Body-worn sensor for characterizing patients with heart failure

• US 9,974,444 B2
• Filed: 12/31/2013
• Issued: 05/22/2018
• Est. Priority Date: 12/31/2012
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Tosense Inc (Baxter International Inc.)
• Inventors: Banet, Matthew, Pede, Susan Meeks, Dhillon, Marshal Singh, Hunt, Kenneth Robert
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): Alter, Mitchell E
• Application Number:
  US14/145,243
• Publication Number:
  US 20140187974A1
• Time in Patent Office: 1,603 Days
• 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 5/1117 Fall detection
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• 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 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots

Abstract

The invention provides a sensor for measuring both impedance and ECG waveforms that is configured to be worn around a patient'"'"'s neck. The sensor features 1) an ECG system that includes an analog ECG circuit, in electrical contact with at least two ECG electrodes, that generates an analog ECG waveform; and 2) an impedance system that includes an analog impedance circuit, in electrical contact with at least two (and typically four) impedance electrodes, that generates an analog impedance waveform. Also included in the neck-worn system are a digital processing system featuring a microprocessor, and an analog-to-digital converter. During a measurement, the digital processing system receives and processes the analog ECG and impedance waveforms to measure physiological information from the patient. Finally, a cable that drapes around the patient'"'"'s neck connects the ECG system, impedance system, and digital processing system.

Claims

1. A system worn entirely on a body of a patient for measuring heartbeat-induced impedance pulses, ECG signals, and motion signals exclusively from the patient'"'"'s chest, comprising:

a monitoring system comprising both rigid and flexible substrates supporting electrical circuit components, the monitoring system configured to rest on the patient'"'"'s chest and not wrap around the patient'"'"'s chest;

an impedance-measuring system integrated within the monitoring system, the impedance-measuring system comprising an analog impedance circuit in electrical contact with at least two electrodes and configured to receive a first set of electrical signals from the patient'"'"'s chest and process them to determine the heartbeat-induced impedance pulses exclusively from the patient'"'"'s chest;

an ECG-measuring system integrated within the monitoring system, the ECG-measuring system comprising an analog ECG circuit in electrical contact with at least two electrodes and configured to receive a second set of electrical signals from the patient'"'"'s chest and process them to determine the ECG signals;

a motion-measuring system connected to the monitoring system, the motion-measuring system comprising a motion-detecting circuit and configured to generate a set of motion signals in response to the patient'"'"'s movements;

a data-processing system connected to the monitoring system and in electrical contact with the impedance-measuring system, the ECG-measuring system, and the motion-measuring system, the data-processing system comprising a microprocessor configured to operate a set of computer algorithms configured to process the heartbeat-induced impedance pulses, the ECG signal, and the motion signal;

a wireless transmitter integrated connected to the monitoring system and in electrical contact with the data-processing system, the wireless transmitter configured to transmit processed values of the heartbeat-induced impedance pulses, the ECG signal, and the motion signal; and

a battery system comprising a battery in electrical contact with and configured to power the impedance-measuring system, the ECG-measuring system, the motion-measuring system, the data-processing system, and the wireless transmitter.

2. The system of claim 1, wherein the continuous monitoring system comprises at least one rigid circuit board electrically connected to a flexible substrate comprising an electrical system.

3. The system of claim 2, wherein the flexible substrate supports the electrical system.

4. The system of claim 3, wherein the flexible circuit comprises Kapton®

.

5. The system of claim 1, wherein the monitoring system comprises at least two rigid circuit boards connected by a flexible substrate.

6. The system of claim 5, wherein the flexible substrate supports an electrical system.

7. The system of claim 6, wherein the flexible substrate comprises Kapton®

.

8. The system of claim 5, wherein the flexible substrate comprises a flexible wire harness.

9. A system worn entirely on a body of a patient for measuring heartbeat-induced impedance pulses, ECG signals, and motion signals from the patient, comprising:

a monitoring system comprising both rigid and flexible substrates supporting electrical circuit components, the monitoring system configured to rest on the patient'"'"'s chest but not wrap around the patient'"'"'s chest;

an impedance-measuring system integrated within the monitoring system, the impedance-measuring system comprising an analog impedance circuit in electrical contact with at least two electrodes and configured to receive a first set of electrical signals from the patient'"'"'s chest and process them to determine the heartbeat-induced impedance pulses exclusively from the patient'"'"'s chest;

an ECG-measuring system integrated within the monitoring system, the ECG-measuring system comprising an analog ECG circuit in electrical contact with at least two electrodes and configured to receive a second set of electrical signals from the patient'"'"'s chest and process them to determine an ECG signal;

a motion-measuring system integrated within the monitoring system, the motion-measuring system comprising a motion-detecting circuit and configured to generate a set of motion signals in response to the patient'"'"'s movements; and

, a data-processing system connected to the monitoring system and in electrical contact with the impedance-measuring system, the ECG-measuring system, and the motion-measuring system, the data-processing system comprising a microprocessor configured to operate a set of computer algorithms configured to process the impedance signal, the ECG signal, and the motion signal.

10. The system of claim 9, wherein the monitoring system comprises at least one rigid circuit board electrically connected to a flexible substrate.

11. The system of claim 10, wherein the flexible substrate supports an electrical system.

12. The system of claim 11, wherein the flexible circuit comprises Kapton®

.

13. The system of claim 10, wherein the flexible substrate comprises a wire harness.

14. A system worn entirely on a body of a patient for measuring heartbeat-induced impedance pulses, ECG signals, and motion signals from the patient, comprising:

a monitoring system comprising both rigid and flexible substrates supporting electrical circuit components, the monitoring system configured to rest on the patient'"'"'s chest but not wrap around the patient'"'"'s chest;

an impedance-measuring system integrated within the monitoring system, the impedance-measuring system comprising an analog impedance circuit in electrical contact with at least two electrodes and configured to receive a first set of electrical signals from the patient'"'"'s chest and process them to determine heartbeat-induced impedance pulses;

an ECG-measuring system integrated within the monitoring system, the ECG-measuring system comprising an analog ECG circuit in electrical contact with at least two electrodes and configured to receive a second set of electrical signals from the patient'"'"'s chest and process them to determine an ECG signal;

a motion-measuring system integrated within the monitoring system, the motion-measuring system comprising a motion-detecting circuit and configured to generate a set of motion signals in response to the patient'"'"'s movements;

a location-measuring system integrated within the monitoring system, the location-measuring system configured to wirelessly receive signals and, in response, determine a set of location coordinates describing the patient'"'"'s geographic location;

a data-processing system integrated within the monitoring system and in electrical contact with the impedance-measuring system, the ECG-measuring system, the motion-measuring system, and the location-measuring system, the data-processing system comprising a microprocessor configured to operate a set of computer algorithms configured to process the heartbeat-induced impedance pulses, the ECG signal, the set of location coordinates, and the motion signal;

a wireless transmitter integrated within the monitoring system and in electrical contact with the data-processing system, the wireless transmitter configured to transmit processed values of the impedance signal, the ECG signal, the set of location coordinates, and the motion signal; and

a battery system comprising a battery in electrical contact with and configured to power the impedance-measuring system, the ECG-measuring system, the motion-measuring system, the data-processing system, and the wireless transmitter.