WO2019224732A1

WO2019224732A1 - System for monitoring electro-medical apparatuses installed in the home

Info

Publication number: WO2019224732A1
Application number: PCT/IB2019/054216
Authority: WO
Inventors: Claudio PAPEI; Mauro CALIANI; Andrea Abrardo
Original assignee: Universita' Degli Studi Di Siena; Azienda Usl Toscana Sud Est
Priority date: 2018-05-22
Filing date: 2019-05-22
Publication date: 2019-11-28
Also published as: IT201800005591A1

Abstract

A system for monitoring electro-medical apparatuses installed in a patient's home is described, comprising a control device that includes: a control node that may be associated with at least one electro-medical apparatus; a plurality of functional modules coupled to the electro-medical apparatus, arranged to perform at least one of the following functions: - detecting operating parameters of the apparatus; - communicating information to the patient; - receiving commands from the patient, wherein the control node is adapted to establish a first communication link with each of the functional modules through a first communication protocol and a second communication link with a remote management unit through a second communication protocol, and wherein a module (20) is arranged for detecting over time a supply energy provided to the apparatus (A), to record variations in the consumption of electrical power by the apparatus (A) and to identify the operating status of the apparatus (A).

Description

System for monitoring electro-medical apparatuses installed in the home

The present invention generally concerns care services for patients at home and in particular home electro-medical apparatuses. Specifically, the invention concerns a system for monitoring electro-medical apparatuses installed in a patient's home, according to the preamble of claim 1.

In the health sector, there has recently been an increasing development of home care services, i.e. the possibility of providing therapies to patients directly at home is becoming more widespread.

In effect, for patients who frequently need to use medical apparatuses to monitor their health condition or to provide simple care, the health service provides for the installation of electro- medical apparatuses in the home. This is the case, for example, if patients are unable to reach a treatment centre or to allow them to benefit from continuous treatment services without incurring the cost of hospitalization or the engagement of staff and hospital facilities, while also avoiding the inconvenience of going to such centres and waiting their turn to be treated.

As an indication, the number of electro-medical apparatuses distributed in Italy is about 55 medical apparatuses per 1000 inhabitants, 15 of which are home medical apparatuses.

One of the major problems associated with the widespread use of such apparatuses is the need to carry out a periodic inspection of the apparatuses that ensures their continuous efficiency, i.e. to ensure the proper operation of the apparatuses located in the homes of patients in the absence of technical and/or health personnel who can easily access or intervene promptly while the apparatus is being used. This necessity arises both for purely therapeutic reasons and to ensure adequate effectiveness in the home care service, limiting of eliminating altogether the cases where the apparatuses are returned because of discontinued use by the patient.

Providing electro-medical apparatuses in the home of a patient involves some critical issues, both for the care facility and for the user, which include: (i) keeping a record of the apparatuses delivered and the logistical management thereof, (ii) the correct use of the aforesaid apparatuses, (iii) the management of the maintenance thereof with regard to fault resolution and downtime, (iv) monitoring interventions performed and finally (v) the recovery of the apparatus and its possible reuse.

As is well known, electro-medical apparatuses are in need of periodic checks, which include electrical and operational checks and the coordination of such functions is the first important aspect in order to improve the safety of patients using such apparatuses.

A second important aspect is inherent to the correct management and use of the apparatuses, because a limited or even non-existent use affects the costs of the health service without producing any benefit to the population, but rather takes resources away from the home care system.

The last aspect is the quality of service offered to patients using the apparatuses, whereby it is believed that a timely monitoring of the frequency of interventions of the operators, both healthcare and technical, at the home of a patient, which is currently difficult to achieve, would bring benefits to the entire system of home care, allowing it to become a viable alternative to hospital care.

The aim of the present invention is therefore generally to implement and monitor a home healthcare service more efficiently than with the traditional procedures. Another object of the invention is to implement a system for monitoring home electro-medical apparatuses that provides valuable support in the management of the same apparatuses, while at the same time ensuring the safety of the patients who use them.

According to the present invention, this object is achieved by means of a system for monitoring electro-medical apparatuses having the features claimed in claim 1.

