U.S. patent application number 10/506817 was filed with the patent office on 2005-07-14 for medical dispenser, a blister card for use in the dispenser and a method of dispensing medical doses.
Invention is credited to Fabricius, Paul Erik, Jorgensen, Niels Toft.
Application Number | 20050150897 10/506817 |
Document ID | / |
Family ID | 27789989 |
Filed Date | 2005-07-14 |
United States Patent
Application |
20050150897 |
Kind Code |
A1 |
Fabricius, Paul Erik ; et
al. |
July 14, 2005 |
Medical dispenser, a blister card for use in the dispenser and a
method of dispensing medical doses
Abstract
A medical dispenser adapted to inform a user of when to take
medication, detect when the user accesses the medication and inform
the user of his/tiers compliance to a medication schedule. The
dispenser may inform the user with differing manners of informing
(sound, light, vibration, higher of lower frequency or intensity)
depending on the users compliance. Blister cards for use in the
dispenser may be coded in order to inform the dispenser of a
medication schedule, a desired compliance level, etc. The user may
himself code the blister card. The dispenser may hold a blister
card or may be adapted for providing medical doses for inhalation
or injection.
Inventors: |
Fabricius, Paul Erik;
(Holstebro, DK) ; Jorgensen, Niels Toft; (Losning,
DK) |
Correspondence
Address: |
HARNESS, DICKEY & PIERCE, P.L.C.
P.O. BOX 8910
RESTON
VA
20195
US
|
Family ID: |
27789989 |
Appl. No.: |
10/506817 |
Filed: |
March 10, 2005 |
PCT Filed: |
March 6, 2003 |
PCT NO: |
PCT/DK03/00142 |
Current U.S.
Class: |
221/2 |
Current CPC
Class: |
G16H 20/13 20180101;
A61M 15/0083 20140204; A61J 7/0436 20150501; A61J 7/0481 20130101;
A61J 7/0418 20150501; A61J 2200/30 20130101; A61J 1/035 20130101;
A61M 15/008 20140204; A61M 15/0045 20130101 |
Class at
Publication: |
221/002 |
International
Class: |
G07F 011/00 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 7, 2002 |
DK |
PA 2002 00352 |
Sep 16, 2002 |
DK |
PA 2002 01365 |
Claims
1-102. (canceled)
103. A medical dispenser being adapted to removably hold one or
more blister cards for each holding a number of medical doses, and
to inform a user or patient in relation to the taking of one or
more medical doses, wherein: the blister card comprises an
indentation, a hole, or a protrusion at each of one or more of a
plurality of predetermined positions, the dispenser having means
for detecting an indentation, a hole, or a protrusion at each of
the predetermined positions, means for operating the informing
means on the basis of an output from the detecting means, and
wherein the dispenser is adapted to identify, from the positions of
the blister card where indentations, holes, or protrusions are
detected, one or more of: a frequency of recommended intake of the
medical doses, recommended points in time of intake of the medical
doses, and a manner of informing the user or operator.
104. A medical dispenser according to claim 103, further comprising
means for determining a compliance of the user's or operator's
intake of the medical doses based on: a predetermined medication
schedule identified by indentations, holes, or protrusions or the
lack of indentations, holes, or protrusions at predetermined
positions of the blister card and information relating to points in
time when the user or operator gains access to at least one of the
doses of medication.
105. A medical dispenser according to claim 103, further comprising
means for informing the user or operator to take a dose of the
medication and means for determining when it is time to inform the
user on the basis of: a predetermined medication schedule
identified by indentations, holes, or protrusions or the lack of
indentations, holes, or protrusions at predetermined positions of
the blister card and a clocking device.
106. A medical dispenser according to claim 103, further comprising
stationary means for introduction into further indentations at
other positions of the blister card, the stationary means
preventing a blister card not having the further indentations from
engaging with the detecting means.
107. A medical dispenser according to claim 103, the dispenser
being able to hold the one or more blister card(s) in a manner so
that the blister card is curved in a direction at least
substantially along a longitudinal direction thereof.
108. A blister card for use in the dispenser according to claim
103, and having a number of blisters for each holding a medical
dose, the blister card further comprising an indentation or a
protrusion at each of one or more of a plurality of predetermined
positions.
109. A method of operating a dispenser being adapted to removably
hold one- or more blister cards for each holding a number of
medical doses, the blister card comprises an indentation, a hole,
or a protrusion at each of one or more of a plurality of
predetermined positions, and to inform a user or patient in
relation to the taking of one or more medical doses, the method
comprising: detecting, using detecting means of the dispenser, at
each of the predetermined positions any indentation, hole or
protrusion at that position, and operating the informing means on
the basis of an output from the detecting means, further comprising
the step of identifying, from the positions of the blister card
where indentations, holes, or protrusions are detected, one or more
of: a frequency of recommended intake of the medical doses,
recommended points in time of intake of the medical doses, a manner
of informing the user or operator.
110. A method according to claim 109, wherein the detecting step
comprising, at each of the predetermined positions having a
protrusion or if no hole or indentation is present at the position,
displacing a displaceable detecting means.
111. A method according to claim 109, further comprising the step
of determining a compliance of the user's or operator's intake of
the medical doses based on: a predetermined medication schedule
identified by indentations, holes, or protrusions or the lack of
indentations, holes, or protrusions at predetermined positions of
the blister card and information relating to points in time when
the user or operator gains access to at least one of the doses of
medication.
112. A method according to claim 109, further comprising the steps
of informing the user or operator to take a dose of the medication
and of determining when it is time to inform the user on the basis
of: a predetermined medication schedule identified by indentations,
holes, or protrusions or the lack of indentations, holes, or
protrusions at predetermined positions of the blister card and a
clocking device.
113. A method according to claim 109, comprising the step of the
dispenser holding the one or more blister card(s) in a manner so
that the blister card is curved in a direction at least
substantially along a longitudinal direction thereof.
Description
[0001] The present invention relates to a medical dispenser which
may be able to determine when a user gains access to medical doses
held thereby and which may be able to inform the user of when to
take one or more medical doses or how the user conforms to a
medication schedule. In addition, the invention relates to a
blister card for use in the dispenser, the blister card providing a
novel feature in that it may inform the dispenser of certain
functionalities and situations, and the user may inform the
dispenser of certain selections via the blister card.
[0002] Intelligent dispensers are heavily researched these days in
that they may unload the public service functions (doctors,
hospitals, other caretakers) as well as prevent or reduce wrongful
medication.
[0003] Such dispensers may be seen in WO00/25720, FR2 787 317,
WO98/42591, U.S. Pat. No. 4,660,991, and WO02/24141.
[0004] Most of these intelligent dispensers aim to overtake the
full responsibility for the providing of the medication and are
aimed at weak patients that tend to forget their medication or take
wrong doses at the wrong times.
[0005] The present invention aims at stronger patients that only
need to be reminded to take the medication or who need to be
reminded of how closely they follow a given medication
schedule.
[0006] In a first aspect, the invention relates to a medical
dispenser being adapted to hold a number of medical doses and being
adapted to determine when a user or patient gains access to one or
more of the medical doses, the dispenser comprising:
[0007] means for determining each of a first plurality of points in
time or time intervals at which the user or patient should take a
medical dose,
[0008] means for detecting each of a second plurality of points in
time where the user or patient gained access to the medical doses,
and
[0009] means for providing to the user or patient information
relating to a relation between the first and second
pluralities.
[0010] In the present context, the dispenser holds the medical
doses but does not necessarily dispense only a single dose to the
user or patient. The access of the user may be to all doses in the
dispenser, whereby the user will then dispense the dose(s) required
himself.
[0011] In the present context, "gains access to" means that the
dispenser is able to determine when the user has the ability to
take a dose of medication. This does not necessarily mean that the
user actually takes the medication. This rather simple dispenser
needs not have means for preventing the user from gaining access to
the medication, but it will detect that access.
[0012] Normally, when determining a medication schedule for a user
or patient, the medication should preferably be given with fixed
time intervals in order to control the concentration of the
medicine in the users body. Thus, in order to obtain that,
preferred times or time intervals (usually starting at or shortly
before the preferred time of intake of the medication) are normally
set for the actual medication and the person in question.
