U.S. patent application number 12/087775 was filed with the patent office on 2010-09-23 for container for a blister package.
This patent application is currently assigned to ALK-ABELLO A/S. Invention is credited to Ulf Ahag, Ulf Blom, George Sioustis.
Application Number | 20100236973 12/087775 |
Document ID | / |
Family ID | 36917273 |
Filed Date | 2010-09-23 |
United States Patent
Application |
20100236973 |
Kind Code |
A1 |
Ahag; Ulf ; et al. |
September 23, 2010 |
Container For a Blister Package
Abstract
The present invention provides a container for storing a blister
package and for managing medication with a pharmaceutical
composition comprised in the blister package. The container
comprises a housing which forms a compartment for the blister
package, means for indicating towards a user an appropriate time of
accessing the blister package, and means for detecting a users
access to a blister package in the compartment. The blister package
is moved into and out of the compartment by means of an ejection
structure to which the blister package may be fixed. The ejection
structure facilitates an enhanced handling of the blister package
during insertion and removal of the blister package and facilitates
a more accurate indication of a user's access to the blister
package.
Inventors: |
Ahag; Ulf; (Sollentuna,
SE) ; Blom; Ulf; (Loddekoping, SE) ; Sioustis;
George; (Loddekoping, SE) |
Correspondence
Address: |
JACOBSON HOLMAN PLLC
400 SEVENTH STREET N.W., SUITE 600
WASHINGTON
DC
20004
US
|
Assignee: |
ALK-ABELLO A/S
Horsholm
DK
|
Family ID: |
36917273 |
Appl. No.: |
12/087775 |
Filed: |
January 18, 2007 |
PCT Filed: |
January 18, 2007 |
PCT NO: |
PCT/DK2007/050003 |
371 Date: |
July 15, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60759621 |
Jan 18, 2006 |
|
|
|
Current U.S.
Class: |
206/531 ;
206/468; 206/534 |
Current CPC
Class: |
A61J 7/0481 20130101;
B65D 83/0463 20130101; A61J 7/0436 20150501 |
Class at
Publication: |
206/531 ;
206/534; 206/468 |
International
Class: |
B65D 83/00 20060101
B65D083/00; B65D 83/04 20060101 B65D083/04; B65D 73/00 20060101
B65D073/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 18, 2006 |
DK |
PA 2006 00079 |
Claims
1. A container (1) for a blister package, the container comprising:
a housing (4) forming a compartment for the blister package, means
for indicating towards a user an appropriate time of accessing the
blister package, and means for detecting a users access to a
blister package in the compartment, characterised in that the
package further comprises an ejection structure to which the
blister package may be fixed, the ejection structure (6) being
movable towards an open position for moving the package in an
outward direction out of the compartment and movable towards a
closed position for moving the package in an inward direction into
the compartment.
2. A container according to claim 1, wherein the users access to
the blister package in the compartment is detected by detection of
movement of the ejection structure relative to the housing.
3. A container according to claim 1, wherein the ejection structure
is attached to the housing via a linear slide allowing a linear
movement of the ejection structure relative to the housing.
4. A container according to claim 1, wherein separation of the
ejection structure from the housing is prevented.
5. A container according to claim 1, further comprising detection
means capable of detecting presence of a blister package fixed to
the ejection structure.
6. A container according to claim 1, further comprising a
compliance structure adapted to indicate a time at which the user
latest gained access to the blister package in the compartment.
7. A container according to claim 6, wherein the compliance
structure is adapted to switch from an attentive state to a
non-attentive state upon receiving a user-access registration
signal.
8. A container according to claim 7, wherein the user-access
registration signal can be provided by movement of the ejection
structure.
9. A container according to claim 8, wherein the user-access
registration signal can only be provided by movement of the
ejection structure when the compliance structure is in the
attentive state.
10. A container according to claim 7, wherein the user-access
registration signal can be provided by activation of a button.
11. A container according to claim 10, wherein the user-access
registration signal can be provided by activation of a button
irrespective of the state of the compliance structure.
12. A container according to claim 7, further comprising a timer
adapted to switch the compliance structure from the non-attentive
state to the attentive state after a pre-specified duration in the
non-attentive state.
13. A container according to claim 12, further comprising
indicating means for transmitting a notification signal upon shift
of the compliance structure from the non-attentive state to the
attentive state.
14. A container according to claim 13, wherein the indicating means
transmits a notification at pre-specified periods of time after the
shift of the compliance structure from the non-attentive state to
the attentive state.
15. A container according to claim 7, adapted to shift to the
non-attentive state after a pre-specified period of time in the
attentive state without receiving the registration signal.
16. A container according to claim 1, further comprising processing
means adapted to determine a compliance level indicating a
difference between a desired consumption frequency for the
substance and a frequency of receipts of the registration
signal.
