FR2997306A1 - ELECTROMEDICAL SYSTEM COMPRISING AT LEAST ONE ELECTROMEDICAL APPARATUS AND MEANS FOR THE MANAGEMENT OF SAID ELECTROMEDICAL APPARATUS - Google Patents

Abstract

The present invention relates to an electromedical system (1) comprising at least one electromedical appliance (2), and means (3) for the management of said electromedical appliance (2). According to the invention, these management means (3) comprise a tactile electronic device (4), distinct from said one or more electromedical devices (2), which comprises: an interface (4a) in the form of a touch screen; communication means (4b) for the exchange of information with said electromedical apparatus (2) provided with communication means (2b), and - software means (4c) for management by an operator of said electromedical apparatus ( 2) through said interface (4a).

Description

TECHNICAL FIELD TO WHICH THE INVENTION RELATES The present invention relates to the medical field, and in particular to an electromedical system comprising an electromedical device, or even several electromedical devices cooperating with means for their management. BACKGROUND ART Medical devices are intended to be used in humans for a variety of purposes, in particular for the diagnosis, prevention, control, treatment or palliation of a disease.

Some of these medical devices, commonly referred to as "electromedical devices", require a source of electrical power and management means for their operation. Each electromedical apparatus usually has its own management means. In practice, the operator is thus obliged to use the management means dedicated to each electromedical device. However, this approach can be quickly tedious when a protocol requires the implementation of different electromedical devices, in that the operator must work with various management means.

In addition, these various medical electrical equipment generally operate independently of each other, not allowing global management by the operator. More generally, the management means of such electromedical systems are not very ergonomic for the operator; they are also little evolutive according to the needs of the latter. In addition, the remote management means generally consist of simple remote controls, allowing manipulation of the device without providing additional functionality. There is therefore a need for a system comprising means for ergonomic, reliable and efficient management of an electromedical device, or even of several separate electromedical devices. OBJECT OF THE INVENTION In view of the above, the applicant proposes a new electromedical system comprising: - at least one electromedical device, and - means for the management of said electromedical apparatus, which management means comprise a tactile electronic device, distinct and separable from said electromedical apparatus, which comprises: an interface in the form of a touch screen; communication means for exchanging information with said electromedical apparatus (and possibly a remote computer server) also provided with means of communication, and - software means, for the management by an operator of said electromedical apparatus through said interface.

Such an approach has the advantage of offering the operator a device for ergonomic, reliable and comprehensive management, which can be associated with one or more electromedical devices identical or different. The operator thus has an effective management tool, providing many features.

Other advantageous characteristics, which can be taken in combination or independently of one another, are listed below: the system comprises at least two separate medical electrical appliances, and the tactile, separate and separable electronic device of said medical electrical equipment comprises: communication means, for exchanging information with each of said electromedical devices provided with communication means, and - software means, for management by an operator of each of said electromedical devices through said interface; - The software means comprise means for collecting data from the or electromedical devices (and possibly a remote computer server) and for the processing of said collected data; the communication means comprise wireless communication means, and possibly wired communication means; the software means equipping the electronic tactile device comprise means for controlling electromedical devices and / or for collecting data from said electromedical devices; the electromedical system comprises a remote computer server capable of exchanging information by means of communication means; the electromedical devices are chosen from devices for eluting and / or preparing and / or injecting and / or dosing a radiopharmaceutical product intended to be injected into a patient. According to this latter characteristic, the system preferably consists of a system for determining the radioisotope activity injected into a patient via an injection solution containing a radiopharmaceutical for the nuclear medicine.

In this case, this electromedical system advantageously comprises: an electromedical "measuring" apparatus comprising: (a) means for filling a packaging with said injection solution, and (b) means for measuring the initial radioisotopic activity of said injection solution packaged in said receiving pack, and - an electromedical apparatus comprising: (a) means for receiving the receiving pack containing said injection solution, (b) means for receiving connection between said attached package and an injection catheter for connection to the patient, (c) means for routing said injection solution into said connection means from said receiving package to said injection catheter .

