• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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    • 专利摘要:
    In one aspect, the embodiments of the present invention provide an aerosolization device to ensure adequate delivery of an aerosolized medication to a user's respiratory system. The aerosolization device may include a conduit, an aerosol generator, a restrictor disposed within the conduit and an indicator mechanism. The conduit may include an end of the mouthpiece through which a user can cause an inspiratory flow through the conduit. The aerosol generator may include a vibrating mesh. The restrictor can define a plurality of openings arranged along an external periphery of the restrictor configured to provide an increase in the pressure differential that varies with an inspiratory flow within the conduit and to provide a relatively laminar flow downstream of the restrictor compared to upstream of the restrictor. The indicator mechanism can indicate to a user a state of an inspiratory flow parameter in relation to a predefined desired range.
    公开号:BR112016030805B1
    申请号:R112016030805-0
    申请日:2015-06-24
    公开日:2021-02-23
    发明作者:Jim Fink；Lisa Molloy；Ronan MacLoughlin；Claire Elizabeth Lillis；Michael Joseph Casey；John Matthew Mullins；Kieran James Hyland；Joseph Martin Grehan
    申请人:Dance Biopharm Inc；
    IPC主号:
    专利说明:

    CROSS REFERENCE TO RELATED ORDERS
    [001] This application for the patent cooperation treaty claims the priority benefit of US patent application No. 14 / 743,627, filed on June 18, 2015; which claims the priority benefit of provisional US application No. 62 / 019,791, filed on July 1, 2014, the contents of which are incorporated herein by reference in their entirety for all purposes. BACKGROUND OF THE INVENTION
    [002] Aerosolization systems provide effective administration for a variety of medications, such as insulin and asthma medications. Such systems deliver medications directly to a user's respiratory system by aerosolizing a desired dose of the medication in liquid form. The user then inhales the aerosolized medication directly into the respiratory system, enabling faster treatment of various medical conditions.
    [003] Providing accurate and consistent metered doses of aerosolized medication to a user is very important. Current aerosolization systems often provide inconsistent doses by allowing part of the drug to remain in a liquid reservoir after the aerosolization process is completed. In addition, the aerosolized drug is often supplied with too great or too little force for substantially the entire measured dose to properly enter the user's respiratory system. Another problem with current aerosolization systems is a tendency for the medication to become contaminated by the user or other sources. Contamination of the drug is particularly problematic since some or all of the contaminated drug is thereafter delivered directly to the user's respiratory system after aerosolization. Modalities of the invention can provide solutions to these and other problems. BRIEF SUMMARY OF THE INVENTION
    [004] In one embodiment, an aerosolization device to ensure an appropriate delivery of an aerosolized medication to a user's respiratory system is provided. The aerosolization device may include a duct, an aerosol generator in communication with the duct, a restrictor disposed within the duct and an indicator mechanism. The conduit may include a nozzle end through which a user can cause an inspiratory flow through the conduit. The aerosol generator may include a vibrating mesh. The restrictor can define a plurality of openings arranged along an outer periphery of the restrictor. The plurality of openings can be configured to provide an increase in the pressure differential that varies with an inspiratory flow within the conduit and to establish a relatively laminar flow downstream of the restrictor compared to the upstream of the restrictor. The indicator mechanism can indicate to a user a state of an inspiratory flow parameter in relation to a predefined desired range.
    [005] In another embodiment, a different aerosolization device to ensure proper administration of an aerosolized medication to a user's respiratory system is provided. The aerosolization device may include a conduit, an aerosol generator in communication with the conduit and a restrictor disposed within the conduit. The conduit may have a nozzle end through which a user can cause an inspiratory flow through the conduit. The aerosol generator may include a vibrating mesh. The restrictor can define a plurality of openings arranged along an outer periphery of the restrictor. The plurality of openings can be configured to provide an increase in pressure differential that varies with an inspiratory flow within the conduit and to provide a relatively laminar flow downstream of the restrictor compared to the upstream of the restrictor. The vibrating mesh can produce a plume of aerosolized medication within the relatively laminar flow when the inspiratory flow is within an operating range of the aerosol device.
    [006] In another embodiment, a method of administering an 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 a nozzle end through which a user can cause inspiratory flow within the conduit. The method may also include vibrating an aerosol generator mesh in communication with the duct for aerosolizing a volume of a liquid drug to produce an aerosolized drug plume within the duct when the state of the flow parameter is within a desired range. preset. The aerosolized medicine plume may be provided within a relatively laminar flow produced by a restrictor disposed within the conduit upstream of the aerosolized medicine plume. The restrictor can define a plurality of openings arranged around an outer periphery of the restrictor. The aerosolized medicine plume can be carried by the relatively laminar flow to the nozzle end of the conduit. The method may further include providing an indication using a mechanism indicating the status of the flow parameter in relation to the predefined desired range. BRIEF DESCRIPTION OF THE DRAWINGS
    [007] The present invention is described together with the attached figures:
    [008] FIG. 1A illustrates an interior of an aerosolization device according to embodiments of the invention.
