Nebulizer device and method of using a nebulizer device

Abstract

The nebulizer includes a nebulizer upper portion removably coupled to a nebulizer lower portion having a nozzle assembly that fits between the nebulizer upper portion and the nebulizer lower portion. Each nebulizer component is configured to be easily replaced with a corresponding component of similar design but with different characteristics. The nozzle assembly is configured to be replaced with a second nozzle assembly having a different aperture size that produces aerosol droplets of a different size. Additionally, the diffuser attached to the nebulizer upper portion or the nebulizer lower portion can be replaced with a second nebulizer upper portion or nebulizer lower portion having a second diffuser in a different position that produces aerosol droplets of a different size. A sensor module attached to the nebulizer measures characteristics related to the performance of the nebulizer.

Description

[Technical Field]

[0001] (Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 373,986, filed August 30, 2022, the contents of which are incorporated herein by reference.

[0002] FIELD OF THE INVENTION Embodiments of the present technology generally relate to nebulizers for delivering therapeutic agents to the lungs of a patient. [Background technology]

[0003] A nebulizer is a device used to deliver therapeutic agents to the lungs. Nebulizers typically use mechanical means, such as airflow, a mesh, or ultrasonic means, to disperse a liquid therapeutic agent into an aerosol of droplets that are inhaled by the patient. While improvements have been made to nebulizers in recent years, various drawbacks remain.

[0004] First, the size of the therapeutic agent droplets in the aerosol may be too large for the intended treatment. Oversized aerosol droplets are more likely to be wasted by dispersion into the surrounding environment before they can be inhaled by the patient. Also, certain types of therapeutic agents and treatment methods may require, or be more effective with, smaller droplet sizes in the aerosol to reach the intended area of ​​the lungs. If the aerosol droplets are too large, the therapeutic agent may deposit in the throat instead of reaching the lungs. If the therapeutic agent droplets deposit in the throat, they also tend to be wasted when the patient exhales, expelling the droplets from the mouth into the surrounding environment.

[0005] Second, with existing nebulizers, it can be difficult to estimate the dosage of therapeutic agent delivered to a patient and to repeatedly provide a consistent dosage to the patient. Third, handling of the therapeutic agent and the possibility of contamination can be challenges with existing nebulizers. Therefore, improvements to existing nebulizers would be beneficial. Summary of the Invention

[0006] One exemplary embodiment is directed to a nebulizer including a nebulizer body and a nozzle assembly. The nebulizer body can include a nebulizer mouthpiece, a nebulizer upper portion, and a nebulizer lower portion, with the nebulizer upper portion configured to removably couple to the nebulizer lower portion. The nozzle assembly can include an aspiration line having an aspiration line inlet, an aspiration line outlet, and an aspiration line longitudinal axis passing through the aspiration line inlet and the aspiration line outlet, and a nozzle integrally joined to the aspiration line, the nozzle having a nozzle inlet, a nozzle outlet, and a nozzle longitudinal axis passing through the nozzle inlet and the nozzle outlet, the nozzle longitudinal axis being substantially perpendicular to the aspiration line longitudinal axis, and the nozzle assembly configured to removably couple to the nebulizer body between the nebulizer upper portion and the nebulizer lower portion. The nebulizer can further include a diffuser protruding from an inner surface of the nebulizer upper portion or the nebulizer lower portion toward the nozzle assembly, the diffuser including an impingement surface. Finally, at least one of the nebulizer top, nebulizer bottom, and nozzle assembly may be interchangeable with a corresponding component having at least one different characteristic, the corresponding component being selected to produce a target droplet size for the medicament disposed within the nebulizer.

[0007] Another exemplary embodiment includes a method of using a nebulizer that may include providing a nebulizer upper portion and a nebulizer lower portion, inserting a nozzle assembly between the nebulizer upper portion and the nebulizer lower portion and coupling the nebulizer upper portion to the nebulizer lower portion with the nozzle assembly positioned between the nebulizer upper portion and the nebulizer lower portion, coupling a gas supply to a nozzle inlet of the nozzle assembly, providing atomized medicament flowing from a mouthpiece of the nebulizer, collecting data related to operation of the nebulizer using a sensor in a sensor module coupled to the nebulizer, and providing the data to a processor that analyzes the data and generates a report related to operation of the nebulizer.

[0008] The foregoing embodiments are non-limiting examples, and other aspects and embodiments are described herein. The foregoing Summary is provided to introduce various concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify required or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. [Brief explanation of the drawings]

[0009] The accompanying drawings illustrate only exemplary embodiments of nebulizer devices and methods of using nebulizers. Therefore, the examples provided should not be considered limiting of the scope of the present disclosure. The principles illustrated in the exemplary embodiments of the drawings may be applied to alternative methods and devices. Additionally, elements and features in the drawings are not necessarily to scale, emphasis instead being placed on clearly illustrating the principles of the exemplary embodiments. Certain dimensions or locations may be exaggerated to help visually convey such principles. In the drawings, the same reference numbers used in different embodiments designate similar or corresponding, but not necessarily identical, elements. [Figure 1] 1 illustrates a nebulizer according to an exemplary embodiment of the present disclosure. [Figure 2] 1 illustrates a nebulizer top according to an exemplary embodiment of the present disclosure. [Figure 3] 1 illustrates a nebulizer top according to an exemplary embodiment of the present disclosure. [Figure 4] 1 illustrates a nebulizer top and nozzle assembly according to an exemplary embodiment of the present disclosure. [Figure 5] 1 shows an enlarged view of a portion of the top of the nebulizer and a portion of the nozzle assembly according to an exemplary embodiment of the present disclosure. [Figure 6] 1A and 1B show top and bottom views, respectively, of a lower portion of a nebulizer according to an exemplary embodiment of the present disclosure. [Figure 7] 1A and 1B show top and bottom views, respectively, of a lower portion of a nebulizer according to an exemplary embodiment of the present disclosure. [Figure 8] 10 shows a cross-sectional view of the top of another nebulizer according to an exemplary embodiment of the present disclosure. [Figure 9A] 10 illustrates a nozzle assembly having different characteristics according to an exemplary embodiment of the present disclosure. [Figure 9B] 10 illustrates a nozzle assembly having different characteristics according to an exemplary embodiment of the present disclosure. [Figure 9C] 10 illustrates a nozzle assembly having different characteristics according to an exemplary embodiment of the present disclosure. [Figure 10] 10 presents data showing the effect of nebulizer characteristics on aerosol droplet size, according to an exemplary embodiment of the present disclosure. [Figure 11] 10 presents data showing the effect of nebulizer characteristics on aerosol droplet size, according to an exemplary embodiment of the present disclosure. [Figure 12] 1 illustrates a method of using a nebulizer according to an exemplary embodiment of the present disclosure. [Figure 13] 1 illustrates a method for estimating drug intake according to an exemplary embodiment of the present disclosure. [Figure 14] 1 illustrates a method for determining pulmonary function according to an exemplary embodiment of the present disclosure. [Figure 15] 1 illustrates a method of using data from a nebulizer to control a ventilator, according to an exemplary embodiment of the present disclosure. [Figure 16] 1 illustrates a sensor module for use with a nebulizer, according to an exemplary embodiment of the present disclosure. [Figure 17] 1 illustrates a sensor module for use with a nebulizer, according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] Exemplary embodiments discussed herein are directed to nebulizer devices and methods of using nebulizer devices. As discussed above, nebulizers can have various drawbacks. Improvements to nebulizers are described in commonly owned U.S. Patent Nos. 9,227,029 and 9,452,270, the contents of which are incorporated herein by reference. However, the exemplary embodiments described herein provide further improvements over existing nebulizers. First, the exemplary nebulizers disclosed herein allow for easy interchangeability of nebulizer components to provide greater control over the size of droplets in the aerosol generated by the nebulizer. Greater control of aerosol droplet size allows for more effective administration of a therapeutic agent to a patient. A second advantage of the disclosed nebulizer embodiments is that greater control of aerosol droplet size results in more efficient use of a therapeutic agent, resulting in less therapeutic agent waste. The exemplary nebulizer devices described herein may also include one or more sensors, which provide additional benefits, as described further below. The nebulizer embodiments described herein can be implemented as oral nebulizers, metered dose nebulizers, or ventilator nebulizers.

