Dual Chamber Nebulization Device

JP2023541279A5Pending Publication Date: 2025-10-30SANOTIZE RES & DEV CORP
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Patent Information

Application Number
JP2023516651
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2020-09-16
Filing Date
2021-09-16
Publication Date
2025-10-30

AI Technical Summary

Technical Problem

Existing systems for administering nitric oxide (NO) are cumbersome, difficult to transport, require medical supervision, and pose risks of overdose due to NO's high reactivity, making self-administration challenging.

Method used

A dual chamber nebulizing device with separate pumps for each liquid, allowing for precise mixing of an active pharmaceutical ingredient precursor and an activator just before use, ensuring stability and safety during extended storage and user-friendly delivery.

Benefits of technology

Enables stable, controlled, and user-friendly delivery of nitric oxide releasing solutions, maintaining efficacy over extended storage periods and reducing the risk of overdose.

✦ Generated by Eureka AI based on patent content.

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Abstract

[Solution]
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Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 079,277, filed Sep. 16, 2020, the content of which is incorporated herein by reference.

[0002] The present invention generally relates to spraying devices and related methods. Accordingly, the present invention relates to the fields of mechanical technology and chemical technology.

Background Art

[0003] Among chemical substances, although various uses and applications can be expected, many are not practically usable due to various problems such as instability, difficulty in transportation and administration, and other reasons. An example of such a compound is nitric oxide (NO). NO is one of the main oxides of nitrogen. Since it is a free radical, it has an unpaired electron and is highly reactive. In mammals, NO is a signaling molecule in many physiological and pathological processes. For example, NO is biosynthesized in vivo from L-arginine, oxygen, and NADPH by various nitric oxide synthase enzymes and is known as endothelium-derived relaxing factor (EDRF). This is due, at least in part, to the fact that the vascular endothelium uses NO to send a relaxation signal to the surrounding smooth muscle, resulting in vasodilation. Thus, NO plays a role in conditions that benefit from vasodilation, particularly erectile dysfunction and angina pectoris.

[0004] Because NO is a free radical, it is highly reactive, making storage and administration for therapeutic purposes extremely difficult. For example, closed systems that directly administer NO gas to subjects from airtight gas cylinders have been the primary mechanism for administering NO for respiratory or dermatological treatments. Such systems are cumbersome, difficult to obtain, and difficult to transport. Furthermore, such systems typically carry a high risk of overdose and therefore must be administered under the direct supervision of a healthcare professional. Thus, there is a need for systems and devices that facilitate transport, mitigate or eliminate stability problems, and allow subjects to self-administer NO. [Overview of the project] [Means for solving the problem]

[0005] In one embodiment, the spraying device may have a liquid container comprising a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid. In one embodiment, the spraying device may have a first pump partially located in the first chamber and operable to draw in and hold the first liquid, and a second pump partially located in the second chamber and operable to draw in and hold the second liquid. In another embodiment, the spraying device may have a plurality of mixing spaces fluid-connected to the first and second pumps and operable to enable mixing of the first liquid and the second liquid. In yet another embodiment, the spraying device may have nozzles fluid-connected to the plurality of mixing spaces.

[0006] In another embodiment, the spraying device may have a liquid container comprising a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid. In one embodiment, the spraying device may include a first pump partially located in the first chamber and operable to draw in and hold the first liquid, and a second pump partially located in the second chamber and operable to draw in and hold the second liquid. In another embodiment, the spraying device may include mixing spaces fluidly coupled to the first and second pumps and operable to allow mixing of the first and second liquids. In one embodiment, the plurality of mixing spaces may be substantially empty between each operation of the pumps. The spraying device may further include a nozzle.

[0007] In another embodiment, the spraying device may have a liquid container comprising a plurality of chambers operable to hold a plurality of distinct liquids. In one embodiment, the spraying device may include a first pump partially located in a first chamber and operable to draw in and hold a first liquid, and a second pump partially located in a second chamber and operable to draw in and hold a second liquid. In another embodiment, the spraying device may include a plurality of mixing spaces fluidly coupled to the first and second pumps and operable to allow mixing of the first liquid and the second liquid. The spraying device may further have a nozzle.

[0008] In another embodiment, the method for dispensing the solution may include the steps of providing an active pharmaceutical ingredient (API) precursor to a first chamber of the liquid container of the spray device and an activator to a second chamber of the liquid container of the spray device. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor and the activator multiple times within the spray device. In another embodiment, the method may include the step of dispensing the solution from the spray device.

[0009] In another embodiment, the method for activating the solution may include the steps of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of the spray device and a solution containing an activator to a second chamber of the liquid container of the spray device. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device.

[0010] In another embodiment, a method for administering treatment may include the steps of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and an activator to a second chamber of the liquid container of the spray device. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution multiple times within the spray device. In another embodiment, the method may include the step of dispensing the mixed solution from the spray device to the treatment site.

[0011] In another embodiment, a method for administering treatment may include the steps of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and an activator to a second chamber of the liquid container of the spray device. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device to the treatment site.

[0012] In another embodiment, a method for providing a therapeutically effective amount of an unstable active pharmaceutical ingredient (API) may include the step of providing an API precursor-containing solution to a first chamber of a liquid container of a spray device. In one embodiment, the method may include the step of providing an activator-containing solution to a second chamber of the liquid container of the spray device. In another embodiment, the method may include the step of activating the therapeutically effective amount of the API precursor by mixing the API precursor-containing solution and the activator-containing solution multiple times within the spray device. In yet another embodiment, the method may include the step of dispensing the mixed solution to a treatment site.

[0013] In another embodiment, a method for producing a product suitable for administering a nitric oxide-releasing solution (NORS) after a long storage period may include the steps of providing a nitric oxide (NO) donor-containing solution to a first chamber of the liquid container of a spray device, and providing an activator-containing solution to a second chamber of the liquid container of the spray device. The method may further include the step of activating the NORS by mixing the NO donor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device.

[0014] Therefore, the following detailed description has been broadly outlined so that the present invention may be better understood and its contribution to the art may be better appreciated. Other features of the present invention will become apparent from the following detailed description of the invention in conjunction with the accompanying drawings and claims, or from the practice of the present invention. [Brief explanation of the drawing]

[0015] [Figure 1] Figure 1 is a side view of a dual-chamber spray device in an exemplary embodiment. [Figure 2] Figure 2 is an exploded view of a dual-chamber spray device in an exemplary embodiment. [Figure 3a] Figure 3a is a perspective view of a dual-chamber spray device fitted with a safety cap in an exemplary embodiment. [Figure 3b] Figure 3b is a side cross-sectional view and a front cross-sectional view of a dual-chamber spray device fitted with a safety cap, in an exemplary embodiment. [Figure 3c] Figure 3c is a side cross-sectional view of a dual-chamber spray device fitted with a safety cap in an exemplary embodiment. [Figure 4a] Figure 4a is a side view of a dual-chamber spray device with a safety cap attached, in an exemplary embodiment. [Figure 4b] Figure 4b is a side cross-sectional view of a dual-chamber spray device fitted with a safety cap in an exemplary embodiment. [Figure 4c] Figure 4c is a side cross-sectional view of a dual-chamber spray device fitted with a safety cap in an exemplary embodiment. [Figure 4d] Figure 4d is a side view of a dual-chamber spray device with a safety cap attached, in an exemplary embodiment. [Figure 4e]Figure 4e is a side cross-sectional view of a dual-chamber spray device with a safety cap attached in an exemplary embodiment. [Figure 4f] Figure 4f is a side cross-sectional view of a dual-chamber spray device with a safety cap attached in an exemplary embodiment. [Figure 5a] Figure 5a is a perspective view of a dual-chamber spray device in an exemplary embodiment. [Figure 5b] Figure 5b shows the flow path inside a dual-chamber spray device in an exemplary embodiment. [Figure 5c] Figure 5c shows the flow path through a dual-chamber spray device in an exemplary embodiment. [Figure 6a] Figure 6a is a side cross-sectional view of the pump of a dual-chamber spray device in an exemplary embodiment. [Figure 6b] Figure 6b is a side cross-sectional view of the pump of a dual-chamber spray device in an exemplary embodiment. [Figure 7] Figure 7 is a side cross-sectional view of a dual-chamber spray device in an exemplary embodiment. [Figure 8a] Figure 8a is a top view of the pump housing of a dual-chamber spray device in an exemplary embodiment. [Figure 8b] Figure 8b is a perspective view of a dual-chamber spray device in an exemplary embodiment. [Figure 8c] Figure 8c is a side view of a dual-chamber spray device in an exemplary embodiment. [Figure 9a] Figure 9a is a top view of the gasket of a dual-chamber spray device in an exemplary embodiment. [Figure 9b] Figure 9b is a perspective view of the gasket of a dual-chamber spray device in an exemplary embodiment. [Figure 9c] Figure 9c is a side cross-sectional view of the gasket of a dual-chamber spray device in an exemplary embodiment. [Figure 10a]Figure 10a is a top side view of a dual-chamber spray device in an exemplary embodiment. [Figure 10b] Figure 10b is a perspective view of the upper housing of a dual-chamber spray device in an exemplary embodiment. [Figure 10c] Figure 10c is a top view of the upper housing of a dual-chamber spray device in an exemplary embodiment. [Figure 11a] Figure 11a is a top view of the connection plate of a dual-chamber spray device in an exemplary embodiment. [Figure 11b] Figure 11b is a side view of the connection plate of a dual-chamber spray device in an exemplary embodiment. [Figure 11c] Figure 11c is a side cross-sectional view of the connection plate of a dual-chamber spray device in an exemplary embodiment. [Figure 11d] Figure 11d is a perspective view of the connection plate of a dual-chamber spray device in an exemplary embodiment. [Figure 12a] Figure 12a is a top side view of a dual-chamber spray device in an exemplary embodiment. [Figure 12b] Figure 12b is a perspective view of the upper housing of a dual-chamber spray device in an exemplary embodiment. [Figure 12c] Figure 12c is a top view of the upper housing of a dual-chamber spray device in an exemplary embodiment. [Figure 12d] Figure 12d is a side cross-sectional view of the upper housing of a dual-chamber spray device in an exemplary embodiment. [Figure 13a] Figure 13a is a top view of the support column of a dual-chamber spray device in an exemplary embodiment. [Figure 13b] Figure 13b is a side view of the support column of a dual-chamber spray device in an exemplary embodiment. [Figure 13c] Figure 13c is a perspective view of the support column of a dual-chamber spray device in an exemplary embodiment. [Figure 13d] Figure 13d is a top view of the support column of a dual-chamber spray device in an exemplary embodiment. [Figure 14a] Figure 14a is a perspective view of a dual-chamber spray device in an exemplary embodiment. [Figure 14b] Figure 14b is a front view of a dual-chamber spray device in an exemplary embodiment. [Figure 14c] Figure 14c is a side view of a dual-chamber spray device in an exemplary embodiment. [Figure 15] Figure 15 is a front view of a dual-chamber spray device in an exemplary embodiment. [Figure 16] Figure 16 is an exploded view of a dual-chamber spray device in an exemplary embodiment. [Figure 17a] Figure 17a is a front view of a dual-chamber spray device in an exemplary embodiment. [Figure 17b] Figure 17b is an exploded view of a dual-chamber spray device in an exemplary embodiment. [Figure 18a] Figure 18a is a three-dimensional rendering of a dual-chamber spray device in an exemplary embodiment. [Figure 18b] Figure 18b is a three-dimensional rendering of a dual-chamber spray device in an exemplary embodiment. [Figure 18c] Figure 18c is a three-dimensional rendering of a dual-chamber spray device in an exemplary embodiment. [Figure 19a] Figure 19a is a three-dimensional rendering perspective view of a dual-chamber spray device in an exemplary embodiment. [Figure 19b] Figure 19b is a three-dimensional rendering perspective view of a dual-chamber spray device in an exemplary embodiment. [Figure 20] Figure 20 shows how to use a dual-chamber spray device in an exemplary embodiment. [Figure 21]Figure 21 shows a spraying device in an exemplary embodiment. [Figure 22] Figure 22 shows a spraying device in an exemplary embodiment. [Figure 23] Figure 23 shows a spraying device in an exemplary embodiment. [Figure 24] Figure 24 shows a method of a spraying device in an exemplary embodiment. [Figure 25] Figure 25 shows a method of a spraying device in an exemplary embodiment. [Figure 26] Figure 26 shows a method of a spraying device in an exemplary embodiment. [Figure 27] Figure 27 shows a method of a spraying device in an exemplary embodiment. [Figure 28] Figure 28 shows a method of a spraying device in an exemplary embodiment. [Figure 29a] Figure 29a shows a nasal spray device in an exemplary embodiment. [Figure 29b] Figure 29b shows a spraying device in an exemplary embodiment. [Figure 29c] Figure 29c shows a throat spray device in an exemplary embodiment. These drawings are provided to illustrate various aspects of the invention and are not intended to limit the scope in terms of dimensions, materials, configuration, arrangement, or proportions, unless limited by the claims. [Modes for carrying out the invention]

