Note: Descriptions are shown in the official language in which they were submitted.
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Device and method for indicating an event of administration
The invention relates to a device for indicating an event of administra-
tion, with an indicator for registering an event of administration of a
medicament that should be administered usually regularly. The inven-
tion relates also to a method for indicating such administration.
It is known to use various medicament containers with alarm systems
based on timers for drug doses which are to be taken at intervals and
are usually in the form of pills, tablets, or corresponding doses to be
taken orally. For example, the application publication GB-2 179 919
discloses a medicament container which gives an alarm that can be
turned off only by opening the container. Such a container can also
contain a syringe or an ampoule. The application publication FR-
2 666 225, in turn, discloses an alarm system for a medicament con-
tainer equipped with compartments for pills, tablets or corresponding
orally administered doses, each compartment having a separate iid and
being provided with a separate alarm. The alarm is turned off automati-
cally within 15 seconds, and consequently no information is left in the
container, whether the dose has been taken or not.
For doses injected with electrically operated syringes, there are
systems integrated in the syringe, coupled with the electronics of the
syringe and used for controlling the administration of the doses. For
example, US patent 4 417 889 discloses a system for preventing an
extra dose integrated in the syringe, to prevent the use of the syringe a
second time within a certain time interval after taking the dose, i.e.
there is a kind of time lock. It is the fact that the syringe is operated with
an electric motor that the detection of the administration and data
storage is based on. US Patent 4 950 245 discloses a syringe intended
for the use of a person having diabetes, an "injection pen", which can
be used to administer a predetermined dose of insulin. The syringe has
an integrated system with a sensor monitoring the progression of a
pump rod inside the syringe and giving information to an electronic
control unit for administering a correct dosage at the time of injection. In
this syringe, the only alarm is an indication on the emptying of the
reservoir to be expected.
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Up to date, there has been no detector device or detection method that
could be applied in a variety of syringes for controlling an event of
administration. For example, diabetics must take a dose at regular
intervals. Thus, it may remain uncertain whether a dose was really
taken. For example, the most common injection pens are of the type
that a dose is administered by setting a push button back and pressing
it at the time of injection, wherein it moves a piston in a medicament
container forward the set distance. The same problem occurs when
different types of doses are taken in a regimen, for example within a
day, whereby it is difficult to keep a register on the doses administered.
It is an aim of the invention to present a device, whereby the event of
administering a dose can be detected in a reliable manner. For achiev-
ing the aim, the device according to the invention is primarily character-
ized in that it comprises a detector arranged to detect the mechanical
movement of the dosage unit of medicament in connection with an
event of administration. This movement can be the movement of a
piston in the dosage unit or a part kinetically connected with it, or the
release of the dosage unit from a support reserved for it.
It is also an aim of the invention to present a method for detecting an
event of administration. For achieving this aim, the method is primarily
characterized in that the dosage unit is equipped with a separate,
detachable indicating device, and when administering the dose, a
specific detector means belonging to the indicating device is used to
detect a mechanical movement, the event being automatically regis-
tered from the detector means in a memory.
By means of the invention, it is possible to create a completely novel
regimen e.g, for the treatment of diabetes, which is not previously
known and which can be easily implemented by the equipment avail-
able. Consequently, no structural changes need to be made in the
injection pen itself, and it is possible to use ordinary injection pens in
the market, which do not have the memory function in question as
such. Moreover, the invention does not require the use of injection pens
based on electrical operation, as presented in the patents US-
4 417 889 and US-4 950 246, but it can be used in purely mechanical
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injection pens in which the administration is effected by a movement
effected manually.
In the following, the invention will be described in more detail with
reference to the appended drawings, in which
Fig. 1 is a schematic view showing the principle of a first embodi-
ment of the invention in connection with an injection pen,
Fig. 2 is a side view on the first embodiment of the invention in
connection with an injection pen when assembled,
Fig.3 shows the embodiment of Fig.2 seen from a direction
perpendicular to the direction of Fig. 2,
Fig. 4 shows the first embodiment in an end view seen from the
direction of arrow IV,
Fig. 5 is a side view on a second embodiment of the invention
containing several dosage units,
Fig. 6 shows the embodiment of Fig. 5 seen from above,
Fig. 7 illustrates the use of the embodiment of Figs. 5 and 6,
Fig. 8 shows another alternative of the embodiment of Figs. 2 to 4,
Fig. 9 shows another alternative of the embodiment of Figs. 5 and
6, and
Figs. 10 and 11 show further embodiments of the invention.
