Device for coupling a syringe to an actuator

The described device addresses the challenge of precise and ergonomic coupling of syringes to actuators in radiopharmaceutical administration by using a mechanism with pivoting hooks and a force sensor for zero-play lock, ensuring accurate and reliable dose delivery.

JP2025532805APending Publication Date: 2025-10-03TRASIS
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Patent Information

Application Number
JP2025517173
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-09-21
Filing Date
2023-09-05
Publication Date
2025-10-03

AI Technical Summary

Technical Problem

Existing automated devices for administering radiopharmaceutical doses face challenges in achieving precise, rapid, and ergonomic coupling of syringes to actuators, with a need for zero play between the syringe pusher and actuator to ensure accurate dose delivery.

Method used

A device for reversibly coupling a syringe to an actuator, featuring an inner body with sliding pins and pivoting hooks, utilizing pre-stressed springs to ensure a zero-play lock and automatic coupling and decoupling, facilitated by a force sensor for real-time monitoring.

Benefits of technology

Enables precise, rapid, and ergonomic coupling with zero play, ensuring accurate dose delivery and detection of mechanical failures, thereby enhancing the reliability and efficiency of radiopharmaceutical administration.

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Abstract

In one embodiment, the present invention relates to a device (4) for reversibly coupling a syringe (5) to an actuator (3), the device comprising an inner body (41) having a longitudinal axis and an outer sleeve (46) movable relative to the inner body (41) along the longitudinal axis, the inner body (41) having a sliding shaft terminated in a slack adjustment plate (42) held longitudinally within the inner body (41) in a resting position by a pre-stressed spring (43), and a coupling member (44) for coupling the longitudinal axis, the outer portion of the hook (44), and the sleeve (46). and at least one pair of hooks (44) longitudinally disposed within the inner body (41) and mounted to pivot in pairs about two respective axes (47) perpendicular to the inner portion of the inner body (41), the outer portion facing the inner portion, the inner portion having respective contours (50, 51) configured to pivot about their respective pivot axes (47) upon contact with the contours (50, 51, thereby opening the hooks (44).
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Description

[Technical Field]

[0001] The present invention relates to the technical field of automated devices for administering precise doses of drugs, more particularly radiopharmaceutical doses, to patients, for example intravenously, subcutaneously, etc.

[0002] More particularly, the present invention relates to a system for coupling a syringe to an actuator. [Background technology]

[0003] Automated devices for administering doses of radiopharmaceuticals are known that collect a volume of solution corresponding to the required amount of radioactivity from a multi-dose vial. The device then pushes the collected volume into a transfer line connected to the patient. The assembly of the line and other devices for administering the dose to the patient is a kit that must be replaced daily.

[0004] In certain embodiments where administration is accomplished by a syringe assembled with a three-way valve, an example of such a kit is depicted in the diagram shown in Figure 1. Kit 100 includes: a syringe 101 with a nominal volume of, for example, 10 ml, - for example, radiopharmaceutical vials 107 having a maximum volume of 20 ml, usually filled with 10-15 ml of solution and fitted with a punctured septum; - Three-way valve 103, a container comprising a saline solution 109 and a conduit 108; a collection line 106 connecting the radiopharmaceutical vial 107 to the three-way valve 103 via a needle 118 that punctures the vial's septum and a tube that extends through the bubble detector 112; a "T" 104 connecting the three-way valve 103 to the NaCl solution line 108, to the injection line 110 and to the syringe 101; a line 108 connecting a saline solution container 109 to an inlet line 110 via a check valve 105; an injection line 110 provided with a non-return valve 105′, a ventilation filter 111 and a self-closing luer fitting 113, said line passing through a bubble detector 112′ upstream of the self-closing fitting 113; a patient extension set 114 connected downstream of the line 110 by a luer fitting 115 and having at its other end another luer fitting 116, the connector 116 being connected to a catheter or to an infusion line or to another syringe for preparing a dose in a syringe external to the machine for the purpose of manually administering a dose to a patient; - a dose calibrator 117 located at the height of the syringe 101 Equipped with.

