Electronic skin patch for real time monitoring of cardiac activity and personal health management

• US 8,734,339 B2
• Filed: 11/30/2004
• Issued: 05/27/2014
• Est. Priority Date: 12/16/1996
• Status: Expired due to Fees

• Current Assignee: IP Holdings Incorporated (IP Holdings LLC)
• Original Assignee: IP Holdings Incorporated (IP Holdings LLC)
• Inventors: Rao, Raman K., Rao, Sunil K., Rao, Rekha K., Rao, Sanjay K.
• Primary Examiner(s): Thomson, Bill
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US11/001,668
• Publication Number:
  US 20120191147A1
• Time in Patent Office: 3,465 Days
• Field of Search: 600/300, 600/301, 128903-905, 128/920
• US Class Current: 600/300
• CPC Class Codes: A61B 2505/01 Emergency care
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/1171 based on the shapes or appearances of their bodies or parts thereof
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4872 Body fat
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/747 in case of emergency, i.e. alerting emergency services
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 1/37288 : Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3904 : External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3925 : Monitoring; Protecting
• CPC Class Codes: A61N 1/3987 : characterised by the timing or triggering of the shock
• CPC Class Codes: G06F 3/023 : Arrangements for converting discrete items of information into a coded form, e.g. arrangements for interpreting keyboard generated codes as alphanumeric codes, operand codes or instruction codes
• CPC Class Codes: G06Q 2250/30 : Record keeping
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 10/65 : stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y10S 128/92 : Computer assisted medical diagnostics

Abstract

A novel wearable electronic skin patch sensor device configured for the real time acquisition, processing and communicating of cardiac activity and other types of biological information within a wired or wireless network is disclosed. A system level scheme for networking the sensor device with client devices that include intelligent personal health management appliances, cellular telephones, PDAs, portable computers, personal computers, RFID Tags and servers is disclosed. The sensor device and the system enable distributed processing, archival and correlation of the biological information with biometrics, gastronomic information, user profiles and health factors that include height, weight, blood pressure and physical activity facilitating real time personal health management at any time and any place.

Claims

1. A system having a sensor device, comprising:

a substrate with conductive adhesive material for communicating electrical signals and attaching to a body of a user;

circuitry coupled to the substrate and acquiring electrical signals representing one or more biological parameters of the body;

a processor coupled to the circuitry and the substrate, wherein the processor is programmed to generate processed information by processing the electrical signals representing the biological parameters including electrical signals received from a heart of the user;

an identification device coupled to the processor, the identification device providing device identification data for uniquely identifying the sensor device and user identification data for uniquely identifying the user;

a database coupled to the processor and configured for carriage on the body, the database storing one or more of the electrical signals, the processed information and health information of the user, the health information selected from the group consisting of gastronomic information, dietary information, physical activity information, exercise information, allergy information, information of ingested food, information of ingested medication, user profile, and emergency response information;

a transmitter coupled to the processor and transmitting the electrical signals and the processed information representing the biological parameters;

a power source coupled to the substrate and controlled by the processor to deliver calibrated energy to the body in response to the processed information representing one or more biological parameters such that the energy has a level and intensity sufficient for application through a surface of the body and which is selected by the processor in response to the information sufficient to stimulate a selected heart activity; and

,

a cellular telephone in wireless communication with the transmitter, the cellular telephone having a local processor programmed to initiate a selected query or action with the processor coupled to the circuitry such that the cellular telephone enables control of the circuitry and further having a display programmed to display a response to the query or action from the processor coupled to the circuitry,

wherein the processor is further programmed to correlate the biological parameters including the electrical signals from the heart and the health information and, in response, render an electrocardiogram representative of the electrical signals and further generate and output a warning when the processed information includes data of an emergency health condition in the user.

2. The sensor device of claim 1, comprising a receiver coupled to the processor, the receiver configured to receive the health information and control and command signals, the receiver configured for wired and/or wireless communication.

3. The sensor device of claim 2, comprising a power source comprising one or more of battery and line power coupled to one or more of the processor, the circuitry, the transmitter, the receiver, and the substrate.

4. The sensor device of claim 1, wherein the biological parameters include information of one or more of cardiac activity, cardiac function, heart muscle function, heart valve function, heart efficiency, vascular function, artery function, an electrocardiogram (ECG), an echo cardiogram, blood pressure, pulse rate, heart rhythm, brain activity and electroencephalogram (EEG).

