System and method for high resolution wireless full disclosure ECG episode monitoring and analysis

• US 8,301,236 B2
• Filed: 05/06/2010
• Issued: 10/30/2012
• Est. Priority Date: 05/22/2009
• Status: Active Grant

• Current Assignee: Cardionet LLC (Koninklijke Philips N.V.)
• Original Assignee: Biomedical Systems Corporation (Explorer Holdings, Inc.)
• Inventors: Baumann, Eric, Korzinov, Lev, Bondietti, David, Ott, James E.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US12/774,781
• Publication Number:
  US 20100298664A1
• Time in Patent Office: 908 Days
• Field of Search: None
• US Class Current: 600/523
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

High resolution full disclosure ECG data is transferred from a body sensor device to a handheld device via a wireless protocol. The handheld device transfers the full disclosure ECG data via a cellular network to a data center for analysis. A monitoring center communicating with the data center facilitates technician and physician review and interactions.

Claims

1. A system for use by a patient having access to a cellular network comprising:

a body sensor device adapted to be worn by the patient and having a sensor circuit, a sensor processor, a sensor storage memory and a sensor transmitter, wherein the sensor circuit detects an analog full disclosure ECG signal of the patient, wherein the sensor processor stores full disclosure ECG data corresponding to the detected analog signal in the sensor storage memory, and wherein the sensor transmitter transmits a full disclosure ECG signal including the full disclosure ECG data stored in the sensor storage memory;

a handheld device adapted to be carried by the patient and having a handheld storage memory, a handheld processor, a handheld receiver and a handheld transmitter, wherein the handheld receiver receives the full disclosure ECG signal, wherein the handheld processor stores the full disclosure ECG data included in the received full disclosure ECG signal in the handheld storage memory, and wherein the handheld transmitter transmits a packet signal including the full disclosure ECG data stored in the handheld storage memory via the cellular network;

a data center remote from the patient and having a data center receiver, a data center processor and a data center storage memory, wherein the data center receiver receives the packet signal, wherein the data center processor stores the full disclosure ECG data included in the received packet signal in the data center storage memory, and wherein the data center processor analyzes the full disclosure ECG data stored in the data center storage memory to identify any anomalies in the full disclosure ECG data stored in the data center storage memory;

a monitoring center linked to the data center and having a technician port accessible by a technician device for evaluating the full disclosure ECG data stored in the data center storage memory, for considering any identified anomalies and for providing reports, and a physician port accessible by a physician for viewing provided technician reports and for viewing the full disclosure ECG data stored in the data center storage memory,

whereby the system has the ability to telemeter full disclosure ECG data from remote locations.

2. The system of claim 1 wherein the sensor transmitter streams the full disclosure ECG signal including the full disclosure ECG data in near real-time almost immediately after the detected full disclosure ECG data is stored in the sensor storage memory, wherein the handheld transmitter streams the packet signal including the full disclosure ECG data almost immediately after the full disclosure ECG data is stored in the handheld storage memory and wherein the data center streams the full disclosure ECG data included in the received packet signal to the technician port for near real-time viewing by the technician and/or wherein the data center streams the full disclosure ECG data included in the received packet signal to the physician port for near real-time viewing by the physician.

3. The system of claim 1 wherein the data center presents the technician or physician with an option to view full disclosure ECG data which is previous to and/or subsequent to the full disclosure data being viewed.

4. The system of claim 1 wherein the data center processes the full disclosure ECG data from multiple patients simultaneously.

5. The system of claim 1 further comprising two way communication between the handheld device and the data center and between the data center and the monitoring center such that the system has the ability to transmit to a transducer of the handheld device a voice instruction to the patient from the technician via the monitoring center and/or from the physician via the monitoring center to meet a particular clinical need.

6. The system of claim 1 wherein the full disclosure ECG signal acquired by the body sensor device comprises at least 2 channels of data from the sensor, each channel providing a high resolution full disclosure ECG acquisition signal.

7. The system of claim 1 wherein the full disclosure ECG signal acquired by the body sensor device comprises at least 2 channels, each providing a dynamic range of +/−

40 mV.

8. The system of claim 1 wherein the data center incorporates a muscle artifact rejection algorithm for noise rejection.

9. The system of claim 1 wherein the handheld device comprises an integrated application and baseband processor in a pre-certified module.

10. The system of claim 1 wherein the handheld device accesses a WAN and includes at least one of:

Graduated back off and PDP context re-connect algorithms;

Use of adaptive full disclosure ECG resolution to reduce data payload;

Use of lossless compression to reduce data payload; and

Ability to connect to a home based POTS modem with a class 1 BT Radio incorporated in the handheld device.

