Conformal sensor systems for sensing and analysis of cardiac activity

• US 9,949,691 B2
• Filed: 11/21/2014
• Issued: 04/24/2018
• Est. Priority Date: 11/22/2013
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: Huppert, Gilbert Lee, Ghaffari, Roozbeh, Ceruolo, Melissa, Keen, Bryan, Raj, Milan, McGrane, Bryan
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US15/038,401
• Publication Number:
  US 20160287177A1
• Time in Patent Office: 1,250 Days
• Field of Search: 600300, 600513
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02444 Details of sensor A61B5/02427 takes precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• 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 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/486 : Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/4866 : Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/4875 : Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/7271 : Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

Systems, methods and apparatuses for monitoring cardiac activity of an individual using a conformal cardiac sensor device are presented herein. A conformal cardiac sensor device for analyzing cardiac activity includes a flexible substrate for coupling to the user, and a heart sensor component embedded on/in the substrate. The heart sensor component contacts a portion of the users skin and measures electrical variable(s) indicative of cardiac activity. A biometric sensor component is embedded on/in the flexible substrate and measures physiological variable(s) indicative of cardiac activity of the user. A microprocessor, which is embedded on/in the flexible substrate, is communicatively coupled to the heart sensor component and biometric sensor component and operable to execute microprocessor executable instructions for controlling the measurements of electrical data and physiological data. A wireless communication component is embedded on/in the flexible substrate and is operable to transmit data indicative of the measurements obtained by the sensor components.

Claims

1. A conformal cardiac sensor device for analyzing cardiac activity of a user, the conformal cardiac sensor device comprising:

at least one flexible substrate configured to couple to the user;

at least one heart sensor component embedded on or within the at least one flexible substrate, the at least one heart sensor component being configured to directly contact a portion of skin of the user, measure electrical activity indicative of the cardiac activity of the user, and output a signal indicative thereof;

at least one biometric sensor component embedded on or within the at least one flexible substrate, the at least one biometric sensor component being configured to measure physiological activity indicative of the cardiac activity of the user and output a signal indicative thereof;

at least one microprocessor embedded on or within the at least one flexible substrate, the at least one microprocessor being communicatively coupled to the at least one heart sensor component and the at least one biometric sensor component and operable to execute microprocessor executable instructions for controlling measurement of the electrical activity and the physiological activity indicative of the cardiac activity of the user;

at least one wireless communication component embedded on or within the at least one flexible substrate and operable to transmit data indicative of the measurements obtained by the at least one heart sensor component and the at least one biometric sensor component; and

at least one therapeutic component embedded on or within the at least one flexible substrate, the at least one therapeutic component being configured to provide medicinal treatment to the user based, at least in part, on the measurements obtained by the at least one heart sensor component and the at least one biometric sensor component,

wherein the at least one therapeutic component is configured to administer to the user an emollient, a pharmaceutical drug or other drug, a biologic material, or other therapeutic material, or any combination thereof, in response to a detected occurrence of a predetermined triggering event.

2. The conformal cardiac sensor device of claim 1, wherein the emollient, pharmaceutical drug or other drug, biologic material, or other therapeutic material are delivered to the user transdermally.

3. The conformal cardiac sensor device of claim 1, wherein an amount of the emollient, pharmaceutical drug or other drug, biologic material, or other therapeutic material delivered to the user is calibrated, correlated or otherwise modified based on a magnitude of the detected occurrence of the predetermined triggering event.

4. The conformal cardiac sensor device of claim 1, further comprising at least one feedback component embedded on or within the at least one flexible substrate, the at least one feedback component being configured to analyze the measurements obtained by the at least one heart sensor component and the at least one biometric sensor component and provide diagnostic information or other physiological information to the user based on the analyzed measurements.

5. The conformal cardiac sensor device of claim 4, wherein the at least one feedback component is configured to display to the user an indication of the user'"'"'s overall fitness, VO2 max, cardiovascular demand, energy expenditure, activity level, quality of sleep, stress level, heart plasticity or abnormality, or disordered breathing, or any combination thereof.

6. The conformal cardiac sensor device of claim 1, wherein the least one heart sensor component includes an electromyography (EMG) component, an electrocardiogram (EKG) component, or an electroencephalogram (EEG) component, or any combination thereof.

7. The conformal cardiac sensor device of claim 1, wherein the least one biometric sensor component includes an accelerometer module, a gyroscope module, a muscle activation measurement module, or any combination thereof.

8. The conformal cardiac sensor device of claim 1, further comprising at least one power supply embedded on or within the at least one flexible substrate and operable to power the at least one heart sensor component, the at least one biometric sensor component, the at least one microprocessor and the at least one wireless communication component.