[0013] In the present context, the user should preferably (taking
into account the optimal function of the medication) take the
medicine at the points in time or within the time intervals.
However, as is described above, the present dispenser needs not
ascertain that the user in fact does take the medication.
[0014] Knowing when the medication should have been taken and when
the medication was (presumably) taken, a relation between those
periods of time may be made in order to have a measure of how well
the user conforms to the medication schedule.
[0015] Preferably, the first and second pluralities are taken
within a predetermined period of time or within a predetermined
number of accesses to the medication or a predetermined number of
times/intervals in the first plurality. The period of time or
number of accesses/times/intervals may be varied from user to user
and medication to mediation. For some medications, providing a
relation over the intake of medication over a month may be desired,
whereas a relation extending over only a few days may be suitable
for other medications.
[0016] Preferably, the providing means are adapted to provide a
relation between pairs of one of the first plurality of points in
time or time intervals and one of the second plurality of points in
time. A suitable manner of providing the relation is to compare
pairs of an optimal time of intake and the actual (presumed)
intake. In that situation, the compliance may be determined or
quantified simply by the time difference between recommended intake
and access to the medication.
[0017] Also, preferably, the providing means are adapted to provide
a relation between the pairs of one of the first plurality of
points in time or time intervals and a first of the second
plurality of points in time occurring after the pertaining point in
time of the first plurality or within the pertaining time interval
of the first plurality. In this manner, if the user gains access to
the medication (such as by accident) multiple times per point in
time or time interval, only the first time the user gains access to
the medication is used in the relation. Any remaining times of
access are discarded. In this aspect, the dispenser may have means
for warning the user, if he has already gained access to the
medication once during this interval or after the last point in
time for recommended intake or the dispenser may inform the user
that dose intake is allowed and that the dose access is registered
as a dose intake.
[0018] As mentioned, one manner of determining the relation is to
have the relation relate to a time difference between the pairs of
the point in time or a starting time of the time interval of the
first plurality and the point in time of the second interval.
[0019] Another manner of quantifying compliance is one where the
providing means are adapted to provide a relation between a number
of times wherein a point in time of the second number occurs within
a time interval of the first plurality, and a number of times
wherein a point in time of the second number does not occur within
a time interval of the first plurality. Thus, the number of times
where the user actually gains access to the medication when he
should are registered together with the number of times where he
did not.
[0020] A number of manners exist of informing the user of the
compliance. According to a first manner, the providing means are
adapted to provide, as the information, one of a plurality of
predetermined colours to the user, the colour being determined on
the basis of the relation. Suitable colours may be red, yellow and
green.
[0021] According to another manner, the providing means are adapted
to provide, as the information, one of a plurality of predetermined
numbers to the user, the number being determined on the basis of
the relation. Suitably, the higher the number the higher the
compliance.
[0022] A third manner is one wherein the providing means are
adapted to activate, as the information, one or more of a plurality
of predetermined areas of a display, such as a LCD display, visible
to the user, the area(s) activated being determined on the basis of
the relation. Such a display may illustrate a bar or pie
diagram.
[0023] A fourth manner is one wherein the providing means are
adapted to provide, as the information, one of a plurality of
predetermined sound signals to the user, the sound signal being
determined on the basis of the relation. This sound may vary from
pleasant (high compliance) to unpleasant (low compliance).
[0024] Yet another manner is one wherein the providing means are
adapted to provide, as the information, one of a plurality of
predetermined graphical images to the user, the image being
determined on the basis of the relation. Suitable images may be
happy/neutral/sad face or thumb up/down.
[0025] The dispenser preferably further comprises, as described
above, means for informing the user, if a point in time of the
second plurality occurs outside a time interval of the first
plurality in order to e.g. warn the user if he gains access to the
medication outside an interval.
[0026] A second aspect of the invention relates to a medical
dispenser being adapted to hold a number of medical doses and to
inform a user or patient of when to take a dose, the dispenser
comprising:
[0027] means for informing the user in one of a plurality of
different manners,
[0028] means for determining a compliance of the users taking of
medical doses, and
[0029] means for selecting a manner of informing based on the
determined compliance.
[0030] Thus, the dispenser may be able to inform the user
differently depending on the users compliance.
[0031] Again, "when" to take a dose would normally be in accordance
with a medication schedule determined either for the actual
medication or set in the dispenser.
[0032] A number of different manners of informing a user are known.
However, the most preferred manners are ones where the informing
means are adapted to inform the user using one of sound, visual
information, and/or vibration.
[0033] In that situation, the determining means may be adapted to
determine a compliance selected between a predetermined number of
compliances, and wherein the selecting means are adapted to select
visual information based on a first compliance of the predetermined
number of compliances, vibration based on a second compliance of
the predetermined number of compliances, and sound based on a third
compliance of the predetermined number of compliances.
[0034] Normally, especially when in a public place, visual
information is the most pleasant and private information, where
sound information (especially if loud) is the most unpleasant
information. Thus, the dispenser may use this information manner in
order to ensure that the user both takes his medication and is
informed (such as by the severity of the information manner) of his
compliance. This may bring the user to a better compliance in order
to avoid that particular manner of informing.
[0035] Preferably, the informing means are adapted to provide the
sound, visual information, or vibration with different intensities
and/or frequencies.
[0036] In that manner, the determining means are preferably adapted
to determine a compliance selected between a predetermined number
of compliances, and wherein the selecting means are adapted to
select an intensity and/or frequency based on the determined
compliance. Again, the lower the compliance, the hither the
frequency or intensity may be in order to ensure that the user
"gets the message". The predetermined number of compliances may be
the numbers of an interval (e.g. integers in the interval 0-10), a
number being selected or calculated relating to the compliance.
[0037] As mentioned above, preferably, the dispenser is adapted to
hold a number of medical doses and being adapted to determine when
a user or patient gains access to one or more of the medical doses,
the dispenser comprising:
[0038] first means for determining each of a first plurality of
points in time or time intervals at which the user or patient
should take a medical dose, and
[0039] means for detecting each of a second plurality of points in
time where the user or patient gained access to the medical
doses,
[0040] wherein the compliance determining means determine the
compliance as a relation between the first and second
pluralities.
[0041] As mentioned above:
[0042] the compliance determining means are preferably adapted to
provide a relation between pairs of one of the first plurality of
points in time or time intervals and one of the second plurality of
points in time and/or
[0043] the compliance determining means are preferably adapted to
provide a relation between the pairs of one of the first plurality
of points in time or time intervals and a first of the second
plurality of points in time occurring after the pertaining point in
time of the first plurality or within the pertaining time interval
of the first plurality
[0044] where the relation preferably then relates to a time
difference between the pairs of the point in time or a starting
time of the time interval of the first plurality and the point in
time of the second interval.
[0045] Also, the compliance determining means are preferably
adapted to provide a relation between a number of times wherein a
point in time of the second number occurs within a time interval of
the first plurality, and a number of times wherein a point in time
of the second number does not occur within a time interval of the
first plurality.
[0046] Again, the compliance determining means are preferably
adapted to provide, as the information, one of a plurality of
predetermined colours to the user, the colour being determined on
the basis of the relation.
[0047] In addition, the compliance determining means may be adapted
to provide, as the information:
[0048] one of a plurality of predetermined numbers to the user, the
number being determined on the basis of the relation,
[0049] one or more of a plurality of predetermined areas of a
display visible to the user, the area(s) activated being determined
on the basis of the relation,
[0050] one of a plurality of predetermined sound signals to the
user, the sound signal being determined on the basis of the
relation, and/or
[0051] one of a plurality of predetermined graphical images to the
user, the image being determined on the basis of the relation,
[0052] Also, means may be provided for informing the user, if a
point in time of the second plurality occurs outside a time
interval of the first plurality.
