WO2008142015A2

WO2008142015A2 - A dispenser and a method for operating a dispenser

Info

Publication number: WO2008142015A2
Application number: PCT/EP2008/056017
Authority: WO
Inventors: Søren SØRENSEN; Søren Vestergaard JACOBSEN; Bjørn Knud ANDERSEN; Søren Christrup
Original assignee: Bang & Olufsen Medicom A/S
Priority date: 2007-05-18
Filing date: 2008-05-16
Publication date: 2008-11-27
Also published as: WO2008142015A3

Abstract

A breath actuated dispenser wherein the force derived from the flow of gas is used for allowing dispensing of a dose, and further comprising locking means adapted to prevent the force from allowing dispensing. Thus, locking may be performed using a much lower force. In addition, the dispenser has motion detectin g means adapted to determine a degree of physical activity of a user.

Description

A DISPENSER AND A METHOD OF OPERATING A DISPENSER

The present invention relates to a dispenser and a method of operating a dispenser, and in particular a dispenser/method in which dispensing may be locked for one of a large number of reasons.

Dispensers adapted to control dispensing are known, which adapters normally comprise a container holding the drug/substance and a biasing means, typically a spring, for compressing the container. Such dispensers have means for either preventing the spring from being biased in the first place or which take up the biasing force of the spring until dispensing is desired. A dispenser of that type may be seen in US-A-5, 692,492.

It has been found that this taking up of the relatively large force, such as in excess of 4ON, requires relatively thick components, and the releasing of that force in itself requires a large force. This is especially difficult to obtain when the releasing force is to be derived from the actual force of the gas flow during inhaling.

Thus, in a first aspect, the invention relates to a breath actuated dispenser comprising:

- a flow path for guiding air or gas for inhalation, a container holding a substance to be dispensed, the container having an output adapted to dispense the substance into the flow path, the container being adapted to dispense the substance due to a compression thereof, biasing means for compressing the container, - retaining means for preventing compression of the container, the retaining means being movable between a first position, in which compression of the container is prevented, and a second position, in which compression of the container is allowed, force generating means positioned in the flow path and being adapted to generate a force from a gas flow in the flow path, the generating means being adapted to apply the force in order to allow the retaining means to move from its first position to the second position,

the dispenser further comprising locking means operative to prevent the force generating means from applying the force and/or the retaining means from moving from its first position to its second position.

In the present context, the flow path is a path in the dispenser in which gas flows during inhalation. This path may or may not be a specifically created path, such as a channel or tube, or may simply be openings and the like in the dispenser in/through which gas may flow, when the person inhales from the inhaler. Normally, this flow path extends inside a housing of the dispenser, but the flow path may additionally be formed of other elements, such as the container etc.

Naturally, any type of substance may be dispensed by an inhaler, such as medical substances, such as broncho and/or bronchiodilating substances or insulin. A large number of other types of medications are presently inhaled, and research is carried out in order to formulate additional medications so as to be inhalable.

The dispensing of the container may be performed in any of a number of manners. The substance may be output as a jet of a mixture of the substance and a carrier liquid, which jet is required in order to provide the substance as microscopic droplets or separated particles of a powder. Another type of dispensing is the outputting of a powder, by itself or with a carrier liquid. The powder may be output as a high velocity jet or may simply be positioned on a suitable surface in the flow path, where the flow generated may then "pick up" the powder and transfer it to the user.

Normally, the biasing is the providing of a force directed in a direction of desired compression of the container. This compression normally is the displacement of one part of the container in a direction toward other parts of the container. A deformation is not required. Standard containers for dispensing powder or fluid substances comprise a dispensing stud and an internal biasing spring biasing the stud outwardly. Depression of the stud inwardly against the biasing (thus compressing the container) will facilitate dispensing.

A number of manners exist of generating a force due to a gas flow. All such manners may be used in the present context, and the force derived may directly be used for displacing the retaining means from its first to its second position, or the force may be used for allowing this movement/displacement, such as for removing or disabling a means preventing this movement/displacement.

Naturally, the force may be dependent on the flow in the flow channel and may not be applied before a predetermined minimum flow is present. This may be obtained by requiring a certain minimum force, before this may be applied.

