CA2199858A1 - Inhalation device - Google Patents
Inhalation deviceInfo
- Publication number
- CA2199858A1 CA2199858A1 CA002199858A CA2199858A CA2199858A1 CA 2199858 A1 CA2199858 A1 CA 2199858A1 CA 002199858 A CA002199858 A CA 002199858A CA 2199858 A CA2199858 A CA 2199858A CA 2199858 A1 CA2199858 A1 CA 2199858A1
- Authority
- CA
- Canada
- Prior art keywords
- reservoir
- face
- dosing member
- powder
- user
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0065—Inhalators with dosage or measuring devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0065—Inhalators with dosage or measuring devices
- A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
Abstract
An inhalation device is provided by means of which material in powder form can be inhaled. The device comprises a body (55) defining a reservoir (56) for medicaments in powder form, an outlet (57) through which a user can inhale and a dosing member (53) with at least one metering recess (65) formed therein. The dosing member (53) is moveable between a position in which the at least one metering recess (65) communicates with the reservoir (56) to receive a dose of powder therefrom and a position in which the at least one metering recess (65) communicates with the outlet (57) to permit the user to inhale the dose. The at least one metering recess (65) is formed in a face of the dosing member (53), the said face being mounted in contact against a similar mating face (60) of the body (55) at the lower end of the reservoir (56). At least one moveable weight may be incorporated within the device, adapted to strike an anvil surface when the device is shaken.
Description
wo 96/08284 2 1 9 q 8 5 8 pcT/EP95/03603 INHALATION DEVICE
This invention relates to an inhalation device by means of which metered doses of medicament in the form of a powder can be dispersed to a user. In S particular it relates to a device of the type in which the medicar"enl powder is held in bulk in a reservoir with which the device is provided and is metered to the user from the reservoir.
In devices of the type just described it is difficult to obtain doses which are equal to a nominal value to within the app,upriate tolerance. It will be uncler~lood that the tolerance permitted is often very small as it is important that the user should be given a dose which is very close to the nominal value. In order to ",ainlai" the medicament powder in a manageable state it needs to be kept dry. Any i"yless of moisture into the reservoir from O utsicle can cause the medicament powder to agglome(~te and this may be detrimental to its free flowing prope,lies rendering it difficult to meter consisle"l doses from the reservoir. In the absence of Adeq~Ate reservoir sealing it may be necessAry to incorporate a desiccal ,t cartridge into the reservoir to absorb any moisture that does enter. This is often insufficient to prevent deterioration of the medi~",enl powder.
It is an object of the present invention to provide a device of the type just described in which doses can be repeatedly accurately dispersed without requiring a dispensing mechanism of undue complexity.
It is a further object of the present invention to provide a device of the type just described but which additionally incorporates a simple and efficient sealing means to prevent ingress of moisture into the reservoir.
21 9~J858 According to the prese"t invention there is provided an inhalation device comprising a body defining a reservoir for medicar"ent in the form of a powder an outlet through which a user can inhale and a dosing member with at least one metering recess foi Illed therein the dosing member being moveable 5 between a first position in which the at least one ",etering recess communicates with the reservoir to receive a dose of powder ther~,~ ", and a second position in which the at least one metering recess communicates with the outlet to permitthe user to inhale the dose the at least one ",eteri"g recess being formed in a face of the dosing member the said face being mounted in conlact against a 10 similar mating face~of the body at the lower end of the reservoir and at least one moveable weight adapted when the device is shaken to strike an anvil surface defined in the device.
The at least one weight may be slidable longitudinally of the device in a respective bore with the anvil surface being.at the lower end of the bore.
Alle",dl,vely the weight may be in the form of a ring encircling the device and slidable longitudinally ll ,ereof.
Accor~i.,g to a further aspect of the invention the face of the dosing member and the mating face of the body are sealing faces with highly polished smooth surfaces which form a sliding seal which excludes substanlially all air from the inle, race therebetween.
Suitably the sealing faces have a surFace texture sufficiently smooth to have a roughness average value (Ra) of 0.5 microns or less preferably 0.2 microns or less.
Suitably the sealing faces are flat. More suitably they have a flatness of 0.005mm or less preferably 0.003mm or less.
This invention relates to an inhalation device by means of which metered doses of medicament in the form of a powder can be dispersed to a user. In S particular it relates to a device of the type in which the medicar"enl powder is held in bulk in a reservoir with which the device is provided and is metered to the user from the reservoir.
In devices of the type just described it is difficult to obtain doses which are equal to a nominal value to within the app,upriate tolerance. It will be uncler~lood that the tolerance permitted is often very small as it is important that the user should be given a dose which is very close to the nominal value. In order to ",ainlai" the medicament powder in a manageable state it needs to be kept dry. Any i"yless of moisture into the reservoir from O utsicle can cause the medicament powder to agglome(~te and this may be detrimental to its free flowing prope,lies rendering it difficult to meter consisle"l doses from the reservoir. In the absence of Adeq~Ate reservoir sealing it may be necessAry to incorporate a desiccal ,t cartridge into the reservoir to absorb any moisture that does enter. This is often insufficient to prevent deterioration of the medi~",enl powder.
It is an object of the present invention to provide a device of the type just described in which doses can be repeatedly accurately dispersed without requiring a dispensing mechanism of undue complexity.
It is a further object of the present invention to provide a device of the type just described but which additionally incorporates a simple and efficient sealing means to prevent ingress of moisture into the reservoir.
21 9~J858 According to the prese"t invention there is provided an inhalation device comprising a body defining a reservoir for medicar"ent in the form of a powder an outlet through which a user can inhale and a dosing member with at least one metering recess foi Illed therein the dosing member being moveable 5 between a first position in which the at least one ",etering recess communicates with the reservoir to receive a dose of powder ther~,~ ", and a second position in which the at least one metering recess communicates with the outlet to permitthe user to inhale the dose the at least one ",eteri"g recess being formed in a face of the dosing member the said face being mounted in conlact against a 10 similar mating face~of the body at the lower end of the reservoir and at least one moveable weight adapted when the device is shaken to strike an anvil surface defined in the device.
The at least one weight may be slidable longitudinally of the device in a respective bore with the anvil surface being.at the lower end of the bore.
Alle",dl,vely the weight may be in the form of a ring encircling the device and slidable longitudinally ll ,ereof.
Accor~i.,g to a further aspect of the invention the face of the dosing member and the mating face of the body are sealing faces with highly polished smooth surfaces which form a sliding seal which excludes substanlially all air from the inle, race therebetween.
Suitably the sealing faces have a surFace texture sufficiently smooth to have a roughness average value (Ra) of 0.5 microns or less preferably 0.2 microns or less.
Suitably the sealing faces are flat. More suitably they have a flatness of 0.005mm or less preferably 0.003mm or less.
Alle",ali~/ely the sealing faces may be frusto-conical. The sealing faces may aller"ali~/ely be cylindrical. In a further alle",dli~/e the sealing faces may be spherical.
The sealing surfaces are suitably made of a hard rigid material such as 5 acetal resins ceramics or metals.
A further aspect of the invention provides an inhalation device comprising a reservoir for medicament in the form of a powder an outlet through which a user can inhale a ",eterir,g means adapted to communicate with the reservoir to receive a dose of powder therer,u", and with the outlet to permit the 10 user to inhale the dose and at least one weight moveable in the device and adapted when the device is shaken to strike an anvil surface defined in the device.
Additionally the invention provides an inhalation device comprising a body forming a reservoir for medicaments in the form of a powder an outlet 15 through which a user can inhale and a dosing ",e",ber with at least one metering recess formed therein the dosing ",e~ber being moveable between a position in which the at least one metering recess communicates with the reservoir to receive a dose of powder thererrc,m and a position in which the at least one metering recess communicates with the outlet to permit the user to 20 inhale the dose the at least one metering recess being formed in a face of the dosing member the said face being mounted in conla~;l against a similar mating face of the body characterised in that the said face of the dosing member and the said mating face of the body have highly polished smooth surfaces which form a co"~ac~i"g face to face kinetic seal which excludes substantially all air25 from the interface. The term kinetic seal in this context means a seal that can withstand relative movement of the two faces.
