U.S. patent application number 13/099183 was filed with the patent office on 2012-04-19 for delivery devices.
This patent application is currently assigned to OptiNose AS. Invention is credited to Per Gisle Djupesland, Andrew Robert Fry, Christopher John Hurlstone, Matthew Egerton Young.
Application Number | 20120090608 13/099183 |
Document ID | / |
Family ID | 27758847 |
Filed Date | 2012-04-19 |
United States Patent
Application |
20120090608 |
Kind Code |
A1 |
Djupesland; Per Gisle ; et
al. |
April 19, 2012 |
DELIVERY DEVICES
Abstract
A delivery device for and method of delivering substance, the
delivery device comprising: a delivery outlet from which substance
is in use delivered; a gas chamber containing a gas and being of
reducible volume, wherein a reduction in the volume of the gas
chamber to a predeterminable volume acts to pressurize the
contained gas to a predeterminable pressure; a seal element
disposed between the gas chamber and the delivery outlet; and an
opening mechanism configured, on reduction of the volume of the gas
chamber to a predeterminable volume, to open the seal element,
whereupon a gas flow from the gas chamber acts to deliver substance
from the delivery outlet.
Inventors: |
Djupesland; Per Gisle;
(Oslo, NO) ; Young; Matthew Egerton;
(Cambridgeshire, GB) ; Fry; Andrew Robert;
(Hertfordshire, GB) ; Hurlstone; Christopher John;
(Essex, GB) |
Assignee: |
OptiNose AS
Oslo
NO
|
Family ID: |
27758847 |
Appl. No.: |
13/099183 |
Filed: |
May 2, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10520957 |
Nov 30, 2005 |
7934503 |
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PCT/GB03/02961 |
Jul 9, 2003 |
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13099183 |
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Current U.S.
Class: |
128/203.21 |
Current CPC
Class: |
B05B 11/062 20130101;
B05B 11/061 20130101; A61M 15/0028 20130101; A61M 15/003 20140204;
A61M 15/0041 20140204; A61M 2202/04 20130101; A61M 2202/064
20130101; A61M 2202/30 20130101; A61M 15/08 20130101 |
Class at
Publication: |
128/203.21 |
International
Class: |
A61M 16/10 20060101
A61M016/10; A61M 15/00 20060101 A61M015/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 9, 2002 |
GB |
0215904.4 |
Nov 22, 2002 |
GB |
0227345.6 |
Claims
1. A delivery device actuatable to deliver substance, comprising: a
delivery outlet from which substance is in use delivered; a gas
chamber containing a gas and being of reducible volume, wherein a
reduction in the volume of the gas chamber to a predeterminable
volume acts to pressurize the contained gas to a predeterminable
pressure; a seal element disposed between the gas chamber and the
delivery outlet; and an opening mechanism configured, on reduction
of the volume of the gas chamber to a predeterminable volume, to
open the seal element, whereupon a gas flow from the gas chamber
acts to deliver substance from the delivery outlet.
2. The delivery device of claim 1, wherein the gas chamber is
defined in part by a flexible member to which an actuating force is
in use applied in actuating the delivery device, with the actuating
force acting to depress the flexible member such as to reduce the
volume of the gas chamber and pressurize the gas contained
therein.
3. The delivery device of claim 2, wherein the flexible member
comprises an outwardly-projecting member which is depressed on
application of an actuating force.
4. The delivery device of claim 3, wherein the flexible member
comprises a dome-shaped member.
5. The delivery device of claim 3 or 4, wherein the flexible member
is configured such as to provide for deflection thereof in a
controlled, predeterminable fashion in depressing the same on
application of an actuating force.
6. The delivery device of claim 5, wherein the flexible member is
one or both of shaped or sized to provide for controlled
deflection.
7. The delivery device of claim 6, wherein the flexible member
includes ribs which provide for controlled deflection.
8. The delivery device of any of claims 2 to 7, wherein the seal
element comprises a rupturable element, and the opening mechanism
includes a rupturing element which acts to rupture the rupturable
element on depression of the flexible member to a predetermined
extent.
9. The delivery device of claim 8, wherein the rupturing element is
supported at an inner surface of the flexible member in opposed
relation to the rupturable element such as to be moved in a
direction of an actuating force as applied to the flexible
member.
10. The delivery device of claim 8, wherein the opening mechanism
comprises an actuating arm which supports the rupturing element,
with the actuating arm being movably disposed relative to the
rupturable element on engagement by the flexible member, such that,
on depression of the flexible member to a predetermined extent, the
actuating arm is moved such as to cause the rupturing element to
rupture the rupturable element.
11. The delivery device of claim 10, wherein the actuating arm is
hingeably supported such that the rupturing element is rotated to
rupture the rupturable element.
12. The delivery device of claim 8, wherein the opening mechanism
comprises a link assembly which supports the rupturing element,
with the link assembly being movable relative to the rupturable
element on engagement by the flexible member, such that, on
depression of the flexible member to a predetermined extent, the
link assembly is moved such as to cause the rupturing element to
rupture the rupturable element.
13. The delivery device of claim 12, wherein the link assembly
comprises first, second and third hinged links, with the first link
being hinged relative to the rupturable element, the second link
supporting the rupturing element at one, forward end thereof and
the third link coupling the respective other ends of the first and
second links, whereby depression of the flexible member acts to
hinge the first link relative to the rupturable element, which
movement, through the coupling provided by the third link, acts to
drive the second link forwardly to cause the rupturing element
supported thereby to rupture the rupturable element.
14. The delivery device of any of claims 2 to 7, wherein the seal
element comprises a valve element, and the opening mechanism is
configured to release the valve element on depression of the
flexible member to a predetermined extent.
15. The delivery device of claim 14, further comprising: a gas
supply passage operatively in fluid communication with the delivery
outlet; and wherein the valve element is normally in a closed
position in sealing engagement with the gas supply passage, and
moved to an open position out of sealing engagement with the gas
supply passage by the opening mechanism on depression of the
flexible member to a predetermined extent.
16. The delivery device of claim 15, wherein the opening mechanism
comprises a link assembly which supports the valve element, with
the link assembly being movable relative to the gas supply passage
on engagement by the flexible member, such that, on depression of
the flexible member to a predetermined extent, the link assembly is
moved such as to cause the valve element to be moved to the open
position.
17. The delivery device of claim 16, wherein the link assembly
comprises first, second and third hinged links, with the first link
being hinged relative to the gas supply passage, the second link
supporting the valve element at one, forward end thereof and the
third link coupling the respective other ends of the first and
second links, whereby depression of the flexible member acts to
hinge the first link relative to the gas supply passage, which
movement, through the coupling provided by the third link, acts to
drive the second link to cause the valve element supported thereby
to be moved to the open position.
18. The delivery device of claim 17, wherein the link assembly is
configured such that the valve element is withdrawn from the gas
supply passage on depression of the flexible member to a
predetermined extent.
19. The delivery device of claim 16, wherein the link assembly
comprises first and second hinged links, with the first link being
hinged relative to the gas supply passage and the second link
supporting the valve element at one, forward end thereof, whereby
depression of the flexible member acts to hinge the first link
relative to the gas supply passage, which movement acts to drive
the second link to cause the valve element supported thereby to be
moved to the open position.
20. The delivery device of claim 19, wherein the valve element is
pushed from the gas supply passage on depression of the flexible
member to a predetermined extent.
21. The delivery device of claim 19 or 20, wherein the link
assembly further comprises a supporting arm which acts normally to
support the link assembly such that the valve element is in the
closed position.
22. The delivery device of claim 15, wherein the opening mechanism
comprises an actuating arm which supports the valve element, with
the actuating arm being movably disposed relative to the gas supply
passage on engagement by the flexible member, such that, on
depression of the flexible member to a predetermined extent, the
actuating arm is moved such as to move the valve element to the
open position.
