Remote monitoring system for a patient with Parkinson's disease

Abstract

Title of the Invention: Remote Monitoring System for a Patient with Parkinson's Disease. The invention relates to a remote monitoring system (100) for a patient (P) with Parkinson's disease, comprising an infusion pump (1) including control means for delivering medication based on a value of an operating parameter set at the infusion pump (1); signal transmission means (101) for remotely collecting and transmitting (102) a signal representative of said value; data processing computer means (103) for receiving and providing said signal to display means (104) for displaying the value of said operating parameter; and input means (105) allowing a user to modify the value displayed by the display means (104). Abstract Figure: Fig. 2

Description

Title of the invention: Remote monitoring system for a patient with Parkinson's disease

[0001] The invention relates to a remote monitoring system, i.e. remote monitoring and / or remote surveillance, of a patient with Parkinson's disease, in particular of a Parkinson's patient treated at home by administration of an antiparkinsonian drug by means of an infusion pump, in particular apomorphine or duodopa®, i.e. carbidopa / levodopa or any other molecule.

[0002] Parkinson’s disease is a chronic neurological disease characterized by the destruction of dopamine neurons present in the brain of individuals with this disease, called Parkinson’s patients.

[0003] Dopamine neurons are involved in the control of body movements and their destruction then causes various symptoms in these parkinsonian patients, such as tremors, muscle stiffness, slowness of movement, more or less significant involuntary movements, called dyskinesias, muscle rigidity, postural instability, blocking (or freezing Phase Off in English).

[0004] To treat this disease, patients are administered various medications, including dopaminergic drugs, which stimulate dopamine neurons, such as L-Dopa. However, it has been observed that this type of medication, particularly L-Dopa, exhibits fluctuations in effectiveness in some Parkinson's patients.

[0005] Therefore, in Parkinson's patients with such fluctuations in efficacy and / or in the case of severe dyskinesias, it is recommended to use other antiparkinsonian drugs, such as apomorphine, which is a stimulator of postsynaptic dopaminergic receptors, thus exerting an antiparkinsonian action.

[0006] Apomorphine is generally administered automatically to the patient by means of an infusion pump delivering doses of apomorphine during the day to the patient, via a catheter implanted subcutaneously in the patient.

[0007] The patient can also, on his own, activate the pump to deliver an additional dose of apomorphine, called a bolus, for example in case of excessive tremor.

[0008] Generally speaking, in order to obtain fully effective treatment for a Parkinson's patient, it is essential to be able to deliver the correct dose of medication, particularly apomorphine, to the patient throughout the day and, above all, to be able to adjust this dose, that is, reduce or increase it, if it is observed that the dose that has been set is not (sufficiently) effective or leads to adverse effects in the patient, including allergy, hallucinations, behavioral disturbances, troublesome dyskinesias, all-day sleepiness, nausea / vomiting under domperidone.

[0009] However, Parkinson's patients are generally not hospitalized or their hospitalization period is very short to define the optimal dose for all life situations, i.e. their treatment takes place at home, therefore in the absence of healthcare personnel, i.e. doctor and / or nurse, who can ensure the proper conduct of the treatment and, if necessary, intervene quickly to adjust the treatment provided, for example the dose or flow rate of antiparkinsonian drug administered to the patient or another operating parameter of the infusion pump.

[0010] The problem that arises is therefore to be able to quickly detect a treatment by infusion of a drug against Parkinson's disease, that is to say an antiparkinsonian drug, such as apomorphine, duodopa® or other, which is not or insufficiently effective to treat a parkinsonian patient who is outside of hospital, in particular at home, and to be able if possible to intervene quickly i.e. to react remotely in order to make one or more adjustments to the settings of the pump delivering the drug to the patient concerned.

[0011] The solution of the invention relates to a remote monitoring system, i.e. a medical device for remote monitoring and / or remote surveillance, of at least one patient with Parkinson's disease, i.e. a Parkinson's patient, comprising: - an infusion pump comprising control means for delivering a drug as a function of at least one quantity of at least one operating parameter set at the level of the infusion pump, - signal transmission means cooperating with the perfusion pump and configured to collect and remotely transmit at least one signal representative of said magnitude of the operating parameter of the perfusion pump under consideration, - computer data processing means configured to receive said at least one signal transmitted by signal transmission means and to provide said at least one signal to display means, - display means configured to display the magnitude of said operating parameter corresponding to said signal provided by the computer data processing means, and - input means allowing a user to modify the magnitude of said operating parameter displayed by the display means.

