• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    A synthesizer (1) of a radio-plotter includes a universal confined enclosure (10) configured to insert and remove a synthesis cassette (30) specific to the radiotracer. The synthesis cassette (30) includes a synthesis module configured to receive reagents and a radioisotope to synthesize the radiotracer. An internal circuit board (17) has at least one input, configured to be connected on the one hand to an arrival of the radioisotope and on the other hand to the input of the cassette, and an output, configured to be connected on the one hand to a syringe to fill with the radio-tracer and on the other hand to the output of the cassette. Such a synthesis device may be implanted in an installation comprising in a confined room, in addition to such devices normally arranged in a storage area, a synthesis station, a radioisotope arrival, at least one communication window with a remote control. outside, and a handling robot.
    公开号:FR3035262A1
    申请号:FR1553402
    申请日:2015-04-16
    公开日:2016-10-21
    发明作者:Laurent Tanguy；Jerome Corneille；Bernard Loubanton；Marc Delmas；Delaume Alain Perez
    申请人:P M B；
    IPC主号:
    专利说明:

    [0001] The present application relates to a device for synthesizing a radiotracer, an installation comprising such a device as well as a method for obtaining a radiotracer by means of such a device. Clinical molecular imaging, and more specifically Positron Emission Tomography (PET), is gaining prominence in medicine.
    [0002] In particular, it helps to define in a personalized way the most appropriate treatments for each patient and to evaluate their therapeutic efficacy. However, the potential of this technology, particularly with the numerous tracers labeled with fluorine-18 (18F) and carbon-11 (11C), is not currently fully exploited in clinical and research because of technical constraints, logistics , organizational and economic, related to the very short half-life of these radioisotopes which are for example about 110 minutes for 18F and 20 minutes for 11C. Other difficulties are also related to the regulatory complexity of their implementation. Their access is therefore very limited. One of the objectives of the present application is to propose an integrated system for the production of "on demand" radio-tracers for molecular imaging (PET), making it possible to widen the clinical potential of molecular imaging by facilitating its access to preclinical and clinical research centers, and hospitals. The subject of the present application is intended for an installation in situ without major constraint of irradiation within the research centers and hospitals concerned. The use of very short half-life radioisotopes, such as carbon-11 ("C"), allows access to a very wide range of bio-markers hitherto reserved for a few world centers.
    [0003] The object of the present application is thus to improve at least in part the aforementioned drawbacks. For this purpose, is proposed in a first aspect, a device for synthesizing a radio-tracer from a radioisotope characterized in that it comprises: - A universal confined enclosure in which is formed a trap door access configured to insert a specific synthesis cassette of the radio-tracer and remove it, the radio-tracer synthesis cassette, which comprises reagents 10 and a synthesis module, the synthesis module comprising a reaction chamber and being configured to receive the reagents and the radioisotope to synthesize the radiotracer, the synthesis module being fluidly connected to an input of the cassette configured to route the radioisotope into the reaction chamber and to an output of the cassette configured to deliver the radio-plotter out of the cassette, - an internal circuit board of connection, comprising at least one input, configured to be connected on the one hand to an arrival radioisotope and secondly at the inlet of the cassette, and an outlet, configured to be connected on the one hand to a syringe to be filled with the radiotracer and on the other hand to the output of the cassette. The radioisotopes considered here are preferably liquid or gaseous. Thus, such a device makes it possible to synthesize various radio-tracers 25 by means of a universal architecture enclosure in which a cassette specific to the radio-tracer to be synthesized is arranged. This speaker, taken without the cassette, is a simple box intended to contain a cassette when a synthesis is to achieve. It is interesting to note that the speaker does not have to be shielded.
    [0004] According to an exemplary embodiment, the device comprises a gas suction pipe, configured for pumping a gas contained in the chamber, preferably in the upper part of the device. For example, the gas suction pipe is fluidly connected to the connection plate of the device. According to another embodiment, the device comprises a clean gas injection pipe, configured to bring clean gas into the enclosure at the bottom of the device. For example, the clean gas injection pipe is fluidly connected to the connection plate of the device. The injection of clean gas can simply result from the aforementioned gas suction. According to an advantageous arrangement, the cassette comprises a module 10 for pretreatment of the radioisotope. According to another advantageous arrangement, the device comprises a purification module of the radio-tracer. For example, the purification module of the radio-tracer comprises an HPLC column (acronym for High Performance Liquid Chromatography).
    [0005] According to an exemplary embodiment, the device comprises an external system for managing the quality of air (or gas) in the chamber possibly using the aforementioned pipes. The air quality management system in the enclosure may include a pump configured to create a vacuum in the enclosure 20 and a pressure sensor configured to control the depression. The air quality management system in the enclosure optionally includes a flow controller upstream of the enclosure and a flow controller downstream of the enclosure configured to control both a flow of gas that flows through the enclosure. speaker and a pressure in the enclosure.
