WO2020229907A1

WO2020229907A1 - A medicament dispensing device

Info

Publication number: WO2020229907A1
Application number: PCT/IB2020/053877
Authority: WO
Inventors: Sharad Chandmal CHANDAK; Mayur Balkrushna Sangwai; Suraj Raghunath KELVALKAR; Ashok TYAGI; Satish Madhukar Gokhale
Original assignee: Glenmark Pharmaceuticals Ltd.
Priority date: 2019-05-10
Filing date: 2020-04-24
Publication date: 2020-11-19

Abstract

The present disclosure relates to the field of medical devices and discloses a medicament dispensing device (100) comprising an actuator body (102), a medicament canister (108), a dispensing valve (112), a dose counter, a shake switch (302), and a display unit (106). The canister (108) stores a medicament under pressure. The dispensing valve (112) discharges a dose of the medicament from the medicament canister (108) into an outlet (110) when a user depresses the canister (108). The dose counter maintains a count of total number of medicament doses dispensed from the canister (108). The switch (302) detects shaking of the canister (108) and generates an activation signal when shaking of the canister (108) is detected for a pre-defined number of times. The display unit (106) displays number of medicament doses left in the canister (108) or number of consumed medicament doses, upon receiving the activation signal from the switch (302).

Description

A MEDICAMENT DISPENSING DEVICE

FIELD

The present disclosure relates generally to the field of medical equipment and devices. More particularly, the present disclosure relates to a medicament dispensing device.

BACKGROUND The background information herein below relates to the present disclosure but is not necessarily prior art.

The use of medicament dispensing devices for administration of medicaments, for example in conditions like asthma and bronchitis, is well known. Such devices generally include a body/housing and a medicament carrying canister which is either removably or fixedly housed within the body. The canister contains medicament which is required to be dispensed in discrete doses. The canister usually includes a dispensing valve for dispensing dose of the medicament from the device into the buccal cavity or nasal cavity of a user.

The medicament contained within the canister is in the form of a homogenous suspension comprising multiple phases, i.e., liquid phase, gas phase, solid phase, and the like. The homogenous suspension usually includes one or more actives, propellant, fillers, solvent, and/or other compounds. When not in use, the device with the canister is allowed to remain in a static position. In time, the phases in the suspension tend to separate and settle in accordance with gravity. For proper and precise administration, it is important that the homogeneity of the suspension is reconstituted at the time of dispensing. It may also happen that if the medicament is in powdered form, there may be agglomeration/caking of the particles in the medicament. Again, at the time of dispensing, it is imperative that the powdered form medicament needs to have uniform particle size and the agglomerates need to be broken up.

In both cases, the user is advised to vigorously shake the dispensing devices which, in one case, restores the homogeneity of the suspension, and in the other case, breaks up the lumps/ agglomerates into free-flowing powder. When correctly used, the medicament dispensing device delivers a predetermined effective amount (metered dosage) of the drug directly to site in the lungs, for quick onset of action. However, several patients/users either ineffectively shake the device or do not shake the device at all. This may be a result of ignorance or an urgent need of using the device in the onset of an attack. In both the cases, less than an effective amount of the active compound reaches the site of action. This may happen in the conventional medicament dispensing devices in spite of providing directions such as “shake before use”, thus leading to inconsistent delivery of medicament and poor disease control, which is not desired.

In the prior art, a number of efforts have been made to ensure proper shaking of the medical dispensing devices to maximize the effect of medicament. However, none of the prior art documents teaches a feature that ensures patient compliance.

For example, US patent US9381313 discloses a waterproof inhaler comprising a canister, a housing, a motion sensor, a counter, and a display. The counter is configured to count the number of displacements between the canister and the housing, i.e., number of usages of the inhaler. The display indicates the number of doses left in the canister based on the number of displacements provided by the counter. In this solution, the operation of the display is initiated when the motion sensor detects vibration or movement of the device along any axis. It is known that a motion sensor detects even slight movements or displacements. Thus, the motion sensor of this solution will initiate the display upon detecting even a slight movement of the inhaler along any axis. Therefore, the use of a motion sensor does not ensure adequate shaking of the inhaler and therefore, homogenization of the medicament in the canister. Similarly, PCT publication WO2016187156A1 also describes a propellant-based metered dose inhaler which has a‘shake-to-wake screen’ feature. This solution also does not describe any method for ensuring adequate shaking of the medicament within the canister.

