PRABAAKER R SABARI (IN)
DE DEBASHIS; MUKHERJEE ANWESHA; SAU ARKAPRABHA; BHAKTA ISHITA: "Design of smart neonatal health monitoring system using SMCC", HEALTHCARE TECHNOLOGY LETTERS, THE INSTITUTION OF ENGINEERING AND TECHNOLOGY, MICHAEL FARADAY HOUSE, SIX HILLS WAY, STEVENAGE, HERTS. SG1 2AY, UK, vol. 4, no. 1, 2 November 2016 (2016-11-02), Michael Faraday House, Six Hills Way, Stevenage, Herts. SG1 2AY, UK , pages 13 - 19, XP006076114, DOI: 10.1049/htl.2016.0054
| We Claim: 1. A system implementation of a medical device connected gateway to digitise the workflow in Intensive Care Unit and Step Down ward that comprises of: (a) A plurality of processing units; (b) A stack of connectivity modules wherein the wired connectivity modules are selected from a group of wired connectivity options like Serial ports, USB, RS232, Ethernet LAN port, micro USB interfaces that includes USB type A, USB type B, USB type C, micro USB and other similar connectors, HDMI and other similar protocols; (c) A stack of connectivity modules wherein the wireless connectivity modules are selected from a group of wireless connectivity modalities that includes Bluetooth, Bluetooth Low Energy, Wi-Li, ANT+, Lora WAN, NBIoT, RE, 2.4GHz communication channel, NRL, custom band communications, and other similar protocols; (d) A memory storage and computational memory for running complex processes; (e) Antennas for reception of long, mid range and short range signals from medical device and other instruments in the ICU; (f) Peripheral pins for connecting one or more sensors and devices that will aid in information acquisition and capture non clinical data from systems; (g) Audio visual alerting system; haptic feedback system; authenticator using REID mechanism; comprising of predefined programs and algorithms for decision making locally; (h) A power unit comprising of batteries that can work even when there is a power cut, and AC/DC convertors for operating on power supply when available; (i) Remote connectivity using WI-FI, Ethernet, NBIoT and 5G and similar protocols for short and long range communication to stream data from devices to storage unit remotely and retrieve inferences and trends from health records and stored data; (j) A display unit for showing live data, data trends, predictive scores and state of patient and summary of workflows that were digitised; 2. The novel gateway system of the claim 1 wherein the said system helps in standardising medical data sharing and healthcare across various healthcare facilities, minimizes human intervention, helps in adaptation of pre-programmed workflows and protocols, and increases security and reliability of data. 3. The novel gateway system of the claim 1 wherein the said system converts all data irrespective of input source into any acceptable interoperable standards like HL7, FHIR and others. Backed by a effecient, versatile, multimodal patient monitoring and connectivity stack implementation that combines plurality of advanced measurements with complex add on and scale up capabilities, it helps ensure that whatever the source is given as input, all patient data can be accurately and efficiently captured and presented to clinicians in the most suitable ways with recommendations. 4. The novel gateway system of the claim 1 wherein the said system utilizes Internet of Medical Things and allows remote access to medical data and avoids human error in decision making by facilitating error free automated decision making and has capability of predictive cognitive intelligent applications. 5. The novel gateway system of the claim 1 wherein the said system promotes uniform decision making during medical care and completely eliminates the person-to-person variation in decision making using essential charts, scores, trends and summarisation of notes that can lead to automated discharge summary, and hence provides better clinical outcomes and increased survival chances. It allows display of essential charts, scores, trends and summarisation of notes that can lead to automated discharge summary. 6. The novel gateway system of the claim 1 wherein the said system generates timely alerts to ensure that patient is attended by medical care providers and patient attendants in cases of medical emergency. 7. The novel gateway system of the claim 1 wherein the said system provides an efficient way to physically connect up to 24 medical devices at the bedside and automatically capture data, a vendor independent connectivity solution for Electronic Medical record integration, surveillance monitoring, alarm management, mobile notifications, smart displays, prediction, historical data comparison and analytics. The said system can connect to various medical devices such as Blood gas analysers, nebulisers, Feeder, food pump and other pumps, dialysis machines, Electronic bed, ventilator, CPAP, anesthesia unit, drips machine, infusion pump, patient monitors, phototherapy units, ECG machine, weighing scale, infant warmer and other legacy and modern wireless devices. 