Intranasal cryotherapy device

Abstract

An intranasal cryotherapy device having a canister with an actuator. The canister stores a coolant and compressed air and is configured to dispense the coolant and compressed air when actuated. The device also includes an intranasal catheter having a manifold with a pair of inlet flow channels for receiving the coolant and compressed air and two pairs of outlet flow channels for outputting the coolant and compressed air. The catheter further includes a pair of tubular nostril inserts projecting away from the manifold, a pair of tubular nasal cavity inserts having a nozzle plate projecting away from the nostril inserts, and two pairs of delivery flow channels having a first end connected to one of the outlet flow channels and a second end proximate to one of the nozzle plates forming a mixing chamber in an intermediate space between the second end of the delivery flow channels and the nozzle plate.

Description

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 569,500, filed March 25, 2024, which is incorporated herein by reference. Technical Field

[0002] This instruction manual generally relates to cryotherapy devices, and more specifically to point-of-care intranasal cryotherapy devices. Background Technology

[0003] Migraine is a common neurological disorder affecting an estimated 1 billion people worldwide and 33 million in the United States. The 2016 Global Burden of Disease Study and its 2019 update found migraine to be the second leading cause of disability globally, followed by lower back pain. In the United States, migraine generates up to $17 billion annually due to direct costs of outpatient services and indirect costs of lost productivity for individuals suffering from migraines. In 2017, the estimated market value of the seven major migraine markets (the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan) was $3.8 billion, representing a CAGR of 13.3%. However, existing pharmacological point-of-care treatments for migraines that focus on providing rapid symptom relief have several drawbacks, such as: nonsteroidal anti-inflammatory drugs (NSAIDs) may be ineffective for severe migraines, long-term use may cause gastrointestinal problems such as ulcers and bleeding, and they are not suitable for individuals with kidney problems or certain cardiovascular diseases; acetaminophen has limited migraine relief efficacy compared to NSAIDs, and its overuse can lead to liver damage; triptans are contraindicated in individuals with certain cardiovascular conditions, can cause side effects such as chest tightness and dizziness, and overuse can lead to overdose headaches (rebound headaches); combination analgesics carry the risk of overuse due to their caffeine content, which can cause rebound headaches, and due to acetaminophen, long-term use... Use can cause gastrointestinal problems and liver damage; antiemetics cause side effects such as drowsiness, dry mouth, and movement disorders, and are ineffective in all migraine sufferers; ergotamine derivatives cause potentially serious side effects such as ergot poisoning (vasoconstriction) and dependence, and are contraindicated in individuals with cardiovascular disease; corticosteroids are reserved for severe cases due to possible side effects such as weight gain, mood changes, and increased risk of infection, and are not suitable for long-term use due to systemic effects; intranasal lidocaine has limited evidence to support its efficacy, and its potential side effects include nasal discomfort and taste disturbances; botulinum toxin injections require an invasive procedure with potential side effects such as neck weakness, injection site pain, and allergic reactions, and their long-term efficacy is still under investigation. Summary of the Invention

[0004] One aspect of this specification provides an intranasal cryotherapy device, the intranasal cryotherapy device comprising: a canister having an actuator, the canister being configured to store a coolant and compressed air, and dispensing the coolant and compressed air when actuated; and an intranasal catheter comprising: a manifold having: a pair of inlet channels configured to receive the coolant and the compressed air; and two pairs of outlet channels configured to discharge the coolant and the compressed air; a pair of tubular nostril inserts extending away from the manifold; and a pair of tubular nasal cavity inserts. The pair of tubular nasal inserts extend away from the nostril insert, each of the tubular nasal inserts including a nozzle plate at an outlet on the distal side of the nostril insert; and two pairs of delivery channels, each of the two pairs of delivery channels extending through the interior of the tubular nostril inserts and each of the nasal inserts, a first end of each of the delivery channels connecting to one of the outlet channels, and a second end of each of the delivery channels proximate to one of the nozzle plates, forming a mixing chamber in the intermediate space between the second end of the delivery channel and the nozzle plate inside the nasal insert.

[0005] Another aspect of this specification provides an intranasal catheter comprising: a manifold having: a pair of inlet channels configured to receive two different fluids; and two pairs of outlet channels configured to discharge the two different fluids; a pair of tubular nostril inserts extending distally from the manifold; a pair of tubular nasal cavity inserts extending distally from the nostril inserts, each of the tubular nasal cavity inserts including a nozzle plate at an outlet distal to the nostril insert; and two pairs of delivery channels extending through the interior of the tubular nostril inserts and each of the nasal cavity inserts, a first end of each delivery channel being connected to one of the outlet channels, and a second end of each delivery channel being proximate to the nozzle plate, forming a mixing chamber in an intermediate space between the second end of the delivery channel and the nozzle plate within the nasal cavity insert.

