Device for administering predetermined amount of compound to patient

Abstract

A device (1) for administering a predetermined amount of a compound to a patient, comprising: a predetermined volume of a reservoir (2) and a piston (3) slidably mounted in the reservoir; at least one compartment (5) for receiving a predetermined amount of compound; a mouthpiece (6) having an internal passage (7) and being configurable in at least one rest position in which the mouth of the patient cannot contact the mouthpiece (6); a dose body (9) comprising at least one dose conduit (10) of a compound; an actuation mechanism (8) for moving the dose body (9) between a loading position of the compound, in which the dose conduit (10) communicates with the compartment (5), and a dosing position, in which the dose conduit (10) communicates the reservoir (2) and the channel (7). The plunger (3) is operably connected to an actuation mechanism (8).

Description

Technical Field

[0001] The present invention relates to a device for administering a predetermined amount of a compound to a patient.

[0002] The present invention is applied to the oral administration of a certain volume of a substance (e.g., a drug) in microliter doses to a patient. Background Art

[0003] Thanks to the great development of nanomaterials in nanomedicine and nanotoxicology research, drug administration by inhalation of substances in the form of gases, liquids or powders has grown exponentially in preclinical and clinical studies.

[0004] For certain drugs with poor intravenous injection effects or those that are difficult to reach the target or are slow, inhalation administration has also become a popular alternative method.

[0005] There are various types of metered-dose inhalers known, i.e., pressure devices for applying drug products to the respiratory tract by inhalation.

[0006] Such metered-dose inhalers (abbreviated as MDI (metered-dose inhaler) in the industry) include a drug reservoir and a metering valve. The drug reservoir contains a suspension or a drug formulation dissolved in a liquid propellant, and the metering valve is installed in the drug reservoir. By manually operating the dose valve, a certain dose of the product can be dispensed with the help of the propellant that serves as the carrier of the drug formulation.

[0007] The main disadvantages of the prior art metered-dose inhalers are that the device contains a compound (e.g., a drug) mixed with a propellant or only contains a powdered drug without any propellant.

[0008] Another disadvantage is that the patient has to independently manage the therapy prescribed by the doctor. Summary of the Invention

[0009] In this context, the technical task of the present invention is to propose a device for administering a predetermined amount of a compound to a patient, which eliminates the above-mentioned disadvantages of the prior art.

[0010] Specifically, the object of the present invention is to propose a device for administering a predetermined amount of a compound to a patient, wherein the compound is not contained inside the device.

[0011] Another object of the present invention is to provide a device for administering a predetermined amount of a compound to a patient, which is easy to use and safe.

[0012] The above-mentioned technical task and specific object are basically achieved by a device for administering a predetermined amount of a compound to a patient, the device comprising:

[0013] a drug reservoir of a predetermined capacity;

[0014] A plunger or piston, slidably mounted inside a reservoir;

[0015] At least one compartment or housing, receiving a predetermined amount of a compound;

[0016] A nozzle, configurable to be in at least one rest position and an operating position, in the rest position, the patient's mouth cannot contact the nozzle, in the operating position, the patient's mouth can contact the nozzle, the nozzle including an internal passage for discharging the compound;

[0017] A dose body, including at least one dose conduit for the compound;

[0018] An actuation mechanism, configured to move the dose body between a loading position and a dosing position, in the loading position, the dose conduit is in communication with the compartment to receive a predetermined amount of the compound, in the dosing position, one side of the dose conduit is in communication with the reservoir and the other side is in communication with the passage of the nozzle.

[0019] The plunger is operably connected to the actuation mechanism.

[0020] According to a first embodiment, the reservoir is selectively in communication with the environment external to the device to accommodate a gaseous mixture. Preferably, the plunger defines a compression mechanism for compressing the gaseous mixture contained in the reservoir.

[0021] Preferably, the dose conduit extends between a first end and a second end, the dose conduit being shaped such that: in the loading position, the first end is in communication with the compartment, in the dosing position, the first end is in communication with the passage and the second end is in communication with the reservoir.

[0022] According to a second embodiment, when the dose body moves towards the loading position, the plunger operably acts on the reservoir to create a vacuum.

[0023] Preferably, the device includes a conduit branch originating from the reservoir. The dose conduit extends between a first end and a second end, the dose conduit being shaped such that: in the loading position, the first end is in communication with the compartment and the second end is in direct communication with the reservoir; in the dosing position, the first end is in communication with the passage and the second end is in communication with the conduit branch.

[0024] According to one embodiment, the dose conduit has a three-way extension and includes a third end. The dose conduit is shaped such that: in the loading position, the third end is in communication with the external environment, in the dosing position, the third end is in communication with the reservoir.

