U.S. patent application number 11/073739 was filed with the patent office on 2005-08-11 for inhaler.
Invention is credited to Allan, Robert David, Pike, Gregory Charles.
Application Number | 20050172963 11/073739 |
Document ID | / |
Family ID | 27424539 |
Filed Date | 2005-08-11 |
United States Patent
Application |
20050172963 |
Kind Code |
A1 |
Allan, Robert David ; et
al. |
August 11, 2005 |
Inhaler
Abstract
An inhaler for delivering metered doses of powdered medicament,
the inhaler having a plurality of compartments spaced in an array
and each arranged to contain a metered dose of the medicament, a
lever to displace the compartments one by one into line with an
inhalation aperture that constitutes a mouthpiece, each compartment
including inner and outer edges, the plurality of compartments
being closed by a sealing layer, the inhaler further having a
mechanism adapted to lift the sealing layer off the inner and outer
edges of the compartment to open an air passageway defined by the
compartment and the sealing layer so that, in use, on inhalation
through the mouthpiece, air flow in the air flow passageway picks
up and entrains the powder in the compartment to be drawn with the
air out of the inhaler through the mouthpiece.
Inventors: |
Allan, Robert David;
(Greensborough, AU) ; Pike, Gregory Charles;
(Dandenong, AU) |
Correspondence
Address: |
STITES & HARBISON PLLC
1199 NORTH FAIRFAX STREET
SUITE 900
ALEXANDRIA
VA
22314
US
|
Family ID: |
27424539 |
Appl. No.: |
11/073739 |
Filed: |
March 8, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11073739 |
Mar 8, 2005 |
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10275478 |
Nov 6, 2002 |
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6871647 |
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10275478 |
Nov 6, 2002 |
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PCT/AU02/01284 |
Sep 18, 2002 |
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Current U.S.
Class: |
128/203.15 ;
128/203.21 |
Current CPC
Class: |
A61M 15/0025 20140204;
A61M 15/0043 20140204; A61M 15/0071 20140204; A61M 15/0048
20140204; A61M 15/0031 20140204; A61M 2205/583 20130101; A61M
15/0015 20140204; A61M 15/0045 20130101; A61M 11/003 20140204; A61M
2202/064 20130101 |
Class at
Publication: |
128/203.15 ;
128/203.21 |
International
Class: |
B05D 007/14; A61M
015/00; A61M 016/00 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 19, 2001 |
AU |
PR7766 |
Sep 19, 2001 |
AU |
PR7767 |
Sep 19, 2001 |
AU |
PR7830 |
Jun 13, 2002 |
AU |
PS2938 |
Claims
1. An inhaler for delivering metered doses of powdered medicament,
the inhaler having a plurality of compartments spaced in an array
and each arranged to contain a metered dose of the medicament, a
lever to displace the compartments one by one into line with an
inhalation aperture that constitutes a mouthpiece, each compartment
including inner and outer edges, the plurality of compartments
being closed by a sealing layer, the inhaler further having a
mechanism adapted to lift the sealing layer off the inner and outer
edges of the compartment to open an air passageway defined by the
compartment and the sealing layer so that, in use, on inhalation
through the mouthpiece, air flow in the air flow passageway picks
up and entrains the powder in the compartment to be drawn with the
air out of the inhaler through the mouthpiece.
2. The inhaler according to claim 1 wherein the compartments are
spaced in an annular array and the means to lift the sealing layer
lifts the inner and outer edges of the sealing layer.
3. The inhaler according to claim 1 wherein each compartment is
covered by a perforated layer and the sealing layer covers the
perforated layer with the lifting means lifting the inner and outer
edges of the sealing layer from the perforated layer.
4. The inhaler according to claim 1 wherein the lever is moveable
from an inoperative position to an operative position in which one
compartment is indexed to align with the inhalation aperture and
the inner and outer edges of the sealing layer are lifted off the
compartment, the lever being returnable to the operative
position.
5. The inhaler according to claim 4 wherein the inhaler has a
sealing bar that pushes down the inner and outer edges of the
compartment as the lever is returned to the inoperative
position.
6. The inhaler according to claim 1 wherein the inhaler comprises a
body adapted to receive a cartridge that carries the compartments,
the inhalation aperture being provided in the body in a position
aligned with an outlet aperture in the cartridge, and the lever
being mounted on the body to be displaceable from the inoperative
position to the operative position in which a fresh compartment is
displaced and opened so that the opened compartment is aligned with
the inhalation aperture.
