Device for coupling a syringe to an actuator

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) comprising: a sliding pin terminating in a gap occupying plate (42), the gap-occupying plate is longitudinally held inside the inner body (41) in a rest position by means of a pre-stressed spring (43); and at least one pair of hooks (44) arranged longitudinally inside the inner body (41), mounted to pivot and retract in pairs with respect to two respective pins (47) perpendicular to the longitudinal axis, the outer portions of these hooks (44) being positioned opposite the inner portion of the sleeve (46), the inner and outer portions having respective profiles (50, 51), the contours (50, 51) are configured such that the sleeve (46) slides relative to the inner body (41) in a direction facing away from the hooking area of the hooks (44) such that the hooks (44) are opened by pivoting about their respective pivot pins (47) when in contact with the contours (50, 51).

Description

Technical Field

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

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

[0003] Prior art and problem statement

[0004] Automated devices for administering radiopharmaceutical doses are known that collect a volume of solution corresponding to the desired amount of radioactivity from a multidose vial. The device then pushes the collected volume back into a delivery line connected to the patient. The assembly of lines and other devices for administering doses to the patient is a kit that must be replaced daily.

[0005] In a specific embodiment where dosing is accomplished via a syringe in combination with a three-way valve, an example of such a kit is provided in Figure 1 The kit 100 includes:

[0006] - a syringe 101, with a nominal capacity of, for example, 10 mL;

[0007] - a vial 107 of radiopharmaceutical product, e.g. with a maximum capacity of 20 mL, typically filled with 10 mL to 15 mL of solution and equipped with a septum to be pierced;

[0008] - three-way valve 103;

[0009] - a container with brine 109 and a pipeline 108;

[0010] - a collection line 106 connecting a radiopharmaceutical product vial 107 to a three-way valve 103 via a needle 118 piercing the vial's septum and a tube extending through a bubble detector 112;

[0011] - a “T” 104 that connects the three-way valve 103 to the NaCl solution line 108 , the injection line 110 and the syringe 101 ;

[0012] - a line 108 which connects a saline container 109 to an injection line 110 via a non-return valve 105;

[0013] - an injection line 110 comprising a non-return valve 105', a ventilation filter 111 and a self-closing Luer connector 113. The line passes through a bubble detector 112' upstream of the self-closing connector 113;

[0014] a patient extension set 114 connected downstream of the line 110 by means of a Luer connector 115 and comprising at its other end another Luer connector 116, the connector 116 being connected to a catheter, or an infusion line or else to another syringe for preparing a dose in a syringe outside the machine, with the purpose of manually administering the dose to the patient;

[0015] A dose calibrator 117 , which is located at the level of the syringe 101 .

[0016] The automatic operating sequence implemented with kit 100 is as follows:

[0017] - collecting a specific amount of solution from a vial 107 by suction through a syringe 101, via a three-way valve 103, through a collection line 106, the plunger of the syringe being pulled by an actuator, the collection line being opened and the injection line being closed by the three-way valve 103;

[0018] - The concentration of the injectable solution can be adjusted by collecting an appropriate amount of saline from a saline container 109 via a three-way valve through line 108, which is drawn into the syringe 101;

[0019] - The solution (if appropriate, diluted solution) is injected via the three-way valve 103 through the injection line 110, the collection line 106 is closed. The ventilation filter 111 prevents the passage of air bubbles to the patient, the detector 112 'checks the passage of air bubbles;

[0020] The solution is directed to the patient extension set 114 .

[0021] A person skilled in the art who is capable of designing such a device must take into account various considerations which determine:

[0022] - Required collection accuracy: the dose delivered to the patient must be very precise (e.g. + / - 5%), regardless of the concentration of the initial product. Both the concentration of the initial product and the dose to be administered (the dose depends on the patient's weight and can even be a pediatric dose) are very variable;

[0023] - Selection of maximum syringe volume; and

[0024] -Control the pressure applied to the syringe when it is actuated.

[0025] Other ergonomic and practical considerations determine the placement and replacement of the set including the syringe.

[0026] In light of this consideration, placing and replacing the kit on its actuator, known as the injector, should be simple and rapid. The operation and performance of the administration system must not be dependent on the dexterity of the operator.