[0025] According to one embodiment, the actuation mechanism includes at least one arm rotatable about an axis between a first position and a second position. The dose body is connected to the arm to rotate therewith.

[0026] According to one embodiment, the device includes a conversion mechanism for converting the rotational movement of an arm into the translational movement of a compression mechanism.

[0027] According to one embodiment, the conversion mechanism includes a pinion connected to the arm and a rack constrained to the compression mechanism. The rack is slidably coupled to the pinion.

[0028] According to one embodiment, the device includes a mechanical or magnetic stop mechanism configured to hold the arm in a third intermediate position between a first position and a second position.

[0029] Preferably, the stop mechanism acts operatively on the rack to prevent it from sliding in a predetermined position corresponding to the third position of the arm.

[0030] Preferably, the device includes a counter for recording the number of administrations. The counter is configured to increment the total number of administrations performed by one each time the arm moves from the third position to the second position.

[0031] According to one embodiment, the device includes:

[0032] a baffle arranged inside the channel and movable between a first position and a second position, in the first position, the baffle allows fluid to pass through the channel, and in the second position, the baffle prevents fluid from passing through the channel;

[0033] a moving mechanism for moving the baffle from the first position to the second position, the moving mechanism being shaped to be activated in response to the sucking action of the patient's docking nozzle.

[0034] According to one embodiment, the channel includes a first section and a second section. The cross-sectional dimension of the first section is smaller than that of the second section. The baffle is arranged to prevent fluid from flowing from the first section to the second section in the second position.

[0035] According to one embodiment, the device further includes:

[0036] one or more air inlets selectively communicating with the first section of the channel;

[0037] a closure for each air inlet, movable between a closed position and an open position, in the closed position, the closure blocks the air inlet, and in the open position, the closure allows air to pass through the air inlet;

[0038] a moving mechanism for moving the closure between the two positions, the moving mechanism being shaped to configure the closure in the open position in response to the patient's sucking.

[0039] According to one embodiment, the arm and the nozzle are shaped such that in their movement towards the second position, the arm forces the nozzle to reach its operating position.

[0040] According to one embodiment, the compartment is shaped to receive a capsule containing the predetermined amount of the compound.

[0041] According to one embodiment, the device includes a plurality of compartments that are selectively positioned in a predetermined area and, at a loading position of the dose body, the compartments communicate with a conduit in the predetermined area.

[0042] According to one embodiment, the device further includes:

[0043] an identification system for identifying the position of each compartment;

[0044] a control unit configured to receive information about the position of each compartment from the identification system and provide instructions or information to the patient regarding the specific compartment to be selected. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Further features and advantages of the present invention will become more apparent from the following illustrative but non - restrictive description of a preferred but non - exclusive embodiment of a device for administering a predetermined amount of a compound to a patient, as shown in the drawings, in which:

[0046] Figure 1a and Figure 1b a first embodiment of a device for administering a predetermined amount of a compound to a patient in an unused state according to the present invention (the plunger is for compressing the gaseous mixture) is shown in side view and side cross - section respectively;

[0047] Figure 2a and Figure 2b show respectively Figure 1a and Figure 1b side views and side cross - sections of the device in a loaded state in the embodiments of;

[0048] Figure 3a and Figure 3b show respectively Figure 1a and Figure 1b side views and cross - sectional side views of the device in the embodiments of, where the nozzle is in an operating position;

[0049] Figure 4a and Figure 4b show respectively Figure 1a and Figure 1b side views and side cross - sections of the device in a third intermediate position of the arm in the embodiments of;

[0050] Figure 5a and Figure 5b show respectively Figure 1a and Figure 1b side views and side cross - sections of the device in a dosing state in the embodiments of;

[0051] Figures 6a to 6eShows a second embodiment of a device for administering a predetermined amount of a compound to a patient (the plunger operates under reduced pressure) in the states shown for the first embodiment in Figure 1b , Figure 2b , Figure 3b , Figure 4b , Figure 5b respectively; a side sectional view;

[0052] Figures 7a to 7e Shows a side sectional view of an alternative embodiment (a three-way) of the dosing catheter of the device in the states shown in Figures 6a to 6e respectively;

[0053] Figure 8a And Figure 8b Shows an alternative embodiment of the device in which a tap is provided between the dosing body and the reservoir, Figure 8a And Figure 8b The alternative embodiment of the device is shown in two side sectional views with the tap closed and open respectively.

