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

• US 9,763,596 B2
• Filed: 09/29/2016
• Issued: 09/19/2017
• 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:
  US15/280,528
• Publication Number:
  US 20170014045A1
• Time in Patent Office: 355 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. A method for assessing tissue health at and around a target location, comprising the steps of:

obtaining a bioimpedance signal at the target location using a handheld apparatus comprising a bioimpedance sensor,

obtaining a first plurality of bioimpedance signals at a respective plurality of locations along a first tissue assessment ring centered on and having a first radial distance from the target location using the handheld apparatus,

obtaining a second plurality of bioimpedance signals at a respective plurality of locations along a second tissue assessment ring centered on and having a second radial distance from the target location, wherein the second radial distance is greater than the first radial distance,

calculating a first average of the first plurality of bioimpedance signals,

calculating a first difference between the first average and the bioimpedance signal obtained at the target location,

calculating a second average of the second plurality of bioimpedance signals,

calculating a second difference between the second average and the bioimpedance signal obtained at the target location, and

determining whether the tissue is damaged;

wherein the step of determining whether the tissue is damaged comprises determining that the tissue is damaged if any of the first difference and second difference exceed the predetermined threshold.

2. The method of claim 1, wherein the first tissue assessment ring is positioned equidistantly between the target location and the second tissue assessment ring.

3. The method of claim 1, wherein the locations along the first and second tissue assessment rings are disposed on a single straight line passing through the target location.

4. The method of claim 1, further comprising the step of:

determining that an edge of erythema exists between a first location on the first tissue assessment ring and a second location on the second tissue assessment ring, wherein the first and second locations are generally disposed on a common radial line emanating from the target location, when the bioimpedance signal at either one of the first and second locations is less than or equal to a difference calculated by subtracting the predetermined threshold from the bioimpedance signal measured from the other of the first and second locations.

5. The method of claim 4, further comprising the steps of:

determining a plurality of edges of erythema from a plurality of pairs of first and second locations disposed on a respective plurality of radial lines emanating from the target location, and determining an area of erythema by connecting the plurality of edges of erythema in a closed path around the target location.

6. The method of claim 1, further comprising the steps of:

obtaining a third plurality of bioimpedance signals at a respective plurality of locations along a third tissue assessment ring centered on and having a third radial distance from the target location, wherein the third radial distance is greater than the second radial distance, calculating a third average of the third plurality of bioimpedance signals, and calculating a third difference between the third average and the bioimpedance signal obtained at the target location;

wherein the step of determining whether the tissue is damaged comprises determining that the tissue is damaged if any of the first difference and second difference and third difference exceed the predetermined threshold.

7. The method of claim 6, wherein the second tissue assessment ring is positioned equidistantly between the first tissue assessment ring and the third tissue assessment ring.

8. The method of claim 6, wherein the locations along the first, second, and third tissue assessment rings are disposed on a single straight line passing through the target location.

9. The method of claim 6, further comprising the step of:

determining that an edge of erythema exists between a third location on the second tissue assessment ring and a fourth location on the third tissue assessment ring, wherein the third and fourth locations are generally disposed on a common radial line emanating from the target location, when the bioimpedance signal at either one of the third and fourth locations is less than or equal to the difference calculated by subtracting the predetermined threshold from the bioimpedance signal at the other of the third and fourth locations.

10. The method of claim 9, further comprising the steps of:

determining that an edge of erythema exists between a first location on the first tissue assessment ring and a second location on the second tissue assessment ring, wherein the first and second locations are generally disposed on a common radial line emanating from the target location, when one of the bioimpedance signals at the first and second locations is less than or equal to the difference calculated by subtracting the predetermined threshold from the bioimpedance signal at the other of the first and second locations, and determining an area of erythema by connecting the plurality of edges of erythema in a closed path around the target location.

11. The method of claim 1, further comprising the step of:

converting each of the bioimpedance signals to a sub epidermal moisture (SEM) value;

wherein the steps of calculating an average value, calculating a difference, and determining that the tissue is damaged are performed using the SEM value in place of the bioimpedance signal.

12. The method of claim 1, wherein the target location is a bony prominence selected from the group consisting of a sternum, a sacrum, a heel, a scapula, an elbow, and an ear.

