Drug delivery apparatus

A personalized drug delivery apparatus including drug containing structure; a spout configured to receive full lung exhalation; a mechanism configured to determine a personalized drug dosage according to the exhalation, the spout further configured to enable inhalation of the determined dosage.

FIELD OF THE INVENTION

The present invention generally relates to drug delivery systems and specifically to an adaptive personalized drug dosage delivery apparatus.

BACKGROUND

An inhaler (or puffer) is a medical device used for delivering medication into the body via the lungs. It is mainly used in the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD).

To reduce deposition in the mouth and throat, and to reduce the need for precise synchronization of the start of inhalation with actuation of the device, MDIs are sometimes used with a complementary spacer or holding chamber device.

Decongestant inhalers are popular over-the-counter remedies for nasal congestion in the upper respiratory tract.

The most common type of inhaler is the pressurized metered-dose inhaler (MDI). In MDIs, medication is typically stored in solution in a pressurized canister that contains a propellant, although it may also be a suspension. The MDI canister is attached to a plastic, hand-operated actuator. On activation, the metered-dose inhaler releases a fixed dose of medication in aerosol form. The correct procedure for using an MDI is to first fully exhale, place the mouth-piece of the device into the mouth, and having just started to inhale at a moderate rate, depress the canister to release the medicine. The aerosolized medication is drawn into the lungs by continuing to inhale deeply before holding the breath for 10 seconds to allow the aerosol to settle onto the walls of the bronchi and other airways of the lung. Some inhalers are made to act before an asthma attack, some are made to act instantly in case of an asthma attack and others are made to act later.

Another type of inhaler is a dry powder inhaler (DPI). Dry powder inhalers release a metered or device-measured dose of powdered medication that is inhaled through a DPI device.

Existing inhalers are configured to release a predetermined drug dosage.

There is a long felt need for a drug delivery apparatus which enables to provide a personalized drug dosage to a patient according to his respiratory flow.

SUMMARY

According to an aspect of the present invention there is provided a personalized drug delivery apparatus comprising: drug containing means; a spout configured to receive full lung exhalation; a mechanism configured to determine a personalized drug dosage according to the exhalation, the spout further configured to enable inhalation of the determined dosage.

The drug containing means may comprise one of compartment, individual cells and strip.

The drug containing means may be replaceable.

The replaceable drug containing means may be a capsule.

The mechanism may comprise a drug release mechanism.

The mechanism may further comprise a sensor configured to measure the exhalation; and a controller configured to determine the drug dosage according to the measured exhalation; wherein the drug release mechanism may comprise a valve configured to enable: a. the exhalation and b. inhalation of the personalized drug dosage.

The mechanism may further comprise a first sensor mounted in the narrowest part of a venturi nozzle and configured to measure the exhalation; a second sensor mounted in the widest part of the venturi nozzle and configured to measure the exhalation; and a controller configured to determine the drug dosage according to the measurements.

The release mechanism may comprise a pump and an air source.

The release mechanism may comprise an actuator connected with a disk; the actuator may be configured to move the disk which opens at least one individual cell containing drug, according to the determined drug dosage.

The release mechanism may comprise a peeling mechanism configured to peel the drug from a strip.

The release mechanism may comprise a spiral mounted in a drug compartment; the spiral having slots and configured to rotate and release drug according to the personalized dosage.

The id release mechanism may comprise two moveable parts mounted in a calculated distance from each other; the calculated distance may be configured to be mounted under the drug containing means and to be filled with the drug dosage; and the two moveable parts are configured to move together and release the drug dosage.

The release mechanism may comprise an actuator configure to actuate a conveyor mounted under the drug containing means; the drug lays on the conveyor which may be configured to move and release the drug through an orifice.

The release mechanism may comprise a nozzle configured to connect the drug containing means with a cavity; the release mechanism may be configured to release drug from the drug containing means through the nozzle and into the cavity.

The cavity may comprise a fixed size cavity and an adjustable size cavity.

The adjustable size cavity volume may be changed by one of an actuator and manually.

The release mechanism may comprise an actuator configured to move a piston; the piston may be configured to suck the drug from the drug containing means.

The mechanism may comprise a flap configured to be push by the exhalation and to indicate the personalized drug dosage accordingly.

The mechanism may comprise a wind cup configured to be pushed by the exhalation and determine the personalized drug dosage.

The mechanism may further comprise a propeller configured to actuate the release mechanism when a patient blows toward it.