    [0006] The air management system in the chamber may also include a filter, for example of type H14, upstream of the chamber and potentially downstream to prevent the propagation of the population, configured to ensure air purity. class A. The air management system in the enclosure optionally comprises an independent control loop configured to perform particulate and possibly radiological control of the air in the enclosure. The control loop may include a particulate counter configured to pumping the loop. Is also proposed, in another aspect, a synthesis facility of at least one radio-tracer comprising a confined room 5 comprising: A synthesis station, fixed in the room, comprising an external circuit board connector having at least one configured input to carry a radioisotope and an output configured to connect a syringe to be filled with the radiotracer, 10 A radioisotope arrival from a source, for example a target, located outside the room and connected to the radioisotope. input of the external circuit board of connection, A storage area of at least two device enclosures as described above, empty and identical, At least one window (preferably an airlock) for communication between an inside and an outside of the room configured for a practitioner to provide at least one synthesis cassette of the radio-plotter, and - A handling robot configured to at least take one of the 20 speakers and the bring on the synthesis post. From the source, the radioisotope circulates in a supply pipe, in practice a small diameter or "capillary" pipe, which is fixedly connected to the connector plate of the synthesis station which is fixed in the room. The circuit board of the synthesis station is for example fixed in the room and unique. The source of the radioisotope may be, as indicated above, a targeting associated with a cyclotron, but may also, in particular be a generator (for example for 68Ga), or a radioisotope input generated elsewhere.
    [0007] There are advantageously different windows (or airlocks) for the introduction of the cassettes and any syringes to be filled, and for the extraction of the radio-tracers, preferably already contained by syringes. In a particular case of use of carbon, an intermediate module between the target and the circuit board of the synthesis station 5 may exist. An enclosure is fixed on the connection plate of the synthesis station and, depending on the cassette introduced into the selected chamber, a specific connection is established between the connection plate of the synthesis station, and consequently with the feed pipe, 10 and the cassette introduced into the enclosure. All the speakers are for example identical constitutions although in practice it is preferable, as a precaution, that each speaker is dedicated to a particular radio-tracer. It is possible, however, to use the same radioisotope to synthesize different radio-tracers. In such a case, one can alternatively choose that all the speakers dedicated to the formation of a radio-tracer from the same radioisotope are identical. According to an exemplary embodiment, the synthesis facility comprises an external quality control module of the synthesized radiotracer.
    [0008] The quality control module is for example fluidly connected to the output of the connector plate of the synthesis station. For regulatory reasons, such a quality control module is in practice located outside the room; to arrange it as close as possible to an enclosure in which a synthesis has just been made, this station is advantageously arranged outside the room opposite the synthesis station. According to an interesting example, the installation includes an ambient air management system of the room, for example to maintain it in Class C.
    [0009] According to yet another aspect, a method for obtaining a radiotracer comprising the following steps is also proposed: A step of positioning an enclosure of a device as described above on a synthesis station an installation as described previously by a handling robot; A step of connecting an internal circuit board of the device with an external connector plate of the synthesis station; - A step of inserting a specific synthesis cassette of the radio-tracer, previously provided by a practitioner via a window of the installation, in the enclosure by the robot; A step of providing a radioisotope routed from a source positioned outside a room of the installation to a synthesis module of the cassette; A step of synthesizing a radio-tracer in the synthesis module of the cassette from the radioisotope and reagents contained in the cassette; and a step of extracting the radio-tracer out of the device. The method also optionally comprises a step of sterilizing filtration and dilution / formulation of the radio-tracer in a product for injection into man, for example physiological saline.
    [0010] According to a preferred mode of implementation, the method further comprises: a step of connecting a syringe at the output of the external circuit board of the synthesis station, and - a step of syringing the radio-tracer from of the device.
    [0011] The method also advantageously comprises a step of quality control of the radio-tracer at the output of the external circuit board of the synthesis station by a quality control module located outside the room.