Figure 1 shows a normal injection pen 1 and an indicating device 2 to
be placed as a separate piece around it. The indicating device can
have e.g. a sleeve-like or corresponding structure so that it can be fixed
to an ordinary injection pen without making changes in the structure of
the latter. For example, it can be pushed in the axial direction at the
rear end of the injection pen around the same (arrow). Similarly, it can
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be equipped with a separate push-button piece 3 which can be fixed
firmly around the normal push-button at the rear end of the injection
pen.
Figures 2 to 4 show a combination of the indicating device 2 and the
injection pen in assembled state. The indicating device 2 surrounds the
upper end of the injection pen underneath the press 3. The indicating
device 2 comprises a battery 4 and a pair of indicators 5a, 5b. The first
indicator 5a is arranged to indicate when it is time to administer a dose.
The device has also a means 7 for detecting a movement in connection
with administering the dose, in this case the movement of a part moving
with respect to the body of the injection pen, such as the push-button or
a piston or another injection means and/or parts kinetically connected
with the same. In the embodiment of Figs. 1 and 2, this is accomplished
in a way that to the push-button 3, which has been set back and pushes
a piston forward by means of a piston rod, is attached a part 6 which is
drawn back with the setting movement and presses a micro-switch
present in the indicating device 2, acting as said detector means 7,
during the pushing movement. The part 6 moving together with the
movement of the piston can be e.g. a tube-like piece which is received
in a space reserved for it in the body of the indicating device 2 and
which can be of a transparent material. In general, it is possible to use
the movement of any part of the injection pen, which results in or which
is a sign of administration of a medicament in the body.
When the movement of the piston is recognized in the above-described
manner, the first indicator 5a is shifted into a state in which it reports
that a dose was administered, i.e, the alarm stops. At the same time,
information on the administration of the dose is stored in the device 1,
and if one attempts to set the injection pen again for administration
within a certain time from this event, the second indicator 5b of the
indicator pair gives a warning.
It is also possible that, depending on the capacity of the power supply,
such as a battery, the second indicator is turned on for a certain time
period from the administration of the dose or until the next alarm is
given. Thus, there is always information available on whether the
previous dose was taken.
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The indicators 5a, 5b of the indicator pair can be e.g, visual indicators,
such as indicator lights. The indicator lights can be realized in practice
with LED's. The indicator lights are preferably of different colours, e.g.
5 one green and the other red. At the same time with the operation of
either or both of the indicators, an acoustic indicator can be arranged to
give a sound signal, e.g. a suitable buzzer. This acoustic indicator is
schematically indicated with the reference number 5c.
The indicating device 2 is also equipped with a setting switch 8, which
can be used to select the alarm time corresponding to the dosage
intervals. Similarly, it is provided with a window 17, through which the
dosage scale in the body of the injection pen can be seen.
Figures 3 and 4 also show an electronics part 9 arranged on one side
of the device 2 and also equipped with a space for a battery. The elec-
tronics part contains the couplings to the detector means 7, the memory
functions required for registering the event, and the circuits required for
the control of the alarms and the indicators.
Figures 5 to 7 and 9 show another indicating device 2 applying the
same inventive idea. Also in this case, the indicating device 2 is a piece
separate from the injection pen, and in this case it forms a stand for two
or more injection pens 1. The purpose of the stand is to control and
monitor the administration of several doses to be taken during the day.
To each injection pen 1, there is allotted a time of the day in the
memory of the device telling when the injection should be taken. When
it is the time to administer a dose from the pen, a visual indicator by the
pen shows that the dose should be taken from the pen in question.
Also, an acoustic alarm is given. When the dose has been taken from
the pen, the visual indicator by the pen remains, for a given time, for
example until the beginning of the standby time of the same pen, in a
state that shows that the dose has already been taken from the pen.
This is indicated advantageously with an illuminated colour that can be
easily detected. The indicator for the pen showing that a dose should
be administered and the indicator showing that the dose has been
taken can be different indicators which are turned "on" and "off". It is, of
course, possible to use physically the same indicator which changes its
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state, e.g. colour, according to the state of the pen in question. The
operating principle is the same for each injection pen 1 to be monitored
in the stand. The injection pens can be different in that they contain
medicaments which act differently and which each should be
administered at a certain time of a day. In the treatment of diabetes, the
pens may contain different types of insulin.
The stand shown in Fig. 5 has vertical recesses 10 for placing injection
pens in an erected position in the stand. The main principle of operation
is the same as in the embodiment of Figs. 1 to 3, and it is best
illustrated in Fig. 6. Each injection pen 1 is allotted an indicator pair 5a,
5b of its own. The device is arranged to alarm in a certain order,
wherein the first indicator 5a of the respective injection pen alarms that
it is time to administer a dose from the injection pen in question. The
indicating device 2 detects the removal of this injection pen 1 from the
stand by an arrangement where it has a means 7 detecting the
movement of the injection pen away from the stand in a suitable way.
