HK1236881B - Aerosolization system with flow restrictor and feedback device - Google Patents

Description

Atomization system with flow restrictor and feedback device

CROSS-REFERENCE TO RELATED APPLICATIONS

This Patent Cooperation Treaty application claims priority to U.S. Patent Application No. 14/743,627, filed June 18, 2015; which claims priority to U.S. Provisional Application No. 62/019,791, filed July 1, 2014, the entire contents of which are incorporated herein by reference for all purposes.

Background Art

Nebulizer systems provide efficient delivery of a variety of medications, such as insulin and asthma medication. These systems deliver the desired dose of liquid medication directly to the user's respiratory system by aerosolizing it. The user then inhales the aerosolized medication directly into their respiratory system, enabling faster treatment of a variety of conditions.

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

Summary of the Invention

In one embodiment, a nebulizer device is provided for ensuring that aerosolized medicine is correctly delivered to the respiratory system of a user. The nebulizer device may include: a catheter, an aerosol generator connected to the catheter, a throttle disposed inside the catheter, and an indicator mechanism. The catheter may include an interface tube end, which the user can use to form an inspiratory flow through the catheter. The aerosol generator may include a vibrating mesh. The throttle may define a plurality of orifices disposed along the periphery of the throttle. The plurality of orifices may be configured to provide an increase in pressure difference that varies with the inspiratory flow rate inside the catheter and provides a relatively laminar flow at a position downstream of the throttle compared to a position upstream of the throttle. The indicator mechanism may indicate to the user the state of an inspiratory flow parameter relative to a predetermined expected range.

In another embodiment, a different atomizing device is provided for ensuring that aerosolized medicine is correctly delivered to the user's respiratory system. The atomizing device may include: a conduit, an aerosol generator connected to the conduit, and a throttle disposed inside the conduit. The conduit may have an interface tube end, which the user may use to form an inspiratory flow through the conduit. The aerosol generator may include a vibrating mesh. The throttle may define a plurality of orifices disposed along the periphery of the throttle. The plurality of orifices may be configured to provide an increase in the pressure difference that varies with the inspiratory flow inside the conduit, and to provide a relatively laminar flow at a position downstream of the throttle compared to a position upstream of the throttle. When the inspiratory flow is within the operating range of the atomizing device, the vibrating mesh may generate a plume of aerosolized medicine in a relatively laminar flow.

In another embodiment, a method for delivering aerosolized medication to a user's respiratory system is provided. The method may include sensing a state of a flow parameter of an inspiratory flow within a conduit. The conduit may have an interface tube end, by means of which the user can initiate 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 medication, thereby generating a plume of aerosolized medication within the conduit when the flow parameter state is within a predetermined desired range. The plume of aerosolized medication may be provided within a relatively laminar flow generated by a restrictor disposed within the conduit upstream of the aerosolized medication plume. The restrictor may define a plurality of orifices disposed about a periphery of the restrictor. The relatively laminar flow may deliver the plume of aerosolized medication toward the interface tube end of the conduit. The method may also include providing an indication of the flow parameter state relative to the predetermined desired range using an indicator mechanism.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be described below in conjunction with the accompanying drawings:

FIG1A shows the interior of an atomizing device according to an embodiment of the present invention;

FIG1B shows a cross-section of FIG1A according to an embodiment of the present invention;

FIG2 shows the front portion of the atomizing device of FIG1A according to an embodiment of the present invention;

3A-3K show a flow restrictor plate according to an embodiment of the present invention;

4A and 4B illustrate a flow restriction plate inside a conduit of an atomizing device according to an embodiment of the present invention;

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

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

FIG9 shows an input device on an atomizing device according to an embodiment of the present invention;

FIG. 10 is a block diagram of a method of using an atomizing device according to an embodiment of the present invention.

In the accompanying drawings, similar components and/or features may have the same reference numerals. In addition, various components of the same type may be distinguished by the following reference numerals and letters, which distinguish among similar components and/or features. If only the first reference numeral is used in this specification, the description applies to any of the similar components and/or features having the same first reference numeral, regardless of the letter suffix.