[0011] Although exemplary embodiments of nebulizer devices and methods of using nebulizer devices are provided in the following description, it should be understood that modifications to the embodiments described herein are within the scope of this disclosure. In the following paragraphs, specific embodiments are described in more detail, by way of example, with reference to the drawings. In this description, well-known components, methods, and / or processing techniques are omitted or briefly described. Furthermore, reference to various features of embodiments does not imply that all embodiments must include the referenced features.

[0012] Referring now to FIG. 1, an exploded view of an exemplary nebulizer 10 is shown. The nebulizer includes a nebulizer upper portion 12, a nebulizer lower portion 60, and a nozzle assembly 40 that fits between the nebulizer upper portion 12 and the nebulizer lower portion 60. FIGS. 2-7 provide various views of the components of the exemplary nebulizer 10. Specifically, FIGS. 2 and 3 show top and bottom views, respectively, of the nebulizer upper portion 12. FIGS. 4 and 5 show the coupling of the nebulizer upper portion 12 and the nozzle assembly 40. FIGS. 6 and 7 show top and bottom views, respectively, of the nebulizer lower portion 60. The features of nebulizer 10 shown in FIGS. 1-7 and further described below are illustrative; in alternative embodiments, certain features may be modified or omitted, while other features may also be added to the nebulizer.

[0013] 1-7 , the components of the nebulizer 10 are designed to promote interchangeability. That is, one or more of the nebulizer upper section 12, the nebulizer lower section 60, and the nozzle assembly 40 can be interchangeable with a corresponding nebulizer upper section, nebulizer lower section, or nozzle assembly that is similar in design but has one or more different characteristics. The one or more different characteristics can be selected to generate a target aerosol droplet size that is optimized for a particular application. The target aerosol droplet size can be a discrete size, such as 5 microns, or can be within a size range, such as 0.5 to 5 microns. Therapeutic agents administered to patients using the nebulizer can have an optimal aerosol droplet size that improves the efficacy of the therapeutic agent and / or minimizes therapeutic agent waste. Therapeutic agent properties, such as viscosity and density, can affect aerosol droplet size. Thus, the nebulizer 10 allows for the selection of components that generate an aerosol droplet size that matches or approximates the target size of a particular therapeutic agent.

[0014] 1-5 illustrate features of an exemplary nebulizer top 12. The nebulizer top 12 includes an upper top wall 14 surrounded by an upper outer edge 16. The upper top wall 14 has a generally horizontal, planar portion and a curved portion that partially defines an upper chamber 22. The horizontal, planar portion of the upper top wall 14 includes a vent 20 having an external aperture in the horizontal, planar portion of the upper top wall 14 and an internal aperture located proximate to the low-pressure chamber outlet 48 of the nozzle assembly 40. The vent allows air to flow between the interior of the nebulizer 10 and the ambient environment surrounding the nebulizer 10. As described further below, the location of the vent 20 accelerates the flow of air through the nozzle assembly 40, thereby accelerating aerosol droplets of therapeutic agent toward the patient.

[0015] FIG. 4 shows a sensor module 80 attached to the exterior surface of the curved portion of the upper top wall 14. The sensor module 80 is shown in dashed lines to indicate that it is an optional component that is not required for all embodiments of the nebulizers described herein. The sensor module 80 may be removably coupled to the upper top wall 14 so that it can be replaced with other sensor modules, or in some cases, so that the nebulizer can be used without the sensor module. The sensor module 80 may include one or several sensors that detect signals corresponding to characteristics such as temperature, humidity, air pressure, airflow, the level of therapeutic agent in the nebulizer lower portion 60, biological characteristics of the patient, and characteristics of particles in the nebulizer 10. One or more apertures in the curved portion of the upper top wall 14 allow the sensors to collect data from the interior of the nebulizer 10, and in some examples, allow one or more sensors to protrude through the upper top wall 14 into the interior of the nebulizer 10 for the purpose of collecting data from the interior of the nebulizer. Additional aspects of the sensor module 80 are further described in connection with subsequent figures.

[0016] The exterior of the nebulizer top 12 also includes a mouthpiece 24 at one end that is designed to fit within a patient's mouth. The mouthpiece 24 is attached to the upper outer wall of the nebulizer top 12. The mouthpiece 24 has a generally cylindrical shape that is symmetrical about a mouthpiece axis 26. As shown in Figures 1, 2, and 4, the mouthpiece 24 can be oriented at an upward angle for ease of use, such that the mouthpiece axis 26 forms an obtuse angle with the horizontal plane of the upper top wall 14.