According to another aspect of the present invention there is provided a method of delivering a personalized drug dosage comprising: performing a test comprising measuring full-lung exhalation through a spout; determining a personalized drug dosage according to the test; and releasing the personalized drug dosage according to the determination.

The releasing may comprise opening a valve connecting a drug compartment with the spout.

The releasing may comprise activating a pump and an air source.

The releasing may comprise activating an actuator which opens individual cells.

The releasing may comprise peeling the drug dosage from a strip.

The releasing may comprise rotating a spiral having slots filled with drug.

The determining may comprise calculating a distance between a first moveable part and a second moveable part.

The releasing may comprise moving the two movable parts.

The releasing may comprise actuating a conveyor.

The releasing may further comprise pushing a spout.

The determining may comprise activating an actuator configured to control an adjustable cavity's size.

The determining may comprise rotating a screw configured to control an adjustable cavity's size.

The releasing may comprise activating an actuator configured to: a. pull a piston and b. push a piston.

The releasing may comprise: a. pulling a piston and b. pushing a piston.

The determining may comprise rotating a dial.

The steps of performing a test, determining and releasing may comprise blowing towards a propeller; the propeller may actuate a release mechanism.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention provides an apparatus and method for adjusting and providing a personalized drug dosage to a patient having asthma or a Chronic Obstructive Pulmonary Disease (COPD). The apparatus measures the patient's respiratory flow and adjusts and provides a personalized drug dosage to him accordingly.

FIG. 1shows a schematic block diagram of the drug delivery apparatus100components according to embodiments of the invention comprising an inhale\exhale spout101, a spirometry\FEV1test mechanism102, a personalized drug dosage release mechanism104, drug105and a controller103configured to control the spirometry\FEV1test mechanism102, determine a personalized drug dosage according to the test and control the personalized drug dosage release mechanism104.

FIG. 2shows an exemplary delivery apparatus200according to embodiments of the present invention comprising: a housing106comprising a medicine compartment130storing medicine powder135(drug), a first tube107connected to a second tube110and a third tube115through a drug release mechanism implemented by a valve120, a test mechanism implemented by a flow sensor125mounted in the third tube115, an ON\OFF switch (not shown), an actuator (not shown) configured to move the valve120and a controller140configured to control the flow sensor125and the valve120actuator and to enable full operation of the apparatus.

The apparatus200may further comprise a plastic cover (not shown) configured to cover the inhale\exhale spout145mounted at the end of the third tube115and a status LED (not shown) which indicates the apparatus's status. For example: Off—the apparatus is off; Red—Fault—reset the apparatus or if the reset didn't work, do not use the apparatus; Yellow—perform a spirometry\FEV1(Forced Expiratory Volume) test; Green—Inhale the medicine (drug).

According to embodiments of the invention, the medicine compartment130may be a replaceable compartment.

The flow sensor125(test mechanism) comprises a transducer which may be implemented by, but is not limited to the following techniques:Piezo resistive technique:A piezo resistive pressure or very common air-turbine technique.The transducer's output is a variable impedance signal.The transducer's output signal is detected by an analog detector.The Analog detector's output is a low voltage analog signal.Infra Red (IR) technique:Based on detection and counting of an IR reflection signals.The number of reflections during the counting period is proportional to the airflow speed.Reverse turbine effect:An impeller attached to an encoding wheel counts speed, rate and direction, thus it dynamically measures the airflow.The encoder records its data into a microprocessor unit to be further converted into a precise motor RPM unit counter to deploy powder.Pitot tube pressure gauge:This method is based on pressure measured along a tiny orifice.By monitoring the FEV1indicator, a microprocessor, calculates drug amounts required.

The controller may additionally comprise an MP3/MP4 media player and\or an LCD driver.

The A\D converter converts analog signal(s), received from the sensor, to digital signal(s).

The CPU uses the digital signal(s) to verify the FEV1and according to the result, determines the proper drug dosage.

The FEV1, details of used drug dosage and related time stamp may be stored in a memory as history.

According to embodiments of the invention, if the CPU does not receive any signal for a predefined period of time, the apparatus switches to a sleep or latent mode for power saving purposes.

The unit includes BIT process for majority of the apparatus's modules and Low Battery indication.