8. The novel gateway system of the claim 1 wherein the said system significantly increase computation power, connectivity, data streaming and extensively increase efficiency by enabling a many to one node to hub to centralized storage and processing unit architecture. 9. A method for implementation of a connected medical device hub to digitise the complete workflow in Intensive Care Unit and Step Down ward that comprises steps of (a) Data processing of streamed in data from several sources ; (b) A stack of connectivity modules wherein the wired connectivity modules are selected from a group of wired connectivity options like Serial ports, USB, RS232, Ethernet LAN port, micro USB interfaces that includes USB type A, USB type B, USB type C, micro USB and other similar connectors, HDMI and other similar protocols; (c) A stack of connectivity modules wherein the wireless connectivity modules are selected from a group of wireless connectivity modalities that includes Bluetooth, Bluetooth Low Energy, Wi-Fi, ANT+, Lora WAN, NBIoT, RF, 2.4GHz communication channel, NRF, custom band communications, and other similar protocols; (d) Storage of data using a memory storage and computational memory for running complex processes; (e) Communication of data using antennas for reception of long, mid range and short range signals from medical device and other instruments in the ICU; (f) Local alerting using audio visual alerting system and haptic feedback system System authentication for genuine parts and consumables being used using a RFID or similar protocol authenticator (g) Analysing and computing through predefined programs and algorithms for decision making locally; (h) Power management using a power unit comprising of batteries that can work even when there is a power cut, and AC Dc convertors for operating on power supply when available (i) Remote connectivity using WI-FI, Ethernet, NBIoT and 5G and similar protocols for short and long range communication to stream data from devices to storage unit remotely and retrieve inferences and trends from health records and stored data ; (j) Displaying live data, data trends, predictive scores and state of patient and summary of workflows that were digitised; 10. The method for implementation of a connected medical device hub of claim 8 wherein the said method allows real-time data capture from plurality of connected medical devices, laboratory test results, and patient bedside clinical notes, analyse the said medical data and generate standard medical reports which helps in enhanced quality of healthcare to patients admitted to the ICUs. 11. The method for implementation of a connected medical device hub of claim 8 wherein the said method significantly increases computation power, connectivity, data streaming and extensively increases efficiency by enabling a many to one node to hub to cloud architecture. 12. The novel method of the claim 8 wherein the said method helps in standardising medical data sharing and healthcare across various healthcare facilities, minimizes human intervention, helps in adaptation of pre-programmed workflows and protocols, and increases security and reliability of data. 13. The novel method of the claim 8 wherein the said method converts all data irrespective of input source into any acceptable interoperable standards like HL7, FHIR and others. Backed by an efficient, versatile, multimodal patient monitoring and connectivity stack implementation that combines plurality of advanced measurements with complex add on and scale up capabilities ,it helps ensure that whatever the source is given as input, all patient data can be accurately and efficiently captured and presented to clinicians in the most suitable ways with recommendations. 14. The novel method of the claim 8 wherein the said method utilizes Internet of Medical Things and allows remote access to medical data and avoids human error in decision making by facilitating error free automated decision making and has capability of predictive cognitive intelligent applications. 15. The novel method of the claim 8 wherein the said method promotes uniform decision making during medical care and completely eliminates the person-to-person variation in decision making using essential charts, scores, trends and summarisation of notes that can lead to automated discharge summary, and hence provides better clinical outcomes and increased survival chances. It allows display of essential charts, scores, trends and summarisation of notes that can lead to automated discharge summary. 16. The novel method of the claim 8 wherein the said method generates timely alerts to ensure patient is attended by medical care providers and patient attendants in cases of medical emergency. 