Method and apparatus to measure bioelectric impedance of patient tissue

• US 8,903,484 B2
• Filed: 03/26/2013
• Issued: 12/02/2014
• Est. Priority Date: 04/18/2008
• Status: Expired due to Fees

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis Inc (Medtronic Plc)
• Inventors: Mazar, Scott T.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US13/850,678
• Publication Number:
  US 20140012154A1
• Time in Patent Office: 616 Days
• Field of Search: 600/372, 600/382, 600/384, 600/386, 600/391, 600/393, 600/394, 600/547
• US Class Current: 600/547
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61B 7/00 Instruments for auscultation

Abstract

A device to measure tissue impedance comprises drive circuitry coupled to calibration circuitry, such that a calibration signal from the calibration circuitry corresponds to the current delivered through the tissue. Measurement circuitry can be coupled to measurement electrodes and the calibration circuitry, such that the tissue impedance can be determined in response to the measured calibration signal from the calibration circuitry and the measured tissue impedance signal from the measurement electrodes. Processor circuitry comprising a tangible medium can be configured to determine a complex tissue impedance in response to the calibration signal and the tissue impedance signal. The processor can be configured to select a frequency for the drive current, and the amount of drive current at increased frequencies may exceed a safety threshold for the drive current at lower frequencies.

Claims

1. A device for measuring an impedance of a tissue of a patient, the device comprising:

an adhesive patch that includes at least four electrodes configured to couple to the tissue of the patient, the at least four electrodes comprising two measurement electrodes and two drive electrodes; and

an electronics module comprising circuitry coupled to the at least four electrodes, the circuitry including drive circuitry coupled to the two drive electrodes to pass a current through the two drive electrodes, and sensing circuitry coupled to the two measurement electrodes to measure a signal generated across the two measurement electrodes as a result of the current through the drive electrodes, and a processor programmed to receive and process the signal measured from the two measurement electrodes to determine a tissue impedance of the patient;

wherein the adhesive patch and the electronics module are separable.

2. The device of claim 1, wherein the adhesive patch can be replaced and the electronics module reused with multiple adhesive patches.

3. The device of claim 1, wherein the electronics module further comprises a printed circuit board on which at least some of the electronics are mounted.

4. The device of claim 3, wherein the printed circuit board is a flex printed circuit board.

5. The device of claim 4, wherein the electronics module further comprises:

an electronics housing;

a battery; and

a cover over the electronics housing, battery, and flex printed circuit board.

6. The device of claim 1, further comprising a flexible, breathable cover over the electronics module.

7. The device of claim 1, further comprising wireless communications circuitry that transmits data to a remote server.

8. The device of claim 1, wherein the device takes impedance readings periodically, and wherein the electronic module further comprises a memory of sufficient size to hold impedance readings accumulated over a period of 90 days or more.

9. The device of claim 1, wherein the electronics module further comprises electrocardiogram circuitry coupled to two or more of the at least four electrodes, the electrocardiogram circuitry configured to measure an electrocardiogram signal of the patient.

21. The device of claim 1, further comprising calibration circuitry that includes a calibration impedance, wherein:

the drive circuitry is configured to pass current through the tissue and the calibration impedance simultaneously;

the sensing circuitry is configured to couple to the calibration circuitry to measure a calibration signal from the calibration impedance; and

the processor is further programmed to receive the calibration signal and to determine the tissue impedance of the patient based in part on the calibration signal.

10. A system, comprising:

an adherent device for measuring an impedance of a tissue of a patient, the adherent device comprising

     1) an adhesive patch that includes at least four electrodes configured to couple to the tissue of the patient, the at least four electrodes comprising two measurement electrodes and two drive electrodes; and

     2) an electronics module comprising circuitry coupled to the at least four electrodes, the circuitry including drive circuitry coupled to the two drive electrodes to pass a current through the two drive electrodes, and sensing circuitry coupled to the two measurement electrodes to measure a signal generated across the two measurement electrodes as a result of the current through the drive electrodes, a processor programmed to receive and process the signal measured from the two measurement electrodes to determine a tissue impedance of the patient, and wireless communication circuitry that transmits data, wherein the adhesive patch and the electronics module are separable; and

an intermediate device having circuitry that wirelessly receives data transmitted via the wireless communication circuitry from the adherent device and forwards the data to a remote server.

11. The system of claim 10, wherein the electronics module further comprises a rechargeable battery.

12. The system of claim 11, wherein the intermediate device includes a battery charger, and wherein the electronics module can be removed from the adhesive patch and coupled to the intermediate device to charge the rechargeable battery.

13. A method of monitoring a patient, the method comprising:

adhering an adherent device to a skin of the patient, the adherent device comprising

     1) an adhesive patch that includes at least four electrodes configured to couple to the tissue of the patient, the at least four electrodes comprising two measurement electrodes and two drive electrodes; and

     2) an electronics module comprising circuitry coupled to the at least four electrodes, the circuitry including drive circuitry coupled to the two drive electrodes to pass a current through the two drive electrodes, and sensing circuitry coupled to the two measurement electrodes to measure a signal generated across the two measurement electrodes as a result of the current through the drive electrodes, and a processor programmed to receive and process the signal measured from the two measurement electrodes to determine a tissue impedance of the patient;

monitoring the patient for a period of time using the adherent device; and

separating the electronics module from the adhesive patch.

14. The method of claim 13, wherein the electronics module is a first electronics module, the method further comprising:

replacing the electronics module with a second electronics module; and

resuming monitoring of the patient.

15. The method of claim 14, wherein the first electronics module further comprises a rechargeable battery, the method further comprising charging the rechargeable battery.

16. The method of claim 13, wherein the adhesive patch is a first adhesive patch, the method further comprising:

removing the adhesive patch from the skin of the patient;

replacing the adhesive patch with a second adhesive patch;

coupling the electronics module to the second adhesive patch; and

resuming monitoring of the patient.

17. The method of claim 16, further comprising accumulating measurements derived from the tissue impedance in a memory in the electronics module, the accumulated measurements including measurements taken using the first adhesive patch and measurements taken using the second adhesive patch.

18. The method of claim 13, wherein the electronics module comprises a calibration impedance, and wherein the method further comprises:

measuring the complex impedance of the calibration impedance;

measuring the complex impedance of the patient tissue; and

correcting the measured complex impedance of the patient tissue using the measured complex impedance of the calibration impedance.

19. The method of claim 18, further comprising generating both hydration data and respiration data from the tissue impedance.

20. The method of claim 13, wherein the electronics module comprises electrocardiogram circuitry, and wherein the method further comprises:

coupling the electrocardiogram circuitry to two or more of the at least four electrodes; and

measuring an electrocardiogram signal of the patient using the electrocardiogram circuitry.