Further, US patents US6358058B1 and US9072846B2 describe a dispenser which informs a user as to whether the dispenser has been shaken to a sufficient extent. Specifically, US patent US6358058B1 describes the use of a magnetic sensor, such as a Hall element or a magneto-resistive element, to measure the movement or deflection of a movable vane located within the housing of the dispenser. US patent US9072846B2, on the other hand, teaches a complicated method which includes arriving at a particular color shade of the medicament, which can be viewed by a user through a window, for identifying if the dispenser has been shaken adequately. This method is not useful for users with vision deficiencies and defects, such as color blindness, as such users will not be able to conclusively identify the exact shade of color corresponding to a homogenous state of the medicament. Further, this solution is not adequate for powdered medicaments. Thus, while both the patents teach an inhaler comprising a device for checking if the inhaler has been shaken adequately, they describe complicated methodologies for arriving at the same.

There is, therefore, felt a need for a medicament dispensing device that eliminates the above- mentioned drawbacks.

OBJECTS

Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative.

An object of the present disclosure is to provide a medicament dispensing device.

Another object of the present disclosure is to provide a medicament dispensing device that ensures consistent delivery of medicament dose.

Still another object of the present disclosure is to provide a medicament dispensing device that facilitates detection of release of a medicament dose from the medicament canister.

Yet another object of the present disclosure is to provide a medicament dispensing device that includes a display device for providing a visual display of remaining number of medicament doses prior to administrating a dose.

Still another object of the present disclosure is to provide a medicament dispensing device integrated with a shake switch.

Yet another object of the present disclosure is to provide a medicament dispensing device that includes both the shake switch and the display device, wherein the shake switch generates an activating signal for the display device upon detecting shaking of the medicament dispensing device for a pre-determined number of times. Still another object of the present disclosure is to provide a medicament dispensing device that eliminates the need for a manual switch for activating the display of the device.

Yet another object of the present disclosure is to provide a medicament dispensing device that improves patient compliance.

Still another object of the present disclosure is to provide a medicament dispensing device which provides a visual display of remaining number of medicament doses using only 2.5 units of a seven segment display.

Yet another object of the present disclosure is to provide a medicament dispensing device that can be used by non-English speaking users.

Still another object of the present disclosure is to provide a medicament dispensing device with the display device that is aligned along the longitudinal axis of the medicament dispensing device.

Yet another object of the present disclosure is to provide a medicament dispensing device that has a sleek and ergonomic design.

Yet another object of the present disclosure is to provide a medicament dispensing device that is compact.

Still another object of the present disclosure is to provide a medicament dispensing device that is cost-effective.

Yet another object of the present disclosure is to provide a medicament dispensing device that includes an indicator for alerting a user when the remaining number of medicament doses falls below a threshold limit.

Still another object of the present disclosure is to provide a medicament dispensing device that includes a safety mechanism for preventing unintended/accidental activation of the display device for pro-longed durations.

Yet another object of the present disclosure is to provide a medicament dispensing device that avoids unnecessary drainage of the battery. Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY

In accordance with an aspect of the present invention, a medicament dispensing device comprising an actuator body, a medicament canister, a dispensing valve, a dose counter, a shake switch, and a display unit is disclosed. The medicament canister is located within the actuator body and is configured to store a pre-determined number of doses of a medicament under pressure. The dispensing valve is connected to the medicament canister. The dispensing valve discharges a dose of the medicament from the medicament canister into an outlet when a user depresses the medicament canister. The outlet is covered with a cap. The dose counter is located within the actuator body. The dose counter is configured to maintain a count of either the total number of medicament doses available in the canister or the total number of medicament doses dispensed from the canister. The shake switch detects shaking of the medicament canister and generates an activation signal when shaking of the medicament canister is detected for a pre-defined number of times. Accordingly, the shake switch is implemented as a vibration sensor selected from the group consisting of a capacitive sensor, an electrodynamic sensor, a piezoelectric sensor, an accelerometer, a gyroscope, and a Micro-Electro-Mechanical Systems (MEMS) sensor. The display unit is configured to cooperate with the dose counter to display, either the number of medicament doses remaining in the medicament canister or the total count of consumed medicament doses, upon receiving the activation signal from the shake switch.

In an embodiment, the medicament canister is an aerosol canister containing a medicament in the form of a homogenous suspension comprising one or more actives, a propellant, fillers, others, and a solvent.

In another embodiment, the medicament canister is a dry-powder canister which contains a medicament in dry-powder form mixed with an excipient.

