FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
PROVISIONAL SPECIFICATION
(See section 10 and rulel3)
1. TITLE OF THE INVENTION:
"MULTI-DOSE INHALER DEVICE"
2. APPLICANT:
(a) NAME: CIPLA LTD.
(b)NATIONALITY: Indian Company incorporated under the Indian Companies ACT, 1956
(c) ADDRESS: 289, Bellasis Road, Mumbai Central, Mumbai - 400 008, Maharashtra, India
3. PREAMBLE TO THE DESCRD7TION:
The following specification describes the invention.

Related application:
This application claims priority from the Indian Patent application No. 520/MUM/2007 dated 21/03/2007.
Technical field:
The present invention relates to inhaler device for the administering of medicament. The invention relates particularly to multi-dose inhalers and more particularly to inhalers which are used with piercable sealed cartridges having a plurality of medicament compartments. Such inhalers allow for the administration of predetermined doses of medicament (typically a dry powder medicament).
Background and prior art:
A wide variety of multi-dose inhalers are presently available on the market and they are designed for the inhalation of predetermined multiple doses of medicament by a patient. A problem often associated with multi-dose inhalers relates to the need for a cartridge comprising multiple doses of medicament to be advanced and a sealed cartridge compartment to be pierced before a dose of medicament can be dispensed. This requirement has in the past resulted in complicated and expensive mechanisms for allowing a multiple dose cartridge to be conveniently used by a patient.
Therefore, it is an object of the present invention to provide an inhaler device which is less expensive and less complicated in construction than prior art multi-dose inhaler devices.
Summary of the invention:
A first aspect of the present invention provides an inhaler device for dispensing medicament, the inhaler device comprising medicament extraction facilitating means comprising a resiliency displaceable member.
A second aspect of the present invention provides an inhaler device for dispensing medicament, the inhaler device comprising medicament extraction facilitating means wherein said means is sprung biased or is operated by a cam mechanism and displaced over a pivot. Ideally, said means is biased into a medicament extraction position allowing extraction of medicament from a medicament cartridge. Preferably said means is sprung
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biased by virtue of the resiliency deflectable character of the material from which said means is manufactured.
A third aspect of the present invention provides an inhaler device for dispensing multiple doses of medicament, the inhaler comprising means for receiving a medicament cartridge comprising a plurality of compartments containing medicament; medicament extraction facilitating means for locating adjacent a compartment of a received cartridge and thereby allowing an extraction of medicament from the compartment; and operating means moveable in first and second directions by a user; wherein the medicament extraction facilitating means is driven by the operating means so as to locate the medicament extraction facilitating means in an extraction position in response to movement of the operating means in the first direction, the extraction position of the medicament extraction facilitating means allowing extraction of medicament from said cartridge compartment upon inhalation by a user, and wherein the medicament cartridge is driven by the operating means so as to advance a cartridge compartment into a predetermined position relative to the medicament extraction facilitating means in response to movement of the operating means in the second direction.
The medicament extraction facilitating means may preferably be formed from delrin, but ABS, nylon, polycarbonate, HDPE, LDPE or acetal may also be used.
It will be understood therefore that an inhaler device according to the present invention allows for a comparatively simple operation by a user through appropriate movement of the operating means. If a user wishes to inhale a dose of medicament from a cartridge within the inhaler device, then the user need only move the operating means in a first direction so as to move the extraction facilitating means to an extraction position in which medicament may be extracted from the cartridge compartment. A user may then readily move the operating means in a second direction so as to advance or index the next dose of medicament to an appropriate position. Typically, this position will be one adjacent the medicament extraction facilitating means. It will be appreciated that the operating means drives both the advancement of the cartridge and movement of the medicament extraction facilitating means.
Alternatively, rather than the operating means driving the medicament extraction facilitating means into an extraction position, the medicament extraction facilitating
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means may be driven by the operating means so as to move the medicament extraction facilitating means from the extraction position. The medicament extraction facilitating means may be moved to a retracted position which allows for the advancement of the medicament cartridge.
Whilst the operating means drives the medicament extraction facilitating means to one of the extraction and retracted positions, biasing means may be provided for moving the medicament extraction facilitating means to the other of the extraction and retracted positions. The biasing means may comprise a resilient elastic member. The resilient elastic member may be provided as a cantilever arm, with one end thereof fixed to a housing of the inhaler device and a free end thereof being provided with the medicament extraction facilitating means.
