Matter of manufacture of compression legging system and associated uses

Inventors

Albaugh, MatthewArgote, PabloPatel, NealPatel, RajBoppana, SriramOcken, AlexanderMasquelin, AxelHoilett, OrlandoMiller, DavidDrakopoulos, Michael

Assignees

Predictive Wear

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Publication Number

US-11672288-B2

Patent

Publication Date

2023-06-13

Expiration Date


Abstract

Described herein, is the manufacture, matter of compositions, function, methods and uses of a compression legging system that combines a swelling monitor, a patient activity monitor, medical compression legging material, and a mobile application to help PTS patients detect recurrent DVT and seek medical attention quickly before the development of PE, while reducing swelling and preventing DVT via compression therapy.

Core Innovation

The invention relates to a system for detection of a human disease that includes a compression garment with a wearable sensor network and an application. The compression garment incorporates a wearable sensor network having a plurality of electrodes configured for alternating and ipsilateral activation in each leg of a user, with four electrodes activated in a configuration consisting of two current-injecting electrodes and two voltage-sensing electrodes.

A multiplexor sequentially alternates which two electrodes of the four electrodes are activated as the voltage-sensing electrodes, enabling data collection and data analysis from a plurality of different locations of each leg. The collected data comprises ipsilateral bio-impedance measurements of each location positioned between the two voltage-sensing electrodes, and the bio-impedance module delivers a plurality of current signals having varying current magnitudes across a frequency range of 5 kHz to 100 kHz and analyzes the plurality of delivered current signals after they pass through tissue at each location.

The wearable sensor network further includes a central hardware unit connected to accelerometer-gyroscope modules and bio-impedance modules by wiring, textile electronic traces, or conductive connections. The central hardware unit supplies power to the modules, temporarily stores the ipsilateral bio-impedance measurements and an additional data set comprising acceleration and gyroscopic data from each leg, and transmits both data sets to a mobile application. The mobile application receives a third data set from additional modules and transmits the ipsilateral bio-impedance measurements, the additional data set, and the third data set to an online server.

Claims Coverage

The independent claim provides a system-level framework with six inventive features: a compression garment carrying a wearable sensor network; a specific four-electrode tetrapolar configuration; a multiplexing approach for sequentially activating voltage-sensing electrodes across multiple leg locations; combined ipsilateral bio-impedance measurement plus accelerometer-gyroscope data collection; mobile application and online server transmission; and varying-frequency current delivery with tissue-path impedance analysis.

Compression garment with wearable sensor network and application for disease detection

A compression garment comprising a wearable sensor network and an application, wherein the system is for detection of a human disease.

Ipsilateral four-electrode alternating activation with current-injecting and voltage-sensing electrodes

Four electrodes of the plurality of electrodes are configured to be alternately and ipsilaterally activated in each leg of a user, wherein the four electrodes are configured to be activated in a configuration consisting of two current-injecting electrodes and two voltage-sensing electrodes.

Sequential multiplexing of voltage-sensing electrodes across multiple leg locations

A multiplexor sequentially alternates which two electrodes of the four electrodes are activated as the voltage-sensing electrodes, enabling data collection and data analysis from a plurality of different locations of each leg, with collected data comprising ipsilateral bio-impedance measurements at each location positioned between the two voltage-sensing electrodes.

Central hardware unit combining bio-impedance measurements and accelerometer-gyroscope data

A central hardware unit connected to an accelerometer-gyroscope module and a bio-impedance module, configured to supply power, temporarily store the ipsilateral bio-impedance measurements and an additional data set comprising acceleration and gyroscopic data from each leg, and transmit the measurements and the additional data set to a mobile application.

Mobile application and online server transmission using additional third data set

The mobile application receives a third data set from additional modules and further transmits the ipsilateral bio-impedance measurements, the additional data set, and the third data set to an online server.

Varying-frequency current delivery and tissue-path impedance analysis

A bio-impedance module configured to collect ipsilateral bio-impedance measurements by delivering a plurality of current signals to each location positioned between the two voltage-sensing electrodes, the plurality of current signals having varying current magnitudes across a frequency range of 5 kHz to 100 kHz, and further configured to analyze the plurality of delivered current signals after the plurality of delivered current signals have passed through a section of tissue at each location.

Across the independent claim, the main inventive aspects are the integration of ipsilateral tetrapolar bio-impedance measurement into a compression garment using sequential multiplexing across multiple leg locations, combined with accelerometer-gyroscope data, centralized collection, and transmission to a mobile application and an online server for disease detection.

Stated Advantages

Enables data collection and data analysis from a plurality of different locations of each leg using sequentially alternating voltage-sensing electrodes.

Provides ipsilateral bio-impedance measurements for each location positioned between two voltage-sensing electrodes.

Collects an additional data set including acceleration and gyroscopic data from each leg and transmits it together with bio-impedance measurements for further processing at a mobile application and online server.

Documented Applications

Home detection of recurrent deep vein thrombosis (DVT) in post-thrombotic syndrome (PTS) using the claimed compression legging system, including tetrapolar bio-impedance spectroscopy combined with activity monitoring and classification.

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