Also in this case it is possible to use a suitable micro-switch operating
on the contact principle, e.g. a switch placed on the bottom of the
respective recess 10. W hen the sensor has detected the removal of the
injection pen 1, the state of the first, alarming indicator 5a is reset. At
the same time, the second indicator 5b is shifted to a state in which it
indicates that the dose has been administered. For example, it is
possible to use visual indicators, such as indicator lights. The light of
the first indicator 5a can be turned off and the light of the second
indicator 5b can be lit at the same time as a sign of removal of the
injection pen. This can be realized in practice with LED's in the same
way as in the embodiment of Figs. 1 and 2.
Furthermore, the device 2 has, e.g. by the recesses 10 for receiving the
injection pens, similar alarm setting switches 8 as described above, one
for each injection pen 1. These can also be used to set the suitable
time intervals for example in a way that one switch is used to set the
time telling at what time of the day the alarm is to be given, and the next
switches can be used to set the dosage intervals, i.e. the time to the
next alarm.
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The figure shows a stand for five injection pens corresponding to five
times of administration during a day. If there are fewer times of admini-
stration, the last space or spaces in the stand can be simply left empty.
Furthermore, Fig. 6 shows a separate indicator panel 12 coupled to the
stand with a connection cable 11 and equipped with indicator pairs 5a,
5b operating in a way identical with the indicator pairs in the stand but
provided also with a supplementary acoustic indicator 5c, such as a
buzzer, common to all the indicators. Furthermore, the device com-
prises a mains transformer 13, a "power on" indicator 14 in the indicator
panel, as well as a main switch 15 which is in the stand but which may
also be in the indicator panel 12.
Figure 7 illustrates a way of using the device of Figs. 4 and 5. The
injection pens 1 can be in a stand at a temperature suitable for them,
for example in a refrigerator 1 fi. The indicator panel can be brought with
the connecting cable outside the refrigerator or a corresponding space,
in which it reports the situation continuously. Thus, the administration
situation can be monitored continuously, and the doses are kept at a
lower temperature suitable for them. A refrigerator is not necessary if
allowed by the indoor temperature or the stability of the medicament to
be administered. In this case, there is no need for a separate panel
brought outside the refrigerator either, but all the functions can be
contained in the same device body. On the other hand, a separate
indicator panel equipped with a connection cable may be useful in
situations in which it is desirable to have the indicators in a visible
place, even if the actual stand is not kept in a closed place.
The injection pens kept in the stand may still have their own indicating
devices 2 according to Figs. 1 to 4, wherein it is possible to register
both the removal of the injection pen from the stand and the admini-
stration of the dose from this injection pen.
Figure 8 shows another indicating device which is also suitable for use
with a pen-type injection means. The device can be used to set a
maximum of two injection times, which can give the alarm according to
the need. A setting switch 8 is used to set the alarm times and to reset
both timings. When the switch is pressed down a first time at the time
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of the day when the first dose should be administered, the device
beeps once with a buzzer 5c as a sign that the first alarm time is set.
When the switch is pressed down again at a second time of day, this
time of day is set as the second alarm time, and the device beeps twice
as a sign of this. If the switch is pressed after this, the device beeps
three times as a sign that both the alarm times are already set. If the
switch is pressed continuously for a certain time, e.g, for at least
3 seconds, both of the alarm times are reset. The device beeps in this
event five times and returns to its initial state. Thus, the setting switch 8
is a simple one acting on pushing principle, and the timer of the device
registers as the alarm time the time of day when the switch is pressed.
The detector means 7 is a micro-switch detecting the movement of the
piston in the injection pen, i.e. the loading and administration of an
injection. The micro-switch projects out from the end of the device 2,
and a push-button at the end of the pen, which may be an extension
piece arranged around the push-button of a commercial pen according
to Fig. 1, presses the switch down in the normal position. When the pen
is set for administration, the push-button is moved back and it releases
the switch, and when the injection is administered after the setting, the
push-button presses the micro-switch down again.
Each timing has a standby time which starts an hour before the alarm
time and ends two hours after it. When the time to administer the dose
comes up, the device beeps four times with the buzzer 5c. If the dose is
administered not earlier than one hour before the selected alarm time,
an alarm is unnecessary and will not be given. If the injection pen is
loaded again (that is, at least a second time) within the standby state of
the dose, the device gives three sound signals with the buzzer 5c,
thereby warning from taking the same injection twice. At the same time,
a visual indicator, e.g, the indicator light 5, flashes at the pace of the
sound signal. This warning signal will not be given at other times, so
that e.g. the insulin container can be changed at that time without an
alarm.
