WO2022224167A1

WO2022224167A1 - Device and system for improving care on subjects on medical devices

Info

Publication number: WO2022224167A1
Application number: PCT/IB2022/053703
Authority: WO
Inventors: Tony CHAMOUN; Joseph CHAMOUN
Original assignee: Chamoun Tony; Chamoun Joseph
Priority date: 2021-04-21
Filing date: 2022-04-20
Publication date: 2022-10-27

Abstract

The present invention relates to a device for monitoring and collecting parameters from a medical device connected to a human subject. The invention further discloses a system for analyzing the collected parameters, enabling a health care provider to evaluate, modify and implement said medical device's settings, in-person or remotely, to provide for improved health care delivery.

Description

DEVICE AND SYSTEM FOR IMPROVING CARE ON SUBJECTS ON MEDICAL DEVICES FIELD OF THE INVENTION

[0001] The present invention relates to medical devices and systems and in particular to patient monitoring systems for managing medical data and patient vitals. The application is specifically directed to a system for managing medical devices in communication with a wireless communication network and managing patient care. More particularly, to a remote monitoring system for monitoring medical devices that communicate with the wireless communication network via one or more wireless relay modules and a wireless relay network.

BACKGROUND OF THE INVENTION

[0002] In hospitals and other health care environments, it is generally necessary to collect and analyze a variety of medical data from a patient on a continuous basis. These data may include electrocardiogram signals, body temperature, blood pressure, respiration, pulse and other parameters. It is also necessary to analyze said data live and react rapidly to the results in order to adjust or make changes to maintain or improve a patient's status.

[0003] In critical care and home care health service centers such as those which may be found in hospitals, clinics, assisted living centers and the like, care giver-patient interaction time is at a premium. Moreover, response times by care givers to significant health conditions and events may be critical.

[0004] Patient monitoring devices and systems have been developed decades ago as technology allowed for them. For example, US6221012 discloses a transportable patient monitoring apparatus that provides collection and display of patient data signals collected from a medical patient using sensors, including periods when the patient is being transported. The apparatus comprises a portable monitor coupled to a plurality of distinct data acquisition modules, which are coupled to the sensors. The ability to keep a patient connected to a monitoring apparatus during transportation allows for improved and uninterrupted monitoring, hence providing for better care. [0005] As more and more complex diagnostic and monitoring devices became standard use, it was clear that healthcare facilities required improved management of these systems and devices. US6578002 describes a service platform for medical diagnostic systems designed to respond to these needs. The platform may be implemented through specific hardware, firmware, software, or a combination, depending upon the preferred configuration of the scanners. The platform preferably provides a uniform and consistent basis for configuring interactive service routines over a wide range of scanner types, and system modalities. The platform may be implemented directly in computers coupled to the scanners, and may also be installed in centralized control stations, such as stations linking a series of scanners in a radiology department of a medical facility.

[0006] The next evolution in providing even better patient care resides in developing centralized monitoring systems. In such systems, physiological data from each patient is transmitted to a centralized location. At this centralized location, a single or small number of technicians monitor all of this patient information to assess patient status. Information indicating a patient alarm condition will cause the technicians and/or system to communicate with local care givers to provide immediate patient attention, for example via wireless pagers and/or cell phones, and/or by making a facility-wide audio page.

[0007] US8943168 discloses such a centralized system. The patent is directed to a remote monitoring system for monitoring medical devices in communication with a wireless communication network, and more particularly, to a remote monitoring system for monitoring medical devices that communicate with the wireless communication network via one or more wireless relay modules and a wireless relay network.

[0008] Further improvements relate to monitoring alarms and providing for faster and improved response. As one example, WO 2004/070799 discloses a system having a medication administration module and a wireless remote device located within a healthcare facility. The medication administration module is associated with the medication treatment application device, such as an infusion pump. The wireless remote device includes a message indicator, such as a visual display or an audible alarm that is responsive to a status information output generated by the medication administration module and transmitted over a wireless communication link. The wireless remote device also includes a module or application for generating a time-out when the wireless communication link is lost.

[0009] Despite a number of advances and improvements in this space, the currently existing devices and systems still present some defects that have not been addressed, considered or taught. One of these relates to the smart monitoring of a patient's parameters in order to avert a developing crisis. Another, relates to the ability of a primary care giver, i.e. the physician, rather than the nurse or technician, to be able to take immediate action to rectify a developing situation or resolve a crisis. A further solution provided is the use of artificial intelligence to monitor, alert and respond as needed to mitigate and avoid deterioration of a patient's health under care. The present device and system propose a solution to address these current defects and more.