[0017] 1 and 4, when the components of nebulizer 10 are assembled, nebulizer top 12 and nebulizer bottom 60 are removably coupled with nozzle assembly 40 located therebetween. When the components of nebulizer 10 are assembled, the interior features of nebulizer top 12 rest on horizontal nozzle 41 of nozzle assembly 40. Specifically, nebulizer top 12 includes upper inner wall 18 that extends vertically downward from the inner surface of upper top wall 14 and from the inner edge of mouthpiece 24. Upper inner wall 18 is surrounded by upper outer edge 16 and by upper inner edge 17, which is disposed within and generally identical in shape to upper outer edge 16. Upper inner wall 18 includes a first upper slot 32 located adjacent to the end of nebulizer top 12 opposite mouthpiece 24. The first upper slot 32 is positioned above the nozzle 41 when the two components are joined together. Similarly, the front vent wall 36 and the rear vent wall 35 define the vent 20 and extend vertically downward from the inner surface of the upper top wall 14. The rear vent wall 35 has a second upper slot 33, and the front vent wall 36 has a third upper slot 34, which are positioned above the nozzle 41 when the two components are joined together. The configuration of the first upper slot 32, the second upper slot 33, and the third upper slot 34 allows the nebulizer top 12 and the nozzle assembly 40 to be easily joined and separated so that the nozzle assembly 40 can be replaced with another nozzle assembly having different dimensions to provide a different aerosol droplet size. The upward arrows in FIG. 4 indicate the positioning of the nozzle assembly 40 into the first upper slot 32, the second upper slot 33, and the third upper slot 34. Although the exemplary nebulizer 10 of FIG. 4 shows three top slots into which the nozzle assembly 40 fits, it should be understood that other arrangements of slots and a greater or lesser number of top slots can be implemented in other embodiments for securing the nozzle assembly to the top of the nebulizer.

[0018] Also shown in Figures 2, 3, 4, and 5 is a diffuser 30 suspended from the nebulizer top inner surface 28. The diffuser projects generally vertically downward so that it is disposed adjacent to the low-pressure chamber outlet 48 of the nozzle assembly 40 when the nozzle assembly and nebulizer top 12 are coupled together. The diffuser 30 has an impact surface 31, which is the surface facing toward and closest to the low-pressure chamber outlet 48. As shown in the enlarged view provided in Figure 5, the shortest distance between the impact surface 31 of the diffuser 30 and the low-pressure chamber outlet 48 is referred to as the offset distance 38. Aerosol droplets of therapeutic agent that exit the low-pressure chamber outlet 48 and strike the impact surface 31 generally break up into smaller aerosol droplets. Generally, a shorter offset distance 38 increases the likelihood that aerosol droplets will strike the diffuser's impact surface 31 and break up into smaller aerosol droplets. Nebulizer 10 facilitates control of aerosol droplet size in that nebulizer top 12 can be replaced with a second nebulizer top, such as nebulizer top 112 of FIG. 8, having a second diffuser with a second offset distance different from offset distance 38 of diffuser 30. Thus, aerosol droplet size can be controlled by selecting a nebulizer top having a diffuser with a desired offset distance from low-pressure chamber outlet 48. While diffuser 30 is shown suspended from nebulizer top inner surface 28 in the examples of FIGS. 2, 3, 4, and 5, in alternative embodiments, the diffuser can be mounted on nebulizer bottom 60 so that it projects vertically upward from nebulizer bottom 60 to low-pressure chamber outlet 48.

[0019] 1 and 4, the nozzle assembly 40 includes a nozzle 41 and a suction line 50 oriented generally perpendicular to one another. When the nebulizer is in use to deliver atomized therapeutic agent to a patient, the nozzle 41 is in a generally horizontal position and the suction line 50 is in a generally vertical position. The nozzle 41 is an elongated tube having an internal channel with a nozzle inlet 44 at one end and a nozzle outlet 46 at the opposite end. A nozzle longitudinal axis 42 passes through the center of the nozzle inlet 44 and the center of the nozzle outlet 46. The exterior surface of the nozzle 41 includes a pair of flanges 45 that secure the nozzle assembly 40 in place when the nebulizer 10 is assembled. Specifically, on the lower side of the nozzle 41, the pair of flanges 45 are located on either side of a lower slot 64 in the nebulizer lower part 60, thereby holding the nozzle assembly 40 in place when the nozzle assembly 40 is positioned between the nebulizer upper part 12 and the nebulizer lower part 60. As shown in Figures 1 and 4, at least one of the flanges can also extend along the outer periphery of the nozzle 41 to the upper side of the nozzle 41 so that the flange rests against the upper inner wall 18 when the nozzle 41 is positioned within the first upper slot 32.

[0020] When nebulizer 10 is in use, a supply of gas, such as air, is coupled to nozzle inlet 44 to force the gas through nozzle 41 toward nozzle outlet 46. For example, the gas supply may be a pump or canister of pressurized gas. The interior channel of nozzle 41 is shaped so that nozzle outlet 46 is narrower than nozzle inlet 44. This narrowing shape of the interior channel creates a phenomenon known as the Venturi effect, whereby air flowing from the gas supply through the interior channel accelerates, creating a zone of low pressure at nozzle outlet 46.

[0021] The nozzle assembly also includes a low-pressure chamber 47 where the nozzle outlet 46 and the suction line outlet 56 intersect. The low-pressure chamber 47 is a zone of low pressure resulting from air passing through an aperture at the nozzle outlet 46 that is narrower than the aperture at the nozzle inlet 44. This low-pressure zone draws the therapeutic agent up from the suction line 50 and into the low-pressure chamber 47, where the low-pressure conditions atomize the therapeutic agent into small aerosol droplets. The low-pressure chamber 47 also includes a low-pressure chamber outlet 48 through which the aerosol droplets exit the nozzle assembly 40 and travel toward the mouthpiece 24. The low-pressure chamber 47 and the low-pressure chamber outlet 48 are adjacent to the internal aperture of the vent 20 when the nozzle assembly 40 is positioned within the first upper slot 32, the second upper slot 33, and the third upper slot 34, as indicated by the upward arrows in FIG. 4 . As explained above, the location of vent 20 further increases the pressure drop across low pressure chamber 47 , further accelerating the aerosol droplets of medication exiting low pressure chamber outlet 48 .

[0022] Although somewhat similar in shape to nozzle 41, suction line 50 is an elongated tube with an internal channel having a suction line inlet 54 at one end of the internal channel and a suction line outlet 56 at the opposite end of the internal channel. Suction line longitudinal axis 52 passes through the center of suction line inlet 54 and the center of suction line outlet 56. When the three components of nebulizer 12 are assembled, suction line 50 sits within reservoir 66 of nebulizer lower portion 60, with suction line inlet 54 immersed in the medication within reservoir 66. A zone of low pressure in low-pressure chamber 47 draws medication from reservoir 66 up through the internal channel of suction line 50, through suction line outlet 56, and into low-pressure chamber 47, where it mixes with the gas flow from nozzle 41 and the low-pressure conditions atomize the medication into an aerosol of droplets. Similar to nozzle 41, the interior channel of suction line 50 may be narrower near suction line outlet 56 than near suction line inlet 54 to take advantage of the Venturi effect, which accelerates the medication as it is drawn up through suction line 50. As further described in connection with Figures 6 and 7, the exterior surface of suction line 50 includes a number of bosses 57 that aid in mounting suction line 50 in the proper position within nebulizer lower section 60.

