Extended wear electrocardiography and physiological sensor monitor

• US 10,433,748 B2
• Filed: 05/25/2017
• Issued: 10/08/2019
• 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: Bishay, Jon Mikalson, Felix, Jason, Bardy, Gust H., Green, Joshua Djon, Floyd, Jared Brandon
• Primary Examiner(s): Stoklosa, Joseph A
• Assistant Examiner(s): Antiskay, Brian M
• Application Number:
  US15/605,842
• Publication Number:
  US 20170258358A1
• Time in Patent Office: 866 Days
• Field of Search: 600372, 600382, 600384, 600386, 600388, 600390-393, 600508-509
• 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:

a pair of electrocardiographic electrodes;

an integrated flexible circuit comprising;

a pair of circuit traces each electrically coupled to one of the electrocardiographic electrodes; and

a single piece of material shaped to fit longitudinally between a pair of breasts in the intermammary cleft, comprising;

a first end of the material shaped with a proximal end wider than a distal end and positioned over one of the electrocardiographic electrodes;

a second end of the material connected to the first end via a longitudinal midsection; and

a mirror image of the first end extending from a portion of the first end along a side of the wider proximal end and folding directly over a portion of the first end, wherein the first end and the mirror image of the first end cover a portion of at least one of the circuit traces and one of the electrocardiographic electrodes;

a non-conductive receptacle securely adhered on an outward facing surface of the mirror image 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 a region overlying the xiphoid process on a 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 in a midline along the sternum from the one electrocardiographic electrode.

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

wherein the distal end of the material of the integrated flexible circuit is provided for being adhered to a region overlying the xiphoid process on a patient'"'"'s chest with a narrow longitudinal midsection of the integrated flexible circuit oriented in a midline along the sternum.

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 between the first end and the mirror image of the first end 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 an adhesive layer on a contact surface of the integrated flexible circuit.

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 an adhesive layer on a contact surface of the integrated flexible circuit.

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

a disposable extended wear electrode patch, comprising;

a pair of electrocardiographic electrodes;

an integrated flexible circuit comprising;

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

a single piece of material shaped to fit longitudinally between a pair of breasts in the intermammary cleft, comprising;

a first end of the material shaped with a proximal end wider than a distal end and positioned over one of the electrodes;

a second end of the material connected to the first end via a longitudinal midsection; and

a mirror image of the first end extending from a portion of the first end along a portion of the wider proximal end and folding directly over a portion of the first end, wherein the first end and the mirror image cover a portion of at least one of the circuit traces and one of the electrocardiographic electrodes;

a non-conductive receptacle securely adhered on an outward surface of the mirror image 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 microcontroller 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.

10. An extended wear electrocardiography and physiological sensor monitor according to claim 9, further comprising:

one of the electrocardiographic electrodes being disposed for being adhered to a region overlying the xiphoid process on a 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 in a midline along the sternum from the one electrocardiographic electrode.

11. An extended wear electrocardiography and physiological sensor monitor according to claim 9,

wherein the distal end of the material of the integrated flexible circuit is provided for being adhered to a region overlying the xiphoid process on a patient'"'"'s chest with a narrow longitudinal midsection oriented in a midline along the sternum.

12. An extended wear electrocardiography and physiological sensor monitor according to claim 9, further comprising:

a stiffener affixed to at least a portion of the integrated flexible circuit between the first end and the mirror image of the first end of the integrated flexible circuit.

13. An extended wear electrocardiography and physiological sensor monitor according to claim 9, 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.

14. An extended wear electrocardiography and physiological sensor monitor according to claim 9, further comprising:

an electrode seal positioned between the integrated flexible circuit and an adhesive layer on a contact surface of the integrated flexible circuit.

15. An extended wear electrocardiography and physiological sensor monitor according to claim 9, further comprising:

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

16. An extended wear electrocardiography and physiological sensor monitor according to claim 9, further comprising:

a liner layer removably covering a bottom surface of an adhesive layer on a contact surface of the integrated flexible circuit.