WO2023003963A1

WO2023003963A1 - Nasal irrigation device and system for diagnostic applications

Info

Publication number: WO2023003963A1
Application number: PCT/US2022/037739
Authority: WO
Inventors: Martin HOKE
Original assignee: Rhinosystems, Inc.
Priority date: 2021-07-20
Filing date: 2022-07-20
Publication date: 2023-01-26

Abstract

A nasal irrigation device communicates an irrigant to a device user and comprises a mechanics module, an upper reservoir, and a lower reservoir. A pump is used to generate suction within the lower reservoir, encouraging fluid flow through the device. Effluent received in the lower reservoir can be tested using diagnostic tools provided with the device. The lower reservoir can include additional assemblies including such diagnostic tools. In some embodiments, the pump is a manually operated pump.

Description

NASAL IRRIGATION DEVICE AND SYSTEM FOR DIAGNOSTIC APPLICATIONS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63/223,643, filed on July 20, 2021, which is incorporated by reference in its entirety.

BACKGROUND

[0002] The present disclosure generally relates to methods and devices for irrigating or rinsing the nasal cavity and anatomical openings thereto to obtain mucosal material for testing and diagnostic purposes and applications.

[0003] Nasal irrigation can be used to bathe the nasal and sinus cavities with saline water to wash away encrusted mucous, irritants, and foreign particles, and to shrink the turbinates for the purpose of improving airflow and relieving nasal congestion. [0004] There are two methods by which the nasal cavity can be irrigated: pressure that is positive relative to atmospheric pressure (i.e. the irrigant is “pushed” through the nasal cavity), and pressure that is negative relative to atmospheric pressure (i.e. the irrigant is “pulled” through the nasal cavity). Positive pressure can be effected two ways: first, by gravity, and second, by means of manufactured pressure. Negative pressure, also called vacuum or suction, can also be effected two ways: first, anatomically by nasal inhaling or sniffing, and second, by means of manufactured suction.

[0005] For testing and diagnostic purposes, a useful collection device should be a convenient handheld device that can safely irrigate the nasal cavity with a controlled, gentle supply, draw the irrigant through the nasal cavity under the influence of gentle powered suction, collect the effluent safely, is readily adaptable to a wide variety of nasal dimensions, and facilitates the testing of mucosal material collected in the effluent. In some particular embodiments, it would be desirable to provide a disposable low-cost nasal irrigation device for one-time use. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 is a perspective view of an embodiment of a nasal irrigation device and system of the present disclosure.

[0007] FIG. 2 is an exploded view of the embodiment of FIG. 1.

[0008] FIG. 3 is a perspective view showing the embodiment of FIG. 1 with an open lid and a saline concentrate capsule received in the device.

[0009] FIG. 4 is a cross sectional view of the embodiment of FIG. 1.

[0010] FIG. 5 is a lower perspective view showing the bottom of the mechanics module, particularly showing the bottom wall thereof.

[0011] FIG. 6A and FIG. 6B illustrate one version of a manual pump for use in the nasal irrigation device.

[0012] FIG. 6A shows a bulb being squeezed to force air out the bulb.

[0013] FIG. 6B shows the bulb being released and drawing air into the bulb, creating suction.

[0014] FIG. 7A and FIG. 7B illustrate a second version of a manual pump for use in the nasal irrigation device.

[0015] FIG. 7A shows a piston being pulled out to create suction and push air out of the piston body.

[0016] FIG. 7B shows the piston being pushed inwards to transfer air between two internal chambers.

[0017] FIG. 8 illustrates some different modifications that can be made to the lower reservoir for diagnostic and/or testing purposes.

[0018] FIG. 9 is a perspective view of another embodiment of a manually operated nasal irrigation device according to the present disclosure.

DETAILED DESCRIPTION

[0019] The present disclosure generally relates to methods and devices for irrigating or rinsing the nasal cavity and anatomical openings thereto to obtain mucosal material for testing and diagnostic purposes and applications. Briefly, a nasal irrigation device is used to introduce irrigant into the nasal cavity, and then collect the effluent in a collection reservoir. The effluent contains mucosal material from within the nasal cavity which can then be collected for testing. Alternatively, a testing or diagnostic assembly may be present within the collection reservoir, permitting analysis of the mucosal material within the collection reservoir itself. In some embodiments, the nasal irrigation device is made to be disposable, using a relatively simple construction and relatively cheap components.

[0020] The Nasal Irrigation Device

[0021] FIG. 1 shows an embodiment of a nasal irrigation device or controller A for introducing an irrigating liquid solution into the nasal cavity of a user for irrigating and washing the cavity, and for collecting the effluent in a collection reservoir. The irrigation device A is comprised of three principal components: a housing which could be termed a mechanics module 10, a supply or upper reservoir 12, and a collection or lower reservoir 14.

[0022] Continuing with FIG. 1, the mechanics module 10 includes a nasal interface 20 for engaging the nostrils of a user with nasal pillows or nozzles 22 that are partially inserted into the nostrils and sealed against the opening perimeters thereof, as will be more fully explained below. A pump actuator 24 indicates a location by which a pump is used to evacuate the lower reservoir 14 and apply differential pressure to the lower reservoir 14 and the nasal cavity of a user. For example, the pump actuator could be an on/off switch for a motorized pump, or could be a location where a manual pump is operated.

[0023] A hinged lid 26 is present for introducing water into the upper reservoir 12. In addition, a saline concentrate capsule can be inserted through the lid, so that when the lid is closed the concentrate falls into and is mixed with the water. The upper reservoir surrounds the lid and creates a watertight seal. In some embodiments, the lid may be connected to the upper reservoir. The upper reservoir 12 is physically located above the nasal interface 20, and acts as a source of irrigant to the nasal interface. The lower reservoir 14 is physically located below the nasal interface, and receives and collects effluent received from the nasal interface 20.

[0024] FIG. 2 shows an exploded version of the device. In some embodiments as illustrated here with respect to the mechanics module 10, the nozzles 22 may be received upon nozzle posts 28 which depend from a coaxial turntable mount 30 mounted for fluid sealing engagement on a coaxial turntable receiver 32. As illustrated here, the receiver 32 also includes an irrigant supply channel 33 which is located around the perimeter of an irrigant effluent channel 35. The mount 30 is shaped so that one nozzle 22 is always in communication with the irrigant supply channel 33, and the other nozzle is always in communication with the irrigant effluent channel 35. This permits the irrigant to flow into one nostril from a first nozzle 22, through the nasal cavity, and then be received from the other nostril through a second nozzle 22. The coaxial turntable mount 30 is readily rotatable so that the direction of flow through the nasal cavity can be selectively reversed as desired by the user. One of the nozzles will always send fluid into the nose regardless of turntable position, while the other nozzle will always receive fluid out of the nose for capture within the lower reservoir 14.

[0025] Continuing, the mechanics module 10 may include a cartridge or capsule tower assembly 40 having the openable and closeable lid 26 thereon. The upper reservoir 12 is shaped to receive the capsule tower assembly. Also illustrated are bayonets 44 disposed on the inlet flange 43 surrounding the upper outer rim of lower reservoir opening 42. It can be seen that the upper reservoir 12 covers a greater surface area of the mechanics module 10 than the lid 26, when considered from a top view.

[0026] Referring now to FIG. 3, some internal components proximate the hinged lid 26 are shown. Disposable saline concentrate capsule B is shown being received within the capsule tower assembly. The lid 26 is opened through a push button 50 typically comprising a latch and catch assembly. The capsule tower assembly has a recessed seat area 56 that mates with the overall outer configuration of the capsule B to facilitate crushing, piercing, and proper camming operation. The lid 26 includes engaging members 52, 54 which engage predetermined areas of the capsule B. Engaging member 52 comprises opposed engaging projections or surfaces 52A, 52B spaced by recess 52C. These structures are used for authentication purposes not relevant to the present disclosure.

[0027] Referring now to FIG. 4 and FIG. 5 together, additional parts of the mechanics module 10 are visible. A one-way fluid release valve 72 is shown extending into the upper reservoir from the mechanics module. This one-way valve controls the flow of the irrigant through the whole fluid passageway from the upper reservoir to the lower reservoir. The pump 70 is used to create suction. Batteries for powering the pump are located in battery chamber 100.

[0028] The lower wall 71 of the mechanics module 10 includes a module outlet port 39, which engages the lower reservoir opening 42 (see FIG. 2). Elastomeric engagement seal 102 surrounds the inner perimeter of the module outlet port, for contacting the upper outer rim of lower reservoir opening 42 and ensuring an air-tight and water-tight seal. Bayonet reception slots 37 are present for receiving the bayonets 44. Two fluid openings are also present within the module outlet port 39. The first fluid opening is a pump inlet port 73 for drawing air out of the lower reservoir 14 by the pump 70. The second fluid opening is a fluid outlet port 75 for allowing the effluent, which has cleaned the user’s nasal cavity, to fall into the lower reservoir 14. The air inlet port is protected against drawing effluent into the mechanics module 10 by a float valve and cover 79. The lower reservoir 14 also includes a plug 46 in its bottom wall, which could be used to drain the lower reservoir without separating it from the mechanics module. [0029] Referring now to FIGS. 1-5 together, when assembled and loaded with irrigant, the system is intended to provide a closed system relative to fluid pressure when sealed against the nasal cavity of a user so that a differential negative pressure resulting in a slight vacuum (relative to atmospheric pressure) is applied at the lower reservoir 14 to allow the fluid to flow from the upper reservoir 12 through the mechanics module 10, the nasal interface 30, and the nasal cavity of a user into the lower reservoir 14. The amount of differential pressure is relatively slight, just enough to overcome the combination of human nasal cavity resistance and a declining head pressure due to the evacuating irrigant in the upper reservoir 12. A negative pressure of something between 6 and 24 inches of water should be adequate.

[0030] In operation in some embodiments, the lower reservoir is first inserted into the mechanics module by alignment between the opening 42 and the module 10 at a slight rotational angle, and then by effecting a slight rotation of the reservoir 14 to the position shown in FIG. 1. A tactile “click” indicates to the user that the reservoir is properly sealed against the module 10. Upper reservoir 12 is similarly applied to the mechanics module 10 by a twisting click indication and similarly must be sealed against the mechanics module 10 with an elastomeric seal to preclude the irrigant from leaking out of the upper reservoir 12 either before or during use. It is not important for the upper reservoir to be air-tight, as air is intended to be pulled into the upper reservoir as the fluid is evacuated therefrom to allow the irrigant to properly flow through the system. [0031] The pump actuator 24 indicates where the user activates or operates a pump to cause fluid flow through the device and the nose of the user. It is contemplated that the pump acts as a vacuum source that will create a slight vacuum in the lower reservoir 14, causing fluid to flow from the upper reservoir 12 through the mechanics module 10, the nasal interface 30, and into one nostril of the user through the nasal cavity of a user. The fluid then exits through the other nostril of the user and flows through the nasal interface 30 into the lower reservoir 14. The vacuum may be cyclical, or it may be constant. If desired, the pump actuator may also engage a linkage (not shown) that controls the opening and closing of valve 72.

[0032] The irrigating process continues until the fluid has been drained from the upper reservoir which is apparent to the user either by viewing the fluid through the transparent side walls of the upper reservoir, or until a sensation is detected that the system is no longer sealed against ambient air pressure by the pulling of ambient air through the valve 72 as the upper reservoir 12 has been emptied. During operation, effluent is collected in the lower reservoir 14.

[0033] Alternative Embodiments

[0034] As previously mentioned, a disposable low-cost nasal irrigation device is desirable for testing and diagnostic purposes. One way to reduce costs is to reduce the machinery needed for operation of the nasal irrigation device. For example, a high-cost item is the motorized pump and the batteries needed for use thereof. Thus, in particular embodiments, the nasal irrigation device uses a manually operated pump. As previously mentioned, pump actuator 24 identifies a location for manually operating the pump. This location is illustrative, and the pump actuator can be placed in any location desired on the mechanics module, including on the top or bottom of the mechanics module (with the mechanics module, upper reservoir, and/or lower reservoir being resized as needed). It is also contemplated that more than one such pump actuator might be present. For example, there might be a pump actuator on each side of the mechanics module for operating the pump. It is noted that the pump does not have to be located physically within the mechanics module, though such an embodiment is preferred. Generally, the manual pump can be any device that uses manual power to operate a pump in such a manner that creates suction through the pump inlet port 73 and thus draws air out of the lower reservoir 14. The mechanics module 10 can be sized accordingly.

[0035] Very generally, a manually operated pump is formed from at least two one-way valves that control air flow through a chamber. The volume of the chamber can be increased or decreased. The increased volume creates a suction of air into the chamber, and the decreased volume causes pumping of air out of the chamber. In this way, a small vacuum can be formed. For example, the chamber may have flexible walls, with the chamber being resilient so that the walls have a rest state.

[0036] FIG. 6A and FIG. 6B are figures showing one example of such a manual pump. The pump 100 is formed from a bulb 110 having two one-way valves which control air flow in and out of the bulb. The first one-way valve 120 allows air to enter the bulb from the exterior, and is connected to the pump inlet port 73 (see FIG. 5). The second one-way valve 130 allows air within the bulb to exit. The bulb can be made from a suitable material, such as rubber or plastic. The one-way valves can be any suitable type of valve, such as a ball valve, a diaphragm valve, a swing valve, a tilting disc valve, a flap valve, or a duckbill valve. The one-way valves can also be made from any suitable material, such as rubber or plastic.

[0037] In operation, when the bulb is squeezed as seen in FIG. 6A, the second one-way valve 130 opens and air exits the bulb. The first one-way valve 120 remains closed. When the bulb is released as seen in FIG. 6B, the second one-way valve 130 closes and the lower pressure within the bulb causes air from the lower reservoir to open the first one-way valve 120 and flow into the bulb, thus creating suction in the lower reservoir. The bulb is repeatedly squeezed and released to increase or maintain a vacuum in the lower reservoir to draw irrigant through the nasal cavity. It is contemplated that the pump 100 could be located within the mechanics module 10, with the bulb 110 being accessible from both sides of the mechanics module so it can be pinched by the finger and thumb of one hand. Alternatively, the bulb could extend from one side of the mechanics module to be squeezed by one hand. It is noted that the mechanics module 10 can contain vents (not illustrated) to expose its interior to atmosphere, to permit air exiting the pump to exit to atmosphere.

[0038] FIG. 7A and FIG. 7B are figures showing another example of a manual pump. This embodiment is very similar to a bicycle pump. The pump 100 includes a body 140 through which a piston 150 can pass. The piston includes a crown 152 located within the body, a stem 154, and a handle 156 located outside the body. The crown of the piston divides the interior of the body 140 into a compression chamber 142 and an expansion chamber 144, and the crown could be considered as forming a wall of each chamber. The crown includes a one-way valve 158 which permits airflow from the compression chamber 142 into the expansion chamber 144.

[0039] Two one-way valves control air flow in and out of the body 140. The first one-way valve 120 allows air to enter the compression chamber 142 from the exterior, and is connected to the pump inlet port 73 (see FIG. 5). The second one-way valve 130 allows air within the expansion chamber 144 to exit to atmosphere.

[0040] In operation, when the piston is pulled out of the body 140 to reduce the volume of the expansion chamber 144 as seen in FIG. 7A, the second one-way valve 130 opens and air exits the expansion chamber to atmosphere. Due to the increased volume of the compression chamber 142, the first one-way valve 120 opens, thus creating suction in the lower reservoir. The piston crown valve 158 remains closed. When the piston is pushed into the body 140 to reduce the volume of the compression chamber 142 as seen in FIG. 7B, the first one-way valve 120 and the second one-way valve 130 are closed. The crown piston valve 158 opens and air passes from the compression chamber 142 into the expansion chamber 144. The piston 150 is repeatedly moved through the body 140 to increase or maintain a vacuum in the lower reservoir to draw irrigant through the nasal cavity. Again, the mechanics module 10 can contain vents (not illustrated) to expose its interior to atmosphere, to permit air exiting the pump to exit to atmosphere.

[0041] Besides using a manually operated pump, other structural changes to the nasal irrigation device might reduce costs and complexity. For example, referring back to FIG. 2, the nozzles 22 are mounted upon a coaxial turntable mount 30, which is rotatable. In some embodiments, the mount 30 is integrally formed with the mechanics module 10, or in other words the mount is not separable from the mechanics module 10. In functional terms, the nozzles 22 cannot be rotated to change the direction of flow through the nasal cavity. This change could also simplify the construction of the mechanics module. In such embodiments, the nozzle posts 28 could be considered as extending directly from the mechanics module 10.

[0042] Referring still to FIG. 2, the upper reservoir 12 and the lower reservoir 14 are described as being separable from the mechanics module 10. In some embodiments, the upper reservoir 12 is integrally formed with the mechanics module 10, or in other words is not separable from the mechanics module 10. In some embodiments, the lower reservoir 14 is integrally formed with the mechanics module 10, or in other words is not separable from the mechanics module 10. In these embodiments, the walls of the upper reservoir and the lower reservoir are desirably transparent, so the contents thereof can be seen. This is helpful for viewing their contents and diagnostic results therein, as explained further herein.

[0043] Referring now to FIG. 2 and FIG. 3, the capsule tower assembly 40 is present in embodiments where a saline concentrate capsule B will be mixed with water to obtain a saline solution, and/or where the nasal irrigation device can be refilled and reused. In some embodiments, it is contemplated that the upper reservoir is provided as a single unit which is pre-filled with a saline solution. In such embodiments, a lid 26 and capsule tower assembly 40 are not needed at all in the nasal irrigation device. Again, this change can simplify the construction of the mechanics module.

[0044] Finally, a larger volume of irrigant is usually used for nasal cleaning purposes, whereas a smaller volume may be preferred for diagnostic purposes. Reducing the size / volume of the upper reservoir and lower reservoir, and/or also reducing the size / volume of the mechanics module, can also reduce costs and simplify construction. For example, referring to FIG. 2, the length and/or height of the mechanics module 10, the upper reservoir 12, and/or the lower reservoir 14 could be reduced. Whereas a device used for cleaning purposes might have reservoirs sized for volumes of 6 oz to 12 oz, a device for diagnostic purposes may only need a reservoir sized for volumes of 2 oz to 5 oz. [0045] FIG. 9 illustrates an embodiment of a manually operated nasal irrigation device in schematic form, which incorporates some of the changes described herein. A housing 200 is provided, which acts as the mechanics module. The housing includes a handle 205, so the device can be hand-held. Mounted atop the housing is an upper reservoir 210 containing irrigant. A lower reservoir 220 is mounted beneath the housing for capturing effluent. Both of these reservoirs are of a smaller volume / size. No lid or capsule tower assembly is present in this embodiment.

[0046] Located on a face or wall of the housing is a first nozzle post 230, and spaced therefrom is a second nozzle post 240. The two nozzle posts engage the nostrils of the user, and are integrally formed with the housing 200, and are not rotatable. Mounted to another face or wall of the housing is a manually operated pump 250. Suitable fluid passageways (not shown) connect one of the nozzle posts 230, 240 to the upper reservoir 210, and the other nozzle post to the lower reservoir 220. Another suitable fluid passageway (not shown) connects the suction pump 250 to the lower reservoir 220, to draw air from the lower reservoit 220 and create a vacuum that causes suction. While the manually operated pump 250 can be of the types shown in FIGS. 6A-7B, the pump can also be a flexible diaphragm, a bellows construction or a plunger of the type employed with a syringe. Due to the location of the upper reservoir 210 above the housing 200, it should be appreciated that a gravity-driven flow of the irrigant to a nostril of a user through one of the nozzle posts 230, 240 can take place. By drawing a suitable suction on the lower reservoir 220 via the manually operated pump 250, a flow of effluent from the other nostril of the user also takes place. If desired, a test substrate 260 can be provided in the lower reservoir. It should be appreciated that at least one wall of the lower reservoir can be transparent so that the test substrate can be visually inspected without having to separate the lower reservoir from the housing. [0047] Diagnostics and/or Testing

[0048] Briefly, a nasal irrigation device is used to introduce irrigant into the nasal cavity, and then collect the effluent in a collection reservoir. The effluent contains mucosal material from within the nasal cavity, and the mucosal material may include genetic material from viruses, bacteria, or fungi. The mucosal material can then be collected for testing. Alternatively, a testing or diagnostic assembly may be present within the collection reservoir, permitting analysis of the mucosal material within the collection reservoir itself.

[0049] Several diagnostic assays are known in the art. For example, in a conventional lateral flow immunochromatographic assay commonly used for detecting pregnancy, a test substrate contains a sample zone, a reaction zone downstream of the sample zone, and a trapping zone downstream of the reaction zone. The sample containing the mucosal material is applied to the sample zone, and the sample subsequently travels through the reaction zone and the trapping zone (through capillary action or wicking). The reaction zone contains antibodies which are attached to a label. The antibodies are specific for the desired antigen, and bind to the antigen. The sample then passes to the trapping zone, which also contains immobilized antibodies that are specific for the desired antigen. The antigen also binds to the immobilized antibodies, which traps the label in the trapping zone. This creates a visual change in the trapping zone due to the concentrated presence of the label, confirming that the antigen was present. If no antigen is present, then there will be no visual change in the trapping zone.

[0050] Other immunoassays are also contemplated to be used with the mucosal material in the effluent. For example, in immunofluorescence, a reagent contains an antibody which is linked to a fluorophore, and the antibody binds to the antigen. Upon exposure to light, the fluorophore makes a visible color change indicating the presence of the antigen.

[0051] For such assays, typically the bound antibody-antigen complexes need to be separated from the unbound antibodies, so that the signal can be identified. This can be done by providing a location where the antigen is fixed in place and is separated from the effluent itself, so the unbound antibodies can flow into the effluent.

[0052] To achieve this, as illustrated in FIG. 8, the lower reservoir 14 could be modified with a platform 160 located below the lower reservoir opening 42 and above the floor of the lower reservoir. The test substrate 162 is attached to the platform 160, so that the effluent is deposited on the test substrate. The reaction zone 164 and the trapping zone 166 are also labeled. The platform can be tilted to direct the flow of the effluent. The results of the assay could then be viewed through the front of the transparent lower reservoir, or by separating the lower reservoir 14. from the mechanics module 10.

[0053] Alternatively, as also illustrated in FIG. 8, the lower reservoir could be modified to include a wall 170 that divides the lower reservoir into two separate chambers of very different volumes. As illustrated here, the wall is located near the rear of the lower reservoir, and is sized so that a small clearance gap remains to the top or roof of the lower reservoir. The test substrate 162 is attached to the rear of the wall, in the smaller chamber. The wall can be vertical, or may be tilted at a desired angle. After the effluent is collected in the larger chamber, the device is slowly tipped so that some of the effluent runs down the wall and through the test substrate. The results of the assay could then be viewed through the rear of the transparent lower reservoir.

[0054] Alternatively, the test substrate 162A could be placed on a wall of the lower reservoir relatively close to the roof of the lower reservoir. Again, after the effluent is collected in the lower reservoir, the device is slowly tipped so that some of the effluent contacts the test substrate, and the diagnostic result of the assay can then be viewed through the transparent wall of the lower reservoir.

[0055] In yet another embodiment also illustrated in FIG. 8, the plug 46 is modified to include a filter 180. It is contemplated that when the plug is pulled, the effluent will flow through the filter. The filter is used to concentrate and trap the mucosal material for later testing. The filter could be made to be separable from the lower reservoir, or the lower reservoir could be used together with the filter for testing.

[0056] The lower reservoir may be built as a low-cost disposable component that is separable from the mechanics module, while the upper reservoir and the mechanics module are reusable.

[0057] Other immunoassays or bioassays are also contemplated to be compatible with use in the nasal irrigation device of the present disclosure. The mechanics module may contain a battery 100 or other power source for powering such assays. For example, a lab-on-a-chip may require power for creating electrical fields or operating small pumps, valves, or other electronics.

[0058] It is contemplated that microbiological, chemical, or toxicological tests could be performed with the collected mucosal material. Such tests could be used to detect, for example, influenza, coronavirus, rhinovirus, Streptococcus pneumonia, or Haemophilus influenzae, or the use of drugs such as cocaine, opioids, heroin, amphetamines, benzodiazepines, or others.

[0059] It will be appreciated that variants of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims.

Claims

PCT/U522/37739 20 July 2022 (20.07.2022) WO 2023/003963 PCT/US2022/037739CLAIMS:

1. A nasal irrigation device, comprising: a mechanics module including a pump and a nasal interface; an upper reservoir located above the mechanics module; a lower reservoir located below the mechanics module; a diagnostic assembly within the lower reservoir; a first fluid passageway running from the upper reservoir to the nasal interface for providing irrigant to an associated user of the device; and a second fluid passageway running from the nasal interface to the lower reservoir for capturing effluent. wherein the pump is configured to provide suction through the lower reservoir.

2. The device of claim 1, wherein the diagnostic assembly comprises a test substrate on a tilted platform or a wall within the lower reservoir.

3. The device of claim 2, wherein the wall separates the lower reservoir into two separate volumes, with a gap present between the wall and a roof of the lower reservoir.

4. The device of claim 2, wherein the wall is vertical or is tilted.

5. The device of claim 1, wherein the diagnostic assembly comprises a filter for capturing material within the effluent for testing.

6. The device of claim 5, wherein the lower reservoir includes a plug, and the filter is placed to capture material as the effluent is drained through the plug.

7. The device of claim 1 , wherein the pump is manually operated.

8. The device of claim 7, wherein the manually operated pump comprises at least two one-way valves controlling air flow through a chamber. PCT/U522/37739 20 July 2022 (20.07.2022)

WO 2023/003963 PCT/US2022/037739

9. The device of claim 1 , wherein the mecnanics moauie inciuaes a cartridge tower assembly comprising a lid, for introducing saline into the upper reservoir.

10. The device of claim 9, wherein the upper reservoir is disposed about the cartridge tower assembly.

11. The device of claim 1, wherein the mechanics module further includes a fluid release valve associated with a pump actuator for controlling fluid flow from the upper reservoir into the mechanics module.

12. The device of claim 1, wherein the mechanics module includes a float valve to preclude effluent rising into the mechanics module from the lower reservoir.

13. The device of claim 1 , wherein the upper reservoir surrounds the lid.

14. The device of claim 1, wherein the upper reservoir covers a greater surface area of the mechanics module than the lid.

15. A method for diagnosis, comprising: placing a nasal irrigation device to the nose of a user, the nasal irrigation device comprising: a mechanics module including a pump and a nasal interface; an upper reservoir located above the mechanics module; a lower reservoir located below the mechanics module; a diagnostic assembly within the lower reservoir; a first fluid passageway running from the upper reservoir to the nasal interface for providing irrigant to an associated user of the device; and a second fluid passageway running from the nasal interface to the lower reservoir for capturing effluent; wherein the pump is configured to provide suction through the lower reservoir; operating the pump to draw irrigant through the nasal cavity of the user and draw effluent into the lower reservoir; and PCT/U522/37739 20 July 2022 (20.07.2022)

WO 2023/003963 PCT/US2022/037739 exposing the diagnostic assembiy to mucosai maienai in me eniueni 10 obtain a diagnostic result.

16. The method of claim 15, wherein the diagnostic assembly comprises a test substrate on a platform or wall within the lower reservoir; or

17. The method of claim 15, wherein the diagnostic result is visible through a wall of the lower reservoir.

18. A nasal irrigation device, comprising: a mechanics module including a manually operated pump and a nasal interface; an upper reservoir located above the mechanics module; a lower reservoir located below the mechanics module; a first fluid passageway running from the upper reservoir to the nasal interface for providing irrigant to an associated user of the device; and a second fluid passageway running from the nasal interface to the lower reservoir for capturing effluent; wherein the manually operated pump is configured to provide suction through the lower reservoir.

19. The device of claim 18, further comprising a diagnostic assembly within the lower reservoir; wherein the diagnostic assembly comprises a test substrate on a tilted platform or a wall within the lower reservoir; or wherein the diagnostic assembly comprises a filter for capturing material within the effluent for testing.

20. The device of claim 18, further comprising a platform below a lower reservoir opening and above a floor of the lower reservoir; or further comprising a wall that separates the lower reservoir into two separate volumes, with a gap present between the wall and a roof of the lower reservoir.