[0016] While these exemplary embodiments are described in sufficient detail to enable those skilled in the art to carry out the invention, it should be understood that other embodiments can also be realized and that various modifications can be made to the invention without departing from the spirit and scope of the invention. Accordingly, the following more detailed description of embodiments of the invention is not intended to limit the claimed scope of the invention, but is presented merely as an example to illustrate the features and characteristics of the invention, the best mode of operation of the invention, and to enable those skilled in the art to fully carry out the invention. Accordingly, the scope of the invention should be defined solely by the appended claims.

[0017] definition In describing and claiming the present invention, the following terms shall be used according to the definitions set forth below.

[0018] In this specification, the singular forms "a," "an," and "the" explicitly support multiple references unless the context clearly indicates otherwise.

[0019] In this disclosure, “comprise,” “comprising,” “containing,” and “having,” etc., may have the meanings assigned to them under U.S. patent law, and may mean “includes,” “including,” etc., and are generally interpreted as open-ended terms. The terms “consisting of” or “consists of” are closed terms and include only the components, structures, processes, etc., specifically enumerated in connection with such terms, and are in accordance with U.S. patent law. “Consisting essentially of” or “consists essentially of” has the meanings generally assigned by U.S. patent law. In particular, such terms are generally closed terms, with the exception of allowing the inclusion of additional items, materials, components, processes, or elements that do not materially affect the basic and novel characteristics or functions of the item used in connection with them. For example, trace elements present in a composition but not affecting the composition's properties or characteristics may be acceptable under the term "consisting essentially of," even if they are not explicitly listed in the list of items following such a term. It is understood that, when open-ended terms such as "comprising" or "including" are used herein, the terms "consisting of" and "consisting essentially of" should also be given direct support as if they were explicitly stated, and vice versa.

[0020] In this specification and in the claims, terms such as “first,” “second,” “third,” and “fourth” are used to distinguish similar elements and are not necessarily used to describe a specific sequential or chronological order. Terms used in this manner are interchangeable under appropriate circumstances, and it should be understood that the embodiments described herein may, for example, operate in an order other than those shown herein or otherwise described. Similarly, where a method is described as comprising a series of steps, the presented order of such steps is not necessarily the only order in which such steps may be performed, some of the described steps may be omitted, and / or other steps not described herein may be added to the method.

[0021] In this specification and in the claims, terms such as “left,” “right,” “front,” “back,” “top,” “bottom,” “over,” and “under” are used for descriptive purposes and are not necessarily intended to describe permanent relative positions. Terms used in this manner are interchangeable under appropriate circumstances, and it should be understood that the embodiments described herein may, for example, operate in orientations other than those shown herein or otherwise described. In this specification, the term “coupled” is defined as being connected directly or indirectly by mechanical or non-mechanical means. In this specification, objects or structures described as “adjacent” to each other may be in physical contact with each other, in close proximity to each other, or in the same general area or location, depending on the context in which the phrase is used. In this specification, the occurrence of the phrases “in one embodiment” or “in one aspect” does not necessarily refer to the same embodiment or aspect.

[0022] In this specification, any reference to “one embodiment” means that a particular feature, configuration, or characteristic described in relation to that embodiment is included in at least one embodiment. Therefore, the appearance of the phrase “in one embodiment” in various places in this specification does not necessarily all refer to the same embodiment.

[0023] This specification may refer to devices, configurations, systems, or methods that provide “improved” performance. Unless otherwise specified, such “improvement” should be understood as the degree of benefit obtained based on a comparison with devices, configurations, systems, or methods in the prior art. Furthermore, it should be understood that the degree of improved performance may vary among the disclosed embodiments, and that the quantity, degree, or equality or consistency in realization of improved performance should not be assumed to be universally applicable.

[0024] In this specification, the term "approximately" is used to allow flexibility in the endpoints of a given numerical range, meaning that a given value may be "slightly greater" or "slightly less" than the endpoints of a given numerical range. However, it should be understood that even when the term "approximately" is used herein in relation to a specific numerical value, support for other exact numerical values ​​is also provided.

[0025] In this specification, the term “substantially” means the degree or extent of complete or near-completeness of an action, feature, characteristic, state, composition, item, or result. For example, an object “substantially” enclosed means that the object is either completely enclosed or nearly completely enclosed. The exact range of deviation from absolute completeness may depend in some cases on the specific circumstances. However, generally speaking, proximity to completeness is for having the same overall result as if absolute and total completeness had been achieved. The use of “substantially” also applies equally when used in a negative sense to mean the complete or near-complete absence of an action, feature, characteristic, state, composition, item, or result. For example, a composition “substantially” free of particles is either completely lacking in particles or nearly completely lacking in particles to the extent that it produces the same effect as if it were completely lacking in particles. That is, a composition “substantially” free of a certain component or element may still, in practice, contain such an item, as long as there is no measurable effect of it.

[0026] In this specification, multiple items, components, elements of compositions, and / or materials may be shown in common lists for convenience. However, these lists should be interpreted so that each member of the list is individually identified as a distinct and unique member. Accordingly, individual members of such lists should not be interpreted, without contrary indication, as de facto equivalents of other members of the same list based solely on their presentation in a common group.

[0027] In this specification, comparative terms such as “increased,” “decreased,” “better,” “worse,” “higher,” “lower,” and “enhanced” refer to the properties of a device, component, or activity that are measurably different from other devices, components, or activities when compared to those in a surrounding or adjacent area, in a single or multiple equivalent devices, in a group or class, in multiple groups or classes, or in comparison to those known in the art. For example, a composition or system having or providing “increased” stability exhibits a higher level of stability compared to a different but equivalent composition or system, or to a composition or system known in the art. Many factors can contribute to such an improvement in stability, including compositional components, system components or configuration, and operation.

[0028] In this specification, the term “coupled” is defined as being connected directly or indirectly. “Directly coupled” objects or components are physically in contact and attached. “Fluidally connected” objects, components, or components are sufficiently connected to allow the movement or transfer of fluid from one object, component, or component to the other. Objects described herein as “adjacent” to each other may, depending on the context in which the phrase is used, be physically in contact with each other, in close proximity to each other, or in the same general area or region to each other.

[0029] In this specification, numerical data may be expressed or presented in range format. Since such range formats are used merely for convenience and simplification, it should be understood that they should be interpreted flexibly, including not only the numerical values ​​explicitly listed as range limits, but also all individual numerical values ​​or partial ranges contained within that range, just as if each numerical value and partial range were explicitly listed. As an example, the numerical range "approximately 1 to approximately 5" should be interpreted to include not only the explicitly listed values ​​approximately 1 to approximately 5, but also the individual values ​​and partial ranges within the indicated range. Therefore, this numerical range includes individual values, e.g., 2, 3, and 4, as well as partial ranges, e.g., 1 to 3, 2 to 4, and 3 to 5, and the individual 1, 2, 3, 4, and 5. The same principle applies to ranges that list only one numerical value as the minimum or maximum value. Furthermore, such interpretation should apply regardless of the width or characteristics of the range described.

[0030] Description of the Embodiment The following provides an introductory overview of embodiments of the present technology, followed by a more detailed description of specific embodiments of the technology. This introductory overview is intended to help readers understand the present technology more quickly, but is not intended to identify any important or essential features of the present technology, nor is it intended to limit the scope of the claimed subject matter.

[0031] Nitric oxide (NO) and other gases can affect biological systems, and therefore, these gases can be used for therapeutic purposes. However, due to the cumbersome nature of gas containers and supply equipment, applying such gases in a gaseous state to the skin, mucous membranes, or body cavities in a manner that can promote such biological effects or provide therapeutic effects can sometimes be impractical. While it may be possible to produce therapeutic amounts of NO from a solution containing a nitric oxide precursor and an activator of the nitric oxide precursor, when these components are combined, NO production typically proceeds in an uncontrolled manner, and the generated NO may be lost before being presented to the application site (e.g., even if it is in a container) due to its high reactivity with other elements and compounds. Furthermore, combining nitric oxide precursors and activators at the time of treatment is cumbersome and may not be effective.

[0032] Furthermore, using a single dispensing mechanism to separate the nitric oxide precursor and activator into individual parts of a single container may compromise the stability of the combination if the nitric oxide precursor and activator are combined for a long period before administration. Additionally, even if the nitric oxide precursor and activator are combined without decomposition before treatment, thorough mixing of the nitric oxide precursor and activator may be difficult. For example, mixing the nitric oxide precursor and activator only once before administering the compound may result in insufficient mixing of the compound, preventing the use of all available reactants. Moreover, mixing the nitric oxide precursor and activator may be unsafe for untrained users.

[0033] Therefore, it is useful to deliver unstable compounds in a way that prevents degradation over time, ensures thorough mixing of the compounds, and maintains a user-friendly delivery mechanism.

[0034] In one embodiment, the spraying device may have a liquid container comprising a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid. In one embodiment, the spraying device may have a first pump partially located in the first chamber and operable to draw in and hold the first liquid, and a second pump partially located in the second chamber and operable to draw in and hold the second liquid. In another embodiment, the spraying device may have a plurality of mixing spaces fluid-coupled to the first and second pumps and operable to allow mixing of the first liquid and the second liquid. In another embodiment, the spraying device may have nozzles fluid-coupled to the plurality of mixing spaces. In another embodiment, the plurality of mixing spaces may be substantially empty between each operation of the pump.

[0035] In another embodiment, the method for dispensing the solution may include the steps of providing a pharmaceutically active ingredient (API) precursor to a first chamber of the liquid container of a spray device and providing an activator to a second chamber of the liquid container of the spray device. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor and the activator multiple times within the spray device. In another embodiment, the method may include the step of dispensing the solution from the spray device.

[0036] In another embodiment, the method for activating the solution may include the steps of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of the spray device and a solution containing an activator to a second chamber of the liquid container of the spray device. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device.