[0053] A third aspect of the invention relates to a medical
dispenser being adapted to hold a number of medical doses, to
inform a user or patient of when to take a dose, and to determine
when the user or patient accesses a medical dose, the dispenser
comprising:
[0054] means for informing the user in one of a plurality of
different manners,
[0055] means for, a number of times, operating the informing means
in order to inform the user with different manners of
informing,
[0056] means for, during operation of the operating means,
determining which manner(s) of informing brings the user or patient
to access a medical dose,
[0057] means for, subsequently to the operation of the operating
means, selecting a manner of informing based on the
determination.
[0058] Thus, the dispenser is adapted to select a manner of
informing based on knowledge of which manner(s) brings the user or
patient to actually access the medication.
[0059] Normally, the informing means would be adapted to inform the
user using at least one of sound, visual information, or vibration.
Preferably, the informing means are adapted to provide the sound,
visual information, and/or vibration with different intensities
and/or frequencies.
[0060] In a preferred embodiment, the determining means are adapted
to determine that a manner of informing brings the user or operator
to access a medical dose, when the user or operator accesses the
dose while or within a predetermined period of time after the
actual manner of operating is used. The predetermined period of
time after the actual manner was used provides time for the user to
react to the manner.
[0061] In order for the dispenser to determine which manner is e.g.
the most efficient and in order to have the user take the
medication, the operating means are preferably adapted to
subsequently (one after the other) use different manners of
information until the user gains access to a medical dose.
[0062] Not always will the user respond to the same manner of
informing. This may be due to a number of reasons. Therefore,
preferably, the selecting means are adapted to select a manner,
which the most often brings the user or operator to gain access to
the medical dose. This may be obtained when the operating means are
adapted to be operated a plurality of times, the determining means
being adapted to determine, for each of the plurality of times,
which manner brings the user of operator to access the medical
dose, and wherein the selecting means are adapted to select the
manner having brought the user or operator the most often to access
the medical dose.
[0063] A number of different dispenser types may advantageously use
this technology, such as:
[0064] a dispenser being adapted to hold one or more blister cards
holding the number of medical doses, and being adapted to detect
that the user or patient has accessed a medical dose when the
blister card is removed from the dispenser,
[0065] a dispenser being adapted to provide one or more medical
doses to the user or patient by inhalation, the dispenser having an
air passage connected to a medical output and means for covering or
closing the output or air passage when not in use, and being
adapted to detect that the user or patient has accessed a medical
dose when the covering means is removed from the dispenser,
and/or
[0066] a dispenser being adapted to provide one or more medical
doses to the user or patient by injection by an injection needle,
the dispenser having means for covering the injection needle when
not in use, and being adapted to detect that the user or patient
has accessed a medical dose when the covering means is removed from
the dispenser.
[0067] It is interesting to note that the detecting means,
informing means, etc. may, in fact, be positioned in the cover
means in the injector/inhaler, so that standard injectors (such as
an injector pen) or inhalers may be used and still gain the present
functionality.
[0068] A fourth aspect of the invention relates to a medical
dispenser being adapted to removably hold one or more blister cards
for each holding a number of medical doses, and to inform a user or
patient in relation to the taking of one or more medical doses,
wherein:
[0069] the blister card comprises an indentation, a hole, or a
protrusion at each of one or more of a plurality of predetermined
positions,
[0070] the dispenser having means for detecting an indentation, a
hole, or a protrusion at each of the predetermined positions,
and
[0071] means for operating the informing means on the basis of an
output from the detecting means.
[0072] Normally, a blister card is a square card without any
indentations, holes or protrusions (apart from the blisters). The
card may have rounded corners but will otherwise normally have
straight sides.
[0073] Thus, the mechanical features (such as indentations, holes,
protrusions) of the blister card are able to actually determine the
operation of the dispenser. In this manner, the same dispenser may
be used for different medications in that the medication when
inserted will have the dispenser function correctly. Also,
different manufacturers may "code" their blister cards differently
in order to obtain different manners of operation of the
dispenser.
[0074] In the context of the present invention, it should be noted
that a blister card is a card holding a number of medical doses on
or in a sheet-shaped (with blisters) member. Any form of
sheet-shaped member may be used, and it is not required that the
medication actually is present in blisters. The sheet-shaped member
has advantages used in a number of the present embodiments in that
it may be slid into and out of the dispenser and that it may have
the mechanical features detected by detecting means in a number of
the present embodiments.
[0075] Preferably, the detecting means has, at each of the
predetermined positions, displaceable detecting means being
displaced by a protrusion at the position of the blister card, or
indentation or hole exists at the position. Such detecting means
may operate on any of a wide variety of detecting schemes
(mechanical, magnetic, optical detection, etc.)
[0076] The dispenser may be adapted to identify, from the positions
of the blister card where indentations, holes, or protrusions are
detected, one or more of:
[0077] a manufacturer of the medical doses,
[0078] a type of medication in the medical doses,
[0079] a frequency of recommended intake of the medical doses,
[0080] recommended points in time of intake of the medical
doses,
[0081] a dose strength of one or more of the medical doses, and
[0082] a manner of informing the user or operator (such as for
reminder or compliance readout).
[0083] In a preferred embodiment, the dispenser further comprises
means for determining a compliance of the user's or operator's
intake of the medical doses based on:
[0084] a predetermined medication schedule identified by
indentations, holes, or protrusions or the lack of indentations,
holes, or protrusions at predetermined positions of the blister
card and
[0085] information relating to points in time when the user or
operator gains access to at least one of the doses of
medication.
[0086] The identified medication schedule may be fully coded in the
positions of the indentations etc, or may be stored in the
dispenser and identified by e.g. a code or address coded in the
positions of the indentations etc.
[0087] Preferably, the dispenser also comprises means for informing
the user or operator to take a dose of the medication and means for
determining when it is time to inform the user on the basis of:
[0088] a predetermined medication schedule identified by
indentations, holes, or protrusions or the lack of indentations,
holes, or protrusions at predetermined positions of the blister
card and
[0089] a clocking device.
[0090] An interesting aspect is one where the dispenser being
adapted to receive, from the user, information relating to:
[0091] how to calculate compliance, and/or
[0092] how to inform the user of compliance.
[0093] Thus, the user may himself set e.g. a compliance level which
he desires to follow. The dispenser may then adapt its manners and
times of informing--and may adapt a specific e.g. limit between
levels of compliance (low, sufficient, high) so as to inform the
user of his compliance in related to the selected compliance.
[0094] This information may be entered by the blister card(s) being
adapted to have indentations, holes, or protrusions made subsequent
to manufacture thereof, and wherein the dispenser is adapted to
derive the information from the indentations, holes, or protrusions
made subsequent to manufacture thereof. Thus, the user himself may
provide the indentations etc. and thereby "code" the dispenser
accordingly.
[0095] As mentioned above, the dispenser preferably comprises means
for detecting or determining when the user or operator gains access
to at least one of the medical doses.
[0096] Also, preferably, the dispenser comprises stationary means
for introduction into further indentations at other positions of
the blister card, the stationary means preventing a blister card
not having the further indentations from engaging with the
detecting means. In this manner, only blister cards having those
further indentations will not be useable in the dispenser. This
will prevent wrongful use of unoriginal blister cards in the
dispenser.
[0097] In any of the above embodiments using a blister card, the
dispenser may be able to hold the one or more blister card(s) in a
manner so that the blister card is curved in a direction at least
substantially along a longitudinal direction thereof. This curved
state has a number of advantages in that the blister card is then
biased against inner surfaces of the dispenser. A curved element
(which in its rest position is straight) will obtain a much more
stiff state across the direction of the bend. This may be used for
a number of purposes, such as to maintain the blister card in the
dispenser and to position the indentations etc. more precisely in
the dispenser.
[0098] Preferably, the dispenser is adapted to receive the blister
card(s), in a slot thereof, in a direction along the longitudinal
direction of the blister card(s).
[0099] Preferably, the dispenser has a first surface and is adapted
to bias an edge portion of each blister card being received thereby
against the first surface. Then, the detecting means are preferably
positioned a predetermined distance from the first surface and are
able to detect the blister card(s) when positioned between the
detecting means and the surface. The bent shape of the blister card
will ensure that the positioning of the indentations etc is more
precise.