[0027] More specifically, once the kit is in place, attaching and detaching the pusher of the syringe to and from the coupler of the actuator must be automatic. The coupler should not include any "active" components, i.e., components that need to be specifically enabled by a control system other than the syringe actuator. Therefore, the mechanism for hooking and releasing the pusher button should be passive. In addition, when the pusher button is attached to the actuator coupler, no gap can be left between the pusher button and the actuator.

[0028] Document WO 2018 / 075386 A1 discloses an engagement mechanism associated with a reverse plunger of a fluid injector, the engagement mechanism being configured to removably engage an engagement portion at the proximal end of a rolling diaphragm syringe, the engagement portion having a flexible sidewall configured to roll up itself when touched by the plunger. The engagement mechanism includes a plurality of engagement elements that reversibly and radially move relative to the syringe engagement portion between a first position and a second position, in the first position, the plurality of engagement elements are disengaged from the syringe engagement portion, and in the second position, the plurality of engagement elements are engaged with the syringe engagement portion. The engagement mechanism further includes a drive mechanism for displacing the plurality of engagement elements between the first position and the second position.

[0029] Document WO 2015 / 085929 A1 discloses a syringe plunger clamping device for a syringe pump, which includes a housing, a lever, a connecting rod, a limiting element, an elastic element, a clamping claw and a button. The middle part of the lever is rotatably connected to the housing, the connecting rod slidably extends through the housing, and one end of the connecting rod is movably connected to one end of the lever. The limiting element is attached to the connecting rod, the elastic element is sleeved on the connecting rod, and the two ends of the elastic element are respectively against the inner wall and the limiting element of the housing. The clamping claw is arranged on the housing and is firmly connected to the end of the connecting rod away from the lever, and the clamping claw engages with the outer surface of the housing to clamp the plunger of the syringe. The button slides through the housing and contacts with the end of the lever away from the connecting rod. The button can slide into the housing to push the lever to rotate, so that the connecting rod slides toward the outside of the housing.

[0030] Document WO 97 / 07838A1 discloses a syringe driver, which is intended to use available disposable syringes for controlled parenteral infusion of medical fluids. The driver device includes a frame on which a movable bracket is mounted (a force-applying element is accommodated in the movable bracket). The disposable syringe is mounted on the frame, and a long microporous tube is attached to the syringe outlet end. When force is applied to the plunger of the syringe, the fluid is discharged from the syringe, but its flow rate depends on the diameter of the microporous tube. The driver device allows the administration of multiple sequential doses of fluid.

[0031] Document EP 1 447 105 A2 discloses a liquid injector having a clamping detector arranged on the front face of a plunger pusher, the clamping detector being used to detect when the plunger is pushed by the plunger pusher and thereby detect when a plunger flange arranged on the plunger is clamped by a pair of engaging claws on the plunger pusher. When the plunger flange is not clamped by the engaging claws, the plunger pusher cannot be actuated.

[0032] Document EP 1 779 830 A1 discloses a drug transfer device, which includes a vertically movable vial clamp for holding vials of different sizes in place (with their diaphragms facing downward), a syringe holder, and an actuator, the actuator including a clamp for clamping the plunger of the syringe and a movable plate for supporting a bag containing an infusion solution. The syringe holder can move between an aspiration position and a discharge position under the vial clamp, in which the syringe or the needle attached thereto points to the diaphragm of the vial, and in the discharge position, the syringe or the needle attached thereto points to the injection port of the infusion bag. When the vial and the syringe are in place and the syringe holder is in the aspiration position, the vial clamp moves downward so that the syringe needle pierces the diaphragm. The actuator retracts the plunger to a predetermined distance, thereby inhaling a desired amount of medicine. Then, the vial clamp moves upward, thereby releasing the needle. This is followed by the movement of the syringe holder toward the discharge position. Then, the plate moves toward the syringe holder until the needle enters the injection port. The actuator then pushes the plunger and the drug is expelled into the bag, whereupon the plate moves away from the syringe to disengage the needle.

[0033] Document WO 2014 / 129493 A1 discloses a chemical solution suction device, which is provided with 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 the plunger holding mechanism and the cylinder holding mechanism move toward and away from each other. In addition, the chemical solution suction device is provided with a pressing mechanism, which applies a pressing force 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 to (ii) a second state, in which the plunger holding mechanism and the cylinder holding mechanism are positioned adjacent to each other, and in the second state, the two mechanisms are separated from each other by a predetermined distance. Summary of the invention

[0034] The present invention aims to provide a simple, accurate and fast device for coupling a radiopharmaceutical kit and an automated system for dispensing a dose to a patient.