23. The delivery device of claim 22, wherein the actuating arm is
hingeably supported such that the valve element is rotated from the
closed position.
24. The delivery device of claim 23, wherein the valve element
comprises a flap.
25. The delivery device of any of claims 22 to 24, wherein the
valve element is normally biased to the gas supply passage in the
closed position.
26. The delivery device of any of claims 22 to 24, wherein the
valve element is bonded to the gas supply passage in the closed
position.
27. The delivery device of any of claims 1 to 26, further
comprising: at least one substance chamber for containing substance
operatively in fluid communication with the delivery outlet.
28. The delivery device of claim 27, comprising: first and second
substance chambers, each separately containing substance components
which are combined for delivery.
29. The delivery device of any of claims 1 to 28, wherein the
delivery device is for insertion into a body cavity; and further
comprising: an expansion mechanism for expanding the body
cavity.
30. The delivery device of claim 29, wherein the expansion
mechanism provides for sealing engagement with the body cavity.
31. The delivery device of claim 29 or 30, wherein the expansion
mechanism comprises first and second expansion arms disposed in
opposed relationship to respective sides of the delivery outlet,
and an actuation member which in use is actuated by a subject in
actuating the delivery device and effects expansion of the
expansion arms.
32. The delivery device of claim 31, wherein the actuation member
comprises an actuation body and first and second biasing arms
extending forwardly of the actuation body such as to engage
respective ones of the first and second expansion arms, whereby
actuation of the actuation body acts to cause expansion of the
first and second expansion arms.
33. The delivery device of claim 32, wherein the first and second
biasing arms comprise resilient elements which act to bias
respective ones of the first and second biasing arms outwardly.
34. The delivery device of claim 29 or 30, wherein the expansion
mechanism comprises first and second levers which are pivotally
hinged relative to opposed sides of the delivery outlet, each of
the levers comprising a first, expansion arm extending forwardly
and laterally of the delivery outlet and a second, biasing arm
extending rearwardly, whereby, on application of an actuation force
to the biasing arms such as to bias the same inwardly, the
expansion arms are driven outwardly to effect expansion of the
same.
35. The delivery device of claim 34, wherein the actuation member
comprises an actuation body and first and second links which couple
respective ones of the biasing arms to the actuation body.
36. The delivery device of claim 29 or 30, wherein the expansion
mechanism comprises a lever which is hinged relative to delivery
outlet, the lever comprising a loading arm which is acted upon by a
subject in actuating the delivery device, and an expansion arm
extending forwardly to one side of the delivery outlet, whereby the
expansion arm is moved outwardly relative to the delivery outlet on
a subject acting upon the loading arm.
37. The delivery device of any of claims 1 to 36, wherein the
delivery device is a nasal delivery device.
38. The delivery device of any of claims 1 to 36, wherein the
delivery device is an oral delivery device.
39. The delivery device of any of claims 1 to 38, wherein substance
is delivered as a liquid.
40. The delivery device of any of claims 1 to 38, wherein substance
is delivered as a powder.
41. A delivery device, comprising: a gas-filled chamber of variable
volume; a delivery outlet coupled to the chamber and from which
substance is deliverable, carried by the gas from the chamber; a
seal between the chamber and the delivery outlet; and opening means
for opening the seal on reduction of the volume of the chamber to a
predeterminable volume, to allow the gas pressurized by the
reduction in the volume of the chamber to flow through the delivery
outlet.
42. A method of delivering substance, comprising the steps of:
reducing the volume of a gas-filled chamber to pressurize the gas
contained therein; when the volume of the chamber is reduced to a
predeterminable volume, providing a fluid connection between the
chamber and a delivery outlet such as cause the pressurized gas to
deliver substance from the delivery outlet.
43. A delivery device substantially as hereinbefore described with
reference to any of FIGS. 1 to 3, FIGS. 4 and 5, FIGS. 6 and 7,
FIGS. 8 to 10, FIGS. 11 and 12, FIGS. 13 and 14, FIGS. 15 and 16,
FIGS. 17 and 18 or FIGS. 19 and 20, optionally in conjunction with
any of FIGS. 21 and 22, FIGS. 23 and 24 or FIGS. 24 and 25, of the
accompanying drawings.
44. A delivery method substantially as hereinbefore described with
reference to any of FIGS. 1 to 3, FIGS. 4 and 5, FIGS. 6 and 7,
FIGS. 8 to 10, FIGS. 11 and 12, FIGS. 13 and 14, FIGS. 15 and 16,
FIGS. 17 and 18 or FIGS. 19 and 20, optionally in conjunction with
any of FIGS. 21 and 22, FIGS. 23 and 24 or FIGS. 24 and 25, of the
accompanying drawings.
Description
[0001] The present invention relates to a delivery device for and a
method of delivering substance, in particular one of a liquid, as a
suspension or solution, or a powder, and especially nasal and oral
delivery device for delivering substances containing a medicament,
especially systemic or topical pharmaceuticals, or a vaccine.
[0002] Nasal and oral delivery of powdered and liquid substances
has been established for some time and there are numerous products
on the market which provide for such delivery.
[0003] As regards nasal delivery, there are many nasal conditions
which require treatment. One such condition is nasal inflammation,
specifically rhinitis, which can be allergic or non-allergic and is
often associated with infection and prevents normal nasal function.
By way of example, allergic and non-allergic inflammation of the
nasal airway can typically effect between 10 and 20% of the
population, with nasal congestion of the erectile tissues of the
nasal concha, lacrimation, secretion of watery mucus, sneezing and
itching being the most common symptoms. As will be understood,
nasal congestion impedes nasal breathing and promotes oral
breathing, leading to snoring and sleep disturbance. Other nasal
conditions include nasal polyps which arise from the paranasal
sinuses, hypertrophic adenoids, secretory otitis media, sinus
disease and reduced olfaction.
[0004] In the treatment of certain nasal conditions, the topical
administration of medicaments is preferable, particularly where the
nasal mucosa is the prime pathological pathway, such as in treating
or relieving nasal congestion. Medicaments that are commonly
topically delivered include decongestants, anti-histamines,
cromoglycates, steroids and antibiotics. At present, among the
known anti-inflammatory pharmaceuticals, topical steroids have been
shown to have an effect on nasal congestion. Topical decongestants
have also been suggested for use in relieving nasal congestion. The
treatment of hypertrophic adenoids and chronic secretory otitis
media using topical decongestants, steroids and anti-microbial
agents, although somewhat controversial, has also been proposed.
Further, the topical administration of pharmaceuticals has been
used to treat or at least relieve symptoms of inflammation in the
anterior region of the nasopharynx, the paranasal sinuses and the
auditory tubes.
[0005] Medicaments can also be systemically delivered through the
nasal pathway, the nasal pathway offering a good administration
route for the systemic delivery of pharmaceuticals, such as
hormones, for example, oxytocin and calcitonin, and analgetics,
such as anti-migraine compositions, as the high blood flow and
large surface area of the nasal mucosa advantageously provides for
rapid systemic uptake.
[0006] Nasal delivery also provides for the administration of
medicaments requiring a rapid onset of action, for example,
analgetics, anti-emetics, insulin, anti-epileptics, sedatives and
hypnotica, and also other pharmaceuticals, for example,
cardio-vascular drugs. It is envisaged that nasal administration
will provide for a fast onset of action, at a rate similar to that
of injection and at a rate much faster than that of oral
administration. Indeed, for the treatment of many acute conditions,
nasal administration is advantageous over oral administration,
since gastric stasis can further slow the onset of action following
oral administration.
[0007] Nasal delivery also further provides an effective delivery
route for the administration of proteins and peptides as produced
by modern biotechnological techniques. For such substances, the
metabolism in the intestines and the first-pass-effect in the liver
represent significant obstacles for reliable and cost-efficient
delivery.