Another embodiment of the invention provides an inhalation device comprising a body defining a reservoir for "ledicar,lent in the form of a powder, an outlet through which a user can inhale, and a dosing member with at least one metering recess formed therein, the dosing member being moveable 5 between a first position in which the at least one Illelering recess communicates with the reservoir to receivc a dose of powder therefrom and a second position in which the at least one metering recess communicates with the outlet to permitthe user to inhale the dose, the at least one metering recess being forrned in aface of the dosing member, the said face being mounted in contact against a 10 similar mating face of the body at the lower end of the reservoir, characterised in that the said face of the dosing member and the said mating face of the body are sealing faces with highly polished surfaces which form a sliding seal which excludes subslarilially all air from the interface therebetween.
The invention is further described below with reference to the 15 accon)panying drawings in which:
Figure 1 is a perspective view of an embodiment of a device according to the invention, showing the main body cG~Iponellls in disassembled form;
Figure 2 is an underplan view of the body of the device of Figure 1;
20 Figure 3 is a rear view of the body, partly cut away;
Figure 4 is a section on line A-A in Figure 2;
Figure 5 is a plan view of the body;
Figure 6 is a perspective view of a guide insert which is located inside the reservoir defined in the body;
25 Figure 7 is a plan view, partly cut away and on a larger scale, of a dosing member which forms part of the device of Figure 1;
W0 96/08284 2 1 q 9 ~ 5 8 pCT/~ 5~'~3603 _ Figure 8 is a partial section on line B-B in Figure 7;
Figure 9 shows a spring-retaining element which is inserted in the dosing member;
Figure 10 is a side elevation of the dosing member of Figures 7 and 8;
5 Figure 11 is a section through a second embodiment of a device according to the invention;
Figure 12 is a section on line X-X in Figure 1 1; and Figures 13 to 15 are perspective views showing three steps in the operation of the devices according to Figures 11, 12 and 16 to 19.
10 Figure 16 is a section through a third embodiment of a device according to the invention.
Figure 17 is a sec~ion on line Y-Y in Figure 16;
Figure 18 is an exploded view of the embodiment shown in Figures 16 and 17;
and 15 Figure 19 is an exploded perspective view, partly cut away, showing the dose indicator n,ecl)a"is"~ of the embodiment shown in figures 16 to 18, As shown in Figure 1, the device comprises a body 1, a cover 2, a dosing member 3 and a nut 4. The body 1 has a elongate main body portion 5 which defines a reservoir 6. The body may be moulded from polycarbonate, 20 aluminium or any other rigid material which will transmit vibrations. The reservoir 6 co"t~;ns a supply of medicament in the form of a powder. As is common in powder inhaler devices of this type, the reservoir 6 may contain an overfill of powder to ensure that there is sufficient powder in the reservoir todeliver the correct dosage of powder for each of the prescribed number of doses 25 for the powder supply contained. Thus, whilst the device may be provided with a prescribed life of 200 doses of powder, the reservoir may contain the W096/08284 2199858 PCr/EP95/03603 equivalent of 240 doses of powder. The reservoir 6 may also be provided with a window (not shown) to allow the user to check whether there is sufficient powderremaining.
The medicar"~"l is one which is suitable for inhalation and many such 5 medical"er,~s are well known to those skilled in the art for example for the l~ealme"l of aal~ la. Powdered medicaments suitable for this purpose include s~lb~ ~t~rnol beclol"ell ,asone salmeterol flulicAsone ro",~oterol terbutaline b~desonide and flunisolide and physiologically acceptable salts solvates and esters or any combination thereof. r,erer,ed medicar"enls are salbutamol 10 5~lhuPrnol sulphate saln~eterol sal")eterol xinaroale flu(icAsone propionate beclomethasone dipropionate and terbutaline sulphate. Individual isor"era such as R-salbutamol can also be used. It is to be u"derslood that the medicament powdar may consist purely of one or more active ingredients or there may addiliol,ally be a carrier for exa",ple lactose powder.
The upper end of the reservoir is closed by the cover 2 which rnay for example be provided with a desiccanl cartridge (not shown) to absorb moisture and reduce the risk of the powder in the reservoir absorbing moisture and underyoing agglomeration of the particles tl,er~of. The cover 2 may be removably secured to the body 1 by any known means for example by means of 20 a screw thread or a snap fit to enable refilling of the reservoir 6 with powder. In this case a pl,~""aceutical grade rubber sealing ring (not shown) may be incorporated between the cover 2 and body 1 to prevent ingression of moisture into the reservoir 6. Alle")alively the device may be intended to be disposable after exhaustion of the supply of powder in the reservoir in which case the 25 cover 2 may be permanently secured to the body 1 by use of an adhesive ultrasonic welding or any other method. It is to be understood that the WO 96/08284 2 1 9 9 8 5 8 pCT/E1'95103603 _, medicament powder may consist purely of one or more active ingredients, or there may additionally be a carrier, for example l~tose powder.
Eklendi"g laterally from the lower end of the main body portion 5 is an outlet 7, which, in the embodiment illusl,aled in Figure 1 is in the form of a 5 mouthpiece. If, however, the device were intended for nasal inhalation this would be repl-Ged by a nosepiece. At its radially inner end the interior of the mouthpiece has a downwardly opening aperture 8 which communicates, as described below, with a dosing chamber containing a dose of powder to be inhaled. The outlet 7 is also provided with a pair of air inlets 9, one on each 10 side, which allow the user to inhale additional air, and reduce the resistance to inhalation which the user experienoes. It is understood that more air inlets could be provided on outlet 7 to allow more air into the outlet and to vary the air flow characterislics.
The main body portion 5 has a base 10 in which is provided an arcuate 15 aperture 11 through which powder can pass from the reservoir to the dosing member 3. The aperture 11 is surrounded by a wall 11a which extends downwardly from the base 10. Powder is guided to the aperture 11 by a guide insert 12, which is illustrated in Figure 6. The guide insert 12 also serves to close ofl the reservoir from the interior of the outlet 7, so that powder cannot20 pass directly from the reservoir to the outlet.
A shaft 13, integral with the base 10 or fixedly secured thereto, extends downwardly therer,um. The shaft has a first portion 14 of larger diameter in which is formed a longitudinally extending slot 15, and a second portion 16 which is of smaller diameter and has a screwthreaded external surface. The 25 base 10 is further provided with two lugs 30 arranged approximately equidistantly from one another and from the centre of the aperture 11, which extend downwardly from the base by an amo'unt equal to the height of the wall 11a surrounding the aperture 11. The lugs 30 and wall 11a together define a planar surface for engagement by the upper surface of the dosing member 3.
The wall of the main body ~.o,lion 5 of the body 1 is of sufficient thicl~r,ess at least in certain regions to permit two longitudinal bores 18 to be formed therein. It is to be understood that inslead of two bores a single bore or more than two bores for example three bores may be provided. An elongate weight 17 is slidably received in each of the bores. The weight is of a dense "~alerial preferdbly metal and one suitable material is stainless steel. An anvil 19 may be fixedly secured in the lower end of each bore. This is also preferablyof metal and brass has been found to be a suitable material. The upper end of each bore has a screwthreaded portion 20 which can receive a screw (not shown) used to secure the cover 2 to the body 1.
The dosing ",e",ber 3 has an upper surface 21 in which is formed a ",etering recess 22. This has a volume equal to the volume of one dose of the powder in the reservoir. As seen in plan view the recess 22 has a shape which is congruent to the aperture 11 in the base of the main body portion. As seen insection in figure 8 the recess has the form of shallow arcuate depression with gently sloping sides. The advan~ages of this shape of recess will be explained below. It has been found that a recess capacity of between 5 mg and 26 mg of powder may be effectively employed. As shown in figure 7 the dosing member 3 has a nearly radial bore 23 in which a ratchet pawl 24 is slidably received.
The pawl is urged inwardly by a spring 25 which is held in con,,,ression by a retaining element 26 received in a dovetail-shaped recess 27 in the periphery ofthe member 3. The inner end of the pawl 24 is urged against the portion 14 of the shaft 13. When the member 3 is in one particular position the pawl engages 4 2 1 9 9 8 5 8 pCT/EP95/03603 in the slot 15 in the portion 14. This is the position which is required during - inhalation, as will be explained further below.