13. The method of claim 1, wherein the target location is a fleshy tissue.

14. A method for assessing tissue health at and around a target location, comprising the steps of:

obtaining a plurality of bioimpedance signal at the target location using a handheld apparatus comprising a bioimpedance sensor, obtaining a first plurality of bioimpedance signals at a respective plurality of locations along a first tissue assessment ring centered on and having a first radial distance from the target location using the handheld apparatus, obtaining a second plurality of bioimpedance signals at a respective plurality of locations along a second tissue assessment ring centered on and having a second radial distance from the target location, wherein the second radial distance is greater than the first radial distance, calculating an average target value of the plurality of bioimpedance signals at the target location, calculating a first average of the first plurality of bioimpedance signals, calculating a first difference between the first average and the average target value, calculating a second average of the second plurality of bioimpedance signals, calculating a second difference between the second average and the average target value, and

determining whether the tissue is damaged;

wherein the step of determining whether the tissue is damaged comprises determining that the tissue is damaged if any of the first difference and second difference exceed the predetermined threshold.

15. The method of claim 14, further comprising the step of:

determining that an edge of erythema exists between a first location on the first tissue assessment ring and a second location on the second tissue assessment ring, wherein the first and second locations are generally disposed on a common radial line emanating from the target location, when the bioimpedance signal at either one of the first and second locations is less than or equal to a difference calculated by subtracting the predetermined threshold from the bioimpedance signal measured from the other of the first and second locations.

16. The method of claim 14, further comprising the steps of:

obtaining a third plurality of bioimpedance signals at a respective plurality of locations along a third tissue assessment ring centered on and having a third radial distance from the target location, wherein the third radial distance is greater than the second radial distance, calculating a third average of the third plurality of bioimpedance signals, and calculating a third difference between the third average and the average target value;

wherein the step of determining whether the tissue is damaged comprises determining that the tissue is damaged if any of the first difference and second difference and third difference exceed the predetermined threshold.

17. The method of claim 16, further comprising the step of:

determining that an edge of erythema exists between a third location on the second tissue assessment ring and a fourth location on the third tissue assessment ring, wherein the third and fourth locations are generally disposed on a common radial line emanating from the target location, when the bioimpedance signal at either one of the third and fourth locations is less than or equal to a difference calculated by subtracting the predetermined threshold from the bioimpedance signal at the other of the third and fourth locations.

18. The method of claim 17, further comprising the steps of:

determining that an edge of erythema exists between a first location on the first tissue assessment ring and a second location on the second tissue assessment ring, wherein the first and second locations are generally disposed on a common radial line emanating from the target location, when one of the bioimpedance signals at the first and second locations is less than or equal to a difference calculated by subtracting the predetermined threshold from the bioimpedance signal at the other of the first and second locations, and determining an area of erythema by connecting the plurality of edges of erythema in a closed path around the target location.

19. A method for assessing tissue health at and around a target location, comprising the steps of:

obtaining a bioimpedance signal at the target location using an apparatus configured to measure bioimpedance, obtaining a first plurality of bioimpedance signals at a respective plurality of locations along a first tissue assessment ring centered on and having a first radial distance from the target location using the apparatus, obtaining a second plurality of bioimpedance signals at a respective plurality of locations along a second tissue assessment ring centered on and having a second radial distance from the target location, wherein the second radial distance is greater than the first radial distance, calculating a first average of the first plurality of bioimpedance signals, calculating a first difference between the first average and the bioimpedance signal obtained at the target location, calculating a second average of the second plurality of bioimpedance signals, calculating a second difference between the second average and the bioimpedance signal obtained at the target location, and

determining whether the tissue is damaged;

wherein the step of determining whether the tissue is damaged comprises determining that the tissue is damaged if any of the first difference and second difference exceed the predetermined threshold.

20. A method for assessing tissue health at and around a target location, comprising the steps of:

obtaining a plurality of bioimpedance signal at the target location using an apparatus configured to measure bioimpedance, obtaining a first plurality of bioimpedance signals at a respective plurality of locations along a first tissue assessment ring centered on and having a first radial distance from the target location using the apparatus, obtaining a second plurality of bioimpedance signals at a respective plurality of locations along a second tissue assessment ring centered on and having a second radial distance from the target location, wherein the second radial distance is greater than the first radial distance, calculating an average target value of the plurality of bioimpedance signals at the target location, calculating a first average of the first plurality of bioimpedance signals, calculating a first difference between the first average and the average target value, calculating a second average of the second plurality of bioimpedance signals, calculating a second difference between the second average and the average target value, and

determining whether the tissue is damaged;

wherein the step of determining that the tissue is damaged comprises determining that the tissue is damaged if any of the first difference and second difference exceed the predetermined threshold.