[0008] Furthermore, nasal delivery also further provides for the
treatment of many common neurological diseases, such as
Alzheimer's, Parkinson's, psychiatric diseases and intracerebral
infections, where not possible using existing techniques. The nasal
delivery technique of the present invention allows for delivery to
the olfactory region, which region is located in the superior
region of the nasal cavities and represents the only region where
it is possible to circumvent the blood-to-brain barrier (BBB) and
enable communication with the cerebrospinal fluid (CSF) and the
brain.
[0009] Still furthermore, and a prime focus of the present
invention is the nasal delivery of vaccines. The nasal delivery
device of the present invention has been developed with the
particular aim of providing a delivery device for the mass
treatment, in particular the mass vaccination, of subjects.
[0010] It is an aim of the present invention to provide an improved
delivery device and delivery method, and, in particular, a
low-cost, mass-producible delivery device which can provide for the
generation of a gas flow at a predeterminable pressure on
actuation, thereby providing for precise delivery of substance.
[0011] U.S. Pat. No. 5,215,221 discloses a disposable unit-dose
delivery device for the delivery of a powdered medicament, which
comprises a gas chamber separated from a substance chamber
containing a powdered medicament by a frangible seal element. When
pressure is applied to the gas chamber by squeezing, the gas
pressure within the chamber rises and this pressure ruptures the
seal element. The pressurized gas then suddenly exits through the
substance chamber, where the powdered medicament is fluidized and
entrained by the gas flow.
[0012] This prior art delivery device, whilst being of simple
construction, suffers from the particular disadvantage that it is
very difficult to fabricate the frangible seal element to provide
for rupture reliably at a predetermined gas pressure, as required
to fluidize and dispense substances accurately.
[0013] In one aspect the present invention provides a delivery
device actuatable to deliver substance, comprising: a delivery
outlet from which substance is in use delivered; a gas chamber
containing a gas and being of reducible volume, wherein a reduction
in the volume of the gas chamber to a predeterminable volume acts
to pressurize the contained gas to a predeterminable pressure; a
seal element disposed between the gas chamber and the delivery
outlet; and an opening mechanism configured, on reduction of the
volume of the gas chamber to a predeterminable volume, to open the
seal element, whereupon a gas flow from the gas chamber acts to
deliver substance from the delivery outlet.
[0014] Preferably, the gas chamber is defined in part by a flexible
member to which an actuating force is in use applied in actuating
the delivery device, with the actuating force acting to depress the
flexible member such as to reduce the volume of the gas chamber and
pressurize the gas contained therein.
[0015] More preferably, the flexible member comprises an
outwardly-projecting member which is depressed on application of an
actuating force.
[0016] Still more preferably, the flexible member comprises a
dome-shaped member.
[0017] Preferably, the flexible member is configured such as to
provide for deflection thereof in a controlled, predeterminable
fashion in depressing the same on application of an actuating
force.
[0018] More preferably, the flexible member is one or both of
shaped or sized to provide for controlled deflection.
[0019] Still more preferably, the flexible member includes ribs
which provide for controlled deflection.
[0020] In one embodiment the seal element comprises a rupturable
element, and the opening mechanism includes a rupturing element
which acts to rupture the rupturable element on depression of the
flexible member to a predetermined extent.
[0021] In one embodiment the rupturing element is supported at an
inner surface of the flexible member in opposed relation to the
rupturable element such as to be moved in a direction of an
actuating force as applied to the flexible member.
[0022] In another embodiment the opening mechanism comprises an
actuating arm which supports the rupturing element, with the
actuating arm being movably disposed relative to the rupturable
element on engagement by the flexible member, such that, on
depression of the flexible member to a predetermined extent, the
actuating arm is moved such as to cause the rupturing element to
rupture the rupturable element.
[0023] Preferably, the actuating arm is hingeably supported such
that the rupturing element is rotated to rupture the rupturable
element.
[0024] In a further embodiment the opening mechanism comprises a
link assembly which supports the rupturing element, with the link
assembly being movable relative to the rupturable element on
engagement by the flexible member, such that, on depression of the
flexible member to a predetermined extent, the link assembly is
moved such as to cause the rupturing element to rupture the
rupturable element.
[0025] Preferably, the link assembly comprises first, second and
third hinged links, with the first link being hinged relative to
the rupturable element, the second link supporting the rupturing
element at one, forward end thereof and the third link coupling the
respective other ends of the first and second links, whereby
depression of the flexible member acts to hinge the first link
relative to the rupturable element, which movement, through the
coupling provided by the third link, acts to drive the second link
forwardly to cause the rupturing element supported thereby to
rupture the rupturable element.
[0026] In another embodiment the seal element comprises a valve
element, and the opening mechanism is configured to release the
valve element on depression of the flexible member to a
predetermined extent.
[0027] Preferably, the delivery device further comprises: a gas
supply passage operatively in fluid communication with the delivery
outlet; and wherein the valve element is normally in a closed
position in sealing engagement with the gas supply passage, and
moved to an open position out of sealing engagement with the gas
supply passage by the opening mechanism on depression of the
flexible member to a predetermined extent.
[0028] In one embodiment the opening mechanism comprises a link
assembly which supports the valve element, with the link assembly
being movable relative to the gas supply passage on engagement by
the flexible member, such that, on depression of the flexible
member to a predetermined extent, the link assembly is moved such
as to cause the valve element to be moved to the open position.
[0029] In one embodiment the link assembly comprises first, second
and third hinged links, with the first link being hinged relative
to the gas supply passage, the second link supporting the valve
element at one, forward end thereof and the third link coupling the
respective other ends of the first and second links, whereby
depression of the flexible member acts to hinge the first link
relative to the gas supply passage, which movement, through the
coupling provided by the third link, acts to drive the second link
to cause the valve element supported thereby to be moved to the
open position.
[0030] Preferably, the link assembly is configured such that the
valve element is withdrawn from the gas supply passage on
depression of the flexible member to a predetermined extent.
[0031] In another embodiment the link assembly comprises first and
second hinged links, with the first link being hinged relative to
the gas supply passage and the second link supporting the valve
element at one, forward end thereof, whereby depression of the
flexible member acts to hinge the first link relative to the gas
supply passage, which movement acts to drive the second link to
cause the valve element supported thereby to be moved to the open
position.
[0032] Preferably, the valve element is pushed from the gas supply
passage on depression of the flexible member to a predetermined
extent.
[0033] Preferably, the link assembly further comprises a supporting
arm which acts normally to support the link assembly such that the
valve element is in the closed position.
[0034] In a further embodiment the opening mechanism comprises an
actuating arm which supports the valve element, with the actuating
arm being movably disposed relative to the gas supply passage on
engagement by the flexible member, such that, on depression of the
flexible member to a predetermined extent, the actuating arm is
moved such as to move the valve element to the open position.
[0035] Preferably, the actuating arm is hingeably supported such
that the valve element is rotated from the closed position.
[0036] More preferably, the valve element comprises a flap.
[0037] In one embodiment the valve element is normally biased to
the gas supply passage in the closed position.
[0038] In another embodiment the valve element is bonded to the gas
supply passage in the closed position.
[0039] In one embodiment the delivery device further comprises: at
least one substance chamber for containing substance operatively in
fluid communication with the delivery outlet.
[0040] Preferably, the delivery device comprises: first and second
substance chambers, each separately containing substance components
which are combined for delivery.
[0041] In another embodiment substance may be stored within the gas
chamber.
[0042] In one embodiment the delivery device is for insertion into
a body cavity; and further comprising: an expansion mechanism for
expanding the body cavity.
[0043] Preferably, the expansion mechanism provides for sealing
engagement with the body cavity.
[0044] In one embodiment the expansion mechanism comprises first
and second expansion arms disposed in opposed relationship to
respective sides of the delivery outlet, and an actuation member
which in use is actuated by a subject in actuating the delivery
device and effects expansion of the expansion arms.