In an embodiment, the shake switch and the display unit are mounted on a Printed Circuit Board (PCB). The PCB is housed within a moulded jacket placed in the actuator body. The moulded jacket is provided with a snap locking mechanism for interlocking with the actuator body. Advantageously, the display unit is an LED display comprising 2.5 units of a seven-segment display, wherein the left segment of the display is configured to show the digit‘ 1’ , thereby facilitating displaying digits up to‘199’. The display unit is configured to display Ό’ when the count of total number of doses in the medicament canister falls to zero.

The components of the device are powered by a battery.

In an embodiment, the device comprises a safety mechanism to prevent accidental activation of the display unit for pro-longed durations, thereby minimizing unnecessary drainage of the battery. The safety mechanism comprises a timer circuit configured to turn off the display unit after a pre-set time interval. The pre-set time interval is preferably in the range of 7 seconds to 20 seconds.

In an embodiment, the dose counter comprises an orifice, a lever, a sensing unit, a memory, and processing unit. The orifice extends from the medicament canister to a wall of the actuator body. The lever is located within the orifice and is movable therewithin. The lever is configured to swing downwards each time the user depresses the medicament canister. The sensing unit is configured to detect the swinging movement of the lever, and is further configured to generate a displacement detection signal. The memory is configured to store the count of the total number of medicament doses dispensed. The processing unit is configured to cooperate with the memory to update the count upon receiving the displacement detection signal from the sensing unit.

In an embodiment, the device includes a pseudo cap cover for the medicament canister, a collar, and a flange. The collar is ultrasonically welded to a top portion of the moulded jacket. The flange is configured at the rim of the pseudo cap cover and is inserted in the collar before ultrasonically welding the collar to the moulded jacket. This obstructs the removal of the medicament canister from the actuator body.

Advantageously, the device includes at least one indicator configured to receive the activation signal from the shake switch, and further configured to cooperate with the dose counter to provide an indication of medicament doses remaining in the medicament canister upon receiving the activation signal.

In an embodiment, the indicator is an LED indicator. The indicator is placed within an indicator jacket provided with a light pipe. The light pipe is configured to receive the light emitted by the indicator, and is further configured to enhance the visibility of the received light to clearly provide the indication of medicament doses remaining in the medicament canister.

Alternatively, the device includes a miniature speaker configured to receive the activation signal from the shake switch, and further configured to cooperate with the dose counter to provide an audio notification indicating the medicament doses remaining in the medicament canister upon receiving the activation signal.

In accordance with another aspect of the present invention, a medicament dispensing device comprising an actuator body, a medicament canister, a dispensing valve, a dose counter, a shake switch, a display unit, and at least one indicator is disclosed. The medicament canister is located within the actuator body. The medicament canister is configured to store a pre determined number of doses of a medicament under pressure. The dispensing valve is connected to the medicament canister. The dispensing valve discharges a dose of the medicament from the medicament canister into an outlet when a user depresses the medicament canister. The dose counter is located within the actuator body, and is configured to maintain a count of at least one of the total number of medicament doses available in the canister and the total number of medicament doses dispensed from the canister. The dose counter is further configured to compare the count with a pre-determined threshold value and generate an alert signal when the count is less than the pre-determined threshold value. The shake switch is configured to detect shaking of the medicament canister, and is further configured to generate an activation signal when shaking of the medicament canister for a pre-defined number of times is detected. The display unit is configured to cooperate with the dose counter to display, either the number of medicament doses remaining in the medicament canister or the total count of consumed medicament doses, upon receiving the activation signal from the shake switch. The indicator is configured to turn on upon receiving the alert signal from the dose counter to provide an indication that medicament doses remaining in the medicament canister is less than the threshold value.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING

A medicament dispensing device of the present disclosure will now be described with the help of the accompanying drawing, in which:

Figure 1 illustrates a cross-sectional side view of a medicament dispensing device, in accordance with the present disclosure; Figure 2 illustrates an exploded view of the medicament dispensing device of Figure 1, in accordance with the present disclosure;

Figure 3 illustrates a cross-sectional top view of the medicament dispensing device of Figure 1, in accordance with the present disclosure;

Figure 4A illustrates a schematic view of a PCB tray having a PCB fitted therein, of the medicament dispensing device of Figure 1, in accordance with the present disclosure;

Figure 4B illustrates a schematic view of a moulded jacket for the PCB tray of the medicament dispensing device of Figure 1, in accordance with the present disclosure;

Figure 5 illustrates an exploded view of the medicament dispensing device of Figure 1, in accordance with another embodiment of present disclosure; and

Figure 6 illustrates a cross-sectional side view of a medicament dispensing device, in accordance with yet another embodiment of present disclosure.