[0012] Depending on the embodiment considered, the tracking, i.e. remote monitoring and / or remote surveillance system of the invention may include one or more of the following features: - the infusion pump includes control means for delivering a controlled-administration drug, in particular apomorphine. - The infusion pump is configured to administer the medication subcutaneously for the treatment of Parkinson's disease. - the display means are further configured to display the modified magnitude of the operating parameter. - the computer means of data processing are configured to transmit remotely to the signal transmission means at least one return signal representative of the modified magnitude of said operating parameter. - the signal transmission means are further configured to receive said at least one return signal and transmit said return signal to the infusion pump. - the means of data transmission include at least a modem or similar device. - the means of controlling the perfusion pump are configured to modify the magnitude of the operating parameter considered according to said feedback signal received by the perfusion pump. - the signal transmission means are integrated into the infusion pump. - Alternatively, the signal transmission means are included in an independent communication module communicating with the infusion pump, for example in Bluetooth mode. - The magnitude of the operating parameter set at the pump is chosen from: • an infusion rate value (i.e., continuous administration), • a daily schedule for starting the infusion, • a daily end-of-infusion schedule, • a programmed number of daily boluses, • a bolus volume, • the bolus rate, • the time interval between boluses, • adjusting the flow rate within (pre)defined time ranges, • the volume to be infused and • the concentration of the drug to be infused. - The other parameter(s) set at the pump level include: • the type of tank and unit, • Patient information, in particular name, surname, date of birth, name of the medication administered... • the automatic (i.e. AUTO) or manual (MANUAL) infusion mode, • the flow rate(s) in AUTO and / or MANUAL mode, and • Alarm configuration. The operating parameter quantity is preferably a flow rate value, preferably a flow rate value between 0 and 8 ml / h or between 0 and 40 mg / h (for a concentration of 5 mg / ml). The computer means of data processing include at least one computer server. The computer server comprises one or more processors implementing one or more algorithms, software, programs or the like. The computer server includes a communication module, including BLE, WIFI, 2G / 3G / 4G / 5G smart card or other types. Display means include a viewing screen, for example the screen of one (or more) desktop or laptop computers, or the screen of a digital tablet or a smartphone. Display means include a color or monochrome (e.g., black and white) viewing screen. Display options include a touchscreen. Input methods include a computer, a numeric keypad, a digital tablet, or a smartphone. The infusion pump includes a reservoir containing the drug in liquid form, in particular Tapomorphine or duodopa®, i.e. carbidopa / levodopa combination. The reservoir is removable, meaning it can be detached from the pump, particularly when empty, in order to replace or refill it. the reservoir has a capacity less than or equal to 100 ml, typically less than or equal to about 50 ml, for example 20 ml, 30 ml or 50 ml. the reservoir comprises a hollow reservoir body containing the liquid drug to be injected, a piston movable in translation within said hollow body and a fluid distribution orifice, preferably carried by a nozzle. The hollow tank body is generally tubular in shape, preferably with a circular or oval cross-section. The infusion pump further includes an actuation means, such as a rod or a pusher, which cooperates with the reservoir piston in such a way to push the liquid medication towards the fluid distribution orifice, i.e. the liquid medication outlet. - the means of controlling the infusion pump directly or indirectly control the movement of said actuation means so as to supply the liquid drug at the desired flow rate. - the means of controlling the perfusion pump control a translational movement of the actuation means within the reservoir body. - the infusion pump further includes an electric motor cooperating with an actuating means and the control means of the infusion pump control said electric motor to operate a displacement of said actuating means so as to supply the liquid drug at the desired flow rate. - the perfusion pump further includes means of memorization, such as a memory configured to record (i.e. memorize) the desired quantity or quantities of the operating parameter or parameters considered, in particular one or more flow rate values. - the infusion pump also includes a power supply, for example one or more electric batteries, preferably a rechargeable battery via a mains charger which connects to the pump. - the infusion pump also includes a pump housing, i.e. an external casing or shell, carrying a digital screen. - the infusion pump also includes at least one on / off button. - the infusion pump also includes an access hatch to a battery compartment where the power supply battery(ies) is / are housed. - the control means control the supply of medicine from the reservoir according to said at least one quantity of said at least one operating parameter set at the level of the infusion pump or modified according to the feedback signal received by the infusion pump. - the control means include a microprocessor embedded in the infusion pump, for example carried by an electronic card.

[0013] The invention also relates to the use of a remote monitoring and / or remote surveillance system according to the invention to operate remote monitoring / tracking and treatment of a Parkinson's patient.