[0005] The automated sequence of operations accomplished using kit 100 is as follows: - a specific amount of solution is collected from the vial 107 by aspiration through the collection line 106, via the three-way valve 103, by the syringe 101, the plunger of the syringe being pulled by the actuator, which opens the collection line and closes the injection line by the three-way valve 103; - the concentration of the injectable solution can be adjusted by collecting an appropriate amount of saline solution from a saline solution container 109, via a line 108, by means of a three-way valve, which is drawn into the syringe 101; The solution, diluted if necessary, is injected through the injection line 110 by the three-way valve 103, the collection line 106 being closed. The ventilation filter 111 prevents the passage of bubbles to the patient, and the detector 112' checks this passage. The solution is directed to the patient extension set 114.

[0006] Those skilled in the art in a position to design such a device must take into account various considerations that determine: - Required collection accuracy: the dose delivered to the patient must be very accurate (e.g., ±5%), regardless of the initial product concentration. Both the initial product concentration and the administered dose (which depends on the patient's weight and may also be a pediatric dose) can vary widely. - Selection of the largest syringe volume, and - Controlling the pressure applied to the syringe when activated.

[0007] Other ergonomic and practical considerations dictate the placement and replacement of kits containing syringes.

[0008] According to these considerations, placing and exchanging the kit on its actuator, called an injector, should be simple and quick. The operation and performance of the administration system should be independent of the operator's dexterity.

[0009] More specifically, after the kit is deployed, the attachment and detachment of the syringe pusher to the actuator coupler should be automatic. The coupler should not include any "active" components, i.e., components that must be specifically activated by a control system beyond such syringe actuator. Therefore, the mechanism for engaging and releasing the pusher button should be passive. Furthermore, when the pusher button is attached to the actuator coupler, no play can be left between the pusher button and the actuator.

[0010] Document WO2018 / 075386A1 discloses an engagement mechanism associated with a reverse plunger of a fluid injector configured to removably engage an engagement portion at a proximal end of a rotating septum syringe having a flexible sidewall configured to rotate on itself when contacted by the plunger. The engagement mechanism includes a plurality of engagement elements movable in a reverse direction and radially relative to the engagement portion of the syringe between a first position in which the plurality of engagement elements are disengaged from the syringe engagement portion and a second position in which the plurality of engagement elements are engaged with the syringe engagement portion. The engagement mechanism further includes a drive mechanism for shifting the plurality of engagement elements between the first position and the second position.

[0011] WO2015 / 085929A1 discloses a syringe plunger clamping device for a syringe pump, comprising a housing, a lever, a connecting rod, a limiting element, an elastic element, a clamping jaw, and a button. The lever has a central portion rotatably connected to the housing, a connecting rod slidably extending through the housing, and one end of the connecting rod movably connected to one end of the lever. The limiting element is attached to the connecting rod, and the elastic element is attached to the connecting rod, with two ends of the elastic element abutting the inner wall of the housing and the limiting element, respectively. The clamping jaw is disposed on the housing and firmly connected to the end of the connecting rod remote from the lever, and the clamping jaw engages with the outer surface of the housing to clamp the syringe plunger. The button slides through the housing and contacts the end of the lever remote from the connecting rod. The button slides into the housing and can push and rotate the lever to slide the connecting rod outward from the housing.

[0012] Document WO 97 / 07838 A1 discloses a syringe driver intended for controlled parenteral perfusion of medical fluids using available disposable syringes. The driver device comprises a frame with a movable carriage, on which a force-applying element is mounted and housed. The disposable syringe is attached to the frame, and a long micro-bore tube is attached to the syringe's outlet tip. When force is applied to the syringe plunger, the fluid is expelled from the syringe, the flow rate of which depends on the diameter of the micro-bore tube. The driver device allows for the administration of multiple successive doses of fluid.

