System and method for pelvic floor feedback and neuromodulation

Patent metadata

Field	Value
Publication number	US-11426115-B2
Application number	US-202117486859-A
Country	US
Kind code	B2
Filing date	Sep 27, 2021
Priority date	Mar 29, 2019
Publication date	Aug 30, 2022
Grant date	Aug 30, 2022

Abstract

A computer-implemented method for pelvic floor feedback. The method includes capturing a strength of action potentials via wireless sensors, the wireless sensors positioned proximate to a pelvic floor of a user. The method also includes transmitting the strength of the action potentials to a mobile device. The method also includes recording the strength of the action potentials on the mobile device.

First claim

What is claimed is:

1. A device for electromyography (EMG)-based biofeedback-augmented pelvic floor muscle training by a user in need thereof, the device comprising:
a. a housing comprising a pillow that is configured as a garment or a saddle;
b. a plurality of sensor electrodes configured for detection of EMG signals generated by an anal sphincter muscle of the user in response to a voluntary contraction of the anal sphincter muscle by the user, the plurality of sensor electrodes coupled to the housing at locations for positioning the plurality of sensor electrodes adjacent to the anal sphincter muscle of the user when the housing is mounted or worn by the user;
c. an EMG signal sensing and processing processor in functional communication with the plurality of sensor electrodes, wherein the EMG signal sensing and processing processor is configured to receive and interpret parameters of the EMG signals from the anal sphincter muscle generated in response to the voluntary contraction of the anal sphincter muscle of the user; and
d. a control processor configured to transmit the parameters of the EMG signals to a remote user interface module,

wherein the pillow has a compression rate of 25% for an applied pressure of between 0.6 and 4.0 psi.

2. The device of claim 1 , wherein the pillow is configured as a garment configured to be worn by the user.

3. The device of claim 1 , wherein the plurality of sensor electrodes are arranged in a sensor electrode array comprising at least one opposing pair of sensor electrodes separated by a distance.

4. The device of claim 3 , wherein the distance between the at least one opposing pair of sensor electrodes ranges from about 0.75″ to about 1.5″, or about 1.0″.

5. The device of claim 3 , wherein each sensor electrode of the plurality of sensor electrodes is between about 0.75″ and 1.25″, or about 1.0″ wide.

6. The device of claim 1 , wherein the plurality of sensor electrodes comprise at least one pair of elongated sensor electrodes arranged along a longitudinal axis of the housing.

7. The device of claim 6 , wherein each sensor electrode in the at least one pair of elongated sensor electrodes is between about 3.5″ to about 4.5″ long, and between 0.75″ and about 1.25′ wide, and a distance between each sensor electrode in the least one pair of elongated sensor electrodes ranges from about 0.75″ to about 1.5″ or about 1.0″.

8. The device of claim 1 , wherein the plurality of sensor electrodes are included on a disposable flexible circuit comprising a polyethylene terephthalate (PET) substrate.

9. The device of claim 1 , further comprising a ground electrode against which sensed electrical activity is compared to detect the generated EMG signals.

10. The device of claim 1 , wherein the plurality of sensor electrodes comprise a ground electrode and at least one pair of elongated electrodes arranged along a longitudinal axis of the housing, wherein the plurality of sensor electrodes are arranged in a sensor electrode array comprising at least one opposing pair of sensor electrodes, wherein a distance between opposing sensor electrodes in the at least one opposing pair of sensor electrodes is about 1.0″, wherein each electrode in the at least one pair of elongated electrodes is between about 3.5″ to about 4.5″ long, and between 0.75″ and about 1.25″ wide, and wherein the plurality of sensor electrodes are included on a disposable flexible circuit comprising a polyethylene terephthalate (PET) substrate.

11. The device of claim 1 , wherein the parameters of the EMG signal comprise the amplitude, frequency, and phase of the EMG signal.

12. The device of claim 1 , further comprising a power source, a voltage regulator, an EMG signal amplifier, a microprocessor associated memory for program storage and data storage, a pre-amplifier and analog-to-digital converter, a data transceiver, a patient isolation circuitry, a transmitter, or any combination thereof.

13. The device of claim 1 , wherein the control processor further comprises a transmitter configured to transmit the parameters of the EMG signals to the remote user interface module.

14. The device of claim 13 , wherein the transmitter is configured to communicate wirelessly through a Bluetooth Low Energy (BLE) device.

15. The device of claim 13 , wherein the remote user interface module comprises a mobile device.

16. The device of claim 1 , wherein the housing is configured to be mounted by the user.

17. A method for a user to train pelvic floor muscles using biofeedback, the method comprising:
a. obtaining or having obtained a device of claim 1 ,
b. wearing or mounting the device;
c. performing controlled contractions and relaxations of the anal sphincter muscle by the user, wherein the device;
i. detects EMG signals generated by the voluntary contraction of the anal sphincter muscle by the user ii. receives and interprets parameters of the detected EMG signals; and
iii. transmits the parameters of the detected EMG signals to a remote computing device, wherein a remote user interface of the remote computing device provides feedback to the user; and
iv. based on the transmitted detected EMG signal parameters, providing feedback to the user to:
I. adjust the controlled contractions and relaxations of the anal sphincter muscle;
II. adjusting placement of the device; or
III. a combination thereof;

d. based on the feedback provided by the device:
i. adjusting the controlled contractions and relaxations of the anal sphincter muscle;
ii. adjusting mounting of the device; or
iii. combinations thereof.

18. A device for electromyography (EMG)-based biofeedback-augmented pelvic floor muscle training by a user in need thereof, the device comprising:
a. a saddle configured to be mounted by the user;
b. a disposable electrode sensor array comprising:
i. a pair of opposing elongated sensor electrodes arranged along a longitudinal axis of the saddle, wherein each sensor electrode in the pair of opposing elongated sensor electrodes is between about 3.5″ to about 4.5″ long, and between 0.75″ and about 1.25″ wide, and a distance between the sensor electrodes in the pair of opposing elongated sensor electrodes ranges from about 0.75″ to about 1.5″ or about 1.0″, and wherein the disposable electrode sensor array is included on a disposable flexible circuit comprising a polyethylene terephthalate (PET) substrate;
ii. a ground electrode against which sensed electrical activity is compared;

c. an EMG signal sensing and processing processor in functional communication with the sensor electrodes, wherein the EMG signal sensing and processing unit is configured to receive and interpret parameters of the EMG signals from an anal sphincter muscle of the user in response to voluntary contraction of the anal sphincter muscle by the user; and
d. a control processor configured to transmitting the parameters of the EMG signals to a remote user interface module.

Assignees

• Univ Cornell

Inventors

• Wiygul Jeremy B
• Ganoo Saie Milind
• Curucundhi Rohit

Classifications

• A61B5/7225

  Details of analogue processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation (input circuits for detecting, measuring, or recording bioelectric or biomagnetic signals A61B5/30; specific diagnostic methods using bioelectric or biomagnetic signals A61B5/316) · CPC title

• A61B5/7435

  Displaying user selection data, e.g. icons in a graphical user interface · CPC title

• A61B5/0004

  characterised by the type of physiological signal transmitted · CPC title

• A61N1/36007

  of urogenital or gastrointestinal organs, e.g. for incontinence control · CPC title

• A61B5/6804 Primary

  Garments; Clothes · CPC title