US20160294927A1 - Variable data usage personal medical system and method - Google Patents

Variable data usage personal medical system and method Download PDF

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Publication number
US20160294927A1
US20160294927A1 US15/092,950 US201615092950A US2016294927A1 US 20160294927 A1 US20160294927 A1 US 20160294927A1 US 201615092950 A US201615092950 A US 201615092950A US 2016294927 A1 US2016294927 A1 US 2016294927A1
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Prior art keywords
self
data
communication device
care device
care
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Abandoned
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US15/092,950
Inventor
Fan Meng
Gary A. Cohen
Eileen H. Dempster
George W. Patterson
Cary D. Talbot
Mark Sebastian Verghese
Maral Gharib
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Medtronic Minimed Inc
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Medtronic Minimed Inc
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Priority to US15/092,950 priority Critical patent/US20160294927A1/en
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Abandoned legal-status Critical Current

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    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
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    • H04L67/01—Protocols
    • H04L67/10—Protocols in which an application is distributed across nodes in the network
    • G—PHYSICS
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    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
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    • G—PHYSICS
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    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
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    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
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    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
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    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/005—Parameter used as control input for the apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
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    • H04W4/80—Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication

Definitions

  • the technical field of this disclosure is personal medical systems, particularly, variable data usage personal medical systems and methods.
  • Wearable medical devices oftentimes communicate with a remote computer system over a cellular network.
  • Data such as a glucose reading or pump information
  • a remote computer system is obtained at the person under treatment then sent to the computer system periodically for analysis.
  • data is often transmitted at a regular frequency which may be higher than what is required.
  • Sending a large amount of data over a cellular network is expensive. Also, sending data too often can deplete the batteries on the personal medical device.
  • One aspect of the invention provides a variable data usage personal medical system for use with a patient including a self-care device attached to the patient, the self-care device being operable to generate self-care device data and to transmit the self-care device data at a fixed interval; a cellular communication device operably connected to the self-care device, the cellular communication device being operable to receive and store the transmitted self-care device data, to register a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data is received, to generate a data cellular packet from overhead plus the stored self-care device data when the interval counter equals a fixed interval index, and to transmit the data packet; and a cloud infrastructure operably connected to the cellular communication device over a cellular network, the cloud infrastructure being operable to receive, process, and store the transmitted data packet.
  • the cellular communication device is operable to store the fixed interval index and the cloud infrastructure is operable to transmit a value for the fixed interval index to the cellular communication device for storage.
  • Another aspect of the invention provides a method of personal medical variable data usage for a patient including transmitting a value for a fixed interval index remote from the patient; storing the fixed interval index at the patient; generating self-care device data for the patient; transmitting the self-care device data at a fixed interval; receiving and storing the transmitted self-care device data; registering a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data is received; generating a data cellular packet from overhead plus the stored self-care device data when the interval counter equals the fixed interval index; transmitting the data packet from the patient over a cellular network; and receiving, processing, and storing the transmitted data packet remote from the patient.
  • Another aspect of the invention provides a system of personal medical variable data usage for a patient including means for transmitting a value for a fixed interval index remote from the patient; means for storing the fixed interval index at the patient; means for generating self-care device data for the patient; means for transmitting the self-care device data at a fixed interval; means for receiving and storing the transmitted self-care device data; means for registering a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data is received; means for generating a data cellular packet from overhead plus the stored self-care device data when the interval counter equals the fixed interval index; means for transmitting the data packet from the patient over a cellular network; and means for receiving, processing, and storing the transmitted data packet remote from the patient.
  • FIG. 1 is a block diagram of a variable data usage personal medical system made in accordance with the invention.
  • FIG. 2 is a schematic diagram of self-care devices and a cellular communication device for a variable data usage personal medical system made in accordance with the invention.
  • FIG. 3 is a timing chart of communications for a variable data usage personal medical system made in accordance with the invention.
  • FIG. 4 is a flow chart of a method of personal medical variable data usage for a patient in accordance with the invention.
  • FIG. 5A-5I is a table of alarms and accompanying data for a variable data usage personal medical system made in accordance with the invention.
  • FIG. 1 is a block diagram of a variable data usage personal medical system made in accordance with the invention.
  • the variable data usage personal medical system 100 is designed for use with a patient and includes a self-care device 110 , a cellular communication device 120 , and a cloud infrastructure 130 .
  • the variable data usage personal medical system 100 also includes an optional display device 140 .
  • the variable data usage personal medical system 100 allows the cloud infrastructure 130 to control the time interval at which the cellular communication device 120 communicates data from the self-care device 110 to the cloud infrastructure 130 .
  • the self-care device 110 can be attached to the patient and is designed to be carried or worn by a patient.
  • the self-care device 110 can be any personal medical device which delivers therapy to a patient and/or monitors a physiological parameter of the patient.
  • Exemplary self-care devices include pumps, cell pumps, continuous glucose monitors, and the like.
  • the self-care device 110 is an insulin delivery device.
  • the self-care device 110 is a continuous glucose monitoring (CGM) device.
  • the self-care device 110 can both deliver therapy and monitor a physiological parameter.
  • One example of such a device would be a paired insulin delivery and CGM device.
  • the self-care device 110 can be any self-care device as desired for a particular application.
  • the self-care device 110 generates self-care device data 115 and transmits the self-care device data 115 to the cellular communication device 120 at fixed intervals.