[0023] Referring again to FIGS. 1-4 , when the nebulizer 10 is assembled and used to deliver a therapeutic agent to a patient, a gas, such as air, is provided to the nozzle inlet 44 by a gas supply. The gas flow rate to the nozzle inlet 44 can be selected based on the dimensions of the nebulizer and the characteristics of the therapeutic agent being nebulized. Exemplary gas flow rates from the gas supply to the nozzle inlet 44 can range from less than 1 liter per minute to a maximum of 15 liters per minute. As the gas travels from the nozzle inlet 44 to the nozzle outlet 46, the narrowing of the nozzle 41's internal channel accelerates the gas, creating a low-pressure condition in the low-pressure chamber 47. In other words, the low-pressure condition is the difference in pressure in the low-pressure chamber 47 relative to the pressure in the reservoir 66 where the therapeutic agent is located. The low-pressure condition created as the gas flows from the gas supply through the nozzle 41 can be referred to as the initial pressure. A typical range for the initial pressure can be -1 to -3 cmH2O. However, the nebulizer can be configured so that the medication is atomized only when the pressure in the low-pressure chamber 47 drops below the operating pressure as the medication is drawn up through the suction line 50. In other words, the nebulizer is configured so that the initial pressure is insufficient to draw the medication through the suction line 50. The operating pressure, which can range from -3 to -52 cmH2O, can be achieved when a patient inhales with the nebulizer positioned in the patient's mouth. The operating pressure in the low-pressure chamber 47 is achieved by gas flow from the gas supply through the nozzle 41 in combination with the patient's inhalation. Configuring the nebulizer so that the operating pressure is achieved only when the patient inhales in combination with the gas flow reduces atomization of the medication when the patient is not inhaling, thus reducing medication waste.

[0024] Once the operating pressure is achieved, the pressure difference between the low-pressure chamber 47 and the reservoir 66 draws the medication up through the suction line 50, where it mixes with the gas flowing through the nozzle 41 and atomizes it into an aerosol of droplets. As shown in FIG. 5 , the gas flowing through the nozzle 41 pushes the aerosol of medication droplets out the low-pressure chamber outlet 48, where it strikes the impact surface 31 of the diffuser 30. Impact with the impact surface 31 causes the medication droplets to break up into smaller droplets, thereby facilitating inhalation into the lungs. After encountering the diffuser 30, the aerosol of droplets flows through the upper chamber 22 toward the mouthpiece 24. The upper chamber 22 is located between the internal aperture of the mouthpiece 24 and the curved portion of the upper wall 14. When the nebulizer is in use with a patient, the upper chamber 22 is located at an elevated position above the low-pressure chamber outlet 48 and the impact surface 31 of the diffuser. The elevated position of the upper chamber 22 allows larger droplets of medication to fall back into the reservoir 66 by gravity, while smaller droplets of medication continue to flow into the mouthpiece 24. Thus, the design of the upper chamber 22 is advantageous because it is generally preferable to have the patient inhale relatively small droplets of medication, which are more likely to be inhaled into the lungs, while larger droplets are more likely to be lodged in the patient's mouth and throat.

[0025] The mouthpiece 24 has a generally cylindrical shape and is sized to fit into a patient's mouth. The mouthpiece 24 rests on the upper outer wall 19 and has an inner aperture adjacent to the upper chamber 22 and an outer aperture that fits into the patient's mouth. The mouthpiece 24 is positioned in close proximity to the low-pressure chamber outlet 48 and the diffuser 30 to minimize the distance the medication droplets must travel to reach the patient's mouth and lungs. If the medication droplets have a longer distance to travel, the droplets are more likely to collide with each other and coalesce into larger, less desirable droplets. Therefore, to promote smaller droplet size and medication uptake, the mouthpiece 24 is in close proximity to the low-pressure chamber outlet 48 and the diffuser 30.

[0026] 6 and 7, the nebulizer lower portion 60 is shown in more detail. The nebulizer lower portion 60 includes a lower wall 62 surrounding a reservoir 66. Although not shown in FIGS. 6 and 7, the reservoir 66 contains a liquid medication that is atomized and administered to a patient. The lower wall includes a lower slot 64 that receives the lower side of the nozzle 41 when the nebulizer lower portion 60, nozzle assembly 40, and nebulizer upper portion 12 are coupled together according to the arrangement shown in FIG. 1. The lower portion of the reservoir 66 includes a mount 68 that includes a plurality of protruding supports 69. The supports 69 are configured to receive the aspiration line 50 when the nebulizer lower portion 60, nozzle assembly 40, and nebulizer upper portion 12 are coupled together according to the arrangement shown in FIG. 1. The supports 69 are shaped to engage with bosses 57 located on the exterior of the aspiration line 50. In alternative embodiments of the nebulizer, the configuration of the lower slot 64 and mount 68 can be modified to receive nozzle assemblies having other shapes and sizes.

[0027] The exemplary nebulizer lower portion shown in Figures 6 and 7 can be replaced with other types of nebulizer components that deliver therapeutic agent to the nebulizer. As an example, the nebulizer lower portion may include a piercing mechanism to which a drug ampoule can be attached. A drug ampoule can be a sealed container that contains one or more doses of drug, and when the drug is depleted, the drug ampoule can be removed and replaced with a new drug ampoule.

[0028] The nebulizers shown in Figures 1-7 are examples of oral nebulizers in which the therapeutic agent is atomized in proximity to the opening of the patient's mouth. However, it should be understood that the components of the exemplary nebulizers can be modified to allow the nebulizer to be used as a ventilator nebulizer or a metered dose nebulizer.

[0029] 8, 9A, 9B, and 9C, interchangeability of nebulizer components will be described in further detail. As previously mentioned, an advantage of the design of the nebulizer embodiments described herein is that one or more of the nebulizer components can be interchanged with similar corresponding components. Similar corresponding components may have one or more different characteristics, such as different dimensions, configurations, or textures, which result in changes in nebulizer performance. Because droplet size of the nebulized medication is important for effective delivery of the medication to the patient's lungs, the ability to control droplet size by customizing the nebulizer configuration provides a significant advantage.