[0054] Figure 9a And Figure 9b Shows Figure 8a And Figure 8b Another embodiment of the device, in which the communication between the reservoir and the channel is achieved through a tap and a shutter;

[0055] Figures 10a to 10e Shows the device in the first embodiment of the plunger in the states shown in Figure 1b , Figure 2b , Figure 3b , Figure 4b , Figure 5b respectively, in which the administration of the compound to the patient is triggered by sucking together with pressing a button;

[0056] Figures 11a to 11e Shows the device in the second embodiment of the plunger in the states shown in Figures 6a to 6e respectively, in which the administration of the compound to the patient is triggered by sucking together with pressing a button;

[0057] Figure 12a And Figure 12b Shows the housing of a device for administering a predetermined amount of a compound to a patient according to the present invention, in the stationary position and the operating position of the nozzle respectively;

[0058] Figure 13 The loading drum of the compound is shown in a perspective view. Detailed Description

[0059] Referring to the accompanying drawings, the numeral 1 denotes a device for administering a predetermined amount of a compound to a patient. For example, the compound can be presented in different states: liquid, gas, powder or hydrogel.

[0060] According to one aspect of the present invention, the compound is a drug.

[0061] The device 1 includes a reservoir 2 of a predetermined capacity. Specifically, reservoirs of different capacities can be selected according to needs, and these reservoirs can be connected in series or in parallel.

[0062] The device 1 includes a plunger or piston 3 slidably mounted within the reservoir 2. Preferably, the device 1 includes a hollow cylinder constituting the reservoir 2 for a gaseous mixture. The plunger 3 is slidably mounted within the hollow cylinder 2.

[0063] The device 1 includes at least one compartment or housing 5 for receiving a predetermined amount of the compound.

[0064] The device 1 includes a mouthpiece 6 for the patient to place in the mouth to orally administer a predetermined amount of the compound. The mouthpiece 6 can be configured in at least one rest position (where the mouthpiece 6 cannot contact the patient's mouth) and an operating position (where the mouthpiece 6 can contact the patient's mouth). The mouthpiece 6 includes an internal channel 7 for discharging the compound.

[0065] The device 1 includes a dosing body 9, and within the dosing body 9 there are one or more dosing conduits 10. Herein, the dosing body 9 is referred to as the "lung".

[0066] Specifically, the lung 9 is a calibrated lung.

[0067] The device 1 further includes an actuating mechanism 8 for the lung 9, which is configured to rotate the lung 9 and move it between different positions.

[0068] According to one embodiment, the actuating mechanism 8 includes at least one arm 8, which can rotate about an axis X between a first position and a second position.

[0069] In the embodiment shown herein, the dosing body 9 includes a dosing conduit 10 for the compound. The dosing body 9 is connected to the arm 8 so as to rotate with it.

[0070] Specifically, the dosing body 9 can rotate between:

[0071] a loading position, where the dosing conduit 10 is in fluid communication with the compartment 5 to receive a predetermined amount of the compound, and

[0072] a dosing or dispensing position, where the dosing conduit 10 is in fluid communication with the reservoir 2 on one side and the channel 7 of the mouthpiece 6 (configured in the operating position) on the other side.

[0073] The loading position of the dose body 9 corresponds to the first position of the arm 8. The dosing position of the dose body 9 corresponds to the second position of the arm 8.

[0074] Preferably, at the first and second positions, the arm 8 is arranged on the opposite side with respect to the dose body 9. Preferably, at the first position, the arm 8 extends upward away from the axis X. Preferably, at the second position, the arm 8 extends downward away from the axis X.

[0075] The plunger 3 is operatively connected to the actuating mechanism 8 so that the plunger 3 can move within the reservoir 2 when the dose body 9 rotates between the respective positions. Specifically, the plunger 3 can slide between the first position and the second position. At the first position, the plunger 3 is positioned adjacent to the dose body 9; at the second position, the plunger 3 is positioned away from the dose body 9. That is, at the first position, the distance of the plunger 3 relative to the dose body 9 is shorter than that at the second position.

[0076] When the dose body 9 moves from the loading position to the dosing position, the plunger 3 moves from the second position to the first position, that is, closer to the dose body 9. Specifically, when the arm 8 is in the first position, that is, when the dose body 9 is in the loading position, the plunger 3 is in the first position (the distance from the dose body 9 is the smallest).

[0077] By changing the stroke of the plunger 3, that is, the distance between the first position and the second position, the pressure value applied will change.

[0078] In the embodiment described and illustrated herein, the device 1 includes a box-shaped housing 30 provided with an upper cover 31.

[0079] At least the reservoir 2, the plunger 3, the compound compartment 5, the dose body 9 and the actuating mechanism 8 are accommodated within the box-shaped body 30.

[0080] In the embodiment described and illustrated herein, the nozzle 6 is rotatably mounted in the box-shaped housing 30.

[0081] In the rest position, the nozzle 6 is located inside the box-shaped housing 30, specifically below the cover 31, which is provided with a silicone protrusion 32 to prevent dust or foreign objects from entering the inside of the nozzle. In the operating position, the nozzle 6 at least partially protrudes from the box-shaped housing 30 so as to be accessible to the patient's mouth.