    [0012] The invention, according to an exemplary embodiment, will be well understood and its advantages will appear better on reading the detailed description which follows, given for information only and in no way limitative, with reference to the appended drawings in which: FIG. shows an elevational view of a device for synthesizing a radio-plotter according to an exemplary embodiment of the present invention. FIG. 2 shows a bottom of an enclosure of the device of FIG. 1 serving as a support for various elements. of the device and having an internal circuit board connector, Figure 3 shows the device of Figure 1 open to insert a synthesis cassette of a radiotracer and remove it and an external plate 10 connection of a post FIG. 4 is a sectional perspective view of an access hatch in the enclosure of the device comprising an opening in the chamber. FIG. 5 shows an exemplary embodiment of the elements arranged in the device and positioned on the support shown in FIG. 2; FIG. 6 illustrates an approach of the cassette for connection with an internal circuit board of connectors. FIG. 7 shows a first sectional view of a connection 20 between the cassette and the internal connection plate of the device. FIG. 8 shows a second sectional view along a plane orthogonal to that of FIG. 7. illustrating the connections between the cassette and the connector plate of the device, FIG. 9 schematically illustrates an example of an arrangement of a synthesis installation in which different radio-tracers can be synthesized using a device according to the invention. FIG. 10 shows an internal perspective view of a device according to another exemplary embodiment, and FIG. 11 shows an exemplary embodiment. of a cassette.
    [0013] The identical elements shown in the above figures are identified by identical reference numerals.
    [0014] With reference to FIG. 1, a device for synthesizing a radiotracer 1 according to an exemplary embodiment of the present invention comprises an enclosure 10, or box, in which are arranged different elements allowing the synthesis of the radio-tracer. .
    [0015] The enclosure 10 here has a generally parallelepipedal shape and defines a hermetic and confined space, and is for example (but not necessarily) shielded. The enclosure 10 measures for example at most 50 cm in each of the three dimensions, that is to say in height, in width or in length. It could also be cubic or cylindrical but a parallelepiped shape facilitates the storage of a plurality of such speakers in a storage or waiting area. The enclosure 10 is here formed of a support 11, for example forming a bottom of the enclosure, and a cover 12. The support 11 serves for example here to position at least the various elements allowing the synthesis of the radio -tracer. The cover 12, here comprising a side wall and an upper face substantially opposite to the support 11, is secured to the support 11, for example by being screwed. Optionally, a seal (for example toric), positioned on a periphery of the support 11 so as to be compressed when the cover 20 is screwed onto the support, makes it possible to reinforce this seal. The enclosure 10 further comprises here an access hatch 13, formed by an opening 14 and a plug 15 for closing or clearing the opening 14 (visible in particular Figure 3). The hatch 13 is configured to insert a synthesis cassette of a radio-tracer 30 (visible in FIG. 5) into the enclosure 10 and remove it therefrom. In the present embodiment, the access door 13 is formed in the upper face of the cover 12 of the enclosure 10. However, it could of course be formed in the side wall. The enclosure 10 also includes a handling interface 16 for a robot (illustrated in FIG. 9) configured to move the device 1 in a synthesis room 110 (shown schematically in FIG. 9).
    [0016] The handling interface 16 is for example here formed in the side wall of the cover 12. This is for example a handle, a relief imprint or any type of socket to which can anchor a robot arm to catch, hold and move the device.
    [0017] The materials used to form the enclosure 10 are, for example, stainless steel (type 316 or 316L), in particular for the support 11 for example, and / or plastic, for example for the cover 12. The FIG. 2 shows the support 11, which is bare, that is to say here devoid of any element, and in particular of the various elements allowing the synthesis of the radio-tracer. The support 11 is for example here formed of a flat plate of substantially rectangular shape. At the periphery, there are holes allowing screwing of the cover 12. The enclosure, and in particular here the support 11, mainly comprises an internal circuit board 17. This is of substantially parallelepipedal shape. It has many connectors 18 detailed below. The connection plate 17 of the support is in particular configured to be connected to an external connection board 20 (visible in FIG. 3) which is fixed to a synthesis station 114 of a room 110 of a synthesis installation 100 (by example shown schematically in Figure 9). These connectors 18 form inputs and outputs of the enclosure of the device. They are here aligned in different rows, here mainly three rows. For example, a connector allows routing of a radioisotope into the cassette; another connector allows extraction of the radio-tracer, synthesized in the cassette, out of the device. For this purpose, these connectors are configured to be connected, on the one hand to the cassette, and on the other hand to the external circuit board 20 mentioned above. A connection between the cassette and the enclosure is for example provided by TEGO D1000 type connectors.
