IP Library Granted Patent US 10,004,415
Granted Patent B2
US 10,004,415 · App. 15/256,189 · Granted Jun 26, 2018

Extended wear electrocardiography patch

Inventors: Jon Mikalson Bishay (Seattle, WA); Gust H. Bardy (Carnation, WA); Jason Felix (Vashon Island, WA)
Assignee: Bardy Diagnostics, Inc.
A61B5/04085A61B5/02055A61B5/04017A61B5/0432A61B5/04087A61B5/6823A61B5/6833A61B5/021A61B5/04325A61B5/087A61B5/14532A61B5/14551A61B5/7455A61B2505/07A61B2560/0214A61B2560/045A61B2560/0412A61B2560/0443A61B2562/0209A61B2562/164A61B2562/168
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Quick Facts
Patent No.
US 10,004,415
App. No.
15/256,189
Granted
Jun 26, 2018
Kind
B2
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 (36)

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.

Assignments (2)
RELEASE OF SECURITY INTEREST (SENT FOR RECORDAL OCTOBER 25, 2021) Recorded Dec 14, 2021
From: JPMORGAN CHASE BANK, N.A.
To: BREATHE TECHNOLOGIES, INC.; HILL-ROM SERVICES, INC.; ALLEN MEDICAL SYSTEMS, INC.; WELCH ALLYN, INC.; HILL-ROM, INC.; VOALTE, INC.; BARDY DIAGNOSTICS, INC.; HILL-ROM HOLDINGS, INC.
Reel/Frame 058516/0312 →
SECURITY AGREEMENT SUPPLEMENT Recorded Oct 25, 2021
From: BARDY DIAGNOSTICS, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 058567/0677 →
Continuity (4)
Continuation 14736257 · Jun 10, 2015
Continuation In Part 14080717 · Nov 14, 2013
Provisional Application 61882403 · Sep 25, 2013
Related Publication 20160367163A1 · Dec 22, 2016
Cited By (15)
US 1,063,079 US 1,083,114 US 12,213,791 US 12,245,859 US 12,245,860 US 12,274,554 US 12,303,275 US 12,303,277 US 12,324,668 US 12,357,212 US 12,402,819 US 12,408,856 US 12,507,931 US 12,582,339 US 12,603,173