17. A container according to claim 16, wherein the processing means
is adapted, for a plurality of time intervals in each of which a
user is supposed to have access to the blister package at least
once, to register for each interval a compliance signification when
a registration signal has been received in that interval or an out
of compliance signification when no registration signal has been
received for that interval.
18. A container according to claim 17, wherein the processing means
is adapted to determine a grading level based on the numbers of
compliance signification and out of compliance signification in a
pre-specified number of succeeding intervals.
19. A container according to claim 18, wherein the transmitting
structure comprises a light emitting diode (LED) arranged to
transmit a coloured light and to select a colour out of a plurality
of colours based on the grading level.
20. A container according to claim 19, wherein the LED is arranged
to transmit the coloured light transversely into a prism which
forms part of a front cover of the container.
21. A container according to claim 20, wherein the prism comprises
a shape which identifies the substance in the blister package.
22. A container according to claim 1, further comprising a timer
adapted to determine a period of time in which the ejection
structure has not been in the closed position.
23. A container according to claim 22, wherein the compliance
structure is adapted only to switch from the attentive state to the
non-attentive state if the timer has determined that the ejection
structure has not been in the closed position in a time interval
which is longer than a pre-specified time interval.
24. A container according to claim 1, wherein fixing means for
fixing the blister package to the ejection structure comprises a
back member and an adjacent front member, the fixing means being
adapted to receive a blister card between the back member and the
front member.
25. A container according to claim 24, wherein the back member and
front member are movable relative to each other in a direction
towards and away from each other.
26. A container according to claim 24, wherein at least one of the
back and front members comprises a gripping structure adapted at
least partly to encircle a protruding portion of the blister
package.
27. A container according to claim 1, further comprising a
supplementary compartment for an additional blister card.
28. A container according to claim 1, wherein the ejection
structure is in the form of a sheet (30) substantially coplanar
with the housing (4).
29. A container according to claim 1, further comprising cover
means (34) for covering an opening of the container in a closed
condition of the container and being movable between a closed end
position and an open end position, the cover means (34) in the open
end position having been rotated about a longitudinal axis of the
container in order to form a stand for positioning of the container
in an inclined position on a horizontal surface.
30. A container according to claim 29, wherein at least part of the
movement of the cover means from the closed end position to the
open end position actuates movement of the ejection structure from
an idle position to an ejected position, and vice versa.
31. A combination comprising a container with a compartment for a
blister package and a blister package, said blister package forming
at least one row of cavities with doses of a pharmaceutical
composition, the row extending between a first end portion and a
second end portion, characterized in that at least one of the end
portions and an adjacent cavity cooperate with gripping means of an
ejection structure adapted to move the blister package into or out
of the container.
32. A combination according to claim 31, wherein the blister
package comprises a plurality of weakening lines facilitating
division of the blister package between each of the cavities
whereby the user may tear off a used portion of the blister package
when removing a dose.
Description
[0001] The present invention relates to a container for a blister
package e.g. containing doses of a pharmaceutical composition, the
container comprising a housing forming a compartment for the
blister package, means for indicating towards a user an appropriate
time of taking a dose of the pharmaceutical composition, and means
for detecting a user's access to the blister package and thereby
access to the pharmaceutical composition.
BACKGROUND OF THE INVENTION
[0002] A blister package is typically a transparent, moulded piece
of plastic forming a cavity or a plurality of cavities which are
sealed with a peelable or breakable foil or a sheet of cardboard.
Blister packages are typically used to package and display an item
of merchandise or for packing doses of pharmaceutical compositions,
sweets, chewing gum etc. A blister package is sometimes referred to
as a bubble pack.
[0003] In connection with blister packages with pharmaceutical
compositions, dispensers and containers exist with timer means for
noticing the user when to take a dose. Some of the existing systems
automatically record the removal of a dose from a blister package,
or record compliance of the removed doses with a prescribed
medication plan for the pharmaceutical composition in question. The
user may e.g. receive a signal which indicates when to take a dose
of the medical composition, or which indicates how much overdue the
last dose is.
[0004] WO 03/003970 discloses a method for identifying blister
packages with medicaments, and WO 99/43283 discloses a device for
indicating an event of administration.
DESCRIPTION OF THE INVENTION
[0005] It is an object of the present invention to improve the
existing containers for blister packages. In a first aspect, the
invention provides a container of the kind mentioned in the
introduction in which the container further comprises an ejection
structure or rejection structure to which the blister package can
be fixed. "Ejection structure" and "rejection structure" are to be
understood as interchangeable expressions in the following
specification.
[0006] The ejection structure is movable towards an open position
for moving the blister package in an outward direction out of the
compartment and movable towards a closed position for moving the
blister package in an inward direction into the compartment.
