Home patient remote monitoring system

Abstract

Title of the Invention: Remote Monitoring System for a Patient at Home. The invention relates to a remote monitoring system (10) for a patient (P) treated at home using a medical device (1). The remote monitoring system (10) comprises data processing computer means (11) cooperating with the medical device (1) to collect at least one monitoring parameter; a processor (13) for processing the monitoring parameter and triggering (14) an alert when it deviates from a reference stored by storage means (12); and a human-machine interface (20) with a display screen (21) for displaying an alert (22) following an alert triggering (14). The human-machine interface (20) includes alert blocking means (23) for preventing, during a blocking period, any repetition by the processor (13) of the alert triggering (14). Abstract Figure: Fig. 1

Description

Title of the invention: Remote monitoring system for a patient at home

[0001] The invention relates to a remote monitoring or surveillance system, i.e., a remote monitoring medical device, for one (or more) patients treated at home with a medical treatment device, comprising computer means for data processing to remotely detect treatment that is not or is not sufficiently effective, or a deteriorating clinical condition in the patient, or any other non-compliant parameter, and alert means configured to inform and / or alert a user in the event of such detection, in particular a home healthcare provider (HCP).

[0002] Patients with chronic illnesses sometimes require the initiation of treatment with a medical device at home, i.e., outside of a hospital or similar setting, and for extended periods, typically several months or years.This could be a respiratory support device, such as a medical ventilator, a continuous positive pressure ventilator, an oxygen concentrator, an insulin pump, an apomorphine pump, an L-Dopa pump...or something else.

[0003] Monitoring patients with chronic illnesses treated at home requires regular visits from healthcare professionals, such as technicians and / or nurses, to the patient's home. These visits are necessary to verify the clinical effectiveness and adherence to treatment, monitor for any adverse effects, and record the operation of medical devices for the prescribing physician, for example. Such monitoring allows for actions to be taken to improve adherence and / or limit adverse effects, and to adjust the operating parameters of the treatment devices being used.

[0004] Despite these regular follow-ups, many patients are treated in a less than fully effective manner due to poorly adapted settings or other reasons, such as patient fatigue or discouragement leading to a decrease in adherence to treatment, or the occurrence of a technical problem.

[0005] Home visits to patients can be made more efficient by having prior knowledge of the patient's parameters, or even their history since the last visit. Variations in measured physiological parameters can also contribute to the rapid and remote detection of acute events in some patients, that is, to making an early diagnosis and potentially at a less severe stage of the acute event.

[0006] It is therefore essential to be able to quickly detect an ineffective or insufficient treatment, or a deteriorating health condition in a patient treated at home with a medical treatment device, so as to be able to intervene quickly and avoid an impact on the health condition of the patient concerned.

[0007] Remote monitoring or remote tracking systems allow remote monitoring of one or more parameters from the medical device for treating the patient(s) treated at home, processing of the monitored data or parameters.

[0008] These systems operate an alert trigger to warn or inform a user, such as a PS AD, when one (or more) parameter(s) is non-compliant, for example when its value exceeds a given threshold value.

[0009] Currently, the triggering of an alert is based solely on the value(s) of the data / parameters collected and processed by computer, i.e. without taking into account the action(s) already programmed, taken in response to an alert that has been triggered, which are intended to correct the alert that has been triggered.

[0010] We then witness an automatic generation of new occurrences of the alert, which no longer provide value to remote monitoring, or even degrade its performance due to the number and / or frequency of the alerts generated which can be high, and the time spent closing these new alerts without any more action than on the first occurrence of the alert.

[0011] Indeed, the intervention decided upon following an initial alert does not always have an immediate effect on the measured parameters and therefore does not trigger subsequent alerts. For example, it may require a visit to the patient, a change in the settings of the medical treatment device as prescribed by a doctor, or therapeutic education.

[0012] The problem is therefore to avoid unnecessary repetitive alerts being generated in response to a remote detection of one (or more) non-compliant parameter at the level of the medical device used to treat a patient at home and to the triggering of a first alert, that is to say to avoid a (or more) new occurrence of this alert being generated until a corrective intervention has been completely carried out.