    [0018] FIG. 3 illustrates an opening of the access hatch 13, formed of the opening 14 and the plug 15, as well as an approach (following the arrows) of the enclosure 10 of the device in order to be positioned and connected to the external circuit board 20 of the synthesis station. The external circuit board 20 has for example a shape similar to that of the internal circuit board 17, or here a substantially parallelepipedal shape. Of course, the external plate 20 and the internal plate of connector 17 could have any other shape, for example a cylindrical or square shape or any. The external circuit board 20 comprises several endpieces 21. The end pieces 21 are here aligned in different rows, here three rows, like the connectors 18 10 of the internal circuit board 17 of the enclosure 10. They exceed here d an upper surface of the outer plate 20. In addition to the end pieces 21, the external circuit board 20 comprises two holes 22 passing through a thickness of the plate 20 configured to form a connecting passage of a fluid circuit of the enclosure, by example for the control of ambient air in the enclosure. FIG. 4 details the access hatch 13 according to the embodiment of FIG. 3. The access hatch 13 is for example opened or closed by a handling robot 60 (represented in FIG. 9), or by an internal actuator to the enclosure 10 or else by an external actuator pooled for different speakers. The access door is for example positioned above the internal circuit board 17, or in general vis-à-vis thereof, so as to facilitate positioning of the cassette in the enclosure, by The opening 14, which is here purely illustrative circular shape, comprises a neck 14a which here comprises a thread, here on an outer periphery of the neck. In addition, the opening 14 is here provided with a collar 14b configured 30 to serve as a stop for a platform 15a of the cap 15. The stopper 15 comprises, in addition to the platform 15a, a cage 15b.
    [0019] The platform 15a and the cage 15b are pivotally mounted to each other via an upper wall of the cage. The cage 15b has a side wall, here circular cylindrical, which here comprises a thread, here on an inner periphery of the side wall 5 to cooperate with the thread of the neck 14a. The plug 15 is thus configured so that, when the cage is screwed onto the neck, the platform which comes into contact with the collar remains fixed relative to the collar while it rotates relative to the cage. In the present embodiment, the plug 15, and in particular here the platform 15a, comprises a seal 15c, for example arranged in a contour of the platform 15. Thus, when the platform is in contact with the flange 14b, the 15c seal is taken between the platform and the collar. As the plug is screwed in, the seal is compressed, which contributes to ensuring a tightness of the enclosure at the level of the access hatch 13. According to an embodiment option, not shown, the plug 15 is provided with of return elements, for example a helical spring or several, attached under the cap, for example here to a face of the platform facing the inside of the enclosure when the cap 15 closes the opening 14. Thus, 20 when a cassette is positioned in the enclosure and the enclosure is closed, the return element is supported on the cassette to improve retention in position of the cassette in the enclosure, in particular on the connector plate 17 Other embodiments of the hatch 13 are of course conceivable, such as for example a sliding window or a pivoting hatch or the like. According to yet another option, the enclosure comprises a jack configured to ensure a junction between a cassette and the internal plate of connector 17. If not, the handling robot 60 (shown in FIG. 9) itself ensures the positioning and the connection of a cassette to the internal circuit board 17.
    [0020] Figure 5 now illustrates the various elements arranged in the enclosure for the synthesis of a radio-tracer. The device 1 mainly comprises two circuits: a chemical synthesis fluid circuit and a ventilation circuit.
    [0021] In the example shown, the ventilation circuit comprises a gas suction pipe 51, configured to pump gas contained in the upper part of the chamber of the device 1, and a clean gas injection pipe 52 configured to bring clean gas into the lower part of the chamber of the device 1.
    [0022] The suction pipes 51 and injection pipes 52 are for example U-shaped plugged at their two ends and functioning for example as shower pipes. The injection pipe 52 comprises for example blowholes oriented towards the bottom of the device for suspending any particle deposits. The clean gas injected is, for example, nitrogen (N) or argon (Ar), but any other inert gas could be suitable. The suction pipe 51 and the injection pipe 52 are connected to the internal circuit board 17 by flexible hoses. They are thus connected, through the external circuit board 20, to pumps located outside the enclosure, upstream and / or downstream in a direction of gas flow. It may be sufficient for a pump to suck the air contained in the enclosure and, therefore, to suck clean gas. For example, a pump makes it possible to create a controlled depression in the enclosure. This depression is for example verified by a pressure sensor. The use of two possible flow controllers, one upstream and one downstream, makes it possible to control both the air flow through the enclosure and the pressure in the enclosure. The use of a possible filter, for example of type H14, at the inlet 30 ensures sufficient air purity to introduce class A air. Advantageously, an independent additional loop allows the particulate and possibly radiological control. air. The pumping of this loop is for example provided by the particle counter itself. In the example shown, the fluidic circuit mainly comprises in series a valve 41, fluid circulation hoses 42, a purification module of the radio-tracer 43, comprising for example an HPLC column, and a shielded detector 44. valve 41 is here an injection valve for decoupling the low pressure circuits (the cassette for example) and high pressure (the HPLC column for example); it is for example a Rheodyne valve (A) 6.2 type (6 ports 2 positions) with an injection loop (a volume of less than one ml in practice). It is for example a motorized valve electrically (24V (volts) in direct current (DC), 8 son). The valve 41 is connected to the plate 17 via hoses 42. The hoses 42 furthermore optionally include, for example, two non-return valves and / or a 3-way valve (3V). The detector 44 is configured to detect a possible peak of radioactivity resulting from the purification. It also controls for example the actuation of a valve 3V just after to allow the extraction of the peak representing the purified product.