[0006] The nasal insert may have a length of approximately 3 cm. The nasal cavity insert may extend approximately 1 cm beyond the nasal insert. The coolant may be perfluorocarbon. The coolant may be perfluorohexane. The coolant may also be at least one of carbon dioxide and nitrogen. This device can be used to treat migraines and / or heatstroke. The actuator may include an actuation mechanism configured to dispense a dose of coolant and compressed air for approximately 30 seconds.

[0007] Another aspect of this specification provides an intranasal cryotherapy device comprising: a canister having an actuator cap configured to separately store coolant and compressed air, and to dispense a mixture of the coolant and compressed air when the actuator cap is actuated; and an intranasal catheter comprising: a manifold; a cap channel fluidly connected to the manifold and configured to connect the intranasal catheter to the actuator cap of the intranasal cryotherapy device; and two nasal inserts fluidly connected to the manifold, configured to be inserted into a user's nose and to deliver the mixture of coolant and compressed air to the user when the actuator cap is actuated.

[0008] Each nasal insert may include a nostril insertion portion and a nasal cavity insertion portion. The intranasal cannula may also include a set of channels to regulate and guide the flow of a mixture of coolant and compressed air through the nasal cannula. The set of channels includes: at least one channel that guides the mixture of coolant and compressed air from the cap channel to each of the nasal inserts; and at least one additional channel that guides additional fluid to the nasal inserts. The device may also include: an additional fluid storage unit fluidly connected to the at least one additional channel. This device can be used to treat migraines and / or heatstroke. Attached Figure Description

[0009] Embodiments are described with reference to the following accompanying drawings. In the provided drawings, certain components or details may be omitted for clarity and simplicity. However, it should be understood that these elements will be apparent to those skilled in the art and are considered to be within the scope of this disclosure.

[0010] Figure 1 A schematic diagram of an exemplary intranasal cryotherapy device is described.

[0011] Figure 2 It shows Figure 1 A schematic diagram of an exemplary nasal cannula for an exemplary device.

[0012] Figure 3 A schematic diagram of another exemplary intranasal cryotherapy device is described.

[0013] Figure 4 It shows Figure 3 A schematic diagram of an exemplary tank of an exemplary device.

[0014] Figure 5 A schematic diagram depicts a user using an exemplary intranasal cryotherapy device.

[0015] Figure 6 A schematic diagram of another exemplary intranasal cryotherapy device is described.

[0016] Figure 7 A front view of another exemplary intranasal cryotherapy device is depicted.

[0017] Figure 8 Described Figure 7 Top, rear, and right perspective views of an exemplary actuator cover of an exemplary intranasal cryotherapy device.

[0018] Figure 9 It shows Figure 8 A left plan view of an exemplary actuator cover.

[0019] Figure 10 The illustration depicts the top, rear, and right perspective views of an exemplary connector element of an exemplary actuator cover.

[0020] Figure 11 It shows Figure 8 Exploded perspective views of the top, rear, and right sides of an exemplary actuator cover and two exemplary connectors.

[0021] Figure 12 It shows Figure 7 Left plan view of an exemplary intranasal cryotherapy device.

[0022] Figure 13 A frontal view of another exemplary nasal cannula is shown. Detailed Implementation

[0023] Although the mechanisms underlying migraines remain unclear, they are believed to be disorders of the trigeminal vascular system, a complex network of nerves and blood vessels including the trigeminal nerve and blood vessels surrounding the brain. Preclinical data have demonstrated that activation of the trigeminal vascular system leads to the release of vasoactive signaling molecules such as calcitonin gene-related peptide (CGRP), which has been shown to contribute to vasodilation and sensitization of pain receptors within the trigeminal vascular system, thereby contributing to pain and other migraine symptoms. Furthermore, intravenous infusion of CGRP has been shown to induce headaches in migraine-prone individuals.