One type of generating means may be means movable or displaceable/rotatable by the gas flow, whereby the force may be generated. Other types of generating means may be means adapted to generate power from the gas flow, which power is provided to an actuator thereby generating the force.

An embodiment incorporating a generating means of the first type is one, wherein the force generating means comprises obstructing means for obstructing the flow path, the obstructing means being adapted to move between a first position, in which the obstructing means obstructs the flow path and prevents the retaining means from moving to its second position, and a second position, in which the obstructing means does not obstruct the flow path to any substantial degree, the obstructing means allowing, in its second position, the retaining means to move to its second position. Movement from the first to the second position normally is at least partly in the direction of the flow.

In this respect, it is noted that the obstructing means need not fully close the flow path. It is fully sufficient to limit the flow there through sufficiently for the gas flow to actually move the obstructing means from its first to the second position, such as when the flow has a desired size.

In this situation, the obstructing means and the retaining means may be formed by a rotatable element having two parts extending from an axis of rotation, the rotatable element having:

a first rotational position in which a first of the two parts extends into the flow channel and forms the obstructing means in its first position, and the other part forms the retaining means in its first position by extending from the axis of rotation in a direction being at an angle to a direction perpendicular to that of the biasing force (normally in a direction at least partly opposite to the biasing direction) exerted by the biasing means, and abutting the container and/or biasing means,

a second rotational position in which the first part does no longer obstruct the flow path to any significant degree and in which the second part is rotated to a position where compression of the container is allowed.

In that embodiment, the locking means, when operated, preferably engages the rotatable element and prevents it from rotating from the first to the second rotational position.

An interesting embodiment is one which further comprises means for detecting movement or shaking of the dispenser. Movement or shaking of the dispenser may be interesting for a number of reasons. The most usual reason is encountered when the substance to be dispensed from the container is a suspension or emulsion, whereby it is desired to ensure sufficient mixing of the contents before dispensing or dosing the next dose. Further below, another reason is explained.

In this embodiment, preferably the locking means comprise means for determining a point in time of shaking of the dispenser and for operating the locking means when a predetermined period of time has elapsed after the period of time. This may be in order to ensure that no dispensing is made after a predetermined point in time, such as if the substance is a suspension/emulsion, the mixing of which is ensured by the shaking. After the predetermined period of time, the mixing may no longer be optimal or suitable.

It may also be desired to have the detecting means be adapted to quantify the shaking and determine whether the shaking fulfils predetermined requirements. This may be in order to ascertain that a mixing is sufficient. Thus, a too weak shaking or a shaking for a too short time may not ensure sufficient mixing. Such requirements may be a minimum period of time during which the shaking (such as a minimum shaking) should take place. Also, the requirements may be related to the quality of the shaking, such as how vigorously the shaking is performed, for example a quantification of the accelerations performed or the velocities reached during the shaking. This may be both in a single dimension, two dimensions or even three dimensions (such as a combination of a linear/bent shaking and rotation).

In this situation, determining means may be provided which are adapted to determine a point in time of shaking, such as where the shaking fulfils the predetermined requirements. Thus, shaking not fulfilling the requirements may then not be taken into account.

In general, a preferred embodiment is one further comprising means for quantifying or estimating, on the basis of movement of the dispenser, a physical activity level of the user. This activity level may be used for numerous purposes. One purpose is the adaptation of a dispensing scheme (doses and points of time of dispensing) to the activity of the user. Certain drugs or substances are more quickly taken up by the body during activity, others are not need to the same degree during or due to the activity, and again others are desired/required due to the activity.

The quantification of the level of activity may be performed in any desired manner, such as on the basis of a period of time during which the person is active, accelerations/velocities/frequencies/distances obtained, a rise in skin temperature, a rise in pulse, or the like. In addition, a particular pattern of such parameters may be recognized based on e.g. a predetermined training program, on the basis of which the activity level is also known.

One example is insulin, which is used by patients suffering from type I diabetes to facilitate transport of carbohydrates (sugar) into the cells. A larger level of activity requires the transport of more carbohydrates, whereby it may be desired to actually dispense more insulin and/or dispense insulin at shorter time intervals, if the user is more active than expected (such as when defining a dispensing scheme for the user).

Another example is bronchio/bronchia dilating substances, such as ventoline, which may be desired during the activity in order to ensure that the user has sufficient breathing/lung capacity during the activity.