In addition, the software means of the tactile electronic device then comprise: means for collecting and time stamping said initial radioisotopic activity value from said electromedical measuring apparatus, means for calculating an intermediate time, corresponding to the time interval between the measurement of the initial radioisotopic activity and the actuation of said means for the flow of said injection solution to the injection catheter, and - means for calculating the radioisotopic injected activity, taking into account said intermediate time and the half-life (half-life) of the radioisotope.

In this embodiment, the electromedical system advantageously comprises: means for traceability of the injection solution, integrating, for example, data on the name of the operator, the serial number of the consumables, the names of the patients injected and the names of the drugs used, and / or - means for monitoring the quality controls performed on the various medical electrical equipment, and / or - means for the printing of labels containing information relating to traceability and / or Quality Control. The present invention also advantageously relates to an electronic tactile device for an electromedical system specified above, this tactile electronic device comprising: an interface in the form of a touch screen; communication means for exchanging information with least one electromedical device, possibly at least two separate medical electrical equipment, provided with communication means, and - software means, for management by an operator of said electromedical apparatus through said interface, which advantageously comprise means for data collection from the electromedical device (s) and for processing said collected data. It will be noted that, in the context of the management of apparatus (s) implementing one or more radiopharmaceutical products, the use of a tactile electronic device with wireless communication means enables the operator to remotely manage radiation-emitting products, and thus limits its exposure to radiation. DETAILED DESCRIPTION OF THE INVENTION The present invention is further illustrated, without being limited in any way, by the following description in relation to the accompanying drawings, in which: FIG. 1 schematically illustrates an electromedical system in accordance with the invention; and FIG. 2 represents, in a general and schematic manner, an electromedical system according to the invention, for nuclear medicine, comprising a tactile electronic device associated, on the one hand, with an electromedical apparatus for measuring the radioisotopic activity. an injection solution and, on the other hand, an electromedical appliance for administering this injection solution to a patient.

The electromedical system 1, as illustrated very schematically in FIG. 1, comprises - separate electromedical devices 2, and - means for the management of these electromedical medical devices 2, comprising a tactile electronic device 4. Such an electromedical system 1 is advantageously intended to be used for a therapeutic purpose and / or for the purpose of diagnosis. The electromedical devices 2 of this electromedical system 1, here two in number, may be identical or different devices from each other. Each medical electrical appliance 2, operating from a source of electrical energy, consists of a unit, an instrument, a device or an equipment, which is used alone or in combination with others, for a medical application (therapeutic and / or diagnosis). For example, these electromedical devices 2 may consist of devices used in nuclear medicine, as detailed below in connection with Figure 2. These electromedical devices 2 may also consist of a dialysis system, an artificial heart, a pump insulin, etc. For their integration in this electromedical system 1, each electromedical appliance 2 comprises here: control means 2, illustrated very schematically in FIG. 1, comprising for example a microcontroller integrating a suitable operating program and / or an associated industrial computer, and - communication means 2, for its connection with the tactile electronic device 4.

The control means 2a control an operative part (not shown) of the electromedical apparatus 2 which, in particular, performs the physical actions (movement of moving parts, etc.) and measures the physical quantities (radioactivity, physiological parameter, etc.). . The communication means 2b advantageously comprise two different means: - wired communication means (for example through a computer bus for the connection of computer peripherals, such as a connector including the USB connector type) and wireless communication means, for example in the form of a transmitter / receiver antenna which is adapted in particular for a connection of the Wifi and / or Bluetooth type, or even in the form of a telecommunication means encountered in the mobile telephony (using, for example, the UMTS standard or the LTE Advanced standard) or in a means of communication by radiofrequency controller.