[0030] As an example, a user, such as a medication provider, healthcare provider, or patient, can replace the nebulizer top 12 of the embodiment shown in Figures 1-5 with a corresponding nebulizer top 112 shown in Figure 8. The corresponding nebulizer top 112 has features similar to those of the nebulizer 12 so that it can be coupled to the nozzle assembly 40 and the nebulizer bottom 60. The nebulizer top 112 includes an upper outer edge 116 that surrounds an upper top wall 114. The upper top wall 114 includes a horizontal, planar portion and a curved portion that partially defines an upper chamber 122 and supports a removable sensor module 180. The upper top wall 114 includes an external opening for a vent 120, which is partially defined by a front vent wall 136 and a rear vent wall 135. Similar to the nebulizer top 12, the nebulizer top 112 includes a first upper slot 132, a second upper slot 133, and a third upper slot 134 that receive a nozzle assembly. A diffuser 130 extends downward from the upper interior surface of the nebulizer top 112 and has an impingement surface 131. The location of the impingement surface 131 of the diffuser 130 defines an offset distance 138 from the low-pressure chamber outlet of a nozzle assembly that can be coupled to the nebulizer top 112. Finally, the mouthpiece 124 is shaped to fit within a patient's mouth and deliver atomized therapeutic agent. The descriptions provided above of the components of the nebulizer top 12 in connection with FIGS. 1-5 generally apply to corresponding components of the nebulizer top 112 having the same last two digits in their reference numerals. Therefore, these further descriptions will not be repeated for the nebulizer top 112.

[0031] However, the nebulizer top 112 may have one or more characteristics that differ from those of the nebulizer top 12, thereby producing different results when the nebulizer is operated. Examples of characteristics that may differ in the nebulizer top 112 relative to the nebulizer top 12 include the shape of the vent 120, the size and shape of the mouthpiece 124, and the shape, texture, or location of the diffuser 130. Taking the example of the location of the diffuser 130, replacing the nebulizer top 12 with a nebulizer top 112 in which the diffuser 130 is positioned closer to the nozzle assembly reduces the offset distance, which generally has the effect of producing smaller atomized medication droplets. As another example, the density or viscosity of a particular medication may require a diffuser with a different shape or texture to optimize delivery of the therapeutic agent to the patient.

[0032] In another example of nebulizer component interchangeability, a user can replace nozzle assembly 40 with a corresponding nozzle assembly, such as one of the nozzle assemblies shown in FIGS. 9A, 9B, and 9C, as a replacement for the nebulizer top. Corresponding nozzle assemblies 140, 240, and 340 in FIGS. 9A, 9B, and 9C have similar features to nozzle assembly 40 so that they can be easily coupled to the nebulizer top and bottom in a manner similar to that described in connection with FIGS. 1-7, respectively. Nozzle assembly 140 includes a nozzle 141 oriented generally perpendicular to suction line 150. Nozzle 141 includes an internal channel having a nozzle inlet 144 at one end and a narrower nozzle outlet 146 at the opposite end. A nozzle longitudinal axis 142 passes through the centers of nozzle inlet 144 and nozzle outlet 146. Similarly, suction line 150 comprises an internal channel having suction line inlet 154 at one end and narrower suction line outlet 156 at the opposite end. Suction line longitudinal axis 152 passes through the centers of suction line inlet 154 and suction line outlet 156. Nozzle assembly 140 further comprises a low-pressure chamber 147 where nozzle outlet 146 and suction line outlet 156 intersect. When the nebulizer is operating, a pressure differential, referred to as the operating pressure, within low-pressure chamber 147 draws therapeutic agent from the reservoir through suction line 150, where it mixes with gas flowing through nozzle 141 and is atomized to form an aerosol of therapeutic agent droplets that exit through low-pressure chamber outlet 148. Finally, the suction line includes boss 157 to aid in mounting nozzle assembly 140 within the reservoir, and the lower surface of nozzle 141 includes flange 145 to aid in mounting the nozzle assembly to the bottom of the nebulizer. The descriptions provided above of the components of nozzle assembly 40 in connection with Figures 1, 4, and 5 generally apply to corresponding components of nozzle assembly 140 having the same last two digits in their reference numbers. Accordingly, these further descriptions will not be repeated for nozzle assembly 112.

[0033] Figure 9B shows nozzle assembly 240, and Figure 9C shows nozzle assembly 340. The components of nozzle assembly 240 and nozzle assembly 340 are generally similar to the components of nozzle assembly 40 and nozzle assembly 140, which have the same last two digits in their reference numbers. Therefore, further description of the components of nozzle assembly 240 and nozzle assembly 340 will not be repeated.

[0034] However, while the components of the aforementioned nozzle assemblies are generally similar, each may have unique characteristics that produce different results when the nebulizer is operated. Examples of characteristics that may differ between exemplary nozzle assemblies include the size of the nozzle outlet, the size of the suction line outlet, and the size of the low-pressure chamber. Thus, a nozzle assembly with characteristics optimized for the density or viscosity of the drug can be selected, thereby producing a drug droplet size that improves delivery of the atomized therapeutic agent to the patient.

[0035] Figures 10 and 11 provide examples of test data collected from two different configurations of nebulizer components for a drug having a particular density and viscosity. The test data demonstrate that varying the characteristics of the nebulizer components, such as the offset distance, nozzle outlet size, suction line outlet size, or diffuser size, affects the size of droplets in the atomized therapeutic agent. Referring to Figure 10, the test data for the first nebulizer configuration shows a median droplet size ranging from 1.90 microns to 2.25 microns. The data further demonstrate that the percentage of particles in the test sample falling within the range of 0.1 microns to 5 microns ranged from 84.27% to 88.10%. In comparison, referring to Figure 11, the test data for the second nebulizer configuration shows a median droplet size ranging from 2.92 microns to 3.30 microns. The data further demonstrate that the percentage of particles in the test sample falling within the range of 0.1 microns to 5 microns ranged from 77.06% to 83.94%. Thus, if the therapeutic agent tested targets a smaller droplet size, the test data may indicate that a first nebulizer configuration provides better results than a second nebulizer configuration. Given that various variables involving the agent and nebulizer characteristics can affect nebulizer performance, similar additional testing can be used to create a lookup table showing the performance of different nebulizer configurations. Such a lookup table can be used by a therapeutic agent provider, a healthcare provider, or a patient to select the optimal nebulizer configuration.