The device registers the administration of a dose, when the push-
button has been set backwards and it has returned forward, i.e. the
micro-switch has returned to the initial state. For giving a warning
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WO 99/43283 PCT/FI99/OOI54
against a double injection, the setting of the push-button backwards will
be sufficient.
The device can remind of administering the dose with the same alarm if
the administration of the dose has not been registered within a certain
time. The reminder can be repeated at given time intervals.
The following is a summary of the sound signals of the device:
1 Bee Alarm time 1 set
2 Bee s Alarm time 2 set
3 Beeps Warning sound signal (wrong operation)
If the indicator li ht Warnin a ainst double in'ection
flashes
4 Bee s Alarm on in'ection
5 Bee s Resettin of both alarm times
Figure 9 shows an indicating device 2 intended for several dosage
units 1. By pressing dosage unit specific setting switches 8, it is
possible to set the alarm times and to reset the timings according to the
same principle as in the device of Fig. 8. When the switch is pressed
down (e.g. with a pointed tool, such as a pen) a first time, the device
beeps once with the buzzer 5c as a sign that the alarm time is set. If the
switch is pressed again, the device beeps four times as a sign that the
alarm time is already set (error signal). By pressing the switch down
continuously for a certain time, e.g, at least 3 seconds, said alarm time
is reset. The device beeps five times and switches off the alarm of that
injection pen whose setting switch 8 was pressed.
Each timing has a standby time which starts one hour before the alarm
time and ends three hours after that. During the standby time, the
administration of the injection is being monitored. When the set alarm
time is up, the device alarms with a sound signal and a green light is lit
at the correct injection pen. The green light can be lit already when the
standby time begins before the actual alarm. The detector 7 in the
stand of injection pens detects that the injection pen is lifted from the
stand, i.e. an injection is administered. When the pen is lifted at the
right time, the green signal light is turned off and the red signal light is
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turned on at the pen in question to remind that the injection has been
taken. The red signal light is turned off only one hour before the alarm
time of the same pen (when it is already allowed to administer a new
injection). If the injection pen is lifted at the earliest one hour before the
5 selected alarm time, the alarm is not necessary and is not given. If the
injection pen is lifted again (i.e. at least a second time) within the
standby time, the device gives eight quick sound signals, thereby
warning to take the same injection twice. This signal is not given at any
other time, so that e.g, the insulin container can be exchanged during
10 that time without causing an alarm. After lifting the pen, there is a short
delay (ca. 3 to 6 seconds), during which time the pen can still be put
down if one e.g. notices that a wrong pen has been lifted. This delay
time is set so that it is in no way possible to administer an injection
during that time, i.e. the detection of returning the pen within a certain
maximum time will not register a dose as having been administered.
The device may remind of administering a dose with the same alarm if
an administration is not registered within a certain time, e.g. in four
minutes. The reminder may be repeated at certain intervals. The
following is a summary of the sound and light signals of the device:
1 Ion bee Alarm time of desired en set
4 bee s Error si nal wron o eration
8 bee s Warnin to avoid double in'ection
4 x 4 bee s Alarm to take an in'ection
5 slow bee s Resettin of desired alarm time
Red si nal li ht Do not take an in'ection from this
en
Green si nal li You can take an in'ection from this
ht en
In the alternatives of Figs. 5 to 7 and 9, there can be also a special
alarm function, that is, if the injection pen has not been removed from
the stand within a certain time, e.g. during the predetermined standby
time, a special alarm is given that is different from the alarms of the
indicators 5a and 5b. Moreover, such a special alarm can be triggered
first after two injection pens intended to be used in succession have not
been removed during the respective times. The alarm can be given as
a remote alarm outside the home of the user via a fixed telephone
network or by using wireless telecommunication, such as GSM technol-
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ogy. Visually, this can be indicated as a special signal in the device,
e.g. both of the lights are turned off.
The detector means 7 can be arranged to operate by the contact prin-
ciple, such as micro-switches, but it is also possible to use contactless
movement sensors, such as optical or magnetic movement sensors,
whereby it may be necessary to provide the part which moves in
relation to another part in connection with the operation of administering
a dose with a corresponding element, such as a ferrite or Hall element
or an IR transmitter and receiver.
The embodiment of Figs. 5 to 7 and 9 can also be used for monitoring
the administration of other types of doses than those injected from
syringes. For example, it is possible that the stand is fitted for dosage
units containing other types of medical doses, for example ampoules.
