxin sensor.
5. The intravaginal device of claim 2 , wherein:
the length of the device is about 25.5 cm.
6. A system comprising the intravaginal device of claim 1 and a graphical user interface.
7. The system of claim 6 , wherein the graphical user interface is tethered wirelessly to the intravaginal device; and/or wherein the system further comprises:
(a) a transmitter and receiver;
(b) a detachable cable;
(c) a tool for insertion of the intravaginal device;
(d) an electronic device; and/or
(e) a database.
8. The intravaginal device of claim 3 , wherein the display is a graphical user interface.
9. The intravaginal device of claim 8 , wherein the graphical user interface comprises a touch user interface.
10. The intravaginal device of claim 1 , wherein the device comprises six accelerometers.
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 Apr 28, 2020
From: BEER, MARC D.; IGLESIAS, RAMON JOSE; LORIE, YOLANDA
To: RENOVIA INC.
Reel/Frame 052515/0147 →
Continuity (3)
Provisional Application
62625301
· Feb 1, 2018
Provisional Application
62577811
· Oct 27, 2017
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