# US 11,304,652 B2 · Measurement of tissue viability

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- Number: US 11,304,652 B2
- Document ID: US11304652B2
- Status: Granted
- Kind: B2
- Application number: 15/887,837
- Filed: 2018-02-02
- Published: 2018-08-09
- Granted: 2022-04-19
- Earliest claimed: 2017-02-03
- Assignees: BBI Medical Innovations, LLC
- Applicants: BBI Medical Innovations, LLC
- Inventors: Martin F. Burns; Sara Barrington; Graham O. Ross
- Web page: https://patentgrep.com/patent/US11304652B2

## CPC

- A61B 5/445: {Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore}
- A61B 5/0531: Measuring skin impedance
- A61B 5/4881: {Determining interstitial fluid distribution or content within body tissue (measuring analytes in interstitial fluid in-vivo A61B5/1451)}
- A61B 5/0537: Measuring body composition by impedance, e.g. tissue hydration or fat content
- A61B 5/4878: {Evaluating oedema}
- A61B 2560/0412: Low-profile patch shaped housings
- A61B 2560/0468: Built-in electrodes
- A61B 2562/046: in a matrix array
- A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier
- G01R 27/2605: {Measuring capacitance (capacitive sensors G01D5/24)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01R: MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES (indicating correct tuning of resonant circuits H03J3/12)

## Abstract

The present disclosure provides apparatuses and methods for measuring sub-epidermal moisture as an indication of tissue viability and providing information regarding the location of a boundary of non-viable tissue.

## Claims

### Claim 1

An apparatus for mapping regions of damage around a wound, said apparatus comprising:
a plurality of electrodes embedded on a substrate configured to be placed over an area of tissue that includes the wound, wherein combinations of said plurality of electrodes are capable of forming a plurality of virtual capacitive sensors, each of said virtual capacitive sensors comprising more than two electrodes of said plurality of electrodes and configured to measure a capacitance of a region of tissue proximate to said respective virtual capacitive sensor,
a plurality of visual indicators embedded on said substrate, wherein each visual indicator of said plurality of visual indicators is disposed between at least two electrodes, wherein each of said plurality of visual indicators is a light-emitting diode (LED) comprising a plurality of modes of display based on said capacitance measured by said virtual capacitive sensors disposed on each side of said respective visual indicator,
a drive circuit electronically coupled to said plurality of electrodes and plurality of visual indicators,
a processor electronically coupled to said drive circuit, and
a non-transitory computer-readable medium electronically coupled to said processor and comprising instructions stored thereon that, when executed on said processor, perform the steps of:
receiving information regarding said measured capacitance from a subset of said plurality of virtual capacitive sensors via said drive circuit,
determining a boundary between viable and non-viable tissue, and
activating via said drive circuit a portion of said plurality of visual indicators to indicate said boundary.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein said substrate comprises a plurality of perforations that allow marking of said region of tissue along said boundary.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein said drive circuit is configured to selectively drive pairs of said electrodes and measure said capacitance between each of said pairs of electrodes.

### Claim 4 (depends on 3)

The apparatus of claim 3, wherein each of said selectively driven pairs of electrodes form one of said plurality of virtual capacitive sensors.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein said drive circuit is configured to selectively drive subsets of said plurality of electrodes to form a virtual center electrode and a virtual ring electrode and measuring said capacitance between said virtual center electrode and said virtual ring electrode.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein each of said plurality of virtual capacitive sensors comprises a virtual center electrode and a virtual ring electrode.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein said instructions further comprise the steps of:
converting each of said measured capacitance to an associated sub-epidermal moisture (SEM) value that is associated with said virtual capacitive sensor used to measure said capacitance,
comparing a first subset of said SEM values to a first threshold, and
identifying regions of viable tissue corresponding to said virtual capacitive sensors that are associated with SEM values that are greater than said first threshold.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein said instructions further comprise the steps of:
comparing a second subset of said SEM values to a second threshold, and
identifying regions of non-viable tissue corresponding to said virtual capacitive sensors that are associated with SEM values that are less than said second threshold.

### Claim 9 (depends on 7)

The apparatus of claim 7, wherein said plurality of modes of display comprises a first mode of display and a second mode of display.

### Claim 10 (depends on 9)

The apparatus of claim 9, wherein said instructions further comprise the steps of:
activating a first portion of said plurality of visual indicators in said first mode of display to indicate said regions of viable tissue, and
activating a second portion of said plurality of visual indicators in said second mode of display to indicate said regions of non-viable tissue.

### Claim 11 (depends on 9)

The apparatus of claim 9, wherein:
said first mode of display comprises emitting light having a first characteristic, and
said second mode of display comprises emitting light having a second characteristic.

### Claim 12 (depends on 11)

The apparatus of claim 11, wherein:
said first characteristic comprises a first spectral content, and
said second characteristic comprises a second spectral content that is different from said first spectral content.