[0013] The solution of the invention relates to a remote monitoring system, i.e., a remote surveillance system, for a patient treated at home using a medical device, said remote monitoring system comprising: - computer data processing equipment configured to cooperate with the medical device located in the patient's home, to collect at least one monitoring parameter provided by the medical device, said computer data processing equipment comprising:

[0014] . means for storing at least some reference parameters compliant and

[0015] . at least one processor implementing at least one algorithm configured for process at least one tracking parameter and trigger an alert when said at least one tracking parameter does not conform to at least one stored reference, that is to say, it reflects a non-conformity after comparison with at least one stored compliant reference parameter, and - a human-machine interface (HMI) comprising a display screen cooperating with the computer data processing means to display at least one alert on said display screen in response to an alert trigger,

[0016] characterized in that the human-machine interface (HMI) includes alert blocking means to prevent (i.e. block or prohibit), for a blocking period, any repetition by the processor of the triggering of the alert having been triggered, that is to say any new occurrence of the alert already triggered and displayed on the HMI.

[0017] Depending on the embodiment considered, the system of the invention may comprise one or more of the following features: - The HMI includes one or more selection keys or buttons, or similar, allowing the user to make one or more choices, adjustments, selections, validations or other actions. - The HMI includes a touchscreen display. - The HMI includes a touchscreen display configured to display one or more virtual selection keys. - The HMI includes a color or black and white display screen. - the given blocking duration is a predefined or adjustable duration. - The user interface is configured to allow the user to choose or select the blocking duration. - the blocking duration corresponds to the time required to complete an intervention undertaken to resolve the ongoing alert and / or to security and / or regulatory requirements relating to the treatment of said patient. - typically, the blocking duration is several minutes, preferably one or several tens of minutes, or even one to several hours, or even in some cases one to several days. - according to a first embodiment, the means of blocking alerts are actionable, activatable or selectable by the user. - the means of blocking alerts include a selection key which, when activated by the user, blocks any repetition of the triggering of the alert which has been triggered, for the duration of the block, including a virtual selection key displayed on the display screen of the HMI. - according to a second embodiment, the means of blocking the alert are at automatic. In this case, the processor is programmed not to trigger a new alert during the pre-set and memorized blocking period, once an alert has been triggered. The processor is configured to be able to repeat an alert that has already been triggered only when the blocking time has elapsed. The alert blocking means are configured to deliver a blocking signal to the processor to prevent any reiteration of alert triggering during the blocking duration memorized by the memorization means. The processor is configured to compare said at least one tracking parameter with said at least one stored compliant reference parameter and deduce whether the tracking parameter conforms or does not conform to said stored reference parameter. said at least one stored conforming reference parameter is a reference threshold, that is to say a threshold value, in particular one or more upper and / or lower thresholds of one or more parameters. For example, the reference parameter may be a respiratory rate (RR) and a duration of treatment or something else. The display screen is configured to show one or more pieces of information relating to at least one triggered and / or blocked alert, in particular an alert and / or blocking date, a blocking duration and a blocking end date. said at least one processor implements at least one configured algorithm For :

[0018] . process said at least one tracking parameter and obtain at least one processed value said at least one tracking parameter,

[0019] . compare said at least one processed value with at least one parameter of a stored conforming reference, for example at least one stored threshold value or a range of values, and