[0100] A fifth aspect of the invention relates to a blister card
for use in the dispenser according to the fourth aspect of the
invention, the blister card has a number of blisters for each
holding a medical dose, the blister card further comprising an
indentation or a protrusion at each of one or more of a plurality
of predetermined positions.
[0101] Normal blister cards have no protrusions, indentations or
holes except for medicine blisters themselves and maybe small
mechanical features used for manipulating the blister cards during
manufacture or packing.
[0102] Normally the present blister card is manufactured as a
normal blister card with a subsequent step of providing the
indentations etc. Optionally, protrusions may, in fact, be provided
at the positions during providing of the blisters for the
medication.
[0103] The blister card may also comprise further protrusions,
holes, or indentations at the above-mentioned other positions in
order to ensure that un-original blister cards are not used in the
dispenser.
[0104] A sixth embodiment of the invention relates to a method of
operating a medical dispenser being adapted to hold a number of
medical doses and being adapted to determine when a user or patient
gains access to one or more of the medical doses, the method
comprising:
[0105] determining each of a first plurality of points in time or
time intervals at which the user or patient should take a medical
dose,
[0106] detecting each of a second plurality of points in time where
the user or patient gained access to the medical doses, and
[0107] providing to the user or patient information relating to a
relation between the first and second pluralities.
[0108] As mentioned above, the providing step preferably comprises
providing a relation between pairs of one of the first plurality of
points in time or time intervals and one of the second plurality of
points in time. Then, the providing step could comprise providing a
relation between the pairs of one of the first plurality of points
in time or time intervals and a first of the second plurality of
points in time occurring after the pertaining point in time of the
first plurality or within the pertaining time interval of the first
plurality.
[0109] In one embodiment, the relation relates to a time difference
between the pairs of the point in time or a starting time of the
time interval of the first plurality and the point in time of the
second interval.
[0110] In another embodiment, the providing step comprises
providing a relation between a number of times wherein a point in
time of the second number occurs within a time interval of the
first plurality, and a number of times wherein a point in time of
the second number does not occur within a time interval of the
first plurality.
[0111] The providing step may comprise providing, as the
information;
[0112] one of a plurality of predetermined colours to the user, the
colour being determined on the basis of the relation,
[0113] one of a plurality of predetermined numbers to the user, the
number being determined on the basis of the relation,
[0114] one or more of a plurality of predetermined areas of a
display visible to the user, the area(s) activated being determined
on the basis of the relation,
[0115] one of a plurality of predetermined sound signals to the
user, the sound signal being determined on the basis of the
relation, and/or
[0116] one of a plurality of predetermined graphical images to the
user, the image being determined on the basis of the relation.
[0117] Also, the method may further comprise the step of informing
the user, if a point in time of the second plurality occurs outside
a time interval of the first plurality.
[0118] A seventh aspect of the invention relates to a method of
operating a medical dispenser being adapted to hold a number of
medical doses, to inform the user in one of a plurality of
different manners, and to inform a user or patient of when to take
a dose, the method comprising:
[0119] determining a compliance of the user taking of medical
doses, and
[0120] selecting a manner of informing based on the determined
compliance.
[0121] Thus, the informing step may comprise informing the user
using one of sound, visual information, or vibration. Then, the
determining step could comprise determining a compliance selected
between a predetermined number of compliances, and the selecting
means could be adapted to select visual information based on a
first compliance of the predetermined number of compliances,
vibration based on a second compliance of the predetermined number
of compliances, and sound based on a third compliance of the
predetermined number of compliances.
[0122] Also, the informing step could comprise providing the sound,
visual information, or vibration with different intensities and/or
frequencies. Then, the determining step could comprise determining
a compliance selected between a predetermined number of
compliances, and the selecting means could be adapted to select an
intensity and/or frequency based on the determined compliance.
[0123] Preferably, dispenser is adapted to hold a number of medical
doses and is adapted to determine when a user or patient gains
access to one or more of the medical doses, the method
comprising:
[0124] determining each of a first plurality of points in time or
time intervals at which the user or patient should take a medical
dose, and
[0125] detecting each of a second plurality of points in time where
the user or patient gained access to the medical doses,
[0126] wherein the compliance determining step comprises
determining the compliance as a relation between the first and
second pluralities.
[0127] As mentioned above, the compliance determining step
preferably comprises providing a relation between pairs of one of
the first plurality of points in time or time intervals and one of
the second plurality of points in time. Also, the compliance
determining step could comprise providing a relation between the
pairs of one of the first plurality of points in time or time
intervals and a first of the second plurality of points in time
occurring after the pertaining point in time of the first plurality
or within the pertaining time interval of the first plurality.
[0128] Then, the relation could relate to a time difference between
the pairs of the point in time or a starting time of the time
interval of the first plurality and the point in time of the second
interval.
[0129] Also, the compliance determining step could comprise
providing a relation between a number of times wherein a point in
time of the second number occurs within a time interval of the
first plurality, and a number of times wherein a point in time of
the second number does not occur within a time interval of the
first plurality.
[0130] In any case, the compliance determining step preferably
comprises providing, as the information:
[0131] one of a plurality of predetermined colours to the user, the
colour being determined on the basis of the relation,
[0132] one of a plurality of predetermined numbers to the user, the
number being determined on the basis of the relation,
[0133] one or more of a plurality of predetermined areas of a
display visible to the user, the area(s) activated being determined
on the basis of the relation,
[0134] one of a plurality of predetermined sound signals to the
user, the sound signal being determined on the basis of the
relation,
[0135] and/or one of a plurality of predetermined graphical images
to the user, the image being determined on the basis of the
relation.
[0136] The method preferably also comprises the step of informing
the user, if a point in time of the second plurality occurs outside
a time interval of the first plurality.
[0137] An eighth aspect of the invention relates to a method of
operating a medical dispenser being adapted to hold a number of
medical doses, to inform a user or patient of when to take a dose,
inform the user in one of a plurality of different manners, and to
determine when the user or patient accesses a medical dose, the
method comprising:
[0138] a number of times, operating the informing means in order to
inform the user with different manners of informing,
[0139] during operation of the operating means, determining which
manner(s) of informing brings the user or patient to access a
medical dose,
[0140] subsequently to the operation of the operating means,
selecting a manner of informing based on the determination.
[0141] Preferably, the informing step comprises informing the user
using one of sound, visual information, or vibration. Then, the
informing step could comprise providing the sound, visual
information, or vibration with different intensities and/or
frequencies.
[0142] The determining step preferably comprise determining that a
manner of informing brings the user or operator to access a medical
dose, when the user or operator accesses the dose while or within a
predetermined period of time after the actual manner of operating
is used.
[0143] Also, preferably, the operating step comprises subsequently
using different manners of information until the user gains access
to a medical dose.
[0144] In the preferred embodiment, the selecting step comprises
selecting a manner, which the most often brings the user or
operator to gain access to the medical dose. Preferably, the
operating step is operated a plurality of times, the determining
step comprising determining, for each of the plurality of times,
which manner brings the user of operator to access the medical
dose, and wherein the selecting step comprises selecting the manner
having brought the user or operator the most often to access the
medical dose.
[0145] In a preferred embodiment of any of the sixth, seventh or
eighth aspects, the method comprises the steps of the dispenser
holding one or more blister cards holding the number of medical
doses, and detecting that the user or patient has accessed a
medical dose when the blister card is removed from the
dispenser.
[0146] In another embodiment, the dispenser is adapted to provide
one or more medical doses to the user or patient by inhalation, and
the dispenser has an air passage connected to a medical output and
means for covering or closing the output or air passage when not in
use, the method comprising the step of detecting that the user or
patient has accessed a medical dose when the covering/closing means
is removed from the dispenser.
[0147] In a third embodiment, the dispenser is adapted to provide
one or more medical doses to the user or patient by injection by an
injection needle, and the dispenser has means for covering the
injection needle when not in use, the method comprising the step of
detecting that the user or patient has accessed a medical dose when
the covering means is removed from the dispenser.
