Ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation

• US 9,717,433 B2
• Filed: 09/16/2014
• Issued: 08/01/2017
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Felix, Jason, Bishay, Jon Mikalson, Bardy, Gust H.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US14/488,256
• Publication Number:
  US 20160007875A1
• Time in Patent Office: 1,050 Days
• Field of Search: 600382, 600391-393, 600509
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence

Abstract

Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally on the patient'"'"'s chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.

Claims

1. An ambulatory electrocardiography monitor optimized for capturing low amplitude cardiac action potential propagation using embedded electrodes, comprising:

a disposable extended wear electrode patch comprising;

a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection, the flexible backing further comprising a distal end and a proximal end, each end of the flexible backing comprising an adhesive contact surface adapted to serve as a crimp relief;

a distal electrically conductive adhesive positioned on the distal end and configured for directly contacting a patient;

a proximal electrically conductive adhesive positioned on the proximal end and configured for directly contacting the patient;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode by a portion of the one wire embedded within the distal electrically conductive adhesive on the distal end, the one wire continuing back along an axial path through the narrow longitudinal midsection, another one of the wires forming another electrocardiographic electrode by a portion of the another wire embedded within the proximal electrically conductive adhesive on the proximal end, wherein the embedded portion of the one wire receives electrical potentials of the patient directly from the distal electrically conductive adhesive and the embedded portion of the another wire receives electrical potentials of the patient directly from the proximal electrically conductive adhesive; and

a non-conductive receptacle affixed to a non-contacting surface of the flexible backing and comprising an electro mechanical docking interface, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of the flexile wires to an ambulatory electrocardiography monitor recorder; and

wherein the ambulatory electrocardiography monitor further comprises the ambulatory electrocardiography monitor recorder, the ambulatory electrocardiography monitor recorder comprising;

a wearable housing adapted to securely fit into the non-conductive receptacle; and

electronic circuitry provided within the wearable housing and comprising an external interface configured to be removably connected to the electrocardiographic electrodes via the docking interface, further comprising;

a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware;

an electrocardiographic front end circuit under the control of the microcontroller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the microcontroller as electrocardiographic signals representative of amplitudes of the action potential propagation; and

non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals throughout the extended period.

2. An ambulatory electrocardiography monitor in accordance with claim 1, wherein the electrocardiographic front end circuit is optimized to sense P-wave signals in the electrocardiographic signals.

3. An ambulatory electrocardiography monitor in accordance with claim 1, wherein the disposable extended wear electrode patch is disposed for being adhered to the patient'"'"'s chest positioned axially along the midline of the sternum with one of the electrocardiographic electrodes overlying a region of the manubrium and one of the electrocardiographic electrodes overlying a region of the lower sternum.

4. An ambulatory electrocardiography monitor in accordance with claim 1, wherein the electronic circuitry is configured so that an orientation of the ambulatory electrocardiography monitor recorder is compensated if the ambulatory electrocardiography monitor recorder is installed upside down.

5. An ambulatory electrocardiography monitor in accordance with claim 1, the microcontroller further comprising:

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of the amplitudes;

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

at least one high pass filter comprised in the firmware,

wherein the 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.

6. An ambulatory electrocardiography monitor in accordance with claim 5, the microcontroller further comprising:

a compression algorithm comprised in the firmware,

wherein the amplitudes are compressed with the compression algorithm into compressed digital representations prior to being stored in the non-volatile memory.

7. An ambulatory electrocardiography monitor in accordance with claim 1, further comprising:

a direct current power cell comprised in the non-conductive receptacle and connected to the docking interface; and

the external interface further configured to removably and electronically couple the power cell with the electronic circuitry through the docking interface.

8. An ambulatory electrocardiography monitor according to claim 1, further comprising:

a plurality of holes arranged at regularly spaced intervals along an axial path defined between the non-conductive receptacle and the distal end of the flexible backing, through which one of the flexile wires is threaded.