    [009] FIG. 1B shows a cross section of FIG. 1A according to the modalities of the invention.
    [0010] FIG. 2 illustrates a front of the FIG aerosolization device. 1A according to embodiments of the invention.
    [0011] FIGS. 3A-3K illustrate restrictive plates according to the commodities of the invention.
    [0012] FIGS. 4A and 4B show a restrictor plate within a duct of an aerosolization device according to embodiments of the invention.
    [0013] FIGS. 5-7 show laminar flows created by restrictor plates within the conduit of FIG. 4 according to embodiments of the invention.
    [0014] FIGS. 8A-8C illustrate conduits having mouth ends at various angles according to embodiments of the invention.
    [0015] FIG. 9 shows an input device on an aerosolization device according to embodiments of the invention.
    [0016] FIG. 10 is a block diagram of a method of using an aerosolization device in accordance with embodiments of the invention.
    [0017] In the attached figures, components and / or similar characteristics may have the same numerical reference marking. In addition, several components of the same type can be distinguished by following the reference mark by a letter that distinguishes between components and / or similar characteristics. If only the first numerical reference mark is used in the specification, the description is applicable to any of the components and / or similar characteristics having the same first numerical reference mark regardless of the suffix letter. DETAILED DESCRIPTION OF THE INVENTION
    [0018] The following description provides only exemplary modalities and is not intended to limit the scope, applicability or configuration of the 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 invention. It will be understood that several changes can be made in the function and arrangement of elements without departing from the spirit and scope of the invention as defined in the attached claims. For example, any detail discussed with respect to a modality may or may not be present in variations of that modality and / or in other modalities discussed here.
    [0019] Modalities of an aerosolization device to assist in the appropriate administration of an aerosolized medication to a user's respiratory system are described here. In many embodiments, liquid medication can be delivered to an aerosolization device in a metered dose. The liquid medication can be dispensed to an aerosol generator. In some embodiments, the liquid medicine can be delivered via a chamber or reservoir that funnels the liquid medicine into the aerosol generator where the liquid medicine is aerosolized for administration to a user's respiratory system. In other embodiments, a separate container containing the liquid medication can be coupled with the aerosolization device to deliver the liquid medication to it.
    [0020] In some embodiments, an aerosolization device may include a duct, an aerosol generator in communication with the duct, a restrictor plate disposed within the duct, and an indicator mechanism coupled with the duct. In many embodiments, a part or all of these components are arranged within a housing. In some embodiments, the duct and / or the aerosol generator may be removably coupled with or received within the housing. Providing an aerosol generator and / or removable duct, the aerosolization device can be easily cleaned and dried, thus preventing contamination and accumulation of pathogens and / or other contaminants.
    [0021] In some modalities, the conduit may include an end of the nozzle through which a user can cause an inspiratory flow through the conduit. A user can inhale through the mouthpiece to create the inspiratory flow of air that can deliver an aerosolized medication to the user. In some embodiments, the nozzle end of the conduit can deliver the aerosolized medication to the user at an angle to a horizontal plane. Such an angle of administration can be selected based on the dosage and type of medication to be administered to the user's respiratory system to ensure that a substantial portion of the aerosolized medication is administered to the respiratory system without being clinging to the mouth, throat and / or other area. of user.
    [0022] In many embodiments, a sensor is used to determine when an inspiratory flow parameter is within a predefined or desired operating range of the aerosolization device and / or the aerosol generator. For example, a flow sensor or pressure transducer can be used to determine a flow or pressure differential within the conduit. Other types of sensors and flow parameters can also be used / measured. For example, the flow parameter can be an inspiratory flow, inspiratory pressure, inspiration time and others sensed by a flow sensor, timer, pressure transducer or other sensor mechanism. A processing unit coupled with the sensor can compare the sensed value with a desired stored range. In some embodiments, the desired range of a flow parameter for the delivery of a particular drug may correspond to the operating range of the aerosol generator. In other embodiments, the desired range of a flow parameter may be narrower or wider than the operating range of the aerosol generator.
    [0023] In some embodiments, the aerosol generator may include a vibrating mesh. When the inspiratory flow parameter is within the desired or operating range, the vibrating mesh can be vibrated for a period of operation sufficient to aerosolize substantially all of any liquid medication disposed on top of the vibrating mesh. The vibrating mesh can be dome shaped and vibrated by an annular piezoelectric element (not shown) or another electromechanical resonant device that circumscribes the vibrating mesh. The vibrating mesh is vibrated when one or more flow parameters are within the operating range of the aerosol generator. For example, a flow sensor and / or pressure transducer in communication with the duct may sense that an inspiratory flow and / or a pressure differential within the duct are within the operating range of the aerosol generator. A processor can control a circuit to supply an electrical current to the piezoelectric element to vibrate the mesh. Typically, the vibrating mesh will be vibrated at a frequency in the range of about 50 kHz to about 150 kHz for aerosolizing the dose of liquid medicine.
