US 2021/0046356 A1Published application

Method and Apparatus for Early Detection of Diabetic Foot Disorders by Analyzing Foot Temperature and Vertical and Shear Forces on Feet

AssigneeIPComm

InventorsStanislaw Czaja, Lora O'Leary

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Abstract

A system for analysis of user gait and foot disorder intended to minimize risks ulceration and limb amputation associated with the uncontrolled increase of the foot temperature in persons with diabetes. This system comprises a motion, force and temperature sensors and a processing element configured to process motion algorithms, measure ground reaction force (GRF) and changes in foot temperature embedded in the footwear insoles in communication with a smartphone based analysis application using wireless radio interface. The analysis application processes data received from the footwear sensors, compares the results with set of criteria and rules, and if any of the predefined criteria is exceeded, provides alerts to the user and the remote medical supervisor. Additionally, the insoles may be equipped with a haptic actuators configured to determine the level of the user neuropathy by measuring vibration perception threshold (VPT) level.

Claims21

Dependent claims

A system for detecting foot disorders in diabetic subjects, wherein a subject may experience some loss of sensation in the subject's foot due to the subject being a diabetic, comprising:

(a) a first footwear fitted for a subject's first foot, wherein the first footwear includes the following sensors and elements:
(1) a 3-axis accelerometer;
(2) a 3-axis gyroscope;
(3) a 3-axis magnetometer;
(4) a plurality of force sensors;
(5) a plurality of temperature sensors;
(6) a haptic actuator;
(7) a control microprocessor;
and
(8) a motion processing element, wherein the motion processing element obtains samples of sensor data produced by the accelerometer, the gyroscope, the magnetometer, the plurality of force sensors and the plurality of temperature sensors at a predetermined sample data rate;
and wherein the motion processing element executes motion processing algorithms;
and wherein, at the end of sampling periods, motion processing information is assembled into a plurality of data packets, wherein the plurality of data packets include motion information including g-force, acceleration information, Euler Angles, Quaternion information and force vectors from the plurality of the force sensors;
and
(b) a smartphone including a smartphone based analysis application, wherein the smartphone is in wireless communication with the first footwear and is capable of receiving the plurality of data packets and temperature sensor data from the plurality of temperature sensors, and wherein the smartphone based analysis application uses data included in the data packets and the temperature sensor data to determine whether the subject has a foot disorder;
wherein variations in foot temperature parameters and shear force parameters are compared to calibrated safety thresholds, and wherein if any parameter exceeds a predetermined safety threshold an alert is transmitted alerting to the analysis result.

12 more elements

A method of detecting disorders in a foot of a diabetic subject, wherein a subject may experience a loss of sensation in the subject's foot due to the subject being a diabetic, the method comprising:

(a) fitting the subject's first foot with a first footwear, wherein the first footwear includes the following plurality of first footwear sensors and elements:
(1) a 3-axis accelerometer;
(2) a 3-axis gyroscope;
(3) a 3-axis magnetometer;
(4) a plurality of force sensors;
(5) a plurality of temperature sensors;
(6) a haptic actuator;
(7) a control microprocessor;
and
(8) a motion processing element;
(b) sampling motion processing data at a selected sampling rate;
(c) executing motion processing algorithms based upon the motion processing data;
(d) obtaining g-force, acceleration information, Euler Angles, Quaternion information, force vectors and temperature sensor data;
and
(e) analyzing the g-force, the acceleration information, the Euler Angles, the Quaternion information, the force vectors and the temperature sensor data to determine whether the subject has a foot disorder;
wherein variations in foot temperature parameters and shear force parameters are compared to calibrated safety thresholds, and wherein if any parameter exceeds a predetermined safety threshold an alert is transmitted alerting to the analysis result.

13 more elements

Dependencies are inferred from the claim text.

Facts

Application: 17/086,163Filed 30 Oct 2020
Priority: 23 Jun 2015
Published: 18 Feb 2021
Term ends: Not estimatedThe source records don’t support an estimate.

Classification65 codes

A61B 5/6807
Garments; Clothes: footwear
A43B 3/34
Footwear characterised by the shape or the use: with electrical or electronic arrangements
A43B 5/04
Footwear for sporting purposes: ski or like boots
A43B 5/0405
Ski or like boots: linings, paddings or insertions; Inner boots

Family

Application14/747,179Continuation in part · filed 23 Jun 2015
Application15/464,083Continuation · filed 20 Mar 2017
Application16/897,163Continuation in part · filed 9 Jun 2020
Application17/086,163Continuation in part
Application16/897,163Continuation
Application15/464,083Continuation in part
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From the US filing history. Foreign family members aren’t listed.