Figures 10 and 11 show some further embodiments. In Fig. 10, an
injection pen is equipped with an indicating device with a lid to be
turned away from the top of the push-button. The movement of turning
the lid can be detected with a detector means, to register a dose as
administered. Figure 11 shows a simple housing for one injection pen,
in which the pen can be inserted and pulled out to administer a dose.
This housing can operate in a corresponding way as a stand intended
for several pens, with the only difference that it is used for monitoring
one dosage unit only, and the functions of the panel are integrated in
the housing.
Furthermore, in connection with all the devices it is possible to use a
locking function after the administration of the dose is registered. Thus,
the device is equipped with a latch that prevents the preparative
measures for the administration, such as a switch or latch in the stand
or in the housing, to prevent the turning of the lid shown in Fig. 10 or
the removal of the injection pen from the stand or housing. This locking
can be on for a certain precautionary time, which can start from the
registration of an event of administration or end at a certain moment of
time, e.g. as long as the predetermined allowance time (standby time
of the next administration starts or for a shorter time, e.g. until the end
of the predetermined standby time. In the following, these possibilities
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will be described with reference to Fig. 9. In the stand 2, the injection
pens are intended to be placed, the ends with a pocket clip foremost,
into their compartments 10, which have a shaped space, such as a
widened portion made at the side of the recess for this purpose. In
connection with each space, there is a latch 18 which in the locking
position projects out above the pocket clip and prevents the pulling out
of the injection pen. The latch 18 is activated when the pen is inserted
back and the administration of the dose is registered. A precautionary
time can be arranged with any of the principles mentioned above. The
latch is arranged to be opened at the latest when the standby time of
the injection pen in question starts, i.e. when it is allowed to administer
a dose from the pen. The latch operates preferably in such a way that
energy must be brought to it to keep it in the locking position and in the
state without energy it will be open, for example a magnetic latch which,
upon switching off of the current, is withdrawn by the effect of a spring
to the open position. Thus, by turning off the current, the pen can be
removed from the stand, if necessary, the settings being stored in the
memory.
The indicating device, particularly one to be attached to an injection
pen, does not necessarily need to have an alarm and remind function,
but it can be intended only to register the event of administration, for
example in the case of a dose which is to be taken in connection with
having a meal and which has no definite time of the day. On the other
hand, in connection with such an effective insulin, it is particularly
important to prevent a double dosage.
The device can be implemented with normal electronic components,
such as various sensors, sound and light indicators, a microprocessor,
a timer, and a memory which is preferably a memory retaining its infor-
mation in spite of a failure in the supply of current. These means are
functionally coupled to each other to implement the functions of the
device. The electronics of the device is, in its simplest form, arranged to
register an administered dose, and the registration can, in its simplest
form, be such that information about the event of administration is left in
the device 2 without data on the quantity of the dose. Also, it is feasible
that the device in connection with the injection pen is equipped with a
function that indicates the quantity of the dose, wherein the detector
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means must be capable of measuring the extent of the forward
movement of the piston.
The indicating device 2 to be fixed to an injection pen can be attached
to it in several ways. If the injection pen in question is intended for
permanent use, the device can be equipped with fixing screws pressed
against the surface of the pen, or the device 2 can be attached from the
side, wherein it has a turnable or loose fixing plate which is tightened
against the device so that the pen is clamped in between. Also, the
device 2 can be pushed around the pen in the longitudinal direction of
the pen and fixed with a quick coupling, e.g. with a rotatable quick
coupling acting by the pressing principle placed in the device 2 at the
end proximal to the tip of the injection pen. This is suitable particularly
for disposable pens which are discarded when the insulin container is
empty and to which the device 2 should be easily attachable. The
device to be fixed to the injection pen may be provided with a
rechargable battery instead of a disposable battery. The battery can be
placed with the injection pen in the charging stand. It can also be
connected by means of a cable to a special portable power supply, and
via the same cable it can be connected to a sound signalling apparatus
with a good output capacity. The cable can be connected to the device
2 with a plug. The battery of the device 2 serves thus as reserve and
produces the current required by the device if no separate battery is
connected.
The design of the indicating device 2 intended for several dosage units
1 can be different than that presented above. The dosage units 1 are
presented above as being placed in an upright position, but they can
also be in a inclined or in a horizontal position. in addition to light and
sound signals, the device may be provided with additional displays,
such as close to each dosage unit 1 a numerical display showing the
quantity of the dose and/or a numerical display showing the time of
administration. The readings of the additional displays can naturally be
changable. .
