Extended wear sewn electrode electrocardiography monitor

• US 10,264,992 B2
• Filed: 07/27/2017
• Issued: 04/23/2019
• 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): Dvorak, Linda C
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US15/661,362
• Publication Number:
  US 20170319095A1
• Time in Patent Office: 635 Days
• 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 with sewn electrodes and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The 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 extended wear sewn electrode electrocardiography monitor, comprising:

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 via a contact surface that is defined on each of the ends and on which an adhesive is provided;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode, the electrocardiographic electrode formed by a portion of the one wire that is sewn into the distal end of the elongated strip and that is configured for directly contacting a patient, the one wire continuing back along an axial path through the midsection, another one of the wires forming another electrocardiographic electrode, the another electrocardiographic electrode formed by a portion of the another wire that is sewn into the proximal end of the elongated strip and that is configured for electrically contacting the patient, each of the electrodes comprising an electrically conductive area only exposed on the contact surface; and

a printed circuit board affixed on one of the ends of the elongated strip and connected to both of the flexile wires and comprising a plurality of electrical contact mating pads operable to electrically couple an electrocardiography monitor recorder with the electrodes.

2. An extended wear sewn electrode electrocardiography monitor in accordance with claim 1, wherein another portion of the one flexile wire is back stitched across an exposed edge of the circuit board.

3. An extended wear sewn electrode electrocardiography monitor in accordance with claim 2, wherein the exposed edge is connected to one of the electrical contact mating pads.

4. An extended wear sewn electrode electrocardiography monitor in accordance with claim 1, wherein another portion of the another flexile wire is connected to an exposed circuit trace comprised in the circuit board and the exposed circuit trace is connected to one of the electrical contact mating pads.

5. An extended wear sewn electrode electrocardiography monitor in accordance with claim 1, further comprising:

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

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 electrical contact mating 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 action potential propagation; and

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

6. An extended wear sewn electrode electrocardiography monitor in accordance with claim 5, 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.

7. An extended wear sewn electrode 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.

8. An extended wear sewn electrode electrocardiography monitor in accordance with claim 5, further comprising:

a direct current power cell comprised in the non-conductive receptacle and connected to one or more additional electrical contact mating pads; and

the external interface further configured to removably and electronically couple the direct current power cell with the electronic circuitry through one or more of the additional electrical contact mating pads.

9. An extended wear sewn electrode electrocardiography monitor in accordance with claim 8, further comprising:

a power up sequence stored as part of the firmware, wherein the microcontroller is operable to execute the power up sequence upon the direct current power cell being electronically coupled to the electronic circuitry.

10. An extended wear sewn electrode electrocardiography monitor in accordance with claim 9, the power up sequence comprising one or more of a power cell voltage checking procedure, a flash memory state checking procedure, and a microcontroller diagnostic procedure.

11. An extended wear spiral electrode electrocardiography monitor, comprising:

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 via a contact surface that is defined on each of the ends and on which an adhesive is provided;

a pair of flexile wires, one of the wires forming an electrocardiographic electrode configured for directly contacting a patient, the electrocardiographic electrode formed by a portion of the one wire sewn in a spiral pattern into the distal end of the elongated strip, the one wire continuing back along an axial path through the midsection, another one of the wires forming another electrocardiographic electrode, the electrocardiographic electrode formed by a portion of the another wire sewn in a further spiral pattern into the proximal end of the elongated strip, each of the electrodes comprising an electrically conductive area only exposed on the contact surface; and

a circuit board affixed on one of the ends of the elongated strip and connected to both of the flexile wires and comprising a plurality of electrical pads operable to electrically couple an electrocardiography monitor recorder with the electrodes.

12. An extended wear spiral electrode electrocardiography monitor in accordance with claim 11, wherein another portion of the one flexile wire is back stitched across an exposed edge of the circuit board.

13. An extended wear spiral electrode electrocardiography monitor in accordance with claim 12 wherein the exposed edge is connected to one of the electrical contact mating pads.

14. An extended wear spiral electrode electrocardiography monitor in accordance with claim 11, wherein another portion of the another flexile wire is connected to an exposed circuit trace comprised in the circuit board and the exposed circuit trace is connected to one of the electrical contact mating pads.

15. An extended wear spiral electrode electrocardiography monitor in accordance with claim 11, further comprising:

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

the electrocardiography monitor recorder comprising;

a wearable housing adapted to securely fit into the 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 electrical contact mating 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 action potential propagation; and

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

16. An extended wear spiral electrode electrocardiography monitor in accordance with claim 15, 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.

17. An extended wear spiral electrode electrocardiography monitor in accordance with claim 15, 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.

18. An extended wear spiral electrode electrocardiography monitor in accordance with claim 15, further comprising:

a direct current power cell comprised in the non-conductive receptacle and connected to one or more additional electrical contact mating pads; and

the external interface further configured to removably and electronically couple the direct current power cell with the electronic circuitry through one or more of the additional electrical contact mating pads.

19. An extended wear spiral electrode electrocardiography monitor in accordance with claim 18, further comprising:

a power up sequence stored as part of the firmware, wherein the microcontroller is operable to execute the power up sequence upon the direct current power cell being electronically coupled to the electronic circuitry.

20. An extended wear spiral electrode electrocardiography monitor in accordance with claim 19, the power up sequence comprising one or more of a power cell voltage checking procedure, a flash memory state checking procedure, and a microcontroller diagnostic procedure.