LIST OF REFERENCE NUMERALS

100 - Device

102 - Actuator body

104 - Battery

106 - Display unit

108 - Medicament canister

110 - Outlet

112 - Dispensing valve

202 - Moulded Jacket for PCB

204 - Printed Circuit Board (PCB)

206 - Cap for outlet

208 - Indicator 210 - Light pipe for indicator

212 - Indicator jacket 214 - Slot for pull tab 302 - Shake switch 304 - PCB tray

402 - Snap locking mechanism 502 - Pseudo cap cover 504 - Flange 506 - Collar 508 - Groove/Indentation

602 - Lever 604 - Orifice 606 - Spray stem

DETAILED DESCRIPTION Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.

Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details, are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail. The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising,"“including,” and“having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, operations, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, integers, operations, elements, components, and/or groups thereof.

When an element is referred to as being "mounted on,"“engaged to,” "connected to," or "coupled to" another element, it may be directly on, engaged, connected or coupled to the other element. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed elements.

Existing medicament dispensers/inhalers do not ensure proper shaking of the medicament canister prior to its use by the patients, thereby causing less than an effective amount of the active compound to reach the site of action. This happens in spite of directions such as“shake before use” imprinted on the medicament dispensers, thus leading to inconsistent delivery of medicament and poor disease control.

A number of efforts have been made to ensure proper shaking of the medical dispensing devices to maximize the effect of medicament. However, there exists no medicament dispenser that ensures patient compliance.

In addition to this, certain existing medicament dispensers include electronic counters that record a dosage count even when an effective dosage is not delivered to the patient. Therefore, it is important to ensure that a dosage count is recorded by the counter only when all active components of the medicament are dispensed.

In order to overcome above-mentioned problems, a medicament dispensing device 100

(hereinafter referred as“device 100”) of the present disclosure is now being described with reference to Figure 1 through Figure 6. Referring to Figure 1, the device 100 comprises an actuator body 102, a medicament canister 108, a dispensing valve 112, a dose counter, and a shake switch 302. The medicament canister 108 is located within the actuator body 102. The medicament canister 108 may be an aerosol canister containing a medicament in the form of a homogenous suspension comprising one or more actives, a propellant, fillers, others, and a solvent. Alternatively, the medicament canister 108 may be a dry-powder canister which contains a medicament in dry-powder form mixed with an excipient. The medicament for a pre-determined number of doses is stored under pressure in the medicament canister 108. The dispensing valve 112 is connected to the medicament canister 108 and is configured to discharge a dose of the medicament from the medicament canister 108 when a user depresses the medicament canister 108. As the medicament is forced from the medicament canister 108 through the dispensing valve 112, the propellant rapidly vaporizes/atomizes into a fast moving cloud of fine particles of the medicament which are directed into the buccal cavity or nasal cavity of the user. Referring to Figure 2, the actuator body 102 includes an outlet 110 through which the medicament from the dispensing value 112 is released into the buccal cavity or the nasal cavity of the user. A cap 206 is provided for covering the outlet 110 of the actuator body 102, when the dispensing device 100 is not in use.

The shake switch 302 is configured to detect shaking of the medicament canister 108, and is further configured to generate an activation signal when shaking of the medicament canister 108 is detected for a pre-defined number of times. Accordingly, the shake switch 302 is a vibration sensor selected from the group consisting of, but not limited to, a capacitive sensor, an electrodynamic sensor, a piezoelectric sensor, an accelerometer, a gyroscope, and a Micro- Electro-Mechanical Systems (MEMS) sensor. The shake switch 302 can be aligned either along the longitudinal axis or along the transverse axis or along both the axes of the device 100. Accordingly, the shake switch 302 is configured to detect shaking of the medicament canister 108 along at least one of a longitudinal axis or a transverse axis of the device 100. For example, an accelerometer (or magnetometer or gyroscope) can be used to detect changes in acceleration i.e. shaking movement in substantially the same axis or plane.

In an embodiment, the shake switch 302 is aligned along the longitudinal axis of the device 100, and is configured to detect shaking of the device 100 along the longitudinal axis. In another embodiment, the shake switch 302 is aligned along the transverse axis of the device 100, and is configured to detect shaking of the device 100 along the transverse axis. In yet another embodiment, the shake switch 302 is aligned along the longitudinal axis of the device 100, and is configured to detect shaking of the device 100 along the transverse axis. In still another embodiment, multiple shake switches 302 are used and therefore, the device 100 can be shaken along any axis or transversely. Thus, the orientation of the shake switch 302 with respect to the actuator body 102 determines the direction of shaking for generating activation signal.

