Cartridge for an inhalation apparatus

ES 2 300 568 T3

DESCRIPTION

Inhalation apparatus.

Technical field

The present invention is directed to inhalers, and in particular to dry powder inhalers.

Background

Inhalers or inhalation devices that deliver their content in the form of liquid mist and powder in the form of an aerosol, are in common use today. However, these inhalers generally used propellants whose efficiency depends on the pressure, and therefore on the altitude and the atmosphere. Additionally, propellants such as chlorofluorocarbon are prohibited by the treaties, as they are harmful to the environment.

As a result, dry powder inhalers or inhalation devices were developed. However, these dry powder inhalers were of limited use, especially when transmission of the drug deep into the lung was desired.

These dry powder inhalers had disadvantages in that their design produced particles that moved too fast or clumped together. When the particles traveled too fast, they generally reached the back of the throat, where they were absorbed, never reaching the lungs. Similarly, the agglomerated particles were too heavy, and generally fell out of the inhaled breath stream into the mouth or oral cavity, where they were swallowed without ever reaching the lungs. Consequently, if any dust reached the lungs it was generally in ineffective amounts for proper treatment.

Furthermore, these conventional inhalers are relatively large. As a result of its large size, its portability in pockets and other compartments is limited, and to a large extent, the space required for its use is large. For example, the space required for the use of these conventional inhalers would make it difficult, if not impossible, to use them under a gas mask or the like, since the air space in it is extremely limited. Coupled with the amount of space they take up in pockets, first aid kits, etc., many of these conventional inhalers are not recommended for the battlefield and other emergency uses.

US Patent No. 5,394,868 describes an inhalation device in which a chamber that discharges substances is attached to a mouthpiece. A base mechanism is moved relative to the chamber to load the chamber with the inhalation substance in a subsequent operation that follows subsequent movement of the base mechanism.

The structure of the device of US 5,394,868 is complex, and does not lend itself to economical use as a single dose article.

WO-A-97/30743 describes a similar configuration, in which rotating parts are used to load a chamber that is attached to a nozzle.

Summary

According to a first aspect of the invention there is provided an inhalation apparatus according to Claim 1.

In a second aspect of the invention there is provided a method according to Claim 8.

Summary

The apparatus, components, and methods described in the present application improve upon the current art by providing a dry powder inhaler whose contents can reach the lungs in amounts effective for the treatment of various ailments. The apparatus described in the present application includes an inhaler (inhalation piece) that uses the user's breath to pass dry powder from the body of the device to the user's lungs, eliminating the need for propellants. Accordingly, the inhaler described in the present application can be used regardless of altitude and atmospheric conditions.

The inhaler described in the present application has a configuration such that, when the user's breath reaches a sufficient predetermined flow rate, the dry powder contained therein will de-agglomerate. These non-agglomerated dry powder particles then enter the inhaled breath stream, thus allowing the contents of the inhaler to reach the lungs in effective amounts.

The inhaler is small and compact. This small size makes it possible to use it in small spaces. For example, the inhaler can be worn under, or inserted into, a gas mask or other protective device, utilizing the closed air space of the inhaler without interrupting its function. The inhaler can also be single or one-time use and can be disposable.

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The inhaler is activated instantly when removed from a cover or cover unit. The inhaler is detached from the cover by simply pushing it in a direction away from the cover or by rotation, if a helix-shaped screw mechanism is present between the cover and the inhaler. By rotating a cartridge component of the inhaler, where the medication from the inhaler is stored in a chamber, a channel is opened from this chamber to the environment. Additionally, the storage chamber opens to the mouthpiece, providing immediate access to chamber contents for immediate inhalation.

The inhaler is hygienic and its contents are protected until use, while the mouthpiece and the opening to the environment are under a cover that puts the inhaler body in a locking configuration until use is desired. Each inhaler can be individually covered, or the individual covers can be joined to make a single unit consisting of multiple covers with corresponding inhalers.

