UA68382C2 - Apparatus for aerosolizing powdered medicament (variants) method and system for aerosolizing powdered medicament, method for delivery of aerosolized medicament (variants) - Google Patents

Abstract

The invention provides various apparatus and methods for aerosolizing a powdered medicament. In one exemplary embodiment, an apparatus includes a pressurization cylinder, and a piston which is slidable within the cylinder to pressurize a gas. A handle is coupled to the piston and is movable between an extended position and a home position to pressurize the gas. An aerosolizing mechanism is included and is configured to aerosolize a powdered medicament that is held within a receptacle with pressurized gas from the cylinder. A carriage assembly is included to receive the receptacle and to couple the receptacle to the aerosolizing mechanism. A first and a second interlock are operably engageable with the carriage assembly to prevent coupling of the receptacle with the aerosolization mechanism. The first interlock is released to allow movement of the carriage upon movement of the handle to the extended position. The second interlock remains engaged if the receptacle is only partially inserted into the carriage assembly.

Description

Description of the invention

The invention relates, in general, to the pulmonary method of drug delivery. More specifically, invention 2 relates to devices for dispersing dry powder and to methods of dispersing medicinal products in the form of dry powder, carried out by the patient by the inhalation method.

The pulmonary method of drug delivery is becoming increasingly promising from the point of view of drug delivery to the patient's body. Pulmonary method of drug delivery is based on inhalation of drug dispersion or aerosol carried out by the patient himself, thanks to which the active medicinal ingredient contained in the dispersion can reach the distal (alveolar) regions of the lungs. It was established that some drugs are easily absorbed through the alveolar regions directly into the circulatory system. Pulmonary delivery is particularly promising, for example, for the delivery of proteins and polypeptides that are difficult to deliver by other routes of administration. For the treatment of lung diseases, this pulmonary method of delivery is effective both for systemic delivery and for local delivery. 12 A number of approaches have been developed to implement the pulmonary method of drug delivery. These approaches involve the use of liquid nebulizers, metered-dose inhalers, and dry powder dispersal devices. Of all these approaches, dry powder dispersion devices are of particular interest. Exemplary embodiments of such devices for dispersing dry powder are described in US Patent No. 5,740,794 and US Patent Application No. 08/309,691, filed September 21, 1994, the full disclosure of which is incorporated herein by reference. These patent materials describe hand-held powder dispersing devices that draw powder from a receiver and agrosolize the powder so that the patient can inhale the aerosolized powder. The use of devices for dispersing dry powder of this type turned out to be very successful with the appropriate aerosolization of dry powders for further inhalation.

But even so, it would be desirable to make some improvements in order to increase market demand, provide ease of use, increase functionality and improve other Ge) characteristics of devices for dispersing dry powder of this type. Therefore, the purpose of the invention is to create improved devices for dispersing dry powder and methods of their use.

In accordance with the invention, exemplary implementation options for systems, devices and methods for aerosolization of powdered medicine are proposed. According to one of the exemplary embodiments of the device, proposed in accordance with the invention, contains a high-pressure cylinder and a piston, made with the possibility of sliding in the cylinder to increase the gas pressure in the specified cylinder. In addition, there is an aerosolization mechanism designed for aerosolization of the powdered medicinal product contained in the receiver using gas contained in a cylinder under high pressure. It is provided Ge) the presence of a carriage unit for receiving the receiver and for connecting the receiver to the aerosolization mechanism, 32 thanks to which the powder can be extracted from the receiver and subjected to aerosolization. The device additionally contains ee, first and second blocking mechanisms that can work in the mode of interaction with the carriage assembly in order to prevent the attachment of the receiver to the aerosolization mechanism. The first locking mechanism disengages, allowing movement of the carriage assembly when the handle is moved to the fully extended position. "

The second locking mechanism is engaged with the carriage assembly when the receiver C 740 is only partially inserted into the carriage assembly. c Such a design allows the device to operate in the mode of aerosolization of powdered medicine by inserting the receiver into the carriage assembly in the fully loaded position to prevent the interaction of the second locking mechanism with the carriage assembly. The handle is then moved to the fully extended position and retracted to the initial position in order to generate a high-pressure gas charge and remove the first locking mechanism from engagement with the carriage assembly. Then the start button of the device would be actuated, as a result of which the carriage assembly moves in the direction

Ge | aerosolization mechanism until the receiver engages with the aerosolization mechanism. After connecting to the aerosolization mechanism, the gas charge under high pressure is released for aerosolization of the powdered drug in the receiver. o 20 The advantage of this design is that the device for aerosolization cannot be activated if the receiver is not fully inserted and the handle is not fully extended. Thus, a control is introduced that ensures the proper operation of the aerosolization device.

According to one particularly preferred aspect of the invention, the receiver has a front end, a back end and a chamber containing the drug. The front end contains at least one notch and the carriage assembly 25 contains a key, so that the receiver cannot be fully inserted into the carriage assembly if between

GF) there is no interaction between the recess and the key. Thus, the carriage assembly cannot operate to attach the receiver to the aerosolization mechanism unless the notch is in engagement with the key, thereby preventing the receiver from being fully inserted into the carriage assembly.

According to one of the specific aspects of the invention, the device for aerosolization additionally contains a sensitive lever 60 equipped with a roller. The roller rolls over the chamber surface as the receiver is inserted into the carriage assembly and moves the sensing lever into abutment with the second locking mechanism, causing the latch on the second locking mechanism to engage with the carriage assembly as the roller rolls over the entire chamber surface. Thus, the latch will remain engaged with the carriage assembly to prevent it from moving as long as the roller is in contact with the camera. According to another aspect of the invention, the sensitive lever 62 determines the limits of the well that receives the camera when the receiver is in the fully inserted position.

According to one of the specific aspects of the invention, the device additionally includes a grip that engages with the carriage assembly when the carriage assembly is moved to connect the receiver to the aerosolization mechanism. A return button is provided to release the carriage unit from capture. Thus, the carriage unit cannot be accidentally lowered to disconnect the receiver from the aerosolization mechanism until the powdered medicine is aerosolized. According to another aspect of the invention, a valve is located in the duct between the cylinder and the aerosolization mechanism.

The valve can have an open position and a closed position and is usually in the closed (but unlocked) position when the handle is moved to the extended position. This design has the advantage that the air used to fill the cylinder is not sucked into the air duct, so a cleaner source is used to fill the cylinder with air.

According to one specific embodiment of the invention, a device for aerosolization is proposed, which includes a housing, a high-pressure cylinder and a piston, which is installed with the possibility of sliding inside the cylinder and is designed to increase the pressure of the gas inside the cylinder. The piston is hinged /5 fixed to the housing, and a handle is attached to both the housing and the cylinder, made with the possibility of movement between working positions. The handle is designed to move the cylinder relative to the piston, which is designed to increase the pressure of the gas inside the cylinder. There is an aerosolization mechanism designed to receive gas from the cylinder for the purpose of aerosolization of powdered medicine.

This design of the device has the advantage that when the handle is actuated, the piston can rotate relative to the housing. Thus, when the handle is actuated, the piston remains, in general, coaxial with the cylinder, which facilitates the operation of the handle and reduces wear between the elements.