    [0023] The waste is taken out of the enclosure by one of the connectors provided on each of the plates. The device 1 also comprises the synthesis cassette 30, which is a consumable unit, that is to say a single-use unit. The cassette 30, when positioned in the enclosure 10, is connected in series in the fluid circuit, in particular thanks to the connection plate 17. FIG. 6 shows in more detail the positioning of the cassette 30 on the plate connector 17 for its fluidic connection with the connector plate 20. In particular, the external plate 20 and the internal circuit board 17 are configured to allow the connection of a syringe (not shown). An orifice of the internal circuit board 17 dedicated for this purpose is for example surrounded by a seal 19, for example an O-ring, 3035262 14 for reinforcing a seal between the cassette 30 and the internal plate of connector 17. According to d Other views, FIGS. 7 and 8 illustrate a connection between the cassette 30 and the connector plate 17 thanks to a so-called mother connector 5 located in the cassette 30 and a so-called daughter connector located in the connection plate 17. The combination of these connectors is in Figure 7, designated as 18B. For example, the radioisotope is injected via the circuit board 20 and the plate 17 into the cassette 30. The radiator obtained at the output of the cassette passes into flexible tubes 42, then into the column. HPLC for purification then in the detector 44. At the output of the detector 44, it passes through a valve at the end of which a part returns to the cassette 30 for possible final steps (including for example a sterilizing filtration and a possible formulation) then put in a syringe; The other part goes to the trash via the turntables. Thus, such a device makes it possible to synthesize different radio-tracers by means of a universal architecture enclosure in which is disposed a specific radio-tracer cassette to be synthesized, from the radioisotope injected at the input.
    [0024] FIG. 9 shows an exemplary arrangement of a synthesis facility of at least one radiopharmaceutical according to the invention, noted 100 as a whole. The installation 100 comprises a sealed room 110 in which is mainly disposed a set of speakers 10 of devices 1 as previously described at a storage location 113 and a handling robot 60, substantially positioned here in the middle of the room 110 The benefits of using a robot are related to diversification application and sterile devices or quality assurance procedures. In addition, since personnel are less likely to be present, they are less exposed to ionizing radiation; this makes it possible not to have to necessarily shield each enclosure, which allows cost reductions.
    [0025] Indeed, before, a robot was not necessary since there was always a same radio-tracer, and therefore a fixed line was sufficient for the reactions. Because of the plurality of tracers, the devices remain at the same location and the fluids are conveyed therein, or the devices themselves are moved (solution retained in the present embodiment) according to a predetermined path of the fluids. (ie mainly radioisotope and cassette). For this, the robotization here concerns a robot 60 configured to move the speakers 10 of devices and the other elements concerned in the room 110 automatically. The robot 60 is for example a 6-axis robotic arm. The robot 60 is here configured to arrange one of the enclosures 10 at a predetermined location to fluidly connect it to an external source of at least one radioisotope, for example a target in a room, for example adjacent, in which is also arranged a cyclotron, to obtain the radioisotope to use. For this, the robot 60 takes an enclosure from its storage location 113 and positions it on a synthesis station 114.
    [0026] This is the synthesis station 114 which comprises the external circuit board 20 described previously. The synthesis station, like the external circuit board, are fixed in the room. The connector plate 20 is connected by several pipes, or capillaries, to different sources of radioisotopes located outside the room 110.
    [0027] It may be targeteries, but also generators (especially for the 68Ga) or even a feeding zone where radioisotopes generated remotely from the room are brought. It comprises, for example, a radioisotope pipe, and therefore a feed pipe inlet of a given radioisotope. The connection between the selected enclosure 10 and the synthesis station 114, more precisely the external circuit board 20, is provided by either a motor (and a worm for example) or a 3035262 16 other gripping mechanism , for example of the type designed and made by the company Staubli. In addition, the robot 60 is configured to, on the one hand, insert a synthesis cassette into the chamber 10 and, on the other hand, add a syringe thereto. For this, the cassette is provided by a practitioner, present outside the room 110, through an access window 112. To insert the cassette into the chamber, the robot 60 retrieves the cassette from the access window 112 ( it is preferably an airlock), unscrews the cap 15 of the enclosure, inserts and positions the cassette by passing it through the opening 14 and screws the cap 15 on the opening 14. After use, that is, after the synthesis of the radio-tracer from the appropriate radioisotope, the robot unscrews the cap, removes the cassette and throws it into a solid waste recycling bin 111.