FIG. 3is a flowchart300showing the process performed by a patient who uses the delivery apparatus200ofFIG. 2according to embodiments of the present invention. At the beginning of the process, the valve (release mechanism)120connects the first tube107with the third tube115. In step210, the patient turns the apparatus ON. If in step212the LED turns red (within a predefined X times it is allowed to be red), in step215, reset the apparatus. If the reset didn't work X+1 times (the LED continues to be red), the apparatus is turned OFF, namely, do not use the apparatus or check it. If in step212the LED turns yellow, in step220, perform the spirometer test. The spirometer test includes two stages, in the first stage—225, the patient inhales full lung capacity (not through the apparatus) and in the second stage—230, he exhales the air through the apparatus for at least 1.5 sec. During the second stage, in step231, the flow sensor (test mechanism)125measures the air flow and in step232, the controller140calculates the FEV1and determines the patient's needed drug dosage accordingly. When the test is completed, in step235, the controller redirects the valve120to connect the second tube110to the third tube115, in step240, the LED turns green and in step245the patient may inhale the medicine (drug) through the inhale\exhale spout. In step250, the controller redirects the valve120to connect the first tube107to the third tube115according to the determined dosage in order to stop the medicine flow.

According to a predefined calibration table the ratio between the FEV1and the medicine quantity is predefined—Q*

Q may be calculated as follows:
Q=∫t1t0F*A*C
Where:

T0=the starting time when the patient starts to inhale.

T1=is defined as the time when Q=Q*.

According to embodiments of the invention, X is determined by the apparatus's manufacturer.

According to embodiments of the invention, prior to the process ofFIG. 3, the patient may have to input his weight, age, height and sex for the apparatus to know the anticipated limits of the spirometry test.

FIG. 4shows another exemplary delivery apparatus400according to embodiments of the present invention comprising: a housing305comprising a medicine reservoir325storing medicine (drug) (not shown), a test mechanism implemented by a Venturi nozzle310and a flow sensor335mounted in the Venturi nozzle310, the venturi nozzle is connected with the medicine reservoir (compartment)325, a release mechanism implemented by a piezo-electric pump315and an air source320(such as a fan, compressed air, etc.), an optional air flow monitor (not shown) and a controller330connected with the test mechanism and the release mechanism. An inhale\exhale spout (not shown) is connected to the end350of the venturi nozzle310.

According to embodiments of the invention, the medicine reservoir325may be a replaceable reservoir.

FIG. 5is a flowchart500showing the process performed by a patient who uses the delivery apparatus400ofFIG. 4according to embodiments of the invention. In step415, the patient inhales full lungs capacity (not through the apparatus). In step420, the patient exhales through the spout into the nozzle310. In step425, the velocity and quantity of air is measured by the sensor335. In step430, the measured air is compared with predefined values and the controller330determines the amount of medicine to dispense accordingly. In step435, the air source320increases the air pressure behind the venturi nozzle. In step440, The Piezo-Electric pump315dispenses in rapid succession tiny drops of the medicine into the airflow. These drops may be broken into even smaller drops due to the increased air velocity in the venturi nozzle. In step445, the patient inhales the medicine saturated air.

FIG. 6shows an exemplary mechanical delivery apparatus600according to embodiments of the present invention comprising: a medicine compartment530storing medicine powder (drug)535, an upper compartment515, a spout510connected to the upper compartment515, a unidirectional valve520which enables airflow in the direction of arrow525, a release mechanism implemented by a mechanical component540and a knob545configured to transfer medicine from the medicine compartment530to the upper compartment515and to enable opening of the valve\shutter. The apparatus also comprises a shutter550configured to enable\disable the path between the spout510and the upper compartment515(by moving in the direction of the dual head arrow555) and a test mechanism implemented by an accurate micro mechanic element (MME)560. The MME is sensitive to the airflow exhaled by the patient and is pushed back, in the direction of arrow565, by the patient's exhalation. The full operation is explained below in conjunction withFIG. 7. The test mechanism in this embodiment does not provide test results but leaves the personalized medicine dosage in the upper compartment according to the patient's airflow.

According to embodiments of the invention, in a case where the operation is performed manually by the patient, a controller is not needed. In a case where at least part of the process is performed automatically, the apparatus further comprises a controller and an actuator.

According to embodiments of the invention, the medicine compartment530may be a replaceable compartment.