[0013] Document EP1447105A2 discloses a liquid injector having a grip detector arranged on the front face of a plunger pusher for detecting when the plunger is pushed by the plunger pusher and thereby detecting when a plunger flange arranged on the plunger is gripped by a pair of engaging claws on the plunger pusher. The plunger pusher cannot be operated when the plunger flange is not gripped by the engaging claws.

[0014] Document EP1779830A1 discloses a drug transfer device including a vertically movable vial clamp for holding vials of various sizes in place with their septums facing downwards, a syringe holder, a clamp for gripping the syringe's plunger, and an actuator with a movable plate for supporting a bag containing irrigation solution. The syringe holder can be moved between an intake position, with the attached needle facing the vial clamp of the syringe or the vial's septum, and an ejection position, with the syringe or its attached needle facing the injection port of the irrigation bag. When the vial and syringe are in place with the syringe holder in the intake position, the vial clamp moves downwards, causing the syringe needle to pierce the septum. The actuator retracts the plunger a predetermined distance, thereby aspirating the desired amount of drug. The vial clamp then moves upwards, thereby releasing the needle. This event is followed by movement of the syringe holder toward the ejection position. The plate then moves towards the syringe holder until the needle enters the injection port. The actuator then pushes the plunger, expelling the medication into the bag, and the plate moves away from the syringe, removing the needle.

[0015] WO2014 / 129493A1 discloses a chemical solution suction device including a plunger holding mechanism for holding a plunger element and a cylinder holding mechanism for holding a cylinder element. The plunger holding mechanism and the cylinder holding mechanism are designed to be movable so that they can move between each other. In addition, the chemical solution suction device includes a compression mechanism that applies pressure to the plunger holding mechanism and / or the cylinder holding mechanism, thereby moving one of the plunger holding mechanism and the cylinder holding mechanism from (i) a first state in which the plunger holding mechanism and the cylinder holding mechanism are positioned near each other to (ii) a second state in which the two mechanisms are spaced a predetermined distance from each other. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] WO2018 / 075386A1 [Patent Document 2] WO2015 / 085929A1 [Patent Document 3] WO97 / 07838A1 [Patent Document 4] EP1447105A2 [Patent Document 5] EP1779830A1 [Patent Document 6] WO2014 / 129493A1 Summary of the Invention [Problem to be solved by the invention]

[0017] The present invention aims to provide a simple, accurate and rapid device for coupling radiopharmaceutical kits and automated systems for delivering doses to patients.

[0018] It is a further object of the present invention to provide a zero play coupling between the syringe pusher and actuator. [Means for solving the problem]

[0019] A first aspect of the invention is a device for reversibly coupling a syringe to an actuator, comprising an inner body having a longitudinal axis and an outer sleeve intended to move relative to the inner body along the longitudinal axis, the inner body comprising sliding pins with play plates at their ends that are held longitudinally inside the inner body in a rest position by pre-stressed springs, and at least one pair of hooks arranged longitudinally inside the inner body, two of which are pivotally and retractably mounted around each of the two pins perpendicular to the longitudinal axis, the outer parts of the hooks being located opposite the inner part of the sleeve, in which the hooks of the same pair each have a zone for hooking onto the proximal end of the play plate and are connected to each other at their distal ends by a return spring. a device characterized in that, in the rest position of the coupling device, the distal portions of the hooks have outwardly protruding portions intended to be inserted into hollow zones of a first depth in the inner contour of the sleeve, the zones for hooking the hooks are in a contact position for locking the pusher button, the hooks approach due to relative sliding of the sleeve against the inner body, and as the sleeve moves away from the distal ends of the hooks (upward if a syringe is placed on the coupling device), the hooks are opened by pivoting around the respective pivot pins, as the protruding portions of each hook pass into hollow zones of a second depth in the inner contour of the sleeve, the hollow zones of the second depth being adjacent to the hollow zones of the first depth, and the first depth being greater than the second depth.