The dosing member 3 has a central opening 28 of stepped diameter, corresponding to the diameters of the portions 14 and 16 of the shaft 13, and is5 retained on the shaft by the nut 4 which engages the threaded surface of the shaft portion 16. A pha""aceutical grade rubber sealing ring or washer (not shown) may be incorporated in a groove around aperture 11 to prevent ingress of moisture between the body 1 and dosing member 3 into the reservoir 6. Such a sealing ring or washer may have a low friction coating such as 10 polytetrafluo,uell,ylene. The dosing member 3 has an indicator arrow 29 in its peri,~,l,eral surface, and cor,espG"ding marks (not shown) are provided on the surface of the body 1, with which the user aligns the arrow at the various stages of operation of the device.
In opera~ion, the user initially rotates the dosing member to the position 15 in which the dosing recess is directly below the aperture 11, and thus in communication with the reservoir 6. The user then shakes the device in a generally upward and downward motion, while maintaining the device in a generally upright orie,ltation. The weights 17 are thereby caused to travel up and down their respe~ /e bores 18. In so doing, the weights repeatedly strike 20 against the anvils 19. The jolts which this produces cause the powder in the reservoir to be urged downwardly, and powder thus enters the metering recess 22. The jolts also have the effects of eliminating any bridging of powder, and ensuring that the powder is packed to a constant density. The latter point is important in ensuring uniform doses. What is desired is a uniform weight of 25 powder, and the metering recess will not provide this unless the powder is ofconstant density. The shape of the metering recess 22 will have a direct effect on its filling ~)ar~cterislics. A shallow arcuate depression will provide for rapid and complete filling of the recess with powder from the reservoir at s~ nlially co, Islal ,l density throughout the recess.
The user then rotates the dosing member 3 through 180~ to bring the 5 recess 22 into alignment with the aperture 8 at the radially inner end of the outlet 7. The user knows when this posilioll has been reached as the pawl 24 is felt to engage with the slot 15. The user then inhales through the outlet 7 causing air to enter the outlet through the air inlets 9. The turbulent air flowcreated by the user inhaling through the outlet causes the powder in the recess 10 22 to be e~ dL~ed in the airflow and inhaled by the patient. The shallow arcuate shape of the recess 22 allows.for ~frici~nt entrainment of powder in theair flow. After iul,ala~iûn the user retums the dosing member to its initial position ready for use again when required.
It will be appreci~ted by one skilled in the art that the size number and 15 configuration of the weights 17 in the device may be varied to provide optimurn pe,ro""ance of the device depending on the size of the reservoir 6 the material from which the body 1 is moulded its capacily to transmit vibraliol1s and the characte,i~lics of the powder in the reservoir. For example it has been found that positioning the bores 18 within the reservoir provides improved recess 20 powderfilling pe,rur~l,ance.
An alternative embo~illlelll of the invention is shown in Figures 11 to 15.
As in the ~n,bodin,ent shown in Figures 1 to 10 the embodiment of the device shown in cross section in Figures 11 and 12 comprises a main body portion 5 which defines a reservoir 6 and a reservoir cover or end cap 2. The reservoir 6 2~ contains a supply of medicament in the form of a powder (not shown). The wo 96/08284 Pcr/~;~ss~3603 medicar,le"t may be as described above with rerere,lce to the embodiment shown in figures 1 to 10.
The reservoir cover 2 may be provided with a desiccant cartridge (not shown) to absorb moisture and reduce the risk of the powder in the reservoir absorbing moisture and u"dergoing agglomeration of the particles thereof. The cover 2 may be removably secured to the body 5 by any known means for example by means of a screw thread or a snap fit to enable refilling of the reservoir 6 with powder. In this case a pharmaceutical grade rubber sealing ring4 may be incor~uo~ a~ed between the cover 2 and body 5 to prevent ingression of moisture into the reservoir 6. Aller"atively the device may be intended to be ~Jisposable after exhaustion of the supply of powder in the reservoir in which case the cover 2 may be per",~nently secured to the body 5 by use of an adhesive ull,asonic~eldi.1g or any other ",etl,od.
At its lower end the main body portion 5 is fitted with a base 10 which together with body 5 defines an aperture 1 1 which is offset from the vertical axis of the device and through which powder can pass from the reservoir to the dosing ~el~lber 3. Powder is guided to the aperture by the walls of the reservoir which form a l,opper. Extending laterally from the lower end of main body 5 is mouthpiece 7. If however the device were i"lenlled for nasal inhalation this would be replaced by a nosepiece. Dosing member 3 is mounted upon lower body portion 9 which is pivotally connected to main body 5 such that it may rotate about the vertical axis of the device. As explained in more detailbelow lower body portion 9 serves to allow rotation of the dosing member 3 whilst maintaining the same in axial alignment with base 10. It also urges the dosing member 3 into close contact with base 10. Dust cover 33 is attached to lower body portion 9 through pivot 34.
WO 96t08284 2 1 ~ 9 8 5 8 PCT/EP95/03603 A weight 31 in the form of a ring encircles the reservoir 6 and is slidable longitudinally ll,ereor. The locus of movement of the weight 31 is defined towards the top of the reservoir by an end stop 32 formed as an integral part ofthe body 5 and towards the bottom of the reservoir by base 10 which behaves 5 as an anvil. It is to be understood that whilst the device described herein in~",orates a weight for the purpose des~ibed below the weight is not an essenlial ~le",en! of the invention and it might be chosen to omit the incorporation of the weight.
The lower face of base 10 is provided with a highly polished smooth and 10 flat surface as is the conta~ting upper face of dosing member 3. These surfaces are ground and polished to render a surface finish giving a flatness which does not undulate over its area by more than 0.003mm and a surface texture having a roughness average value (Ra) of 0.2 microns as inler"ationally designated under ISO/R468 meaning that the average height of the irregularities 15 co"sli~uting surface texture is 0.2 microns. These highly polished flat faces' provide contacting surfaces between which there is substantially no clearance.
It has been found that by providing such highly polished flat faces the faces adhere to each other yet slide over each other as they are wrung together during assembly and use in the same way as mecl ,al ,ical slip gauges adhere to 20 each other when wrung together. Air and powder are thus excluded from the interface between the base 10 and dosing member 3. When assembled the faces adhere firmly together but may be slid over eachother without arrecling the closeness of the inle, racial contact. Such contacting surfaces have been found to provide excellent sealing characteristics both in the static state and during25 the sliding motion of one face over the other preventing both loss of powder from and ingression of moisture into the reservoir 6 through the interface WO 96/08284 2 1 9 ~ 8 5 8 PcI/~;l 5 ,~'~3603 -between the base 10 and dosing member 3. This type of kinetic or sliding seal obviates the need for any ~drlitional sealing means between base 10 and dosing member 3. The contacting surfaces of base 10 and dosing member 3 are made of a hard rigid ",alerial, and suitable materials include acetal resins, 5 ceramics and metals.
In the embodi",~nt described, the two faces are formed by the surfaces of flat discs. It will be appreciatecl that disc shapes are not essential. Contact faces may be formed by the surfaces of a frusto-cone and a correspondingly frusto co"ical socket, by the co"~ading surfaces of two co-axial cylinders or by10 two correspondingly partially sphe,ical co"la.;~ing ball and socket surfaces.In operation, the user initially shakes the device in a generally upward and downward motion while maintaining the device in a generally upright orienlalion as shown in Figure 13. Weight 31 is II,ereby caused to travel up anddown the reservoir, so repeatedly striking end stop 32 and base 10. The jolts 15 which this produces c~l ~ses the powder in the reservoir to be urged downwardly and to enter the metel ing recess 22.
The user then opens dust cover 33, as shown in Figure 14, and rotates the cover which is connected to lower body portion 9 as described above, through 90~ as shown in Figure 5, to move the dust cover 33 away from the 20 mouthpiece 7 to allow ~ccess ll,er~to and to bring the recess 22 into alignment with the aperture 8 leading to the mouthpiece 7. The user knows when this position has been reached as the lower body portion 9 engages a stop (not shown) and will not move any further. The user then inhales through mouthpiece 7. After inhalation the user returns the lower body portion 9 to its 25 initial position and closes the dust cover 33.