This adaptation of the dosing scheme (scheme correlating doses and points in time of desired dosing/dispensing) may be determined in real time in order to be able to e.g. inform the user of when to take the next dose (especially if a different point in time than that according to the original dispensing scheme is determined). This informing may be performed in any desired manner (visible, tactile, and/or audio information or the like). Alternatively or additionally, the dose amount/quantity may be altered, which the user could also be made aware of.

In fact, these quantifying/estimating means are preferably adapted to perform the quantification/estimation on the basis of an output of the detecting means. Thus, the detecting means may be used for both determining a presence/quality/quantity of a shaking of the container and may be used for determining the level of activity of the user. Naturally, the signals of the detecting means may be filtered etc. in order to separate e.g. the movement caused by the user running from the movement caused by the user shaking the container - or the user riding a car on a bumpy road (which may not be seen as shaking and/or activity at all).

In general, the dispenser may further comprise means for determining a point in time of dispensing the substance. This information may both be used for determining a next point in time of dispensing or for storing and for reading out for a physician or the like to analyze in order to check whether the user takes the substance in accordance with a dispensing scheme. This information may also be used in a dispenser wherein the locking means comprise means for determining a point in time of dispensing substance and for operating the locking means according to a predetermined schedule incorporating the determined dispensing time(s). Thus, it may be ensured that two doses are not taken/dispensed too close to each other. This is important in relation to e.g. pain reducing substances, an overdose of which may be dangerous or even lethal. In addition, misuse of drugs may be prevented.

Naturally, the above detecting means may comprise any means adapted to detect a movement. Standard movement/acceleration determining components are: an accelerometer, a gyrometer, a magnetic sensor, an inductive sensor, an optical sensor, a GPS sensor, a MEMS sensor, a piezo element, and a tilt sensor.

Also, the retaining means mentioned above may be formed by any type of means able to prevent movement of another element, such as all types of actuators and motors having at least two positions (and which preferably use energy only when changing position), such as the motors used as vibrators in cell phones, linear magnetic actuators, such as a solenoid, bimetal springs, piezo actuators, or the like.

Another aspect of the invention relates to a method of operating a breath actuated dispenser, the method comprising:

1. providing, in the dispenser, a flow path,

2. biasing a container holding a substance to be dispensed, the container having an output adapted to dispense the substance into the flow path, the container being adapted to dispense the substance to the flow path due to a compression thereof,

3. providing a retaining means being movable between a first position, in which compression of the container is prevented, and a second position, in which compression of the container is allowed, moving the retaining means to the first position,

4. providing a force generating means in the flow path and which is adapted to generate a force from a gas flow in the flow path, the generating means being adapted to apply the force in order to allow the retaining means to move from its first position to the second position, 5. operating a locking means in a first position thereof while providing an air flow in the flow path, the locking means in its first position preventing the retaining means in moving from its first position to its second position and/or the generating means from applying the force, 6. operating the locking means in a second position thereof while providing an air flow in the flow path, the locking means in its second position allowing the power generating means to apply the force and the retaining means to move from its first position to the second position.

As is indicated further above, in one embodiment:

- step 4. comprises providing an obstructing means being adapted to move between a first position, in which the obstructing means obstructs the flow path, and a second position, in which the obstructing means does not obstruct the flow path to any substantial degree, positioning the obstructing means in the first position, and

step 5. comprises the obstructing means obstructing the flow in the flow path, and

step 6. comprises the flow moving the obstructing means from the first to the second position.

Then, steps 3 and 4 may comprise providing the obstructing means and the retaining means as a rotatable element having two parts extending from an axis of rotation, and step 6. may then comprises rotating the rotatable element between:

a first rotational position in which a first of the two parts extends into the flow channel and forms the obstructing means in its first position, and the other part forms the retaining means in its first position by extending from the axis of rotation in a direction being at least substantially parallel to and opposite to a biasing force exerted by the biasing means, and abutting the container,

Also, then the step of operating the locking means in the first position could comprise the locking means engaging the rotatable element and preventing it from rotating from the first to the second rotational position.

In general, a preferred embodiment comprises the step of identifying a shaking and/or movement of the dispenser. In that embodiment, the step of operating the locking means in its first position may comprise determining a point in time of shaking of the dispenser and operating the locking means in its first position when a predetermined period of time has elapsed after the point in time.

