Title of Invention

AN IMPROVED MULTIDOSE INHALER

Abstract

An improved multidose inhaler comprising; a base cap (1) a top cap (2) lockably engaged to said base cap (1) and adapted for relative rotation against said base cap; a center cap (3) assembled with the top cap (2) and base cap (1) having a mouth piece mounted for guiding the flow of powder medicament; a medicament cartridge (6) being accommodated in the base cap (1) and comprising plurality of cavities for holding predetermined quantity of medicament and ; a cam member (2c) preferably arranged in pair configured on the top cap (2); a lever arrangement (4) located on said center cap (3) and operable by said cam member; a hollow spike (7) adapted in contact with the lever (4) for movement of the spike by said lever arrangement (4); spring loaded pins (10) mounted below the top cap (2) for enabling indexing movement of the medicament cartridge; characterized in that the hollow spike (7) comprises an axial flow path (7a) and a venturi flow path (7b) oriented perpendicular to said axial flow path (7a) whereby upon rotation of the top cap relative to the base cap; the cam member effects the spike for piercing the foil and subsequently allowing predetermined degree of rotational movement of the cartridge (6)

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) COMPLETE SPECIFICATION [See section 10, Rule 13] AN IMPROVED MULTIDOSE INHALER; CIPLA LIMITED, A COMPANY INCORPORATED UNDER THE INDIAN COMPANIES ACT, 1913, WHOSE ADDRESS IS 289 BELLASIS ROAD, MUMBAI CENTRAL, MUMBAI - 400 008, MAHARASHTRA, INDIA; THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE NATURE OF THIS INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED FIELD OF INVENTION: The present invention relates to the field of inhalers. Particularly, the present invention relates to the field of multidose inhalers especially those comprising a pierceable sealed cartridge having a plurality of medicament cavities, for administration of predetermined dosage of powder medicament to a patient by inhalation. PRIOR ART: Conventionally, a wide variety of multidose inhalers are available in the market, which are designed for convenient handling and inhalation of predetermined dosage of medicament by a patient. Reference is hereby made to applicants co-pending application No 975/MUM/2002 dated November 12, 2002 which discloses an inhaler having top and bottom containers enclosing a circular cartridge of medicament comprising a plurality of cavities holding a predetermined quantity of medicament. A spike member, operable by the user, is pressed down by hand, to pierce the foil sealing the cartridge and thereby begin inhalation of the medicament through a mouth piece. However, once the inhalation from one cavity is completed, then fresh medicament cavity is brought to inhalation position by manually lifting the spike fully or to a certain height above the top container, and then rotating the top container relative to the bottom container. However, in the above type of inhalers, the user has to perform multiple operations for inhaling a specified dosage of medicament. The present invention provides an improved multidose inhaler, which overcomes and finds solution to problems associated with the above inhaler and various other inhalers known in the art. The multidose inhaler according to the present invention provides an extreme ease of use and offers very high level of performance. SUMMARY OF INVENTION The present invention provides an improved multidose inhaler comprising a base cap (1) a top cap (2) lockably engaged to said base cap (1) and adapted for relative rotation against said base cap; a center cap (3) assembled with the top cap (2) and base cap (1) having a mouth piece mounted for guiding the flow of powder medicament; a medicament cartridge (6) being accommodated in the base cap (1) and comprising plurality of cavities for holding predetermined quantity of medicament and ;a cam member (2c) preferably arranged in pair configured on the top cap (2); a lever arrangement (4) located on said center cap (3) and operable by said cam member; a hollow spike (7) adapted in contact with the lever (4) for movement of the spike by said lever arrangement (4); spring loaded pins (10) mounted below the top cap (2) for enabling indexing movement of the medicament cartridge; characterized in that the hollow spike (7) comprises an axial flow path (7a) and a venturi flow path (7b) oriented perpendicular to said axial flow path (7a) whereby upon rotation of the top cap relative to the base cap; the cam member effects the spike for piercing the foil and subsequently allowing predetermined degree of rotational movement of the cartridge (6). The hollow spike member comprises a venturi flow path (7b) comprises at least one converging path (7d) and at least one diverging path (7c) to reduce the resistance to follow of powder medicament