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

• US 10,485,447 B2
• Filed: 09/29/2016
• Issued: 11/26/2019
• 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): Fernandes, Patrick
• Application Number:
  US15/280,487
• Publication Number:
  US 20170014044A1
• Time in Patent Office: 1,153 Days
• 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 comprising:

one or more bioimpedance sensors capable of interrogating tissue;

at least one contact sensor proximate to, and fixed on the same planar surface as, at least one of said one or more bioimpedance sensors;

a first circuit coupled to said at least one contact sensor and configured to cause at least one of said one or more bioimpedance sensors to provide a bioimpedance signal when said at least one contact sensor is in complete contact with a skin surface over said tissue;

a second circuit electronically coupled to said one or more bioimpedance sensors and configured to convert said bioimpedance signal into a sub-epidermal moisture (SEM) value;

a processor electronically coupled to said second 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 an anatomical site of a single patient;

determining a maximum SEM value and a minimum SEM value from said at least two SEM values received from different locations around said anatomical site;

calculating a delta difference by subtracting said minimum SEM value from said maximum SEM value.

2. The apparatus of claim 1, wherein said bioimpedance signal is representative of a moisture content of said tissue.

3. The apparatus of claim 2, wherein an increase in said moisture content is indicative of an increase in fluid within said tissue.

4. The apparatus of claim 3, wherein said increase in fluid within said tissue is indicative of tissue damage.

5. The apparatus of claim 1, wherein said at least one contact sensor comprises one or more sensors selected from the group consisting of a pressure sensor, a light sensor, a temperature sensor, a pH sensor, a perspiration sensor, an ultrasonic sensor, and a bone growth stimulator sensor.

6. The apparatus of claim 1, further comprising a substrate having a first side, and wherein said one or more bioimpedance sensors and said at least one contact sensors are embedded on said first side of said substrate.

7. The apparatus of claim 6, wherein said substrate is flexible.

8. The apparatus of claim 6, wherein said substrate is rigid.

9. The apparatus of claim 1, wherein said one or more bioimpedance sensors comprise a coaxial sensor.

10. The apparatus of claim 1, where at least one of said one or more bioimpedance sensors comprises a first electrode and a second electrode.

11. The apparatus of claim 1, further comprising a visual display coupled to said processor, wherein said instructions further comprise a step of providing at least one of said determined values on said display.

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

13. The apparatus of claim 1, wherein said at least one contact sensor comprises a plurality of contact sensors surrounding said at least one of said one or more bioimpedance sensors.

14. The apparatus of claim 13, wherein said plurality of contact sensors comprise four or more contact sensors.