Des brief description of the drawings

Attention is now directed to the drawing figures, where like reference numerals or characters indicate corresponding or similar components. In the drawings:

Fig. 1 is an isometric view of one embodiment of the apparatus described in the present application as a single unit;

Fig. 2 is an exploded view of the device of Fig. 1;

Fig. 3A is an isometric view of the nozzle of Fig. 2;

Fig. 3B is a front view of the nozzle of Fig. 2;

Figs. 3C and 3D are side views of the nozzle of Fig. 2;

Fig. 3E is a rear view of the nozzle of Fig. 2;

Fig. 4 is a cross-sectional view of the apparatus of Fig. 1 showing it in a closed position;

Fig. 5A is a view of the nozzle of Fig. 3D, taken along line 5A-5A;

Figs. 5B, 5C, 5D are cross-sectional views of Fig. 5A, taken along lines 5B-5B, 5C5C, and 5D-5D, respectively;

Fig. 6A is a front view of the cartridge of Fig. 2;

Fig. 6B is a view of the cartridge of Fig. 6A taken along line 6B-6B;

Fig. 6C is an exploded view of the cartridge of Fig. 6A;

Fig. 7A is a front view of the apparatus of Fig. 1 with the cover repositioned on the inhaler part;

Fig. 7B is a cross-sectional view of the apparatus of Fig. 7A taken along line 7B-7B;

Fig. 8 is an isometric view of a second embodiment of an apparatus described in the present application; Y

Fig. 9 is an isometric view of the embodiment of Fig. 8, showing removal of the part of the inhaler.

Detailed description of the drawings

Figs. 1 and 2 show an apparatus 20 formed by an inhaler (inhaler) part 22 and a cover 24. The inhaler part 22 includes a mouthpiece 26, formed by a tube section 28 and a body section 30, and a cartridge 32 The nozzle 26 includes an inner bore 40 (Figs. 4 and 5A) to receive the cartridge 32 in a friction and rotary joint, allowing the rotation of the cartridge 32 with respect to the nozzle 26, and vice versa (according to the arrow dual direction 41). This connection is maintained by the correspondingly positioned tabs 44 (Figs. 4 and 5A), 45 on the nozzle 26 and cartridge 32, which are joined together. Both the mouthpiece 26 and the cartridge 32 include ribbed neck sections 48, 49 to facilitate gripping by the user in order to rotate the cartridge 32 in the mouthpiece 26.

The cover 24 is generally attached to the inhaler portion 22 at the shank 52 of the mouthpiece 26. This shank 52 is generally only slightly smaller in diameter than the corresponding internal diameter of the cover 24 (between the inner surfaces 53 of the cover 24). Shaft 52 also includes at least one recess 54, for engaging correspondingly formed protrusion (s) 57, typically extending continuously around inner surface 53 (Fig. 4) of the cover 24. The dimensions of the shank 52 and cover 24, linked to the recess 54 and the corresponding projection (s) 57, allow the cover 24 to be retained on the nozzle 26 in a friction joint,

ES 2 300 568 T3 where removing the cover 24 from the nozzle 26 requires minimal effort. Cover 24 may include a cylindrical grooved finger grip 58 that assists the user in grasping cover 24 when it is desired to use inhaler portion 22.

Cover 24 and nozzle 26 are typically designed, where reattachment of cover 24 to nozzle 26 is not possible, as recess 54 or projection (s) 57 are damaged during removal of cover 24 , for which they will no longer serve to maintain the aforementioned coupling. Alternatively, the cover 24 and the mouthpiece 26 could include threaded portions as structures, at least one of which is removed in separation of the inhaler portion 22 from the cover 24, or both the cover 24, or the mouthpiece 26 they include one-way ratchet-like structures that damage said separation. This ensures that the inhaler section 22 will be a one-time use device. Therefore, testing the apparatus 20 to ensure that it has not been used simply involves flipping the apparatus 20 upside down, with the cover 24 pointing to the ground. If the cover 24 falls off easily, this is a true indication that the inhaler portion 22 has been used.