[0148] A ninth aspect of the invention relates to a method of
operating a dispenser being adapted to removably hold one or more
blister cards for each holding a number of medical doses, the
blister card comprises an indentation, hole, or a protrusion at
each of one or more of a plurality of predetermined positions, and
to inform a user or patient in relation to the taking of one or
more medical doses, the method comprising:
[0149] detecting, using detecting means of the dispenser, at each
of the predetermined positions any indentation, hole, or a
protrusion at that position, and
[0150] operating the informing means on the basis of an output from
the detecting means.
[0151] Then, the detecting step could comprise, at each of the
predetermined positions having a protrusion or if no hole or
indentation is present at the position, displacing a displaceable
detecting means.
[0152] The method preferably comprises the step of identifying,
from the positions of the blister card where indentations, holes,
or protrusions are detected, one or more of:
[0153] a manufacturer of the medical doses,
[0154] a type of medication in the medical doses,
[0155] a frequency of recommended intake of the medical doses,
[0156] recommended points in time of intake of the medical
doses,
[0157] a dose strength of one or more of the medical doses, and
[0158] a manner of informing the user or operator.
[0159] Also, the method may comprise the step of determining a
compliance of the user's or operator's intake of the medical doses
based on:
[0160] a predetermined medication schedule identified by
indentations, holes, or protrusions or the lack of indentations,
holes, or protrusions at predetermined positions of the blister
card and
[0161] information relating to points in time when the user or
operator gains access to at least one of the doses of
medication.
[0162] Further, the method may comprise the steps of informing the
user or operator to take a dose of the medication and of
determining when it is time to inform the user on the basis of:
[0163] a predetermined medication schedule identified by
indentations, holes, or protrusions or the lack of indentations,
holes, or protrusions at predetermined positions of the blister
card and
[0164] a clocking device.
[0165] In an interesting embodiment, the method comprises the step
of the dispenser receiving, from the user, information relating
to:
[0166] how to calculate compliance, and/or
[0167] how to inform the user of compliance.
[0168] Then, the blister card(s) may have indentations, holes, or
protrusions made subsequent to manufacture thereof, and wherein the
dispenser derives the information from the indentations, holes, or
protrusions made subsequent to manufacture thereof.
[0169] Preferably, the method of this aspect further comprises the
step of detecting or determining when the user or operator gains
access to at least one of the medical doses.
[0170] In any of the embodiments of the sixth, seventh, eighth and
ninth aspects incorporating a blister card, the method preferably
comprises the step of the dispenser holding the one or more blister
card(s) in a manner so that the blister card is curved in a
direction at least substantially along a longitudinal direction
thereof. Then, the method may comprise the dispenser receiving the
blister card(s), in a slot thereof, in a direction along the
longitudinal direction of the blister card(s).
[0171] The method also preferably comprises the step of biasing an
edge portion of each received blister card against a first surface
of the dispenser. Then, the detecting means could be positioned a
predetermined distance from the first surface and detect the
blister card(s) when positioned between the detecting means and the
surface.
BRIEF DESCRIPTION OF THE DRAWINGS
[0172] In the following, preferred embodiments of the invention
will be described with reference to the accompanying drawing,
where
[0173] FIG. 1A-1F illustrate a first preferred embodiment of a
device according to the invention, and with means for monitoring
the position of a blister card,
[0174] FIG. 2A-2G illustrate a second embodiment of a device
according to the invention, and with means for monitoring the
position of a covering part,
[0175] FIG. 3A-D illustrate a blister card and the use thereof, the
blister card having holes, indentations or protrusions,
[0176] FIG. 4A-4B are timelines showing possible ways of
administering drugs utilising a device according to the
invention,
[0177] FIG. 5 illustrates an embodiment of the invention used in an
injector, and
[0178] FIG. 6 illustrates an embodiment of the invention use in an
inhaler.
DETAILED DESCRIPTION OF THE INVENTION
[0179] FIG. 1A-1F show a first embodiment of a device 1 for holding
a blister card B. In FIG. 1F, the device is shown with a blister
card B inserted into the device. The device 1 has a closed surface
2 and oppositely thereto a partly open surface 3. The partly open
surface 3 has a slot 4 extending partly down the surface. The slot
4 is intended for inserting a finger for sliding the blister card B
into and out of the device. The one end 5 of the device has an
inlet 6 for inserting the blister card into and taking the blister
card B out of the device. The other end of the device 1 has
monitoring means (See FIG. 3) for registering the position of the
blister card B.
[0180] The monitoring means is intended for registering a first
position of the blister card B within the device, said first
position being a position where the blister card is fully or almost
fully inserted into the device (See FIG. 3B). Fully or almost fully
inserted is a position where the closed surface 2 covers all of the
tablets in the blister card B, so that not even one tablet can be
taken from the blister card.
[0181] The monitoring means is preferably also intended for
registering another position (See FIG. 3A) of the blister card B in
relation to the device, said other position being a position where
the blister card B is fully or partly pulled out of the device.
Fully or partly pulled out is a position where the closed surface 2
does not cover the tablets T in the blister card B, or at least
does not cover outer tablets in the blister card, so that at least
one tablet can be taken.
[0182] In the embodiment shown the device also comprises a small
signalling means 7 such as an LED or other lighting means placed in
another end 8 of the device. The signalling means 7 may have
different functions. The signalling means may be for signalling to
the user when the blister card is in the first position or not,
i.e. in the position, where tablets cannot be taken from the
blister card.
[0183] The signalling means 7 may also be a means for reminding the
user of when to take a tablet according to information from a
dosage plan stored in an electronic memory (See FIG. 3) of the
device. The signalling means 7 may also be a means for displaying
to the user a level of compliance. A first level may be a level of
compliance where the dosage of tablets to be taken and the time at
which the tablets are to be taken have been fulfilled according to
the dosage plan. In this situation, the signalling means 7 may show
a steady green light. A second level of compliance may be a level
of compliance, where the dosage of tablets to be taken and/or the
time at which the tablets are to be taken, have not been fulfilled
according to the dosage plan, but where satisfactory compliance
still may be established if the dosage of tablets are taken now. In
this situation the signalling means may show a steady yellow light.
A third level of compliance may be a level of compliance where the
dosage of tablets to be taken and/or the time at which the tablets
are to be taken, have not been fulfilled according to the dosage
plan, and where satisfactory compliance cannot be established, even
if the dosage of tablets are taken now. In this situation, the
signalling means may show a blinking red light, or a steady red
light. Other ways of signalling may be established depending on
other defined intermediate levels of compliance according to the
information of dosage plan stored in the device.
[0184] The device is designed (See FIG. 1B) so that the closed
surface 2 and the opposite surface 3 are curved. This has the
advantage that when the blister card B is inserted through the
inlet 6 into the device, the blister card B will be slightly bent
compared to the planar configuration of the blister card B before
insertion into the device. The slight bending of the blister card B
will lead to the blister card B being wedged in the device, thereby
holding the blister card B in the device without any elements as
such for holding the blister card B within the device.
[0185] Thus, when the blister card B is inserted into the device
through the inlet and is pushed all the way to the first position,
where the blister card B is fully inserted in the device, the
blister card B cannot drop out of the device. The curvature of the
closed surface and the partly open surface 3 may have any rise H of
the curvature in relation to a length of the blister card B. The
only demand of the rise H of the curvature is that the blister card
B must be so hardly wedged as not to drop out of the device by
accident, perhaps when the inlet 6 of the device is directed
downwards.
[0186] The device is also so designed that the one end 5 and the
other end 6 of the device have flattened parts 9. The flattened
parts 9 enable the placement of the device at a supporting surface
such as a table. The device also has a shape and a size making it
possible easily to bring the device along during the day, either in
a bag, even a small lady's handbag, or in a pocket of a shirt or of
a pair of trousers. The size of the device is not much larger than
the size of the blister card B contained in the device. Thus, the
device itself will not be limiting the compliance of the user, only
the "discipline" of the user will determine the compliance.
