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

• US 9,179,851 B2
• Filed: 10/25/2012
• Issued: 11/10/2015
• 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:
  US13/660,614
• Publication Number:
  US 20130046162A1
• Time in Patent Office: 1,111 Days
• Field of Search: None
• US Class Current: 1/1
• 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 network to a center for analysis.

Claims

1. A system for use by a patient comprising:

a storage memory;

a processor;

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

a handheld device adapted to be carried by the patient and having a handheld transmitter, wherein the handheld transmitter transmits in near-real time the stored full disclosure ECG data with low latency almost immediately after the full disclosure ECG data is stored by the processor in the storage memory while the body sensor device is being worn, and wherein the handheld transmitter transmits via a cellular network a data stream of packet signals including the full disclosure ECG data stored in the storage memory;

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 signal, wherein the data center processor stores the full disclosure ECG data included in the received 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.

2. The system of claim 1 wherein the handheld transmitter streams the signal including the full disclosure ECG data almost immediately after the full disclosure ECG data is stored in the storage memory and at least one of the following:

wherein the data center streams the full disclosure ECG data included in the received signal to a technician port for near real-time viewing by a technician and wherein the data center streams the full disclosure ECG data included in the received signal to a physician port for near real-time viewing by a 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 such that the system has the ability to transmit to a transducer of the handheld device a voice instruction to the patient from a technician via the data center and/or from a physician via the data 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 handheld device comprises an integrated application and baseband processor in a pre-certified module.

9. 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.

10. 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 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.

11. 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.

12. The system of claim 1 wherein the storage memory comprises at least 30 days of full disclosure ECG data storage.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. A system for use by a patient comprising:

a storage memory;

a processor;

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

a handheld device adapted to be carried by the patient and having a handheld transmitter, wherein the handheld transmitter transmits in near-real time the stored full disclosure ECG data with low latency almost immediately after the full disclosure ECG data is stored by the processor in the storage memory while the body sensor device is being worn, and wherein the handheld transmitter transmits via a cellular network a data stream of packet signals, including the full disclosure ECG data stored in the storage memory;

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 signal, wherein the data center processor stores the full disclosure ECG data included in the received 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

wherein the 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 storage 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 network, and wherein the SADA program provides an alert to the patient when one or more events is detected.

19. A system for use by a patient, said system comprising:

a storage memory;

a processor;

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

a handheld device adapted to be carried by the patient and having a handheld transmitter, wherein the handheld transmitter transmits in near-real time the stored full disclosure ECG data with low latency almost immediately after the full disclosure ECG data is stored by the processor in the storage memory while the body sensor device is being worn, and wherein the handheld transmitter transmits via a cellular network a data stream of packet signals using a PDP (Packet Data Protocol) context re-connect algorithm including the full disclosure ECG data stored in the storage memory;

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

20. The system of claim 19 wherein the sensor circuit 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 a pulse oxygen level of the patient.

21. A method implemented by a processor comprising:

detecting by a body sensor device an analog full disclosure ECG signal of a patient while the body sensor device is being worn,

storing by the processor full disclosure ECG data corresponding to the detected analog signal in a storage memory,

transmitting in near-real time the stored full disclosure ECG data with low latency almost immediately after the full disclosure ECG data is stored by the processor in the storage memory while the body sensor device is being worn a signal including the full disclosure ECG data stored in the storage memory via a cellular network, said transmitted signal comprising a data stream of packet signals using a PDP (Packet Data Protocol) context re-connect algorithm;

receiving the transmitted signal,

storing the full disclosure ECG data included in the received signal in a data center storage memory, and

analyzing 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.

22. A system for use by a patient comprising:

a device adapted to be worn by the patient and having a sensor circuit, a processor, and a storage memory, wherein the sensor circuit is adapted to detect an analog full disclosure ECG signal of the patient while the device is being worn, and wherein the processor is adapted to store full disclosure ECG data corresponding to the detected analog signal in the storage memory;

the device further comprising a handheld transmitter, wherein the handheld transmitter is coupled to the memory and adapted to transmit in near-real time with low latency as the sensing circuit detects the ECG signal a signal including the full disclosure ECG data stored in the storage memory via a cellular network, and wherein the handheld transmitter is further adapted to transmit while the device is being worn a data stream of packet signals of the full disclosure ECG data stored in the storage memory via the cellular network; and

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 is adapted to receive the transmitted signal, wherein the data center processor is adapted to store the full disclosure ECG data included in the received signal in the data center storage memory, and wherein the data center processor is adapted to analyze 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.

23. The system of claim 22 further comprising:

a monitoring center linked to the data center, said monitoring center having a first port accessible by a technician for evaluating the full disclosure ECG data stored in the data center storage memory, wherein the monitoring center is adapted to determine any identified anomalies and to provide reports, and wherein the monitoring center has a second port accessible by a physician device for viewing the 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.

24. A system of claim 22 wherein the device comprises:

a body sensor device adapted to be worn by the patient and having the sensor circuit, a sensor processor, a sensor storage memory and a sensor transmitter, wherein the sensor circuit is adapted to detect an analog full disclosure ECG signal of the patient while the body sensor device is being worn, wherein the sensor processor is adapted to store full disclosure ECG data corresponding to the detected analog signal in the sensor storage memory, and wherein the sensor transmitter is adapted to transmit while the body sensor device is being worn 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 the handheld transmitter, wherein the handheld receiver is adapted to receive the full disclosure ECG signal, wherein the handheld processor is adapted to store the full disclosure ECG data included in the received full disclosure ECG signal in the handheld storage memory, and wherein the handheld transmitter is adapted to transmit a signal including the full disclosure ECG data stored in the handheld storage memory via a network.