According to one of the specific aspects of the invention, a lever gear is located between the handle and the body. The lever gear is hinged on the body and cylinder in order to further facilitate the operation of the handle. According to another aspect of the invention, the housing includes an upper end and a lower end, and the aerosolization mechanism is located at the lower end. In addition, a piston is hinged and) attached to the lower end of the housing. This construction has an advantage in the case when the piston has a one-way check valve, since the check valve will be located near the lower end of the housing in order to minimize the risk of powder accumulation on the check valve, which can seep through the housing.

According to an additional embodiment of the invention, a device for aerosolization is proposed, which includes a housing and a capture chamber that extends in the direction away from the housing. An aerosolization mechanism is located in the housing, designed to introduce the powdered medicinal product into the capture chamber. The aerosolization mechanism is equipped with air ducts that allow air to enter the chamber with 5 Capture, when the patient inhales to extract the powdered drug from the capture chamber. The aerosolization mechanism additionally contains a structural assembly designed to distribute the air entering the capture chamber through air ducts, so that the powdered medicine is removed from the capture chamber in the form of a bolus, which, in fact, does not mix with the incoming air.

The operation of a device of this type consists in dispersing the powdered medicinal substance in the capture chamber followed by inhalation from the capture chamber to extract the powdered medicinal product. Air is allowed to enter the capture chamber by the air ducts in such a way that essentially no incoming air mixes with the powdered medicinal product, resulting in extraction;" the drug is administered in the form of a bolus. Therefore, by introducing air in this way, the air serves as a piston to uniformly push the aerosolized powder upwards through the capture chamber, from where the latter is inhaled by the patient. b According to one of the specific aspects of the invention, the capture chamber has a geometric center, and the aerosolization mechanism is located with an offset from the specified center due to the presence of other structural elements inside the housing. The proposed design provides for the distribution of a larger amount of air in those 2) sections of the capture chamber that are farthest from its geometric center. Thus, the furthest parts of the capture chamber will receive more air, as a result of which, as air is drawn into the capture chamber during the inhalation of the drug by the patient, some significant mixing of the latter with

Ge does not happen in the air. According to another aspect of the invention, the proposed design contains a bent flange element and serves to direct part of the air immediately outside as it enters the capture chamber.

According to one of the particularly preferred aspects of the invention, the aerosolization mechanism contains a cylindrical passage or channel through which the powdered medicine passes in order to enter the chamber (F, capture. The upper end of the housing is located, in general, perpendicular to the distal end of the indicated passage. Thus, as the powdered medicine enters the capture chamber, it undergoes uniform dispersion throughout the entire volume of the capture chamber. According to another aspect of the invention, the body is provided with an elastic sealing element that provides a seal between the body and the capture chamber. the nature of the sealing element has the advantage that the capture chamber can easily slide over the housing without causing excessive wear to the sealing element.

In accordance with one of the specific embodiments of the invention, a device for aerosolization 65 of powdered medicine is proposed, which contains a body having at least one piercing element for piercing a hole in the receiver, in which the powdered medicine is located. A core (tube) with an exhaust cavity and at least one air channel can be inserted into the body.

When the core is inserted into the body, the air channel is located on the same line with the piercing element, as a result of which air has the opportunity to enter the receiver through this air channel. In addition, a high-pressure air source is provided for drawing the pulverized medicinal product through the extraction cavity when the extraction cavity communicates with the receiver.

The use of a body and core has the advantage that the core can be manufactured at relatively low cost and can be made removable, and the body containing the piercing element can be reused. 70 Brief description of drawings

Fig. 1 is a perspective view from the front in a disassembled state of a device for aerosolization of powdered medicine made in accordance with one of the exemplary embodiments of the invention.

Fig. 2 is a perspective view behind the device shown in Fig. 1.

Fig. 2A is a side view in section of a sealing element designed to interact with a narrowed portion of the capture chamber of the device shown in Fig. 1, according to the invention.

Fig. 3 is a perspective view of the core of the aerosolization mechanism, made in accordance with one of the exemplary embodiments of the invention. Fig. 4. - an image of the body of the aerosolization mechanism, dug out according to one of the exemplary embodiments of the invention, which is designed to receive the core shown in fig. 3. 20 Fig. ZA and ЗВ - a side view in section of the core shown in Fig. 3, made along the lines A-A and B-B, respectively.

Fig. 4F and 48 - a side view in section of the case shown in Fig. 4, made along the lines A-A and B-B, respectively.

Fig. 5 is an image of the core shown in Fig. 3A, inserted into the body shown in Fig. 4A, with the formation of an aerosolization mechanism, and the aerosolization mechanism is connected to the receiver and illustrates the method of extracting the powder from the receiver, according to the invention. c 25 Fig. 6 - an image of the mechanism of aerosolization, shown in Fig. 5, in a section made along the lines 6-6.

Fig. 7 is an image of the aerosolization mechanism shown in Fig. 5, illustrating the method of air distribution according to i) the extent of inhalation by the patient in order to draw in air through the aerosolization mechanism, according to the invention.

Fig. 8 - a view of the mechanism of aerosolization, shown in Fig. 7, in a section made along the lines 8-8.

Fig. 9 is a schematic representation of the air capture chamber, illustrating the pattern of air flow that is created when the patient inhales, according to the invention.

Fig. 9A is a schematic representation of a capture chamber illustrating the removal of an aerosolized medicinal product when the patient inhales, according to the invention. with

Fig. 10 is a sectional side view of the base assembly of the aerosolization device shown in Fig. 1, taken along lines 10-10 (when the aerosolization mechanism and receiver are inserted into the base assembly). 35 Fig. 1OA-1OR is a side view in section of the basic unit shown in Fig. 10, made along the lines А-А - Р-Р "о, respectively (and the basic unit is in different working states).

Fig. 11 is a side view in section of the device for aerosolization, shown in Fig. 1, illustrating the handle in an extended position for creating gas pressure inside the cylinder, according to the invention.

Fig. 11A is an enlarged view of the base unit of the aerosolization device shown in Fig. 1. 40 Fig. 118 is a side view in section of the device for aerosolization, shown in Fig. 11, made along the lines B-B. with c Fig. 11C is a top view in section of the device for aerosolization shown in Fig. 11, made along the lines C-C. . Fig. 12. - a side view in section of the device for aerosolization, shown in Fig. 1, illustrating the handle in u? to the initial (retracted) position after increasing the gas pressure in the cylinder, according to the invention.

Fig. 12A is an enlarged view of the base unit of the aerosolization device shown in Fig. 11. 45 Fig. 128 is a side view in section of the device for aerosolization, shown in Fig. 12, made along the lines B-B.

Ge» Fig. 12C is a top view in section of the device for aerosolization shown in Fig. 12, made along the lines C-C.

Fig. 13 is a top view of the receiver, which has a turnkey notch for adjusting the degree of insertion of the receiver into the device for aerosolization, which is made in accordance with one of the variants of the invention. 2) Fig. 14 is an illustration of another, alternative embodiment of the receiver, which has a pair of keyholes, 50 According to the invention. The following is a description of one of the exemplary versions of the device for aerosolization of crushed in

Ge powder of the medicinal product marked on Fig. 171 and 2 by position 10. The device 10 contains a base assembly 12 and a capture chamber 14 attached to the base assembly 12 with the possibility of disconnection. The capture chamber 14 is made with the possibility of sliding over the base unit 12, which allows to reduce the overall overall dimensions of the device 10 during its storage and to protect the structural elements that are in the base unit 12. The aerosolization mechanism 16 is shown in the detached from the base unit 12 state, contains core 18 and body 20. Basic

F) node 12 has an opening 21 designed to receive the aerosolization mechanism 16. The basic unit 12 is made with the possibility of receiving the receiver 22, which contains the powdered medicine. The operation of the device consists in connecting the aerosolization mechanism 16 to the receiver 22 and extracting the powdered medicine from the receiver 22. Then the extracted powder undergoes deagglomeration and dispersion and is delivered to the capture chamber 14, where it will be available to the patient for inhalation.