W0 96/08284 2 1 9 9 8 5 8 PcT/~ss~3603 In the device shown in Figures 11 and 12 the aperture 11 is radially offset by an angle of 90~ about the vertical axis of the device from the aperture 8 at the inner end of the moutl,,l~iece to allow the dust cover and lower body po,lion 9 to be moved through 90~ for ease of ~ccess to the mouthpiece.
5 However it will be appreci~ted that this angle can be suL ~la"lially increasedor slightly ~~ecreased accor~i"y to the desired angle of rotation of the dust cover lower body portion and dosing member.
Further possi~ls modificaliGrls to the device described include inco,~oralion of a suitable dose counting mechanism to give the user an 10 ir~dicalio" of the amount of powder remaining in the device.
A further ~r,lL.odi",er,t of the invention is shown in Figures 16 to 19. As.in the previous embodiments the device shown in cross sec~ion in Figures 16 and 17 and in exploded view in figure 18 cG",~rises an elongale main body portion 55 which defines a reserYoir 56 and a reservoir cover or end cap 52. The 15 reservoir 56 contains a supply of medicament in the form of a powder (not shown). The reservoir cover 52 is secured to the body 55 by a snap fit and a pharmaceutical grade rubber sealing ring 54 is i"co,~oraled between the cover 52 and body 55 to prevent i"~ression of moisture into the reservoir 56.
At its lower end the main body portion 55 is fitted with a base member 60 20 which together with body 55 defines an aperture 51 which is offset from the vertical axis of the device and through which powder can pass from the reservoir to a recess 65 in dosing member 53. The lower face of base member 60 is provided with a similarly highly polished smooth and flat surface to that described with ,efere"ce to the e",bodi "ent shown in Figures 11 to 15 as is the25 upper face of dosing member 53. Powder is guided to the aperture by the wallsof the reservoir which form a hopper. Extending laterally from the lower end of the main body 55 is mouthpiece 57. Dosing member 53 is mounted upon lower body asse",bly 59 which is pivotally connected to main body 55 such that it may rotate about the vertical axis of the device. Lower body assembly 59 serves to transmit rotational movement thereof to the dosing member 53 whilst 5 maintaining the same in axial alig"",enl with base member 60. It also urges dosing ",e,~ber 53 into close conla-:t with base 60 by means of spring 61. Dust cover 63 (not shown in figures 16 and 17) is allaol ,ed to lower body portion 69through pivot 64.
The wall of the main body 55 is provided with three longitudinal bores 58 10 sl ~sl~r,lially equidistantly sp~ced around the reservoir 56. A cylindrical weight 67 is slideably -received in each of the bores 58. The weigl ,ls 67 may be made of a rust resistanl metal such as stainless steel or other hard material such asacetal resin. The bores are each blind at their upper ends and closed by a pressed-in stainless steel ball bearing 68 at their lower ends which also act as15 anvils against which u~i~hls 67 rnay impact as described later.
A dose indicator drive means co",l.rising a shaft 70 provided with a screw thread over much of its length a sprung lug 71 at the base of the thread and a sprocl~el 72 with inclined teeth positioned below the lug is rctalably mounted within a bore 73 in the wall of the main body 55 (see figure 19). An 20 indicator nut 77 is threaded into the shaft with a projection protruding through an indicator window 74 in the wall of bore 73 which prevents the indicator nut 77 from ro~aling with shaft 70. Sprung lug 71 engages with teeth 75 formed within bore 73 to form a ratchet allowing shaft 70 to rotate in one direction only.
Sprocket 72 is located ~ cent the periphery of dosing member 53 which is 25 provided with a second sprung lug 76.
W096/08284 2 1 9 ~ 8 5 8 PCT/~5s~3603 OperdtiGn of the device is similar to that des~i,ibed with reference to the em~odi",e"l shown in Figures 11 to 15. The user initially shakes the device in age"erally upward and downward motion while maintaining the device in a generally upright orienld~iol) as shown in figure 13. Weights 67 are thereby 5 c~sed to travel up and down bores 58 next to the reservoir so repeatedly striking anvils 68. The vibrations which this proch~Ges are transmitted through base member 60 and body 55 to the powder in the reservoir and this encourages powder to flow downwardly and enter metering recess 65 within dosing member 53.
The user then opens dust cover 63 as shown in Figure 14 and rotates the cover which is connected to lower body asse"~bly 59 as described above through 90~ as shown in Figure 5 to move dust cover 63 away from mouthpiece 57 to allow ~ccess ll,e~to and to bring recess 65 into alignment with the aperture at 66 leading to the mouthpiece 57. As the dosing member 53 rotates 15 with the lower body assel,lbly 59 lug 76 e"gayes an inclined tooth presented by sprocket 72 of the dose indicator drive means. The dose ir,d;calor drive means is prevented from turning in the direction urged by lug 76 by virtue of the ratchet mechanis"~ formed by teeth 75 and lug 71. As a result lug 76 rides over the inclined tooth and out of engagel"ent with sprocket 72. The lower body 20 assembly 59 engages a stop (not shown) and will not move any further when the recess 65 is correctly aligned with aperture 66.
The user now inhales through mouthpiece 57. Air is drawn through grill 80 and passage 81 defined by body 55 and hole 82 in base member 60 and entrains the powder in recess 65 of dosing member 53. The airflow draws the 25 entrained powder through the mouthpiece 57 and is inhaled by the user. Further air is drawn into the mouthpiece through holes 82 on either side of mouthpiece 21 q9858 57 and this creales turbulence which helps to break-up any agylomerales of powder entrained.
After i,lhalalion the user retums lower body assembly 59 to its initial position and closes the dust cover 63. As dosing member 53 rotates lug 76 5 again engages sprocket 72 of the dose in-lic~tor drive means. As the ratchet mechanism formed by teeth 75 and lug 71 allows movement of the dose indicator drive means in the direction as now urged by lug 76 the dose indicatordrive means is r~laled by one tooth pitch through enyagen,ent with lug 76 as it p~sses sprocket 72. Rotation of the dose indicatior drive means causes the 10 captive dose indictor nut 73 to travel down ll,readed shaft 70. The pitch of the thread and the number of teeth on sprocket 72 are selected to ensure that the dose indicalor nut travels from the uppermost "full" position to the lower"~osl "empty" positiG" when the device has been used sufficiently to deliver its p, esu ibed number of doses so indicting to the user that the device is empty.
It will be u"der~lood that thè ~,rese"l ~lisclos~re is for the purpose of illustration only and the invention eAlends to modi~icalions varialio,)s and improvements ll,ereto.
The sealing surfaces are suitably made of a hard rigid material such as 5 acetal resins ceramics or metals.
A further aspect of the invention provides an inhalation device comprising a reservoir for medicament in the form of a powder an outlet through which a user can inhale a ",eterir,g means adapted to communicate with the reservoir to receive a dose of powder therer,u", and with the outlet to permit the 10 user to inhale the dose and at least one weight moveable in the device and adapted when the device is shaken to strike an anvil surface defined in the device.
Additionally the invention provides an inhalation device comprising a body forming a reservoir for medicaments in the form of a powder an outlet 15 through which a user can inhale and a dosing ",e",ber with at least one metering recess formed therein the dosing ",e~ber being moveable between a position in which the at least one metering recess communicates with the reservoir to receive a dose of powder thererrc,m and a position in which the at least one metering recess communicates with the outlet to permit the user to 20 inhale the dose the at least one metering recess being formed in a face of the dosing member the said face being mounted in conla~;l against a similar mating face of the body characterised in that the said face of the dosing member and the said mating face of the body have highly polished smooth surfaces which form a co"~ac~i"g face to face kinetic seal which excludes substantially all air25 from the interface. The term kinetic seal in this context means a seal that can withstand relative movement of the two faces.