    [0028] The robot 60 is also, for example, configured to add a syringe (possibly provided with a shielding), for example also provided by the practitioner by the same access window 112. The access window 112 allows here to the both the entrance to the syringe room and new consumables (cassettes); the receiving areas of these syringes and consumables can be differentiated. Once the radioisotope and the cassette in the chamber positioned on the synthesis station, a radiotracer is generated and placed in the syringe at a syringe station 115 connected to the connection plate 20. The connection between the syringe and the cassette is at least by the connector plate 17, or even by the external circuit board 20 and the internal plate connector 17 As mentioned above, the tightness of the enclosure is advantageously provided by an O-ring 19, for example placed around a TEGO connector D1000. The connection / disconnection movement is for example ensured by a syringe automaton which uses a vertical translational movement, in particular because this makes it possible to avoid more simply a possible presence of air bubble in the syringe.
    [0029] The quality of the radio-tracer contained in the syringe is controlled and, provided that the control is positive, that is to say in accordance with the expectations and specifications, the syringe is returned to the practitioner by the robot 60, outside of the room, via an exit window 116 (preferably an airlock) allowing access to an area in practice distinct from the areas 112a and 112b. The access and exit windows are here adjacent but may, alternatively, be located at two ends of the room when, for example, the robot has a narrow and elongated range of action. In general, part of the radio-tracer from device 1 goes into the syringe and another part goes to quality control. The sampling for the quality control can be ensured, in practice outside the room, in several ways, for example: - By the automaton of syringe by filling a syringe of sampling. This sampling syringe can then either be given to a user who uses it to carry out various quality controls, or is automatically injected into an automaton carrying out all the quality checks. - By use of a transfer line (for example capillary type) between a quality control module and the chamber for a transfer of fluid between them. The quality control module may then optionally include the aforementioned quality control automaton. The quality control module is for example an independent module outside the room 110 which applies to all the radio-plotters. Such an installation thus makes it possible to propose a compact, lightweight, autonomous and reliable solution (without danger, for example in all circumstances, the robot acts in a secure mode (current cut, false manipulations, etc.)) since the practitioner brings his product. (the cassette and in practice the syringe when it is useful) and everything works in an automated way.
    [0030] The room may further comprise a fluid box 120, a module 121 here called CH3I (ie a module producing here iodomethane by conversion of CO2 or CH4), a liquid waste collection station 3035262 18 122 , a maintenance zone 123 preferably near the access and exit windows 112 and 116. In the example shown, a door 124 to access the room is slidably mounted so as to block access to the windows. open configuration.
    [0031] The interior of the room is maintained in class C, with a depression which is, for example, ideally between -35 Pa at -45 Pa, but the depression may be lower (-20MPa); the depression may be different inside the transfer airlock, for example +15 Pa and -25Pa. With such a device and such an installation, a radio-tracer is for example obtained in the following manner: an enclosure 10 of a device 1 is positioned on the synthesis station 114 by the handling robot 60; - The connector plate 17 of the device is connected with the connector plate 20 of the synthesis station 114; A synthesis cassette 30 of the radio-tracer, previously supplied by a practitioner via the window 112, is inserted into the enclosure 10 by the robot 60; A radioisotope routed from a source positioned outside a room 110 of the installation 100 is injected into a synthesis module of the cassette 30; The radio-tracer is synthesized in a synthesis module of the cassette 30 from the radioisotope and reagents contained in the cassette 30; and the radio-tracer is extracted out of the device, or even put into a syringe if the practitioner has provided one, for example by means of the syringe module. If necessary, the radio-tracer is diluted in a product for injection into man, for example physiological saline, for example before being extracted or put into a syringe.
    [0032] The syringe is for example connected at the output of the connection plate 20 of the synthesis station 114.
    [0033] Finally, the quality of the radiotracer at the output of the connector board 20 of the synthesis station 114 is controlled by the quality control module. By way of example, FIGS. 10 and 11 show other embodiments of a device 1 'and a cassette 30'.
    [0034] Elements similar to those previously described bear the same reference surmounted by a "prime" sign and are therefore not described again. Of course, the present invention is not limited to the foregoing description or the appended figures, but extends to any variation within the scope of those skilled in the art. The different features presented can be advantageously combined. Their presence in the description does not exclude, indeed, the possibility of combining them. The terms "comprising" or "comprising" are to be construed herein as "inclusive" in the broad sense and not in a limiting, exclusive or exhaustive manner.