[0036] Referring now to FIGS. 12-17, the functionality of a nebulizer's sensor module is described in more detail. As previously mentioned, the sensor module can be attached to the nebulizer and can include one or more sensors for collecting data related to the nebulizer. Previously described FIGS. 4 and 8 include examples of sensor module 80 and sensor module 180, respectively. In certain exemplary embodiments, the sensor module can be removably coupled to the nebulizer so that it can be easily replaced, adjusted, or maintained. Alternatively, in certain embodiments, the sensor module can be permanently attached to the nebulizer. As shown in FIGS. 4 and 8, the sensor module is preferably attached to a component of the nebulizer that also includes the mouthpiece. Taking the example shown in FIGS. 4 and 8, the nebulizer upper portion, including the mouthpiece and sensor module, can be retained by the user for repeated use, while other components of the nebulizer, such as the nozzle assembly and / or the nebulizer lower portion, can be replaced after use or from time to time. For example, the nebulizer lower portion may be a disposable component containing a single dose of medication, after which the single dose of medication is administered to the patient the nebulizer lower portion is disposed of and a new replacement nebulizer lower portion is provided for the next dose of medication for the patient.

[0037] As shown in the example of FIG. 4 , the sensor module 80 is preferably located proximate the mouthpiece 24, which is an optimal location for collecting data related to the nebulizer. Positioning the sensor module 80 on the curved portion of the upper top wall 14 adjacent to the upper chamber 22 is advantageous because one or more sensors of the sensor module can collect data regarding the atomized aerosol of therapeutic agent as it is inhaled by the patient and exits the nebulizer 10 through the mouthpiece 24, and can collect data regarding the patient's exhaled breath returning to the nebulizer 10. The location of the sensor module 80 is also advantageous because there is a line of sight to the reservoir 66 in the lower nebulizer section 60, allowing for monitoring of the therapeutic agent within the reservoir. In some examples, one or more sensors of the sensor module can extend into the upper chamber 22 toward the mouthpiece 24 or toward the lower nebulizer section 60. While a single sensor module is shown in the examples of FIGS. 4 and 8 , in other embodiments, there may be multiple sensor modules at various locations on the nebulizer. Furthermore, the functionality associated with the sensor module may be distributed among separate components, such that, by way of example, the sensor is located within the sensor module 80, but the processor and / or transmitter that receives the data collected by the sensor is located in a different location on the nebulizer.

[0038] Referring now to FIG. 12 , an exemplary method 400 for using the sensing capabilities of a nebulizer is shown. Beginning at operation 402, consistent with the configurable nebulizers described herein, a user can provide a nebulizer top and a nebulizer bottom. As previously described, the user can be a therapeutic agent supplier, a healthcare provider, or a patient. In operation 404, the user inserts a nozzle assembly between the nebulizer top and the nebulizer bottom, coupling the components together to form the configurable nebulizer. The nebulizer top, nozzle assembly, and nebulizer bottom can be removably coupled together so that they can be easily separated later by hand or using a tool such as a screwdriver. The nebulizer top, nebulizer bottom, and nozzle assembly can be selected based on their specific characteristics (e.g., dimensions, features, texture) to optimize the nebulizer's performance to deliver an atomized aerosol of therapeutic agent droplets having a particular size or size range.

[0039] In operation 406, a gas supply is connected to the nozzle inlet of the nozzle assembly, providing a flow of gas, such as air, to the nebulizer. When the nebulizer is inserted into a patient's mouth and the patient inhales, the combination of the patient's inhalation and the flow of gas from the gas supply through the nozzle assembly creates a pressure differential sufficient to meet the operating pressure. As previously explained, the operating pressure is the pressure difference between the low-pressure chamber of the nozzle assembly and the reservoir containing the medication. This pressure differential is sufficient to draw the medication upward through the suction line and into the low-pressure chamber, where it mixes with the gas flow passing through the nozzle assembly and is atomized into an aerosol of medication droplets. As the patient inhales toward the mouthpiece, the medication droplets can impact the impact surface of the diffuser, where they break up into smaller droplets. In operation 408, the patient inhales, drawing the atomized medication through the nebulizer mouthpiece and into the patient's mouth and lungs.

[0040] In operation 410, sensors in the sensor module can detect signals associated with the nebulizer and collect data related to the signals. As further described in connection with FIGS. 13-17, the sensors and collected data can relate to various characteristics, including humidity, temperature, airflow, air pressure, therapeutic agent levels, or other biological characteristics. In operation 412, the sensors provide the collected data to a processor, where the data is analyzed. FIGS. 13, 14, and 15 provide example methods for analyzing and using data collected by the sensor module. Data collected by one or more sensors in the sensor module can be analyzed for various purposes related to verifying effective delivery of therapeutic agents to a patient and evaluating aspects of the patient's health. It should be understood that the methods of FIGS. 13, 14, and 15 are illustrative, and that the data collected by the sensor module can have various uses.

[0041] Referring to FIG. 13 , method 420 illustrates an application for humidity data that may be collected by a sensor module. Method 420 emphasizes that the sensor module may include multiple sensors that collect different categories of data. For example, in operation 422, the sensor module may include an internal humidity sensor that collects humidity measurements from the interior of the nebulizer and an external humidity sensor that collects humidity measurements from the exterior of the nebulizer. Referring to sensor module 80 of FIG. 4 , the external humidity sensor may be located on an outward-facing surface of sensor module 80, while the internal humidity sensor may be located on a portion of the sensor module that faces the interior of the nebulizer. In operation 424, a processor located within the sensor module may execute instructions to calculate relative humidity based on the difference between the internal humidity data and the external humidity data. The relative humidity may provide an indication of how much medication has been inhaled by the patient. In operation 426, the processor executes instructions to determine an estimated medication intake based on the relative humidity data. In operation 428, the previous operations may be repeated so that the relative humidity and estimated medication intake are tracked over time. Finally, in operation 430, the processor can execute instructions to generate and provide a report of the relative humidity calculations and estimated medication intake over time. Such a report can be useful to a healthcare provider monitoring the levels of therapeutic medication administered to a patient. As further described in connection with Figures 16 and 17, the sensor module can include a transmitter to enable wired or wireless transmission of collected data and / or any generated reports to a computer, such as a handheld tablet or a nearby desktop computer.

[0042] 14 , method 440 illustrates applications for other types of data that the sensor module can collect. In exemplary method 440, the sensor module includes a temperature sensor, a humidity sensor, an air pressure sensor, and an airflow sensor. As shown in operation 442, the aforementioned sensors of the sensor module collect data related to a patient inhaling and exhaling into the nebulizer. In operation 444, a processor can receive the collected data from the sensors and execute instructions to analyze the collected data to determine aspects of the patient's pulmonary function, including vital capacity, lung volume, and flow rate as the patient inhales and exhales. The processor that analyzes the collected data can be a component of the sensor module, or can be located in another portion of the nebulizer, or can be a component of an external computing device, such as a tablet computer or desktop computer. In operation 446, operations 410, 412, 442, and 444 can be repeated to determine the patient's pulmonary function over time. Finally, in operation 448, the processor can execute instructions to generate a report of the analysis indicative of the patient's pulmonary function over time.

