FI105654B - Inhaling device - Google Patents

Description

105654

An inhalation. - Inhaleringsanordning.

This invention relates to an inhalation device, namely, an apparatus for use in delivering a dose of a drug or other agent for inhalation to the lungs.

The most common form of inhaler device pushes a dose of medicament as a pressurized gas from an aerosol. However, this form of inhaler becomes less popular due to environmental and other considerations. Distribution of some drugs in dry, finely divided form has been shown to have certain medical benefits over other forms of delivery.

Some of the known proposals for subdivision of a drug in fine form cannot be used with one hand. One-handed operation is considered to be an important feature of such an inhaler.

EP 079478, EP 166294 and GB 2165159 disclose all dry powder inhalers which can be operated with one hand. In each of these proposals, the inhalation device includes a drug storage chamber and an inhalation passage through which air is drawn through the mouthpiece. A metering member provided with a dosing recess delivers a dose of drug from the storage chamber and

«V

place it in the inhalation chamber. It is contemplated that the accuracy of such an arrangement may be very poor: the repeated indexing of the second wave interleaving element has a · · · ._...

: It is possible to place two or more doses of the drug in the inhalation channel

MI: 25 leading to distribution of drug overdose; on the other hand, since the drug normally drops from the dosing recess into the inhalation channel under gravity · ·:, the drug particles can stick to the inside of the dosing recess • 9 · m t '* * by delivering an underdose.

• ____: _j__ _ »• · ·« · ·.

* ML · 30 US 2587215 also discloses dry powder inhalers having the same drawbacks as those mentioned above. However, this document also discloses an embodiment in which the dosing member directs the drug upward in an open dose dial to the mixing chamber where it is mixed with air before being sucked into the inhalation tube through a nozzle with a narrow opening. The air drawn into the inhalation device passes into the inhalation tube either directly or through the nozzle of the mixing chambers. Thus, not all air passes over the dosing cup. If the drug adheres to the surface of the dosing cup but is not sucked from it, an underdose of the drug is delivered to the user. With repeated use of the cavities to deliver doses to the inhalation canal, it has been found that a continuously increasing amount of powder adheres to the bottom of the cavity, resulting in progressively reduced dosing to the patient. The tendency for adherent powder to accumulate is thought to be a source of inaccurate dosing in many previously proposed inhalation devices.

In inhalation devices of US 2587215, the metering member is a rotatably sliding device fitted to a cylindrical pivoting member extending from the bottom of the device body. Such an arrangement tends to get stuck due to powder entering between the cylindrical contact surface of the pivoting member and the dispensing member.

Another form of inhaler device currently available includes a metering member which includes a plurality of tapered metering recesses open at the top and bottom. In use, the finely divided drug from the storage chamber V20 is packed into the recesses, after which the dispensing member is moved to the dispensing position, where the air can be drawn through the recesses to suck out the drug. This device has been identified as having several major drawbacks. First, the dosing and dosing recesses tend to clog. Second, a large amount of air is needed • · ·; so that the device is unsuitable for many patients with breathing problems.

• · ·: 25 Third, two hands are required to operate the machine.

It is an object of the present invention to provide a form of an inhaled thiol device for a single-handed operation capable of delivering precise doses and avoiding the risk of multiple dosing. A further object is to provide an inhalation device that does not require a large volume of suction for effective function: V :.

• · - i · · «· 3 105654

The present invention provides an inhalation device for dispensing material in a finely divided form, the inhalation device comprising a body defining a storage chamber for the substance to be dispensed and further defining an inhalation passage through which the air is inhaled in use; and a metering member capable of transferring a volume dose of substance 5 from the storage chamber into the inhalation channel, the metering member having a metering surface notched to form at least one dispensing cup and movable between a first and a second position a dose of substance is directed to the inhaled thiocarbon channel in a dispensing cup which is open upwards, characterized in that the body comprises a housing having an annular contact surface for sliding contact with the dispensing surface, the dispensing surface comprising a frustoconical wall and the contact surface on the inside of which the metering member is arranged to rotate between its first and second positions.

Preferably, the dispensing member is in flexible contact with the body and is movable when in contact with the body.