[0014] 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 the accompanying Figures, among which:

[0015] [Fig. 1] schematically illustrates a system for administering an antiparkinsonian drug by infusion to a Parkinson's patient, and

[0016] [Fig.2] schematically illustrates an embodiment of a remote monitoring system for a Parkinson's patient according to the invention.

[0017] [Fig. 1] schematically illustrates the administration by infusion of an antiparkinsonian drug that stimulates dopaminergic receptors, namely apomorphine for example, in a Parkinson's patient. However, another drug can be used instead of apomorphine, such as duodopa® (i.e., carbidopa / levodopa). Apomorphine is used below as an illustrative but not limiting example.

[0018] As can be seen, the administration of apomorphine (or other) is carried out by means of an infusion pump 1 comprising a piston reservoir 6 connected to a catheter 2 implanted subcutaneously in patient P. The reservoir 6 containing the apomorphine in liquid form typically has a capacity of a few tens of ml, for example 20, 30 or 50 ml. Advantageously, the reservoir 6 is removable, that is to say, it can be mounted or detached from the rest of the pump 1, in particular to replace it or to refill it with apomorphine when it is empty.

[0019] The catheter 2 includes a tube 3 connected to an outlet of the reservoir of the pump 1, used to deliver the apomorphine to a subcutaneous injection needle which allows it to be injected into the patient.

[0020] Preferably, an adhesive or similar system is provided to hold the catheter in place on the patient's body. It can be fixed to different locations on the body, such as the flanks, shoulder blades, or periumbilical area.

[0021] Such an infusion set allows apomorphine to be injected into patient P either automatically and continuously during the day, or as a bolus by activation of the pump 1 by the patient himself, for example in case of excessive tremor requiring the delivery of an additional dose of apomorphine.

[0022] In general, apomorphine (or other drug) injections are given during the day, i.e. between the patient P getting up and going to bed. However, in some cases, one or more apomorphine administrations may take place during the night.

[0023] The operating parameters of the pump 1 are set by a user, such as a doctor and / or nurse, i.e., an authorized healthcare professional, at the pump level and stored in a memory integrated into the pump, in particular one (or more) infusion flow rate value(s), a daily infusion start time and a daily end-of-infusion time, and possibly a maximum number of daily boluses allowed and a bolus volume,...

[0024] Furthermore, the pump 1 also provides control means, such as a microprocessor carried by an electronic card, allowing the supply of apomorphine at the desired flow rate to be controlled directly or indirectly, for example by controlling an electric motor controlling a translational movement of an actuation means, such as a pusher or a rod, acting on the piston of the reservoir in which the apomorphine is contained so as to push back said piston and therefore also the apomorphine (which is pushed by the piston) towards a fluid distribution orifice and thus supplying apomorphine to the tubing of the catheter 3.

[0025] The apomorphine pump 1 is preferably inserted into a case 4, a pouch, a small bag or similar which the patient P can for example attach to his belt 5 (as illustrated), wear over his shoulder or hang around his neck.

[0026] In general, the tracking system 100 of the invention described below is compatible with all connected pumps 1 of this type or similar.

[0027] Figure 2 schematically illustrates an embodiment of a remote monitoring system, i.e., remote monitoring or remote tracking, of a Parkinson's patient P according to the invention.

[0028] It includes an infusion pump 1 with removable reservoir 6, as described above, delivering a drug in liquid form, namely here apomorphine, according to at least one quantity of at least one operating parameter set at the level of the infusion pump 1, for example an apomorphine infusion rate value typically between 0 and 8 ml / h.

[0029] The delivery of apomorphine at the desired flow rate is controlled by control means in auto or manual mode according to the parameter setting, such as a (or more) microprocessor carried by an electronic card embedded in the pump 1.

[0030] Also provided are storage means, such as a memory card or similar device, integrated into the pump 1, for example carried by the electronic board on which the microprocessor is mounted. These storage means serve to record the operating parameters of the pump 1 and the quantities / values ​​of these parameters, for example an infusion rate value between 0 and 8 ml / h, a daily start and / or end time for the infusion, a number of daily boluses authorized, a bolus volume... or other parameters.

[0031] In the embodiment of the system 100 of the invention illustrated in [Fig. 2], the infusion pump 1 communicates in Bluetooth mode 111 with signal transmission means 101 integrated into an independent communication module 110, such as a connected box, communicating with the infusion pump 1 and configured to remotely collect and transmit 102 the representative signal(s) of the magnitude of the operating parameter of the perfusion pump 1 under consideration, namely here a perfusion flow rate value.