[0037] In another embodiment, a method for producing a product suitable for administering a nitric oxide-releasing solution (NORS) after a long storage period may include the steps of providing a nitric oxide (NO) donor-containing solution to a first chamber of the liquid container of a spray device, and providing an activator-containing solution to a second chamber of the liquid container of the spray device. The method may further include the step of activating the NORS by mixing the NO donor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device.

[0038] In one embodiment, as shown in Figure 1, the spraying device 100 may have a liquid container 110 including a first chamber 111a operable to hold a first liquid and a second chamber 111b operable to hold a second liquid. In one embodiment, the spraying device 100 may have a first pump 140a operable to communicate with the first chamber 111a (e.g., entirely or partially inside therein) to draw in and hold the first liquid, and a second pump 140b operable to communicate with the second chamber 111b (e.g., entirely or partially inside therein) to draw in and hold the second liquid.

[0039] In one embodiment, the spraying device 100 may have a plurality of mixing spaces 155, 165, 175 that are fluid-connected to a first pump 140a and a second pump 140b and are operable to enable mixing of a first liquid and a second liquid. In another embodiment, the spraying device 100 may have a nozzle 172 that is fluid-connected to the plurality of mixing spaces 155, 165, 175.

[0040] In one embodiment, the plurality of mixing spaces 155, 165, 175 may include a first mixing space 155 and a second mixing space 165 fluidly connected between the first mixing space 155 and a nozzle 172. The first mixing space 155 may be fluidly connected to a first outlet from a first pump 140a and a second outlet from a second pump 140b. The plurality of mixing spaces may further include a nozzle mixing space 175, which has a vortex tip at the nozzle 172. In another embodiment, the spraying device 100 may further include a pump housing 130, a connecting plate 150, and an upper housing 170.

[0041] In another embodiment, the spraying device 100 may have a mixing space 155 or 165 that is fluid-coupled to a first pump 140a and a second pump 140b and is operable to allow mixing of the first liquid and the second liquid. In one embodiment, the mixing space 155 or 165 may be substantially empty between the operations of pumps 140a and 140b. In another embodiment, the mixing space 155 or 165 may be substantially empty between the operations of pumps 140a and 140b. The spraying device may further have a nozzle 172 fluid-coupled to the mixing space 155 or 165.

[0042] In another embodiment, the spraying device 100 may have a liquid container 110 comprising a plurality of chambers operable to hold a plurality of distinct liquids. The spraying device 110 may have a first pump 140a partially located in a first chamber 111a and operable to draw in and hold a first liquid, and a second pump 140b partially located in a second chamber 111b and operable to draw in and hold a second liquid. The spraying device 100 may have a plurality of mixing spaces 155, 165, 175 fluid-coupled to the first pump 140a and the second pump 140b and operable to allow mixing of the first liquid and the second liquid. The spraying device 100 may have a nozzle 172. In one embodiment, the number of chambers may be two or more. In another embodiment, the number of pumps may be two or more.

[0043] In another embodiment, the method for dispensing the solution may include the steps of providing a pharmacokinetic (API) precursor to a first chamber 111a of the liquid container 110 of the spray device 100 and an activator to a second chamber 111b of the liquid container 110 of the spray device 100. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor and the activator multiple times within the spray device 100. In another embodiment, the method may include the step of dispensing the solution from the spray device 100.

[0044] In another embodiment, the method for activating the solution may include the steps of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber 111a of the liquid container 110 of the spray device 100 and a solution containing an activator to a second chamber 111b of the liquid container 110 of the spray device 100. In one embodiment, the method may further include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device 100.

[0045] In another embodiment, a method for administering treatment may include the steps of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber 111a of the liquid container 110 of the spray device 100 and an activator to a second chamber 111b of the liquid container 110 of the spray device 100. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution multiple times within the spray device 100. In another embodiment, the method may include the step of dispensing the mixed solution from the spray device 100 to the treatment site.

[0046] In another embodiment, a method for administering treatment may include the step of providing a pharmacokinetic (API) precursor to a first chamber 111a of a liquid container 110 and an activator to a second chamber 111b of the liquid container 110 of a spray device 100. In one embodiment, the method may include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device 100 to the treatment site.

[0047] In another embodiment, a method for providing a therapeutically effective amount of unstable active pharmaceutical ingredient (API) may include the step of providing an API precursor-containing solution to a first chamber 111a of the liquid container 110 of the spray device 100. In one embodiment, the method may include the step of providing an activator-containing solution to a second chamber 111b of the liquid container 110 of the spray device 100. In another embodiment, the method may include the step of activating a therapeutically effective amount of API precursor by mixing the API precursor-containing solution and the activator-containing solution multiple times within the spray device 100. In yet another embodiment, the method may include the step of dispensing the mixed solution to the treatment site.

[0048] With this introductory overview in mind, the spraying devices of this disclosure will now be described in more detail. Figure 2 shows an exploded view of a dual-chamber spraying device 200 in one embodiment. The dual-chamber spraying device may include one or more of the following: a liquid container 210, a gasket 220, a pump housing 230, two or more pumps 240a and 240b, a connecting plate 250, a support column 260, an upper housing 270, or a cap 280.

[0049] In one embodiment, the liquid container 210 may include a partition 212 separating a first chamber 211a from a second chamber 211b. The first chamber 211a may be operable to hold a first liquid. The second chamber 211b may be operable to hold a second liquid. In one embodiment, the volume of the first chamber 211a or the volume of the second chamber 211b may be about 1 ml to about 100 ml. In one embodiment, the ratio of the volume of the first chamber 211a to the volume of the second chamber 211b may be about 1:10 to about 10:1. In another embodiment, the volumes of the first chamber 211a and the second chamber 211b may be substantially equal.

[0050] In one embodiment, the liquid container 210 may include an outer housing 214 and a bottom 216 forming the bottoms of a first chamber 211a and a second chamber 211b. The liquid container 210 may include a connecting end 218 which may be a connecting valve operable to connect to a groove 233 in the base 234 of the pump housing 230. The liquid container 210 may have any suitable material, including but not limited to food-grade or pharmaceutical-grade materials that meet the United States Pharmacopeia (USP) 661 standard, such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and plasticized polyvinyl chloride (PVC). Other suitable materials may include, but are not limited to, materials suitable for liquids or gels in accordance with USP 1663 and USP 1664 for extracts / leachates.

[0051] In another embodiment, the spraying device may include a gasket 220. The gasket may be connected between the liquid container 210 and the pump housing 230. The gasket may include a gasket partition 225. The gasket 220 may be made of any suitable material, including but not limited to plastics, Teflon®, rubber, silicone, nitrile, vinyl, neoprene, and combinations thereof.

[0052] In another embodiment, the spraying device may include a pump housing 230. In one embodiment, the pump housing 230 may be connected between a liquid container 210, an outlet pipe 242a of a first pump 240a, and an outlet pipe 242b of a second pump 240b. In another embodiment, the pump housing may include a first pump fitting 232a configured to hold the first pump 240a and a second pump fitting 232b configured to hold the second pump 240b. In another embodiment, the pump housing may include a base 234 with a groove 233 that is operable to connect to a connecting valve 218 of the liquid container 210. In another embodiment, the pump housing may include a collar 236 that is operable to connect to a connecting plate 250. The pump housing 230 may have any suitable material, including but not limited to food-grade or pharmaceutical-grade materials that meet USP661 standards, such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and plasticized polyvinyl chloride (PVC). Other suitable materials may include, but are not limited to, materials suitable for liquids or gels that comply with USP1663 and USP1664 for extracts / leachates.

[0053] In another embodiment, the spraying device may include a first pump 240a and a second pump 240b. The first pump 240a may include a first inlet pipe 242a, a first inlet 241a, a first outlet pipe 248a, and a first outlet 249a. The first inlet pipe 242a may be partially located within the first chamber 211a. The first pump 240a may be partially located within the first chamber 211a and operable to draw in and hold a first liquid. The first inlet 241a may be located within the first chamber 211a and operable to receive a first liquid from the first chamber 211a.

[0054] In one embodiment, the first pump 240a or the second pump 240b may have any suitable material, including but not limited to food-grade or pharmaceutical-grade materials that meet USP661 standards, such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and plasticized polyvinyl chloride (PVC). Other suitable materials may include, but are not limited to, materials suitable for liquids or gels that comply with USP1663 and USP1664 for extracts / leachates.

[0055] In one embodiment, the first pump 240a may be operable to aspirate and hold a liquid volume of approximately 0.01 ml to approximately 5 ml. In another embodiment, the first pump 240a may be operable to aspirate and hold a liquid volume of approximately 0.1 ml to approximately 2 ml. In another embodiment, the first pump 240a may be operable to aspirate and hold a liquid volume of approximately 0.5 ml to approximately 1 ml. In another embodiment, the first pump 240a may be operable to aspirate and hold a liquid volume of approximately 0.01 ml to approximately 0.50 ml.

[0056] In another embodiment, the second pump 240b may include a second inlet pipe 242b, a second inlet 241b, a second outlet pipe 248b, and a second outlet 249b. The second inlet pipe 242b may be partially located within the second chamber 211b. The second pump 240b may be partially located within the second chamber 211b and operable to draw in and hold the second liquid. The second inlet 241b may be located within the second chamber 211b and operable to receive the second liquid from the second chamber 211b.

[0057] In one embodiment, the second pump 240b may be operable to aspirate and hold a liquid volume of approximately 0.01 ml to approximately 5 ml. In another embodiment, the second pump 240b may be operable to aspirate and hold a liquid volume of approximately 0.1 ml to approximately 2 ml. In another embodiment, the second pump 240b may be operable to aspirate and hold a liquid volume of approximately 0.5 ml to approximately 1 ml. In yet another embodiment, the second pump 240b may be operable to aspirate and hold a liquid volume of approximately 0.01 ml to approximately 0.50 ml.

[0058] In one embodiment, the viscosity of the first liquid in the second liquid, or a combination thereof, may be about 0.1 centipoise (cP) to about 10,000 cP. In another embodiment, the viscosity of the first liquid in the second liquid, or a combination thereof, may be about 0.1 centipoise (cP) to about 1,000 cP. In another embodiment, the viscosity of the first liquid in the second liquid, or a combination thereof, may be about 0.1 centipoise (cP) to about 100 cP. In another embodiment, the viscosity of the first liquid in the second liquid, or a combination thereof, may be about 0.1 centipoise (cP) to about 100 cP. In another embodiment, the viscosity of the first liquid in the second liquid, or a combination thereof, may be about 0.1 centipoise (cP) to about 10 cP.

[0059] In one embodiment, the spraying device 200 may be operable to spray approximately 0.01 ml to approximately 5 ml of liquid each time the first pump 240a or the second pump 240b is activated. In another embodiment, the spraying device 200 may be operable to spray approximately 0.1 ml to approximately 2 ml of liquid each time the first pump 240a or the second pump 240b is activated. In another embodiment, the spraying device 200 may be operable to spray approximately 0.5 ml to approximately 1 ml of liquid each time the first pump 240a or the second pump 240b is activated. In another embodiment, the spraying device 200 may be operable to spray approximately 0.01 ml to approximately 0.50 ml of liquid each time the first pump 240a or the second pump 240b is activated.

[0060] In another embodiment, the first pump 240a and the second pump 240b may be fluid-connected to one or more mixing spaces to enable the merging, combination, and / or mixing of a first liquid from the first pump 240a and a second liquid from the second pump 240b. In one embodiment, the first outlet pipe 248a may include a first outlet 249a that can be connected to one or more mixing spaces. In another embodiment, the second outlet pipe 248b may include a second outlet 249b that can be connected to one or more mixing spaces.

