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

• US 20070255153A1
• Filed: 02/06/2007
• Published: 11/01/2007
• Est. Priority Date: 02/06/2006
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Kumar, Uday, Au-Yeung, Kit, Knight, Joseph, White, John
• Granted Patent: US 8,160,682 B2
• Time in Patent Office: Days
• US Class Current: 600/515
• 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 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.

2. The cardiac monitor according to claim 1 wherein the same at least two electrodes are used to detect cardiac signals of the mammal for as long as the adhesive remains affixed to the mammal.

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 wiring is entirely within the housing.

7. The cardiac monitor according to claim 1 wherein the electronic memory, the wiring and the electrodes are a single, hard wired unit.

8. The cardiac monitor of claim 1 further comprising:

a rim extending from the surface on the housing.

9. The cardiac monitor according to claim 8 wherein a portion of each of the least two electrodes is within a portion of the surface bounded by the rim.

10. 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.

11. The cardiac monitor according to claim 10 wherein the watertight chamber comprises separate watertight enclosures around each electrode of the at least two electrodes.

12. The cardiac monitor according to claim 1 wherein when the adhesive is affixed to the mammal, a watertight chamber forms around the at least two electrodes.

13. The cardiac monitor according to claim 12 wherein the watertight chamber comprises separate watertight enclosures around each electrode of the at least two electrodes.

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

a port for electronically accessing the electronic memory.

15. The cardiac monitor of claim 14 further comprising:

a seal on the port.

16. 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.

17. The cardiac monitor of claim 16 wherein actuation of the event trigger increases the fidelity of the cardiac information stored in the electronic memory.

18. The cardiac monitor of claim 16 wherein an indication of event trigger activation is stored in the electronic memory with contemporaneous cardiac information.

19. The cardiac monitor of claim 1 further comprising:

an indicator that activates when cardiac information of the mammal is being detected.

20. The cardiac monitor of claim 1 further comprising:

an indicator that provides a continuous indication as long as cardiac information of the mammal is detected.

21. The cardiac monitor of claim 1 further comprising:

an indicator that activates when a monitoring period is completed.

22. 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.

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

24. The cardiac monitor according to claim 1 wherein the adhesive on the surface that is adapted to remain affixed to the mammal for at least 7 days is a pressure sensitive adhesive selected from the group consisting of:

polyacrylates, polyisobutylenes, and polysiloxanes.

25. 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 electronic memory and wiring.

26. A cardiac monitor, comprising:

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.

27. The cardiac monitor according to claim 26 wherein the portion of each of the plurality of electrodes that is in contact with the mammal has a rounded surface.

28. The cardiac monitor according to claim 26 wherein the sealing surface comprises a lip having a tapered thickness.

29. The cardiac monitor according to claim 28 wherein the thinnest portion of the sealing surface is in the outer perimeter of the sealing surface.

30. The cardiac monitor according to claim 28 wherein the thickness of the outer perimeter of the sealing surface is less than about 2 mm.

31. The cardiac monitor according to claim 28 wherein when the sealing surface is affixed to the mammal each electrode of the plurality of electrodes is contained within a separate watertight chamber.

32. The cardiac monitor according to claim 26 wherein the sealing surface comprises a rim extending from the self contained and sealed housing.

33. The cardiac monitor according to claim 32 wherein when the sealing surface is affixed to the mammal each electrode of the plurality of electrodes is contained within a separate watertight chamber.

34. The cardiac monitor according to claim 26 wherein adhesive on the sealing surface is a pressure sensitive adhesive suited to long term cardiac monitoring.

35. The cardiac monitor according to claim 26 wherein adhesive on the sealing surface is a pressure sensitive adhesive selected from the group consisting of:

polyacrylates, polyisobutylenes, and polysiloxanes.

36. The cardiac monitor according to claim 26 wherein the state machine within the housing is further configured to offload data stored in memory.

37. The cardiac monitor according to claim 26 wherein the housing is made of a flexible biocompatible polymer that provides a watertight enclosure for the state machine.