U.S. patent application number 12/381145 was filed with the patent office on 2010-08-05 for medicament inhalers.
This patent application is currently assigned to Nexus6 Limited. Invention is credited to Pavel Bezmaternykh, Michael J. Gormack, Garth C. Sutherland.
Application Number | 20100192948 12/381145 |
Document ID | / |
Family ID | 40600397 |
Filed Date | 2010-08-05 |
United States Patent
Application |
20100192948 |
Kind Code |
A1 |
Sutherland; Garth C. ; et
al. |
August 5, 2010 |
Medicament Inhalers
Abstract
This invention relates to improvements in or relating to
medicament inhalers. In particular, the invention relates to a
device for releasable attachment to a medicament inhaler, which
monitors patient usage of the medicament inhaler. The invention may
be particularly suitable for use with medicament inhalers used for
the treatment of respiratory diseases.
Inventors: |
Sutherland; Garth C.;
(Auckland, NZ) ; Gormack; Michael J.; (Auckland,
NZ) ; Bezmaternykh; Pavel; (Auckland, NZ) |
Correspondence
Address: |
Davidson, Davidson & Kappel, LLC
485 7th Avenue, 14th Floor
New York
NY
10018
US
|
Assignee: |
Nexus6 Limited
Auckland
NZ
|
Family ID: |
40600397 |
Appl. No.: |
12/381145 |
Filed: |
March 6, 2009 |
Current U.S.
Class: |
128/203.15 |
Current CPC
Class: |
A61M 2205/3584 20130101;
A61M 2205/18 20130101; A61M 2205/3375 20130101; A61M 15/008
20140204; A61M 15/0065 20130101; A61M 2205/502 20130101; A61M
2205/583 20130101; A61M 15/0068 20140204; A61M 15/0083 20140204;
A61M 2205/3313 20130101; A61M 2205/52 20130101; A61M 2205/3592
20130101; A61M 2202/064 20130101; A61M 2205/581 20130101; A61M
2205/3553 20130101; G16H 20/10 20180101; A61M 15/009 20130101 |
Class at
Publication: |
128/203.15 |
International
Class: |
A61M 15/00 20060101
A61M015/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 5, 2009 |
NZ |
574666 |
Claims
1. A device for monitoring patient usage of a medicament inhaler,
said medicament inhaler being adapted to deliver doses of
medicament, and wherein said medicament inhaler includes parts
which move during the dispensing of a dose of medicament, wherein
said device includes: a) a housing, said housing being releasably
attachable to said medicament inhaler, b) an optical dose counter
associated with said housing, said optical dose counter being
adapted to determine when a dose of medicament has been dispensed
by transmitting optical signals through the medicament inhaler, c)
an electronic control module associated with said housing, said
electronic control module including, or being in communication
with, said optical dose counter, d) said electronic control module
being adapted to monitor and/or store data relating to patient
usage of said medicament inhaler, the arrangement and construction
being such that said device is attachable to said medicament
inhaler, and subsequently operable, without any modifications being
required to be made to said medicament inhaler.
2. A device for monitoring patient usage of the medicament inhaler,
as claimed in claim 1, wherein said electronic control module
further includes processing means to enable the electronic control
module to perform operations on said data.
3. A device for monitoring patient usage of the medicament inhaler,
as claimed in claim 1 wherein said housing is adapted to fully
enclose the medicament inhaler.
4. A device for monitoring patient usage of the medicament inhaler,
as claimed in claim 3, wherein said housing is provided with a
hinged portion which, when open, allows the medicament inhaler to
be placed within the housing, and which, when closed, serves to
retain the medicament inhaler within the housing.
5. A device for monitoring patient usage of the medicament inhaler,
as claimed in claim 4, wherein said hinged portion is provided with
closure and release means, to secure said hinged portion in a
closed position, and release said hinged portion from said closed
position, respectively.
6. (canceled)
7. A device for monitoring patient usage of the medicament inhaler,
as claimed in claim 1, wherein said optical dose counter utilises
infrared light.
8. A device for monitoring patient usage of the medicament inhaler,
as claimed in claim 1, wherein said optical dose counter utilises
visible spectrum light.
9. A device for monitoring patient usage of the medicament inhaler,
as claimed in claim 1, wherein said optical dose counter includes:
a) at least one light transmitter able to transmit an optical
signal, b) at least one light receiver able to receive an optical
signal, the arrangement and construction being such that the
movement of said part(s) within the medicament inhaler during the
delivery of a dose of medicament alters the optical signal(s)
whereby the optical dose counter is able to determine that said
dose has been dispensed.
10. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 1, wherein said electronic control
module includes, or is in communication with, a dose counter
display for viewing by the patient.
11. (canceled)
12. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 10, wherein said dose counter display
is adapted to serve as a non-absolute dose counter.
13. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 10, wherein said dose counter display
is adapted to serve as an absolute dose counter.
14. (canceled)
15. (canceled)
16. (canceled)
17. (canceled)
18. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 1, wherein said electronic control
module includes, or is in communication with, a wireless
transmitter to enable the wireless transmitting of data relating to
patient usage of said medicament inhaler.
19. (canceled)
20. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 18, wherein the wireless transmitter
is able to transmit said data in real time.
21. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 18, wherein the wireless transmitter
is able to transmit said data at predetermined intervals and/or as
a result of a predetermined event(s).
22. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 18, wherein said electronic control
module further includes, or is in communication with, a wireless
receiver to enable the wireless receipt of data or instructions
from a third party.
23. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 1, wherein said optical dose counter
includes means to determine deterioration in the inner surfaces of
the medicament inhaler, due to changes in the light levels
reflected from the inner surfaces of the medicament inhaler over
time.
24. (canceled)
25. (canceled)
26. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 1, wherein said medicament inhaler is
a pMDI.
27. A device for monitoring patient usage of the medicament
inhaler, as claimed in claim 1, wherein said medicament inhaler is
a DPI.
28. In combination, a medicament inhaler, said medicament inhaler
being adapted to deliver doses of medicament to a patient, and
wherein said medicament inhaler includes parts which move during
the dispensing of a dose of medicament; and a device for monitoring
patient usage of said medicament inhaler, said device including: a)
a housing, said housing being releasably attachable to said
medicament inhaler, b) an optical dose counter associated with said
housing, said optical dose counter being adapted to determine when
a dose of medicament has been dispensed by transmitting optical
signals through the medicament inhaler, and from a position outside
of the medicament inhaler, c) an electronic control module
associated with said housing, said electronic control module
including, or being in communication with, said optical dose
counter, d) said electronic control module being adapted to monitor
and/or store data relating to patient usage of said medicament
inhaler, the arrangement and construction being such that said
device is attachable to said medicament inhaler, and subsequently
operable, without any modifications being required to be made to
said medicament inhaler.
29. A method of treating a respiratory disease, said method
including the step of utilising said medicament inhaler and said
device, as claimed in claim 28.
Description
[0001] This application claims priority to New Zealand Patent
Application No. 574666, filed Feb. 5, 2009, the contents of which
are hereby incorporated by reference in their entirety.
FIELD
[0002] This invention relates to improvements in or relating to
medicament inhalers. In particular, the invention relates to a
device for releasable attachment to a medicament inhaler, which
monitors patient usage of the medicament inhaler. The invention may
be particularly suitable for use with medicament inhalers used for
the treatment of respiratory diseases such as asthma, COPD, cystic
fibrosis, and bronchiectasis. However, it is to be understood and
appreciated that the invention is not to be limited to such use.