The capture chamber 14 includes a mouthpiece 24 which is rotatably mounted between an open position and a closed position. During the aerosolization process, the mouthpiece 24 is in the closed position, as shown in FIG. 1 and 2. When the patient is ready to inhale using the aerosolized medication 65, the mouthpiece is rotated 180" to an open position in which the patient can place the mouthpiece in the mouth and inhale by inhaling the powdered medication from the capture chamber 14.

As mentioned earlier, the capture chamber 14 is designed to slide over the base assembly 12 in order to reduce the overall dimensions of the device 10 during its storage and protect the structural elements of the base assembly 12. The base assembly 12 contains a sealing element 26 that extends radially from the outside base unit 12 and interacts with the walls of the capture chamber 14, thanks to which a seal will form between the base unit 12 and the capture chamber 14. As is more clearly shown in Fig.2A, the capture chamber 14 includes a narrowed section 28 that comes into contact with the sealing element 26 as the capture chamber 14 moves to the fully extended position. The sealing element 26 is preferably made of rubber using a two-step molding method to attach the sealing element 26 to the base assembly 12. The use of the tapered portion 28 has a particular advantage in that the sealing element is disengaged from the capture chamber 14 as it , as the capture camera 14 slides over the base unit 12 in the direction of the closed position (storage position).

Thus, the wear of the sealing element 26 is significantly reduced.

As shown in Fig.1 and 2, the narrowed section 28 additionally contains a pair of slits Z0 into which a pair of latches 32 located on the base unit 12 are inserted when the capture camera 14 is moved to the extended position. Upon reaching the extended position, the indicated latches, which are spring-loaded, enter the slots

ZO to prevent the capture chamber 14 from being pushed out of the base assembly 12. In addition, the engagement of the latches 32 with the slots 30 holds the capture chamber 14 in an extended position so that it cannot accidentally slide back onto the base assembly 12. To disengage 32 from engagement with the slots 30 the return button 34 is pressed. After pressing the return button 34, the latches 32 are returned to the base assembly 12, while the capture camera 14 can either be removed from the base assembly 12, or reattached to the base assembly 12, corresponding to the storage position.

Preferably, the base assembly 12 includes an extraction ring 36 that can be grasped with a finger of one hand while holding the capture chamber 14 with the other hand, which facilitates movement of the capture chamber 14 from the stowed position to the extended position. The extraction ring 36 is fixed to the base unit 12 by a spring-loaded hinge i) mechanism, due to which the extraction ring returns to a recessed position in the base unit 12 when not in use.

The device 10 is actuated by inserting the receiver 22 into the carriage assembly 38 of the base assembly 12. As an alternative, the device 10 can be actuated without inserting the receiver if a "dry fire" is desired. As will be apparent from the more detailed description that follows, the device 10 cannot be actuated until the receiver 22 is fully inserted into the carriage assembly 38. Therefore, this design prevents the aerosolization mechanism 16 from being attached to the receiver 22 until the receiver 22 takes the proper position

To aerosolize the medication, a discharge handle 40 is provided extending from the base assembly at 12. As described in more detail below, when the discharge handle 40 is moved to the fully extended position and then returned to the initial (retracted) position (as shown in Fig. .1 and 2), the gas pressure increases in the cylinder of the base assembly 12. Then the gas under high pressure is released in the place where, when the trigger button 42 is pressed (see Fig. 2), it will flow through the aerosolization mechanism 16. When the button 42 is pressed, the carriage unit 38 is actuated in order to move the receiver p») 22 into engagement with the aerosolization mechanism 16 when the holes 44 are introduced into the receiver 22. As soon as the holes 44 are introduced into the aerosolization mechanism 16, the gas under high pressure in base node 12, ;" is produced for extracting the powdered medicinal product from the receiver 22, deagglomerating and dispersing the powdered medicinal product and delivering the powdered medicinal product in an aerosolized form to the capture chamber 14 in a manner similar to that described in the US patent

Ge" Mo5,740,794, to which reference was made earlier.

As described in more detail below, one of the characteristic features of the device 10 is that, in addition to excluding the possibility of connecting the receiver 22 to the aerosolization mechanism 16, if the receiver 22 is not completely 2) inserted into the carriage assembly 38, the start button 42 cannot be inserted into action if the discharge handle 40 5r is not transferred to the fully extended position. Thus, the device 10 cannot be actuated until the user fully extends the handle 40, whereby the required amount can be provided

He air (after moving the handle 40 to the retracted position), which is under high pressure for the proper operation of the aerosolization mechanism 16.

Therefore, the device 10 has two consistent characteristics that ensure that the chamber 14 captures the aerosolized medicinal product in the proper proportion. First, the receiver 22 must be fully inserted into the carriage assembly 38. Second, the handle 40 must be fully moved to (F, the extended position. If both of these conditions are not met, the trigger button 42 cannot be pressed to engage receiver 22 to the mechanism 16 of aerosolization and release of air under high pressure to extract the powder from the receiver 22. When the start button 42 is pressed, the carriage unit 38 rises, as a result of which the receiver 22 is connected to the mechanism 16 of aerosolization, which aerosolizes the powder located in receivers 22. After actuating the trigger button 42 for the purpose of aerosolizing the drug, the receiver 22 remains attached to the aerosolization mechanism 16 and, thus, cannot be removed from the carriage assembly 38. To disconnect the receiver 22 from the aerosolization mechanism 16, the button is pressed 46 return, as a result of which 65 the carriage assembly 38 is lowered. After this, the receiver 22 can be removed from the carriage node 38, when there will be holes 44 in it.

One particular advantage of releasing the high-pressure gas immediately after inserting the holes 44 into the receiver 22 is that the user cannot attach the receiver 22 to the aerosolization mechanism 16 and then delay the release of the high-pressure gas. Thus, the pulverized drug in the receiver 22 will not be exposed to the long-term effects of the environment, which can render the drug unusable.

A more detailed description of the aerosolization mechanism 16 follows with reference to Figs. 3-3B and 4-48, with the core 18 shown in Fig. 3-3B and the housing 20 shown in Fig. 4-48. The core 18 contains an exhaust tube 48 having a pointed tip 50, which is designed to pierce a hole in the receiver, for example, the central 7/0 hole 44 in the receiver 22 (see Fig.1). The pointed tip 50 has two slits 52, which allow the pulverized medicine in the receiver to be drawn into the exhaust tube 48. A nozzle 54 is attached to the exhaust tube 48, which, in turn, connects to the high-pressure injection nozzle 56 ( see Fig. 3B). A deagglomeration channel 58 branches off from the nozzle 54, which ends in an outlet 60. The core 60 additionally contains a plurality of air ducts 62, which serve both to ensure the entry of air into the punctured receiver during the aerosolization process, and to form an air passage into the capture chamber when the patient inhales aerosolized drug as described in more detail below. When attached to the housing 20, the core 18 aerosolizes the pulverized drug contained in the receiver in a manner similar to that described in US Pat. No. 5,740,794 and US Pat. link. A more detailed description of the operation of the 2o aerosolization mechanism for aerosolization of the powdered medicinal product also follows below with reference to Fig. 5-8.

