Aerosol-generating medical device for the administration of medication by inhalation

Abstract

Aerosol-generating medical device for the administration of medication by inhalation. The medical assembly (1) comprises: - a removable, airtight reservoir (3) containing a liquid medication, and having a closable dispensing orifice and a through-tube, - a heating plate (17), located below the reservoir, comprising a receiving cavity (18), open at the top and equipped with a heating element, - a vertical shaft (13), driven in rotation by a motor (14), on which the reservoir is mounted, pivoting between a dispensing position and an inhalation position, - an oral or nasal inhalation interface (6). In the dispensing position, the dispensing orifice is open and extends above the receiving cavity to fill it with medication. In the inhalation position, the dispensing orifice is closed and the tube extends above the receiving cavity.When heated, the resistance creates an aerosol that travels through the chimney to reach the inhalation interface. Figure to be published with the abbreviation: Figure 2.

Description

Title of the invention: Aerosol-generating medical device for the administration of medication by inhalation. TECHNICAL FIELD OF THE INVENTION

[0001] The present invention relates to a medical device for administering a drug by inhalation, which generates a precise quantity of a fine particle aerosol from a drug in liquid form whose quality is preserved.

[0002] The invention finds applications in the medical field, in particular, for the administration of drugs by respiratory route to the deep pulmonary level, with a view to a systemic or local effect. TECHNOLOGICAL BACKGROUND OF THE INVENTION

[0003] The inhaled route is an interesting route of drug administration because it has the advantage of being non-invasive, ensuring very good bioavailability due to an extensive alveolo-capillary absorption surface in direct contact with the venous pulmonary circulation (arterial blood), avoiding undesirable early metabolism via the gastro-enteric and hepatic routes, and presenting a very short time to onset of the therapeutic effect.

[0004] The inhalation route is generally used for local actions, primarily bronchial, via an aerosol generated by suitable medical devices. An aerosol is a suspension in a gas or gaseous mixture (air) of a collection of small-diameter solid or liquid particles.

[0005] The medical devices currently used for this are mainly nebulizers, which generate an aerosol of liquid particles by means of a flow of air or oxygen under pressure which passes through a chamber where the liquid drug is located and carries it in the form of a mist (aerosol) which is inhaled by the patient using a mask or a mouthpiece or nasal tip.

[0006] This mist, or aerosol, has the advantage of delivering the active ingredient rapidly to the sites of action (bronchi) with relatively little passage of the active ingredient into the systemic circulation. However, the aerosol particles delivered by a nebulizer are on average between 3 and 5 µm in diameter, which limits the amount of active ingredient reaching the bronchial alveoli. Indeed, a large portion of the active ingredient (approximately 80-85%) remains in the oral cavity and esophagus, and only about 20% of the particles reach the bronchi (targets and sites of action). Of this 20%, only a tiny fraction, corresponding to the finest particles with a diameter of less than 2 µm, reaches the deep lung (bronchioles and alveoli) and / or contributes to systemic effects, which are therefore not targets. realistic therapeutic approaches for these medications. This method of administering medications via a conventional nebulizer should therefore be reserved for medications targeting the upper respiratory tract (extending from the nasal cavity to the large-diameter bronchi) but is unsuitable if action at the level of the deep lung or a systemic action of the medications is desired.

[0007] Nebulizers also have the disadvantage of being noisy, bulky, expensive, and cumbersome to use, as they require regular maintenance and the intervention of trained personnel to prepare the medication to be administered. They are therefore not well suited for outpatient and independent use by the patient.

[0008] Other medical devices used for inhalation administration include metered-dose inhalers (or sprays) and dry powder inhalers, generally used in the treatment of asthma. Although these devices are easy to use and perfectly suited for outpatient use, they have the disadvantage—like nebulizers—of generating aerosols with large particles (diameter greater than 2 µm) which mostly remain within the medical device itself or in the mouth and esophagus. Furthermore, these devices require perfect hand-inhalation coordination, a deep, sustained forced inhalation, and the need for oral irrigation after use.

[0009] A more advantageous medical device was described in application WO 2023 / 166025A1. This device comprises a housing in which is mounted a hermetically sealed reservoir containing the liquid drug, a drug aerosolization device which generates a micro-particulate aerosol containing particles with a diameter of less than 2 pm dispersed in the air, a mouthpiece in fluidic connection with the reservoir and through which the aerosol can be inhaled by the patient, and a control unit which processes data relating to the administration of the drug and controls the dosage of the drug inhaled by the patient.

[0010] The aerosolization device comprises a movable heating element that engages with the reservoir and heats the medication to aerosolize it. This heating element is housed in a hollow sheath that allows air to pass through and includes an electrical resistance wire surrounded by a layer of cotton that forms a porous interface between the liquid contained in the reservoir and the resistance wire. The liquid medication absorbed into the cotton layer is heated by the resistance wire, creating microdroplets that are carried by the air passing through the sheath, thus forming the aerosol.