  • the cellular communication device 120 is operably connected to the self-care device 110 .
  • the cellular communication device 120 is a radio protocol converter and repeater device.
  • the cellular communication device 120 stores the self-care device data 115 received by the cellular communication device 120 from the self-care device 110 .
  • the link between the cellular communication device 120 and the self-care device 110 can be wired or wireless, using standard protocols such as 802.11b/g/n.
  • the radio protocol conversion can be stored in firmware in the cellular communication device 120 .
  • Exemplary cellular communication devices include CloudPostTM glucose monitors and remote controllers therefor, controllers, display meters, mobile phones, on-body communicators, on-body repeaters, and the like.
  • the cellular communication device 120 can request that the self-care device 110 send data stored in the self-care device 110 to provide the data backfill when the connection between the self-care device 110 and the cellular communication device 120 has been disconnected such that the cellular communication device 120 has not been receiving the self-care device data 115 from the self-care device 110 .
  • the cellular communication device 120 maintains a complete data record.
  • the cellular communication device 120 can be combined and integrated in a single package with the self-care device 110 .
  • the cellular communication device 120 can register a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data 115 is received.
  • the interval counter can be incremented or decremented as desired for a particular application.
  • the cellular communication device 120 can generate a data cellular packet 125 , which includes the self-care device data stored in the cellular communication device 120 since data was last sent to the cloud infrastructure 130 plus overhead.
  • the overhead can include information about the particular data cellular packet 125 , such as identifiers, encryption keys, and the like.
  • the overhead can include any information desired for a particular application to facilitate communication between the cellular communication device 120 and the cloud infrastructure 130 .
  • the data cellular packet 125 is sent from the cellular communication device 120 to the cloud infrastructure 130 over a cellular network, i.e., a mobile radio network in which each land area is served by one or more local radio transceivers.
  • the cellular communication device 120 can store the data cellular packets when communication is lost between the cellular communication device 120 in the cloud infrastructure 130 , and the cellular communication device 120 can send the stored data cellular packets when communication is restored.
  • the cloud infrastructure 130 receives the data cellular packet 125 from the cellular communication device 120 , and can generate display data 135 from the data cellular packets received for transmission to the display device 140 .
  • the cloud infrastructure 130 can include a data center 132 , a cloud application 134 , and a database 136 .
  • the cloud infrastructure 130 can be a single device or can include multiple or distributed interconnected components performing the functions of the data center 132 , the cloud application 134 and the database 136 .
  • the data cellular packet 125 can be received by the data center 132 , processed by the cloud application 134 , and stored in the database 136 .
  • the cloud infrastructure 130 determines the value of the fixed interval index, which controls how often the cellular data packets are transmitted from the cellular communication device 120 to the cloud infrastructure 130 .
  • the cloud infrastructure 130 also transmits the value of the fixed interval index to the cellular communication device 124 storage in the cellular communication device 120 .
  • the cellular communication device 120 counts the number of times self-care device data 115 is received from the self-care device 110 by registering a count at an interval counter, then transmits the data cellular packet 125 when the interval counter equals the fixed interval index.
  • the value of the fixed interval index can be selected as desired for a particular application. In one embodiment, the value of the fixed interval index can be a fixed integer.
  • the fixed integer can be selected based on factors such as medical condition and history of a particular patient, statistical analysis of patient group experience, or the like.
  • the value of the fixed interval index can be selected by the cloud infrastructure 130 based on activity in the variable data usage personal medical system 100 , such as viewing data on the display device 140 .
  • the value of the fixed interval index can be selected based on communication costs, so that the data cellular packets are transmitted from the cellular communication device 122 the cloud infrastructure 130 more often when communication costs are low.
  • Exemplary cloud infrastructures include CareLink® Personal Software, SMS aggregators, servers, computers, and the like.
  • the display device 140 can be any human machine interface in communication with the cloud infrastructure 130 capable of receiving and displaying the display data 135 .
  • Exemplary displays for display devices 140 include displays on dedicated display devices, consumer devices, mobile phones, computers (e.g., desktops, laptops), computer tablets, Internet-enabled televisions, and the like.
  • the display device 140 can be integrated with the self-care device 110 and/or the cellular communication device 120 .
  • the display device 140 can be updated continuously or periodically.
  • the display device 140 can generate a display device data request when the display device 140 is enabled, i.e., when the display device is energized and/or being used.
  • the display device data request is transmitted from the display device 140 to the cloud infrastructure 130 .
  • the cloud infrastructure 130 sends a wake up message to the cellular communication device 120 , followed by repeated cloud infrastructure data requests to the cellular communication device 120 .
  • the cellular communication device 120 sends a data cellular packet 125 to the cloud infrastructure 130 every time the self-care device 110 sends the self-care device data 115 to the cellular communication device 120 , i.e., each time the interval counter equals the fixed interval index.
  • the cloud infrastructure 130 then generates continuous display data from the data cellular packets and provides the display data 135 to the display device 140 , providing a continuous update of the display device 140 .
  • the cellular communication device 120 can include a continuous communication index that is responsive to a toggle command from the cloud infrastructure 130 .
  • the display device 140 can generate a display device data request when the display device is enabled and transmit the display device data request to the cloud infrastructure 130 .