Above the air ducts 62 with the help of a row of ribs 64, a bent flange element 66 is installed. The bent flange element 6b serves to direct the displacing air into the aerosolization chamber with axial and radial components in order to facilitate the removal of the aerosolized medicinal product, as described in more detail below. Preferably, the fins 64 divide the ducts 62 into four quadrants. As described in more detail below, the size of the specified four quadrants can be varied in order to change the volume of air that i) passes through each quadrant.

The core 18 additionally includes a flat surface 68 that is aligned with the flat surface 70 of the housing 20 to facilitate centering of the core 18 when inserted into the housing 20. When the core 18 is inserted into the housing 20, the edge 72 of the core 18 rests on the upper end 74 of the base assembly 12. The core 18 also includes a projection 76 that rests on the upper end of the base assembly 12 when the aerosolization mechanism 16 is inserted into the opening 21 of the base assembly 12. It is also desirable that the housing 20 includes a key 78 that would help ensure proper orientation of the aerosolization mechanism 16 when inserted into the base unit 12.

In fig. 4-48 shows the structure of the housing 20 in more detail. The housing 20 contains a pair of side punches so 80, which are made with the possibility of punching a pair of holes in the receiver, for example, external holes in the receiver 22, shown in Fig.1. Side punches 20 are located at an angle in such a way that they separate the receiver as they enter. The housing 20 has a pair of openings 82 that communicate with the air ducts 62 when the core 18 is inserted into the housing 20. Thus, air can pass through the air ducts 62 through the openings 82 into the receiver, facilitating the extraction of the powdered drug. The body 20 additionally includes an opening 84 (see FIG. 48) that receives the pointed tip 50 of the core 18 when the core 18 is attached to the body 20. The body of c 20 has a stop 86 that serves to stop the penetration of the side punches 80 and the pointed tip 50 when connecting the aerosolization mechanism 16 to the receiver. The presence of a sealing element 87 is provided, which;" provides a seal between the aerosolization mechanism 16 and the receiver 22.

As more clearly shown in Fig.A4A and 4B, the case 20 has a window 88 located on one axis with

High pressure nozzle 56 when the core 18 is inserted into the housing 20. As more clearly shown in

48, the body 20 is made of an elastic material in the area around the window 88 and the limiter 86, which allows creating a sealing element 90 with compression. The sealing element 90 provides a seal between the window 88 and the valve through which gas is supplied under high pressure to extract the powder from the receiver and its 2) deagglomeration, and also provides a seal between the limiter 86 and the receiver. Sealing element 90 5or Can be manufactured by the method of two-stage molding, known in this field of technology. In addition, the angled sealing member 90 near the window 88 helps to properly align the window

88 relative to the air supply tube through which the high-pressure gas is delivered through the nozzle 54. As more clearly shown in Figs. , when the patient inhales from the capture chamber to extract the aerosolized medicine from it. The non-return valve 92 is made in the form of a plate valve, which opens when the limit pressure is exceeded. The use of such a valve has the advantage that it consists in (Ф, because at the beginning of the inhalation by the patient, a pressure drop occurs, due to which an essentially uniform pressure is created in the area 94 of increased ka pressure (see Fig. b). As described in more detail below, as a result of the creation of essentially uniform pressure in the area 92 of increased pressure, a more favorable opportunity appears for Control of the process of controlling the air flow in the capture chamber.

One particular advantage of making the core 18 removable from the housing 20 is that the core 18 can be periodically removed and replaced with a new core. Thus, the service life of the aerosolization device can be significantly increased. In addition, due to the inclusion of 20 structural elements in the body, the cost of replacing the more expensive core can be significantly reduced. 65 Despite the fact that the aerosolization mechanism 16 is shown in the form of two structural elements, it should be borne in mind that it can also be performed in the form of a system manufactured as a whole.

Below, with reference to Fig. 5-8, follows a description of the operation of the aerosolization mechanism 16, which is carried out for the purpose of deagglomeration of the powdered medicinal product and its delivery to the capture chamber. When the receiver 22 is attached to the aerosolization mechanism 16, the sealing element 87 is located near the upper surface 96 of the receiver 22, forming a seal between the aerosolization mechanism 16 and the upper surface 96. In addition, the limiter 86 engages with the carriage assembly 38 (see Fig. 1OM) in order to prevent further lifting of the carriage unit 38. The pointed tip 50 and the side punches 80 penetrate through the upper surface 96 and are located inside the cavity (pocket) 98, which contains the powdered medicine. To extract the powdered medicinal product through the window 88 and the discharge nozzle 70 of the high-pressure nozzle 56, gas under high pressure is supplied, as indicated by the arrows. High-pressure gas passes through nozzle 54, forcing air through ducts 62, through pocket 98, and through exhaust tube 48, as indicated by the arrows. The involved air enters a closed air circuit, which directs this air into the capture chamber, into the aerosolization mechanism and into the receiver. Such a process is essentially identical to the process described in US Pat. No. 5,740,794, previously incorporated by reference.

The powdered drug in the exhaust tube 48 then enters the deagglomeration channel 58, which serves to deagglomerate the powder to a state suitable for inhalation.

The deagglomeration channel 58 preferably has a constant diameter and a length that is approximately equal to the diameter or exceeds it by ten times, more preferably exceeds the diameter by three to seven times, and most preferably exceeds the diameter by about five times. As shown in the drawings, the deagglomeration channel 58 is interrupted by 2° at the outlet 60. Thus, a "discharge diffuser" will be formed, as a result of which the gas flowing out of the agglomeration channel 58 tends to further grind the powdered drug and not slow down the flow rate. Thus, the degree of dispersion of the aerosolized medicinal product entering the capture chamber increases.

After dispersing the powdery medicinal product entering the capture chamber, the patient inhales in order to extract the powdered medicinal product from the capture chamber, as a result of which the extruding air passes through the aerosolization mechanism 16, as shown in Figs. 7 and 8. When the patient i) exhaling air must enter the capture chamber in order to remove the aerosolized medicinal substance.

Such extruding air passes through the aerosolization mechanism 16 after entering the area 94 with increased pressure through the inlet check valve 92. The housing 20 has an opening 100 (see Fig. 8), which allows the extruding air to open the inlet valve 92 and pass through the air ducts 62, as marked with arrows. with

The mechanism 16 of aerosolization is made in such a way that the squeezing air entering the capture chamber manages to minimize the degree of mixing of the aerosolized medicinal product with the incoming squeezing air. Thus, the powdered drug can be extracted from the chamber with capture in the form of a bolus, which takes place after passing the extruding air through the aerosolization mechanism 16. This distribution of forced air in the capture chamber is partly due to the presence of a check valve 92, which provides a pressure drop, as a result of which the air in the region 94 of increased pressure will be under essentially constant pressure. The proper distribution of air is ensured by the "also bent flange element 66, which divides the air flow inside the air ducts 62 into axial pt") and radial components. So, as the patient inhales from the mouthpiece of the camera, the capture, extruding . air passing through the aerosolization mechanism 16 is distributed in the capture chamber in such a way that the amount of air that mixes with the powdered drug is minimized.