5. The sensor device of claim 1, wherein the information of the biological parameters is used for one or more of observation, research study, real time monitoring, periodic monitoring, correlation, diagnosis, treatment, database archival, communication, command and control.

6. The sensor device of claim 1, comprising a memory device coupled to the processor, wherein the memory device is configured to store the information of the biological parameters for one or more of real time utility, utility at a selected time, and utility for a selected purpose.

7. The sensor device of claim 1, wherein the information of the biological parameters is further transmitted to a remote medical device carried by the user, wherein the remote device includes a memory that stores the electrical signals, the processed information representing the biological parameters, and the health information, wherein the remote device includes a processor configured to correlate the information of the biological parameters and the health information.

8. The sensor device or claim 1, wherein the transmitter is configured to transmit using one or more communication protocols.

9. The sensor device of claim 1, wherein the transmitter is configured to transfer the information of the biological parameters to a remote device that includes one or more of a cellular telephone, mobile device, another medical device, a local server, a network server and a RFID tag, wherein the remote device includes a memory that stores the electrical signals, the processed information representing the biological parameters, and the health information, wherein the remote device includes a processor configured to manipulate the information of the biological parameters and the health information, the manipulation including one or more of processing, analysis, correlation, tracking, storing, monitoring, command, control and communicating.

10. The sensor device of claim 1, wherein the electrical signals includes one or more of analog and digital electrical signal information 20 from one or more of the heart, heart muscles, pectoral muscles, arteries, blood vessels, and one or more of different chambers or the heart, different regions of the heart muscle, human tissue surrounding the heart and different regions of the human anatomy.

11. The sensor device of claim 1, wherein the database is in an RFID tag.

12. The sensor device of claim 1, wherein the substrate is configured to provide one or more of flexibility, rigidity, conformance to the contour of the body, varying geometric size form factors, varying shape form factors, comfort, resistance to body fluids, resistance to external fluids, temperature stability, corrosion resistance, electrical stability and ease of use.

13. The sensor device of claim 1, comprising a hermetically sealed assembly that houses one or more of the substrate, the circuitry, the processor, the transmitter a memory device, storage, a receiver, and a power source.

14. The sensor device of claim 13, wherein the storage includes a battery compartment configured to house a battery, wherein the battery is the power source and is removable and replaceable.

15. The sensor device of claim 13, wherein the assembly is configured to allow selective replacement, reuse, and disposal of the transmitter, the receiver, the memory device, and the power source.

16. The sensor device of claim 1, comprising a patch having a plurality of sides, wherein at least one side includes a conductive adhesive coating, wherein a first side of the patch is affixed to the bottom of the substrate and the reverse side of the patch is affixed to the body.

17. The sensor device of claim 16, wherein the patch includes perforations configured for one or more of air flow, fluid flow, and comfort.

18. The sensor device of claim 16, wherein the patch is configured to conform to the substrate.

19. The sensor device of claim 16, wherein the patch is configured to be disposable.

20. The sensor device of claim 16, wherein the conductive adhesive coating includes at least one property, wherein the at least one property includes electrical conductivity.

21. The sensor device of claim 1, comprising an adhesive connected to the substrate, wherein the adhesive is directly applied to the substrate for affixing the substrate directly to the body.

22. The sensor device of claim 1, wherein the biological parameters are received from one or more implanted devices implanted in the body.

23. The sensor device of claim 1, wherein the biological parameters are received as a component of an analog electrical signal from the body.

24. The sensor device of claim 1, wherein the processing includes converting the analog signal to a digital signal.

25. The sensor device of claim 1, wherein the transmitter includes one or more of a wireless transmitter and/or a wired transmitter.

26. The sensor device of claim 1, wherein the transmitter uses one or more channels to transmit.

27. The sensor device of claim 1, comprising at least one other transmitter, wherein the at least one other transmitter is configured for transmitting on one or more channels.

28. The sensor device of claim 1, comprising a receiver coupled to the processor, wherein the receiver uses one or more channels to receive.

29. The sensor device of claim 1, comprising a plurality of receivers at least one of which is coupled to the processor, wherein the plurality of receivers each receive on one or more channels.

30. The sensor device of claim 1, comprising at least one other processor, the processors configured for processing one or more types of information.

31. The sensor device of claim 1, comprising a memory device, the memory device storing one or more of the biological parameters and the processed information.

32. The sensor device of claim 1, comprising a second receiver, wherein the second receiver includes one or more of a wired receiver and a wireless receiver.