[0082] According to the first embodiment, the reservoir 2 is selectively in communication with the external environment of the device 1 to accommodate a gaseous mixture. The plunger 3 defines a compression mechanism for compressing the gaseous mixture accommodated in the reservoir 2. Preferably, the gaseous mixture is air.

[0083] The compressed gaseous mixture is intended to act as a propellant for the compound.

[0084] According to the embodiments described and illustrated herein, the gaseous mixture contained in the hollow cylinder 2 is compressed by pushing the plunger 3.

[0085] Preferably, the device 1 includes a one-way valve 4 configured to enable the reservoir 2 to selectively communicate with the external environment.

[0086] In this first embodiment, the dose conduit 10 extends between a first end 10a and a second end 10b. In the loading position, the first end 10a communicates with the compartment 5. In the dosing position, the second end 10b communicates with the reservoir 2 and the first end 10a communicates with the channel 7 of the nozzle 6.

[0087] Advantageously, the compression mechanism 3 is operatively connected to the arm 8 for compressing the gaseous mixture when the arm 8 moves towards the second position.

[0088] Thus, only by the patient's movement of the arm 8, the rotation of the dose body 9 between the loading position and the dosing position and the compression of the gaseous mixture can be achieved.

[0089] In a preferred embodiment, there are two arms 8 arranged on opposite sides of the dose body 9.

[0090] The cycle of administering the compound to the patient is as follows.

[0091] The arm 8 is brought to the first position such that the dose body 9 is in the loading position.

[0092] Accordingly, the dose conduit 10 is in fluid communication with the compartment 5 and receives a predetermined amount of the compound.

[0093] In this loading step, the nozzle 6 is located inside the cartridge body 30 and is inaccessible to the patient.

[0094] Once the loading is complete, the arm 8 moves from the first position to the second position.

[0095] During the rotation of the arm 8 towards the second position, the dose body 9 rotates between the loading position and the dosing position while the gaseous mixture is compressed by the compression mechanism 3.

[0096] When the arm 8 reaches the second position, the dose conduit 10 communicates with the upstream reservoir 2 and with the channel 7 of the downstream nozzle 6.

[0097] Simultaneously, the configuration of the nozzle 6 also changes and it moves to the operating position where it partially extends outside the cartridge body 30 so as to be accessible to the patient's mouth.

[0098] The compressed gaseous mixture is dispensed through the channel 7 of the nozzle 6 via the dose conduit 10. Thus, the gaseous mixture acts as a carrier, i.e., it carries the predetermined amount of the compound in the dose conduit 10 and thus enters the patient's mouth.

[0099] According to the second embodiment, the plunger 3 operably acts on the reservoir 2 to create a vacuum. In this case, in technical terms, the expression "forming a vacuum" is used.

[0100] Specifically, when the plunger 3 moves away from the dose body 9, i.e., when it moves from the first position to the second position, a vacuum is created. This occurs when the dose body 9 rotates towards the loading position.

[0101] Preferably, the device 1 includes a catheter branch 16 originating from the reservoir 2. The dose catheter 10 extends between a first end 10a and a second end 10b. In the loading position, the first end 10a communicates with the compartment 5, while the second end 10b communicates directly with the reservoir 2. Thus, once the dose body 9 reaches the loading position, due to the vacuum created by the plunger 3, the compound is inhaled into the reservoir 2 through the dose catheter 10. Therefore, the dose catheter 10 and the reservoir 2 define two "lungs" in series.

[0102] In the dosing position, the first end 10a communicates with the channel 7 of the nozzle 6, while the second end 10b communicates with the catheter branch 16 (and thus indirectly with the reservoir 2).

[0103] The second embodiment is preferably employed when the compound to be administered is a mixture. In this case, the compartment 5 is shaped to accommodate a vial of the compound. Generally, the vial is screwed into the compartment 5.

[0104] The cycle of administering the compound to the patient is as follows.

[0105] The arm 8 is brought to the first position such that the dose body 9 is in the loading position.

[0106] Thus, the dose catheter 10 is in fluid communication with the compartment 5 on one side and with the reservoir 2 on the other side. The plunger 3 creates a vacuum, causing the reservoir 2 to receive a predetermined amount of the compound in the form of a mixture through the dose catheter 10.

[0107] In this loading step, the nozzle 6 is located inside the box-shaped body 30 and is inaccessible to the patient.

[0108] Once the loading is complete, the arm 8 moves from the first position to the second position.

[0109] During the rotation of the arm 8 towards the second position, the dose body 9 rotates between the loading position and the dosing position while the compound mixture is compressed by the plunger 3.

[0110] When the arm 8 reaches the second position, the dose catheter 10 communicates with the upstream reservoir 2 and with the downstream channel 7 of the nozzle 6.