FIG. 7is a flowchart700showing the process performed by a patient who uses the delivery apparatus600ofFIG. 6. At the beginning of the process the knob545is mounted at the bottom of the mechanical component540and the shutter550is open (namely, the path between the spout510and the upper compartment515is open). In step610, the patient pushes the knob up. By doing that, the maximum medicine dosage is delivered from the medicine compartment530to the upper compartment515. In step615, the patient inhales full lungs capacity (not through the apparatus) and in step620, he exhales into the spout510. In step625, after a predefined period of time (e.g. 1 sec) the shutter550closes the path between the spout510and the upper compartment515. In step630, as a result of the patient's exhalation, the MME is pushed and some of the medicine is pushed back into the medicine compartment530(in proportion to the exhaled airflow according to the FEV1\quantity calibration function). This process adjusts the medicine dosage personally to each patient. In step635, the patient twists the knob (e.g. 90 degrees) in order to open the shutter. In step640, the patient inhales the medicine. In step645, the patient turns the knob (e.g. 90 degrees back) and pulls it back down.

FIG. 8demonstrates another personalized drug dosage release mechanism (104ofFIG. 1)800. According to embodiments of the present invention, the dosage determination mechanism and process may be one of the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4. The medicine powder (drug) is contained inside individual powder cells710. After the dosage has been determined, the release mechanism implemented by an actuator720(e.g. motor) pulls a disk730which opens a number of powder cells that will result in the right dosage of powder to be released into the container (intermediate compartment)740for the patient to inhale via the spout750(101ofFIG. 1).

FIG. 9demonstrates another personalized drug dosage release mechanism900(104ofFIG. 1). According to embodiments of the invention, the strip810(which may be part of a roll) is coated on one side with dry powder (drug)820. After the medicine dosage has been determined by one of the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4, the medicine powder820is peeled off the strip810accordingly (by a peeling mechanism—not shown).

Each peeled distance equals a certain amount of powder (peeled volume).

According to embodiments of the present invention, the opposite side of the strip may be used as a test mechanism. A chemical agent may determine parameters involved in the FEV1test. The apparatus may have a color chart correlated to FEV1results, namely, each color indicates a different dosage. By analyzing the color (e.g. by a camera and image processing) the apparatus may determine the right dosage.

FIG. 10demonstrates another personalized drug dosage release mechanism1000(104ofFIG. 1). According to embodiments of the present invention, after the medicine dosage has been determined by one of the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4, the personalized dosage may be delivered from the medicine compartment910to the patient by a spiral or a screw920. The spiral (or the screw) has circumferential slots thus when it rotates medicine fills the slots and is delivered to an intermediate compartment or to the Inhale\exhale spout (not shown) for the patient to inhale. The dosage is controlled by controlling the rotation of the spiral\screw.

FIGS. 11A and 11Bdemonstrate another personalized drug dosage release mechanism1100(104ofFIG. 1). According to embodiments of the present invention, the medicine may be delivered from the medicine compartment1010to the patient through a channel1015having two movable parts1020and1030(e.g. cylinders). After the medicine dosage has been determined by one of the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4, the gap1035between the parts is determined accordingly and placed under the medicine compartment1010. When the medicine fills the gap, the parts1020and1030move together in the direction of arrow1040and the medicine is delivered to an intermediate compartment or to the Inhale\exhale spout (not shown) through pipe1050.

FIGS. 12A and 12Bdemonstrate another personalized drug dosage release mechanism1200(104ofFIG. 1). According to embodiments of the present invention, a medicine compartment1110is placed above a conveyor1120. The medicine (drug) from the compartment lays on the conveyor. After the medicine dosage has been determined by one of the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4, the conveyor progresses via an actuator1125(e.g. stepper motor) and the determined amount of the medicine is released through the orifice1130into an intermediate compartment (not shown) for the patient to inhale. The apparatus that uses this mechanism is configured to determine the conveyor's progression rate in accordance with the determined medicine dosage. Part1140may be configured to clean the remnants of the medicine from the conveyor1120. According to embodiments of the invention, the orifice1130may be a fixed size orifice. Alternatively, the apparatus may be configured to control the orifice's size in order to assist in faster medicine release.

According to embodiments of the invention, the conveyor1120may be grooved, namely, it may have grooves configured to be filled with medicine. When the conveyor progresses, the grooves pass beneath the medicine compartment and are filled with medicine. The apparatus that uses this mechanism is configured to determine the conveyor's progression rate in accordance with the determined medicine dosage in order to release the right number of grooves.

