Neck-worn physiological monitor

• US 9,924,902 B2
• Filed: 09/11/2015
• Issued: 03/27/2018
• Est. Priority Date: 09/11/2014
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: OtoSense, Inc. (Analog Devices, Inc.)
• Inventors: Banet, Matthew, Hunt, Kenneth Robert, Dhillon, Marshal Singh, Pede, Susan Meeks
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): KUO, JONATHAN T
• Application Number:
  US14/852,347
• Publication Number:
  US 20160106366A1
• Time in Patent Office: 928 Days
• Field of Search: 600300-301, 600382, 600483-484, 600508, 600529-538, 600561
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

The invention provides a neck-worn sensor that is a single, body-worn system that measures the following parameters from an ambulatory patient: heart rate, pulse rate, pulse oximetry, respiratory rate, temperature, thoracic fluid levels, stroke volume, cardiac output, and a parameter sensitive to blood pressure called pulse transit time. From stroke volume, a first algorithm employing a linear model can estimate the patient'"'"'s pulse pressure. And from pulse pressure and pulse transit time, a second algorithm, also employing a linear algorithm, can estimate systolic blood pressure and diastolic blood pressure. Thus, the sensor can measure all five vital signs along with hemodynamic parameters. It also includes a motion-detecting accelerometer, from which it can determine motion-related parameters such as posture, degree of motion, activity level, respiratory-induced heaving of the chest, and falls.

Claims

1. A sensor for simultaneously measuring from a patient systolic blood pressure (SYS), stroke volume (SV), and an index correlating to fluid content in the thoracic cavity (TFI), the sensor comprising:

a sensing portion having a flexible housing;

an elongated securement member extending from the sensing portion, the elongated securement member being configured to pass at least substantially around the patient'"'"'s neck with sufficient length to support the sensing portion generally against the sternal portion of the patient'"'"'s chest when the sensor is in use and operating;

at least one pair of electrode contact points disposed within the housing, with each pair of electrode contact points comprising a current-injecting electrode contact point and a voltage-sensing electrode contact point;

an analog ECG circuit disposed within the housing and in electrical contact with said at least one pair of electrode contact points, the ECG circuit configured to generate an analog ECG waveform based on sensed voltage;

an analog impedance circuit disposed within the housing and in electrical contact with said at least one pair of electrode contact points, the impedance circuit being configured to generate an analog impedance waveform based on sensed voltage;

a digital processing system disposed within the housing and comprising a microprocessor and an analog-to-digital converter, the digital processing system being configured to;

     1) digitize the analog ECG waveform to generate a digital ECG waveform, and

     2) digitize the analog impedance waveform to generate a digital impedance waveform;

a blood pressure-monitoring system disposed within the housing and configured to operate a first algorithm, which first algorithm collectively processes the digital impedance and digital ECG waveforms to determine a value of SYS;

a SV-monitoring system disposed within the housing and configured to operate a second algorithm, which second algorithm processes the digital impedance waveform to determine a value of SV; and

a thoracic fluid-measuring system disposed within the housing and configured to operate a third algorithm, which third algorithm processes the digital impedance waveform to determine a value of TFI.

2. The sensor of claim 1, wherein the blood pressure-monitoring system is configured to measure SYS from a pulse transit time (PTT), with the first algorithm configured to:

1) process the digital ECG waveform to determine a first time point;

     2) process the digital impedance waveform to determine a second time point;

     3) analyze the first and second time points to determine PTT; and

     4) analyze the PTT to determine a value of SYS.

3. The sensor of claim 1, wherein the second algorithm is configured to process the digital impedance waveform to extract an amplitude of a derivatized value of the impedance waveform'"'"'s AC component, an amplitude of the impedance waveform'"'"'s DC component, and an estimated injection time to determine SV.

4. The sensor of claim 1, wherein the third algorithm is configured to process an amplitude of a DC component of the digital impedance waveform to determine the value of TFI.

5. The sensor of claim 1, wherein the housing comprises two or more rigid housing segments that are connected to each other by means of one or more flexible connectors.

6. The sensor of claim 5, wherein the sensing portion includes first and second pairs of electrode contact points, with 1) the first pair of electrode contact points including a first voltage-sensing electrode contact point that is located in a first housing segment arranged to contact a first side of the patient'"'"'s chest, and 2) the second pair of electrode contact points including a second voltage-sensing electrode contact point that is located in a second housing segment arranged to contact a second side of the patient'"'"'s chest that is laterally opposite to the first side of the patient'"'"'s chest.

