Note: Descriptions are shown in the official language in which they were submitted.
CA 02288413 1999-11-16
INgALATION DEVICE
This invention is a divisional application of Canadian
Patent Application Serial No. 2, 037, 421 which was filed on
March 1, 1991.
This invention relates to an inhalation device by
means of which a user can inhale medicament in the form of
a powder.
Inhalation devices are known for use with blister
packs in which the medicament is held in powder form in the
blisters thereof. Such devices include a puncturing member
which punctures each blister in turn, thus enabling the
medicament to be inhaled therefrom. It is an object of the
present invention to provide an inhalation device the
design of which has the potential, if desired, to handle a
medicament pack having a large number of discrete unit
doses, without the device becoming unacceptably large.
According to the present invention there is provided
an inhalation device for use with a medicament pack in
which at least one container for medicament in powder form
is defined between two members peelably secured to one
another, the device comprising means defining an opening
station for the said at least one container; means for
peeling the members apart at the opening station to open
the container; and an outlet, communicating with the opened
CA 02288413 1999-11-16
2
- container, through which a user can inhale medicament in
powder form from the opened container. Various suitable
inhalable medicaments include without limitation
beclomethasone dipropionate (9a-chloro-11~-hydroxy-16~-methyl-
17a, 21-dipropionyloxypregna-1, 4-dime-3, 20- dione), as is
disclosed in Canadian Patent No. 813,895 which issued to Glaxo
Laboratories Limited on May 27, 1969; salbutamol (al-tert-
butyl-aminomethyl-4-hydroxy-m-xylene-al, a3-diol) and
salbutamol sulphate (al-t-butylaminomethyl-4-hydroxy-m-xylene-
al, a3-diol sulphate) which is described in Canadian Patent No.
932,734 which issued to Allen and Hanburys Limited on August
28, 1973; salmeterol xinofoate ([previously known as
salmeterol hydroxynaphthoate] (4-Hydroxy-al [[[6-(4-
phenylbutoxy)hexyl]amino]methyl]-1, 3-benzenedimethanol 1-
hydroxy-2-naphthalenecarboxylate) described in the applicant's
U.K. Patent No. GB 2140800 B which issued September 23, 1987;
and fluticasone propionate (S-Fluoromethyl 6a, 9a-Difluoro-
11~-hydroxy-16a-methyl-17a-propionyloxy-3-oxoandrosta-1, 4-
diene-17~-carbothioate) as described in the applicant's
earlier Canadian Patent No. 1,205,464 which issued June 3,
1986.
Preferably the medicament pack is formed from two
elongate sheets which define a plurality of medicament
containers spaced along the length thereof, means being
provided for indexing each container in turn to the opening
station.
The invention also provides a medicament pack for use in
an inhalation device, the pack comprising an elongate strip
formed from a base sheet having a plurality of recesses spaced
along its length and a lid sheet hermetically but peelably
sealed thereto to define a plurality of containers, each
container having therein inhalable medicament in powder form.
CA 02288413 1999-11-16
2a
- The strip is preferably sufficiently flexible to be wound
into a roll.
In other of its aspects, the invention provides an
inhalable medicament in powder form, in a medicament pack for
use in an inhalation device, the pack comprising an elongate
strip formed from a base sheet having a plurality of recesses
spaced along its length and a lid sheet hermetically but
- peelably sealed thereto to define a plurality of containers,
each container having the inhalable medicament therein.
In another of its aspects, the invention provides an
inhalable medicament in a medicament pack for use with an
inhalation device, a said medicament pack having a plurality
of containers for containing said medicament in powder form
wherein the containers are spaced along the length of and
defined between two peelable sheets secured to each other,
said inhalation device comprising:
an opening station for receiving a container of a
medicament pack being used with said inhalation device;
means positioned to engage peelable sheets of a container
which has been received in said opening station for peeling
apart the peelable sheets, to open such a container;
an outlet, positioned to be in communication with an
opened container, through which a user can inhale said
medicament from such an opened container; and
indexing means for indexing in communication with said
outlet containers of a medicament pack in use with said
inhalation device.
In a further aspect, the medicament pack comprises a
medicament selected from the group consisting of
beclomethasone dipropionate, salbutamol, salbutamol sulphate,
salmeterol xinofoate and fluticasone propionate.