    权利要求:
    Claims (21)
    [0001]
    REVENDICATIONS1. Device for synthesizing (1) a radio-tracer from a radioisotope, characterized in that it comprises: A universal confined enclosure (10) comprising an internal circuit board (17) and in which is formed a access hatch (13) configured to insert and remove a synthesis cassette (30) specific for the radio-tracer, the radio-tracer synthesis cassette (30), which comprises reagents and a synthesis module , the synthesis module comprising a reaction chamber and being configured to receive the reagents and the radioisotope to synthesize the radio-tracer, the synthesis module being fluidly connected to an input of the cassette configured to carry the radioisotope in the reaction chamber and an output of the cassette configured to deliver the radio-plotter out of the cassette (30), the internal circuit board (17), comprising at least one input, configured to be connected to a part at an arrival of the radioisotope and secondly at the entrance of the cassette, and an output, configured to be connected on the one hand to a syringe to be filled with the radio-tracer and on the other hand to the out of the cassette.
    [0002]
    2. Device according to claim 1, characterized in that it comprises a gas suction pipe (51), configured to pump a gas contained in the enclosure (10) in the upper part of the device (1). 3035262 21
    [0003]
    3. Device according to claim 2, characterized in that the gas suction pipe (51) is fluidly connected to the internal circuit board (17) of the device (1).
    [0004]
    4. Device according to any one of claims 1 to 3, characterized in that it comprises a clean gas injection pipe (52), configured to bring clean gas in the enclosure (10) in the lower part of the device (1).
    [0005]
    5. Device according to claim 4, characterized in that the clean gas injection pipe (52) is fluidly connected to the internal circuit board 10 (17) of the device (1).
    [0006]
    6. Device according to any one of claims 1 to 5, characterized in that the cassette (30) comprises a pretreatment module of the radioisotope.
    [0007]
    7. Device according to any one of claims 1 to 6, characterized in that it comprises a purification module (43) of the radio-tracer.
    [0008]
    8. Device according to claim 7, characterized in that the purification module of the radio-tracer (43) comprises an HPLC column.
    [0009]
    9. Device according to any one of claims 1 to 8, characterized in that it comprises an external system for managing the quality of the gas in the chamber.
    [0010]
    10. Device according to claim 9, characterized in that the system for managing the quality of the gas in the chamber comprises a pump configured to create a vacuum in the chamber and a pressure sensor 25 configured to control the depression.
    [0011]
    11. Device according to any one of claims 9 or 10, characterized in that the system for managing the quality of the gas in the chamber comprises a flow controller upstream of the enclosure and a flow controller in downstream of the enclosure configured to control both a flow of gas through the enclosure and a pressure in the enclosure.
    [0012]
    12. Device according to any one of claims 9 to 11, characterized in that the system for managing the quality of the gas in the chamber comprises a filter, for example of type H14, upstream and possibly downstream of the enclosure, configured to provide Class A air purity.
    [0013]
    13. Device according to any one of claims 9 to 12, characterized in that the system for managing the quality of the gas in the enclosure comprises an independent control loop configured to perform a particulate control and possibly radiological control of the air in the enclosure and in that the control loop includes a particulate meter configured to pumping the loop.
    [0014]
    14. Synthesis facility (100) of at least one radiotracer comprising a synthesis device (1) according to any one of claims 1 to 13 and a confined room (110) comprising: a storage area (113) at least two empty and identical synthesis device housings (1), at least one communication window (112, 116) between an interior and an exterior of the room (110) configured to a practitioner supplies at least one synthesis cassette (30) of the synthesizer's radio-plotter (1), 25 - A handling robot (60) configured to at least take one of the speakers (10) and the cassette of synthesis (30), bring them to a synthesis station (114) and associate them to form the synthesis device (1) according to any one of claims 1 to 13, the synthesis station (114), fixed in the room (110) and configured to receive the synthesis device (1), comprising an external connection plate that (20), configured to receive the internal stage (17) of the enclosure (10) of the synthesis device (1), having at least one input configured to carry a radioisotope in the synthesis cassette (30) and an output configured to connect a syringe to be filled with the radiotracer, and a radioisotope input from a source located outside the room and connected to the input of the external circuit board (20) .
    [0015]
    15. Installation according to claim 14, characterized in that the room (110) comprises an external quality control module synthesized radio-tracer. 15
    [0016]
    16. Installation according to claim 15, characterized in that the quality control module is fluidly connected to the output of the external circuit board (20) of the synthesis station (114).
    [0017]
    17. Installation according to any one of claims 14 to 16, characterized in that it comprises an ambient air management system 20 of the room.