17. The novel method of the claim 8 wherein the said method provides an efficient way to physically connect up to 24 medical devices at the bedside and automatically capture data, a vendor independent connectivity solution for Electronic Medical record integration, surveillance monitoring, alarm management, mobile notifications, smart displays, prediction, historical data comparison and analytics. The said system can connect to various medical devices such as Blood gas analysers, nebulisers, Feeder, food pump and other pumps, dialysis machines, Electronic bed, ventilator, CPAP, anesthesia unit, drips machine, infusion pump, patient monitors, phototherapy units, ECG machine, weighing scale, infant warmer and other legacy and modern wireless devices. 18. An apparatus to digitise the workflow in Intensive Care Unit and Step Down ward that comprises of: (a) A plurality of processing units; (b) A stack of connectivity modules wherein the wired connectivity modules are selected from a group of wired connectivity options like Serial ports, USB, RS232, Ethernet LAN port, micro USB interfaces that includes USB type A, USB type B, USB type C, micro USB and other similar connectors, HDMI and other similar protocols; (c) A stack of connectivity modules wherein the wireless connectivity modules are selected from a group of wireless connectivity modalities that includes Bluetooth, Bluetooth Low Energy, Wi-Fi, ANT+, Lora WAN, NBIoT, RF, 2.4GHz communication channel, NRF, custom band communications, and other similar protocols; (d) A memory storage and computational memory for running complex processes; (e) Antennas for reception of long, mid range and short range signals from medical device and other instruments in the ICU; (f) Peripheral pins for connecting one or more sensors and devices that will aid in information acquisition and capture non clinical data from systems; (g) Audio visual alerting system; haptic feedback system; authenticator using RFID mechanism; comprising of predefined programs and algorithms for decision making locally; (h) A power unit comprising of batteries that can work even when there is a power cut, and AC/DC convertors for operating on power supply when available; (i) Remote connectivity using WI-FI, Ethernet, NBIoT and 5G and similar protocols for short and long range communication to stream data from devices to storage unit remotely and retrieve inferences and trends from health records and stored data; (j) A display unit for showing live data, data trends, predictive scores and state of patient and summary of workflows that were digitised; Although the present disclosure describes specific embodiments of the present invention, the disclosure does not limit the scope of the present invention. All the modifications obvious to the person skilled in the art fall within the general scope of the present invention. |
THE COMPLETE WORKFLOW IN AN INTENSIVE CARE UNIT
FIELD OF THE INVENTION
The present invention belongs to the Internet of Medical Things (IoMT) field. It utilizes the IoMT platform to provide affordable and quality healthcare in Intensive Care Units (ICUs) located in hospitals, healthcare facilities, and resource-poor settings to reduce mortality and morbidity.
BACKGROUND
[01] Recent decades have seen unprecedented technological advancements in the field of medical devices. The technological advancements in medical devices and allied sectors have significantly changed the healthcare delivery. The use of advanced computers, the incorporation of wireless technology and the Internet of Things (IoT) have further transformed how medical devices are used.
IoMT is an emerging area that connects various medical devices and data generated from these medical devices, and provides remote access to medical data, offers better health monitoring and diagnostics, and consequently provides appropriate and timely treatment. According to Deloitte's recent report, the IoMT market was valued at $41.2 billion in 2017, and the same will rise to $158.1 billion in 2022.
[02] IoMT significantly improves interconnectivity among medical devices, reduces healthcare costs, and increases the efficiency of a healthcare delivery system. Moreover, IoMT can collect, store, analyze, and transmit a large amount of healthcare data leading to a rapid change in healthcare delivery. IoMT is particularly useful for patients suffering from chronic disease and illnesses or medical conditions that require immediate medical attention.
[03] Intensive Care Units (ICUs) treat the critically ill patients and show the highest mortality rates in any hospital. According to some estimates, the mortality rate in ICUs varies between 8- 19% in the United States. Patients admitted to ICUs require highly complex medical care and multiple interventions, therefore the chances of error also get substantially increased.
[04] The access to quality healthcare suffers from several operational limitations. For instance, the healthcare practices in Intensive Care Units (ICUs) do not follow a standard operating procedure and hence lowers the probability of adequate and appropriate treatment strategies in critical cases.