In the accompanying drawings:
Figure 1 is a rear view of a first embodiment of the
invention;
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2b
- Figure 2 is an axonmetric exploded view of the
components of the embodiment of Figure 1;
Figures 3a, 3b and 3c are an axonometric view, a
longitundinal section and an end view (partly broken away)
showing a clutch used in the embodiment of Figures 1 and 2;
Figures 4a and 4b are an axial section and cross-
CA 02288413 1999-11-16
3
section respectively, on a larger scale than Figures 1
and 2, of a mouthpiece which may be used in the first
embodiment (or in some other embodiment);
Figure 5 is a front view of a second embodiment,
with a cover thereof removed to show the interior;
Figure 6 is a rear view of the second embodiment,
but showing the interior thereof
Figure 7 is an axonometric front view of the
second embodiment;
Figure 8 is an axonometric rear view of the
second embodiment;
Figure 9 is an axonometric exploded view of the
second embodiment;
Figure 10 is a front view of a third embodiment,
showing the interior structure thereof;
Figure 11 is an axial view, on a larger scale,
showing the mouthpiece of the third embodiment;
Figure 12 is a view from below of the third
embodiment;
Figures 13 to 16 show a fourth embodiment of the
invention, Figure 13 being an underplan view, Figure 14
a section on line A-A in Figure 13, Figure 15 a section
on line B-B in Figure 13, and Figure 16 an exploded
view on a smaller scale;
Figures 16a to 16d show the fourth embodiment in
successive stages of operation, and Figure 16e is a
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4
section taken on line A-A in Figure 16a;
Figures 17 to 20 show a fifth embodiment of the
invention, Figure 17 being an end view, Figure 18 a
section on line A-A in Figure 17, Figure 19 a section
on line B-B in Figure 17, and Figure 20 an exploded
view;
Figures 21 to 24 show a sixth embodiment of the
invention, Figure 21 being an end view, Figure 22 a
section on line A-A in Figure 21, Figure 23 a section
on line B-B in Figure 21, and Figure 24 an exploded
view;
Figures 25 to 29 show a modified clutch which may
be used in those embodiments of the invention which
require it, and are, respectively, a front view, a top
view, a back view, a left side view and an axonometric
view;
Figure 30 is an exploded perspective view
showing a further embodiment of clutch which may be
used;
Figure 31 is an exploded perspective view of yet
another embodiment of clutch which may be used;
Figure 31a is transverse section through the
clutch shown in Figure 31;
Figures 32 to 34 show successive positions of
operation of another embodiment of the invention, in
rear view; and
CA 02288413 1999-11-16
Figure 35 is a perspective view on a larger scale
showing an embodiment of medicament pack according to
the invention.
Referring now to Figures 1, 2 and 3a to 3c, these
show an inhalation device in which is mounted a
flexible strip 1 defining a plurality of pockets 2 each
of which contains a dose of medicament which can be
inhaled, in the form of a powder. The strip 1
comprises a base sheet 3 in which blisters are formed
to define the pockets 2, and a lid sheet 4 which is
hermetically sealed to the base sheet 3 except in the
region of the blisters, in such a manner that the lid
sheet and the base sheet can be peeled apart. The
sheets are sealed to one another over their whole
width except for leading end portions thereof where
they are preferably not sealed to one another at all.
The lid and base sheets are each preferably formed of a
plastics/aluminium laminate, and the lid and base
sheets are preferably adhered to one another by heat
sealing. By way of example, the lid material may be a
laminate consisting of 50 gsm bleach kraftpaper/12
micron polyester (PETP) film/20 micron soft temper
aluminium foil/9 gsm vinylic peelable heat seal lacquer
(sealable to PVC), and the base material may be a
laminate consisting of 100 micron PVC/45 micron soft
temper aluminium foil/25 micron orientated polyamide.
CA 02288413 1999-11-16
6
The lacquer of the lid material is sealed to the PVC
layer of the base material to provide the peelable seal
between the lid and base sheets.
The strip 1 is shown as having elongate pockets
which run transversely with respect to the length of
the strip. This is convenient in that it enables a
large number of pockets to be provided in a given strip
length. The strip may, for example, be provided with
sixty or one hundred pockets, but it will be understood
that the strip may have any suitable number of pockets.
The inhalation device comprises a body 10
defining three storage chambers, namely a chamber 11 in
which the strip 1 is initially housed and from which it
is dispensed, a chamber 12 for receiving the used
portion of the base sheet 3, and a chamber 13 within
which the used portion of the lid sheet can be wound up
on a wheel 14. The chambers 11 and 12 contain
respective curved leaf springs 28 and 29, the purpose
of which is described below. The body defines a
further chamber 15 which houses an index wheel 16.
This has a plurality of grooves 17 extending parallel
to the axis of the wheel 16. The grooves are spaced
at a pitch which is equal to the distance between the
centre lines of adjacent pockets 2. The chambers 11,
12, 13 and 15 are closed by a lid 30. The chamber 15
communicates with the chambers 11, 12 and 13 via
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7
passages 31, 33 and 32 respectively.