Also, the identifying step preferably comprises quantifying the shaking and determining whether the shaking fulfils predetermined requirements.

In addition, the determining step could comprise determining a point in time of shaking, such as only if the predetermined requirements are fulfilled.

In a particular situation, the predetermined point in time is determined on the basis of the quantified shaking. Then, the method could further comprise the step of quantifying or estimating, on the basis of movement of the dispenser, a physical activity level of the user.

In that situation, the quantifying/estimating step could be performed on the basis of an output of the detecting means.

In general, the method may comprise the step of determining a point in time of dispensing the substance. Then, the locking step could comprise determining a point in time of dispensing substance and operating the locking means according to a predetermined schedule incorporating the determined dispensing time(s).

As mentioned, both the activity determination and the points of time of dispensing may be used to correlate to or adapt a dispensing scheme of the user. This dispensing scheme may be stored in the dispenser, and the dispenser may comprise means for informing the user of when to dispense and maybe even the dose to dispense, if the dispenser does not automatically adapt the dose.

A third aspect relates to a dispenser comprising:

a flow path for guiding air or gas for inhalation, - a container holding a substance to be dispensed, the container having an output adapted to dispense the substance into the flow path, means for facilitating a dispensing from the container, retaining means for preventing dispensing, movement detecting means adapted to detect movement of the dispenser and/or container, controlling means for determining, on the basis of the detected movement, a level of activity of the user.

Naturally, this dispenser may be a breath actuated dispenser according to the first aspect.

Naturally, a shaking of the dispenser/container may also be determined from the detected movement, and this may be used for operating the retaining means in its first position, until a sufficient shaking is detected.

Also, the above-mentioned quantification/quality determination of the shaking may be used, as may the timing relationship where dispensing may be prevented for a predetermined period of time from shaking or from a point in time after the shaking, depending on the reason for preventing dispensing. Also, the manner of separating movement of the user and shaking of the dispenser/container may be trivial signal treatment/filtering.

In one embodiment, the dispenser further comprises means for indicating to a user that substance should be inhaled, the indicating means being operated on the basis of an output of the activity determining means.

This may be in accordance with a dispensing scheme, and the indication may be visual, audio, and/or tactile. The point in time of indicating dispensing, or the time interval between two dispensings, to the user may be determined on the basis of the activity determined, as is described above. This may be an adaptation on the basis of the most recent activity or may be determined over a longer period of time.

In the same or another embodiment, the dispenser may further comprise means adapted to adapt a dose dispensed by the container, the adapting means being operated on the basis of an output of the activity determining means. In this manner, the point in time of dispensing may be unaltered and the dose adapted instead. A combination may also be suitable. Multiple manners of adapting the dose are known.

Thus, the dispenser may comprise controlling means determining the activity and the shaking and determining dispensing times and/or dispensing doses and informing the user accordingly (or adapting the doses automatically).

Naturally, the facilitating means and the retaining means may be a simple processor and a means for dispensing, where the processor may not operate the dispensing, until the different requirements are met. A fourth aspect relates to a method of operating a dispenser having: a flow path for guiding air or gas for inhalation, a container holding a substance to be dispensed, the container having an output adapted to dispense the substance into the flow path, - means for facilitating dispensing from the container, and retaining means for preventing dispensing, the method comprising: detecting movement of the dispenser and/or container, and determining, on the basis of the detected movement, a level of activity of the user.

Naturally, a shaking of the dispenser/container may be quantified on the basis of the detected movement and the retaining means may be operated in its first position, until a sufficient shaking is detected.

Thee method may further comprise the step of indicating to a user that substance should be inhaled, the indicating being performed on the basis of the determined level of activity.

Also, the method may further comprise adapting a dose dispensed by the container, the adapting being performed on the basis of the determined level of activity.

In the following, preferred embodiments of the invention will be described with reference to the drawing, wherein:

Figure 1 illustrates a first embodiment of the dispenser in a loaded, locked state, - Figure 2 illustrates the dispenser of figure 1 in a loaded, unlocked state,

Figure 3 illustrates the dispenser of figure 1 during dispensing, Figure 4 illustrates another embodiment of a dispenser, and Figure 5 illustrates a third embodiment of a dispenser according to the invention.