[0111] At the same time, the configuration of the mouthpiece 6 has also changed and it has been moved to the operating position so that a part thereof extends outside the box-shaped body 30 to be accessible to the patient's mouth.

[0112] The compressed gaseous mixture is dispensed through the branch 16 and the dosing catheter 10 from the channel 7 of the mouthpiece 6.

[0113] According to an alternative embodiment of the second embodiment, the dosing catheter 10 has a tee extension and thus includes a first end 10a, a second end 10b and a third end 10c. Except for what has been described above for the second embodiment, the dosing catheter 10 is shaped such that: in the loading position, the third end 10c communicates with the external environment, and in the dosing position, the third end 10c communicates directly with the reservoir 2.

[0114] This embodiment is preferred when the compound is in liquid form. In the loading position, the third end 10c sucks in air and mixes the air with the compound sucked in by the vacuum through the reservoir 2.

[0115] Preferably, the mouthpiece 6 rotates about an axis X between a rest position and an operating position. In a preferred embodiment, the arm 8 and the mouthpiece 6 are shaped to cooperate with each other such that when the arm 8 moves towards the second position, it forces the mouthpiece 6 to reach its operating position.

[0116] In an alternative embodiment (not shown), the patient manually positions the mouthpiece 6 in the operating position.

[0117] Preferably, the dosing body 9 is substantially cylindrical. That is to say, the dosing body 9 is a canister.

[0118] Preferably, the dosing body 9 includes a plurality of dosing catheters 10 for simultaneously administering multiple drugs. These dosing catheters 10 are independent of each other. That is to say, these dosing catheters 10 do not communicate with each other.

[0119] Preferably, the device 1 includes conversion mechanisms 11, 12 for converting the rotational movement of the arm 8 into the translational movement of the compression mechanism 3.

[0120] In the embodiments described and illustrated herein, the conversion mechanism includes a pinion 11 integral with the arm 8 and a rack 12 integral with the compression mechanism 3. The rack 12 is slidably connected to the pinion 11. Thus, the rotation of the pinion 11 (due to the arm 8) is converted into the translation of the rack 12, and thus into the translation of the compression mechanism 3.

[0121] In an embodiment where the compression mechanism 3 is a plunger, the plunger is connected to the rack 12.

[0122] As an alternative to the rack and pinion pair, any known mechanism or system that allows the conversion of rotational movement into translational movement can be used.

[0123] According to one embodiment, the device 1 includes a mechanical or magnetic stop mechanism 13 that positions the arm 8 at a third intermediate position between a first position and a second position. Thus, the patient must apply a force greater than the resistance exerted by the stop mechanism 13 in order to move the arm 8 beyond the third position and reach the second position.

[0124] Once in the second position, the dose conduit 10 is in communication with the upstream reservoir 2 (directly in the first embodiment and indirectly via a branch 16 in the second embodiment), and with the channel 7 of the nozzle 6 downstream, to dispense a predetermined amount of the compound. Specifically, in the first embodiment, the compressed gaseous mixture in the reservoir 2 contacts the predetermined amount of the compound in the dose conduit 10 and transports it into the channel 7 of the nozzle 6 and then into the patient's mouth.

[0125] In the second embodiment, the compressed compound mixture in the reservoir 2 flows through the branch 16, the dose conduit 10, and the channel 7 of the nozzle 6 to reach the patient's oral path.

[0126] In such an embodiment with the stop mechanism 13, the administration of the compound is triggered by the patient's pushing force on the arm 8.

[0127] Preferably, the stop mechanism 13 acts operatively on the rack 12 to prevent its sliding when a predetermined position is reached, which corresponds to the third position of the arm 8. Preferably, one or more magnets are arranged within the box-shaped housing 30, and one or more ferromagnetic portions are arranged on the rack 12, and vice versa.

[0128] Preferably, the device 1 includes a counter for recording the number of administrations performed. The counter is configured to increment the total number of administrations performed by one each time the arm 8 moves from the third position to the second position. In this embodiment, this step is used to identify successful administration.

[0129] According to another embodiment, the device 1 includes a baffle 14 disposed within the channel 7 of the nozzle 6. The baffle 14 is movable between a first position and a second position, in which, in the first position, the baffle 14 allows fluid to pass through the channel 7, and in the second position, the baffle 14 prevents fluid from passing through the channel 7. Thus, in this case, the first position of the baffle 14 is associated with an open configuration of the channel 7, while the second position of the baffle 14 is associated with a closed configuration of the channel 7.

[0130] Specifically, the baffle 14 is a cover.

[0131] In one embodiment, the baffle 14 is manually operated.

[0132] Preferably, the device 1 includes a moving mechanism for moving the baffle 14 between the first position and the second position.