SUMMARY OF THE INVENTION

[00010] The present invention is directed to a device monitoring system to enable physicians to monitor patients remotely, from anywhere in the world, and to also take preventive and/or responsive action based on an analysis of the readings or a pre-set alarm.

The device and system also comprise an artificial intelligence system and a knowledge database which roles are indispensable in continuously improving patient care.

[00011] The device of the present invention is connected to or associated with and collects the data from a medical device to which a patient is connected, i.e. ventilator. The device comprises at least the following components:

A monitoring tool for collecting the parameters of the associated medical device;

A non-transitory memory for saving the collected parameters;

A communication tool for sending the collected parameters to an external device such as a computer, a mobile phone, a tablet or other such device; and for receiving instructions from a remote device such as a computer, a mobile phone, a tablet or other such device;

A display screen;

A battery; A power input;

A processor;

A program that collects and analyzes data, and sends instructions ; and An artificial intelligence module.

[00012] The device may additionally comprises a plurality of sensors which may be connected directly to a patient. These sensors will in turn render the device into a monitoring device in addition to its intended functionalities.

[00013] The device of the present invention may be viewed as an intermediary device connecting a patient to a medical device and to a smart system which comprises a plurality of servers. The said device may be an external intermediary device, as it may be a built-in component part of a specific medical device.

[00014] The system relies on sensors that measure parameters such as body temperature, pulse rate, respiratory rate, blood pressure, etc. to collect the relevant data for reporting and analysis. The desired information is directly sent wirelessly to the primary healthcare provider via any type of wireless network, such as for example, Wi-Fi. All of the data may also be stored internally on a memory card or externally on a secure server.

[00015] The primary healthcare provider may preset alarm values for one or more vital signs measured by the device. These preset values may be set remotely from the provider's smartphone or smart device and receive automatically a notification, for example a push notification, if any of the conditions were not met or an alarm is triggered.

[00016] The device and system of the present invention further provision for a hybrid setting. In said hybrid mode setting, the system may remotely and automatically regulate any of the medical device parameters without the primary healthcare provider's interference. The system benefits from artificial intelligence that is constantly being enhanced by each and every wireless monitoring device connected to a server to help stabilize a patient's condition. For example, if the primary healthcare provider is not available, the hybrid mode will be automatically activated to monitor and take the necessary action and provide the same quality of healthcare. Alternatively, when the primary healthcare provider is available online, said physician may remotely access and regulate any of the medical device's parameters, with or without the assistance of an artificial intelligence bot. This latter, ensures that the physician is making the best choice possible.

BRIEF DESCRIPTION OF THE DRAWINGS

[00017] FIG. 1 is a representation showing the device of the invention and how it is connected to the various elements which enable the disclosed system.

[00018] FIG. 2 represents the main elements comprising the device of the invention.

[00019] FIG. 3 is a flow chart illustrating exemplary processing of the system of the invention using the device of the invention.

DETAILED DESCRIPTION

[00020] Reference will now be made in detail to exemplary embodiments of the invention, and in particular, for ease of representation and description, the exemplary embodiment will refer to an embodiment wherein the device (102) is a separate standalone device as represented in FIG. 1.

[00021] The device (102) represented in FIG. 1, comprises a multitude of functional components which interconnect a medical device (103) connected to a patient (101) and the primary healthcare provider (106) via a network, wherein said network may be a wireless network such as WiFi, Bluetooth or any other such connection and communication network, or in the absence of availability of such wireless networks, via a local area network (LAN). The device (102) may be external to the medical device (103) as shown in FIG. 1. Alternatively, the device may be internalized, built-into any medical device (such as a ventilator), providing the same functionalities as will be described herein and throughout this application.

[00022] To better understand the functioning of the device, FIG. 2 represents key elements of the device (102). As is known by a person skilled in the art, there are required components to enable the device to function and which will be described herein, albeit not specifically shown in a diagram as these do not contribute to understanding the invention. [00023] As such, device (102) comprises these components but is not limited to only these components as these are being used as representatives for the functionalities of the device and system disclosed herein. As an example, a screen provides for a display and interactive medium. The screen may be an LED, LCD, plasma or any other display medium which currently exists or may be developed and used in its function of displaying information and receiving input through tactile, facial, voice or other means of interaction with said screen (i.e. touch screen). The said screen is connected via proper connectors to a graphics processing unit (GPU) installed in the device.

