Apparatus and methods for determining damaged tissue using sub-epidermal moisture measurements

• US 10,178,961 B2
• Filed: 09/22/2016
• Issued: 01/15/2019
• Est. Priority Date: 04/24/2015
• Status: Active Grant

• Current Assignee: Bruin Biometrics LLC
• Original Assignee: Bruin Biometrics LLC
• Inventors: Tonar, Ya-Chen, Rhodes, Shannon, Clendenin, Marta, Burns, Martin, Jaradeh, Kindah
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US15/273,202
• Publication Number:
  US 20170007153A1
• Time in Patent Office: 845 Days
• Field of Search: 600372, 600374, 600388, 600393, 600442, 600506, 600547
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• 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 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

The present disclosure provides apparatuses and computer readable media for measuring sub-epidermal moisture in patients to determine damaged tissue for clinical intervention. The present disclosure also provides methods for determining damaged tissue.

Claims

1. An apparatus for assessing tissue health, said apparatus comprising:

one or more coaxial sensors capable of interrogating tissue at and around an anatomical site, wherein each of said one or more coaxial sensors is configured to generate a bioimpedance signal;

a circuit electronically coupled to said one or more coaxial sensors and configured to convert said bioimpedance signal into a sub-epidermal moisture (SEM) value, the SEM value corresponding to moisture content of a location around the anatomical site;

a processor electronically coupled to said circuit and configured to receive said SEM value; 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 at least two of said SEM values from different locations around the anatomical site of a patient;

determining a maximum SEM value and a minimum SEM value from said received SEM values;

determining a delta difference between said maximum SEM value and said minimum SEM value, wherein said delta difference is an indicator related to tissue health.

2. The apparatus of claim 1, further comprising a visual display coupled to said processor, wherein said instructions further comprise a step to provide said delta difference on said display.

3. The apparatus of claim 1, further comprising a substrate, and wherein said one or more coaxial sensors are embedded on a first side of said substrate.

4. The apparatus of claim 3, wherein said substrate is flexible.

5. The apparatus of claim 3, wherein said substrate is rigid.

6. The apparatus of claim 1, further comprising a second circuit configured to receive and transmit data to a remote device.

7. The apparatus of claim 1, further comprising a temperature probe.

11. The apparatus of claim 1, wherein the instructions stored on said processor require receipt of at least three SEM values from different locations prior to determining said maximum and minimum SEM values from said received SEM values.

8. An apparatus for assessing tissue health, said apparatus comprising:

one or more coaxial sensors capable of interrogating tissue at and around an anatomical site, wherein each of said one or more coaxial sensors is configured to generate a bioimpedance signal;

a circuit electronically coupled to said one or more coaxial sensors and configured to convert said bioimpedance signal into a sub-epidermal moisture (SEM) value, the SEM value corresponding to moisture content of a location around the anatomical site;

a processor electronically coupled to said circuit and configured to receive said SEM value; 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 at least two of said SEM values from different locations around the anatomical site of a patient;

determining an average of said received SEM values; and

determining a delta difference between one of said received SEM values and said average SEM value, wherein said delta difference is an indicator related to tissue health.

9. The apparatus of claim 8, wherein said instructions further comprise:

determining a maximum SEM value from said received SEM values; and

determining said delta difference between said maximum SEM value and said average SEM value.

10. The apparatus of claim 8, wherein said instructions further comprise:

determining delta differences between each of said received SEM values and said average SEM value.