[0011] Heating the drug solution to produce the aerosol advantageously reduces the size of the particles dispersed in the air to a diameter of less than 2 µm. The aerosolized drug can thus penetrate much more deeply. deep into the airways when inhaled by the patient and reach the bronchioles and pulmonary alveoli in sufficient quantity for local bronchoalveolar action or with sufficient bioavailability for effective and rapid systemic action, making it usable in various indications.

[0012] Although promising, this prior device for the delivery of drugs by inhalation has several disadvantages.

[0013] First, since the moving heating element penetrates the reservoir to heat the medication, the entire contents of the reservoir are heated with each use. Furthermore, when the reservoir contains multiple doses, the entire contents are heated with each use, and therefore multiple times before being inhaled. These repeated, overall heating processes are likely to cause degradation of the medication, potentially reducing its therapeutic efficacy.

[0014] Furthermore, accurately dosing the medication administered to the patient is difficult. Indeed, when the heating element is engaged in the reservoir, the cotton layer continuously absorbs medication as it is consumed in the aerosol produced. The precise amount of liquid used is therefore difficult to control. Moreover, when the device is used several times in succession, a fraction of the previous dose remains impregnated on the cotton wall and mixes with the new dose, making the dosage approximate.

[0015] Furthermore, the cotton barrier through which the drug solution passes represents a significant potential source of contamination. Indeed, its composition is not fully known and is difficult to control. It often contains numerous impurities that can contaminate the drug.

[0016] Furthermore, when the device has not been used for a long time or is used to administer several different medications, a fraction of the previous dose, whether old or of a different nature, may be impregnated on the cotton wall and may contaminate or pollute the new dose of medication. The cotton must therefore be changed regularly by the patient to avoid such problems. However, this is a relatively delicate operation, which is not always carried out by patients despite recommendations, and which, if performed incorrectly, can lead to a risk of lung infection.

[0017] This prior device therefore does not guarantee the administration of a precise dose of drug of preserved quality and under sterile conditions.

[0018] Furthermore, vaping devices (electronic cigarettes) are known; they are inexpensive, very easy to use, and also generate an aerosol inhaled by the user from a heated liquid. However, these vaping devices are not medical devices and are not at all suitable for administering These devices are not safe, and the amount inhaled is not measured. They do not allow for the delivery of a precise dose and do not comply with medical device regulations. They are therefore incompatible with therapeutic use. Furthermore, they also include a layer of cotton that serves as a porous interface between the liquid to be aerosolized and the heating element. As no system for removing the heating element and the cotton is provided in these devices, the risk of contamination and degradation of the active ingredient is significantly higher than that of the previous device.

[0019] There is therefore an unmet need for a medical device for inhalation administration allowing self-administration, in the form of a micro-particulate aerosol, of a precise dose of a liquid drug whose quality is preserved. Summary of the invention

[0020] The invention aims to meet this need.

[0021] For this purpose, a first aspect of the invention teaches an assembly comprising a medical device for administering a drug by inhalation and a removable hermetically sealed reservoir containing said drug in liquid form, the medical device generating an aerosol inhalable by the patient by raising the temperature of the drug.

[0022] This medical device comprises: • a structure containing a housing in which the tank is placed, • an aerosol inhalation interface, • a control unit, controlling the operation of the medical device.

[0023] According to the invention, this medical device further comprises: • a vertical shaft, one end of which protrudes into the housing and on which the tank is mounted, • a motor that drives the vertical shaft in rotation and which, via this vertical shaft, pivots the reservoir between at least one dispensing position and at least one inhalation position, • a heating plate, located under the housing, which includes at least one drug receiving cavity, having a top opening and equipped with a heating element to raise the temperature inside the receiving cavity.

[0024] On the other hand, the reservoir comprises: • a lower wall in which a dispensing orifice is provided, allowing the drug to flow out of the reservoir, said dispensing orifice being located above the upper opening of the receiving cavity when the reservoir is in the dispensing position, • a sealing element, which blocks the dispensing orifice when the tank is not in the dispensing position and leaves it open when the tank is in the dispensing position, and • at least one through-tube, which, when the reservoir is in the inhalation position, is located above the upper opening of the receiving cavity, putting the receiving cavity in fluidic communication with the inhalation interface.

[0025] When a dose of medicine is to be administered, the control unit causes the reservoir to rotate, via the motor which rotates the vertical shaft on which the reservoir is mounted, until it reaches a dispensing position.

[0026] In this position, the sealing element releases the reservoir's dispensing orifice, which is located just above the upper opening of the receiving cavity. The liquid medication flows from the reservoir and fills the receiving cavity, which serves as a heating unit.

[0027] When the receiving cavity is full, the control unit rotates the rotating reservoir again until it reaches an inhalation position. As soon as the reservoir leaves the dispensing position, the sealing element closes the reservoir's dispensing orifice, preventing any unwanted leakage.

[0028] When the reservoir reaches an inhalation position, the chimney is positioned above the receiving cavity. The control unit then activates the heating element of the receiving cavity, which heats the dose of medication contained within the cavity (only the cavity itself, not the entire reservoir). This temperature increase aerosolizes the dose of medication, which rises above the receiving cavity, passes through the chimney, and reaches the inhalation interface through which it is administered to the patient.