Returning also to Figs. 3A-3E and 4 (apparatus 20 is shown in the closed or stowed position in Fig. 4), port 60, extends through shank 52. Port 60 includes an intake opening 62 (through which air from the environment enters the part of the inhaler 22) above which the cover 24 extends. This allows the inhaler portion 22 to be detached from the cover simply by fracturing / detaching the cover or by twisting or turning it (in the direction of the two-way arrow 63), if a mechanical screw-in system is employed (e.g. screw type) between the inhaler part 22 and the cover 24.

Cover 24 extends over and into intake opening 62 and port 60 such that shank 52 fits beyond intake opening 62, since it is desired that port 60 and intake opening be low. the cover and not exposed to the environment until use (ie, separation of the inhaler portion 22 from the cover 24). Being below the cover minimizes the likelihood that dust or other particles could get into port 60 and clog it. Port 60 is, for example, rectangular in cross-section, with other cross-sectional shapes, such as round, also appropriate. Port 60 terminates in an interior aperture 64, which corresponds in shape and dimensions to aperture 122 (FIG. 6B) in cartridge 32.

The nozzle 26, in its tubular section 28, includes the reed 52, with a particle discharge conduit 70 (from chamber 110, detailed below), which extends the entire length. As shown in FIG. 5A, conduit 70 includes an opening 72, typically a rounded or circular opening at its inner end 73. Moving to the outside, the conduit 70 has a constant diameter portion 74, followed by a tapered portion 76, and a straight portion 78, terminating in an opening 80, at the outer end 81 through which the particles leave the inhaler portion. 22 and enter the oral cavity of a user. These three parts 74, 76 and 78, join the aggregations of the residual non-agglomerated particles within the particle flow and control the rate at which they are discharged into the oral cavity. Additionally, the lengths of each portion 74, 76, and 78 were optimized such that flow separation (backward flow creating vortices or eddies) did not increase.

The constant diameter portion 74 is of a constant diameter and of sufficient length to provide the particles with a direct entry conduit for particle / gas acceleration and the development of a high flow shear field. This portion is typically oval or rounded in cross section, as shown in Fig. 5B. This geometry allows the removal of most of the residual agglomerated particles.

The tapered portion 76 tapers outwardly (toward the outer opening 80), typically at angles of about 3 to 7 degrees, and for example about 4 degrees to achieve, for example, a 2: 1 aspect ratio. In this aspect ratio, there may be transition of the velocity of the particle stream traveling in this tube 70. This tapered portion 76 originates, for example, with an oval cross section (Fig. 5B) and tapers outwardly into a bean or kidney shaped cross section, as shown in Fig. 5C.

The straight portion 78 is of constant dimensions. This allows collimation and control of the velocity of the particle stream leaving conduit 70. This portion 78 is typically bean or kidney shaped in cross section, as shown in Fig. 5D, similar to that of aperture 80. However, other shapes are also possible, as long as they allow control of the velocity of the particle stream.

A bulb 86 on the exterior of tubular section 28, typically a raised oval or other rounded shape, functions as a tongue depressor as well as the nozzle discharge passage locator. Specifically, as shown in detail in Figs. 3C-3E, 4 and 7B, this shape and dimensions for bulb 86 keep the tongue down, so as not to block the flow of particles in the mouth (oral cavity). Shaft 52, particularly where it is larger in diameter than conduit 70, serves as a stop surface to support the user's lips, allowing the lips to form a seal around the tube section 28 at this point for suction, in order to reinforce inhalation. Alternatively, there may be a protrusion on the tubular section 28, on the opposite side of the bulb 86 (i.e., tongue depressor), which serves as a butt surface for the lips, allowing the lips to form a seal around the tubular section. 28 at this suction point, in order to reinforce the inhalation.