The electronic tactile device 4, distinct and separable electromedical devices 2, is advantageously in the form of a device commonly referred to as "touch pad", "electronic tablet", "electronic slate" or even "digital tablet". This tactile electronic device 4 could also have any other appropriate form, especially that of a mobile phone called "smartphone". Such a tactile device 4 thus consists of a mobile and portable computer, in the form of a thin tablet, devoid of keyboard and mouse, but advantageously equipped with an internal source of electrical energy (in particular in the form of a battery) . This tactile electronic device 4 is thus separable (or transportable independently) with respect to medical electrical equipment 2, so as to authorize the management thereof at a distance. For use by an operator, this electronic tactile device 4 comprises a human-machine interface 4a consisting of a touch screen. The touch screen 4a is a computing device that combines the display features of a screen (monitor), but also those of a pointing device, such as the mouse or the touchpad. Such a touch screen 4a may be based on any appropriate technology, for example a capacitive technology or an analog resistive technology. This tactile electronic device 4 further comprises communication means 4, for the exchange of information with the associated medical electrical equipment 2 (or even with a remote computer server of a computer network).

These communication means 4b are chosen to be adapted to those equipping the electromedical medical devices 2. In this respect, the communication means 4b integrating the electronic tactile device 4 again include, advantageously, wireless communication means, for example under the form of a transmitter / receiver antenna which is suitable in particular for a connection type Wifi and / or Bluetooth, or even in the form of a telecommunication means encountered in mobile telephony (using for example the UMTS standard or the LTE Advanced standard ) or radiofrequency controller communication means. These communication means 4b also preferably comprise wired communication means (for example, via a computer bus, such as a connector, particularly of the USB connector type).

These communication means 4b are also intended to allow the exchange of information with a remote computer server, integrated within a computer network equipping an infrastructure, a building or a site (for example the hospital infrastructure in which find the medical electrical equipment (s) 2).

This connection can be made wirelessly from inside or outside this infrastructure, building or site. This tactile electronic device 4 further integrates software means 4c (illustrated very schematically in FIG. 1) which are programmed to enable an operator to manage each of said medical electrical equipment 2 through its interface 4a. The software means 4c advantageously consist of an application software (also called "computer application"). These software means 4c may in particular be in the form of a "Web application", that is to say an application software manipulable through an Internet browser. Such an application is advantageously placed on a computer server and is manipulated by operating icons of an Internet browser installed on the touch-sensitive electronic device 4, via a computer network (Internet, etc.). This is for example the case when the user is out of range of communication with the electromedical apparatus.

In this case, when the electronic tactile device is connected to a network having an Internet access, the user can, indirectly, control the device which itself is connected to an Internet access. It is also possible to control the device by being connected to the computer network of the site or the hospital infrastructure (within this site), or even from outside. These software means 4c are advantageously provided for generating interactive display elements on the touch screen, for controlling the associated electromedical devices 2.

These interactive display elements consist for example of pushbuttons, icons, text areas or GUI components (commonly referred to as "Widget"). For the management of the electromedical system 1, the software means 4c comprise means, for example in the form of computer modules, for controlling the electromedical equipment 2 and / or for collecting data from said electromedical devices 2, through the means of communication 2b and 4b associated. The information exchanged between, on the one hand, the software means 4c of the tactile electronic device 4 and, on the other hand, the control means 2a equipping the medical electrical equipment 2, can thus consist of: - piloting commands issued by the software means 4c of the tactile electronic device 4, intended for medical electrical equipment 2, and / or - data and values collected by sensors equipping the medical electrical equipment 2, for the software means 4c of the tactile electronic device 4. The software means 4c may also comprise data processing means, in particular data collected from medical electrical equipment 2, for example (i) to provide automatic control of medical electrical equipment 2, taking into account the values collected by them and / or (ii) ) to generate data from the processing of values collected by medical electrical equipment 2. L electronic tactile device 4 also incorporates components ensuring its operation, preferably a motherboard, a processor possibly supported by a graphics processor, a random access memory, a data storage unit and a rechargeable battery. This tactile electronic device 4 can still integrate one or more speakers, a microphone, an accelerometer and / or gyroscope, a physical connection (USB port, SD memory card port in particular), a geolocation means, a camera, etc. The operator can thus manage, in a simple and ergonomic manner, each of the medical electrical equipment 2 from the tactile electronic device 4 in his possession.