DETAILED DESCRIPTION

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

Embodiments of a nebulizer that assists in properly delivering aerosolized medication to a user's respiratory system are described herein. In many embodiments, the liquid medication can be provided to the nebulizer in metered doses. The liquid medication can be distributed to an aerosol generator. In some embodiments, the liquid medication can be provided via a chamber or reservoir for funneling the liquid medication into the aerosol generator, where it is aerosolized for delivery to the user's respiratory system. In other embodiments, a separate container containing the liquid medication can be coupled to the nebulizer to provide the liquid medication to the nebulizer.

In some embodiments, the atomizing device may include: a conduit, an aerosol generator in communication with the conduit, a restrictor disposed within the conduit, and an indicator mechanism coupled to the conduit. In many embodiments, some or all of these components and/or the aerosol generator may be removably coupled to the housing or housed within the housing. Providing a removable conduit and/or aerosol generator allows for easy cleaning and drying of the atomizing device, thereby preventing contamination and accumulation of pathogens and/or other contaminants.

In some embodiments, the conduit may include an interface tube end, by means of which the user can initiate an inspiratory flow through the conduit. The user can inhale through the interface tube, thereby forming an inspiratory flow of air that can deliver the aerosolized medication to the user. In some embodiments, the interface tube end of the conduit can deliver the aerosolized medication to the user at an angle relative to the horizontal plane. This delivery angle can be selected based on the dose and type of medication to be delivered to the user's respiratory system to ensure that most of the aerosolized medication is delivered to the respiratory system without becoming blocked in the user's mouth, throat, and/or other areas.

In many embodiments, the sensor is used to determine when the parameter of the inspiratory flow is within the predetermined desired range or operating range of the atomizing device and/or aerosol generator. For example, a flow sensor or a pressure sensor can be used to determine the flow or pressure difference inside the conduit. Other types of sensors and flow parameters can also be adopted/measured. For example, the flow parameter can be the inspiratory flow, inspiratory pressure, inspiratory time, etc. detected by a flow sensor, a timer, a pressure sensor, or other sensing mechanisms. The processing unit connected to the sensor can compare the sensed value with the desired range stored. In certain embodiments, the desired range of the flow parameter for a specific drug delivery can correspond to the operating range of the aerosol generator. In other embodiments, the desired range of the flow parameter can be narrower or wider than the operating range of the aerosol generator.

In certain embodiments, the aerosol generator may include a vibrating net. When the parameters of the inspiratory flow are within the desired range or operating range, the vibrating net may be vibrated to a stage sufficient to atomize substantially all of the liquid medicaments disposed on the top of the vibrating net. The vibrating net may have a dome shape and utilize an annular piezoelectric element (not shown) or other electromechanical resonance device that limits the vibrating net to vibrate. When one or more flow parameters are within the operating range of the aerosol generator, the vibrating net may be vibrated. For example, a flow sensor and/or a pressure sensor that is communicated with a conduit may detect whether the inspiratory flow and/or pressure difference inside the conduit are within the operating range of the aerosol generator. The processor may control the circuit so that current is provided to the piezoelectric element so that the net is vibrated. Typically, the vibrating net will be vibrated at a frequency within the range of approximately 50kHz to approximately 150kHz, thereby atomizing the liquid medicament of the dose.

In many embodiments, the inhaled air can pass through a restrictor array inside the conduit. In one embodiment, the restrictor array can be a restrictor plate having a plurality of orifices passing therethrough. As air passes through the orifices, the orifices provide an increase in the pressure differential that varies according to the inspiratory flow rate inside the conduit. The orifices also provide a relatively laminar flow at a position downstream of the restrictor plate compared to an upstream position of the restrictor plate. In many embodiments, the orifices are arranged along the periphery of the restrictor plate. In some embodiments, a vibrating screen can be located downstream of the restrictor plate or other restrictor array and produce a plume of atomized medicine in a relatively laminar flow formed by the restrictor array. In some embodiments, the restrictor array may include a plurality of restrictors connected in series.