In figure 1, dispenser 10 is seen having a housing 12, in which a container 14 is present in the shape of a pressurized canister which, when compressed (see further below), will dispense a dose of a drug.

The container 14 is biased, by a spring 16, toward a holding element 18, which is movable in a vertical direction. In figure 1, the holding element 18 is in an upper position, and in figure 3, it is in a lower state. The container 14 has a tip or output 19, which is received in a mouth piece 20 which is adapted to receive the dosed drug and forward it to the mouth of the user.

The mouth piece 20 is adapted to engage the tip 19 so that, when the holding element 18 is in the lower position, the tip 19 is forced into the container 14 (the container is compressed along that direction), in order to obtain the dosing of the drug.

In figure 1, downward movement of the holding element 18 is prevented by a rotatable element 28 rotatable around an axis 30 and having two arms 32 and 34.

The arm 32 counteracts the force exerted by the spring 16, as it transfers this force to the axis 30, which takes up this force.

The arm 34 blocks or obstructs a flow path F through which air will pass from outside the dispenser 10 to the mouth piece 20 during inhaling of the user. Inhaling will cause a flow which will exert a force on the arm 34, and if the inhalation is sufficiently strong, the force exerted will result in a rotation of the element 28, which again will remove the counteraction of the force exerted by the spring 16, whereby compression of the container 14 will be possible. This resulting action and position may be seen in figure 3.

However, in order to better control the timing, etc. of dispensing, a blocking/locking means 37 is provided, which prevents rotation of the element 28 due to inhalation/flow.

This blocking means 37 engages the arm 32 from the side toward which the arm 32 would move during rotation. The blocking means 40 thus prevents dispensing.

As the blocking means 37 merely needs to block the force provided by an inhalation and not the force exerted by the spring 16, the blocking means 37 may be made much smaller and simpler than known blocking means which must block the force exerted by the spring 16.

In the present embodiment, the blocking means 37 comprises a stationary part and a moving part, the stationary part comprising a solenoid/coil, and the moving part comprising a magnet or magnetic material. Thus, providing power to the solenoid or coil will make the moving part move and thus abut the arm 32.

Naturally, any other manner of blocking the arm 32 may be used, and the same blocking action may be obtained by blocking the arm 34 or the rotation around the axis 30. A number of manners or strategies exist as to why and when to prevent dispensing of the drug.

A simple manner is simply that of preventing dispensing of a drug for a predetermined period of time since a previous dispensing.

Dispensing may be detected in a number of manners, one being a sensor sensing the compression of the container 14. Another sensor type is a detector sensing vibrations or sound generated by the dispensing of the drug. Further sensor types may detect the presence of drug in the mouth piece or flow in the flow channel.

Another strategy of preventing dispensing of the drug may be one combined with a dispensing scheme in which preferred points in time of dispensing are provided together with time windows or intervals in which dispensing is or is not allowed.

Which strategy is used will depend heavily on the type of drug. Some drugs may be taken freely and with no restrictions, whereas others must be taken strictly in accordance with a dispensing scheme. Some drugs may not be harmful if a dispensing scheme is not followed, such as if a user forgets a dose or if two doses are dispensed too close to each other, whereas this may be dangerous for other drugs.

In addition, it may be desirable to be able to determine whether the container 14 has been shaken before dispensing. One situation in which this is desired is one wherein the drug in the container 14 is dispersed in a carrier liquid (i.e. an emulsion or a suspension), which will boil when brought to ambient pressure and temperatures. Such containers 14 may have an internal dosing chamber in which the next dose of the drug and carrier liquid is dosed. In that situation, it will be desirable to ensure that the drug and liquid in the container is sufficiently mixed upon dosing.

Naturally, a number of different types of sensor may be used for sensing shaking or mixing of the contents of the container 14, such as accelerometers (2-dimensional or 3-dimensional as may be found in airbags or pedometers), piezo elements, capacitive sensors, electrolytic tilt sensors (where e.g. a resistive liquid partly connects electrodes resulting in a resistor value indicating inclination).