· J V 20 The dispensing surface may contain a number of spaced dispensing cups.

* *: Use of a frustoconical shape in the dispensing member containing the dispensing cups, Y ·: allows good sealing between the dispensing member and the housing against which the frustoconical wall is joined. So either rigid or semi-rigid • · · .........

v: plastic material can be used and appropriate shapes can be produced with relatively modest tolerances. Other shapes, such as, for example, spherical or cylindrical, require either significantly stricter tolerances to achieve the required type of sealing or flexible • «· —— · · · Materials should be used or, if applicable, an additional elastic sealing ring • ·: should be included. The good compaction of the forged ^ above should be such that | The integrity of the stored drug is maintained, for example, by preventing: Y: all moisture and / or dirty air from entering the storage chamber.

«« • «4 105654

The frustoconical shape also makes it possible to form the delivery member in such a way that it occupies relatively little space so that the inhalation channel may be shorter than many prior inhalation devices, reducing the amount of suction required from the patient.

5

The longitudinal axis of the frustoconical wall is located when the inhaler is held in its normal operating position, preferably between a vertical and an angle of 60 ° to the vertical. More preferably, this axis is located at an angle of about 45 ° to the vertical.

10

Preferably, the inhalation device further comprises cup cleaning means to ensure that the one or each delivery cup is substantially free of material prior to being introduced into the storage chamber. Preferably, the cup cleaning means includes means for moving said one or each dispensing cup to a position where, in normal use of the inhaler, any substance remaining in the dispensing cup tends to fall, under gravity, out of the cup following a dose into the cup inhalation channel is again directed to the storage chamber. Thus, in normal use of the inhaler device, the repeated indexing of the metering member does not lay multiple layers: doses of V 20 agent into the inhalation channel.

The cup cleaning means may additionally or alternatively include an inhalation channel formed such that a dose of the substance directed into the inhalation channel is substantially exposed to a flow of air through the inhalation channel as the air is drawn through the mouthpiece. Thus, whether or not air is drawn into the inhaler device through a single or multiple openings, the air flow through the device is such that all air flows through one channel at the point where the metering cup is directed to the air flow through this channel. ·: Inside. Removal of substance from dosing organ by inhalation air

«M

30 flow rather than under gravity, can ensure that • · v .: the dose is removed more thoroughly.

• · • · • I · «· 5 105654

Alternatively or additionally, the cup cleaning means may consist of flexible wiping means or include flexible wiping means for removing any residual material from said one or each cup after a dose of substance is directed therein into the inhalation passage and before this cup is reintroduced into the storage chamber. Providing such removal means ensures that the one or each dosing cup is cleaned before refilling and thereby prevents the accumulation of adherent material in repeated refills.

Preferably, the inhalation device of the invention includes a chamber for holding the moisture-absorbing Mateo, with which chamber one or each of the I delivery cups can be displaced after the dose of substance is directed into the inhalation channel and before this cup is again directed into the storage chamber. Hereby, the empty cup can be dried before filling to reduce the adhesion of the surface of the cup. A filled delivery cup can also move in alignment with the same skilled moisture absorbent chamber as it moves from the storage chamber to the inhalation channel. This can help prevent moisture from passing from the inhalation channel to the storage chamber.

The V 20 "inhalation device preferably includes display means which are indexed in cooperation with the delivery means to display information to the user. The display elements can «• · · · # .....-.

Includes calculating means for counting the number of times the delivery cup is · 0 ____ directed to the inhalation channel and / or the number of remaining doses which are intended to be so directed.

··· * ♦ · *;!. * As noted above, the arrangement of the frustoconical metering member is. · · * --------— • I 'particularly advantageous by allowing greater manufacturing tolerances than might be the case. : possible other structuresThe metering member itself has a uniform metering surface, as is the case with the above-mentioned embodiment of US 2587215: V, then it is necessary to form a separate shaft or pin mounted on: / · j part of the device . Such a different axis tends to get stuck due to the powder being pushed between the contact surfaces associated with the axis.