This characteristic feature is illustrated in Fig. 9 and 9A, which show how the powdered drug retains its bolus shape, which is uniformly removed from the capture chamber. In Fig. 9 b, arrows mark the trajectory of the flow of the incoming extruding air as it passes through the capture chamber. As shown, the flow paths are generally parallel, indicating that essentially no amount of displacement air is mixed with the aerosolized drug. Figure 9A shows the mass 2) fraction of air in the capture chamber approximately 100 milliseconds after the start of inhalation. Contours C1-C10 5or illustrate the contours of the mass fraction of air. The ST contour illustrates the incoming exhaust air. As shown, there is no mixing of the incoming displacement air with the bolus. As a result, the bolus is uniform

Ge rises up and out of the mouthpiece, where it will be followed by the expelling air. Thus, in the first part of the respiratory volume, the patient receives a powdered medicine. During the other part of the respiratory volume, the extruding air follows into the patient's lungs, contributing to the delivery of the powdered medicinal product to the deep lung regions. Therefore, the beginning of the inhalation cycle is used to extract the pulverized drug from the capture chamber, and the rest of the inhalation cycle serves (F) to further deliver the pulverized drug into the lungs. As shown in Fig. 1, the aerosolization mechanism 16 is offset relative to the center of the base unit 12. In order to obtain the proper air flow entering the aerosolization chamber, the location of the ribs 64 (see Fig. 3) can be changed in order to ensure the passage of a larger amount expelling air through a quadrant facing a larger area of the capture chamber, as a result of which the air flow has the ability to be more evenly distributed in the capture chamber.

Fig. 10 shows a side view in section of the device 10 shown in Fig. 1, made along the lines 10-10. As shown in fig. 10, the aerosolization mechanism 16 is located inside the base assembly 12, and the receiver 22 65 is inserted into the carriage assembly 38. FIG. 10 serves as a reference to illustrate the various views shown in FIG. device 10 includes a locking mechanism that prevents operation of the trigger button 42 when the receiver 22 is only partially inserted into the carriage assembly 38. Such a characteristic feature is illustrated in Fig. 10A-10E. For clarity, the aerosolization mechanism 16 in the base unit 12 is not shown.

In Fig. 1OA, the base node 12 is shown in the initial state (ready state). In the ready state, the locking mechanism 102 of the receiver is in the rest position. While in the rest position, the rammer 104 of the carriage assembly 38 is able to return upwards around the pivot pin 106. A trigger button 42 is also hinged to the base assembly 12 by means of the pivot pin 108, which, when the trigger button 42 is pressed, allows the group of teeth 110 located on start button 42, arrive at 7/0 Bushenia. In turn, the PO teeth set in motion a group of teeth 112 located on the pestle 104, as a result of which the pestle 104 rises vertically upwards. The base assembly 12 further includes a sensing lever 114 that is biased in its rest position by a spring 116. As described in more detail below, when the sensing lever 114 is in its rest position, the receiver locking mechanism 102 is also in its rest position, in which case the trigger button 42 can be actuated to raise the ram 104. 7/5 Preferably, the sensitive lever 114 includes a roller 118 over which the receiver 22 passes during insertion into the carriage assembly 38. Although the roller is shown, it should be noted that instead of the roller 118 any stationary mechanism can also be installed. In order to facilitate the insertion of the receiver 22 into the carriage unit 38, it is preferable to have a guide 120.

In FIG. 10B, the receiver 22 is shown partially inserted into the carriage assembly 38. In the partially inserted position, the pocket 98 of the receiver 38 engages the roller 118, which causes the spring 116 to compress and rotate the sensing lever 114 downward, as shown. In turn, the sensitive lever rotates the receiver locking mechanism 102 about the pivot pin 122. As shown in Fig. 10C, the receiver locking mechanism 102 includes a latch 124 that moves over a projection 126 located on the ram 104. When the latch 124 is located above the projection 126, the rammer 104 cannot rotate around the pivot pin 106. In turn, the start button 42 cannot be pressed. Therefore, if the receiver 22 is only partially inserted, as shown in FIG. 108, the trigger button 42 cannot be actuated to raise the carriage assembly 38, i) thereby preventing the attachment of the receiver 22 to the mechanism 16 of aerosolization.

When the receiver 22 is fully inserted into the carriage assembly 38, the pocket 98 moves to a position above the roller 118 and is located in the well 128 of the sensing arm 114. When the pocket 98 is located in the well c 128, the spring 116 moves the sensing arm 114 back to the rest position as shown in Fig. 100. In turn, the locking mechanism 102 of the receiver is returned to the rest position. As shown in Fig. 1OE, when the locking mechanism 102 of the receiver is returned to the rest position, the latch 124 is released from the projection 126 located on the rammer 104. Thus, the movement of the rammer 104 is not limited by the locking mechanism 102 of the receiver. However, as described in more detail below, the trigger button 42 still cannot be actuated until the interlock valve is released. co

Briefly, the sensitive lever 114 and the locking mechanism 102 of the receiver serve to prevent the trigger button 42 from being activated if the receiver 22 is only in the partially inserted position. If it is not inserted, or if it is fully inserted, the locking mechanism 102 of the receiver is in a rest position in which it cannot prevent the movement of the ram 104 of the carriage assembly 38. When the unlocking of the valve blocker occurs, as described below, the trigger button 42 can be is pressed in order to move the carriage assembly 38 upwards, as a result of which the receiver 22 can be engaged with the aerosolization mechanism 16. Thus, there is a characteristic feature of agreement, which provides ;" the ability to prevent activation of the device 10 for aerosolization if the receiver 22 is inserted incorrectly. In addition, due to the presence of the well 128 in the sensitive lever 114, a mechanism is created

Alignment that ensures proper axial location of the pocket 98 in relation to the mechanism 16

He" of aerosolization. Thus, each time the device 10 is actuated to generate an aerosolized medication, the receiver 22 is coupled to the aerosolization mechanism 16 in an appropriate manner. The following is a description of the operation of the valve blocker 130, which is carried out with reference to Fig. t1OB-TOK. 2) in order to extract the aerosolized medicinal product located in the receiver 22, gas under high pressure must be supplied to the mechanism 16 5r of aerosolization (see Fig. 10). As described in more detail below, the high pressure gas supply is provided by actuating the handle 40 to increase the pressure

From the gas in the cylinder. Before increasing the gas pressure in the cylinder, valve 132 must be closed and opened to create gas pressure in the cylinder. As shown in Fig. 10E, the valve blocker 130 is in a ready state. In the ready state, the valve 132 is unlocked, and the valve interlock 130 ov Excludes the possibility of actuating the start button 42. As described in more detail below, the valve interlock 130 is not unlocked in order to ensure the possibility of actuating the start button 42 until (F, while the handle 40 will not be transferred to the fully extended position. Upon reaching the fully extended position of the handle, the valve 132 is blocked, and the valve blocker 130 is unlocked, as a result of which, as the handle 40 is moved back to the initial (retracted) position, the exact amount of gas is produced, because it is under high pressure, which can be released by actuating the trigger button 42.