[0133] In one embodiment, the device 1 includes a button 26 operably connected to a moving mechanism of the baffle 14. When the patient presses the button 26, the moving mechanism configures the baffle 14 in a first open position.

[0134] In one embodiment, the moving mechanism is shaped to be activated in response to a sucking action of the patient's docking nozzle 6.

[0135] In such an embodiment, the administration of the compound is triggered by the patient's sucking.

[0136] Preferably, the baffle 14 is a membrane whose tension is calibrated to open under the vacuum generated by the patient's sucking. This can solve the synchronization problem between the patient's breathing and the triggering of drug administration, which is crucial for certain clinical situations.

[0137] Preferably, the device 1 includes an auxiliary channel 27 that extends between one end in communication with the external environment and one end facing the dose body 9. Preferably, the auxiliary channel 27 is located on the opposite side relative to the nozzle 6. The device 1 includes an air loading valve 28 that is provided at the end in communication with the external environment for establishing selective communication with the external environment. Specifically, the air loading valve 28 moves between a closed position and an open position.

[0138] Preferably, the button 26 is operably connected to the air loading valve 28 and the baffle 14 to synchronously configure them in an open or closed position.

[0139] Consider an embodiment in which the dose catheter 10 is a three-way one.

[0140] In a first embodiment of the plunger 3, a gaseous mixture is used as a propellant. In the compound loading step, the air loading valve 28 and the baffle 14 are opened. By acting on the arm 8 to bring the dose body 9 into the loading position, the piston 3 moves to a second position (i.e., the position at the maximum distance from the dose body 9). During this movement, air is drawn back into the reservoir 2. During this operation, the compound is transported from the compartment 5 to the dose catheter 10.

[0141] Subsequently, the baffle 14 and the air loading valve 28 are closed, and by acting on the arm 8, the dose body 9 is moved towards the administration position. During this movement, the piston 3 moves to a first position, i.e., the position at the minimum distance from the dose body 9, applying pressure to the gaseous mixture (air) in the reservoir 2. After reaching the second position, the patient can inhale and simultaneously press the button 26 to trigger drug administration. The air loading valve 28 and the baffle 14 open, and the compressed air in the reservoir 2 flows through the dose catheter 10 together with the ambient air entering through the auxiliary channel 27. This air flow impinges to carry the compound in the dose catheter 10, which then enters the patient's mouth through the channel 7.

[0142] In a second embodiment of the plunger 3, a vacuum is generated within the reservoir 2, and during the compound loading step, the air loading valve 28 and the baffle 14 remain closed. By acting on the arm 8 to move the dose body 9 into the loading position, the piston 3 moves to a second position (i.e., the position at the maximum distance from the dose body 9), thereby generating a vacuum. During this operation, due to the negative pressure generated within the reservoir 2, the compound is drawn in.

[0143] The remaining operations are carried out in the same manner as described above.

[0144] Preferably, the presence of the baffle 14 inside the channel 7 serves to define the first and second sections of the channel 7.

[0145] The baffle 14 is arranged between the first and second sections such that, in the first position, the baffle 14 prevents fluid from flowing from the first section to the second section.

[0146] Specifically, the first section is closer to the axis X relative to the second section. When the dose body 9 is in the dosing position, the first section is in communication with the catheter 10.

[0147] Advantageously, the cross-sectional dimension of the first section is smaller than that of the second section.

[0148] According to another embodiment, the device 1 includes an adapter 24 between the reservoir 2 and the dose body 9. When the dose body 9 is in the dosing position, the adapter 24 puts the reservoir 2 and the dose catheter 10 in communication. The adapter 24 can be configured in an open position and a closed position. The device 1 includes a flow sensor 25 disposed in the channel 7 for detecting the patient's sucking.

[0149] The device 1 includes a motor M configured to open the adapter 24 when the flow sensor 25 detects sucking.

[0150] Specifically, the flow sensor 25 is configured to activate the motor M when detecting a flow greater than a predetermined value. The motor M is configured to modularly open the baffle 14 according to the flow value detected by the flow sensor 25.

[0151] Alternatively, the flow sensor 25 can be replaced by the baffle 14. In one embodiment, the baffle 14 is configured to open when a predetermined pressure difference is manually reached or after the patient presses a button, as described above.

[0152] In an alternative embodiment, there is a button 26 operatively connected to the baffle 14 and the adapter 24 to synchronously configure them in the closed or open position.

[0153] According to one embodiment, the device 1 suitably includes one or more air inlets 15 selectively in communication with the channel 7. The air inlets 15 are made such that the supplied air helps to open the baffle 14.

[0154] Specifically, the air inlet 15 communicates with the first section of the channel 7. When the patient sucks, the air inlet 15 communicates with the channel 7, such that the additional air flow entering from the outside facilitates the opening of the baffle 14.

