Apparatus and Methods for Determining Damaged Tissue Using Sub-Epidermal Moisture Measurements

• US 20170007153A1
• Filed: 09/22/2016
• Published: 01/12/2017
• 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
• Granted Patent: US 10,178,961 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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

1-22. -22. (canceled)

23. 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 emit and receive a radiofrequency signal 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;

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;

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

determining a delta difference between said maximum SEM value and said minimum SEM value.

24. The apparatus of claim 23, further comprising a visual display coupled to said processor, wherein said instructions further comprise a step to provide said delta on said display.

25. The apparatus of claim 23, further comprising a substrate, and wherein said one or more coaxial sensors are embedded on a first side of said substrate.

26. The apparatus of claim 25, wherein said substrate is flexible.

27. The apparatus of claim 25, wherein said substrate is rigid.

28. The apparatus of claim 27, further comprising a pressure sensor disposed on a second side opposing said first side of said substrate.

29. The apparatus of claim 23, wherein said radiofrequency signal has a frequency of less than 100 kilohertz (kHz).

30. The apparatus of claim 23, further comprising a second circuit configured to receive and transmit data to a remote device.

31. The apparatus of claim 23, further comprising a temperature probe.

32. The apparatus of claim 25, further comprising a plurality of contact sensors surrounding each of the one or more coaxial sensors.

33. The apparatus of claim 32, wherein said plurality of contact sensors are embedded on said first side of said substrate.

34. The apparatus of claim 32, wherein said plurality of contact sensors are selected from the group consisting of a plurality of pressure sensors, a plurality of light sensors, a plurality of temperature sensors, a plurality of pH sensors, a plurality of perspiration sensors, a plurality of ultrasonic sensors, a plurality of bone growth stimulator sensors, and a combination thereof.

35. 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 emit and receive a radiofrequency signal 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;

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; and

determining an average of said received SEM values.

36. The apparatus of claim 35, wherein said instructions further comprise:

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

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

37. The apparatus of claim 35, wherein said instructions further comprise:

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

38. A method for assessing tissue health, said method comprising:

obtaining at least three measurements of sub-epidermal moisture (SEM) from collinear locations of an subject'"'"'s skin;

plotting said at least three measurements graphically to generate a graph, wherein said at least three measurements are plotted such that the x-axis coordinates correspond to the order of said at least three measurements'"'"' relative collinear locations; and

determining whether any of said at least three measurements deviate from a given value.

39. The method of claim 38, wherein said given value is determined by taking the average value of measurements plotted at the two ends of said graph.

40. The method of claim 38, wherein said given value is a pre-determined value.

41. The method of claim 38,wherein a deviation from said given value indicates unhealthy tissue.

42. The method of claim 38,wherein a lack of deviation from said given value indicates healthy tissue.