[0007] Since the blister package is moved into, and out of the
compartment by the ejection structure which forms part of the
container, sliding contact between the container and the blister
package during insertion or removal of the blister package from the
compartment may be avoided completely. This enables enhanced
functioning of the container, e.g. with an improved guiding of the
blister package into and out of the compartment and in particular
with respect to the use of blister packages of various kinds, sizes
and conditions. Due to the guided insertion of the blister package
into the compartment, the user may feel more certain about correct
positioning of the blister package in the compartment, and sensors
for detecting presence of a blister package or a user's access to a
blister package may operate more reliably. Furthermore, the
avoidance of direct sliding contact between the blister package and
the container may increase the protection of the blister package,
and unwanted opening and exposure of a dose of a pharmaceutical
compound due to wear can be avoided.
[0008] The ejection structure may be guided by sliding contact
between a surface of the ejection structure and a surface of the
housing, and to improve the ease of movement, matching surfaces
could form a sliding bearing or a linear roller bearing. The
ejection structure may preferably be guided in the housing by a
linear slide allowing a linear movement of the ejection structure
relative to the housing, and the position of the ejection structure
may preferably be supported by friction between a surface of the
ejection structure and a surface of the housing. In one embodiment,
the ejection structure moves back and forth in a slot which is
dimensioned to receive the blister package--i.e. the compartment is
formed by a slot in the housing. To facilitate insertion of the
blister package into the slot, the slot may form an opening with a
bevelled or chamfered edge which guides the blister package into
the slot.
[0009] The linear slide may define an end-stop beyond which further
movement of the ejection structure relative to the housing is
prevented. Separation of the ejection structure from the housing is
thereby prevented.
[0010] User-access to the blister package may be detected e.g. by
surveillance of the blister package itself in the device, e.g. by
mechanical, optical or other means which is triggered by movement
of the blister package itself. Blister packages may, however, be of
varying size, type and condition. As an example, the size or shape
of the blister packages may be different from blister package to
blister package, and some users may already have removed a portion
of a blister package before inserting the remaining portion into
the compartment. The varying conditions of blister packages render
detection of movement of the blister package difficult and
inaccurate. In one embodiment of the invention, the user-access is
detected by detection of movement of the ejection structure rather
than by surveillance of the blister package itself. Accordingly,
increased safety in the detection of the user-access may be
obtained independent on the type, size and condition of the blister
package. The user-access may be detected by any mechanical
switching means, by an optical detector, by a magnetically
triggered switch or by magnetic-inductive means arranged to detect
movement of the ejection structure relative to the housing. As an
example, user-access may be determined by a mechanical switch which
is embedded in the linear guide, or which is located along the
linear guide to be triggered when the ejection structure is moved
in the outward or inward direction.
[0011] The user-access may also be detected optically, e.g. by
interruption of a beam of electromagnetic radiation, by a
magnetically sensitive switch located on one of the housing and the
ejection structure or by electrical induction triggered by the
movement of the ejection structure relative to the housing.
[0012] User-access may also be registered by manual activation of
an alternative registration structure, e.g. a compliance button
switch etc.
[0013] To provide a clear indication to the user that the
user-access has been recorded, the switch may provide a tactile
indication, or indication may be given by means of an electrically
or mechanically generated sound.
[0014] In one embodiment, user-access is only registered by
movement of the ejection structure in one of the outward and inward
directions. As an example, user-access may not be registered upon
movement of the ejection structure out of the compartment but only
when the ejection structure and thus also the blister package are
moved into the compartment.
[0015] In one embodiment, the container is adapted to store a
blister package containing doses of a pharmaceutical composition,
e.g. pills, tablets, capsules, suppositories, dragees, chewing
gums, powder, granule, gels, a liquid etc., e.g. for parenteral
use, such as adapted for buccal or sublingual administration. If
such a composition is designed for administration at a fixed time
interval, in the following refereed to as In accordance with a
medication plan", i.e. not too often or seldom, support may be
provided to the user by a compliance structure adapted to indicate
a time at which the latest user-access occurred, i.e. when the user
gained access to the blister package latest. The compliance
structure may further be adapted to provide the duration since last
user-access.
[0016] In a more advanced embodiment, the compliance structure
contains information relating to a medication plan and
automatically alerts the user when it is time to take a dose of the
pharmaceutical composition. As an example, the compliance structure
could be adapted to switch between an attentive state in which the
user is supposed to take a dose of the drug compound, and a
non-attentive state in which the user is supposed to wait for the
state to change to the attentive state before taking further doses.
The switching from the non-attentive state to the attentive state
could be triggered by a timer which is programmed in accordance
with medication plan for the drug compound in question. The
switching from the attentive state to the non-attentive state could
be triggered by user-access, e.g. by registration of movement of
the ejection structure. User-access may thereby reset the timer
which once again counts when the next dose of the pharmaceutical
composition is due and switches the container to the attentive
state.
