Non-invasive cardiac monitor and methods of using continuously recorded cardiac data

• US 8,150,502 B2
• Filed: 02/06/2007
• Issued: 04/03/2012
• Est. Priority Date: 02/06/2006
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Kumar, Uday N., Au-Yeung, Kit Yee, White, John Warren, Knight, Joseph A.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US11/703,428
• Publication Number:
  US 20070249946A1
• Time in Patent Office: 1,883 Days
• Field of Search: 607/507, 607/509, 607513-517, 607/523
• US Class Current: 600/509
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Embodiments of the invention provide methods of obtaining continuous cardiac information from a mammal. First, attach a self-contained, wearable, portable continuous cardiac monitor to the mammal to create a chamber containing electrodes used to detect cardiac signals from the mammal. Next, continuously detect without analyzing the cardiac signals from the mammal for at least 24 hours. Next, store information related to substantially all detected cardiac signals in the cardiac monitor.

Claims

1. A method of obtaining continuous cardiac rhythm information from a mammal, the method comprising:

providing a self-contained, wearable, portable cardiac monitor enclosed in a watertight housing configured for continuous attachment to the mammal for at least 7 days, wherein the cardiac monitor includes at least two electrodes used to detect the continuous cardiac rhythm information from the mammal and an adhesive configured for continuous attachment to the mammal for the at least 7 days, wherein a distance between a center of one of the electrodes and a center of another of the electrodes is at least about 5 cm;

detecting, using the at least two electrodes, the continuous cardiac rhythm information from the mammal continuously for the at least 7 days, including both normal cardiac rhythm information and abnormal cardiac rhythm information, and

operating an action sequencer having no central processing unit for rhythm analysis to store, for the at least 7 days, all of the continuous cardiac rhythm information detected during the at least 7 days, including the normal cardiac rhythm information and the abnormal cardiac rhythm information, without performing a rhythm analysis of the continuous cardiac rhythm information,

wherein the watertight housing of the cardiac monitor allows the mammal to bathe and otherwise expose the cardiac monitor to water without requiring removal of the monitor during the at least 7 days and thus provides for the detecting and storing of continuous cardiac rhythm information by the monitor throughout the at least 7 days, thereby allowing for a more complete assessment of all normal and abnormal cardiac rhythms and their total durations during the at least 7 days, based on continuous, uninterrupted cardiac rhythm information stored by the monitor.

2. The method according to claim 1, wherein the at least two electrodes, a power source and the memory of the self-contained, wearable, portable cardiac monitor are contained within the watertight housing.

3. The method according to claim 2, wherein the adhesive on the housing is configured to create separate, watertight chambers around each electrode when the housing is attached to the mammal.

4. The method according to claim 1, further comprising indicating that the cardiac monitor is operating, using an indicator on the cardiac monitor.

5. The method according to claim 4, wherein the indicating is performed after the cardiac monitor is attached to the mammal.

6. The method according to claim 4, wherein the indicating is performed during the operating step.

7. The method according to claim 1, further comprising retrieving all the stored cardiac rhythm information from the monitor.

8. The method according to claim 7, further comprising removing the cardiac monitor from the mammal before the retrieving step.

9. The method according to claim 7, further comprising analyzing the retrieved cardiac rhythm information to identify cardiac events.

10. The method according to claim 9 wherein the analyzing step is performed after the cardiac monitor is removed from the mammal.

11. The method according to claim 1, wherein the operating step is performed without transferring information between the housing and a device not attached to the mammal.

12. The method according to claim 1, wherein the operating step is performed without transferring information between the housing and a device not contained within the housing.

13. The method according to claim 1, further comprising processing the stored continuous cardiac rhythm information after the operating step to determine the presence of an arrhythmia.

14. The method according to claim 13, wherein processing the stored continuous cardiac rhythm information comprises using more than one algorithm to determine the presence of the arrhythmia.

15. The method according to claim 13, wherein processing the stored continuous cardiac rhythm information comprises determining the presence of the arrhythmia during a selected time interval.

16. The method according to claim 15, wherein the continuous cardiac rhythm information from the operating step is processed during the same selected time interval on more than one day.

17. The method according to claim 13, wherein processing the stored continuous cardiac rhythm information comprises determining the presence of the arrhythmia during a time interval indicated by the mammal during the detecting step.

18. The method according to claim 9 wherein the analyzing step is performed by a processor not contained within the housing.

19. The method according to claim 1, wherein the same at least two electrodes are used while performing the operating step for the at least 7 days.

20. The method according to claim 3, wherein the housing comprises separate rims surrounding each of the two electrodes, and wherein the rims are configured to create the separate watertight chambers around the electrodes.