AU2020101619A4 - Low energy communicator between external programmer and implantable medical devices using ble technology - Google Patents

Low energy communicator between external programmer and implantable medical devices using ble technology Download PDF

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AU2020101619A4
AU2020101619A4 AU2020101619A AU2020101619A AU2020101619A4 AU 2020101619 A4 AU2020101619 A4 AU 2020101619A4 AU 2020101619 A AU2020101619 A AU 2020101619A AU 2020101619 A AU2020101619 A AU 2020101619A AU 2020101619 A4 AU2020101619 A4 AU 2020101619A4
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low energy
ble
medical devices
external programmer
bluetooth
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AU2020101619A
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Mohammed Azahar Ahmed
Lalit GARG
Rahul Dev Gupta
Gourav Kalra
Suresh N. S.
Muzeeb Khan Patan
Jonnala Subba Reddy
Anil Kumar T.
Ramakrishna V.
Prashant kuna
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N S Suresh Dr
T Anil Kumar Dr
V Ramakrishna Dr
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N S Suresh Dr
T Anil Kumar Dr
V Ramakrishna Dr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • 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
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W4/00—Services specially adapted for wireless communication networks; Facilities therefor
    • H04W4/80—Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W84/00—Network topologies
    • H04W84/18—Self-organising networks, e.g. ad-hoc networks or sensor networks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00—Network arrangements or protocols for supporting network services or applications
    • H04L67/01—Protocols
    • H04L67/04—Protocols specially adapted for terminals or networks with limited capabilities; specially adapted for terminal portability
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02D—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN INFORMATION AND COMMUNICATION TECHNOLOGIES [ICT], I.E. INFORMATION AND COMMUNICATION TECHNOLOGIES AIMING AT THE REDUCTION OF THEIR OWN ENERGY USE
    • Y02D30/00—Reducing energy consumption in communication networks
    • Y02D30/70—Reducing energy consumption in communication networks in wireless communication networks

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Signal Processing (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
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  • General Business, Economics & Management (AREA)
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  • Business, Economics & Management (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

LOW ENERGY COMMUNICATOR BETWEEN EXTERNAL PROGRAMMER AND IMPLANTABLE MEDICAL DEVICES USING BLE TECHNOLOGY ABSTRACT Healthcare technology is an integral part of the diagnosis and the treatment, as there is a rapid growth in the medical devices and the sensors. Online telemedical services to individuals are very much useful due to possible flexibility and effective healthcare services. This type of service is developed because of the advanced technologies in wearable sensors and wireless communication. The medical costs get reduced due to the electronic wireless sensor and has capability of enabling the physicians to monitor the signs like blood pressure, the glucose level in the blood, and blood oxygenation of the patient while they remain at home. Implantable medical devices (IMDs) are used to monitor the patient's condition continuously. In case, if any of the emergencies is necessary, the treatment can be applied to the patient. IMDs will be useful only for the patients who visit the hospitals regularly. The Bluetooth low energy is used to link the wireless sensors through the radio signals of the mobile phones and computers, which will be fitted for the next generation of Bluetooth wireless technology. Bluetooth Low Energy is used as the communication method in the medical devices and the sensors. The BLE offers power efficiency, and the transmission data rate is moderate. 1 P a g e LOW ENERGY COMMUNICATOR BETWEEN EXTERNAL PROGRAMMER AND IMPLANTABLE MEDICAL DEVICES USING BLE TECHNOLOGY Diagram User Human Heart Rate Acquisition Module Sensor Bluetooth Low Energy Android Handh eld Device iiiI Web Server Doctor and Clinic Figure 1: Block diagram of Low Energy Communication between the IMD and External Programmer using BLE 1| P a g e