The chamber 15 communicates via a slit 18 which,
in turn, extends upwardly within a mouthpiece 20. The
slot 18 also communicates with air inlets, as will be
described below with reference to the specific
mouthpiece shown in Figures 4a and 4b. The mouthpiece
20 is provided with additional air inlets 21 shown here
in the form of a pair of circular apertures, though
they may be of some other shape, as they are in Figures
4a and 4b. The primary purpose of the additional air
inlets 21 is to provide additional air to the user and
thus reduce the resistance to inhalation, though they
may serve one or more additional purposes, as they do
in Figure 4a and 4b and as is described below with
reference to those Figures.
A means is provided by which the user can rotate
the index wheel and the lid wheel in steps of a
predetermined size. This means comprises a ratchet
wheel 22 and a gear wheel 23, both connected to rotate
in unison with the index wheel 16, a lever 24 arranged
to rotate about the same axis as the ratchet wheel 22
and gear wheel 23, but independently thereof, and a
gear wheel 25 which meshes with the gear wheel 23 and
is arranged to rotate the lid wheel 14. The lever 24
carries a pusher arm 26, the end of which is arranged
to engage the teeth of the ratchet wheel 22. The
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8
teeth of the ratchet wheel are also engaged by a pawl
27 fixedly secured to the body 10. For reasons which
will become apparent from the description below of the
operation of this embodiment, the gear wheel 25 is not
connected directly to the lid wheel 14, but is
connected via a slipping clutch 50 which is housed
within the lid wheel 14. The effect of the provision
of this clutch is that slipping occurs between the lid
wheel and the gear wheel 25 when the force required to
rotate the lid wheel exceeds a predetermined amount.
The clutch 50 comprises a disc 51 provided with
radially extending serrations 52, or other surface
roughness, which is held in engagement with a similarly
serrated or roughened surface 53 provided on an end
face of the lid wheel 14 by a compression spring 54.
The spring 54 bears at one end against an inwardly
directed surface 55 of the lid wheel and at the other
end against a nut 56 threaded on a bolt 57.
The device described above can be made so as to
be reusable after the doses of medicament contained in
the pockets 2 have all been dispensed. In that case,
provision can be made for the user to gain access to
the interior of the device, for example by removing the
lid 30, so as to insert therein a fresh strip 1, for
example in a cassette. Alternatively, however, the
device may be made to be disposable once the strip 1
CA 02288413 1999-11-16
9
with which it is supplied has been used up.
In either event, when the device is first used
the bulk of the strip 1 is within the chamber 11, kept
in a relatively tight reel by the leaf spring 28, with
a short portion at the leading end thereof passing out
of the chamber 11 through the passage 31 to the index
wheel 16. The foremost part of the leading end of the
strip is peeled apart so that the leading end of the
lid sheet 4 can be secured to the lid wheel 14, and so
that the leading end of the base sheet 3 can enter the
passage 33. The end of the lid sheet 4 is held in
place on the lid wheel 14 by means of a key 34 which is
a force fit in a slot 35 in the wheel 14.
A user desiring to use the device pushes the
lever 24 in an anticlockwise direction, as viewed in
Figure 1, so that the pusher arm 26 urges the ratchet
wheel 22 through an angle equal to the angular distance
between two adjacent teeth. This causes the ratchet
wheel 16 to rotate by an angular amount equal to the
pitch of the groove 17 thereof and thus equal to the
distance between two adjacent pockets 2 in the strip 1.
This brings a pocket 2 opposite the slot 18 in the
body 10. Since the ratchet wheel 22 and gear wheel 23
move in unison, and since the gear wheel 25 meshes with
the gear wheel 23, movement of the lever 24 also causes
the lid wheel 14 to rotate. This peels a sufficient
CA 02288413 1999-11-16
portion of the lid sheet 4 away from the base sheet 3
to expose the contents of the pocket 2 which is being
brought into alignment with the slot 18.
When the user inhales through the mouthpiece 20
the flow of air which this produces entrains powder
from the opened pocket, so that the powder is inhaled
by the user. One way in which this can occur is
explained in more detail below with reference to the
embodiment of mouthpiece shown in Figures 4a and 4b.
Each time the above procedure is repeated a further
length of lid sheet is wrapped around the lid wheel 14
and a further length of base sheet enters chamber 12
through passage 33. The leaf spring 29 therein
ensures that the base sheet is coiled up and does not
snag on the wall of the chamber 12.
One effect of winding up the lid sheet on the lid
wheel 14 is that the external diameter of the wheel
plus the sheet wound thereon gradually increases.
Were it not for the use of a slipping clutch to connect
the gear wheel 25 to the lid wheel 14 this would have
the result that successive operations of the lever 24
would try to cause a progressively longer length of lid
sheet to be wound on to the lid wheel. The slipping
clutch 50, however, avoids this effect, the clutch
slipping each time by an amount sufficient to ensure
that for every operation of the lever the amount of lid
CA 02288413 1999-11-16
11
sheet wound on is precisely equal to the pitch of the
pockets 2.