[0043] 15 , method 460 illustrates the use of a nebulizer as a ventilator nebulizer, where the nebulizer is attached to a ventilator that is assisting a patient's breathing. In operation 462, the air pressure sensor, airflow sensor, and humidity sensor of the sensor module can collect data as the patient inhales and exhales through the ventilator nebulizer. In operation 464, the processor of the sensor module can determine the patient's inhalation and exhalation frequency over time by analyzing the data collected in operation 462. In operation 466, the processor can transmit the breathing frequency to a ventilator controller that controls the operation of the ventilator. Finally, in operation 468, the ventilator controller can use the breathing frequency data to modify the ventilator frequency as needed to assist the patient's breathing.

[0044] 16 and 17, an example of a sensor module that can be attached to one of the configurable nebulizers described previously in this specification is shown. In FIG. 16, the sensor module 500 includes a power source 506, such as a battery, that provides power to the other components of the sensor module 500. The sensor module 500 also includes one or more sensors 512, such as a temperature sensor, a humidity sensor, a pressure sensor, an airflow sensor, a pathogen sensor, an optical biosensor, or a drug level sensor. As previously mentioned, the temperature sensor, humidity sensor, pressure sensor, and airflow sensor can collect data related to the patient's inhalation from the nebulizer and exhalation into the nebulizer. As an additional example of a sensor, a pathogen sensor can analyze the patient's breath to detect specific bacteria or viruses. The optical biosensor can take various forms and can be configured for one of fluorescence detection, surface plasmon detection, surface-enhanced Raman scattering detection, colorimetric detection, fiber Bragg grating detection, and multimode optical fiber detection. Finally, the medication level sensor can take the form of an optical or ultrasonic sensor capable of measuring the level of medication located beneath the nebulizer.

[0045] One or more of the aforementioned sensors may be located at various locations within and on the sensor module so that data can be collected from inside and / or outside the nebulizer. Referring to Figure 16, the sensor module 500 also includes a transmission module 508 that provides a wired and / or wireless communication link between the sensor module 500 and an external device. In the example of Figure 16, an external computing device 525 in the form of a portable tablet is shown exchanging data 520 with the sensor module 500 via the communication link provided by the transmission module 508. The data 520 exchanged between the sensor module 500 and the computing device 525 may include sensor data collected by the sensor 512 and control commands sent from the computing device 525 to the sensor module 500.

[0046] FIG. 17 shows another sensor module that can be attached to a nebulizer and is more complex than the sensor module of FIG. 16 . Similar to sensor module 500, sensor module 550 includes a power source 556, one or more sensors 562, and a transmission module 558. In addition, sensor module 550 is more complex in that it includes a processor 552, memory 554, a storage device 555, and an input / output interface 560. Processor 552 may be a hardware processor, such as an application-specific integrated circuit, that executes instructions stored in memory to analyze data collected by the sensors and / or to execute instructions received from an external computer 575. Storage device 555 may be non-volatile memory that stores data collected by sensors 562 and instructions for execution by processor 552. Transmission module 558 can provide a wired and / or wireless communication link for exchanging data 570 between sensor module 550 and external computer 575. Finally, the input / output interface 560 may take the form of one or more buttons, indicators, or a touch screen to allow control and communication with a user.

[0047] Assumptions and definitions For any figure shown and described herein, one or more of the components may be omitted, added to, repeated in, and / or substituted for components from another figure. Accordingly, the embodiment shown in a particular figure should not be considered limited to the specific arrangement of components shown in such figure. Furthermore, if a component in a figure is described but not explicitly shown or labeled in that figure, the label used for the corresponding component in another figure may imply that component. Conversely, if a component in a figure is labeled but not described, the description of such component may be substantially the same as the description of the corresponding component in another figure.

[0048] With respect to the exemplary methods described herein, it should be understood that in alternative embodiments, certain steps of these methods may be performed in a different order, performed in parallel, or omitted. Furthermore, in alternative embodiments, additional steps may be added to the exemplary methods described herein. Accordingly, the exemplary methods provided herein should be construed as illustrative, rather than limiting, of the present disclosure.

[0049] Referring generally to the examples herein, any component of the nebulizer described herein can be fabricated from a single piece (e.g., by molding, injection molding, die casting, a 3D printing process, an extrusion process, a stamping process, or other prototyping method). Additionally, or alternatively, a device component can be fabricated from multiple parts that are mechanically coupled to one another. In such cases, the multiple parts can be mechanically coupled to one another using one or more of a number of coupling methods, including, but not limited to, epoxy, welding, fastening devices, compression fittings, mating threads, and slotted fittings. The one or more parts that are mechanically coupled to one another can be coupled to one another in one or more of a number of ways, including, but not limited to, mating, hinged, detachable, slidable, and screwed couplings.

[0050] As used herein, "removably coupled" means components that can be joined together to form a single unit, but can also be separated by hand or with a tool. Examples of means for removably coupling nebulizer components include, but are not limited to, snap-fit ​​features, compression fittings, interlocking features, magnets, and fasteners such as screws.

[0051] As used herein, the term "therapeutic agent" should be interpreted broadly to include drugs, vaccines, and any other compound that can be delivered to a human by a nebulizer for medical treatment.

[0052] Unless otherwise specified, terms such as "horizontal" and "vertical" are used herein to refer to the position when the nebulizer is in use to administer a therapeutic agent to a patient.

[0053] Terms such as "first" and "second" are used merely to distinguish one element (or state of an element) from another. Such terms are not meant to indicate a preference, and are not meant to limit the embodiments described herein. In the exemplary embodiments described herein, numerous specific details are set forth to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention may be practiced without these specific details. In other instances, well-known features have not been described in detail to avoid unnecessarily obscuring the description.

[0054] The terms "a," "an," and "the" are intended to include plural options, e.g., at least one. As used herein, the terms "including," "with," and / or "having" are defined as comprising (i.e., open language) unless otherwise specified.

[0055] Values, ranges, or characteristics may be expressed herein as "about," "from" one particular value, and / or "about" another particular value. When such values ​​or ranges are expressed, other disclosed embodiments include the recited particular values ​​from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It will be further understood that there are a number of values ​​disclosed therein, and that each value, in addition to the value itself, is also herein disclosed as "about" that particular value. In other aspects, use of the term "about" can mean ±20% of the stated value, ±15% of the stated value, ±10% of the stated value, ±5% of the stated value, ±3% of the stated value, or ±1% of the stated value.