[0020] According to a preferred embodiment, the device further comprises at least one of the following features, or a suitable combination of several of them: - the device comprises two to four pairs of hooks; - the hook has a hook area defined by a protruding portion with an inwardly sloping chamfer, below which is a recess that is dimensioned to lock without any play with the hook, and the play-removal plate is pressed by its pre-stressed spring and attached to the pusher button of the syringe.

[0021] A second aspect of the invention relates to a reversible coupling of a syringe and an actuator for injecting a calibrated product, the syringe comprising a pusher with a pusher button, the actuator intended to be coupled to the pusher of the syringe by means of the device described above, characterized in that in the coupled position the pusher button of the syringe is locked in a recess between the protruding part of the hook (44) and the play plate, and a pre-stressed spring applies a force in the direction of the pusher so as to eliminate any play between the pusher and the coupling device.

[0022] Advantageously, the reversible coupling comprises a force sensor located at the rear of the coupling mechanism between the actuator and the coupling device, intended to measure the force directly during injection and coupling.

[0023] A third aspect of the invention relates to an automatic machine for administering doses of a product, comprising an actuator (3), at least one syringe (5) for injecting a calibrated product, comprising a pusher (6) having a pusher button (7), and a reversible coupling of the syringe (5) and the actuator (3) according to claim 5.

[0024] Preferably, the automated machine for administering doses of the product is a machine for administering a radiopharmaceutical drug to a patient, the machine also comprising a disposable radiopharmaceutical kit with at least one syringe for administering the dose to the patient.

[0025] A fourth aspect of the present invention relates to a method for reversible coupling and decoupling of at least one syringe and an actuator of the syringe, implementing the coupling device described above, the method comprising steps for coupling and decoupling, the coupling step comprising the following steps: - the coupling device is in a rest position, the coupling body protruding relative to the sleeve in the direction of the syringe, preferably upwards when the syringe is located above the coupling device and downwards when the syringe is located below the coupling device, - an actuator pushing the coupler towards a pusher button of the syringe; - the pusher button presses the hook with its chamfer, causing the hook to open, so that the protuberance of the hook shifts continuously from contact with the hollow zone of the first depth of the inner contour of the sleeve to a non-contact position; - the hook automatically closes on the pusher button by means of a return spring as soon as the pusher button reaches the end of the protruding portion of the hook, the pusher button and the play plate coming into contact and inserted into the recess. - The pusher button is locked without play between the hook and the play plate. It is characterized by:

[0026] Advantageously, a method for reversible coupling and decoupling of a syringe and an actuator therewith, implementing the coupling device previously described herein, comprises, after the reversible coupling of the syringe and the actuator has been performed as described above, the following steps: - from a rest position of the coupling, the actuator pulls the coupler in the direction of retraction of the pusher, preferably downwards or upwards depending on the relative positions of the actuator and the syringe, retracting the pusher into the syringe; - the sleeve coming to rest against a support surface of the actuator chassis while the body continues to move, preferably downwards or upwards, under the action of the actuator; - cooperating by contact of an outer contour of the hook with a hollow zone of an inner contour of the sleeve, wherein, in order to pivot and open the hook, the raised portions of the hook are successively shifted from contact with a hollow zone of a first depth of the inner contour of the sleeve to contact with a hollow zone of a second depth of said contour, - the pusher button is separated from the coupling and the pusher automatically passes through the syringe body as soon as the hook opens, if a negative pressure has previously been created in the syringe by closing a valve in the downstream line that communicates with the syringe; - The syringe is released from the binding and can be removed. The separation is characterized by:

[0027] Alternatively, a method for reversibly coupling and decoupling a syringe and a syringe actuator implementing the aforementioned device may comprise the following steps (not included in the present invention): - from the rest position of the coupling, the sleeve is manually moved in the direction of the syringe pusher, preferably the sleeve is manually raised or lowered, respectively, in the direction of the syringe pusher, - interacting by contacting an outer contour of the hook with a hollow inner contour of the sleeve to pivot or open the hook, the raised portion of the hook shifting continuously from contacting a hollow zone of a first depth of the inner contour of the sleeve to contacting a hollow zone of a second depth of said contour, - the pusher button is disengaged from the coupling device and, if a vacuum has previously been created in the syringe by closing a valve in the downstream line that communicates with the syringe, the pusher automatically enters the syringe body as soon as the hook is opened, and the actuator can be withdrawn to alternatively release the pusher button from the coupling device, - the syringe is released from the coupler and can be removed, or alternatively, can be used to continue the collection and injection operation by manual operation of the pusher. It is characterized by:

[0028] Thus, in the event of a mechanical failure, a manual action allows the pusher to be released from the faulty actuator. [Brief explanation of the drawings]

[0029] [Figure 1] FIG. 1 is a schematic diagram illustrating the components and operation of a kit for use in an automated device for administering a dose of a radiopharmaceutical in a specific embodiment of the present invention. [Figure 2] 1 is a three-dimensional overview of an actuator, a syringe, and a device for coupling the two elements according to an embodiment of the present invention. [Figure 3] 1A-1C are different cross-sectional views (in orthogonal planes) of a coupler and its components; [Figure 4] 1A and 1B show views of the coupler in positions with closed hooks (a) and with open hooks (b), respectively. [Figure 5] 10A-10C show multiple views of the coupler relative to the syringe and the mechanism for securing the syringe using the relative opening / closing movement of the hooks. [Figure 6] 10A-10C show multiple views of the coupler relative to the syringe and the mechanism for separating the syringe using the relative opening / closing movement of the hook. DETAILED DESCRIPTION OF THE INVENTION

[0030] The figures show embodiments of the invention with elements in a vertical orientation, however, it should be understood that the invention is not limited to such a particular orientation and that embodiments in other suitable orientations are also within the scope of protection of the present invention.

[0031] A unique system for gripping the syringe pusher has been developed in accordance with the present invention.

[0032] Figure 2 shows a fixing structure 1 with its support surface 2 for coupling, a syringe actuator 3, its coupling device 4, a syringe with its body 5 and pusher 6 in a position fixed to the coupler 4, a system 8 for fixing the syringe to the chassis, a three-way valve 9 and the start of each collection tube 10, a saline connection tube 11, and an injection tube 12.

[0033] The coupler 4 is shown in detail in cross section on the right side of Figure 2. The pusher button 7 of the syringe inserted into the coupler can also be seen.

[0034] FIG. 3 shows only the passive coupling device 4 with its various components, namely: - coupling body 41, - a clearance plate 42 and its pre-stressed spring 43, - a plurality of pivoting hooks 44, - a prestressed return spring 45 for each pair of hooks 44, - a sleeve 46 for controlling the opening of the hook 44 is.

[0035] Figure 4a) shows the coupler 4 in a default (or rest) state, i.e. with closed hooks 44. Figure 4b) shows the coupler 4 with open hooks 44 due to relative movement of the sleeve 46 with respect to the body of the coupler 41.

[0036] According to one embodiment, the hooks 44 are mounted longitudinally in pairs, with the hooks of each pair arranged along an axis perpendicular to the mean axis of the hooks and connected at their lower parts by return springs 45 fixed to the hooks. For example, there are two perpendicular pairs of hooks 44, with their respective springs 45 also located at different heights. The hooks 44 are mounted to pivot about a pin 47 located approximately halfway along the hook's height. In the vertical direction, each hook 44 has an inner protruding portion 48 followed by a recess 49, which, after coupling, can lock the syringe button pusher 7 relative to the clearance plate 42. Furthermore, according to the present invention, lifting the sleeve 46 relative to the coupling body 41 serves to open the hooks and release the syringe pusher button 7 and pusher 6. For this purpose, the outer structure of the hooks 44 must cooperate with the inner structure of the sleeve 46. According to one embodiment, the lower outer portions of the hooks include raised ridges 50, and the inner portion of the sleeve includes a hollow profile 51 that accommodates the desired displacement of the raised ridges 50 when the sleeve is raised relative to the coupler body. In the default position, the hooks 44 of the coupler 4 are closed, with the raised ridges 50 located in the hollow of the sleeve profile 51 (FIG. 4a). When the coupling body 41 moves downward relative to the sleeve, the raised ridges 50 extend downwardly from the sleeve's inner profile 51, and contact between the lower edge of the protruding profile 51 and the raised ridges 50 automatically pivots each hook 44 about its pivot pin 47, thus opening the hooks outward and releasing the pusher button 7 and, therefore, the syringe pusher 6.