[0017] In one embodiment, user-access is only registered when the
compliance structure is in the attentive state. When the compliance
structure is in the non-attentive state, i.e. when it is not time
for the next dose of the pharmaceutical composition, neither
movement of the ejection structure, nor manual operation of a push
button switch resets the timer which counts the time until the next
dose of the pharmaceutical composition is due. In another
embodiment, user-access may only be registered, and the timer thus
be reset, by manual operation of the push button switch when the
compliance structure is in the attentive state. I.e. movement of
the ejection structure does not reset the timer. This reduces the
electrical consumption of the device if the user moves the blister
package into or out of the container when the compliance structure
is in the non-attentive state, and the feature thus saves battery
and further allows replacement of the blister package without
resetting the timer.
[0018] In a more advanced embodiment, the compliance structure is
adapted to read a medication plan from the blister package, e.g. by
means of any technique for electronic reading known in the art,
e.g. magnetically, optically etc. In one embodiment, the container
comprises a plurality of reading sensors, e.g. adapted to read
individual medication plans for a plurality of doses included in a
blister package. In this embodiment, the sensors could also be
utilised for recording the history of the medication, e.g. that
dose no. 1 was taken at a specific point in time, dose no. 2 at
another point in time etc. This feature facilitates documentation
of a medication which is based on a number of different doses
included in a single blister package.
[0019] The user may indicate a desire for obtaining information
relating to the compliance in a very simple way by use of a push
button switch. As an example, the user may push a pre-specified
number of times, e.g. three times to request information about the
state of the compliance structure, i.e. if it is time for a new
dose of the pharmaceutical composition or optionally--when it is
time for the next dose.
[0020] To indicate towards the user if the ejection structure and
thus also the blister package are not in the closed position, the
container may further comprise a second timer adapted to determine
a period of time in which the ejection structure has not been in
the closed position. The compliance structure may be adapted only
to switch from the attentive state to the non-attentive state if
the timer has determined that the ejection structure has not been
in the closed position in a time interval which is longer than a
pre-specified time interval.
[0021] The attentive state may be indicated to the user by a
notification signal such as a light, sound, or vibration signal, or
a combination there between, or the container may even transmit a
notification signal by wireless communication, e.g. via
Bluetooth.TM. communication to an external device. Wireless
communication of the notification signal facilitates remote
surveillance of a patient, e.g. at a hospital or at a home for
people who require care.
[0022] The user may not notice the notification signal, e.g. due to
noise or other circumstances. In order to save battery or in order
not to disturb unnecessarily, the notification signal may be
transmitted as repeated signals at pre-specified periods of time
after the shift of the compliance structure from the non-attentive
state to the attentive state. In one embodiment, the pre-specified
period of time increases between each transmission. As an example,
one notification signal lasting e.g. 15 seconds may be transmitted
once the compliance structure switches to the attentive state,
after 5 minutes a subsequent notification signal may be transmitted
if the container is still in the attentive state. After e.g. 15
minutes yet another notification signal could be transmitted
etc.
[0023] If the user ignores the signal, the container may be
adapted, e.g. after a pre-selected number of repeated signals, to
shift automatically back to the non-attentive state. In this case,
the container may record a non-compliance insignia for that period.
According to medication instructions for a specific pharmaceutical
composition, a number of subsequent "correct" points in time at
which a dose of the pharmaceutical composition is to be taken, i.e.
a specific interval between "correct" user-accesses. The container
may be adapted for each interval to determine if user-access has
been established, i.e. e.g. if the ejection structure has been
moved. If the ejection structure has been moved, the container
registers "compliance" for the interval, and if not, it registers
"non-compliance" for the interval. After a certain amount of
intervals, the number of compliances or non-compliances out of a
number of intervals may be presented to the user or transmitted via
an interface to an external device.
[0024] The number of compliances within a period could be
transformed into a more easily understandable identifier of the
compliance, e.g. numeral score, or into a signal given by
illumination of a light emitting diode (LED) or similar light on an
outer surface of the container, e.g. in a accordance with a colour
code, or a sound signal may be transmitted in accordance with a
code which indicates the number of compliances or non-compliances
for a period involving a certain number of intervals.
[0025] As an example, more than one registration of non-compliance
out of five may result in a red light signal or a warning tone to
be transmitted to the user, whereas one or less non-compliances out
of five may result in a green colour, or no warning tone being
transmitted to the user. The container could be adapted always to
calculate the compliance from a period comprising a fixed number of
intervals. I.e. each time a new interval is started, the evaluation
of compliance is based on the latest interval and a fixed number of
previous intervals. This provides a moving average, i.e. an average
over a fixed preceding period of time.
[0026] In one embodiment, the container comprises an interface
structure e.g. based on an USB interface etc by which the container
may communicate with an external computer system. As an example,
the compliance data may be communicated to a computer, e.g. at
health centre, in order to monitor the medication and compliance.
Alternatively, or additionally, the container could be adapted for
wireless communication or it may comprise a memory module which is
replaceable, e.g. an SD-memory module of the kind known from
electronic appliances. This would allow the user to forward the
compliance date to an external computer system e.g. by regular
mail.
