HK1236881A1 - Aerosolization system with flow restrictor and feedback device - Google Patents

Description

Atomization system with flow restrictor and feedback device

Cross Reference to Related Applications

The patent Cooperation treaty application claims the preferred rights of U.S. patent application No. 14/743,627 filed on 18/6/2015; this patent application claims priority to U.S. provisional patent application 62/019,791 filed on 7/1/2014, which is incorporated herein by reference in its entirety for all purposes.

Background

Nebulizing systems provide effective delivery of a variety of drugs, such as insulin and asthma drugs. Such systems deliver a medicament directly to the respiratory system of a user by aerosolizing a desired dose of the medicament in liquid form. The user then inhales the aerosolized drug directly into the respiratory system, thereby enabling faster treatment of various conditions.

It is important to deliver accurate and consistent metered doses of aerosolized medicament to a user. Current nebulization systems often provide inconsistent dosing by allowing a portion of the drug in liquid form to remain in the reservoir after the nebulization process is complete. Furthermore, with aerosolized medicaments, it is often the case that substantially the entire metered dose is correctly delivered into the respiratory system of the user with too much or too little force. Another problem with current aerosolization systems is the tendency of the drug to become contaminated by the user or other source. Contamination of the medicament is particularly problematic because some or all of the aerosolized medicament is thereafter delivered directly to the user's respiratory system after aerosolization. Embodiments of the present invention may provide solutions to these and other problems.

Disclosure of Invention

In one embodiment, a nebulizing device for ensuring proper delivery of a nebulized drug to a respiratory system of a user is provided. The atomization device may include: the aerosol generator comprises a conduit, an aerosol generator communicated with the conduit, a restrictor arranged in the conduit and an indicating mechanism. The conduit may include a mouthpiece end with which a user may create an inspiratory flow through the conduit. The aerosol generator may comprise a vibratable mesh. The restrictor may define a plurality of apertures disposed along an outer periphery of the restrictor. The plurality of orifices may be configured to provide an increase in pressure differential that varies with inspiratory flow rate inside the conduit and provides a relatively laminar flow at a location downstream of the restriction compared to a location upstream of the restriction. The indicating mechanism may indicate to a user a status of an inspiratory flow parameter relative to a predetermined desired range.

In another embodiment, a different aerosolization device for ensuring proper delivery of an aerosolized drug to a user's respiratory system is provided. The atomization device may include: the aerosol generator comprises a conduit, an aerosol generator communicated with the conduit, and a restrictor arranged in the conduit. The conduit may have a mouthpiece end with which a user may create an inspiratory flow through the conduit. The aerosol generator may comprise a vibratable mesh. The restrictor may define a plurality of apertures disposed along an outer periphery of the restrictor. The plurality of orifices may be configured to provide an increase in pressure differential that varies with inspiratory flow within the conduit and provide a relatively laminar flow at a location downstream of the restriction compared to a location upstream of the restriction. The vibrating mesh may produce a plume of aerosolized drug in a relatively laminar flow when the inspiratory flow rate is within the operating range of the aerosolization device.

In another embodiment, a method of delivering an aerosolized medicament to a user's respiratory system is provided. The method may include sensing a state of a flow parameter of the inspiratory flow inside the conduit. The conduit may have a mouthpiece end with which a user may induce an inspiratory flow within the conduit. The method may also include vibrating a mesh of an aerosol generator in communication with the conduit to aerosolize a volume of liquid medicament to generate a plume of aerosolized medicament inside the conduit when the flow parameter state is within a predetermined desired range. The plume of aerosolized drug may be provided within a relatively laminar flow created by a flow restriction disposed within the conduit at a location upstream of the plume of aerosolized drug. The restrictor may define a plurality of apertures disposed near an outer periphery of the restrictor. The relatively laminar flow may deliver a plume of aerosolized drug toward the mouthpiece end of the catheter. The method may further include providing an indication using an indication mechanism of the state of the flow parameter relative to a predetermined desired range.

Drawings

The invention is described below with reference to the accompanying drawings:

FIG. 1A shows the interior of an atomizing device according to an embodiment of the present invention;

FIG. 1B shows the cross-section of FIG. 1A in accordance with an embodiment of the present invention;

FIG. 2 illustrates a front portion of the atomization device of FIG. 1A in accordance with an embodiment of the present disclosure;

3A-3K illustrate a restrictor plate according to an embodiment of the invention;

FIGS. 4A and 4B illustrate a restrictor plate inside a conduit of an aerosolization device in accordance with an embodiment of the present invention;

5-7 illustrate laminar flow created by a restrictor plate inside the conduit of FIG. 4, according to an embodiment of the present invention;

8A-8C illustrate a catheter having a hub tube end at various angles according to an embodiment of the present invention;

FIG. 9 shows an input device on a nebulizing device according to an embodiment of the invention;

fig. 10 is a block diagram of a method of using an atomization device in accordance with an embodiment of the present invention.