FIG. 13is a schematic view of another exemplary drug delivery apparatus1300according to embodiments of the present invention. In order to inhale a personalized medicine dosage, a patient may input his personal details to the apparatus via a user interface such as a touch screen for example (not shown) and place a medicine capsule in the designated location1205. The details may be age, weight, height, sex, etc. Then, the patient inhales full lungs capacity (not through the apparatus), places his mouth on the spout1210and exhales. The exhaled air flows through the tube1220and is measured twice by a test mechanism, once by a sensor1230mounted in the widest part of a venturi nozzle1250and a second time by a sensor1240mounted in the narrowest part of the nozzle1250. The difference between the measurements is translated into a volumetric flow rate according to which the controller (not shown) determines the personalized dosage of medicine to release. The determined dosage may be released by one of the release mechanisms describe above in conjunction withFIGS. 8 through 12B(For example the mechanism ofFIGS. 12A and 12Bis shown). The medicine dosage is released to the bottom of the funnel1255(top of part1270).

FIG. 13Adescribes the inhalation stage of the process described in conjunction with the apparatus ofFIG. 13. According to embodiments of the invention, in order to inhale the medicine, the patient pushes the spout1210in the direction of arrow1260. As a result of this action, the part1270connected to the tube1220, moves in the same direction, the medicine dosage is released from the bottom of the funnel1255into the tube1220and the patient may inhale it. Spring1280which has been pressed when to patient pushed the spout1210is configured to return the spout to its original position (in the direction of arrow1290).

According to embodiments of the invention, as depicted inFIG. 13B, an opposite slant part1270A may be mounted in the upper left side of part1270in order to assist the medicine dosage to be released into the tube1220(not shown) and\or clean remnants.

FIGS. 14 and 14Ademonstrate another personalized drug dosage release mechanism (104ofFIG. 1). According to embodiments of the present invention, the medicine (pressurized fluid) contained in the compartment1310, passes through a nozzle1315and fills a fixed size circumferential cavity1320and an adjustable circumferential cavity1330. The size of the adjustable circumferential cavity1330may be determined according to the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4. The adjustable circumferential cavity1330size's adjustment may be done manually by, for example, instructing the patient to manually rotate part1340(which rotates around part1360) which changes the cavity's size or automatically by an actuator (not shown) configured to do so (for example). When part1340rotates to a predefined direction, it enlarges the cavity1330volume and when it rotates to the other direction, it minimizes the cavity1330volume. The cavities1320and1330are connected to each other and a pressure inside the medicine compartment ensures filling them. In order to inhale the medicine (FIG. 14A) the patient pushes part1360in the direction of arrow1370, the upper side of the nozzle1375(hole1376) reaches the cavity1320(FIG. 14A) and the medicine is released through a spout (not shown) connected to the nozzle1375. Seals1380A-1380D are mounted as depicted in the figures and are configured to prevent medicine leakage. Spring1385which has been pressed when the patient pushed the part1360is configured to return the nozzle1375to its original position (in the direction of arrow1395).

According to embodiments of the invention, the nozzle may be fixed to the apparatus's cover and the medicine compartment may be pressed by the patient against it in order to release the medicine.

FIG. 14Bdemonstrates a similar personalized drug dosage release mechanism (104ofFIG. 1) to the one described in conjunction withFIGS. 14 and 14A, except the adjustable cavity1330A. According to embodiments of the present invention, the adjustable cavity1330A is mounted between the parts1340A and1360A and is connected to the fixed size cavity1320A. The adjustable cavity1330A may be circumferential or not. If it is not, at least one cavity1330A may be placed on the circumference of the apparatus and is (are) connected to the fixed size cavity1320A. By screwing the part1360A in a predetermined direction, the cavity's volume increases. The screwing may be done manually by the patient or automatically by an actuator according to the determined personalized drug dosage. If the adjustable cavity1330A is circumferential, the size determination mechanism is similar to the one described in conjunction withFIGS. 14-14A.

FIG. 15demonstrates an outer view of an exemplary manual mechanism which enables to determine the drug dosage. The mechanism may be configured to adjust the size of the adjustable cavities (1330or1330A) that were described in conjunction withFIG. 14 through 14B(the circumferential cavities embodiments). Part1402rotates parts1340or1360A according to the embodiment which determine the adjustable cavity's size (volume).