In Fig. 10o, the receiver 22 is shown fully inserted, as a result of which the locking mechanism 102 of the receiver (see Fig. 10A) is in a ready state and is not engaged with the rammer 104. The handle 40 is in the initial (retracted) position, and the valve 132 is unlocked, as a result, the gas contained in the base assembly 12 is not under high pressure. As shown in Fig.10P, the valve blocker 130 65 includes a latch 134, which occupies a position over the protrusion 136 located on the rammer 104, when the valve blocker 130 is in a state of rest (ready). At rest, the drive lever 138, which is hinged to the base assembly 12 with the help of a pivot pin 140, is in the unlocked position, due to which the valve 132 is also in the unlocked position. The base assembly 12 additionally contains a valve adjusting lever 142. As shown in Fig. 10OE and 1005, valve adjusting lever 142

It is in the open position when it is engaged with the valve blocker 130, causing the latch 134 to be located above the protrusion 136. As more clearly shown in Fig. 100, the handle 40 includes a discharge branch 144, which is hinged to the base assembly 12 with the help of a rotary pivot 146. The discharge branch 144 includes a nose portion 148 which is located some distance from the valve adjusting lever 142 when in the open position. 70 As the handle 40 is moved from the initial position to the extended position, the discharge branch 144 rotates around the pivot pin 146, as a result of which the nose part 148 is engaged with the valve adjusting lever 142, as shown in Fig. 1ON. The base assembly 12 includes a running part 150 having a protrusion 152. As the nose part 148 presses on the valve adjusting lever 142, the latter slides under the protrusion 152 on the running part 150, as a result of which the valve adjusting lever 142 7/5 is fixed. In turn, the drive lever 138 turns around the pivot pin 140 (see Fig. 101), as a result of which the drive lever 138 is in the locked position. Thus, the valve 132 (see Fig. 10I) is closed and opened, due to which, as the handle 40 is moved in the direction of the base assembly 12, the gas pressure can be increased.

As more clearly shown in Fig. 10I, as the handle 40 moves to the fully extended position, the drive lever 138 moves above the center to the locked position, in which case the valve 132 is closed and locked. In the fully extended position, the valve actuating lever 142 rotates the valve detent 130 to disengage the valve detent 134 from engagement with the lug 136. In this position, both the valve detent 130 and the receiver detent mechanism 102 are in the disengaged position, as a result of which the trigger button 42 can be actuated. in order to actuate the carriage unit 38 and open the valve 132, due to which the gas under high pressure is delivered to the aerosolization mechanism 16, as described in more detail below. and)

Below follows a more detailed description of the design of the valve 132, which is carried out with reference to Fig.109. In Fig.10) the receiver is shown in the fully inserted position, and the handle 40 is shown moved to the fully extended position, as a result of which both the blocker 130 and the blocking mechanism 102 are in the Released state. The valve 132 is made in the form of a housing 154, which has a channel 156, which is located on the same axis as the window 88 (see fig.b), when the aerosolization mechanism is inserted into the base assembly 12. Across the channel 156 is the seat 159 of the valve. A corrugated membrane 160 departs from the valve seat 158, which ends in a ring 162 of circular cross-section. As shown in fig. 10), the valve actuator 164 and the drive lever 138 are firmly pressed into the valve seat 158 (see Fig. 101). Thus, valve 132 is in the closed, locked position. The housing 154 further includes a high pressure region 166 for receiving high pressure gas from the high pressure cylinder in the base assembly 12, as described in more detail below. It is desirable that the housing 154 is provided with a nozzle 168, which allows connecting a tube to the housing 154.

When the valve 132 is in the closed and locked position, gases cannot escape from the high pressure region 166 through the channels 156. Thus, high pressure gas will be produced when the handle 40 is moved to the initial (retracted) position. When the valve 132 is in the open c position, the gas under high pressure will pass through the channel 156 into the aerosolization mechanism 16, as a result of which the powdered drug will be extracted from the receiver 22. As shown in Fig. 10O0, the valve drive 164 is in the unlocked position when the handle 40 is moved to an incompletely extended position. In the unlocked position, valve seat 158 still occludes passage 156. Thus, when handle 40 is extended, air is not drawn from passage 156 and

Ge" region 166 of increased pressure. Instead, the high-pressure cylinder, which creates high air pressure when the handle 40 is actuated, is filled with air through a check valve in the bottom part of the base assembly so 12, as described in more detail below. Thus, the possibility of extracting any 2) residues of the powdered medicinal product, which is in the aerosolization mechanism 16, through the 5or Valve 132 and its entry into the high-pressure cylinder, where they could interfere with the normal operation of the device 10, is excluded. and in the closed state before moving the handle 40 to the fully extended position,

Ge valve seat 158 does not provide a seal, as a result of which air under high pressure is produced in the cylinder until the valve actuator 164 is in the locked position. Thus, if the handle 40 is only partially extended and then retracted to its original position, the gases from the cylinder 55 will freely pass through the high pressure region 166 and through the valve 132.

Fig. 10OK shows the device 10 with the aerosolization mechanism 16 inserted into the base assembly 12. The receiver 22 (F) is fully inserted, and the handle 40 is moved back to its original position after its fully extended position, as a result of which the locking mechanism 102 and the locking device 130 are in the unlock position. With such a position of the specified locking mechanisms, the trigger button 42 is in a position ready to be pressed in order to initiate the aerosolization process. As shown, the receiver 22 is in the fully inserted position and the cat 98 is co-axial with the pointed tip and side punches 80.

As shown in Fig.10Y, when the start button 42 is pressed, the teeth 110 turn around the pivot pin 108, as a result of which the rammer 104 of the carriage unit 38 moves the receiver 22 in the direction 65 of the mechanism 16 of aerosolization. When fully depressed, the pointed tip 50 and side punches 80 penetrate through the receiver 22 and enter the pocket 98 as shown. The limiter 86 engages with the carriage unit 38 (see Fig. 1OM) in order to prevent the bottom part of the pocket 98 from being pressed by the pointed tip 50 and the side punches 80, and the sealing element 87 provides a seal between the aerosolization mechanism 16 and the receiver 22. Pressing the trigger button 42 leads to the withdrawal of the valve 164 drive lever 138 from its position above the center, as a result of which the valve 132 is unlocked. The high-pressure gas inside the base assembly 12 then passes through the high-pressure region 166 as indicated by the arrow, causing the valve 132 to "pop" open. More specifically, the unlocking of the valve actuator 164 causes the high-pressure gas to contact the reverse side of the membrane 160, causing the valve seat 158 70 to be raised above the channel 156. Thus, air is able to flow through the channel 156 in mechanism 16 of aerosolization. The high-pressure gas then pulls the pulverized drug from the pocket 98, deagglomerates the pulverized drug, and disperses the pulverized drug into the capture chamber as previously described.

One of the specific advantages of the device 10 for aerosolization is that the powdered /5 Medicine is extracted from the receiver 22 almost immediately after it has been pierced by the mechanism 16 of aerosolization. Thus, the powdered medicine remains fresh in the receiver 22 until the moment of aerosolization.

Below follows a description of the process of actuating the start button 42 in order to remove the actuator 138 from the unlocked position, which is carried out with reference to Fig. 1OM and 10M. The start button 42 contains a flap 170, which engages with a stop 172 located on the valve adjustment lever 142. When the start button 42 is pressed further, the flap 170 pushes the valve adjustment lever 142 out from under the protrusion 152 located on the running part 150 (see fig. 10OH). In turn, the valve drive lever 138 has the ability to move back from its position above the center, squeezing the membrane 160 (see Fig. 10)3. As shown in Fig. 1OM, the start button 42 is in a fully pressed state, as a result of which the stop 172 on the adjusting lever 142 is in the released position.

