Wire Free Self-Contained Single or Multi-Lead Ambulatory ECG Recording and Analyzing Device, System and Method Thereof
First Claim
1. A self contained, wire-free, ambulatory ECG device for non-invasive continuous recording and analysis of ECG signals, the device comprising:
- a device body having a flexible substrate, the substrate having embedded electronic components including a microcontroller, a memory embedded with a diagnosis software, a second memory for storing indexed ECG data, a real time clock, a functional switch, electronic circuitry, a plurality of conductors, a battery, and an interface for data communication;
two or more snap connectors integrated onto the substrate for engaging with two or more ECG electrodes separate from the device, the electrodes having a means to adhere to the skin of the body;
wherein the device body is detachable from the electrodes via the snap connectors and reusable with two or more new electrodes for a subsequent recording and analysis.
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Abstract
A device, method and system are provided to continuously store and analyze single or multi-lead ambulatory ECG signals. Each ECG device is self-contained, wire-free, reusable and capable of non-invasive continuous recording, analyzing and indexing of ECG data independently. A pair of snap connectors on the device body attaches the device to standard ECG electrodes to minimize noise caused by the wires. Each device contains a real-time clock to link the ECG data and a detected cardiac event with actual date and time. The device contains a USB port to upload the data to a host system. Multiple such devices are wearable by a patient to form a multi-lead ECG system. There is provided a method to continuously record and analyze ECG data using a self-contained, wire-free ECG device or multiple such devices; and further a method to synchronize the ECG data in multiple devices to realize multi-lead ECG recording.
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Citations
22 Claims
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1. A self contained, wire-free, ambulatory ECG device for non-invasive continuous recording and analysis of ECG signals, the device comprising:
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a device body having a flexible substrate, the substrate having embedded electronic components including a microcontroller, a memory embedded with a diagnosis software, a second memory for storing indexed ECG data, a real time clock, a functional switch, electronic circuitry, a plurality of conductors, a battery, and an interface for data communication; two or more snap connectors integrated onto the substrate for engaging with two or more ECG electrodes separate from the device, the electrodes having a means to adhere to the skin of the body; wherein the device body is detachable from the electrodes via the snap connectors and reusable with two or more new electrodes for a subsequent recording and analysis. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. An ECG monitoring and recording system comprising:
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a self-contained, wire free, ambulatory single lead ECG device which continuously records and analyzes ECG data, the device comprising; electronic components operatively coupled and embedded within a flexible substrate of the device, the components including an embedded microcontroller, circuitry and conductors, a real time clock, a data communication interface, memory and software, and at least two electrode snap connectors disposed on the substrate of the device, and wherein the device indexes the ECG data and records the indexed ECG data; a pair of electrodes for engaging with the snap connectors of the device, each of the pair of electrodes having a means for adhering to a patient'"'"'s skin; a computer host system having one or more processors for executing commands that direct operations of the computer system and software executing within the one or more processors that directs the one or more processors to; obtain recorded indexed ECG data from the device through the data communications interface, the indexed ECG data comprising raw ECG data, analyzed ECG data and real time information; extract the analyzed ECG data and the real time information from the indexed ECG data; and display the analyzed ECG data from the device.
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12. A multi-lead ECG monitoring and recording system comprising:
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a plurality of self-contained, wire free, ambulatory single lead ECG devices, each device continuously records and analyzes ECG data, each device comprising electronic components operatively coupled, including an embedded microcontroller, circuitry and conductors, a real time clock, a functional switch, a battery, a data communication interface, memory and software, embedded within a flexible substrate of the device, each device having at least two electrode snap connectors disposed on the substrate of the device, and wherein each device indexes its ECG data and records its indexed ECG data; a pair of electrodes for engaging with the snap connectors of the device, each of the pair of electrodes are adhered to a patient'"'"'s skin; a computer host system having one or more processors for executing commands that direct operations of the computer system and software executing within the one or more processors that directs the one or more processors to; obtain recorded indexed ECG data from each device through the data communications interface, the indexed ECG data comprising raw ECG data, analyzed ECG data and real time information; extract the analyzed ECG data and real time information from the indexed data of each device; calculate a relative time offset amongst each real time clock of each device; update all real time analyzed ECG data of the devices with the calculated time offset; correlate the analyzed ECG data from each device into a multi-lead ECG data array; combine the analyzed ECG data of each of the devices and display the analyzed ECG data from the devices. - View Dependent Claims (13, 14, 15, 16, 17, 18)
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19. A computer implemented method for continuous ambulatory ECG recording and analysis, using a wire free, self contained ambulatory ECG device having embedded electronic components operatively coupled, including a microcontroller, memory with an embedded diagnosis algorithm, a real time clock, a functional switch, a battery, electronic circuitry, a plurality of conductors, and an interface for data communication, the method comprising the steps of:
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adhering a pair of electrodes onto a patient'"'"'s skin; engaging the device with the pair of electrodes through a set of electrode snap connectors integrated onto a bottom side of a flexible substrate of the device; acquiring ECG signals through the electrodes and recording the signals as raw ECG data temporarily in a memory; electronically analyzing the raw ECG data in real-time resulting in analyzed ECG data, through the microcontroller; electronically registering the analyzed ECG data with a time stamp with the embedded real time clock, through the microcontroller; electronically indexing the raw ECG data with the analyzed ECG data and the real time clock, through the microcontroller; and electronically storing the indexed and analyzed ECG data into the memory. - View Dependent Claims (20, 21, 22)
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Specification