For example, the medicament inhalers could be used to supply
medicaments to treat diseases such as diabetes, heart disease, and
cancer. Furthermore such medicament inhalers could also be used to
supply pain medicament, or medicaments to treat disorders such as
erectile dysfunction and nicotine addiction. The prior art and
possible applications of the invention, as discussed below, are
therefore given by way of example only.
BACKGROUND
[0003] The use of medicament inhalers for the treatment of diseases
or disorders is well known. Such inhalers are generally referred to
as Metered Dose Inhalers (MDI).
[0004] A common type of MDI is what is known as a pressurised
Metered Dose Inhaler (pMDI). Such inhalers generally comprise a
medicament canister and an actuator. The medicament canister
contains medicament under pressure and is designed to deliver a
metered dose of medicament in the form of an aerosol spray. The
actuator generally comprises a substantially L-shaped hollow tube
which has a first open end adapted to receive the medicament
canister, and a second open end which acts as a mouth piece.
Medicament canisters for use with a pMDI generally have a spray
stem extending from one end which is adapted to engage with a
spray-directing element housed within the actuator, and adjacent to
the mouth piece of the actuator. When the canister is pushed down
into the actuator, the spray stem and spray-directing element
combine to direct a metered dose of medicament out through the
mouthpiece and into the mouth of the user.
[0005] Another common type of MDI is what is known as a Dry Powder
Inhaler (DPI). DPI's are generally in the form of a disc or grinder
which may be rotated, or otherwise actuated, in order to dispense a
metered dose of dry powder into an appropriate receptacle such as a
mouthpiece. The dry powder may then be inhaled by the user, for
example, by sucking strongly through the mouthpiece.
[0006] Further examples of medicament inhalers include delivery
devices such as nebulisers and nasal sprays. Such delivery devices
are generally designed to supply a dose of medicament in the form
of a fine mist, which is directed either into the mouth or nasal
cavity of a user.
[0007] Some medicament inhalers are kept on hand for use in a
specific event or emergency. For example, if a person were to have
a sudden asthma attack, they may reach for a medicament inhaler
which contains what is generally known as a "reliever" medicament.
A reliever medicament is fast acting and in most cases will relieve
(or reduce the severity of) an asthma attack, almost
instantaneously.
[0008] Other medicament inhalers are designed for regular use in
order to prevent an event such as an asthma attack and/or to manage
or control a disease such as asthma. Such inhalers are generally
known as "preventers" because the regular use of such inhalers
serves to prevent (or minimise the likelihood of) an asthma attack.
The regular use of preventer medicament by asthma sufferers is
generally effective in controlling the disease and/or preventing
the vast majority of asthma attacks. Commonly, preventer medicament
for asthma sufferers is taken twice a day, usually at a set time in
the morning and in the evening.
[0009] There are now also available "combination" medicament
inhalers which combine both a reliever and preventer
medicament.
[0010] Studies have shown that many people overuse their reliever
medicament, for example by using it when only mildly short of
breath. The overuse of a reliever medicament has the potential to
reduce the effectiveness of the medicament, which may render the
medicament less effective in times of real need, for example during
a severe asthma attack.
[0011] Moreover, a patient's increased use of a reliever medicament
over a period of time may be indicative of a pending exacerbation
event.
[0012] It would therefore be of advantage if there was available a
device for monitoring patient usage of a reliever medicament
inhaler in order to determine any potential overuse and/or for
predicting a potential exacerbation event, prior to the event
occurring.
[0013] A problem or difficulty associated with the use of preventer
(or "combination") medicament inhalers is poor medicament
compliance. That is, many studies have shown that users frequently
do not take their medicament at the predetermined or prescribed
times and/or in the required amounts.
[0014] The consequences of poor medicament compliance are reduced
disease control, lower quality of life, lost productivity,
hospitalisation and avoidable deaths.
[0015] Not only is compliance to preventative medicaments typically
low, but it has also been shown that actual compliance by a user is
lower than the same user's estimated compliance.
[0016] In order to address these problems and difficulties, there
are available a number of compliance monitoring devices for use
with medicament inhalers.
[0017] Virtually all compliance monitoring devices incorporate dose
counting means. In a general sense, dose counting means provide the
simplest embodiment of a compliance monitor, as the dose count may
indicate the number of medicament doses delivered and/or the number
of medicament doses remaining in the medicament inhaler (the latter
known as an "absolute dose counter"). The doses dispensed or
remaining may also be displayed on a dosage counter, such as an LCD
display, housed on the medicament inhaler.
[0018] The earliest dose counting mechanisms for pMDI's usually
incorporated mechanical dose counting switch mechanisms such as
levers or springs or trigger rods--which were mechanically actuated
by movement of the canister within the actuator when a dose of
medicament was dispensed. For example, see U.S. Pat. No. 4,817,822
(Rand et al) and U.S. Pat. No. 5,020,527 (Dessertine).
[0019] There are several problems associated with the use of such
mechanical dose counting means. Firstly, the mechanical switch
mechanisms include moving parts which may suffer wear and tear or
otherwise deteriorate over time. Secondly, the switch mechanisms
could break off and enter the medicament delivery pathway, and be
inadvertently swallowed by the user. Thirdly, the mechanical switch
mechanisms, which are commonly housed inside the actuator, can
change the airflow characteristics of the inhaler, which may
adversely impact on the medicament delivery performance of the
inhaler. Lastly, mechanical switch mechanisms may be inadvertently
triggered by the user, for example during washing of the actuator
body to clean away any built up medicament residue (which must be
done from time to time).
[0020] In recognition of some of the above problems or
difficulties, U.S. Pat. No. 6,601,582 (Rand et al--but referred to
herein as "GSK") describes a mechanical dose counter which is
integrally formed on the medicament canister. However, a
disadvantage associated with GSK is that the incorporation of a
dose counting mechanism into each and every medicament canister
adds cost to the end user. Moreover, given that each canister
typically contains a one month supply of medicament, it is
economically and environmentally wasteful to supply and then
discard such technology with each month's medication.
[0021] More recent dose counting mechanisms incorporate electronic
counting means. For example, see U.S. Pat. No. 5,544,647 (Jewettt
et al), U.S. Pat. No. 6,202,642 (McKinnon et al) and US Patent
Publication No. 2005/0028815 (Deaton et al).
[0022] However, most electronic dose counting mechanisms also rely
on the canister physically engaging with a switch mechanism for the
purpose of closing an electrical switch (to indicate a dosage count
of one). For example, in order to record a dosage count of one,
Jewett includes a microswitch (42) which is physically engaged by
the leading edge (19) of a sleeve (17) which is attached to the
canister (16)--see FIG. 1. Similarly, Deaton utilises a ramp
portion (42) which is physically engaged by the shoulder (26) of
the canister (14) during the dispensing of a dose of
medicament--see FIGS. 22a and 22b.
[0023] Hence, because such electronic dose counting means also
include moving parts, these parts are likewise susceptible to wear
and tear and/or deterioration over time (they may also be
susceptible to breaking off and/or interfering with the airflow
within the inhaler).