  • the cloud infrastructure 130 can send a toggle command to the cellular communication device 120 to toggle the value of a continuous communication index. This, in turn, toggles the operating mode of the cellular communication device 120 from the current mode to the alternate mode, i.e., from continuous to normal or from normal to continuous.
  • the fixed interval index governs how often the cellular communication device 120 sends the data cellular packet 125 to the cloud infrastructure 130 .
  • the cellular communication device 120 sends the data cellular packet 125 to the cloud infrastructure 130 every time the cellular communication device 120 receives self-care device data 115 from the self-care device 110 .
  • the cloud infrastructure 130 can send another toggle command to the cellular communication device 120 that changes the value of the continuous communication index back to its initial value, for example, returning the cellular communication device 120 to the normal mode when the display device 140 is turned off.
  • the fixed interval index can be changed to provide a continuous update.
  • the display device 140 can generate a data interval increase request when the display device 140 is enabled.
  • the data interval increase request is transmitted from the display device 140 to the cloud infrastructure 130 , which sends a wake up message and new value for the fixed interval index to the cellular communication device 120 .
  • the new value is typically less than the present value of the fixed interval index, so that the data cellular packets 125 are sent to the cloud infrastructure 130 more often to keep the display device 140 current.
  • the new value is one, so that a data cellular packet 125 is transmitted to the cloud infrastructure 130 every time the cellular communication device 120 receives self-care device data 115 from the self-care device 110 .
  • the display device 140 can generate a display device data request when the display device is enabled and transmit the display device data request to the cloud infrastructure 130 .
  • the cloud infrastructure 130 sends the display data 135 generated from the most recent data cellular packet 125 received at the cloud infrastructure 130 to the display device 140 .
  • the cloud infrastructure 130 also sends a single cloud infrastructure data request to the cellular communication device 120 .
  • the cellular communication device 120 sends a data cellular packet 125 containing the latest self-care device data 115 stored in the cellular communication device 120 to the cloud infrastructure 130 , which generates latest display data 135 from the data cellular packet 125 and sends the latest display data 135 to the display device 140 .
  • the display device 140 displays the most recent data received by the cloud infrastructure 130 with updated data requested from the cellular communication device 120 .
  • the data packet includes overhead providing information about the transmission and a payload including stored self-care device data.
  • the data usage is 5.8 Mb per month when the fixed interval index causes the five minute data packet of 672 bits [565+107] to be sent every 5 minutes.
  • the data usage is 1.7 Mb per month when the fixed interval index causes the thirty minute data packet of 1207 bits [565+(6*107)] to be sent every 30 minutes.
  • FIG. 2 is a schematic diagram of self-care devices and a cellular communication device for a variable data usage personal medical system made in accordance with the invention.
  • the patient 200 and is wearing two self-care devices, a therapy administration device 210 and a physiological monitoring device 220 , both of which are in wired and/or wireless communication with a cellular communication device 230 .
  • the therapy administration device 210 is an insulin delivery device and the physiological monitoring device 220 is a continuous glucose monitoring (CGM) device.
  • CGM continuous glucose monitoring
  • the self-care device as defined herein can be any personal medical device designed to be carried or worn by a patient.
  • FIG. 3 is a timing chart of communications for a variable data usage personal medical system made in accordance with the invention. The communications occur between the components described above: a self-care device 310 , a cellular communication device 320 , a cloud infrastructure 330 , and a display device 340 .
  • the self-care device 310 sends self-care device data to the cellular communication device 320 at a fixed interval 312 , such as 5 minutes in this example.
  • the cellular communication device 320 receives and stores the self-care device data, and increments and interval counter each time the self-care device data is received.
  • the cellular communication device 320 sends a data cellular packet to the cloud infrastructure 330 when the interval counter equals a fixed interval index.
  • the data cellular packet is generated by the cellular communication device and includes overhead plus stored self-care device data.
  • the fixed interval index is 6 so that the data cellular packet is transmitted to the cloud infrastructure 330 every 30 minutes.
  • the cloud infrastructure 330 can return an optional data received response to the cellular communication device 320 .
  • the cycle of data transfer from the self-care device 310 to the cellular communication device 320 , followed by the less frequent transfer of data from the cellular communication device 320 to the cloud infrastructure 330 can be repeated indefinitely.
  • the display device 340 When the display device 340 is enabled, the display device 340 sends a display device data request to the cloud infrastructure 330 at 345 .
  • the cloud infrastructure 330 sends a wake up message to the cellular communication device 320 in response at 335 .
  • the cellular communication device 320 sends the latest data cellular packet to the cloud infrastructure 330 in response to the wake up message at 322 .
  • the cloud infrastructure 330 generates display data including the latest data cellular packet and transmits the display data to the display device 340 at 332 .
  • the cellular communication device 320 transmits a data cellular packet to the cloud infrastructure 330 when the interval counter equals the fixed interval index.
  • the display device 340 After a fixed interval, the display device 340 sends another display device request to the cloud infrastructure 330 and the cycle is repeated with the return of the latest display data to the display device 340 .
  • the display device 340 When the display device 340 is disabled, display data is no longer transmitted from the cloud infrastructure 330 to the display device 340 , and the variable data usage personal medical system returns to the cycle of data transfer from the self-care device 310 to the cellular communication device 320 , followed by the less frequent transfer of data from the cellular communication device 320 to the cloud infrastructure 330 .
  • the communications for the variable data usage personal medical system can include security features as desired for a particular application.
