U.S. patent application number 10/007617 was filed with the patent office on 2002-04-11 for dry powder inhaler.
This patent application is currently assigned to Dura Pharmaceuticals, Inc.. Invention is credited to Davies, Karen, Eisele, Robert F., Holton, Nelson, Kline, Tim, Smith, Ian.
Application Number | 20020040713 10/007617 |
Document ID | / |
Family ID | 26997298 |
Filed Date | 2002-04-11 |
United States Patent
Application |
20020040713 |
Kind Code |
A1 |
Eisele, Robert F. ; et
al. |
April 11, 2002 |
Dry powder inhaler
Abstract
A drug powder inhaler has a cover plate pivotably attached to a
lid on an inhaler housing. A lever is pivotably attached to the
cover plate. A blister pack disk is rotatably mounted on the
housing under the cover plate. A powder duct in the housing extends
from a staging chamber underneath one end of the lever to an
aerosolizing chamber. An actuator in the housing is pressed to
shear open a blister on the blister pack disk and thereby deliver
the drug dose contents of the blister into the staging chamber. A
switch senses pressure in the mouthpiece and switches on a motor
spinning an impeller within the aerosolizing chamber, when
inhalation is detected.
Inventors: |
Eisele, Robert F.; (San
Diego, CA) ; Davies, Karen; (San Diego, CA) ;
Holton, Nelson; (Boulder, CO) ; Kline, Tim;
(Boulder, CO) ; Smith, Ian; (Boulder, CO) |
Correspondence
Address: |
LYON & LYON LLP
633 WEST FIFTH STREET
SUITE 4700
LOS ANGELES
CA
90071
US
|
Assignee: |
Dura Pharmaceuticals, Inc.
|
Family ID: |
26997298 |
Appl. No.: |
10/007617 |
Filed: |
November 7, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10007617 |
Nov 7, 2001 |
|
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|
09351895 |
Jul 13, 1999 |
|
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09351895 |
Jul 13, 1999 |
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08428960 |
Apr 24, 1995 |
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Current U.S.
Class: |
128/203.21 ;
128/203.15 |
Current CPC
Class: |
A61M 2205/8206 20130101;
A61M 15/0031 20140204; A61M 15/0006 20140204; A61M 2016/0024
20130101; A61M 2202/064 20130101; A61M 15/0045 20130101; A61M
15/0025 20140204; A61M 15/0048 20140204; A61M 15/0033 20140204 |
Class at
Publication: |
128/203.21 ;
128/203.15 |
International
Class: |
B05D 007/14; A61M
015/00; A61M 016/00; B65D 083/06 |
Claims
We claim:
1. An inhaler comprising: a housing; a staging chamber in the
housing, with the staging chamber having an open top, to allow a
dose of a dry powder pharmaceutical to move via gravity into the
staging chamber from a dose carrier above the staging chamber, and
with the staging chamber having a substantially closed bottom end
to allow the staging chamber to temporarily hold the dose of dry
powder; a mixing chamber in the housing spaced apart from the
staging chamber; and an enclosed continuous duct extending from the
staging chamber to the mixing chamber.
2. The inhaler of claim 1 further comprising an inlet extending
into the housing to the staging chamber.
3. The inhaler of claim 1 further comprising a barrier between the
staging chamber and the inlet.
4. The inhaler of claim 1 further comprising means for opening the
dose carrier aligned above the staging chamber.
5. The inhaler of claim 1 wherein the enclosed duct extends
substantially horizontally in the housing.
6. The inhaler of claim 1 wherein the duct and the mixing chamber
have round cross sections, and the diameter of mixing chamber is
greater than the diameter of the duct.
7. An inhaler comprising: a housing; an air flow path extending
through the housing and comprising: an inlet extending into the
housing; a staging chamber within the housing with the inlet
joining into the staging chamber; a mixing chamber within the
housing; a duct in the housing having a first end connecting into
the staging chamber and having a second end connecting into the
mixing chamber.
8. The inhaler of claim 7 further comprising a mouthpiece forming a
wall of the mixing chamber.
9. The inhaler of claim 7 with the mixing chamber having a
circumferential wall between flat first and second walls, and
wherein the duct connects into the mixing chamber through the first
flat wall.
10. The inhaler of claim 7 wherein the staging chamber has an open
top for receiving a dose of power via gravity.
11. The inhaler of claim 9 wherein the circumferential wall has a
diameter greater than the diameter of the duct.
12. The inhaler of claim 7 wherein the staging chamber has a closed
off bottom surface and an open top end.
13. The inhaler of claim 12 wherein the duct connects into the
staging chamber adjacent to the closed off bottom surface.
14. The inhaler of claim 7 further including a mouthpiece
connecting to the mixing chamber and wherein the duct provides the
only connection between the staging chamber and the mixing chamber,
such that all air entering into the mixing chamber via the duct,
upon inhalation on the mouthpiece by a user of the inhaler, comes
from the staging chamber.
15. The inhaler of claim 7 wherein the duct has a round cross
section.
16. The inhaler of claim 15 wherein the duct has a length greater
than its diameter.
17. The inhaler of claim 7 with the housing having a flat top
surface and the duct extends in a direction parallel to the flat
top surface.
18. The inhaler of claim 7 wherein the duct is longer than the
inlet.
Description
BACKGROUND OF THE INVENTION
[0001] This application is a continuation of U.S. patent
application Ser. No. 09/351,895, filed Jul. 13, 1999, and now
pending, which is a continuation-in-part of application Ser. No.
08/428,960, filed Apr. 24, 1995 and now U.S. Pat. No. 5,622,166,
and incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The field of the invention is inhalers. More specifically,
the invention relates to inhalers for delivering drugs in a solid
finely divided dry powder or fluid form.
[0003] Inhalers are used to deliver drugs into a patient's lungs.
Typically, an inhaler contains or provides a mixture of drugs and
air or propellants. The mixture is delivered via the patient
inhaling from a mouthpiece on the inhaler, for treatment of various
conditions, for example, bronchial asthma. However, delivery of
drugs via inhalation can be used for many other treatments,
including those unrelated to lung condition.
[0004] One well known inhaler, the Diskhaler, described in U.S.
with each successive dose. However, while the device described in
U.S. Pat. No. 4,627,432 has met with varying degrees of success,
disadvantages remain in indexing or advancing a blister disk within
an inhaler, with opening the blisters to access the drug contents,
with reliably providing intended dosages, and in other areas.
[0005] Accordingly, it is an object of the invention to provide an
improved inhaler.
SUMMARY OF THE INVENTION
[0006] To these ends, the present inhaler preferably includes a
cover plate pivotably attached to a lid on an inhaler housing. A
blister pack disk is rotatably mounted on the housing under the
cover plate, and is movable in a single forward direction. An
actuator in the housing is most desirably aligned with a lever on
the cover plate. The patient pushes the actuator which shears open
a blister on the disk and then causes the lever to crush the
blister, to deliver the drug powder contents of the blister into a
duct within the housing, for subsequent inhalation by the
patient.
[0007] Other and further objects will appear hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] In the drawings, wherein similar reference characters denote
similar elements throughout the several views:
[0009] FIG. 1 is perspective view of the present inhaler with the
mouthpiece covered by the cover assembly;
[0010] FIG. 2 is a perspective view thereof with the mouthpiece
uncovered;
[0011] FIG. 3 is a plan view of the inhaler as shown in FIG. 1;
[0012] FIG. 4 is a plan view of the inhaler as shown in FIG. 2;
[0013] FIG. 5 is an exploded perspective view of the inhaler of
FIGS. 1 and 2;
[0014] FIG. 6 is an plan view of the inhaler of FIGS. 1 and 2 with
the lid open;
[0015] FIG. 7 is a partial section view taken along line 7-7 of
FIG. 6;
[0016] FIG. 8 is an enlarged top and front perspective view of the
cover assembly on the inhalers of FIGS. 1 and 2;
[0017] FIG. 9 is a bottom and rear perspective view of the cover
assembly of FIG. 8;
[0018] FIG. 10 is an enlarged view of features shown in FIG. 9;
[0019] FIG. 11 is a partial section view taken along line 11-11 of
FIG. 5;
[0020] FIG. 12 is similar view showing positions of various
components during use of the device;
[0021] FIG. 13 is a partial section view taken along line 13-13 of
FIG. 3;
[0022] FIG. 14 is a partial section view taken along line 14-14 of
FIG. 4;
[0023] FIGS. 15, 16 and 17 are partial section view fragments
illustrating movement of components within the device;
[0024] FIG. 18 is a section view taken along line 18-18 of FIG.
5;
[0025] FIG. 19 is a similar view thereof with various components
omitted for drawing clarity, and showing positions of components
during use;
[0026] FIG. 20 is an exploded perspective view of a blister disk
for use with the inhaler shown in FIGS. 1 and 2;
[0027] FIG. 21 is a partial plan view thereof; and
[0028] FIG. 22 is a section view taken along line 22-22 of FIG.
21.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] Turning now in detail to the drawings, as shown in FIGS.
1-4, a dry powder inhaler includes a housing 32 having a lid 38
attached to the housing with a hinge 36. The lid 38 is preferably a
transparent material, e.g., clear plastic. A removable mouthpiece
34 is provided on one side of the housing 32. A sliding cover
assembly 40 may be pivoted on the lid 38 from a closed position
covering the mouthpiece 34, as shown in FIGS. 1 and 3, to an opened
position exposing the mouthpiece 34, as shown in FIGS. 2 and 4. As
best shown in FIGS. 3 and 4 (looking down through the transparent
lid 38), a disk 42 having a plurality of radially spaced apart
blisters 44 is generally centered on top of the housing 32 on a
center post 140 extending upwardly from the housing 32. A lid stop
46 on the housing 32 limits sliding movement of the cover assembly
40 in the opened position.
[0030] Turning momentarily to FIGS. 8 and 9, the sliding cover
assembly 40 includes an enclosure 48 having a front curved wall 54,
a side wall 56, a top wall 58 and a bottom wall 60. A rim 62
extends upwardly and radially inwardly on the top wall 58.
[0031] Referring now to FIG. 9, a glide block 64 and an outside
retainer 66 extend downwardly and inwardly on the underside of the
top wall 58. A generally flat cover plate 50 is preferably
integrally formed with the enclosure 48, with the cover plate 50
and enclosure comprising the cover assembly 40. An inside retainer
68 on the cover plate 50 extends radially outwardly. A lever 74 is
pivotably supported on a lever pin 76 held in place by lever blocks
72 on the underside of the cover plate 50. The lever 74 can pivot
through a lever opening 78 in the cover plate 50, as best shown in
FIG. 8. A ramp 80 and a guide wall 82 project downwardly from the
cover plate 50, adjacent to the lever 74, as shown in FIG. 9. The
entire cover assembly 40, which includes the enclosure 48 and cover
plate 50 is pivotably attached to the lid 38, with the lid post 52
extending through a center hub 84 on the cover plate 50. Clearance
holes 70 through the cover plate 50 on either side of the lever
opening 78 allow the cover plate to sit on top of the blister disk,
as shown in FIG. 18, without excessive vertical interference.
[0032] Referring to FIGS. 8, 9 and 10, a spring arm 86 having a
downwardly projecting end tab 88 is attached to or integral with
the cover plate 50. As shown in FIG. 13, the spring arm 86 includes
an arm wedge 96 at its free end, alongside the tab 88. As shown in
FIG. 10, an arm lifter 102 extends downwardly from the lid 38. An
outer slot 94 through the cover plate 50 overlies the spring arm
86. An inner slot 92 adjoining the outer slot 94 through the cover
plate 50 provides clearance for the arm lifter 102, and allows the
cover assembly 40 to rotate (preferably about 90.degree.). The arm
lifter 102 includes an internal ramp, and is dimensioned to engage
the arm wedge 96, and lift the arm 86 up towards the lid 38, as the
arm wedge 96 moves into full engagement with the lifter 102.
[0033] Turning now to FIG. 5, the housing 32 includes a mixing
chamber 120, and a staging chamber 124 connected to the mixing
chamber 120 via a duct 122. Referring now also to FIGS. 6 and 7, an
inlet duct 126 extends from one side of the housing 32 to the
staging chamber 124 via a duct recess 130. A crescent barrier 128
around the top of the staging chamber 124 creates an indirect air
flow path from outside of the housing, through the inlet duct 126
and into the staging chamber 124.
[0034] In a first embodiment of the present invention, referring
once again to FIG. 5, a pressure port or opening 132 in the housing
32 alongside the mixing chamber 120 connects to a pressure switch
170 via a tube 172. The pressure port aligns with a mouthpiece port
135 leading into the central opening of the mouthpiece. This
provides a continuous duct from the mouthpiece opening to the
pressure switch. The mouthpiece 34 or an alternative embodiment
mouthpiece 136 is secured to the housing 32 with a hook 134. The
mouthpiece is removable by twisting or rotating the mouthpiece, to
disengage the hook 134, and then by pulling it off. Rachet posts
142 having angled top surfaces project slightly above the flat top
surface 138 of the housing 32. An actuation button 146 has a post
148 extending entirely through a post opening 144 in the housing
32.
[0035] Referring momentarily to FIG. 18, a detent 145 on the
housing engages and holds the post 148 in the up position (driving
the lever to crush a blister), until the disk is advanced to the
next blister. At the front of the housing, behind the mixing
chamber 120, is an inwardly projecting housing inner rim 150, and
an outwardly projecting housing outer rim 152. The outer rim 152 is
engaged by the outside retainer 66, and the inner rim is engaged by
the inside retainer 68, as the cover assembly 40 is moved between
opened and closed positions. The interaction of the inner rim 150
and inside retainer 68 and outer rim 152 and outside retainer 66,
holds the cover assembly and lid down on top of the housing 32.
[0036] Referring still to FIG. 5, a bottom cover 158 attached to
the housing 32 has a button recess 164 around the actuation button
146, so that the actuation button 146 does not project beyond the
bottom surface of the cover 158. An impeller 162 within the mixing
chamber 120 is supported on the shaft of an electric motor 160
behind the mixing chamber 120 in the housing 32. The motor 160 is
wired to batteries 168 and the pressure switch 170. A battery
indicator LED 174 and a status indicator LED 176 are positioned in
the housing 32, above the pressure switch 170.
[0037] Turning now to FIGS. 20-22, the disk 42 includes a blister
foil ring 190, preferably a metal or aluminum foil having generally
conical blisters formed in it. The blister foil ring 190 and a foil
seal ring 192 are adhered or bonded onto a carrier disk 194. As
shown in FIG. 21, the carrier disk 194 has tabs 196 suspended
within tab slots 198 by bridges 200. Each blister 44 on the blister
foil ring 190 is aligned over a tab 196. The bridges 200 hold the
tabs 196 in position, but allow the tab to pivot about the bridges,
with nominal torque. As shown in FIG. 22, powdered drug 202 is
sealed within the blisters 44. The carrier disk 194 is preferably
plastic. The tab supports 200 are small enough to support the tabs
196, but also to allow the tab to pivot under force of the post of
the actuation button.
[0038] In use, a disk 42 is first loaded into the inhaler 30 by
sliding the cover assembly 40 from the closed position shown in
FIG. 1 to the open position shown in FIG. 2. In this position, the
lid 38 and cover assembly 40 are still held down on top of the
housing 32 by the interaction of the outside retainer 66 and inside
retainer 68 on the housing outer rim 152 and inner rim 150. The
side wall 56 of the enclosure 48 is lifted slightly away from the
housing 32, to a allow it to pass over the lid stop 46. As this
occurs, the retainers 66 and 68 move off of and release from the
inner and outer rims 150 and 152. The cover assembly 40 and lid 38
are then pivoted upwardly about the hinge 36, to open up the
inhaler 30, as shown in FIG. 6, for placement or replacement of a
disk 42.
[0039] A disk 42 is placed over the center post 140 over the
housing top surface 138 with the blisters 44 on top. The lid 38 and
cover assembly 40 are pivoted back about the hinge 36, from the
position shown in FIG. 6, to the position shown in FIG. 2. The
inhaler 30 is then ready for use.
[0040] The rachet posts 142 on the housing top surface 138 project
slightly into the open ends 203 of the tab slots 198. The disk 42
is accordingly oriented so that a blister 44 will be aligned over
the staging chamber 124. The rachet posts 142 also prevent the disk
42 from moving in reverse (i.e., clockwise in FIG. 6).
[0041] With the lid 38 closed, but with the cover assembly 40
opened (as shown in FIG. 2), the inner end of the lever 74 is
aligned over the top of the post 148. The outer end of the lever 74
is aligned over the top of a blister 44, and over the staging
chamber 124.
[0042] With the inhaler 30 preferably held upright, the actuation
button 146 is pushed up. As shown in FIGS. 11, 12 and 19, the
upward movement of the post 148 on the actuation button 146 first
pivots the tab 196 on the blister 44 over the staging chamber 124.
The tab pivots on the bridges 200. As this occurs, the foil seal
ring 192 sealing the blister 44 on the bottom shears away opening
the blister and allowing the powdered drug 202 to fall into the
staging chamber 124.
[0043] As upward movement of the post 148 continues, the post
pivots the lever 74 causing the outer end of the lever to crush the
blister 44 down, to release any residual powder into the staging
chamber 124.
[0044] With one dose of the powdered drug now delivered from a
sealed blister 44 into the staging chamber 124, the patient places
the mouthpiece 34 into the mouth and inhales. The inhalation draws
air from outside of the housing through the inlet duct 126, around
and under the crescent barrier 128 and into the staging chamber
124. Air and powdered drug 202 move through the duct 122 and into
the mixing chamber 120. At the same time, upon inhalation, the
reduced air pressure at the mouthpiece 136 is detected by the
pressure switch 170 via the tube 172 extending to the pressure port
132. The switch 170 turns on the motor 160, spinning the impeller
162 within the mixing chamber 120. The air and drug is mixed in the
mixing chamber 120, as further described in U.S. Pat. Nos.
5,327,883, and 5,577,497, incorporated herein by reference. As the
impeller is already spinning at high speed when the drug enters the
mixing chamber, the air/drug mixing and deagglomeration are
enhanced.
[0045] The patient inhales on the mouthpiece drawing in the
air/drug mixture from the mixing chamber 120 via holes 125 in the
rear wall of the mouthpiece 34 (which rear wall also forms the
front wall of the mixing chamber 120).
[0046] To prepare for delivery of the next dose, the cover assembly
40 is moved from the position shown in FIG. 2, to the position
shown in FIG. 1, to cover the mouthpiece 34. As this closing
movement of the cover assembly 40 occurs, the arm wedge 96 on the
spring arm 86 is released from the lifter 102. This allows the
spring arm 86 to flex downwardly with the tab 88 engaging into the
opened end 202 of a tab slot 198, approximately at position A as
shown in FIGS. 3 and 6. With the continued closing motion of the
cover assembly 40 to the position shown in FIG. 3, the tab 88 on
the spring arm 86 advances the disk 42 to the next blister 44
(moving the disk 42 counter-clockwise in FIG. 3). For a disk having
16 blisters, the advancing movement, from engagement of the tab 88
to the disk 42, until the end of movement, is about 22.degree.. As
the disk 42 is advanced by the spring arm 86 on the closing cover
assembly 40, the disk 42 rides up and over the angled top surfaces
of the rachet posts 142 and then settles back down onto the housing
surface 138 with the rachet posts 142 engaged into the next set of
opened ends 203 of the tab slots 198. In this manner, the next
blister 44 on the disk 42 is positioned for delivery and
inhalation, as described above. When the cover assembly 40 is
reopened, to the position shown in FIG. 4, the disk 42 does not
move, as the spring arm 86 is lifted up and out from engagement
with the disk by the interaction of the lifter 102 on the lid 38
and the arm wedge 96 on the spring arm 86. Through this repeated
motion of opening and closing the cover assembly 40, each blister
44 on the disk 42 can be sequentially accessed, until all of the
blisters are used.
[0047] As the cover assembly 40 is closed, the ramp 80 on the cover
plate 50 rides over the top of the post 148, the push it down,
resetting the actuation button 146 for the next dose, as shown in
FIGS. 15-17. Simultaneously, the guide wall 82, which ramps
upwardly from the lever 74, pushes down on the pivoted tab 196 from
the blister delivered. The tab 196 is accordingly pushed back down
into the plane of the disk 42, so that the disk can be advanced
without interference. The rachet posts 142 prevent the disk 42 from
moving in reverse (clockwise in FIG. 3) at anytime.
[0048] Accordingly, a novel inhaler is described and shown with
various advantages over the prior art design. The above-described
inhaler may contain various changes and modifications, including
various substitutions and equivalents, without departing from the
spirit and scope of the present invention.
* * * * *