    [0024] In many modalities, the inhaled air can pass through a restrictor set inside the duct. In one embodiment, the restrictor assembly may be a restrictor plate that has a plurality of openings passing through it. As the air passes through the openings, the openings provide an increase in the pressure differential that varies according to the inspiratory flow inside the duct. The openings also provide a relatively laminar flow downstream of the restrictor plate compared to upstream of the restrictor plate. In many embodiments, the openings are arranged along an outer periphery of the restrictor plate. In some embodiments, the vibrating mesh may be located downstream of the restrictor plate or other restrictor assembly and produce a plume of aerosolized medication within the relatively laminar flow produced by the restrictor assembly. In some embodiments, the restrictor assembly may include multiple restrictor plates in series.
    [0025] The indicator mechanism can indicate to a user a status of an inspiratory flow parameter in relation to a predefined desired range. In some embodiments, the indicating mechanism may alternatively indicate to the user a state of the aerosolization device or in addition to indicating a state of a flow parameter. For example, the indicator can be a light, analog / digital display or reader, speaker, vibration generating device and / or another feature that alerts a user to the status of the parameter. In some modalities, the status of the parameter can be an inspiratory flow, inspiratory pressure, inspiration time and others sensed by a flow sensor, timer, pressure transducer or other sensor mechanism. The indicator can inform the user if they are within or outside the desired range for the parameter.
    [0026] In some modalities, an indication of 'end of dose' may be provided to a user when an entire dose of the drug has been aerosolized. Such an indication can be provided when a sensor, such as a load or flow sensor, only sores that substantially all of the drug has been aerosolized. Another indication can also be provided to the user informing him of when the liquid medication is being effectively aerosolized by the activated vibrating mesh. Such indications of a state of the flow parameter and / or state of the aerosolization device can be provided by the indicator mechanism described above, such as providing a distinguishable indication from the indication of the state of the flow parameter. For example, the status of the flow parameter can be indicated by a green light and the indication of the end of dose can be provided by a blue light. In other modalities, the end of dose indication and / or the aerosolization indication can be provided by one or more separate indicator mechanisms.
    [0027] In some embodiments, the indicator mechanism can be used to instruct a user on how to inhale properly and thereby ensure the appropriate delivery of the drug to the user's respiratory system. To do this, the indicator mechanism can alert the user when a parameter, such as an inspiratory flow within the conduit, is within a predefined desired range. The aerosol generator can be configured to aerosolize the liquid medication when the inspiratory flow is within the predefined flow range. For example, the predefined desired range of inspiratory flow within the conduit can be between about 5 and 14 liters per minute (L / min). An indication as described above, such as a light or sound emitted from a loudspeaker, can be produced to alert the user that the inhalation by the user is keeping the inspiratory flow within the desired range, and thus when the aerosol generator is active .
    [0028] In some modalities, a first indication can be provided with the parameter is within the desired range and a second indication can be provided when the parameter is outside the desired range. For example, the first indication may include a light that is on or a sound, such as a beep, that is emitted. The second indication can include a light that is turned off or a previous continuously emitting sound that ceases. Other indications may include emitting a different color of light or a different sound frequency than those of the first indication to indicate a variation in the state of a parameter. In some modes, the second indication can alert a user if the status of the parameter is higher or lower than the desired range. For example, a flickering light can be emitted with a relatively long period between flickers to alert the user when the state of the parameter is lower than the desired range and a flickering light having a relatively short period between flickers can be emitted to alert the user. user that the parameter status is higher than the desired range. Similar uses of vibrations and sounds can be used in conjunction with, or as an alternative to light indicators.
    [0029] In some modalities indicating the user the status of the inspiratory flow parameter in relation to the predefined desired range may include the indicator mechanism providing a first indication when the inspiratory flow parameter is within the predefined desired range, the indicator mechanism providing a second indication when the inspiratory flow parameter is within a predefined secondary range (ie, potentially an acceptable but less than optimal range) and the indicator mechanism provides a third indication when the inspiratory flow parameter is outside both the predefined and the desired range preset secondary range.
    [0030] In some embodiments, the aerosolization device may also include an input device for receiving and adjusting the desired predefined range of the inspiratory flow parameter. For example, the input device may include a bar code scanner, radio frequency identification (RFID) reader, keyboard or any other input device that can receive input from the user with respect to one or more flow parameters inspiratory pressure, such as a desired flow rate, inspiratory pressure, or inspiration time. In some embodiments, the desired flow rate can be encoded visually or otherwise on the drug delivery container and read by the aerosolization device thereafter.
    [0031] In some modalities, the inspiratory flow parameter may include the inspiratory flow within the conduit. The predefined desired range of the inspiratory flow can be between about 5 and 14 liters per minute (L / min). In some modalities, the inspiratory flow parameter may include the inspiration time. The predefined desired range of inspiration time can be between about 5 and 26 seconds. In some modalities, multiple parameters can be measured and consulted. For example, in a modality, a certain amount of inspiration time for an inspiratory flow may be minimal.