7. The inhaler according to claim 6 wherein the lever includes a
component that closes the inhalation aperture in the inoperative
position and opens the aperture in the operative position.
8. The inhaler according to claim 5 wherein the body defines a
compartment into which the cartridge is located, a lid being
pivoted to the body to close off the compartment.
9. The inhaler according to claim 8 wherein the lid includes an air
entry aperture.
10. The inhaler according to claim 9 wherein the lid includes
indicator means to provide a visual indication that air has been
drawn through the inhaler.
11. The inhaler according to claim 10 wherein the indicator means
comprises a member displaceable in response to a minimum air
flow.
12. The inhaler according to claim 11 wherein the member is
displaceable from a start position to a finish position, the finish
position reflecting minimum air flow.
13. The inhaler according to claim 5 wherein the cartridge
comprises a disc assembly mounted within upper and lower covers,
the disc assembly being axially rotatable relative to the lower
cover.
14. The inhaler according to claim 13 wherein the disc assembly
comprises the array of spaced compartments sealed by a disc shaped
sealing layer.
15. The inhaler according to claim 14 wherein the array of
compartments are formed in a metal foil disc shaped sheet that is
positioned on a similarly formed disc shaped base member.
16. The inhaler according to claim 13 wherein the lower cover has a
pair of spaced projections that extend past slots in the disc
assembly to engage the underside of the sealing layer whereby
rotation of the disc assembly past the projections causes the
projections to lift the sealing layer off the inner and outer edges
of the compartments one by one as the compartments move over the
projections.
17. The inhaler according to claim 13 wherein the upper cover is
capable of oscillating relative to the lower cover, the oscillation
causing rotation of the member to the start position.
18. The inhaler according to claim 1 wherein the mechanism
comprises a flip top member secured to the sealing layer and having
portions adapted to flex upwardly relative to the compartment to
lift the sealing layer off the inner and outer edges of the
compartment.
19. The inhaler according to claim 18 wherein the inhaler includes
means to flex the portions upwardly as the compartment is displaced
relative to the inhaler.
20. The inhaler according to claim 1 wherein the mechanism
comprises an opener in the form of wedge shaped members mounted
spaced apart on a plate which is positioned beneath the array of
compartments, the wedge shaped members engaging the underside of
the sealing layer, the plate being fixed relative to the inhaler so
that displacement of the array of compartments relative to the
inhaler causes each compartment to move past the wedge shaped
members to lift the sealing layer off the inner and outer edges of
the compartment.
21. The inhaler according to claim 1 wherein the inhaler has a one
way valve that allows air to be drawn in through the inhaler and
out of the mouthpiece but prevents flow of air in the reverse
direction.
22. The inhaler according to claim 1 wherein ten compartments are
spaced in an array.
23. A disposable cartridge adapted to be received in a body of an
inhaler, the cartridge having a plurality of compartments spaced in
an array and each arranged to contain a metered dose of medicament,
the compartments being displaceable one by one into line with an
outlet aperture, each compartment including inner and outer edges,
the plurality of compartments being closed by a sealing layer, and
a mechanism adapted to lift the sealing layer off the inner and
outer edges of the compartment to open an air passageway defined by
the compartment and the sealing layer so that, in use, air flow in
the air flow passageway picks up and entrains the powder in the
compartment to be drawn with the air out of the cartridge through
the outlet aperture.
24. An inhaler for delivering metered doses of powdered medicament,
the inhaler comprising a body adapted to receive a disposable disc
shaped cartridge, the cartridge having a plurality of compartments
spaced in an annular array and each arranged to contain a metered
dose of the medicament, a lever to displace the compartments one by
one into line with an inhalation aperture positioned in the body to
constitute a mouthpiece, each compartment including inner and outer
edges, the plurality of compartments being closed by a sealing
layer, the inhaler also being provided with a mechanism adapted to
lift the sealing layer off the inner and outer edges of the
compartment to open an air passageway defined by the inner and
outer edges, the compartment and the sealing layer so that, in use,
on inhalation through the mouthpiece, air flow in the air flow
passageway picks up and entrains the powder in the compartment to
be drawn with the air out of the inhaler through the mouthpiece.
Description
[0001] This invention relates to inhalers and in particular to
inhalers for use with powered medicaments.
BACKGROUND OF THE INVENTION
[0002] There are many types of inhalers that can provide delivered
metered doses. The majority of inhalers of this kind are designed
to provide multiple doses. It is however known that inhalers of
this kind can also be used to provide a single dose.