[0024] Cryotherapy offers a non-pharmacological alternative for treating migraines and can optionally be combined with pharmacological treatments. It is estimated that 27% of migraine sufferers self-medicate with various external cryotherapy methods, such as using cold compresses or directing a cooling fan to the neck or forehead, but these methods have limited effectiveness. While the exact mechanisms by which cryotherapy relieves migraines are not fully understood, the benefits may be attributed to inducing local vasoconstriction by directly affecting the smooth muscle cells of the lining of blood vessels. This helps reduce vessel diameter, normalizes blood flow, inhibits the release of vasodilators such as CGRP and nitric oxide, and affects pain signaling pathways in the brain, leading to a reduction in pain sensations associated with migraines.

[0025] The intranasal cryotherapy device is configured to deliver cooling fluid (e.g., at a temperature between about 5°C and about 15°C, such as at about 10°C) to the cribriform plate, a thin plate of the ethmoid bone that separates the brain from the nasal cavity. The intranasal cryotherapy device is able to cool the cribriform plate, which in turn allows for effective cooling of the brain. Furthermore, the intranasal cryotherapy device can also cool the blood flowing to the brain as it passes through the nasopharynx, further contributing to brain cooling. The cooling of the brain ultimately induces vasoconstriction, thereby helping to alleviate migraine attacks.

[0026] Additionally, by helping to cool the brain, intranasal cryotherapy devices targeting the cribriform plate can help lower the body's core temperature, reduce metabolic demands, decrease inflammation, and protect brain cells from heatstroke-related damage, especially when body temperature has already risen to dangerously high levels (e.g., above 40°C). Portable intranasal cryotherapy devices can be used as an aid for first responders to treat heatstroke in environments where people may be exposed to the sun for extended periods and where transport to permanent medical facilities may be challenging (e.g., on hiking trails, at music festivals, summer sporting events, etc.).

[0027] Figure 1 An exemplary intranasal cryotherapy device 100 is described. Device 100 includes a nasal cannula 104 configured to be introduced through a user's nose and reach the nasal cavity to atomize a cooling fluid mixture 108, thereby delivering the cooling fluid mixture 108 to a sieve plate. Device 100 also includes a canister 112 configured to store coolant and air, and enabling the user to actuate the delivery of coolant and air to the nasal cannula 104. The nasal cannula 104 may optionally be detachable from the cryotherapy device 100, for example, to allow the user to interchange the nasal cannula 104 with alternative nasal cannulas of different sizes.

[0028] Figure 2A nasal cannula 104 of an exemplary device 100 is shown. The nasal cannula 104 includes a manifold 200, which includes a pair of inlet channels 204-C and 204-A (collectively referred to as inlet channel 204, and individually referred to as inlet channel 204, the same naming convention applies elsewhere) that are divided into two pairs of outlet channels 208-C1 and 208-A1 and 208-C2 and 208-A2. Figure 2 In the diagram, the inlet channel 204 is shown divided into an outlet channel 208 by a T-shaped branch, and although the outlet channel 208 is shown to include a 90° bend within the manifold 200, the portions of the inlet channel 204 to the outlet channel 208 and their arrangement within the manifold 200 can be configured differently, for example, by including a Y-shaped branch and removing the 90° bend to reduce pressure loss of the fluid flowing from the inlet channel 204 to the outlet channel 208. The manifold 200 may be made of rigid or semi-rigid medical-grade materials (e.g., medical-grade polymers such as Polyetheretherketone (PEEK), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), acetal (polyoxymethylene, POM), etc.). Alternatively, the manifold 200 may be made of other rigid medical-grade materials (e.g., stainless steel, titanium, ceramic, etc.). Manifold 200 and channels 204 and 208 can be manufactured as a single piece by any known manufacturing method, such as injection molding, 3D printing, etc. Alternatively, channels 204 and 208 can be manufactured as separate components from manifold 200 and subsequently closed by manifold 200 by assembling channels 204 and 208 into manifold 200 or by forming manifold 200 over channels 204 and 208.

