Computer-implemented system and method for evaluating ambulatory electrocardiographic monitoring of cardiac rhythm disorders

• US 9,037,477 B2
• Filed: 10/08/2010
• Issued: 05/19/2015
• Est. Priority Date: 10/08/2010
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Inventors: Bardy, Gust H., Bishay, Jon Mikalson
• Primary Examiner(s): Ng, Jonathan K
• Application Number:
  US12/901,461
• Publication Number:
  US 20120088998A1
• Time in Patent Office: 1,684 Days
• Field of Search: 705 2- 3
• US Class Current: 705/2
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

A computer-implemented method for evaluating ambulatory electrocardiographic (ECG) monitoring of cardiac rhythm disorders is provided. A patient is registered online and medical records for the patient are assembled. An ambulatory ECG monitor that includes leadless integrated sensing electrodes independently suspended from a flexible housing, is registered to the patient. An electrocardiogram is retrieved from the recording circuitry. The electrocardiogram and the medical records are evaluated against diagnostic criteria. Upon making a finding when the diagnostic criteria is met, the patient is referred to a cardiac rhythm specialist online, which includes sending the cardiac rhythm abnormality finding. As a result, both physicians and patients enjoy an ease-of-use not found with conventional ambulatory ECG monitors. By bypassing determining whether a referral is needed and separately establishing the referral, patients can be treated more completely and more rapidly than through conventional patient referral, especially for serious illness, with less cost and less delay.

Claims

1. A computer-implemented method for evaluating ambulatory electrocardiographic (ECG) monitoring of cardiac rhythm disorders, comprising the steps of:

registering a patient online and assembling medical records for the patient;

registering an ambulatory ECG monitor, including a monitor RFID tag, that comprises leadless integrated sensing electrodes independently suspended from a flexible housing that encloses an ECG recording circuitry connected to the electrodes, to the patient;

assigning a tracking number to the monitor in relation to an ambulatory ECG monitoring and matching the tracking number to the patient;

associating the tracking number with an envelope RFID tag accompanying an envelope in which to send the monitor for an evaluation upon a completion of the ambulatory ECG monitoring;

tracking the physical whereabouts of the monitor through the tracking number of the monitor RFID tag and the envelope RFID tag prior to receipt of the monitor for the evaluation;

retrieving an electrocardiogram from the recording circuitry;

evaluating the electrocardiogram and the medical records for the patient against diagnostic criteria comprising statistical correlations of cardiac disease states and cardiac rhythm patterns using a processor;

following up with the patient within a fixed, predetermined amount of time after evaluating the electrocardiogram and medical records; and

upon making a finding of a cardiac rhythm abnormality when the diagnostic criteria is met, automatically referring the patient to a cardiac rhythm specialist online, including sending the cardiac rhythm abnormality finding and automatically scheduling an appointment for the patient with the cardiac rhythm specialist,

wherein the steps are performed by a suitably programmed computer.

2. A method according to claim 1, further comprising:

providing the tracking number to the patient; and

in response to an online inquiry by the patient, determining a status of the evaluation and referral keyed to the tracking number.

3. A method according to claim 2, wherein the status concerns one or more of the ambulatory ECG monitoring, the retrieval of the electrocardiogram, the evaluation of the electrocardiogram, the finding of a cardiac rhythm abnormality, and the referral to a cardiac rhythm specialist.

4. A method according to claim 3, further comprising:

setting a time period for one or more of the completion of the ambulatory ECG monitoring, the retrieval of the electrocardiogram, the evaluation of the electrocardiogram, the finding of a cardiac rhythm abnormality, and the referral to a cardiac rhythm specialist; and

undertaking a follow up upon expiry of one or more of the time periods.

5. A method according to claim 1, further comprising:

electronically sending the electrocardiogram for the evaluation from the recording circuitry directly upon the completion of the ambulatory ECG monitoring.

6. A method according to claim 1, wherein the monitor is placed on the patient'"'"'s chest at midline, covering the center third of the sternum and centered between the manubrium and the xiphoid process on the inferior border of the sternum.

7. A computer-implemented method for diagnosing cardiac rhythm disorders through recorded ambulatory electrocardiograms, comprising the steps of:

registering a patient online with a referral center and assembling medical records for the patient in a centralized database maintained by the referral center;

registering an ambulatory electrocardiographic (ECG) monitor, including a monitor RFID tag, that comprises leadless integrated sensing electrodes independently suspended from a flexible housing that encloses an ECG recording circuitry connected to the electrodes, to the patient;

assigning a tracking number to the monitor in relation to an ambulatory ECG monitoring and matching the tracking number to the patient in the database;

associating the tracking number with an envelope RFID tag accompanying an envelope in which to send the monitor for an evaluation upon a completion of the ambulatory ECG monitoring;

tracking the physical whereabouts of the monitor through the tracking number of the monitor RFID tag and the envelope RFID tag prior to receipt of the monitor for the evaluation;