[0027] To increase the area of visual appearance of a light signal
on an outer surface of the container, the light may be generated by
illuminating means such as an LED which is arranged to transmit the
light transversely into a prism, e.g. a prism which forms part of a
front cover of the container. The prism may spread the light and
make the signal more easily detectable.
[0028] In one embodiment, the prism may form a shape which
indicates the type of drug substance for which the medication
instructions are provided and which is comprised in the blister
package.
[0029] The blister package could be fixed to the ejection structure
by a gripping means comprising two parts forming a slot into which
the blister package is inserted. As an example, the gripping means
may comprise a back member and an adjacent front member located
relative to each other so that a blister card can be received there
between. The back member and front member may e.g. be movable
relative to each other in a direction towards and away from each
other in a manner corresponding to a clip or clothes-pin. The
clip-like gripping means may be dimensioned relative to the slot
into which the blister package is received so that the back and
front members are pressed together by the inner surfaces of the
slot.
[0030] In one embodiment, the gripping means is adapted to support
a blister package of the kind wherein a number of doses, e.g.
tablets or pills are located in individual bulges or cavities in a
surface of the blister package. In this embodiment, at least one of
the back and front members may comprise a gripping structure
adapted at least partly to encircle a portion of one of the bulges
in the surface of the blister package. The gripping means may in
particular prevent rotation of the blister package during the
movement of the ejection structure into and out of the container.
As an example, the gripping means may comprise one or more support
profiles which extend along one or more outer edges of the blister
package and thus prevent rotation of the blister package relative
to the ejection structure. The support profiles may e.g. comprise
grooves in which the edges of the blister package are received.
[0031] In one embodiment, the container comprises detection means
capable of detecting presence of a blister package which is fixed
to the ejection structure. As an example, the detection means may
alert the user if no blister package is present in the container
for a certain amount of time. In another embodiment, the container
may comprise detection means capable of determining the content,
e.g. the number of doses which remains in a blister package, and to
inform the user when a certain level is reached. This will allow
the user to procure a new blister package in due time. The
detection means could form part of the gripping means. In one
embodiment, the detection means is divided into two separate
sensors which register the contents of a blister with two rows of
doses. In this embodiment, the sensors may e.g. determine the
number and locations of doses in each of the two rows of doses.
[0032] The container may be adapted to accommodate further blister
packages, e.g. in separate compartments.
[0033] The container may comprise a tearing-off edge along which a
portion of the blister package may be torn off. This may e.g.
facilitate removal of one single dose or one row of doses from the
blister package. For this purpose, the ejection structure moves
between different locations which are determined by tactile
indications. By movement between two of these locations, one row of
doses is moved across the tearing off edge whereby that row of
doses may be torn off.
[0034] In one embodiment, the container is shaped so that it can be
located in an upright position on a table, e.g. as a frame for a
picture with an un-foldable stand on a back surface or like a book
which can be unfolded. In the embodiment wherein the container is
opened like a book, the opening of the container may register the
user-access.
[0035] In one embodiment, the container comprises one single
operation button by which various functions may be controlled
depending on a number of times the button is operated. As an
example, a single activation may indicate user-access, three
activations within a certain time, e.g. three activations within 5
seconds may indicate that the user requests data concerning
compliance, and a larger number of activations, e.g. 5 may indicate
a desire of switching the compliance structure off. In this case,
the container may be used as a regular container for storing
blister packages.
[0036] Preferably, the ejection structure is in the form of a sheet
substantially coplanar with the housing.
[0037] In one embodiment, cover means for covering an opening of
the container in a closed condition of the container are provided,
the cover means being movable between a closed end position and an
open end position, the cover means in the open end position having
been rotated about a longitudinal axis of the container in order to
form a stand for positioning of the container in an inclined
position on a horizontal surface. Preferably, at least part of the
movement of the cover means from the closed end position to the
open end position actuates movement of the ejection structure from
an idle position to an ejected position, and vice versa. These
features provide an easy-to-use, very functional and aesthetically
appealing container with a cheap structure that can be easily
manufactured.
[0038] In a second aspect, the invention provides a container with
a compartment for a blister package, and a blister package, said
blister package forming at least one row of cavities with doses,
the row extending between a first end portion and a second end
portion, characterized in that at least one of the end portions and
an adjacent cavity cooperate with gripping means of the container
to facilitate movement of the blister package into the compartment
and out of the compartment. In one embodiment, the blister package
comprises a plurality of weakening lines facilitating division of
the blister package between each of the cavities whereby the user
may tear off a used portion of the blister package when removing a
dose. In this embodiment, it is an object not to provide the
weakening line between at least one of the end portions and an
adjacent cavity. This facilitates that the user can not, by
accident, remove that end portion from the blister package, and
that end portion may thus serve for engagement with the gripping
means of the container.