[0037] FIG. 5 shows in three successive steps the relative movement of coupler 4 to syringe 5 and the mechanism for securing syringe 5 (assuming it is secured) using opening and closing of hook 44.

[0038] By moving along the injection direction, the coupler 4 comes into contact with the button pusher 7 of the syringe 5 and its hook. Opening of the hook 44 occurs due to the contact of the pusher button 7 of the syringe 5 onto the hook 44 (Fig. 5b). Closure of the hook 44 to the button pusher 7 occurs as soon as the pusher button 7 of the syringe 5 protrudes beyond the end of the protruding portion 48 of the hook 44 (Fig. 5b), thereby compressing the clearance plate 42 mounted on a pre-stressed spring 43 so as to be embedded in the recess 49 of the hook (Fig. 5c).

[0039] The plate 42 attached to its pre-stressed spring 43 takes up the play between the gripping hook 44 and the upper support surface of the pusher button 7, and between the lower support surface of the pusher button 7 and the play-taking plate 42. The hooking process has to overcome the force of the spring.

[0040] Once hooked together, the pusher 6 and actuator 3 are held tightly together, whatever the direction of movement of the actuator 3, within the limits of the force of the plate's pre-stressed spring (Fig. 5c).

[0041] FIG. 6 then shows (from left to right) the various steps for separating the syringes. Separation is achieved by the actuator's maximum downward retraction (FIG. 6a). When the coupler 4 is lowered, the sleeve 46 contacts the support surface 2 of the fixed structure 1, which prevents the sleeve 46 from moving further downward while the body 41 of the coupler 4 continues to move downward. Due to its relative movement with respect to the body 41 of the coupler, the sleeve 46 uses its inner contour to receive the ridges of the hooks 44, pivoting them open (as described above). Once the hooks are released, the pusher button 7 is then detached from the coupler 4, and the pusher 6 can automatically rise. Indeed, if the downward movement of the pusher 6 is achieved with the three-way valve in the closed position, it creates a negative pressure in the syringe, and the pusher 6 immediately rises back into the body 5 of the syringe as soon as the hooks 44 open. The syringe 5 is released from the coupler 4 and the kit can be easily removed from the machine.

[0042] Decoupling can also be performed manually by lifting the sleeve 46 and the actuator is deactivated (not part of the invention).

[0043] The sleeve 46 can be attached (a) to the coupler (as previously shown) or (b) to a support surface of a fixed structure. Note that in the latter case, it may not be manually actuable.

[0044] Description of the Preferred Embodiments of the Invention In a preferred embodiment of the invention, the syringe has a nominal volume of 10 ml for a stroke of around 48 mm, and the plunger can move several mm beyond the nominal fill volume. 10 to 15 ml represents a typical volume of radiopharmaceutical delivered in a vial for PET (positron emission tomography).

[0045] For example, pediatric doses of 18F-FDG can be as low as 30 MBq (megabecquerels), while adult doses are in the 200 to 300 MBq range. The most challenging case occurs when the starting solution concentration is high, e.g., 30 GBq in 10 ml, and a pediatric dose needs to be prepared. In that case, the volume to be drawn is 10 * (30 / 30000) ml = 0.01 ml (10 μl).