Figures 4a and 4b show a portion of the index
wheel 16 with a pocket 2 therein, in conjunction with a
mouthpiece which differs slightly from the mouthpiece
20 shown in Figures 1 to 3, and which is denoted by
reference numeral 120. The mouthpiece 120 has air
inlets 140, to which reference in general terms has
already been made in connection with Figures 1 to 3,
and a central powder outlet 119, one end of which is
open to the pocket 2 and the other end of which opens
into the interior of the mouthpiece 120.
When a user inhales through the mouthpiece 120
this causes air to flow in through the inlets 140 and
thence through the pocket 2, into the powder outlet
119, and out through the mouthpiece 120. By thus
directing the flow of air through the pocket 2,
efficient entrainment of powder in the airflow is
achieved, with consequent efficient emptying of the
pocket. The mouthpiece 120 is provided with
additional air inlets 121, shown here by way of example
as being four in number, which open tangentially into
the mouthpiece. When the user inhales air is drawn
into the mouthpiece not only through the air inlets 140
but also through the air inlets 121, and the air
entering through the inlets 121 produces a swirling
CA 02288413 1999-11-16
12
airflow which helps to distribute powder effectively
within the airflow and reduce the extent to which
powder is deposited on the inside of the mouthpiece.
This also helps to break up any aggregates of powder
which may be present in the blister.
An alternative clutch arrangement is shown in
Figures 25 to 29. In this, the index wheel 16 and the
lid wheel 14 have respective toothed gear wheels 63 and
64 secured to them for rotation therewith. The
direction of rotation is indicated by arrows in Figure
27.
Gear wheel 63 has a toothed surface 65, with the
teeth being provided continuously all the way round the
surface 65 and at a constant pitch. By contrast, the
gear wheel 64 has a toothed surface 66 from which some
teeth are missing by virtue of the provision of
radially extending slots 67. The circumferential
width of each slot at the surface 66 is equal to one
tooth pitch. The drawings show three such slots, but
it should be understood that there could instead be one
slot, two slots, or more than three slots. To one
side of each of the slots 67, in fact upstream of each
slot as considered in the direction of rotation of the
gear wheel 64, a toothed section 68 is defined between
the slot 67, and a narrow slit 69. The radially inner
end of each slit 69 communicates with an aperture 70,
CA 02288413 1999-11-16
13
- so that each toothed portion 68 is connected to the
remainder of the gear wheel 64 only by an arm 71. The
gear wheel 64, or at least those portions thereof which
provide the arms 71, is made of a material which
permits the toothed portions 68 to flex resiliently
back and forth in a circumferential direction. The
rest position of the portions 68 is as shown in the
drawings, but when a force is applied to a portion 68
in the direction of rotation of the gear wheel 64, the
portion 68 can move so as to close the gap 67 at the
radially outer end. This has the effect that a tooth
is then "missing" not at the end of the slot 67 but at
the end of the slit 69.
When the circumferential force applied by the gear
wheel 63 to the gear wheel 64 is below a predetermined
level the toothed portions 68 remain in their rest
positions and the gear wheel 64 behaves just as if it
had a continuous toothed surface like that of gear
wheel 63. However, if the load exceeds a
predetermined value, each time a toothed section 68
meshes with the gear wheel 63 it is moved
circumferentially to close up the slot 67 at its outer
end and open the slit 69. This movement of the
toothed section 68 by a distance equal to the tooth
pitch has the effect of producing slippage of the gear
wheel 64 with respect to the gear wheel 69 equal to one
CA 02288413 1999-11-16
14
tooth pitch. In this way, the illustrated arrangement
is able to permit a total slippage of the gear wheels
with respect to one another by a maximum of a distance
equal to three times the tooth pitch per revolution,
and hence a corresponding slippage of the lid wheel and
index wheel with respect to one another. As will be
appreciated, providing more or fewer toothed sections
than the three illustrated will permit more or less
than this maximum slippage.
A second embodiment of the inhalation device
according to the invention is shown in Figures 5 to 9.
This is intended for use with a strip 201, similar to
the strip 1 used in the first embodiment except as
regards the spacing of the pockets (for which see
below). In many respects the second embodiment
resembles the first embodiment, and components in the
second embodiment which correspond in general terms to
particular components in the first embodiment are
denoted by the same reference numerals, but with the
addition of 200. The main difference between the first
embodiment and the second embodiment is that in the
latter there is no index wheel corresponding to the
index wheel 16 of the first embodiment. Instead,
indexing of the strip 1, to ensure that each operation
of the lever advances the strip by an amount equal to
the pitch of the pockets, is achieved by a resiliently
CA 02288413 1999-11-16
- flexible arm 250 terminating in a tooth 252 which
engages between adjacent pockets. Each time the lever
224 is operated the arm 250 is resiliently depressed as
a pocket slides past the tooth 252 thereof, and the
tooth then springs back into engagement with the strip
to the rear of the pocket which has just passed it.