[0020] . trigger an alert when said at least one value is processed by said at least one monitoring parameter becomes greater (e.g. a high threshold) or lesser (e.g. a low threshold) audit at least one compliant stored reference parameter. - it includes means of power supplying the various elements of the system of the invention which require electric current to operate, in particular the processor and the display screen, for example a connection to the mains (110 / 220V). - the means of memorization include computer memory, such as flash memory or other. The means of transmitting data from the patient's medical device include a modem and / or a transmitting antenna or any other device enabling remote communication via the internet or another network, such as GSM networks including 4G / 5G, LoRa or Sigfox, and / or via a virtual computer space of the "cloud" type. The medical device's data transmission means are configured to remotely transmit at least the said tracking parameter. The means of data transmission can either be integrated into the medical device, or be part of an external module connected to the medical device, for example by attaching to said medical device. The medical device is a medical ventilator, an oxygen concentrator, or something similar. The medical device is preferably a medical ventilator, that is to say a respiratory assistance device, including measuring means configured to determine at least one ventilatory parameter serving as a monitoring parameter. The alert triggered by the alert means in order to warn or inform the user includes a prior notification, for example one or more characters (letters, numbers or others), including a message in text format, a color code, an icon, a bar graph, or other and / or their combinations, for example a bar graph of several colors. The monitoring parameter(s) from the medical device, typically a medical ventilator, include one or more primary monitoring parameters chosen from respiratory rate (RR), leaks, an abnormal respiratory event (e.g., apneas, hypopneas, etc.) and / or treatment duration, preferably respiratory rate (RR) and treatment duration. The ventilatory parameter(s) from the medical device, typically a medical ventilator, include one or more secondary monitoring parameters chosen from tidal volume (Vt), the proportion (ie %) of spontaneous inspirations (relative to the total number of inspiratory cycles, i.e. triggered by the ventilator and the patient), and minute ventilation. The parameter(s) from the medical device, typically a ventilator, also include one or more operating parameters, notably information regarding a failure to transmit data by the ventilator. This allows the user (e.g., PS AD) to be notified of a ventilator fault or malfunction affecting the proper transmission of data, i.e., parameters. - the monitoring parameter(s) are determined and / or measured over a given period which can be modified by a user, in particular a PSAD or a healthcare professional, for example a period of several consecutive days. - the medical ventilator supplies air or an air / oxygen mixture at a pressure higher than atmospheric pressure (i.e. 1 bar absolute). - the computer means of data processing include at least one remote computer server, that is to say located at a distance from the patient's home of at least several tens or hundreds of meters, typically several kilometers. - the processor is a (or microprocessors). - the processor(s) is arranged on an electronic board(s). - the data storage means are configured to store at least one alert threshold value for respiratory rate and / or duration of use. - the display screen can be that of a computer, a digital tablet or a multifunction phone (i.e. smartphone).

[0021] Within the scope of the present invention: - the duration of use of non-invasive ventilation by a medical ventilator is the duration for which the patient has used the ventilator for a given period of time, for example one day (i.e. 24h). - Respiratory rate (RR) is the number of respiratory cycles, i.e. phases of inspiration and expiration, per unit of time, measured in a patient, for example it is 12 to 20 cycles per minute (cycles / min) in a healthy adult but which can increase in case of respiratory disorders or decrease during sleep. - Leaks are the escape of gas (e.g., air) around the mask, limiting the effectiveness of ventilation and causing discomfort for the patient. Leaks are estimated by the ventilator based, for example, on measured gas flow rates. - the proportion (%) of spontaneous inspirations corresponds to the percentage of respiratory cycles that are initiated by the patient, and not by the ventilator, relative to the total number of cycles. - the number of respiratory events (i.e. apneas, hypopneas) per hour of treatment corresponds to the number of stops and / or decreases in airflow during a given period of time, for example greater than or equal to 10 seconds, also called the apnea-hypopnea index. - Tidal volume (Vt) is the volume of air entering the patient's lungs with each respiratory cycle, for example, a volume of air of approximately 0.5 L. - the minute ventilation corresponds to the product Vt.FR.

[0022] A system according to the invention is suitable for use in monitoring a patient suffering from severe chronic respiratory failure, including chronic obstructive pulmonary disease (COPD), obesity hypoventilation syndrome (OHS), or a neuromuscular disease, such as amyotrophic lateral sclerosis or Duchenne muscular dystrophy.

[0023] The invention will now be better understood with reference to the following detailed description, given by way of illustration but not limitation, with reference to:

[0024] [Fig-1] which schematically represents a patient monitoring system according to the invention.

[0025] [Fig.1] schematically represents a monitoring system 10 of a patient P being treated at home, for example a patient P under non-invasive ventilation (NIV) delivered by a medical device 1, namely here a medical ventilator, typically a patient P being treated for severe chronic respiratory failure, including chronic obstructive pulmonary disease (COPD), obesity hypoventilation syndrome (OHS) or a neuromuscular disease, such as amyotrophic lateral sclerosis or Duchenne muscular dystrophy.