The operating means may, alternatively, drive the medicament extraction facilitating means to both the extraction and retracted positions. Biasing means may also be provided to bias the medicament extraction facilitating means towards one of the extraction and retracted positions.
The operating means may drive the medicament extraction facilitating means through use of a cam arrangement. Ideally, a cam is provided on the operating means. The cam may be provided as a ramp surface. The arrangement may be such that, when the operating member is moved in the second direction, the ramp surface moves laterally in abutment with the medicament extraction facilitating means and thereby displaces the medicament extraction facilitating means. Preferably, the medicament extraction facilitating means is provided with a roller or bearing before abutment with the cam.
The medicament extraction facilitating means may be provided with a tubular element for locating in a cartridge compartment when the medicament extraction facilitating means is located in the extraction position. A free end of the tubular element may be provided with a piercing portion. The piercing portion may be of a frusto-conical shape. Furthermore, the arrangement of the medicament extraction facilitating means may be such that, when the medicament extraction facilitating means is located in the extraction position, the tubular element is in fluid communication with a mouthpiece of the inhaler
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device. This fluid communication may be made through an aperture or discontinuity in the operating means. This aperture or discontinuity is ideally aligned with a flow path through the mouthpiece when the operating means has been moved in the first direction so as to drive the medicament extraction facilitating means into the extraction position.
It is also preferable for the operating means to close a flow path through the mouthpiece when the operating means is moved in the second direction. Ideally, the aperture or discontinuity is moved out of alignment with the mouthpiece flow path when the operating means is moved in the second direction. Fluid communication between the mouthpiece and the extraction facilitating means is ideally prevented when the medicament extraction facilitating means is in the retracted position.
Furthermore, it is preferable for the medicament extraction facilitating means to comprise a venturi.
It is also desirable for ratchet means to be provided for allowing the operating means to drive the medicament cartridge. The operating means may be provided with a ratchet tooth so that the medicament cartridge is moved in response to movement of the operating means in the second direction, but is not moved in response to movement of the operating means in the first direction. Said ratchet tooth may be arranged so as to engage in turn with each of a plurality of ratchet teeth provided on the medicament cartridge.
Ideally, said first direction is opposite to said second direction. It is also preferable for movement of the operating means in said first and second directions to comprise a movement of the operating means along a part-circular path. The part-circular path is ideally concentrically positioned relative to an annular arrangement of medicament compartments of the medicament cartridge.
An element of the operating means may extend through a slot in a housing of the inhaler device. The slot is ideally configured so as to allow movement of said element between opposite ends of the slot and thereby move the operating means in said first and second directions. Retaining means may be provided for preventing movement of said element
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of the operating means. Said retaining means may be provided on a cover for the mouthpiece.
The inhaler device may be provided with means for retaining a medicament cartridge in a required position. The retaining means may comprise the roller, wheel or bearing to press against the cartridge whilst allowing movement of the cartridge. The retaining means may be sprung biased so as to press against the medicament cartridge. The retaining means is preferably made from delrin, but may be made from ABS, nylon, polycarbonate, HDPE, LDPE or acetal. The inhaler may also comprise means for driving a dose counter in response to movement of a medicament cartridge. Said drive means may comprise one or more teeth or detents for engaging a medicament cartridge. The drive means may also comprise a gear wheel for engaging means for displaying a dose count.
An embodiment of the present invention will now be described with reference to the accompanying drawings, in which:
Brief description of drawings:
Figure 1 is an exploded view of an inhaler device according to the present invention;
Figures 2A-D are perspective, front, top and bottom views respectively of the assembled inhaler device shown in Figure 1;
Figures 3A-G are perspective, front, right side, rear, left side, top and bottom views respectively of the base of said inhaler device;
Figures 4A-F are perspective, front, left side, rear, top and bottom views respectively of a mouthpiece of said inhaler device;
Figures 5A-D are perspective, front, bottom and rear views respectively of a mouthpiece cover of said inhaler device;
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Figures 6A-D are perspective, top, bottom and side views respectively of a dose counter wheel 26 of said inhaler device;
Figures 7A-D are perspective, top, bottom and side views respectively of a drive gear of said inhaler device;
Figure 8 is a perspective view of a medicament cartridge centring mechanism and associated roller of said inhaler device;
Figure 9 is a side view of the roller shown in Figure 8;
Figures 10A-G are perspective, front, right side, rear, left side, top and bottom views respectively of an operating member of said inhaler device;
Figures 11A-D are perspective, bottom, right side and left side views respectively of a support arm of said inhaler device;
Figures 12A & B are top and side views respectively of a medicament cartridge of said inhaler device;
Figures 13A-E are, respectively, a perspective view of a spiking component of said inhaler device and a roller to be mounted to said component, and right side, rear, top and bottom views of the spiking component alone;
Figures 14A-G are perspective, front, right side, rear, left side, top and bottom views respectively of a middle cover of said inhaler device; and
Figures 15A-G are perspective, front, right side, rear, left side, top and bottom views respectively of a top cover of said inhaler device.