    [0032] In some embodiments, the aerosolization system may include electronic elements including, but not limited to, a processing element and a memory unit. The processing element can be used to control the performance of the aerosol generator, indicating mechanisms, and input devices, as well as any sensors such as flow sensors and pressure transducers. The memory unit can be configured to store gradations and ranges defined by the input device for the parameters of the indicator mechanism and / or aerosol generator. The memory unit can also be configured to store data related to past aerosolization sessions, as well as information provided by medication delivery bottles attached to them.
    [0033] Turning now to the drawings, FIGs. 1A and 1B illustrate an aerosolization device 100, according to various embodiments of the invention. The aerosolization device 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, shown here as indicator lights. The one or more indicator mechanisms can be coupled with a housing or some other portion of the device 100. The conduit 102 and the aerosol generator 104 can also optionally be coupled with the housing 108.
    [0034] In some embodiments, conduit 102 may include a nozzle end 110 through which a user can inhale to produce an inspiratory flow to deliver aerosolized medication to the user's respiratory system. As seen in FIG. 1B, the aerosol generator 104 can include a vibrating mesh 112. Liquid medication can be dispensed over the vibrating mesh 112, either directly from a liquid medicine bottle or indirectly being funneled over the vibrating mesh 112 through tapered walls of a fluid receiving chamber 114. In many embodiments, the vibrating mesh 112 is vibrated via a processor-controlled mechanism for aerosolizing a volume of liquid medication when an inspiratory flow rate is within the operating range of the aerosol generator. 104. When vibrated, the vibrating mesh 112 operates to produce a plume of aerosolized medication within the conduit 102 in such a way that the aerosolized medication can be inhaled into the user's lungs.
    [0035] Exemplary aerosol generators that can be used are also described in US 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, incorporated herein by reference. These references describe exemplary aerosol generators, means for making these aerosol generators and means of supplying liquid to the aerosol generators and are incorporated by reference for at least these characteristics.
    [0036] In some embodiments, the one or more indicator mechanisms 106 may include lights, such as LEDs. Indicator mechanisms 106 may also include loudspeaker and / or vibration generating mechanisms to instruct users as to the state of the aerosolization device. For example, indicator mechanisms 106 can be used to instruct a user when the aerosolization device 100 is ready for use. Indicator mechanisms 106 may also indicate a state of a user-created inspiratory flow parameter. For example, indicator mechanisms 106 can instruct a user to change an inhalation rate to increase or decrease a flow rate within the conduit 102 to ensure proper administration of the aerosolized drug and / or to ensure that the flow rate is within the operating range. of the aerosol generator 104 such that the vibrating mesh 112 aerosolizes the liquid medicament. Indicator mechanisms 106 can also be used to indicate to a user when substantially an entire dose of liquid medication has been aerosolized and / or inhaled. Additional sensors may be required in order to provide for the functionality described above.
    [0037] In some embodiments, the aerosolization device 100 includes a processing unit or integrated circuit (IC) 138 that controls the function of or rotates computer code to control other electronic components of the aerosolization device 100. The aerosolization device 100, including CI 138, can be powered by batteries 140 that are coupled with CI 138. CI 138 can be electrically coupled with electronic components such as any sensors, indicating mechanisms 106 and / or an aerosol generator piezoelectric element 104. CI 138 can control the performance of the indicator mechanisms and / or the aerosol generator 104 based on information received from any sensors, such as flow sensors or pressure transducers in fluid communication with the conduit 102. In some modalities, CI 138 can be electrically coupled to the duct 102 and / or the aerosol generator 104 using a plug 124. the duct 102 and / or aerosol generator 10 4 can be removable from housing 108. Flue 102 and / or aerosol generator 104 can be inserted into housing 108 and interface with plug 124 to feed power to, and control the performance of, aerosol generator 104 based on measurements from sensors in fluid communication with conduit 102. For example, plug 124 may have a male connector 144 that interfaces with a female connector 146 over conduit 102. In some embodiments, plug 124 may include a female connector that interfaces with a male connector over the duct 102.
    [0038] FIG. 2 shows a top view of the aerosolization device 100 and indicating mechanisms 106 in accordance with embodiments of the invention. In some embodiments, indicator mechanisms 106 may include a breath indicator 116 and a battery indicator 118. Breath indicator 116 can instruct a 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 several colored LEDs to provide the user with a more detailed guideline. The breathing indicator 116 can be in the shape of a border that includes 3 colors of LEDs.
    [0039] In some modalities, optimal pulmonary administration of medications such as liquid insulin occurs at specified inspiratory flows and times. For example, an optimal flow rate can be between about 5 and 14 L / min, or more often between about 7 and 14 L / min. Flow rates that are too high or too low can result in losses in the amount of aerosolized medication administered to the appropriate locations in a user's respiratory system. Optimum inspiratory time can be between 6 and 24 seconds. The breathing indicator 116 can be used to instruct a user to maintain an inhalation within these parameters.