Moreover, the ICUs are primarily handled by nurses and duty doctors who may lack expertise, and they generally initiate treatment merely based on instrument reading, intuition, and paper- based calculations. Decision-making is very subjective and depends on expertise levels and training. Furthermore, patient load and frequent change in the medical staff in ICUs increases the risk of human error and thus raises the risk for incorrect diagnosis and treatment. [05] Despite significant progress in medical care facilities and access, a majority of healthcare records are maintained in hard-copy files. The hard-copy medical records significantly reduces the timely access to healthcare data and wastes precious time because all the data generated using medical devices must be manually pulled before the treatment. In medical health emergencies of enormous magnitudes, such as observed during the ongoing COVID-19 pandemic, delay in access to medical data and treatment can cause loss of precious lives.
[06] Apart from operational limitations, the medical devices suffer from some technological limitations. For example, most medical devices work in silos and generate individual data, and do not share data with other medical devices and a shared system. Medical equipment also needs frequent manual calibration and require human intervention during operation. Thus, a human-error component is inherently built-in to the health monitoring system that can have devastating consequences, especially in critical cases. According to an estimate, doctors water 70% of their time in documenting medical data and ensuring the correctness of data generated during medical care. The digitization of data generated from various medical devices follows different protocols to capture data streams, making the digitization process difficult and cumbersome. Medical devices often have a lower capacity to store historical data, making it challenging to observe trends and historical fluctuations in various clinical parameters. Finally, each instrument needs to have a separate display which adds to cost, and in resource- constrained settings, price sensitivity is a huge criterion for adoption and usage. Existing central monitoring systems using WLAN need an infrastructure in place, wiring and coming at a considerable premium.
[07] There is unstructured data from devices in several formats, handwritten notes, lab reports, images, and history taken that can be valuable when digitized and can be used to create analysis algorithms and augment doctors' capabilities and also aid in the usage of cutting edge AI models for improving diagnosis and medical care.
[08] Therefore, there is an urgent need for a tool to enable these overloaded healthcare workers to monitor and diagnose the critical conditions more accurately, provide timely treatment, optimize workflows in an ICU, and spend their time on treatment and not documenting values and readings.
SUMMARY OF THE INVENTION
[09] An embodiment of the present invention provides a gateway system for comprehensive and non-invasive monitoring of patient health. More particularly, the present invention's novel gateway system is specifically designed to offer a 24X7 monitoring of newborns. The disclosed system generates alerts for healthcare workers/nursing staff, and caretakers at the appropriate time and provides an efficient and accurate way to monitor newborn health. The present invention's novel gateway system is an intelligent platform based on a deep learning algorithm and accurately detects medical conditions that require immediate attention and treatment. The present gateway system's sophisticated algorithms perform at a very high accuracy level and provide an excellent tool for continuous monitoring.
[10] The innovative gateway system disclosed in the present invention connects multiple medical devices that monitor multiple biological parameters such as blood gas analyzers, nebulizers, feeder, food pump and other pumps, dialysis machines, Electronic bed, ventilator, CPAP, anesthesia unit, drip machine, infusion pump, patient monitors, phototherapy units, ECG machine, weighing scale, infant warmer and other legacy and modern wireless devices. The said gateway system acts as a data hub to store the data from a plurality of medical devices and offers cloud data sharing, and allows quick and easier data access to the clinicians sitting in the remote location. Alternatively, the said gateway system can work without cloud storage and benefits the clinicians serving in resource-constrained settings.
[Oil] The innovative gateway system disclosed in the present invention offers a biofeedback mechanism and establishes an IoMT among various medical devices. The devices connect and are automated based on rule based engines and can be used in hospitals with basic infrastructure. The gateway system and hub can be easily scaled up, and the number of connected medical devices integrated with the hub can be increased based on the user's need. To achieve Sustainable Development Goal-3, the Indian Government has set up fully equipped, Wi-Fi-enabled hospitals at district levels. Thus, the disclosed system can be used in district tertiary care centres with level 2 ICUs and above.