  • devices which desire to communicate such as the cellular communication device and the cloud infrastructure, can employ a handshake protocol to verify each other's identity before data is sent between them.
  • devices can establish a virtual private network across publicly accessible communications networks.
  • the data being transmitted can be encrypted to verify integrity and security.
  • FIG. 4 is a flow chart of a method of personal medical variable data usage for a patient in accordance with the invention.
  • the method 400 includes transmitting a value for a fixed interval index 410 remote from the patient; storing the fixed interval index 420 at the patient; generating self-care device data for the patient 430 ; transmitting the self-care device data at a fixed interval 440 ; receiving and storing the transmitted self-care device data 450 ; registering a count at an interval counter for each of the fixed intervals 460 in which the transmitted self-care device data is received; generating a data cellular packet 470 from overhead plus the stored self-care device data when the interval counter equals the fixed interval index; transmitting the data packet from the patient over a cellular network 480 ; and receiving, processing, and storing the transmitted data packet 490 remote from the patient.
  • the term “at the patient” as defined herein means that the action occurs on, in, or near the patient; the term “remote from the patient” as defined herein means that the action occurs away from the body of the patient at a distance.
  • storing a fixed interval index at the patient can be performed by storing the fixed interval index in a cellular communication device, while receiving, processing, and storing the transmitted data packet remote from the patient can be performed in the cloud infrastructure.
  • the method 400 can further include generating display data from the transmitted data packet, and presenting the display data.
  • the method 400 can further include transmitting an alarm packet with accompanying data from the patient, and optionally adjusting therapy for the patient based on the accompanying data.
  • the method 400 can be carried out on a variable data usage personal medical system as described for FIG. 1 .
  • FIG. 5A-5I is a table of alarms and accompanying data for a variable data usage personal medical system made in accordance with the invention.
  • the table includes the alarm number 510 , the alarm name 520 with definition, the notification text message 530 , and the accompanying data 540 .
  • the alarm packet includes the alarm number as an identifier plus the accompanying data for use in making therapy adjustments.
  • Accompanying data as defined herein is any data available at the cellular communication device which is useful to the cloud infrastructure in making therapy adjustments. For example, referring to alarm number A 101 of FIG.
  • the alarm is transmitted from the self-care device when the self-care device measures glucose above a user specified high limit.
  • the accompanying data to be sent in the alarm packet includes data useful in making therapy adjustments, such as information concerning time, injection history, glucose measurement history, patient activity history, and the like.
  • the accompanying data can be used for therapy management by patients, health care providers, health service payors, caregivers, and the like.
  • FIGS. 1-5I illustrate specific applications and embodiments of the invention, and are not intended to limit the scope of the present disclosure or claims to that which is presented therein.

Abstract

A variable data usage personal medical system including a self-care device attached to a patient, and operable to generate self-care device data and to transmit the self-care device data at a fixed interval; a cellular communication device operable to receive and store the transmitted self-care device data, to register a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data is received, to generate a data cellular packet from overhead plus the stored self-care device data when the interval counter equals a fixed interval index, and to transmit the data packet; and a cloud infrastructure operably connected to the cellular communication device over a cellular network, and operable to receive, process, and store the transmitted data packet. The cloud infrastructure is operable to transmit a value for the fixed interval index to the cellular communication device for storage.

Description

    RELATED APPLICATION
  • The present disclosure is a continuation of U.S. patent application Ser. No. 13/904,343 filed on May 29, 2013, the contents of which are herein incorporated by reference in their entirety.
    • TECHNICAL FIELD
  • The technical field of this disclosure is personal medical systems, particularly, variable data usage personal medical systems and methods.
    • BACKGROUND OF THE INVENTION
  • Advances in electronics and telemetry have resulted in the miniaturization of medical devices such that medical devices which previously required large stationary equipment can now be worn about the person, who can be monitored or receive treatment while pursuing normal daily tasks.
  • One area of such advances has been in the treatment of diabetes. An estimated twenty-six million people in the United States, or about 8% of the population, have diabetes. This percentage is expected to increase in the near-term as the population ages. Wearable glucose monitors and insulin pumps have been developed which allow persons under treatment for diabetes to be monitored and receive insulin while carrying on their day-to-day tasks.
  • Wearable medical devices oftentimes communicate with a remote computer system over a cellular network. Data, such as a glucose reading or pump information, is obtained at the person under treatment then sent to the computer system periodically for analysis. Unfortunately, data is often transmitted at a regular frequency which may be higher than what is required. Sending a large amount of data over a cellular network is expensive. Also, sending data too often can deplete the batteries on the personal medical device.
  • Other problems arise with the treatment of data received at the remote computer system. The data may not be current, making it unreliable and causing potential misdiagnosis of ongoing status. Further, alarms received at the remote computer system may be minimal, providing insufficient information on which to take appropriate corrective action.
  • It would be desirable to have a variable data usage personal medical system that would overcome the above disadvantages.
    • SUMMARY OF THE INVENTION
  • One aspect of the invention provides a variable data usage personal medical system for use with a patient including a self-care device attached to the patient, the self-care device being operable to generate self-care device data and to transmit the self-care device data at a fixed interval; a cellular communication device operably connected to the self-care device, the cellular communication device being operable to receive and store the transmitted self-care device data, to register a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data is received, to generate a data cellular packet from overhead plus the stored self-care device data when the interval counter equals a fixed interval index, and to transmit the data packet; and a cloud infrastructure operably connected to the cellular communication device over a cellular network, the cloud infrastructure being operable to receive, process, and store the transmitted data packet. The cellular communication device is operable to store the fixed interval index and the cloud infrastructure is operable to transmit a value for the fixed interval index to the cellular communication device for storage.