[0003] In situations where a metered dose is to be dispensed it is
important that the inhaler always dispenses the exact dose. There
is also a problem with inhalers of this kind if there is a tendency
to allow unintentional additional dosing. Inhalers need to be
small, compact, easy to use and yet not too expensive. The inhalers
also need to satisfy safety criteria set down by appropriate
standards.
[0004] It is these issues that have brought about the present
invention.
SUMMARY OF THE INVENTION
[0005] In accordance with one aspect of the present invention there
is provided an inhaler for delivering metered doses of powdered
medicament, the inhaler having a plurality of compartments spaced
in an array and each arranged to contain a metered dose of the
medicament, means to displace the compartments one by one into line
with an inhalation aperture that constitutes a mouthpiece, each
compartment including inner and outer edges, the plurality of
compartments being closed by a sealing layer, means to lift the
sealing layer off the inner and outer edges of the compartment to
open an air passageway defined by the compartment and the sealing
layer so that, in use, on inhalation through the mouthpiece, air
flow in the air flow passageway picks up and entrains the powder in
the compartment to be drawn with the air out of the inhaler through
the mouthpiece.
[0006] In accordance with another aspect of the present invention
there is provided a disposable cartridge adapted to be received in
a body of an inhaler, the cartridge having a plurality of
compartments spaced in an array and each arranged to contain a
metered dose of medicament, the compartments being displaceable one
by one into line with an outlet aperture, each compartment
including inner and outer edges, the plurality of compartments
being closed by a sealing layer, means to lift the sealing layer
off the inner and outer edges of the compartment to open an air
passageway defined by the compartment and the sealing layer so
that, in use, air flow in the air flow passageway picks up and
entrains the powder in the compartment to be drawn with the air out
of the cartridge through the outlet aperture.
DESCRIPTION OF THE DRAWINGS
[0007] Embodiments of the present invention will now be described
by way of example only in which:
[0008] FIG. 1 is an exploded view perspective view of an inhaler in
accordance with a first embodiment of the invention,
[0009] FIGS. 2A & 2B are perspective views of the inhaler,
[0010] FIG. 3 is an exploded perspective view of the inhaler that
shows a lid of the inhaler in an open position with a cartridge
outside the inhaler,
[0011] FIG. 4 is an exploded perspective view of the cartridge,
[0012] FIG. 5 is a perspective view of a lower cover of the
cartridge,
[0013] FIG. 6 is a perspective view of the underside of a base of
the cartridge,
[0014] FIG. 7 is a perspective view of the underside of a upper
cover of the cartridge,
[0015] FIGS. 8a and 8b are perspective views of the assembled
cartridge viewed from the top,
[0016] FIG. 9 is a plan view of the cartridge,
[0017] FIG. 10 is a cross sectional view taken along the lines A-A
of FIG. 9,
[0018] FIG. 11 is a perspective view of the cartridge with part
cutaway showing an open compartment,
[0019] FIG. 12 is a perspective view with part cut away of the
assembled inhaler showing the air passageway,
[0020] FIGS. 13a and 13b are perspective views of the top of the
inhaler with part of a cover cut away, and
[0021] FIG. 14 are perspective views of the underside of the lid of
the inhaler,
[0022] FIG. 15 is an exploded perspective view of a cartridge in
accordance with a second embodiment of the invention,
[0023] FIG. 16 is a perspective view of an upper cover of the
cartridge of FIG. 15,
[0024] FIG. 17 is a cross sectional view taken along the lines 8-8
of FIG. 16,
[0025] FIG. 18 is an exploded perspective view of a cartridge in
accordance with a third embodiment of the invention, and
[0026] FIG. 19 is an enlarged perspective view of the mouth of the
cartridge shown in FIG. 18.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] As shown in the exploded view of FIG. 1 an inhaler 10
comprises a disposable medicament cartridge 50 that is located in
an inhaler body 11 that includes an upper body 12, lower body 13
that fit together to support a drive cam 18 and lever 30 and define
a recess 14 into which the cartridge 50 fits. The body 11 is closed
by a lid 15 that is hinged to one side 16 of the body 11. The upper
surface of the lid supports a window 100, air entry inlet 19 and
air entry indicator 110 and a one way valve 112.