In the drawings, similar components and/or features may have the same reference numerals. In addition, various components of the same type may be identified by the following reference numerals and letters that identify similar components and/or features. If only the first reference numeral is used in this specification, the description applies to any one of the similar components and/or features having the same first reference numeral, regardless of the alphabetic suffix.

Detailed Description

The following description is merely exemplary in nature and is not intended to limit the scope, applicability, or form of the invention. Rather, the ensuing description of the exemplary embodiments will provide those skilled in the art with an enabling description for implementing various embodiments of the invention. It being understood that various changes may be made in the function and arrangement of elements without departing from the spirit and scope of the invention as set forth in the appended claims. For example, any details described with respect to one embodiment may or may not be present in variations of that embodiment, and/or other embodiments described herein.

Embodiments of a nebulizing device that facilitates proper delivery of a nebulized drug to a user's respiratory system are described herein. In many embodiments, the liquid medicament may be provided to the aerosolization device in metered doses. The liquid medicament may be dispensed to an aerosol generator. In some embodiments, the liquid medicant can be provided via a chamber or reservoir for pooling the liquid medicant into an aerosol generator where the liquid medicant is aerosolized for delivery into a user's respiratory system. In other embodiments, a separate container containing the liquid medicament may be coupled to the aerosolization device in order to provide the liquid medicament to the aerosolization device.

In some embodiments, the atomization device can include: the aerosol generator comprises a conduit, an aerosol generator communicated with the conduit, a restrictor plate arranged inside the conduit, and an indicating mechanism connected with the conduit. In many embodiments, some or all of these components and/or the aerosol generator may be removably coupled with the housing or housed within the interior of the housing. By providing a removable conduit and/or aerosol generator, the aerosolization device can be easily cleaned and dried, thereby preventing contamination and accumulation of pathogens and/or other contaminants.

In some embodiments, the conduit may include a mouthpiece end with which a user may initiate inspiratory flow through the conduit. The user may inhale through the mouthpiece to create an inspiratory flow of air that may deliver the aerosolized medicament to the user. In some embodiments, the mouthpiece end of the conduit may deliver aerosolized medicament to a user at an angle relative to horizontal. Such a delivery angle may be selected based on the dose and type of medicament to be delivered to the user's respiratory system to ensure that a substantial portion of the aerosolized medicament is delivered to the respiratory system without becoming occluded in the user's mouth, throat, and/or other areas.

In many embodiments, the sensor is a parameter for determining when the inspiratory flow is within a predetermined desired range or operating range of the aerosolization device and/or aerosol generator. For example, a flow sensor or pressure sensor may be used to determine the flow or pressure differential inside the conduit. Other types of sensors and flow parameters may also be employed/measured. For example, the flow parameter may be inspiratory flow, inspiratory pressure, inspiratory time, etc., as detected using a flow sensor, timer, pressure sensor, or other sensing mechanism. A processing unit coupled with the sensor may compare the sensed value to a stored expected range. In some embodiments, the desired range of flow parameters for a particular drug delivery may correspond to the operating range of the aerosol generator. In other embodiments, the desired range of flow parameters may be narrower or wider than the operating range of the aerosol generator.

In some embodiments, the aerosol generator may comprise a vibrating mesh. When the parameter of the inspiratory flow is within a desired range or operating range, the vibrating mesh may be vibrated for an operating period sufficient to aerosolize substantially all of any liquid drug disposed atop the vibrating mesh. The vibrating mesh may have a dome shape and is vibrated by an annular piezoelectric element (not shown) or other electromechanical resonance device defining the vibrating mesh. The vibratable mesh is vibrated when the one or more flow parameters are within an operating range of the aerosol generator. For example, a flow sensor and/or pressure sensor in communication with the conduit may detect whether the inspiratory flow and/or pressure differential inside the conduit is within an operating range of the aerosol generator. The processor may control the circuit to provide current to the piezoelectric element to cause the mesh to vibrate. Typically, the vibrating mesh will be vibrated at a frequency in the range of about 50kHz to about 150kHz to aerosolize the dose of liquid medicament.

In many embodiments, the intake air may pass through an array of flow restrictors inside the conduit. In one embodiment, the restrictor array may be a restrictor plate having a plurality of apertures therethrough. As air passes through the orifices, the orifices provide an increase in pressure differential that varies according to the inspiratory flow rate inside the conduit. These orifices also provide relatively laminar flow at a location downstream of the restrictor plate as compared to a location upstream of the restrictor plate. In many embodiments, the aperture is disposed along an outer periphery of the restrictor plate. In some embodiments, a vibrating mesh may be located downstream of a restrictor plate or other restrictor array and produce a plume of aerosolized drug in a relatively laminar flow formed by the restrictor array. In some embodiments, the restrictor array may comprise a plurality of restrictor plates in series.