[0035] It is a further object of the present invention to provide a backlash-free coupling of the actuator to the pusher of the syringe.

[0036] Main characteristic elements of the present invention

[0037] A first aspect of the invention relates to a device for reversibly coupling a syringe to an actuator, the device comprising an inner body having a longitudinal axis and an outer sleeve intended to be movable relative to the inner body along the longitudinal axis, the inner body comprising: a sliding pin terminating in a gap occupying plate, the gap occupying plate being longitudinally held inside the inner body in a static position by a prestressed spring; and at least one pair of hooks longitudinally arranged inside the inner body, mounted to pivot and retract in pairs around two corresponding pins perpendicular to the longitudinal axis, the outer portion of the hooks being positioned opposite the inner portion of the sleeve, characterised in that the same pair of hooks each have a zone for hooking the proximal end of the gap occupying plate, and Connected to each other at the distal end by a return spring, the distal portions of these hooks are provided with projections outwardly, which are intended to be inserted into a hollow zone of a first depth of the internal profile of the sleeve in the rest position of the coupling device, in which the zone for hooking the hook is in a contact position for locking the pusher button, the hooks are brought closer, the sleeve slides relatively with respect to the internal body, wherein the sleeve moves away from said distal end of the hook (upward if the syringe is arranged above the coupling device), thereby causing the hook to open by pivoting around the corresponding pivot pin, because the projection of each hook penetrates into a hollow zone of a second depth of the internal profile of the sleeve, the hollow zone of the second depth being adjacent to the hollow zone of the first depth, the first depth being greater than the second depth.

[0038] According to a preferred embodiment, the device further comprises at least one of the following features or a suitable combination of a plurality of them:

[0039] - the device comprises 2 to 4 pairs of hooks;

[0040] - These hooks have a hooking area defined by a projection with an inwardly inclined chamfer, below which is followed a recess whose dimensions are designed to lock, without play, a gap-occupying plate pushed by its prestressed spring and attached to the pusher button of the syringe by these hooks.

[0041] A second aspect of the invention relates to a reversible connection between a syringe and an actuator for injecting a calibrated product, the syringe being provided with a pusher with a pusher button, the actuator being intended to be connected to the pusher of the syringe by means of the above-mentioned device, characterised in that in the connected position the pusher button of the syringe is locked in a recess between a protruding part of a hook (44) and a gap occupying plate which exerts a force directed towards the pusher by means of a prestressed spring so as to eliminate any gap between the pusher and the coupling device.

[0042] Advantageously, the reversible coupling comprises a force sensor arranged behind the coupling mechanism between the actuator and the coupling device and intended to measure the forces directly during injection and during coupling.

[0043] A third aspect of the invention relates to an automatic machine for administering a dose of a product, comprising an actuator (3) and at least one syringe (5) for injecting a calibrated product, and a reversible connection of the syringe (5) and the actuator (3) according to claim 5, the syringe being provided with a pusher (6) having a pusher button (7).

[0044] Preferably, the automatic machine for administering a dose of a product is a machine for administering a radiopharmaceutical to a patient and the machine further comprises a disposable radiopharmaceutical kit having at least one syringe for administering the dose to the patient.

[0045] A fourth aspect of the invention relates to a method for reversibly coupling and decoupling at least one syringe and an actuator of the syringe, the method implementing the above coupling device, the method comprising steps for coupling and decoupling, the coupling being characterized by the following steps:

[0046] the coupling device is in a rest position, wherein the coupling body projects relative to the sleeve in the direction of the syringe, preferably upwards when the syringe is above the coupling device and downwards when the syringe is below the coupling device;

[0047] - the actuator pushes the coupling towards the pusher button of the syringe;

[0048] - the pusher button pushes the hook at its chamfer and causes it to open, the projection of the hook being successively displaced from contact with the hollow zone of the first depth of the internal profile of the sleeve to a non-contact position;

[0049] - once the pusher button reaches the end of the protruding part of the hook, the hook automatically closes on the pusher button due to the return spring, the pusher button and the gap occupying plate contacting the recess and being inserted therein; and

[0050] The pusher button is locked without play between the hook and the gap occupying plate.