[0029] These operations can be repeated as many times as necessary if a larger quantity of medication needs to be administered to the patient.

[0030] With the device according to the invention, the dosage of the drug is thus carried out automatically and very precisely thanks to the filling of the receiving cavity, the inhaled dose corresponding exactly to one or more volumes of this receiving cavity.

[0031] Since the aerosol is obtained by raising the temperature of the drug, it is composed of very small particles, the majority of which have a diameter of less than 2 µm. The aerosolized drug can thus penetrate very deeply into the respiratory tract when inhaled by the patient, and have significant diffusion in the lower respiratory tract down to the alveolar level.

[0032] Advantageously, the assembly according to the invention makes it possible to heat only the precise quantity of medication to be administered and not the entire quantity of medication contained in the reservoir, thus avoiding the risk of drug overdose or premature degradation. The unused medication remaining in the reservoir is therefore preserved and does not unnecessarily undergo several heating cycles as in prior art devices.

[0033] Furthermore, in the device according to the invention, the heating element is free of any impregnating material, such as cotton or silica, for example. Since the medication is not impregnated onto an absorbent material like cotton or other materials, which could constitute a potential source of contamination or pollution, the quality of the medication is again preserved. This elimination of cotton or other liquid impregnation systems also ensures the correct quantity of medication delivered by preventing retention of medication from previous administrations.

[0034] Furthermore, this device ensures the safety of drug administration, both in terms of controlling administration and dosage, and in terms of handling and maintenance, because the patient only has access to the removable reservoir, which is hermetically sealed and which they simply insert into the housing and then remove. They do not have access to the drug inside the reservoir, which is kept in a sterile environment, and the dosage adjustment is automatically controlled and configured by the device itself. The patient does not have to perform any delicate maintenance operations (such as replacing the cotton, for example), which could otherwise be forgotten or done incorrectly.

[0035] Finally, the device according to the invention is portable and ergonomic (i.e. of sufficiently small dimensions to allow easy manual use), and allows self-administration by the patient on an outpatient basis.

[0036] Advantageously, the heating plate may comprise several, and preferably four, receiving cavities, each equipped with a heating element. The reservoir then comprises a number of through-channels corresponding to the number of receiving cavities, said through-channels each being located above the upper opening of one of the receiving cavities when the reservoir is in the inhalation position, thus placing said receiving cavity in fluidic communication with the inhalation interface.

[0037] In this case, it is possible to fill several receiving cavities by chaining together several dispensing operations, by simply rotating the reservoir, successively placing it in the dispensing position above each of the receiving cavities to be filled. As the sealing element plugs the dispensing orifice As soon as the tank leaves one of the distribution positions, no unwanted flow occurs between distribution operations.

[0038] When all the desired receiving cavities are filled, the control unit rotates the rotating reservoir again until it reaches an inhalation position. In this position, each of the receiving cavities is surmounted by a through-channel which establishes fluidic communication with the inhalation interface.

[0039] The control unit then activates the heating elements of the pre-filled receiving cavities, which heat the dispensed drug solutions contained within them, preferably until complete aerosolization. Once aerosolized, these aerosols contain fine drug particles that rise above these receiving cavities, pass through the chimneys, and reach the inhalation interface, allowing their inhalation by the patient.

[0040] This makes it possible to precisely control the dosage of the medication to be administered and to adapt it, for example, according to the pathology, the patient, the concentration of the medication, or the phase of treatment. Indeed, any number of receiving cavities, from one to the total number of cavities, can be filled with each cycle, which makes it possible to modify the total volume of medication transformed into an aerosol (corresponding to the dose) per administration.

[0041] Such an embodiment also makes it possible to aerosolize a large quantity of medication with a reduced heating time. Indeed, it is much faster to heat small quantities of medication contained in several receiving cavities simultaneously with several heating elements than to heat a larger quantity of medication, corresponding to the sum of these quantities, with a single heating element in a single receiving cavity with a larger capacity. The device thus makes it possible to limit the heating time to only a few minutes (2 to 3 minutes, for example, for four receiving cavities).

[0042] Another advantage of this embodiment is that it also allows drugs that are difficult to soluble to be administered in sufficient quantity to be effective.

[0043] Advantageously, in this case, the receiving cavities of the heating plate and the through-vents of the reservoir can be distributed radially with respect to the vertical shaft with a constant angular spacing. The angular displacement of the reservoir is thus identical to successively reach each of the dispensing positions, an inhalation position being interposed between each dispensing position.

[0044] Advantageously, the assembly may further comprise at least one annular seal, disposed at the interface between the heating plate and the lower wall of the reservoir (the seal being preferably fixed on the heating plate), which surrounds the upper opening of the receiving cavity in the dispensing position.

[0045] In the dispensing position, the seal between the reservoir and the heating plate is thus improved around the opening of the receiving cavity.