It will be appreciated that, as in the case of
the first embodiment, the diameter of the lid wheel 214
with the lid sheet thereon gradually increases during
operation. Since a slipping clutch cannot be used in
this embodiment the effect just described is
compensated by having the spacing of the pockets 2
gradually increasing towards the rear end of the strip.
One other difference which will be noted between
the first and second embodiments, is that in the latter
the chambers 211 and 212 form a single composite
chamber, unlike the separate chambers 11 and 12 in the
first embodiment. However, this need not be so, and
the first embodiment could use a single composite
chamber and the second embodiment could use separate
chambers.
Figures 10 to 12 show a third embodiment. In
many respects this resembles the second embodiment, and
components in the third embodiment which correspond in
general terms to components in the second embodiment
are denoted by the same reference numerals but with the
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16
addition of a further 100.
One difference which will be observed between the
second and third embodiments is that in place of the
lid wheel 114 a pair of wheels 314a and 314b are
employed, with the lid sheet being gripped in the nip
between the wheels 314a and 314b, which act as a
mangle. These wheels are knurled or otherwise
roughened to improve the grip between the wheels and
the lid sheet. The used lid sheet is not wound up but
is fed into a chamber 313, so that no problem arises,
as it does in the first two embodiments, with the lid
wheel attempting to wind up progressively longer
lengths of lid as operation of the device continues.
Figure 11 shows the mouthpiece to be of a
somewhat different design to that shown in Figures 4a .
and 4b. The mouthpiece is shown as having a single
air inlet 340 in place of the pair of air inlets 140,
and the powder outlet 119 of Figures 4a and 4b is
replaced by a mouthpiece portion 319 of reduced width.
It should be understood, however, that the device shown
in Figures 10 to 12 could be modified so as to
incorporate a mouthpiece more closely resembling
Figures 4a and 4b.
Figure 10 shows the device as being provided with
a hinged cover 360, and such cover could be provided
for either of the first two embodiments. Figure 12
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17
shows the device as having a window 370 through which
indicia on the strip can be viewed. By printing the
strip with numbers or other indicia which correlate
with the number of pockets from which powder has been
dispensed, or alternatively is to be dispensed, the
user is provided with an indication of how many doses
have been used or, alternatively, how many doses
remain. Another possibility is to use a dose counting
device driven by one of the rotating components of the
inhalation device. It should be noted that similar
indicia and means for viewing those indicia could be
provided in all the embodiments.
Figures 13 to 16 show a further embodiment of the
invention. Th-is is similar in the principle of its
operation to the first embodiment, and components in
the fourth embodiment which correspond in general terms
to components in the first embodiment are denoted by
the same reference numerals but with the addition of
400.
As in the first embodiment, the device receives a
flexible strip, here denoted as 401, comprising a base
sheet 403 in which pockets 402 are defined and a lid
sheet 404. The strip 401, is shown most clearly in
Figure 35. The lid sheet 404 has a loop 404a formed at
the leading end thereof for engagement over a post 471a
extending upwardly from a toothed wheel 471 (described
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18
below). The base sheet has a lead portion 403a of
reduced width for engagement in a slot 470a formed in
the base winding wheel 470 (described below). The
leading end portions of the base sheet and lid sheet
are not sealed together, as can be seen in Figure 35.
The body 410 comprises a base 410a and a top 410b
both of generally circular shape. When the device is
assembled the base and top are snap-fitted together.
The body defines a single internal chanber within which
the strip 401 is housed and within which are also
housed a wheel 414 for winding up the used portion of
the lid sheet 404, a base winding wheel 470 and an
index wheel 416. The index wheel 416 is hollow and an
index ratchet wheel 422 is housed within it. All the
wheels just mentioned are mounted in the chamber
defined by the body, for rotational movement with
respect thereto. A pawl 470b is attached to the body
410 and engages the teeth of the base winding wheel 470
to prevent the wheel moving anticlockwise, thus
ensuring that the strip 401 can only proceed forwards
through the device.
The lid winding wheel 414 is formed in two parts,
namely a toothed wheel 471 having teeth 472 and a shaft
473, and a collapsible wheel 474 having a hollow
central shaft 475 and a plurality of resilient arms
476, for example, as shown, eight such arms, extending
CA 02288413 1999-11-16
19
from the central shaft 475 each at an angle to a
radius. The toothed wheel 471 has a lug 477 which
engages in a corresponding notch in the shaft 475 so
that the wheels 471 and 474 rotate in unison.