The indicating mechanism can indicate the state of the inspiratory flow parameter relative to a predetermined expected range to the user. In some embodiments, instead of indicating the flow parameter state or in addition thereto, the indicating mechanism can indicate the state of the atomizing device to the user. For example, the indicator can be a light, an analog/digital display or readout, a speaker, a vibration generating device, and/or other features that will warn the user about the situation of the parameter state. In some embodiments, the state of the parameter can be the inspiratory flow, inspiratory pressure, inspiratory time, etc. detected by a flow sensor, a timer, a pressure sensor, or other sensing mechanisms. The indicator can inform the user whether the state of the parameter is within or outside the expected range of the parameter.

In certain embodiments, when the medicine of whole dose has been atomized, "dose end" indication can be provided to the user. When a sensor (such as a load or flow sensor) detects that substantially whole medicine has been atomized, this indication can be provided. Another indication can also be provided to the user, thereby informing them when the liquid medicine is actually atomized by the vibrating net that is activated. This indication to the flow parameter state and/or the atomizing device state can be provided by the above-mentioned indicating mechanism, for example, by providing a discernible indication based on the indication of the flow parameter state. For example, the state of the flow parameter can be indicated with green light, and the indication that the dose ends can be provided with blue light. In other embodiments, the dose end indication and/or the atomization indication can be provided by one or more separate indicating mechanisms.

In certain embodiments, indicating mechanism can be used for instructing the user how to correctly inhale and guarantee that medicine is correctly delivered to the respiratory system of user.For this reason, when parameter (for example, the inspiratory flow rate at conduit interior) is in predetermined expected range, indicating mechanism can inform user.Aerosol generator can be configured to atomize liquid medicine when inspiratory flow rate is in predetermined flow range.For example, the predetermined expected range at the inspiratory flow rate at conduit interior can be between about 5 and 14 liters per minute (L/min).Can generate indication as above (for example, light or sound sent by loudspeaker), so that inspiratory flow rate is maintained in expected range and when aerosol generator is working to the user's inspiratory flow rate to inform the user.

In some embodiments, a first indication may be provided when a 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 sound that was previously emitted continuously ceasing. Other indications may include emitting a light of a different color or a sound of a different frequency than the first indication to indicate a change in the parameter state. In some embodiments, the second indication may inform the user whether the parameter state is above or below a desired range. For example, when the parameter state is below the desired range, a flashing light with a relatively long flashing interval may be emitted to warn the user, and when the parameter state is above the desired range, a flashing light with a relatively short flashing interval may be emitted to warn the user. Similar use of vibrations and sounds may be applied in conjunction with or in place of light indicators.

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

In some embodiments, the nebulizer device may further include an input device for receiving and setting a predetermined desired range of an inspiratory flow parameter. For example, the input device may include a barcode 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 (e.g., a desired flow rate, inspiratory pressure, or inspiratory time). In some embodiments, the desired flow rate can be visually encoded on the drug delivery container and read from the delivery container by the nebulizer device.

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

In certain embodiments, atomization system may include electronic components, which include but are not limited to processing elements and storage units. Processing elements may be used for controlling the start of an aerosol generator, an indicating mechanism, and an input device, and any sensor (e.g., a flow sensor and a pressure sensor). The storage unit may be configured to store settings and ranges of parameters for indicating mechanism and/or aerosol generator set by the input device. The storage unit may also be configured to store data relevant to the atomization phase of the past and information provided by a drug delivery container attached to the storage unit.

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

In certain embodiments, conduit 102 may include an interface tube end 110, through which a user can inhale to generate an inspiratory flow, thereby atomized medicine is delivered to the user's respiratory system. As shown in Figure 1B, aerosol generator 104 may include a vibrating net 112. Liquid medicine can be directly dispensed onto the vibrating net 112 from a glass vial of liquid medicine, or liquid medicine can be indirectly dispensed onto the vibrating net 112 by utilizing the tapered wall of a fluid receiving chamber 114 to converge onto the vibrating net 112. In many embodiments, when the flow rate of inspiratory flow is within the operating range of aerosol generator 104, the mechanism controlled by the processor is utilized to vibrate the vibrating net 112 so that a certain volume of liquid medicine is atomized. When vibrating, the effect of the vibrating net 112 is to generate a plume of atomized medicine inside the conduit 102, so that atomized medicine can be inhaled into the lungs of the user.