following the completion of the ambulatory ECG monitoring by the patient, performing analysis and referral through the referral center, comprising;

providing a status upon demand regarding the analysis and referral to the patient keyed to the tracking number;

retrieving an electrocardiogram from the recording circuitry; and

evaluating the electrocardiogram and the medical records for the patient against diagnostic criteria comprising statistical correlations of cardiac disease states and cardiac rhythm patterns using a processor;

following up with the patient within a fixed, predetermined amount of time after evaluating the electrocardiogram and medical records; and

upon making a finding of a cardiac rhythm abnormality when the diagnostic criteria is met, automatically undertaking a direct referral, comprising;

setting an appointment for the patient with a cardiac rhythm specialist online, including sending the electrocardiogram, medical records, and cardiac rhythm abnormality finding; and

notifying the patient of the appointment with confirmation,

wherein the steps are performed by a suitably programmed computer.

8. A method according to claim 7, the diagnostic criteria further comprising at least one of:

identifying physiological symptoms comprising one or more of arrhythmic episodes and ectopic episodes, as recorded during the monitoring period;

determining a mode of onset of each arrhythmic episode;

determining a mode of termination of each ectopic episode; and

comparing the physiological symptoms, the mode of onset of each arrhythmic episode, and the mode of termination of each ectopic episode to statistical correlations of cardiac rhythm patterns indicating possible cardiac disease states.

9. A method according to claim 7, further comprising one or more of:

timing receipt of the monitor from the patient following the completion of the ambulatory ECG monitoring;

timing performance of the analysis and referral of the patient;

timing notifying the patient;

timing sending of the sending the electrocardiogram, medical records, and cardiac rhythm abnormality finding; and

timing confirmation of the patient'"'"'s appointment, wherein a time period for follow up is triggered if any one of the timings exceed a set time period.

10. A method according to claim 9, wherein the follow up is undertaken by the referral center.

11. A method according to claim 7, further comprising:

registering an electronically-stored diary to the patient with the referral center under the tracking number;

recording entries into the diary as provided by the patient contemporaneous to the ambulatory ECG monitoring;

temporally matching the diary entries to cardiac rhythm patterns found in the electrocardiogram; and

pairing the physiological symptoms with the diary entries.

12. A method according to claim 11, further comprising one or more of:

directly recording the diary entries into the diary in electronic form;

electronically transcribing the diary entries from dictated verbal form; and

electronically transcribing the diary entries from written form.

13. A method according to claim 7, further comprising:

sensing disconnection of the recording circuitry from the electrodes during the monitoring; and

sending reconnection of the recording circuitry to electrodes and resuming the monitoring.

14. A method according to claim 7, wherein the medical records for the patient comprise one or more of monitored patient identification data, prior electrocardiograms, laboratory results, physical examination results, exercise testing results, and medical history.

15. A method according to claim 7, wherein the monitor is placed on the patient'"'"'s chest at midline, covering the center third of the sternum and centered between the manubrium and the xiphoid process on the inferior border of the sternum.

16. A computer-implemented method for automated diagnosis and follow up ambulatory electrocardiographic monitoring, comprising the steps of:

enrolling a patient in a referral center;

registering an ambulatory electrocardiographic (ECG) monitor, including a monitor RFID tag, to the patient;

assigning a tracking number to the monitor in relation to an ambulatory ECG monitoring and matching the tracking number to the patient;

associating the tracking number with an envelope RFID tag accompanying an envelope in which to send the monitor for an evaluation upon a completion of the ambulatory ECG monitoring;

tracking the physical whereabouts of the monitor through the tracking number of the monitor RFID tag and the envelope RFID tag prior to receipt of the monitor for the evaluation;

retrieving an electrocardiogram from a recording circuitry of the ambulatory electrocardiographic monitor following the ambulatory ECG monitoring;

evaluating the electrocardiogram against diagnostic criteria comprising statistical correlations of cardiac disease states and cardiac rhythm patterns appearing in the electrocardiogram during the ambulatory monitoring using a processor; and

automatically performing follow up care of the patient through the referral center based on outcomes from the evaluation of the electrocardiogram within a fixed, predetermined amount of time after evaluating the electrocardiogram,

wherein the steps are performed by a suitably programmed computer.

17. A method according to claim 16, further comprising:

upon making a finding of a cardiac rhythm abnormality when the diagnostic criteria is met, directly referring the monitored patient and providing the finding and electrocardiogram to a cardiac rhythm specialist online.

18. A method according to claim 16, further comprising:

upon making a finding of a non-cardiac rhythm abnormality, directly referring the monitored patient and providing the finding and electrocardiogram to a non-cardiac rhythm specialist online.

19. A method according to claim 16, further comprising:

upon making a finding of no apparent health abnormalities based on the electrocardiogram, notifying the monitored patient.

20. A method according to claim 16, wherein the monitor is placed on the patient'"'"'s chest at midline, covering the center third of the sternum and centered between the manubrium and the xiphoid process on the inferior border of the sternum.