Necklace-shaped physiological monitor

• US 10,314,496 B2
• Filed: 02/19/2014
• Issued: 06/11/2019
• Est. Priority Date: 02/20/2013
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: OtoSense, Inc. (Analog Devices, Inc.)
• Inventors: Banet, Matthew, Pede, Susan Meeks, Dhillon, Marshal Singh, Terry, Andrew, Hunt, Kenneth Robert
• Primary Examiner(s): Winakur, Eric F
• Application Number:
  US14/184,608
• Publication Number:
  US 20140235978A1
• Time in Patent Office: 1,938 Days
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• 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 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6822 Neck

Abstract

The invention provides a neck-worn sensor (referred to herein as the ‘necklace’) 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 necklace 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 system adapted to be worn entirely on a patient'"'"'s body for measuring a pulse oximetry (Sp02) value and an impedance-related parameter, comprising:

a pulse oximetry system connected to the system and adapted to be worn on a location of the body that is not on the patient'"'"'s hands or fingers and comprising a pulse oximetry circuit connected to an optical sensor comprising a first light source operating in the red spectral region, and a second light source operating in the infrared spectral region, the pulse oximetry circuit configured to generate a first waveform representing a signal generated with the first light source, and a second waveform representing a signal generated with the second light source;

an impedance system adapted to be worn completely on the patient'"'"'s torso without wrapping around the torso and connected to a first electrode that injects electrical current into the patient below the neck, and a second electrode that senses an impedance signal from the patient below the neck that results from the injected current, the first and second electrodes adapted to be adhesively attached to the patient'"'"'s torso;

a digital processing system adapted to be worn completely on the patient'"'"'s torso without wrapping around the torso, and adapted to be attached to the torso by the first and second electrodes, the digital processing system comprising a microprocessor configured to receive the first and second waveforms, or processed versions thereof, and configured to process the first and second waveforms, or processed versions thereof, to generate an Sp02 value, and further configured to receive the impedance signal and process it, or processed versions thereof, to generate the impedance-related parameter, and,

a flexible component adapted to be attached to the patient'"'"'s torso by the first and second electrodes and containing a first distal end and a second distal end, the flexible component connected to the pulse oximetry circuit, the impedance system, and the digital processing system.

2. The system of claim 1, wherein the flexible component further comprises a plurality of wires that connect the pulse oximetry circuit to the digital processing system.

3. The system of claim 1, wherein the flexible component comprises a flexible circuit that connects the pulse oximetry circuit to the digital processing system.

4. The system of claim 1, wherein the flexible component comprises at least two non-flexible circuit boards connected to each other with a flexible conductor.

5. The system of claim 4, wherein the pulse oximetry circuit is comprised by a first non-flexible circuit board, and the digital processing system is comprised by a second non-flexible circuit board.

6. The system of claim 4, wherein the flexible conductor is a flexible circuit.

7. The system of claim 4, wherein the flexible conductor is a plurality of wires.

8. The system of claim 1, wherein the pulse oximetry circuit comprises a circuit board comprising a first connector, and the optical sensor is connected to the pulse oximetry circuit by an oximetry cable that comprises a second connector mated to the first connector.

9. The system of claim 1, wherein the optical sensor comprises a clip configured to attach to the patient'"'"'s ear.

10. The system of claim 1, wherein the optical sensor comprises an adhesive component configured to attach to the patient'"'"'s ear.

11. The system of claim 1, wherein the flexible component comprises a battery system.

12. The system of claim 11, wherein the flexible component comprises a first connector and the battery system comprises a second connector, with the first connector mated to the second connector so that the battery system can be detachably removed.

13. The system of claim 1, further comprising a wireless transceiver that is one of a Bluetooth transceiver and an 802.11-based transceiver.

14. The system of claim 1, further comprising an ECG system.

15. The system of claim 14, wherein the ECG system is housed in the flexible component.