[0028] As shown in FIG. 2, the inhaler 10 is substantially circular
in plan and has a mouthpiece 26 having an inhalation aperture 27
positioned in the body periphery on one side with the displacement
lever 30 located on that side to be displaceable relative to the
body 11 between the open position shown in FIG. 2a to the closed
position in which the lever 30 covers the mouthpiece 26 as shown in
FIG. 2b.
[0029] The cartridge 50 is shown in greater detail in FIG. 4 and
comprises a multi-layered annular disc assembly that is located
between upper and lower covers 52, 51 that clip together as shown
in FIG. 10. The upper cover 52 has an air inlet aperture 45 that
communicates with the disc assembly to define an air passageway
that exits the cartridge via slot 29 on the periphery of the lower
cover 51. The disc assembly includes a cartridge base 55 that is of
disc shape with a central aperture 56. The cartridge base 55
supports a base foil 60 that has a central aperture 61 and contains
ten recessed compartments 70 spaced around the periphery of the
base foil 60. The compartments are equally spaced except that there
is a wider gap between the first 64 and the last 65 compartments.
The base 55 is formed with recesses that correspond to the
compartments 70.
[0030] The base foil 60 is covered first by a perforated layer 80
which is in turn covered by a lidding foil layer 90. Both the
perforated layer and lidding foil 80 and 90 have internal apertures
81 and 91. The apertures 56, 61, 81 in the cartridge base 55, base
foil 60 and perforated layer 80 include a cut-out 57, 62 and 82
that is radially aligned with a cut-out 58, 63, and 83 in the outer
periphery. The lidding foil 90 is securely bonded to the perforated
layer 80 which is attached to the base foil 60 to seal the
compartments 70 once filled with medicament powder.
[0031] The cartridge 50 is designed to hold a plurality of metered
doses of powdered medicament in separate sealed compartments 70 and
the operation of the lever 30 displaces the drive cam 18 which
rotates components of the cartridge 50 to expose individual doses
to the air passageway that is in communication with the mouthpiece
26. As shown in FIG. 5, the cartridge 50 includes openers 86, 87
located in the lower cover 51 that operates to expose a single dose
by unsealing each compartment 70 so that when the user inhales
through the mouthpiece 26 air is drawn through an aperture in the
lid 15 of the inhaler 10 through the inlet aperture of the
cartridge, across the unsealed compartment 70 to pick up the powder
in the compartment 70 for delivery to the mouthpiece 26 via the
outlet slot 29. The cartridge 50 can be disposed of and be replaced
by a new cartridge when all or part of the compartments 70 of the
powered medicament have been emptied. The inhaler is in consequence
reusable. The cartridge may be removed or reinserted as
required.
[0032] As shown in FIG. 6, the underside of the periphery of the
cartridge base 55 is provided with a plurality of equally spaced
cutouts 53, that are adapted to be engaged by the drive cam 18
driven by the lever 30 to cause the cartridge base 55, base foil
60, perforated layer 80, lidding foil 90 and upper cover 52 to be
rotated through a small angle when the lever 30 is displaced in the
anti-clockwise direction. The upper cover 52 is also rotated by the
drive cam 18 through a small angle when the lever 30 is displaced
in the clockwise direction.
[0033] It is however understood that more or less than ten
compartments 70 can be positioned on the base foil 60 and the
cartridge base 55 can include as many peripheral cutouts as are
necessary to ensure that each compartment is indexed to the
required position by displacement of the lever 30. The base foil 60
is positioned axially aligned on top of the cartridge base 55.
[0034] The lower cover 51 has an arcuate slot 9 through which the
drive cam 18 extends to engage the cartridge base. The lower cover
51 of the cartridge 50 has a central upstanding circular spigot 84
that includes an internal upstanding ring 85. As shown in FIGS. 4
and 5 a pair of radially aligned wedges 87 and 86 extend outwardly
and inwardly from the spigot 84 and inner wall of the lower cover
51. When the base foil compartments 70 have been filled and covered
by the perforated layer 80 and sealed by the lidding foil 90, the
laminated cartridge assembly is lowered into the lower cover 51
with the wedge shaped openers 87, 86 clearing the inner and outer
slots 57, 58, 62, 63, 82 & 83 on the central apertures and
outer peripheries of the base, base foil and perforated layers
respectively. It should be noted that the lidding foil layer 90
does not have slots on the inner and outer peripheries which means
that the foil rests on the wedges 86, 87. The cartridge 50 is
completed by location of the upper cover 52 into locked engagement
with the lower cover 51. As shown in FIG. 7, the upper cover 52 has
a peripheral downwardly extending skirt 49 with a rectangular
cut-out 48 into which a lug 108 on the end of the drive cam 18
locates so movement of the drive cam 18 causes a rotational
movement of the upper cover 52.