[0029] The nasal cannula 104 further includes: two tubular nasal insertions 212-1 and 212-2 extending remotely from the manifold 200; and two tubular nasal cavity insertions 216-1 and 216-2, respectively concentric with and partially located inside the nasal insertions 212-1 and 212-2, and extending further remotely from the manifold 200 than the nasal insertion 212. The nasal insertion 212 may be made of a rigid or semi-rigid medical-grade material (e.g., a medical-grade polymer) and may optionally include an outer layer of medical-grade cushioning material (e.g., silicone, polyurethane, memory foam, etc.) to facilitate insertion into the nostril. It may be fixed to the manifold 200 by, for example, adhesive bonding, threaded connection, thermal riveting, etc., or alternatively, may be optionally manufactured integrally with the manifold 200 and optionally further coated with medical-grade cushioning material. The nasal insert 216 can be made of a soft, flexible medical-grade material (e.g., silicone, polyurethane (PU), PE, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), nylon, PP, etc.) to allow it to be easily inserted into the nasal cavity through the nasal opening. The outer diameter of the nasal insert 216 can be approximately 5 / 3 mm (approximately 5 French inch), while the inner diameter of the nostril insert 212 can be slightly smaller than approximately 5 / 3 mm (slightly smaller than approximately 5 French inch), thus securing an interference fit connection between the outer diameter of the nasal insert 216 and the inner diameter of the nostril insert 212. Alternatively, the nasal insert 216 can be secured to the nostril insert 212 by different methods (e.g., by adhesive bonding, threaded connection, thermal riveting, etc.). The nostril insert 212 has a length of approximately 3 cm, allowing it to extend to the entire length of the user's nostril when the nasal cannula 104 is placed inside the user's nose. Users with shorter nostrils can position only a portion of the nasal insert 212 within their nose to ensure that the nasal insert 212 extends the entire length of their nostril. The nasal insert 216 has a length of approximately 4 cm and extends approximately 1 cm beyond the end of the nasal insert 212 along its entire length from the manifold 200, such that when the nasal cannula 104 is placed inside the user's nose, the nasal insert 216 can extend approximately 1 cm into the user's nasal cavity. Alternatively, the nasal insert 216 may have a length longer than approximately 1 cm and shorter than approximately 4 cm (e.g., approximately 2 cm) and extend partially into the nasal insert 212 while extending approximately 1 cm away from the end of the nasal insert 212. The outer diameter, length, and material of the nasal insert 216 facilitate insertion into the nasal cavity through the nasal opening.The nostril insert 212-1 and the nasal cavity insert 216 can extend away from the manifold 200 at a non-parallel angle, such that the width W1 between the nasal cavity inserts 216 at the distal end of the nostril insert 212 is smaller than the width W2 between the nostril inserts 212 at the adjacent ends of the manifold 200. For example, W1 can be approximately 0.7 cm and W2 can be approximately 1.2 cm, thereby orienting the inserts 212 and 216 in a direction that allows for easy insertion into the user's nose. Furthermore, the outer diameter of the nostril insert 212 at the distal end of the manifold 200 can be smaller than the outer diameter at the adjacent end of the manifold 200 to further facilitate insertion into the user's nose.

[0030] Each nasal insert 216 includes an atomizing plate 220 at its distal end on the nasal insert 212. The atomizing plate 220 may be made of a medical-grade rigid material (e.g., stainless steel, titanium, borosilicate glass, etc.) and may be fixed to the nasal insert 216 by means of, for example, bonding, threaded connection, press fitting, thermal riveting, ultrasonic welding, etc. Each atomizing plate 220 may include at least one atomizing nozzle. Alternatively, each atomizing plate 220 may include at least one main atomizing nozzle and at least two secondary atomizing nozzles, for example, the diameter of the secondary atomizing nozzles being smaller than the diameter of the main atomizing nozzles. The atomizing nozzles may be straight or angled to create vortices in the fluid as it flows through the nozzles.

[0031] The nasal cannula 104 also includes two pairs of delivery channels 224-C1 and 224-A1, and 224-C2 and 224-A2, each pair of delivery channels 224-C and 224-A located inside the nostril insert 212 and its corresponding nasal cavity insert 216, extending from the manifold 200 to a length longer than about 3 cm and shorter than about 4 cm (e.g., about 3.65 cm), thereby forming a mixing chamber 228 within the nasal cavity insert 216 between the end of the delivery channel 224 and the atomizing plate 220, and thus forming a fluid flow path from the inlet channel 204 to the atomizing plate 220, the fluid flow path being configured to deliver a mixture of the two fluids to each atomizing plate 220. The channels 224 may be made of a flexible medical-grade material, and their inner diameter may be about 1 / 3 mm (about 1 French). Alternatively, the inner diameter of the channels 224 may be up to about 2 / 3 mm (up to about 2 French). The inner diameter of the outlet channel 208 may be slightly smaller than the outer diameter of the conveying channel 224, so that the conveying channel 224 can be fixed to the outlet channel 208 by an interference fit connection. Alternatively, these conveying channels 224 can be fixed to these outlet channels 208 by other means (e.g., bonding, threaded connection, hot riveting, etc.).