The amount of shaking or mixing required will depend on the drug and carrier liquid, or other combination of substances which are required to be mixed, and routine testing is performed in order to determine for how long or how vigorously the shaking should be. The blocking means 37 may be actuated to block dispensing, until the mixing/shaking is sufficient. In this respect, it should be noted that the dosing of the next dose need not be at the time of dispensing of a dose. The container 14 may be of a type in which the dosing takes place when the container 14 is again released and not at the time of compression. This may be taken into account in the dispenser.

Having provided a sensor adapted to detect movement (shaking/mixing), this sensor may be used also for other purposes.

One such purpose may be to quantify the physical activity of the user. For a number of drugs or dispensing schemes, it is desirable to learn about the user's physical activity and actually adapt the dispensing or dispensing scheme to this activity.

Physical activity may be determined on the basis of a frequency or signal analysis of a signal from the detector. This signal may be filtered in order to determine the type of exercise and remove signals not related to exercise, such as the bumping caused by a car on a bumpy road. Other types of sensors may be added to determine the physical activity, such as GPS- sensors, pulse sensors, breath sensors, or the like.

In general, this may be relevant for drugs affected by or affecting the metabolism of the person, such as persons taking growth hormone or hormones affecting the metabolism, such as steroid hormones (such as adrenal cortex hormone, growth hormone, and heart medicine, such as digitalis glycosides (e.g. nitro glycerine). Also, it may be relevant for drugs broken down in the liver in that heavy physical activity may shut of or reduce the blood flow to the liver and the intestines. Thus, great physical activity may reduce the breaking down of drugs to be broken down in the liver.

For persons suffering from asthma, it may be relevant to allow dispensing of a bronchio dilating drug more often, if the person is physically active.

For persons suffering from at least type I diabetes, it may be relevant to allow more often dispensing of insulin, or allow the dispensing of larger doses in that the physical activity will require a higher transport of carbohydrates to the cells.

In fact, it may be desirable to not only allow variations in the dispensing and/or the dispensing of larger/smaller doses of the drug, it may be desirable to determine or calculate such variations in the dispensing scheme or routine. In that situation, the dispenser may additionally comprise means for determining a drug dose to dispense and/or means for notifying the user that a dose should be taken in accordance with a, such as a revised, dispensing scheme. The revision of this dispensing scheme may depend heavily on the amount of the activity.

Routine testing may be performed in order to determine this adaptation of the dispensing scheme.

It should be noted that even though the attached figures are described with reference to a container 14 comprising a drug and a carrier liquid, other types of containers may be used. Thus, a container adapted to e.g. dispense a dose of a powder or of a liquid into the gas flow in the gas flow path. This need not be a pressurized dispensing, and in fact, the container 14 may be replaced by e.g. a blister card from which a powder or liquid from a blister is guided to the gas flow path for inhalation.

Figure 4 illustrates another embodiment again using the dispenser 14 with the tip 19 and biased by a spring 16.

In this embodiment, a yoke 38 is provided between the spring 16 and the container 14, and is additionally engaged a first arm 42 of a lever 39 comprising another arm 44 and being rotatable about an axis 40. This lever prevents downward movement of the yoke 38 and thereby compression of the container 14.

The lever 39 is prevented from rotating counter clockwise by an arm 52 of a lever 51 comprising also another arm 54 and being rotatable around an axis 50. It is seen that as long as the lever 51 cannot be rotated, upward movement of the arm 44 and thereby downward movement of the yoke 38 is not allowed.

The lever 51 is connected, via a rotatable engagement 58, to an arm 56 engaging a rotatable element 62 connected to a flap 60.

The flap 60 is positioned in the flow path of the inhaler, and the operation of the inhaler dispensing mechanism is as follows:

Inhalation will generate a flow which will make the flap rotate clockwise. This movement will make the arm 56 move above the element 62 and thereby, via the non-perpendicular angle of the arm 52 on the arm 44, make the lever 51 rotate counter clockwise, which was previously prevented due the engagement of the arm 56 on the element 62. Thus, the arm 44 will be allowed to move upwards, whereby dispensing will be allowed.

In figure 4 is also illustrated a number of positions A), B), C), D), which all are useful for blocking the above dispensing, if this dispensing is not desired or allowed. These positions require, contrary to the position E), a force much lower than that exerted by the spring 16, in order to prevent dispensing. These forces may easily be calculated by the spring force of the spring 16 and the force required or provided by inhalation and via the flap 60 as well as the individual distances and angles.

