Granted Patent B1

US 12,303,278 · App. 19/029,540 · Granted May 20, 2025

Inventors: Jason Felix (Vashon Island, WA); Jon Mikalson Bishay (Seattle, WA); Gust H. Bardy (Carnation, WA)

A61B5/335A61B5/0006A61B5/0022A61B5/02055A61B5/14532A61B5/14542A61B5/259A61B5/282A61B5/6823A61B5/6833A61B5/7405A61B5/7455A61B5/7475G16H40/67A61B5/021A61B5/03A61B5/0816A61B5/087A61B5/1118A61B5/14551A61B5/349A61B2560/0214A61B2560/0443

Abstract

Claims (124)

1. A wearable electrocardiograma, comprising:

a flexible backing having a mid-section, a distal end, and a proximal end, wherein each of the distal end and the proximal end taper inward to the mid-section, wherein the mid-section includes a first edge parallel to a second edge, and wherein the mid-section is narrower than the distal end and the proximal end;

an SpO 2 sensor provided on the flexible backing;

a discontinuous adhesive layer disposed on a contact surface of the flexible backing to adhere the flexible backing to skin of a patient's chest, wherein the discontinuous adhesive layer includes a first portion disposed on the distal end and a second portion disposed on the proximal end;

a monitor recorder having a rigid housing with rounded edges on a top surface, wherein the monitor recorder is configured to draw power from a battery, and wherein electrocardiogramals are stored in the monitor recorder, the monitor recorder comprising:

a flash memory;

a temperature sensor;

a wireless transceiver;

a microcontroller; and

an electrocardiogramant end circuit;

a non-conductive receptacle disposed between the skin of the patient's chest and the monitor recorder, the non-conductive receptacle comprising a battery compartment for the battery;

a circular feedback button disposed on the top surface of the housing, wherein the circular feedback button is configured to output feedback to the patient;

a flexible circuit disposed on a top surface of the flexible backing, wherein the flexible circuit comprises:

an inline resistor;

a proximal circuit trace, wherein the proximal circuit trace is electrically coupled to a proximal electrocardiogramalectrode, and wherein the proximal electrocardiogramactrode is disposed on the proximal end; and

a distal circuit trace electrically coupled to a distal electrocardiogra wherein the distal electrocardiogramaposed on the distal end, and wherein the electrocardiogramant end circuit senses the electrocardiogramaignals via the distal electrocardiogramalectrode and the proximal electrocardiogra electrode.

2. The wearable electrocardiogramavice of claim 1 , wherein the inline resistor is disposed between the housing and the skin of the patient's chest.

3. The wearable electrocardiograma of claim 1 , wherein the wearable electrocardiogramaevice further comprises tabs for placement of the wearable electrocardiograma on the skin of the patient's chest.

4. The wearable electrocardiogramaim 1 , wherein the non-conductive receptacle includes a concave feature.

5. The wearable electrocardiograma of claim 1 , wherein the circular feedback button is waterproof.

6. The wearable electrocardiogramavice of claim 1 , wherein the housing engages the non-conductive receptacle to form a moisture-resistant seal.

7. The wearable electrocardiogram 1 , wherein the non-conductive receptacle comprises a seal.

8. The wearable electrocardiograma of claim 7 , wherein the seal is a circular shape that surrounds an electrical pad.

9. The wearable electrocardiograma of claim 1 , further comprising an analog-to-digital converter.

10. The wearable electrocardiogramavice of claim 1 , wherein the wearable electrocardiogramavice senses electrocardiogramaignals via a single channel.

11. The wearable electrocardiograma of claim 1 , wherein the distal end and the proximal end are asymmetric about the mid-section.

12. A wearable electrocardiograma, comprising:

a monitor recorder configured to record and store electrocardiogramaignals, the monitor recorder comprising:

a wireless transceiver, wherein the wireless transceiver communicates via Bluetooth communications;

a microcontroller;

an electrocardiogramant end circuit; and

a flash memory;

a non-conductive receptacle disposed between skin of a patient's chest and the monitor recorder, the non-conductive receptacle comprising a battery to provide power to the monitor recorder;

a flexible backing having a mid-section, a distal end, and a proximal end, wherein the mid-section includes a first edge parallel to a second edge, and wherein the mid-section is narrower than the distal end and the proximal end;

an SpO 2 sensor provided on the flexible backing;

an adhesive layer, wherein the adhesive layer is disposed on at least a portion of a first surface of the flexible backing, and wherein the adhesive layer adheres the distal end and the proximal end to the skin of the patient's chest;

a button disposed on a housing, wherein the wearable electrocardiograma is configured to output feedback to the patient to confirm that the wearable electrocardiogra device is recording the electrocardiogramals;

a physiological sensor;

a flexible circuit disposed on a second surface of the flexible backing, wherein the flexible circuit comprises:

an inline resistor;

a proximal circuit trace, wherein the proximal circuit trace is electrically coupled to a proximal electrocardiogramd wherein the proximal electrocardiogramaposed on the proximal end; and

a distal circuit trace electrically coupled to a distal electrocardiogramalectrode, wherein the distal electrocardiogramalectrode is disposed on the distal end, and wherein the electrocardiogramt end circuit senses the electrocardiogramaignals via the distal electrocardiogramalectrode and the proximal electrocardiogra electrode.

13. The wearable electrocardiograma of claim 12 , wherein the monitor recorder comprises a physiological sensor, and wherein the physiological sensor is a temperature sensor.

14. The wearable electrocardiogramavice of claim 12 , wherein a physiological sensor is provided on the flexible backing.

