SEM scanner sensing apparatus, system and methodology for early detection of ulcers

• US 10,188,340 B2
• Filed: 04/09/2016
• Issued: 01/29/2019
• Est. Priority Date: 05/08/2010
• Status: Active Grant

• Current Assignee: Bruin Biometrics LLC, Regents of the University of California (University of California)
• Original Assignee: Bruin Biometrics LLC, Regents of the University of California (University of California)
• Inventors: Sarrafzadeh, Majid, Kaiser, William, Mehrnia, Alireza, Bates-Jensen, Barbara M., Wang, Frank, Flesch, Michael, Boystak, Joseph, Lam, Yeung
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): TRAN, THO Q
• Application Number:
  US15/095,046
• Publication Number:
  US 20160220172A1
• Time in Patent Office: 1,025 Days
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/066 in a matrix array
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/0533 Measuring galvanic skin response
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/443 Evaluating skin constituents, e.g. elastin, melanin, water
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61B 5/447 specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6844 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence

Abstract

A handheld, conforming capacitive sensing apparatus configured to measure Sub-Epidermal Moisture (SEM) as a mean to detect and monitor the formation of pressure ulcers. The device incorporates an array of electrodes which are excited to measure and scan SEM in a programmable and multiplexed manner by a battery-less RF-powered chip. The scanning operation is initiated by an interrogator which excites a coil embedded in the apparatus and provides the needed energy burst to support the scanning/reading operation. Each electrode measures the equivalent sub-epidermal capacitance corresponding and representing the moisture content.

Claims

1. A Sub-Epidermal Moisture (SEM) sensing apparatus, comprising:

a flexible substrate,

a first electrode and a second electrode that are both disposed on a common side of the flexible substrate, and

an electronics package that is individually wired to each of the first and second electrodes and configured for independent interrogation, excitation, and data retrieval and further configured to measure a sub-epidermal capacitance of a target region of skin between the first and second electrodes, the sub-epidermal capacitance corresponding to the moisture content of the target region.

2. The SEM apparatus of claim 1, wherein the first electrode and the second electrode and their electrical coupling to the electronics package are configured such that the first and second electrodes form a bipolar radiofrequency (RF) sensor.

3. The SEM apparatus of claim 1, wherein the flexible substrate and the first electrode and the second electrode are configured to be placed on the target region of skin of a patient'"'"'s body such that both the first and second electrode are in close proximity with the target region of skin.

4. A Sub-Epidermal Moisture (SEM) sensing apparatus, comprising:

a flexible substrate,

four or more electrodes disposed on a common side of the flexible substrate, and

an electronics package that is individually wired to each of the four or more electrodes configured for independent interrogation, excitation, and data retrieval, wherein said electronics package is further configured to select a pair of electrodes from said four or more electrodes and measure a sub-epidermal capacitance of a target region of skin between the selected pair of electrodes, the sub-epidermal capacitance corresponding to an amount of moisture content of the target region.

5. The SEM sensing apparatus of claim 4, wherein the four or more electrodes and their electrical coupling to the electronics package are configured such that the selected pair of electrodes form a bipolar radiofrequency (RF) sensor.

6. The SEM sensing apparatus of claim 4, wherein the flexible substrate and the four or more electrodes are configured to be placed on the target region of a patient'"'"'s body such that the four or more electrodes are in close proximity with the target region.

7. The SEM sensing apparatus of claim 4, wherein the four or more electrodes define a target location, wherein the measured capacitance corresponds to the SEM at a sub-location defined by the selected pair of electrodes, and wherein the SEM is an indicator of pressure ulcer formation at the sub-location.

8. The SEM sensing apparatus of claim 7, wherein the four or more electrodes are configured to measure SEM values at two or more sub-locations to generate a SEM image of the target location without using a scanning motion.