Extended wear electrocardiography patch

• US 10,004,415 B2
• Filed: 09/02/2016
• Issued: 06/26/2018
• 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, Bardy, Gust H., Felix, Jason
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US15/256,189
• Publication Number:
  US 20160367163A1
• Time in Patent Office: 662 Days
• Field of Search: 600372, 600382, 600384, 600386, 600388, 600390-393, 600508-509
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/316 Modalities, i.e. specific diagnostic methods
• 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 5/363 Detecting tachycardia or bradycardia
• 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 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

An extended wear electrocardiography patch is provided. A flexible backing is formed of an elongated strip of stretchable spunlace material. A layer of stretchable adhesive is applied on at least a portion of a contact surface of the flexible backing, which defines a pair of openings on both ends. A non-stretchable circuit is axially affixed to an outward-facing surface of the flexible backing and has a pair of circuit traces. The flexible backing acts as a buffer between the non-stretchable circuit and the stretchable adhesive and prevents disadhesion of the flexible backing during bending. A pair of electrocardiographic electrodes are electrically coupled to each of the circuit traces. Conductive gel is provided in each of the openings and in electrical contact with the pair of electrocardiographic electrodes as the electrodes shift away from the openings in the flexible backing during the bending.

Claims

1. An extended wear electrocardiography patch, comprising:

a flexible backing formed of an elongated strip of stretchable spunlace material with a narrow longitudinal midsection tapering evenly inward from both ends of the elongated strip;

a layer of stretchable adhesive applied on at least a portion of a contact surface of the flexible backing, the flexible backing defining a pair of openings on both ends;

a non-stretchable circuit axially affixed to an outward-facing surface of the flexible backing and comprising a pair of circuit traces both originating within one of the ends of the elongated strip, wherein the flexible backing acts as a buffer between the non-stretchable circuit and the stretchable adhesive and prevents disadhesion of the flexible backing during bending; and

a pair of electrocardiographic electrodes electrically coupled to each of the circuit traces and conductively exposed on the contact surface of each end of the elongated strip through each of the openings, wherein each electrode is initially centered over the respective opening in the flexible backing and shifts during the bending of the flexible backing, traverses away from a center of the opening during the bending of the flexible backing, and shifts between a portion of the flexible backing and the non-stretchable circuit.

2. An electrocardiography patch according to claim 1, wherein the non-stretchable circuit is adhered to the outward-facing surface of the flexible backing via one or more electrode seals.

3. An electrocardiography patch according to claim 1, wherein the flexible backing comprises a non-conductive receptacle.

4. An electrocardiography patch according to claim 3, wherein the non-conductive receptacle is adhered to the flexible backing via at least one circuit seal.

5. An electrocardiography patch according to claim 3, further comprising:

a monitor recorder configured to fit within the non-conductive receptacle.

6. An electrocardiography patch according to claim 1, wherein the non-stretchable circuit comprises a strain relief having cutouts defined in an S-shaped pattern.

7. An electrocardiography patch according to claim 1, wherein the flexible backing comprises an hourglass shape.

8. An electrocardiography patch according to claim 7, further comprising:

tabs each defined on opposite ends of the hourglass shape of the flexible backing.

9. An electrocardiography patch according to claim 1, wherein a portion of one or more of the electrodes shift over the flexible backing during the bending.

10. An electrocardiography patch according to claim 1, wherein porosity of the flexible backing allows sweat to be transmitted from a patient'"'"'s skin to the outward-facing surface of the flexible backing.

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

a disposable extended wear electrode patch, comprising;

a flexible backing formed of an elongated strip of stretchable spunlace material with a narrow longitudinal midsection tapering evenly inward from both ends of the elongated strip;

a layer of stretchable adhesive applied on at least a portion of a contact surface of the flexible backing, the flexible backing defining a pair of openings on both ends;

a non-stretchable circuit axially affixed to an outward-facing surface of the flexible backing and comprising a pair of circuit traces both originating within one of the ends of the elongated strip, wherein the flexible backing acts as a buffer between the non-stretchable circuit and the stretchable adhesive and prevents disadhesion of the flexible backing during bending;

a pair of electrocardiographic electrodes electrically coupled to each of the circuit traces and conductively exposed on the contact surface of each end of the elongated strip through each of the openings, wherein each electrode is initially centered over the respective opening in the flexible backing and shifts during bending of the flexible backing, traverses away from a center of the opening during the bending of the-flexible backing, and shifts between a portion of the flexible backing and the non-stretchable circuit; and

a non-conductive receptacle securely adhered on one of the ends of the flexible backing on the outward-facing surface; and

a reusable electrocardiography monitor having a sealed housing adapted to be removably secured into the non-conductive receptacle.

12. An electrocardiography and physiological sensor monitor according to claim 11, wherein the non-stretchable circuit is adhered to the outward-facing surface of the flexible backing via one or more electrode seals.

13. An electrocardiography and physiological sensor monitor according to claim 11, wherein the non-conductive receptacle is adhered to the flexible backing via at least one circuit seal.

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

at least one of a retention catch and tension clip molded into the non-conductive receptacle.

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

a battery compartment formed on the contact surface of the non-conductive receptacle.

16. An electrocardiography and physiological sensor monitor according to claim 11, wherein the non-stretchable circuit comprises a strain relief having cutouts defined in an S-shaped pattern.

17. An electrocardiography and physiological sensor monitor according to claim 11, wherein the flexible backing comprises an hourglass shape.

18. An electrocardiography and physiological sensor monitor according to claim 17, further comprising:

tabs each defined on opposite ends of the hourglass shape of the flexible backing.

19. An electrocardiography and physiological sensor monitor according to claim 11, wherein a portion of one or more of the electrodes shift over the flexible backing during the bending.

20. An electrocardiography and physiological sensor monitor according to claim 11, wherein porosity of the flexible backing allows sweat to be transmitted from a patient'"'"'s skin to the outward-facing surface of the flexible backing.