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

• US 10,182,740 B2
• Filed: 04/20/2016
• Issued: 01/22/2019
• 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:
  US15/134,110
• Publication Number:
  US 20160310034A1
• Time in Patent Office: 1,007 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 identifying damaged tissue in a patient, said apparatus comprising

one or more coaxial electrodes capable of interrogating tissue at and around an anatomical site of a patient,

wherein each of said one or more coaxial electrodes is configured to generate bioimpedance signals;

a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said bioimpedance signals into sub-epidermal moisture (SEM) values;

a processor electronically coupled to said circuit and configured to receive said SEM values; 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 from said processor one of said SEM values measured at said anatomical site of a patient and at least two of said SEM values measured around said anatomical site and their relative measurement locations;

determining a maximum SEM value from said SEM values measured at and around said anatomical site of a patient;

determining a difference between said maximum SEM value and each of said SEM values measured at and around said anatomical site of a patient; and

flagging said anatomical site associated with a difference greater than a predetermined threshold as damaged tissue.

2. The apparatus according to claim 1, further comprising a substrate, and wherein said one or more coaxial electrodes are embedded on a first side of said substrate.

3. The apparatus according to claim 2, wherein said substrate is flexible.

4. The apparatus according to claim 3, wherein said substrate comprises a material selected from the group consisting of kapton, polyimide, and a combination thereof.

5. The apparatus according to claim 3, further comprising a conformal pressure pad disposed in a layer adjacent to a second side opposing said first side of said substrate.

6. The apparatus according to claim 2, wherein said substrate is hard.

7. The apparatus according to claim 6, further comprising a first pressure sensor disposed on a second side opposing said first side of said substrate.

8. The apparatus according to claim 7, wherein said first pressure sensor is selected from a high pressure sensor and a low pressure sensor.

9. The apparatus according to claim 7, further comprising a second pressure sensor disposed on a second side opposing said first side of said substrate.

10. The apparatus according to claim 9, wherein said first pressure sensor is a low pressure sensor, and said second pressure sensor is a high pressure sensor.

11. The apparatus according to claim 1, further comprising a user interface to display said SEM values and said relative measurement locations associated with a difference in value greater than 0.5.

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

13. The apparatus according to claim 1, wherein said radiofrequency signal has a frequency of less than 100 kilohertz (kHz).

14. The apparatus according to claim 13, wherein said radiofrequency signal has a frequency of 32 kHz.

15. The apparatus according to claim 1, wherein said one or more coaxial electrodes have a diameter ranging from 4 millimeters (mm) to 40 mm.

16. The apparatus according to claim 1, further comprising a temperature probe.

17. A non-transitory computer readable medium for identifying damaged tissue in a patient, comprising instructions stored thereon that when executed on a processor, perform the steps of

receiving from said processor at least one sub-epidermal moisture (SEM) values derived from at least one bioimpedance measurements measured at an anatomical site of a patient and at least two of SEM values derived from at least two bioimpedance measurements measured around said anatomical site and their relative measurement locations;

determining a maximum SEM value from said SEM values measured at and around said anatomical site of a patient;

determining a difference between said maximum SEM value and each of said SEM values measured at and around said anatomical site of a patient; and

flagging said anatomical site associated with a difference greater than a predetermined threshold as damaged tissue.

18. The non-transitory computer readable medium according to claim 17, having a geometry that is configured to be incorporated in a handheld device for identifying damaged tissue.

19. A method for identifying damaged tissue, said method comprising

measuring at least three sub-epidermal moisture values at and around an anatomical site of a patient using an apparatus comprising:

one or more coaxial electrodes capable of interrogating tissue at and around an anatomical site,

wherein each of said one or more coaxial electrodes is configured to generate bioimpedance signals;

a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said bioimpedance signals into sub-epidermal moisture (SEM) values;

a processor electronically coupled to said circuit and configured to receive said SEM values; 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 from said processor one of said SEM values measured at said anatomical site of a patient and at least two of said SEM values measured around said anatomical site and their relative measurement locations;

determining a maximum SEM value from said SEM values measured at and around said anatomical site of a patient;

determining a difference between said maximum SEM value and each of said SEM values measured at and around said anatomical site of a patient; and

flagging said anatomical site associated with a difference greater than a predetermined threshold as damaged tissue; and

obtaining said measurement locations flagged as damaged tissue from said apparatus.

20. The method according to claim 19, wherein said anatomical site is a bony prominence.

21. The method according to claim 20, wherein at least two SEM values measured around said anatomical site are recorded at equidistance from said bony prominence.

22. The method according to claim 21, further comprising two or more SEM values are measured at positions that are located on one or more concentric circles about said bony prominence.