[0024] Furthermore, the fitting of mechanical or electronic dose
counters to an inhaler usually requires modifications to the
inhaler, for example the drilling of a hole in the side of the
actuator or the attachment of a cap or sleeve to the canister. The
fitting of such dose counters to an inhaler can therefore be a
fiddly or time consuming operation.
[0025] More importantly however, any modifications made to the
actuator (or canister) have the potential to interfere with the
airflow characteristics within the actuator, possibly affecting the
effectiveness of delivery of a dose of medicament. This may result
in the patient not receiving the required amount of medicament in
order to treat the disease.
[0026] Any modifications made to the actuator may also be prone to
disruption when washing the actuator. This may subsequently result
in inaccurate dose counting or compliance monitoring (Jewett and
Deaton address this issue by housing the compliance monitoring
means within a hermetically sealed housing--which increases cost
and manufacturing complexity).
[0027] Most mechanical or electronic dose counters are designed to
be absolute dose counters. That is, when a new medicament canister
is placed in the actuator, the counters are either manually or
automatically set to the number of doses remaining in the full
canister (typically around 120 doses which usually comprises one
month's supply of a preventer medicament). The GSK device referred
to previously is an example of an absolute dose counter (but formed
on the canister, rather than the actuator).
[0028] Every time a dose of medicament is dispensed, the dose
counter serves to reduce the displayed number of doses remaining by
one. Hence a user is able to keep track of the number of doses
remaining in the canister, and can therefore ensure he/she has a
replacement canister at hand prior to when the first canister is
due to run out.
[0029] A disadvantage associated with absolute dose counters is
that they are dedicated to only one canister at a time. Hence, they
are not able to monitor the ongoing compliance characteristics of a
user over a period of time which may involve the user going through
many canisters of medicament. Moreover, absolute dose counters are
not able to monitor a person's usage over all four seasons to
determine useful information such as any seasonal fluctuations.
Absolute dose counters are also not able to monitor the ongoing
compliance characteristics of a user should they change medications
when only half way through an existing canister.
[0030] Presently available electronic compliance monitoring devices
also include means to record a range of compliance data, in
addition to dose counting. For example, Dessertine includes a timer
to indicate time between doses. McKinnon includes an electronic
module to record date and time as well as more comprehensive
patient usage information.
[0031] Most electronic compliance monitoring devices are integrally
formed with the inhaler, usually by being mounted on, or integrally
formed with, the actuator body (eg, see Jewett and Deaton). This
presents its own difficulties or limitations.
[0032] Firstly, because the compliance monitoring device is
integrated with the medicament inhaler, it cannot generally be
reused for longer than the life of the inhaler. Furthermore,
compliance monitoring technology, and especially electronic
compliance monitoring technology, adds cost when integrated into
each and every inhaler.
[0033] However, reusing an actuator over more than one medicament
canister can lead to residual medicament build-up that reduces the
quantity of the drug delivered by the inhaler, and can also change
the deposition properties of the aerosol particles, meaning
patients get less medication.
[0034] Furthermore, repeatedly discarding the plastic and
electronic compliance monitoring technology also creates an
environmental sustainability problem that needs to be addressed.
Additionally, as not all disease sufferers exhibit poor disease
control or poor compliance, it is wasteful to provide such features
embedded into each inhaler of a given type.
[0035] Perhaps partly in recognition of the above disadvantages
associated with inhalers with integrally formed compliance
monitoring means, McKinnon describes an electronic module which is
releasably attachable to a sleeve which is fitted to the actuator.
However, the removal of the electronic module from the sleeve
renders the sleeve inoperable, which must then be removed and
discarded, which is wasteful and expensive. Furthermore, the
electronic module must be reprogrammed once it has been removed
from the sleeve and prior to the module being fitted to another
sleeve. Moreover, the fitting of the sleeve and electronic module
to an inhaler is a time consuming and complex operation--which may
present significant operational difficulties, especially for young
children, the elderly or people of reduced mental capacity.
Furthermore, the sleeve is preferably designed for attachment to
only one specific brand of actuator. Hence, the McKinnon device
cannot be used across a range of different actuators.
[0036] U.S. Pat. No. 5,564,414 (Walker et al) describes the concept
of a removable sleeve designed to fit the body of a manufacturer's
inhaler. However, Walker uses a mechanical counting mechanism (an
external plunger-type trigger rod), which has the same
disadvantages generally associated with mechanical counting means,
as referred to previously.
[0037] PCT/US2008/052869 (Levy et al) describes a sleeve housing
which is releasably attachable to an actuator body. The sleeve
housing includes electronic monitoring apparatus and the device is
designed to monitor usage in order to predict an exacerbation
event. However, Levy relies on a counting means which requires
attachment of a cap to the canister which is adapted to engage with
a dose-dispensing sensor during the delivery of a dose of
medicament. Hence, Levy requires modifications to the inhaler prior
to being able to be used--which has the potential, over time, to
interfere with the effectiveness of the inhaler to properly deliver
medicament.
[0038] Levy also discloses the use of wireless technology to
transmit compliance date to a remote device such as the laptop of a
health professional. This data may be transmitted in real time or
at predetermined set times.
[0039] Furthermore, the sleeve components described in McKinnon,
Walker and Levy would not be able to be used in relation to a
medicament canister already fitted with an absolute dose counter,
eg the GSK device referred to previously.
[0040] Another problem associated with integrated electronic
compliance monitoring devices is that many drugs are regulated and
require exact actuator conformity. That is, there should be no
modifications made to the actuator structure as any modifications
may distort the reliability of the delivery of the medicament.
Moreover, physicians, researchers, insurance companies, and so on,
would not want to risk (for example, in terms of liability) the
possibly of affecting the proper delivery of the medicament through
these dedicated electronic instruments without the same assurance
of proper drug delivery as with the commercial actuator provided by
the drug manufacturer.
[0041] Having regard to the foregoing, it would therefore be of
advantage if there was available a device for monitoring patient
usage of a medicament inhaler which was releasably attachable to
range of different medicament inhalers, and without any
modifications being required to the inhaler.
Object
[0042] It is an object of the present invention to provide an
improved medicament inhaler which goes some way towards addressing
the aforementioned problems or difficulties, or which at the very
least provides the public with a useful choice.
[0043] It is a further object of the present invention to provide a
releasably attachable device for a medicament inhaler which goes
some way towards addressing the aforementioned problems or
difficulties, or which at the very least provides the public with a
useful choice.
Definitions
[0044] Throughout this specification unless the text requires
otherwise, the word `comprise` and variations such as `comprising`
or `comprises` will be understood to imply the inclusion of a
stated integer or step or group of integers or steps but not the
exclusion of any other integer or step or group of integers or
steps.
[0045] Throughout this specification, the term "patient" or "user",
when used in relation to a medicament inhaler, is to be understood
to refer to any person that uses a medicament inhaler.
Statements of Invention
[0046] According to one aspect of the present invention, there is
provided a device for monitoring patient usage of a medicament
inhaler, said medicament inhaler being adapted to deliver doses of
medicament, and wherein said medicament inhaler includes parts
which move during the dispensing of a dose of medicament, [0047]
wherein said device includes: [0048] a) a housing, said housing
being releasably attachable to said medicament inhaler, [0049] b)
an optical dose counter associated with said housing, said optical
dose counter being adapted to determine when a dose of medicament
has been dispensed by transmitting optical signals through the
medicament inhaler, [0050] c) an electronic control module
associated with said housing, said electronic control module
including, or being in communication with, said optical dose
counter, [0051] d) said electronic control module being adapted to
monitor and/or store data relating to patient usage of said
medicament inhaler, [0052] the arrangement and construction being
such that said device is attachable to said medicament inhaler, and
subsequently operable, without any modifications being required to
be made to said medicament inhaler.