[0046] Depending on the variants, this annular seal can be placed on the lower wall of the rotating tank, around the distribution orifice, or more preferably on the upper wall of the heating plate, around the opening of the receiving cavity.

[0047] Advantageously, the medical device may further include an aerosol collection chamber, for example truncated conical or inverted funnel-shaped, located above the housing, which collects the aerosol rising through all the through chimneys and guides it to the inhalation interface.

[0048] This chamber thus makes it possible to collect and gather all the aerosol fractions formed in the different receiving cavities of the heating plate, which rise from the different chimneys, and to guide them towards the inhalation interface so that they are all inhaled by the patient.

[0049] Advantageously, the sealing element may comprise a piston having a rod with a lower end to which a plug is attached and an upper end which protrudes outside the tank. This piston slides in a cylindrical conduit inside the tank between a lower position, in which it is returned by an elastic return means and in which the plug is pressed against the dispensing orifice, and an upper position, in which the dispensing orifice is released, obtained by pulling upwards the upper end of the rod.

[0050] These means advantageously allow the rotary reservoir's distribution orifice to be opened, closed automatically and kept closed.

[0051] Advantageously, the frame may include a circular rim extending above the housing, which includes an upward-projecting notch located radially at each receiving cavity. The reservoir may further include a lever, to which the upper end of the piston rod is fixed, and one end of which slides against said circular rim, so that, when the reservoir is pivoted, the end of the lever rises at each notch, pulling the upper end of the piston rod upwards.

[0052] These means advantageously allow the sealing element to be opened automatically in order to release the dispensing orifice when the tank reaches a dispensing position and to be closed automatically to re-plug the dispensing orifice as soon as the tank leaves this dispensing position.

[0053] Indeed, when the reservoir reaches a dispensing position, the end of the lever, which is sliding along the circular edge, reaches the protruding notch located radially at the level of the corresponding receiving cavity. By mounting this At the notch, the end of the lever lifts and pulls upwards the upper end of the piston rod attached to it. The piston then slides in its vertical cylinder and the plug which is attached to the other end of its rod moves away from the distribution orifice, which is thus opened.

[0054] When the reservoir resumes rotation and leaves the dispensing position, the end of the lever, which is sliding against the circular edge, moves down from the protruding notch. The elastic return means then returns the piston to the lowered position and again presses the cap against the dispensing orifice, thus closing it.

[0055] Advantageously, the tank may further comprise a cylindrical side wall from which extends at least one rib projecting laterally outwards, which rises and falls alternately so as to form a ramp of variable height substantially in the shape of a wave, or from which extend several pairs of guide pins projecting laterally outwards and arranged one above the other at the same height in each pair.

[0056] The frame may include a cylindrical side wall from which extend several pairs of guide pins projecting laterally inwards and arranged one above the other at the same height in each pair, or from which extends at least one rib projecting laterally inwards, which rises and falls alternately so as to form a ramp of variable height substantially in the shape of a wave.

[0057] Said rib can then slide between the guide pins of each pair during the pivoting of the reservoir.

[0058] In this way, as the variable height rib slides between the fixed height pins when the tank pivots, the height and relative inclination of the tank with respect to the frame changes automatically according to its angular position depending on the height of the ramp at that level.

[0059] The shape of the rib can thus be advantageously provided so that, when the reservoir reaches a dispensing position, it lowers the part of the reservoir near the dispensing orifice in order to improve the seal between the reservoir and the heating plate by compressing the annular seal that surrounds the opening of the receiving cavity if the device is equipped with one, and to tilt the reservoir in order to facilitate the flow of the liquid drug through the dispensing orifice.

[0060] The shape of this rib can also be advantageously provided to raise the reservoir when it is not in the dispensing position, in order to move it away from the heating plate and thus facilitate its rotation.

[0061] Advantageously, the frame may include an intermediate shell serving as a support for the heating plate and enclosing the housing for the reservoir. The edge The circular and cylindrical side wall can then advantageously belong to the intermediate hull.

[0062] This intermediate shell thus serves as a support for the entire distribution system and contains the protruding notches and the pairs of guide pins or the rib which cooperate respectively with the lever and the rib or the guide pins of the reservoir.

[0063] Advantageously, a vent can be provided in a wall of each receiving cavity, this vent being temporarily closed by a cover element, preferably made of silicone, which is held in contact with the vent by an electromagnet in the unpowered position of the electromagnet and which is away from the vent in the powered position of the electromagnet.

[0064] This vent makes it easier to flow the liquid medicine out of the reservoir so that the receiving cavity can be filled, which is sealed when the device is in the dispensing position.

[0065] The electromagnet allows this vent to be opened by moving the cover element apart to trigger the filling and then closed again by pressing the cover element against the vent to prevent leakage of liquid medicine at this point.

[0066] In addition, since the cover element is held against the vent in the unpowered position of the electromagnet, leakage protection is improved.

[0067] Alternatively, the device may not include an electromagnet, the vent being able to be opened and / or closed by any other type of suitable mechanism.