7. The sensor of claim 5, wherein the sensing portion includes first and second pairs of electrode contact points, with 1) the first pair of electrode contact points including a first current-injecting electrode contact point that is located in a first housing segment arranged to contact a first side of the patient'"'"'s chest, and 2) the second pair of electrode contact points including a second current-injecting electrode contact point that is located in a second housing segment arranged to contact a second side of the patient'"'"'s chest that is laterally opposite to the first side of the patient'"'"'s chest.

8. The sensor of claim 5, wherein the sensing portion includes first and second pairs of electrode contact points, with 1) the first pair of electrode contact points including a first voltage-sensing electrode contact point and a first current-injecting electrode contact point that are both located in a first housing segment arranged to contact a first side of the patient'"'"'s chest;

and

     2) the second pair of electrode contact points including a second voltage-sensing electrode contact point and a second current-injecting electrode contact point that are both located in a second housing segment arranged to contact a second side of the patient'"'"'s chest that is laterally opposite to the first side of the patient'"'"'s chest.

9. The sensor of claim 8, wherein the ECG circuit and the impedance circuit generate the ECG waveform and the impedance waveform, respectively, using the same voltage sensed at the voltage-sensing electrode contact point, of each pair of electrode contact points, within each of the first and second housing segments.

10. The sensor of claim 1, wherein the ECG and impedance circuits and the digital processing system are located on rigid circuit boards disposed within the housing segments and the ECG circuit, impedance circuit, and digital processing system are interconnected via one or more flexible conductors located within the one or more flexible connectors.

11. The sensor of claim 10, wherein each of the one or more flexible connectors comprises a flexible circuit.

12. The sensor of claim 11, wherein the ECG circuit and the digital processing circuit are located on separate rigid circuit boards located in separate housing segments.

13. The sensor of claim 11, wherein the impedance circuit and the digital processing circuit are located on separate rigid circuit boards located in separate housing segments.

14. The sensor of claim 11, wherein the housing comprises three rigid housing segments, with the ECG circuit, the impedance circuit, and the digital processing system each being located in one of the three housing segments.

15. The sensor of claim 14, wherein the digital processing system is located in a middle segment of said three housing segments, with each of the ECG circuit and the impedance circuit being located in a respective outboard housing segment and being connected to the digital processing system via a respective flexible circuit.

16. The sensor of claim 1, wherein the ECG circuit and the impedance circuit generate the ECG waveform and the impedance waveform, respectively, using the same voltage sensed at the voltage-sensing electrode contact point.

17. The sensor of claim 1, further comprising a battery that powers the ECG system, the impedance system, and the digital processing system.

18. The sensor of claim 17, wherein the battery is located at a medial position along the length of the securement member.

19. The sensor of claim 17, wherein the battery is rechargeable.

20. The sensor of claim 1, further comprising a wireless transceiver.

21. The sensor of claim 20, wherein the wireless transceiver is located in the housing.

22. The sensor of claim 20, wherein the wireless transceiver is one of a Bluetooth®

transceiver and an 802.11-based transceiver.

23. A sensor for simultaneously measuring from a patient systolic blood pressure (SYS), stroke volume (SV), and an index correlating to fluid content in the thoracic cavity (TFI), the sensor comprising:

a sensing portion having a flexible housing;

an elongated securement member extending from the sensing portion and configured to position the sensing portion in a consistent location on the patient'"'"'s body for measurements made by the sensor,

at least one pair of electrode contact points disposed within the housing, with each pair of electrode contact points comprising a current-injecting electrode contact point and a voltage-sensing electrode contact point;

an analog ECG circuit disposed within the housing and in electrical contact with said at least one pair of electrode contact points, the ECG circuit configured to generate an analog ECG waveform based on sensed voltage;

an analog impedance circuit disposed within the housing and in electrical contact with said at least one pair of electrode contact points, the impedance circuit being configured to generate an analog impedance waveform based on sensed voltage;

a digital processing system disposed within the housing and comprising a microprocessor and an analog-to-digital converter, the digital processing system being configured to;

     1) digitize the analog ECG waveform to generate a digital ECG waveform, and

     2) digitize the analog impedance waveform to generate a digital impedance waveform;

a blood pressure-monitoring system disposed within the housing and configured to operate a first algorithm, which first algorithm collectively processes the digital impedance and digital ECG waveforms to determine a value of SYS;

a SV-monitoring system disposed within the housing and configured to operate a second algorithm, which second algorithm processes the digital impedance waveform to determine a value of SV; and

a thoracic fluid-measuring system disposed within the housing and configured to operate a third algorithm, which third algorithm processes the digital impedance waveform to determine a value of TFI.