An exploded view of an inhaler device 1 is shown in Figure 1 of the accompanying drawings. Various views of the inhaler device 1 in an assembled condition are shown in
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Figures 2A-D. Individual components of the inhaler device 1 are also shown in Figures 3 to 15.
Disclosure of the invention:
The inhaler device 1 comprises an outer housing and a plurality of internal components including a cartridge having a plurality of compartments containing medicament. The housing comprises a base 2 (see Figure 3), a middle cover 4 (see Figure 14) and a top cover 6 (see Figure 15). Four apertures 100 are provided along an upper perimeter edge 102 of the base 2 in order to receive four posts 104 extending downwardly from a lower perimeter edge 106 of the middle cover 4. The apertures 100 are asymmetrically positioned along the perimeter edge 102 of the base 2 and the posts 104 are arranged in corresponding positions along the perimeter edge 106 of the middle cover 4 so that all four posts 104 can only be simultaneously inserted within the apertures 100 when the base 2 and middle cover 4 are correctly aligned relative to one another. Insertion of the posts 104 into the apertures 100 secures the base 2 and middle cover 4 together.
Furthermore, the middle cover 4 is provided with four apertures 140 for receiving and retaining therein four pegs 142 projecting downwardly from the underside of the top cover 6. In this way, the top cover 6 is securable to the middle cover 4.
The housing is provided with a mouthpiece 8 and a mouthpiece cover 10. The mouthpiece 8 includes a mouthpiece opening 112 (through which medicament is inhaled) which is provided with three helical guide vanes 114 for imparting a swirl motion onto medicament/fluid to be inhaled. Other means for imparting a swirl motion on medicament/fluid may be provided. An aperture 14 in the front side of the housing allows for fluid communication through the mouthpiece 8 between the interior and exterior of the inhaler housing. In use, a user of the inhaler device 1 places the mouthpiece to the lips of their mouth and inhales through the mouthpiece so as to extract and inhale medicament. In an alternative embodiment, the mouthpiece 8 may be replaced with a construction suitable for nasal inhalation.
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The housing is provided with a slot 18 along which a knob 20 may be moved so as to advance a cartridge of medicament within the housing and so as to displace a spiking component 22. The mouthpiece cover 10 is pivotally mounted to the knob by means of a hinge arrangement 12. In use of the inhaler device 1, the mouthpiece cover 10 is detached from the housing of the inhaler device 1 at one end thereof by disengaging a clip element 116 on the mouthpiece cover from a lip 118 provided by the base 2 and middle cover 4. In so doing, the mouthpiece cover 10 is rotated from the housing. This rotation is permitted by means of the hinge arrangement 12, which is a flexible strip of material integrally connecting the mouthpiece cover 10 and the knob 20. Accordingly, the cover 10 and the knob 20 move together during actuation of the device. A single hand can be used to open the mouthpiece cover 10 and actuate the device by moving the knob 20.
An aperture or window 24 (see Figure 2D) is also provided in the bottom of the base 2 so that an indication of the number of doses used or the number of doses remaining can be seen provided on a dose counter wheel 26 located within the housing.
The wheel 26 is located on and rotatably attached to a first boss 28 upstanding from an interior surface of the base 2. A drive gear 30 (having three apertures 150) is provided for driving the counter wheel 26 and is rotatably mounted to a second boss 32. The second boss upstands from the same surface as the first boss 28 and is spaced from the first boss 28 so that teeth 34 on the lower side of the drive gear 30 engage with teeth 36 on the circumferential edge of the counter wheel 26 (see Figures 6 and 7). In use, the drive gear 30 rotates with a medicament cartridge and, due to the engagement of the teeth 34, 36, rotates the counter wheel 26 so that an appropriate indicator provided on the underside of the wheel 26 may be viewed through the window 24 and thereby provide a user with an indication of the remaining doses or the doses used.