[0068] Alternatively, the vent can be permanently open, the time in the distribution position being precisely set to obtain the desired filling while avoiding leaks. BRIEF DESCRIPTION OF THE FIGURES

[0069] Other advantages and features of the invention will become apparent from the following description, illustrated by the figures in which:

[0070] Fig. 1 is a general perspective view of an example of a medical assembly according to the invention.

[0071] Fig. 2 is a longitudinal sectional view of the whole of Fig. 1.

[0072] Figure 3 is a perspective view of the heating plate of the entire assembly. [Fig.l].

[0073] Fig. 4 is a portion of a cross-sectional view along axis IV-IV of Fig. 3 illustrating more particularly a receiving cavity.

[0074] Fig. 5 and Fig. 6 are perspective views, respectively from above and below, of the removable tank of the assembly of Fig. 1.

[0075] Fig. 7 and Fig. 8 are cross-sectional views of the removable reservoir of Figures 5 and 6, taken at the distribution orifice and its sealing element, which respectively closes or leaves the distribution orifice open.

[0076] Fig. 9 is a perspective view of the intermediate hull of the whole of Fig. 1.

[0077] Fig. 10 and Fig. 11 are views, respectively from above and in longitudinal section, of the intermediate shell, the heating plate and the tank of the whole of Fig. 1, in the tank distribution position.

[0078] Fig. 12 and Fig. 13 are perspective views, respectively from above and from the side, of the heating plate and reservoir of the entire [Fig. 1], in the inhalation position.

[0079] Fig. 14 and Fig. 15 are perspective views from below of the heating plate of the whole of Fig. 1, illustrating more particularly the vent of a receiving cavity respectively closed or open by means of a silicone cover element and an electromagnet. DETAILED DESCRIPTION

[0080] The figures show an example of an embodiment of an assembly 1, comprising a medical device 2 and a removable reservoir 3, which is described in detail below to illustrate the features and advantages of the invention. It should be noted, however, that the invention is not limited to this example.

[0081] Unless otherwise specified, the same element appearing on different figures presents a single reference. For readability reasons, the size scales between represented elements are not necessarily respected.

[0082] In this application, the term "medicinal product" is used to refer to a medicinal product in liquid form. This medicinal product, also called a medicated solution, may contain one or more active ingredients and one or more excipients, liquid or in solution.

[0083] By convention in this application, the terms "top", "bottom", "upper", "lower", "above", "below", "horizontal" and "vertical" will be defined according to the orientation adopted by the elements on the different figures, this orientation being intended to be that of these elements in use.

[0084] Similarly, the adjectives "internal" or "external" and "interior" or "exterior" are defined in relation to the part in question.

[0085] In [Fig.1], assembly 1 is seen from the outside.

[0086] The medical device 2 comprises a frame 4 containing functional elements of the device, extended at the top by a cap 5 substantially in the shape of an inverted funnel (i.e., a structure with a wide lower base). gradually narrowing upwards) and terminates with an inhalation interface 6 allowing the patient to inhale the aerosol.

[0087] The inhalation interface 6 shown is a mouthpiece 7, for example similar to the mouthpieces of traditional oral inhalers. Depending on the variant, it may alternatively be a nasal mouthpiece or a mask allowing the aerosol to be inhaled through both the nose and the mouth.

[0088] The medical device 2 shown is also equipped with a viewing and control interface 8, which serves as an interface between the patient and the device, and which includes, for example, a display screen 9 and several buttons 10, including, for example, an ON / OFF button allowing the patient to control the aerosolization of the medication and the switching off of the device (which can also or alternatively be automatic) and / or navigation buttons.

[0089] The display screen 9 can display various data, for example data relating to the date and time of taking the medicine, the name of the medicine, its expiry date, the heating temperature of the heating elements, the number of possible or remaining uses or doses of the medicine, therapeutic or technical indications, etc.

[0090] In [Fig.2], assembly 1 is shown in cross-section, which allows visualization its internal functional elements. For better understanding, the important elements are also shown separately in the following figures.

[0091] As can be seen in this figure, the frame 4 contains a housing 11 intended to receive the reservoir 3, into which the upper end 12 of a shaft 13 which extends vertically, preferably substantially in the center of the frame 4, opens.

[0092] This shaft 13 is driven in rotation by a motor 14, powered by a battery 15 preferably rechargeable.

[0093] The medical device 2 also includes an aerosolization device 16, comprising a heating plate 17, also housed in the frame 4, under the housing 11. This heating plate 17 includes one or more receiving cavities 18, each equipped with a heating element 19. These heating elements 19 are also powered by the battery 15 and are arranged so as to be able to raise the temperature of the contents of the corresponding receiving cavity 18 when they are in operation.

[0094] A control unit 20, also powered by the battery 15, controls the operation of the entire medical device 2 and in particular controls the rotation of the vertical shaft 13 and the ignition of the heating elements 19. This control unit 20 includes, for example, a printed circuit board (commonly called a PCB, meaning "Printed Circuit Board" in English) on which electronic components are assembled.

[0095] The frame 14 further includes an intermediate shell 21, serving as a support for the heating plate 17 and containing in its upper part the housing 11 for the reservoir 3.