The hollow index wheel 416 has external teeth 478
which mesh with the teeth of the base winding wheel 470
and the teeth of the wheel 471. Ratchet teeth 479 are
formed on the internal walls of the index wheel 416,
and the index ratchet wheel 422 has two pawls 480 which
engage the ratchet teeth 479.
The device further comprises a lever 424 which
comprises an arcuate wall 481 with a finger tab 482,
and an arm 483 which extends inwardly from the wall 481
and carries an arcuate array of teeth 484 at its distal
end. The lever is pivotally mounted to the centre of
the base 410a for movement about an axis which is at
the centre of the pitch circle of the teeth 484, the
teeth 484 mesh with the teeth 485 on the index ratchet
wheel 422.
A manifold 486 provides communication between the
chamber within the body 410 and a mouthpiece 420. The
manifold has a powder outlet 419 and also has a
passageway 487 to allow used lid strip 404 to pass to
the collapsible wheel 474. Optionally, a roller 488
may be provided to guide the strip 404 into the
passageway 487.
CA 02288413 1999-11-16
A dose monitor ring 489 having teeth 490 is
arranged to be rotatable within the body base 410a. On
its lower surface this bears indicia (not visible in
the drawings) which can be viewed by the user through
a window 494 in the body 410. It will be noted from
Figures 16a to 16d that the window can be seen both
when the cover 491 (see below) is closed and when it is
open. The indicia indicate either exactly or
approximately the number of doses left (or the number
of doses used, if preferred). The ring 489 is rotated
by virtue of the fact that its teeth 490 are engaged by
the teeth 478 of the index wheel.
The device is provided under a cover 491 which is
pivotally mounted on the body 410 by means of a lug 492
on the body top 410b and a corresponding lug 493 on the
body base 410a. The cover is pivotal between an open
position (shown in Figure 14) in which the mouthpiece
is exposed and a closed position in which it is not, as
is described more fully below.
In operation, the user moves the cover 491 to its
open position and then presses on the finger tab 482 of
the lever 424 to cause it to move as the lever pivots.
This makes the index ratchet wheel 422 rotate which,
via the pawls 480, causes the index wheel 416 also to
rotate. Rotation of the index wheel 416 produces
rotation of both the base winding wheel 470 and the lid
CA 02288413 1999-11-16
21
winding wheel 414, thus peeling the base sheet and lid
sheet apart over a distance sufficient to expose a
previously unopened pocket 402 opposite the end of the
powder outlet 419 in the manifold 486. The patient can
then inhale through the mouthpiece, as in the preceding
embodiments.
Successive stages in the operation of the device
are shown in Figures 16a to 16d. The device is in its
closed position in Figure 16a. The finger tab 482 of
the lever 424 is at this stage in a recess 482b formed
in the body 410 (seen more clearly in Figures 16b and
16c). The cover 419 is held stationary as the body 410
is rotated anticlockwise, a recess 410c being provided
in the periphery of the body to enable the user to
insert a finger for this purpose. The device is thus
moved to the partly open position shown in Figure 16b.
During this process the lever 424 remains stationary
with respect to the cover 491. This is achieved by the
lever being provided internally with a resilient az-~a
424a the tip 424b of which engages in a recess 491a in
the cover 491. The arm 424a is attached to the lever
424 via a cylindrical member 424c. As viewed in Figure
16a, the arm 424a extends anticlockwise from the member
424c over an arc of about 90°. The cylindrical member
424c is guided in an arcuate slot 410d formed in the
body 410. The slot 410d extends through an arc of
CA 02288413 1999-11-16
22
about 180', and in Figure 16a the member 424c is shown
as being approximately half way along its length. In
Figure 16b it is shown as being at one end.
The user continues to rotate the body 410 from
the position shown in Figure 16b to the position shown
in Figure 16c. During this further rotation tip 424b
of the arm 424a jumps out of the recess 491a. This
occurs because, With the member 424c at one end of the
slot 410d, movement of the body 410 carries the member
424c with it in an anticlockwise direction and hence
compels the arm 424a likewise to move anticlockwise.
The user then moves the lever 424 by pushing on the
finger tab 482 to cause it to rotate anticlockwise
through the position shown in Figure 16c to the
position shown in Figure 16d where the finger tab 482
re-enters the recess 482b. The steps thus far
described both expose the mouthpiece 420 and open a
fresh blister. The device is therefore now ready for
the user to inhale.
After use, the body 410 is rotated clockwise, the
lever 424 moving in unison with the body, to bring the
device back to the position of Figure 16a.