The dose counter wheel 26 is further provided with an aperture 110 which is alignable with a yet further aperture 108 extending through the base 2. It will be understood that, when the dose counter wheel 26 is mounted on the first boss 28, it may be rotated relative to the base 2 and thereby positioned so that the apertures 108, 110 align. An element (not shown) may then be temporarily inserted through the aligned apertures 108, 110 so as to
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prevent relevant rotation between the dose counter wheel 26 and the base 2 during assembly and/or storage of the second inhaler device 1.
A medicament cartridge 38 locates on three equi-spaced support members 40 provided on the base 2. The medicament cartridge 38 locates above the counter wheel 26 but in the same plane as the drive gear 30.
The cartridge 38 is provided as an annular ring having a plurality of compartments 42. Each compartment contains medicament in a powder form. The annular ring comprises two operative walls - an outer operative wall and an inner operative wall. Both walls have a plurality of teeth integral therewith. The inner wall comprises a plurality of integral teeth 44 which engage with a plurality of teeth 46 provided on the perimeter of the drive gear 30. The arrangement is such that a small number of teeth 46 are engaged at any one time with the same number of teeth 44 of the medicament cartridge 38. Thus, as the cartridge 38 rotates whilst supported on the support members 40, the drive gear 30 is rotated on the boss 32 by virtue of the engagement between the aforesaid teeth 44, 46.
The engagement of the drive gear 30 with the medicament cartridge 38 also assists in retaining the cartridge 38 in a required position within the inhaler housing. The position of the medicament cartridge 38 is further retained by means of a centring mechanism 50 which presses a roller 52 against the teeth 44. The roller 52 has four apertures 154 extending therethrough so as to provide radially extending spokes 156. Apertures 51 in the centring mechanism 50 are snap-fitted to posts 53 upstanding from the base 2. The posts 53 have a flange (not shown) provided on their free ends so as to retain the centring mechanism 50 on the base 2.
The centring mechanism 50 is made from a resiliency displaceable member so as to allow the roller 52 to be biased against the cartridge 38. In this way, undesirable lateral movement and/or rotation of the medicament cartridge 38 is prevented.
The medicament cartridge 38 is indexed from one medicament compartment 42 to the next through movement by the inhaler user of an operating member 54 (an enlarged view of which is provided in Figure 10).
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An element 56 of the operating member 54 extends through the slot 18 and attaches with the knob 20 by means of a clip 120. The clip 120 is orientated so as to engage and thereby support the full depth of the knob 20. The arrangement ensures that the knob 20 is not merely supported at its centre and, accordingly, avoids the knob 20 being pressed against the housing of the device at its upper and lower ends during use.
The operating member 54 comprises a ratchet tooth 58 which engages with a plurality of ratchet teeth 60 provided on the outer operative wall of the medicament cartridge 38. The configuration and engagement of the ratchet teeth 58, 60 is such that, when the operating member 54 is moved in the direction of arrow A (see Figures 1 and 10F) the ratchet tooth 58 of the operating member 54 abuts against an adjacent ratchet tooth 60 of the cartridge 38 and rotates the cartridge 38 in the direction of arrow A. The extent of movement of the operating member 54 allowed by the slot 18 indexes the cartridge 38 by one compartment 42 (i.e. to the next compartment 42). The movement of the cartridge 38 will also be understood to drive the dose counter wheel 26 as already described above.
When the operating member 54 is moved in an opposite direction to that indicated by arrow A, the configuration of the ratchet mechanism allows the ratchet tooth 58 on the operating member 54 to ride over the ratchet teeth 60 of the cartridge 38. The cartridge 38 is therefore not rotated by movement of the operating member 54 in a direction opposite to that indicated by arrow A.
The operating member 54 further comprises a sealing face plate 66 which aligns with the flow path 14 associated with the mouthpiece 8 when the operating member 54 has been moved to the fullest extent in the direction indicated by arrow A. Furthermore, the operating member 54 is provided with an aperture 68 which aligns with the flow path 14 when the operating member 54 has been moved to the fullest extend in the direction opposite to that indicated by arrow A.
The operating member 54 yet further comprises a camming member/strip or ramp 70 which engages with a roller 72 mounted on the spiking component 22. The assembly of spiking component 22 along with the roller 72 is attached to the opposite end of the hook
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element 92 of the arm 90. In the assembled inhaler 1 the camming strip 70 is located above the roller 72 and the arrangement is such that, when the operating member 54 is moved in a direction opposite to that indicated by arrow A, the roller 72 rolls against the underside of the cam strip 70 and is pressed downwardly by the camming strip 70 so as to locate the spiking component within a previously advanced compartment 42 of medicament. In so locating the spiking component 22, a seal provided across the top of the compartment 42 is perforated by the spiking component 22. The spiking component 22 comprises a tubular element 80 which is located in fluid communication with the aperture 68 and flow path 14. Thus, with the operating member 54 having been moved in a direction opposite to that indicated by arrow A, the tubular element 80 is located in a compartment containing medicament and the aperture 68 of the operating member 54 is aligned with the mouthpiece flow path 14. Medicament may then be inhaled from the medicament compartment from the mouthpiece.