As shown in Fig. 1OM and 10M, as the trigger button 42 is pressed, the teeth 110 and 112 work to transmit i) the starting movement from the trigger button 42 to the rammer 104. The rammer 104 has a spring rod 174 that engages with a groove 176 in the carriage unit 38. The spring rod 174 is used to raise the carriage unit 38, as a result of which the receiver 22 can be attached to the aerosolization mechanism 16. As shown in the figure, the limiter 86, located on the aerosolization mechanism 16, does not completely come into contact with the carriage assembly 38. As shown in Fig. 1OM, the carriage assembly 38 is engaged with the limiter 86, due to which the movement of the carriage assembly 38 discontinued In addition, the elastic rod 174 is deformed as a result of the further movement of the rammer 104 upwards. Thus, the spring rod 174 serves to lower the carriage assembly 38 back to its original position after the inhalation is completed, as described below. co

The base node 12 contains a hook 178, which is connected to the return button 46 (see Fig. 101). The hook 178 "o captures the petal 180 on the rammer 104 when the carriage assembly 38 is in the fully raised position and the gas under high pressure is released, as shown in Fig.100. When the return button 46 is pressed, the hook 178 is released from the flap 180, due to which the carriage unit 38 can be lowered to the initial position. As described earlier, the spring rod 174 helps to move the carriage unit 38 back to its original position. As shown in Fig. LoR, the carriage unit 38 is returned to the initial position from c (ready position), in which case the receiver 22 can be removed from the carriage unit 38.

One particular advantage of using the return button 46 is that the mechanism 16; of aerosolization remains attached to the receiver 22 until the start button 42 is pressed. Thus, the risk of puncturing the receiver 22 and subsequent lowering of the carriage is eliminated for the user

Nodes Z8 without aerosolization of the medicinal product. b The following is a description of the operation of the handle 40 in order to obtain gas under high pressure for its further delivery to the aerosolization mechanism 16, which is carried out with reference to Fig. 11-118 and 12-128. The handle 40 is connected to the discharge branch 144 with the help of a screw 182. The discharge branch 144, in its 2) turn, is connected with the cylinder 186 by means of a rotary pin 184. A piston 188 is hinged to the running part 150 of the basic 5or Node 12 by means of a rotary pin 190 . The piston 188 so is installed with the possibility of sliding inside the cylinder 186 in order to obtain the gas located under

High pressure. The cylinder 186 additionally contains an opening 192 with which a tube (not shown) communicates. This tube passes through the base assembly 12 and connects to the nozzle 168 to provide a hydraulic connection between the cylinder 186 and the valve 132. If the valve 132 is not in the locked position, the translational movement of the piston 188 inside the cylinder 186 causes the diaphragm 160 to sag, due to why is air able to pass through valve 132 as previously described. If, however, valve 132 is in

F) in the locked position, the translational movement of the piston 188 inside the cylinder 186 produces a charge of gas that is under high pressure inside the cylinder 186. Fig. 11-118 shows the handle 40 when it has not yet reached the fully extended position. Thus, the valve drive 164 is not yet in the locked position. In fig.12-128, the handle 40 is shown in a fully extended position, as a result of which the valve drive 164 of the drive lever 138 is blocked, after which the handle is moved back to the initial position. Thus, the cylinder 186 contains a gas under high pressure that is ready to be delivered to the aerosolization mechanism 16 upon actuation of the trigger button 42 as previously described. 65 As more clearly shown in Fig. 11A, the use of pivot pins 184 and 190 provides, in general, a coaxial arrangement of the cylinder 186 and the piston 188 during translation of the handle 40 in the extended and retracted position. Thus, the amount of wear between the cylinder 186 and the piston is significantly reduced. In addition, ensuring proper alignment between the cylinder 186 and the piston 188 reduces the amount of effort required to move the handle 40 when the gas pressure increases. For example, when the cylinder 186 has a volume of approximately eight milliliters with the handle 40 fully extended, a force of approximately ten pounds (44.48 N) will be required to return the handle 40 to its original position and create increased gas pressure.

Ensuring the actual alignment of the piston 188 and the cylinder 186 during the operation of the handle also allows applying, in fact, constant (equal) effort to the handle 40 in the process of manipulating it.

As shown in Fig. 11A, the piston 188 contains a check valve 194 and a filter 196. The check valve 194 70 is made in such a way that, as the handle 40 is extended, air has the opportunity to enter the cylinder 186 through the check valve 194. When the handle 40 is moved back to the initial position, the check valve 194 is closed, as a result of which the gas under high pressure can be generated in the cylinder 186. The filter 196 is designed to filter the air entering the cylinder 186. A part of the powder not consumed during the previous operations ("traveling" powder) can settle on the bottom part of the base assembly 12. The filter 196 prevents such powder from entering the cylinder 186. In order to further preventing the "traveling" powder from entering the cylinder 186, the latter is installed in such a way that the open end 198 of the cylinder 186 is actually oriented downward. Thus, the "traveling" powder falling through the base assembly 12 will not fall directly on the piston 188, from where it could be drawn into the cylinder 186 during operation.

As described earlier, if the receiver 22 is not fully inserted into the carriage assembly 38, the trigger button 42 2o cannot be actuated to connect the receiver 22 to the mechanism 16 of aerosolization. Therefore, the receivers used in conjunction with the aerosolization device 10 can be locked to prevent the receiver from being fully inserted into the carriage assembly 38 until the proper receiver is inserted. Thus, the receiver can be blocked depending on the pulverized drug contained in it, as a result of which the patient will not receive the wrong drug. An exemplary scheme of blocking receivers with ob is shown in fig. 13 and 14. As shown in fig. 13, the receiver 22" includes a cutout 200. The receiver 22" is used in conjunction with the aerosolization device only if the carriage assembly contains a key that is received by the cutout 200 when the receiver 22" is inserted into the carriage assembly. If the receiver does not include the cutout 200 , it cannot be fully inserted, preventing the carriage assembly from working as previously described.

As shown in fig. 14, the receiver 22" contains a pair of slots 202 and 204. In this embodiment, the carriage assembly c zo will contain a pair of keys that coincide with the slots 202 and 204, which will allow the receiver 22" to be fully inserted. By increasing the number and changing the location of various cutouts and openings, all kinds of combinations can be obtained, thanks to which receivers with a wide range of drugs can be blocked from a particular aerosolization device in order to prevent delivery of the wrong drug to the patient. Although rectangular cutouts and slots are shown in the drawings, it should be noted that cutouts, slots, or recesses of any geometric shape may be used provided that complete insertion of the receiver is prevented, unless it is intended for a specific aerosolization device. .