By an appropriate configuration of the software means 4, the tactile electronic device 4 may for example offer one and / or the following of the following interactions remotely: a collection of data from a first electromedical device 2 (or even a remote computer server), then the processing of these collected data, then the control of a second electromedical device 2 taking into account the data processed, - a collection of data from the different medical electrical equipment 2 (or even a remote computer server) , then the processing of these data for the transmission of processed data to said medical electrical equipment 2 and / or to said remote computer server, - a collection of data from one or more medical electrical equipment 2 (or even a remote computer server), and then the treatment of these data in order to trigger for example an alarm if a fault is detected and possibly to put e The operations to remedy this defect are automatically performed. Such an approach is particularly interesting in that the operator can manage the various electromedical devices concerned through the same tactile electronic device, and this in a global manner. The management means of the electromedical system are thus particularly ergonomic for the operator. They are also evolving according to the needs of the latter. In the case of an addition or replacement of an electromedical device in the system, a posteriori, the tactile electronic device has the advantage of being able to be the subject of a simple update for its connection with this new device.

In general, this tactile electronic device 4 has the advantage of implementing software means 4c providing additional possibilities and functionalities, by processing data from the associated electromedical device (s) 2 (or even from a remote computer server ), which go far beyond the control encountered with a simple remote control. Such a tactile electronic device 4 enables the operator to supervise the associated electromedical appliance (s) 2, by a control of the operations and without any obligation to intervene physically in the good functioning of these apparatuses 2. The electromedical system according to the invention is particularly interesting for an application in the field of nuclear medicine, that is to say an approach in which radioisotopes or radiopharmaceuticals are used for the diagnosis or treatment of certain diseases or malfunctions of organs. Such a radioisotope, or radiopharmaceutical, is a drug containing radionuclides used for diagnostic purposes and / or for therapy purposes. For example, the radioisotope may be chosen from galium 68, iodine 124, zirconium 89, copper 64, rubidium 82, iodine 131, lithium 90 and lutetium 177, fluorine 18, tungsten 188, technetium 99m, thallium 201, yttrium 90, holmium 166, astate 211 and indium 111. The electromedical apparatus of such a system advantageously consist of apparatus for elution and / or preparation and or the injection and / or the dosage of the radiopharmaceutical product intended to be injected into the patient. A particular embodiment of this system is described below in relation to FIG. 2. For the sake of simplification, the reference marks used previously in relation to FIG. 1 will be retained for the description of FIG. 2. In particular, this system Electromedical 1 is structured to determine the radioisotope activity injected into a patient via an injection solution containing a radioisotope for nuclear medicine.