[0032] However, according to another embodiment (not shown), the signal transmission means 101 can also be integrated directly into the perfusion pump 1.

[0033] In other words, the pump 1 here includes embedded telecommunication means, preferably operating via Bluetooth, used to transmit signals, i.e., data, information, parameters, or other signals, to the signal transmission means 101 integrated into the independent communication module 110, which is itself a communicating module, i.e., designed to receive and then retransmit 102 the signal(s) representing the magnitude of the operating parameter of the perfusion pump 1 under consideration, namely, in this case, the perfusion flow rate value, to data processing computing means 103, such as one or more computer servers located remotely, i.e., at another site. The data processing computing means 103 may further include a virtual computing space, also called a "cloud" or "middleware".

[0034] Preferably, the signal transmission means 101 are configured to transmit the signal(s) remotely, via the internet or another communication network, such as GSM, Wi-Fi, LoRa, or Sigfox networks. For example, they include a GSM or other type modem and a transmitting antenna.

[0035] The computer means for data processing 103, i.e. the server(s) and / or a (or more) virtual computing space (i.e. cloud), are configured to receive (or send) the signal transmitted by signal transmission means 101, and then provide it, after possible computer processing by means of an (or more) algorithm hosted on the server(s), to display means 104, i.e. a (or more) digital screen, typically a viewing screen, for example the screen or monitor of a computer, a digital tablet or a smart phone.

[0036] The display means 104 then allow the magnitude of the operating parameter considered to be displayed, for example here the perfusion rate, corresponding to the signal provided by the computer data processing means 103.

[0037] A user, typically healthcare personnel, in particular a doctor or nurse, can then consult the value of the operating parameter in question displayed on the screen, namely here the infusion rate, and thus decide either to leave the operation of pump 1 unchanged, or on the contrary decide to change the value of the parameter in question in order to decrease or increase the titration (dose) of the drug for example.

[0038] To this end, input means 105 are provided, enabling the user to modify the magnitude of the operating parameter displayed by the display means 104, e.g., the infusion rate. These include, for example, a desktop or laptop computer, a numeric keypad, a digital tablet, or a smartphone, and a web or mobile application designed to assist the physician or other healthcare professional in monitoring the data and making adjustments (decision-making) as needed (remote monitoring).

[0039] The input means 105 cooperate with the computer data processing means 103, i.e. the server(s), so that the modification(s) of the parameter(s) made are taken into account and / or recorded by the computer data processing means 103.

[0040] Once the user has changed the magnitude of the operating parameter displayed by the display means 104, for example the perfusion rate, the changed magnitude, i.e. the new flow rate value for example, is then displayed by the display means 104.

[0041] The computer means for data processing 103 then remotely retransmit 102 the parameter(s) considered to the signal transmission means 101 via a return signal representative of the modified magnitude of the operating parameter(s).

[0042] The signal transmission means 101 receive this return signal and provide it to the control means and / or the memory means of the perfusion pump 1.

[0043] The control means are configured to take into account this feedback signal, i.e. the modification(s) made, to modify the magnitude of the operating parameter considered according to the feedback signal received by the infusion pump 1 either automatically, or by a sub-validation by another healthcare professional during remote reception, for example to modify the infusion rate set on the pump 1 and replace it with the new infusion rate received, i.e. a higher rate or, conversely, a lower rate than the rate initially set on the pump 1.

[0044] In general, the remote monitoring system 100 of the invention also allows for the collection of information or data, namely not only the operating parameter(s) from the pump 1, such as the infusion rate, but also other information, clinical data, parameters or other data from one (or more) other connected medical device(s) and / or responses to health questionnaires or other data, then their analysis and transmission to one or more users or stakeholders, such as healthcare staff, including doctors, nurses or others in hospitals or at home.

[0045] For example, clinical data may include, for each infusion and each patient, the pump configuration, the date and time of the start and end of the infusion, the flow rate(s) applied during the infusion, the date and time of boluses, the date, time and type of adverse events, the date and time of drug alarms, and more generally any patient information.

[0046] The system 100 of the invention therefore makes it possible to carry out real-time monitoring and / or surveillance of the treatment of the Parkinson's patient.

[0047] Preferably, pump 1 of system 100 communicates using Bluetooth Low Energy (BLE) to conserve its battery. Communication usually occurs once a day with frames containing one day's worth of data. However, the transmission frequency can be adjusted to suit patient monitoring needs, for example, twice a day or more.