[0096] This intermediate shell has been shown alone in [Fig.9] and with the heating plate 17 and the reservoir 3 in [Fig. 11].

[0097] It comprises a lower part 22 substantially cylindrical, which continues into an upper part 23 also substantially cylindrical but of greater diameter, these two parts 22, 23 being joined by a circular shoulder 24 on which rests the heating plate 17.

[0098] The lower part 22 has a central opening 25 allowing the passage of the shaft 13 and houses the constituent elements of the heating plate 17, such as the receiving cavities 18, the heating resistors 19 and their connection lugs 26.

[0099] The upper part 23 contains the housing 11 and has an open upper face allowing the tank 3 to be inserted and removed.

[0100] It also comprises a cylindrical side wall 27, terminated at its upper end by a circular edge 28 which has several notches 29 projecting upwards and preferably distributed radially with a constant angular spacing with respect to the center of the circular edge (four notches with an angular spacing of 90° in the example shown). These projecting notches 29 form a ramp with a gradual rise on one side, followed by an abrupt descent on the other.

[0101] The cylindrical side wall 27 also has, on its inner face, pairs of guide pins 30, arranged one above the other and extending into the housing 11, which are located at a constant height relative to each other. One pair of guide pins 30 is located at each of the notches 29.

[0102] The heating plate has been shown alone in figures 3 and 4. It comprises a circular plate 31, also pierced with a central opening 32 to allow the passage of the shaft 13, and in which the receiving cavities 18 are provided. These are four in number in the example shown, arranged radially around the central opening 32 with a constant angular spacing of 90°.

[0103] The receiving cavities 18 are sealed hollow chambers, substantially cylindrical in shape, having a top opening 33 allowing them to be filled by the drug flowing from the reservoir 3. Their free internal volume is fixed and precisely defined. It corresponds, for example, to a capacity between 50 and 150 pL, and preferably equal to 100 pL.

[0104] Each of the receiving cavities 18 contains a heating element 19, for example in the form of a coil, one end 34 of which is connected to the circular plate 31, which is electrically conductive and constitutes a first terminal for the resistor 19, and whose second end 35 plunges into the receiving cavity 18 without touching its wall 36 and engages in a connection lug 26 opening into the bottom of cavity 18. This connection lug 26 is electrically insulated from the wall 36 by a seal 37 made of electrically insulating and heat-resistant material, and constitutes a second terminal of opposite sign for the resistor 19.

[0105] Thus arranged, the heating elements 19 are capable of heating the liquid medication contained in the receiving cavity 18 to cause its aerosolization. They can be switched on simultaneously or independently of each other, which makes it possible to heat any number of cavities 18 simultaneously and thus vary the amount of aerosolized medication.

[0106] The heating plate 17 also includes annular seals 38, for example O-rings, fixed to the plate 31 around the opening 33 of each of the receiving cavities 18, which ensure a seal between the reservoir and the receiving cavity 18 during drug dispensing. Alternatively, an annular seal could be fixed to the reservoir, around its dispensing orifice.

[0107] As shown in Figures 14 and 15, each receiving cavity 18 further includes a vent 39 drilled in its wall 36, which allows the drug to flow into the receiving cavity 18, despite the sealed nature of the reservoir 3, the cavity 18 and their junction.

[0108] This vent 39 can be closed by a cover element 40, preferably made of silicone, which is for example in the form of a tab 41, articulated to a ring 42 which is threaded around and outside the receiving cavity 18.

[0109] This tab 41 is fixed to the rod 43 of an electromagnet 44 which holds it against the vent 39 preferably when the electromagnet is not powered and which moves it away from the vent 39 by retracting when the electromagnet 44 is powered.

[0110] The control unit 20 controls the power supply of the electromagnet 44 and triggers the opening of the vent 39 only when a flow of the drug is desired in the dispensing position of assembly 1.

[0111] Although only one electromagnet 44 has been shown in Figures 14 and 15, a An equivalent system exists for each of the receiving cavities 18.

[0112] In addition to the medical device 2, the assembly 1 according to the invention includes a reservoir 3, which is shown alone in Figures 5 to 8.

[0113] The reservoir 3 is a hermetically sealed, removable component, independent of the medical device 2, which contains the medication to be administered to the patient. It is a consumable component, marketed separately from the medical device 2. The medical device 2, in itself, does not contain any medication.

[0114] The reservoir 3 is pre-filled with medicine and sealed by a professional (in the medical or pharmaceutical field) so that the patient cannot access it audit drug. Although he does not have access to the contents of reservoir 3, the patient has access to reservoir 3 itself, which he can mount in or dismount out of housing 11.

[0115] This reservoir 3 is a closed container, substantially cylindrical in shape, comprising a lower wall 45, a cylindrical side wall 46 and an upper wall 47.