[0187] FIG. 2A-2G show a second embodiment of a device for holding
a blister card B. In FIG. 2G, he device is shown with a blister
card B inserted into the device. The device has a movable covering
part 10; in the embodiment shown, a hinged covering part 10. In an
alternative embodiment, the covering part 10 may be slidable along
grooves in the device instead of being rotated as shown. In yet
another embodiment, the covering part may just be liftable from a
lowered closed state on top of the device to a raised open state
separated from the device.
[0188] The covering part 10 is intended for covering a compartment
11 for holding the blister card B within the device. In an open
state of the covering part 10, both the compartment 11 and control
buttons 12 of the device are covered. In the embodiment shown, the
covering part 10 has an aperture 13 for allowing viewing of a
display 14, even if the covering part 10 is in the closed state. A
small signalling means 15 is situated to the right of the covering
part 10, and the covering part 10 does not cover this signalling
means 15 either, even if the covering part 10 is in the closed
state.
[0189] As mentioned above, in the embodiment shown the device also
comprises a small signalling means 15 such as a LED or other
lighting means such as the one shown in the first device of FIG.
1A-1F. The function and purpose of the signalling means 15 of the
second embodiment shown in FIG. 2A-2G may be any one of the same
purposes and functions as the ones described in relation to the
first embodiment. Accordingly, the description related to the first
embodiment of FIG. 1A-1F regarding the function and the purpose of
the signalling means is hereby, by reference, incorporated into the
description of the signalling means of the second embodiment shown
in FIG. 2A-2G.
[0190] Apart from the signalling means 15, as mentioned, the second
embodiment of the device also has a display 14. The display 14 may
be used for many purposes and may include different functions. A
display increases the amount of and the kind of information which
may be given to the user apart from the information given by the
previously described signalling means 15. Also, apart from the
display 14, as mentioned, the second embodiment of the device has
control buttons 12. Control buttons 12 may be used for different
purposes. The control buttons 12 may be used for entering data into
an electronic memory of the device. The control buttons may also be
used for scrolling between different data or different sets of
date, all capable of being shown in the display 14.
[0191] A bottom part 16 of the device shown in FIG. 2A-2G is
provided with holes 17 intended as outlets for tablets from the
blister card B contained in the compartment 11 of the device. The
outlets 17 may have an orifice 18 planar with surface 19 of the
bottom part 16. This will however necessitate holding the device in
the hands of the user, when having to dispense one or more tablets
from the blister pack in the compartment.
[0192] Therefore, in an alternative embodiment of the device, the
outlets may have an orifice 18 being situated at a level above a
level of the bottom surface 19. This leads to the advantage that
the device may be placed at a supporting surface such as a table,
when dispensing the tablets from the blister pack. In order for
this function to be realised, the level at which the orifices of
the outlets are situated must be situated above the level of the
bottom surface in a distance being the same as or larger than a
height of the tablets to be dispensed.
[0193] Thus, due to the possibility of orifices of the outlets
situated in a plane above a level of the bottom surface, and thus
above the supporting surface, there is room for the tablets between
the orifice of the outlets and the supporting surface, when the
device is placed with the bottom surface on the supporting surface.
Being able to place the device on the supporting surface when
dispensing the tablets, makes it very much easier to dispense the
tablets from the blister pack, especially for elderly people or
others having only a limited amount of strength in hands and
fingers.
[0194] The bottom surface has a small cover (not illustrated). This
cover is intended as cover for batteries for powering the
signalling device, the display and any electronic memory storage
means of the device. The batteries may also be used for powering
possible means for transmitting data from the device or receiving
data to the device from to a remote data receiving or data
transmitting apparatus for storing, or in any other way handling
data related to the usage and the monitoring facilities of the
device.
[0195] The one side of the device has a plug 21. One or more plugs
may be provided for different purposes. One purpose of a plug may
be to provide the device with electrical power from an external
power source, either as an alternative to the batteries, or as a
supplement to the batteries. Another purpose of one or more plugs
may be to provide the device with a wired link to an external data
receiving and/or data transmitting apparatus. The number of plugs
may also be intended for a telecommunication means such as modem or
the like for providing the device with a wireless link to an
external data receiving and/or data transmitting apparatus.
Finally, the plug may be used for transmitting data to other
devices related to the use of the device according to the
invention, such other devices perhaps being a sound alarm, a
lighting alarm or a tactile alarm in the vicinity of the device and
of the user and having the purpose of alerting the user of when to
take a tablet from the device in order to maintain or in order to
obtain satisfactory compliance.
[0196] Monitoring the actual direct status of the dispenser and
monitoring the compliance may take place by any suitable means. The
display may, as shown in FIG. 2, constitute a part of the
dispenser. However, alternatively the display may be connected to
the dispenser either physically by a permanent or detachable
wiring, or non-physically by means of wireless signals either to a
separate display unit or perhaps to a mobile phone, or any other
means of receiving wire-less signals.
[0197] Using wire-less signals to transmit the monitoring of
compliance has the advantage that means for receiving messages that
may be more frequently used than the dispenser, such as a mobile
phone, will constitute the display means. This will increase the
safety of the user taking the tablets at the prescribed times of
drugs, and thereby maintain proper compliance. Furthermore, it will
be possible for others than the user to monitor the compliance of
the user, perhaps a doctor or other supervisor related to the
dosage plan.
[0198] At least the device shown in FIG. 1, and possibly also the
device shown in FIG. 2 may be provided with a mechanical switch
which is engaged when a blister card B is stored in the device.
Referring to the embodiment shown in FIG. 1, when the blister card
B is removed from the first position, the switch is disengaged,
this being monitored by a timer in the device. When the blister
card B is moved to the first position again, the timer monitors
this as a dosage of drugs having been taken.
[0199] In a possible functionally extended embodiment, the timer
may compute when the next dosage of drugs has to be taken according
to a drug dosage plan, and the user may be reminded according to
this drug dosage plan. When the switch is disengaged again, this is
monitored as the blister card B having been removed from the first
position, and compliance having been fulfilled if the removal
complies with the drug dosage plan.
[0200] To avoid a user to achieve a misleading good compliance by
pulling the card from and to the first position a number of times,
the removal of the card could be registered as a tablet taken, only
if it happens during an active alarm. This reduces the risk of a
misleading compliance indication by failed operation, and makes it
more cumbersome to cheat the device. This way of detecting the
consumption of tablets is rather simple and inexpensive, but still
relatively reliable and valuable as a new tool to optimise a
treatment, and enable distinction between non-compliers and
non-responders.
[0201] Referring to the embodiment shown in FIG. 2, the same
functionality as above may be incorporated in a functionally
extended embodiment. However, the monitoring is not a monitoring of
a removal of the blister card B, but is a monitoring of lifting the
covering part from the first and closed position to another and
open position. In this way, exactly the same function as described
above with reference to the embodiment of FIG. 1 may be obtained
just by monitoring the covering part in stead.
[0202] Alternatively to a mechanical switch used for monitoring at
least when the blister card B or the covering part is in the first
position or not, other means of monitoring could be used. Thus, a
capacitive monitoring may be used where the blister card B or the
covering part introduces a change in a capacitor, when being placed
in the first position compared to not being in the first position.
Also magnetic means or optical means may be used to monitor when
the blister card B or the covering part is in the first position or
not. Additionally, seeing that the blister card B often have a back
foil made of aluminium foil or perhaps another metal foil,
electrical means sensing a conductivity of the foil of the blister
card B may be used to monitor whether the blister card B is in the
first position or not.
[0203] FIGS. 3A and B illustrate a dispenser 1 of the type
illustrated in FIG. 1. The illustrated dispenser is flat but may
also be curved as that of FIG. 1 in order to obtain the advantages
thereof.
[0204] In FIG. 3A, the blister card B and the dispenser 1 are
slightly separated in that the blister card B has been sided a
little outwardly of the dispenser 1. In FIG. 3B, the blister card B
is fully inserted into the dispenser 1.
[0205] The blister card B has two indentations or cut-away parts 40
which mate with corresponding protrusions 41 of the dispenser 1.
These protrusions and indentations serve the purpose of preventing
an unoriginal blister card from being fully inserted into the
dispenser 1.