[0061] In one embodiment, the volume ratio of the capacity of the first pump 240a or the second pump 240b to the volume of the first mixing space or the second mixing space may be about 100:1 to about 1:1. In one embodiment, the volume ratio of the capacity of the first pump 240a or the second pump 240b to the volume of the first mixing space may be about 100:1 to about 1:1. In one embodiment, the volume ratio of the capacity of the first pump 240a or the second pump 240b to the volume of the second mixing space may be about 100:1 to about 1:1. In another embodiment, the ratio of the volume of the first mixing space to the volume of the second mixing space may be about 100:1 to about 1:1.

[0062] In another embodiment, the spraying device 200 may include a connecting plate 250 comprising a first inlet 251a, a second inlet 251b, a central contact portion 252, an inner circumferential wall 254 defining at least a portion of the first mixing space, and an outer circumferential wall 256. In one embodiment, the connecting plate 250 may have a recess defining at least a portion of the mixing space and openings 251a and 251b for fluidly connecting the first pump 240a and the second pump 240b to the mixing space. The connecting plate 250 may be made of any suitable material, including but not limited to food-grade or pharmaceutical-grade materials that meet USP661 standards, such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and plasticized polyvinyl chloride (PVC). Other suitable materials may include, but are not limited to, materials conforming to USP1663 and USP1664 for extracts / leachates, in the form of liquids or gels.

[0063] In another embodiment, the spraying device 200 may have a column 260 including a plurality of nozzle grooves 262 and a plurality of channel-forming protrusions 264. In one embodiment, the nozzle grooves 262 can fluidly connect different mixing spaces. In one embodiment, the number of nozzle grooves 262 may be one or more integers. In another embodiment, the number of nozzle grooves may be one or more integers. The column 260 may have any suitable material, including but not limited to food-grade or pharmaceutical-grade materials that meet USP661 standards, such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and plasticized polyvinyl chloride (PVC). Other suitable materials may include, but are not limited to, materials suitable for liquids or gels that comply with USP1663 and USP1664 for extracts / leachates.

[0064] In another embodiment, the spraying device 200 may include an upper housing 270. The upper housing may include one or more of a nozzle opening 272, a support cover 276, a support collar 278, or a side wall 279. In one embodiment, the upper housing 270 may define a portion of the second mixing space and a portion of the nozzle mixing space. In one embodiment, the nozzle opening 272 may be at the tip of the support cover 276. In another embodiment, the nozzle opening 272 may be at the side of the support cover 276. The upper housing 270 may have any suitable material, including but not limited to food-grade or pharmaceutical-grade materials that meet USP661 standards, such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and plasticized polyvinyl chloride (PVC). Other suitable materials may include, but are not limited to, materials that conform to USP1663 and USP1664 relating to extracts / leachates, in the form of liquids or gels.

[0065] In one embodiment, the nozzle opening 272 can be fluid-connected to a plurality of mixing spaces (e.g., a first mixing space, a second mixing space, or a nozzle mixing space). In another embodiment, the plurality of mixing spaces may be substantially empty between each operation of pumps 240a and 240b.

[0066] In another embodiment, the tip portion of the upper housing can be configured to spray liquid at an angle in the range of approximately 0° to approximately 90° with respect to the flow path exiting the second mixing space. In one embodiment, if the spraying device 200 is positioned upright on a certain surface, the second mixing space may have a flow direction perpendicular to that surface.

[0067] In this embodiment, when the direction of flow exiting the second mixing space is perpendicular, the tip portion of the upper housing can be configured to spray liquid at an angle of approximately 0° to the flow path exiting the second mixing space (i.e., the direction of flow exiting the second mixing space can be perpendicular, and the direction of spray from the tip portion of the upper housing can also be perpendicular).

[0068] In another embodiment, when the direction of flow exiting the second mixing space is perpendicular, the tip portion of the upper housing can be configured to spray liquid at an angle of approximately 90° to the flow path exiting the second mixing space (i.e., the direction of flow exiting the second mixing space can be perpendicular, and the direction of spray flow from the tip portion of the upper housing can be perpendicular to the flow path exiting the second mixing space).

[0069] In another embodiment, the volume ratio of the capacity of the first pump 240a or the second pump 240b to the volume of the nozzle mixing space 275 may be about 100,000:1 to about 10:1. In another embodiment, the ratio of the volume of the first mixing space to the volume of the nozzle mixing space may be about 10,000:1 to about 10:1. In another embodiment, the ratio of the volume of the second mixing space to the volume of the nozzle mixing space may be about 10,000:1 to about 10:1.

[0070] In another embodiment, the nozzle opening 272 may be configured to spray a liquid in a predetermined pattern, including one or more of the following: a hollow cone, a solid cone, a helical cone, a solid flow, a mist, a fog, a flat fan, or a combination thereof. In another embodiment, the liquid sprayed from the spraying device may have an outlet velocity of about 6.5 m / s to about 19.5 m / s from the nozzle opening 272. In another embodiment, the outlet velocity may be about 5 m / s to about 25 m / s. In another embodiment, the outlet velocity may be about 13 m / s to about 19.5 m / s.

[0071] In another embodiment, the spraying device 200 may include a cap 280 that is operable to connect to an upper housing 270. The cap 280 may further include a cap base 282 and a cap collar 285. The cap 280 may have any suitable material, including but not limited to food-grade or pharmaceutical-grade materials that meet USP661 standards, such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and plasticized polyvinyl chloride (PVC). Other suitable materials may include, but are not limited to, materials suitable for liquids or gels that comply with USP1663 and USP1664 for extracts / leachates.

[0072] Figures 3a to 3c show various perspective views of a dual-chamber spray device in one embodiment. Figure 3a is a perspective view of a dual-chamber spray device 300a with a safety cap 380 attached in one embodiment. The spray device 300a may include a liquid container 310 and a base of a pump housing 330.

[0073] In another embodiment, Figure 3b is a front cross-sectional view of a dual-chamber spray device 300ba and a side cross-sectional view of a dual-chamber spray device 300bb with a safety cap 380 attached. In one embodiment, as described above, the dual-chamber spray devices 300ba, 300bb may include a liquid container 310, a pump housing 330, a first pump 340a, a second pump 340b, a connecting plate 350, and an upper housing 370 including a nozzle opening 372.

[0074] The liquid container 310 may include a partition 312 forming a first chamber 311a and a second chamber 311b. The liquid container may further include an outer housing 314 and a bottom 316. In another embodiment, the first pump 340a may include a first inlet 341a, a first inlet pipe 342a, and a first spring 344a. In another embodiment, the second pump 340b may include a second inlet 341b, a second inlet pipe 342b, and a second spring 344b.

[0075] In another embodiment, Figure 3c shows a side cross-sectional view of a dual-chamber spray device 300c with a safety cap 380 attached, according to one embodiment. The dual-chamber spray device 300c may include one or more of a liquid container 310, a first pump 340a, a second pump 340b, a pump housing 330, a connecting plate 350, a support column 360, an upper housing 370, or a safety cap 380. In one embodiment, the first pump 340a may include a first inlet pipe 342a, which may include a first inlet 341, a first ball valve 345a, a first spring 344a, and a first piston 346a. In another embodiment, the second pump 340b may include a second inlet pipe 342b, which may include a second inlet 341b, a second ball valve 345b, a second spring 344b, and a second piston 346b.

[0076] In this embodiment, the plurality of mixing spaces may include two or more of the first mixing space 355 and the second mixing space 365, or the nozzle mixing space 375. The first mixing space 355 may be defined by a connecting plate 350 having a recess that at least partially defines the first mixing space 355 and an opening that fluidly connects the first pump 340a and the second pump 340b to the first mixing space 355. In this embodiment, the second mixing space 365 may be fluidly connected between the first mixing space 355 and the nozzle opening 372. In this embodiment, the nozzle mixing space 375 may have a vortex tip in the nozzle. In one embodiment, the plurality of mixing spaces may be substantially empty between each operation of pumps 340a and 340b.

[0077] In another embodiment, Figures 4a to 4f show various diagrams of a dual-chamber spray device. Figure 4a shows a side view of dual-chamber spray devices 400a and 400ab with safety caps attached in one embodiment. The dual-chamber spray device 400ab may include a safety cap 480, a base of a pump housing 430, and a liquid container 410 including a bottom 416.

[0078] In this embodiment, as shown in Figure 4b, the dual-chamber spraying device 400b may include a liquid container comprising a partition 412, an outer housing 414, and a valve 418. The first pump 440a may include a first inlet pipe 442a, which may include a first inlet 441a, a first ball valve 445a, a first spring 444a, and a first piston 446a. The second pump 440b may include a second inlet pipe 442b, which may include a second inlet 441b, a second ball valve 445b, a second spring 444b, and a second piston 446b. The first pump 440a may further include a first outlet pipe 448a and a first outlet 449a. The second pump 440b may further include a second outlet pipe 448b and a second outlet 449b.

[0079] In this embodiment, the dual-chamber spray device 400b may include a pump housing 430. The pump housing 430 may include a first pump fitting portion 432a, a second pump fitting portion 432b, and a base groove 433. The first pump fitting portion 432a may be molded and sized to hold a first pump 440a, and the second pump fitting portion 432b may be molded and sized to hold a second pump 440b.

[0080] In this embodiment, the dual-chamber spraying device 400b may further include a connecting plate 450. The connecting plate 450 may include a central contact portion 452. The dual-chamber spraying device 400b may further include a support column 460 which may include one or more projections 464.

[0081] Figure 4c shows a side cross-sectional view of a dual-chamber spray device 400c with a safety cap attached in one embodiment. The dual-chamber spray device 400c may include a gasket 420.

[0082] In various embodiments, the dual-chamber spray device may not include a safety cap, as shown in Figures 4d to 4f. In one embodiment, Figure 4d shows a side view of dual-chamber spray devices 400da and 400db without a mounting safety cap. In one embodiment, Figure 4e shows a side cross-sectional view of dual-chamber spray device 400e without a mounting safety cap. In one embodiment, Figure 4f shows a side cross-sectional view of dual-chamber spray device 400f without a mounting safety cap.

[0083] In various embodiments, Figures 5a to 5c show a support column 560 of a dual-chamber spray device. Figure 5a is a perspective view of a support column 560 of a dual-chamber spray device 500a in one embodiment. The support column may include a plurality of channel-forming projections 564 that can form a plurality of channels 562 or grooves 562. The upper part of the support column may be connected to a nozzle opening 572. The support column may abut against a central contact portion 552 of a connecting plate 550. The connecting plate may include an inner circumferential wall 554 that can partially define the periphery of a first mixing region. The connecting plate may include an outer circumferential wall 556. The connecting plate may include a first fluid inlet 551a and a second fluid inlet 551b. The first fluid inlet may be fluid-connected to a first outlet pipe of a first pump, and the second fluid inlet may be fluid-connected to a second outlet pipe of a second pump. The dual-chamber spray device 500a may further include a pump housing 530.