Another embodiment of the invention provides an inhalation device comprising a body defining a reservoir for "ledicar,lent in the form of a powder, an outlet through which a user can inhale, and a dosing member with at least one metering recess formed therein, the dosing member being moveable 5 between a first position in which the at least one Illelering recess communicates with the reservoir to receivc a dose of powder therefrom and a second position in which the at least one metering recess communicates with the outlet to permitthe user to inhale the dose, the at least one metering recess being forrned in aface of the dosing member, the said face being mounted in contact against a 10 similar mating face of the body at the lower end of the reservoir, characterised in that the said face of the dosing member and the said mating face of the body are sealing faces with highly polished surfaces which form a sliding seal which excludes subslarilially all air from the interface therebetween.
The invention is further described below with reference to the 15 accon)panying drawings in which:
Figure 1 is a perspective view of an embodiment of a device according to the invention, showing the main body cG~Iponellls in disassembled form;
Figure 2 is an underplan view of the body of the device of Figure 1;
20 Figure 3 is a rear view of the body, partly cut away;
Figure 4 is a section on line A-A in Figure 2;
Figure 5 is a plan view of the body;
Figure 6 is a perspective view of a guide insert which is located inside the reservoir defined in the body;
25 Figure 7 is a plan view, partly cut away and on a larger scale, of a dosing member which forms part of the device of Figure 1;
W0 96/08284 2 1 q 9 ~ 5 8 pCT/~ 5~'~3603 _ Figure 8 is a partial section on line B-B in Figure 7;
Figure 9 shows a spring-retaining element which is inserted in the dosing member;
Figure 10 is a side elevation of the dosing member of Figures 7 and 8;
5 Figure 11 is a section through a second embodiment of a device according to the invention;
Figure 12 is a section on line X-X in Figure 1 1; and Figures 13 to 15 are perspective views showing three steps in the operation of the devices according to Figures 11, 12 and 16 to 19.
10 Figure 16 is a section through a third embodiment of a device according to the invention.
Figure 17 is a sec~ion on line Y-Y in Figure 16;
Figure 18 is an exploded view of the embodiment shown in Figures 16 and 17;
and 15 Figure 19 is an exploded perspective view, partly cut away, showing the dose indicator n,ecl)a"is"~ of the embodiment shown in figures 16 to 18, As shown in Figure 1, the device comprises a body 1, a cover 2, a dosing member 3 and a nut 4. The body 1 has a elongate main body portion 5 which defines a reservoir 6. The body may be moulded from polycarbonate, 20 aluminium or any other rigid material which will transmit vibrations. The reservoir 6 co"t~;ns a supply of medicament in the form of a powder. As is common in powder inhaler devices of this type, the reservoir 6 may contain an overfill of powder to ensure that there is sufficient powder in the reservoir todeliver the correct dosage of powder for each of the prescribed number of doses 25 for the powder supply contained. Thus, whilst the device may be provided with a prescribed life of 200 doses of powder, the reservoir may contain the W096/08284 2199858 PCr/EP95/03603 equivalent of 240 doses of powder. The reservoir 6 may also be provided with a window (not shown) to allow the user to check whether there is sufficient powderremaining.
The medicar"~"l is one which is suitable for inhalation and many such 5 medical"er,~s are well known to those skilled in the art for example for the l~ealme"l of aal~ la. Powdered medicaments suitable for this purpose include s~lb~ ~t~rnol beclol"ell ,asone salmeterol flulicAsone ro",~oterol terbutaline b~desonide and flunisolide and physiologically acceptable salts solvates and esters or any combination thereof. r,erer,ed medicar"enls are salbutamol 10 5~lhuPrnol sulphate saln~eterol sal")eterol xinaroale flu(icAsone propionate beclomethasone dipropionate and terbutaline sulphate. Individual isor"era such as R-salbutamol can also be used. It is to be u"derslood that the medicament powdar may consist purely of one or more active ingredients or there may addiliol,ally be a carrier for exa",ple lactose powder.
The upper end of the reservoir is closed by the cover 2 which rnay for example be provided with a desiccanl cartridge (not shown) to absorb moisture and reduce the risk of the powder in the reservoir absorbing moisture and underyoing agglomeration of the particles tl,er~of. The cover 2 may be removably secured to the body 1 by any known means for example by means of 20 a screw thread or a snap fit to enable refilling of the reservoir 6 with powder. In this case a pl,~""aceutical grade rubber sealing ring (not shown) may be incorporated between the cover 2 and body 1 to prevent ingression of moisture into the reservoir 6. Alle")alively the device may be intended to be disposable after exhaustion of the supply of powder in the reservoir in which case the 25 cover 2 may be permanently secured to the body 1 by use of an adhesive ultrasonic welding or any other method. It is to be understood that the WO 96/08284 2 1 9 9 8 5 8 pCT/E1'95103603 _, medicament powder may consist purely of one or more active ingredients, or there may additionally be a carrier, for example l~tose powder.
Eklendi"g laterally from the lower end of the main body portion 5 is an outlet 7, which, in the embodiment illusl,aled in Figure 1 is in the form of a 5 mouthpiece. If, however, the device were intended for nasal inhalation this would be repl-Ged by a nosepiece. At its radially inner end the interior of the mouthpiece has a downwardly opening aperture 8 which communicates, as described below, with a dosing chamber containing a dose of powder to be inhaled. The outlet 7 is also provided with a pair of air inlets 9, one on each 10 side, which allow the user to inhale additional air, and reduce the resistance to inhalation which the user experienoes. It is understood that more air inlets could be provided on outlet 7 to allow more air into the outlet and to vary the air flow characterislics.
The main body portion 5 has a base 10 in which is provided an arcuate 15 aperture 11 through which powder can pass from the reservoir to the dosing member 3. The aperture 11 is surrounded by a wall 11a which extends downwardly from the base 10. Powder is guided to the aperture 11 by a guide insert 12, which is illustrated in Figure 6. The guide insert 12 also serves to close ofl the reservoir from the interior of the outlet 7, so that powder cannot20 pass directly from the reservoir to the outlet.
A shaft 13, integral with the base 10 or fixedly secured thereto, extends downwardly therer,um. The shaft has a first portion 14 of larger diameter in which is formed a longitudinally extending slot 15, and a second portion 16 which is of smaller diameter and has a screwthreaded external surface. The 25 base 10 is further provided with two lugs 30 arranged approximately equidistantly from one another and from the centre of the aperture 11, which extend downwardly from the base by an amo'unt equal to the height of the wall 11a surrounding the aperture 11. The lugs 30 and wall 11a together define a planar surface for engagement by the upper surface of the dosing member 3.
The wall of the main body ~.o,lion 5 of the body 1 is of sufficient thicl~r,ess at least in certain regions to permit two longitudinal bores 18 to be formed therein. It is to be understood that inslead of two bores a single bore or more than two bores for example three bores may be provided. An elongate weight 17 is slidably received in each of the bores. The weight is of a dense "~alerial preferdbly metal and one suitable material is stainless steel. An anvil 19 may be fixedly secured in the lower end of each bore. This is also preferablyof metal and brass has been found to be a suitable material. The upper end of each bore has a screwthreaded portion 20 which can receive a screw (not shown) used to secure the cover 2 to the body 1.
The dosing ",e",ber 3 has an upper surface 21 in which is formed a ",etering recess 22. This has a volume equal to the volume of one dose of the powder in the reservoir. As seen in plan view the recess 22 has a shape which is congruent to the aperture 11 in the base of the main body portion. As seen insection in figure 8 the recess has the form of shallow arcuate depression with gently sloping sides. The advan~ages of this shape of recess will be explained below. It has been found that a recess capacity of between 5 mg and 26 mg of powder may be effectively employed. As shown in figure 7 the dosing member 3 has a nearly radial bore 23 in which a ratchet pawl 24 is slidably received.
The pawl is urged inwardly by a spring 25 which is held in con,,,ression by a retaining element 26 received in a dovetail-shaped recess 27 in the periphery ofthe member 3. The inner end of the pawl 24 is urged against the portion 14 of the shaft 13. When the member 3 is in one particular position the pawl engages 4 2 1 9 9 8 5 8 pCT/EP95/03603 in the slot 15 in the portion 14. This is the position which is required during - inhalation, as will be explained further below.