FIGS. 16 and 16Ademonstrate another personalized drug dosage release mechanism (104ofFIG. 1)1600. According to embodiments of the present invention, the medicine (pressurized fluid) contained in the compartment1410, passes through the nozzle1415and fills a fixed size circumferential cavity1420and an adjustable cavity1430. The cavities1420and1430are connected to each other and a pressure inside the medicine compartment ensures filling them. The size of the adjustable cavity1430is determined according to one of the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4. The size adjustment may be done manually by, for example, instructing a patient to rotate a screw(s)1435which changes the cavity's size (e.g. by the manual mechanism ofFIG. 15) or automatically by an actuator1436configured to do so. The screw(s) or the actuator moves part1440in the directions of the dual head arrow1450according to the determined dosage. In order to inhale the medicine the patient pushes part1460in the direction of arrow1470, the upper side of the nozzle1475reaches the cavity1420(FIG. 16A) and the medicine is released through a spout (not shown) connected to the nozzle1475. The Seals1480A-1480D are mounted as depicted in the figures and configured to prevent medicine leakage. Spring1485is configured to return the nozzle1475to its original position (in the direction of arrow1495).

According to embodiments of the invention, the nozzle may be fixed to the apparatus's cover and the medicine compartment may be pressed by the patient against it in order to release the medicine.

FIGS. 17A through 17Cdemonstrate another personalized drug dosage release mechanism (104ofFIG. 1)1700. According to embodiments of the present invention, the dosage determination mechanism and process may be one of the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4. According to the determined dosage, an actuator1530pulls a piston1540in the direction of arrow1560. As a result of this action, a medicine from a medicine compartment1570is sucked through a unidirectional valve1580and fills the created cavity1590(FIG. 17B). A unidirectional valve1515seals a nozzle1520in order to enable the suction from the medicine compartment. When the dosage is ready, the apparatus which uses this release mechanism may instruct the patient to place his mouth on a spout (not shown) connected to the nozzle1520, press a button (for example) and inhale the medicine released by the actuator1530(FIG. 17C).

FIGS. 18 and 18Ademonstrate another personalized drug dosage release mechanism (104ofFIG. 1)1800. According to embodiments of the present invention, the dosage determination mechanism and process may be one of the dosage determination mechanisms and processes that were described above in conjunction withFIGS. 2 and 4. According to the determined dosage, part1610is pulled by the patient in the direction of arrow1620and sucks medicine (pressurized fluid) from the medicine compartment1630into an intermediate compartment1635. In order to inhale the medicine, the patient pushes the part1610(FIG. 18A) in the direction of arrow1625, a small sphere1645seals the connection between the intermediate compartment1635and the medicine compartment1630and the medicine flows in the direction of arrow1620through the nozzle1640mounted inside the part1610. The nozzle is connected to a spout (not shown) for the patient to inhale.

According to embodiments of the invention, the medicine compartment1630may be a replaceable medicine compartment or a fixed medicine compartment.

According to embodiments of the invention, the medicine in some of the embodiments described above is released from the medicine compartment to an intermediate compartment (the personalized dosage compartment) in a constant flow rate (according to the medicine compartment's pressure). In order to maintain this flow rate while enlarging the intermediate compartment, the present invention offers to control the nozzle's flow rate.

FIG. 19demonstrates a solution to the intermediate compartment pressure regulation—a nozzle1900which may be mounted in or at the spout's end of any one of the nozzles described above in conjunction withFIGS. 14, 14A, 14B and 16 through 18A. According to the determined medicine dosage, the intermediate compartment's size is changed or being changed. While enlarging the compartment's size, the pressure of the content in the compartment decreases. In order to release the medicine from this compartment for the patient to inhale in the original pressure (or at least close to the original pressure), the apparatus which uses the nozzle1900may adjust the nozzle's flow rate. The nozzle1900adjustment may be done by rotating a nut1910which increases or decreases the cavity's1920volume created between the nozzle head1930and the nut1910. By rotating the nut in a predetermined direction, the cavity's volume increases thus lower pressure is created. By rotating the nut to the other direction, the cavity's volume decreases thus a higher pressure is created. The nut may rotate by an actuator (not shown) controlled by a controller (not shown) which determines the rotation according to the intermediate compartment's size.

The actuators described hereinabove may be DC Motor, servo motor, stepper motor, PZT, shape memory alloy (SMA), pneumatic actuator, hands power, magnetic actuator, magnetostrictive actuator, solenoid, thermal actuator or any other actuator known in the art and suitable for the task.