[0032] Figure 3A schematic diagram of another exemplary intranasal cryotherapy device 300 is described. Device 300 includes a nasal cannula 104, and further includes a canister 304 containing a coolant storage unit 306-C and an air storage unit 306-A, an intermediate flow channel 308, coolant flow channels 312-C and 312-A, which are located inside the intermediate flow channel 308, respectively connecting the coolant storage unit 306-C to the inlet flow channel 204-C and the air storage unit 306-A to the inlet flow channel 204-A. The intermediate flow channel 308 may be made of a flexible medical material with a length of approximately 10 cm and an outer diameter of approximately 5 / 3 mm (approximately 5 French). The two opposite ends of the intermediate flow channel 308 may be secured to the nasal cannula 104 and the canister 304 by any known means (e.g., adhesive bonding, threaded connection, compression fitting, thermal riveting, ultrasonic welding, etc.). The coolant and airflow channels 312 can be made of a flexible medical-grade material with a length greater than about 10 cm, for example, about 11 to about 12 cm, and their inner diameter can be about 1 / 3 mm (about 1 French). Alternatively, the inner diameter of the coolant and airflow channels 312 can be up to about 2 / 3 mm (up to about 2 French). The inner diameter of the inlet channel 204 can be smaller than the outer diameter of the coolant and airflow channels 312, so that the coolant and airflow channels 312 can be fixed to the inlet channel 204 by an interference fit. Alternatively, the coolant and airflow channels 312 can be fixed to the inlet channel 204 by other means, such as bonding, threaded connection, thermal riveting, etc.

[0033] Figure 4A schematic diagram of a canister 304 of an exemplary device 300 is shown. A coolant storage unit 306-C and an air storage unit 306-A are containers with open ends 400-C and 400-A, respectively, and valves 404-C and 404-A are connected to the open ends 400-C and 400-A by any known means (e.g., adhesive, threaded connection, press fit, thermal riveting, ultrasonic welding, etc.). The coolant storage unit 306-C can store a bio-inert coolant, such as perfluorocarbon or perfluorohexane, at a pressure slightly above 1 bar (e.g., about 1.5 bar). The coolant storage unit 306-C can be a flexible bag made of, for example, a medical-grade low-density polymer. The air storage unit 306-A can be a cylinder made of a high-strength, abrasion-resistant, and corrosion-resistant medical-grade metal, such as stainless steel, titanium, cobalt-chromium, nickel-titanium, tantalum, etc., configured to store high-pressure air, for example, between about 15 bar and about 40 bar. Storage unit 306 can be safely stored in tank 304, which can be made of a high-strength, wear-resistant and corrosion-resistant metal, such as stainless steel or aluminum filled with propellant. The propellant is, for example, nitrogen (N2) or compressed air at a high pressure between about 5 bar and about 10 bar, preferably about 9 bar, so that when device 100 is actuated (e.g., valve 404 is opened in a manner similar to the bag valve distribution technology used in asthma emergency inhalers), coolant can be discharged from tank 304.

[0034] In another embodiment, another coolant storage unit may store different bio-inert coolants, such as carbon dioxide (CO2). Alternative coolant storage units may be made, for example, from cold-rolled, uncoated low-carbon steel strips, such as W-No. 10338 EN 1039 DC04, and may be configured to store, for example, about 24 grams of CO2, about 33 grams of CO2, about 38 grams of CO2, about 60 grams of CO2, etc., at a fluid density of, for example, about 0.75 kg / l and at a temperature range of, for example, about -30°C to about 65°C. The alternative coolant storage unit may be configured to release the coolant when actuated without the aid of a propellant. In another alternative embodiment, another alternative coolant storage unit may store different bio-inert coolants, such as nitrogen (N2).

[0035] Coolant and air channels 312-C and 312-A are connected to valves 404-C and 404-A respectively by any known means, such as bonding, threaded connection, compression fitting, hot riveting, ultrasonic welding, etc. Valve 404 is a normally closed valve that prevents coolant and compressed air from leaving storage unit 306. Canister 304 also includes an actuation mechanism (not shown) that allows the user to simultaneously open valve 404. When coolant valve 404-C is open, the propellant in canister 304 pressurizes coolant storage unit 306-C and pushes coolant out of coolant storage unit 306-C. Simultaneously, when air valve 404-A is open, compressed air is allowed to leave air storage unit 306-A. Coolant and air are then delivered to mixing chamber 228 through channels 312, 204, 208, and 224, and the mixture of coolant and air is delivered through atomizing plate 220. The device 300 injects a mixture of air and coolant at a pressure of about 3 bar and a temperature between about 5°C and about 15°C (e.g., at about 10°C). The mixture is directed to the user's screen plate, and when the nasal cannula 104 is inserted into the user's nose and the user triggers the actuation mechanism, the mixture has sufficient kinetic energy to reach the screen plate.