The dose counter is located within the actuator body 102, and is configured to store a count of the total number of medicament doses available in the canister 108 or total number of medicament doses dispensed from the canister 108. The dose counter is further configured to detect dispensation of a medicament dose from the medicament canister 108 and update the count based on said detection. The display unit 106 is configured to cooperate with the dose counter to display the number of doses remaining in the medicament canister 108 prior to administrating a dose. In an alternate embodiment, the display unit 106 is configured to indicate the total count of consumed doses.

Conventional medicament dispensing devices include a mechanical push button to activate the display unit for the user to see the number of doses remaining prior to administrating the dose. However, the medicament dispensing device 100, of the present disclosure, is configured with a‘shake to wake’ feature to activate the display unit 106. In the medicament dispensing device 100, the conventional mechanical push button is replaced with the shake switch 302, or is provided as a fail safe alternative. The shake switch 302 is configured to supply the generated activation signal to the display unit 106. The display unit 106 is configured to turn on only upon receiving the activation signal from the shake switch 302. Thus, it becomes necessary for a patient to‘shake’ the actuator body 102 to view the number of doses remaining in the medicament canister 108 before inhaling a dose, thereby improving the patient compliance by shaking the device 100.

In an embodiment, the shake switch 302 and the display unit 106 are mounted on a Printed Circuit Board (PCB) 204 as shown in Figure 3. In one embodiment, the shake switch 302 is mounted on an operative back side of the PCB 204. In another embodiment, the shake switch 302 is mounted on an operative front side of the PCB 204. The placement of the shake switch 302 is determined as per the design of the device 100. The PCB 204 is mounted on a PCB tray 304. As illustrated in Figures 4A and 4B, the PCB tray 304 is housed within a moulded jacket 202. The moulded jacket 202 is placed within the actuator body 102. Thus, the actuator body 102 accommodates the display unit 106. The display unit 106 may be a Liquid Crystal Display (LCD), an LED display, or a seven-segment display. In a preferred embodiment, the display unit 106 comprises 2.5 units of a seven-segment display, thereby, creating a sleek and ergonomic design. The left segment of the display unit 106 can be configured to show only the digit‘G. The display unit 106 can thus display digits up to‘199’.

In a preferred embodiment, the display unit 106 is aligned along the longitudinal axis of the actuator body 102. This arrangement helps in further reducing the width of the actuator body 102. In an alternative embodiment, the display unit 106 is aligned along the transverse axis of the actuator body 102. As the display unit 106 is of 2.5 segments, in this embodiment as well, the device 100 of the present disclosure will be sleek.

In another embodiment, the display unit 106 is configured to display Ό’ when the number of doses within the medicament canister 108 falls to zero. The digit Ό’ connotes ‘Nil’ or ‘Empty’. This configuration of the display unit 106 eliminates the language issues associated with the non-English speaking user groups.

Referring to Figure 2, the moulded jacket 202 is provided with a slot 214 for the pull tab. Referring to Figure 4B, the moulded jacket 202 is further provided with a snap locking mechanism 402 for interlocking with the actuator body 102.

In yet another embodiment, the device 100 includes at least one indicator 208 along with the shake switch 302 and the display unit 106. The indicator 208 can be an LED indicator. The indicator 208 is configured to receive the activation signal from the shake switch 302, and is further configured to cooperate with the dose counter to provide an indication of medicament doses remaining in the medicament canister 108 upon receiving the activation signal. For example, an exemplary green light emitting diode (LED) indicates that the device 100 is ready to use and the medicament canister 108 contains sufficient number of doses. The user can use the device 100 without worrying about the number of doses remaining in the medicament canister 108. An exemplary flashing red LED indicates that the total number of medicament doses in the medicament canister 108 is below a threshold limit. An exemplary constant red LED indicates that the medicament within the medicament canister 108 has been exhausted. Alternatively, the green/red LED may be replaced with multiple single-colored light emitting diodes.

As shown in Figure 2, the indicator 208 is placed within an indicator jacket 212. The indicator jacket 212 is provided with a light pipe 210 that is configured to receive the light emitted by the indicator 208, and is further configured to enhance the visibility of the received light to clearly provide the indication of number of medicament doses remaining in said medicament canister 108.

Alternatively, the device 100 includes a miniature speaker (not shown in figures) configured to receive the activation signal from the shake switch 302, and further configured to cooperate with the dose counter to provide an audio notification indicating the number of medicament doses remaining in the medicament canister 108 upon receiving the activation signal.