[0084] In one embodiment, Figure 5b shows the flow path in a dual-chamber spray device 500b. In this embodiment, a first liquid may flow from a first chamber 511a of a liquid container 510 to a first inlet 541a of a first pump 540a. The first chamber 511a may be bounded by a bottom 516, a partition 512, an outer housing, and a gasket. The first pump 540a may include a first inlet 541a, a first inlet pipe 542a, and a first spring 544a. The second pump 540b may include a second inlet 541b, a second inlet pipe 542b, and a second spring 544b. The first pump 540a and the second pump 540b may be held in place by a first pump fitting 532a and a second pump fitting 532b of a pump housing 530. The pump housing may include a base 534 and a collar 536.

[0085] In one embodiment, when the ball valve 545a moves upward due to a dispensing event, the first liquid may flow from the first inlet 541a through the first inlet tube 542a to the first spring 544a. When an unused dual-chamber spray device 500b performs its first dispensing event, the spring 544a may be empty. In the first dispensing event, the piston can displace the spring 544a downward, creating a pressure reduction, which can move the ball valve 545a upward. Once the ball valve 545a moves upward, the first liquid may flow from the first inlet tube to the spring 544a until the ball valve 545a moves downward to its original position, preventing the first inlet tube 542a from directing further liquid towards the first spring 554a.

[0086] If the dual-chamber spray device 500b has previously performed a dispensing event, the spring 544a can hold the first liquid. If a further dispensing event occurs, the first liquid may flow upward through the spring and enter the outlet pipe of the first pump 540a and flow out to the first outlet. The first liquid can exit the first outlet and enter the first mixing space 555, which is partially formed from the inner circumferential wall of the connecting plate 550.

[0087] In another embodiment, when the ball valve 545b is displaced upward by a dispensing event, the second liquid may flow from the second inlet 541b through the second inlet tube 542b to the second spring 544b. When an unused dual-chamber spray device 500b performs its first dispensing event, the spring 544b may be empty. In the first dispensing event, the piston can displace the spring 544b downward, creating a pressure reduction, which can move the ball valve 545b upward. Once the ball valve 545b is in the upward position, the second liquid may flow from the second inlet tube to the second spring 544b until the ball valve 545b moves downward to its original position, preventing the second inlet tube 542b from directing further liquid towards the second spring 554b.

[0088] If the dual-chamber spray device 500b has previously performed a dispensing event, the second spring 544b can hold the second liquid. If a further dispensing event occurs, the second liquid may flow upward through the second spring 544b, enter the second outlet tube of the second pump 540b, and flow out to the second outlet. The second liquid can exit the second outlet and enter the first mixing space 555.

[0089] In one embodiment, when both the first liquid and the second liquid enter the first mixing space 555, the first and second liquids can be mixed to initially form a mixed solution. In one embodiment, the mixed solution can flow from the first mixing space 555 through a plurality of nozzle grooves 562 formed in the column 560 by channel-forming projections 564. In one embodiment, after exiting the plurality of nozzle grooves 562, the mixed solution can be mixed in the second mixing space 565 within the upper housing 570. In one embodiment, after exiting the second mixing space 565, the mixed solution can enter the nozzle mixing space 575. The mixed solution can be sprayed from the dual-chamber spraying device 500b and from the nozzle mixing space 575.

[0090] In one embodiment, Figure 5c shows a flow path through a dual-chamber spray device 500c in one embodiment. The dual-chamber spray device 500c includes a liquid container 510, a pump housing 530, a connecting plate 550, a support column 560, and an upper housing 570. The pump housing 530 includes a base 534 and a collar 536. The connecting plate 550 includes an inner circumferential wall 554, an outer circumferential wall 556, a central contact portion 552, a first fluid inlet 551a which can be fluid-connected to a first pump, and a second fluid inlet 551b which can be fluid-connected to a second pump.

[0091] In one embodiment, a first liquid from a first pump and a second liquid from a second pump can be combined in a first mixing space 555. The mixed solution may be directed from the first mixing space 555 to a nozzle groove 562 formed from a channel-forming projection 564 on a column 560. After exiting the nozzle groove 562, the mixed solution can be mixed in a second mixing space 565, which may be partially housed within an upper housing 570 that may include a column cover, a column collar, and side walls. After exiting the second mixing space 565, the mixed solution may be directed upward to the tip of the upper housing 570 adjacent to the nozzle opening 572. The tip of the upper housing 570 may include a third mixing space 575, which can mix the mixed liquid before exiting the spraying device 500c.

[0092] In another embodiment, Figures 6a and 6b show a pump 640. In one embodiment, as shown in the cross-sectional view of Figure 6a, the pump 640 includes one or more of the following: inlet 641, inlet pipe 642, spring 644, ball valve 645, piston 646, outlet pipe 648, or outlet 649. In another embodiment, as shown in the cross-sectional view of Figure 6b, the pump 640 includes one or more of the following: inlet 641, inlet pipe 642, spring 644, ball valve 645, piston 646, outlet pipe 648, or outlet 649.

[0093] In one embodiment, Figure 7 is a side cross-sectional view of a dual-chamber spray device 700 in one embodiment. In this embodiment, the dual-chamber spray device 700 may include a liquid container 710, a pump housing 730, a connecting plate 750, an upper housing 770, and a nozzle opening 772. In one embodiment, Figure 8a is a top view of the pump housing 830 of the dual-chamber spray device 800 in one embodiment. Figure 8b is a perspective view of the dual-chamber spray device 800 in one embodiment. The dual-chamber spray device may include a liquid container 810 that can be fluid-coupled to the pump housing 830. Figure 8c shows a side view of the dual-chamber spray device 800 in one embodiment.

[0094] In another embodiment, Figure 9a is a top view of the gasket 920 of a dual-chamber spray device 900 in one embodiment. Figure 9b is a perspective view of the gasket 920 of a dual-chamber spray device in one embodiment. The gasket 920 may include a valve 922 that can be connected to a liquid container. The gasket may include a partition 925 that can prevent the mixing of the first liquid and the second liquid before the first liquid enters the first mixing space. Figure 9c is a side cross-sectional view of the gasket 920 of a dual-chamber spray device in one embodiment. The gasket 920 may include the valve 922 and the partition 925.

[0095] In one embodiment, Figure 10a is a side view of the upper housing 1070 of the dual-chamber spray device 1000 in one embodiment. The upper housing may include a nozzle opening 1072, a third mixing space at the tip of the upper housing, a second mixing space, a support cover 1076, a support collar 1078, and a side wall 1079. Figure 10b is a perspective view of the upper housing 1070 of the dual-chamber spray device in one embodiment. Figure 10c is a top view of the upper housing 1070 of the dual-chamber spray device in one embodiment.

[0096] In another embodiment, Figure 11a is a top view of the connection plate 1150 of a dual-chamber spray device 1100 in one embodiment. The connection plate may include a first fluid inlet 1151a, a second fluid inlet 1151b, a central contact portion 1152, an inner circumferential wall 1154, and an outer circumferential wall 1156. Figure 11b is a side view of the connection plate 1150 of a dual-chamber spray device in one embodiment. The connection plate may include a central contact portion 1152 and an outer circumferential wall 1156. Figure 11c is a side cross-sectional view of the connection plate 1150 of a dual-chamber spray device in one embodiment. The connection plate may include a first fluid inlet 1151a, a second fluid inlet 1151b, a central contact portion 1152, and an outer circumferential wall 1156. Figure 11d is a perspective view of the connection plate 1150 of a dual-chamber spray device in one embodiment. The connecting plate may include a central contact portion 1152, a first fluid inlet 1151a, a second fluid inlet 1151b, an inner circumferential wall 1154, and an outer circumferential wall 1156.

[0097] In another embodiment, Figure 12a shows a side view of the upper housing 1270 of the dual-chamber spray device 1200 in one embodiment. The upper housing 1270 may include a nozzle opening 1272. Figure 12b is a perspective view of the upper housing 1270 of the dual-chamber spray device, showing that the upper housing 127 may include a nozzle opening 1272, a third mixing space at the tip of the upper housing 1270, a second mixing space, a support cover 1276, a support collar 1276, and a side wall 1279. Figure 12c is a top view of the upper housing 1270 of the dual-chamber spray device 1200 in one embodiment. A connecting plate 1250 can abut against the upper housing 1270, and the connecting plate can be connected to a liquid container 1210. Figure 12d is a side cross-sectional view of the upper housing 1270 of the dual-chamber spray device in one embodiment. The upper housing may include a nozzle opening 1272, a third mixing space 1275 at the tip of the upper housing 1270, a second mixing space 1265, a support column cover 1276, a support column collar 1278, and a side wall 1279.

[0098] In another embodiment, Figure 13a is a top view of the support column 1360 of a dual-chamber spray device in one embodiment. The upper part of the support column 1360 may include a first nozzle inlet 1374a, a second nozzle inlet 1374b, and a nozzle mixing space 1375. Mixed solution from the second mixing chamber can enter the first nozzle inlet 1374a and the second nozzle inlet 1374b from opposing flow directions. The mixed solution can be mixed in the nozzle mixing space 1375 before exiting the spray device through the nozzle opening 1372. Figure 13b is a side view of the support column 1360 of a dual-chamber spray device in one embodiment. Figure 13c is a perspective view of the support column 1360 of a dual-chamber spray device in one embodiment. The support column 1360 may include a nozzle groove 136 and a channel-forming projection 1364. The upper part of the support column 1360 may include a first nozzle inlet, a second nozzle inlet 1374b, a third mixing space 1375, and a nozzle opening 1372. Figure 13d is a top view of the support column 1360 of a dual-chamber spray device in one embodiment, in which the support column 1360 includes a nozzle groove 1362, a channel-forming projection 1364, a first nozzle inlet 1374a, a second nozzle inlet 1374b, a nozzle mixing space 1375, and a nozzle opening 1372.

[0099] In another embodiment, Figure 14a is a perspective view of a dual-chamber spray device 1400 in one embodiment. The dual-chamber spray device 1400 may include a liquid container 1410 and a safety cap 1480. Figure 14b is a front view of the dual-chamber spray device 1400 which may include a liquid container 1410 and a safety cap 1480. Figure 14c is a side view of the dual-chamber spray device 1400 which may include a liquid container 1410 and a safety cap 1480.

[0100] Figure 15 is a front view of a cross-section 1500a of a dual-chamber spray device 1500b in one embodiment. The dual-chamber spray device 1500b may include a liquid container 1510 and a safety cap 1580.

[0101] Figure 16 is an exploded view of a dual-chamber spray device 1600 in one embodiment. The dual-chamber spray device 1600 may include a liquid container 1610, a gasket 1620, a pump housing 1630 including a first pump fitting portion 1632a and a second pump fitting portion 1632b, a first pump 1640a, a second pump 1640b, a first connector 1650, a second connector 1660, an upper housing 1670, a nozzle opening 1672, and a safety cap 1680.

[0102] In another embodiment, Figure 17a shows a three-dimensional rendering of a front view of the dual-chamber spray device 1700a. Figure 17b is an exploded view of the dual-chamber spray device 1700b in one embodiment.

[0103] In another embodiment, Figure 18a is a three-dimensional rendering of the dual-chamber spray device 1800a in one embodiment. Figure 18b is a three-dimensional rendering of the dual-chamber spray device 1800b in one embodiment. Figure 18c is a three-dimensional rendering of the dual-chamber spray device 1800c in one embodiment.

[0104] Figure 19a is a three-dimensional rendering perspective view of a dual-chamber spray device 1900a in one embodiment. Figure 19b is a three-dimensional rendering perspective view of a dual-chamber spray device 1900b in one embodiment.

[0105] Figure 20 shows the usage methods of the dual-chamber spray device in one embodiment, 2000a and 200b.