Description

LOW ENERGY COMMUNICATOR BETWEEN EXTERNAL PROGRAMMER AND IMPLANTABLE MEDICAL DEVICES USING BLE TECHNOLOGY
Diagram
User Human Heart Rate Acquisition Module Sensor
Bluetooth Low Energy
Android Handh eld Device
iI Web Server Doctor and Clinic
Figure 1: Block diagram of Low Energy Communication between the IMD and External Programmer using BLE
1| P a g e
LOW ENERGY COMMUNICATOR BETWEEN EXTERNAL PROGRAMMER AND IMPLANTABLE MEDICAL DEVICES USING BLE TECHNOLOGY
Description
Field of the Invention.
Field of the invention related toComputer Information Systems
Background of the invention.
BLUETOOTH LOW ENERGY (BLE)
Bluetooth Low Energy is a wireless communication method that is designed mainly for short range communication. The BLE helps the devices to communicate with each other. When the battery life is preferred for high data transfer speed, in that case, the BLE can be preferred. Nowadays, most of the smartphones and tablets are comfortable with the BLE. They can communicate appropriately with the Bluetooth enabled wireless headphones, car stereos, smartwatches, and hardware devices such as beacons.
The data transfer in the BLE is one-way communication. For example, the BLE beacons will try to communicate with the smartphone in the range of shorter distances. The BLE beacon device will transfer the packets of data in a regular interval of time. The services will detect these data packets on the smartphone. The BLE communication will trigger the action like pushing a message.
The Bluetooth core specification consists of two major technology. 1. Bluetooth classic, and 2. Bluetooth Low Energy (Bluetooth Smart). The main difference between the two hardware or beacon technology is power consumption.
The factors for the Bluetooth smart technology which made out the impressive technology in most of the applications.
1. Power Consumption: The Higher data throughput will be given for the Bluetooth classic so that its power consumption will be high compared to the BLE technology. In BLE technology, fewer batteries will be used to power the Bluetooth low energy hardware devices for several months or years. The power consumption for Bluetooth is approximately 30mA, and BLE is less than l5mA. This technology has capable of running in Ultra-low power consumption. 2. Applications: Bluetooth classic is the well-suited beacon device for the application, which requires continuous data streaming. For example, Headphones. The Bluetooth low energy is the well-suited beacon device for the application, which requires the periodic transfer of the data, because of that, the significant amount of battery usage can be reduced. The reduction in power consumption and periodic transfer of data made the BLE technology more attractive and suitable for IoT and proximity marketing-related applications. 3. Simultaneous Connections: the Bluetooth classic can handle seven simultaneous connections. But BLE can able to handle up to the 20 connections simultaneously. BLE has the capability of handling a more significant number of simultaneous connections comparing to Bluetooth classic because it can transfer small data packets and establishes the connections as soon as possible. 4. Data Transfer Rate: The data transfer rate for Bluetooth classic is 2-3 Mbps. The data transfer rate for BLE is 200Kbps. BLE also operates in the range of 2.4 GHz ISM band. The BLE will activate only when the connection is initiated and will go to sleep mode once the BLE is disconnected. 5. Time to send data: Bluetooth classic transfers the data typically 100ms. BLE transfers the data typically 3ms.
The beacons will communicate through Bluetooth Low Energy, which is also known as BLE beacons. Beacon device is the hardware transmitter (small radio transmitter) that is placed in all locations to transfer the low energy Bluetooth signals based on the range of the hardware capability. On average, in the 80 meters range, the BLE signals can be transmitted by the beacon device.
The BLE devices consist of 4 different types of connections with different functions.
1. Broadcaster: The Broadcaster will be used as the server. This is used to transfer the data to the device, but it won't support any incoming connection.
2. Observer: The observer can only monitor and able to read the data which is sent by the broadcaster. In that case, the objects cannot send any connection to the server. 3. Central: A smartphone or tablet will be present here. The different types of connections, such as connected mode or the advertising mode, will be provided here. This can able to trigger the data transfer and can lead to the overall process. 4. Peripheral: On the periodical basis, the peripheral devices will allow the connections and the data transfer with the central. The main goal is to make sure of universal data transmission using the standard process so that the other devices will read and able to understand the data.
BLE TECHNOLOGY IN MEDICAL DEVICES
The advanced version of Bluetooth is Bluetooth Low Energy (BLE). This technology gives more opportunities for medical device designers. The BLE is a low energy device, and it is the most popular protocol for medical device communication. This device is inexpensive and also offers excellent connectivity to most of the smartphones. In the medical field, there are a lot of applications. For example: If the patient has the heart rate monitor, the patient wants to send the data in a few bytes for every second. This data is deficient compared to audio streaming. The BLE is an excellent option for the body area network for medical testing either in the home or the clinic. For example: While sleeping, if the person wears the sensor for covering the heartbeat rate, breathing, blood oximetry, chest expansion, etc. For this, BLE will be an excellent resource, and it allows the sensors to be small. The BLE will be more compatible with the smartphone. If the person needs the app for a medical device, the BLE can be a more excellent option for colossal connectivity.
The BLE consists of two types of implementations: 1. Single-mode (Ex: Watch, Keyboard, Heart rate monitor), 2. Dual Mode (Ex: Phone). Single-mode devices are flexible with radio communication signals and incorporate the wireless medical device for monitoring. The size is measured in tens of millimeters. The power consumption is also low, and medical monitoring will run for either in months or years based on the standard coin-cell batteries. For example, The Blood Glucose level measurement is transmitted once in every minute, based on 24 hours/ 365 days. Dual-mode devices also come under radio communication devices, and it targets the personal computers and the handset. The cell phone manufacturers will also use this device when this device is in availability, as it will cost a little higher than the classic Bluetooth. The functionality added to the cell phone or PC is that a dual-mode BLE device can communicate with the single-mode device directly. The medical data can also be transferred through the wireless monitor either to the PC or cell phone, and then it will be transferred to the remote physician.
The Wireless monitors will be linked to the cellular or the internet infrastructure through radio communication in the range of 2.4 GHz. This will allow the patients to avoid the stay in the hospital and will be infrequent in electronic contact with the health care providers. The wireless connectivity technology does not yet meet the requirements which are needed for widespread adoption. The requirements such as
1. Interoperability: It makes sure of the products from the various manufacturers to communicate with each other.
2. Low power operation: The medical monitors run for even the months or years based on coin cell batteries, which leads to the reduction of maintenance and the costs.
3. The medical authorities will request for transmitting the data in the format and also the customized software which is optimized for the medical applications.