[0045] Preferably, the actuation member comprises an actuation body
and first and second biasing arms extending forwardly of the
actuation body such as to engage respective ones of the first and
second expansion arms, whereby actuation of the actuation body acts
to cause expansion of the first and second expansion arms.
[0046] More preferably, the first and second biasing arms comprise
resilient elements which act to bias respective ones of the first
and second biasing arms outwardly.
[0047] In another embodiment the expansion mechanism comprises
first and second levers which are pivotally hinged relative to
opposed sides of the delivery outlet, each of the levers comprising
a first, expansion arm extending forwardly and laterally of the
delivery outlet and a second, biasing arm extending rearwardly,
whereby, on application of an actuation force to the biasing arms
such as to bias the same inwardly, the expansion arms are driven
outwardly to effect expansion of the same.
[0048] Preferably, the actuation member comprises an actuation body
and first and second links which couple respective ones of the
biasing arms to the actuation body.
[0049] In a further embodiment the expansion mechanism comprises a
lever which is hinged relative to delivery outlet, the lever
comprising a loading arm which is acted upon by a subject in
actuating the delivery device, and an expansion arm extending
forwardly to one side of the delivery outlet, whereby the expansion
arm is moved outwardly relative to the delivery outlet on a subject
acting upon the loading arm.
[0050] In one embodiment the delivery device is a nasal delivery
device.
[0051] In another embodiment the delivery device is an oral
delivery device.
[0052] In one embodiment substance is delivered as a liquid.
[0053] In another embodiment substance is delivered as a
powder.
[0054] In another embodiment the present invention provides a
delivery device, comprising: a gas-filled chamber of variable
volume; a delivery outlet coupled to the chamber and from which
substance is deliverable, carried by the gas from the chamber; a
seal between the chamber and the delivery outlet; and opening means
for opening the seal on reduction of the volume of the chamber to a
predeterminable volume, to allow the gas pressurized by the
reduction in the volume of the chamber to flow through the delivery
outlet.
[0055] In a further aspect the present invention provides a method
of delivering substance, comprising the steps of: reducing the
volume of a gas-filled chamber to pressurize the gas contained
therein; when the volume of the chamber is reduced to a
predeterminable volume, providing a fluid connection between the
chamber and a delivery outlet such as cause the pressurized gas to
deliver substance from the delivery outlet.
[0056] The present invention advantageously provides an improved
delivery device, which both provides for efficient delivery of
substances, particularly in critical applications such as drug
delivery where the delivered jet or cloud of liquid or powder needs
to be tightly controlled, and in being of relatively low cost.
[0057] In a preferred embodiment the delivery device provides for
delivery in a repeatable and reproducible manner, particularly as
to the flow characteristics of the entraining gas flow, with
actuation not being influenced by the rate of application of an
actuating force, or ambient conditions, such as temperature or
humidity, or previous storage conditions. Also, in its preferred
embodiment, any manipulation of the characteristics of the seal
element, for example, through cyclic loading of the gas chamber
below its critical pressure limit, does not influence
repeatability.
[0058] Also, it will be appreciated that, in providing for the seal
element to be ruptured separately from the application of pressure,
it is possible to "tune" a predetermined pressure at which the
barrier seal is opened and to prevent premature or undesired
failure of the seal due to misuse or abuse, including storage in
adverse conditions.
[0059] In its preferred embodiment the present invention allows for
manufacture using high-volume, low-cost technologies. "Form, fill
and seal" packaging is one such technology, which utilizes vacuum
forming and laminating technologies, typically using aluminium foil
or polymer materials. Such packaging is well established for a
range of product types, including products in the pharmaceutical
sector, such as capsule blister packs and sachets for lyophilised
drugs, and for a large range of other types of product, such as
coffee sachets and adhesives. It is also known in many
applications, and especially in non-pharmaceutical applications, to
make "form, fill and seal" plastic products which incorporate
welded-in injection-moulded components.
[0060] The present invention thus enables the manufacture of an
effective, low-cost disposable delivery device, such as a drug
delivery device, based on manufacturing processes that are
separately already well-established.
[0061] Preferred embodiments of the present invention will now be
described hereinbelow by way of example only with reference to the
accompanying drawings, in which:
[0062] FIG. 1 illustrates a perspective view of a delivery device
in accordance with a first embodiment of the present invention;
[0063] FIG. 2 illustrates a sectional view of the delivery device
of FIG. 1;
[0064] FIG. 3 illustrates a sectional view of the delivery device
of FIG. 1 following actuation;
[0065] FIG. 4 illustrates a sectional view of a delivery device in
accordance with a second embodiment of the present invention;
[0066] FIG. 5 illustrates a sectional view of the delivery device
of FIG. 4 following actuation;
[0067] FIG. 6 illustrates a sectional view of a delivery device in
accordance with a third embodiment of the present invention;
[0068] FIG. 7 illustrates a sectional view of the delivery device
of FIG. 6 following actuation;
[0069] FIG. 8 illustrates a sectional view of a delivery device in
accordance with a fourth embodiment of the present invention;
[0070] FIG. 9 illustrates a sectional view of the delivery device
of FIG. 8 during actuation;
[0071] FIG. 10 illustrates a sectional view of the delivery device
of FIG. 8 following actuation;
[0072] FIG. 11 illustrates a sectional view of a delivery device in
accordance with a fifth embodiment of the present invention;
[0073] FIG. 12 illustrates a sectional view of the delivery device
of FIG. 11 following actuation;
[0074] FIG. 13 illustrates a sectional view of a delivery device in
accordance with a sixth embodiment of the present invention;
[0075] FIG. 14 illustrates a sectional view of the delivery device
of FIG. 13 following actuation;
[0076] FIG. 15 illustrates a sectional view of a delivery device in
accordance with a seventh embodiment of the present invention;
[0077] FIG. 16 illustrates a sectional view of the delivery device
of FIG. 15 following actuation;
[0078] FIG. 17 illustrates a sectional view of a delivery device in
accordance with an eighth embodiment of the present invention;
[0079] FIG. 18 illustrates a sectional view of the delivery device
of FIG. 17 following actuation;
[0080] FIG. 19 illustrates a sectional view of a delivery device in
accordance with a ninth embodiment of the present invention;
[0081] FIG. 20 illustrates a sectional view of the delivery device
of FIG. 19 following actuation;
[0082] FIG. 21 illustrates a sectional view of a delivery device as
one modification of the delivery device of FIG. 1;
[0083] FIG. 22 illustrates a sectional view of the delivery device
of FIG. 21 following actuation;
[0084] FIG. 23 illustrates a sectional view of a delivery device as
another modification of the delivery device of FIG. 1;
[0085] FIG. 24 illustrates a sectional view of the delivery device
of FIG. 23 following actuation;
[0086] FIG. 25 illustrates a sectional view of a delivery device as
another modification of the delivery device of FIG. 10; and
[0087] FIG. 26 illustrates a sectional view of the delivery device
of FIG. 25 following actuation.
[0088] FIGS. 1 to 3 illustrate a delivery device in accordance with
a first embodiment of the present invention.
[0089] In this embodiment the delivery device is configured as a
unit-dose, disposable nasal delivery device for delivering
substance to a nasal airway of a subject.
[0090] The delivery device comprises a body unit 3 which comprises
a nosepiece 5 for insertion into a nostril of a subject which
includes a delivery outlet 7 from which substance S is delivered,
and a substance chamber 9 in fluid communication with the delivery
outlet 7 which is defined in part by a rupturable seal element 11,
in this embodiment a frangible membrane, here a film, and contains
substance S to be delivered.
[0091] In this embodiment the substance S is a powder, but in
another embodiment could equally be a liquid. For embodiments which
deliver liquids, the delivery outlet 7 can be configured to deliver
the liquid as an aerosol spray, that is, as liquid particles, or a
liquid jet, that is, as a column of liquid.
[0092] In this embodiment the nosepiece 5 has an elongate tubular
body, here of frusto-conical shape, which defines the substance
chamber 9 and includes the delivery outlet 7 at one, forward end
thereof and the seal element 11 at the other, rear end thereof.