The dosing member 3 has a central opening 28 of stepped diameter, corresponding to the diameters of the portions 14 and 16 of the shaft 13, and is5 retained on the shaft by the nut 4 which engages the threaded surface of the shaft portion 16. A pha""aceutical grade rubber sealing ring or washer (not shown) may be incorporated in a groove around aperture 11 to prevent ingress of moisture between the body 1 and dosing member 3 into the reservoir 6. Such a sealing ring or washer may have a low friction coating such as 10 polytetrafluo,uell,ylene. The dosing member 3 has an indicator arrow 29 in its peri,~,l,eral surface, and cor,espG"ding marks (not shown) are provided on the surface of the body 1, with which the user aligns the arrow at the various stages of operation of the device.
In opera~ion, the user initially rotates the dosing member to the position 15 in which the dosing recess is directly below the aperture 11, and thus in communication with the reservoir 6. The user then shakes the device in a generally upward and downward motion, while maintaining the device in a generally upright orie,ltation. The weights 17 are thereby caused to travel up and down their respe~ /e bores 18. In so doing, the weights repeatedly strike 20 against the anvils 19. The jolts which this produces cause the powder in the reservoir to be urged downwardly, and powder thus enters the metering recess 22. The jolts also have the effects of eliminating any bridging of powder, and ensuring that the powder is packed to a constant density. The latter point is important in ensuring uniform doses. What is desired is a uniform weight of 25 powder, and the metering recess will not provide this unless the powder is ofconstant density. The shape of the metering recess 22 will have a direct effect on its filling ~)ar~cterislics. A shallow arcuate depression will provide for rapid and complete filling of the recess with powder from the reservoir at s~ nlially co, Islal ,l density throughout the recess.
The user then rotates the dosing member 3 through 180~ to bring the 5 recess 22 into alignment with the aperture 8 at the radially inner end of the outlet 7. The user knows when this posilioll has been reached as the pawl 24 is felt to engage with the slot 15. The user then inhales through the outlet 7 causing air to enter the outlet through the air inlets 9. The turbulent air flowcreated by the user inhaling through the outlet causes the powder in the recess 10 22 to be e~ dL~ed in the airflow and inhaled by the patient. The shallow arcuate shape of the recess 22 allows.for ~frici~nt entrainment of powder in theair flow. After iul,ala~iûn the user retums the dosing member to its initial position ready for use again when required.
It will be appreci~ted by one skilled in the art that the size number and 15 configuration of the weights 17 in the device may be varied to provide optimurn pe,ro""ance of the device depending on the size of the reservoir 6 the material from which the body 1 is moulded its capacily to transmit vibraliol1s and the characte,i~lics of the powder in the reservoir. For example it has been found that positioning the bores 18 within the reservoir provides improved recess 20 powderfilling pe,rur~l,ance.
An alternative embo~illlelll of the invention is shown in Figures 11 to 15.
As in the ~n,bodin,ent shown in Figures 1 to 10 the embodiment of the device shown in cross section in Figures 11 and 12 comprises a main body portion 5 which defines a reservoir 6 and a reservoir cover or end cap 2. The reservoir 6 2~ contains a supply of medicament in the form of a powder (not shown). The wo 96/08284 Pcr/~;~ss~3603 medicar,le"t may be as described above with rerere,lce to the embodiment shown in figures 1 to 10.
The reservoir cover 2 may be provided with a desiccant cartridge (not shown) to absorb moisture and reduce the risk of the powder in the reservoir absorbing moisture and u"dergoing agglomeration of the particles thereof. The cover 2 may be removably secured to the body 5 by any known means for example by means of a screw thread or a snap fit to enable refilling of the reservoir 6 with powder. In this case a pharmaceutical grade rubber sealing ring4 may be incor~uo~ a~ed between the cover 2 and body 5 to prevent ingression of moisture into the reservoir 6. Aller"atively the device may be intended to be ~Jisposable after exhaustion of the supply of powder in the reservoir in which case the cover 2 may be per",~nently secured to the body 5 by use of an adhesive ull,asonic~eldi.1g or any other ",etl,od.
At its lower end the main body portion 5 is fitted with a base 10 which together with body 5 defines an aperture 1 1 which is offset from the vertical axis of the device and through which powder can pass from the reservoir to the dosing ~el~lber 3. Powder is guided to the aperture by the walls of the reservoir which form a l,opper. Extending laterally from the lower end of main body 5 is mouthpiece 7. If however the device were i"lenlled for nasal inhalation this would be replaced by a nosepiece. Dosing member 3 is mounted upon lower body portion 9 which is pivotally connected to main body 5 such that it may rotate about the vertical axis of the device. As explained in more detailbelow lower body portion 9 serves to allow rotation of the dosing member 3 whilst maintaining the same in axial alignment with base 10. It also urges the dosing member 3 into close contact with base 10. Dust cover 33 is attached to lower body portion 9 through pivot 34.
WO 96t08284 2 1 ~ 9 8 5 8 PCT/EP95/03603 A weight 31 in the form of a ring encircles the reservoir 6 and is slidable longitudinally ll,ereor. The locus of movement of the weight 31 is defined towards the top of the reservoir by an end stop 32 formed as an integral part ofthe body 5 and towards the bottom of the reservoir by base 10 which behaves 5 as an anvil. It is to be understood that whilst the device described herein in~",orates a weight for the purpose des~ibed below the weight is not an essenlial ~le",en! of the invention and it might be chosen to omit the incorporation of the weight.
The lower face of base 10 is provided with a highly polished smooth and 10 flat surface as is the conta~ting upper face of dosing member 3. These surfaces are ground and polished to render a surface finish giving a flatness which does not undulate over its area by more than 0.003mm and a surface texture having a roughness average value (Ra) of 0.2 microns as inler"ationally designated under ISO/R468 meaning that the average height of the irregularities 15 co"sli~uting surface texture is 0.2 microns. These highly polished flat faces' provide contacting surfaces between which there is substantially no clearance.
It has been found that by providing such highly polished flat faces the faces adhere to each other yet slide over each other as they are wrung together during assembly and use in the same way as mecl ,al ,ical slip gauges adhere to 20 each other when wrung together. Air and powder are thus excluded from the interface between the base 10 and dosing member 3. When assembled the faces adhere firmly together but may be slid over eachother without arrecling the closeness of the inle, racial contact. Such contacting surfaces have been found to provide excellent sealing characteristics both in the static state and during25 the sliding motion of one face over the other preventing both loss of powder from and ingression of moisture into the reservoir 6 through the interface WO 96/08284 2 1 9 ~ 8 5 8 PcI/~;l 5 ,~'~3603 -between the base 10 and dosing member 3. This type of kinetic or sliding seal obviates the need for any ~drlitional sealing means between base 10 and dosing member 3. The contacting surfaces of base 10 and dosing member 3 are made of a hard rigid ",alerial, and suitable materials include acetal resins, 5 ceramics and metals.
In the embodi",~nt described, the two faces are formed by the surfaces of flat discs. It will be appreciatecl that disc shapes are not essential. Contact faces may be formed by the surfaces of a frusto-cone and a correspondingly frusto co"ical socket, by the co"~ading surfaces of two co-axial cylinders or by10 two correspondingly partially sphe,ical co"la.;~ing ball and socket surfaces.In operation, the user initially shakes the device in a generally upward and downward motion while maintaining the device in a generally upright orienlalion as shown in Figure 13. Weight 31 is II,ereby caused to travel up anddown the reservoir, so repeatedly striking end stop 32 and base 10. The jolts 15 which this produces c~l ~ses the powder in the reservoir to be urged downwardly and to enter the metel ing recess 22.
The user then opens dust cover 33, as shown in Figure 14, and rotates the cover which is connected to lower body portion 9 as described above, through 90~ as shown in Figure 5, to move the dust cover 33 away from the 20 mouthpiece 7 to allow ~ccess ll,er~to and to bring the recess 22 into alignment with the aperture 8 leading to the mouthpiece 7. The user knows when this position has been reached as the lower body portion 9 engages a stop (not shown) and will not move any further. The user then inhales through mouthpiece 7. After inhalation the user returns the lower body portion 9 to its 25 initial position and closes the dust cover 33.