In an embodiment, the device 100 includes a battery 104 for powering the components i.e. the display unit 106, the shake switch 302, and the indicator 208. The battery 104 is mounted on the PCB 204.

Although the dose counter, the display unit 106, and the indicator 208 are implemented separately in the above example, the present invention is not limited to the example. In an alternate embodiment, the display unit 106 and the indicator 208 can also be incorporated in the dose counter so that they are implemented as a single unit. Advantageously, the medicament dispensing device 100 additionally comprises a safety mechanism to prevent unintended/accidental activation of the display unit 106 for pro-longed durations, thereby minimizing unnecessary drainage of the battery 104. The safety mechanism comprises a timer circuit (not shown in figure) configured to turn off the display unit 106 after a pre-set time interval. In an exemplary embodiment, the timer circuit is configured to store a pre-set time interval. The display unit 106 displays the remaining number of doses, post administrating the dosage, for the pre-set time interval. The timer circuit can be configured to turn off the display unit 106 after the pre-set time interval. The pre-set time interval may be in the range of 7 seconds to 20 seconds. In another exemplary embodiment, if the display unit 106 is activated accidently, the timer circuit deactivates the display unit 106 after the pre-set time interval (for example, 15 seconds).

In one embodiment, the dose counter includes a displacement detection unit and a processing unit. The displacement detection is configured to detect the movement of the medicament canister 108 within the actuator body 102 at the time of release of the medicament. During each operation of the medicament dispensing device 100, the displacement detection unit is configured to generate a displacement detection signal.

Referring to an exemplary embodiment of Figure 6, the displacement detection comprises an orifice 604, a lever 602, and a sensing unit. The orifice 604 extends from the medicament canister 108 to a wall/collar of the actuator body 102. The lever 602 is located within the orifice 604 and is movable therewithin. The lever 602 is configured to swing downwards each time the user depresses the medicament canister 108. The swinging movement of the lever 602 is detected by the sensing unit which generates corresponding displacement detection signal. Alternatively, the orifice 604, the lever 602, and the sensing unit can be configured proximal to a spray stem 606, of the medicament canister 108, to detect the movement of the medicament canister 108.

In another embodiment, the displacement detection unit includes an emitter, a light pipe, and a detector. The emitter is configured to continuously emit a radiation. The emitter can be a light emitting diode (LED), a laser, an incandescent lamp, an electroluminescent light source or a fluorescent light source. The detector is configured to receive the radiation through the light pipe. The radiation, being received by the detector, is interfered with, when a dose of the medicament is dispensed from the medicament canister 108 through the outlet 110. The detector is configured to detect this interference and generate an interference detection signal.

The processing unit comprises a memory and a processor.

In one embodiment, the memory stores the count of the total number of medicament doses dispensed. The processor cooperates with the memory to update the stored count upon receiving the displacement detection signal or the interference detection signal from the displacement detection unit. The updated count is displayed on the display unit 106.

In another embodiment, the memory stores the count of dosages available for dispensing prior to the usage. The processor cooperates with the displacement detection unit to receive the interference detection signal or displacement detection signal and further deducts the total number of medicament doses by one each time an interference detection signal or a displacement detection signal is generated. The processor displays the updated total number of medicament doses on the display unit 106. When the number of doses within the medicament canister 108 reduces to zero, the display unit 106 may be configured to display Ό’ which connotes‘Nil’ or‘Empty’. This configuration of the display unit 106 eliminates the language issues associated with the non-English speaking user groups.

As shown in Figure 5, the actuator body 102 can have at least one groove or indentation 508 along its length. The groove 508 may have a matte or gloss finish for improved aesthetics of the device 100.

Advantageously, the medicament canister 108 is provided with a pseudo cap cover 502 as shown in Figure 5. A collar 506 is ultrasonically welded to a top portion of the moulded jacket 202. A flange 504 is configured at the rim of the pseudo cap cover 502. The flange 504 is inserted in the collar 506 before ultrasonically welding the collar 506 to the moulded jacket 202. This ensures that the medicament canister 108 cannot be removed from the actuator body 102 without breaking the weld. Thus, removal of the medicament canister 108 from the actuator body 102 is obstructed.