[0051] Advantageously, the method for reversibly coupling a syringe and an actuator and decoupling the actuator from the syringe has a decoupling, which implements the coupling device described above, characterized by the following steps, once the reversible coupling of the syringe and the actuator has been performed as described above:

[0052] - from the rest position of the coupling, the actuator pulls the coupling in the retraction direction of the pusher, preferably downwards or upwards, depending on the relative position of the actuator and the syringe, respectively, so as to retract the pusher in the syringe;

[0053] - the sleeve comes to rest against the bearing surface of the actuator base and stops, whereas the body continues to move under the action of the actuator, preferably downwards or upwards;

[0054] - the external profile of the hooks cooperates by coming into contact with a hollow zone of the internal profile of the sleeve, the projections of the hooks being successively displaced from contact with a hollow zone of a first depth of the internal profile of the sleeve to contact with a hollow zone of a second depth of said profile, in order to pivot these hooks and cause them to open;

[0055] - the pusher button is separated from the coupling and, if negative pressure has been previously created in the syringe by closing the valve in the downstream line communicating with the syringe, once these hooks are opened, the pusher automatically penetrates the syringe body;

[0056] -The syringe is released from the coupling and can be removed.

[0057] Alternatively, a method for reversibly coupling and disconnecting a syringe and an actuator of the syringe implementing the above device is characterized by the following steps (not included in the present invention):

[0058] - from the rest position of the coupling, the sleeve is manually moved towards the pusher of the syringe, preferably the sleeve is manually raised or lowered towards the pusher of the syringe, respectively;

[0059] - the outer profiles of the hooks interact by contact with the hollow inner profile of the sleeve in order to pivot the hooks and cause them to open, the projections of the hooks moving successively from contact with a hollow zone of a first depth with the inner profile of the sleeve to contact with a hollow zone of a second depth of said profile;

[0060] - the pusher button is disengaged from the coupling and, if a vacuum has been previously created in the syringe by closing the valve communicating with the syringe in the downstream line, once these hooks are opened, the pusher automatically enters the syringe body, thereby alternately withdrawing the actuator and allowing the pusher button to be disengaged from the coupling device;

[0061] - The syringe is released from the coupling and can be removed or used in place to continue the collection operation and injection operation by manually moving the pusher.

[0062] Thus, in the event of a machine malfunction, manual operation allows the pusher to be released from the malfunctioning actuator. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1The components and operation of a kit for use in an automated device for administering a dose of a radiopharmaceutical in a particular embodiment of the invention are schematically illustrated.

[0064] Figure 2 A three-dimensional general view showing an actuator, a syringe and means for coupling these two elements according to an embodiment of the invention is shown.

[0065] Figure 3 Different cross-sectional views (in orthogonal planes) of the coupling and its components are shown.

[0066] Figure 4 Views of the coupling are shown in hook-closed (a) and hook-open (b) positions, respectively.

[0067] Figure 5 The mechanism for securing the syringe is shown in various views with relative movement of the coupling with respect to the syringe and opening / closing of the hook.

[0068] Figure 6 The mechanism for detaching the syringe is shown in various views, with relative movement of the coupling with respect to the syringe, and hook opening / closing.

[0069] The accompanying drawings show an embodiment of the present invention, wherein the components are in a vertical orientation. However, the present invention is not limited to this specific orientation, and it should be understood that embodiments in another appropriate orientation fall within the scope of protection of the present invention. DETAILED DESCRIPTION

[0070] According to the invention a specific system has been developed for holding a pusher of a syringe.

[0071] Figure 2 Shown are: a fixed structure 1 having a bearing surface 2 for a connector; a syringe actuator 3, its coupling device 4; a syringe in a position fixed to the connector 4, with its body 5 and pusher 6; a system 8 for fixing the syringe to a base; a three-way valve 9; and the starting points of the corresponding collecting tube 10, saline connection tube 11 and injection tube 12.

[0072] exist Figure 2 On the right side of the figure, the coupling 4 is shown in detail in a cross-sectional view. The pusher button 7 of the syringe inserted into the coupling can also be seen.

[0073] Figure 3 The passive coupling device 4 and its different components are shown separately, namely:

[0074] - a coupling body 41;

[0075] - gap occupying plate 42 and its prestressing spring 43;

[0076] - a plurality of pivoting hooks 44;

[0077] - a prestressed return spring 45 for each pair of hooks 44; and

[0078] A sleeve 46 for controlling the opening of the hook 44 .