DETAILED DESCRIPTION OF THE INVENTION
[0039] In the following, preferred embodiments of the invention
will be described in further details with reference to the drawing
in which:
[0040] FIG. 1 shows three different views of a first embodiment of
a container according to the present invention,
[0041] FIG. 2 shows a variant of the container of FIG. 1 with a
removable stand,
[0042] FIG. 3 shows a logic flow diagram of the container of FIG.
1,
[0043] FIG. 4 shows another variant of the container of FIG. 1
wherein the second compartment is opened,
[0044] FIG. 5 shows the slots into first and second compartments of
the container of FIG. 1,
[0045] FIG. 6 shows yet another variant of the container of FIG. 1
with a tear-off edge for separation of one row of doses from a
blister package in the container,
[0046] FIGS. 7 to 9 show three different views of a second
embodiment of the container according to the invention, FIG. 10
shows a partial cross section of parts of the embodiment of FIGS. 7
to 9, and
[0047] FIG. 10a shows a detail of FIG. 10.
[0048] FIGS. 1, 2 and 4-6 show a first embodiment of a container 1
according to the invention.
[0049] As shown in FIG. 1, the container 1 of the first embodiment
comprises a first slot 2 forming an opening into a first
compartment and a second slot 3 forming an opening into a second
compartment. The first compartment is for storing a first blister
package and the second compartment is for storing a second blister
package. The first blister package is an active blister package
from which a pharmaceutical composition is consumed, and the second
blister package is a "spare" blister package which can be moved to
the first compartment when the blister package stored in the first
compartment is empty. The container comprises a housing 4, means
for indicating towards a user an appropriate time of accessing the
blister package, e.g. by means of a sound signal, fixing means 5
for holding the blister package, and means for detecting a users
access to a blister package in the compartment.
[0050] Insertion and withdrawal of the blister into an out of the
first compartment is facilitated by an ejection structure which is
operated by the handle 6 which can slide back and forth on the
outer surface of the container and thereby moves the blister
package into and out of the compartment. The rejection structure is
movable towards an open position for moving the package in an
outward direction out of the first compartment and movable towards
a closed position for moving the package in an inward direction
into the first compartment. When the user moves the rejection
structure, the movement is registered as being a users access to
the blister package in the first compartment. The rejection
structure is attached to the housing via a linear guide providing
linear sliding of the rejection structure relative to the
housing.
[0051] The container comprises a single compliance push button
switch 7 by which the user may activate various functions depending
on the number of activations of the switch within a pre-specified
period of time.
[0052] The container comprises signal transmitting means 8 which
transmits a coloured light signal where the colour indicates the
compliance of the user, i.e. how many times within a specified
period the user has complied with a medication plan. In addition,
the container comprises a transmitter to transmit a sound signal
which indicates when it is time for a user to take a dose of the
pharmaceutical composition in the blister package. In this
embodiment, the container shifts from a non-attentive to an
attentive state. When the user moves the rejection structure out of
the closed position and back into the closed position, i.e. when
moving the blister package back into the first compartment after
having taken the dose, the container shifts back from the attentive
state to the non-attentive state and compliance is registered for
the interval in which the dose is taken in accordance with the
medication plan.
[0053] To support correct medication, the container has a timer,
and the following functions are performed by processing means in
the container: [0054] A time which is counted by the timer is reset
by registration of user-access to the blister package. In practise
this registration is achieved either by moving the rejection
structure to an open position and back to the closed position or by
a users activation of compliance button 7. [0055] Alarm is
transmitted after a specific period, e.g. after 24 hours when the
medication plan prescribes a dose of the pharmaceutical composition
once a day. [0056] Snooze function if dose is not taken after 15
minutes and 30 minutes from the first alarm [0057] Remind alarm if
dose is not taken within 6 hours after first alarm. [0058] Remind
alarm if dose is not taken within 12 hours after first alarm.
[0059] If dose is not taken later within 24 hours+12 hours, a count
is set to "out of compliance"
[0060] In addition, the container is adapted to determine
interactive compliance as follows:
[0061] "Adherence" is defined as the sum of compliance and
persistence
[0062] "Compliance" is taking the medication as prescribed by the
medication plan, e.g. once daily.
[0063] "Persistence" is staying on treatment over the whole
treatment regiment
[0064] "Compliance time" is defined as 24 hours plus reminder time,
max 12 hours (total 24+12=36 hours). Compliance time starts always
from default time (start time set by user when resetting the
device). "Default time" is defined as the time the user sets as
alarm time by pressing compliance button>5 seconds. "Compliance
time frame"="compliance time"-6 hours to "compliance time"+12
hours.
[0065] Example of alarm time (4 times reminding alarm after the
first alarm for the worst case)
TABLE-US-00001 First day XX:XX Default time + Sound 1 Second day
XX:XX Alarm 2. Not taken (as example) Second day, snooze Alarm 2.
Not taken (as example) XX:XX + 15 min Second day, snooze XX:XX +
Alarm 2. Not taken (as example) 30 min Second day XX:XX + 12 hours
Alarm 2. Not taken: Not compliance Taken: Compliance Third day
XX:XX Alarm 2. First alarm on default time. Etc.