When the operating member 54 is moved back in the direction indicated by arrow A, the aperture 68 is moved out of alignment with the mouthpiece flow path 14. The flow path 14 is then covered by the sealing plate 66 of the operating member 54. Also, as the operating member 54 is moved in the direction of arrow A, the downward pressure applied by the cam 70 is released and the spiking component 22 is moved upwardly by a second camming strip 130. It will be understood that the second cam 130 is orientated so as to press the roller 72 associated with the spiking component 22 upwardly, thereby returning the support arm 90 to an upper position within the housing (as the operating member 54 is moved in a direction as indicated by arrow A). In this way, the arm 90 is returned to its storage/retracted position by means of a camming action.
In an alternative embodiment, the spiking component 22 is moved upwardly by spring biasing means, such as inherent elasticity in the arm 90.
At an opposite end of the arm 90, a hooking element 92 is provided for securing the arm 90 to the middle cover 4 through an aperture 94 provided in said cover 4. The arm 90 is therefore provided as a cantilever. The arm 90 is a resiliently displaceable member, and is preferably made from delrin, but may be made from nylon, polycarbonate or acetal.
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The above materials, among others, are also suitable for the manufacture of various other parts of the device, including, but not limited to; the spiking component 22, the hooking element 92, the cartridge centring mechanism 50 and the rollers 52, 72.
It will be understood that sliding the operating member 54 in the direction of arrow A in Figure 1 results in moving the inhaler 1 into a closed position, whilst sliding the operating member 54 in the direction opposite to that indicated by arrow A results in moving the inhaler 1 into an open position.
The operating member 54 is located within the inhaler housing in a groove 98. The groove 98 allows the operating member 54 to be displaced along the inner side of the housing (i.e. circumferential movement) whilst limiting undesirable radial movement. Although not illustrated in the drawings, the spiking component 22 comprises a venturi which is positioned so that inhalation by a user causes medicament to travel up the tubular element 80 and into the venturi before eventually entering the lungs of the user.
With reference to Figure 14, the under side of the middle cover 4 is shown wherein it can be seen that resilient clip elements 132 project downwardly from either side of aperture 94 and are provided with bosses 134 for snap-fitting into apertures 136 of the arm 90. During operation of the inhaler device 1, the arm 90 rotates up and down about the bosses 134. When the arm 90 is located in its upper-most position within the housing of the inhaler device 1, the arm 90 locates between two elements 138 projecting downwardly from the under-side of the middle cover 4. In this way, the end of the arm 90 distal to the apertures 136 is prevented from moving from side to side.
The inhaler 1 may be sealed so that once the medicament within the cartridge 38 has been used, the inhaler 1 must be discarded. Alternatively, the inhaler 1 may be provided with a lid which allows access to the interior of the inhaler and thereby allows for a replacement of the used cartridge with a fresh cartridge. Accordingly, it will be understood that the inhaler 1 may incorporate a replaceable medicament cartridge so that, once the cartridge is exhausted, it can be replaced with a medicament cartridge which is fully loaded with medicament.
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Furthermore, with regard to materials of manufacture, the top cover 6, middle cover 4, drive gear 30, dose counter 26 and base 2 may be manufactured from Acrylonitrile Butadiene Styrene (MF45). Also, the arm 90, spike 22 and associated roller 72, operating member 54, and centring mechanism 50 and associated roller 52 are manufactured from Acetyl co-polymer. Finally, the mouthpiece 8 and associated cover 10 are manufactured from polypropylene, and the medicament cartridge 38 is manufactured from polystyrene (206). The corresponding components of the first inhaler device 1 may be manufactured from these same materials.
The present invention is not limited to the specific embodiment described above. Alternative arrangements and suitable materials will be apparent to a reader skilled in the art. For example, in an alternative embodiment, a dose counter is not provided. In such an inhaler, the counter wheel 26, teeth 34 and window 24 will not be required and may be omitted. It will be understood therefore that the dose counter is an optional feature.
Dated this 7th day of September 2007

Dr. Gopakumar. G. Nair Agent for the Applicant
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