[0093] The delivery device further comprises a flexible member 15,
in this embodiment an outwardly-projecting diaphragm, here
dome-shaped, typically part-spherical, and in one embodiment
hemi-spherical, which is disposed to the body unit 3 such as to
define a compressible gas chamber 17 which is in fluid
communication with a surface of the seal element 11 which is
opposite the substance chamber 9. The flexible member 15 is
configured such as to be depressed by a subject in applying an
actuating force F to actuate the delivery device. In depressing the
flexible member 15, typically through the application of a thumb of
the subject where gripping the body unit 3 in ones of the
forefingers, the pressure of the gas contained in the gas chamber
17 progressively increases to generate a gas supply which is at a
pressure sufficient to expel the substance S from the substance
chamber 9 and through the delivery outlet 7 in the nosepiece 5.
[0094] In this embodiment the flexible member 15 supports a
rupturing element 19, here a sharp spike, on the inner surface
thereof which is centrally located such as to oppose the seal
element 11, and, as will be described in more detail hereinbelow,
acts to rupture the seal element 11 on depression of the flexible
member 15 to a predetermined extent, with the actuating force F
being applied in the direction of movement of the rupturing element
19. In this embodiment the seal element 11 has a rupture strength
which exceeds the pressure which can be generated in the gas
chamber 17, such that actuation of the delivery device requires the
rupturing element 19 to rupture the seal element 11, and, in
requiring the flexible member 15 to be advanced to a predetermined
extent to cause the rupturing element 19 to rupture the seal
element 11, the generation of a predetermined pressure in the gas
chamber 17 can be ensured prior to actuation of the delivery
device.
[0095] In this embodiment the flexible member 15 is configured,
here including annular ribs 21, to provide for a controlled
deformation of the flexible member 15 on being depressed, thereby
ensuring the generation of a predetermined pressure in the gas
chamber 17 at the point of the rupturing element 19 rupturing the
seal element 11, and avoiding the possibility of the flexible
member 15 being depressed in a non-uniform manner which could
result in the rupturing element 19 reaching the seal element 11
without the predetermined gas pressure having been achieved.
[0096] In this embodiment the delivery device further comprises a
closure member 23, here a sealing tape, which provides for closure
of the delivery outlet 7 in the nosepiece 5 prior to use of the
delivery device.
[0097] Operation of the delivery device will now be described
hereinbelow.
[0098] A subject first removes the closure member 23 and inserts
the nosepiece 5 into one of his/her nostrils.
[0099] The subject then depresses the flexible member 15, typically
by the application of his/her thumb when gripping the body unit 3
in his/her forefingers. In depressing the flexible member 15, the
rupturing element 19, as supported thereby, advances, and the
pressure of the gas contained in the gas chamber 17 progressively
increases.
[0100] As illustrated in FIG. 3, at a predetermined point in the
depression of the flexible member 15, the rupturing element 19
reaches the seal element 11 and acts to rupture the same. At this
predetermined point, and through the depression of the flexible
member 15, the gas in the gas chamber 17 has a predetermined
pressure, and this pressurized gas passes into and through the
substance chamber 9 such as to expel substance S from the delivery
outlet 7 in the nosepiece 5.
[0101] In this embodiment the delivery device is fabricated using a
"form, fill and seal" approach, where the body unit 3 is
injection-moulded and utilizing a combination of vacuum-forming
techniques with aluminium foil or metallized polymer materials.
[0102] FIGS. 4 and 5 illustrate a delivery device in accordance
with a second embodiment of the present invention.
[0103] The delivery device of this embodiment is quite similar to
the delivery device of the above-described first embodiment, and
thus, in order to avoid unnecessary duplication of description,
only the differences will be described in detail.
[0104] The delivery device of this embodiment differs from that of
the above-described first embodiment in that the substance chamber
9 is defined in part by first and second rupturable seal elements
11, 25, where the first seal element 11 has the same construction
as the seal element 11 of the above-described first embodiment, and
the second seal element 25 has a lower rupture strength than the
predetermined gas pressure generated in the gas chamber 17 in
actuation of the delivery device, such that the second seal element
25 is ruptured on being exposed to the generated gas pressure. With
this configuration, the substance S to be delivered is contained
within a closed environment, and the closure member 23 could be
omitted.
[0105] Operation of the delivery device is identical to that of the
above-described first embodiment, with the second seal element 25
being ruptured by the generated gas pressure subsequent to
rupturing of the first seal element 11 by the rupturing element
19.
[0106] FIGS. 6 and 7 illustrate a delivery device in accordance
with a third embodiment of the present invention.
[0107] The delivery device of this embodiment is quite similar to
the delivery device of the above-described first embodiment, and
thus, in order to avoid unnecessary duplication of description,
only the differences will be described in detail.
[0108] The delivery device of this embodiment differs from that of
the above-described first embodiment in comprising first and second
substance chambers 9, 27 for separately containing first and second
substances S1, S2 which are defined by respective ones of first to
third rupturable seal elements 11, 29, 31, where the first seal
element 11 has the same construction as the seal element 11 of the
above-described first embodiment, and the second and third seal
elements 29, 31 have lower rupture strengths than the predetermined
gas pressure generated in the gas chamber 17 in actuation of the
delivery device, such that the second and third seal elements 29,
31 are ruptured successively subsequent to being exposed to the
generated gas pressure. This embodiment finds particular
application in enabling the delivery of a required substance S
which comprises first and second substances S1, S2 which would
interact when stored together, and in enabling the constitution of
a required substance S from first and second substances S1, S2,
typically where the first substance S1 comprises a diluent and the
second substance S2 comprises a powder which is to be
re-constituted as a required liquid substance S by exposure to the
diluent.
[0109] Operation of the delivery device is identical to that of the
above-described first embodiment, with the second and third seal
elements 29, 31 being ruptured by the generated gas pressure
subsequent to rupturing of the first seal element 11 by the
rupturing element 19.
[0110] FIGS. 8 to 10 illustrate a delivery device in accordance
with a fourth embodiment of the present invention.
[0111] The delivery device of this embodiment is quite similar to
the delivery device of the above-described first embodiment, and
thus, in order to avoid unnecessary duplication of description,
only the differences will be described in detail.
[0112] The delivery device of this embodiment differs from that of
the above-described first embodiment in comprising first and second
substance chambers 9, 27 for separately containing first and second
substances S1, S2 which are defined by respective ones of first to
third rupturable seal elements 11, 29, 31, and in that the
rupturing element 19 is extended such as to reach the third seal
element 31 in actuation of the delivery device, where the first and
third seal elements 11, 31 have the same construction as the seal
element 11 of the above-described first embodiment, in being
required to be ruptured by the rupturing element 19, and the second
seal element 29 has a lower rupture strength than the predetermined
gas pressure generated in the gas chamber 17 in actuation of the
delivery device, such that the second seal element 29 is ruptured
on being exposed to the generated gas pressure. This embodiment
finds particular application in enabling the constitution of a
required substance S from first and second substances S1, S2,
typically where the first substance S1 comprises a diluent and the
second substance S2 comprises a powder which is to be
re-constituted as a required liquid substance S by exposure to the
diluent.
[0113] Operation of the delivery device is identical to that of the
above-described first embodiment, with the first seal element 11
first being ruptured by the rupturing element 19 on being advanced
through depression of the flexible member 15, the second seal
element 29 being ruptured by the generated gas pressure subsequent
to rupturing of the first seal element 11 and thereby providing for
the mixing of the first and second substances S1, S2 to
re-constitute the required substance S, as illustrated in FIG. 9,
and the third seal element 31 being ruptured by the rupturing
element 19 on further advancement thereof through depression of the
flexible member 15, at which point the gas within the gas chamber
17 is at the predetermined delivery pressure.