[0066] The device communicates compliance with the user according
to the logarithm shown below. The compliance logarithm shall be
counted seven days moving average. When restarted/reset the
compliance shall start the calculation with a full 7 days
compliance in the log. See example below. The numbers below
represents the sum of taken tablets during compliance time. Seven
days back (if restarted /reset calculating with the fictive seven
day full compliance):
TABLE-US-00002 5-7 days inside compliance (Green) 3-4 days
Attention compliance (Orange) 0-2 days Out of compliance (Red)
Example of compliance function
[0067] 1=taken tablet inside compliance window
[0068] 0=not taken tablet inside compliance window
[0069] R=Restarted device
[0070] The logarithm starts with full compliance 7 days back.
TABLE-US-00003 ##STR00001##
[0071] The signal transmitting means 8 comprises a light emitting
diode (LED). The LED illuminates a prism with a shape which
indicates the type of pharmaceutical composition for which the
medication plan is programmed in the compliance structure. In the
present embodiment, the shape indicates a straw, and the
pharmaceutical compound is directed towards allergy against grass.
Three-color codes shall be used to signalize compliance: Green,
Orange and Red. Green means "Inside compliance", Orange means
"Attention compliance", and Red means "Out of compliance".
[0072] The transmitter to transmit a sound is adapted to transmit a
sound level at 74 dB with background 65 dB measured 8 inches from
the device. Alarm is activated in 30 seconds or recommended action
is performed.
[0073] Following alarms/sounds shall be used:
TABLE-US-00004 Alarm Sound description Comment Alarm/sound 1 xx
"Default time set" Two short peeps within 0.5 seconds Alarm 2
xx-xx-xx-xx-xx- "Take a dose" Alarm 3 xxx-xxx-xxx-xxx "Push blister
package back into the compartment" Alarm 4 xx---xx---xx--- "Press
compliance button" xx---
[0074] The container is adapted to be operated on batteries 9.
[0075] The container is specifically made for a blister package 10
comprising two columns 11, 12 of doses in tablet form. Each column
forms a row with 5 doses, and between each row, the blister package
comprises a weekend line 13 at which the row may be torn off from
the remaining portion of the blister package.
[0076] The gripping structure comprises a front member and a back
member which is located on the opposite side of the blister package
10 (not visible in FIG. 1). The front member comprises two elements
14, 15, one of which comprises an arched portion which partly
encircles a protruding portion of the blister package, i.e. partly
encircles one of the portions in a last row in one of the
columns.
[0077] FIG. 2 shows a variant of the container according to the
first embodiment of the invention with a removable stand 16 which
is attachable to the back surface of the container and allows the
container to be positioned in an upright position on a table.
[0078] FIG. 3 shows a logic flow diagram.
[0079] FIG. 4 shows another variant of the container according to
the first embodiment wherein a lid 17 is hinged to the housing 4
and enables complete opening of one of the compartments, in this
case the second compartment.
[0080] FIG. 5 shows the slots 2, 3 into the first and second
compartments. The first slot comprises first and second enlarged
openings 18, 19 and an intermediate portion 20. The slot thus
matches the shape of a blister package 10 of the kind disclosed in
FIG. 1, i.e. with two rows with doses, e.g. tablets or pills.
[0081] FIG. 6 shows yet another variant of the container according
to the first embodiment with a tear-off edge 21 for separation of
one row 22 of doses from the blister package. In this variant, the
handles 23, 24 for moving the rejection structure and thus the
blister package into and out of the compartment is provided with a
tactile indication of the locations at which the doses in the
blister package is in a correct position relative to the tear-off
edge 21, e.g. when a weakened line of the blister package is
located adjacent the tear-off edge.
[0082] FIGS. 7 to 10a show a second embodiment of the container
according to the present invention. Similar reference numerals
refer to similar elements or elements of the same function as in
the embodiment of FIGS. 1 to 6.
[0083] The container 1 comprises a housing 4, which may on its
front side shown in FIG. 7 comprise not shown indicating means such
as an LED or LCD and/or a compliance structure such as has been
described in the above, e.g. in the form of a push button or the
like. The housing 4 is in the form of a sheet of material, such as
plastic, bent to form a compartment for a blister package 10. An
ejection structure in the form of an ejection sheet 30 is housed
inside the housing 4 in a closed end position of the container 1
shown in FIG. 7. In an intermediate position shown in FIG. 8 and in
an open end position shown in FIG. 9 the ejection sheet 30 has been
ejected from the housing 4 to project from the side of the housing
4. FIG. 10 shows the ejection sheet 30 in the ejected position
corresponding to FIGS. 8 and 9, and FIG. 10a shows a detail of the
ejection sheet 30 of FIG. 10.