11. The system of claim 1 further comprising a modem connected to the data center via the Internet or a phone line, wherein the handheld transmitter transmits a second signal including the full disclosure ECG data to the modem when the handheld is not communicating with the cellular network and wherein said modem has a receiver for receiving the second signal including the full disclosure ECG data and a transmitter for transmitting the full disclosure ECG data to the data center via the Internet or the phone line.

12. The system of claim 1 wherein the handheld transmitter transmits the packet signal with low latency.

13. The system of claim 1 wherein the body sensor device is battery powered, wherein the handheld device is battery powered, wherein the body sensor device transmits to the handheld device information indicative of its battery level, and wherein the handheld device includes a display for displaying the battery levels of both the body sensor device and the handheld device.

14. The system of claim 1 wherein the body sensor device and/or the handheld storage memory comprises at least 30 days of full disclosure full disclosure ECG data storage.

15. The system of claim 1 wherein the body sensor device and the handheld device communicate via a low power local RF link protocol for power saving.

16. The system of claim 1 wherein the sensor processor includes a serious arrhythmia detection algorithm (SADA) which is executed by the processor, said SADA program analyzing at a low resolution in near real-time the full disclosure ECG data stored in its memory to detect any predefined arrhythmia events when the sensor device and the handheld device are not communicating or when the handheld device is not communicating with the cellular network, and wherein the SADA program provides an alert to the patient when one or more events is detected.

17. The system of claim 1 wherein the data center processor provides a full disclosure navigable waveform that provides drill down access to portions of a particular day'"'"'s full disclosure ECG data by presenting a secondary measure such as HR or noise level of the full disclosure ECG data.

18. The system of claim 1 wherein the data center permits the technician and/or the physician to view the stored full disclosure ECG data in low resolution and to drill down selected full disclosure ECG data at a higher resolution.

19. The system of claim 1 wherein the data center permits the technician and/or the physician to view the stored full disclosure ECG data of a particular period of time and to view related ECG data before or after the particular period of time.

20. The system of claim 1 further comprising a plurality of sensor devices and a corresponding plurality of handheld devices, each handheld device transmitting a full disclosure ECG data signal to the data center, wherein the data center includes a plurality of algorithm instances for identifying anomalies in the ECG data and wherein one instance is executed and applied to each full disclosure ECG data signal received by the data center.

21. A system for use by a patient having access to a cellular network, said system comprising:

a body sensor device adapted to be worn by the patient and having a sensor circuit, a sensor processor, a sensor storage memory and a sensor transmitter, wherein the sensor circuit detects a full disclosure analog signal of a parameter indicative of a body function of the patient, wherein the sensor processor stores full disclosure data corresponding to the detected analog signal in the sensor storage memory, and wherein the sensor transmitter transmits a full disclosure signal including the full disclosure data stored in the sensor storage memory;

a handheld device adapted to be carried by the patient and having a handheld storage memory, a handheld processor, a handheld receiver and a handheld transmitter, wherein the handheld receiver receives the full disclosure signal, wherein the handheld processor stores the full disclosure data included in the received full disclosure signal in the handheld storage memory, and wherein the handheld transmitter transmits a packet signal including the full disclosure data stored in the handheld storage memory via the cellular network;

a data center remote from the patient and having a data center receiver, a data center processor and a data center storage memory, wherein the data center receiver receives the packet signal, wherein the data center processor stores the full disclosure data included in the received packet signal in the data center storage memory, and wherein the data center processor analyzes the full disclosure data stored in the data center storage memory to identify any parameter anomalies in the full disclosure data stored in the data center storage memory;

a monitoring center linked to the data center and having a technician port accessible by a technician device for evaluating the full disclosure data stored in the data center storage memory, for considering any identified anomalies and for providing reports, and a physician port accessible by a physician for viewing provided technician reports and for viewing the full disclosure data stored in the data center storage memory,

whereby the system has the ability to telemeter full disclosure parameter data from remote locations.

22. The system of claim 21 wherein the sensor comprises at least one of:

a sensor circuit detecting a full disclosure analog ECG signal indicative of the heart of the patient;

a sensor circuit detecting a full disclosure analog blood pressure signal indicative of the blood pressure of the patient;

a sensor circuit detecting a full disclosure analog body temperature signal indicative of the body temperature of the patient;

a sensor circuit detecting a full disclosure analog uterine contraction signal indicative of the contractions of the uterine of the patient;

a sensor circuit detecting a full disclosure analog signal indicative of the level of the patient.