[0114] FIGS. 11 and 12 illustrate a delivery device in accordance
with a fifth embodiment of the present invention.
[0115] In this embodiment the delivery device is configured as a
unit-dose, disposable nasal delivery device for delivering
substance to a nasal airway of a subject.
[0116] The delivery device comprises a body unit 33 which comprises
a nosepiece 35 for insertion into a nostril of a subject which
includes a delivery outlet 37 from which substance S is delivered,
a substance chamber 39 in fluid communication with the delivery
outlet 37 which is defined in part by a rupturable seal element 41,
in this embodiment a frangible membrane, here a film, and contains
substance S to be delivered, and a rupturing mechanism 42 which is
actuatable to rupture the seal element 41, as will be described in
more detail hereinbelow.
[0117] In this embodiment the substance S is a powder, but in
another embodiment could equally be a liquid. For embodiments which
deliver liquids, the delivery outlet 37 can be configured to
deliver the liquid as an aerosol spray, that is, as liquid
particles, or a liquid jet, that is, as a column of liquid.
[0118] In this embodiment the nosepiece 35 has an elongate tubular
body, here of frusto-conical shape, which defines the substance
chamber 39 and includes the delivery outlet 37 at one, forward end
thereof and the seal element 41 at the other, rear end thereof.
[0119] In this embodiment the rupturing mechanism 42 comprises an
actuating arm 43 and a rupturing element 44, here a sharp spike,
which is supported by the actuating arm 43, with the actuating arm
43 being movable, here resiliently hinged to the rear end of the
nosepiece 35, between a first, normal position, as illustrated in
FIG. 11, in which the rupturing element 44 is disposed adjacent the
seal element 41 and a second, actuated position, as illustrated in
FIG. 12, in which the actuating arm 43 is deflected such as to
cause the rupturing element 44 to rupture the seal element 41.
[0120] The delivery device further comprises a flexible member 45,
in this embodiment an outwardly-projecting diaphragm, here
dome-shaped, typically part-spherical, and in one embodiment
hemi-spherical, which is disposed to the body unit 33 such as to
enclose the rupturing mechanism 42 and define a compressible gas
chamber 47 which is in fluid communication with a surface of the
seal element 41 which is opposite the substance chamber 39. The
flexible member 45 is configured such as to be depressed by a
subject in applying an actuating force F to actuate the delivery
device. In depressing the flexible member 45, typically through the
application of a thumb of the subject where gripping the body unit
33 in ones of the forefingers, the pressure of the gas contained in
the gas chamber 47 progressively increases to generate a gas supply
which is at a predetermined pressure sufficient to expel the
substance S from the substance chamber 39 and through the delivery
outlet 37 in the nosepiece 35, and, on depression of the flexible
member 45 to a predetermined extent, the rupturing mechanism 42 is
actuated through movement of the actuating arm 43 thereof to the
actuated position.
[0121] In this embodiment the seal element 41 has a rupture
strength which exceeds the pressure which can be generated in the
gas chamber 47, such that actuation of the delivery device requires
the rupturing element 44 of the rupturing mechanism 42 to rupture
the seal element 41, and, in requiring the flexible member 45 to be
advanced to a predetermined extent to cause the rupturing element
44 to rupture the seal element 41, the generation of a
predetermined pressure in the gas chamber 47 can be ensured prior
to actuation of the delivery device.
[0122] In this embodiment, the flexible member 45 is configured,
here including annular ribs 51, to provide for a controlled
deformation of the flexible member 45 on being depressed, thereby
ensuring the generation of a predetermined pressure in the gas
chamber 47 at the point of the rupturing element 44 rupturing the
seal element 41, and avoiding the possibility of the flexible
member 45 being depressed in a non-uniform manner which could
result in the rupturing element 44 rupturing the seal element 41
without the predetermined gas pressure having been achieved.
[0123] Operation of the delivery device will now be described
hereinbelow.
[0124] A subject first inserts the nosepiece 35 into one of his/her
nostrils.
[0125] The subject then depresses the flexible member 45, typically
by the application of his/her thumb when gripping the body unit 33
in his/her forefingers. In depressing the flexible member 45, the
pressure of the gas contained in the gas chamber 47 progressively
increases.
[0126] As illustrated in FIG. 12, at a predetermined point in the
depression of the flexible member 45, the actuating arm 43 of the
rupturing mechanism 42 is moved such that the rupturing element 44
reaches the seal element 41 and acts to rupture the same. At this
predetermined point, and through the depression of the flexible
member 45, the gas in the gas chamber 47 has a predetermined
pressure, and this pressurized gas passes into and through the
substance chamber 39 such as to expel substance S from the delivery
outlet 37 in the nosepiece 35.
[0127] In this embodiment the delivery device is fabricated using a
"form, fill and seal" approach, where the body unit 33 is
injection-moulded and utilizing a combination of vacuum-forming
techniques with aluminium foil or metallized polymer materials.
[0128] FIGS. 13 and 14 illustrate a delivery device in accordance
with a sixth embodiment of the present invention.
[0129] The delivery device of this embodiment is quite similar to
the delivery device of the above-described fifth embodiment, and
thus, in order to avoid unnecessary duplication of description,
only the differences will be described in detail.
[0130] The delivery device of this embodiment differs from that of
the above-described fifth embodiment in that the rupturing
mechanism 42 comprises a hinged link assembly 53, in this
embodiment resiliently hinged as a single unit, which supports the
rupturing element 44 such as to provide for movement of the same to
the actuated position, in which the rupturing element 44 ruptures
the seal element 41, on depression of the flexible member 45 to a
predetermined point.
[0131] In this embodiment the rupturing mechanism 42 comprises a
first link 53a which is hinged, here resiliently hinged, at one end
thereof to the rear end of the nosepiece 35, a second link 53b
which supports the rupturing element 44 at one, forward end
thereof, and a third link 53c which couples the respective other
ends of the first and second links 53a, 53b, where the other end of
the first link 53a is located beyond the other end of the second
link 53b In the sense of movement of the second link 53b. With this
configuration, depression of the flexible member 45 acts to hinge
the first link 53a relative to the nosepiece 35, and this movement
of the first link 53a, through the coupling provided by the third
link 53c, acts to drive the second link 53b forwardly to cause the
rupturing element 44, as supported thereby, to rupture the seal
element 41.
[0132] Operation of the delivery device is the same as for that of
the above-described fifth embodiment.
[0133] FIGS. 15 and 16 illustrate a delivery device in accordance
with a seventh embodiment of the present invention.
[0134] In this embodiment the delivery device is configured as a
unit-dose, disposable nasal delivery device for delivering
substance to a nasal airway of a subject.
[0135] The delivery device comprises a body unit 63 which comprises
a nosepiece 65 for insertion into a nostril of a subject which
includes a delivery outlet 67 from which substance S is delivered,
a substance chamber 69 in fluid communication with the delivery
outlet 67 which contains substance S to be delivered, a gas supply
passage 71 which is in fluid communication with and disposed
upstream of the substance chamber 69, and a valve mechanism 72
which is actuatable to open the gas supply passage 71, as will be
described in more detail hereinbelow.
[0136] In this embodiment the substance S is a powder, but in
another embodiment could equally be a liquid. For embodiments which
deliver liquids, the delivery outlet 67 can be configured to
deliver the liquid as an aerosol spray, that is, as liquid
particles, or a liquid jet, that is, as a column of liquid.
[0137] In this embodiment the nosepiece 65 has an elongate tubular
body, here of frusto-conical shape, which defines the substance
chamber 69 and includes the delivery outlet 67 at one, forward end
thereof and the gas supply passage 71 at the other, rear end
thereof.
[0138] In this embodiment the valve mechanism 72 comprises a hinged
link assembly 73, here resiliently hinged as a single unit, and a
seal element 74 which is supported by the link assembly 73, such as
to provide for movement of the seal element 74 from a first, normal
closed position, as illustrated in FIG. 15, in which the seal
element 74 acts to close the gas supply passage 71 and a second,
actuated open position, as illustrated in FIG. 16, in which the gas
supply passage 71 is open.