[0046] The smallest possible collection, and therefore the smallest variation in the target volume (ΔV), is ~0.01 mL, with an expected accuracy of ±10%. Such a ΔV corresponds to a displacement of 0.01 [ml] * (48 mm / 10 ml) = 0.048 mm, or 48 ± 6 μm.

[0047] The resolution of the push-syringe device is ∼2 μm, and such a dose is only possible with the desired precision without any play and with good control of the applied force.

[0048] According to another embodiment of the invention, a force sensor (not shown) is placed at the rear of the coupling mechanism between the actuator and the coupling device and serves to directly measure the force during injection and during coupling, which in particular: - Creating a vacuum in the syringe allows you to verify that the bond is actually occurring, and - Pressure differences in the kit can be ascertained, since the pressure exerted by the substance in the syringe on the syringe plunger is so transmitted to the pusher button, which is directly connected to a coupler which is itself connected to an actuator via the force sensor in question. Anomalies such as broken tubing in the kit can thereby be detected when fluid is transferred with the syringe. [Explanation of symbols]

[0049] 1 Fixed structure (chassis) 2 Support surface 3 Actuator 4 Combiner 5 Syringe (optical tube) 6 Pusher 7 Pusher Button 8 Syringe Fixation System 9 Three-way valve 10 Collection Pipe 11 Saline connection line 12 Injection line 41 Combined Body 42 Play Plate 43 Pre-stressed spring (from take-up plate) 44 Pivoting Hook 45 Return spring (pair of hooks) 46 coupling sleeve 47 Pivot pin 48 Hook protruding part 49 Hook recess 50 Ridges 51 Inner sleeve contour 100 Radiopharmaceutical Kits 101 Syringe 102 Valve-syringe connecting line 103 Three-way valve 104 T-shaped pipe 105, 105' check valve 106 Collection Pipe 107 Vials of concentrated radiopharmaceuticals 108 Saline connection pipe 109 Small bottle of saline solution 110 Injection line 111 Ventilation filter 112, 112' Bubble detector 113 Self-closing lure 114 Patient Extension Set 115 Mechanical Luer Fitting 116 Patient Luer Mating 117 Dose Calibrator 118 Puncture needle

Claims

1. A device (4) for reversibly coupling a syringe (5) to an actuator (3), comprising an inner body (41) with a longitudinal axis, and an outer sleeve (46) intended to move relative to the inner body (41) along said longitudinal axis, the inner body (41) being fitted with a sliding pin having at its end a play plate (42) which is held longitudinally inside the inner body (41) in a rest position by a pre-stressed spring (43), and two sliding pins (42) extending perpendicular to the longitudinal axis. and at least one pair of hooks (44) longitudinally disposed inside the inner body (41), two of which are pivotally and retractably mounted on each of the pins (47) of the inner body (41), with outer portions of the hooks (44) located opposite the inner portion of the sleeve (46), wherein the hooks (44) of the same pair each have zones (48, 49) for hooking onto the proximal end of the play plate (42), and are connected to each other at their distal ends by a return spring (45), The distal part of the hook (44) has an outwardly extending ridge (50) intended to be inserted into a hollow zone of a first depth of the inner contour (51) of the sleeve (46) in the rest position of the coupling device (4), the zones (48, 49) for hooking the hook (44) being in a contact position for locking the pusher button (7), the hooks (44) being brought together by sliding the sleeve (46) relative to the inner body (41) and the sleeve (46) being brought into contact with the hook (44). a sleeve (46) moving away from the distal end of the hooks (44) and pivoting about its respective pivot pin (47) to open the hooks (44) because the raised portion (50) of each hook (44) passes through a hollow zone of a second depth in the inner contour (51) of the sleeve (46), the hollow zone of the second depth being adjacent to the hollow zone of a first depth, and the first depth being greater than the second depth.

2. 2. A device (4) according to claim 1, characterized in that it comprises two to four pairs of hooks (44).