  • Another aspect of the invention provides a method of personal medical variable data usage for a patient including transmitting a value for a fixed interval index remote from the patient; storing the fixed interval index at the patient; generating self-care device data for the patient; transmitting the self-care device data at a fixed interval; receiving and storing the transmitted self-care device data; registering a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data is received; generating a data cellular packet from overhead plus the stored self-care device data when the interval counter equals the fixed interval index; transmitting the data packet from the patient over a cellular network; and receiving, processing, and storing the transmitted data packet remote from the patient.
  • Another aspect of the invention provides a system of personal medical variable data usage for a patient including means for transmitting a value for a fixed interval index remote from the patient; means for storing the fixed interval index at the patient; means for generating self-care device data for the patient; means for transmitting the self-care device data at a fixed interval; means for receiving and storing the transmitted self-care device data; means for registering a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data is received; means for generating a data cellular packet from overhead plus the stored self-care device data when the interval counter equals the fixed interval index; means for transmitting the data packet from the patient over a cellular network; and means for receiving, processing, and storing the transmitted data packet remote from the patient.
  • The foregoing and other features and advantages of the invention will become further apparent from the following detailed description of the presently preferred embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention, rather than limiting the scope of the invention being defined by the appended claims and equivalents thereof.
    • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a block diagram of a variable data usage personal medical system made in accordance with the invention.
  • FIG. 2 is a schematic diagram of self-care devices and a cellular communication device for a variable data usage personal medical system made in accordance with the invention.
  • FIG. 3 is a timing chart of communications for a variable data usage personal medical system made in accordance with the invention.
  • FIG. 4 is a flow chart of a method of personal medical variable data usage for a patient in accordance with the invention.
  • FIG. 5A-5I is a table of alarms and accompanying data for a variable data usage personal medical system made in accordance with the invention.
    •  DETAILED DESCRIPTION
  • FIG. 1 is a block diagram of a variable data usage personal medical system made in accordance with the invention. The variable data usage personal medical system 100 is designed for use with a patient and includes a self-care device 110, a cellular communication device 120, and a cloud infrastructure 130. In this example, the variable data usage personal medical system 100 also includes an optional display device 140. The variable data usage personal medical system 100 allows the cloud infrastructure 130 to control the time interval at which the cellular communication device 120 communicates data from the self-care device 110 to the cloud infrastructure 130.
  • The self-care device 110 can be attached to the patient and is designed to be carried or worn by a patient. The self-care device 110 can be any personal medical device which delivers therapy to a patient and/or monitors a physiological parameter of the patient. Exemplary self-care devices include pumps, cell pumps, continuous glucose monitors, and the like. In one example, the self-care device 110 is an insulin delivery device. In another example, the self-care device 110 is a continuous glucose monitoring (CGM) device. In one embodiment, the self-care device 110 can both deliver therapy and monitor a physiological parameter. One example of such a device would be a paired insulin delivery and CGM device. Those skilled in the art will appreciate that the self-care device 110 can be any self-care device as desired for a particular application. The self-care device 110 generates self-care device data 115 and transmits the self-care device data 115 to the cellular communication device 120 at fixed intervals.
  • The cellular communication device 120 is operably connected to the self-care device 110. The cellular communication device 120 is a radio protocol converter and repeater device. The cellular communication device 120 stores the self-care device data 115 received by the cellular communication device 120 from the self-care device 110. The link between the cellular communication device 120 and the self-care device 110 can be wired or wireless, using standard protocols such as 802.11b/g/n. The radio protocol conversion can be stored in firmware in the cellular communication device 120. Exemplary cellular communication devices include CloudPost™ glucose monitors and remote controllers therefor, controllers, display meters, mobile phones, on-body communicators, on-body repeaters, and the like. In one embodiment, the cellular communication device 120 can request that the self-care device 110 send data stored in the self-care device 110 to provide the data backfill when the connection between the self-care device 110 and the cellular communication device 120 has been disconnected such that the cellular communication device 120 has not been receiving the self-care device data 115 from the self-care device 110. Thus, the cellular communication device 120 maintains a complete data record. In one embodiment, the cellular communication device 120 can be combined and integrated in a single package with the self-care device 110.
  • The cellular communication device 120 can register a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data 115 is received. The interval counter can be incremented or decremented as desired for a particular application. When the interval counter equals a fixed interval index provided by the cloud infrastructure 130 and stored in the cellular communication device 120, the cellular communication device 120 can generate a data cellular packet 125, which includes the self-care device data stored in the cellular communication device 120 since data was last sent to the cloud infrastructure 130 plus overhead. The overhead can include information about the particular data cellular packet 125, such as identifiers, encryption keys, and the like. Those skilled in the art will appreciate that in the art will appreciate that the overhead can include any information desired for a particular application to facilitate communication between the cellular communication device 120 and the cloud infrastructure 130. The data cellular packet 125 is sent from the cellular communication device 120 to the cloud infrastructure 130 over a cellular network, i.e., a mobile radio network in which each land area is served by one or more local radio transceivers. In one embodiment, the cellular communication device 120 can store the data cellular packets when communication is lost between the cellular communication device 120 in the cloud infrastructure 130, and the cellular communication device 120 can send the stored data cellular packets when communication is restored.