The indication mechanism may indicate to a user a status of the inspiratory flow parameter relative to a predetermined desired range. In some embodiments, the indication mechanism may indicate the status of the aerosolization device to a user instead of or in addition to indicating the status of the flow parameter. For example, the indicator may be a light, an analog/digital display or readout, a speaker, a vibration generating device, and/or other features that alert the user of the condition regarding the status of the parameter. In some embodiments, the state of the parameter may be an inspiratory flow, inspiratory pressure, inspiratory time, etc., detected by a flow sensor, timer, pressure sensor, or other sensing mechanism. The indicator may inform the user whether the state of the parameter is within or outside of a desired range of the parameter.

In some embodiments, an "end of dose" indication may be provided to the user when the entire dose of medicament has been aerosolized. Such an indication may be provided when a sensor (e.g., a load or flow sensor) detects that substantially all of the medicament has been aerosolized. Another indication may also be provided to the user to inform them when the liquid medicament is actually aerosolized by the activated vibrating mesh. Such an indication of the state of the flow parameter and/or the state of the atomizing device may be provided by the above-described indication mechanism, for example by providing a discernible indication based on the indication of the state of the flow parameter. For example, the status of the flow parameter may be indicated with green light, and the end of dose indication may be provided with blue light. In other embodiments, the end-of-dose indication and/or the indication of aerosolization may be provided by one or more separate indication mechanisms.

In some embodiments, an indicator mechanism may be used to instruct the user how to properly inhale and thereby ensure that the drug is properly delivered to the user's respiratory system. To this end, the indication mechanism may inform the user when a parameter (e.g., inspiratory flow rate inside the conduit) is within a predetermined desired range. The aerosol generator may be configured to aerosolize the liquid medicament when the inspiratory flow rate is within a predetermined flow rate range. For example, the predetermined desired range of inspiratory flow inside the conduit may be between about 5 and 14 liters per minute (L/min). An indication as described above (e.g., a light or sound emitted by a speaker) may be generated to inform the user that inhalation by the user is maintaining the inhalation flow within a desired range, and thus when the aerosol generator is functioning.

In some embodiments, a first indication may be provided when the parameter is within a desired range and a second indication may be provided when the parameter is outside the desired range. For example, the first indication may include a light being turned on, or a sound being emitted (e.g., a beep). The second indication may include a light being turned on, or a cessation of a previous continuous sound. Other indications may include emitting a different color of light or a different frequency of sound than the first indication to indicate a change in the parameter status. In some embodiments, the second indication may inform the user whether the state of the parameter is above or below a desired range. For example, a parameter with a state below a desired range may emit a flashing light with a relatively long flashing interval period to alert the user, and a parameter with a state above a desired range may emit a flashing light with a relatively short flashing interval period to alert the user. Similar vibration and sound uses may be applied in conjunction with or instead of the light indicators.

In some embodiments indicating to the user the status of the inspiratory flow parameter relative to the predetermined desired range may comprise: an indication mechanism that provides a first indication when the parameter of the inspiratory flow is within a predetermined desired range, an indication mechanism that provides a second indication when the parameter of the inspiratory flow is within a predetermined second range (i.e., possibly acceptable, but less than the optimal range), and an indication mechanism that provides a third indication when the parameter of the inspiratory flow is outside both the predetermined desired range and the predetermined second range.

In some embodiments, the aerosolization device can further comprise an input device for receiving and setting a predetermined desired range of an inspiratory flow parameter. For example, the input device may include: a bar code scanner, a Radio Frequency Identification (RFID) reader, a keyboard, or any other input device that can receive input from a user regarding one or more parameters of the inspiratory flow, such as a desired flow rate, inspiratory pressure, or inspiratory time. In some embodiments, the desired flow rate may be visually encoded on the drug delivery container and read from the delivery container by the aerosolization device.

In some embodiments, the parameter of the inspiratory flow may comprise an inspiratory flow rate inside the conduit. The predetermined desired range of inspiratory flow may be between about 5 and 14 liters per minute (L/min). In some embodiments, the parameter of inspiratory flow may comprise inspiratory time. The predetermined desired range of inspiratory time may be between about 5 and 26 seconds. In some embodiments, multiple parameters may be measured and referenced. For example, in one embodiment, some amount of inspiratory time for a minimum inspiratory flow rate may be necessary.

In some embodiments, the nebulizing system can include electronic components including, but not limited to, a processing component and a memory unit. The processing element may be used to control the activation of the aerosol generator, the indicating mechanism, and the input device, as well as any sensors (e.g., flow and pressure sensors). The storage unit may be configured to store settings and ranges for parameters of the indication mechanism and/or the aerosol generator set by the input device. The memory unit may also be configured to store data relating to past nebulization periods, as well as information provided by drug delivery containers attached to the memory unit.

