Systems, methods, and sensors for measuring tissue

• US 9,113,808 B2
• Filed: 03/15/2013
• Issued: 08/25/2015
• Est. Priority Date: 04/28/2011
• Status: Active Grant

• Current Assignee: Skulpt, Inc.
• Original Assignee: Skulpt, Inc.
• Inventors: Taylor, Haydn, Lupton, Elmer C., Bohorquez, Jose L., Rinehart, Michael, Li, Ken
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US13/842,698
• Publication Number:
  US 20130338473A1
• Time in Patent Office: 893 Days
• Field of Search: 600/393, 600/547
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2562/0223 Magnetic field sensors
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/14 Coupling media or elements to improve sensor contact with skin or tissue
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/684 Indicating the position of the sensor on the body
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7225 : Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7228 : Signal modulation applied to the input signal sent to patient or subject; demodulation to recover the physiological signal modulation H03C
• CPC Class Codes: A61B 5/7235 : Details of waveform analysis A61B5/349 takes precedence
• 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 5/7405 : using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: F04C 2270/041 : Controlled or regulated

Abstract

Embodiments of devices and methods for evaluating tissue are disclosed. In one embodiment, a method for measuring a characteristic of a tissue may include passing a current through the tissue, measuring a signal corresponding to the voltage resulting from passing the current through the tissue, analyzing current passed through the tissue and resulting voltage to determine the electrical characteristics of the tissue; and analyzing the electrical characteristics of the tissue to determine a status of the tissue. Disposable sensors are disclosed.

Claims

1. A method for measuring a localized biological transfer impedance (LBTI) of a tissue using a device including a sensor with a plurality of electrodes, the plurality of electrodes including at least a pair of current electrodes and a pair of voltage electrodes, wherein the sensor includes a flex circuit having at least a first side portion, a second side portion, a third side portion, and a fourth side portion, wherein the first side portion and the third side portion are fixed to restrict motion, and the second side portion and the fourth side portion are allowed to move freely, the method comprising:

positioning the plurality of electrodes of the device in contact with a portion of the tissue;

passing a current through the tissue using the pair of current electrodes;

measuring a signal corresponding to a voltage resulting from the current across the pair of voltage electrodes;

verifying electrical contact between (i) the tissue and the pair of current electrodes, and (ii) the tissue and the pair of voltage electrodes;

indicating to a user of the device, a status of electrical contact between the tissue and at least one electrode of the plurality of electrodes; and

analyzing the current passed through the tissue and the measured signal to determine the localized biological transfer impedance (LBTI) of the tissue.

3. The method of claim 1, wherein the sensor includes at least one of a foam substrate, a gel block, and a saline pouch.

4. The method of claim 1, wherein a method used to fix the first side portion and the third side portion of the flex circuit is a linear fastening means.

5. The method of claim 1, wherein the portion of the tissue is a region of an approximately cylindrical portion of an arm or a leg and the flex circuit is applied to the portion of the tissue such that the first side portion and the third side portion are positioned approximately parallel to an axis of the approximately cylindrical portion, second side portion and the fourth side portion substantially to contours of the region of the approximately cylindrical portion.

9. The method of claim 1, wherein indicating to the user includes informing the user (a) if the pair of current electrodes is making electrical contact with the tissue, and (b) if the pair voltage electrodes is making electrical contact with the tissue.

10. The method of claim 1, wherein the sensor includes a flex circuit and the pair of current electrodes and the pair of voltage electrodes are positioned on the flex circuit such that the step of verifying electrical contact confirms that the flex circuit conforms to a surface of the tissue that subtends at least 90 degrees of arc (pi/2 radians) around an approximately cylindrical portion of an arm or a leg.

12. The method of claim 1, wherein verifying electrical contact includes comparing the applied current and the measured signal to a predefined range and determining the status of electrical contact using the comparison.

13. The method of claim 1, wherein the device includes a display mechanism, and the step of indicating to the user includes indicating on the display mechanism the status of electrical contact.

14. The method of claim 13, wherein indicating on the display mechanism includes using a first indication to indicate to the user that the electrical contact of the at least one electrode with the tissue is suitable for the analyzing, and a second indication to indicate to the user that the electrical contact is not suitable for the analyzing, wherein the first indication is different from the second indication.

16. The method of claim 5, wherein indicating to the user includes separately informing the user (a) if the pair of current electrodes is making electrical contact with the tissue, and (b) if the pair voltage electrodes is making electrical contact with the tissue.

17. The method of claim 16, wherein indicating to the user further includes informing the user that the flex circuit conforms to the contours of the region sufficiently for the current electrodes and the voltage electrodes to make electrical contact with the tissue in the region.