In accordance with another aspect of the present disclosure, the device 100 comprises an actuator body 102, a medicament canister 108, a dispensing valve 112, a dose counter, a shake switch 302, a display unit 106, and at least one indicator 208. The medicament canister 108 is located within the actuator body 102. The medicament canister 108 is configured to store a pre-determined number of doses of a medicament under pressure. The dispensing valve 112 is connected to the medicament canister 108. The dispensing valve 112 discharges a dose of the medicament from the medicament canister 108 into an outlet 110 when a user depresses the medicament canister 108. The dose counter (not shown in figure) is located within the actuator body 102 and is configured to maintain a count of at least one of the total number of medicament doses available in the medicament canister 108 or the total number medicament doses dispensed from the canister 108. The dose counter is further configured to compare the count with a pre-determined threshold value and generate an alert signal when the count is less than or equal to the pre-determined threshold value. The shake switch 302 is configured to detect shaking of the medicament canister 108, and is further configured to generate an activation signal when shaking of the medicament canister 108 for a pre-defined number of times is detected. The display unit 106 is configured to cooperate with the dose counter to display, either one of the number of medicament doses remaining in the medicament canister 108 and the total count of consumed medicament doses, upon receiving the activation signal from the shake switch 302. The indicator 208 is configured to turn on upon receiving the alert signal from the dose counter to provide an indication that medicament doses remaining in the medicament canister 108 is less than said threshold value.

In an embodiment, the pre-defined threshold value is 20 doses.

In another embodiment, the medicament dispensing device 100 includes a miniature speaker. The speaker can be configured to receive the alert signal from the dose counter, and can be further configured to provide audio notification to the user based on the received alert signal, wherein the audio notification indicates that the total number of medicament doses left within the medicament canister 108 is below the pre-determined threshold dose limit.

The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

TECHNICAL ADVANCEMENTS

The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a medicament dispensing device that:

• ensures consistent delivery of medicament dose;

• facilitates detection of release of a medicament dose from the medicament canister;

• includes a display device for providing a visual display of remaining number of medicament doses to a user prior to administrating a dose;

• includes a shake switch which generates an activating signal for the display device upon detecting shaking of the medicament dispensing device for a pre-determined number of times;

• provides a visual display of remaining number of medicament doses using only 2.5 units of a seven segment display;

• is compact;

• is cost-effective;

• eliminates the need for a manual switch for activating the display of the device;

• improves patient compliance;

• can be used by non-English speaking users; • has a sleek and ergonomic design;

• includes an indicator for alerting the user when remaining number of doses falls below a threshold value;

• includes a safety mechanism for preventing unintended/accidental activation of the display device for pro-longed durations;

• has an in-built battery unit which powers various electronic components of the device; and

• avoids unnecessary drainage of the battery.

The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

The foregoing description of the specific embodiments so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

The use of the expression“at least” or“at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.

The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.

While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

CLAIMS:

1. A medicament dispensing device (100) comprising:

• an actuator body (102);

• a medicament canister (108) located within said actuator body (102), said medicament canister (108) configured to store a pre-determined number of doses of a medicament under pressure;

• a dispensing valve (112) connected to the medicament canister (108), said valve (112) configured to discharge a dose of said medicament from said medicament canister (108) into an outlet (110) when a user depresses said medicament canister (108);

• a dose counter (not shown in figure) located within said actuator body (102) and configured to maintain a count of the total number of medicament doses available in said canister (108) or the total number of medicament doses dispensed from said canister (108);

• a shake switch (302) configured to detect shaking of said medicament canister (108), and further configured to generate an activation signal when shaking of said medicament canister (108) is detected for a pre-defined number of times; and

• a display unit (106) configured to cooperate with said dose counter to display, either one of the number of medicament doses remaining in said medicament canister (108) and the total count of consumed medicament doses, upon receiving said activation signal from said shake switch (302).

2. The device (100) as claimed in claim 1, wherein said medicament canister (108) is an aerosol canister containing a medicament in the form of a homogenous suspension comprising one or more actives, a propellant, fillers, others, and a solvent.

3. The device (100) as claimed in claim 1, wherein said medicament canister (108) is a dry- powder canister which contains a medicament in dry-powder form mixed with an excipient.

4. The device (100) as claimed in claim 1, which includes a cap (206) for covering said outlet (110) of said actuator body (102).

5. The device (100) as claimed in claim 1, wherein said shake switch (302) is a vibration sensor selected from the group consisting of a capacitive sensor, an electrodynamic sensor, a piezoelectric sensor, an accelerometer, a gyroscope, and a Micro-Electro-Mechanical Systems (MEMS) sensor.

6. The device (100) as claimed in claim 1, wherein said shake switch (302) is configured to detect shaking of said medicament canister (108) along at least one of a longitudinal axis or a transverse axis of said device (100).