Turning now to the drawings, fig. 1A and 1B illustrate an atomization device 100 according to various embodiments of the present invention. The aerosolization apparatus 100 includes a conduit 102 and an aerosol generator 104 in communication with the conduit 102. The aerosolization device 100 may also include one or more indicator mechanisms 106, here illustrated as indicator lights. One or more indication mechanisms may be coupled with the housing 108, or some other portion of the device 100. The conduit 102 and aerosol generator 104 may also optionally be coupled with the housing 108.

In some embodiments, the conduit 102 may include a mouthpiece end 110 through which a user may inhale to generate an inspiratory flow to deliver the aerosolized drug to the user's respiratory system. As seen in fig. 1B, the aerosol generator 104 may include a vibratable mesh 112. The liquid drug may be dispensed directly onto the vibrating mesh 112 from a glass vial of the liquid drug, or indirectly onto the vibrating mesh 112 by funneling onto the vibrating mesh 112 with the tapered wall of the fluid receiving chamber 114. In many embodiments, the vibratable mesh 112 is vibrated using a mechanism controlled by the processor to aerosolize a volume of liquid medicament when the flow rate of the inspiratory flow is within an operating range of the aerosol generator 104. When vibrated, the vibrating mesh 112 functions to create a plume of aerosolized drug inside the conduit 102 so that the aerosolized drug may be inhaled into the lungs of the user.

Exemplary aerosol generators that may be used are also described in U.S. patents 5164740, 6629646, 6926208, 7108197, 5938117, 6540153, 6540154, 7040549, 6921020, 7083112, 7628339, 5586550, 5758637, 6085740, 6467476, 6640804, 7174888, 6014970, 6205999, 6755189, 6427682, 6814071, 7066398, 6978941, 7100600, 7032590, 7195011, the contents of which are incorporated herein by reference. These references describe exemplary aerosol generators, methods of manufacturing such aerosol generators, and methods of providing liquids to aerosol generators, and at least these features of them are incorporated herein by reference.

In some embodiments, the one or more indication mechanisms 106 may include a light, such as an LED. The indication mechanism 106 may also include a speaker or/and a vibration generating mechanism to indicate the status of the aerosolization device to a user. For example, the indication mechanism 106 may be used to indicate to a user when the aerosolization device 100 is ready for use. The indicator mechanism 106 may also indicate a parameter status of the inspiratory flow created by the user. For example, the indication mechanism 106 may instruct the user to change the inhalation rate in order to increase or decrease the flow rate inside the conduit 102 to ensure proper delivery of the aerosolized drug and/or to ensure that the flow rate is within the operating range of the aerosol generator 104 in order to vibrate the mesh 112 to aerosolize the liquid drug. The indication mechanism 106 may also be used to indicate to the user when substantially the entire dose of liquid medicament has been aerosolized and/or inhaled. Additional sensors may be required to provide the above-described functionality.

In some embodiments, the nebulizing device 100 includes a processing unit or Integrated Circuit (IC)138 that controls the functions of or runs computer code sent to other electronic components of the nebulizing device 100. The aerosolization device 100 including IC138 may be powered by a battery 140 coupled with IC 138. The IC138 may be electrically connected with electronic components (e.g., any sensors, the indication mechanism 106, and/or the piezoelectric element of the aerosol generator 104). The IC138 may control activation of the indication mechanism and/or the aerosol generator 104 based on information received from any sensor (e.g., a flow sensor or a pressure sensor) in fluid communication with the conduit 102. In some embodiments, the IC138 may be electrically connected to the conduit 102 and/or the aerosol generator 104 using the plug 124. The conduit 102 and/or the aerosol generator 104 may be removable from the housing 108. The conduit 102 and/or the aerosol generator 104 may be inserted into the housing 108 and connected with the plug 124 to power the aerosol generator 104 and control activation of the aerosol generator 104 based on measurements from a sensor in fluid communication with the conduit 102. For example, the plug 124 may have a male connector 144 that interfaces with a female connector 146 on the catheter 102. In some embodiments, the plug 124 may include a female connector that interfaces with a male connector on the catheter 102.

Fig. 2 shows a top view of the atomizing device 100 and the indicating mechanism 106 according to an embodiment of the present invention. In some embodiments, the indication mechanism 106 may include a breath indicator 116 and a battery indicator 118. The breath indicator 116 may instruct the user when and how to breathe to maximize delivery of the aerosolized drug to the user's lungs. In some embodiments, the breathing indicator 116 may include multiple indicators, such as various colored LEDs, to provide more detailed instruction to the user. The breathing indicator 116 may take the shape of a chevron pattern including 3 color LEDs.