[0155] The device 1 includes one or more closures for the air inlet 15. There may be a single closure for all the air inlets, or each air inlet 15 has a closure. Each closure is movable between a closed position, where it blocks the air inlet 15, and an open position, where it allows air to pass through the air inlet 15.

[0156] The device 1 includes a moving mechanism for moving the closure between the two positions. The moving mechanism is shaped such that it can configure the closure to the open position in response to the sucking action of the patient on the docking nozzle 6.

[0157] Preferably, the opening and closing of the baffle 14 is carried out by a common or synchronous moving mechanism.

[0158] In a preferred embodiment, a predetermined amount of the compound is contained within a capsule. Accordingly, the compartment 5 is shaped to accommodate the capsule.

[0159] Alternatively, the compartment 5 is shaped to accommodate other types of compound containers, e.g., vials. The type of container depends on the compound to be loaded in the device 1.

[0160] Preferably, the device 1 includes a plurality of compartments 5. The compartments 5 can be selectively positioned in a predetermined area, where the compartments 5 communicate with the dose catheter 10 when the lung 9 is in the loading position. This meets the requirements of combination therapy with multiple drugs.

[0161] In such a predetermined area, the device 1 includes a mechanism for piercing the capsule.

[0162] In the embodiment disclosed and illustrated herein, the device 1 includes a rotating drum 17, and the compartments 5 are located within the drum. By rotating the drum 17, the desired compartment 5 can be positioned in the predetermined area.

[0163] Since different compounds can be loaded into each compartment 5, the device 1 can accurately determine which compound is being administered, which is crucial.

[0164] According to one embodiment, each compartment 5 has a cross-section of a different shape.

[0165] According to one embodiment, the device 1 includes an identification system 23 for identifying the position of each compartment 5. The identification system can be of a known type, e.g., mechanical, inductive, resistive, etc. In Figure 13In the exemplary embodiment shown, each compartment 5 is associated with a notch or groove 23 of a different size (in this example, starting from the bottom of the drum 17). Alternatively, a metal plate, an electronic resistor, a chip, etc. can also be used.

[0166] Preferably, the device 1 includes a control unit 18 configured to receive information about the position of each compartment 5 from the identification system 23 and send a position signal of the compartment 5 containing the compound capsule to be taken to the patient. Preferably, the control unit 18 is further configured to send instructions to the patient on how to bring the identified compartment 5 to a predetermined area.

[0167] Preferably, the device 1 is provided with a Bluetooth antenna 19 for connecting to an application on a mobile device, for example, which is dedicated to supporting the patient in taking medicine.

[0168] Preferably, the device 1 includes a first compensation channel 20 and a second compensation channel 21, and the second compensation channel is located within the lung 9. The first compensation channel 20 communicates with the external environment, and the second compensation channel 21 is shaped such that when the lung 9 is in the loading position, the first compensation channel 20 communicates with the medicine reservoir 2. This helps to transport the gaseous mixture from the outside to the medicine reservoir 2.

[0169] Preferably, the device 1 includes an ambient channel 22, and the arrangement and shape of this channel are designed such that when the lung 9 is in the dosing position and the mouthpiece 6 is in the stationary position, the first end 10a of the catheter communicates with it. This prevents the device 1 from forming steam and breeding bacteria when not in use.

[0170] In the second embodiment of the plunger 3, when the dose catheter 10 is of the three-way type, in the loading position, the third end 10c communicates with the ambient channel 22.

[0171] In a preferred embodiment, the box-shaped housing 30 and all components of the device 1 are made of biodegradable materials, for example, PLA.

[0172] In the embodiments described and illustrated herein, the device 1 is portable. The box-shaped housing 30 houses all the above components, in particular the body 9, the pinion 11, the rack 12, the compartment 5, and the medicine reservoir 2.

[0173] According to the present invention, the features and advantages of the device for administering a predetermined amount of a compound to a patient are clear from the description.

[0174] Specifically, due to the presence of the dose catheter and its selective communication with the compartment containing the compound and the medicine reservoir, an inhaler device that does not contain the prepared compound can be manufactured. Instead, the compound is loaded only when the patient intends to take it.

[0175] In addition, the connection between the arm, the body, and the plunger enables the arm to compress the gaseous mixture (in one embodiment) or the compound mixture (in another embodiment) with a single movement, and to put the conduit in communication with the reservoir. This makes the device compact and safe, and easy to carry, as the patient only needs to make a simple movement of the arm.

[0176] In addition, the rotary drum is equipped with an identification system for identifying the position of the compartments and the control unit, capable of guiding and assisting the patient during the treatment process, significantly reducing the possibility of errors. This is particularly useful in combination drug therapies, as the patient has to take different drugs at specific times.