3. 2. The device (4) according to claim 1, characterized in that the hook (44) has a hooking area defined by a protruding portion (48) with an inwardly beveled chamfer, followed by a recess (49) below the protruding portion (48), the recess (49) being dimensioned to lock with the hook (44) without play, and the play-relief plate (42) being pressed by its pre-stressed spring (43) into abutment with the pusher button (7) of the syringe (5).

4. 1. A reversible coupling of a syringe (5) and an actuator (3) for injecting a calibrated product, the syringe (5) comprising a pusher (6) having a pusher button (7), the actuator (3) intended to be coupled to the pusher (6) of the syringe (5) by the device (4) according to any one of claims 1 to 3, characterized in that in the coupled position, the pusher button (7) of the syringe (5) is locked in the recess (49) between the protruding portion (48) of the hook (44) and the play plate (42), and the pre-stressed spring (43) applies a force towards the pusher (7) so as to eliminate any play between the pusher (7) and the coupling device (4).

5. 5. The reversible coupler according to claim 4, characterized in that it comprises a force sensor arranged at the rear of the coupling mechanism between the actuator (3) and the coupling device (4) and intended to measure the force directly during injection and during coupling.

6. 10. An automated machine for administering doses of a product, comprising an actuator (3), at least one syringe (5) for injecting a calibrated product, comprising a pusher (6) having a pusher button (7), and a reversible coupling of the syringe (5) and the actuator (3) according to claim 4.

7. 7. An automated machine for administering doses of a product according to claim 6, characterized in that the product is a radiopharmaceutical drug and the machine also comprises a disposable radiopharmaceutical kit (100) comprising at least one syringe (5) for administering the dose to a patient.

8. A method for reversible coupling and decoupling of at least one syringe (5) and of an actuator (3) with said syringe (5), implementing the coupling device (4) according to any one of claims 1 to 3, comprising a coupling step and a decoupling step, said coupling comprising the following steps: - the coupling device (4) is in a rest position, with the coupling body (41) protruding relative to the sleeve (46) towards the syringe (5). - the actuator pushing the coupler (4) towards the pusher button (7) of the syringe (5); - the pusher button (7) presses the hook (44) at the level of its chamfer, causing the hook (44) to open, the protuberance (50) of the hook (44) then shifting from contact with the hollow zone of the first depth of the inner contour (51) of the sleeve (46) to a non-contact position. - as soon as the pusher button (7) reaches the end of the protruding part (48) of the hook (44), automatic closing of the hook (44) on the pusher button (7) occurs due to the return spring (45), the pusher button (7) and the clearance plate (42) come into contact and are inserted into the recess (49). - the pusher button (7) is locked without play between the hook (44) and the play plate (42); The method characterized by:

9. A method for reversible coupling and decoupling of a syringe (5) and of an actuator (3) with said syringe, wherein after the reversible coupling of the syringe (5) and of the actuator (3) is carried out according to claim 8, said decoupling comprises the following steps: - from the rest position of the coupler (4), the actuator pulls the coupler in a direction to withdraw the pusher from the syringe (5); - the sleeve (46) abuts against the support surface (2) of the chassis (1) of the actuator (3) and the body (41) comes to a stop while continuing to move under the influence of the actuator (3); - cooperating by contact of the outer contour of the hook (44) with the hollow zone of the inner contour of the sleeve (46), such that the protuberances (50) of the hook (44) sequentially shift from contact with the hollow zone of the inner contour (51) of the sleeve (46) at a first depth to contact with the hollow zone of the contour (51) at a second depth, causing the hook (44) to pivot open; - the pusher (6) automatically rises into the syringe body (5) as soon as the hook (44) opens, if the pusher button (7) separates from the coupler (4) and a negative pressure has previously been created in the syringe (5) by closing a valve communicating with the syringe in a downstream line; - the syringe (5) is released from the coupler (4) and can be removed. The method characterized by:

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