In some embodiments, optimal pulmonary delivery of a drug (e.g., liquid insulin) is performed at a prescribed flow rate and number of inhalations. For example, the optimum flow rate may be between about 5 and 14L/min, or more commonly between about 7 and 14L/min. Too high or too low a flow rate may result in a loss of the amount of aerosolized drug that is delivered to the correct location of the user's respiratory system. The optimal inspiration time may be between 6 and 24 seconds. The breath indicator 116 may be used to instruct the user to maintain inspiration within these parameters.

In one embodiment, a light (e.g., a steady green light emitted from an LED) will be generated with the breath indicator 116 to indicate to the user that the flow inside the aerosolization device 100 is within the operating range of the aerosolization device 100 in order to aerosolize a dose of a drug. When a user inhales at the mouthpiece end 110 of the conduit 102, the inspiratory flow is detected using a flow sensor or pressure sensor that can convert the pressure differential inside the conduit 102 into a flow. Detection of an inhalation with the correct flow parameters results in activation of the aerosol generator 104, thereby generating aerosolized drug particles that enter the conduit 102. The light from the breath indicator 116 may flash slowly to indicate to the user that the user is breathing too slowly (i.e., resulting in a low flow) compared to the operating range and that the inspiratory status should change. For example, a flashing green light having a period of between about 500 and 1000 milliseconds (ms) and a frequency of about 1.25 hertz (Hz) may be emitted, indicating that the aerosolization device 100 is activated during times with little or no air flow. The light may flash quickly to indicate to the user that they are breathing too quickly (i.e., causing a high flow). For example, when the flow is excessive, a flashing green light having a period of between about 50 and 250ms and a frequency of about 6.25Hz may be emitted from the respiratory indicator 116. The aerosol generator 104 may be configured not to aerosolize any medicament when the flow rate is too high or too low.

The breath indicator 116 may produce a different color of light when the "end-of-dose" indicator indicates that substantially the entire dose of medicament has been delivered. For example, a blue light may be emitted for a period of time (e.g., between about 1 and 10 seconds) to alert the user that substantially the entire dose has been aerosolized and inhaled. Delivery of a "full" dose may be predefined as when at least about 95%, more preferably 98%, most preferably more than 99% of the dose is delivered. To receive the dose, the user may take several inhalations or a single inhalation, based on the volume of liquid drug to be delivered and the user's lung capacity. Each inhalation may be monitored by the device using feedback provided to the user via indicator 116 to ensure proper delivery to the lungs. In some embodiments, operation of the end-of-dose indicator may be delayed for a period of time (e.g., up to about 5 seconds) after substantially all of the dose has been delivered, thus providing an "chaser" of air into the lungs. The chaser may be used to clean the upper airway and maximize the amount of dose delivered to the user's lungs.

In embodiments in which the conduit 102 and/or aerosol generator 104 are removable from the housing 108, light may be emitted to indicate to a user that one or both of the conduit 102 and aerosol generator are not fully seated, coupled together, and/or engaged inside the housing 108. It should also be understood that other shapes and numbers of lights may be used in the respiratory indicator 116. The breath indicator 116 may also use different numbers or types of light emitting elements, colors of lights, intensities of lights, light flashes with different periods of time, vibration patterns, sounds, and/or any combination of such indications to guide the user how to properly inhale using the aerosolization device 100. The indication mechanism 106 may also be used to provide other indications related to the aerosolization apparatus 100.

In some embodiments, the battery indicator 118 may indicate to the user the amount of charge remaining in a battery of the aerosolization device 100 that powers the functionality of the aerosolization device. The battery indicator may be a digital readout of the charge level or may be a light emitting device (e.g., an LED) that emits light in one or more colors to indicate the relative charge status. For example, the battery indicator 118 may emit a single color of light when the charge level is low. In other embodiments, the battery indicator 118 may emit three or more colors of light to indicate various levels of charging in order to display the state of charge over time.

Fig. 3A-3K illustrate embodiments of flow restrictor plates that may be located inside a conduit (e.g., conduit 102 of fig. 1A and 1B). A restrictor plate (e.g., restrictor plate 300a) creates resistance to and restricts air flow through the conduit while adding little or no length to the conduit.

Restrictor plate 300a provides an increase in pressure differential that varies with inspiratory flow. This pressure differential exists between the conduit and the exterior of the conduit and/or atmospheric pressure, so that as the user's inspiratory effort increases, the pressure differential decreases to maintain a relatively constant flow rate inside the conduit that remains within the desired flow rate range. In some embodiments, as the user's inspiratory effort increases, the pressure differential increases in a linear relationship to the flow rate. Sensory feedback provided by a sensor and/or an indicating mechanism (such as described above) may allow a user to correlate inhalation pressure to a desired flow rate required to operate the aerosol generator. Restrictor plate 300a defines a plurality of apertures 302a for the passage of air. The apertures 302a may be along the outer perimeter of the restrictor plate 300a such that air passing through the apertures creates a relatively laminar flow at a location downstream of the restrictor plate 300 a. The orifice 302a may have any shape or size so as to create a relatively laminar flow. For example, the orifice may be circular and have a diameter of between about 0.5mm and 1.5 mm. The size and pattern of the plurality of apertures 302a may prevent air flow through the solid center portion of the restrictor plate 300a while allowing air flow through the apertures on its outer periphery.