9. An ambulatory electrocardiography monitor according to claim 1, further comprising:

a layer of insulation material covering at least part of a surface of the flexile wires.

10. An ambulatory electrocardiography monitor according to claim 1, further comprising:

a moisture-resistant seal formed on the non-conductive receptacle circumferentially about the electrode terminals and adapted to substantially protect the ambulatory electrocardiography monitor recorder against moisture intrusion.

11. An extended wear electrocardiography patch, comprising:

a flexible backing formed of an elongated strip of stretchable material with a narrow longitudinal midsection evenly tapering inward from a distal end and a proximal end, the elongated strip adherable only to a contact surface defined on each of the ends;

a distal electrically conductive adhesive positioned on the distal end and configured for directly contacting a patient;

a proximal electrically conductive adhesive positioned on the proximal end and configured for directly contacting the patient;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode by a portion of the wire embedded within the distal electrically conductive adhesive on the distal end, the one wire continuing back along an axial path through the narrow longitudinal midsection, another one of the wires forming another electrocardiographic electrode by a portion of the another wire embedded within the proximal electrically conductive adhesive, wherein the embedded portion of the one wire receives electrical potentials of the patient directly from the distal electrically conductive adhesive and the embedded portion of the another wire receives electrical potentials of the patient directly from the proximal electrically conductive adhesive;

a circuit board affixed on the proximal end of the elongated strip, comprising a battery compartment operable to hold a battery for powering an electrocardiography monitor recorder, and one or more electrical pads operable to electrically couple the electrocardiography monitor recorder with the flexile wires; and

a non-conductive receptacle securely adhered to one of the ends of the elongated strip opposite the contact surface and formed to removably receive the electrocardiography monitor recorder.

12. An electrode patch according to claim 11, further comprising:

one of the electrocardiographic electrodes being disposed for being adhered to a region overlying the lower sternum on the patient'"'"'s chest; and

an other of the electrocardiographic electrodes being disposed for being adhered to a region near the manubrium upwards on the patient'"'"'s chest oriented centrally (in the midline) along the sternum from the one electrocardiographic electrode.

13. An electrode patch according to claim 11, further comprising:

a non-irritating adhesive dressing at least partially coated on each end of the elongated strip on the contact surface.

14. An electrode patch according to claim 11, further comprising:

a plurality of holes arranged at regularly spaced intervals along an axial path defined between the circuit board and the distal end of the flexible backing, through which the one of the flexible wires is threaded.

15. An electrode patch according to claim 11, further comprising:

a layer of insulation material covering at least part of a surface of the flexile wires.

16. An electrode patch according to claim 11, further comprising:

a moisture-resistant seal formed on the non-conductive receptacle circumferentially about electrical pads and adapted to substantially protect the electrocardiography monitor recorder against moisture intrusion when the electrocardiography monitor recorder is receives in the non-conductive receptacle.

17. An electrode patch according to claim 11, further comprising:

the electrocardiography monitor recorder comprising;

a wearable housing adapted to securely fit into the non-conductive receptacle; and

electronic circuitry provided within the wearable housing and comprising an external interface configured to be removably connected to the electrocardiographic electrodes via the one or more electrical pads, further comprising;

a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware;

an electrocardiographic front end circuit under the control of the microcontroller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the microcontroller as electrocardiographic signals representative of amplitudes of the action potential propagation; and

non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals throughout the extended period.

18. An electrode patch in accordance with claim 17, the microcontroller further comprising:

an analog-to-digital converter operable to convert the electrocardiographic signals into digital representations of the amplitudes;

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

at least one high pass filter comprised in the firmware,

wherein the 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.

19. An electrode patch in accordance with claim 18, the microcontroller further comprising:

a compression algorithm comprised in the firmware,

wherein the amplitudes are compressed with the compression algorithm into compressed digital representations prior to being stored in the non-volatile memory.