[00024] Power may be supplied to the device (102) either via external current (203) or a battery is provided to allow for autonomy of the device in situations where there is absence of electrical input (203). The battery is a rechargeable battery providing for a long life use of the device in support of the many functionalities which will be drawing power from said battery in the absence of electrical power. The main characteristic of the battery is that it be rechargeable and accordingly, may be a lithium-ion (Li-ion) battery, a Nickel-Cadmium (NiCd) battery, lead- acid battery, Nickel-Metal Hydride (NiMH) battery including any currently existing rechargeable batteries or batteries which may be used as replacement to currently existing technologies of rechargeable batteries. The battery is connected to a charge controller, which among other things limits the rate at which electric current is added to or drawn from the battery. It also prevents overcharging and may protect against overvoltage, which can reduce battery performance or lifespan and may pose a safety risk, especially given the role of the device in providing improved healthcare. It may also prevent completely draining a battery, or perform controlled discharges, depending on the battery technology, to protect battery life.

[00025] Data storage is also comprised as part of the device (102). However, as it will become clearer, the device is connected to an external storage server (105) that will allow for the storage and management of large amounts of data. The device (102) will also include a memory card slot to be used as needed and when required. The off-site storage though will act as the primary storage destination as this will enable the system to help in making informed decisions and for the analysis of all of the collected data for the reasons to be discussed further below. [00026] The device (10)2 will also comprise a plurality of input and output connectors such as but not limited to electrical input for charging or connecting to a power outlet, USB slots, USB-C, HDMI for graphics or other, Ethernet for connecting to a LAN, and other potential new connections as needed to connect with specific external devices or tools.

[00027] Furthermore, the device (102) may comprise its own sensor connectors (206) such as oxygen sensor, pressure sensor, etc. which would connect directly to the patient (101). These will display relevant data on the interactive screen display of the device (102) and which may also be viewed remotely by the healthcare practitioner (106) on their own device via the LAN or WiFi connectivity.

[00028] The device comprises a system on a chip (SoC) that integrates all the different components of the device as described herein before. These components include a central processing unit (CPU), memory, input/output ports and secondary storage, alongside the other components such as radio modems and the GPU. The SoC may contain digital, analog, mixed- signal, and often radio frequency signal processing functions.

[00029] As can be seen from FIG. 2, the device comprises a processor (CPU) which is powered via an external power supply ( i.e . plugged into an electrical outlet) or an internal re chargeable battery (203). The physical interaction with the device may be through a touch screen (202), a keyboard, a pointing device; as the interaction may also be made remotely via the network (105) by the healthcare provider. The remote connection is secured via the local network connection or wireless connection (205).

[00030] The device of the invention is interconnected with a plurality of external elements via a system which will be described herein. The system relies on an international interface (II) module (204) which will enable communication between different types of tools and devices. The II (104) will communicate with the device (102) and with an artificial intelligence (Al) module (107). Through the Al (107), the II (104) communicates with the server (105) hosting the system which will act as a storage for data and applications and is accessible by the healthcare provider (106) and the Al module (107). [00031] As described herein above, and again in reference to FIG. 1, the device (102) is connected to a medical device (103) and a patient. It collects in real time physiological data from the patient, i.e. body temperature, pulse, etc. via the sensors (206) and the settings and data from the medical device (103). All of the data collected from these various inputs may be stored on site on the local network or a memory card, and also on an off-site server (105), physical or cloud. The healthcare provider (106) may at any time access all of the data stored via a mobile or fixed terminal such a smartphone, tablet or desktop. The healthcare provider

(106) may also share the data with others, change parameters or settings on the device (102) or medical device (103), set alarms or any other settings for notification, taking action or more.

[00032] Since a patient's status may evolve, requiring interference in adjusting the settings on the medical device, such as for example, adjusting oxygen flow rate, adjusting intravenous flow, implementing a different protocol, etc. the healthcare provider (106) or Al

(107), depending on the availability status of the former, may automatically and remotely adjust those settings to benefit the patient. The ability to constantly and continuously monitor and update a patient's status and state in real time, will provide for a highly improved delivery of health care. The real time implementation of this system is expected to result in improved standard of delivering health care and living.

[00033] All of the data is collected and preserved for a patient and all patients, thus collectively building a database of knowledge upon which the Al (107) can develop solutions for automatic execution or in support of the healthcare provider's decision.