[0035] As shown in FIGS. 7 and 10, the upper cover 52 has a central
tapered boss 95 that clips into the ring 85 in the lower cover 51.
A downwardly extending annular flange 96 fits against the exterior
of the ring 85 allowing the upper cover 52 to oscillate relative to
the lower cover 51. The upper surface of the upper cover 52
includes a viewing aperture 44 and an air inlet aperture 45. A
finger tab 46 extends down from the upper surface of the cover to
provide ease of removal of the cartridge 50 from the inhaler body.
The underside of the upper cover 52 also has an elongate downwardly
extending bar 47 that, in use, engages the top of the lidding foil
90 to push back the lidding foil onto the perforated layer 80, base
foil 60 and base 55 after the contents of a compartment have been
ejected. The bar 47 thus partially reseals the compartment.
[0036] FIG. 3 shows how the cartridge 50 can be lowered into the
inhaler body 11. The cartridge 50 is gripped by the finger tab 46
and lowered into the recess 14 of the inhaler body 11 with outlet
slot 29 aligned with the mouthpiece 26. The shape of the cartridge
50 is such that it can only be positioned in the inhaler in the
correct position. The lever 30, through the drive cam (not shown),
engages the cutouts 53 in the underside of the cartridge base 55 so
that movement of the lever 30 has the effect of causing rotational
movement of the disc base 55. The lever that drives the cartridge
base 55 to rotate relative to the lower cover 51 of the cartridge
50 also has the effect of causing the upper cover 52 to oscillate
on the lower cover 51 by contact between the lug 108 on the drive
cam 18 and the cut-out 48 in the upper cover 52. The connection
between the lever 30 and drive cam 18 introduces a small degree of
free play or neutral movement.
[0037] The role of the wedge shaped openers 86, 87 is illustrated
with particular reference to FIGS. 10 and 11. As mentioned above,
when the cartridge is assembled, the disc assembly sits in the
lower cover 51 with the wedge shaped openers 86, 87 resting against
the underside of the lidding foil layer 90. As the lever is
actuated to cause the disc assembly to rotate relative to the lower
cover 51, the inclined ramp on the upper surface of the openers 86,
87 has the effect of partially lifting the lidding foil 90 at the
inner and outer sections from the top of the perforated layer 80
thereby exposing the powder within the compartment 70. The openers
can either be positioned in a leading, central or trailing position
in relation to the medicament compartment 70 on the assembly and as
the disc continues to rotate, the openers lift the inner and outer
sections of the lidding foil to expose the contents for removal
upon inhalation and then allow the lidding foil to fall back into
position against the perforated layer 80 thereby re-closing the
compartment 70. The trailing bar 47 on the underside of the upper
cover 52 then pushes the foil back against the base foil to
partially reseal the compartment.
[0038] The lid 15 of the inhaler is shown in greater detail in
FIGS. 2, 12 and 13. The lid has a circular shaped clear cover 100
with a viewing tab 101 on one side and an arcuate window 102 on the
opposite side. The circular shaped clear cover 20 is obscured
except for an area 103. There is a gap extending about 90.degree.
around the clear cover 100 defining the air inlet 19. The underside
of the lid has a central spigot 104 which supports a flow indicator
110 and a flap valve 112. As air is drawn into the inhaler through
the air inlet 19, the flexible flap valve 112 pivots open as shown
in detail B. Any attempt to blow air back through the inhaler is
prevented by the flap valve 112 moving to the closed position shown
in detail A.
[0039] As shown in FIG. 13, the flow indicator 110 is in the form
of an arcuate flag 113 that has downward projections 114, that
reside in grooves 116 in the underside of the lid. As air is drawn
into the inhaler 10 it causes the flag 113 to move in the grooves
116 and to rise up a ramp to assume a visible position through the
area 103 of the window 100. The ramp tends to hold the flag 113 in
the operative position after inhalation. When the lever 30 is
indexed to the closed position, the oscillating movement of the top
of the cartridge 50 causes arcuate cut-outs 117 and 118 in the top
52 of the cartridge to engage the projections 114 to return the
flag 113 to the inoperative and less visible position. The incoming
air current is sufficient to drive the flag 113 to the operative
position. Thus, as shown in FIG. 13 the airflow is such that when
the user inhales on the mouthpiece 26 air is drawn into the inhaler
10 via the air inlet 19 around the underside of the window 100 into
the inhaler to move the flag 113 to the position shown in FIG. 13b.