    [0040] In one embodiment, a light, such as a steady green light emitted from an LED, will be produced using the breathing indicator 116 to instruct a user that this flow within the aerosolization device 100 is within the operating range aerosolization device 100 for aerosolizing a dose of drug. When a user inhales at the nozzle end 110 of conduit 102, the inhalation flow is sensed by a flow sensor or pressure transducer that can convert a pressure differential within conduit 102 into a flow. Sensing an inhalation having appropriate flow parameters results in activation of the aerosol generator 104 to produce particles of aerosolized medication in the duct 102. The light from the breathing indicator 116 can be slowly flickered to indicate that the user is breathing very slowly ( ie, causing a low flow) compared to the operating range, if the aspiration conditions change. For example, a sparkling green light can be emitted having a period of between about 500 and 1000 milliseconds (ms) and a frequency of about 1.25 hertz (Hz) to indicate that the aerosolization device 100 is activated for a time with little or no time. no air flow. The light can be flickered quickly to instruct the user that he is breathing very quickly (i.e., causing a high flow). For example, a sparkling green light can be emitted from the breathing indicator 116 having a period of between about 50 and 250 ms and a frequency of about 6.25 Hz when the flow is excessive. The aerosol generator 104 can be configured to not aerosolize any medication when the flow rate is too high, high or too low.
    [0041] Breathing indicator 116 may produce a cordiferous light as an "end of dose" indicator to indicate that substantially the entire dose of medication has been administered. For example, a blue light may be emitted for a period of time, such as between about 1 and 10 seconds to alert the user that substantially the entire dose has been aerosolized and inhaled. The administration of the 'full' dose can be predefined as when at least about 95% of the dose is administered, more preferably 98% and most preferably when more than 99% of the dose is aerosolized. To receive the dose, the user can take several inhalations or a single inhalation depending on the volume of liquid drug to be administered and the user's breathing capacity. Each inhalation can be monitored by the device, with feedback provided to the user via indicator 116, to ensure proper delivery to the lungs. In some embodiments, the operation of the end of dose indicator may be delayed for a period, such as up to about 5 seconds after substantially the entire dose has been administered, thereby providing an air "plumber" into the lungs. This plumber can serve to unblock the upper airway and maximize the amount of the dose that is transported to the user's lungs.
    [0042] In modalities where the duct 102 and / or aerosol generator 104 are removable from the housing 108, a light can be emitted to instruct a user that one or both of the duct 102 and the aerosol generator are not fully seated, coupled between themselves and / or engaged within housing 108. It will also be appreciated that other shapes and numbers of lights can be used on the breathing indicator 116. The breathing indicator 116 can also use different numbers or types of lighting elements, colors of light , light intensities, light flickers having different periods, vibration patterns, sounds and / or any combination of these indications to instruct a user on how to inhale properly using the aerosolization device 100. Indicator mechanisms 106 can also be used to provide other indications related to the aerosolization device 100.
    [0043] In some embodiments, the battery indicator 118 may indicate to a user an amount of charge remaining on a battery of the aerosolization device 100 that energizes its functions. The battery indicator can be a digital reading of a charge level or it can be a light emitting device, such as an LED, which emits one or more colors of light to indicate a relative state of charge. For example, battery indicator 118 can emit a single color of light to indicate when a charge is low. In other embodiments, the battery indicator118 can emit three or more colors of light to indicate various levels of charge to show a charge status over time.
    [0044] FIGS. 3A-3K illustrate flow restrictor plate modalities that can be positioned within a conduit, such as conduit 102 of FIGS. 1A and 1B. The restrictor plates, such as the restrictor plate 300a, create resistance to and limit airflow through a duct while adding minimal or no length to a duct.
    [0045] The restrictor plate 300a provides an increase in differential depression that varies with inspiratory flow rates. This pressure differential exists between the duct and outside the duct and / or atmospheric pressure in such a way that as the user's inhalation force increases, the pressure differential drops to maintain a relatively constant flow within the duct that remains in a desired flow range. In some embodiments, the pressure differential increases in a linear relationship with the flow rate as the user's inhalation force increases. A sensor feedback provided by sensors and / or indicating mechanisms, such as those described above, can allow the user to relate the inspiratory pressure with the necessary flow required to operate the aerosol generator. The restrictor plate 300a defines a plurality of openings 302a for air to pass through. The openings 302a can be positioned around an outer periphery of the restrictor plate 300a in such a way that air passing through the openings forms a relatively laminar flow downstream of the restrictor plate 300a. The openings 302a can be of any shape or size to create a relatively laminar flow. For example, the openings can be circular and have diameters ranging from about 0.5 mm to 1.5 mm. The size and pattern of the plurality of openings 302a can prevent air flow through a massive central portion of the restrictor plate 300a, while allowing air flow through the openings at its periphery.