    [0018]
    18. A method for obtaining a radiotracer in an installation (100) according to any one of claims 14 to 17 comprising the following steps: a step of positioning a chamber (10) of a synthesis device ( 1) on a synthesis station (114) of the installation (100) by a handling robot (60); A step of connecting an internal circuit board (17) of the enclosure (10) of the synthesis device (1) with an external circuit board (20) of the synthesis station (114); A step of inserting a specific synthesis cassette (30) of the radio-tracer into the enclosure (10) of the synthesis device (1) by the robot (60), the cassette (30) being previously provided by a practitioner via a window of the plant (112), thereby forming the synthesis device (1) of the plant (100), the synthesis device (1) being according to any one of claims 1 to 13 ; A step of providing a radioisotope routed from a source positioned outside a room (110) of the facility (100) to a synthesis module of the cassette (30); A step of synthesizing a radio-tracer in the synthesis module of the cassette (30) from the radioisotope and reagents contained in the cassette (30); and a step of extracting the radiotracer from the synthesis device (1).
    [0019]
    19. The method of claim 18, characterized in that it further comprises a sterilizing filtration step and dilution / formulation of the radio-tracer in a product for injection into man. 20
    [0020]
    20. Method according to any one of claims 18 or 19, characterized in that it further comprises: A step of connecting a syringe at the output of the external circuit board (20) of the synthesis station (114) and a step of syringing the radio-tracer from the device (1).
    [0021]
    21. Method according to any one of claims 18 to 20, characterized in that it comprises a quality control step of the radiotracer at the output of the external circuit board (20) of the synthesis station (114). by a quality control module located outside the room.
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    同族专利:
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    CA2981976A1|2016-10-20|
    AU2016250124B9|2020-04-09|
    WO2016166486A1|2016-10-20|
    US20180071704A1|2018-03-15|
    JP2018517126A|2018-06-28|
    ES2744825T3|2020-02-26|
    EP3283212A1|2018-02-21|
    EP3283212B1|2019-06-12|
    BR112017020992A2|2018-07-10|
    BR112017020992B1|2021-02-09|
    UY36623A|2016-12-30|
    AU2016250124B2|2020-03-19|
    CN107530675B|2021-07-30|
    US11219875B2|2022-01-11|
    PL3283212T3|2020-01-31|
    CN107530675A|2018-01-02|
    FR3035262B1|2020-02-07|
    SG11201708035VA|2017-10-30|
    SG10201909219VA|2019-11-28|
    引用文献:
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    WO2013079578A1|2011-11-30|2013-06-06|Ge Healthcare Limited|Production of 18f- labelled compounds comprising hydrolytic deprotection step and solid phase extraction|
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    法律状态:
    2016-04-22| PLFP| Fee payment|Year of fee payment: 2 |
    2016-10-21| PLSC| Publication of the preliminary search report|Effective date: 20161021 |
    2017-06-29| PLFP| Fee payment|Year of fee payment: 3 |
    2018-02-27| PLFP| Fee payment|Year of fee payment: 4 |
    2019-02-08| PLFP| Fee payment|Year of fee payment: 5 |
    2020-04-15| PLFP| Fee payment|Year of fee payment: 6 |
    2021-03-19| PLFP| Fee payment|Year of fee payment: 7 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1553402|2015-04-16|
    FR1553402A|FR3035262B1|2015-04-16|2015-04-16|DEVICE FOR SYNTHESIZING A RADIO-PLOTTER, INSTALLATION COMPRISING SUCH A DEVICE AND METHOD FOR OBTAINING A RADIO-PLOTTER BY MEANS OF SUCH A DEVICE|FR1553402A| FR3035262B1|2015-04-16|2015-04-16|DEVICE FOR SYNTHESIZING A RADIO-PLOTTER, INSTALLATION COMPRISING SUCH A DEVICE AND METHOD FOR OBTAINING A RADIO-PLOTTER BY MEANS OF SUCH A DEVICE|
    UY0001036623A| UY36623A|2015-04-16|2016-04-13|SYNTHESIS DEVICE OF A RADIOTRAZADOR, INSTALLATION THAT CONSISTS OF SUCH DEVICE AND PROCEDURE OF OBTAINING A RADIOTRAZADOR BY MEANS OF SUCH DEVICE|
    PL16731204T| PL3283212T3|2015-04-16|2016-04-14|Device for the synthesis of a radiotracer, facility comprising such a device, and method for producing a radiotracer by means of such a device|
    SG10201909219V| SG10201909219VA|2015-04-16|2016-04-14|Device for synthesizing a radioactive tracer, installation comprising such a device and method of obtaining a radioactive tracer by means of such a device|
    US15/565,740| US11219875B2|2015-04-16|2016-04-14|Device for the synthesis of a radiotracer, facility comprising such a device, and method for producing a radiotracer by means of such a device|
    EP16731204.0A| EP3283212B1|2015-04-16|2016-04-14|Device for the synthesis of a radiotracer, facility comprising such a device, and method for producing a radiotracer by means of such a device|
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