[0079] Figure 4 a) shows the coupling 4 in the default (or rest) state, ie with the hook 44 closed. Figure 4 b) shows the coupling 4 with the hook 44 opened due to the relative movement of the sleeve 46 with respect to the body 41 of the coupling.

[0080] According to one embodiment, the hooks 44 are mounted longitudinally in pairs, the same pair of hooks being connected by a return spring 45 arranged along an axis perpendicular to the central axis of the hook and fixed to the hook at the lower part of the hook. There are, for example, two pairs of vertical hooks 44, whose corresponding springs 45 are also vertical and located at different heights. The hooks 44 are mounted to pivot around a pin 47, which is located at about half the height of the hook. In the top-down direction, each hook 44 has an inwardly protruding portion 48, followed by a recess 49, which will allow the pusher button of the syringe to be locked on the gap occupying plate once the pusher button 7 and the gap occupying plate 42 are engaged. In addition, according to the present invention, the rising movement of the sleeve 46 relative to the coupling body 41 will serve to open the hook and release the pusher button 7 and the pusher 6 of the syringe. To this end, the external structure of the hook 44 must cooperate with the internal structure of the sleeve 46. According to one embodiment, the lower outer part of the hook is provided with a protrusion 50 and the inner part of the sleeve is provided with a hollow profile 51 corresponding to the desired displacement of the protrusion 50 when the sleeve is raised relative to the body of the coupling. In the default position, the hook 44 of the coupling 4 is closed, the protrusion 50 of the hook is located in the hollow profile 51 of the sleeve ( Figure 4 a). When the coupling body 41 moves downwardly relative to the sleeve, the projections 50 move downwardly away from the inner contour of the sleeve 51 and the contact of the projections 50 with the lower edge of the protruding contour 51 automatically pivots each hook 44 about its pivot pin 47 so that the hooks open outwardly and release the pusher button 7 and, therefore, the pusher 6 of the syringe.

[0081] Figure 5 The mechanism for fixing the syringe 5 (assuming it is fixed) is shown in three successive steps, with relative movement of the coupling 4 with respect to the syringe 5 and opening / closing of the hook 44 .

[0082] By moving in the injection direction, the coupler 4 contacts and hooks onto the pusher button 7 of the syringe 5. The opening of the hook 44 is caused by the contact of the pusher button 7 of the syringe 5 on the hook 44 ( Figure 5b). Once the push button 7 of the syringe 5 extends beyond the end of the protruding portion 48 of the hook 24 ( Figure 5 b) Closing of the hook 44 on the pusher button 7 occurs, thereby compressing the gap-occupying plate 42 mounted on the prestressed spring 43 so that it engages in the recess 49 of the hook ( Figure 5 c).

[0083] The plate 42 mounted on its prestressed spring 43 occupies the gap between the clamping hook 44 and the upper bearing surface of the pusher button 7 and the gap between the lower bearing surface of the pusher button 7 and the gap occupying plate 42. The hooking process requires overcoming the force of the spring.

[0084] Once hooked together, pusher 6 and actuator 3 are rigidly held together within the limits of the force of the prestressed springs of the plate, whatever the direction of movement of actuator 3 ( Figure 5 c).

[0085] Figure 6 The different steps for separating the syringe are shown (from left to right). Separation is initiated by a maximum downward retraction movement of the actuator ( Figure 6 a). When the coupler 4 is lowered, the sleeve 46 comes into contact with the bearing surface 2 of the fixed structure 1, which prevents the sleeve 46 from moving further downwards, while the body 41 of the coupler 4 continues to move downwards. Through its relative movement relative to the body 41 of the coupler, the sleeve 46 uses its internal contour to bear on the protrusion of the hook 44 so as to pivot the hook and open it (as described above). When the hook moves apart, the pusher button 7 is then separated from the coupler 4, and the pusher 6 can automatically rise upwards. In fact, if the downward movement of the pusher 6 has been achieved when the three-way valve is in the closed position, it creates a negative pressure in the syringe, and once the hook 44 is opened, the pusher 6 immediately rises back into the body 5 of the syringe. The syringe 5 is released from the coupler 4 and the kit can be easily removed from the machine.

[0086] The disconnection can also be done manually by lifting the sleeve 46, the actuator being stopped (not part of the invention).