[0053] The medicament inhaler may be any suitable medicament
inhaler capable of delivering a dose(s) of medicament, and
preferably (but not exclusively) a metered dose of medicament. For
example, the medicament inhaler may be a pMDI, a DPI, a nebuliser
or a nasal spray.
[0054] Preferably, the medicament inhaler may include part(s) which
move during the delivery of a dose of medicament. For example, in
the case of a pMDI, the moving part would be a medicament canister,
which moves within an actuator during the dispensing of a dose of
medicament. Likewise, a DPI may include a rotating disk, which
moves in order to place a dose of dry medicament into a
compartment, for subsequent inhalation by the patient.
[0055] The device may be utilised for use with inhalers that
contain a preventer medicament and/or inhalers that contain a
combination medicament. The device may therefore serve as a
compliance monitor in respect of the patient usage of such
inhalers.
[0056] The device may also be used to monitor patient usage of a
reliever medicament in order to determine any potential overuse
and/or for predicting a potential exacerbation event, prior to the
event occurring.
[0057] The device may preferably include a housing which may be
releasably attachable to an inhaler.
[0058] An advantage associated with having a releasably attachable
housing is that the device may be reused by the patient. For
example, when an inhaler exhausts its supply of medicament, the
device may be removed from the inhaler and releasably fitted to
either another inhaler or the device may remain on the same
inhaler, but with a replacement supply of medicament added.
Furthermore, any data being collected by the device in relation to
the patient usage of the inhaler may therefore be continuous over a
period of time that may include the patient going through many
supplies of medicament (either with the same inhaler or across a
range of inhalers and/or medicaments). Hence, a comprehensive
amount of patient usage data may be obtained over a significant
period of time.
[0059] The releasably attachable housing may preferably be
attachable to the inhaler, and subsequently operable, without any
modifications being required to the inhaler. That is, the inhaler
simply sits partially or fully within the housing of the
device.
[0060] A significant advantage of such an arrangement is that the
device does not in any way interfere with, or otherwise affect, the
ability of the inhaler to administer medicament. This compares
favourably with the prior art devices referred to previously, most
of which require modifications to the inhaler in order to be fitted
and/or operable. For example, modifications may include the
drilling of a hole into the side of the inhaler or the fitting of a
cap to a medicament canister--both of which have the potential to
interfere with the airflow characteristics within the inhaler
and/or adversely affect the ability of the inhaler to dispense
medicament.
[0061] Furthermore, the attaching of the housing to the inhaler
preferably does not require the use of any tools in order to be
fitted (for example, the housing is not releasably screwed into or
onto the inhaler). Instead, the inhaler to be used with the present
invention is simply placed within the housing of the device.
[0062] The housing may be of any suitable size, shape or
configuration as required or desired, or as dictated by the type or
configuration of the inhaler.
[0063] In one embodiment, the housing may be in the form of a
sleeve adapted to be fitted around the outside of the inhaler.
[0064] The housing may be adapted to partially enclose the inhaler
and/or to clip onto the inhaler. For example, the housing may be in
the form of a substantially U-shaped sleeve adapted to clip snugly
around the outside of the inhaler. In such an embodiment the
housing may be provided with additional means to help secure the
housing to the inhaler, for example by the use of ties, straps or
clips.
[0065] In another embodiment, the housing may be adapted to fully
encircle and/or fully contain the inhaler.
[0066] The housing may be provided with a hinged portion, which,
when open, allows the inhaler to be placed within the housing, and
which, when closed, serves to retain and/or secure the inhaler
substantially within the housing. In such an embodiment, the hinged
portion may be provided with closure and release means, to secure
the hinged portion in a closed position, and release the hinged
portion from said closed position, respectively. For example, the
closure and release means may be provided by a suitable fastener
such as a VELCRO brand fastener, or alternatively by a latch-type
mechanism. The closure and release means may also be provided by
the closing edge of the hinged portion having a male portion which
is adapted to releasably engage with a corresponding female portion
formed in the housing proper.
[0067] The housing may be made of any suitable material although a
plastics material may be preferred as it is relatively light, and
may be conveniently and inexpensively mass produced, for example by
injection moulding technology.
[0068] The housing may be substantially opaque, translucent or
transparent. For example, the housing may be substantially opaque
and of the same colour as a particular manufacturer's range of
inhalers to which it is intended to be fitted.
[0069] Alternatively, the housing may be substantially transparent
(or translucent). This may have practical implications given that
the inner working of the housing and/or the inhaler may be
inspected or monitored through the housing. Such an embodiment may
also have some aesthetic appeal given that the inner workings of
the housing may be viewed.
[0070] The optical dose counter may preferably be adapted to
determine when a dose of medicament has been dispensed by
transmitting optical signals through the inhaler.
[0071] Preferably, the optical dose counter transmits (and
receives) optical signals from a position outside of the inhaler.
Hence, the optical dose counter does not impact, in any way, on the
ability of the medicament inhaler to dispense medicament.
[0072] Preferably, the optical dose counter may be incorporated
within the housing of the device. Alternatively the optical dose
counter may be housed on the outside of the housing.
[0073] An advantage of utilising an optical dose counter generally
is that the dose counter does not require any physical connection
with the medicament inhaler in order to be able to register when a
dose has been dispensed. Furthermore, the recording of a dose of
medicament does not require any moving parts such as mechanical or
electrical switches.
[0074] The optical dose counter may utilise any type of light from
within the electromagnetic spectrum. For example, the dose counter
may utilise infrared light. Alternatively, the dose counter may
utilise visible light.
[0075] According to another aspect of the present invention there
is provided a device for monitoring patient usage of a medicament
inhaler, substantially as described above, wherein said optical
dose counter includes: [0076] a) at least one light transmitter
able to transmit an optical signal, [0077] b) at least one light
receiver able to receive an optical signal, [0078] the arrangement
and construction being such that movement of the part(s) within the
medicament inhaler during the delivery of a dose of medicament
alters the optical signal(s) whereby the optical dose counter is
able to determine that a dose has been dispensed.
[0079] In one embodiment, the light receiver(s) may be positioned
substantially opposite the light transmitter(s) in order to receive
a substantially direct beam of light, for example a laser beam. In
such an embodiment, the movement of part(s) within the inhaler
during the dispensing of a dose may temporarily block the beam of
light, thus enabling the dose counter to register that a dose of
medicament has been dispensed.
[0080] In an alternative embodiment, the light transmitter(s) may
transmit a normal beam of light, which will generally disperse
outwardly from the point of transmission. The movement of part(s)
within the inhaler during the dispensing of a dose will therefore
affect the light signal, for example by the light reflecting off
the part(s) as they move. This will alter the intensity of light
being received by the light receiver(s), thus enabling the dose
counter to register that a dose of medicament has been dispensed.
In such an embodiment, it is not necessary that the moving part(s)
actually block the light signal to enable a dose to be detected
and/or counted. Hence, the light transmitter(s) and light
receiver(s) need not necessarily be positioned substantially
opposite each other. It is also possible that the light
transmitter(s) and light receiver(s) could be positioned next to
each other or side by side.