    [0046] FIGS. 3B-3K show restrictor plate modalities defining alternative opening arrangements. For example, FIG 3B shows a restrictor plate 300b defining a plurality of openings 302b arranged in a striped pattern. FIG. 3C shows a restrictor plate 300c defining a plurality of openings 302c arranged in a circular pattern. FIG. 3D shows a restrictor plate 300d defining a plurality of openings 302d arranged in a semicircular pattern along a bottom of the restrictor plate 300d. FIG. 3E shows a restrictor plate 300e defining a plurality of openings 302e arranged in a semicircular pattern along a top of the restrictor plate 300e. FIG. 3F shows a restrictor plate 300f defining an opening 302f that reduces an effective diameter of a conduit. FIG. 3G shows a 300g restrictor plate defining an opening 302g that reduces an effective diameter of a conduit. FIG. 3H shows a restrictor plate 300h defining an opening 302h that reduces the effective diameter of a duct. FIG. 3I shows a restrictor plate 300i defining a closely grouped plurality of openings 302i arranged along an outer periphery of the restrictor plate 300i. FIG. 3J shows a restrictor plate 300j defining a plurality of openings 302j arranged in a semicircular pattern along a top half of the restrictor plate 300j. FIG. 3K shows a 300k restrictor plate defining a plurality of openings 302k scratched in a circular pattern.
    [0047] FIG. 4 illustrates a restrictor plate 400 positioned within a conduit 402 in accordance with embodiments of the invention. The restrictor plate 400 is arranged inside the conduit between a pressure transducer 404 that is in fluid communication with an interior of the conduit and an aerosol generator 406. The pressure transducer 404 monitors a pressure differential inside the conduit 402 in relation to the outside flue and / or atmospheric pressure. A processing unit or IC, such as CI 138 of FIGS. 1A and 1B, you can run software that converts the pressure reading to a flow through the entire line 402. This flow can be used to determine when to activate the aerosol generator 406 for aerosolizing a volume of liquid medication. The restrictor plate 400 may have the characteristics of the restrictor plates 300a-300k discussed above. The restrictor plate 400 creates a laminar flow upstream of the aerosol generator 406 in such a way that the aerosolized medicine is deposited within the laminar flow and dragged into the laminar flow before the aerosolized medicine contacts an opposite conduit wall 402 of the aerosol generator. 406, in order to maximize the amount of medication administered to the user.
    [0048] FIGS. 5-7 are laminar flow diagrams of air flow through conduit 402 and restrictor plate 400 having a structure similar to the restrictor plate 300a. An air flow reaches the restrictor plate 400, the pressure differential is increased and a relatively laminar flow is created to contact the aerosolized medication. The laminar flow provides a consistent velocity field to deliver aerosolized particles to the user's respiratory system in a consistent manner while minimizing impact losses. In addition, the laminar flow minimizes an amount of aerosolized medication that can be deposited on a wall of the conduit. FIG. 7 shows the laminar flow contacting the aerosolized drug produced by the aerosol generator 406. The aerosolized drug is entrained in the laminar flow before the drug contacts an opposite wall of the aerosol generator 406. The entrained aerosolized drug is then carried out of the conduit 402 to a user's respiratory system.
    [0049] FIGS. 8A-8C show an aerosolization device having a mouthpiece angled at various angles to direct airflow into a user's respiratory system. The nozzle end angles can be adjusted based on the volume of a dose, the type of medication to be administered and the length and diameter of the duct of an aerosolization device. FIG. 8A shows an aerosolization device 800 having a nozzle end 802 angled downwards at 15 ° with respect to a horizontal plane. FIG 8B shows the aerosolization device 800 having the nozzle end 802 parallel to a horizontal plane. FIG. 8C shows the aerosolization device 800 having the nozzle end 802 angled upwards at 15 ° with respect to a horizontal plane. Other angles in relation to a horizontal plane of up to 30 ° upwards or downwards in relation to a horizontal plane can be used to maximize the administration of the medication to the user's respiratory system.
    [0050] FIG. 9 shows an aerosolization device 900 having an inlet device 902 coupled with a housing 904. In some embodiments, the inlet device 902 can be coupled with a conduit. Input device 902 is configured to receive input from a user who sets parameters for an inspiratory flow determined by a pressure transducer (not shown) within the conduit. The entry can be manually entered by a user, provided via the wireless interface, provided via the wired interface such as universal serial bus (USB), or in any other way. The parameters, which may include a flow rate, inspiratory pressure, inspiratory time and others, can be used to determine when an aerosol generator from the aerosolization device 900 is actuated, as well as to adjust ranges for indicator mechanisms (not shown) that instruct the user on when and how to breathe. An input device 902 can include a keyboard or similar interface, a barcode scanner or RFID reader to receive flow parameters from a user or a drug container or label. The aerosolization device 800 can be configured similarly to any of the aerosolization devices described here, and can include the same or similar characteristics.