[0087] The sleeve 46 can be attached (a) to a coupling (as shown above) or (b) to a bearing surface of a fixed structure. It should be noted that in the latter case it cannot be manually actuated.

[0088] Description of the Preferred Embodiments of the Invention

[0089] In a preferred embodiment of the invention, the syringe has a nominal capacity of 10 mL for a stroke of approximately 48 mm, and the plunger may move several millimeters (mm) beyond the nominal fill. 10 mL to 15 mL represents a typical volume of radiopharmaceuticals delivered in vials for TEP (positron emission tomography).

[0090] Pediatric doses of 18F-FDG can be as low as 30 MBq, for example, while adult doses are in the range of 200 MBq to 300 MBq. This is the most difficult case if the concentration of the starting solution is high, for example 30 GBq in 10 mL, and a pediatric dose should be prepared. The volume to be drawn is then 10*(30 / 30000) mL=0.01 mL (=10 μL).

[0091] The minimum collection volume considered, and therefore the minimum change in target volume (ΔV), is ~0.01 mL, with an expected accuracy of ±10%. This ΔV corresponds to a displacement of 0.01 [mL] * (48 mm / 10 mL) = 0.048 mm, or 48 ± 6 μm.

[0092] The resolution of a push syringe device is ~2 μm and such dosing can only be accomplished with the required accuracy without any play and with good control of the applied force.

[0093] According to another embodiment of the invention, a force sensor (not shown) is arranged behind the coupling mechanism between the actuator and the coupling device and is used to measure the forces directly during injection and during coupling, which in particular allows:

[0094] - Check that the connection has actually been made by creating a vacuum in the syringe;

[0095] - Checking the pressure difference in the kit, since the pressure exerted on the syringe plunger by the substance in the syringe is transmitted to the pusher button directly connected to the coupling, which itself is connected to the actuator via the force sensor in question. Thus, anomalies in the kit (such as a crushed tube) can be detected when the fluid moves with the syringe.

[0096] List of Reference Numerals

[0097] 1 Fixed structure (base)

[0098] 2 Support surface

[0099] 3 Actuator

[0100] 4 Connectors

[0101] 5. Syringe (barrel)

[0102] 6 Pusher

[0103] 7 Pusher buttons

[0104] 8 Syringe fixing system

[0105] 9 Three-way valve

[0106] 10 Collection pipeline

[0107] 11 Brine connection line

[0108] 12 Injection Line

[0109] 41 Connector body

[0110] 42 Gap Occupancy Plate

[0111] 43 Prestressed spring (from the occupying plate) 44 Pivot Hook

[0112] 45 Return spring (a pair of hooks)