[0084] The ejection sheet 30, which is seen best in FIGS. 9 and 10,
has been bent such that a front side 30b and a back side 30c lie
substantially coplanar with a front side 4b and a back side 4c,
respectively, of the housing 4. A curved connection portion 30a of
the ejection sheet 30 abuts a similarly shaped connection portion
4a of the housing 4 in the closed end position of the container 1
shown in FIG. 7. The ejection sheet 30 comprises a linear slide in
the form of a slot 31 engaging a inward facing projection 32 of the
front side 4b of the housing 4 to ensure a smooth and linear
movement of the ejection sheet 30 between the open and closed end
positions of the container 1. The projection 32 may form a stop,
e.g. in the form of a wider portion (not shown), to ensure that the
ejection sheet 30 at all times remains attached to the housing
4.
[0085] The ejection sheet 30 further comprises fixing means in the
form of an insert 33 for securing the blister package 10 to the
ejection sheet 30. As is shown in FIG. 10a the insert 33 comprises
two projections, which are able to hold a blister package 10
inserted as shown by means of the arrow of FIG. 10a, i.e. a sheet
portion of the blister package 10 is forced to enter a secured or
fixed position. In the secured or fixed position of the blister
package the projections push against each other on either side of
the sheet portion of the blister package 10. In a not shown variant
of the second embodiment of the invention two blister packages are
held in the insert 33, the second blister package for example being
held between one of the projections and a third projection of the
insert.
[0086] The ejection sheet 30 comprises a recess 35, which provides
a better grip on the blister package 10.
[0087] The back side 30c of the ejection sheet 30 may as an
alternative or supplement comprise further fixing means in the form
of apertures (not shown) corresponding to tablet projections 10a of
the blister package 10 in order to provide an even better
attachment of the blister package 10 on the ejection sheet 30. In
case of a blister package 10 with ten tablet projections the back
side would comprise ten correspondingly positioned and shaped
apertures. In this variant the projections face the back side 30c
of the ejection sheet 30, they may however in other embodiments
face the opposite way. In another not shown variant the apertures
are provided on a separate sheet positioned to be coplanar with the
back side 30c of the ejection sheet 30.
[0088] In a not shown variant of the second embodiment of the
invention the ejection structure does not comprise the front and
back sides 30b, 30c. In this variant the insert 33 in itself pushes
the blister package 10 out of the housing during the ejecting
movement. However, the shown variant is preferred since the front
and back sides 30b, 30c provide support for the blister package
10.
[0089] Means for detecting when a user gains access to the
container 1 may as examples be provided as a sensor in the insert
33 or at an end of the projection 32.
[0090] The container 1 further comprises cover means in the form of
a cover 34 for covering an opening of the container 1 in a closed
condition of the container 1 as is shown in FIG. 7. As can be seen
from FIGS. 8 and 9 the opening extends from a top edge along a side
edge and to a bottom edge of the housing 4. Parts 34a, 34b and 34c
correspond to the top, side and bottom edges, respectively. The
cover 34 is movable between the closed end position of FIG. 7 and
the open end position of FIG. 9, the cover 34 being in the
intermediate position of FIG. 8 between the said two end positions.
The cover 34 is attached to the ejection sheet 30 by means of stub
shafts (not shown) embedded in corresponding apertures 36 of a side
portion of the ejection sheet 30. In an alternative not shown
variant the stub shafts are replaced by a through-going shaft
extending through both apertures 36.
[0091] When wanting to open the container 1 in order to gain access
to a tablet, a user moves the cover 34 from the closed end position
of FIG. 7 to the intermediate position of FIG. 8. This may be done
by gripping the housing 4 with one hand and the cover 34 with the
other, pulling them away from each other. This provides a linear
slide of the cover 34 actuating movement of the ejection sheet 30
from its idle position in the housing 4 by pulling it out of the
side edge opening of the housing 4 by means of the stub shafts. The
housing 4 is formed such that when the cover 34 and ejection sheet
30 enter the intermediate position of the container 1 of FIG. 8,
the cover 34 is released from the linear slide and is able to
rotate about a longitudinal axis of the container 1 defined by the
stub shafts. The user then rotates the cover 34 to the second end
position shown in FIG. 9. Now, easy access to the blister package
10 is provided. The user takes out the blister package 10, breaks
off or pushes out a tablet, and reinserts the blister package 10
into the insert 33. In order to close the container 1 an inverse
operation is carried out by the user such as to bring the container
1 from the open end position to the closed end position.
[0092] In the open end position shown in FIG. 9 the rotated cover
34 forms a stand for positioning of the container 1 in an inclined
position on a horizontal surface such as a table (not shown). The
container 1 preferably comprises spring means (not shown) or other
suitable retaining means known to the skilled person for retaining
the cover 34 in the rotated position shown in FIG. 9 such as to not
collapse when positioned on said horizontal surface.
[0093] In variants of the second embodiment of the invention
further spring means may be provided for biasing the ejection sheet
30 towards the ejected position, such spring means for example
being actuated by means of a button or the like.
* * * * *