[0116] It comprises a central through opening 48 (or alternatively a recess in its lower wall 45), allowing the end 12 of the shaft 13 to be engaged and which has a shape, for example hexagonal, complementary to that of the end 12, enabling the shaft 13 to drive the reservoir 3 in rotation. Advantageously, an indexing rib 49 extends vertically inside the opening 48 and serves both as a keying feature to ensure correct mounting position for the reservoir 3 and as an anti-rotation tab to oppose relative movements between the reservoir 3 and the shaft 13.

[0117] The reservoir 3 also includes chimneys 50, which pass through the lower wall 45 and the upper wall 47, and whose number and location correspond to those of the receiving cavities 18, that is to say, they are arranged so that each is found just above the upper opening 33 of one of the receiving cavities 18 in a particular position of the reservoir, called the "inhalation position", obtained during its rotation.

[0118] In this position illustrated in figures 12 and 13, the receiving cavities 18 are in fluidic communication, via the chimneys 50, with an aerosol collection chamber 51 inside the cap 5 which communicates with the mouthpiece 7.

[0119] If the receiving cavities 18 and the chimneys are arranged radially around the shaft 13 with a constant angular spacing, in particular as in the example shown, there are then several inhalation positions which are reached successively by a rotation of the reservoir by an angle corresponding to this angular spacing.

[0120] In order to better channel the aerosol escaping from the receiving cavities 18 in the inhalation position, the chimneys 50 can advantageously be extended downwards by a collar 52.

[0121] The reservoir 3 further includes a distribution orifice 53 provided in its lower wall 45 and arranged so as to be just above the upper opening 33 of each of the receiving cavities 18 when the reservoir 3 is, after rotation, in one of the particular positions called "distribution positions".

[0122] The orifice 53 is preferably surrounded by a portion of a conical wall 54 sloping towards the orifice 53 and extended by a cylindrical end piece 55, the assembly being similar to the "cone" of a syringe to facilitate the flow of very small quantities of medicine, especially when it has a certain viscosity.

[0123] The distribution orifice 53 is also surrounded by a collar 56 extending downwards, intended to bear against the corresponding annular seal 38 when the reservoir is in a distribution position as illustrated in Figures 10 and 11.

[0124] A sealing element 57 blocks the dispensing orifice 53 when the reservoir 3 is not in the dispensing position. In the example shown, this is a plug 58 made of a flexible material and conical in shape complementary to that of the wall portion 54, which is mounted at the lower end of the rod 59 of a piston 60 sliding in a vertical cylindrical conduit 61 present in the reservoir 3 and having openings 62 to allow the entry of the drug.

[0125] An elastic return means 63, for example a spring 64, pushes the rod 59 downwards and presses the plug 58 against the distribution orifice 53.

[0126] The upper end 65 of the rod 59 passes through the upper wall 47 and can slide in a sealed manner through it. It is fixed to the middle part of a lever 66 which extends radially above the upper wall 47.

[0127] The lever 66 has a first end 67, directed towards the central opening 48, which is in contact with the upper wall 47 and serves as a pivoting support point for the lever 66, and a second end 68 which protrudes laterally beyond the side wall 46.

[0128] When the reservoir 3 is placed in the housing 11 of the intermediate shell 21, the second end 68 of the lever 66 rests on the circular edge 58 (visible in [Fig. 11]) and slides along it as the reservoir pivots. When the reservoir reaches a dispensing position, the end 68 passes a notch 29, which tilts the lever 66 and pulls upwards the upper end 65 of the rod 59, thus freeing the dispensing orifice 53 from the cap 54.

[0129] When the reservoir leaves this distribution position, the end 68 drops abruptly from the notch 29 and the upper end 65 of the rod 59 is immediately pushed downwards by the spring 64, which closes the distribution orifice 53.

[0130] The reservoir 3 further includes a wave-shaped rib 69, that is to say a rib whose profile has successive undulations with an alternation of hollows and bumps and of rising and falling portions, which extends laterally from the side wall 46 outwards and goes around it.

[0131] This rib 69 is located at a height enabling it to be positioned between the guide pins 30 of each pair of the intermediate shell 21 when the reservoir 3 is in the housing 11 as illustrated in [Fig. 11]. This rib 69 thus allows the relative height and inclination of the reservoir 3 with respect to the intermediate shell 21 to be modified according to the angular position of the reservoir during its rotation.

[0132] Interruptions 70 are provided in the rib 69 to allow the tank 3 to be placed or removed from the housing 11 despite the presence of the guide pins 30, their positioning being coordinated with that of the indexing rib 49 to be at the level of the guide pins when the tank is engaged.

[0133] According to another embodiment, the rib 69 and the guide pins 30 can be reversed, the rib 69 being carried by the intermediate shell 21 and the guide pins by the reservoir 3.

[0134] The reservoir 3 may further include a label 71 displaying information about the medicinal product it contains, for example in the form of a barcode or a QR code which can be read and used by the control unit 20.