[0106] In one embodiment, as shown in the flowchart of Figure 21, the spraying device 2100 may have a liquid container including a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid, as shown in block 2110. The spraying device may further have a first pump partially located in the first chamber and operable to draw in and hold the first liquid, as shown in block 2120. The spraying device may further have a second pump partially located in the second chamber and operable to draw in and hold the second liquid, as shown in block 2130. The spraying device may further have a plurality of mixing spaces, as shown in block 2140, which are fluid-coupled to the first and second pumps and operable to enable mixing of the first and second liquids. The spraying device may further have a nozzle fluid-coupled to the plurality of mixing spaces, as shown in block 2150.

[0107] In one embodiment, as shown in the flowchart of Figure 22, the spraying device 2200 may have a liquid container including a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid, as shown in block 2210. The spraying device may further have a first pump partially located in the first chamber and operable to draw in and hold the first liquid, as shown in block 2220. The spraying device may further have a second pump partially located in the second chamber and operable to draw in and hold the second liquid, as shown in block 2230. The spraying device may further have a mixing space fluid-coupled to the first and second pumps and operable to allow mixing of the first and second liquids, as shown in block 2240, the mixing space being substantially empty between each pump operation. The spraying device may further have a nozzle, as shown in block 2250.

[0108] In one embodiment, as shown in the flowchart of Figure 23, the spraying device 2300 may have a liquid container including a plurality of chambers operable to hold a plurality of distinct liquids, as shown in block 2310. The spraying device may further have a first pump partially located in a first chamber and operable to draw in and hold a first liquid, as shown in block 2320. The spraying device may further have a second pump partially located in a second chamber and operable to draw in and hold a second liquid, as shown in block 2330. The spraying device may further have a plurality of mixing spaces fluid-coupled to the first and second pumps and operable to allow mixing of the first and second liquids, as shown in block 2340. The spraying device may further have a nozzle, as shown in block 2350.

[0109] Methods for dispensing solutions are also described herein. Figure 24 shows an embodiment of method 2400 for dispensing a solution, as shown in the flowchart. The method may include steps of providing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and an activator to a second chamber of the liquid container of the spray device, as shown in block 2410. The method may include steps of activating the API precursor by mixing the API precursor and the activator multiple times within the spray device, as shown in block 2420. The method may include steps of dispensing the solution from the spray device, as shown in block 2430.

[0110] Furthermore, the method may include a step of mixing the API precursor and the activator during the operation of dispensing the solution from the spray device. In one embodiment, the method may include a step of mixing the API precursor and the activator less than 50 milliseconds before dispensing the solution from the spray device. In another embodiment, the method may include a step of mixing the API precursor and the activator for the first time when the API precursor exits the first pump and the activator exits the second pump.

[0111] In another embodiment, the method may include a step of mixing the API precursor and activator a second time when the combined API precursor and activator leaves the first mixing space of the spraying device and enters the second mixing space of the spraying device. In one embodiment, the method may include a step of mixing the API precursor and activator a third time when the combined API precursor and activator enters the nozzle tip of the spraying device.

[0112] In one embodiment, the method may include a step of mixing the volumes of the first chamber and the second chamber in a ratio of about 1:10 to about 10:1. In one embodiment, the method may include a step of pressurizing the combination of the API precursor and the activator when dispensing the solution from the spray device. In another embodiment, the method may include a step of spraying the solution in an amount of about 0.01 ml to about 5 ml with each dispensing event. In another embodiment, the method may include a step of spraying the solution at an outlet velocity from the spray device of about 6.5 m / s to about 19.5 m / s. In another embodiment, the outlet velocity may be about 5 m / s to about 25 m / s. In another embodiment, the outlet velocity may be about 13 m / s to about 19.5 m / s. In another embodiment, the viscosity of the first liquid, the second liquid, or a combination thereof may be about 0.1 centipoise (cP) to about 10,000 cP.

[0113] Methods for activating solutions are also described herein. Figure 25 shows an embodiment of method 2500 for activating a solution, as shown in the flowchart. The method may include the step of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and an activator-containing solution to a second chamber of the liquid container of a spray device, as shown in block 2510. The method may include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device, as shown in block 2520.

[0114] Furthermore, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution less than 50 milliseconds before dispensing the mixed solution from the spraying device. In one embodiment, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the first time when the API precursor-containing solution exits the first pump and the activator-containing solution exits the second pump. In another embodiment, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the second time when the combined API precursor-containing solution and activator-containing solution exits the first mixing space of the spraying device and enters the second mixing space of the spraying device. In yet another embodiment, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the third time when the combined API precursor-containing solution and activator-containing solution enters the nozzle tip of the spraying device.

[0115] Furthermore, methods for administering treatment are described herein. Figure 26 shows an embodiment of method 2600 for administering treatment, as shown in the flowchart. The method may include the step of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and an activator to a second chamber of the liquid container of the spray device, as shown in block 2610. The method may include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution multiple times within the spray device, as shown in block 2620. The method may include the step of dispensing the mixed solution from the spray device to the treatment site, as shown in block 2630.

[0116] Furthermore, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the first time when the API precursor-containing solution exits the first pump and the activator-containing solution exits the second pump. In one embodiment, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the second time when the combined mixture exits the first mixing space and enters the second mixing space of the spraying device. In another embodiment, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the third time when the combined mixture enters the nozzle tip of the spraying device.

[0117] Methods for administering treatment are described herein. Figure 27 shows an embodiment of method 2700 for administering treatment, as shown in the flowchart. The method may include the step of providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and an activator to a second chamber of the liquid container of the spray device, as shown in block 2710. The method may also include the step of activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device to the treatment site, as shown in block 2720.

[0118] Furthermore, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution within 50 milliseconds before dispensing the mixed solution from the spraying device.

[0119] Methods for providing a therapeutically effective amount of unstable active pharmaceutical ingredient (API) are also described herein. Figure 28 shows an embodiment of method 2800 for providing a therapeutically effective amount of unstable active pharmaceutical ingredient (API), as shown in the flowchart. The method may include the step of providing an API precursor-containing solution to a first chamber of the liquid container of a spray device, as shown in block 2810. The method may include the step of providing an activator-containing solution to a second chamber of the liquid container of a spray device, as shown in block 2820. The method may include the step of activating a therapeutically effective amount of API precursor by mixing the API precursor-containing solution and the activator-containing solution multiple times within the spray device, as shown in block 2830. The method may include the step of dispensing the mixed solution to the treatment site, as shown in block 2840.

[0120] Furthermore, the method may include a step of activating a therapeutically effective amount of API during the operation of dispensing the mixed solution from the spray device. In one embodiment, the method may include a step of activating a therapeutically effective amount of API less than 50 milliseconds before dispensing the mixed solution from the spray device. In another embodiment, the method may include a step of activating a therapeutically effective amount of API by mixing the volume of the API precursor with the volume of the activator in a ratio of about 1:10 to about 10:1. In one embodiment, the method may include a step of activating a therapeutically effective amount of API by pressurizing the combination of the API precursor and the activator when dispensing the mixed solution from the spray device.

[0121] Furthermore, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the first time when the API precursor-containing solution exits the first pump and the activator-containing solution exits the second pump. In one embodiment, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the second time when the combined mixture exits the first mixing space and enters the second mixing space of the spraying device. In another embodiment, the method may include a step of mixing the API precursor-containing solution and the activator-containing solution for the third time when the combined mixture enters the nozzle tip of the spraying device.

[0122] In another embodiment, a method for producing a product suitable for administering a nitric oxide-releasing solution (NORS) after a long storage period may include the steps of providing a nitric oxide (NO) donor-containing solution to a first chamber of the liquid container of a spray device, and providing an activator-containing solution to a second chamber of the liquid container of the spray device. The method may further include the step of activating the NORS by mixing the NO donor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device.

[0123] In one embodiment, the long-term storage period may be greater than at least one of 5 days, 15 days, 30 days, 45 days, 90 days, 120 days, 180 days, 1 year, 2 years, or 5 years. In another embodiment, the potency of activated NORS after the long-term storage period relative to the potency of activated NORS before the long-term storage period may be greater than one or more of 70%, 80%, 90%, 95%, 99%, or 99.9%. The potency is the concentration of the drug (EC) required to produce 50% of the drug's maximum effect. 50 ) or dosage (ED 50 It can be defined as the EC25 of 25 micromoles (μM) of the solution administered from the spray device before a long period of 180 days. 50It has the following properties, and the efficacy of the solution administered from the spray device after long-term storage is 20M EC 50 If this is the case, the efficacy of activated NORS after the long-term storage period may be approximately 80% compared to the efficacy of activated NORS before the long-term storage period.

[0124] In one embodiment, the NO donor-containing solution and the activator-containing solution can be mixed for a selected time or less before dispensing the mixed solution from the spray device. The selected time can be less than 15 seconds, 5 seconds, 1 second, 100 milliseconds (ms), 50 ms, or 10 ms. In one embodiment, the method may include a step of mixing the NO donor-containing solution and the activator-containing solution multiple times within the spray device during the operation of dispensing the mixed solution from the spray device.

[0125] Unless required by the claims described herein, no particular order is required in these methods; however, it should be noted that, in general, in some embodiments, the steps of the method may be performed sequentially.

[0126] Figures 29a to 29c show various shapes of the upper housing of the spray device. The shape of the upper housing can be configured to adapt to a selected indication or to deliver the spray device to a selected treatment site. For example, the spray device can have a variety of shapes, including cones, cubes, cylinders, pyramids, spheres, ellipsoids, and combinations thereof.

[0127] In one embodiment, as shown in Figure 29a, the spraying device may be a nasal spraying device 2900a. The nasal spraying device 2900a may include a liquid container 2910, a pump housing 2930, and other components described herein. The upper housing of the nasal spraying device 2900a may include a head 2990a, which may be cylindrically shaped and sized for intranasal administration to an individual. The nasal spraying device 2900a may be configured to spray a spray pattern 2995a which can vary from one or more of the following: a hollow cone, a solid cone, a spiral cone, a solid flow, a mist, a fog, a flat fan, or a combination thereof.

[0128] In other embodiments, as shown in Figure 29b, the spraying device may be a 90° angled spraying device 2900b. The spraying device 2900b may include a liquid container 2910, a pump housing 2930, and other components described herein. The upper housing of the spraying device 2900b may include a head 2990b, which may be cylindrically shaped and sized for topical administration to a subject. The head 2990b of the spraying device 2900b may be configured to spray a spray pattern 2995b which may vary from one or more of the following: a hollow cone, a solid cone, a helical cone, a solid flow, a mist, a fog, a flat fan, or a combination thereof.

[0129] In other embodiments, as shown in Figure 29c, the spraying device may be a throat spraying device 2900c. The throat spraying device 2900c may include a liquid container 2910, a pump housing 2930, and other components described herein. The upper housing of the throat spraying device 2900c may include a head 2990c, which may include a mount 2996c, a pivot 2997c, and a tube 2998c. The tube 2998c may rotate around the pivot 2997c to facilitate administration to the throat of the subject. The head 2990c of the throat spraying device 2900c may be configured to spray a spray pattern 2995c which may vary from one or more of a hollow cone, a solid cone, a helical cone, a solid flow, a mist, a fog, a flat fan, or a combination thereof.

[0130] Examples The following embodiments relate to specific embodiments of the technology and list specific features, elements, or processes that may be used or combined in achieving such embodiments.