[0081] One skilled in the art will appreciate that the sensitivity
of the optical dose counter could be calibrated to ensure that the
optical counter only registers when a dose has been dispensed, as
compared to other instances of movement of the part(s) within the
inhaler, for example any movement caused when the inhaler is bumped
or being carried around in the bag of a user.
[0082] The device may also include an audio sensor to detect sound
associated with movement of the medicament container during
delivery of a dose and/or sound associated with the inhalation of
the medicament by the patient. In such an embodiment, the optical
dose counter may be adapted to receive information gathered by the
audio sensor, and use this to confirm its own data that a dose of
medicament has been dispensed. Furthermore, the optical dose
counter may be configured to only record that a dose has been
dispensed when the optical dose sensor and the audio sensor both
determine that a dose has been dispensed. That is, if the audio
sensor determined that a dose had been dispensed, but the optical
dose counter did not (or vice versa), then a dose may not be
recorded.
[0083] It is also envisaged that the optical dose counter may be
adapted or able to monitor for non-dose counting events, for
example: [0084] 1. When a medicament container has been removed
from and/or placed into the inhaler. [0085] 2. When an inhaler has
been removed from and/or placed into the housing of the device.
[0086] 3. The amount of medicament remaining in the medicament
container.
[0087] For Items 1 and 2 above, the removal of the medicament
container or inhaler will affect the light signal, for example by
the light reflecting off the part(s) as they move. This will alter
the intensity of light being received by the light receiver(s),
thus enabling the optical dose counter to register and/or record
that one or both of these events has occurred. Moreover, the
removal of the medicament container will alter the light intensity
in a different way to the removal of the inhaler proper, and hence
the optical dose sensor may be calibrated be able to differentiate
between these two events and/or determine which event has
occurred.
[0088] For Item 3 above, the optical dose counter may be able to
determine the amount of medicament remaining in the medicament
container by monitoring the ongoing intensity of light passing
through the medicament container. The optical dose counter and/or
electronic control module may be further adapted to sound an alert
when the level of medicament remaining reaches a certain
threshold.
[0089] The optical dose counter may also be provided with its own
memory (and real time clock) in order to store any counting or
non-counting data.
[0090] The electronic control module may preferably be housed
within the housing of the device. Alternatively, the electronic
control module may be housed on the outside of the housing.
[0091] The electronic control module may preferably include, or be
in communication with the optical dose counter. Hence, the optical
dose counter may be a stand alone unit in communication with the
electronic control module, or it may be deemed to be incorporated
within the electronic control module.
[0092] It is envisaged that both the optical dose counter and/or
electronic control module may be housed within a hermetically
sealed compartment(s), for example to minimise exposure to dust or
medicament particles or to enable the device to be washed from time
to time.
[0093] The electronic control module may preferably include, or be
in communication with, means for monitoring and/or storing data
relating to patient usage of the medicament inhaler. The means for
storing data may, for example, include a ROM or RAM memory storage
means.
[0094] The electronic control module may further include processing
means to enable the electronic control module to perform operations
on the patient usage data. The result of any operations performed
on the patient usage data may be stored in the memory associated
with the electronic control module.
[0095] The electronic control module may preferably include a user
interface to allow the patient to access any data recorded or
received by the electronic control module, and/or to change the
settings of the device. Preferably, the user interface may include
a visible screen, such as a LCD screen, and at least one control
button.
[0096] The electronic control module may preferably include a dose
counter display for viewing by the patient, for example on a LCD
screen. This LCD screen may be the same as that used with the user
interface. In such an embodiment, the dose counter display may
temporarily disappear when the patient is using the user interface
to change the settings of the device, only to reappear once the
patient has finished, for example after a predetermined length of
time has passed since the user interface was last used.
[0097] Alternatively the dose counter display may have its own
dedicated display.
[0098] Preferably, the dose counter display may be updated each
time a dose of medicament is dispensed.
[0099] The device may be used by the patient to serve as an
absolute dose counter. In such an embodiment, and for example, the
patient may utilise the user interface to choose this option and
then enter the total number of doses remaining to be dispensed by
the medicament, this number being displayed by the dose counter
display. After the dispensing of each dose of medicament by the
inhaler, the dose counter display will reduce the number of doses
remaining by one.
[0100] The device may also be used by the patient to serve as a
non-absolute dose counter. In such an embodiment, and for example,
the patient may utilise the user interface to choose this option
and then reset the dose counter display counter to zero. After the
dispensing of each dose of medicament by the inhaler, the dose
counter display will increase the number of doses taken by one.
Furthermore, the patient may keep an ongoing total of the number of
doses of medicament dispensed over a set period of time, and in
relation to a number of medicament containers, rather than just in
relation to one supply of medicament.
[0101] Preferably, the electronic control module includes, or is in
communication with, a means to record the date and/or time of each
dose of medicament, for example a real time clock. Furthermore, the
real time clock may also be used to date/time stamp any other
events, for example when the processor performed certain
operations, or when an alarm was raised or sent, or when the
inhaler was removed from the device, and so on.
[0102] The electronic control module may preferably include
notification means to notify the patient of a particular event. For
example, the notification means may include a means for reminding
the patient to take a dose of medicament should the electronic
control module determine or receive notification that the patient
has not taken a dose within a predetermined time. Likewise, the
notification means may be adapted to alert the patient to a
situation where they have taken too much of a medicament over a
predetermined time period, which may be indicative of an
exacerbation event.
[0103] The notification means may preferably include, or be in
communication with, a visual display and/or an audio output
means.
[0104] For example, a visual notification display may appear on the
user interface, perhaps as a flashing message to draw attention to
itself. Alternatively, or additionally, an audio output such as an
alarm may be made through the audio output means. Different alarms
may be sounded for different alerts, or if a patient has
continually forgotten to take his/her medicament. In such an
embodiment, it may also be possible for the patient to mute the
audio output means, for example if the patient was in a meeting or
a movie theatre.
[0105] A further example of a notification means that may be used
with the present invention is that described in our granted NZ
Patent No. 540250.
[0106] The electronic control module may preferably include, or be
in communication with, a wireless transmitter to enable the
wireless transmitting of patient usage data. The data may
preferably be transmitted to a public access network such as the
internet. Alternatively, the data may be transmitted to a private
access network such as dedicated computer or intranet
[0107] The wireless transmitter may preferably be in the form of a
cell phone chip housed within the electronic control module (or the
housing). An advantage associated with the present invention is
that the significant cost of installing a cell phone chip may be
mitigated by the fact that the device is reusable and has an
indefinite lifetime. That is, one reason cell phone chips (or like
wireless technology) are not usually included in presently
available monitoring devices is because such monitoring devices are
not designed to be reusable, and hence the cost of installing a
cell phone chip in such a short-lived, disposable device is
prohibitive. The present invention therefore overcomes this problem
because the device is designed to be reusable over a significant
time period, and across a range of different inhalers.
[0108] The wireless transmitter may preferably be adapted to
transmit data to a third party such as a medical practitioner or to
a parent or care giver.
[0109] The wireless transmitter may preferably be adapted to
transmit the data in real time.