20. The method of claim 5, wherein the pair of current electrodes and the pair of voltage electrodes are positioned on the flex circuit such that the step of verifying electrical contact confirms that the flex circuit conforms to a surface of the tissue that subtends at least 90 degrees of arc (pi/2 radians) around an approximately cylindrical portion of an arm or a leg.

21. The method of claim 9, wherein the device includes a display mechanism, and the step of indicating to the user includes displaying on the display mechanism (a) if the pair of current electrodes is making electrical contact with the tissue, and (b) if the pair voltage electrodes is making electrical contact with the tissue.

22. The method of claim 1, wherein the first side portion is located opposite the third side portion, and the second side portion is located opposite the fourth side portion.

23. The method of claim 1, wherein the flex circuit includes a thin flexible laminar structure which contains circuitry.

24. The method of claim 1, wherein indicating the status of electrical contact includes indicating to the user if (a) an electrode of the pair of current electrodes and the pair of current electrodes is not making good contact with the tissue, and (b) an electrode of the pair of current electrodes and the pair of current electrodes is making good contact with the tissue.

25. The method of claim 24, wherein indicating to the user includes indicating on a graphical user interface of the device.

26. The method of claim 24, wherein indicating to the user includes indicating using at least one of an audio signal or a visual signal.

27. The method of claim 1, wherein indicating the status of electrical contact includes providing feedback to the user to make adjustments to the positioning to improve electrical contact of the plurality of electrodes with the tissue.

28. The method of claim 1, further including prompting the user to initiate the analyzing after the indicating.

29. The method of claim 1, further including warning the user of possible error in the determined LBTI if the verification determines that an electrode of the pair of current electrodes and the pair of voltage electrodes is not making good contact with the tissue.

2. A device for measuring a localized biological transfer impedance (LBTI) of a tissue, comprising:

a plurality of electrodes provided in a sensor, wherein the sensor includes a flex circuit having at least a first side portion, a second side portion, a third side portion, and a fourth side portion, the first side portion located opposite the third side portion, wherein the first side portion and the third side portion are fixed to restrict motion, and the second side portion and the fourth side portion are allowed to move freely;

a power supply operably coupled to the plurality of electrodes to supply a signal through the tissue;

analytical electronics operably coupled to the plurality of electrodes for analyzing an input current and resulting voltage to determine the localized biological transfer impedance (LBTI) of the tissue; and

electronics configured to indicate to a user (i) a result of analysis performed by the analytical electronics, and (ii) a status of electrical contact between at least one electrode of the plurality of electrodes and the tissue.

6. The device of claim 2, wherein the sensor includes at least one of a foam substrate, a gel block, and a saline pouch.

7. The device of claim 2, wherein a method used to fix the first side portion and the third side portion is a linear holding means.

8. The device of claim 2, wherein the flex circuit is adapted to be positioned in contact with a region of an approximately cylindrical portion of an arm or a leg such that the first side portion and the third side portion are positioned approximately parallel to an axis of the approximately cylindrical portion and the second side portion and the fourth side portion conform to contours of the region of the approximately cylindrical portion.

15. The device of claim 2, wherein the electronics configured to communicate to the user is a display mechanism of the device, and the device is configured to (a) compare each of the input current and the resulting voltage to one or more predefined ranges to determine the status of electrical contact between the at least one electrode and the tissue, and (b) indicate on the display mechanism if the electrical contact is suitable for the analyzing.

18. The device of claim 2, wherein the device is further configured to indicate to the user whether (a) the pair of current electrodes is making electrical contact with tissue and (b) the pair of voltage electrodes is making electrical contact with the tissue.

19. The device of claim 18, wherein the device is further configured to indicate to the user that the flex circuit conforms to contours of the tissue sufficiently for the current electrodes and the voltage electrodes to make electrical contact with the tissue.

11. A method for measuring a localized biological transfer impedance (LBTI) of a tissue using a device including a sensor with a plurality of electrodes, the plurality of electrodes including at least a pair of current electrodes and a pair of voltage electrodes, the method comprising:

positioning the plurality of electrodes of the device in contact with a portion of the tissue;

passing a current through the tissue using the pair of current electrodes;

measuring a signal corresponding to a voltage resulting from the current across the pair of voltage electrodes, wherein a direction of measuring the signal is not collinear with a direction along which the current is passed;

verifying electrical contact between (i) the tissue and the pair of current electrodes and (ii) the tissue and the pair of voltage electrodes;

indicating to a user of the device, a status of electrical contact between the tissue and at least one electrode of the plurality of electrodes; and

analyzing the current passed through the tissue and the measured signal to determine the localized biological transfer impedance (LBTI) of the tissue.