EXTENDED WEAR ELECTROCARDIOGRAPHY AND PHYSIOLOGICAL SENSOR MONITOR

• US 20170258358A1
• Filed: 05/25/2017
• Published: 09/14/2017
• 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: Bishay, Jon Mikalson, Felix, Jason, Bardy, Gust H., Green, Joshua Djon, Floyd, Jared Brandon
• Granted Patent: US 10,433,748 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• 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 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

An extended wear electrocardiography patch is provided. An integrated flexible circuit includes a pair of circuit traces that each originate within one end. A pair of electrocardiographic electrodes are each electrically coupled to one of the circuit traces. A layer of adhesive is applied on a contact surface of the flexible circuit and includes an opening on each end. Conductive gel is provided in each of the openings of the adhesive layer and is in electrical contact with the electrocardiographic electrodes. A non-conductive receptacle is adhered on one end of an outward surface of the flexible circuit and is operable to removably receive an electrocardiography monitor. The non-conductive receptacle includes electrode terminals aligned to electrically interface the circuit traces to the electrocardiography monitor. A battery is affixed to the outward surface of the flexible circuit and electrically interfaced via battery leads to a pair of electrical pads.

Claims

1. An extended wear electrocardiography patch, comprising:

an integrated flexible circuit comprising a pair of circuit traces each originating within one end of the integrated flexible circuit;

a pair of electrocardiographic electrodes each electrically coupled to one of the circuit traces on the integrated flexible circuit;

a layer of adhesive applied on a contact surface of the integrated flexible circuit and comprising an opening on each end;

conductive gel provided in each of the openings and in electrical contact with the pair of electrocardiographic electrodes;

a non-conductive receptacle securely adhered on one end of an outward surface of the integrated flexible circuit and operable to removably receive an electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of the circuit traces to the electrocardiography monitor; and

a battery affixed to the outward surface of the integrated flexible circuit and electrically interfaced via battery leads to a pair of electrical pads on the non-conductive receptacle.

2. An extended wear electrocardiography patch according to claim 1, further comprising:

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

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

3. An extended wear electrocardiography patch according to claim 1, further comprising:

an upper part defined on one end of the integrated flexible circuit and sized to be affixed to the bottom surface of the non-conductive receptacle, one of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the upper part; and

a lower part defined on the integrated flexible circuit, an other of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the lower part,

wherein the lower part of the integrated flexible circuit is provided for being adhered to the region overlying the Xiphoid process on a patient'"'"'s chest with a narrow longitudinal midsection of the integrated flexible circuit, located between the upper and lower parts, oriented centrally (in a midline) along the sternum and the upper part of the integrated flexible circuit oriented upwards towards the manubrium.

4. An extended wear electrocardiography patch according to claim 1, further comprising:

a stiffener affixed to at least a portion of the integrated flexible circuit.

5. An extended wear electrocardiography patch 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 electrocardiography monitor against moisture intrusion.

6. An extended wear electrocardiography patch according to claim 1, further comprising:

an electrode seal positioned between the integrated flexible circuit and the adhesive layer.

7. An extended wear electrocardiography patch according to claim 1, further comprising:

a battery clip formed on the integrated flexible circuit and oriented to hold captive the battery.

8. An extended wear electrocardiography patch according to claim 1, further comprising:

a liner layer removably covering a bottom surface of the adhesive layer.

9. An extended wear electrocardiography patch according to claim 1, further comprising:

a single piece of material formed, as the integrated flexible circuit, in an elongated shape comprising an upper portion and a lower portion with a mirror image of the upper portion connected to the upper portion.

10. An extended wear electrocardiography patch according to claim 9, wherein the mirror image of the upper portion is folded over the upper portion of the integrated flexible circuit.

11. An extended wear electrocardiography and physiological sensor monitor, comprising:

a disposable extended wear electrode patch, comprising;

an integrated flexible circuit comprising a pair of circuit traces each originating within one end of the integrated flexible circuit;

a pair of electrocardiographic electrodes each electrically coupled to one of the circuit traces on the integrated flexible circuit;

a layer of adhesive applied on a contact surface of the integrated flexible circuit and comprising an opening on each end;

conductive gel provided in each of the openings and in electrical contact with the pair of electrocardiographic electrodes;

a non-conductive receptacle securely adhered on one end of an outward surface of the integrated flexible circuit and operable to removably receive an electrocardiography monitor, the non-conductive receptacle comprising electrode terminals aligned to electrically interface the pair of the circuit traces; and

a battery affixed to the outward surface of the integrated flexible circuit and electrically interfaced via battery leads to a pair of electrical pads on the non-conductive receptacle; and

a reusable electrocardiography monitor having a sealed housing adapted to be removably secured into the non-conductive receptacle such that the electrode terminals are aligned to electrically interface the circuit traces to the electrocardiography monitor and comprising;

a micro-controller operable to execute under micro programmable control and electrically interfaced to an electrocardiographic front end circuit that is operable to sense electrocardiographic signals through the electrocardiographic electrodes via the pair of the electrical pads;

a wireless transceiver electrically interfaced with the micro-controller and operable to wirelessly interface with an external wireless-enabled device to communicate samples of the electrocardiographic signals; and

a flash memory electrically interfaced with the micro-controller and operable to store the samples of the electrocardiographic signals.

12. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

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

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

13. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

an upper part defined on one end of the integrated flexible circuit and sized to be affixed to the bottom surface of the non-conductive receptacle, one of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the upper part; and

a lower part defined on the integrated flexible circuit, an other of the electrocardiographic electrodes being affixed to and conductively exposed on the contact surface of the lower part,

wherein the lower part of the integrated flexible circuit is provided for being adhered to the region overlying the Xiphoid process on a patient'"'"'s chest with a narrow longitudinal midsection, located between the upper and lower parts, oriented centrally (in a midline) along the sternum and the upper part of the integrated flexible circuit oriented upwards towards the manubrium.

14. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a stiffener affixed to at least a portion of the integrated flexible circuit.

15. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

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

16. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

an electrode seal positioned between the integrated flexible circuit and the adhesive layer.

17. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a battery clip formed on the integrated flexible circuit and oriented to hold captive the battery.

18. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a liner layer removably covering a bottom surface of the adhesive layer.

19. An extended wear electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a single piece of material formed, as the integrated flexible circuit, in an elongated shape comprising an upper portion and a lower portion with a mirror image of the upper portion connected to the upper portion.

20. An extended wear electrocardiography and physiological sensor monitor according to claim 19, wherein the mirror image of the upper portion is folded over the upper portion of the integrated flexible circuit.