Particular embodiments are the subject of the dependent claims, the content of which is to be understood as an integral part of the present description. In short, the present invention is based on the principle of making available locally, at the home of a patient where at least one electro-medical apparatus is installed, a non-invasive system of sensors and communication devices able to interface with one or more apparatuses, allowing them to interact with technical assistance operators and healthcare operators and with patients or with those who care for them. This is achieved by associating with an electro-medical apparatus a control device able to communicate with the same apparatus and one or more remote management units, which includes a plurality of modules, preferably integrated within a single enclosure, each of which is able to control a specific monitoring function of the aforesaid apparatus.

'The control device comprises a local control node and a plurality of functional modules operatively coupled to the electro-medical apparatus to be monitored, the local control node being able to communicate with the functional modules on the one hand and with at least one remote management unit on the other. As far as communications are concerned, the device provides for two levels of communication, respectively, a first level of communication from the outside to the patient's home where one or more medical apparatuses are located, i.e. from the remote management unit to the control node, and a second level of communication inside the home, i.e. from the control node to the different modules that collectively make up the control device. The first level of communication is oriented to the transmission of data indicative of the operational status of the apparatus to the remote management unit, as well as to the acquisition from the remote management unit of commands or warnings intended for the home, i.e. for the apparatus or the patient, such as, for example, the notification of a scheduled maintenance intervention or a scheduled medical examination, or also of unscheduled technical interventions or visits to the patient triggered by the analysis of the data previously transmitted by the control unit of the apparatus or by the apparatus itself to the remote management unit. The second level of communication is instead oriented to the exchange of data and/or commands between the control node and the functional modules coupled with the apparatus or apparatuses installed in the home.

All communications must pass through the local control node and are carried out through known communication protocols, for example, wireless telecommunication protocols such as Wi-Fi, LTE, UMTS, GSM, or via cable such as ADSL, for external communications, short range wireless communication protocols such as ZigBee, Bluetooth, Wi-Fi, NFC for communications with the modules inside the home.

The modular structure of the control device which is the subject of the invention allows one to achieve the same with a subset of modules or to extend the monitoring functions thereof as needed and depending on the number of apparatuses to be monitored to which the control device is operatively coupled via cable or radio.

Further features and advantages of the invention will be described in greater detail in the following detailed description of an embodiment thereof, given by way of non-limiting example, with reference to the accompanying drawings wherein:

Figure 1 is a block diagram of the system according to the invention;

Figure 2 is a flow diagram illustrating the operation of a power supply module of the system according to the invention; and

Figure 3 is a flow diagram of the operation illustrating a module for detecting the presence of a technical or healthcare worker near a medical apparatus associated with the system according to the invention.

Figure 1 shows a system for monitoring electro-medical apparatuses installed in the home according to the invention.

The system is arranged to be associated with an electro-medical apparatus A, for example, by interposing it along the power supply cable of the apparatus downstream of the power supply network, and connected to a remote management unit C.

The system comprises a control device 10 adapted to be associated with the aforesaid apparatus and including a control node 12 and a plurality of functional modules, respectively indicated at 20, 22, 24, 26, 28, 30, 32, 34 in the figure, coupled to said control node.

The control node 12 includes first communication means operating according to at least a first telecommunication protocol, adapted to establish a communication link with the remote control unit C and second communication means operating according to at least a second near-field communication protocol, adapted to establish a communication link with the apparatus A.

A detector module arranged to detect over time a supply energy provided to the apparatus A is indicated at 20.

A module detecting the presence of an operator, such as a technical or medical operator, in the vicinity of the apparatus A is indicated at 22.

An event data storage module including a rechargeable backup battery is indicated at 24.

In a currently preferred embodiment of the control device, it is advantageously provided that it further includes a module 26 for the verification of dispersion currents of the apparatus, a module 28 for requesting a health emergency, a module 30 for requesting a technical intervention, a module 32 for communication with the patient, a module 34 for the geo- localization of the apparatus A.