It will be noted that the collapsible wheel 474
in effect assumes the function of the clutch in the
first embodiment. As more lid sheet is wound onto the
wheel 474 the arms 476 gradually flex inwardly, and the
CA 02288413 1999-11-16
23
effect is to keep the external diameter of the reel of
wound up lid sheet substantially constant, while the
internal diameter thereof gradually decreases.
Instead of the wheel 414 with its collapsible
wheel 474 it is possible to use the alternative
structure shown in Figure 30 or that shown in Figures
31 and 31a. The principle of operation of the
structure shown in Figure 30 is very similar to that of
the clutch arrangement shown in Figures 25 to 29. The
structure of Figure 30 comprises two components 800 and
801. The component 800 comprises a generally
cylindrical hollow housing 802 open at its lower end
and three arcuate arrays of teeth 803. The cylinder
802 has a slot 804 extending through the upper surface
thereof, and a post 805 for receiving the leading end
of the lid sheet. The component 801 comprises a disc
806 provided with three arcuate arrays of teeth 807,
and an upright member 808 extending upwardly from the
disc 806. The member 808 is formed of a material,
example a plastics material, which is resilient in
torsion.
The two components 800 and 801 are snap-fitted
together so that the upper end of the member 808 is
received in the slot 804 and cannot rotate with respect
thereto. The arrays of teeth 803 and 807 are coplanar
and alternate with one another. The teeth 803 and 807
CA 02288413 1999-11-16
24
mesh with the teeth 478 of the index wheel. Each array
807 is separated from one of the adjacent arrays 803
(but not from the other) by a gap equal to one tooth.
Thus, there are three gaps, each of one tooth width,
around the assembled arrays. Because the member 808
can flex in torsion, the disc 806 is free to move back
and forth between a position in which the gaps are each
on one side of a respective array 807 and a position in
which the gaps are each on the other side of a
respective array 807. This has the effect of producing
slippage of the structure shown in Figure 30 with
respect to the index wheel.
The structure shown in Figure 31 is a slipping
clutch. It comprises two components 810 and 811, snap-
fitted together. The component 810 comprises a
generally cylindrical housing 812 open at its lower end
and having a post 813 for receiving the leading end of
the lid sheet. The interior of the housing 812 is
provided with longitudinally extending serrations 814,
as can be seen in Figure 31a. The component 811
comprises a cylinder 815 which extends upwardly from a
disc 816 provided with teeth 817. The teeth 817 mesh
with the teeth 478 of the index wheel. The cylinder
815 is provided on its outer surface with a pair of
pips 818 which are in interfering engagement with the
serrations 814. When the rotational force applied by
CA 02288413 1999-11-16
- the component 811 to the component 810 is below a
predetermined level the components rotate together.
However, the cylinder is made of a material, for
example a plastics material, which can deform radially,
and when the rotational force exceeds the predetermined
level such deformation takes place, permitting the pips
818 to move over the serrations 814.
Although in the embodiment of Figures 13 to 16,
with or without the modifications of Figures 30 and 31,
the base sheet is wound up as well as the lid sheet,
it is not necessary for there also to be a slipping
clutch or the like between the index wheel and the base
winding wheel. The diameter of the base winding wheel
is so chosen that initially the base sheet is wound up
only very loosely, and the tightness with which the
sheet is wound increases during operation but without
ever reaching an unacceptable level. In theory, the
base sheet could be wound up precisely via a slipping
clutch or the like, with the lid sheet being only
loosely wound, but in practice it is much easier to
wind up the lid precisely because it is flat and
because it is thinner than the base sheet.
Figures 17 to 20 show in diagrammatic form the
main operative parts of a device which has some
similarities to those shown in Figures 10 to 12, i.e.
it is a mangle device. However, it is to be understood
CA 02288413 1999-11-16
26
- that Figures 17 to 20 do not show a complete device,
the chamber for the unused strip and the used base
material being omitted. Components in this embodiment
which correspond in general terms to particular
components in the embodiment of Figures 10 to 12 are
denoted by the same reference numerals, but with the
addition of a further 200.
The device of Figures 17 to 20 comprises a pair
of wheels 514a and 514b which have meshing teeth formed
thereon and which act as a mangle engaging the used lid
material. This material is fed into a chamber 513.
The wheel 514b is an idler wheel and is urged into
engagement with the wheel 514a by a compression spring
595 which acts on a carrier 596 which carries the wheel
514b. The wheel 514a has a ring of gear teeth 598
which mesh with teeth 597 formed on an index wheel 516
which performs the same indexing function as the index
wheel 16 in the first embodiment and is rotatable in a
chamber 515. The chambers are formed in a body 510 and
lids 530a and 530b are secured to opposite sides of the
chamber. Inhalation is through a mouthpiece 520. The
device is operated by a lever 524 which turns the index
wheel 516 via a pusher arm 526.