The inner bore 40 of the nozzle 26 is formed in correspondence with the shape of the head portion 102 (Figs. 6A-6C) of the cartridge 32. This bore 40 includes a serrated groove 90 (Figs. 4 and 7B) that allows a Correspondingly sized key 154 of cartridge 32 to be retained there, while allowing rotations

ES 2 300 568 T3 of the cartridge 32 in the mouthpiece 26 up to 90 degrees, so that the part of the inhaler 22 moves from the closed or retracted position (shown in Fig. 4), to the open or inhalation position (shown in Figs. 7A and 7B), for inhalation and transport of particles to the lungs. The teeth (not shown), typically positioned at 90 degrees to each other, extend into the surface 94 of the inner bore 40. These teeth are cooperatively configured to adjust edges 150 on cartridge 32, upon passage of cartridge 32 to the open position (detailed below). These teeth generally include radial or rounded edges, which allow movement of cartridge 32 with respect to nozzle 26 (and vice versa), between the open and closed positions. Alternatively, these teeth, if provided with square or sharp edges, will be one-way, thus not allowing movement back to the closed position (Fig. 4) from the open position (Fig. 7B), thereby which apparatus 20 is a one-time or one-time use apparatus.

Figs. 6A-6C show cartridge 32 in detail. Cartridge 32 is generally formed of a head portion 102 and a caudal portion 104, which may be together in a friction snap fit, weld, or bond by other conventional attachment techniques and / or mechanisms. The head 102 and tail 104 portions when brought together house a chamber 110 therein combined.

An inlet duct 112, for air intake extends into chamber 110, at head portion 102. This inlet duct 112 is formed by a feed duct 114, correspondingly formed with respect to port 60, for alignment when the inhaler portion 22 is in the open position, and a collimation tube 116, extending from the feed channel 114 (through opening 117a) into chamber 110 (through opening 117b).

An outlet conduit 118 for the particles extends from chamber 110 (through openings 119) to the outer surface 120 of cartridge 32. This outlet conduit 118 terminates in an opening 122 sized to correspond to opening 72 in the mouthpiece 26 for particle flow through it, when cartridge 32 and mouthpiece 26 are aligned with the portion of inhaler 22 being in the open position (FIG. 7).

Inside chamber 110 are edges 130a, 130b, typically rounded in shape. In the caudal portion 104, the edges 130b extend to form a central boss 132. This boss 132 is typically cone-shaped, and attached to the edges 130a, 130b, creates the vortices for the particles (represented by arrows 134) of the air stream through collimation conduit 116 (represented by arrows 136). By creating the vortexes, the particles are deagglomerated and suspended at a uniform dry propelled aerosol concentration. This maximizes by effectively emptying chamber 110 and allows particles to be introduced into the flow of respiration.

Within this chamber 110, the inhalant, which is typically in dry powder form, is held. This inhalant can be for example bioactive molecule (s) encapsulated in Technosphere particles^® from Mannkind Corporation, Valencia, California, 91355, as described in US 2004/018152, or atropine, antibiotics, such as penicillin, doxycycline, ciprofloxacin, and fluoroquinolones, encapsulated in Technosphere particles^®, these Technosphere® particles and methods for their manufacture are described in US Patent Nos. 5,352,461, 5,503,852 and 6,071,497.

Head portion 102 is generally formed of a cylindrical portion 140, a conical portion 142 (for example at about a 60-70 degree angle), and a disk portion 144, above conical portion 142. Flanges 45 extend typically around cylindrical portion 140 to thereby engage corresponding flanges 44 of nozzle 26, and maintain the frictional and rotational engagement of cartridge 32 and nozzle 26 as detailed above. Conical portion 142 includes an opening 146 for feed channel 114, which is typically rectangular for optimal flow control, as well as opening 122 for outlet conduit 118.