[0036] Figure 5 A schematic diagram of a user 500 using exemplary devices 100 or 300 is shown. As shown, a nasal cannula 104 is inserted into the user's nose such that a nasal insert 216 partially extends into the user's nasal cavity. Devices 100 and 300 are configured to direct a mixture of coolant and air to the user's septum to cool the septum and nasal cavity, thereby also cooling the user's brain. Additionally, the mixture can indirectly affect the user's oxygenation by influencing the partial pressure of oxygen in the environment. The user can activate devices 100 or 300 for approximately 30 seconds each time to treat, for example, an attack of migraine or heatstroke.

[0037] Figure 6 A schematic diagram of another exemplary intranasal cryotherapy device 600 is described. Device 600 does not include an intermediate flow channel, and the nasal cannula of device 600 is directly connected to the canister.

[0038] Figure 7 A front view plan view of another exemplary intranasal cryotherapy device 700 is depicted. Device 700 includes an exemplary tank 704 configured to store coolant and air, and an exemplary actuator cover 708 configured to release coolant and air when actuated by a user.

[0039] Figure 8 and Figure 9An exemplary actuator cover 708 is shown. The actuator cover 708 may be made of rigid or semi-rigid medical-grade materials, such as medical-grade polymers, such as Polyetheretherketone (PEEK), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), acetal (polyoxymethylene, POM), etc. Alternatively, the actuator cover 708 may be made of other rigid medical-grade materials (e.g., stainless steel, titanium, ceramic, etc.). The actuator cover 708 includes a coolant inlet 804-C, an air inlet 804-A, and an outlet 808. The actuator cover 708 also includes an internal chamber 812, to which the inlet 804 and outlet 808 are fluidly connected, allowing coolant and air to flow from the inlet 804 through the internal chamber 812 to the outlet 808. The actuator cover 708 also includes a recessed surface 816 on the top of the cover, allowing a user to easily grasp the actuator cover 708 by positioning their fingers on the surface 816, for example, by pressing the actuator cover 708. (As in...) Figure 9 As can be seen, the direction of the outlet 808 can be at an angle Θ different from 90° relative to the direction of the inlet 804.

[0040] Figure 10An exemplary connector element 1000 is shown that may be included within an internal cavity 812 of an exemplary actuator cover 708. The connector element 1000 may be made of a rigid or semi-rigid medical-grade material (e.g., a medical-grade polymer). The connector 1000 includes a coolant inlet connector 1004-C, an air inlet connector 1004-A, and an outlet connector 1008. The inlet connector 1004 is configured to connect to an inlet 804, and the outlet connector 1008 is configured to connect to an outlet 808. The connector element 1000 also includes a guide channel or channel assembly 1012 that fluidly connects the coolant inlet connector 1004 to the outlet connector 1008 to guide and regulate the fluid flow of coolant and air from the inlet connector 1004 to the outlet connector 1008, for example, by maintaining laminar flow, by minimizing pressure loss, by creating turbulent flow, etc. The outlet connector 1008 may include an outlet nozzle or nozzle assembly to further regulate the flow of coolant and air as they exit the actuator cover 708 through outlet 808. The channel or channel assembly 1012 may be configured to mix coolant and air, or alternatively, to maintain a separate coolant flow from an air flow as coolant and air are delivered from inlet connector 1004 to outlet connector 1008. If the channel or channel assembly 1012 is configured to mix coolant and air, the outlet connector 1008 may be provided with at least one outlet nozzle to regulate the flow of the mixture as it exits the actuator cover 708 through outlet 808. If the channel or channel assembly 1012 is configured to maintain a separate flow of coolant and air from each other, the outlet connector 1008 may be provided with at least two outlet nozzles, each configured to independently regulate the flow of coolant or air as it exits the actuator cover 708 through outlet 808.