Claims

1. An apparatus (1) for administering a predetermined amount of a compound to a patient, comprising: A medicament reservoir (2) of a predetermined capacity; A plunger or piston (3) slidably mounted inside the reservoir (2); At least one compartment or housing (5) that receives a predetermined amount of the compound; A nozzle (6) configurable in at least one rest position and an operating position, in the rest position the patient's mouth cannot contact the nozzle, in the operating position the patient's mouth can contact the nozzle, the nozzle (6) including an internal passage (7) for discharging the compound; A dose body (9) including at least one dose conduit (10) for the compound; An actuating mechanism (8) configured to move the dose body (9) between a loading position and an administration position, in the loading position the dose conduit (10) communicates with the compartment (5) to receive the predetermined amount of the compound, in the administration position one side of the dose conduit (10) communicates with the reservoir (2) and the other side communicates with the passage (7) of the nozzle (6), the plunger (3) being operatively connected to the actuating mechanism (8).

2. The device (1) according to claim 1, wherein, The reservoir (2) selectively communicates with the environment external to the apparatus (1) to accommodate a gaseous mixture, the plunger (3) defining a compression mechanism for compressing the gaseous mixture contained in the reservoir (2).

3. The device (1) according to claim 2, wherein, The dose conduit (10) extends between a first end (10a) and a second end (10b), the dose conduit (10) being shaped such that: in the loading position, the first end (10a) communicates with the compartment (5), in the administration position, the first end (10a) communicates with the passage (7) and the second end (10b) communicates with the reservoir (2).

4. The device (1) according to claim 1, wherein, When the dose body (9) moves towards the loading position, the plunger (3) operatively acts on the reservoir (2) to create a vacuum.

5. The apparatus (1) according to claim 4, including a conduit branch (16) originating from the reservoir (2), the dose conduit (10) extending between a first end (10a) and a second end (10b), the dose conduit (10) being shaped such that: in the loading position, the first end (10a) communicates with the compartment (5) and the second end (10b) communicates directly with the reservoir (2); in the administration position, the first end (10a) communicates with the passage (7) and the second end (10b) communicates with the conduit branch (16).

6. The device (1) according to claim 5, wherein, The dose conduit (10) has a tee extension and includes a third end (10c), the dose conduit (10) being shaped such that: in the loading position, the third end (10c) communicates with the external environment, in the administration position, the third end (10c) communicates with the reservoir (2).

7. The device (1) according to any one of the preceding claims, wherein, The actuating mechanism (8) includes at least one arm (8) rotatable about an axis (X) between a first position and a second position, and the dose body (9) is connected to the at least one arm (8) to rotate therewith.

8. The device (1) according to claim 7, comprising a conversion mechanism (11, 12) for converting the rotational movement of the at least one arm (8) into a translational movement of the compression mechanism (3).

9. The device (1) according to claim 8, wherein, The conversion mechanism (11, 12) includes a pinion (11) constrained to the at least one arm (8) and a rack (12) constrained to the compression mechanism (3), and the rack (12) is slidably coupled to the pinion (11).

10. The device (1) according to any one of claims 7 to 9, further comprising: A baffle (14) disposed inside the channel (7) and movable between a first position and a second position, in the first position, the baffle allows fluid to pass through the channel (7), and in the second position, the baffle blocks fluid from passing through the channel (7); A moving mechanism for moving the baffle (14) from the first position to the second position, the moving mechanism being configured to be activated in response to a sucking action of the patient on the mouthpiece (6).

11. The device (1) according to claim 10, wherein, The channel (7) includes a first section and a second section, the cross-sectional dimension of the first section is smaller than that of the second section, and the baffle (14) is arranged to block fluid from flowing from the first section to the second section in the second position.

12. The device (1) according to claim 11, further comprising: One or more air inlets (15) selectively communicating with the channel (7); A closure for each air inlet (15), the closure being movable between a closed position and an open position, in the closed position, the closure blocks the air inlet (15), and in the open position, the closure allows air to pass through the air inlet (15); A moving mechanism for moving the closure between two positions, the moving mechanism being configured to configure the closure in the open position in response to sucking by the patient.

13. The device (1) according to any one of the preceding claims, wherein, The at least one compartment (5) is shaped to receive a capsule containing the predetermined amount of the compound.

14. The device (1) according to claim 13, comprising a plurality of compartments (5) selectively locatable in a predetermined area, and in the loading position of the dose body (9), the plurality of compartments (5) communicate with the conduit (10) in the predetermined area.

15. The device (1) according to claim 18, further comprising: An identification system (23) for identifying the position of each compartment (5); A control unit (18) configured to receive information about the position of each compartment (5) from the identification system (23) and provide instructions or information to the patient regarding the specific compartment (5) to be selected.

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