[0206] The reason for this may be seen in the detector 42, which,
when the blister card B is fully inserted into the dispenser 1 (so
that the indentations 40 and protrusions 41 mate) will be able to
detect a feature of the blister card B at the position of the
detector 42. Such a feature may be another indentation (not
illustrated) as the indentations 40, a protrusion as is illustrated
at 43 in FIG. 3C, or a hole as illustrated at 44 in FIG. 3D.
[0207] Another embodiment is indicated in FIG. 3E, where the
indentations 46 (which may just as well be protrusions or holes)
are positioned not at the bottom of the blister card B but at sides
thereof so that a detector positioned in the slot receiving the
card may be able to detect the features as the card is inserted--or
when it is inserted.
[0208] Any number of detectors 42 may be used.
[0209] The detector may be based on optical, magnetical, or
mechanical principles.
[0210] The dispenser 1 has electronics 45 to which the detector(s)
42 are coupled. These electronics furthermore comprise batteries,
timer/clock, the reminding means (light emitter, vibrator, sound
provider), a processor or CPU, and memory for storing data, such as
medication schedules or programs for the CPU.
[0211] The features (40, 43, 44, 46) may be provided for informing
the dispenser 1 of a number of different things, such as
[0212] a manufacturer of the medical doses,
[0213] a type of medication in the medical doses,
[0214] expiration date of the medical doses,
[0215] a frequency of recommended intake of the medical doses,
[0216] recommended points in time of intake of the medical
doses,
[0217] a dose strength of one or more of the medical doses,
[0218] a manner of informing the user or operator (which type of
reminder does the user prefer for reminder and compliance readout)
and
[0219] What compliance level does the user himself wish to have (be
informed of)
[0220] This information is detected (using the detector(s) 42) by
the electronics 45 and may be used in the operation of the
dispenser 1.
[0221] Thus, in fact, the user may himself provide indentations or
other features in order to actually program the dispenser
himself.
[0222] The blister card B may be provided from manufacture with
score lines, weakenings, perforations or merely demarcations for
providing such indentations for e.g. informing the electronics of
the level of compliance to which the user wishes to be kept or
which compliance levels should give which outputs by the dispenser
1 (see below).
[0223] Naturally, the blister card B would normally be provided
with features from manufacture, such features informing the
electronics of how the medical doses should be dispensed. Such
features may be used for identifying one of a number of dispensing
schemes kept in the memory of the electronics.
[0224] An optical fit as a recognising means between dispenser 1
and blister card B may be a an optically readable feature of the
blister card B and a corresponding optical reader of the device, so
that it is not possible at all to gather any information form the
blister card B as to a dosage plan, if the optical reader of the
device cannot read a corresponding optical readable feature of the
blister card B. The optical fit may be correlated to perforations,
a breaking off of a corner of the blister pack or the like physical
entities of the blister card B, or the optical fit may be an
optical entity such as a hologram, a certain printing, a bar code
or the like. Perhaps the blister card B may be provided with a
coding intended for a chosen drug dosage plan, said coding being
selected by the user initial to introducing the blister card B in
the device. One of a number of possible optical features fits may
be indicative of the coding chosen by the patient, similarly to the
more mechanical feature, where different levels of e.g. 85%, 90%
and 95% compliance may be chosen, however optically by perhaps
providing a hole at a chosen location of the blister card B, and a
corresponding reader such as a photo cell provided in the device.
In FIG. 3, a feature is used for electronic/mechanical coding,
however similarly, the photo cell recognising light through a hole
in the blister card B may be used for optical coding.
[0225] Any coding of the blister card B itself may be directly
related to the drugs, the number of tablets contained in the
blister card B and other conditions which are essential for proper
and correct drug administration of the drugs in the blister card B
in question.
[0226] An embodiment and functionality as the one described above,
where the blister card B is provided with encoding may be
beneficial for a manufacturer of drugs in blister cards B, because
the manufacturer before handing over to the user the drugs in the
blister card B can be sure of the encoding ensuring a proper
compliance if complied with. Thus, the manufacturer does not have
to rely on a doctor or other exterior medical personnel coding the
device with the risk of wrongful coding of the device.
[0227] As mentioned, perhaps the encoding of the blister card B may
be made by means of visually or electronically readable and
tamper-proof means such as a hologram, a perforation or a small
electronic circuit resembling or in any other way utilising
trademarks solely used by the manufacturer. Thereby, it will be not
be possible to use drugs and blister cards from other
manufacturers. Also, the user can be sure that the drugs in the
blister card B and the encoding with a drug dosage plan are
mutually compatible, and that the drugs, if taken according to the
drug dosage plan, will ensure proper compliance according to the
prescribed manufacturer of the drugs. Even alternatively, the
blister card B may be provided a special design only used by the
manufacturer, and having the same purpose of individualisation as
described above.
[0228] Also as mentioned, another alternative way of implementing
variable compliance targets for the users would be to implement the
break-off tabs on the blister card B itself. This means that the
device is manufactured to reward a certain compliance. After a
while, the user can set higher targets by breaking off tabs, which
will cause the device to give rewards at a higher level of
compliance.
[0229] All the devices shown may have one or more signalling means
capable of reminding the user of taking the drugs either by a
visual, an audible or a tactile signal. The visual signal is a lamp
lighting red or other colour, when the time for delivering the
drugs arises. The audible signal may be a siren sounding a
warning-like signal. The siren may be adjustable, both in relation
to the sound level and in relation to the sound produced. The sound
produced may also differ depending on when the drugs is taken along
a time interval after the time of delivering has been reached. At
the beginning of the time interval, after the time of delivering
has been passed, the audible sound is "pleasant" and/or at a low
level. As long as the drugs is not taken and depending on how long
time after the time of delivering that the drugs is still not
taken, then the audible sound will be less "pleasant", i.e. it will
start being more alert-like or alarm-like, and/or the audible sound
level will increase either stepwise or gradually. The sound may be
a beeping sound or it may be a recording of a voice or an
exclamation.
[0230] Such an adaptive reminding could also be implemented with
visual alarming means, such as light emitting diodes, where a
flashing pattern changes over time, as the interval since the start
of the alarm gets longer. The light produced may also differ
depending on when the drugs is taken along a time interval after
the time of delivering has been reached. At the beginning of the
time interval, after the time of delivering has been passed, the
light could be a flashing green light, different from a steady
green light, or an alternating green and yellow flashing.
[0231] As long as the drugs is not taken and depending on how long
time after the time of delivering that the drugs is still not
taken, then the light could change to alternating yellow and red
flashing and further to a constant and steady red light perhaps
even to a flashing red light. The light could be a single light
with the above-mentioned pattern of alarming, or it could be a
plurality of lights each having their distinct colour and either
not lighting or lighting steadily or flashing depending on the
level of compliance at a certain time, either during or after the
drugs should have been taken according to a drug dosage plan stored
in a memory of the device. If the device, as shown in FIG. 2, is
provided with a display, the level of compliance may also or in
stead be displayed by for example a percentage.
[0232] Alternatively, a display may be used for informing the user
of his/her compliance in the form of a number, a pictogram
(happy/sad face) or other manners which will lead the user to know
his/her compliance.
[0233] In the latter case, either a voice or an exclamation, the
sound may be added some humour or a command-like tone so that the
sound is personalised in relation to the user utilising the device
for taking drugs. By personalising the sound, then the initiative
for taking the drugs may be increased. If the sound is a voice it
may the voice of a doctor, preferably the user himself or the
user's own doctor, motivating the user to take the drugs, and the
command being more and more harsh along with the drugs not being
taken after the time of delivering has been exceeded. If the sound
is added humour it may be one exclamation at the beginning of the
time interval, after the time of delivering has been exceeded, and
being another exclamation late in the time interval if the drugs
are still not taken.
[0234] Any personalised voice and command or any personalised
exclamation which the user chooses will add to the personalising of
the device, and thus to impel to handle the device and the taking
of the drugs seriously. Such sounds could also be attached to the
achieved compliance, so that a good compliance causes a positive or
rewarding sound to be played and a poor compliance causes a
motivating sound to be played.