Exemplary aerosol generators that can be used are also described in U.S. Patents 5,164,740, the contents of which are incorporated herein by reference. These references describe exemplary aerosol generators, methods of making such aerosol generators, and methods of providing liquids to aerosol generators, and at least these features thereof are incorporated herein by reference.

In certain embodiments, one or more indicating mechanisms 106 may comprise lights, such as LEDs. Indicating mechanism 106 may also comprise a speaker or/and a vibration generating mechanism, in order to indicate the atomizing device state to the user. For example, indicating mechanism 106 may be used to indicate when the atomizing device 100 is ready for use by the user. Indicating mechanism 106 may also indicate the parameter state of the inspiratory flow formed by the user. For example, indicating mechanism 106 may instruct the user to change the inspiratory rate so as to increase or reduce the flow inside conduit 102, thereby guaranteeing the correct delivery of atomized medicine and/or guaranteeing that flow is within the operating range of aerosol generator 104, so that vibration net 112 atomizes liquid medicine. Indicating mechanism 106 may also be used to indicate when substantially the liquid medicine of whole dosage has been atomized and/or inhaled to the user. Other sensors may be needed so that above-mentioned function is provided.

In some embodiments, the atomizing device 100 includes a processing unit or integrated circuit (IC) 138, which controls the functions of other electronic components of the atomizing device 100 or runs computer codes sent to these electronic components. The atomizing device 100 including the IC 138 can be powered by a battery 140 connected to the IC 138. The IC 138 can be electrically connected to electronic components (such as any sensor, indicating mechanism 106 and/or piezoelectric element of the aerosol generator 104). The IC 138 can control the activation of the indicating mechanism and/or the aerosol generator 104 based on the information received from any sensor (such as a flow sensor or a pressure sensor) that is in fluid communication with the conduit 102. In some embodiments, the IC 138 can be electrically connected to the conduit 102 and/or the aerosol generator 104 using a plug 124. The conduit 102 and/or the aerosol generator 104 can be removed from the housing 108. The conduit 102 and/or the aerosol generator 104 can be inserted into the housing 108 and connected to 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 can have a male connector 144 that interfaces with a female connector 146 on the conduit 102. In some embodiments, the plug 124 can include a female connector that interfaces with a male connector on the conduit 102.

FIG2 shows a top view of the atomizing device 100 and the indicator mechanism 106 according to an embodiment of the present invention. In some embodiments, the indicator mechanism 106 may include a breathing indicator 116 and a battery indicator 118. The breathing indicator 116 may instruct the user when and how to breathe to maximize the delivery of the atomized drug to the user's lungs. In some embodiments, the breathing indicator 116 may include multiple indicators, such as LEDs with various colors, to provide more detailed guidance to the user. The breathing indicator 116 may be in the shape of a V-shaped pattern including three colors of LEDs.

In certain embodiments, the optimal pulmonary delivery of medicine (such as liquid insulin) is carried out with the flow rate and the number of times of inspiration of regulation. For example, the optimal flow rate can be between about 5 and 14L/min, or more generally between about 7 and 14L/min. Too high or too low flow rate can cause the loss of the amount of aerosolized medicine that is delivered to the correct position of the user's respiratory system. The optimal inhalation time can be between 6 and 24 seconds. Breathing indicator 116 can be used to guide the user to maintain inspiration within these parameters.