The module 20 is adapted to detect over time a supply energy provided to the apparatus A and allows the current used by the apparatus to be detected, indicating possible periods ofinactivity or reduced use. It comprises a synchronized clock, for example, synchronized with a time signal broadcast on a radio communication channel, to correctly record the data. The module 20 may be used to record changes in the electrical power consumption of the apparatus A and thus to identify not only the operational status (on/off) of the apparatus, but also distinguish the "on, but not operating (stand-by)" state from the "on and operating" state. If an apparatus is used sporadically, it will be turned on in an irregular way, whereby it may be deduced - indirectly - that the apparatus is underused or misused. Moreover, if the apparatus were to be left permanently switched on due to carelessness, the monitoring carried out in the ON/OFF state alone would be of little significance, while a dynamic analysis of the power supply makes it possible to distinguish between an apparatus that is permanently on and operational, due to the need for home care, and an apparatus that is permanently on but not operational. Therefore, in the event that an apparatus is occasionally switched on or is always switched on but with fixed current consumption, indicating an unchanging operating condition, a technical and/or healthcare professional may be notified, for example to contact the patient and to understand if the apparatus is inadequate for the pathology encountered or if there is no capacity for autonomous use or if there is carelessness in use.

The clock may be shared, possibly together with memory logs for storing data, among all the functional modules of the control device.

The module 22 detecting the presence of a technical or healthcare operator is arranged to detect the on-site presence of an operator attending to the maintenance of the electro-medical apparatus A or a healthcare operator attending to the patient. For example, the detection of the presence of an operator may be performed by reading information residing on a magnetic medium or transponder (e.g., an RFID tag), the data of which is recorded in the control device memory. The detection of the presence of an operator may also take place in different ways, on a voluntary basis as a result of reading a code possessed by the operator and presented by the operator to the control device, or on an automatic basis, through a process of periodic interrogation implemented by the control device.

The effectiveness of this module allows one advantageously to provide an assurance of an intervention or at least the detection of the presence of an operator, either healthcare for aiding the patient, or technical for the maintenance of the apparatus.

The control node 12 includes communication systems such as cable or GPRS modems for communication between multiple medical apparatuses or between a medical apparatus and a communication network, for example, for Internet access using a network connection available in the vicinity of the apparatus. The related data communication protocol is based on hierarchical interrupts between incoming and outgoing communication requests, whereby an alarm signal takes precedence over any other communication. As an indication, the order of priority, from the highest to the lowest, is as follows:

alarms and requests for health emergencies from the patient;

communications of the safety module, for example, in the event of problems arising from dispersion currents or from any consumption detected by the system; signals from the apparatus, for example, in the event of problems arising from the apparatus being monitored;

service communications between the apparatus and the patient via a multifunction display;

operator presence detection;

energy computation;

geo-localization.

The communication of information on the power supply of the apparatus by the module 20 takes place at a frequency indicative of one communication per minute, the detections of dispersion currents by the module 26 takes place continuously at a refresh frequency of the system after an alarm, and the detection of the presence of technical and healthcare operators is managed through occasional interrupts.

The module 26 for checking dispersion currents is designed to comprise one or more sensing means arranged to encircle a ground conductor coupled to the power conductor(s) of the apparatus A for the purpose of monitoring the dispersion current passing through the apparatus. The module is arranged to emit an alarm when a preset dispersion threshold is exceeded. Although this measurement cannot replace the periodic verification of the operation of the apparatus, it represents the possibility of monitoring the state of operation of the apparatus over time at a frequency much higher than the frequency of scheduled maintenance operations and of obtaining a predictive analysis of any technical problems in the operation of an apparatus, to protect a patient from any anomalies not yet present but which may occur in the future.

Advantageously, this allows one to monitor any problems that electro-medical apparatuses may have using a dynamic analysis of dispersion currents or analyzing the trend of dispersion currents over time and thereby formulating a deductive diagnosis. For example, a dispersion current of 200 mA is not a major technical problem per se, but a constant growth trend in dispersion current could be, thus it is advantageous to issue a fault report before the abnormal operating condition becomes a technical problem. The module 28 for requesting a medical emergency includes, for example, active signaling means, such as a button for transmitting a telephone communication or data for signaling an emergency, or passive signaling means, transparent to the patient, adapted to detect vital parameters of the patient through a diagnosis function of the medical apparatus during the course of the provision of the medical service.

The module 30 for requesting a technical intervention comprises signaling means, such as a button adapted to be pressed in the event of a fault in the apparatus recognized by the patient, or automatic signaling means to detect operating parameters of the apparatus, arranged for transmitting a telephone communication or data for signaling a fault in the apparatus to the remote management unit C.