[0235] Compliance may be determined in a number of manners, and the
user may, e.g., select a specific manner by providing a feature of
the blister card B. Compliance may be determined as how long after
the optimum time (as defined by e.g. a medication schedule) the
user actually takes the medication. Alternatively, time may be
divided into intervals, and the compliance may be determined as the
frequency at which the user takes the medication in a given
interval or after a predetermined period of time after the optimum
point in time.
[0236] Compliance may be determined as a mean over a period of time
depending on e.g. a feature of the blister card B or depending on
the type of medication. For some types of medication, compliance
should be determined over a time interval of at least a month, and
for others, a few days would suffice.
[0237] The specific manner of informing the user that it is time to
take a dose of medication may vary with the users present
compliance. If the user is compliant to the medication scheme, a
pleasant manner of informing the user may be selected, whereas a
non-compliant user may be informed in a less pleasant manner. More
pleasant manners may be the emission of light, a light vibration of
a pleasant sound, whereas less pleasant manners may be more
aggressive vibration and/or sounds.
[0238] Another situation where different manners of informing the
user may be relevant is one where the dispenser determines that a
given manner of informing the user has no effect or that a given
manner has a particularly high effect. A situation of that type
would be to rule out audio information for a user who turns out to
be deaf of light or vibration information when the dispenser is
normally placed in a hand bag.
[0239] Thus, the dispenser may be able to test different manners of
informing and to determine which manners are the most useful--and
to thereafter predominantly use these. The determination of whether
a manner of informing is useful may be made on the basis of whether
the user takes the medication during or shortly after that manner
of informing has been used.
[0240] FIG. 4A-B shows how drugs could be administered with a
device according to the invention, and it visualizes the different
administration rules a device is capable of supporting. Basically,
a prescription of medicine for example from a doctor to a patient
comprises a specification of a drug to be taken and an ideal dosage
of the drug to be taken at a certain moment of time, or within a
certain time interval. The dosage is related to a certain dosage of
drugs (e.g. two tablets) with a certain interval (for example every
24 hours). Therefore the administration is related to a calendar
(100), where a number of ideal dosages (110) should be taken at a
certain moment of time during the day or within a certain time
interval during the day.
[0241] In the example shown, the patient is supposed to take one
tablet every day at 8 AM. If this administration scheme is followed
precisely, the patient compliance is at a maximum. Deviations from
the ideal scheme can be interpreted as varying lack of, or a
decreased level of compliance. The purpose of the device according
to the present invention is to monitor this compliance by
application of different rules dependent on the actual function of
the relevant drug. Further, the purpose of the device according to
the invention is to improve the compliance, both by providing the
patient with information about the actual level of compliance and
by reminding the patient when to take the drug in order to maintain
a certain level of compliance.
[0242] The total time can by way of example be subdivided into two
main categories, described in the following. Allowed periods (117):
The patient is allowed to take a dosage. The period starts at or
before the ideal dosage time or reminding time. It seizes when a
dosage is taken, when all previous dosages have been taken, or when
the next ideal dosage is close-by. Prohibited periods (118): The
patient is not allowed to take a dosage. The purpose of the
prohibited periods is to avoid over-dosage or to avoid risky high
drug concentrations within the patient. The prohibited period
starts when a dosage is taken, when the right average dosages have
been reached, or when the next ideal dosage is close-by. It seizes
when a new ideal dosage is close-by. These periods can be divided
into a number of relevant sub-periods for more detailed monitoring
information.
[0243] For example, this more detailed information could be: Early
intake (125), ideal intake (126), delayed intake (127), intake
prohibited (caused by dosage taking), next dosage prohibited (128)
etc. The number and the kind of sub-periods depends on the therapy,
the kind and amount of drug and on the patients, and might be
related to any relevant information in relation to timing of
dosages or use of the device.
[0244] The term "allowed" and the term "prohibited" refer to
periods of time of a drug dosage plan. Allowed is when drug intake
according to the drug dosage plan is recommended, i.e. where drug
dosage should take place in order to obtain a certain state or a
certain level of compliance according to the drug dosage plan.
Prohibited is when drug intake according to the drug dosage plan is
not recommended, i.e. where drug dosage, if taking place, perhaps
will lead to over-dosage, or where drug dosage, if taking place,
perhaps will lead to an incorrect follow-up of the drug dosage
plan, and a non-existent possibility of reestablishment of
compliance according to the drug dosage plan.
[0245] The allowed and prohibited periods (117, 118) are the
default status of the device. However, dependent on the patient's
interaction with the device, the device can change its actual
status. For example, the prohibited period (130) is initiated by
the device activation (131), as the device is trying to make the
patient follow the rule that tablets should not be taken too close
to each other in order to avoid too high drug concentration, i.e. a
over-dosage. The prohibited period (135) is initiated by the
default status, as the dosage was not taken in the allowed period
and the next alarm is approaching. The device activation (136) is
therefore causing a warning signal (121).
[0246] The device can be programmed with the dosage information and
can therefore remind the patient at or linked to the ideal dosage
time. This is done by a reminder or an alarm (120), which informs
the patient that it is time to take the prescribed dosage. An alarm
can continue to be activated until a dosage is taken, or it can be
cancelled or changed from an audio signal to a visual signal after
a certain period of time. In the example shown, the alarm is
cancelled either by an activation of the device (blister card B is
taken out or the covering of the device is lifted), or because the
allowed period ends and the device enters a prohibited period,
where dosage taking is not recommended, because the next alarm is
coming soon. If the device is activated in a prohibited period, the
device could give the patient an acoustical warning signal (121,
122, 123) indicating that it is not recommended to take a
dosage.
[0247] Dependent on the function of the drug taken, different rules
for administration can be relevant. Events that influence the way
of administration could for example be the time before the active
substance in the tablet is transferred from the tablet to the
blood, the time before the active substance is influencing the
relevant site in the body, the half-time period of the active
substance etc. If the consequences of a high concentration of drugs
within the patient is harmless and/or the half-time period is
longer than the period between taking of drug dosages, the timing
is relative uncritical, and good compliance is achieved by taking,
in average, the acquired number of dosages. For example, it may be
acceptable to take two dosages at the same time if the previous
dosage was forgotten. A device for such drug could therefore add up
the number of reminders, so that previously forgotten dosages still
are reminded to the patient.
[0248] For drugs with a very critical upper limit of active
substance concentration, for example drugs for anticoagulation
treatment, other rulers might be implemented in the device. In this
example, the device will give the patient a warning if a dosage is
taken too close to the previous dosage taken, or too close to the
next ideal dosage to be taken.
[0249] FIGS. 5 and 6 illustrate other embodiments than pill
dispensers holding blister cards.
[0250] In FIG. 5, the dispenser is an injection pen 50 having a
syringe 52 for injection of medication present in a first part 53
of the pen 50. When not in use, the syringe 52 is not in use, it is
covered by a cover 54 which comprises the detecting means, CPU,
memory, informing means, providing means etc (in general denoted
55) desired to obtain th3e desired functionality according to the
invention.
[0251] In this manner, no changes are required for the pen 50 in
order to obtain the desired functionality.
[0252] Thus, when removing the cover 54 in order to gain access to
a medication dose, the detecting means (54) will detect that, and
the dispenser 50 act accordingly.
[0253] FIG. 6 illustrates another embodiment having an inhaler. The
dispenser 60 has the inhaler 63 having a medication output 62 for
the user to inhale through, and a base 63. The inhaler has an air
passage passing through the output 62 and a bottom of the inhaler.
This bottom is blocked by the base 63, when the inhaler 63 is not
in use and positioned in the base 63.
[0254] As is the case for the pen of FIG. 5, the base 63 of the
inhaler comprises all means and functionalities required (denoted
65>) in order to gain the advantages of the present invention.
Again, no changes are required in the actual inhaler 63.
[0255] In this aspect, it should be noted that even further manners
of delivery may be altered in order to obtain the advantages of the
invention: nasal sprays, transdermal deliveries, rectal delivery,
etc.
* * * * *