from the medicament cavity upon inhalation by the user. The base cap further comprises a spiral torsion spring (8) in a substantially energized condition such that the torsion spring tends to unwind by virtue of kinetic energy releasing during unwinding of the spring. An air opening is provided corresponding to the spike member to enable the venturi flow of the medicament. The base cap (1) further comprises a drum (9) fixed in relationship with the medicament cartridge and said torsion spring (8) whereby the torsion spring (8) rotates the medicament cartridge (6) along with said drum (9). The spiral torsion spring (8) in energized condition imparts continuous rotation of the medicament cartridge. The cam members (2c) are preferably gradually tapering profiles projecting from the underside surface of the top cap. The lever. (4) is pivotedly mounted at a fulcrum point located substantially at the central portion of the center cap. At least one spring loaded pins set in energized downward position by at least one cam member obstructs the rotation of the medicament cartridge. The base cap has a central sleeve member(1b), a slit (1c) located in close proximity to the sleeve member (1b). The dust cap according to the present invention is adapted to the inhaler. The dust cap is preferably 'U' shaped and configured to the top cap such that when the base cap is rotated the "IT of the dust cap slides over to one side of the mouth piece (5) so as to allow inhalation. The medicament cartridge has integrally molded radial projections that impart rigidity and assists in indexing movement of the cartridge. At least one radial projection in the medicament cartridge is modified to prevent the rotation of the medicament cartridge. A projection (12) on the base cap allows the rotation of the medicament cartridge and prevents further rotation of the cartridge when the cartridge is exhausted. The base cap may optionally be provided with a view window according to the present invention. BRIEF DESCRIPTION OF DRAWINGS Fig. 1 shows the exploded sectional view of the components of the inhaler according to the present invention. Fig. 2 shows the plan, sectional elevation and side views of the top cap according to the present invention Fig. 3A shows the plan and sectional elevation of the base cap according to the present invention. Fig. 3B shows the plan, front and side sectional views of the center cap according to the present invention. Fig. 4 shows the top and sectional front view of the spike according to the present invention Fig. 5 shows the plan and sectional view of the medicament cartridge according to the present invention. Fig. 6A shows the top and sectional elevation of the lever according to the present invention. Fig.6B shows the plan and sectional elevation of the spiral torsion spring according to the present invention. Fig. 6C shows the plan and sectional elevation of the drum according to the present'invention. Fig. 7A shows the plan, sectional elevation and side views of the mouth piece according to the present invention. Fig. 7B shows the plan and elevation of the pin according to the prese invention. Fig. 7C shows the plan and elevation of the spring which energizes pin of Fig. 7B according to the present invention. Fig 8 shows cross-sectional top view of the base cap. DESCRIPTION: The present invention discloses a multidose inhaler (hereinafter referred to as a device), the constructional and functional features of which will become apparent from the description given herein: FIG 1: The multidose inhaler according to the present invention comprises a base cap (1) and a top cap (2), a centre cap (3) located between the base cap (1) and the top cap (2) and all of said caps lockably assembled in a manner as shown in Fig.1. The base cap (See Fig 3A) comprises a substantially circular body (1a) having a central sleeve member (1b) and a slit (1c) located substantially in close proximity to the sleeve member (1b). Other features and functions of the base cap (1) which would enable assembly of the device, would be apparent from the drawings accompanying this specification. Fig 2 shows the plan, elevation and side views of the top cap (2). In the embodiment shown, the top cap (2) comprises a substantially circular body, having a projection (2a) at a substantially central location of the body. The projection (2a) engages with the sleeve member (1b) of the base cap (1) for lockably assembling the top cap (2) in snap - fitting relationship with the base cap (1). In the locked state, only the relative rotation of the top cap (2) against the base cap (1) is enabled. A dust cap (2b) is configured at the circumferential edge the top cap (2). The dust cap may be adapted in such a manner that the dust cap may not be configured with the inhaler. The dust cap is preferably 'IT shaped and configured to the top cap such that when the base cap is rotated the "IT