[0041] Figure 11An exploded view of an exemplary actuator cover 708 and two exemplary connectors 1100-C and 1100-A is shown. Connector 1100 may be made of a rigid or semi-rigid medical-grade material (e.g., a medical-grade polymer). Coolant connector 1100-C and air connector 1100-A are configured to fluidly connect the coolant inlet 804-C and air inlet 804-A of actuator cover 708 to a coolant storage unit and an air storage unit, respectively. Each connector 1100 includes a cover receiving member 1104 configured to receive inlet 804 and a storage unit connecting member 1112 configured to connect to an end of the storage unit. Each connector 1100 also includes a flow channel 1116 that fluidly connects the cover receiving member 1104 to the storage unit connecting member 1112. Each connector 1100 also includes a valve member (not shown) within a flow channel 1116 to selectively allow or prevent pressurized fluid stored in the storage unit from flowing through the connector 1100 from the storage unit to the cap inlet 804. Each connector 1100 may further include a biasing member 1120, such as a coil spring, configured to bias the inlet 804 into a first position when the inlet 804 is received within the cap receiving member 1104. In the first position, the valve member remains closed, preventing the fluid stored in the storage unit from being discharged. When a user presses the exemplary actuator cap 708 with sufficient force (e.g., about 10 N to about 40 N) in the actuation direction AD1, the force of the biasing member is overcome, and the inlet 804 is pressed into a second position within the cap receiving member 1104 of the connector 1100, and the valve member is set to open, thereby allowing the fluid stored in the storage unit to be discharged through the actuator cap 708. Alternatively, the actuator cap 708 can be configured differently; for example, the valve members and biasing members 1120 within the flow channel 1116 can be configured such that these valve members are opened when a user unscrews the cap 708 in a rotational motion (e.g., in an alternative actuation direction AD2, such as 1 / 4 turn). It will be apparent to those skilled in the art that, in order for the actuator cap 708 to be configured to be actuated by torsion in a selectable actuation direction AD2, the valve members can be configured to work with or not work with selectable biasing members, for example, as part of a rotary valve mechanism, a threaded plunger mechanism, a torsionally actuated spring valve mechanism, etc. An actuator cap 708 configured to dispense its fluid in a torsional motion can be advantageous because, for example, for continuous or large-dose dispensing events of approximately 30 seconds each time, a user who cannot actuate the actuator cap 708 by pressing the cap in the actuation direction AD1 can easily actuate the actuator cap 708.Because of the sustained force required to keep the cap 708 pressed in the actuation direction AD1 during continuous or high-dose dispensing events, and / or because of the temperature drop of the cap 708 caused by coolant flowing through it during continuous or high-dose dispensing events, actuating the cap 708 by pressing may cause user discomfort. Furthermore, alternative actuator caps may be configured to be actuated both when pressed in the actuation direction AD1 and when twisted in the actuation direction AD2, for example, to allow different dispensing modes, such as a discrete or low-dose dispensing mode when pressed in the actuation direction AD1, for example, from about 1 second to about 5 seconds at a time, and a continuous (or high-dose) dispensing mode when twisted in the actuation direction AD2, for example, from about 30 seconds at a time. Figure 12 Another view of an exemplary intranasal cryotherapy device 700 is depicted. Figure 12 In the diagram, inlet 804 is shown as being inserted into cover receiving member 1104, as discussed above. Figure 12 A can 704 including a lid 1200 is also shown. The lid 1200 may be made of a high-strength, wear-resistant, and corrosion-resistant metal (e.g., stainless steel, aluminum, etc.). The lid 1200 can be press-fitted onto the body of the can 704 to seal the can 704. The lid 1200 has a tip 1204, which is configured to engage and support the connector 1100, for example, by interference fit, by threaded connection, by adhesive, etc. The tip 1204 is provided with a pair of holes, such that an inlet 804 can be inserted through the lid 1200 into the connector 1100.