15. The wearable electrocardiogramavice of claim 12 , wherein a physiological sensor is provided on the flexible backing, and wherein the physiological sensor is a blood pressure sensor.

16. The wearable electrocardiograma of claim 12 ,

wherein the button is circular and waterproof;

wherein each of the distal end and the proximal end is rounded on respective outer edges;

wherein the monitor recorder comprises a rounded edge on a top surface;

wherein the physiological sensor is a temperature sensor; and

wherein the electrocardiogramaignals are converted to a different format.

17. The wearable electrocardiograma of claim 12 ,

wherein each of the distal end and the proximal end is rounded on respective outer edges;

wherein the monitor recorder comprises a rounded edge on a top surface;

wherein the physiological sensor is a temperature sensor; and

wherein the electrocardiogramaignals are converted to a different format.

18. The wearable electrocardiogramavice of claim 12 ,

wherein the button is circular and waterproof;

wherein the monitor recorder comprises a rounded edge on a top surface;

wherein the physiological sensor is a temperature sensor; and

wherein the electrocardiogramals are converted to a different format.

19. The wearable electrocardiograma of claim 12 ,

wherein the button is circular and waterproof;

wherein each of the distal end and the proximal end is rounded on respective outer edges;

wherein the physiological sensor is a temperature sensor; and

wherein the electrocardiogramaignals are converted to a different format.

20. The wearable electrocardiograma of claim 12 ,

wherein the button is circular and waterproof;

wherein each of the distal end and the proximal end is rounded on respective outer edges;

wherein the monitor recorder comprises a rounded edge on a top surface; and

wherein the electrocardiogramaignals are converted to a different format.

21. The wearable electrocardiograma of claim 12 ,

wherein the button is circular and waterproof;

wherein each of the distal end and the proximal end is rounded on respective outer edges;

wherein the monitor recorder comprises a rounded edge on a top surface; and

wherein the physiological sensor is a temperature sensor.

22. The wearable electrocardiograma of claim 12 ,

wherein the monitor recorder comprises a rounded edge on a top surface;

wherein the physiological sensor is a temperature sensor; and

wherein the electrocardiogramals are converted to a different format.

23. The wearable electrocardiograma of claim 12 ,

wherein each of the distal end and the proximal end is rounded on respective outer edges;

wherein the physiological sensor is a temperature sensor; and

wherein the electrocardiogramaignals are converted to a different format.

24. The wearable electrocardiogramavice of claim 12 ,

wherein each of the distal end and the proximal end is rounded on respective outer edges;

wherein the monitor recorder comprises a rounded edge on a top surface; and

wherein the electrocardiogramaignals are converted to a different format.

25. The wearable electrocardiograma of claim 12 ,

wherein each of the distal end and the proximal end is rounded on respective outer edges;

wherein the monitor recorder comprises a rounded edge on a top surface; and

wherein the physiological sensor is a temperature sensor.

26. The wearable electrocardiogramavice of claim 12 ,

wherein the button is circular and waterproof;

wherein the physiological sensor is a temperature sensor; and

wherein the electrocardiogramals are converted to a different format.

27. The wearable electrocardiograma of claim 12 ,

wherein the button is circular and waterproof;

wherein the monitor recorder comprises a rounded edge on a top surface; and

wherein the electrocardiogramals are converted to a different format.

28. The wearable electrocardiograma of claim 12 ,

wherein the button is circular and waterproof;

wherein the monitor recorder comprises a rounded edge on a top surface; and

wherein the physiological sensor is a temperature sensor.

29. The wearable electrocardiogramavice of claim 12 ,

wherein the button is circular and waterproof;

wherein each of the distal end and the proximal end is rounded on respective outer edges; and

wherein the electrocardiogramaignals are converted to a different format.

30. A wearable electrocardiograma, comprising:

a flexible backing having a mid-section, a distal end, and a proximal end, wherein the distal end and the proximal end are rounded on respective outer edges, wherein each of the distal end and the proximal end taper inward to the mid-section, wherein the mid-section includes a first edge parallel to a second edge, and wherein the mid-section is narrower than the distal end and the proximal end;

an SpO 2 sensor provided on the flexible backing, wherein the SpO 2 sensor comprises a light emitting diode and a photodiode;

an adhesive layer disposed on a contact surface of the flexible backing, wherein the adhesive layer adheres the flexible backing to skin a patient's chest, and wherein the adhesive layer is disposed only on the distal end and the proximal end of the contact surface of the flexible backing;

a monitor recorder having a rigid housing with rounded edges on a top surface, wherein the monitor recorder is configured to draw power from a battery, the monitor recorder comprising:

a flash memory;

a temperature sensor;

a wireless transceiver;

a microcontroller; and

an electrocardiogramant end circuit;

a non-conductive receptacle configured to engage the monitor recorder, wherein the non- conductive receptacle comprises a battery compartment for the battery, and wherein the battery is vertically aligned with the wireless transceiver;

a waterproof circular feedback button disposed on the top surface of the housing configured to output feedback to the patient;

a flexible circuit disposed on a top surface of the flexible backing, wherein the flexible circuit comprises:

an inline resistor;

a proximal circuit trace, wherein the proximal circuit trace is electrically coupled to a proximal electrocardiogra electrode, and wherein the proximal electrocardiogramad on the proximal end; and

a distal circuit trace electrically coupled to a distal electrocardiogra wherein the distal electrocardiogramalectrode is disposed on the distal end, and wherein the electrocardiogramant end circuit senses electrocardiogramals via the distal electrocardiogramactrode and the proximal electrocardiogramalectrode.

Continuity (14)

References Cited (400)