[0110] Alternatively, the wireless transmitter may be adapted to
transmit data at a predetermined time(s), or in response to when a
predetermined condition eventuates. For example, if too many doses
of medicament have been dispensed over a set time period this may
be indicative of an impending exacerbation event. An appropriate
warning may then be made to either the patient or a third party
such as a care giver or medial practitioner. Likewise, if the
patient has forgotten to take their medicament a certain number of
times and over a predetermined length of time, an appropriate
warning may likewise be transmitted to such a third party.
[0111] The electronic control module may also preferably include,
or be in communication with, a wireless receiver (or transceiver)
to enable the wireless receipt of data or instructions. In such an
embodiment, and for example, the wireless receiver may be utilised
to enable the patient (or a third party) to send instructions from
a remote location or electronic device to change one or more of the
settings of the device, or to access the data stored within the
device. Such an embodiment may provide an alternative to the
patient using the user interface and/or may enable the patient to
have more options regarding the choice of (or change to) settings
of the device. The wireless receiver may also be utilised to
receive notifications and possibly sound an alert or alarm. For
example, if a third party such as a parent or medical practitioner
had received data from the device which indicated that an
exacerbation was imminent, that third party may be able to transmit
a warning to the device, for example by the use of a laptop or
mobile phone.
[0112] The device may alternatively, or additionally, be provided
with a wired port to enable the transmission of data or
instructions between the device and another electronic device.
[0113] The optical dose counter may be adapted to determine
deterioration in the inner surfaces of the medicament inhaler, for
example deterioration caused by build up of medicament residue,
which should be cleaned off to ensure the ongoing optimal
performance of the inhaler. The means for determining this may be
based on changes in the light levels reflected from the inner
surfaces of the medicament inhaler over time. Namely, the light
transmitter(s) of the optical dose counter will be continuously
transmitting light through the inhaler when the medicament inhaler
is in its rest position, that is, in a non-dose dispensing
configuration. Over time, the light receiver(s) may detect a slight
variation in the quality of light reflected off the inside walls of
the inhaler, which may suggest the inhaler may need to be cleaned
and/or replaced once a predetermined variation has been reached.
One such a predetermined variation has been reached, an audible or
visual alarm may be instigated to alert the patient to the
deteriorating condition of the inhaler.
[0114] It may be appreciated that the device, which is the subject
of the present application, may be utilised across a range of
different medicament inhalers of similar design. For example, the
device may be designed whereby it was able to be used across a
certain range (such as one company's range) of pMDI or DPI inhalers
which were of similar size and/or which shared similar design
features. Hence, a patient may be able to utilise the device for
ongoing usage monitoring or compliance if, for example, they
changed medicament (which came with a different inhaler), but
whereby the different inhaler was still able to be utilised with
the device. This may be of particular advantage during clinical
trials where the ongoing monitoring of a patient is being
undertaken over a considerable time period, and perhaps whereby the
patient changes medicament half way through the trial.
[0115] The device may also be adapted to be operationally effective
when attached to a medicament inhaler which already includes an
inbuilt dose counter, for example the GSK device referred to
previously. In such an embodiment, the housing of the device may be
provided with cut away portions so that the inbuilt dose counter
may still be viewed.
Preferred Embodiments
[0116] The description of a preferred form of the invention to be
provided herein, with reference to the accompanying drawings, is
given purely by way of example and is not to be taken in any way as
limiting the scope or extent of the invention.
DRAWINGS
[0117] FIG. 1: is a front perspective view of one possible
embodiment of the present invention,
[0118] FIG. 2: is a front perspective view of the embodiment
illustrated in FIG. 1, when attached to a pMDI medicament
inhaler,
[0119] FIG. 3: is a side view of the embodiment illustrated in FIG.
2,
[0120] FIG. 4: is a cut-away view of the embodiment illustrated in
FIG. 3,
[0121] FIG. 5: is cut away view illustrating one possible
embodiment of an optical dose counter for use with the present
invention, when a medicament canister is in a rest position,
[0122] FIG. 6: is a view of the embodiment illustrated in FIG. 5,
with the medicament canister in a dose dispensing position,
[0123] FIG. 7: is a rear view of a prior art medicament
canister,
[0124] FIG. 8: is a rear view of the prior art medicament canister
illustrated in FIG. 7, when housed within the embodiment
illustrated in FIG. 1,
[0125] FIG. 9: is a perspective view of another possible embodiment
of the present invention, when attached to a DPI medicament
inhaler,
[0126] FIG. 10: is a simplified system block diagram showing one
possible embodiment of an electronic control module and optical
dose counter for use with the present invention.
Description of Preferred Embodiments
[0127] Having regard to the drawings, there is shown a device,
generally indicated by arrow 1, for monitoring the patient usage of
a medicament inhaler, generally indicated by arrow 2 (see FIG.
2).
[0128] The device 1 includes a housing, generally indicated by
arrow 3, for releasable attachment to the inhaler 2. The housing 3
is adapted to fully encircle and/or fully contain the inhaler
2.
[0129] The inhaler 2 is a pMDI inhaler which includes an actuator 4
and a medicament canister 5.
[0130] The housing 3 is comprised of an injection moulded plastics
material and is substantially translucent in appearance.
[0131] The housing 3 is provided with a main body portion 6 and a
hinged body portion 7.
[0132] The main body portion 6 is substantially hollow and includes
an interior portion 8 which is adapted to substantially match the
exterior configuration of the inhaler 2, whereby the inhaler 2 may
be snugly retained within the interior portion 8 of the main body
portion 6. The main body portion 6 also includes lower ledge
portions 9, upon which the underside 10 of the actuator 4 rests,
once the inhaler 2 has been placed within the main body portion
6.
[0133] The hinged portion 7 in FIG. 1 is shown in an open position
which allows the inhaler 2 to be placed into the interior portion 8
of the main body portion 6. Once the inhaler 2 has been placed in
the main body portion 6, the hinged portion 7 is closed, as shown
in FIG. 2. The hinged portion 7 is releasably secured to the main
body portion 6 by the use of a latch (not shown).
[0134] It may be seen from the drawings that the housing 3 is
releasably attachable to, or around, the inhaler 2, and
subsequently operable, without any modifications being required to
the inhaler 2. The inhaler 2 may be operated as normal once
retained within the device 1.
[0135] Furthermore, the attaching of the housing 3 to or around the
inhaler 2 does not require the use of any tools in order to be
fitted; instead the inhaler 2 is simply placed within the housing 3
of the device 1.
[0136] The device 1 includes an electronic control module 11 (not
physically shown, but represented in FIG. 10) housed within a side
12 of the housing 3. The electronic control module 11 is adapted to
monitor and/or store data relating to patient usage of the inhaler
2.
[0137] The side 12 of the housing 3 includes a user interface,
generally indicated by arrow 13. The user interface 13 allows the
patient to access data recorded or received by the electronic
control module, and also to change the settings of the device 1.
The user interface 13 includes operational buttons 14 and a LCD
display 15. One of the operational buttons 14 may be an on/off
switch.
[0138] The device 1 includes an optical dose counter, generally
indicated by arrow 16 (see FIG. 4). The optical dose counter 16 is
housed within the housing 3, and is in electronic communication
with the electronic control module 11 (see FIG. 10). The optical
dose counter 16 is adapted to determine when a dose of medicament
has been dispensed by the inhaler 2, by transmitting optical
signals through the inhaler, 2, and from a position outside of the
inhaler 2 (the operation of the optical dose counter 16 is
described in more detail later).