[0056] The embodiments described herein are made with reference to examples, but it should be understood by those skilled in the art that various modifications are well within the scope of the present disclosure. Those skilled in the art will understand that the exemplary embodiments described herein are not limited to any of the applications specifically discussed, and that the embodiments described herein are illustrative and not limiting. From the description of the exemplary embodiments, equivalents of the elements shown therein will be apparent to those skilled in the art, and methods of constructing other embodiments using the present disclosure will be apparent to practitioners of the art. Therefore, the scope of the exemplary embodiments is not limited herein.

Claims

1. 1. A nebulizer comprising: a nebulizer body, a nozzle assembly, and a diffuser; the nebulizer body includes a nebulizer mouthpiece, a nebulizer upper portion, and a nebulizer lower portion, the nebulizer upper portion being configured to be detachably coupled to the nebulizer lower portion; The nozzle assembly includes: an aspiration line having an aspiration line inlet, an aspiration line outlet, and an aspiration line longitudinal axis passing through the aspiration line inlet and the aspiration line outlet; a nozzle integrally joined to the suction line, the nozzle having a nozzle inlet, a nozzle outlet, and a nozzle longitudinal axis passing through the nozzle inlet and the nozzle outlet; the nozzle longitudinal axis is substantially perpendicular to the suction line longitudinal axis; the nozzle assembly is configured to be removably coupled to the nebulizer body between the nebulizer upper portion and the nebulizer lower portion; the diffuser projects from an inner surface of the nebulizer upper portion or the nebulizer lower portion toward the nozzle assembly and includes an impingement surface; at least one of the nebulizer upper section, the nebulizer lower section, and the nozzle assembly is interchangeable with a corresponding component having at least one different characteristic; A nebulizer wherein the corresponding component is selected to produce a target droplet size for a medicament disposed within the nebulizer.

2. the corresponding component comprises a second diffuser; 10. The nebulizer of claim 1, wherein the at least one different characteristic of the second diffuser is one of a shape, a size, a texture, and an offset distance from the nozzle assembly.

3. the diffuser protrudes from the inner surface of the nebulizer top a first distance from the nozzle assembly; the corresponding component is a second nebulizer top; the second nebulizer top includes a second diffuser protruding from an inner surface of the second nebulizer top; 10. The nebulizer of claim 1, wherein the at least one different characteristic of the second nebulizer upper portion is a second offset distance between the second diffuser and the nozzle assembly.

4. 4. The nebulizer of claim 3, wherein a second nozzle assembly is a second corresponding component that replaces the nozzle assembly, the second nozzle assembly having at least one dimension that is different from a dimension of the nozzle assembly.

5. the corresponding component is a second nozzle assembly; 2. The nebulizer of claim 1, wherein the at least one different characteristic of the second nozzle assembly is a nozzle outlet or a suction line outlet of the second nozzle assembly.

6. The upper part of the nebulizer a vent disposed in an upper wall of the upper portion of the nebulizer, the vent providing fluid communication between a low-pressure chamber within the nebulizer and the exterior of the nebulizer; an upper chamber disposed above the low-pressure chamber and adjacent to the mouthpiece; 2. The nebulizer of claim 1, wherein the diffuser is disposed between the low-pressure chamber and the upper chamber.

7. the nebulizer top includes a sensor module including at least one sensor; 10. The nebulizer of claim 1, wherein the at least one sensor is a temperature sensor, a humidity sensor, a pressure sensor, an airflow sensor, a pathogen sensor, an optical biosensor, or a drug level sensor.

8. the sensor module is detachably coupled to the nebulizer; 8. The nebulizer of claim 7, wherein the sensor module further comprises a processor, a storage device for storing data collected by the at least one sensor, and a transmitter for transmitting the data to an external computing device.

9. the humidity sensor is an internal humidity sensor that measures the internal humidity within the nebulizer; 8. The nebulizer of claim 7, wherein the sensor module further comprises an external humidity sensor that measures external humidity outside the nebulizer.

10. 8. The nebulizer of claim 7, wherein the temperature sensor is configured to measure one of the temperature of the medicament in the lower portion of the nebulizer, the temperature of the atomized medicament, the temperature of the air flowing through the mouthpiece, and the ambient temperature.

11. 8. The nebulizer of claim 7, wherein the optical biosensor is configured for one of fluorescence detection, surface plasmon detection, surface-enhanced Raman scattering detection, colorimetric detection, detection using a fiber Bragg grating, and detection using a multimode optical fiber.

12. The nebulizer of claim 7 , wherein the sensor module is used to determine an intake of the medication by a patient.

13. The nebulizer of claim 7 , wherein the sensor module is used to determine a patient's pulmonary function.

14. The nebulizer of claim 7 , wherein the sensor module is in communication with a ventilator.

15. 10. The nebulizer of claim 1, wherein the nebulizer is a ventilator nebulizer coupled to a ventilator.

16. the nebulizer is a metered dose nebulizer; The nebulizer of claim 1 , wherein the metered dose nebulizer comprises a canister port and a valve.

17. 1. A method of using a nebulizer, comprising: providing a nebulizer upper portion and a nebulizer lower portion; inserting a nozzle assembly between the nebulizer upper portion and the nebulizer lower portion, and coupling the nebulizer upper portion to the nebulizer lower portion with the nozzle assembly positioned between the nebulizer upper portion and the nebulizer lower portion; coupling a gas supply to a nozzle inlet of the nozzle assembly; providing an atomized medicament flowing from a mouthpiece of the nebulizer; collecting data related to operation of the nebulizer using a sensor in a sensor module coupled to the nebulizer; providing the data to a processor that analyzes the data and generates a report related to the operation of the nebulizer; A method comprising:

18. the processor is located within the sensor module; the sensor is at least one sensor; 20. The method of claim 17, wherein the at least one sensor is a temperature sensor, a humidity sensor, a pressure sensor, an airflow sensor, a pathogen sensor, an optical biosensor, or a drug level sensor.

19. the humidity sensor is an internal humidity sensor that measures the internal humidity within the nebulizer; 20. The method of claim 18, wherein the sensor module further comprises an external humidity sensor that measures external humidity outside the nebulizer.

20. 19. The method of claim 18, wherein the temperature sensor is configured to measure one of the temperature of the medicament within the lower portion of the nebulizer, the temperature of the atomized medicament, the temperature of the air flowing through the mouthpiece, and the ambient temperature.

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