7. The device (100) as claimed in claim 1, wherein said shake switch (302) and said display unit (106) are mounted on a Printed Circuit Board (PCB) (204), said PCB (204) housed within a moulded jacket (202) placed in said actuator body (102).

8. The device (100) as claimed in claim 7, wherein said moulded jacket (202) is provided with a snap locking mechanism (402) for interlocking with said actuator body (102).

9. The device (100) as claimed in claim 1, wherein said display unit (106) is an LED display comprising 2.5 units of a seven-segment display, wherein the left segment of said display is configured to show the digit‘G, thereby facilitating displaying digits up to‘199’.

10. The device (100) as claimed in claim 9, wherein said display unit (106) is configured to display Ό’ when said count of total number of doses in said medicament canister (108) reduces to zero.

11. The device (100) as claimed in claim 9, wherein said display unit (106) is aligned along the longitudinal axis of the actuator body (102), thereby reducing the width of the actuator body (102).

12. The device (100) as claimed in claim 1, which comprises a battery (104) for powering the components of said device (100).

13. The device (100) as claimed in claim 1, which comprises a safety mechanism to prevent accidental activation of said display unit (106) for pro-longed durations, thereby minimizing unnecessary drainage of the battery (104).

14. The device (100) as claimed in claim 13, wherein said safety mechanism comprises a timer circuit configured to turn off said display unit (106) after a pre-set time interval.

15. The device (100) as claimed in claim 14, wherein said pre-set time interval is in the range of 7 seconds to 20 seconds.

16. The device (100) as claimed in claim 1, wherein said dose counter comprises:

• an orifice (604) extending from said medicament canister (108) to a wall of said actuator body (102);

• a lever (602) located within said orifice (604) and movable therewithin, said lever (602) configured to swing downwards each time the user depresses the medicament canister (108);

• a sensing unit configured to detect the swinging movement of said lever (602), and further configured to generate a displacement detection signal;

• a memory configured to store said count of the total number of medicament doses dispensed; and

• a processing unit configured to cooperate with said memory to update said count upon receiving said displacement detection signal from said sensing unit.

17. The device (100) as claimed in claim 7, which includes:

• a pseudo cap cover (502) for said medicament canister (108);

• a collar (506) ultrasonically welded to a top portion of said moulded jacket (202); and

• a flange (504) configured at the rim of said pseudo cap cover (502), said flange (504) inserted in said collar (506) before ultrasonically welding said collar (506) to said moulded jacket (202), thereby obstructing the removal of said medicament canister (108) from said actuator body (102).

18. The device (100) as claimed in claim 1, which includes at least one indicator (208) configured to receive said activation signal from said shake switch (302), and further configured to cooperate with said dose counter to provide an indication of number of medicament doses remaining in said medicament canister (108) upon receiving said activation signal.

19. The device (100) as claimed in claim 18, wherein said indicator (208) is an LED indicator.

20. The device (100) as claimed in claim 18, wherein said indicator (208) is placed within an indicator jacket (212) provided with a light pipe (210), said light pipe (210) configured to receive the light emitted by said indicator (208), and further configured to enhance the visibility of the received light to clearly provide the indication of number of medicament doses remaining in said medicament canister (108).

21. The device (100) as claimed in claim 1, which includes a miniature speaker (not shown in figures) configured to receive said activation signal from said shake switch (302), and further configured to cooperate with said dose counter to provide an audio notification indicating the number of medicament doses remaining in said medicament canister (108) upon receiving said activation signal.

22. A medicament dispensing device (100) comprising:

• an actuator body (102);

• a dispensing valve (112) connected to the medicament canister (108), said valve (112) configured to discharge a dose of the medicament from said medicament canister (108) into an outlet (110) when a user depresses said medicament canister (108);

• a dose counter (not shown in figure) located within said actuator body (102) and configured to maintain a count of at least the total number of medicament doses available in the medicament canister (108) and the total number of medicament doses dispensed from the medicament canister (108), said dose counter further configured to compare said count with a pre-determined threshold value and generate an alert signal when said count is less than said pre-determined threshold value;

• a shake switch (302) configured to detect shaking of said medicament canister (108), and further configured to generate an activation signal when shaking of said medicament canister (108) for a pre-defined number of times is detected;

• a display unit (106) configured to cooperate with said dose counter to display, either the number of medicament doses remaining in said medicament canister (108) or the total number of medicament doses consumed, upon receiving said activation signal from said shake switch (302); and • at least one indicator (208) configured to turn on upon receiving said alert signal from said dose counter to provide an indication that medicament doses remaining in said medicament canister (108) is less than said threshold value.