[0026] Here, as part of their treatment, the patient receives a pressurized respiratory support gas (i.e., > 1 bar abs), such as air or an air / O2 mixture, delivered by the medical ventilator, i.e., a respiratory support device, acting as medical device 1. Conventionally, the gas is delivered to the patient's airways via a flexible tube fluidically connected to the ventilator and equipped with a patient breathing interface, such as a mask or similar device (not shown). The medical ventilator is electrically powered by the mains (110 / 220V) or by one or more internal batteries, including rechargeable batteries, or similar devices.The medical ventilator includes means for measuring parameters configured to monitor one or more ventilatory parameters or monitoring parameters, such as respiratory rate (expressed in cycles / min) and duration of use (expressed in min for example) of the ventilator by the patient, which reflects the duration for which the patient inhaled respiratory gas, i.e., followed their treatment.

[0027] According to the invention, a remote monitoring system 10 allows the medical treatment of patient P being treated at home to be monitored remotely.

[0028] The remote monitoring system 10 includes computer means for data processing 11, such as a remote computer server, cooperating with the medical device 1, i.e. the ventilator, located at the patient's home, to collect at least one monitoring parameter provided by the medical device 1.

[0029] Storage means 12, such as flash memory or similar, are also provided for storing conforming reference parameters, such as values- upper and / or lower thresholds or ranges of threshold values.

[0030] One (or more) processor 13 implementing one (or more) algorithm allows processing the monitoring parameter(s) provided by the medical device 1 and triggering 14 an audible and / or visual alert in the event of detection of one (or more) monitoring parameter not conforming to one or more of the reference values ​​stored by the storage means 12, for example exceeding a high threshold value (i.e. maximum value) or falling outside a range of stored values.

[0031] A human-machine interface 20 comprising a display screen 21, preferably in color, cooperates with the computer data processing means 11 so as to display a visual alert 22 on the display screen 21 in response to an alert trigger 14 by the processor 13.

[0032] According to the invention, alert blocking means 23 make it possible to prevent, for a prefixed or adjustable blocking period, any repetition by the processor 13 of the triggering 14 of the alert having been triggered.

[0033] The elements of the system 10 requiring electrical current to operate are powered electrically by the electrical network (110 / 220V), in particular the data processing computer equipment 11, typically the computer server and its components, the HMI...

[0034] In order to ensure the transmission 2 of monitoring parameters to the computer means of data processing 11, i.e. to the server, means of (tele)transmission of data are provided at the level of the medical device 1, i.e. the ventilator, configured to transmit remotely one or more monitoring parameters, such as ventilatory parameters provided by means of measurement of the ventilator.

[0035] For example, the data (tele)transmission means 3 include a GSM or other type modem and a transmitting antenna. The transmitted tracking parameters 2 travel, for example, via the internet or another network, such as GSM, LoRa or Sigfox networks, and / or can be processed in a virtual computing space of the "cloud" type.

[0036] The processing of the monitoring parameters is carried out within the computer means of data processing 10 which include data receiving means 15, configured to receive the monitoring parameters teletransmitted 2 by the data transmission means 3 of the fan 1, which cooperate with the processor 13 implementing one or more processing algorithms.

[0037] Preferably, each day, the system 10 stores the latest data transmitted by the ventilator 1, in particular the duration of use and the respiratory rate (RR), for several consecutive days, preferably between 5 and 10 days.

[0038] Within the framework of the present invention, the algorithm for processing the tracking parameters, which is hosted on one (or more) computer server(s) 10, allows processing at distance measurements (i.e. monitoring parameters measured), for example here respiratory rate (RR) and / or duration of use carried out over several days, and teletransmitted by the communicating ventilator 1 located at the patient's home.

[0039] The alert means displayed on the screen 21 of the HMI 20 allow the user, such as a home healthcare provider (HHCP), to be alerted of any alert triggered by the processor 13 of the data processing computer means 10.