6 105654

The invention is exemplified in the accompanying drawings, in which:

Fig. 1 is a general perspective view of an inhaler device according to the invention; Figure 2 is a side view of the inhaler in use:

Figure 3 is a longitudinal section through the inhalation device;

Figure 4 is a section IV-IV of Figure 3: 10

Figures 5 and 6 are perspective exploded views of the inhaler device illustrated at opposite ends;

Figures 7a and 7b are perspective exploded views of the counting mechanism of the inhaler device, again illustrated at opposite ends; and

Figures 8a and 8b show an assembled counter mechanism viewed from opposite ends.

As shown in the outer views of Figures 1 and 2, the inhalation device comprises: '' a housing 1 provided with an air inlet 2. A tubular mouthpiece 3 • '·' · 'protrudes from the housing.

• · ·

• I I

Referring to Figures 3-6, the housing includes an inner body 4 which, on its side distal to the mouth 3 of the mouthpiece, comprises a recess 5 which forms a housing ... for a dispensing member 6 rotatable about its axis in the recess.

• # «

The metering member includes a portion having a frustoconical metering surface 7 which · · *. 'contains a series of circumferentially arranged cup-like dispensing recesses 8.

• I

i.i i The recess 5 forms a frustoconical shaped housing, dose · '·; · '30 roller surface and housing angular tolerance and peripheral shape are carefully monitored to ensure tight sliding contact between the two, which are connected by a · · \' ·! surface.

7 105654

The opposite side of the body 4 includes a storage chamber 10 for the drug in the form of a micronized powder, the chamber 10 being arranged to align with one of the recesses 8. A second, outer chamber 11 surrounds the storage chamber 10 for containing moisture-absorbing material 5, such as silica gel granules. The second chamber 11 opens into the recesses 8 on each side of the recess which is currently aligned with the storage chamber 10, but the silica gel 12 is prevented from entering the recesses by the formed filter membrane 12. The same side of the body 4 further includes an inhalation channel 15 and a waste container 16, each aligned with one of the recesses 8 The inhalation channel 15 has a smooth inner contour and is aligned with the Air and the inlet 2 and the mouthpiece 3. Air Inlet Includes a filter membrane 17 to remove any dirty particles that can be sucked into the inlet. The waste chamber 16 includes a brush, a piece of foam rubber, or other flexible wiping element 18 which extends into a respective recess 8 to perform a sweeping contact with the walls of the recess.

Referring in more detail to the inhalation channel 15, it can be seen from Figure 3 that, when the inhaler is in use, the inhalation channel 15 extends downwardly into the inlet 2, at least to the position where the dispensing cup 8 is directed to the inhalation channel. The width of the inhalation channel 15 is relatively large for air intake, relatively small in the area of the dispensing cup, and relatively large again in the mouthpiece 3. The inhalation channel includes a first portion of M · which extends substantially downward without the IM - ---- - f I * * · * * 25 inlets 2 to dispenser cup 8 and another relatively less inclined portion extending to dispenser outlet mouthpiece 3. Distributor cup 8 is disposed at the outer edge of the fold connecting the two portions of the inhalation channel. Opposite • · · - -——'— i.

'·) * Dispensing cup The wall of the inhalation passageway bulges across the inhalation passageway • «__.___: the dispensing cup to form a restricted passageway in the area of the dispensing cup. Here

IM

In the 30 regions, the shape of the inhalation channel results in both acceleration of the air and its direction: Y: towards the dispensing cup with a particularly effective material.

Picking Iin from a cup. ~ T- ~ 8 105654

The frustoconical end of the dispensing member 6 is secured to a coaxial circular latch assembly 20, followed by a drum 21. The spring washer 22 acts between the end face of the drum 21 and the housing 1 to force the dispensing member 6 against its housing in recess 5. and is integral integral with indexing finger 26 for engaging latch assembly 20. Spring finger 27, which is also integral with button 25, protrudes transversely to indexing finger 26 to engage internal body 4 and thereby force the button to protrude from housing 1.

10

The strip 30 is wound on a roll 31 which is rotatably rotatable by a pin 32 projecting from the inside of the housing 1. The leading edge of the band 30 is attached to the drum 21, on which it is wound from the roll 30 after rotation of the dispensing member 6. The ribbon 30 is routed past the window 33 in the housing 1, through which window 15 a continuous series of numbers or other information displayed on the ribbon is displayed.