4. Compatibility: The radio devices should exist together with the radio transceivers and does not cause electromagnetic interference in the other electronic devices.
5. To protect the confidentiality, the Transmission of the data should be secured.
6. The communication should exist between the sensors and the services like the internet or the cellular network because the information can be relayed with the remote health practitioners.
The first wireless technology is the Bluetooth Low Energy that meets all these requirements. Wi Fi, Zigbee, Bluetooth, and Bluetooth Low Energy are the four different interoperable technologies. The Manufactures of the medical equipment acquiring any of the wireless connectivity should have products that are approved by another various standard. The equipment from different manufacturers will communicate. For example, The consumer sector people will expect the Bluetooth wireless headset from manufacturer A which is linked successfully to the Bluetooth present in the cell phone from manufacturer B.
1. ZigBee: ZigBee is the wireless technology, and it is maintained by the alliance of commercial companies known as ZigBee Alliance. ZigBee is the low power consumption, and the recent versions can run from the coin-cell batteries. The ZigBee will operate within 2.4 GHz band, and the range can be extended up to hundreds of meters. In the medical field, ZigBee wireless technology has the potential for monitoring. The disadvantage of this technology is that bandwidth is moderate in the range of 250Kbps. This will increase the time to send the amount of data comparing to Bluetooth Low Energy technology. The Transmission of data will consume the battery power and will demand the bulky battery or considers the short span of life of the small batteries. ZigBee cannot communicate directly to the internet or cellular network. 2. Wi-Fi: By using Wi-Fi, the computers can be connected across the wireless local area network, and its wide bandwidth range is 300 Mbps. It operates in the range of 2.4 GHz band. The main drawback of the Wi-Fi is that it's power consumption and expense when it used in a continuous manner or the frequent usage for the medical monitoring applications. 3. Classic Bluetooth: The classic Bluetooth technology also operates in the range of 2.4 GHz. The range of the bandwidth is 1 to 24 Mbps. The range will be up to 30m. In some medical products, the usage of classic Bluetooth is already in use, for Example, Blood Glucose meters. The Classic Bluetooth can run from the coin cells, and the power consumption will be higher. Due to its high-power consumption, battery life is limited only for a few hours. This technology is not suitable for frequent usage in medical monitoring applications because of high power consumption. 4. Bluetooth Low Energy: In BLE technology, the power consumed is low, and this method helps to overcome the problems. The BLE operates at the range of 2.4 GHz. The bandwidth is 1I Mbps, and the range is 15 to 30 m.
Detailed Description of the Invention
Implantable Medical Devices like artificial pacemakers, neuro-stimulators, drug delivery systems will use the minimized computer systems to perform the different health monitoring and functioning automatically. For modemTMDs, wireless communication has become very attractive to health monitoring devices. The external device is also known as radio wave programmer, which is used to communicate with the IMDs in wireless technology for performing the various functions. The IMD is a small wireless device, and it will be inserted in the patient's body for medical monitoring. For example, Pacemakers are the life-saving processing functions for the patients. This type of device will require a long lifetime, nonchargeable, and it should be embedded in the body. The primary purpose of the IMDs is used to monitor the physiological conditions of the patients. The IMD devices consist of the bio sensors, portable computer, and the wireless module. In the patient's chest, the cardiac implant will be placed to monitor the abnormal heartbeat. The pacemakers and ICDs will be switched off when the patient's heartbeat is normal. The wireless device is added to the IMD to find the parameters. After the operation is over, the IMD will be implanted in the patient heart, and the patient needs to see the doctor regularly to take the test because to ensure whether the IMD is working correctly or not. The doctor will tune the IMD based on the patient's conditions. The programmed device will do this to communicate with the IMD via the wireless technologies, as shown in Figure 1. The intention of medical devices and the sensors is to improve the quality of care of the patient in healthcare. For example, wearable devices like heart rate or blood pressure are used to monitor the blood glucose level, insulin pumps, and implantable cardiac devices. Most of the medical devices and the sensors will use wireless communication for the interoperability with the latest version of the Bluetooth called "Bluetooth Low Energy."
From Figure 1, heart rate and heart condition can be detected and monitored in real-time to avoid heart diseases. The wearable sensors are used to extract the medical details to find out the variable parameters like heart rate, blood pressure, skin and body temperature, etc. The various parameters help for early detection of the different diseases like hypertension, hypotension, etc., via the alertness of the system based on the lower and upper threshold values. From figure 1, the monitoring system consists of two different phases. The first phase is that the patient will wear the wearable bio-sensor, which is used to extract the medical information, and it will be transferred to the android device (external reader) via Bluetooth Low Energy (BLE). The microcontroller and BLE will be present in the acquisition module, which helps to sample the heart sound signals, and the data will be transmitted to the android device, which is embedded with the BLE. The usage of BLE is that it improves the compatibility, and the power consumption will be decreased. The BLE will transfer the real-time information from the wearable sensors wirelessly to the server and will process the data to show the reports to the doctor. The Android device will extract the patient data from the bio-sensors. The android device will receive the heart sound data, and the signal curve will be plotted in real-time. The android device will communicate through the 4G or Wi-Fi networks. The display device is the android hand-held device. The GPS, which is the in-built function in the mobile, will help to find out the location of the patient who is under observation. The Portal will extract the data from the database and again transfer via a 4G or Wi-Fi network. In the web portal, the multiple databases will be accessed from the various patients of the wearable sensors, and it will be displayed on the web for the doctors.
The several heart parameters can be accessed from the multiple bio-sensors and also enables the monitoring simultaneously from the different patients. Heart pulse is a rhythmic expansion of the artery. The electric flow of the blood produces it and the number of pulses will be recorded every one minute. The Pulse rate may vary because of body activities or any of the medical problems. For different age groups, the pulse rate will change. In the real-time monitoring system, the measuring accuracy of the sensor will have an impact on the measurement of the heart rate. The Bluetooth Low Energy will make the sensor feasible for a longer time. Blood Pressure is referred based on the flow of the blood against the wall of the atrial during the heart contraction (systole) and the heart expansion (diastole). The early indication is the blood pressure, which helps the experts to take care of the severe patient. A temperature sensor based on Bluetooth is used to monitor the patient body temperature. Then, it is transmitted to the device using wireless communication. Figure 2 shows the BLE hardware architecture of the healthcare system.