[0139] In this embodiment the valve mechanism 72 comprises a first
link 73a which is hinged, here resiliently hinged, at one end
thereof to the rear end of the nosepiece 65, a second link 73b
which supports the seal element 74 at one, forward end thereof, and
a third link 73c which couples the respective other ends of the
first and second links 73a, 73b, where the other end of the second
link 73b is located beyond the other end of the first link 73a in
the sense of movement of the second link 73b. With this
configuration, actuation of the delivery device acts to cause the
first link 73a to be hinged relative to the nosepiece 65, and this
movement of the first link 73a, through the coupling provided by
the third link 73c, acts to drive the second link 73b rearwardly to
open the gas supply passage 71.
[0140] The delivery device further comprises a flexible member 75,
in this embodiment an outwardly-projecting diaphragm, here
dome-shaped, typically part-spherical, and in one embodiment
hemi-spherical, which is disposed to the body unit 63 such as to
enclose the valve mechanism 72 and define a compressible gas
chamber 77 which is in operative fluid communication with the gas
supply passage 71. The flexible member 75 is configured to be
depressed by a subject in applying an actuating force F to actuate
the delivery device. In depressing the flexible member 75,
typically through the application of a thumb of the subject where
gripping the body unit 63 in ones of the forefingers, the pressure
of the gas contained in the gas chamber 77 progressively increases
to generate a gas supply which is at a predetermined pressure
sufficient to expel the substance S from the substance chamber 69
and through the delivery outlet 67 in the nosepiece 65, and, on
depression of the flexible member 75 to a predetermined extent, the
valve mechanism 72 is actuated through withdrawal of the seal
element 74 from the gas supply passage 71.
[0141] In this embodiment actuation of the delivery device requires
the seal element 74 of the valve mechanism 72 to be driven from the
gas supply passage 71, and, in requiring the flexible member 75 to
be depressed to a predetermined extent to cause the seal element 74
to be driven from the gas supply passage 71, the generation of a
predetermined pressure in the gas chamber 77 is ensured prior to
actuation of the delivery device.
[0142] In this embodiment the flexible member 75 is configured,
here including annular ribs 81, to provide for a controlled
deformation of the flexible member 75 on being depressed, thereby
ensuring the generation of a predetermined pressure in the gas
chamber 77 at the point of the seal element 74 of the valve
mechanism 72 being driven from the gas supply passage 71, and
avoiding the possibility of the flexible member 75 being depressed
in a non-uniform manner which could result in the seal element 74
being driven from the gas supply passage 71 without the
predetermined gas pressure having been achieved.
[0143] Operation of the delivery device will now be described
hereinbelow.
[0144] A subject first inserts the nosepiece 65 into one of his/her
nostrils.
[0145] The subject then depresses the flexible member 75, typically
by the application of his/her thumb when gripping the body unit 63
in his/her forefingers. In depressing the flexible member 75, the
pressure of the gas contained in the gas chamber 77 progressively
increases.
[0146] As illustrated in FIG. 16, at a predetermined point in the
depression of the flexible member 75, the first link 73a of the
valve mechanism 72 is hinged to an extent as to cause the seal
element 74 to be driven from the gas supply passage 71, in this
embodiment through the coupling provided by the third link 73c
which acts to drive the second link 73b rearwardly to withdraw the
seal element 74 from the gas supply passage 71. At this
predetermined point, and through the depression of the flexible
member 75, the gas in the gas chamber 77 has a predetermined
pressure, and this pressurized gas passes into and through the
substance chamber 69 such as to expel substance S from the delivery
outlet 67 in the nosepiece 65.
[0147] In this embodiment the delivery device is fabricated using a
"form, fill and seal" approach, where the body unit 63 is
injection-moulded and utilizing a combination of vacuum-forming
techniques with aluminium foil or metallized polymer materials.
[0148] FIGS. 17 and 18 illustrate a delivery device in accordance
with an eighth embodiment of the present invention.
[0149] The delivery device of this embodiment is quite similar to
the delivery device of the above-described seventh embodiment, and
thus, in order to avoid unnecessary duplication of description,
only the differences will be described in detail.
[0150] The delivery device of this embodiment differs from that of
the above-described seventh embodiment in that the gas supply
passage 71 has a smaller radial dimension than the substance
chamber 69, and in that the valve mechanism 72 is configured to
drive the seal element 74 forwardly from sealing engagement with
the gas supply passage 71 in actuation of the delivery device, in
this embodiment by insertion into the substance chamber 69.
[0151] In this embodiment the valve mechanism 72 comprises only
first and second links 73a, 73b, with the second link 73b being
longer than the first link 73a, such that the second link 73b is
driven forwardly on movement of the first link 73a through
engagement with the flexible member 75. In this embodiment the
second link 73b includes a supporting arm 83, here having a
resilient structure, which acts to support the second link 73b in
the closed position.
[0152] Operation of the delivery device is the same as for the
delivery device of the above-described seventh embodiment, with the
sealing element 74 being driven forwardly out of sealing engagement
with the gas supply passage 71, as opposed to being driven
rearwardly in being withdrawn from the gas supply passage 71.
[0153] FIGS. 19 and 20 illustrate a delivery device in accordance
with a ninth embodiment of the present invention.
[0154] In this embodiment the delivery device is configured as a
unit-dose, disposable nasal delivery device for delivering
substance to a nasal airway of a subject.
[0155] The delivery device comprises a body unit 93 which comprises
a nosepiece 95 for insertion into a nostril of a subject which
includes a delivery outlet 97 from which substance S is delivered,
a substance chamber 99 in fluid communication with the delivery
outlet 97 which contains substance S to be delivered, a gas supply
passage 101 which is in fluid communication with and disposed
upstream of the substance chamber 99, and a valve mechanism 102
which is actuatable to open the gas supply passage 101, as will be
described in more detail hereinbelow.
[0156] In this embodiment the substance S is a powder, but in
another embodiment could equally be a liquid. For embodiments which
deliver liquids, the delivery outlet 97 can be configured to
deliver the liquid as an aerosol spray, that is, as liquid
particles, or a liquid jet, that is, as a column of liquid.
[0157] In this embodiment the nosepiece 95 has an elongate tubular
body, here of frusto-conical shape, which defines the substance
chamber 99 and includes the delivery outlet 97 at one, forward end
thereof and the gas supply passage 101 at the other, rear end
thereof.
[0158] In this embodiment the valve mechanism 102 comprises an
actuating arm 103 and a seal element 104, here a flap, which is
supported by the actuating arm 103, with the actuating arm 103
being movable, here hinged to the rear end of the nosepiece 95,
between a first, normal closed position, as illustrated in FIG. 19,
in which the seal element 104 closes the gas supply passage 101 and
a second, actuated position, as illustrated in FIG. 20, in which
the actuating arm 103 is deflected such as to release the seal
element 104 from sealing engagement with the gas supply passage 101
and thereby open the same. In this embodiment the seal element 104
is normally biased into sealing engagement with the gas supply
passage 101. In an alternative embodiment the seal element 104
could be bonded, typically adhered, in sealing engagement with the
gas supply passage 101, with the bond being broken with a
predetermined deflection of the actuating arm 103.
[0159] The delivery device further comprises a flexible member 105,
in this embodiment an outwardly-projecting diaphragm, here
dome-shaped, typically part-spherical, and in one embodiment
hemi-spherical, which is disposed to the body unit 93 such as to
enclose the valve mechanism 102 and define a compressible gas
chamber 107 which is in operative fluid communication with the gas
supply passage 101. The flexible member 105 is configured to be
depressed by a subject in applying an actuating force F to actuate
the delivery device.