Figure 5 illustrates an alternative to the embodiment of figure 4, wherein the rather complex interaction of the arms 54, 56, the flap 60, the element 62 and the joint 58 are simply replaced by the flap 54.

It is clear that counter clockwise rotation of the lever 39 is prevented by the position of the arm 52 of the lever 51, the other arm 54 of which is the flap.

Inhalation will make the flap 54 rotate clockwise, whereby the lever 44 may rotate counter clockwise, and dispensing may take place.

Naturally, a number of positions of the locking means are also possible in the embodiment in figure 5, even though only one is illustrated at position A).

Claims

1. A breath actuated dispenser comprising:

a flow path for guiding air or gas for inhalation, a container holding a substance to be dispensed, the container having an output adapted to dispense the substance into the flow path, the container being adapted to dispense the substance due to a compression thereof, biasing means for compressing the container, retaining means for preventing compression of the container, the retaining means being movable between a first position, in which compression of the container is prevented, and a second position, in which compression of the container is allowed, force generating means positioned in the flow path and being adapted to generate a force from a gas flow in the flow path, the generating means being adapted to apply the force in order to allow the retaining means to move from its first position to the second position,

the dispenser further comprising locking means operative to prevent the force generating means from generating the force and/or the retaining means from moving from its first position to its second position.

2. A dispenser according to claim 1, wherein the force generating means comprises obstructing means for obstructing the flow path, the obstructing means being adapted to move between a first position, in which the obstructing means obstructs the flow path and prevents the retaining means from moving to its second position, and a second position, in which the obstructing means does not obstruct the flow path to any substantial degree, the obstructing means allowing, in its second position, the retaining means to move to its second position.

3. A dispenser according to claim 2, wherein the obstructing means and the retaining means are formed by a rotatable element having two parts extending from an axis of rotation, the rotatable element having:

a first rotational position in which a first of the two parts extends into the flow channel and forms the obstructing means in its first position, and the other part forms the retaining means in its first position by extending from the axis of rotation in a direction being at an angle to a direction perpendicular to that of the biasing force exerted by the biasing means, and abutting the container, a second rotational position in which the first part does no longer obstruct the flow path to any significant degree and in which the second part is rotated to a position where compression of the container is allowed.

4. A dispenser according to claim 3, wherein the locking means, when operated, engages the rotatable element and prevents it from rotating from the first to the second rotational position.

5. A dispenser according to any of the preceding claims, further comprising means for detecting movement or shaking of the dispenser.

6. A dispenser according to claim 5, wherein the locking means comprise means for determining a point in time of shaking of the dispenser and for operating the locking means when a predetermined period of time has elapsed after the point in time.

7. A dispenser according to claim 5, wherein the detecting means are adapted to quantify the shaking and determine whether the shaking fulfils predetermined requirements.

8. A dispenser according to claim 7, further comprising determining means adapted to determine a point in time of shaking, where the shaking fulfils the predetermined requirements.

9. A dispenser according to any of the preceding claims, further comprising means for quantifying or estimating, on the basis of movement of the dispenser, a physical activity level of the user.

10. A dispenser according to claims 5 and 9, wherein the quantifying/estimating means are adapted to perform the quantification/estimation on the basis of an output of the detecting means.

11. A dispenser according to any of the preceding claims, further comprising means for determining a point in time of dispensing the substance.

12. A dispenser according to claim 11, wherein the locking means comprise means for determining a point in time of dispensing substance and for operating the locking means according to a predetermined schedule incorporating the determined dispensing time(s).

13. A dispenser according to any of the preceding claims, wherein the detecting means comprises at least one of the group consisting of: an accelerometer, a gyrometer, a magnetic sensor, an inductive sensor, an optical sensor, a GPS sensor, a MEMS sensor, a piezo element, and a tilt sensor.