33. The sensor device of claim 1, wherein the substrate includes a conductive adhesive for the attaching, wherein the conductive adhesive is removable.

34. The sensor device of claim 1, wherein the substrate includes a conductive adhesive formulated for one more of the attaching and timed release of one or more therapeutic drugs.

35. The sensor device of claim 1, wherein the substrate includes a conductive adhesive formulated for one or more of the attaching and timed release of one or more therapeutic drugs.

36. The sensor device of claim 1, wherein the substrate includes a conductive adhesive that is moisture resistant to enable usage in high-moisture environments.

37. The sensor device of claim 1, wherein one or more of the circuitry, the processor, and the transmitter is configured to be programmable.

38. The sensor device of claim 37, wherein programmable includes programmable relative to one or more of time, identification information, user profile information, functionality information, and health information.

39. The sensor device of claim 37, wherein the processor is configured for programming via inputs made at a remote device selected from a group consisting of a cellular telephone and a mobile device carried by the user.

40. The sensor device of claim 37, wherein one of more of the circuitry, the processor, and the transmitter is configured for programming such that the device is reconfigured from a first function to a second function.

41. A system having a sensor device, comprising:

a substrate having conductive adhesive material for communicating electrical signals and attaching to it body of it user;

circuitry coupled to the substrate and operating to acquire electrical signals representing one or more biological parameters of the body and converting the acquired electrical signals from analog to digital format for further processing by a processor;

the processor coupled to the circuitry and the substrate, the processor being programmed to generate processed information by processing the electrical signals representing;

the biological parameters including electrical signals received from a heart of the user;

an antenna coupled to the circuitry;

a memory having a database coupled to the processor and carried on the body, the database storing one or more of the electrical signals, the processed information and health information of the user, the health information selected from the group consisting of gastronomic information, dietary information, physical activity information, exercise information, allergy information, information of ingested food, information of ingested medication, user profile, and emergency response information;

a transmitter coupled to the processor and transmitting the electrical signals and the processed information representing the biological parameters, wherein the transmitter uses one or more of wired and/or wireless transmission;

a power source coupled to the substrate and controlled by the processor to deliver calibrated energy to the body in response to the processed information representing one or more biological parameters, such that the energy has a level and intensity sufficient for application through a surface of the body and which is selected by the processor in response to the information sufficient to stimulate a selected heart activity, and where the processor is further programmed to correlate the electrical signals from the heart and render an electrocardiogram representative of the electrical signals;

an identification component communicatively coupled to the processor, wherein the identification component authenticates the communication between the processor and an external device using one or more of individual profile information, individual health information, biometric information of a user and/or identification information of the external device; and

,

a cellular telephone in wireless communication with the transmitter, the cellular telephone having a local processor programmed to initiate a selected query or action with the processor coupled to the circuitry such that the cellular telephone enables control of the circuitry and further having a display programmed to display a response to the query or action from the processor coupled to the circuitry.

42. A system having a sensor device, comprising:

a substrate having conductive adhesive material for communicating electrical signals and attaching to a body of a user;

circuitry coupled to the substrate and operating;

to acquire electrical signals representing one or more biological parameters of the body and converting the acquired electrical signals from analog to digital format for further processing by a processor;

the processor coupled to the circuitry and the substrate, the processor being programmed to generate processed information by processing the electrical signals representing the biological parameters including electrical signals received from a heart of the user, the processor encrypting communications to an external device external to the processor and decrypting communications from the external device;

an antenna coupled to the circuitry;

a memory having a database coupled to the processor and carried on the body, the database storing one or more of the electrical signals, the processed information and health information of the user, the health information selected from the group consisting of gastronomic information, dietary information, physical activity information, exercise information, allergy information, information of ingested food, information of ingested medication, user profile, and emergency response information;

a transmitter coupled to the processor and transmitting the electrical signals and the processed information representing the biological parameters, wherein the transmitter uses one or more of wired and/or wireless transmission;

a power source coupled to the substrate and controlled by the processor to deliver calibrated energy to the body in response to the processed information representing one or more biological parameters, such that the energy has a level and intensity sufficient for application through a surface of the body and which is selected by the processor in response to the information sufficient to stimulate a selected heart activity, and where the processor is further programmed to correlate the electrical signals from the heart and render an electrocardiogram representative of the electrical signals;

an identification component communicatively coupled to the process, wherein the identification component authenticates the communication between the processor and the external device using one or more of individual profile information, individual health information, biometric information of a user and/or identification information of the external device; and

,

a cellular telephone in wireless communication with the transmitter, the cellular telephone having a local processor programmed to initiate a selected query or action with the processor coupled to the circuitry such that the cellular telephone enables control of the circuitry and further having a display programmed to display a response to the query or action from the processor coupled to the circuitry.