[00034] As shown in FIG. 1, the system of the present invention allows for communication between the different components and parties in real time. Real time physiological parameters are collected from the patient by the device (102) and stored (105) and analyzed by the Al (107). The data is processed and reported to the Al (107) and the healthcare provider's (106) portable device for access anytime and all the time. The settings on the medical device are also stored on the device and memory and correlated with the current status of the patient. [00035] Should the Al (107) or healthcare provider (106) see the need to adjust the parameters or settings on the medical device, the same may be implemented through the device (102), in person (202) or remotely via the server (105). The new settings are stored and the patient's status and state are monitored in response to these new settings. All of this data is again stored as per above and analyzed by the Al (107).

[00036] The Al (107) continuously learns from the input and healthcare provider responses to events and develops its own ability to respond to scenarios in real time in case the healthcare provider is not available. The system of the invention provisions for a hybrid setting wherein should there be a need for immediate action from the healthcare provider, however, the latter is not accessible or available, i.e. due to busy status or not reachable via network, then the Al (107) may take the necessary action in lieu. The Al (107) may also act as a second opinion to the healthcare provider (106) or may propose real time solutions to the healthcare provider in response to specific data collected by the device and reported to the system.

[00037] The device may be set to send an alarm in urgent situations as pre-defined by the healthcare provider or the Al. Such an alarm may in addition trigger initiating an emergency call to a proper healthcare authority to dispatch first aid or emergency vehicle if the device is used outside an adequate facility, i.e. a hospital.

[00038] The current invention further discloses a system wherein the device of the invention acts as a central device for enabling the various functionalities disclosed herein.

[00039] The system of the invention enables the different parties, namely the patient, the healthcare provider, the medical devices, the healthcare facility to be interconnected in a real time scenario. The patient is hence monitored in real time and his/her health parameters may be checked upon request via the network to which the whole system is connected. The healthcare provider further has access to the medical devices on which the patient is connected, enabling him/her to adjust the parameters on the medical device as needed to correct for the patient's vital signs.

[00040] Pursuant to the system of the invention, the device (102) collects, processes and streams live patient data to the server (105). The server (105) stores the said in a plurality of databases. In a preferred embodiment of the system of the invention, all of the measured parameters may have offset alarms. Should any of the patient's vital signs or health parameters extend beyond the acceptable range, low or high, the system will notify the healthcare provider on their interconnected handheld device. The notification may be in the form of a push notification, call, SMS or any other notification feed available or developed on the system. If more than one healthcare provider are monitoring and following the patient, then all are notified. The system further provides for an inter-healthcare provider communication to enable the different attending healthcare providers from assessing and deciding on the course of action.

[00041] The healthcare provider (106) may revert to the Al (107) as well to obtain a more profound and deep analysis of a patient's status based on the patient's history and risks. The system will be populated with a digital disease library (DDL) which will be an archive of all available disease parameters, related symptoms, incidents, vital signs, patient history, etc. enabling the healthcare provider to rely on the Al to perform a thorough analysis and diagnosis. This will enable the healthcare provider to make an even more informed decision based on complete analysis and real time events.

[00042] The system further utilizes an international interface (104) which enables adequate communication and connectivity between the healthcare provider (106) via the server (105) which is connected to and communicating with the device (102) and with the Al (107). In turn, through this inter-connectivity, the healthcare provider (106) is able to adjust or make modifications on the device (102) or even the medical device (103) to address any critical or non-critical changes in the patient's (101) vital signs.

[00043] In the event that the healthcare provider (106) is not reachable, then the Al (107) takes over and substitutes to address any critical or on-critical needs of the patient (101) as the healthcare provider would have.

[00044] In the event where the healthcare provider is not connected on a wireless system, but is available on a local area network, then the provider may provide the same services via the LAN, locally or remotely within the same facility or facilities connected to the same LAN.

[00045] FIG. 3 is a schematic diagram representing the various interactions of the system of the invention. As stated herein above, the device (102) acts as the data receipt unit (301) and sends the real time live patient data to a data storage unit (304). The data storage unit (304) comprises a plurality of databases for collecting all patients' histories. The said unit (304) may also hold the DDL to enable the Al (107) to perform a full analysis on a patient as described above.

[00046] All of the data collected and stored may be available for viewing on a data display unit (305). The said data display unit (305) may be the device's screen for viewing on site when present with the patient; but also may be viewed on the healthcare provider's handheld device which his connected via the server (105) and the international interface (104).