In use, the inhalation device is normally delivered in a sealed unit with the storage chamber 10 pre-filled with drug or other dry, finely divided powder. . in this form. With button 25 uppermost, the recess 8 which is aligned with the storage chamber 10 is filled with a fixed volume of drug. Wicked-

I

. . with the drawer held in one hand, the mouthpiece 3 is mounted

f I

2, and the button 25 is depressed using the index finger • so that the indexing element 26 causes the metering member 6 to rotate • · one position, thereby bringing the next empty recess 8 into position 25 with the storage chamber 10. At the same time, the filled recess will become ·. I went with inhalation channel 15. Thus, when air is drawn in the inhalation • • ·. ·; ·. 15 through the mouthpiece 3, the internal shape of the inhalation channel provides. *. air striking the material still retained in the recess 8 causes the powder to mix with the air flow and, after passing through the mouthpiece 3, to penetrate into the mouth and into the user's air passages.

It should be noted that the powder in cavity 8 is exposed to all air flow through inhalation passage 15, without inlet 2 to mouthpiece 3, which i 9 105654 allows the user to more easily reach the full dose, and further facilitates substantially completely removing the powder from the well 8.

As the recess passes around the axis of the dispensing member in successive 5 indexing movements of the button 25, they pass past the sweep element 18 so that any powder residue remaining in the recess is removed from it to fall into the waste chamber 16. Further movement of the recess causes it to align with the absorber. from all the humidity recess before it comes into contact with the storage chamber 10 to be refilled with the drug substance. The filled recesses may also move in alignment with the drying chamber 12 to reduce the likelihood of moisture transferring from the inhalation channel 15 to the storage chamber 10. This may further ensure that the drug remains dry, thereby ensuring that a large majority of drug can be easily removed from the recess 15 to the inhaled airflow.

It is important that the movement of the powder dose to the dosing position in the inhalation channel 15 is accomplished in such a way as to maintain good powder compaction storage f. . in the chamber 10 so as to maintain the integrity of the powder. This is facilitated by arranging the dispensing surface 7 and a dedicated housing formed therein. with recess 5, frustoconical shape; such a shape allows t · · to achieve good sealing between the dispensing surface 7 and its housing with less stringent tolerances than is possible with other shapes. Provided - · · · .....—--------- that angular tolerance is maintained (which is relatively simple), other • · «----------- • - The manufacturing tolerances are adjusted by means of a self-sealing arrangement of the housing by means of the dispensing surface 7 and the recess 5.

• ______ • · · • · · _ - • · · _. In normal use of the inhaler, repeated indexing of the dosing member 6 does not result in multiple layers of inhalation duct. Instead, each • · - .. .....

The 30 portion is simply transported around the recess 8 until it is removed to the waste chamber 16.

• · t • · · • · 10 105654

Each time the dosing member is indexed, new information is conveyed to the window 33 by means of a band 30. This information may simply be a number indicating how many servings have been used or how many remain available, or both. The window may also display other information, such as time, since the next dose is to be taken.

Normally, the device will be discarded as soon as the prescribed number of doses has been used. However, it is envisaged that the inner body 4 may include a replaceable cartridge containing a stock of fresh drug and possibly 10 fresh silica gel, new filters 12 and / or 17, and a new ribbon 31. This ribbon may be partially wound on a replaceable drum 21 which engages to the dosing head 6.

The modified counting arrangement is shown in Figures 7 and 8. The housing 1 includes an inner recess 36 of a circular 15 which receives an outer ring 37 and an inner disc 38 disposed coaxially with the dispensing member 6. Disc 38 contains units 0-9 at 36 ° intervals, while ring 37 is denoted by dozens of times at regular angular intervals. Dozens and units are disposed so that they can both be displayed in a window 39 ««] 'in the housing 1. 20 through. The disc 38 is connected to or operated by the dispensing member 6 and includes. . an integral spring arm 40 including a pin 41 to act as a cam lifter.

• I

, ,,; Whenever the disc 38 completes a single rotation, the arm 39 engages the cam 44 attached to the inside of the housing 1, causing the cam lifter to engage one of a series of notches 45 around the outer periphery of the ring 37.