43. A system having a sensor device, comprising:

a substrate having conductive adhesive material or communicating electrical signals and attaching to a body of a user;

circuitry coupled to the substrate and operating to acquire electrical signals representing one or more biological parameters of the body and converting the acquired

electrical signals from analog to digital format for further processing by a processor;

the processor coupled to the circuitry and the substrate, the processor being programmed to generate processed information by processing the electrical signals representing the biological parameters including electrical signals received from a heart of the user;

an antenna coupled to the circuitry;

a memory having a database coupled to the processor and carried on the body, the database storing the one or more of the acquired analog electrical signals, the digital electrical signals, the processed information, individual profile information and/or individual health information;

a multi-channel transmitter/receiver coupled to the processor and transmitting and receiving the electrical signals and the processed information representing the biological parameters using one or more of wired and/or wireless communications, the wireless communications using one or more channel of the multi-channel transmitter/receiver and one or more communication protocol selected from the group consisting of cellular communication, Wi-Fi communication, and IP communication;

a power source coupled to the substrate and controlled by the processor to deliver calibrated energy to the body in response to the processed information representing one or more biological parameters, such that the energy has a level and intensity sufficient for application through a surface of the body and which is selected by the processor in response to the information sufficient to stimulate a selected heart activity, and where the processor is further programmed to correlate the electrical signals from the heart and render an electrocardiogram representative of the electrical signals;

an identification component communicatively coupled to the processor, wherein the identification component authenticates the communication between the processor and an external device using one or more of individual profile information, individual health information, biometric information of a user and/or identification information of the device; and

,

a cellular telephone in wireless communication with the transmitter, the cellular telephone having a local processor programmed to initiate a selected query or action with the processor coupled to the circuitry such that the cellular telephone enables control of the circuitry and further having a display programmed to display a response to the query or action from the processor coupled to the circuitry.

44. A system having a sensor device, comprising:

a substrate having conductive adhesive material for communicating electrical signals and attaching to a body of a user;

circuitry coupled to the substrate and operating to acquire electrical signals representing one or more biological parameters of the body and converting the acquired electrical signals from analog to digital format for further processing by a processor;

the processor coupled to the circuitry and the substrate, the processor being programmed to generate processed information by processing the electrical signals representing the biological parameters including electrical signals received from a heart of the user;

an antenna coupled to the circuitry;

a memory having a database coupled to the processor and carried on the body, the database storing the one or more of the electrical signals, the processed information and health information of the user, the health information selected from the group consisting of gastronomic information, dietary information, physical activity information, exercise information, allergy information, information of ingested food, information of ingested medication, user profile, and emergency response information;

a power source coupled to the substrate and controlled by the processor to deliver calibrated energy to the body in response to the processed information representing one or more biological parameters, such that the energy has a level and intensity sufficient for application through a surface of the body and which is selected by the processor in response to the information sufficient to stimulate a selected heart activity, and where the processor is further programmed to correlate the electrical signals from the heart, and render an electrocardiogram representative of the electrical signals;

an identification component communicatively coupled to the processor, wherein the identification component authenticates the communication between the processor and an external device using one or more of individual profile information, individual health information, biometric information of a user and/or identification information of the device; and

,

a cellular telephone in wireless communication with the transmitter, the cellular telephone having a local processor programmed to initiate a selected query or action with the processor coupled to the circuitry such that the cellular telephone enables control of the circuitry and further having a display programmed to display a response to the query or action from the processor coupled to the circuitry.

45. The sensor device of claim 44, wherein the processor controls the delivering of calibrated energy by controlling a level of the energy and a duration of the delivering.

46. The sensor device of claim 44, wherein the processor controls the delivering in response to detected undesirable heart activity represented by the biological parameters.

47. The sensor device of claim 44, wherein the processor controls the delivering in response to detected real time electrocardiogram data represented by the biological parameters.

48. The sensor device of claim 44, wherein the processor controls the delivering in response to profile information of the user.

49. The sensor device of claim 44, wherein the processor controls the delivering in response to data of the processed biological information.

50. The sensor device of claim 44, wherein the calibrated energy is a defibrillation pulse that delivers electrical energy to the human heart in order to resynchronize the heart function.