  • The cloud infrastructure 130 receives the data cellular packet 125 from the cellular communication device 120, and can generate display data 135 from the data cellular packets received for transmission to the display device 140. The cloud infrastructure 130 can include a data center 132, a cloud application 134, and a database 136. Those skilled in the art will appreciate that the cloud infrastructure 130 can be a single device or can include multiple or distributed interconnected components performing the functions of the data center 132, the cloud application 134 and the database 136. The data cellular packet 125 can be received by the data center 132, processed by the cloud application 134, and stored in the database 136.
  • The cloud infrastructure 130 determines the value of the fixed interval index, which controls how often the cellular data packets are transmitted from the cellular communication device 120 to the cloud infrastructure 130. The cloud infrastructure 130 also transmits the value of the fixed interval index to the cellular communication device 124 storage in the cellular communication device 120. The cellular communication device 120 counts the number of times self-care device data 115 is received from the self-care device 110 by registering a count at an interval counter, then transmits the data cellular packet 125 when the interval counter equals the fixed interval index. The value of the fixed interval index can be selected as desired for a particular application. In one embodiment, the value of the fixed interval index can be a fixed integer. For example, the fixed integer can be selected based on factors such as medical condition and history of a particular patient, statistical analysis of patient group experience, or the like. In another embodiment, the value of the fixed interval index can be selected by the cloud infrastructure 130 based on activity in the variable data usage personal medical system 100, such as viewing data on the display device 140. In another embodiment, the value of the fixed interval index can be selected based on communication costs, so that the data cellular packets are transmitted from the cellular communication device 122 the cloud infrastructure 130 more often when communication costs are low. Exemplary cloud infrastructures include CareLink® Personal Software, SMS aggregators, servers, computers, and the like.
  • The display device 140 can be any human machine interface in communication with the cloud infrastructure 130 capable of receiving and displaying the display data 135. Exemplary displays for display devices 140 include displays on dedicated display devices, consumer devices, mobile phones, computers (e.g., desktops, laptops), computer tablets, Internet-enabled televisions, and the like. In one embodiment, the display device 140 can be integrated with the self-care device 110 and/or the cellular communication device 120.
  • The display device 140 can be updated continuously or periodically. The display device 140 can generate a display device data request when the display device 140 is enabled, i.e., when the display device is energized and/or being used. The display device data request is transmitted from the display device 140 to the cloud infrastructure 130. In one continuous update embodiment and in response to the display device data request, the cloud infrastructure 130 sends a wake up message to the cellular communication device 120, followed by repeated cloud infrastructure data requests to the cellular communication device 120. In response to the repeated cloud infrastructure data requests, the cellular communication device 120 sends a data cellular packet 125 to the cloud infrastructure 130 every time the self-care device 110 sends the self-care device data 115 to the cellular communication device 120, i.e., each time the interval counter equals the fixed interval index. The cloud infrastructure 130 then generates continuous display data from the data cellular packets and provides the display data 135 to the display device 140, providing a continuous update of the display device 140.
  • In another continuous update embodiment, the cellular communication device 120 can include a continuous communication index that is responsive to a toggle command from the cloud infrastructure 130. The display device 140 can generate a display device data request when the display device is enabled and transmit the display device data request to the cloud infrastructure 130. In response, the cloud infrastructure 130 can send a toggle command to the cellular communication device 120 to toggle the value of a continuous communication index. This, in turn, toggles the operating mode of the cellular communication device 120 from the current mode to the alternate mode, i.e., from continuous to normal or from normal to continuous. In the normal mode, the fixed interval index governs how often the cellular communication device 120 sends the data cellular packet 125 to the cloud infrastructure 130. In the continuous mode, the cellular communication device 120 sends the data cellular packet 125 to the cloud infrastructure 130 every time the cellular communication device 120 receives self-care device data 115 from the self-care device 110. The cloud infrastructure 130 can send another toggle command to the cellular communication device 120 that changes the value of the continuous communication index back to its initial value, for example, returning the cellular communication device 120 to the normal mode when the display device 140 is turned off.
  • In yet another continuous update embodiment, the fixed interval index can be changed to provide a continuous update. The display device 140 can generate a data interval increase request when the display device 140 is enabled. The data interval increase request is transmitted from the display device 140 to the cloud infrastructure 130, which sends a wake up message and new value for the fixed interval index to the cellular communication device 120. The new value is typically less than the present value of the fixed interval index, so that the data cellular packets 125 are sent to the cloud infrastructure 130 more often to keep the display device 140 current. In one example, the new value is one, so that a data cellular packet 125 is transmitted to the cloud infrastructure 130 every time the cellular communication device 120 receives self-care device data 115 from the self-care device 110.
  • In a periodic update embodiment, the display device 140 can generate a display device data request when the display device is enabled and transmit the display device data request to the cloud infrastructure 130. In response to the display device data request, the cloud infrastructure 130 sends the display data 135 generated from the most recent data cellular packet 125 received at the cloud infrastructure 130 to the display device 140. In response to the display device data request, the cloud infrastructure 130 also sends a single cloud infrastructure data request to the cellular communication device 120. In response to the single cloud infrastructure data request, the cellular communication device 120 sends a data cellular packet 125 containing the latest self-care device data 115 stored in the cellular communication device 120 to the cloud infrastructure 130, which generates latest display data 135 from the data cellular packet 125 and sends the latest display data 135 to the display device 140. Thus, the display device 140 displays the most recent data received by the cloud infrastructure 130 with updated data requested from the cellular communication device 120.