Above was the description of the invention, which for the purpose of clarity of understanding was illustrative in nature with references to variants of its implementation. However, it should be borne in mind that certain changes and modifications may be made within the scope of the dependent claims of the invention. " - with ;" (22) (ee) (95) at 50

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Claims (23)

The formula of the invention 1. A device for aerosolization of powdered medicinal product, containing: a high-pressure cylinder, a piston installed with the possibility of sliding inside the cylinder to increase the pressure of the gas contained in the cylinder, a handle connected to the cylinder, and the handle is installed with the possibility of 65 movement between extended position and initial position to increase the gas pressure contained in the cylinder; an aerosolization mechanism intended for aerosolization of powdered medicine, which is contained in the receiver, by means of gas under high pressure coming from the cylinder, a carriage assembly designed to receive the receiver and to connect the receiver to the aerosolization mechanism, and first and second locking mechanisms that can be operated in a mode of interaction with the carriage assembly to prevent attachment of the receiver to the aerosolization mechanism, and the first locking mechanism is disengaged to ensure movement of the carriage assembly when the handle is moved to the extended position, and the second locking mechanism is engaged when the receiver is partially inserted into the carriage assembly. 2. The device of claim 1, further comprising a capture device that engages with the carriage 7/0 Assembly when the capture is moved to attach the receiver to the aerosolization mechanism, and a return button for disengagement from the carriage assembly. C. The device of claim 1, further comprising a valve located in the air passage between the cylinder and the aerosolization mechanism, wherein the valve has an open position and a closed position and is generally in the closed position when the handle is moved to the extended position. 4. A method of aerosolization of powdered medicine contained in the receiver, which includes: inserting the receiver into the carriage assembly until the first locking mechanism is disengaged from the carriage assembly, moving the handle to the fully extended position to disengage the second locking mechanism with the carriage assembly, moving the handle to the retracted position to generate the high-pressure gas charge, and actuating the trigger button to move the carriage assembly 2o in the direction of the aerosolization mechanism until the receiver is attached to the aerosolization mechanism and the gas charge, which is under high pressure, will not be released to aerosolize the powdered drug inside the receiver. 5. A device for aerosolization of powdered medicine, containing: a housing, a high-pressure cylinder, a piston installed with the possibility of sliding inside the cylinder to increase the gas pressure, with what is contained in the cylinder, and the piston is hinged to the housing, a handle attached to the body and cylinder with the possibility of interaction with them to ensure the movement of the cylinder relative to the piston for i) increasing the pressure of the gas contained in the cylinder; and an aerosolization mechanism designed to receive gas from a cylinder for aerosolization of powdered medicinal product. b. The device according to claim 5, which additionally contains a lever gear located between the handle and the cylinder, with the lever gear hinged to the body and the cylinder. 7. The device according to claim 5, in which the housing has an upper end and a lower end, and the aerosolization mechanism is located near the upper end, and the piston is hinged to the housing near the lower end. co 8. The device according to claim 5, which additionally includes a one-way check valve located in the piston. 9. The device according to claim 5, further comprising a valve located in the air channel between the piston and the aerosolization mechanism, and the valve has an open position and a closed position and is generally in the closed position when the handle is moved to the extended position. 10. A system for aerosolization of a powdered medicinal product, comprising: a receiver containing a powdered medicinal product, a carriage having an opening for receiving the receiver, an aerosolization mechanism designed to aerosolize the medicinal product contained in the receiver after delivery of the receiver carriage " 40. to the aerosolization mechanism, and a locking mechanism installed with the possibility of engaging with the carriage to prevent movement of the carriage in the direction of the aerosolization mechanism, and the locking mechanism engages with the carriage when the receiver is not fully inserted into the carriage. ;" 11. The system according to claim 10, in which the receiver has a front end, a rear end and a cavity in which the drug is contained, and the front end contains at least one recess, and the carriage contains a key, as a result of which the receiver can be fully inserted into the carriage only if the notch coincides with the key. Gee" 12. The system according to claim 11, which additionally includes a sensitive lever having a roller, and the locking mechanism includes a flap, and the roller rolls over the cavity in the process of inserting the receiver into the carriage to move the sensitive lever opposite the locking mechanism, as a result of which the flap is engaged. with the carriage until the roller rolls over the entire cavity. 13. The system of claim 12, wherein the sensing lever defines the boundaries of the well that receives the cavity when the receiver is fully inserted, and the well centers the cavity with the aerosolization mechanism. Ge 14. A device for aerosolization of powdered medicinal product, containing: a housing, a capture chamber located at a distance from the housing, an aerosolization mechanism located in the housing and intended for introducing a powdered medicinal product into the capture chamber, and the aerosolization mechanism contains air ducts that allow air to enter the capture chamber when the patient inhales to extract the pulverized drug from the capture chamber, and additionally contains (F, a structural assembly designed to distribute the air entering the capture chamber through the air ducts, so that that the powdered medicine is removed from the capture chamber in the form of a bolus, which, in fact, does not mix with the incoming air. 15. The device according to claim 14, in which the capture chamber has a center, and the aerosolization mechanism is located with an offset relative to the specified center, and the structural assembly is made with the possibility of distributing a larger amount of air to those areas of the capture chamber that are on the opposite side of the specified center. 16. The device according to claim 14, in which the specified structural unit is additionally configured to distribute air into the capture chamber such that the specified bolus is extracted from the capture chamber before any significant amount of incoming air is extracted from it 65 . 17. The device according to claim 14, in which the specified structural unit contains a bent flange element. 18. The device according to claim 14, in which the aerosolization mechanism defines the limits of a cylindrical channel through which the powdered medicine passes to enter the capture chamber, and the upper end of the body is located, in general, perpendicular to the distal end of the indicated channel. 19. The device according to claim 14, which additionally contains an elastic sealing element that provides a seal between the housing and the capture chamber. 20. A method of delivering a powdered medicinal product to the patient's body, which includes: dispersing the powdered medicinal product in the capture chamber, inhalation by the patient from the capture chamber to extract the powdered medicinal product; and providing 7/0 air entry into the capture chamber such that the pulverized drug is drawn from the capture chamber as a bolus followed by the incoming air. 21. A method of delivering a powdered drug to the patient's body, including: dispersing the powdered drug in the capture chamber, inhalation by the patient from the capture chamber to extract the powdered drug, and ensuring /5 Air entry into capture chamber such that essentially no amount of incoming air mixes with the powdered drug as the powdered drug is withdrawn from the capture chamber. 22. A device for aerosolization of powdered medicine, containing: a body having at least one piercing element, which is intended for piercing a hole in a receiver containing 2o powdered medicine, a core, which is installed with the possibility of inserting into the body, and the core has an exhaust cavity and at least one air channel, which is located on the same axis with the piercing element, when the core is inserted into the body; and a high-pressure gas source for drawing the pulverized drug through the extraction cavity when the extraction cavity is in the receiver. with 23. A device for aerosolization of powdered medicine, containing: a high-pressure cylinder, a piston installed with the possibility of sliding inside the cylinder to increase the pressure of the gas that i) is contained in the cylinder, a handle connected to the cylinder, and the handle is installed with the possibility of movement in the extended position and the initial position to increase the pressure of the gas contained in the cylinder, the aerosolization mechanism is designed to aerosolize the powdered medicinal product, which is contained in the receiver, with the help of high-pressure gas coming from the cylinder; and a locking mechanism that prevents the aerosolization mechanism from being attached to the receiver until the handle is moved to the extended position. Official Bulletin "Industrial Property". Book 1 "Inventions, useful models, topographies of integrated circuit microcircuits", 2004, M 8, 15.08.2004. State Department of Intellectual Property of the Ministry of Education and Science of Ukraine. - and? (o) (ee) (95) (ee) Ko) ime) 60 b5