[0040] The alert notification includes at least one visual alert 23, such as a notification, displayed on the screen 21, such as a computer monitor or display, a phone screen, or a tablet screen. The notification may include, for example, one or more characters (i.e., letters, numbers, or other symbols), including a message in text format, but also a color code, an icon, a bar graph, or any other graphical representation, and / or combinations thereof, for example, a bar graph of several colors, such as green, yellow, storm, and red, depending on the severity of the alert.

[0041] In general, the system of the invention makes it possible to remotely detect ineffective, insufficient, or deteriorating non-invasive ventilation (NIV) in a given patient and to alert a user, such as a home healthcare professional (HCP), enabling them to intervene quickly at the patient's home in order to avoid or minimize any negative impact on the patient's health. The system of the invention thus makes it possible to quickly, efficiently, and remotely detect one or more elements / indicators representative of NIV that is ineffective, insufficiently effective, or deteriorating, and thereby implement corrective technical actions or inform healthcare professionals about decreased adherence or excessive variation in the patient's respiratory rate, which may be a warning sign of a deteriorating patient condition.

[0042] Thanks to the alert blocking means 23, it is possible to prevent, for a blocking period, any repetition by the processor 13 of an alert which has already been triggered, and this preferably for a predefined period.

[0043] According to the invention, the processor 13 is configured to be able to reiterate an alert that has already been triggered only when the blocking time has elapsed.

[0044] The alert blocking means 23 may include one (or more) key, button or analog, typically a key of the HMI 20, which, when activated, sends a blocking signal to the processor 13 which, in response to this blocking signal, prevents any reiteration of the alert triggering during the blocking duration prefixed and stored by the storage means 12.

[0045] According to another embodiment, the alert blocking means 23 may include one or more keys, buttons or the like, such as a key on the HMI 20 which, when activated, allows the selection of a given duration from among several different pre-set blocking durations stored by the storage means 12, for example several blocking durations displayed by the screen 21 and selectable by means of the alert blocking means 23 within a drop-down menu or similar.

[0046] According to yet another embodiment, the blocking duration is adjustable by the user via the HMI 20. He can set it by means of the alert blocking means 23, such as a key of the HMI 20. Typically, the blocking duration can range from one or more minutes to one or more hours, or even in some cases, up to one or more days.

[0047] In general, the system of the invention is compatible with all communicating medical ventilators and is also capable of censoring the parameters measured during periods of compliance that are too short so that the value is relevant.

Claims

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6. Claims Remote monitoring system (10) for a patient (P) treated at home using a medical device (1), said remote monitoring system (10) comprising: - computer data processing means (11) configured to cooperate with the medical device (1) located at the patient's home, to collect at least one monitoring parameter provided (2) by the medical device (1), said computer data processing means (11) comprising: . storage means (12) for storing at least compliant reference parameters and . at least one processor (13) implementing at least one algorithm configured to process said at least one tracking parameter and trigger (14) an alert when said at least one tracking parameter is non-compliant with at least one stored reference, and - a human-machine interface (20) comprising a display screen (21) cooperating with the data processing computer means (11) to display at least one alert (22) on said display screen (21) in response to an alert being triggered (14), characterized in that the human-machine interface (20) comprises alert blocking means (23) making it possible to prevent, for a blocking period, any repetition by the processor (13) of the triggering (14) of the alert having been triggered. System according to claim 1, characterized in that the data processing computer means (11) comprise a remote computer server. System according to claim 1, characterized in that the given blocking duration is a predefined or adjustable duration. System according to claim 1, characterized in that the human-machine interface (20) is configured to allow the user to choose or select the blocking duration. System according to claim 1, characterized in that the medical device (1) is a medical ventilator or an oxygen concentrator. System according to claim 1, characterized in that the processor

7. (13) is configured to be able to repeat an alert that has already been triggered only when the blocking duration has elapsed. System according to claim 1, characterized in that the alert blocking means (23) are configured to deliver a blocking signal to the processor (13) to prevent any reiteration of alert triggering during the blocking duration stored by the storage means (12).

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