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

• US 8,160,682 B2
• Filed: 02/06/2007
• Issued: 04/17/2012
• 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., Knight, Joseph A., Au-Yeung, Kit Yee, White, John Warren
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US11/703,311
• Publication Number:
  US 20070255153A1
• Time in Patent Office: 1,897 Days
• Field of Search: 600/507, 600/509, 600513-517, 600/523
• 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

One embodiment of the invention is a cardiac monitor having a housing; a plurality of electrodes within and extending from the housing; a state machine within the housing configured to digitialize and store in memory signals from the plurality of electrodes; a sealing surface and an adhesive on the sealing surface configured to form a watertight perimeter around the plurality of electrodes when the housing is affixed to a mammal. Another embodiment of the invention provides a continuous cardiac monitor having a housing; a surface on the housing adapted to be sealably engaged to a mammal; an adhesive on the surface that is adapted to remain affixed to the mammal for at least 7 days; at least two electrodes within the housing positioned to detect a cardiac information of the mammal while the surface is sealably engaged to the mammal; an electronic memory within the housing wherein, the electronic memory is sized to store at least 24 hours of continuous cardiac information; and wiring within the housing connecting the electronic memory to the electrodes.

Claims

1. A continuous cardiac monitor, comprising:

a watertight housing;

a surface on the housing configured to be sealably engaged to a mammal;

an adhesive on the surface configured to remain continuously affixed to the mammal for at least 7 days, without removal until completion of monitoring;

at least two electrodes permanently disposed within the housing, positioned to detect continuous cardiac rhythm information of the mammal while the surface is sealably engaged to the mammal, 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;

an action sequencer circuit within the housing and coupled with the at least two electrodes, the action sequencer circuit having no central processing unit for rhythm analysis and having an electronic memory configured to store all of the continuous cardiac rhythm information for the at least 7 days, the continuous cardiac rhythm information comprising both normal cardiac rhythm information and abnormal cardiac rhythm information; and

electrical connections within the housing connecting the electronic memory to the at least two electrodes throughout the at least 7 days,

wherein the watertight housing 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 cardiac monitor according to claim 1 wherein the same at least two electrodes are used to detect the continuous cardiac rhythm information of the mammal for the at least 7 days.

3. The cardiac monitor according to claim 1 wherein the adhesive is adapted to remain affixed to the mammal for at least 7 days without skin irritation.

4. The cardiac monitor of claim 1 wherein the adhesive is adapted to remain affixed to the mammal for at least 2 weeks.

5. The cardiac monitor of claim 1 wherein the adhesive is adapted to remain affixed to the mammal for at least 4 weeks.

6. The cardiac monitor according to claim 1 wherein the electrical connections are disposed entirely within the housing.

7. The cardiac monitor according to claim 1 wherein the action sequencer, the electrical connections and the electrodes are continuously connected throughout the at least 7 days.

8. The cardiac monitor of claim 1 further comprising a rim extending from a central portion of the housing, wherein the surface extends along the rim.

9. The cardiac monitor according to claim 8 wherein, when the adhesive is affixed to the mammal, the rim forms a watertight chamber around the at least two electrodes.

10. The cardiac monitor according to claim 1 further comprising:

a port for electronically accessing the electronic memory.

11. The cardiac monitor of claim 10 further comprising:

a seal on the port.

12. The cardiac monitor according to claim 1 further comprising:

An event trigger formed in the housing that is accessible while the adhesive is affixed to the mammal.

13. The cardiac monitor of claim 12 wherein actuation of the event trigger increases the fidelity of the continuous cardiac rhythm information stored in the electronic memory.

14. The cardiac monitor of claim 12 wherein an indication of event trigger activation is stored in the electronic memory with contemporaneous cardiac rhythm information.

15. The cardiac monitor of claim 1 further comprising an indicator that activates when cardiac rhythm information of the mammal is being detected.

16. The cardiac monitor of claim 1 further comprising an indicator that provides a continuous indication as long as cardiac rhythm information of the mammal is detected.

17. The cardiac monitor of claim 1 further comprising:

an indicator that activates when a monitoring period is completed.

18. The cardiac monitor according to claim 1 wherein at least a portion of the housing is colored to match the skin tone of the mammal.

19. The cardiac monitor according to claim 1 wherein the surface has a tapered thickness and extends beyond a portion of the housing containing the plurality of at least two electrodes.

20. The cardiac monitor according to claim 1 wherein the adhesive comprises a pressure sensitive adhesive selected from the group consisting of polyacrylates, polyisobutylenes, and polysiloxanes.

21. The cardiac monitor according to claim 1 wherein the housing is made of a flexible bio compatible polymer that provides a watertight enclosure for the action sequencer, and the electrical connections.

22. A continuous cardiac monitor, comprising:

a watertight housing;

a surface on the housing adapted to be sealably engaged to a mammal;

an adhesive on the surface configured to remain continuously affixed to the mammal for at least 7 days, without removal until completion of monitoring;

a rim extending from a central portion of the housing to form a watertight electrode chamber when the surface is affixed to the mammal;

first and second electrodes permanently disposed within the housing and positioned to detect continuous cardiac rhythm information of the mammal while the surface is sealably engaged to the mammal, wherein a distance between a center of the first electrode and a center of the second electrode is at least about 5 cm, and wherein the first and second electrodes are positioned within the watertight electrode chamber;

an action sequencer circuit within the housing having no central processing unit for rhythm analysis, wherein the action sequencer circuit operates to store the continuous cardiac rhythm information detected by the at least two electrodes into an electronic memory without determining whether the continuous cardiac rhythm information corresponds to a normal cardiac rhythm or an abnormal cardiac rhythm; and

electrical connections within the housing connecting the electronic memory to the at least two electrodes throughout the at least 7 days,

wherein the watertight housing 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.

23. The cardiac monitor according to claim 22 wherein the same first and second electrodes are used to detect the continuous cardiac rhythm information of the mammal for the at least 7 days.

24. The cardiac monitor according to claim 22 wherein the adhesive is adapted to remain affixed to the mammal for at least 7 days without skin irritation.

25. The cardiac monitor of claim 22 wherein the adhesive is adapted to remain affixed to the mammal for at least 2 weeks.

26. The cardiac monitor of claim 22 wherein the adhesive is adapted to remain affixed to the mammal for at least 4 weeks.

27. The cardiac monitor according to claim 22 wherein the electrical connections are disposed entirely within the housing.

28. The cardiac monitor according to claim 22 wherein the action sequencer circuit, the electrical connections and the electrodes are continuously connected throughout the at least 7 days.

29. The cardiac monitor according to claim 22 wherein the watertight chamber comprises separate watertight enclosures around each of the first and second electrodes.

30. The cardiac monitor according to claim 22 wherein the adhesive comprises a pressure sensitive adhesive selected from the group consisting of polyacrylates, polyisobutylenes, and polysiloxanes.

31. The cardiac monitor according to claim 22 wherein the watertight housing is made of a flexible bio compatible polymer that provides a watertight enclosure for the electronic memory and electrical connections.

32. The cardiac monitor according to claim 22, wherein the first and second electrodes protrude from the surface and away from the housing when the surface is not sealably engaged to the mammal.