• · · 25 This, in turn, indexes the ring by one angular position with the disc 38 at each rotation. The number displayed in window 40 can thus be incremented, for example, from 1 to 200, to count the number of doses used. Hockey 38. In place of the surrounding ring, another transparent disk could be positioned behind the disk φ · · 'il / 38 so that the units are visible through the second disk, which again contains a number of dozens of times.

»· · I {·••••••••••••••

Claims (11)

11 105654 An inhalation device for dispensing a substance in a finely divided form, the inhalation device comprising a body (4) defining a storage chamber (10) for dispensing 5 substances and further defining an inhalation passage (15) through which the air is inhaled in use; and a metering member (6) which can transfer a volume dose of the substance from the storage chamber to the inhalation channel, the metering member having a metering dispensing surface (7) notched to form at least one dispensing cup (8) and movable between first and second positions the dispensing cup is directed into the storage chamber for receiving a dose of substance and wherein in another position a portion of the substance is directed to an inhalation channel in an upwardly open dispensing cup, characterized in that the body comprises a housing (5) having an annular contact surface for sliding contact with a dispensing 15, the wall (7) and the contact surface being respectively frustoconical in shape so as to define a seat within which the metering member is arranged to rotate between its first and second positions. . . Inhalation device according to claim 1, characterized in that it comprises I · · • '' '. 20 actuating means (22) for contacting the metering member (6) with the housing • I. (5). • I <f < An inhaler device according to claim 1 or 2, characterized in that the longitudinal axis · · · 25 of the frustoconical wall (7), which comprises the dispensing surface, is in the normal operating position between the vertical and the vertical angle of 60 °. • · · • · · · ·. An inhaler according to claim 3, characterized in that the longitudinal axis of the fractured cartilage wall (7) is located when the inhaler is held in its normal operating position at an angle of approximately 45 ° to the vertical. . I · f • · «• · • I An inhaler according to any one of claims 1 to 4, characterized in that it further comprises cup cleaning means to ensure that the one or 12105654 each delivery cups is substantially free of material prior to being introduced into the storage chamber. Inhalation device according to Claim 5, characterized in that the means for cleaning the cup 5 comprise means (20, 25, 26) for moving the one or each dispensing cup (8) to a position where, in normal use of the inhaler, any substance remaining in the dispensing cup , out of the cup after a portion of the agent is directed in the cup into the inhalation passage (15) and before this cup is again directed into the 10 storage chambers (10). Inhalation device according to Claim 5 or 6, characterized in that the cup cleaning means comprises an inhalation channel (15) formed so that a dose of the substance directed into the inhalation channel is exposed to substantially the entire air flow through the inhalation channel when drawing air into the inhaler. Inhalation device according to one of Claims 5 to 7, characterized in that _. _. the cup cleaning means includes a resilient sweeping member (18) for removing; 20 of any residual material from said one or each cup (8) after: a dose of the agent is directed therein to the inhalation channel (15) and before • <I. This cup is redirected to the storage chamber (10). • · · • · · · · Inhalation device according to one of the preceding claims, characterized in that it has a chamber (11) for containing moisture-absorbing material, with which the one or each dispensing cup (8) can be aligned with one another after the dose of substance is directed to the inhalation channel (15). : I ·. and before this cup is again directed to the storage chamber (10). • · «{· Γ.« C. ·, 30 An inhaler device according to any one of the preceding claims, characterized in that it has a chamber (11) for containing moisture-absorbing material, with which the one or each dispenser (8) is movable. 105654 aligned after being directed to the storage chamber (10) and before the dose of substance therein is again directed to the inhalation channel (15). Inhalation device according to one of the preceding claims, characterized in that it comprises display means (30, 31, 32, 33) which are indexed in cooperation with the dosing means (6) for displaying information to the user. «· •« · • I • Il • Il II • II t {I l • · · aaa • · · • aaa III • 1 · aaa • at • aa Ml • · aataaaa -.... ...- - ·· aaaaaa IM C «1C fr lii« - «i« • I c «· i« «f« «14 105654