For this purpose, this electromedical system 1 comprises two electromedical devices 2 associated with the tactile electronic device 4. The two electromedical devices 2 are different from each other, and consist respectively of: a first electromedical apparatus 21 comprising means for filling a packaging with an injection solution and for measuring the radioisotopic activity of this conditioned injection solution, and - a second electromedical apparatus 22, comprising means for receiving this packaging and for injection of the injection solution to a patient. The first electromedical device 21 is for example marketed under the name EASYDOSE by LEMER FAX (Carquefou - France). Only the sampling and measuring systems of this apparatus are here represented for the sake of simplification. Such an electromedical apparatus 21 essentially comprises: a well 21a comprising an activity measurement chamber (not visible) for introducing and withdrawing a syringe S intended to receive the injection solution; pipe 21b connecting a container P source radioactive material and a connection means 21c to the syringe S; - means 21d (for example a peristaltic pump) capable of filling the syringe S with said source radioactive product, - a device receiving 21e, consisting of a tubular casing arranged to receive the syringe S associated with a syringe protector. This apparatus 21 is further provided with means, on the one hand, to automatically extract said syringe S from said syringe protector, within said activity measurement chamber, and to allow direct measurement of the radioactivity contained in the syringe S and on the other hand, to then automatically reintroduce said syringe S into its syringe protector, before it is withdrawn outside said measuring chamber. As discussed above in connection with FIG. 1, this electronic device 21 is further equipped with: management means 2, in particular for controlling the filling means 21d, for collecting radioactivity measurements from the measurement chamber and for transmitting these measurements to the tactile electronic device 4, and - wireless communication means 2, and possibly wired communication means (not shown), for its connection with the tactile electronic device 4. In practice, this electromedical device 21 will thus allow the preparation of a dose of injection solution, with a value of radioisotopic activity called "initial", while providing effective protection of operators against the radiation emitted by the injection solution through to a possibility of remote control. The second electromedical apparatus 22, illustrated for information in FIG. 2, is for example marketed under the name JETTI by LEMER FAX (Carquefou - France). This apparatus comprises a frame 22a equipped with: - means 22b for receiving the syringe S containing the injection solution, here in its syringe protector device, - means 22c for the connection between the syringe S and a catheter injection C intended to be connected to the patient, and - means 22d for the path of the injection solution in the connecting means 22c, from the syringe S to the injection catheter C, in this case a peristaltic pump implanted on the connection means 22. Here again, this electronic device 22 is equipped with: management means 2, in particular for controlling the operating means 22d, and communication means 2b with the tactile electronic device. In practice, this second electromedical apparatus 22 will allow a controlled injection of the injection solution to a patient, while offering a protection of the operators against radiation by the control of the patient. 22. For the management of these devices 2, the electronic tactile device 4 is similar to that described above in connection with FIG. 1, with its touch screen 4, its wireless communication means 4b and its means. software 4.

The software means 4c in question here comprise: means for collecting and time stamping the value of initial radioisotopic activity from the first electromedical apparatus 21, means for calculating an intermediate time, corresponding to the time interval separating measuring the initial radioisotopic activity and actuating the means 22d for the flow of the injection solution, and - means for calculating the injected radioisotope activity, taking into account the infill time and the half-life (or half -vie) of said radioisotope. The means for calculating the injected radioisotope activity consist of a mathematical method for calculating radioactive decay. Thus, in practice, the software means 4c will operate in the following manner: - collection of the initial radioisotopic activity value from the first electromedical apparatus 21, associated with a measurement schedule (time stamp expressed for example in hour: minute: second ), - collecting the schedule of administration of the injection solution by the dedicated electromedical apparatus 22 (time stamp expressed for example in hour: minute: second), - calculation of the injected radioisotope activity, taking into account the a part of the infill time (corresponding to the differential between the measurement schedule and the administration schedule) and secondly the radioactive half-life (or half-life) of said radioisotope.

Alternatively, the interleaving time can be obtained by the implementation of chronometric means equipping the software means 4c. For example, the injection solution contains a fluorine 18 whose radioactive half-life is 1.83 hours. In the case of an initial radioisotope activity of 500 MBq and with a gap time of 1 hour, the tactile electronic device will thus calculate the injected radioisotope activity which would be 342.35 MBq to communicate it to the operator. In general, the electromedical system 1 advantageously still comprises means for traceability of the injection solution, taking into account in particular the following information: - the name of the operator, - the serial number of the consumables, - the names of the injected patients and - the names of the drugs used.

These means of traceability will advantageously be in the form of a database, installed on the remote computer server capable of communicating with the electronic tactile device 4 via wireless communication means and possibly communication means. wired.