At this stage with the flag 113 in the operative position the air
flows in to the inhaler displacing the one way valve 112 and into
the cartridge 50. The air flows through the air inlet 45 at the top
of the cartridge and out under the lidding foil that has been
prized upwardly by the openers 86, 87, through the perforated layer
80 across the top of the compartment 70 and out through the
radially outer section of the compartment through the perforated
layer 80 and the inhalation aperture 27 and mouth piece 26. The air
current is such that it causes turbulence causing the powder to be
drawn through the perforated layer 80 to be entrained in the air
for expulsion. The perforated layer 80 has the role of preventing
escape of powder without the air current so thus, if for some
reason, the lidding foil 90 is removed from the compartment by
accident the perforated layer 80 prevents escape of the powder and
only allows powder escape when it is entrained in an air current.
The perforations in the layer 80 also assist to control the
particle size of the released medicament.
[0040] The lid also includes the small viewing tab 101 that exposes
through magnification an arcuate line of numbering that would be
positioned on the lidding foil 90 and exposed through the hole 44
in the upper cover 52. The numbering reflects the number of
recesses 70 with unused doses so that the user of the inhaler can
know how many doses remain in the cartridge. The inhaler 10 also
includes a number of other features that reduce inadvertent
additional dosage and reduce the likelihood of accidental
displacement of the medicament. It is only on a full displacement
of the lever 30 to the right as shown in FIG. 3 that opens the next
dose and indexes the cartridge so the dose is positioned in line
with the airflow passageway. The lever is connected to an arcuate
band the drive cam 18 that locates on the inner surface of the body
11. The connection between the drive lever 30 and drive cam 18
introduces a small degree of free play or neutral movement. The
lever is coupled to the drive cam having an aperture 109 so that
only full displacement of the lever to the right as shown in FIG. 4
moves the aperture 109 in the drive cam 18 into correct alignment
with the aperture 27 of the mouthpiece 26 to open the air
passageway. When the lever returns to the left or closed position
the drive cam moves to close off the mouthpiece 26.
[0041] The lever 30 that closes off the airflow passageway and does
not open this passageway until the lever has again been displaced
fully to the right. As the lever 30 is displaced the openers 86, 87
lift the lidding foil 90 from the perforated layer 80 to expose the
radially inner and outer sections of recessed compartment 70. By
the time the lever 30 has moved to the fully displaced position the
foil 90 has been lifted from the radially inner and outer sections
of the compartment 70 to open the air passageway. At that time the
air passageway is open to the mouthpiece 26 allowing inhalation. If
the lever is closed i.e. returned to its original position to the
left without taking the dose that dose will then be lost because it
will be indexed into an inoperative position when the lever has
moved again. Thus reducing the possibility of unintentional
additional dosing.
[0042] The cover 52 that is positioned over the foils 60, 80 and 90
protects doses that are not used from escape into the inhaler so
that once the cartridge is discarded any residual medicament is
discarded with the cartridge. Because the openers 86, 87 only lifts
the lidding foil 90 off the perforated layer 80 an unadministered
dose becomes effectively sealed in its recess 70 as it is indexed
past the openers which allows the lidding foil to return to its
former position with the bar 47 closing off the compartment 70.
[0043] The flap 112 operates as a one-way valve to ensure that
exhalation does not have any effect on the medicament. The valve
virtually prevents or at least minimises the amount of air that can
be blown into the device so that exhalation does not dislodge or
disturb a readied dose or for that matter disturb a dose that has
not been administered. When in its uppermost position the one way
valve 112 closes the air flow pathway exit to minimise the
possibility of air flow over the unadministered dose.
[0044] The shape of the cutouts in the periphery of the ase is such
that when the last dose has been dispensed the lever cannot further
rotate the disc so that the user becomes aware that the cartridge
is empty and can thus replace the cartridge.
[0045] FIGS. 15 to 17 illustrate a second embodiment that utilises
a different cartridge which is shown in FIG. 15. The cartridge 150
has a slit top foil layer 190 provided with radial slits 192 that
define segments that correspond to the position of each
compartment. The top foil layer 190 has a central aperture 191 and
is bonded to the lower foil 160 to seal off the compartments 170. A
circular assembly 180 of flip top members 181 is bonded to the top
foil 190. The assembly 180 comprises a plastics moulding in the
form of a plurality of radially extending flip top members 181 that
are interconnected by circumferentially extending webs 182. Each
flip top member 181 comprises a radially outer arm 184 that is
joined to a V-shaped inner arm 185 by the webs 182 that
interconnect that flip top member 181 to the adjacent flip top
members. The underside of both the radially outer and inner arms
include downwardly projecting triangular shaped lugs 187 and 188.