In one embodiment, a breathing indicator 116 is utilized to generate light (e.g., a steady green light emitted from an LED) to indicate that the flow inside the atomizing device 100 is within the operating range of the atomizing device 100 so as to atomize a dose of medicine. When the user inhales at the interface tube end 110 of the conduit 102, a flow sensor or a pressure sensor is utilized to detect the inspiratory flow rate. This pressure sensor can convert the pressure difference inside the conduit 102 into a flow rate. The detection of an inspiratory breath with the correct flow parameters causes the activation of the aerosol generator 104, thereby generating atomized drug particles that enter the conduit 102. The light from the breathing indicator 116 can slowly flash to indicate that the user is breathing too slowly (i.e., causing low flow) compared to the operating range, and that the inspiratory state should be changed. For example, a flashing green light with a period between approximately 500 and 1000 milliseconds (ms) and a frequency of approximately 1.25 Hz (Hz) can be emitted, thereby indicating that the atomizing device 100 is activated during a time period with little or no air flow. The light may flash rapidly to indicate to the user that they are breathing too quickly (i.e., causing a high flow rate). For example, when the flow rate is too high, a flashing green light with a period between approximately 50 and 250 ms and a frequency of approximately 6.25 Hz may be emitted from the breathing indicator 116. The aerosol generator 104 may be configured to not aerosolize any medication when the flow rate is too high or too low.

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

In the embodiment where the conduit 102 and/or the aerosol generator 104 are removable from the housing 108, light can be emitted to indicate that one or both of the conduit 102 and the aerosol generator are not fully seated, coupled together, and/or engaged in the housing 108 inside. It should also be understood that other shapes and quantities of lights can be used in the breathing indicator 116. The breathing indicator 116 can also use any combination of different numbers or types of light-emitting elements, the color of the light, the intensity of the light, lights with different time periods, vibration patterns, sounds, and/or such instructions to guide the user how to use the atomizing device 100 to correctly inhale. The indicating mechanism 106 can also be used to provide other instructions relevant to the atomizing device 100.

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

3A-3K illustrate embodiments of flow restrictors that may be located within a conduit, such as conduit 102 of FIG1A and FIG1B . A restrictor, such as restrictor 300 a, creates resistance to and restricts air flow through the conduit while adding little or no length to the conduit.

The flow restriction plate 300a provides the increase of pressure difference, and this pressure difference changes along with the inspiratory flow.This pressure difference exists between conduit and conduit exterior and/or atmospheric pressure, so when the inspiratory force of user increases, pressure difference descends so as to maintain the relatively constant flow inside conduit, and this flow remains in the desired flow range.In certain embodiments, when the inspiratory force of user increases, pressure difference increases with the linear relationship with flow.The sensor feedback provided by sensor and/or indicating mechanism (such as above-mentioned) can allow the user to link the inspiratory pressure with the required flow required for operating aerosol generator.The flow restriction plate 300a is limited to multiple orifices 302a for making air pass through.Orifice 302a can be along the periphery of flow restriction plate 300a, so that the air by orifice forms relatively laminar flow at the downstream position of flow restriction plate 300a.Orifice 302a can have in order to form any shape or size of relatively laminar flow.For example, orifice can be circular and have the diameter between about 0.5mm to 1.5mm. The plurality of apertures 302a may be sized and patterned to prevent air flow through the solid center portion of the restrictor plate 300a while allowing air flow through the apertures on its periphery.

Figures 3B-3K illustrate embodiments of restrictor plates defining alternative orifice arrangements. For example, Figure 3B illustrates a restrictor plate 300b defining a plurality of orifices 302b arranged in a spoke pattern. Figure 3C illustrates a restrictor plate 300c defining a plurality of orifices 302c arranged in a circular pattern. Figure 3D illustrates a restrictor plate 300d defining a plurality of orifices 302d arranged in a semicircular pattern along the bottom of the restrictor plate 300d. Figure 3E illustrates a restrictor plate 300e defining a plurality of orifices 302e arranged in a semicircular pattern along the top of the restrictor plate 300e. Figure 3F illustrates a restrictor plate 300f defining a single orifice 302f that reduces the effective diameter of a conduit. Figure 3G illustrates a restrictor plate 300g defining a single orifice 302g that reduces the effective diameter of a conduit. Figure 3H illustrates a restrictor plate 300h defining a single orifice 302h that reduces the effective diameter of a conduit. Figure 3I illustrates a restrictor plate 300i defining a plurality of orifices 302i arranged in a tight group along the periphery of the restrictor plate 300i. Figure 3J illustrates a restrictor plate 300j defining a plurality of orifices 302j arranged in a semicircular pattern along the upper half of the restrictor plate 300j. Figure 3K illustrates a restrictor plate 300k defining a plurality of orifices 302k arranged in a circular pattern.