9. The conformal cardiac sensor device of claim 1, further comprising at least one memory device embedded on or within the at least one flexible substrate and storing the microprocessor executable instructions.

10. The conformal cardiac sensor device of claim 1, wherein the at least one heart sensor component comprises a plurality of conformal electrodes embedded on or within the at least one flexible substrate, wherein the plurality of conformal electrodes is configured to directly contact the portion of skin of the user.

11. The conformal cardiac sensor device of claim 1, wherein the at least one flexible substrate is a stretchable polymeric patch surrounding the at least one heart sensor component, the at least one biometric sensor component, the at least one microprocessor, and the at least one wireless communication component.

12. A conformal cardiac sensor assembly for analyzing cardiac activity of an individual, the conformal cardiac sensor assembly comprising:

a flexible substrate operable to attach to a portion of the individual;

a power supply attached or coupled to the flexible substrate;

a microprocessor attached or coupled to the flexible substrate and operable to execute microprocessor executable instructions;

a sensor component attached or coupled to the flexible substrate and configured to measure an electrical variable or a physiological variable, or both, indicative of the cardiac activity of the individual; and

a therapeutic component attached or coupled to the flexible substrate and configured to provide medicinal treatment to the individual based, at least in part, on the measurements obtained by the sensor component,

wherein the therapeutic component is configured to administer to the individual an emollient, a pharmaceutical drug or other drug, a biologic material, or other therapeutic material, or any combination thereof, in response to a detected occurrence of a predetermined triggering event.

13. A conformal cardiac sensor system for monitoring cardiac activity of a user, the conformal cardiac sensor system comprising:

one or more memory devices storing microprocessor executable instructions;

one or more microprocessors electrically coupled to the one or more memory devices and operable to execute the microprocessor executable instructions;

one or more first sensor devices electrically coupled to the one or more microprocessors and operable to obtain one or more first measurements indicative of the cardiac activity of the user;

one or more second sensor devices electrically coupled to the one or more microprocessors and operable to obtain one or more second measurements indicative of the cardiac activity of the user;

one or more wireless communication components electrically coupled to the one or more microprocessors and operable to transmit data indicative of the measurements obtained by the one or more first sensor devices and the one or more second sensor devices; and

one or more power supplies electrically coupled to and operable to power the one or more memory devices, the one or more microprocessors, the one or more first sensor devices and the one or more second sensor devices, and the one or more wireless communication components.

14. The conformal cardiac sensor system of claim 13, further comprising one or more therapeutic components configured to provide medicinal treatment to the user based, at least in part, on the measurements obtained by the one or more first and second sensor devices.

15. The conformal cardiac sensor system of claim 14, wherein at least one of the one or more therapeutic components is configured to administer to the user an emollient, a pharmaceutical drug or other drug, a biologic material, or other therapeutic material, or any combination thereof.

16. The conformal cardiac sensor system of claim 13, further comprising one or more feedback components configured to analyze the measurements obtained by the one or more first and second sensor devices and provide diagnostic information or other physiological information to the user based on the analyzed measurements.

17. The conformal cardiac sensor system of claim 13, wherein the one or more feedback components are is configured to display to the user an indication of the user'"'"'s overall fitness, VO2 max, cardiovascular demand, energy expenditure, activity level, quality of sleep, stress level, heart plasticity or abnormality, or disordered breathing, or any combination thereof.

18. The conformal cardiac sensor system of claim 13, wherein at least one of the one or more microprocessors and at least one of the one or more first and second sensor devices are arranged in a device island arrangement and connected via at least one flexible interconnect, wherein a collar structure is disposed proximate a transition region between the at least one of the one or more first and second sensor devices and the at least one flexible interconnect.

19. A conformal cardiac sensor system comprising:

a memory device storing processor-executable instructions;

a processor communicatively coupled to the memory device and operable to execute the processor-executable instructions;

a communication interface communicatively coupled to the processor;

a first conformal cardiac sensor device including a first flexible substrate configured to attach to a first portion of an individual, a first microcontroller coupled to the first flexible substrate, a first sensor component coupled to the first flexible substrate and configured to measure a first variable indicative of cardiac activity of the individual, and a first communications component coupled to the first flexible substrate and configured to transmit measurements of the first variable to the processor via the communication interface; and

a second conformal cardiac sensor device including a second flexible substrate configured to attach to a second portion of an individual, a second microcontroller coupled to the second flexible substrate, a second sensor component coupled to the second flexible substrate and configured to measure a second variable indicative of the cardiac activity of the individual, and a second communications component coupled to the second flexible substrate and configured to transmit measurements of the second variable to the processor via the communication interface.