[0139] Having regard to FIG. 4, the medicament canister 5 includes
a spray stem 20, which is adapted to engage with the
spray-directing element 21 formed integrally within the actuator
4.
[0140] When a patient wishes to dispense a dose of medicament,
he/she places their mouth over the mouthpiece 17 of the actuator 2,
and presses down on the top 18 of the medicament canister 5--in the
direction shown by arrow 19. This has the effect of pushing the
spray stem 20 into the spray directing element 21, which releases a
metered dose of medicament, and which is directed out of the
mouthpiece 17 and into the mouth of the patient. The patient will
generally inhale deeply at the same time that the medicament is
dispensed so that the medicament is inhaled into the lungs of the
patient.
[0141] FIGS. 5 and 6 show the operation of the optical dose counter
16.
[0142] FIG. 5 shows the canister 5 in the non-dispensing, or rest
position, whereas FIG. 6 shows the canister 5 in the position it
would be when dispensing a dose of medicament.
[0143] Having regard to FIG. 5, it may be seen that the optical
dose counter 16 includes a light transmitter 22 housed within the
housing 3 on one side of the actuator 4, and a light receiver 23,
housed within the housing 3 on the opposite side of the actuator
4.
[0144] The light transmitter 22 is adapted to constantly transmit a
beam of infrared light 24, which disperses outwardly from the point
of transmission, as shown. An alternative arrangement may be to
have the light transmitter 22 transmit a strobe.
[0145] The outwardly dispersing nature of the beam of light 24,
occurs naturally, but this may also be accentuated by diffraction
caused by the beam of light 24 passing through the outside of the
actuator 4.
[0146] The light transmitter 22 may preferably transmit a
continuous beam of light 24. The light receiver 23 is constantly
monitoring receipt of the beam of light 24 from the light
transmitter 22. In a preferred embodiment, the light receiver may
take a reading of the beam of light 24 approximately 30 times per
second. Alternatively, other reading times may be utilised so long
as the readings are frequent enough to detect movement of the
canister 5 during the dispensing of a dose of medicament--the
movement time of the canister (or dispensing time) is typically
around 100 milliseconds.
[0147] When the canister 5 is in the rest position, as shown in
FIG. 5, the canister 5 remains immobile within the actuator 4. The
characteristics (such as intensity and direction) of the beam of
light 24, as it passes through the actuator 4, are therefore not
affected in any significant way. The light receiver 23 constantly
monitors this.
[0148] However, when a dose of medicament is dispensed by the
canister 5, as shown in FIG. 6, the movement of the canister 5
within the actuator 4 has the effect of changing the
characteristics of the beam of light 24, and this is noted by the
light receiver 23--and hence the optical dose counter 16 is thus
able to determine that a dose has been dispensed.
[0149] The optical dose counter 16 is electronically connected to
the electronic control module 11 (see FIG. 10), so that data
relating to the dispensing of doses by the optical dose counter 16
may be communicated to the electronic control module 11, where it
may be stored in memory, and also have other patient usage data
associated with it, for example, date and time.
[0150] It may be seen from FIGS. 5 and 6 that the optical dose
counter 16 is able to determine when a dose of medicament has been
dispensed without impacting in any way whatsoever on the operation
of the inhaler 2 or on the medicament delivery channel (namely the
inside of the actuator 4 and mouthpiece 17). This is because the
optical dose counter 16 is housed within, and operable from, a
position outside of the actuator 4. Furthermore, the use of light
to record the dispensing of a dose is non-intrusive, and does not
involve or require any physical connection whatsoever with the
moving parts 4 (canister 5 and spray stem 20) within the actuator 4
during the dispensing of a dose. This is a significant advantage of
the present invention over and above the prior art devices referred
to previously.
[0151] The electronic control module 11 is represented in the
simplified system block diagram of FIG. 10.
[0152] The electronic control module 11 includes a central
processor/controller unit 25. The processor/controller unit 25 is
adapted to control and manage the overall operation of the device
1, as well as being responsible for processing or performing
operations on the data.
[0153] For example, the electronic control module may be able to
monitor and/or record the date/time of events such as the opening
and/or closing of the hinged portion 7 of the housing 3; the
replacement of the battery; when any alarm notifications were made
and whether the patient received them or responded to them; when a
canister has been removed and/or replaced, and so on.
[0154] The electronic control module 11 is in electronic
communication with the optical dose counter 16, as shown in FIG.
10.
[0155] The electronic control module 11 includes a real time clock,
which is able to note the date and time of each dose of medicament
dispensed by the inhaler 2. Furthermore, the time may be displayed
on the LCD display 15, if required.
[0156] The electronic control module 11 includes a power management
system 27. The power management system 27 includes a battery (not
shown), and may also include warning features whereby if the
battery is getting low, the patient maybe alerted to this. The
battery may be a replaceable battery or a rechargeable battery.
[0157] The electronic control module 11 includes a memory 28 for
storing patient usage data, or any other data relating to the use
of the device 1. The memory, for example, may be RAM and/or
ROM.
[0158] The electronic control module 11 includes a notification
means which includes an audio/visual output 29. The audio output is
in the form of a small speaker (not shown) and the visual output is
in the form of a second small LCD screen (also not shown).
[0159] The audio/visual output 29 is in communication with the
central processor/controller 25 and is adapted to notify the
patient of a particular event. For example, audio/visual output 29
may sound an alarm to remind the patient to take a dose of
medicament should it be determined that the patient has not taken a
dose within a predetermined time. Likewise, the audio/visual output
29 may be adapted to alert the patient to a situation where they
have taken too much of a medicament over a predetermined time
period, which may be indicative of an exacerbation event.
Furthermore, the notification means and audio/visual output may
combine to sound alerts for any particular event, such as a dose
having been recorded (a beep may sound for example), the dose
counter reaching a predetermined number, and so on.
[0160] The electronic control module 11 includes a user interface
13, which includes operational buttons 14 and a LCD screen 15 (see
FIG. 3). The patient may utilise the user interface to change the
operational settings of the device 1.
[0161] The electronic control module 11 includes a wireless
transmitter and receiver to enable the wireless transmitting and
receiving of data or instructions. The wireless
transmitter/receiver is an integrated component and is represented
as a transceiver 30 in FIG. 10. The transceiver 30 is essentially a
means to allow the device to operate interactively (ie, two-way)
with any number or type of outside electronic devices, for example
a cell phone (via a cell phone network) or laptops (via an internet
server).
[0162] The wireless transceiver 30 is in the form of a cell phone
chip (not shown) housed within the electronic control module 11 (or
the housing 3). The significant cost of installing a cell phone
chip is mitigated by the fact that the device 1 is reusable and has
an indefinite lifetime.
[0163] The wireless transceiver 30 is able to transmit data to a
third party or to another electronic device. For example, the
wireless transceiver 30 may transmit patient usage data to a
medical practitioner or to a parent or care giver. It may do this
by transmitting the data to a cell phone network 31, and
subsequently to an internet server 32 (and therefore to a mobile
phone or laptop respectively).
[0164] The wireless transceiver 30 is also adapted to transmit the
data in real time. Alternatively, the wireless transceiver 30 may
be adapted to transmit data at a predetermined time(s), or in
response to when a predetermined condition eventuates, for example
if too many doses of medicament have been dispensed in a set time
period indicating that an exacerbation event may be imminent. An
appropriate warning may then be made to either the patient or a
third party such as a parent or medial practitioner.