The patient communication module 32 is arranged to receive analog or digital signals from the other modules of the control device or from the apparatus A and to transmit them to the control node or to the apparatus for patient communication, for example, for the management of indications for deaf patients such as, for example, notifications of a planned periodic technical check, which are received by the communication module 32 from a remote management unit and displayed through an alphanumeric-type display.

The module 34 for the geo-localization of the electro-medical apparatus exists, for example, for apparatuses such as mobile aid systems, such as wheelchairs, stairlifts, etc. and includes a GPS transmitter and allows the localization of the apparatus from the time of its delivery to the patient, or from the installation in the patient's home.

Mobile aid systems may be equipped with a GPS transmitter to track where they are actually located during use. Alternatively, it is possible to rely on an indirect measurement, based on the control of the state of charge and wear of the batteries, a fundamental parameter to verify the use of the means and the correct use thereof. A battery charge and wear control module is self-powered, with a low consumption of less than 1 mA/h, and is linked directly to the control node via radio. This link is also used to check that the mobile aid system is located near the home. A prolonged communication fault between the control module of the mobile aid system and the control node of the monitoring system allows the possibility that the mobile aid system has been "diverted" to another destination without prior authorization to be signaled. Figure 2 shows a flow diagram that represents a currently preferred embodiment of the operating principle of the module 20 arranged to detect a supply energy provided to the apparatus A over time, integrated with the module 26 for checking dispersion currents.

In step 100, the current is detected along the power supply cable to the apparatus, for example by means of one or more current transformer circuits that do not physically interrupt the power supply conductor, or by means of one or more Hall effect sensors inserted in series in a power supply circuit.

In step 120, it is checked whether anomalies are encountered by comparing the dispersion current detected with a predetermined threshold current. If the detected dispersion current is higher than the predetermined threshold current, an anomaly is found and the procedure advances to step 140, where the consequent fault and emergency signaling actions are implemented, for example emitting a data string including an emergency message and requesting an interrupt of the operation of the apparatus.

If no anomalies are found, the procedure advances to step 160, where a data string including an information message is transmitted, for example comprising the value of current consumed and the dispersion current. In step 170, the module requests a consent for the transmission of the aforesaid data and, in step 180, it is checked whether the consent for the transmission has been received. In the negative case, in step 190, the procedure returns to step 180 to check if the consent for the transmission was received at a later time, or the procedure ends after a predetermined wait time has elapsed. In the affirmative case, in step 200, the data string including the information message is sent and, in step 210, the procedure checks whether a signal confirming the sending of the data string has been received. In the affirmative case, in step 220, logs of the storage module 24 are updated and the procedure returns to the beginning. In the negative case, in step 230, the procedure checks again whether a confirmation signal of sending the data string has been received at a later time, or the procedure ends after a predetermined wait time has elapsed.

Figure 3 shows a flow diagram that represents a currently preferred embodiment of the operating principle of the module 22 for detecting the presence of a healthcare operator.

In step 300, the module 22 requests the reading of a presence device, such as, for example, a card with magnetic strip, an RFID label or similar, from which it acquires a recognition code that is then transmitted to the remote management unit, together with a time record including an intervention start time and an intervention end time, on a bus comprising one or more analog lines or a USB serial port.

In step 320, the module 22 checks for any anomalies identified by means of comparison logs of the acquired data with the reference data or data signaled by the apparatus. If any anomalies are found, in step 340, the module 22 emits a warning signal of non-availability, signaling a fault without interrupting the service, and the procedure returns to the beginning. If no anomalies are found, in step 360, the module 22 prepares to acquire the recognition code and the time record of the intervention and, in step 380, checks for any anomalies in the data acquired, for example integrity of the data and availability of the time record. If any anomalies are found, in step 390, the procedure will emit a warning of the read fault and return to the beginning. If no anomalies are found, in step 400, the procedure sends a data string, then, in step 410, clears the storage logs of the acquired data and prepares ,to start again.

