Application US20190069800

SUBCUTANEOUS INSERTABLE CARDIAC MONITOR OPTIMIZED FOR LONG TERM, LOW AMPLITUDE ELECTROCARDIOGRAPHIC DATA COLLECTION
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US20190069800

1. A subcutaneous insertable cardiac monitor (ICM) optimized for long term, low amplitude, electrocardiographic (ECG) data collection, comprising: (3) (3)

an implantable housing comprised of a biocompatible material that is suitable for implantation within a living body;

at least one pair of ECG sensing electrodes provided on a ventral surface and on opposite ends of the implantable housing operatively placed to facilitate sensing in closest proximity to the low amplitude, low frequency content cardiac action potentials that are generated during atrial activation; and

electronic circuitry provided within the implantable housing, the electronic circuitry comprising: a low power microcontroller operable to execute under modular micro program control as specified in firmware;

an ECG front end circuit interfaced to the microcontroller and configured to capture the cardiac action potentials sensed by at least the pair of ECG sensing electrodes which are output as ECG signals, the ECG front end comprising: a signal lead operable to sense cardiac electrical potentials through one of the ECG sensing electrodes;

a reference lead operable to sense the cardiac electrical potentials through the other of the ECG sensing electrodes; and

a reference generator comprising a pair of resistors configured to inject a driven reference containing power supply noise and system noise into the body; and

a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the ECG signals.

2. A monitor according to claim 1, further comprising: (1) (4)

an analog-to-digital converter operable to convert the ECG signals into digital representations of the cardiac activation wave front amplitudes;

at least one low pass filter comprised in the firmware; and

at least one high pass filter comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through the at least one low pass filter and the at least one high pass filter following conversion into the digital representations.

3. A monitor according to claim 2, further comprising: (4) (2)

a transceiver interfaced to the microcontroller and operable to wirelessly interface to a wireless network;

a download station comprising: a data link operable to interface with the electronic circuitry via the wireless network; and

a download station controller configured to be removably connected to the electronic circuitry via the data link and operable to execute under programmable control as specified in software, the software comprising: a data retrieval module configured to retrieve the samples of the ECG signals from the non-volatile memory; and

a data storage module configured to store the retrieved samples of the ECG signals into local storage.

4. A monitor according to claim 3, the software further comprising: (0) (3)

at least one software-implemented low pass filter that corresponds to the at least one low pass filter comprised in the firmware;

at least one software-implemented high pass filter that corresponds to the at least one high pass filter comprised in the firmware; and

a phase distortion correction module configured to run the retrieved samples of the ECG signals through each of the at least one software-implemented low pass filter and the at least one software-implemented high pass filter in a direction reversed respectively from the at least one low pass filter comprised in the firmware and the at least one high pass filter comprised in the firmware.

5. A monitor according to claim 3, the software further comprising: (0) (2)

6. A monitor according to claim 3, the software further comprising: (0) (1)

7. A monitor according to claim 3, the software further comprising: (0) (1)

8. A monitor according to claim 1, further comprising: (0) (2)

9. A monitor according to claim 1, further comprising: (1) (1)

11. A subcutaneous implantable loop recorder for long term electrocardiographic (ECG) monitoring, comprising: (5) (4)

a hermetically sealed implantable housing and comprised of a biocompatible material that is suitable for implantation within a living body of a patient;

a power source comprised within the implantable housing; and

electronic circuitry provided within the housing, the electronic circuitry comprising: a low power microcontroller operable to execute under modular micro program control as specified in firmware;

a reference lead operable to sense the cardiac electrical potentials through the other of the ECG electrodes; and

a reference generator comprising a pair of resistors configured to inject a driven reference containing power supply noise and system noise into the body, the pair of resistance connected to the power source by a connection pair through which the pair of resistance receives the system noise and the power noise comprised in the driven reference signal; and

a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the ECG signals.

12. A recorder according to claim 11, further comprising: (2) (4)

an analog-to-digital converter operable to convert the ECG signals into digital representations of the cardiac activation wave front amplitudes;

at least one low pass filter comprised in the firmware; and

at least one high pass filter comprised in the firmware,

wherein the cardiac activation wave front amplitudes are passed through the at least one low pass filter and the at least one high pass filter following conversion into the digital representations.

13. A recorder according to claim 12, further comprising: (1) (2)

a transceiver interfaced to the microcontroller and operable to wirelessly interface to a wireless network;

a download station comprising: a data link operable to interface with the electronic circuitry via the wireless network; and

a data storage module configured to store the retrieved samples of the ECG signals into local storage.

14. A monitor according to claim 13, the software further comprising: (0) (3)

at least one software-implemented low pass filter that corresponds to the at least one low pass filter comprised in the firmware;

at least one software-implemented high pass filter that corresponds to the at least one high pass filter comprised in the firmware; and

15. A recorder according to claim 12, further comprising: (0) (2)

16. A recorder according to claim 11, further comprising: (0) (1)

17. A recorder in accordance with claim 11, wherein the electrocardiographic signals are output as an analog signal and the microcontroller acquires the samples by sampling the analog signal, each of the samples comprising a disruption in the analog signal. (1) (0)

19. A recorder in accordance with claim 11, wherein the power source is a long life direct current power cell comprised within the housing. (0)

20. A recorder in accordance with claim 11, the electronic circuitry further comprising: (0) (1)

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Application US20190069800

SUBCUTANEOUS INSERTABLE CARDIAC MONITOR OPTIMIZED FOR LONG TERM, LOW AMPLITUDE ELECTROCARDIOGRAPHIC DATA COLLECTION

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