Claims (8)

LOW ENERGY COMMUNICATOR BETWEEN EXTERNAL PROGRAMMER AND IMPLANTABLE MEDICAL DEVICES USING BLE TECHNOLOGY CLAIMS We claim,
1. The wearable sensor and the wireless communication technologies open up the platform for real-time health care monitoring system.
2. The wearable bio-sensors will measure the different parameters in the body.
3. The Bluetooth Low Energy will transmit the extracted data to the android handheld device, and then it is transmitted to the web server for future processing.
4. The power consumption will be low in Bluetooth Low Energy, and it will be compatible with smartphones and laptops.
5. The BLE transfers the data periodically to the other device.
6. Implantable medical devices will be useful in monitoring the patient parameters continuously.
7. Healthcare systems possibilities have been developed because of the low power communication modules, wearable bio-sensor technologies, and smart mobile devices.
8. The tiny wireless modules in the IMD will be implanted in the patient's body. So, the doctor can configure the different parameters, and the medical data will be transmitted from the IMD or to the IMD using the external programmer.
1 Pag e
LOW ENERGY COMMUNICATOR BETWEEN EXTERNAL PROGRAMMER AND 03 Aug 2020
IMPLANTABLE MEDICAL DEVICES USING BLE TECHNOLOGY
Diagram 2020101619
Figure 1: Block diagram of Low Energy Communication between the IMD and External Programmer using BLE
1|Page
Figure 2: BLE Healthcare Hardware Architecture
2|Page
AU2020101619A 2020-08-03 2020-08-03 Low energy communicator between external programmer and implantable medical devices using ble technology Ceased AU2020101619A4 (en)

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