FIG. 20is a schematic view of another exemplary mechanical delivery apparatus2000according to embodiments of the present invention comprising, a housing2005comprising a medicine compartment2010storing medicine (pressurized fluid—not shown), dosage setting dial2020, nozzle2030, a test mechanism2040, a release mechanism2050, a transparent window (not shown) mounted in front of the test mechanism2040and a spout2060. The function2065represents the correlation between the angle alpha and the dosage setting dial2020. Air flow can pass from the spout2060side to the nozzle2030only through the test mechanism2040. Medicine can pass from the nozzle2030to the spout2060only through the release mechanism2050.

FIG. 20Ashows an enlargement of detail2045ofFIG. 20which comprises the test mechanism2040. The test mechanism2040comprises a flap2071, a spring2072connected to the flap2071on one side and to a fixed location on its other side, and a side flap2073pressed against the flap2071by a spring2074which is connected to the side flap2073on one side and to a fixed location on its other side.

In operation, referring to bothFIGS. 20 and 20A, a patient inhales full lungs capacity (not through the apparatus) and exhales into the apparatus through the spout2060. The air flow pushes the flap2071in the direction of arrow2075. The side flap2073which is pressed against the flap2071is pushed by the flap2071in the direction of arrow2076. The spring's2074pressure keeps the flap2071in its position (e.g. on number 5 as shown inFIG. 20A) long enough for the patient to see through the transparent window (not shown) the dosage he needs to adjust. The patient sets the dosage setting dial2020accordingly and pushes the medicine compartment2010against the apparatus's housing2005. When the compartment is pushed, medicine is released through the nozzle2030. When the patient inhales trough the spout2060, the release mechanism's flap2050A is opened by the force of the patient's suction and the medicine is released.

According to embodiments of the present invention, the test and/or the release mechanisms may be implemented by a mechanical mechanism comprising, a propeller configured to rotate when a patient blows toward it. While rotating, the propeller may actuate any of the release mechanisms described above in conjunction withFIGS. 8-14B and 16-18A. The actuation may be done directly by the propeller. Alternatively, the propeller may load an actuator which may be configured to actuate any of the release mechanisms described above in conjunction withFIGS. 8-14B and 16-18A.

FIG. 21demonstrates an exemplary mechanical mechanism2100according to embodiments of the invention. The test mechanism in this embodiment is implemented by a propeller2110. When a patient blows a full-lung exhalation through a spout (not shown) towards the propeller2110, the propeller rotates in the direction of arrow2115according to the patient's air flow. A cog-wheel2120mounted in the center of the propeller2110and connected with a grooved pole2145connected to a piston2125, lifts the piston2125in the direction of arrow2135and loads a spring2130. While the piston is lifted, it sucks drug from a drug compartment2140, through a unidirectional valve2150, into an intermediate compartment2160. The left side of part2165prevents the return of the piston2125. In order to inhale the drug, the patient presses on the right side of part2165and releases the loaded spring which pushes the piston2125back in the direction of arrow2170. The piston forces the drug out from the intermediate compartment2160, through a unidirectional valve2180, to spout2190for the patient to inhale.

Alternatively, the propeller may be configured to pull the disk which opens the right number of drug cells (FIG. 8), actuate the peeler ofFIG. 9, rotate the spiral ofFIG. 10, determine the distance between the two movable parts ofFIG. 11Aand move them, actuate the conveyor ofFIG. 12A, enlarge the size (volume) of the adjustable cavities ofFIGS. 14-14B and 16-16A, etc.

FIG. 22demonstrates another exemplary mechanical mechanism2200according to embodiments of the invention. The test mechanism in this embodiment is implemented by a propeller2210. When a patient blows a full-lung exhalation through a spout2215towards the propeller2210, the propeller rotates according to the patient's air flow and rotates a pulley2220(directly or via at least one other pulley such as pulley2225). The pulley2220is connected to a conveyor2230which releases the drug according to the propeller rotation. The conveyor and the releasing method may be similar to the one described above in conjunction withFIGS. 12A-12B.

According to embodiments of the invention, the medicine compartment of the delivery apparatuses that were described above may be replaceable, e.g. a capsule containing the medicine. The capsule may have for example an aluminum bottom that is breached (e.g. by a needle) when the capsule is placed in the apparatus.

According to embodiments of the invention, the delivery apparatuses that were described above may also comprise a cover, such as plastic cover, configured to cover the exhale\inhale spout or nozzle.