Claims

1. Demands Assembly (1) comprising a medical device (2) for the administration of a drug by inhalation and a removable hermetically sealed reservoir (3) containing said drug in liquid form, said medical device (2) generating an aerosol inhalable by the patient by raising the temperature of the drug, and comprising: - a frame (4) containing a housing (11) in which the tank (3) is placed, - an inhalation interface (6) for the aerosol, - a control unit (20), controlling the operation of the medical device (2), - characterized in that said medical device (2) further comprises: - a vertical shaft (13), one end (12) of which protrudes into the housing (11) and on which the tank (3) is mounted, - a motor (14) which drives the vertical shaft (13) in rotation and which, by means of this vertical shaft (13), rotates the reservoir (3) between at least one dispensing position and at least one inhalation position, - a heating plate (17), arranged under the housing (11), which includes at least one drug receiving cavity (18), having a top opening (33) and equipped with a heating element (19) for raising the temperature inside the receiving cavity (18), - and in that the reservoir (3) comprises: - a lower wall (45) in which a dispensing orifice (53) is provided, allowing the drug to flow out of the reservoir (3), said dispensing orifice (53) being located above the upper opening (33) of the receiving cavity (18) when the reservoir (3) is in the dispensing position, - a sealing element (57), which blocks the dispensing orifice (53) when the reservoir (3) is not in the dispensing position and leaves it free when the reservoir (3) is in the dispensing position, and - at least one through chimney (50), which, when the reservoir (3) is in the inhalation position, is located above the upper opening (33) of the receiving cavity (18), putting the receiving cavity (18) into fluidic communication with the inhalation interface (6).

2. Assembly (1) according to claim 1, characterized in that the heating plate (17) comprises several, preferably four, receiving cavities (18), each equipped with a heating element (19); and in that the reservoir (3) has a number of through-channels (50) corresponding to the number of receiving cavities (18), said through-channels (50) each being located above the upper opening (33) of one of the receiving cavities (18) when the reservoir (3) is in the inhalation position, putting said receiving cavity (18) into fluidic communication with the inhalation interface (6).

3. Assembly (1) according to claim 2, characterized in that the receiving cavities (18) of the heating plate (17) and the through chimneys (50) of the reservoir (3) are distributed radially with respect to the vertical shaft (13) with a constant angular spacing.

4. Assembly (1) according to any one of the preceding claims, characterized in that it further comprises at least one annular seal (38), disposed at the interface between the heating plate (17) and the lower wall (45) of the reservoir (3), and preferably fixed on the heating plate (17), which surrounds the upper opening (33) of the receiving cavity (18) in the dispensing position.

5. Assembly (1) according to any one of the preceding claims, characterized in that the medical device (2) further comprises an aerosol collection chamber (51), located above the housing (11), which collects the aerosol rising through the assembly of through-pipes (50) and guides it to the inhalation interface (6).

6. Assembly (1) according to any one of the preceding claims, characterized in that the sealing element (57) comprises a piston (60) which has a rod (59) with a lower end on which a plug (58) is fixed and an upper end (65) which protrudes outside the reservoir (3), said piston (60) sliding in a cylindrical conduit (61) inside the reservoir (3) into a lower position, in which it is returned by a return means elastic (63) and in which the plug (58) is pressed against the dispensing orifice (53), and a high position, in which the dispensing orifice (53) is released, obtained by pulling upwards the upper end (65) of the rod (59).

7. Assembly (1) according to the preceding claim, characterized in that the frame (4) has a circular rim (28) extending above the housing (11), which includes a notch (29) projecting upwards located radially at the level of each receiving cavity (18), and in that the reservoir (3) further has a lever (66), on which is fixed the upper end (65) of the rod (59) of the piston (60), and of which an end (68) is in sliding contact with said circular rim (28), so that, when pivoting the reservoir (3), the end (68) of the lever (66) rises at each notch (29), pulling upwards the upper end (65) of the rod (59) of the piston (60).

8. Assembly (1) according to any one of the preceding claims, characterized in that the tank (3) further comprises a cylindrical side wall (46) from which extends at least one rib (69) projecting laterally outwards, which rises and falls alternately so as to form a ramp of variable height substantially in the shape of a wave, or from which extend several pairs of guide pins (30) projecting laterally outwards and arranged one above the other at the same height in each pair;in that the frame (4) comprises a cylindrical side wall (27) from which extend respectively several pairs of guide pins (30) projecting laterally inwards and arranged one above the other at the same height in each pair, or from which extends at least one rib (69) projecting laterally inwards, which rises and falls alternately so as to form a ramp of variable height substantially in the shape of a wave, and in that said rib (69) slides between the guide pins (30) of each pair when pivoting the tank (3).

9. Assembly (1) according to claims 7 and 8, characterized in that the frame (4) comprises an intermediate shell (21) serving as a support for the heating plate (17) and enclosing the housing (11) for the reservoir (3), and in that said circular edge (28) and said cylindrical side wall (27) belong to the intermediate shell (21).

10. Assembly (1) according to any one of the preceding claims, characterized in that a vent (39) is provided in a wall (36) of each receiving cavity (18), this vent (39) being temporarily closed by a cover element (40), which is held in contact with the vent (39) by an electromagnet (44) in the unpowered position of the electromagnet (44) and which is away from the vent (39) in the powered position of the electromagnet (44).

Images