[0160] In depressing the flexible member 105, typically through the
application of a thumb of the subject where gripping the body unit
93 in ones of the forefingers, the pressure of the gas contained in
the gas chamber 107 progressively increases to generate a gas
supply which at a predetermined pressure sufficient to expel the
substance S from the substance chamber 99 and through the delivery
outlet 97 in the nosepiece 95, and, on compression of the flexible
member 105 to a predetermined extent, the valve mechanism 102 is
actuated through movement of the actuating arm 103 to the actuated
position.
[0161] In this embodiment actuation of the delivery device requires
the seal element 104 of the valve mechanism 102 to be released from
sealing engagement with the gas supply passage 101, and, in
requiring the flexible member 105 to be depressed to a
predetermined extent to cause the seal element 104 of the valve
mechanism 102 to be released from sealing engagement with the gas
supply passage 101, the generation of a predetermined pressure in
the gas chamber 107 is ensured prior to actuation of the delivery
device.
[0162] In this embodiment, the flexible member 105 is configured,
here including annular ribs 111, to provide for a controlled
deformation of the flexible member 105 on being depressed, thereby
ensuring the generation of a predetermined pressure in the gas
chamber 107 at the point of the seal element 104 of the valve
mechanism 102 being released from sealing engagement with the gas
supply passage 101, and avoiding the possibility of the flexible
member 105 being depressed in a non-uniform manner which could
result in the seal element 104 being released from sealing
engagement with the gas supply passage 101 without the
predetermined gas pressure having been achieved.
[0163] Operation of the delivery device will now be described
hereinbelow.
[0164] A subject first inserts the nosepiece 95 into one of his/her
nostrils.
[0165] The subject then depresses the flexible member 105,
typically by the application of his/her thumb when gripping the
body unit 93 in his/her forefingers. In depressing the flexible
member 105, the pressure of the gas contained in the gas chamber
107 progressively increases.
[0166] As illustrated in FIG. 20, at a predetermined point in the
depression of the flexible member 105, the actuating. arm 103 of
the valve mechanism 102 is moved to an extent as to cause release
of the seal element 104 from sealing engagement with the gas supply
passage 101. At this predetermined point, and through the
depression of the flexible member 105, the gas in the gas chamber
107 has a predetermined pressure, and this pressurized gas passes
into and through the substance chamber 99 such as to expel
substance S from the delivery outlet 97 in the nosepiece 95.
[0167] In this embodiment the delivery device is fabricated using a
"form, fill and seal" approach, where the body unit 93 is
injection-moulded and utilizing a combination of vacuum-forming
techniques with aluminium foil or metallized polymer materials.
[0168] FIGS. 21 and 22 illustrate a nasal delivery device as one
modification of the delivery device of the above-described first
embodiment of the present invention.
[0169] The delivery device further comprises an expansion mechanism
112 which acts to expand the nasal cavity of the subject into which
the nosepiece 5 is inserted on actuation of the delivery device. In
one embodiment the expansion mechanism 112 can provide for sealing
with the nasal cavity of the subject.
[0170] In this embodiment the expansion mechanism 112 comprises
first and second expansion arms 113, 114, here flexible elements,
which extend forwardly from the body unit 3 and laterally on
opposed sides of the nosepiece 5, and an actuation member 115 to
which an actuation force F is applied by the subject in actuating
the delivery device such as to be depressed and thereby effect
expansion of the expandable arms 113, 114. In an alternative
embodiment the expansion arms 113, 114 could be pivotally hinged to
the body unit 3, as opposed to being resiliently hinged in this
embodiment.
[0171] In this embodiment the actuation member 115 comprises a body
116 which engages the flexible member 15, and first and second
biasing arms 117, 118 which extend forwardly of the body 116
adjacent respective ones of the first and second expansion arms
113, 114 such as to slide thereagainst on depression of the
actuation member 115 and cause expansion of the expansion arms 113,
114, thereby expanding the nasal cavity, and in particular the
anterior nasal valve. In this embodiment the biasing arms 117, 118
comprise resilient elements which act to bias the respective
expansion arms 113, 114 outwardly.
[0172] It will be appreciated that the above-described second to
fourth embodiments could be similarly modified.
[0173] FIGS. 23 and 24 illustrate a nasal delivery device as
another modification of the delivery device of the above-described
first embodiment of the present invention.
[0174] The delivery device further comprises an expansion mechanism
119 which acts to expand the nasal cavity of the subject into which
the nosepiece 5 is inserted on actuation of the delivery device. In
one embodiment the expansion mechanism 119 can provide for sealing
with the nasal cavity of the subject.
[0175] The expansion mechanism 119 comprises first and second
levers 120, 121 which are hinged, here pivotally hinged, to opposed
sides of the body unit 3. The first and second levers 120, 121 each
comprise a first expansion arm 123 which extends forwardly from the
body unit 3 and laterally of the nosepiece 5 and a second biasing
arm 124 which extends rearwardly of the body unit 3, whereby, when
the subject applies an actuation force F to each of the respective
biasing arms 124, typically by gripping between a thumb and ones of
the forefingers of the subject, the expansion arms 123 expand,
thereby expanding the nasal cavity, and in particular the anterior
nasal valve.
[0176] The expansion mechanism 119 further comprises an actuation
member 125 which comprises a body 126 which engages the flexible
member 15, and first and second links 127, 128 which couple the
respective ones of the biasing arms 124, 124 to the body 126 such
as to provide for the body 126 to be advanced, thereby depressing
the flexible member 15, on closing the biasing arms 124 in applying
an actuation force F thereto.
[0177] It will be appreciated that the above-described second to
fourth embodiments could be similarly modified.
[0178] FIGS. 25 and 26 illustrate a nasal delivery device as a
modification of the delivery device of the above-described fifth
embodiment of the present invention.
[0179] The delivery device further comprises an expansion mechanism
135 which acts to expand the nasal cavity of the subject into which
the nosepiece 35 is inserted on actuation of the delivery device.
In one embodiment the expansion mechanism 135 can provide for
sealing with the nasal cavity of the subject.
[0180] In this embodiment the expansion mechanism 135 comprises a
lever 137 which is hinged to the body unit 33, and comprises a
first loading arm 139 which extends over the flexible member 45 and
is acted upon to depress the flexible member 45, and a second
expansion arm 141 which extends adjacent one side of the nosepiece
35 and is moved outwardly on depression of the loading arm 139,
thereby expanding the nasal cavity, and in particular the anterior
nasal valve.
[0181] It will be appreciated that the above-described sixth to
ninth embodiments could be similarly modified.
[0182] 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.
[0183] In the various implementations of this invention, opening
mechanism geometries, barrier seal burst pressures, and different
nozzle types and geometries may be utilized to produce delivery
devices with a range of applications.
[0184] The present invention could also be implemented as a
multi-dose device where including one or more sacrificial elements
that are replaced for each operation in conjunction with other
components that are reused.
[0185] Also, for oral and nasal delivery devices, the delivery
devices can incorporate a mouthpiece through which a subject
exhales to provide for closure of the oropharyngeal velum during
actuation of the delivery devices. In one embodiment the delivery
devices can be breath-actuated.
[0186] Further, in other embodiments, as nasal delivery devices and
by providing for a fluid-tight seal with the nosepiece 5, 35, 65,
95, the delivery devices can be configured to deliver substance
through one nostril of a subject at such a pressure as to flow
around the posterior margin of the nasal septum and out of the
other nostril of the subject, thereby achieving bi-directional
delivery through the nasal cavities as disclosed in WO-A-00/51672,
the content of which is herein incorporated by reference. In
addition, a supplementary gas flow, in one embodiment derived from
the exhalation breath of a subject, can be provided to provide for
such bi-directional delivery.
[0187] In addition, the present invention finds application other
than as a nasal delivery device, such as an oral delivery device or
a topical delivery device, and, indeed, in a range of
non-healthcare applications where controlled delivery of substance,
as either a powder or liquid, is required.
* * * * *