  • The improvement in data usage with the variable data usage personal medical system can be illustrated by looking at data usage at different fixed interval indices. As described above, the data packet includes overhead providing information about the transmission and a payload including stored self-care device data. When the overhead requires 565 bits and the payload taken every 5 minutes is 107 bits, the data usage is 5.8 Mb per month when the fixed interval index causes the five minute data packet of 672 bits [565+107] to be sent every 5 minutes. Using the same 565 bits for overhead plus 107 bits of payload taken every 5 minutes, the data usage is 1.7 Mb per month when the fixed interval index causes the thirty minute data packet of 1207 bits [565+(6*107)] to be sent every 30 minutes.
  • FIG. 2 is a schematic diagram of self-care devices and a cellular communication device for a variable data usage personal medical system made in accordance with the invention. In this example, the patient 200 and is wearing two self-care devices, a therapy administration device 210 and a physiological monitoring device 220, both of which are in wired and/or wireless communication with a cellular communication device 230. In one embodiment, the therapy administration device 210 is an insulin delivery device and the physiological monitoring device 220 is a continuous glucose monitoring (CGM) device. The self-care device as defined herein can be any personal medical device designed to be carried or worn by a patient.
  • FIG. 3 is a timing chart of communications for a variable data usage personal medical system made in accordance with the invention. The communications occur between the components described above: a self-care device 310, a cellular communication device 320, a cloud infrastructure 330, and a display device 340.
  • At 315, the self-care device 310 sends self-care device data to the cellular communication device 320 at a fixed interval 312, such as 5 minutes in this example. The cellular communication device 320 receives and stores the self-care device data, and increments and interval counter each time the self-care device data is received.
  • At 325, the cellular communication device 320 sends a data cellular packet to the cloud infrastructure 330 when the interval counter equals a fixed interval index. The data cellular packet is generated by the cellular communication device and includes overhead plus stored self-care device data. In this example, the fixed interval index is 6 so that the data cellular packet is transmitted to the cloud infrastructure 330 every 30 minutes. At 326, the cloud infrastructure 330 can return an optional data received response to the cellular communication device 320. The cycle of data transfer from the self-care device 310 to the cellular communication device 320, followed by the less frequent transfer of data from the cellular communication device 320 to the cloud infrastructure 330 can be repeated indefinitely.
  • When the display device 340 is enabled, the display device 340 sends a display device data request to the cloud infrastructure 330 at 345. The cloud infrastructure 330 sends a wake up message to the cellular communication device 320 in response at 335. The cellular communication device 320 sends the latest data cellular packet to the cloud infrastructure 330 in response to the wake up message at 322. The cloud infrastructure 330 generates display data including the latest data cellular packet and transmits the display data to the display device 340 at 332. At 324, the cellular communication device 320 transmits a data cellular packet to the cloud infrastructure 330 when the interval counter equals the fixed interval index.
  • After a fixed interval, the display device 340 sends another display device request to the cloud infrastructure 330 and the cycle is repeated with the return of the latest display data to the display device 340. When the display device 340 is disabled, display data is no longer transmitted from the cloud infrastructure 330 to the display device 340, and the variable data usage personal medical system returns to the cycle of data transfer from the self-care device 310 to the cellular communication device 320, followed by the less frequent transfer of data from the cellular communication device 320 to the cloud infrastructure 330.
  • Those skilled in the art will appreciate that the communications for the variable data usage personal medical system can include security features as desired for a particular application. In one example, devices which desire to communicate, such as the cellular communication device and the cloud infrastructure, can employ a handshake protocol to verify each other's identity before data is sent between them. In another example, devices can establish a virtual private network across publicly accessible communications networks. In yet another example, the data being transmitted can be encrypted to verify integrity and security.
  • FIG. 4 is a flow chart of a method of personal medical variable data usage for a patient in accordance with the invention. The method 400 includes transmitting a value for a fixed interval index 410 remote from the patient; storing the fixed interval index 420 at the patient; generating self-care device data for the patient 430; transmitting the self-care device data at a fixed interval 440; receiving and storing the transmitted self-care device data 450; registering a count at an interval counter for each of the fixed intervals 460 in which the transmitted self-care device data is received; generating a data cellular packet 470 from overhead plus the stored self-care device data when the interval counter equals the fixed interval index; transmitting the data packet from the patient over a cellular network 480; and receiving, processing, and storing the transmitted data packet 490 remote from the patient. The term “at the patient” as defined herein means that the action occurs on, in, or near the patient; the term “remote from the patient” as defined herein means that the action occurs away from the body of the patient at a distance. For example, storing a fixed interval index at the patient can be performed by storing the fixed interval index in a cellular communication device, while receiving, processing, and storing the transmitted data packet remote from the patient can be performed in the cloud infrastructure. In one embodiment, the method 400 can further include generating display data from the transmitted data packet, and presenting the display data. In another embodiment, the method 400 can further include transmitting an alarm packet with accompanying data from the patient, and optionally adjusting therapy for the patient based on the accompanying data. The method 400 can be carried out on a variable data usage personal medical system as described for FIG. 1.