Fig. 4 shows a flow restriction plate 400 located inside a conduit 402 according to an embodiment of the present invention. The flow restriction plate 400 is disposed inside the conduit 402 and is disposed between a pressure sensor 404 and an aerosol generator 406 that is in fluid communication with the conduit interior. The pressure sensor 404 monitors the pressure difference within the conduit 402 relative to the conduit exterior and/or atmospheric pressure. A processing unit or IC (e.g., the IC 138 of Fig. 1A and Fig. 1B) can execute software that converts pressure readings into flow rates throughout the conduit 402. This flow rate can be used to determine when to start the aerosol generator 406 so that a certain volume of liquid medicine is atomized. The flow restriction plate 400 can have the features of the above-mentioned flow restriction plates 300a-300k. The flow restriction plate 400 forms a laminar flow at the upstream position of the aerosol generator 406 so that the aerosolized medicine is deposited in the laminar flow and entrained in the laminar flow before contacting the conduit 402 wall relative to the aerosol generator 406, thereby maximizing the amount of medicine delivered to the user.

Fig. 5-Fig. 7 is the laminar flow diagram of the air flow through conduit 402 and the restrictor 400 with the structure similar to restrictor 300a.When air flow arrives restrictor 400, pressure difference increases and forms relative laminar flow to contact with atomized medicine.This laminar flow provides consistent velocity field, so that atomized particles are delivered to the respiratory system of the user in a consistent manner, while minimizing impact loss.In addition, this laminar flow minimizes the amount of atomized medicine that can be deposited on the conduit wall.Fig. 7 shows the laminar flow in contact with the atomized medicine produced by aerosol generator 406.Before medicine contacts with the wall opposite to aerosol generator 406, atomized medicine is entrained in the laminar flow.Then, the entrained atomized medicine is taken out from conduit 402 to the respiratory system of the user.

Fig. 8 A-Fig. 8 C show the atomizing device with the interface tube end that tilts with various angles for air stream being directed into the user's respiratory system.Can be based on the volume of dosage, the type of medicine to be delivered and the length and diameter of the conduit of the atomizing device and set the angle of the interface tube end.Fig. 8 A shows the atomizing device 800 with the interface tube end 802 that tilts downwards 15 ° relative to the horizontal plane.Fig. 8 B shows the atomizing device 800 with the interface tube end 802 that is parallel to the horizontal plane.Fig. 8 C shows the atomizing device 800 with the interface tube end 802 that tilts upwards 15 ° relative to the horizontal plane.Other angles relative to the horizontal plane that tilt upwards or downwards up to 30 ° relative to the horizontal plane can be used for maximizing the delivery of medicine to the user's respiratory system.

Fig. 9 shows a nebulizer 900 having an input device 902 coupled to a housing 904. In certain embodiments, the input device 902 can be coupled to a conduit. The input device 902 is configured to receive input from a user, and this input setting is used for the parameters of the inspiratory flow measured by a pressure sensor (not shown) inside the conduit. This input can be manually input by the user, provided via a wireless interface, provided via a wired interface (such as a universal serial bus (USB)), or provided in any other manner. Parameters that can include flow rate, inspiratory pressure, inspiratory time, etc. can be used to determine when to start the aerosol generator of the nebulizer 900, and for setting a range for an indicator mechanism (not shown) that instructs the user when and how to breathe. The input device 902 can include a keyboard or similar interface, a barcode scanner or an RFID reader to receive flow parameters from a user or a container or a medication label. The nebulizer 800 can be constructed in a manner similar to any nebulizer described herein, and can include identical or similar features.