14. A method of operating a breath actuated dispenser, the method comprising:

1. providing, in the dispenser, a flow path,

2. biasing a container holding a substance to be dispensed, the container having an output adapted to dispense the substance into the flow path, the container being adapted to dispense the substance to the flow path due to a compression thereof, 3. providing a retaining means being movable between a first position, in which compression of the container is prevented, and a second position, in which compression of the container is allowed, moving the retaining means to the first position,

4. providing a force generating means in the flow path and which is adapted to generate a force from a gas flow in the flow path, the generating means being adapted to apply the force in order to allow the retaining means to move from its first position to the second position,

5. operating a locking means in a first position thereof while providing an air flow in the flow path, the locking means in its first position preventing the retaining means in moving from its first position to its second position and/or the generating means from applying the force,

6. operating the locking means in a second position thereof while providing an air flow in the flow path, the locking means in its second position allowing the power generating means to apply the force and the retaining means to move from its first position to the second position.

15. A method according to claim 14, wherein:

step 4. comprises providing an obstructing means being adapted to move between a first position, in which the obstructing means obstructs the flow path, and a second position, in which the obstructing means does not obstruct the flow path to any substantial degree, positioning the obstructing means in the first position, and

step 5. comprises the obstructing means obstructing the flow in the flow path, and step 6. comprises the flow moving the obstructing means from the first to the second position.

16. A method according to claim 15, wherein steps 3 and 4 comprise providing the obstructing means and the retaining means as a rotatable element having two parts extending from an axis of rotation, and wherein step 6. comprises rotating the rotatable element between:

17. A method according to claim 16, wherein the step of operating the locking means in the first position comprises the locking means engaging the rotatable element and preventing it from rotating from the first to the second rotational position.

18. A method according to claim 14, further comprising the step of identifying, using a detecting means, a shaking and/or movement of the dispenser.

19. A method according to claim 18, wherein the step of operating the locking means in its first position comprises determining a point in time of shaking of the dispenser and operating the locking means in its first position when a predetermined period of time has elapsed after the point in time.

20. A method according to claim 18, wherein the identifying step comprises quantifying the shaking and determine whether the shaking fulfils predetermined requirements.

21. A method according to claim 18, wherein the determining step comprises determining a point in time of shaking only if the predetermined requirements are fulfilled.

22. A method according to claim 19 and 20, wherein the predetermined point in time is determined on the basis of the quantified shaking.

23. A method according to any of claims 14-22, further comprising the step of quantifying or estimating, on the basis of movement of the dispenser, a physical activity level of the user.

24. A method according to claims 18 and 23, wherein the quantifying/estimating step is performed on the basis of an output of the detecting means.

25. A method according to any of claims 14-24, further comprising the step of determining a point in time of dispensing the substance.

26. A method according to claim 25, wherein the locking step comprises determining a point in time of dispensing substance and operating the locking means according to a predetermined schedule incorporating the determined dispensing time(s).

27. A dispenser comprising:

a flow path for guiding air or gas for inhalation, a container holding a substance to be dispensed, the container having an output adapted to dispense the substance into the flow path, means for facilitating a dispensing from the container, - retaining means for preventing dispensing, movement detecting means adapted to detect movement of the dispenser and/or container, and activity determining means adapted to, on the basis of the detected movement, determine a level of activity of the user.

28. A dispenser according to claim 27, further comprising controlling means for quantifying, on the basis of the detected movement, a shaking of the dispenser/container and for operating the retaining means in its first position, until a sufficient shaking is detected,

29. A dispenser according to claim 27 or 28, further comprising means for indicating to a user that substance should be inhaled, the indicating means being operated on the basis of an output of the activity determining means.

30. A dispenser according to any of claims 27-29, further comprising means adapted to adapt a dose dispensed by the container, the adapting means being operated on the basis of an output of the activity determining means.

31. A method of operating a dispenser having: a flow path for guiding air or gas for inhalation, a container holding a substance to be dispensed, the container having an output adapted to dispense the substance into the flow path, means for facilitating dispensing from the container, and - retaining means for preventing dispensing, the method comprising: detecting movement of the dispenser and/or container, and determining, on the basis of the detected movement, a level of activity of the user.

32. A method according to claim 30, further comprising the step of quantifying, on the basis of the detected movement, a shaking of the dispenser/container and operating the retaining means in its first position, until a sufficient shaking is detected.

33. A method according to claim 31 or 32, further comprising the step of indicating to a user that substance should be inhaled, the indicating being performed on the basis of the determined level of activity.

34. A method according to any of claims 31-33, further comprising adapting a dose dispensed by the container, the adapting being performed on the basis of the determined level of activity.