  • FIG. 5A-5I is a table of alarms and accompanying data for a variable data usage personal medical system made in accordance with the invention. The table includes the alarm number 510, the alarm name 520 with definition, the notification text message 530, and the accompanying data 540. When the self-care device detects an unusual condition and sends an alarm packet to the cloud infrastructure through the cellular communication device, the alarm packet includes the alarm number as an identifier plus the accompanying data for use in making therapy adjustments. Accompanying data as defined herein is any data available at the cellular communication device which is useful to the cloud infrastructure in making therapy adjustments. For example, referring to alarm number A101 of FIG. 5A, the alarm is transmitted from the self-care device when the self-care device measures glucose above a user specified high limit. The accompanying data to be sent in the alarm packet includes data useful in making therapy adjustments, such as information concerning time, injection history, glucose measurement history, patient activity history, and the like. Those skilled in the art will appreciate that alarms and accompanying data other than the examples of FIG. 5A-5I can be used as desired for a particular application. For example, the accompanying data can be used for therapy management by patients, health care providers, health service payors, caregivers, and the like.
  • It is important to note that FIGS. 1-5I illustrate specific applications and embodiments of the invention, and are not intended to limit the scope of the present disclosure or claims to that which is presented therein. Upon reading the specification and reviewing the drawings hereof, it will become immediately obvious to those skilled in the art that myriad other embodiments of the invention are possible, and that such embodiments are contemplated and fall within the scope of the presently claimed invention.
  • While the embodiments of the invention disclosed herein are presently considered to be preferred, various changes and modifications can be made without departing from the spirit and scope of the invention. The scope of the invention is indicated in the appended claims, and all changes that come within the meaning and range of equivalents are intended to be embraced therein.

Claims (20)

1. A system comprising:
a self-care device of a patient operably connected to a communication device of the patient, wherein the communication device is operably connected to a cloud infrastructure, the self-care device being operable to:
generate self-care device data; and
transmit the self-care device data to the communication device at a fixed interval, wherein the cloud infrastructure transmits a value for a fixed interval index to the communication device, wherein the communication device registers a count at an interval counter for each fixed interval in which the transmitted self-care data is received and wherein the communication device communicates a data packet, which includes the self-care device data, to the cloud infrastructure in response to the count at the interval counter being equal to the fixed interval index.
2. The system of claim 1, wherein the self-care device further comprises a link between the self-care device and the communication device, wherein the link further comprises a wired or a wireless connection.
3. The system of claim 1, wherein the self-care device is operable to, in response to a request from the communication device, send data stored in the self-care device to the communication device.
4. The system of claim 1, wherein the self-care device and the communication device are combined and integrated in a single package.
5. The system of claim 1, wherein in response to the count at the interval counter being equal to the fixed interval, the communication device generates the data packet that includes the self-care device data plus overhead.
6. The system of claim 1, wherein the data packet is sent from the communications device to the cloud infrastructure over a network.
7. The system of claim 1, further comprising a display device operable to receive and display data from at least one data packet.
8. The system of claim 1, wherein the value for the fixed interval index is a fixed integer.
9. The system of claim 1, wherein the value for the fixed interval index is selected based on at least one of a medical condition and history of the patient, statistical analysis of a patient group experience, activity in the system, or communication costs.
10. A self-care device that attaches to a patient, the self-care device comprising:
a communication link operable to communicate with a communication device, the self-care device operable to:
generate self-care device data; and
transmit the self-care device data to the communication device at a fixed interval, wherein the communication device registers a count at an interval counter for each fixed interval in which the transmitted self-care data is received, wherein the communication device communicates a data packet, which includes the self-care device data from the self-care device, to a cloud infrastructure in response to the count at the interval counter being equal to a value for a fixed interval index received from the cloud infrastructure.
11. The self-care device of claim 10 further comprising a personal medical device that delivers therapy to the patient.
12. The self-care device of claim 11, wherein the personal medical device delivers insulin to the patient.
13. The self-care device of claim 10 further comprising a personal medical device that monitors a physiological parameter of the patient.
14. The self-care device of claim 13 wherein the personal medical device is a continuous glucose monitoring (CGM) device.
15. A method comprising:
generating, by a self-care device, self-care device data for a patient; and
transmitting, by the self-care device, the self-care device data to a communication device at a fixed interval, wherein a cloud infrastructure transmits a value for a fixed interval index to the communication device, wherein the communication device registers a count at an interval counter for each fixed interval in which the transmitted self-care data is received, and wherein the communication device communicates a data packet, which includes the self-care device data, to the cloud infrastructure in response to the count at the interval counter being equal to the fixed interval index.
16. The method of claim 15, wherein the transmitting further comprises transmitting the self-care device data to the communication device approximately every 5 minutes.
17. The method of claim 15, wherein, in response to the transmitting, the communication device receives and increments the interval counter each time the self-care device data is received.
18. The method of claim 15, wherein the transmitting comprises a cycle of data transfer from the self-care device to the communication device that is followed by a less frequent transfer of data from the communication device to the cloud infrastructure.
19. The method of claim 15, further comprising sending, by the self-care device, in response to detecting an unusual condition, an alarm packet to the cloud infrastructure through the communication device.
20. The method of claim 19, wherein the alarm packet further comprises an identifier plus accompanying data for use in making therapy adjustments.
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