[0048] Of course, depending on the criticality of the data sent, a system for securing the transmission, in particular an encryption or identification system, may also be provided.

[0049] The signal transmission means 101, in particular the connected box 110, act as a communication gateway ensuring a link and transmission of signals (i.e. data) between the infusion pump 1 present at the patient's home or in any other place (patient in hospital, away from home...) and the remote server(s), e.g. a server in the Cloud, forming all or part of the computer means for data processing 103.

[0050] When a connected box 110 is used, it is preferably automatic, autonomous (i.e. connected to the mains), discreet for the patient, without a patient interface and possibly equipped with a proper functioning LED.

[0051] Communication between the gateway, i.e. the connected box 110, and the server in the Cloud 103 is usually done in 2G-3G, 4G, Wifi or other, at a transmission frequency of once a day or more (possibility of setting), with frames containing the patient and technical data to be sent.

[0052] The centralized server of the computer means of data processing 103 ensures the reception, storage, processing and display of patient data, in particular the operating parameter(s), such as the value(s) of the set and / or modified / adjusted perfusion rate.

Claims

Demands

1. Remote monitoring system (100) for at least one patient (P) with Parkinson's disease comprising: - an infusion pump (1) including control means for delivering a drug as a function of at least one quantity of at least one operating parameter set at the level of the infusion pump (1), - signal transmission means (101) cooperating with the infusion pump (1) and configured to remotely collect and transmit (102) at least one signal representative of said quantity of the operating parameter of the infusion pump (1) considered, - computer data processing means (103) configured to receive said at least one signal transmitted by signal transmission means (101) and to provide said at least one signal to display means (104),- display means (104) configured to display the magnitude of said operating parameter corresponding to said signal provided by the data processing computer means (103), and - input means (105) allowing a user to modify the magnitude of said operating parameter displayed by the display means (104), characterized in that: - the infusion pump includes a reservoir containing the drug in liquid form, said drug being apomorphine or a carbidopa-devodopa combination, said reservoir being removable and having a capacity less than or equal to 100 ml, - a quantity of operating parameter set at the level of the infusion pump (1) is a flow rate value between 0 and 8 ml / h or between 0 and 40 mg / h, and - the control means control the supply of drug from the reservoir (6) according to at least said flow rate value.

2. System according to the preceding claim, characterized in that: - the display means (104) are further configured to display the modified magnitude of the operating parameter, - the computer data processing means (103) are configured to transmit remotely (102) to the signal transmission means (101) at least one return signal representative of the modified magnitude of said operating parameter, the signal transmission means (101) are further configured to receive said at least one return signal and transmit said return signal to the infusion pump (1), and - the control means of the infusion pump (1) are configured to modify the magnitude of the operating parameter considered as a function of said return signal received by the infusion pump (1).

3. System according to any one of the preceding claims, characterized in that the signal transmission means (101) are integrated into the infusion pump (1) or the signal transmission means (101) are included in an independent communication module (110) communicating with the infusion pump (1), preferably in Bluetooth mode (111).

4. A system according to claim 1 or 2, characterized in that another quantity of the operating parameter set at the pump (1) further comprises: - a daily start time for infusion, - a daily end time for infusion, - a programmed number of daily boluses, - a bolus volume, - the bolus flow rate, - the time interval between boluses, - the flow rate setting within the defined time ranges, - the volume to be infused and - the concentration of the drug to be infused.

5. System according to claim 1, characterized in that the infusion pump (1) further comprises an actuating means and an electric motor cooperating with the actuating means, and the piloting means of the infusion pump are configured to control, directly or indirectly, the displacement of said actuating means so as to supply the liquid drug at the desired flow rate.

6. System according to claim 5, characterized in that the means for controlling the infusion pump (1) are configured to control the electric motor to operate a displacement of the actuating means so as to supply the liquid drug at the desired flow rate.

7. System according to any one of the preceding claims, characterized in that the computer means for data processing (103) comprise at least one remote computer server.

8. System according to any one of the preceding claims, characterized in that the display means (104) comprise at least one viewing screen.

9. System according to any one of the preceding claims, characterized in that the input means (105) comprise a computer, a numeric keypad, a digital tablet or a smart phone (smartphone).

10. System according to claim 3, characterized in that the control means control the supply of medicine from the reservoir (6) as a function of said at least one quantity of said at least one operating parameter set at the level of the infusion pump (1) or modified as a function of the feedback signal received by the infusion pump (1).

Images