of the dust cap slides over to one side of the mouth piece (5) so as to allow inhalation. A set of cam members (2c) are configured on the under side surface of the top cap (2). The cam members (2c) are preferably arranged in pair, in opposite sides as shown in FIG 2. The cam members (2c) are preferably gradually tapering profiles projecting from the underside surface of the top cap (2) which provides a good control over rotation. Alternatively, various profiles and features which would function substantially in a similar way to achieve substantially similar result are deemed to be within the scope of this invention. Fig 3 B shows the plan, elevation and sectional view of the centre cap (3). The centre cap (3) comprises a substantially circular body having a passage (3a) for guiding the flow of powder medicament. A lever arrangement (4) (shown in detail in Fig 6A) is pivotedly mounted at a fulcrum point (4b) which is located substantially at the central portion of the centre cap (3). A mouth piece (5) (shown in Fig 7A) is mounted onto the passage for guiding the flow of powder medicament and facilitating inhalation by user. The dust cap (2b) openably closes the mouth piece (5) when the top cap (2) is relatively rotated against the base cap (1). At one position of the top cap (2) in assembled state with the centre cap (3) and the base cap (1), the dust cap (2b) closes the mouth piece (5) and in other relatively rotated position against the base cap (1), opens the mouth piece (5) for inhalation of medicament by the patient. Fig 5 shows the plan and elevation of the medicament cartridge (6). The medicament cartridge (6) comprises a plurality of cavities (6a) for holding a predetermined quantity of medicament thereto for inhalation by user. A thin pierce able foil (not shown) is normally used for sealing the cavities (6a) of the medicament cartridge (6). Several radial projections (6b) which impart rigidity and which assist in indexing movement of the cartridge (6) are integrally molded along with the cartridge (6). The base cap (1) is provided with a projection (12) which enables the movement of the medicament cartridge. At least one of the radial projections (6b) is modified in such a manner that when the cartridge rotates and reaches the projection (12) of the base cap, further rotation of the cartridge is prevented. The radial projections (6b) of the present invention has a flat top surface and a curved surface; and correspondingly the projection (12) on the base cap has a surface that allows the curved surface of the radial projections (6b) to pass through thereby allowing rotation of the cartridge. At least in one of the radial projections (6b) the curved surface is modified to be flat so that when it reaches the projection (12) on the base cap, the cartridge (6) is prevented from rotating further. Fig 4 shows the plan and elevation of a spike (7). The spike (7) comprises a hollow cylindrical body having an axial flow path (7a) and a venturi flow path (7b). The venturi flow path (7b) is oriented substantially perpendicular to the axial flow path (7b). The venturi flow path (7b) has at least one converging path (7d) and at least one diverging path (7c) with a substantially narrow constriction of substantially uniform cross section in-between the converging and diverging flow paths. The purpose of the venturi flow path (7b) is to reduce the resistance to flow of powder medicament from the medicament cavity towards the mouth piece (5) upon inhalation by the user. An air opening (14) (Fig 8)is provided on the device so as to enable the venturi flow of the powder medicament from the medicament cavity towards the mouth piece. The air opening is provided corresponding to the spike member so as to achieve the maximum flow of the medicament. The air opening according to the present invention is preferably positioned on the center cap. The center cap of the present invention is positioned in the base cap and hence the base cap is also provided with an air opening corresponding to the center cap to enable venturi flow of the medicament towards the mouth piece. The spike has a head (7f) which is in contact with the lever (4) for enabling upward and downward movement of the spike (7) by the lever (4). During assembly of the device, the medicament cartridge (6) is positioned within the base cap (1), in concentric relationship with the sleeve member (1b) of the base cap (1). A spiral torsion spring (8) (shown in Fig 6B) hereinafter referred to as torsion spring, is mounted at the periphery of the sleeve member (1b) in-between the medicament cartridge (6) and the sleeve member (1b). The inner end of the torsion spring (8) is fixed onto the slit (1c) adjoining the sleeve member (1b). A drum (9) (as shown in Fig 6C) is mounted over the base cap (1), enclosing the torsion spring (8). The outer end (8a) of the torsion spring (8)' is fixed to the drum (9) in a substantially energized condition such that the torsion spring (8) tends to unwind thereby rotating the drum (9) by virtue of the kinetic energy released during unwinding of the torsion spring (8). The drum (9) with the torsion spring (8) in substantially energized condition is secured to the base cap (1) by a resilient means whereby the torsion spring unwinds as the drum rotates. The drum (9) has slit (9a) which is matched with a projection (6c) of the medicament cartridge (6) as shown in Fig 5 such that the medicament cartridge (6) and the drum (9) are in fixed relationship with each other. As the torsion spring (8) is unwound, the drum (9) rotates thereby rotating the medicament cartridge (6) along with the drum (9). The fitting of the medicament cartridge (6) and the drum (9) may be achieved by suitable mechanism known in the art for achieving the purpose. Spring loaded pins (10) (see Fig 7B & 7C) are mounted below the top cap (2), in coordination with the radial projections (6b) of the medicament cartridge (6) for enabling indexing movement of the medicament cartridge (6). The top cap (2) is configured such that when the top cap (2) is rotated relative to the base cap (1), say for about 60 degrees, the opening of the mouth piece(5), indexed movement of the medicament cartridge (6) and the piercing of the foil for fresh medicament inhalation are simultaneously effected. The indexing movement of the medicament cartridge, according to the present invention refers to the preset degree of unidirectional rotation of the medicament cartridge, for corresponding relative rotation of the top cap (2) against the base cap(1). This indexing movement is achieved by the following configuration of the top cap (2 ) and the associated components thereof described herein: At predetermined relatively rotated positions of the top cap (2) with the base cap (1), at least one among the pair of spring loaded pins (10) is set in energized downward position by at least one of the cam members (2c) such that the ownwardly energized pin (10) obstructs and stops the rotation of the nedicament cartridge (6) which otherwise rotates by virtue of the kinetic energy of the torsion spring (8). Preferably, for a 0 - 180 degree, more preferably for a 45 to 120 degree and most preferably for 90 degree relative rotation of the top cap (2) with the base cap (1), the degree of rotation of the medicament cartridge (6) is set such that an exhausted cavity is replaced by a fresh medicament cavity foe Inhalation, by the patieat. It is to be noted that the torsion spring (8) in substantially energized condition, is used for imparting continuous rotation to the medicament cartridge (6). The spring mentioned in relation to the spring loaded pin is preferably, a conventional helical spring ( as shown in Fig 7C). Furthermore, at least one of the cam members (2c) are in substantial contact with the lever (4). As the top cap (2) rotates, the cam members (2c) effect corresponding downward or upward movement of the lever (4) so as to respectively lift or push the spike (7) for effecting piercing of the foil by the spike (7). In normal closed position of the top cap (2), at least one pin (10) contacts the radial projection (6b) of the cartridge (6) thereby holding the cartridge in stationary position against the rotational force exerted due to kinetic energy the torsion spring. As the top cap (2) is rotated relative to the base cap (1), at least one of the cam members (2c) effect movement of at least one pin (10) towards upward position, thereby releasing the contact of the pin (10) with the radial protections (6b), and subsequently allowing predetermined degree of rotational movement of the cartridge ( 6). In one embodiment, at least a pair of such pins (10) coordinate with at least a pair of cam members (2c) to effect two stage rotational movement of the cartridge (6) from one cavity position to another thereby bringing fresh medicament cavity for inhalation by the patient. The medicament cartridge used herein is loaded at the time of assembly and once the cartridge is exhausted, further rotation of the cartridge is prevented or stopped. The base cap may optionally be provided with a view window such that the number of unused or used doses can be seen which will help the user to know about the same. Numbers are mentioned on the bottom side of the cartridge to view through the view window provided on the base cap. The multidose inhaler of the present invention may be made of transparent material. The multidose inhaler of the present invention may not be made of transparent material. Further details of the invention will be apparent from the drawings accompanying this specification. WE CLAIM 1. An improved multidose inhaler comprising; a base cap (1) a top cap (2) lockably engaged to said base cap (1) and adapted for relative rotation against said base cap; a center cap (3) assembled with the top cap (2) and base cap (1) having a mouth piece mounted for guiding the flow of powder medicament; a medicament cartridge (6) being accommodated in the base cap (1) and comprising plurality of cavities for holding predetermined quantity of medicament and ; a cam member (2c) preferably arranged in pair configured on the top cap (2); a lever arrangement (4) located on said center cap (3) and operable by said cam member; a hollow spike (7) adapted in contact with the lever (4) for movement of the spike by said lever arrangement (4); spring loaded pins (10) mounted below the top cap (2) for enabling indexing movement of the medicament cartridge; characterized in that the hollow spike (7) comprises an axial flow path (7a) and a venturi flow path (7b) oriented perpendicular to said axial flow path (7a) whereby upon rotation of the top cap relative to the base cap; the cam member effects the spike for piercing the foil and subsequently allowing predetermined degree of rotational movement of the cartridge (6) 2. An improved multidose inhaler as claimed in claim 1 wherein the hollow spike member comprises a venturi flow path (7b) comprises at least one converging path (7d) and at least one diverging path (7c) to reduce the resistance to flow of powder medicament from the medicament cavity upon inhalation by the user. 3. An improved multidose inhaler as claimed in claim 1 or 2 wherein the base cap further comprises a spiral torsion spring (8) in a substantially energized condition such that the torsion spring tends to unwind by virtue of kinetic energy releasing during unwinding of the spring. 4. An improved multidose inhaler as claimed in claim 1 wherein an air opening is provided corresponding to the spike member to enable the venturi flow of the medicament. 5. An improved multidose inhaler as claimed in claim 1 wherein the base cap (1) further comprises a drum (9) fixed in relationship with the medicament cartridge and said torsion spring (8) whereby the torsion spring (8) rotates the medicament cartridge (6) along with said drum (9). 6. An improved multidose inhaler as claimed in claim 1 wherein the spiral torsion spring (8) in energized condition imparts continuous rotation of the medicament cartridge. 7. An improved multidose inhaler as claimed in claim 1 wherein said cam members (2c) are preferably gradually tapering profiles projecting from the underside surface of the top cap. 8. An improved multidose inhaler as claimed in claim 1 wherein said lever (4) is pivotedly mounted at a fulcrum point located substantially at the central portion of the center cap. 9. An improved multidose inhaler as claimed in claim 1 wherein at least one spring loaded pins set in energized downward position by at least one cam member obstructs the rotation of the medicament cartridge . 10. An improved multidose inhaler as claimed in any of the preceding claims wherein the base cap has a central sleeve member(1b), a slit (1c) located in close proximity to the sleeve member (1 b). 11. An improved multidose inhaler as claimed in claim 1 or 2 wherein a dust cap is adapted to the inhaler. 12. An improved multidose inhaler as claimed in claim 1 or 2 wherein dust cap is 'U' shaped and configured to the top cap such that when the base cap is rotated the "U' of the dust cap slides over to one side of the mouth piece (5) so as to allow inhalation. 13. An improved multidose inhaler as claimed in claims 1 to 12 wherein the medicament cartridge has integrally molded radial projections that impart rigidity and assists in indexing movement of the cartridge. 14. An improved multidose inhaler as claimed in claims 1 to 14 wherein at least one radial projection is modified so as to prevent the rotation of the medicament cartridge. 15.An improved multidose inhaler as claimed in claims 1 to 13 wherein a projection (12) on the base cap allows the rotation of the medicament cartridge and prevents further rotation of the cartridge when the cartridge is exhausted. 16. An improved multidose inhaler as claimed in any of the preceding claims wherein the base cap may optionally be provided with a view window. Dated this 9th day of July, 2003. FOR CIPLA LIMITED t (MANISH SAURASTRI) KRISHNA & SAURASTRI

Documents:

700-mum-2003-cancelled pages(23-12-2004).pdf

700-mum-2003-claims(granted)-(23-12-2004).doc

700-mum-2003-claims(granted)-(23-12-2004).pdf

700-mum-2003-correspondence(ipo)-(28-06-2007).pdf

700-mum-2003-correspondence1(24-08-2005).pdf

700-mum-2003-correspondence2(01-02-2005).pdf

700-mum-2003-form 1(09-07-2003).pdf

700-mum-2003-form 19(09-07-2004).pdf

700-mum-2003-form 2(granted)-(23-12-2004).pdf

700-mum-2003-form 3(09-07-2003).pdf

700-mum-2003-form 5(09-07-2003).pdf

700-mum-2003-form-2-(granted)-(23-12-2004).doc

700-mum-2003-form-pct-isa-210(13-07-2005).pdf

700-mum-2003-power of attorney(01-02-2005).pdf

700-mum-2003-power of attorney(09-07-2003).pdf