Fig. 3B-3K illustrate restrictor plate embodiments defining alternative orifice arrangements. For example, fig. 3B shows a restrictor plate 300B defining a plurality of apertures 302B arranged in a spoke pattern. Fig. 3C shows a restrictor plate 300C defining a plurality of apertures 302C arranged in a circular pattern. Fig. 3D illustrates a restrictor plate 300D defining a plurality of apertures 302D arranged in a semi-circular pattern along the bottom of the restrictor plate 300D. Fig. 3E illustrates a restrictor plate 300E defining a plurality of apertures 302E arranged in a semi-circular pattern along the top of the restrictor plate 300E. Fig. 3F shows a restrictor plate 300F defining an aperture 302F that reduces the effective diameter of the conduit. Fig. 3G shows a restrictor plate 300G defining an aperture 302G that reduces the effective diameter of the conduit. Fig. 3H shows a restrictor plate 300H defining an aperture 302H that reduces the effective diameter of the conduit. Fig. 3I illustrates a restrictor plate 300I defining a plurality of apertures 302I arranged in close groupings along an outer perimeter of the restrictor plate 300I. Fig. 3J illustrates a restrictor plate 300J defining a plurality of apertures 302J arranged in a semi-circular pattern along an upper half of the restrictor plate 300J. Fig. 3K shows a restrictor plate 300K defining a plurality of apertures 302K arranged in a circular pattern.

Fig. 4 illustrates a restrictor plate 400 positioned inside a conduit 402 according to an embodiment of the present invention. The restrictor plate 400 is disposed inside the conduit 402 and between a pressure sensor 404 and an aerosol generator 406 in fluid communication with the interior of the conduit. The pressure sensor 404 monitors the pressure differential inside the conduit 402 relative to the pressure outside the conduit and/or the atmosphere. A processing unit or IC (e.g., IC138 of fig. 1A and 1B) may execute software that converts pressure readings into flow throughout conduit 402. This flow rate may be used to determine when to activate the aerosol generator 406 in order to aerosolize a volume of liquid medicament. Restrictor plate 400 may have the features of restrictor plates 300a-300k described above. The restrictor plate 400 forms a laminar flow upstream of the aerosol generator 406 such that the aerosolized drug is deposited and entrained in the laminar flow prior to contact with the wall of the conduit 402 opposite the aerosol generator 406 to maximize the amount of drug delivered to the user.

Fig. 5-7 are laminar flow diagrams of air flow through conduit 402 and restrictor plate 400 having a structure similar to restrictor plate 300 a. When the air flow reaches the restrictor plate 400, the pressure differential increases and a relatively laminar flow is established to contact the aerosolized drug. The laminar flow provides a uniform velocity field to deliver aerosolized particles to the user's respiratory system in a uniform manner while minimizing impact losses. In addition, this laminar flow minimizes the amount of aerosolized drug that may be deposited on the walls of the conduit. Fig. 7 illustrates laminar flow in contact with aerosolized drug generated by the aerosol generator 406. The aerosolized drug is entrained in the laminar flow before the drug contacts the wall opposite the aerosol generator 406. The entrained aerosolized drug is then carried out of the conduit 402 to the user's respiratory system.

Figures 8A-8C illustrate nebulizing devices having mouthpiece ends angled at various angles for directing a flow of air into the respiratory system of a user. The angle of the mouthpiece end may be set based on the volume of the dose, the type of drug to be delivered, and the length and diameter of the conduit of the aerosolization device. Fig. 8A shows an aerosolization apparatus 800 having a mouthpiece end 802 that is tilted 15 ° downward relative to horizontal. Fig. 8B shows the aerosolization apparatus 800 with mouthpiece end 802 parallel to the horizontal plane. Fig. 8C shows the aerosolization apparatus 800 with mouthpiece end 802 tilted 15 ° upward relative to horizontal. Other angles relative to horizontal up to 30 ° downward or upward relative to horizontal may be used to maximize the delivery of the drug to the respiratory system of the user.

Fig. 9 shows an aerosolization device 900 having an input 902 coupled with a housing 904. In some embodiments, the input device 902 may be coupled with a catheter. The input device 902 is configured to receive input from a user setting a parameter for inspiratory flow as measured by a pressure sensor (not shown) inside the conduit. The input may be manually entered by a user, provided via a wireless interface, provided via a wired interface, such as Universal Serial Bus (USB), or provided in any other manner. Parameters that may include flow rate, inspiratory pressure, inspiratory time, etc., may be used to determine when to activate the aerosol generator of the aerosolization device 900, as well as to set ranges for an indicator mechanism (not shown) that guides a user when and how to breathe. The input device 902 may include a keyboard or similar interface, a bar code scanner, or an RFID reader to receive flow parameters from a user or a container or drug label. The atomization device 800 may be configured in a manner similar to any of the atomization devices described herein, and may include the same or similar features.