[0165] The transceiver 30 is also able to wirelessly receive data
or instructions. For example, the transceiver 30 may be utilised to
enable the patient (or perhaps a third party) to send instructions
from a remote location or electronic device to change one or more
of the settings of the device 1. The transceiver 30 may also be
utilised to receive outside instructions to sound an alert or
alarm. For example, if a third party such as a parent or medical
practitioner had received data from the device 1 which indicated
that a exacerbation was imminent, that third party may be able to
transmit a warning to the device 1, for example by the use of a
laptop or mobile phone.
[0166] The LCD screen 15 may be utilised, if required, as a dose
counter display, for example for displaying the number of doses of
medicament remaining in the canister 5, or alternatively for
displaying the number of doses taken by the patient over a set time
period.
[0167] Preferably, the dose counter display may be updated each
time a dose of medicament is dispensed.
[0168] The device 1 may be used by the patient to serve as an
absolute dose counter. For example, the patient may utilise the
user interface 13 to choose this option and then enter the total
number of doses remaining to be dispensed by the medicament
canister 5--with this number then being displayed by the dose
display counter on the LCD screen 15. After the dispensing of each
dose of medicament by the inhaler 2, the dose counter display will
reduce the number of doses remaining by one.
[0169] The device 1 may also be used by the patient to serve as a
non-absolute dose counter. For example, the patient may utilise the
user interface 13 to choose this option and then reset the dose
display counter to zero. After the dispensing of each dose of
medicament by the inhaler 2, the dose counter display will increase
the number of doses taken by one. Because the device is reusable
across a range of medicament inhalers 2 or canisters 5, the patient
may keep an ongoing total of the number of doses of medicament
dispensed over a set period of time, rather than just in relation
to one supply of medicament.
[0170] FIGS. 7 and 8 illustrate how the device 1 may be utilised
with a prior art inhaler 37 which has a medicament canister 33 with
an inbuilt mechanical dose counter. The prior art inhaler 33 is the
GSK prior art device referred to previously. The canister 33
includes an absolute dose counter display 34--which indicates that
there are 10 doses remaining in the canister 33. The canister 33 is
adapted to fit within its own dedicated actuator 35.
[0171] FIG. 8 shows the device 1 from the rear, and with the prior
art inhaler 37 housed within the housing 3 of the device 1. The
housing 3 is provided with a cut-away portion 36 which enables the
dose counter display 34 to be viewable once the prior art inhaler
37 has been placed within the housing 3 of the device 1. An
advantage associated with such an embodiment is that the prior art
inhaler 37 may continue to function as an absolute dose counter
with respect to the current canister of medicament 33. Furthermore,
the device 1 may be utilised by the patient to act as a
non-absolute dose counter (as described above), and for a length of
time covering the use of many canisters 33. Hence, the patient may
obtain two useful sets of data--one relating to the patient usage
in relation to each canister 33 of medicament, and the second
relating to general usage information over a significant (or
predetermined) length of time.
[0172] FIG. 9 illustrates another embodiment of the present
invention, for use with a DPI inhaler 38.
[0173] The DPI inhaler 38 is in the form of a disk which includes a
store of dry powder (not shown) for the treatment of a respiratory
disease such as asthma. The inhaler 38 includes a powder release
lever 39 and a mouthpiece 40. In normal use, the lever 39 is moved
in the direction indicated by arrow 41, and this releases a metered
dose of dry powder into an internal cavity (not shown) adjacent the
mouthpiece 40. The patient may then inhale the powder by sucking
strongly through the mouthpiece 40.
[0174] Releasably attached to the inhaler 38 is a device, generally
indicated by arrow 42, for monitoring patient usage of the inhaler
38.
[0175] The device 42 includes a housing 43 which is substantially
U-shaped and which is designed to slide over and fit snugly around
a substantial portion of the inhaler 38. The housing 43 is also
provided with a hinge 46 to enable the housing 43 to hingedly open
up into two halves in order to be fitted to the inhaler 38, if so
desired or required.
[0176] The housing 43 includes an optical dose counter (not shown)
which is able to determine when a dose of medicament has been
dispensed from the inhaler 38 by transmitting optical signals
through the inhaler 38, and sensing movement of the internal parts
of the inhaler 38 during the dispensing of a dose of powder. The
device 42 also includes a an electronic control module (not shown
in FIG. 9, but also represented in the system block diagram of FIG.
10) which works substantially the same as the electronic control
module associated with the pMDI inhaler 2. Furthermore, the housing
43 includes a user interface which includes an LCD screen 44 and
operational buttons 45.
[0177] The device 42 only differs from the device 1 in its shape
and design--in order for the device 42 to be able to fit a DPI
inhaler 38 as compared to a pMDI inhaler 2. The device 42 may
therefore have some or all of the same features and operational
capabilities as the device 1 described previously in relation to
the pMDI inhaler 2. For convenience therefore, a detailed
description of the workings of the device 42 is not considered
necessary, and the reader is instead referred to the detailed
description previously provided in relation to the workings of the
device 1 for use with the pMDI inhaler 2.
[0178] An advantage associated with the device (1, 42) generally is
that it may serve as both a patient compliance monitor (for example
to monitor patient compliance in relation to a medicament such as a
preventer or combination medicament) and also as a device to
monitor patient usage of an emergency drug such as a reliever. The
patient (or a third party such as a parent or medical practitioner)
may therefore obtain important and useful information relating to a
patient's compliance generally, as well as the ability to be
forewarned of the possibility of an event such as an exacerbation
event.
[0179] The invention may be particularly useful for use with large
clinical trials, for example those used to determine whether a
particular medicament may have unwanted side effects. Such trials
may include a number of people in a trial group (those using the
medicament being tested) and a number of people in the control
group (those not using the medicament being tested). There may be
upwards of 3000 people in each group, and the results of the
clinical trail may be very important. Hence, it is imperative that
the people running the trial know for certain whether the trial
group and/or control group has been taking the medicament as
prescribed, and over the set time period of the trial (which may be
many months). Because the present invention is reusable in relation
to each new container of medicament being tested, it may be used by
each patient in the trial, for the entire duration of the
trial.
[0180] The invention may also be useful as a diagnostic tool by a
respiratory specialist for use with their patients. For example, a
specialist may be unsure whether a patient has asthma or heart
disease. The specialist may therefore supply the device to a
patient for use with asthma medicament over a period of time and
the usage information being used by the specialist to diagnose the
disease. Moreover, the patient may return the device to the
specialist at the conclusion of the trial, whereby it may be
supplied the next patient of the specialist.
[0181] The invention may also be useful as a self diagnosis device
for a patient. That is, a patient may use the device to
self-monitor their own personal usage and make conclusions or
changes as a result. Alternatively, it may be used by a parent or
care giver as a tool for ascertaining if someone in their care has
been taking their medicament correctly, or otherwise.
[0182] This may be of particular advantage during clinical trials
where the ongoing monitoring of a patient is being undertaken over
a considerable time period, and perhaps whereby the patient changes
medication half way through the trial.
Variations
[0183] While the embodiments described above are currently
preferred, it will be appreciated that a wide range of other
variations might also be made within the general spirit and scope
of the invention and/or as defined by the appended claims.
* * * * *