The bonding of the assembly 180 to the top foil 190 means that each
segment includes a segmentally shaped piece of foil with the
skeletal framework of the flip top members 181 transcribing the
inner and outer circumferential edges 193 and 194 as well as the
radial edges of the segment. Because the assembly 180 is bonded to
the top foil 190, rotation of the disc base 151 causes rotation of
the assembly 180, top foil 190 and lower foil 160 in unison
relative to the cover 195.
[0046] The assembly of the disc base 151, two foil layers 160 and
190 and flip top assembly 180 is then covered by a plastics cover
195 that has a central aperture 196 and a downwardly extending
annular skirt 197 that covers the components. An arcuate cutout 198
is provided in the periphery of the skirt 197 of the cover 195
through which a lever (not shown), similar to the first embodiment,
can extend to engage the disc base 151. The rotation of the disc
base 151 and foil layers 160 and 190 and flip top assembly 180
relative to the cover 195 is illustrated in FIG. 16. An arcuate
cutout 199 is provided in the periphery of the skirt 197 of the
cover 195 which, prevents the base rotating in the wrong direction
by engaging the disc base 151.
[0047] Displacement of the lever rotates the disc base 151 causing
the inner and outer lugs 187, 188 on the flip top member 181 to
ride up on radial projections on the base of the inhaler (not
shown) to cause the arms 184, 185 of the flip top members 181 to
flex upwardly as shown in FIG. 17 about the central line or webs
182. Upward flexing of the flip top members 181 lifts the top foil
190 from the radially inner and outer edges of the compartments 170
causing an air passageway to form between the centre of the
cartridge 150, the lifted inner flip top arm 184 the compartment
170 and the lifted outer flip top arm 185. In this way the airflow
passageway is defined by the top foil 190, the flip top member 181
and the compartment 170. The cover 195 of the cartridge has
inclined up standing portions 175 and 176 that are positioned to
accommodate the flip top member 181 in the elevated position as
shown in FIG. 17. As the disc base 151 is further rotated the
undersurface of the cover 195 forces the previously opened flip top
members 181 down to the horizontal position, shown around the
remainder of the periphery of the flip top assembly 180 in FIG. 15.
The radial slits 192 in the top foil 190 facilitate the upward
movement of the flip top members 181 relative to the remainder of
the foil 190.
[0048] The flip top assembly 180 has a dual role of displacing the
top foil 190 layer from the lower foil 160 and thus exposing each
compartment 170 whilst at the same time forming a framework for an
air passageway that flows from the aperture in the top of the lid
of the inhaler down through the centre of the inhaler and along the
radial arms 184, 185 to pass through the end of the radial outer
arm 185 and through the mouthpiece in the periphery of the body.
The flip top members 181 lift the top foil 190 off the lower foil
160 and the radial edges of the compartment and the skeletal
structure of the members 181 coupled with the foil surfaces
provides the air passageway so that the user inhales through the
mouthpiece drawing air down and into the inhaler and through the
passageway. The air current picks up the powder in the exposed
recess 170. The powder is then entrained in the air to leave the
inhaler via the mouthpiece.
[0049] In the third embodiment shown in FIGS. 18 and 19, the disc
base 251 and lower foil 260 are provided with radially inner and
outer cutouts 252, 253, 262, 263 in the gap 268 between the first
and last compartment 264, 265. The cut-outs 252, 253, 262, 263
accommodate a disc opener 220 in the form of a bracket having a
flat base 221 terminating an upstanding posts 222, 223, 224, 225 at
either end with the posts having inturned downwardly extending
flanges 226. The posts and flanges 226 are positioned on the
radially outer and radially inner end of the opener 220 and allow
the opener to clip against the underside of the disc base 251 with
the flat base 221 in parallel sliding contact with the underside of
disc base 251 and the flanges 226 extending across the lower foil
260 surface but beneath the upper foil 290. The disc opener 220 is
located in the cover 250 of the cartridge in a manner that it
cannot rotate with the disc base 251 so that as the disc base is
rotated the leading edges of the flanges 226 have the effect of
lifting up the radially inner and radial edge of the top foil 290
on the adjacent compartment 270. As the disc base is indexed to the
operative position as shown in FIG. 19 the radially inner and
radially outer edges of the top foil 290 are lifted clear of the
compartment 270 and the air passageway is defined by the
compartment base and the top foil 290 that has been raised at least
adjacent the radially outer and radially inner edges of the
compartment by the disc opening flanges 226.