The edges 150 protrude a slight distance from the surface 151 of the conical portion 142. By extending this slight distance, attached to the cartridge material, and thus the edge 150, the edges 150 behave in a spring-like manner. Edges 150 are typically square or sharp points 152, but could also be radial or rounded at their edges. The edges 150 are correspondingly dimensioned for the openings 64, 72 of the nozzle 26, where they seat when the apparatus 20 is in the closed position. (Apertures 64, 72 typically include radial or rounded edges to allow rotation of cartridge 32 in nozzle 26 from closed to open position). The edges 150 ultimately rest on the teeth (as detailed above), with the spring-like behavior of the edges 150 providing the tactile sensation that the cartridge 32 and nozzle 26 are no longer attached in the initial closed position and the open position has been reached. These edges 150 are typically positioned 180 degrees from each other (although other positions are also possible), these 180 degrees corresponding to the positions of the nozzle openings 64, 72 and the respective teeth on the nozzle 26.

A key 154 extends from the disk portion 144. The key 154 is typically crescent-shaped, and fits within the slot 90 (Figs. 4 and 7B) in the nozzle 28, with the slot 90 serving as the limit for the key. 154, and consequently has sufficient space to limit the rotation of the cartridge 32 with respect to the nozzle 26 (and vice versa) to eg 90 degrees (so that the rotation is between the open and closed positions).

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The caudal portion 104 includes the ribbed neck section 49, as detailed above. Additionally, there are the threads 158 or teeth of the ring at the end of the caudal portion 104, which can be mated with corresponding threads 159 or edges on the cover 24, to maintain the cover on the inhaler section 22. Alternatively, this section of the caudal portion 104 and the corresponding portion of the cover 24 may be provided with a permanent lock once attached, thus promoting the one-time use of the apparatus 20, as shown in Figs. 7A and 7B. However, this attachment of the cover 24 to the caudal portion 104 is optional, since normal operation of the inhaler portion 22 does not require the cover 24 to be attached to the caudal portion 104.

All of the components mentioned, the cover 24, the nozzle 26 and the cartridge 28, and all the structures on top and / or inside are typically made of plastics, polymers, or the like, one of such plastics being acetal plastic, for example plastics. DELRIN® 500 and “Antistatic” CELCON®. Although these plastics are cited, multiple other plastics, polymers and other materials are also suitable for the components mentioned in the present application. These plastics, polymers, and other materials can be selected, for example, based on the composition that will be in chamber 110, environmental and storage factors, and the like. These components are typically formed by techniques such as molding and, for example, injection molding.

Turning specifically to Figs. 7A and 7B, the inhaler portion 22 is detailed in an open position, ready for use (inhalation of the contents of chamber 110). As shown here, feed channel 114 and outlet conduit 118 are positioned in cartridge 32, which, having been rotated, are respectively aligned with inlet port 60 and discharge conduit 70. This alignment in the open position creates a flow path for inhalation, from inlet opening 62 (for intake of ambient air), through chamber 110, where a flow of particles is created, and through from the discharge conduit 70 of the mouthpiece 26, where the flow of particles is inhaled for final delivery to the lungs, even to the depth of the lungs. Inlet port 60, attached to feed channel 114, and outlet conduit 118, are typically angled at an angle θ, being at approximately 0 to 180 degrees from each other, and for example, approximately 45 degrees, to avoid large back pressures, which inhibit air flow along the flow path.

Figs. 8 and 9 show a multiple unit system 200. Here, the single parts of the inhaler 222, similar in all respects to the parts of the inhaler 22 (detailed above), are in the covers 224, similar to the covers 24 (detailed above). , which come together as a single unit. Covers 224 include weak parts 227 and openings 229 therebetween, allowing easy separation into individual units 20 '.

References cited in description

This list of references cited by the applicant is solely for the convenience of the reader. It is not part of the European Patent document. Although great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims any liability in this regard.

Patent documents cited in the description • US 5394868 A • US 5352461 A • WO 9730743 A • US 2004018152 A • US 5503852 A • US 6071497 A