FIG10 illustrates a method 1000 for delivering aerosolized medication to a user's respiratory system using a nebulizer device as described herein. The method may include, at block 1002, sensing a state of a flow parameter of an inspiratory flow within a conduit. Sensing the state of the flow parameter may be accomplished using a sensor (e.g., the flow sensor or pressure sensor 404 of FIG4 ). The method may also include, at block 1004, vibrating a mesh of an aerosol generator in communication with the conduit to aerosolize a volume of liquid medication. When the state of the flow parameter is within a predetermined desired range, the vibration generates a plume of aerosolized medication within the conduit of the nebulizer device. For example, the mesh may be vibrated when the inspiratory flow rate measured by the pressure sensor is within the operating range of the nebulizer device. The plume of aerosolized medication may be directed into a relatively laminar flow generated by a restrictor disposed within the conduit upstream of the aerosolized medication plume. This laminar flow sweeps the aerosolized medication toward the conduit's interface tube end before the medication contacts the conduit wall opposite the aerosol generator. The aerosolized medication is then directed into the user's respiratory system. The method may also include providing an indication of the state of the flow parameter relative to a predetermined desired range using an indication mechanism coupled to 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 the state of flow parameter in the middle range, the user can change the inhalation rate so that the delivery efficiency of atomized medicine is maximized. For example, with regard to the aerosol generator having the operating range for the flow rate between about 5 and 14L/min, the predetermined desired range can be between about 8 and 11L/min. The predetermined second range can be set in the remaining operating range of the aerosol generator. For example, the second range can be between about 5 and 7L/min and between about 12 and 14L/min. When flow is in the predetermined desired range, a first indication (for example, green light) can be provided. When flow is outside the desired range but in the second range, a second indication (for example, yellow light) can be provided. In other embodiments, the slowly flashing yellow light can be used to indicate that flow is in the lower second range, and the quickly flashing yellow light can indicate that flow is in the higher second range. The third indication (for example, red light) can be used to indicate that flow is outside both the desired range and the second range.

Providing this system of intermediate range can help the user to correct or regulate the inhalation rate so that before flow is unacceptably inefficient or cannot start the aerosol generator, flow is maintained within the desired range or the operating range of the atomizing device. This can help the user to achieve more consistent and efficient inhalation. A plurality of intermediate ranges within or outside the operating range of the aerosol generator can be provided to further help the user regulate the inhalation rate. In addition, the intermediate range can be concentrated on the flow range that guarantees to maintain high efficiency, rather than the operating range that guarantees to maintain the aerosol generator.

In some embodiments, the method may further include providing an indication that the liquid drug is ready to be nebulized and providing an indication that substantially all of the liquid drug has been nebulized.The method may optionally include receiving input via an input device of the nebulizing device to set a predetermined desired range for the flow parameter.

It is obvious to those skilled in the art that various modifications and variations can be made in the methods and systems of the present invention without departing from the spirit and scope of the present invention. Therefore, it is intended that the present invention include modifications and variations within the scope of the appended claims and their equivalents.

Claims (13)