W0 96/08284 2 1 9 9 8 5 8 PcT/~ss~3603 In the device shown in Figures 11 and 12 the aperture 11 is radially offset by an angle of 90~ about the vertical axis of the device from the aperture 8 at the inner end of the moutl,,l~iece to allow the dust cover and lower body po,lion 9 to be moved through 90~ for ease of ~ccess to the mouthpiece.
5 However it will be appreci~ted that this angle can be suL ~la"lially increasedor slightly ~~ecreased accor~i"y to the desired angle of rotation of the dust cover lower body portion and dosing member.
Further possi~ls modificaliGrls to the device described include inco,~oralion of a suitable dose counting mechanism to give the user an 10 ir~dicalio" of the amount of powder remaining in the device.
A further ~r,lL.odi",er,t of the invention is shown in Figures 16 to 19. As.in the previous embodiments the device shown in cross sec~ion in Figures 16 and 17 and in exploded view in figure 18 cG",~rises an elongale main body portion 55 which defines a reserYoir 56 and a reservoir cover or end cap 52. The 15 reservoir 56 contains a supply of medicament in the form of a powder (not shown). The reservoir cover 52 is secured to the body 55 by a snap fit and a pharmaceutical grade rubber sealing ring 54 is i"co,~oraled between the cover 52 and body 55 to prevent i"~ression of moisture into the reservoir 56.
At its lower end the main body portion 55 is fitted with a base member 60 20 which together with body 55 defines an aperture 51 which is offset from the vertical axis of the device and through which powder can pass from the reservoir to a recess 65 in dosing member 53. The lower face of base member 60 is provided with a similarly highly polished smooth and flat surface to that described with ,efere"ce to the e",bodi "ent shown in Figures 11 to 15 as is the25 upper face of dosing member 53. Powder is guided to the aperture by the wallsof the reservoir which form a hopper. Extending laterally from the lower end of the main body 55 is mouthpiece 57. Dosing member 53 is mounted upon lower body asse",bly 59 which is pivotally connected to main body 55 such that it may rotate about the vertical axis of the device. Lower body assembly 59 serves to transmit rotational movement thereof to the dosing member 53 whilst 5 maintaining the same in axial alig"",enl with base member 60. It also urges dosing ",e,~ber 53 into close conla-:t with base 60 by means of spring 61. Dust cover 63 (not shown in figures 16 and 17) is allaol ,ed to lower body portion 69through pivot 64.
The wall of the main body 55 is provided with three longitudinal bores 58 10 sl ~sl~r,lially equidistantly sp~ced around the reservoir 56. A cylindrical weight 67 is slideably -received in each of the bores 58. The weigl ,ls 67 may be made of a rust resistanl metal such as stainless steel or other hard material such asacetal resin. The bores are each blind at their upper ends and closed by a pressed-in stainless steel ball bearing 68 at their lower ends which also act as15 anvils against which u~i~hls 67 rnay impact as described later.
A dose indicator drive means co",l.rising a shaft 70 provided with a screw thread over much of its length a sprung lug 71 at the base of the thread and a sprocl~el 72 with inclined teeth positioned below the lug is rctalably mounted within a bore 73 in the wall of the main body 55 (see figure 19). An 20 indicator nut 77 is threaded into the shaft with a projection protruding through an indicator window 74 in the wall of bore 73 which prevents the indicator nut 77 from ro~aling with shaft 70. Sprung lug 71 engages with teeth 75 formed within bore 73 to form a ratchet allowing shaft 70 to rotate in one direction only.
Sprocket 72 is located ~ cent the periphery of dosing member 53 which is 25 provided with a second sprung lug 76.
W096/08284 2 1 9 ~ 8 5 8 PCT/~5s~3603 OperdtiGn of the device is similar to that des~i,ibed with reference to the em~odi",e"l shown in Figures 11 to 15. The user initially shakes the device in age"erally upward and downward motion while maintaining the device in a generally upright orienld~iol) as shown in figure 13. Weights 67 are thereby 5 c~sed to travel up and down bores 58 next to the reservoir so repeatedly striking anvils 68. The vibrations which this proch~Ges are transmitted through base member 60 and body 55 to the powder in the reservoir and this encourages powder to flow downwardly and enter metering recess 65 within dosing member 53.
The user then opens dust cover 63 as shown in Figure 14 and rotates the cover which is connected to lower body asse"~bly 59 as described above through 90~ as shown in Figure 5 to move dust cover 63 away from mouthpiece 57 to allow ~ccess ll,e~to and to bring recess 65 into alignment with the aperture at 66 leading to the mouthpiece 57. As the dosing member 53 rotates 15 with the lower body assel,lbly 59 lug 76 e"gayes an inclined tooth presented by sprocket 72 of the dose indicator drive means. The dose ir,d;calor drive means is prevented from turning in the direction urged by lug 76 by virtue of the ratchet mechanis"~ formed by teeth 75 and lug 71. As a result lug 76 rides over the inclined tooth and out of engagel"ent with sprocket 72. The lower body 20 assembly 59 engages a stop (not shown) and will not move any further when the recess 65 is correctly aligned with aperture 66.
The user now inhales through mouthpiece 57. Air is drawn through grill 80 and passage 81 defined by body 55 and hole 82 in base member 60 and entrains the powder in recess 65 of dosing member 53. The airflow draws the 25 entrained powder through the mouthpiece 57 and is inhaled by the user. Further air is drawn into the mouthpiece through holes 82 on either side of mouthpiece 21 q9858 57 and this creales turbulence which helps to break-up any agylomerales of powder entrained.
After i,lhalalion the user retums lower body assembly 59 to its initial position and closes the dust cover 63. As dosing member 53 rotates lug 76 5 again engages sprocket 72 of the dose in-lic~tor drive means. As the ratchet mechanism formed by teeth 75 and lug 71 allows movement of the dose indicator drive means in the direction as now urged by lug 76 the dose indicatordrive means is r~laled by one tooth pitch through enyagen,ent with lug 76 as it p~sses sprocket 72. Rotation of the dose indicatior drive means causes the 10 captive dose indictor nut 73 to travel down ll,readed shaft 70. The pitch of the thread and the number of teeth on sprocket 72 are selected to ensure that the dose indicalor nut travels from the uppermost "full" position to the lower"~osl "empty" positiG" when the device has been used sufficiently to deliver its p, esu ibed number of doses so indicting to the user that the device is empty.
It will be u"der~lood that thè ~,rese"l ~lisclos~re is for the purpose of illustration only and the invention eAlends to modi~icalions varialio,)s and improvements ll,ereto.
Claims (24)
1. An inhalation device by means of which material in powder form can be inhaled, comprising a body defining a reservoir for medicament in the form of a powder, an outlet through which a user can inhale, a dosing member with at leastone metering recess formed therein, the dosing member being moveable between a first position in which the at least one metering recess communicates with thereservoir to receive a dose of powder therefrom and a second position in which the at least one metering recess communicates with the outlet to permit the user to inhale the dose, the at least one metering recess being formed in a face of the dosing member, the said face being mounted in contact against a similar mating face of the body at the lower end of the reservoir, and at least one moveable weight adapted, when the device is shaken, to strike an anvil surface defined inthe device.
2. An inhalation device comprising a reservoir for medicaments in the form of a powder, an outlet through which a user can inhale, a metering means adapted to communicate with the reservoir to receive a dose of powder therefrom and with the outlet to permit the user to inhale the dose, and at least one weight moveable in the device and adapted, when the device is shaken, to strike an anvil surface defined in the device.
3. A device according to claim 2, characterised in that the metering means comprises a dosing member with at least one metering recess formed in a face of the dosing member, the said face being mounted in contact against a similar mating face of the body at the lower end of the reservoir.
4. A device according to any preceding claim, characterised in that the at leastone weight is located within a respective bore.
5. A device according to claim 4, characterised in that the at least one weight is slideable longitudinally of the device, with the anvil surface being at the lower end of the respective bore.
6. A device according to claim 5 characterised in that the at least one weight is located within a respective bore adjacent to the reservoir.
7. A device according to any of claims 1 or 3 to 6 characterised in that the said face of the dosing member and the said mating face of the body are sealing faceswith highly polished smooth, surfaces which form a sliding seal which excludes substantially all air from the interface therebetween.