Moreover, this electromedical system 1 advantageously comprises means for monitoring the quality controls performed on the various medical electrical equipment. The electromedical system 1 finally comprises, preferably, means for printing labels containing information relating to traceability and / or quality control above. In general, the electromedical system according to the invention thus allows ergonomic, global and scalable management of the various electromedical devices through the tactile electronic device. This tactile electronic device 4 can thus be associated with a single electromedical appliance 2, with several medical electrical appliances 2 and / or with a remote computer server; the software means 4c then advantageously ensure the processing of data from the associated device (s) (and possibly a computer server), to provide additional functionalities to the system according to the invention.

Claims (10)

1. electromedical system comprising: - at least one electromedical device (2), and - means (3) for the management of said electromedical apparatus (2), characterized in that said management means (3) comprise a device tactile electronic device (4), separate and separable from said electromedical apparatus (2), which comprises: - an interface (4a) in the form of a touch screen, - communication means (4b), for the exchange of information with said electromedical apparatus (2) provided with communication means (2b), and - software means (4c) for the management by an operator of said electromedical apparatus (2) through said interface (4a). 2. Electromedical system according to claim 1, characterized in that it comprises at least two separate electromedical devices (2), and in that the tactile electronic device (4), distinct and separable from said medical electrical equipment (2) comprises communication means (4b) for exchanging information with each of said electromedical devices (2) equipped with communication means (2b), and software means (4c) for management by an operator of each of said electromedical devices (2) through said interface (4a). 3. Electromedical system according to any one of claims 1 or 2, characterized in that the software means (4c) comprise means for the collection of data from the electromedical device (s) (2), or even a computer server remote, and for processing said collected data. 4. Electromedical system according to any one of claims 1 to 3, characterized in that the communication means (2b, 4b) comprise wireless communication means, and possibly wired communication means. 5. Electromedical system according to any one of claims 1 to 4, characterized in that the electromedical devices (2) are selected from the apparatus for elution and / or preparation and / or injection and / or dosage a radiopharmaceutical product intended to be injected into a patient. 6. Electromedical system according to claim 5, characterized in that it consists of a system (1) for determining the radioisotope activity injected into a patient via an injection solution containing a radiopharmaceutical for the nuclear medicine, which system comprises: - a first electromedical apparatus (2, 21) comprising: (a) means (21d) for filling a package (S) with said injection solution, and (b) means (21a) for measuring the initial radioisotopic activity of said injection solution packaged in said conditioning (S), and - a second electromedical appliance (2, 22) comprising: (a) means (22b) for receiving packaging (S) containing said injection solution, (b) means (22c) for connection between said attached package (S) and an injection catheter (C) for connection to the patient, (c) means (22d) for the t of said injection solution in said connecting means (22c), from said conditioning (S) to said injection catheter (C), and in that the software means (4c) of the tactile electronic device (4) comprise: - means for collecting and time stamping said initial radioisotopic activity value from said first electromedical apparatus (2, 21), - means for calculating an intermediate time, corresponding to the time interval separating the measurement of the initial radioisotopic activity and the actuation of said means (22d) for the flow of said injection solution to the injection catheter (C), and - means for calculating the injected radioisotope activity, taking into account said time intermediate and the half-life (half-life) of the radioisotope. 7. Electromedical system according to any one of claims 5 or 6, characterized in that it comprises means for the traceability of the injection solution, including the name of the operator, the serial number consumables, the name of the patients injected and the names of the drugs used. 8. Electromedical system according to any one of claims 5 to 7, characterized in that it comprises means for monitoring the quality checks carried out on the various electromedical devices (2). 9. Electromedical system according to any one of claims 5 to 8, characterized in that it comprises means for printing labels containing information relating to traceability and / or quality control. 10.- electronic touch device for an electromedical system according to any one of claims 1 to 9, characterized in that it comprises: - an interface (4a) in the form of a touch screen, - communication means (4b). ) for the exchange of information with at least one electromedical apparatus (2), possibly at least two separate medical electrical equipment (2), provided with communication means (2b), and - software means (4c), for the management by an operator of said electromedical apparatus (2) through said interface (4a), which optionally comprises means for collecting data from the electromedical device (s) (2) and for processing said collected data.