[012] The system can be connected to the cloud through lazy push using the Wi-Fi in these centers. The disclosed system is also compatible with upcoming technologies such as NBIoT & 5G. The connected central platform can talk to multiple medical devices worn by and connected to the babies, which are connected wirelessly over Bluetooth low energy (BLE), ANT+, Zigbee, NRF, Wi-Fi, RF, custom bands or wired to a hub through RS232, LAN, Ethernet, USB or HDMI and other protocols. The medical data generated from these devices get transmitted to the cloud storage or local storage or hybrid storage and can be accessed at central monitors placed at the nursing station. The duty doctors and nurses can easily access the medical data and trends through a dedicated application and monitor the babies centrally and remotely. Hence this platform will not only help collect, store, visualize and analyze the medical data by also offering a platform through which a doctor can monitor patient health and provide necessary feedback to the patient attendants, nurse, and duty doctors in case of medical emergency. [013] The platform compiles all the vital medical data required to analyze the patient's health such as lab records, nurse and doctor notes, trends, and machine values. The data can be used in real-time and generate an early warning score which helps in predicting critical medical conditions such as VAP, Respiratory distress, necrotizing clots due to IV lines ,bed sores, pneumonia and accurate identification of shock and hospital-acquired infections to human subjects hospitalized to ICUs and emergency wards. The disclosed system acts as a great decision-making tool for the doctors and augments other clinical examination parameters and will help them allocate their resources better and provide quality care and regulate their use of antibiotics. Better diagnosis and treatment offered by the disclosed system helps in predicting the length of hospital stay of patients. The platform will also prove to be a useful tool for policymakers who can now have access to a wealth of data on citizen's health and disease burden. The open API and scalable platform will also ensure straight-forward integration into the hospitals EMR system and onto the NHDM and open EHR platforms online monitoring developed by MHFW- which becomes very valuable data for the programmes run by the Indian Government.
BRIEF DESCRIPTION OF DRAWINGS
FIGURE 1 describes the basic functioning of the novel IoMT -based hospital and patient management system.
FIGURE 2 explains one of the preferred embodiments wherein the integration of the novel IoMT based hub into the hospital and patient management system is described.
DETAIEED DESCRIPTION OF DRAWINGS FIGURE 1 describes the basic functioning of the novel IoMT-based hospital and patient management system. The medical data from various medical devices 101, 102, 103, and 104 are transmitted in real-time to a device hub 106 via various wired-and-wireless communication means 105 including but not limited to Serial ports, USB, RS232, Ethernet LAN port, micro USB interfaces that includes USB type A, USB type B, USB type C, micro USB and other similar connectors, HDMI and other similar protocols. The wireless connectivity modalities include Bluetooth, Bluetooth Low Energy, Wi-Li, ANT+, Lora WAN, NBIoT, RE, 2.4GHz communication channel, NRL, custom band communications, and other similar protocols. The said device hub 106 transfers the medical data in real-time via wireless connectivity option 107 such as Wi-Li to a cloud-based server or local server or a hybrid server or a combination of them 108. The medical data stored in the said cloud 108 can be accessed by a clinician 109 working remotely. Any adverse fluctuation in the medical parameters can be monitored by the said clinician 109. The said clinical immediately 109 raises an alarm and sends the alarm message 111 to the concerned medical healthcare providers such as patient attendant, nurse, and doctors via an Application Programming Interface 110 and facilitates appropriate patient care 112.
FIGURE 2 explains one of the preferred embodiments wherein the integration of the novel IoMT based hub into the hospital and patient management system is described. Medical device 201 and wearable health monitor 202 establish a connection with the hub 204 using various wired- and-wireless connectivity options, including but not limited to, Bluetooth and Ethernet and continuously shares crucial health parameters such as blood pressure, oxygen saturation levels, and ECG records with the said hub 204. The data collected in the said hub 204 is transmitted to the cloud storage or local storage or a hybrid storage 205 via various wireless connectivity options such as Wi-Li, and becomes easily accessible to clinical sitting at a remote place via computer 206 or via a smartphone or tablet-based applications (mobile app) 207. The said cloud storage or local storage or hybrid storage 205 gets a continuous stream of medical data from the said hub 204 and allows continuous monitoring of patient health and critical medical parameters.
In case of any medical emergency, the clinical monitoring of the health via the said monitoring means 206 and 208 immediately alerts the hospital staff via an Application Programming
Interface 208 and facilitates an immediate medical response thus saving patient life.