The system according to the invention allows the status of at least one or a plurality of electro-medical apparatuses installed in the home of a patient to be monitored, as well as to verify whether a home care service is actually provided, for example, by ensuring the ability to verify whether qualified technical operators carry out maintenance on the home apparatuses. Moreover, due to the features provided, the system allows an electro-medical apparatus installed for home care to communicate locally through an information display on the conditions of use for the provision of healthcare services for which this apparatus is intended. Ultimately, the system according to the invention allows one to check the correct and optimal use of the electro-medical apparatuses installed in the home of a patient, verifying if in fact a healthcare service is actually provided. It may be considered for all intents and purposes as an integrated quality control system for the home care of a patient, which allows multiple advantages to be obtained. The first advantage is the possibility to keep under control the proper operation of the apparatuses and more generally the care of the patient. In addition to this, the system allows other indirect benefits to be obtained, namely: (i) monitoring the actual and correct use of the apparatuses by patients; (ii) identifying the location of the apparatuses, i.e. the absence of an apparatus in the area covered by the service; (iii) verifying the actual intervention of maintenance and home care staff according to procedures also established at the contractual level.

On the whole, the system according to the invention allows a patient to be better cared for by the home health service, both from the point of view of the safety and effectiveness of the electro-medical apparatuses used, and from the point of view of the quality of the care service provided.

The system according to the invention is of a modular type, whereby it may be created as a platform adapted to host new elements as needed, as it may provide, as essential functions, for the transmission of information and the detection over time of the supply energy provided to the apparatus (which allows verification of the use of the apparatus), and as required for completeness by selecting additional modules from those described, for example, reading the voltage of the batteries in mobile apparatuses (electric wheelchairs and stairlifts).

Ultimately, the system is arranged to measure, detect, analyze, communicate and verify multiple data with the sole purpose of cross-referencing this information to ensure the proper operation and use of electro-medical apparatuses that assist patients in their homes and indirectly to ensure that the healthcare is actually provided.

The overall quality control of a home care service responds primarily to the expectations of the patient, but also to the economic needs of a health service provider that rents or buys the home care apparatuses. Naturally, without altering the principle of the invention, the embodiments and the details of implementation may vary widely with respect to that which is described and illustrated purely by way of non-limiting example, without thereby departing from the scope of protection of the invention defined by the accompanying claims.

Claims

1. System for monitoring electro-medical apparatuses installed at a patient's home, characterized in that it comprises a control device that includes:

a control node that may be associated with at least one electro-medical apparatus; and

a plurality of functional modules coupled to said at least one electro-medical apparatus, arranged to perform at least one of the following functions:

- detecting operating parameters of said apparatus;

- communicating information to the patient;

- receiving commands from the patient,

wherein said control node is adapted to establish a first communication link with each of said plurality of functional modules through a first communication protocol and a second communication link with a remote management unit through a second communication protocol,

and wherein said plurality of functional modules comprises a module (20) arranged for detecting over time a supply energy provided to the apparatus (A), and adapted to record variations in the consumption of electrical power by the apparatus (A) and identify the operating status of the apparatus (A) between an ON but non-operative state (stand-by), an ON and operative state, and an OFF state.

2. System according to claim 1 , wherein said first communication link is oriented to the exchange of data and/or commands between the control node (12) and the functional modules (20-34) coupled to said apparatus (A), and said second communication link is oriented to the transmission of data indicative of the operational status of the apparatus (A) to the remote management unit (C) as well as to the acquisition from the remote management unit (C) of commands or warnings intended for the apparatus (A) or the patient.

3. System according to claim 1 or 2, wherein said control device (10) is arranged to be interposed along the power supply cable of the apparatus (A) downstream of the power supply electric network.

4. System according to any one of the preceding claims, wherein said plurality of functional modules comprises a module (22) for detecting the presence of an operator in the vicinity of said apparatus (A), said module (22) being arranged to acquire an identification code of an operator stored on a device held by the operator.

5. System according to any one of the preceding claims, wherein said plurality of functional modules comprises a module (24) for storing event data.

6. System according to any one of the preceding claims, wherein said plurality of functional modules comprises a module (26) for checking dispersion currents of the apparatus (A).

7. System according to any one of the preceding claims, wherein said plurality of functional modules comprises a module (28) for requesting a health emergency.

8. System according to any one of the preceding claims, wherein said plurality of functional modules comprises a module (30) for requesting a technical intervention.

9. System according to any one of the preceding claims, wherein said plurality of functional modules comprises a module (32) for communication with the patient.

10. System according to any one of the preceding claims, wherein said plurality of functional modules comprises a module (34) for the geo-localization of the apparatus (A).