[0131] In one embodiment, a spraying device (e.g., a nasal spray, a throat spray, an ear spray, a drug spray, or other spraying device) is provided, comprising a liquid container including a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid; a first pump fluidly communicating with the first chamber and operable to draw in and hold the first liquid; a second pump fluidly communicating with the second chamber and operable to draw in and hold the second liquid; a plurality of mixing spaces fluidly connected to the first and second pumps and operable to enable mixing of the first liquid and the second liquid; and nozzles fluidly connected to the plurality of mixing spaces.

[0132] In one embodiment of the spraying device, multiple mixing spaces are substantially empty between each operation of the pump.

[0133] In one embodiment of the spraying device, the plurality of mixing spaces include a first mixing space and a second mixing space fluidly connected between the first mixing space and the nozzle.

[0134] In one embodiment of the spraying device, the device further includes a connecting plate comprising a first inlet, a second inlet, a central contact portion, an inner circumferential wall defining at least a portion of the first mixing space, and an outer circumferential wall.

[0135] In one embodiment of the spraying device, the first mixing space is fluid-connected to a first outlet from a first pump and a second outlet from a second pump.

[0136] In one embodiment of the spraying device, the plurality of mixing spaces further include a nozzle mixing space, the nozzle mixing space having a vortex tip in the nozzle.

[0137] In one embodiment of the spraying device, the device further includes a connecting plate having a recess that at least partially defines a first mixing space and an opening that fluidly connects a first pump and a second pump to the first mixing space.

[0138] In one embodiment of the spraying device, the device further includes a support column containing a plurality of nozzle grooves and a plurality of channel-forming protrusions that fluidly connect a first mixing space to a second mixing space.

[0139] In one embodiment of the spraying device, the device further comprises an upper housing which includes a nozzle opening and defines a portion of the second mixing space and a portion of the nozzle mixing space.

[0140] In one embodiment of the spraying device, the device further includes a cap that is operable to connect to an upper housing.

[0141] In one embodiment of the spraying device, the device further includes a pump housing connected between a liquid container and the outlet pipes of a first pump and a second pump, a first pump fitting configured to hold the first pump, a second pump fitting configured to hold the second pump, a base operable to connect to a connecting valve of the liquid container, and a collar.

[0142] In one embodiment of the spraying device, the device further includes a gasket connected between the liquid container and the pump housing.

[0143] In one embodiment of the spraying device, the liquid container further includes a partition separating a first chamber and a second chamber, an outer housing, a bottom forming the bottom of the first chamber and the bottom of the second chamber, and a connecting valve operable to connect to the base of the pump housing.

[0144] In one embodiment of the spraying device, the first pump has a first inlet pipe that is in fluid communication with a first chamber and includes a first inlet, a first piston, a first spring, and a first ball valve, and a first outlet pipe that includes a first outlet fluidly connected to a first mixing space, and the second pump has a second inlet pipe that is in fluid communication with a second chamber and includes a second inlet, a second piston, a second spring, and a second ball valve, and a second outlet pipe that includes a second outlet fluidly connected to a first mixing space.

[0145] In one embodiment of the spraying device, the tip portion of the upper housing is configured to spray at an angle ranging from approximately 0° to approximately 90° with respect to the flow path exiting the second mixing space, or the nozzle is configured to spray a predetermined pattern of liquid including one or more of the following: a hollow cone, a solid cone, a helical cone, a solid flow, a mist, a fog, a flat fan, or a combination thereof.

[0146] In one embodiment of the spraying device, the viscosity of the first liquid, the second liquid, or a combination thereof is approximately 0.1 centipoise (cP) to approximately 10,000 cP.

[0147] In one embodiment of the spraying device, the volume of the first chamber is approximately 1 ml to approximately 100 ml, or the volume of the second chamber is approximately 1 ml to approximately 100 ml.

[0148] In one embodiment of the spraying device, the ratio of the volume of the first chamber to the volume of the second chamber is approximately 1:10 to approximately 10:1.

[0149] In one embodiment of the spraying device, the volume of the first chamber and the volume of the second chamber are substantially equal.

[0150] In one embodiment of the spraying device, the spraying device is capable of spraying approximately 0.01 ml to approximately 5 ml of liquid each time the first and second pumps are activated.

[0151] In one embodiment of the spraying device, the ratio of the volume of the first mixing space to the volume of the second mixing space is approximately 1:10 to approximately 10:1, or the ratio of the volume of the first mixing space to the volume of the third mixing space is approximately 1000:1 to approximately 10:1, or the ratio of the volume of the second mixing space to the volume of the third mixing space is approximately 1000:1 to approximately 10:1.

[0152] In one embodiment of the spraying device, the first pump is capable of drawing in and holding a liquid volume of approximately 0.01 ml to approximately 5 ml, or the second pump is capable of drawing in and holding a liquid volume of approximately 0.01 ml to approximately 5 ml.

[0153] In one embodiment of the spraying device, the volume ratio between the capacity of the first or second pump and the volume of the first or second mixing space is approximately 100:1 to approximately 1:1, or the volume ratio between the capacity of the first or second pump and the volume of the nozzle mixing space is approximately 10000:1 to approximately 10:1.

[0154] In one embodiment of the spraying device, the outlet velocity from the nozzle is approximately 6.5 m / sec to approximately 19.5 m / sec.

[0155] In one embodiment, a spray device is provided, comprising a liquid container including a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid; a first pump partially located in the first chamber and operable to draw in and hold the first liquid; a second pump partially located in the second chamber and operable to draw in and hold the second liquid; a mixing space fluidly connected to the first and second pumps and operable to allow mixing of the first liquid and the second liquid, the mixing space being substantially empty between each operation of the pumps; and a nozzle.

[0156] In one embodiment of the spraying device, the device further has an additional mixing space that is fluid-coupled to a first pump and a second pump and is operable to enable mixing of a first liquid and a second liquid.

[0157] In one embodiment of the spraying device, the device further has a nozzle mixing space, the nozzle mixing space having a vortex tip portion in the nozzle.

[0158] In one embodiment of the spraying device, the mixing space is fluid-connected to a first outlet from a first pump and a second outlet from a second pump.

[0159] In one embodiment, a spraying device is provided, comprising a liquid container including a plurality of chambers operable to hold a plurality of separate liquids; a first pump partially located in a first chamber and operable to draw in and hold the first liquid; a second pump partially located in a second chamber and operable to draw in and hold the second liquid; a plurality of mixing spaces fluidly connected to the first and second pumps and operable to enable mixing of the first liquid and the second liquid; and a nozzle.

[0160] In one embodiment of the spraying device, multiple mixing spaces are substantially empty between each operation of the pump.

[0161] In one embodiment of the spraying device, the plurality of mixing spaces include a first mixing space, a second mixing space fluidly connected between the first mixing space and a nozzle, and a nozzle mixing space fluidly connected between the second mixing space and the nozzle opening.

[0162] In one embodiment, a method for dispensing a solution is provided, comprising the steps of: providing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and an activator to a second chamber of the liquid container of a spray device; activating the API precursor by mixing the API precursor and the activator multiple times within the spray device; and dispensing the solution from the spray device.

[0163] In one embodiment of a method for dispensing a solution, the method further includes a step of mixing an API precursor and an activator during the operation of dispensing the solution from a spray device.

[0164] In one embodiment of a method for dispensing a solution, the method further comprises the step of mixing the API precursor and the activator less than 50 milliseconds before dispensing the solution from the spray device.

[0165] In one embodiment of a method for dispensing a solution, the method further includes a step of mixing the API precursor and the activator for the first time when the API precursor exits the first pump and the activator exits the second pump.

[0166] In one embodiment of a method for dispensing a solution, the method further includes a step of mixing the API precursor and the activator a second time when the combined API precursor and activator leaves the first mixing space of the spray device and enters the second mixing space of the spray device.

[0167] In one embodiment of a method for dispensing a solution, the method further includes a step of mixing the API precursor and the activator a third time when the combination of the API precursor and the activator enters the nozzle tip of the spraying device.

[0168] In one embodiment of a method for dispensing a solution, the method further includes a step of mixing the volumes of the first chamber and the second chamber in a ratio of approximately 1:10 to approximately 10:1.

[0169] In one embodiment of a method for dispensing a solution, the method further includes a step of pressurizing a combination of an API precursor and an activator when dispensing the solution from a spray device.

[0170] In one embodiment of a method for dispensing a solution, the method further includes a step of spraying the solution in an amount of approximately 0.01 ml to approximately 5 ml for each dispensing event.

[0171] In one embodiment of a method for dispensing a solution, the method further comprises the step of spraying the solution at an outlet velocity from a spraying device of about 6.5 m / s to about 19.5 m / s.

[0172] In one embodiment of the method for dispensing a solution, the viscosity of the first liquid, the second liquid, or a combination thereof is approximately 0.1 centipoise (cP) to approximately 10,000 cP.

[0173] In one embodiment, a method for activating a solution is provided, comprising the steps of: providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and a solution containing an activator to a second chamber of the liquid container of a spray device; and activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution within the spray device during the operation of dispensing the mixed solution from the spray device.

[0174] In one embodiment of a method for activating a solution, the method further comprises the step of mixing the API precursor-containing solution and the activator-containing solution less than 50 milliseconds before dispensing the mixed solution from a spray device.

[0175] In one embodiment of a method for activating a solution, the method further includes a step of mixing the API precursor-containing solution and the activator-containing solution for the first time when the API precursor-containing solution exits the first pump and the activator-containing solution exits the second pump.

[0176] In one embodiment of a method for activating a solution, the method further includes a step of mixing the API precursor-containing solution and the activator-containing solution a second time when the combined solution exits the first mixing space of the spraying device and enters the second mixing space of the spraying device.

[0177] In one embodiment of a method for activating a solution, the method further includes a step of mixing the API precursor-containing solution and the activator-containing solution a third time when the combined solution enters the nozzle tip of a spraying device.

[0178] In one embodiment of a method for activating a solution, the method further comprises the steps of: providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and a solution containing an activator to a second chamber of the liquid container of a spray device; activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution multiple times within the spray device; and dispensing the mixed solution from the spray device to the treatment site.

[0179] In one embodiment of a method for activating a solution, the method further includes a step of mixing the API precursor-containing solution and the activator-containing solution for the first time when the API precursor-containing solution exits the first pump and the activator-containing solution exits the second pump.

[0180] In one embodiment of a method for activating a solution, the method further includes a step of mixing the API precursor-containing solution and the activator-containing solution a second time when the combination of the API precursor-containing solution and the activator-containing solution exits the first mixing space of the spraying device and enters the second mixing space of the spraying device.

[0181] In one embodiment of a method for activating a solution, the method further includes a step of mixing the API precursor-containing solution and the activator-containing solution a third time when the combined solution enters the nozzle tip of a spraying device.

[0182] In one embodiment, a method for administering treatment is provided, comprising the steps of: providing a solution containing a pharmaceutical active ingredient (API) precursor to a first chamber of the liquid container of a spray device and a solution containing an activator to a second chamber of the liquid container of the spray device; and activating the API precursor by mixing the API precursor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device to the treatment site.

[0183] In one embodiment of a method for administering treatment, the method further comprises the step of mixing the API precursor-containing solution and the activator-containing solution within 50 milliseconds before dispensing the mixed solution from a spray device.

[0184] In one embodiment, the method comprises the steps of: providing a therapeutically effective amount of an unstable active pharmaceutical ingredient (API) in an API precursor-containing solution to a first chamber of the liquid container of a spray device; providing an activator-containing solution to a second chamber of the liquid container of the spray device; activating a therapeutically effective amount of the API precursor by mixing the API precursor-containing solution and the activator-containing solution multiple times within the spray device; and dispensing the mixed solution to the treatment site.

[0185] In one embodiment of a method for administering treatment, the method further comprises the step of activating a therapeutically effective amount of API during the operation of dispensing a mixed solution from a spray device.

[0186] In one embodiment of a method for administering treatment, the method further comprises the step of activating a therapeutically effective amount of API less than 50 milliseconds before dispensing the mixed solution from a spray device.

[0187] In one embodiment of a method for administering treatment, the method further comprises a step of activating a therapeutically effective amount of API by mixing the volume of the API precursor with the volume of the activator in a ratio of approximately 1:10 to approximately 10:1.

[0188] In one embodiment of a method for administering treatment, the method further comprises a step of activating a therapeutically effective amount of API by pressurizing a combination of the API precursor and an activator when dispensing the mixed solution from a spray device.

[0189] In one embodiment of a method for administering treatment, the method further comprises the step of mixing the API precursor-containing solution and the activator-containing solution for the first time when the API precursor-containing solution exits the first pump and the activator-containing solution exits the second pump.

[0190] In one embodiment of a method for administering treatment, the method includes a step of mixing the API precursor-containing solution and the activator-containing solution a second time when the combined solution leaves the first mixing space of the spraying device and enters the second mixing space of the spraying device.

[0191] In one embodiment of a method for administering treatment, the method further includes a step of mixing the API precursor-containing solution and the activator-containing solution a third time when the combined solution enters the nozzle tip of a spraying device.

[0192] In one embodiment, a method for producing a product suitable for administering a nitric oxide releasing solution (NORS) after a long storage period is provided, comprising the steps of: providing a nitric oxide (NO) donor-containing solution to a first chamber of the liquid container of a spray device; providing an activator-containing solution to a second chamber of the liquid container of the spray device; and activating the NORS by mixing the NO donor-containing solution and the activator-containing solution during the operation of dispensing the mixed solution from the spray device.

[0193] In one embodiment of a method for producing a product suitable for administering NORS after a long storage period, the method further comprises the step of mixing the NO donor-containing solution and the activator-containing solution multiple times within the spray device during the operation of dispensing the mixed solution from the spray device.

[0194] In one embodiment of a method for producing a product suitable for administering NORS after a long storage period, the long storage period is longer than at least one of the following: 5 days, 15 days, 30 days, 45 days, 90 days, 120 days, 180 days, 1 year, 2 years, or 5 years.

[0195] In one embodiment of a method for producing a product suitable for administering NORS after a long storage period, the potency of activated NORS after the long storage period relative to the potency of activated NORS before the long storage period is greater than 1 or more of 70%, 80%, 90%, 95%, 99%, or 99.9%.

[0196] In one embodiment of a method for producing a product suitable for administering NORS after a long storage period, the NO donor-containing solution and the activator-containing solution are mixed for a time of a selected duration or less before the mixed solution is dispensed from a spray device.

[0197] In one embodiment of a method for producing a product suitable for administering NORS after a long storage period, the selected time is shorter than one or more of 15 seconds, 5 seconds, 1 second, 100 milliseconds (ms), 50 ms, or 10 milliseconds.

[0198] Naturally, it should be understood that the configurations described above are merely illustrative examples of the application of the principles of the present invention. Those skilled in the art will be able to devise numerous modifications and alternative configurations without departing from the spirit and scope of the present invention, and the appended claims are intended to encompass such modifications and configurations. Thus, although the present invention has been described in specific and detail in relation to what is currently considered to be the most practical and preferred embodiment of the present invention, those skilled in the art will see that numerous modifications are possible, without departing from, and not limited to, the principles and concepts described herein, including changes in size, materials, shape, form, function, as well as changes in operation, assembly, and use.

Claims

1. 1. A spray device comprising: a liquid container including a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid; a first pump in fluid communication with the first chamber and operable to aspirate and retain the first liquid; a second pump in fluid communication with the second chamber and operable to aspirate and retain the second liquid; a plurality of mixing spaces fluidly connected to the first pump and the second pump and operable to allow mixing of the first liquid and the second liquid; a nozzle fluidly connected to the plurality of mixing spaces; A spray device comprising:

2. 2. The spray device of claim 1, wherein the plurality of mixing spaces are substantially empty between each actuation of the pump.

3. 2. The spray device according to claim 1, wherein the plurality of mixing spaces are A first mixing space; a second mixing space fluidly connected between the first mixing space and the nozzle; A spray device comprising:

4. 10. The spraying device of claim 1, further comprising a connecting plate, the connecting plate including a first inlet, a second inlet, a central abutment, an inner peripheral wall defining at least a portion of the first mixing space, and an outer peripheral wall.

5. 10. The spray device of claim 1, further comprising a connection plate having a recess at least partially defining the first mixing space and an opening fluidly connecting the first pump and the second pump to the first mixing space.

6. 10. The spray device of claim 1 further comprising: A support, A plurality of nozzle grooves; a plurality of channel-forming projections fluidly connecting the first mixing space and the second mixing space; A spray device having the support comprising:

7. 10. The spray device of claim 1 further comprising an upper housing comprising: a nozzle opening; defining a portion of the second mixing space and a portion of the nozzle mixing space. A spray device having the upper housing.

8. 10. The spray device of claim 1, further comprising a cap operable to connect to the upper housing.

9. 10. The spray device of claim 1 further comprising: a pump housing connected between the liquid container and an outlet tube of the first pump and an outlet tube of the second pump; a first pump fitting configured to hold the first pump; a second pump fitting configured to hold the second pump; a base operable to connect to a connecting valve of said liquid container; Color and A spray device comprising:

10. 10. The spray device of claim 1, further comprising a gasket coupled between the liquid container and a pump housing.

11. 2. The spray device of claim 1, wherein the liquid container further comprises: a partition separating the first chamber and the second chamber; An outer housing; a bottom forming a bottom of the first chamber and a bottom of the second chamber; a connection valve operable to connect to a base of the pump housing; A spray device comprising:

12. 2. The spray device according to claim 1, The first pump comprises: a first inlet conduit in fluid communication with the first chamber, the first inlet conduit including a first inlet, a first piston, a first spring, and a first ball valve; a first outlet pipe including a first outlet fluidly connected to the first mixing space; and The second pump comprises: a second inlet conduit in fluid communication with the second chamber, the second inlet conduit including a second inlet, a second piston, a second spring, and a second ball valve; a second outlet pipe including a second outlet fluidly connected to the first mixing space; A spray device comprising:

13. 2. The spray device according to claim 1, the tip portion of the upper housing is configured to spray at an angle ranging from about 0° to about 90° relative to the flow path exiting the second mixing space; or The nozzle is configured to spray liquid in a predetermined pattern including one or more of a hollow cone, a solid cone, a spiral cone, a solid stream, a mist, a fog, a flat fan, or a combination thereof. Spraying device.

14. 10. The spray device of claim 1, wherein the viscosity of the first liquid or the second liquid or a combination thereof is from about 0.1 centipoise (cP) to about 10,000 cP.

15. 2. The spray device according to claim 1, the volume of the first chamber is between about 1 ml and about 100 ml; or The volume of the second chamber is from about 1 ml to about 100 ml. Spraying device.

16. 10. The spray device of claim 1, wherein the ratio of the volume of the first chamber to the volume of the second chamber is from about 1:10 to about 10:

1.

17. 2. The spray device of claim 1, wherein the volume of the first chamber and the volume of the second chamber are substantially equal.

18. 10. The spray device of claim 1, wherein the spray device is operable to spray a volume of liquid of about 0.01 ml to about 5 ml upon each actuation of the first and second pumps.

19. 2. The spray device according to claim 1, the ratio of the volume of the first mixing space to the volume of the second mixing space is from about 1:10 to about 10:1; or the ratio of the volume of the first mixing space to the volume of the third mixing space is from about 1000:1 to about 10:1; or the ratio of the volume of the second mixing space to the volume of the third mixing space is from about 1000:1 to about 10:1; Spraying device.

20. 2. The spray device according to claim 1, the first pump is operable to aspirate and retain a liquid volume of about 0.01 ml to about 5 ml; or the second pump is operable to aspirate and retain a liquid volume of about 0.01 ml to about 5 ml; Spraying device.

21. 2. The spray device according to claim 1, a volume ratio between the capacity of the first pump or the second pump and the volume of the first mixing space or the second mixing space is about 100:1 to about 1:1; or The volume ratio of the capacity of the first pump or the second pump to the volume of the nozzle mixing space is about 10,000:1 to about 10:1; Spraying device.

22. 10. The spray device of claim 1, wherein the exit velocity from the nozzle is from about 6.5 m / s to about 19.5 m / s.

23. 1. A spray device comprising: a liquid container including a first chamber operable to hold a first liquid and a second chamber operable to hold a second liquid; a first pump partially within the first chamber and operable to aspirate and retain the first liquid; a second pump partially within the second chamber and operable to aspirate and retain the second liquid; a mixing space fluidly connected to the first pump and the second pump and operable to allow mixing of the first liquid and the second liquid, the mixing space being substantially empty between each operation of the pump; and Nozzle and A spray device comprising:

24. 24. The spray device of claim 23, further comprising an additional mixing space fluidly connected to the first pump and the second pump and operable to allow mixing of the first liquid and the second liquid.

25. 25. The spray device of claim 24, further comprising a nozzle mixing space, said nozzle mixing space comprising a vortex tip of said nozzle.

26. 24. The spray device of claim 23, wherein the mixing space is fluidly connected to a first outlet from the first pump and a second outlet from the second pump.

27. 1. A method of dispensing a solution, comprising: providing an active pharmaceutical ingredient (API) precursor in a first chamber of a liquid reservoir of the spray device and an activator in a second chamber of the liquid reservoir of the spray device; activating said API precursor by mixing said API precursor with said activator multiple times in said spray device; dispensing the solution from the spray device; The method comprising:

28. 28. The method of claim 27 further comprising: mixing the API precursor and the activator during the act of dispensing the solution from the spray device.

29. 28. The method of claim 27 further comprising: mixing said API precursor and said activator less than 50 milliseconds prior to dispensing said solution from said spray device.

30. 28. The method of claim 27 further comprising: mixing said API precursor and said activator a first time as said API precursor exits a first pump and said activator exits a second pump.

31. 31. The method of claim 30 further comprising: mixing said API precursor and said activator for a second time when the combined API precursor and activator exit the first mixing space of the spray device and enter a second mixing space of the spray device.

32. 32. The method of claim 31 further comprising: mixing said API precursor and said activator for a third time as the combination enters the nozzle tip of said spray device.

33. 28. The method of claim 27 further comprising: mixing said first chamber volume to said second chamber volume in a ratio of about 1:10 to about 10:

1.

34. 28. The method of claim 27 further comprising: pressurizing the combination of the API precursor and the activator when dispensing the solution from the spray device.

35. 28. The method of claim 27 further comprising: The method comprises spraying the solution in an amount of about 0.01 ml to about 5 ml per dispensing event.

36. 28. The method of claim 27 further comprising: spraying the solution at an exit velocity from the spraying device of from about 6.5 m / s to about 19.5 m / s.

37. 28. The method of claim 27, wherein the viscosity of the first liquid or the second liquid or a combination thereof is from about 0.1 centipoise (cP) to about 10,000 cP.