[0113] 46 Connecting sleeve

[0114] 47 Pivot pin

[0115] 48 hook protrusion

[0116] 49 Hook recess

[0117] 50 bulge

[0118] 51 Internal profile of sleeve

[0119] 100 Radiopharmaceutical Kit

[0120] 101 Syringe

[0121] 102 Valve-Syringe Connection Line

[0122] 103 Three-way valve

[0123] 104 T-tube

[0124] 105, 105' Check Valve

[0125] 106 Collection pipeline

[0126] 107 Vials of concentrated radiopharmaceuticals

[0127] 108 Brine connection line

[0128] 109 Saline Vial

[0129] 110 Injection Line

[0130] 111 Ventilation filter

[0131] 112, 112' Bubble Detector

[0132] 113 Self-closing Luer connector

[0133] 114 Patient Extension Device

[0134] 115 Machine Luer Connector

[0135] 116 Patient Luer

[0136] 117 Dose Calibrator

[0137] 118 puncture needle

Claims

1. 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) intended to move along the longitudinal axis relative to the inner body (41), the inner body (41) comprising: A sliding pin terminating in a gap-occupying plate (42) which is longitudinally held in a rest position inside the inner body (41) by a prestressed spring (43); and at least one pair of hooks (44) arranged longitudinally inside the inner body (41) and mounted to pivot and retract in pairs relative to two corresponding pins (47) perpendicular to the longitudinal axis, the outer portion of these hooks (44) being positioned opposite the inner portion of the sleeve (46), characterized in that the same pair of hooks (44) each have a zone (48, 49) for hooking the proximal end of the gap-occupying plate (42) and are connected to each other at the distal end by a return spring (45), the distal portions of these hooks (44) being provided with a projection (50) outwardly which is intended to be retracted in the coupling device. The sleeve (46) is inserted into a hollow area of ​​a first depth of the internal profile (51) of the sleeve (46) in a static position, in which the hooking areas (48, 49) of the hooks (44) are in a contact position for locking the pusher button (7), the hooks (44) are closed together, and the sleeve (46) slides relatively with respect to the internal body (41), wherein the sleeve (46) moves away from the distal end of the hooks (44), thereby causing the hooks (44) to open by pivoting around their corresponding pivot pins (47) because the protrusion (50) of each hook (44) penetrates a hollow area of ​​a second depth of the internal profile (51) of the sleeve (46), the hollow area of ​​the second depth being adjacent to the hollow area of ​​the first depth, the first depth being greater than the second depth.

2. The device (4) according to claim 1, characterized in that The device comprises 2 to 4 pairs of hooks (44).

3. The device (4) according to claim 1, characterized in that The hooks (44) have a hooking area defined by a projection (48) with an inwardly inclined chamfer, below which follows a recess (49) whose dimensions are designed to lock the gap-occupying plate (42) pushed by its prestressed spring (43) and abutting against the pusher button (7) of the syringe (5) without play by means of the hooks (44).

4. A reversible coupling of a syringe (5) and an actuator (3) for injecting a calibration product, the syringe (5) being provided with a pusher (6) with a pusher button (7), the actuator (3) being intended to be coupled to the pusher (6) of the syringe (5) by means of a device (4) according to any one of the preceding claims, characterized in that In the coupled position, the pusher button (7) of the syringe (5) is locked in the recess (49) between the protruding parts (48) of the hooks (44) and the gap occupying plate (42), which exerts a force directed towards the pusher (7) via the prestressed spring (43), thereby eliminating any gap between the pusher (7) and the coupling device (4).

5. The reversible connection according to claim 4, characterized in that: The reversible coupling comprises a force sensor which is arranged behind the coupling mechanism between the actuator (3) and the coupling device (4) and which is intended to measure the forces directly during injection and during coupling.

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

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

8. A method for reversibly coupling at least one syringe (5) and an actuator (3) and for separating the actuator from the syringe (5), the method implementing a coupling device (4) according to any one of claims 1 to 3, the method comprising a coupling step and a separation step, the coupling being characterized by the following steps: - the coupling device (4) is in the rest position, wherein the coupling body (41) projects towards the syringe (5) relative to the sleeve (46); - the actuator pushes the coupling (4) towards the pusher button (7) of the syringe (5); - the pusher button (7) pushes the hooks (44) at the level of its chamfer and causes them to open, the projections (50) of the hooks (44) being successively displaced from contact with the hollow zone of the first depth of the internal profile (51) of the sleeve (46) to a non-contact position; - once the pusher button (7) reaches the end of the protruding parts (48) of the hooks (44), due to the return spring (45), the pusher button (7) and the gap occupying plate (42) contact the recess (49) and are inserted therein, The closing of the hooks (44) on the pusher button (7) is automatic; as well as The pusher button (7) is locked without play between the hooks (44) and the play-occupying plate (42).

9. A method for reversibly coupling a syringe (5) and an actuator (3) and for separating the actuator from the syringe, the separation being characterized by the following steps, once the reversible coupling of the syringe (5) and the actuator (3) has been carried out according to claim 8: - from the rest position of the coupling (4), the actuator pulls the coupling in a direction to withdraw the pusher from the syringe (5); - the sleeve (46) comes to rest against the bearing surface (2) of the base (1) of the actuator (3) and stops, The body (41) continues to move under the action of the actuator (3); - the outer profile of the hooks (44) cooperates by contact with the hollow zone of the inner profile of the sleeve (46), the projections (50) of the hooks (44) being successively displaced from contact with the hollow zone of a first depth of the inner profile (51) of the sleeve (46) to contact with the hollow zone of a second depth of said profile (51), so as to pivot the hooks (44) and open them; - the pusher button (7) is separated from the coupling (4) and, if negative pressure is previously generated in the syringe (5) by closing the valve in the downstream line communicating with the syringe, the pusher (6) automatically rises into the syringe body (5) once the hooks (44) are opened; - The syringe (5) is released from the coupling (4) and can be removed.

Images