[0050] To ensure that the top foil 290 lifts off a single
compartment 270 the radially outer 271 and radially inner edges 272
of each compartment 270 are at a position lower than the centre of
the compartment 273 so that the disc opener flanges 226 only have
to lift the radially inner 291 and radial outer 292 edges of the
top foil level with the centre 293. It is for this reason that the
top foil 290 is illustrated with what appear to be concentric
rings. The central ring 293 allows the radially inner and radially
outer sections of the top foil 290 to lift into the open position.
This arrangement provides a narrow passageway whereby the central
portion of the top foil 290 remains above the recessed compartment
270 and the air current to ensure that the air current is in close
proximity to the powdered medicament.
[0051] When the top foil 290 is bonded to the lower foil 260 there
is no bond in the gap 268 between the first 264 and last 265
compartments (except for the compartment periphery--a sealing band
surrounding the compartment) which means that it becomes a simple
exercise to insert the disc opening flanges 226 between the foil
surfaces in that gap 268 to complete assembly.
[0052] The cover 295 of the disc 250 is provided with a raised
inclined section 296 over the position of the disc opener 220 to
accommodate the upstanding posts and flanges 226.
[0053] Features of the Preferred Embodiments
[0054] The inhaler is reusable, whilst the empty cartridges are
discarded.
[0055] Cartridges can be supplied with a range of dose number,
medicament type and volume.
[0056] Full and partially full cartridges can be loaded into and
removed from the inhaler as required--either well before a dose is
required or just prior to use.
[0057] Loading of the cartridge does not open a dose for
inhalation.
[0058] The dose is opened and prepared for inhalation by simply
sliding the indexing lever.
[0059] The access to the mouthpiece is opened or closed by simply
sliding the indexing lever.
[0060] The possibility of unintentional additional dosing is
minimised.
[0061] Exhalation into the inhaler does not affect the
effectiveness of the next dose from the cartridge.
[0062] The inhaler via the cartridge has a "doses remaining"
indicator.
[0063] The inhaler has an indicator to indicate correct dosage
received.
[0064] The cartridge covers and foils protect the user from
residues in opened compartments of the cartridge.
[0065] Although in the preferred embodiments the inhaler comprises
an inhaler body and disposable cartridge it is understood that in a
simple form the inhaler may simply be like the cartridge that is
without the external body. The cartridge would include a mechanism
to displace the compartments and cause opening of each compartment
when it is aligned with an outlet aperture that would serve as the
mouthpiece.
[0066] Medications Used with the Inhaler
[0067] The inhaler may be used to provide medications selected from
the following therapy areas: anti-influenza, analgesic,
anti-anginal preparation, antiallergic, anti-infective, anticancer,
antihistamine, anti-inflammatory, antitussive, bronchodilator,
cortiscosteroid, diuretic, anticholinergic, hormone, xanthine,
osteoporosis, hypertension, therapeutic protein or peptide,
vaccine, diagnostic agent or gene therapy agent.
[0068] The inhaler may be used to provide medications selected from
the following group: zanamivir, codeine, dihydromorphine,
ergotamine, fentanyl, morphine, diltiazem, cromoglycate, ketotifen,
nedocromil, cephalosporins, penicillins, streptomycin,
sulphonamides, tetracyclines, pentamidine, methapyrilene,
beclomethasone dipropionate, fluticasone propionate, flunisolide,
budesonide, rofleponide, mometsasone furoate, triamcinolone
acetonide, noscapine, albuterol sulphate, salmeterol xinafoate,
salmeterol, ephedrine, adrenaline, fenoterol, formoterol,
isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine,
pirbuterol acetate, reproterol hydro chloride, rimiterol,
terbutaline sulphate, isoetharine, tulobuterol, orciprenaline,
adenosine 2a agonists, .alpha.4 integrin inhibitors, amiloride,
ipratropium, tiotropium, atropine or oxitropium, cortisone,
hydrocortisone or prednisolone, aminophylline, choline
theophyllinate, lysine theophyllinate or theophylline, insulin or
glucagon, or salts, esters, or solvates thereof, alone or in
combination.
* * * * *