1. A nebulizer for ensuring proper delivery of nebulized medication to a user's respiratory system, the nebulizer comprising: A conduit with an interface tube end, through which a user can generate an airflow through the conduit; The indicator mechanism indicates to the user the state of the inspiratory flow parameters relative to a predetermined desired range, and also provides a dose end indication to indicate that substantially all doses of the drug have been delivered, wherein the dose end indication is provided after a delay of a period of time after substantially all doses have been delivered. An aerosol generator connected to the conduit and including a vibrating mesh; and A flow regulator disposed inside the duct, wherein the flow regulator defines a plurality of orifices disposed along the outer periphery of the flow regulator, the size and pattern of the plurality of orifices being such that airflow is prevented from passing through the solid center portion of the flow regulator while allowing airflow through the orifices on its outer periphery, and the plurality of orifices are configured as follows: This provides an increase in the pressure differential within the conduit, which varies with the inspiratory flow rate; and Provides a relatively laminar flow at a location downstream of the throttle, compared to a location upstream of the throttle. 2. The nebulizer according to claim 1 for ensuring proper delivery of nebulized medication to a user's respiratory system, wherein instructing the user on the state of the parameters of the inspiratory flow relative to the predetermined desired range includes: When the parameters of the inhalation flow are within the predetermined desired range, the indicating mechanism provides a first indication; and When the parameters of the intake airflow are outside the predetermined desired range, the indicating mechanism provides a second indication. 3. The nebulizer according to claim 1 for ensuring proper delivery of nebulized medication to a user's respiratory system, wherein instructing the user on the state of the parameters of the inspiratory flow relative to the predetermined desired range includes: When the parameters of the intake airflow are within the predetermined desired range, the indicating mechanism provides a first indication; When the parameters of the intake airflow are within a predetermined second range, the indicating mechanism provides a second indication; and When the parameters of the inhalation flow are outside both the predetermined desired range and the predetermined second range, the indicating mechanism provides a third indication. 4. The nebulizer according to claim 1 for ensuring proper delivery of nebulized medication to a user's respiratory system, wherein the indicating mechanism comprises: It is selected from at least one of light, reading, loudspeaker, or vibration generating device. 5. The nebulizer according to claim 1 for ensuring proper delivery of nebulized medication to a user's respiratory system, wherein the parameters of the inspiratory flow include the inspiratory flow rate within the conduit. 6. The nebulizer according to claim 5 for ensuring proper delivery of nebulized medication to the user's respiratory system, wherein the predetermined desired range of the inspiratory flow rate is between 5 and 14 liters per minute (L/min). 7. The nebulizer according to claim 1 for ensuring proper delivery of nebulized medication to a user's respiratory system, the nebulizer further comprising: An input device for receiving and setting a predetermined desired range of parameters for the intake airflow. 8. The nebulizer according to claim 1 for ensuring proper delivery of nebulized medication to the user's respiratory system, wherein, The throttle is configured such that fluid flows only through a plurality of orifices provided along the outer periphery. 9. A nebulizer for ensuring proper delivery of nebulized medication to a user's respiratory system, the nebulizer comprising: A conduit with an interface tube end, through which a user can generate an airflow through the conduit; The indicator mechanism indicates to the user the state of the inspiratory flow parameters relative to a predetermined desired range, and also provides a dose end indication to indicate that substantially all doses of the drug have been delivered, wherein the dose end indication is provided after a delay of a period of time after substantially all doses have been delivered. An aerosol generator connected to the conduit and including a vibrating mesh; and A flow regulator disposed inside the duct, wherein the flow regulator defines a plurality of orifices disposed along the outer periphery of the flow regulator, the size and pattern of the plurality of orifices being such that airflow is prevented from passing through the solid center portion of the flow regulator while allowing airflow through the orifices on its outer periphery, and the plurality of orifices are configured as follows: Provides an increase in the pressure differential within the duct that varies with the inspiratory flow rate; and A relatively laminar flow is provided at the downstream position of the throttle compared to the upstream position of the throttle. When the inhalation flow rate is within the operating range of the nebulizer, the vibrating mesh generates a plume of nebulized drug in the relatively laminar flow. 10. The nebulizer according to claim 9 for ensuring proper delivery of nebulized medication to the user's respiratory system, wherein, The throttle is configured such that fluid flows only through the plurality of orifices provided along the outer periphery. 11. The nebulizer according to claim 9 for ensuring proper delivery of nebulized medication to a user's respiratory system, wherein the parameters of the inspiratory flow include: The inhalation flow rate, and the predetermined desired range is the operating range of the inhalation flow rate. 12. The nebulizer according to claim 9 for ensuring proper delivery of nebulized medication to a user's respiratory system, wherein instructing the user on the state of the parameters of the inspiratory flow relative to the predetermined desired range includes: When the parameters of the intake airflow are within the predetermined desired range, the indicating mechanism provides a first indication; When the parameters of the intake airflow are within a predetermined second range, the indicating mechanism provides a second indication; and When the parameters of the inhalation flow are outside both the predetermined desired range and the predetermined second range, the indicating mechanism provides a third indication. 13. The nebulizer according to claim 9 for ensuring proper delivery of nebulized medication to the user's respiratory system, wherein, The operating range of the inhalation flow rate is between 5 and 14 L/min.