8. A device according to any of claims 1 to 3 or 7 characterised in that the at least one weight is in the form of a ring encircling the body and is slideable longitudinally thereof.
9. A device according to claim 8 characterised in that the anvil surface is defined adjacent to the lower end of the reservoir.
10. An inhalation device comprising a body forming a reservoir for medicaments in the form of a powder an outlet through which a user can inhale and a dosing member with at least one metering recess formed therein the dosing member being moveable between a position in which the at least one metering recess communicates with the reservoir to receive a dose of powder therefrom and a position in which the at least one metering recess communicates with the outlet to permit the user to inhale the dose the at least one metering recess being formedin a face of the dosing member, the said face being mounted in contact against asimilar mating face of the body, characterised in that the said face of the dosing member and the said mating face of the body have highly polished smooth, surfaces which form a contacting face to face kinetic seal which excludes substantially all air from the interface.
11. An inhalation device by means of which material in powder form can be inhaled comprising a body defining a reservoir for medicaments in the form of a powder an outlet through which a user can inhale and a dosing member with at least one metering recess formed therein the dosing member being moveable between a position in which the at least one metering recess communicates with the reservoir to receive a dose of powder therefrom and a position in which the at least one metering recess communicates with the outlet to permit the user to inhale the dose the at least one metering recess being formed in a face of the dosing member the said face being mounted in contact against a similar mating face of the body at the lower end of the reservoir characterised in that the said face of the dosing member and the said mating face of the body are sealing faceswith highly polished surfaces which form a sliding seal which excludes substantially all air from the interface therebetween.
12. A device according to any of claims 7 to 11 characterised in that the sealing faces adhere to eachother.
13. A device according to claim 12 characterised in that the sealing faces have a surface texture sufficiently smooth to have a roughness average value (Ra) of 0.5 microns or less.
14. A device according to claim 13, characterised in that the sealing faces have a surface texture sufficiently smooth to have an Ra value of 0.2 microns or less.
15. A device according to any of claims 12 to 14 characterised in that the sealing faces are flat.
16. A device according to claim 15 characterised in that the sealing faces have a flatness of 0.005 mm or less.
17. A device according to claim 16, characterised in that the sealing faces have a flatness of 0.003 mm or less.
18. A device according to any of claims 12 to 14 characterised in that the sealing faces are cylindrical.
19. A device according to any of claims 12 to 14 characterised in that the sealing faces are spherical.
20. A device according to any of claims 7 to 19 characterised in that the sealing faces are made of a hard rigid material.
21. A device according to claim 20 characterised in that the sealing faces are made of acetal resin.
22. A device according to claim 20 characterised in that the sealing faces are made of ceramics.
23. A device according to claim 20 characterised in that the sealing faces are made of metal.
24. A device according to any preceding claim, further comprising a dose indicating means adapted to display to a user the quantity of medicament remaining within the reservoir.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB9418702.8 | 1994-09-16 | ||
| GB9418702A GB9418702D0 (en) | 1994-09-16 | 1994-09-16 | Device |
| GBGB9507713.7A GB9507713D0 (en) | 1995-04-13 | 1995-04-13 | Device |
| GB9507713.7 | 1995-04-13 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2199858A1 true CA2199858A1 (en) | 1996-03-21 |
Family
ID=26305638
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002199858A Abandoned CA2199858A1 (en) | 1994-09-16 | 1995-09-13 | Inhalation device |
Country Status (19)
| Country | Link |
|---|---|
| US (3) | US6065471A (en) |
| EP (2) | EP0835146B1 (en) |
| JP (1) | JPH10505764A (en) |
| KR (1) | KR970706032A (en) |
| AT (1) | ATE228024T1 (en) |
| AU (1) | AU710027B2 (en) |
| BR (1) | BR9508935A (en) |
| CA (1) | CA2199858A1 (en) |
| DE (2) | DE69529104T2 (en) |
| FI (1) | FI971101A (en) |
| HU (1) | HU219117B (en) |
| IL (1) | IL115298A (en) |
| IS (1) | IS4437A (en) |
| MX (1) | MX9701957A (en) |
| NO (1) | NO971207L (en) |
| NZ (1) | NZ293269A (en) |
| RU (1) | RU2157251C2 (en) |
| TW (1) | TW301611B (en) |
| WO (1) | WO1996008284A2 (en) |
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-
1995
- 1995-09-13 JP JP8509912A patent/JPH10505764A/en active Pending
- 1995-09-13 AU AU35670/95A patent/AU710027B2/en not_active Ceased
- 1995-09-13 US US08/793,612 patent/US6065471A/en not_active Expired - Lifetime
- 1995-09-13 EP EP95932737A patent/EP0835146B1/en not_active Expired - Lifetime
- 1995-09-13 CA CA002199858A patent/CA2199858A1/en not_active Abandoned
- 1995-09-13 NZ NZ293269A patent/NZ293269A/en unknown
- 1995-09-13 HU HU9800106A patent/HU219117B/en not_active IP Right Cessation
- 1995-09-13 EP EP99119531A patent/EP0979661B1/en not_active Expired - Lifetime
- 1995-09-13 DE DE69529104T patent/DE69529104T2/en not_active Expired - Lifetime
- 1995-09-13 AT AT95932737T patent/ATE228024T1/en not_active IP Right Cessation
- 1995-09-13 MX MX9701957A patent/MX9701957A/en not_active IP Right Cessation
- 1995-09-13 BR BR9508935A patent/BR9508935A/en not_active Application Discontinuation
- 1995-09-13 RU RU97106014/14A patent/RU2157251C2/en active
- 1995-09-13 WO PCT/EP1995/003603 patent/WO1996008284A2/en not_active Application Discontinuation
- 1995-09-13 DE DE69528912T patent/DE69528912T2/en not_active Expired - Lifetime
- 1995-09-13 KR KR1019970701710A patent/KR970706032A/en not_active Application Discontinuation
- 1995-09-14 IL IL11529895A patent/IL115298A/en not_active IP Right Cessation
- 1995-11-04 TW TW084111704A patent/TW301611B/zh active
-
1997
- 1997-03-07 IS IS4437A patent/IS4437A/en unknown
- 1997-03-14 FI FI971101A patent/FI971101A/en unknown
- 1997-03-14 NO NO971207A patent/NO971207L/en not_active Application Discontinuation
-
2000
- 2000-02-01 US US09/494,942 patent/US6220243B1/en not_active Expired - Fee Related
- 2000-10-25 US US09/694,892 patent/US6484718B1/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP0835146A2 (en) | 1998-04-15 |
| HU219117B (en) | 2001-02-28 |
| DE69528912T2 (en) | 2003-07-17 |
| IL115298A0 (en) | 1995-12-31 |
| US6484718B1 (en) | 2002-11-26 |
| DE69529104D1 (en) | 2003-01-16 |
| WO1996008284A3 (en) | 1996-05-30 |
| FI971101A0 (en) | 1997-03-14 |
| IS4437A (en) | 1997-03-07 |
| WO1996008284A2 (en) | 1996-03-21 |
| US6220243B1 (en) | 2001-04-24 |
| EP0979661B1 (en) | 2002-12-04 |
| EP0835146B1 (en) | 2002-11-20 |
| JPH10505764A (en) | 1998-06-09 |
| MX9701957A (en) | 1998-02-28 |
| NO971207L (en) | 1997-05-14 |
| AU710027B2 (en) | 1999-09-09 |
| EP0979661A1 (en) | 2000-02-16 |
| BR9508935A (en) | 1998-01-06 |
| US6065471A (en) | 2000-05-23 |
| DE69528912D1 (en) | 2003-01-02 |
| AU3567095A (en) | 1996-03-29 |
| RU2157251C2 (en) | 2000-10-10 |
| KR970706032A (en) | 1997-11-03 |
| TW301611B (en) | 1997-04-01 |
| NZ293269A (en) | 1998-07-28 |
| HUT77459A (en) | 1998-04-28 |
| FI971101A (en) | 1997-03-14 |
| IL115298A (en) | 2000-07-26 |
| NO971207D0 (en) | 1997-03-14 |
| DE69529104T2 (en) | 2003-07-17 |
| ATE228024T1 (en) | 2002-12-15 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |