U.S. patent application number 16/602694 was filed with the patent office on 2020-10-29 for nasal delivery devices.
The applicant listed for this patent is OptiNose AS. Invention is credited to Per Gisle DJUPESLAND, Andy PIDGEON, Colin David SHELDRAKE, Simon SMITH, Tom ST.QUINTIN, Rachel STRIEBIG.
Application Number | 20200338286 16/602694 |
Document ID | / |
Family ID | 1000004954010 |
Filed Date | 2020-10-29 |
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United States Patent
Application |
20200338286 |
Kind Code |
A1 |
DJUPESLAND; Per Gisle ; et
al. |
October 29, 2020 |
NASAL DELIVERY DEVICES
Abstract
A nasal delivery device for and method of delivering particulate
substance to the nasal airway of a subject, the delivery device
comprising: a body assembly including a mouthpiece unit which
includes a mouthpiece through which the subject in use exhales, and
a substance-supply unit which is fluidly connected to the
mouthpiece unit and actuatable to provide particulate substance for
delivery to the nasal airway of the subject; wherein the body
assembly is configured to receive a replaceable nosepiece unit
which includes a nosepiece and contains a container containing
particulate substance.
Inventors: |
DJUPESLAND; Per Gisle;
(Oslo, NO) ; SHELDRAKE; Colin David; (Wiltshire,
GB) ; SMITH; Simon; (Cambridge, GB) ;
STRIEBIG; Rachel; (Cambridge, GB) ; PIDGEON;
Andy; (Cambridge, GB) ; ST.QUINTIN; Tom;
(Cambridge, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
OptiNose AS |
Oslo |
|
NO |
|
|
Family ID: |
1000004954010 |
Appl. No.: |
16/602694 |
Filed: |
November 21, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14674103 |
Mar 31, 2015 |
10525218 |
|
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16602694 |
|
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12516404 |
Jun 21, 2010 |
9010325 |
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PCT/GB2007/004571 |
Nov 28, 2007 |
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14674103 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/0222 20130101;
A61M 2202/064 20130101; A61M 16/1045 20130101; A61M 2210/0625
20130101; A61M 2210/0618 20130101; A61M 15/0028 20130101; A61M
15/0041 20140204; A61M 15/0035 20140204; A61M 15/0098 20140204;
A61M 15/0043 20140204; A61M 15/0018 20140204; A61M 15/08 20130101;
A61M 15/0081 20140204; A61M 15/0021 20140204; A61M 15/0026
20140204 |
International
Class: |
A61M 15/08 20060101
A61M015/08; A61M 15/00 20060101 A61M015/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 28, 2006 |
GB |
GB 0623732.5 |
Claims
1. A nasal delivery device for delivering particulate substance to
the nasal airway of a subject, the delivery device comprising: a
body assembly including a mouthpiece unit which includes a
mouthpiece through which the subject in use exhales, and a
substance-supply unit which is fluidly connected to the mouthpiece
unit and configured to receive a replaceable nosepiece unit which
includes a nosepiece and contains a container containing
particulate substance, wherein the substance-supply unit is
actuatable to provide particulate substance for delivery to the
nasal airway of the subject.
2-9. (canceled)
10. A nasal delivery device for delivering particulate substance to
the nasal airway of a subject, the delivery device comprising: a
mouthpiece unit which includes a mouthpiece through which the
subject in use exhales; a nosepiece unit which includes a nosepiece
for fitting to a nostril of the subject; and a substance-supply
unit which is configured to receive a container containing
particulate substance and operable to provide a metered amount of
substance in fluid communication with the mouthpiece and nosepiece
units, such that an exhalation air flow delivered through the
substance-supply unit entrains the substance.
11-24. (canceled)
25. A nasal delivery device for delivering particulate substance to
the nasal airway of a subject, the delivery device comprising: a
body assembly including a mouthpiece unit which includes a
mouthpiece through which the subject in use exhales, and a
substance-supply unit which is fluidly connected to the mouthpiece
unit and actuatable to provide particulate substance for delivery
to the nasal airway of the subject; wherein the body assembly is
configured to receive a replaceable nosepiece unit which includes a
nosepiece and contains a container containing particulate
substance.
26-47. (canceled)
Description
[0001] The present invention relates to a nasal delivery device for
and method of delivering particulate substance, in particular a
powdered substance, to the nasal airway of a subject, and a
container for use with the same.
[0002] There is an increasing interest in the nasal delivery of
substances, typically pharmaceutical drugs, both as powders and
liquids, for topical and systemic delivery.
[0003] Current delivery systems are not suited to the delivery of
substances to the upper posterior region of the nasal airway, in
particular targeted delivery to the olfactory region and the sinus
ostia.
[0004] U.S. Pat. Nos. 4,013,075 and 4,889,114 disclose examples of
prior art inhalation devices, which provide for the inhalation of a
powdered substance from a capsule.
[0005] WO-A-00/051672, the content of which is herein incorporated
by reference, discloses a delivery device for delivering a
substance, in particular a medicament, in a bi-directional flow
through the nasal cavities, that is, an air flow which passes into
one nostril, around the posterior margin of the nasal septum and in
the opposite direction out of the other nostril. A particular
feature of this bi-directional mode of delivery is the ability to
target defined regions in the nasal airway, for both topical and
systemic delivery, in particular the upper posterior region which
cannot be targeted with existing systems.
[0006] The present inventors have recognized that the delivery of
powdered substances using the exhalation breath of a subject still
presents a significant challenge.
[0007] It is an aim of the present invention to provide a delivery
device which allows for delivery of powdered substances from
containers, typically capsules or blisters, which contain a
pre-metered dose of substance with the appropriate particle size
distribution and surface properties, where using the exhalation
breath of the subject.
[0008] In one aspect the present invention provides a nasal
delivery device for delivering particulate substance to the nasal
airway of a subject, the delivery device comprising: a body
assembly including a mouthpiece unit which includes a mouthpiece
through which the subject in use exhales, and a substance-supply
unit which is fluidly connected to the mouthpiece unit and
configured to receive a replaceable nosepiece unit which includes a
nosepiece and contains a container containing particulate
substance, wherein the substance-supply unit is actuatable to
provide particulate substance for delivery to the nasal airway of
the subject.
[0009] In one embodiment the delivery device further comprises: a
replaceable nosepiece unit which includes a nosepiece for fitting
to a nostril of a subject, and a container chamber which contains a
container containing particulate substance.
[0010] In one embodiment the delivery device is configured to
prevent operation until a nosepiece unit is fitted to the body
assembly.
[0011] In one embodiment the body assembly includes an actuation
mechanism which is manually actuatable by the subject to open the
container, and the delivery device is configured to prevent
actuation of the actuation mechanism until the nosepiece unit is
fitted to the body assembly.
[0012] In one embodiment the substance-supply unit includes an
interlock mechanism which adopts a first, locking configuration
when a nosepiece unit is not fitted to the body assembly, in which
the actuation mechanism is not actuatable, and a second, released
configuration when a nosepiece unit is fitted to the body assembly,
in which the actuation mechanism is actuatable.
[0013] In one embodiment the interlock mechanism comprises an
interlock member which is movably disposed between locking and
released positions and normally biased to the locking position.
[0014] In one embodiment the substance-supply unit includes a valve
unit which is operable between a first, closed configuration in
which a fluid communication path with the mouthpiece is closed, and
a second, open configuration in which the fluid communication path
is open.
[0015] In one embodiment the interlock mechanism is configured to
lock the valve unit in the closed configuration when the interlock
mechanism is in the locking configuration and allow operation of
the valve unit when the interlock mechanism is in the released
configuration.
[0016] In one embodiment the valve unit includes a locking element
which is engaged by the interlock mechanism when the interlock
mechanism is in the locking configuration to prevent operation of
the valve unit.
[0017] In another aspect the present invention provides a nasal
delivery device for delivering particulate substance to the nasal
airway of a subject, the delivery device comprising: a mouthpiece
unit which includes a mouthpiece through which the subject in use
exhales; a nosepiece unit which includes a nosepiece for fitting to
a nostril of the subject; and a substance-supply unit which is
configured to receive a container containing particulate substance
and operable to provide a metered amount of substance in fluid
communication with the mouthpiece and nosepiece units, such that an
exhalation air flow delivered through the substance-supply unit
entrains the substance.
[0018] In one embodiment the container comprises first and second
parts which together define an enclosed chamber and are movable
between a first, closed configuration in which the container is
closed and a second, open configuration in which the container is
open, and the substance-supply unit is operable to move the first
and second parts of the container to the open configuration.
[0019] In one embodiment the first and second parts of the
container are slideably disposed relative to one another and each
include at least one aperture; which are closed with the first and
second parts in the closed configuration and opened by sliding of
the first and second parts to the open configuration.
[0020] In one embodiment the substance-supply unit comprises a
support member, and a body section which is movable relative to the
support member between a first, container-receiving position for
receiving a container in the closed configuration, and a second,
operative position in which the container is opened and disposed in
fluid communication with the mouthpiece and nosepiece units.
[0021] In one embodiment the body section is rotatably disposed to
the support member.
[0022] In one embodiment the body section includes a
container-receiving aperture, which allows for introduction of a
container thereinto when the body section is in the
container-receiving position and is closed when the body section is
in the operative position.
[0023] In one embodiment one of the support member and the body
section includes an inlet aperture which is fluidly isolated from
the mouthpiece unit when the body section is in the
container-receiving position and fluidly connected to the
mouthpiece unit when the body section is in the operative
position.
[0024] In one embodiment the support member and the body section
each include an engagement feature for engaging respective ones of
the first and second parts of the container, and the support member
and the body section are axially movable relative to one another,
such that, on movement of the body section from the
container-receiving position to the operative position, the first
and second parts of the container are moved to the
open-configuration.
[0025] In one-embodiment the support member and the body section
are coupled by a cam mechanism, which provides that the engagement
features thereof are moved between a first spacing in which the
container is received therebetween, a second, closer spacing in
which the first and second parts of the container are moved to the
open configuration, and a third spacing in which the container is
moveable axially between the engagement features.
[0026] In one embodiment the delivery device further comprises: a
housing which supports the mouthpiece unit, the nosepiece unit and
the substance-supply unit.
[0027] In one embodiment the substance-supply unit includes a
container-receiving member which is movably disposed to the housing
between an open position for enabling loading of a container
thereinto, and a closed position in which the container is
contained within the housing.
[0028] In one embodiment the container-receiving member includes a
cavity which defines an air flow channel between the mouthpiece and
nosepiece units, such that an air flow is delivered therethrough on
exhalation by the subject through the mouthpiece, and a support
section for supporting the container in the cavity.
[0029] In one embodiment the container comprises a main body part
and first and second bearing support parts at the respective ends
of the body part, and the support section includes first and second
container supports for rotatably supporting the respective support
parts of the container.
[0030] In one embodiment the support parts of the container
comprise part-spherical projections and the container supports
comprise part-spherical recesses.
[0031] In one embodiment the substance-supply unit includes a
locking mechanism for locking the container-receiving member in the
closed position.
[0032] In a further aspect the present invention provides a nasal
delivery device for delivering particulate substance to the nasal
airway of a subject, the delivery device comprising: a body
assembly including a mouthpiece unit which includes a mouthpiece
through which the subject in use exhales, and a substance-supply
unit which is fluidly connected to the mouthpiece unit and
actuatable to provide particulate substance for delivery to the
nasal airway of the subject; wherein the body assembly is
configured to receive a replaceable nosepiece unit which includes a
nosepiece and contains a container containing particulate
substance.
[0033] In one embodiment the delivery device further comprises: a
replaceable nosepiece unit which includes a nosepiece for fitting
to a nostril of a subject, and a container chamber which contains a
container containing particulate substance.
[0034] In one embodiment the delivery device is configured to
prevent operation until a nosepiece unit is fitted to the body
assembly.
[0035] In one embodiment the body assembly includes an actuation
mechanism which is manually actuatable by the subject to open the
container, and the delivery device is configured to prevent
actuation of the actuation mechanism until the nosepiece unit is
fitted to the body assembly.
[0036] In one embodiment the actuation mechanism is locked in a
locked configuration when a nosepiece unit is not fitted to the
body assembly, such as to prevent operation of the actuation
mechanism.
[0037] In one embodiment the nosepiece unit includes a release
member for releasing the actuation mechanism from the locked
configuration on fitting the nosepiece unit to the body
assembly.
[0038] In one embodiment the actuation mechanism includes an
actuation member which is latched in a locked position in the
locked configuration of the actuation mechanism, and the release
member of the nosepiece unit is operative to release the latched
actuation member on fitting the nosepiece unit to the body
assembly.
[0039] In one embodiment the nosepiece unit is fitted to the body
assembly in one, fitting sense and removed from the body assembly
in the opposite, removal sense, and the release member includes a
support element, an engagement element for engaging the actuation
mechanism and a frangible connection element which connects the
support element to the engagement element, wherein the engagement
element presents a substantially rigid structure when the nosepiece
unit is fitted in a first instance to the body assembly and is
operative to release the actuation mechanism from the locked
configuration, and is deformed on removing the nosepiece unit from
the body assembly.
[0040] In one embodiment the body assembly further comprises a
locking mechanism for locking the actuation mechanism from further
operation following a predeterminable number of operations of the
actuation mechanism.
[0041] In one embodiment the locking mechanism comprises a
rotatable element which is indexed with each actuation of the
actuation mechanism and locks the actuation mechanism to prevent
further operation thereof following a predeterminable number of
operations of the actuation mechanism.
[0042] In a yet further aspect the present invention provides a
container comprising first and second body parts which together
define an enclosed chamber and are movable between a first, closed
configuration in which the container is closed and a second, open
configuration in which the container is open.
[0043] In one embodiment the first and second body parts are
slideably disposed relative to one another and each include at
least one aperture, which are closed with the first and second body
parts in the closed configuration and opened by sliding of the
first and second body parts to the open configuration.
[0044] In one embodiment the first and second body parts include
inter-engaging guides which provide for axial sliding of the first
and second body parts without substantially any rotation
thereof.
[0045] In one embodiment the container is an elongate
container.
[0046] In one embodiment the container is a capsule.
[0047] In one embodiment the container is for containing
particulate substance.
[0048] In a still further aspect the present invention provides a
container comprising a main body part and first and second bearing
support parts at the respective ends of the main body part which
provide bearing supports about which the container is
rotatable.
[0049] In one embodiment the support parts-comprise part-spherical
projections, and preferably substantially hemi-spherical
projections.
[0050] In one embodiment the container is an elongate
container.
[0051] In one embodiment the container is a capsule.
[0052] In one embodiment the container is for containing
particulate substance.
[0053] Preferred embodiments of the present invention will now be
described hereinbelow by way of example only with reference to the
accompanying drawings, in which:
[0054] FIG. 1 illustrates a side view of a delivery device in
accordance with a first embodiment of the present invention;
[0055] FIG. 2 illustrates a plan view of the delivery device of
FIG. 1;
[0056] FIG. 3 illustrates a fragmentary perspective view of the
delivery device of FIG. 1, prior to fitting of the nosepiece unit
to the body assembly;
[0057] FIG. 4 illustrates the perspective view of FIG. 3, where
part cut-away;
[0058] FIG. 5 illustrates a perspective view of the delivery device
of FIG. 1, with the nosepiece unit fitted to the body assembly;
[0059] FIG. 6 illustrates a part cut-away fragmentary perspective
view of the delivery device of FIG. 1 following exhalation by the
subject through the mouthpiece;
[0060] FIG. 7 illustrates a perspective view of a delivery device
in accordance with a second embodiment of the present
invention;
[0061] FIG. 8 illustrates a part cut-away perspective view from the
rear and one side of the delivery device of FIG. 7, with the cover
in an open position;
[0062] FIG. 9 illustrates a part cut-away perspective view from the
front and one side of the delivery device of FIG. 7, with the cover
in an open position;
[0063] FIG. 10 illustrates a part cut-away perspective view from
the rear and one side of the delivery device of FIG. 7, with the
container chamber in the open position;
[0064] FIG. 11 illustrates a part cut-away perspective view from
the rear and one side of the delivery device of FIG. 7, with the
container chamber in the intermediate position;
[0065] FIG. 12 illustrates a container in accordance with one
embodiment of the present invention, in the closed
configuration;
[0066] FIG. 13 illustrates the container of FIG. 12 in the open
configuration;
[0067] FIG. 14 illustrates a perspective view of a delivery device
in accordance with a third embodiment of the present invention,
with the substance-supply unit in the open position for receiving a
container;
[0068] FIG. 15 illustrates the perspective view of FIG. 14, where
partially cut-away and with the substance-supply unit loaded with a
container;
[0069] FIG. 16 illustrates a perspective view of the delivery
device of FIG. 14, where partially cut-away and with the
substance-supply unit loaded with a container;
[0070] FIG. 17 illustrates a perspective view of the delivery
device of FIG. 14, where partially cut-away and with the
substance-supply unit loaded with a container and the actuating
member of the rupturing mechanism in the depressed position;
[0071] FIG. 18 illustrates a part cut-away perspective view of a
delivery device in accordance with a fourth embodiment of the
present invention;
[0072] FIG. 19 illustrates a perspective view of the nosepiece unit
of the delivery device of FIG. 18;
[0073] FIG. 20 illustrates a part cut-away fragmentary perspective
view of the delivery device of FIG. 18, where the nosepiece unit is
being removed from the body assembly and the release member of the
nosepiece unit is being deformed by engagement with the latch
element of the actuating member of the rupturing mechanism;
[0074] FIG. 21 illustrates the perspective view of FIG. 20 in
enlarged scale; and
[0075] FIGS. 22 to 26 illustrate vertical sectional views of the
operative sequence of the delivery device of FIG. 18.
[0076] FIGS. 1 to 6 illustrate a delivery device in accordance with
a first embodiment of the present invention.
[0077] The delivery device comprises a main, body assembly 3 and a
nosepiece unit 5, which contains a container C containing substance
to be delivered to the nasal cavity of a subject and is removably
fitted to the body assembly 3, such as to allow for re-use of the
body assembly 3, as will be described in more detail
hereinbelow.
[0078] In this embodiment the container C comprises a capsule, but
could have any form which contains a metered dose of substance,
such as a blister.
[0079] The body assembly 3 comprises a housing 7, a mouthpiece unit
9 and a substance-supply unit 11 which is fluidly connected to the
mouthpiece unit 9 and to which the nosepiece unit 5 is fitted.
[0080] The mouthpiece unit 9 comprises a mouthpiece 15 which in use
is gripped in the lips of a subject, and an air flow channel 17
which is fluidly connected to the substance-supply unit 11.
[0081] In this embodiment the housing 7 and the mouthpiece unit 9
are integrally formed, typically from a plastics material.
[0082] The substance-supply unit 11 comprises a body section 21
which receives the nosepiece unit 5, a rupturing mechanism 23 which
is operable to rupture the container C as contained by the
nosepiece unit 5, and an interlock member 25 which is operative to
prevent operation of the rupturing mechanism 23 without the
nosepiece unit 5 being fitted, or at least being fitted properly,
to the body section 21.
[0083] The body section 21 comprises a body member 29 which
includes a cavity 31, in this embodiment cylindrical in shape, an
inlet 33 which is in fluid communication with the cavity 31 and
fluidly connected to the air flow channel 17 of the mouthpiece unit
9, and an outlet 35 which is in fluid communication with the cavity
31 and fluidly connected to the nosepiece unit 5 when fitted to the
body section 21. With this configuration, an exhalation air flow,
as delivered through the mouthpiece unit 9, is delivered through
the cavity 31 of the body section 21 and from the nosepiece unit
5.
[0084] The body section 21 further comprises a first guide 41, in
this embodiment comprising a pair of laterally-extending slots 43
on opposed sides of the body member 29, which act to guide the
rupturing mechanism 23 laterally to the body member 29 in rupturing
the contained container C.
[0085] The body section 21 further comprises a second guide 45, in
this embodiment comprising a first pair of longitudinally-extending
slots 47 on opposed sides of the body member 29, which act to guide
the interlock member 25 longitudinally to the body member 29, and a
third longitudinally-extending slot 49, which slideably contains a
contact element 87 of the interlock member 25 and receives a
contact element 97 on the nosepiece unit 5 in providing for release
of the interlock member 25, as will be described in more detail
hereinbelow.
[0086] The substance-supply unit 11 further comprises a valve 51
which is disposed at the inlet 33 of the body member 29 and
operable between a first, closed position, as illustrated in FIG.
4, which substantially prevents an air flow through the cavity 31
of the body member 29, and a second, open position, as illustrated
in FIG. 6, which allows for a flow through the cavity 31 of the
body member 29.
[0087] In this embodiment the valve 51 is a pressure-sensitive
valve which is such as to prevent an air flow through the cavity 31
until a predetermined pressure has been developed upstream
thereof.
[0088] In this embodiment the valve 51 comprises a flap member 57
which is hingeable about a pivot 59 and normally biased to a
closed, sealing position by a resilient element 61, here a spring,
such that a predetermined pressure is required to overcome the
biasing force of the resilient element 61.
[0089] In this embodiment the flap member 57 includes a locking
element 63, here in the form of an arm, which is operably coupled
to the interlock member 25, such that the flap member 57 is locked
in the closed position when the nosepiece unit 5 is not fitted to
the substance-supply unit 11 and is free to be moved to the open
position when the nosepiece unit 5 is fitted to the
substance-supply unit 11, as will be described in more detail
hereinbelow.
[0090] In this embodiment the rupturing mechanism 23 comprises' an
actuating member 73, here in the form of a button, which is
configured to be depressed by the subject, a piercing element 75,
here including two pins, which is supported by the actuating member
73 and operable to pierce the container C, and thereby provide for
release of the contained powdered substance on the generation of a
flow through the cavity 31 of the body section 21, and a biasing
element 76, here a resilient element, such as a compression spring,
for biasing the actuating member 73 to an inoperative position.
[0091] The actuating member 73 includes at least one guide element
77, here a pair of guide elements 77 in the form of arms, which are
slideably disposed in the slots 43 of the first guide 41 of the
body section 21. In this embodiment the at least one guide element
77 includes a detent 79, which retains the actuating member 73
captive in the first guide 41.
[0092] The interlock mechanism 25'comprises an interlock member 81
which is slideably disposed to the body section 21, in this
embodiment longitudinally along the length thereof, and a biasing
element 83, here a resilient element, such as a compression spring,
for normally biasing the interlock member 81 to a locking position,
as illustrated in FIG. 3, such as to prevent operation of the
actuation mechanism 23 when the nosepiece unit 5 is not fitted to
the substance-supply unit 11.
[0093] In this embodiment the interlock member 81 comprises at
least one guide element 85, here a pair of guide elements 85 in the
form of arms, which are slideably disposed in the slots 47 of the
second guide 45 of the body section 21, a contact element 87, here
an elongate element, which is slideably disposed in the slot 49 of
the second guide 45 of the body section 21, and a locking element
89, here defined by an aperture, which is operative to engage with
the locking element 63 on the flap member 57.
[0094] With this configuration, the interlock member 81, when
biased to the locking position, as illustrated in FIG. 3, acts to
lock the flap member 57 in the closed position by engagement of the
locking element 89 of the interlock member 81 and the locking
element 63 of the flap member 57, and the guide elements 85 of the
interlock member 81 are located such as to prevent movement of the
guide elements 77 of the actuating member 73, and thereby prevent
actuation of the same, and, when the nosepiece unit 5 is fitted to
the substance-supply unit 11, as will be described in more detail
hereinbelow, the interlock member 81 is moved against the bias of
the biasing element 83 to a released position, in which the locking
element 89 of the interlock member 81 is disengaged from the
locking element 63 of the flap member 57, such as to allow for the
flap member 57 to be moved and opened on exhalation by the subject
through the mouthpiece unit 9 at a predetermined flow rate, and the
guide elements 85 of the interlock member 81 are moved clear of the
guide elements 77 of the actuating member 73, such as to allow for
actuation of the actuating member 73.
[0095] In one embodiment the mouthpiece unit 9 could include a heat
exchanger which is in fluid communication with the mouthpiece 15
and acts to draw heat from the exhaled air flow as delivered
through the mouthpiece 15, thus decreasing the temperature of the
air flow as delivered to the cavity 31. By decreasing the
temperature of the air flow, the humidity of the air flow is
reduced, with the water vapor condensing in the heat exchanger, and
the impact of condensation is significantly reduced, thus allowing
for successive doses of powdered substance to be delivered without
affecting the release of powdered substance from the containers
C.
[0096] The nosepiece unit 5 comprises a nosepiece 91, in this
embodiment a frusto-conical section, which is inserted into a
nostril of the subject, in this embodiment to provide a sealing fit
therewith, and a container chamber 93 which is in fluid
communication with the nosepiece 91 and contains a container C
containing a powdered substance for delivery to the nasal cavity of
the subject.
[0097] In this embodiment the nosepiece unit 5 further comprises a
grid, here a gauze, which is disposed between the nosepiece 91 and
the container chamber 93, such as to prevent the container C or any
parts thereof, such as resulting from rupturing of the container C,
from passing through the nosepiece 91 and entering the nasal cavity
of the subject.
[0098] In this embodiment the container chamber 93 and the grid, as
components which contact the container C and the contained powder,
are fabricated from a material having a low moisture sensitivity,
here a plastics material, such as to reduce any tendency to become
tacky in the presence of moisture, and therefore reduce the
tendency for the container C and the powdered substance as
contained thereby to adhere to the wall of the container chamber 93
or the grid.
[0099] In this embodiment the nosepiece 91, as a component which
contacts the powdered substance, is fabricated from a material
having a low moisture sensitivity, here a plastics material, such
as to reduce any tendency to become tacky in the presence of
moisture, and therefore reduce the tendency for the powdered
substance to adhere to the wall of the nosepiece 91.
[0100] In one embodiment the container C is a gelatine capsule;
[0101] In another embodiment the container C can be manufactured
from a material which has a reduced tendency to become tacky in the
presence of moisture, as occurs with gelatine capsules, and
therefore reduce the tendency for the container C to adhere to the
wall of the container chamber 93 or the grid.
[0102] In one embodiment the container C is formed of a cellulose
derivative, such as hydroxypropyl methylcellulose (HPMC),
hydroxypropylcellulose, methylcellulose, ethylcellulose and
carboxymethylcellulose
[0103] In another embodiment the container C can comprise a
plastics material, preferably a water insoluble material, such as a
polycarbonate.
[0104] In one embodiment the container C can be manufactured from a
lightweight material, such as thin-wall section polymeric
materials, which reduces the energy required to move the container
C, typically by one or both of vibration and rotation, and thereby
allow the delivery device to be operated at reduced flow rates,
which is particularly advantageous for nasal delivery.
[0105] In an alternative embodiment the container C can include an
outer coating of a material, such as parylene, which has a reduced
tendency to become tacky in the presence of moisture, as occurs
with gelatine capsules, and therefore reduce the tendency for the
container C to adhere to the wall of the container chamber 93 or
the grid.
[0106] In this embodiment, the container C is cylindrical in shape
with hemispherical ends.
[0107] In other embodiments the container C could have other
geometric forms, such as spherical, which allows for efficient
powder release at low flow rates.
[0108] The nosepiece unit 5 further comprises a contact element 97,
in this embodiment an axially-extending element, which is
configured to be a sliding fit in the third slot 49 of the second
guide 45 of the body section 21 of the substance-supply unit 11,
such that, on inserting the nosepiece unit 5 into the body section
21, the contact element 97 engages the contact element 87 of the
interlock member 81, in this embodiment the distal end thereof,
such as to move the interlock member 81 to the released
position.
[0109] Operation of the delivery device will now be described
hereinbelow.
[0110] A subject first inserts a nosepiece unit 5 into the body
section 21 of the substance-supply unit 11. On inserting the
nosepiece unit 5 into the body section 21, the contact element 97
thereof engages the contact element 87 of the interlock member 81,
such as to move the interlock member 81 to the released position
when the nosepiece unit 5 is fully inserted into the
substance-supply unit 11. With the interlock member 81 in the
released position, the flap member 57 is disengaged from the
locking element 89 of the interlock member 81 and free to be moved
by an exhalation air flow, and the actuating member 73 of the
rupturing mechanism 23 is operable by the subject.
[0111] The subject then operates the rupturing mechanism 23 to
rupture the container C as contained in the container chamber 93 of
the nosepiece unit 5.
[0112] The subject then inserts the nosepiece 91 into one of
his/her nostrils, grips the mouthpiece 15 in his/her mouth, and
exhales through the mouthpiece 15.
[0113] The exhaled air flow, where having a sufficient flow rate,
is then driven through the cavity 31 of the body section 21 and the
container chamber 93, which acts to move the container C, in this
embodiment by vibration and rotation, and entrain the powdered
substance as contained by the container C.
[0114] The exhaled air flow, as then entraining the powdered
substance, is delivered though the nosepiece 91 into one nasal
cavity of the subject.
[0115] In this embodiment the exhaled air flow is such as to pass
around the posterior region of the nasal septum, and into the other
nasal cavity, thereby achieving a bi-directional air flow as
described in the applicants' earlier WO-A-00/051672.
[0116] Following use, the nosepiece unit 5 is then removed and the
above-described procedure can be repeated with another nosepiece
unit 5.
[0117] FIGS. 7 to 13 illustrate a delivery device in accordance
with a second embodiment of the present invention.
[0118] The delivery device comprises a housing 103, a nosepiece
unit 105, a mouthpiece unit 109 and a substance-supply unit 111
which is fluidly connected to the nosepiece and mouthpiece units
105, 109. As will be described in more detail hereinbelow, the
delivery device is a re-usable device, to which containers C, in
this embodiment capsules, containing substance to be delivered to
the nasal cavity of a subject are removably loaded.
[0119] As illustrated in FIGS. 12 and 13, the containers C comprise
first and second body parts 115, 117, which together define an
enclosed chamber 119 and are movably disposed, here slideably
disposed relative to one another. The body parts 115, 117 each
include at least one aperture 121, 123, in this embodiment a
plurality of apertures 121, 123, which are closed with the body
parts 115, 117 in a first, closed configuration and are opened by
sliding of the body parts 115, 117 to a second, open configuration
in which the apertures 121, 123 in the body parts 115, 117 are
aligned.
[0120] In this embodiment the body parts 115, 117 include
inter-engaging guides 125, 127, which provide for axial sliding of
the body parts 115, 117 without any rotation thereof, thereby
ensuring alignment of the apertures 121, 123.
[0121] In this embodiment the housing 103 comprises a body 135 to
which the nosepiece unit 105, the mouthpiece unit 109 and the
substance-supply unit 111 are disposed, and a cover 137, here a
hinged lid, which is operable between a closed position in which
the nosepiece and mouthpiece units 105, 109 are enclosed and an
open position in which the nosepiece and mouthpiece units 105, 109
are exposed for use.
[0122] The body 135 includes a container aperture 139, in this
embodiment an elongate aperture, through which a container C is
loaded and removed from the substance-supply unit 111, as will be
described in more detail hereinbelow.
[0123] The nosepiece unit 105 comprises a nosepiece 141, in this
embodiment a frusto-conical section, which is inserted into a
nostril of the subject, here to provide a sealing fit therewith,
and a flow channel 143 which is fluidly connected to the nosepiece
141 and includes a grid 145, in this embodiment a gauze, at one,
lower end thereof.
[0124] The mouthpiece unit 109 comprises a mouthpiece 147 which in
use is gripped in the lips of a subject, and a one-way, non-return
valve 149 which is fluidly connected to the mouthpiece 147 and is
operative to prevent inhalation by the subject through the
mouthpiece 147.
[0125] The substance-supply unit 111 comprises a support member 151
which is fixed to the body 135 of the housing 103, and a body
section 153 which is movably disposed, in this embodiment rotatably
disposed, to the support member 151.
[0126] The support member 151 includes a cam member 161 which
includes a cam track 163 which extends between first and second
positions 165, 167 and includes stops 169 at the respective ends
thereof, in this embodiment at angular positions of 180 degrees. In
this embodiment the cam track 163 includes a first cam section,
corresponding to a first phase of rotation, which is inclined from
a first, lower position 165 to the second, higher position 167 and
a second cam section, corresponding to a second phase of rotation,
which is inclined from the second, higher position 167 to the
first, lower position 165.
[0127] The body section 153 comprises a body member 171, in this
embodiment a tubular member, which defines a container chamber 172
and includes a first, container-receiving aperture 173 in the
lateral wall thereof for receiving a container C, a second, inlet
flow aperture 175 at one, the lower, end thereof, and a third,
outlet flow aperture 177 at the other, upper, end thereof which
receives the flow channel 143 of the nosepiece unit 105 and is
slideably disposed thereto. As will be described in more detail
hereinbelow, the body section 153 is rotatable between a first,
closed position in which the container-receiving aperture 173 is
closed by the enclosure member of the body 135 and the inlet
aperture 175 is in fluid communication with the mouthpiece unit
109, and a second, open position in which the container-receiving
aperture 173 is open to the container aperture 139 in the body 135
and the inlet aperture 175 is closed.
[0128] The body section 153 further comprises a grid 181, here a
gauze, which is located within the body member 171 at a location
intermediate the container-receiving aperture 173 and the inlet
flow aperture 175, which acts to support a container C when loaded
into the body member 171. As will be described in more detail
hereinbelow, the grid 181 is configured to compress the container C
against the grid 145 in the nosepiece unit 105, such as to open the
container C by aligning the apertures 121, 123 thereof.
[0129] The body section 153 further comprises a cam follower 179,
in this embodiment in the form of a projection which projects
laterally from the body member 171, which is configured to ride on
the cam track 163 of the cam member 161 and provide for axial
displacement of the body section 153 relative to the support member
151 on rotation of the body section 153.
[0130] In this embodiment the body section 153 is rotatable between
a closed position, as illustrated in FIGS. 7 to 9, in which the cam
follower 179 is located on the cam track 163 of the cam member 161
at the first, lower position 165, through an intermediate position,
as illustrated in FIG. 11, in which the cam follower 179 is located
on the cam track 163 of the cam member 161 at the second, raised
height 167, and to an open position, as illustrated in FIG. 10, in
which the cam follower 179 is located on the cam track 163 of the
cam member 161 at the first height 165. When the cam follower 179
is located on the cam track 163 of the cam member 161 at the first
height 165, the grid 181 of the body section 153 is spaced from the
grid 145 of the nosepiece unit 105, such as to allow for axial
movement and rotation of a contained container C, and, when the cam
follower 179 is located on the cam track 163 of the cam member 161
at the second height 167, the grid 181 of the body section 153 is
spaced more closely to the grid 145 of the nosepiece unit 105, such
as to cause the compression of the body parts 115, 117 of the
container C and thereby open the container C.
[0131] The body section 153 further comprises an actuating member
183, in this embodiment in the form of a knob, which can be gripped
by the subject and is connected to the body member 171, in this
embodiment at a lower end thereof, such as to provide for rotation
of the body member 171.
[0132] In one embodiment the mouthpiece unit 109 could include a
heat exchanger which is in fluid communication with the mouthpiece
147 and acts to draw heat from the exhaled air flow as delivered
through the mouthpiece 147, thus decreasing the temperature of the
delivered air flow. By decreasing the temperature of the air flow,
the humidity of the air flow is reduced, with the water vapor
condensing in the heat exchanger, and the impact of condensation is
significantly reduced, thus allowing for successive doses of
powdered substance to be delivered without affecting the release of
powdered substance from the containers C.
[0133] In this embodiment the container chamber 172 and the grids
145, 181, as components which contact the container C and the
contained powder, are fabricated from a material having a low
moisture sensitivity, here a plastics material, such as to reduce
any tendency to become tacky in the presence of moisture, and
therefore reduce the tendency for the container C and the powdered
substance as contained thereby to adhere to the wall of the
container chamber 172 or the grids 145, 181.
[0134] In this embodiment the nosepiece 141, as a component which
contacts the powdered substance, is fabricated from a material
having a low moisture sensitivity, here a plastics material, such
as to reduce any tendency to become tacky in the presence of
moisture, and therefore reduce the tendency for the powdered
substance to adhere to the wall of the nosepiece 141.
[0135] In one embodiment the container C is a gelatine capsule.
[0136] In another embodiment the container C can be manufactured
from a material which has a reduced tendency to become tacky in the
presence of moisture, as occurs with gelatine capsules, and
therefore reduce the tendency for the container C to adhere to the
wall of the container chamber 172 or the grids 145, 181.
[0137] In one embodiment the container C is formed of a cellulose
derivative, such as hydroxypropyl methylcellulose (HPMC),
hydroxypropylcellulose, methylcellulose, ethylcellulose and
carboxymethylcellulose
[0138] In another embodiment the container C can comprise a
plastics material, preferably a water insoluble material, such as a
polycarbonate.
[0139] In one embodiment the container C can be manufactured from a
lightweight material, such as thin-wall section polymeric
materials, which reduces the energy required to move the container
C, typically by one or both of vibration and rotation, and thereby
allow the delivery device to be operated at reduced flow rates,
which is particularly advantageous for nasal delivery.
[0140] In an alternative embodiment the container C can include an
outer coating of a material, such as parylene, which has a reduced
tendency to become tacky in the presence of moisture, as occurs
with gelatine capsules, and therefore reduce the tendency for the
container C to adhere to the wall of the container chamber 172 or
the grids 145, 181.
[0141] In this embodiment, the container C is cylindrical in shape
with hemispherical ends.
[0142] In other embodiments the container C could have other
geometric forms, such as spherical, which allows for efficient
powder release at low flow rates.
[0143] Operation of the delivery device will now be described
hereinbelow.
[0144] A subject first operates the actuating member 183 such as to
rotate the body section 153 from the closed position, as
illustrated in FIGS. 7 to 9, in this embodiment through 180
degrees, to the open position, as illustrated in FIG. 10, in which
the container aperture 173 in the body member 171 is aligned with
the container aperture 139 in the housing 103, such as to allow a
container C to be loaded into the container chamber 172 of the body
member 171.
[0145] The subject then again operates the actuating member 183
such as to return the body section 153 to the closed position. In
so operating the actuating member 183, the body section 153 is
first moved from the open position in which the cam follower 179 on
the body section 153 is located on the cam track 163 of the cam
member 161 at the first, lower height 165, through an intermediate
position, as illustrated in FIG. 11, in which the cam follower 179
is located on the cam track 163 of the cam member 161 at the
second, raised height 167. In this intermediate position, the grid
181 of the body section 153 is spaced more closely to the grid 145
of the nosepiece unit 105, such as to cause the compression of the
body parts 115, 117 of the container C and thereby open the
container C. With continued operation of the actuating member 183,
the body section 153 is moved from the intermediate position to the
closed position, as illustrated in FIGS. 7 to 9, in which the cam
follower 179 is located on the cam track 163 of the cam member 161
at the first, lower height 165 and the grid 181 of the body section
153 is spaced further apart from the grid 145 of the nosepiece unit
105, such as to allow for axial movement and rotation of a
contained container C, the container aperture 173 in the body
member 171 is closed by the enclosure member of the housing 103 and
the inlet aperture 175 is in fluid communication with the
mouthpiece unit 109.
[0146] The subject then inserts the nosepiece 141 into one of
his/her nostrils, grips the mouthpiece 147 in his/her mouth, and
exhales through the mouthpiece 147.
[0147] The exhaled air flow, where having a sufficient flow rate,
is then driven through the container chamber 172 of the body member
171 of the body section 153, which acts to move the container C, in
this embodiment by vibration and rotation, and entrain the powdered
substance as contained by the container C.
[0148] The exhaled air flow, as then entraining the powdered
substance, is delivered though the nosepiece 141 into one nasal
cavity of the subject.
[0149] In this embodiment the exhaled air flow has such a pressure
as to pass around the posterior region of the nasal septum, and
into the other nasal cavity, thereby achieving a bi-directional air
flow as described in the applicants' earlier WO-A-00/051672.
[0150] Following use of the device, the actuating member 183 is
first operated such as to rotate the body section 153 from the
closed position, in this embodiment through 180 degrees, to the
open position, in which the container aperture 173 in the body
member 171 is aligned with the container aperture 139 in the
housing 103, such as to allow the used container C to be removed
from the container chamber 172 of the body member 171, and the
actuating member 183 is subsequently operated such as to rotate the
body section 153 from the open position, in this embodiment through
180 degrees, to the closed position, in which the container
aperture 173 in the body member 171 is closed.
[0151] FIGS. 14 to 17 illustrate a delivery device in accordance
with a third embodiment of the present invention.
[0152] The delivery device comprises a housing 203, a nosepiece
unit 205, a mouthpiece unit 209 and a substance-supply unit 211
which is fluidly connected to the nosepiece and mouthpiece units
205, 209. As will be described in more detail hereinbelow, the
delivery device is a re-usable device, to which containers C, in
this embodiment capsules, containing substance to be delivered to
the nasal cavity of a subject are removably loaded.
[0153] As illustrated in FIGS. 14 and 15, the containers C comprise
a main body part 215, in this embodiment of cylindrical section,
and first and second supports 217 at the respective ends of the
body part 215, which act as bearings about which the container C is
rotated. In this embodiment the supports 217 comprise
hemi-spherical structures, which are of smaller radial dimension
than the body part 215 and located on the longitudinal axis of the
body part 215. In one embodiment the supports 217 could be offset
relative to one another or eccentrically weighted, such as to
promote the vibration of the container C on rotation.
[0154] In this embodiment the housing 203 comprises a body 235 to
which the nosepiece unit 205, the mouthpiece unit 209 and the
substance-supply unit 211 are disposed.
[0155] The body 235 includes a container aperture 239, through
which a container C is loaded and removed from the substance-supply
unit 211, as will be described in more detail hereinbelow.
[0156] The nosepiece unit 205 comprises a nosepiece 241, in this
embodiment as defined by a tubular section, which is inserted into
a nostril of the subject, here to provide a sealing fit
therewith.
[0157] In one embodiment the nosepiece unit 205 can include a grid,
such as a gauze, for preventing the container C or parts thereof
from passing through the nosepiece 241 and into the nasal cavity of
the subject.
[0158] The mouthpiece unit 209 comprises a mouthpiece 247 which in
use is gripped in the lips of a subject, and a heat exchanger 249
which is in fluid communication with the mouthpiece 247 and acts to
draw heat from the exhaled air flow as delivered through the
mouthpiece 247, thus decreasing the temperature of the delivered
air flow. By decreasing the temperature of the air flow, the
humidity of the air flow is reduced, with the water vapor
condensing in the heat exchanger 249, and the impact of
condensation is significantly reduced, thus allowing for successive
doses of powdered substance to be delivered without affecting the
release of powdered substance from the containers C.
[0159] In this embodiment the heat exchanger comprises a plurality
of parallel, elongate tubes.
[0160] The substance-supply unit 211 comprises a
container-receiving member 251, which is slideably disposed within
the container aperture 239 in the housing 203 between an open
position for enabling the loading of a container C thereinto, as
illustrated in FIGS. 14 and 15, and a closed position, as
illustrated in FIGS. 16 and 17, in which the container C is
contained within the housing 203.
[0161] In this embodiment the container-receiving member 251
comprises a cavity 253 which defines an air flow channel from the
mouthpiece 245 to the nosepiece 241 and includes first and second
supports 255, in this embodiment part-spherical structures which
act as bearings and are configured to receive the respective
supports 217 of the container C, such that, on delivery of an
exhalation air flow through the cavity 253, the container C is
rotated by the supports 217 thereof.
[0162] The substance-supply unit 211 further comprises a locking
mechanism 261 which is operative to lock the substance-supply unit
211 in the closed position.
[0163] In this embodiment the locking mechanism 261 comprises at
least one arm member 263, in this embodiment a plurality of arm
members 263a, 263b, which are deflectable, here inwardly, and each
include a detent 265 which is engageable with a surface of the
housing 203, such as to lock the substance-supply unit 211 in the
closed position. In this embodiment the substance-supply unit 211
is located in the locked position by pushing the substance-supply
unit 211 into the housing 203, which causes the detents 265 on the
arm members 263a, 263b to ride over the housing 203 and be locked
behind a surface thereof, and withdrawn from the housing 203 by
deflecting the arm members 263a, 263b, here by squeezing the arm
members 263a, 263b inwardly, such as to release the detents 265
from engagement with the respective surfaces of the housing 203,
and pulling the substance-supply unit 211 outwardly.
[0164] The substance-supply unit 211 further comprises a rupturing
mechanism 271 which is operable to rupture the container C as
contained by the nosepiece unit 205.
[0165] In this embodiment the rupturing mechanism 271 comprises an
actuating member 273, here in the form of a button, which is
configured to be depressed by the subject, as illustrated in FIG.
17, a piercing element 275, here including two pins, which is
supported by the actuating member 273 and operable to drive the
piercing element 275 to pierce the container C, and thereby provide
for release of the contained powdered substance on the generation
of a flow through the cavity 253 in the container-receiving member
251, and a resilient element 277, here a compression spring, for
returning the actuating member 273 to the rest position following
piercing of the container C.
[0166] In this embodiment the container-receiving member 251 and
the grid, as components which contact the container C and the
contained powder, are fabricated from a material having a low
moisture sensitivity, here a plastics material, such as to reduce
any tendency to become tacky in the presence of moisture, and
therefore reduce the tendency for the container C and the powdered
substance as contained thereby to adhere to the container-receiving
member 251 or the grid.
[0167] In this embodiment the nosepiece 241, as a component which
contacts the powdered substance, is fabricated from a material
having a low moisture sensitivity, here a plastics material, such
as to reduce any tendency to become tacky in the presence of
moisture, and therefore reduce the tendency for the powdered
substance to adhere to the wall of the nosepiece 241.
[0168] In one embodiment the container C is a gelatine capsule.
[0169] In another embodiment the container C can be manufactured
from a material which has a reduced tendency to become tacky in the
presence of moisture, as occurs with gelatine capsules, and
therefore reduce the tendency for the container C to adhere to the
container-receiving member 251 or the grid.
[0170] In one embodiment the container C is formed of a cellulose
derivative, such as hydroxypropyl methylcellulose (HPMC),
hydroxypropylcellulose, methylcellulose, ethylcellulose and
carboxymethylcellulose
[0171] In another embodiment the container C can comprise a
plastics material, preferably a water insoluble material, such as a
polycarbonate.
[0172] In one embodiment the container C can be manufactured from a
lightweight material, such as thin-wall section polymeric
materials, which reduces the energy required to move the container
C, typically by one or both of vibration and rotation, and thereby
allow the delivery device to be operated at reduced flow rates,
which is particularly advantageous for nasal delivery.
[0173] In an alternative embodiment the container C can include an
outer coating of a material, such as parylene, which has a reduced
tendency to become tacky in the presence of moisture, as occurs
with gelatine capsules, and therefore reduce the tendency for the
container C to adhere to the container-receiving member 251 or the
grid.
[0174] Operation of the delivery device will now be described
hereinbelow.
[0175] A subject first withdraws the substance-supply unit 211 by
deflecting the arm members 263a, 263b of the locking mechanism 261,
here by squeezing the arm members 263a, 263b inwardly, such as to
release the detents 265 thereof from engagement with the respective
surfaces of the housing 203, and pulling the substance-supply unit
211 outwardly.
[0176] The subject then loads a container C into the cavity 253 in
the container-receiving member 251, such that the end parts 217 of
the container C are located on the respective supports 255 of the
cavity 253. It will be appreciated that this design allows the
containers C for different substances to be sized differently, such
as to prevent the device from being used improperly with different
substances.
[0177] The subject then closes the substance-supply unit 211 by
pushing the substance-supply unit 211 into the housing 203, which
causes the detents 265 on the arm members 263a, 263b to ride over
the housing 203 and be locked behind a surface thereof.
[0178] The subject then operates the rupturing mechanism 271 to
rupture the container C, in this embodiment by depressing the
actuating member 273 thereof, as illustrated in FIG. 17, following
which the actuating member 273 is returned to the rest position by
the biasing element 277 thereof.
[0179] The subject then inserts the nosepiece 241 into one of
his/her nostrils, grips the mouthpiece 247 in his/her mouth, and
exhales through the mouthpiece 247.
[0180] The exhaled air flow, where having a sufficient flow rate,
is then driven through the cavity 253 of the container-receiving
member 251, which acts to move the container C, in this embodiment
by vibration and rotation, and entrain the powdered substance as
contained by the container C.
[0181] The exhaled air flow, as then entraining the powdered
substance, is delivered though the nosepiece 241 into one nasal
cavity of the subject.
[0182] In this embodiment the exhaled air flow has such a pressure
as to pass around the posterior region of the nasal septum, and
into the other nasal cavity, thereby achieving a bi-directional air
flow as described in the applicants' earlier WO-A-00/051672.
[0183] Following use of the device, the substance-supply unit 211
is opened by deflecting the arm members 263a, 263b of the locking
mechanism 261, here by squeezing the arm members 263a, 263b
inwardly, such as to release the detents 265 thereof from
engagement with the respective surfaces of the housing 203, and
pulling the substance-supply unit 211 outwardly.
[0184] The subject then unloads the container C from the cavity 253
in the container-receiving member 251, and closes the
substance-supply unit 211, in this embodiment by pushing the
substance-supply unit 211 into the housing 203, which causes the
detents 265 on the arm members 263a, 263b to ride over the housing
203 and be locked behind respective surfaces thereof.
[0185] FIGS. 18 to 26 illustrate a delivery device in accordance
with a fourth embodiment of the present invention.
[0186] The delivery device comprises a main, body assembly 303 and
a nosepiece unit 305, which contains a container C, in this
embodiment a capsule, containing substance to be delivered to the
nasal cavity of a subject and is removably fitted to the body
assembly 303, such as to allow for the re-use of the device, as
will be described in more detail hereinbelow.
[0187] The body assembly 303 comprises a housing 307, a mouthpiece
unit 309, a rupturing mechanism 315 which is operable to rupture
the container C as contained by the nosepiece unit 305, and a
locking mechanism 317 for preventing operation of the rupturing
mechanism 315 without a nosepiece unit 305 being fitted to the
housing 307 and also after a predetermined number of
operations.
[0188] The housing 307 comprises a body 319 which defines a cavity
321 and includes a first, fitting aperture 323 in which the
nosepiece unit 305 is fitted and a second, clearance aperture 325
through which extends an actuating member 371 of the rupturing
mechanism 315.
[0189] In this embodiment the body 319 includes at least one, here
a plurality of projections 327 which are disposed about the fitting
aperture 323, such as to provide for the screw-fitting of the
nosepiece unit 305 to the housing 307.
[0190] The mouthpiece unit 309 comprises a mouthpiece 331 which in
use is gripped in the lips of a subject, an air flow channel 333
which is fluidly connected to the cavity 321 of the housing 307,
and a one-way, non-return valve 335 for preventing inhalation
through the mouthpiece 331.
[0191] In this embodiment the housing 307 and the mouthpiece unit
309 are integrally formed, typically from a plastics material.
[0192] The nosepiece unit 305 comprises a body member 341 which is
configured to fit in the fitting aperture 323 in the housing 307, a
nosepiece 343, here as defined by a tubular section, which is
supported by the body member 341 and is in use inserted into a
nostril of the subject, here to provide a sealing fit therewith,
and a container chamber 345 which is in fluid communication with
the nosepiece 343 and contains a container C containing a powdered
substance for delivery to the nasal cavity of the subject.
[0193] In this embodiment the body member 341 includes at least
one, here a plurality of recesses 351 which are disposed thereabout
in correspondence to the projections 327 which are disposed about
the fitting aperture 323 of the housing 307, such as to provide for
the screw-fitting of the nosepiece unit 305 to the housing 307.
With this configuration, fitting of the nosepiece unit 305 to the
housing 307 first requires insertion of the nosepiece unit 305 into
the housing 307 and subsequently rotation of the nosepiece unit 305
in one sense, here in a counter-clockwise sense when viewed from
above.
[0194] The nosepiece unit 305 further comprises a release member
355 which is configured to engage a counterpart latch member 377 on
the actuating member 371 of the rupturing mechanism 315, such as to
release the actuating member 371 to an operative position following
fitting of the nosepiece unit 305, as will be described in more
detail hereinbelow.
[0195] In this embodiment the release member 355 comprises a
radially-directed arm, which comprises a support element 359 which
is attached to the container chamber 345, an engagement element 361
which is operative to engage the latch member 377 of the actuating
member 371 of the rupturing mechanism 315, and a frangible
connection element 363, here a flexible, deformable element, which
connects the support element 359 to the engagement element 361 in
such a manner that the engagement element 361 presents a rigid
structure when rotated in the one, fitting sense in fitting the
nosepiece unit 305 to the housing 307 and is deformed, here
plastically deformed, when rotated in the other, removal sense in
removing the nosepiece unit 305 from the housing 307, as
represented in FIGS. 20 and 21. In this embodiment the connection
element 363 is bent, and permanently deformed, by engagement with
the latch member 377 of the actuating member 371 of the rupturing
mechanism 315 on removing the nosepiece unit 305 from the housing
307, and this deformation prevents re-use of the nosepiece unit
305, insofar as the release member 355 is no longer operative to
release the actuating member 371 of the rupturing mechanism 315 to
a release position. With this configuration, the possibility of
using a used nosepiece unit 305 is avoided and the subject is thus
ensured of receiving a dose of substance with each operation of the
device.
[0196] In this embodiment the nosepiece unit 305 further comprises
a grid 363, here a gauze, which is disposed between the nosepiece
341 and the container chamber 345, such as to prevent the container
C or any parts thereof, such as resulting from rupturing of the
container C, from passing through the nosepiece 341 and entering
the nasal cavity of the subject.
[0197] In this embodiment the container chamber 345 and the grid
363, as components which contact the container C and the contained
powder, are fabricated from a material having a low moisture
sensitivity, here a plastics material, such as to reduce any
tendency to become tacky in the presence of moisture, and therefore
reduce the tendency for the container C and the powdered substance
as contained thereby to adhere to the wall of the container chamber
345 or the grid 363.
[0198] In this embodiment the nosepiece 341, as a component which
contacts the powdered substance, is fabricated from a material
having a low moisture sensitivity, here a plastics material, such
as to reduce any tendency to become tacky in the presence of
moisture, and therefore reduce the tendency for the powdered
substance to adhere to the wall of the nosepiece 341.
[0199] In one embodiment the container C is a gelatine capsule.
[0200] In another embodiment the container C can be manufactured
from a material which has a reduced tendency to become tacky in the
presence of moisture, as occurs with gelatine capsules, and
therefore reduce the tendency for the container C to adhere to the
wall of the container chamber 345 or the grid 363.
[0201] In one embodiment the container C is formed of a cellulose
derivative, such as hydroxypropyl methylcellulose (HPMC),
hydroxypropylcellulose, methylcellulose, ethylcellulose and
carboxymethylcellulose
[0202] In another embodiment the container C can comprise a
plastics material, preferably a water insoluble material, such as a
polycarbonate.
[0203] In one embodiment the container C can be manufactured from a
lightweight material, such as thin-wall section polymeric
materials, which reduces the energy required to move the container
C, typically by one or both of vibration and rotation, and thereby
allow the delivery device to be operated at reduced flow rates,
which is particularly advantageous for nasal delivery.
[0204] In an alternative embodiment the container C can include an
outer coating of a material, such as parylene, which has a reduced
tendency to become tacky in the presence of moisture, as occurs
with gelatine capsules, and therefore reduce the tendency for the
container C to adhere to the wall of the container chamber 345 or
the grid 363.
[0205] In this embodiment, the container C is cylindrical in shape
with hemispherical ends.
[0206] In other embodiments the container C could have other
geometric forms, such as spherical, which allows for efficient
powder release at low flow rates.
[0207] In this embodiment the rupturing mechanism 315 comprises an
actuating member 371, here in the form of a button, which extends
through the clearance aperture 325 in the housing 307 and is
configured to be depressed by the subject, a piercing element 375,
here including two pins, which is supported by the actuating member
371 and operable to drive the piercing element 375 to pierce the
container C, and thereby provide for release of the contained
powdered substance on the generation of a flow through the
container chamber 345 of the nosepiece unit 305, and a biasing
element 376, here a compression spring, for normally biasing the
actuating member 371 outwardly of the housing 307, such as to
withdraw the piercing element 375.
[0208] The actuating member 371 includes a latch member 377 which
is operative to lock the actuating member 371 in an intermediate
position, as illustrated in FIG. 26, in which the piercing elements
375 are withdrawn from the container chamber 345, such as to allow
for rotation of the contained container C, and first and second lug
members 379, 381 which are operative to operate the locking
mechanism 317 and prevent further depression of the actuating
member 371 from the intermediate position.
[0209] In this embodiment the latch member 377 comprises a
resilient arm 383 and a detent 385 at one end of the arm 383, which
engages a surface of the housing 307 to latch the actuating member
371 in the intermediate position. In this embodiment the latch
member 377 is released, here by deflection of the resilient arm
383, by engagement with the release member 355 of the nosepiece
unit 305 in fitting the nosepiece unit 305 to the housing 307. As
described hereinabove, the release member 355 of the nosepiece unit
305 is not operative to release the latch member 377 on removal of
the nosepiece unit 305 from the housing 307, as the release member
355 is deformed through engagement with the latch member 377.
[0210] In this embodiment the locking mechanism 317 comprises a
rotatable member 391 which includes a plurality of first engagement
elements 393, in this embodiment disposed on a first annulus
centred about the rotation axis of the rotatable member 391, and a
plurality of second engagement elements 395 which are disposed on a
second, larger annulus centred about the rotation axis of the
rotatable member 391.
[0211] The first engagement elements 393 each include an
outwardly-facing, locking surface 397 which, when the actuating
member 371 of the rupturing mechanism 315 is in the intermediate
position, acts to engage an adjacent first lug 379 of the actuating
member 371, such as to prevent depression of the same.
[0212] The second engagement elements 395 each include an indexing
surface 399 which is engaged by respective ones of the lugs 379,
381 such as to index the rotatable member 351, such that the
actuating member 371 of the rupturing mechanism 315 can be
depressed to rupture the contained container C following release of
the actuating member 371 to the released position and prevent
further depression of the actuating member 371 following release of
the actuating member 371 to the intermediate position.
[0213] In one embodiment the mouthpiece unit 309 could include a
heat exchanger which is in fluid communication with the mouthpiece
331 and acts to draw heat from the exhaled air flow as delivered
through the mouthpiece 331, thus decreasing the temperature of the
air flow as delivered to and downstream of the container member
345. By decreasing the temperature of the air flow, the humidity of
the air flow is reduced, with the water vapor condensing in the
heat exchanger, and the impact of condensation is significantly
reduced, thus allowing for successive doses of powdered substance
to be delivered without affecting the release of powdered substance
from the containers C.
[0214] Operation of the delivery device will now be described
hereinbelow.
[0215] A subject first takes a nosepiece unit 305 for fitting to
the body assembly 303, as illustrated in FIG. 22.
[0216] The subject then inserts a nosepiece unit 305 into the
fitting aperture 323 in the housing 307, as illustrated in FIG.
23.
[0217] The subject then rotates the nosepiece unit 305, in this
embodiment in the counter-clockwise sense from above, such as to
lock the nosepiece unit 305 to the housing 307, as illustrated in
FIG. 24. This rotation of the nosepiece unit 305 causes the release
member 355 thereof to engage the latch element 377 of the actuating
member 371, such as to release the same, here by deflection of the
resilient arm 383 of the latch element 377 through engagement with
the release member 355.
[0218] The subject then operates the rupturing mechanism 315 to
rupture the contained container C, as illustrated in FIG. 25,
following which the subject releases the actuating member 371,
which returns to the intermediate position, as illustrated in FIG.
26.
[0219] The subject then inserts the nosepiece 341 into one of
his/her nostrils, grips the mouthpiece 331 in his/her mouth, and
exhales through the mouthpiece 331.
[0220] The exhaled air flow, where having a sufficient flow rate,
is then driven through the cavity 321 in the housing 307 and the
container chamber 345, which acts to move the container C, in this
embodiment by vibration and rotation, and entrain the powdered
substance as contained by the container C.
[0221] The exhaled air flow, as then entraining the powdered
substance, is delivered though the nosepiece 341 into one nasal
cavity of the subject.
[0222] In this embodiment the exhaled air flow has such a pressure
as to pass around the posterior region of the nasal septum, and
into the other nasal cavity, thereby achieving a bi-directional air
flow as described in the applicants' earlier WO-A-00/051672.
[0223] Following use of the device, the nosepiece unit 305 is then
removed from the device assembly 303, in order to allow for the
device to be re-used.
[0224] The nosepiece unit 305 is removed by rotating the nosepiece
unit 305 relative to the housing 307, in this embodiment in a
clockwise sense when viewed from above, and withdrawing the
nosepiece unit 305 from the fitting aperture 323 in the housing
307.
[0225] On rotating the nosepiece unit 305, the release arm 355 of
the nosepiece unit 305 engages the latch member 377 of the
actuating member 371, in this embodiment through engagement with
the engagement element 361 of the release member 355, which causes
the connection element 363 of the release member 355 to be bent,
and permanently deformed. As described hereinabove, this
deformation prevents re-use of the nosepiece unit 305, insofar as
the release member 355 is no longer operative to release the
actuating member 371 of the rupturing mechanism 315 to the
operative position.
[0226] Finally, it will be understood that the present invention
has been described in its preferred embodiments and can be modified
in many different ways without departing from the scope of the
invention as defined by the appended claims.
[0227] In one embodiment the powdered substance can also be
formulated, for example, by coating or blending, such as to reduce
the hygroscopicity and transiently increase the dissolution time,
and thus reduce any loss of powdered substance in the device due to
interaction with condensation on the internal surfaces of the
device.
[0228] Also, the delivery devices of the described embodiments have
been described particularly in relation to the use of capsules. It
is to be understood that the present invention has application with
any kind of powder delivery system, including blisters, and can be
configured as a single-use or multi-use device.
* * * * *