    [0051] FIG. 10 illustrates a method 1000 of administering an aerosolized medication to a user's respiratory system using the aerosolizing devices described herein. The method may include sensing a state of a flow parameter of an inspiratory flow within a conduit in block 1002. Sensing a state of a flow parameter can be done using sensors, such as a flow sensor or the 404 pressure transducer of FIG. 4. The method may also include vibrating an aerosol generator mesh in communication with the duct for aerosolizing a volume of a liquid drug in block 1004. This vibration produces a plume of aerosolized drug within a duct of the aerosolizing device when a state of the flow parameter is within a predefined desired range. For example, when an inspiratory flow determined by the pressure transducer is within the operating range of the aerosolization device, the mesh can be vibrated. The aerosolized medicine plume may be provided within a relatively laminar flow produced by a restrictor plate disposed within the conduit upstream of the aerosolized medicine plume. The laminar flow sweeps the aerosolized medicament to a nozzle end of the conduit before the medicament contacts a conduit wall opposite the aerosol generator. The aerosolized medication is then directed into a user's respiratory system. The method may further include providing an indication using an indicator mechanism coupled with the status conduit of the flow parameter in relation to the desired range predefined in block 1006.
    [0052] In some embodiments, providing an indication may include providing a first indication of when the flow parameter is within the predefined desired range and providing a second indication of when the flow parameter is outside the predefined desired range. In other embodiments, providing an indication may include providing a first indication of when the flow parameter is within the predefined desired range, providing a second indication of when the flow parameter is within a predefined secondary range and providing a third indication of when the flow parameter is outside both the predefined desired range and the predefined secondary range.
    [0053] By indicating the status of the flow parameter within intermediate ranges, a user can change an inhalation rate to maximize the efficiency of an aerosolized drug administration. For example, for an aerosol generator having an operating range for a flow rate of between about 5 and 14 L / min, a predefined desired range can be between about 8 and 11 L / min. a predefined secondary range can be adjusted within the remaining operating range of the aerosol generator. For example, the secondary range can be between about 5 and 7 L / min and between about 12 and 14 L / min. A first indication, such as a green light, can be provided when the flow is within the predefined desired range. A second indication, such as a yellow light, can be provided when the flow rate is outside the desired range, but within the secondary range. In other embodiments, a slowly sparkling yellow light can be used to indicate that the flow rate is within the lower secondary range and a rapidly sparkling yellow light can indicate that the flow rate is within the upper secondary range. A third indication, such as a red light, can be used to indicate that the flow rate is outside both the desired range and the secondary range.
    [0054] Such systems that provide intermediate ranges can help a user to correct or otherwise adjust an inhalation rate to maintain a flow within a desired range or aerosolization device operation before the flow is unacceptably inefficient or inoperative to act. the aerosol generator. This can help a user to develop more consistent and efficient inhalations. Multiple intermediate ranges, both inside and outside the aerosol generator operating range, can be provided to further assist a user in adjusting the rate of inhalation. Additionally, the intermediate ranges can be focused on ensuring that an efficient flow range is maintained, rather than ensuring that an aerosol generator operating range is maintained.
    [0055] In some embodiments, the method may also include providing an indication that the liquid medicine is ready to be aerosolized and providing an indication that substantially all of the liquid medicine has been aerosolized. The method may optionally include receiving an input via an aerosolization device input device to adjust the desired predefined range of the flow parameter.
    [0056] It will be evident 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 or scope of the invention. Thus, it is intended that the present invention includes modifications and variations that are within the scope of the appended claims and their equivalents.
    权利要求:
    Claims (17)
    [0001]
    1. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system, the aerosolization device characterized by the fact that it comprises: a conduit having an end of the mouthpiece through which a user can cause an inspiratory flow through the conduit ; an aerosol generator in communication with the conduit and comprising a vibrating mesh; and a restrictor disposed within the conduit, in which the restrictor defines a plurality of openings arranged along an outer periphery of the restrictor and positioned on a massive central portion, allowing air flow through the plurality of openings arranged along the outer periphery of the restrictor while preventing air flow through the central portion of the restrictor, the plurality of openings being configured to: provide an increase in the pressure differential that varies with an inspiratory flow within the conduit; and providing a relatively laminar flow downstream of the restrictor compared to the upstream of the restrictor.
    [0002]
    2. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system according to claim 1, the aerosolization device characterized by the fact that it additionally comprises: an indicator mechanism that indicates to a user a state of a inspiratory flow parameter in relation to a predefined desired range.
    [0003]
    3. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system according to claim 2, characterized by the fact that indicating the user the status of the inspiratory flow parameter in relation to the predefined desired range comprises: the indicator mechanism provides a first indication when the inspiratory flow parameter is within the predefined desired range; and the indicator mechanism provides a second indication when the inspiratory flow parameter is outside the predefined desired range.
    [0004]
    4. Aerosolization device to ensure the adequate administration of an aerosolized medication to a user's respiratory system according to claim 2, characterized by the fact that indicating the user the status of the inspiratory flow parameter in relation to the predefined desired range comprises: the indicator mechanism provides a first indication when the inspiratory flow parameter is within the predefined desired range; the indicator mechanism provides a second indication when the inspiratory flow parameter is within a predefined secondary range; and the indicator mechanism provides a third indication when the inspiratory flow parameter is outside both the predefined desired range and the predefined secondary range.
    [0005]
    5. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system according to claim 2, characterized by the fact that the indicator mechanism comprises: at least a selection from a group consisting of a light, a digital readout, a speaker or a vibration generating device.