Fig. 10 illustrates a method 1000 of delivering an aerosolized drug to a user's respiratory system using the aerosolization apparatus described herein. The method may include sensing a state of a flow parameter of an inspiratory flow inside a conduit at block 1002. Sensing of the flow parameter condition may be accomplished using a sensor, such as the flow sensor or pressure sensor 404 of fig. 4. The method may also include vibrating a mesh of an aerosol generator in communication with the conduit to aerosolize a volume of liquid medicament at block 1004. The vibration produces a plume of aerosolized medicament within the conduit of the aerosolizing device when the state of the flow parameter is within a predetermined desired range. For example, the mesh may be vibrated when the inspiratory flow rate measured by the pressure sensor is within the operating range of the aerosolization device. The plume of aerosolized drug may be provided to the interior of a relatively laminar flow generated by a restrictor plate disposed within the conduit at a location upstream of the plume of aerosolized drug. This laminar flow sweeps the aerosolized drug toward the mouthpiece end of the conduit before the drug contacts the conduit wall opposite the aerosol generator. The aerosolized drug is then directed into the user's respiratory system. The method may further include providing an indication of a state of the flow parameter relative to a predetermined desired range using an indication mechanism coupled with the conduit at block 1006.

In some embodiments, providing an indication may include providing a first indication when the flow parameter is within a predetermined desired range and providing a second indication when the flow parameter is outside the predetermined desired range. In other embodiments, providing an indication may include providing a first indication when the flow parameter is within a predetermined desired range, providing a second indication when the flow parameter is within a predetermined second range, and providing a third indication when the flow parameter is outside both the predetermined desired range and the predetermined second range.

By indicating a state where the flow parameter is within the intermediate range, the user can vary the inhalation rate to maximize the delivery efficiency of the aerosolized drug. For example, for an aerosol generator having an operating range for flow rates between about 5 and 14L/min, the predetermined desired range may be between about 8 and 11L/min. The predetermined second range may be set within the remaining operating range of the aerosol generator. For example, the second range may be between about 5 and 7L/min and between about 12 and 14L/min. A first indication (e.g., green light) may be provided when the flow rate is within a predetermined desired range. A second indication (e.g., a yellow light) may be provided when the flow rate is outside the desired range but within a second range. In other embodiments, a slowly flashing yellow light may be used to indicate that the flow rate is in the second, lower range, and a rapidly flashing yellow light may indicate that the flow rate is in the second, higher range. A third indication (e.g., red light) may be used to indicate that the flow rate is outside of both the desired range and the second range.

Such a system providing a mid-range may help a user correct or adjust the inhalation rate to maintain the flow within a desired range or operating range of the aerosolization device before the flow is unacceptably inefficient or incapable of activating the aerosol generator. This may help the user achieve a more consistent and efficient inhalation. Multiple intermediate ranges within or outside the operating range of the aerosol generator may be provided to further assist the user in adjusting the inhalation rate. Furthermore, the intermediate range may be focused on ensuring that a high efficiency flow range is maintained, rather than ensuring that an operating range of the aerosol generator is maintained.

In some embodiments, the method may further comprise providing an indication that the liquid medicament is ready to be aerosolized, and providing an indication that substantially all of the liquid medicament has been aerosolized. The method may optionally include receiving input via an input device of the aerosolization device to set the predetermined desired range of flow parameters.

It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.

Claims (22)

1. A nebulizing device for ensuring proper delivery of a nebulized medicament to a respiratory system of a user, the nebulizing device comprising:

a conduit having a mouthpiece end with which a user can induce an inspiratory flow through the conduit;

an aerosol generator in communication with the conduit and comprising a vibrating mesh; and

a restrictor disposed inside the conduit, wherein the restrictor defines a plurality of apertures disposed along an outer periphery of the restrictor, the plurality of apertures configured to:

providing an increase in pressure differential inside the conduit as a function of inspiratory flow; and

providing relatively laminar flow at a location downstream of the restriction compared to a location upstream of the restriction.

2. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 1, the aerosolization device further comprising:

an indication mechanism for indicating to a user the status of the inspiratory flow parameter relative to a predetermined desired range.

3. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 2, wherein indicating to the user the status of the parameter of the inspiratory flow relative to the predetermined desired range comprises:

the indication mechanism providing a first indication when the parameter of the inspiratory flow is within the predetermined desired range; and

the indication mechanism provides a second indication when the parameter of the inspiratory flow is outside the predetermined desired range.

4. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 2, wherein indicating to the user the status of the parameter of the inspiratory flow relative to the predetermined desired range comprises:

the indication mechanism providing a first indication when the parameter of the inspiratory flow is within the predetermined desired range;

the indicating mechanism provides a second indication when the parameter of the inspiratory flow is within a predetermined second range; and

the indication mechanism provides a third indication when the parameter of the inspiratory flow is outside both the predetermined desired range and the predetermined second range.

5. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 2, wherein the indication mechanism comprises:

selected from at least one of light, a reading, a speaker, or a vibration generating device.

6. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 2, wherein the parameter of the inspiratory flow comprises an inspiratory flow rate inside the conduit.

7. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 6, wherein the predetermined desired range of inspiratory flow is between about 5 and 14 liters per minute (L/min).

8. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 2, the aerosolization device further comprising:

an input device for receiving and setting a predetermined desired range of a parameter of the inspiratory flow.

9. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 1, wherein,

the restrictor is configured such that fluid flows only through a plurality of apertures disposed along the outer periphery.

10. A nebulizing device for ensuring proper delivery of a nebulized medicament to a respiratory system of a user, the nebulizing device comprising:

a conduit having a mouthpiece end with which a user can induce an inspiratory flow through the conduit;

an aerosol generator in communication with the conduit and including a vibrating mesh; and

a restrictor disposed inside the conduit, wherein the restrictor defines a plurality of apertures disposed along an outer periphery of the restrictor, the plurality of apertures configured to:

providing an increase in pressure differential within the conduit as a function of inspiratory flow; and

providing relatively laminar flow at a location downstream of the restriction compared to a location upstream of the restriction,

wherein the vibrating mesh produces a plume of aerosolized medicament in the relatively laminar flow when the inspiratory flow rate is within an operating range of the aerosolization device.

11. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 10, wherein,

the restrictor is configured such that fluid flows only through the plurality of apertures disposed along the outer periphery.

12. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 10, the aerosolization device further comprising:

an indication mechanism for indicating to a user the status of a parameter of the inspiratory flow relative to a predetermined desired range.

13. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 12, wherein the parameters of the inspiratory flow comprise:

the inspiratory flow rate, and the predetermined desired range is an operating range of the inspiratory flow rate.

14. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 12, wherein indicating to the user the status of the parameter of the inspiratory flow relative to the predetermined desired range comprises:

the indication mechanism providing a first indication when the parameter of the inspiratory flow is within the predetermined desired range;

the indicating mechanism provides a second indication when the parameter of the inspiratory flow is within a predetermined second range; and

the indication mechanism provides a third indication when the parameter of the inspiratory flow is outside both the predetermined desired range and the predetermined second range.

15. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system according to claim 10, wherein,

the operating range of the inspiratory flow is between about 5 and 14L/min.

16. A method of delivering an aerosolized medicament to a user's respiratory system, the method comprising:

sensing a state of a flow parameter of an inspiratory flow within a conduit, the conduit having a mouthpiece end with which a user can induce the inspiratory flow within the conduit; and

vibrating a mesh of an aerosol generator in communication with the conduit to aerosolize a volume of liquid medicament to generate a plume of aerosolized medicament within an interior of the conduit when a state of the flow parameter is within a predetermined desired range, wherein,

the plume of aerosolized medicament is provided into a relatively laminar flow generated by a flow restrictor disposed inside the conduit at a location upstream of the plume of aerosolized medicament;

the restrictor defines a plurality of apertures disposed along an outer periphery of the restrictor; and is

The relatively laminar flow delivers a plume of the aerosolized drug toward the mouthpiece end of the catheter.

17. The method of delivering an aerosolized medicament to a user's respiratory system according to claim 16, the method further comprising:

providing an indication of the state of the flow parameter relative to the predetermined desired range using an indication mechanism.

18. The method of delivering an aerosolized medication to a user's respiratory system according to claim 17, wherein providing an indication comprises:

providing a first indication when the flow parameter is within the predetermined desired range; and

providing a second indication when the flow parameter is outside the predetermined desired range.

19. The method of delivering an aerosolized medication to a user's respiratory system according to claim 17, wherein providing an indication comprises:

providing a first indication when the flow parameter is within the predetermined desired range;

providing a second indication when the flow parameter is within a predetermined second range; and

providing a third indication when the flow parameter is outside both the predetermined desired range and the predetermined second range.

20. The method of delivering an aerosolized drug to a user's respiratory system according to claim 16,

the predetermined desired range is between about 5 and 14L/min.

21. The method of delivering an aerosolized medicament to a user's respiratory system according to claim 16, the method further comprising:

providing an indication that the liquid medicament is ready to be aerosolized; and

providing an indication that substantially all of the liquid medicament has been aerosolized.

22. The method of delivering an aerosolized medicament to a user's respiratory system according to claim 16, the method further comprising:

an input is received to set the predetermined desired range of the flow parameter.