The embodiment shown in Figures 21 to 24 is
another type of mangle device, but one in which both
the lid and base sheets pass through the wheels of the
CA 02288413 1999-11-16
27
mangle.
The embodiment of Figures 21 to 24 comprises a
body 610 defining a substantially circular chamber 611
and having lids 612a and 612b secured thereto. Within
the chamber 611 an index wheel 613 and a base and lid
winding wheel 614 are rotatably mounted, the wheels 613
and 614 having gear teeth which mesh with one another.
The index wheel 613 has grooves 615, and a lid gripper
wheel 618, rotatably carried in a carrier 619 is also
mounted adjacent the grooves 615, downstream of the
manifold 616. A roller 8?.~I is mounted behind the
manifold 616 to guide the lid sheet.
Flexible strip 601 is provided in the chamber
611, the main part of the strip being initially coiled
up around the internal wall of the chamber. The
leading end of the strip passes between guide members
622 and 623 over part of the circumference of the index
wheel 613, with the powder containing pockets thereof
engaged in the grooves 615. At the point where the
strip meets the manifold 616 it is peeled apart, and
the lid sheet passes behind the manifold and over the
roller 628 while the base sheet passes between the
index wheel and the manifold. After the manifold both
sheets pass between the index wheel and the lid
gripper wheel 618, and are gripped thereby. The front
end of the strip is fixed in the base and lid winding
CA 02288413 1999-11-16
28
_ wheel 614.
In use, the strip 601 is advanced by rotating the
index wheel, by means of a lever 624, via a pusher arm
626, which causes corresponding rotation of the base
and lid winding wheel. This winds up the base and lid,
initially loosely, though increasing in tightness as
the operation proceeds, but without, however, the
tightness ever reaching an unacceptable level. The lid
and base sheets are peeled apart where the strip meets
the manifold 616, presenting a fresh pocket of powder
to the powder outlet 617 . I n h a 1 a t i o n i s v i a a
mouthpiece 620.
Figures 32 to 34 show an embodiment of the
invention incorporating, as a further feature, indicia
which instruct the user as to the successive steps
which the user is to take to operate the device.
Apart from the indicia, the device is largely the same
as the embodiment shown in Figures 1 to 3, and the same
reference numerals are used for the corresponding
components. However, there are some additional
components, as will be apparent from the following
description.
The device shown in Figures 32 to 34 has a cover
700 which is pivotally connected to the remainder of
the device for pivotal movement about an axis 701.
The gear wheels 23 and 25 and the associated components
CA 02288413 1999-11-16
29
are covered by a rear wall 702. This extends over the
whole of the rear of the device, but in the drawings
all except a small portion thereof is shown broken away
for ease of understanding. The lever 24 is provided
with an arcuate extension 703, on an edge whereof is
formed a cam 704. The extension 703 carries indicia
in the form of instructions to the user, in this case
the legends "OPEN COVER", "PRESS BUTTON", "INHALE".
When the lever 24, and hence the extension 703, are in
particular positions a respective one of these legends
is visible through a window 705 in the rear wall 702.
The distal end of the extension 703 constitutes a
button 706. The end of the lever 24 remote from the
extension 703 carries a tongue 707 pivotal therewith.
Figure 32 shows the device in its rest position.
The legend "OPEN COVER" is visible through the window
705. If a patient now opens the cover 700 this brings
the device into the position shown in Figure 33. It
will be seen that the top rear edge of the cover has
struck the cam 704 and moved the extension 703 through
an angle such as to make the legend "PRESS BUTTON"
visible through the window 705. If the user now
presses the button 706 this causes the lever 24 to
rotate, thus opening a powder-containing container, as
described in connection with Figures 1 to 3. This
brings the device into the position shown in Figure 34,
CA 02288413 1999-11-16
30
in which the legend "INHALE" is visible through the
window 705. It will also be seen that in the position
of Figure 34 the tongue 707 protrudes upwardly.
Accordingly, when the user, having inhaled, closes the
cover, the tongue 707 is struck by a lug 708 on the
underside of the cover, which pushes the lever 24, With
its extension 703, back into the position shown in
Figure 32, once again causing the legend "OPEN COVER"
to be displayed.
The device just described not only gives the
step-by-step instructions to the user, thus reducing
the risk of a patient being confused, but also makes it
difficult for the patient to use the device ether than
in the intended manner, by virtue of the fact that the
button 706, once depressed, is not again accessible
until the user closes the cover and reopens it.
In the embodiments described above, reference is
made to a mouthpiece. However, if the device was to be
used for purposes other than oral inhalation some other
outlet would be employed, e.g. a nosepiece.