24. A sensor for measuring trends in systolic blood pressure (SYS), stroke volume (SV), and an index correlating to fluid content in the thoracic cavity (TFI), the sensor comprising:

a sensing portion having a flexible housing;

an elongated securement member extending from the sensing portion and configured to position the sensing portion in a consistent location on the patient'"'"'s body for each of multiple measurements made at different times by the sensing portion,

at least one pair of electrode contact points disposed within the housing, with each pair of electrode contact points comprising a current-injecting electrode contact point and a voltage-sensing electrode contact point;

an analog ECG circuit disposed within the housing and in electrical contact with said at least one pair of electrode contact points, the ECG circuit configured to generate an analog ECG waveform based on sensed voltage;

an analog impedance circuit disposed within the housing and in electrical contact with said at least one pair of electrode contact points, the impedance circuit being configured to generate an analog impedance waveform based on sensed voltage;

a digital processing system disposed within the housing and comprising a microprocessor and an analog-to-digital converter, the digital processing system being configured to;

     1) digitize the analog ECG waveform to generate a digital ECG waveform, and

     2) digitize the analog impedance waveform to generate a digital impedance waveform;

a blood pressure-monitoring system disposed within the housing and configured to operate a first algorithm, which first algorithm collectively processes the digital impedance and digital ECG waveforms to determine a value of SYS;

a SV-monitoring system disposed within the housing and configured to operate a second algorithm, which second algorithm processes the digital impedance waveform to determine a value of SV;

a thoracic fluid-measuring system disposed within the housing and configured to operate a third algorithm, which third algorithm processes the digital impedance waveform to determine a value of TFI; and

a system for calculating trends in SYS, SV, and TFI by analyzing values of SYS, SV, and TFI from measurements made at different times by the sensing portion, wherein the sensing portion is positioned on the patient'"'"'s body for each measurement in substantially the same location by the elongated securement member.

25. A sensor for generating alerts indicating an onset of heart failure by measuring trends in systolic blood pressure (SYS), stroke volume (SV), and an index correlating to fluid content in the thoracic cavity (TFI), the sensor comprising:

a sensing portion having a flexible housing;

an elongated securement member extending from the sensing portion and configured to position the sensing portion in a consistent location on the patient'"'"'s body for each of multiple measurements made at different times by the sensing portion,

at least one pair of electrode contact points disposed within the housing, with each pair of electrode contact points comprising a current-injecting electrode contact point and a voltage-sensing electrode contact point;

an analog ECG circuit disposed within the housing and in electrical contact with said at least one pair of electrode contact points, the ECG circuit configured to generate an analog ECG waveform based on sensed voltage;

an analog impedance circuit disposed within the housing and in electrical contact with said at least one pair of electrode contact points, the impedance circuit being configured to generate an analog impedance waveform based on sensed voltage;

a digital processing system disposed within the housing and comprising a microprocessor and an analog-to-digital converter, the digital processing system being configured to;

     1) digitize the analog ECG waveform to generate a digital ECG waveform, and

     2) digitize the analog impedance waveform to generate a digital impedance waveform;

a blood pressure-monitoring system disposed within the housing and configured to operate a first algorithm, which first algorithm collectively processes the digital impedance and digital ECG waveforms to determine a value of SYS;

a SV-monitoring system disposed within the housing and configured to operate a second algorithm, which second algorithm processes the digital impedance waveform to determine a value of SV;

a thoracic fluid-measuring system disposed within the housing and configured to operate a third algorithm, which third algorithm processes the digital impedance waveform to determine a value of TFI;

a system for calculating trends in SYS, SV, and TFI by analyzing values of SYS, SV, and TFI measured at different times by the sensing portion, wherein the sensing portion is positioned on the patient'"'"'s body for each measurement in roughly the same location by the elongated securement member; and

a system for generating an alert indicating the onset of heart failure when TFI trends to a lower value, SV trends to a lower value, and SYS trends to a lower value.