    [0006]
    6. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system according to claim 2, characterized by the fact that the inspiratory flow parameter comprises: the inspiratory flow within the conduit.
    [0007]
    7. Aerosolization device to ensure adequate delivery of an aerosolized medication to a user's respiratory system according to claim 6, characterized by the fact that: the predefined desired range of the inspiratory flow is between about 5 and 14 liters per minute (L / min).
    [0008]
    8. Aerosolization device to ensure proper delivery of an aerosolized medication to a user's respiratory system according to claim 2, the aerosolization device characterized by the fact that it further comprises: an input device for receiving and adjusting the predefined desired range the inspiratory flow parameter.
    [0009]
    9. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system according to claim 1, characterized by the fact that: the restrictor is configured in such a way that the fluid only flows through the plurality of openings arranged along the outer periphery.
    [0010]
    10. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system, the aerosolization device, characterized by the fact that it comprises: a conduit having an end of the mouthpiece through which a user can cause an inspiratory flow through the conduit; an aerosol generator in communication with the conduit and comprising a vibrating mesh; a restrictor disposed within the conduit, in which the restrictor defines a plurality of openings arranged along an external periphery of the restrictor, the plurality of openings being configured to: provide an increase in the pressure differential that varies with an inspiratory flow within the conduit; and providing a relatively laminar flow downstream of the restrictor compared to the upstream of the restrictor, and an indicator mechanism that indicates to a user a state of an inspiratory flow parameter in relation to a predefined desired range, in which to indicate the user's state of inspiratory flow parameter in relation to the predefined desired range comprises: the indicator mechanism provides a first indication when the inspiratory flow parameter is within the predefined desired range; the indicator mechanism provides a second indication when the inspiratory flow parameter is within a predefined secondary range, where the predefined secondary range extends above or below the desired predefined range and is within an operating range of the aerosol generator; and the indicator mechanism provides a third indication when the inspiratory flow parameter is outside both the predefined desired range and the predefined secondary range, where the vibrating mesh produces a plume of aerosolized medication within the relatively laminar flow when the inspiratory flow is within an operating range of the aerosol device.
    [0011]
    11. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system according to claim 10, characterized by the fact that: the restrictor is configured in such a way that the fluid only flows through the plurality of openings arranged along the outer periphery.
    [0012]
    12. Aerosolization device to ensure the proper administration of an aerosolized medication to a user's respiratory system according to claim 10, characterized by the fact that the inspiratory flow parameter comprises: the inspiratory flow, and the predefined desired range is the operating range of inspiratory flow.
    [0013]
    13. Aerosolization device to ensure adequate administration of an aerosolized medication to a user's respiratory system according to claim 10, characterized by the fact that: the operating range of the inspiratory flow is between about 5 and 14 L / min .
    [0014]
    14. Method for administering an aerosolized medication to a user's respiratory system, the method characterized by the fact that it comprises: sensing a state of a flow parameter of an inspiratory flow within a conduit, the conduit having one end of the nozzle through which user can cause inspiratory flow within the conduit; providing an indication using a mechanism indicating the status of the flow parameter in relation to the predefined desired range, in which providing an indication comprises: providing a first indication when the flow parameter is within the predefined desired range; provide a second indication when the flow parameter is within a predefined secondary range, where the predefined secondary range extends above or below the desired predefined range and is within an operating range of the aerosol generator; and providing a third indication when the inspiratory flow parameter is outside both the predefined desired range and the predefined secondary range; and vibrating a mesh of an aerosol generator in communication with the conduit to aerosolize a volume of liquid medicine to produce an aerosolized medicine plume within the conduit when the state of the flow parameter is within a predefined desired range, where: the aerosol medicine plume is provided within a relatively laminar flow produced by a restrictor disposed within the conduit upstream of the aerosolized medicine plume; the restrictor defines a plurality of openings arranged around an outer periphery of the restrictor; and the aerosolized medicine plume is carried by the relatively laminar flow towards the end of the conduit nozzle.
    [0015]
    15. Method for administering an aerosolized drug to a user's respiratory system according to claim 14, characterized by the fact that: the predefined desired range is between about 5 and 14 L / min.
    [0016]
    16. Method for administering an aerosolized drug to a user's respiratory system according to claim 14, the method characterized by the fact that it further comprises: providing an indication that the liquid drug is ready to be aerosolized; and providing an indication that substantially all of the liquid drug has been aerosolized.
    [0017]
    17. Method for administering an aerosolized drug to a user's respiratory system according to claim 14, the method characterized by the fact that it further comprises: receiving an input to define the desired predefined range of the flow parameter.
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    法律状态:
    2020-05-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-12-08| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-02-23| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/06/2015, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201462019791P| true| 2014-07-01|2014-07-01|
    US62/019,791|2014-07-01|
    US14/743,763|US10471222B2|2014-07-01|2015-06-18|Aerosolization system with flow restrictor and feedback device|
    US14/743,763|2015-06-18|
    PCT/US2015/037505|WO2016003739A1|2014-07-01|2015-06-24|Aerosolization system with flow restrictor and feedback device|
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