[00047] Any alarms which are preset (306) on the system by the healthcare provider (106) or the Al (107) will be triggered upon breach of the allowed range for the patient's vital signs and pushed to the healthcare provider and Al via the international interface (104) and the server (105). The notification sender (307) will notify the interconnected one or more healthcare provider via one of many different available options of push notification, short text messaging, communications messaging platform, or other whichever one is set as the preferred mode of notification by the healthcare provider (106).

[00048] Since the healthcare provider (106) may not necessarily be available or adequately connected to the server (105) or international interface (104) at all times, the system provisions for a hybrid system (308). One this hybrid mode is enabled, the Al (310) will automatically become the default responder to any emergencies or alarm-sent notifications in order to take immediate action in lieu of the healthcare provider. In such cases, the Al (310) will analyze the incoming notification, as well as the patient's history and associate the readings, symptoms and patient history and associate it with the DDL which will enable the Al to respond and make the necessary changes to the medical device to address the reason behind the alarm, or notify the relevant party to take immediate action, i.e. emergency staff, ambulance, etc. via the command sending unit (311).

[00049] Alternatively, if the healthcare provider is available and reachable, then the alarm notification is sent to the said provider (309), who in turn will analyze and send the proper instructions to the command sending unit (311) which is connected with the international interface (104) and can send the instructions to the device (102) and the Al (107), simultaneously or separately.

[00050] A further feature of the system of the invention is one that enables the device to communicate with the applications data and functionality to external third-party developers. As it is known, not all medical devices and systems utilize the same language. The data receipt unit (301) comprises an application program interface (API) enabling ease of communication between the different interfaces and parts of the different devices and tools within the system of the invention.

[00051] To secure the system, there is also a device ban sender (303) to ensure safe and secure communications are maintained between the various components of said system and the healthcare provider and the Al.

[00052] It should of course be understood that while the present invention has been described with respect to disclosed embodiments, numerous variations are possible without departing from the spirit and scope of the present invention as defined in the claims.

[00053] Moreover, it is intended that the scope of the present invention include all other foreseeable equivalents to the elements and components as described herein and with reference to the figures. Accordingly, the invention is to be limited to only by the scope of the claims and their equivalents.

Claims

1. A device for managing a patient's vitals, the device comprising: a plurality of sensors for collecting the patient's vital signs; a screen for displaying the patient's vital signs; a connector interface for connecting the device with a plurality of medical devices; a plurality of network connectors for sending patient vital signs to a plurality of remote receivers and for receiving instructions from a plurality of remote senders, wherein said remote receivers and senders comprise a plurality of servers, wherein said receivers receive data from the device and instructions from a healthcare provider, and wherein said senders send data to the healthcare provider and instructions to the device.

2. The device according to claim 1, wherein the screen is preferably a touch screen.

3. The device according to claim 1, wherein said servers for the receivers and senders are the same.

4. The device according to claim 1, wherein said servers comprise a plurality of databases comprising a digital disease library (DDL).

5. The device according to claim 1, wherein said device may trigger an alarm and notification when the pre-set vital signs limits have been breached.

6. The device according to claim 1, wherein said device is adapted for use in a system, which system comprises:

- a plurality of network connections;

- at least one server; at least one international interface; at least one artificial intelligence (Al) module; and a plurality of databases.

7. A system comprising the device of any one of the preceding claims, wherein said device:

- is connected to a patient for collecting vital signs;

- is connected to a plurality of medical devices;

- is connected to an international interface; and

- is connected to a server.

8. The system according to claim 7, wherein

- the patient's vital signs are collected and displayed on said device and sent to the server via the network for storing and analysis, further forwarded to the healthcare provider's handled device for real time monitoring;

- the Al module continuously communicates with the servers to analyze the data and generate a plurality of solutions adapted to each patient's history and real time vital signs;

- the international interface facilitates communication and connectivity between the different components of the system;

- the healthcare provider and Al may send instructions via the network to the server to adjust or change the parameter settings on the device or on the medical device in response to a patient's status;

- the device sends a notification to the server if the patient's vital signs become critical and require immediate interference;

- the server sends a notification to the healthcare provider for immediate action, wherein in case the healthcare provider is not available, the Al analyzes the emergency and send the instruction to the server in lieu of the healthcare provider; - the server sends the instructions from the healthcare provider or Al to the device to adjust or change the parameter settings on the device or medical device to address the patient's critical need.

9. The device according to claim 6 and the system according to claim 8, wherein the Al utilizes the DDL to continuously improve and learn about specific diseases, patient vital signs, reaction and responses to specific conditions and emergencies.