[0042] Figure 13A front view of another example nasal cannula 1300 is shown. The nasal cannula 1300 may be made of a rigid or semi-rigid medical-grade material, such as a medical-grade polymer, and may optionally include an outer layer of medical-grade cushioning material (e.g., silicone, polyurethane, memory foam, etc.). The nasal cannula 1300 includes a cap channel 1304 for connecting the nasal cannula 1300 to an outlet of an actuator cap, such as outlet 808 of an example actuator cap 708 of an example intranasal cryotherapy device 700. The nasal cannula 1300 also includes left and right nasal inserts 1308-L and 1308-R, respectively. Each nasal insert 1308-L and 1308-R may include a nostril insertion portion and a nasal cavity insertion portion configured to facilitate insertion of the nasal insert 1308 into a user's nose. The nasal insertion portion can be made of a soft, flexible medical-grade material (e.g., silicone, polyurethane (PU), PE, polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), nylon, PP, etc.) for easy insertion into the nasal cavity through the nasal opening. The nasal cannula 1300 also includes a manifold 1312, a cap flow channel 1304, and nasal inserts 1308 fluidly connected to the manifold 1312, such that when the actuator cap 708 is actuated, fluid flowing from an intranasal cryotherapy device such as device 700 is directed through the nasal cannula to each nasal insert 1308. The nasal cannula 1300 may also include a set of branched flow channels 1316 to regulate and guide fluid flow through the nasal cannula 1300. The branched flow channels 1316 can be made of a flexible medical-grade material. If the device 700 is configured to deliver a mixture of coolant and air to the nasal cannula 1300, for example by mixing the coolant and air in the internal chamber 812 of the actuator cover 708, for example through a channel or channel group 1012, the nasal cannula 1300 may include at least one branched channel 1316 having a first end receiving the mixture of coolant and air from an outlet 808 and a second and a third end opposite the first end, such that the mixture is guided toward the outlet of each nasal insert 1308. If the device 700 is configured to deliver coolant and air separately to the nasal cannula 1300, the nasal cannula may include at least two branched channels 1316, such that the coolant and air are guided separately toward the outlet of each nasal insert 1308. Furthermore, each nasal insert 1308 may also include a nozzle plate to regulate the flow of coolant and air (pressure, velocity, droplet size, flow direction, generation of vortices, etc.) as the coolant and air are delivered to the user. The mixing chamber may be defined by the interior of each nasal insert 1308 and the gap between the outlet of each nasal insert 1308 and the corresponding end of the bifurcation channel 1316, which delivers coolant and air to the outlet of the nasal insert 1308, where the coolant and air can be mixed.

[0043] Although the invention has been described with reference to certain specific embodiments, various modifications thereto will be apparent to those skilled in the art without departing from the spirit and scope of the invention as set forth in the appended claims. For example, while exemplary devices 100, 300, and 700 connected to 1300 have been shown as configured to deliver a mixture of coolant and air to a user's screen to cool the user's brain, alternative devices may be configured to include additional channels and storage units to deliver, in addition to the coolant and air mixture, one or more additional fluids, such as supplemental air, oxygen, medication, etc., or combinations thereof, to the user's screen. Furthermore, additional external channels may be provided, for example, configured to connect to additional internal channels of an alternative nasal cannula, for example, via a manifold connection to the alternative nasal cannula, and additional external storage units may be provided to store one or more additional fluids and deliver them to the user. Additionally, while exemplary coolant storage unit 306-C and tank 304 have been disclosed for dispensing coolant when coolant valve 404-C is opened, coolant storage unit 306-C can alternatively be constructed differently, for example, by being made of a high-strength, wear-resistant, and corrosion-resistant medical-grade metal (e.g., stainless steel, titanium, cobalt-chromium, nickel-titanium, tantalum, etc.) and storing coolant under high pressure (e.g., between about 2 bar and about 10 bar), such that when coolant valve 404-C is opened, coolant is delivered through the device without the need for additional propellant. Furthermore, while example channels 312, 204, 208, and 224 have been described as separate components assembled together, they can alternatively be manufactured as a single unit and assembled into other components of the device.

[0044] Those skilled in the art will now recognize that the teachings herein can improve the treatment of migraines by using the disclosed exemplary device or variations thereof, which enables targeted cryotherapy to effectively cool the brain without the need for pharmacological treatments that may typically have undesirable side effects. Additionally, the device can be used to help treat heatstroke attacks. Furthermore, the disclosed exemplary device or variations thereof can be manufactured to be compact and highly portable, facilitating use by users outside of dedicated medical facilities. Moreover, the nasal insert of the disclosed nasal cannula or variations thereof is smaller, only partially inserting into the nasal cavity, achieving a minimally invasive design that is easy for users to operate without the need for professional medical assistance. Additionally, the design of the disclosed nasal cannula or modifications thereof allows a single nasal cannula design to be used by users of various sizes.

[0045] The scope of the claims should not be limited to the embodiments described in the foregoing examples, but should be given the broadest interpretation consistent with the specification as a whole.

[0046] It should be recognized that the features and aspects of the various examples provided above can be combined with other examples that also fall within the scope of this disclosure. Furthermore, the accompanying drawings are not drawn to scale and may have exaggerated dimensions and shapes for illustrative purposes.

Claims

1. An intranasal cryotherapy device, the intranasal cryotherapy device comprising: A canister having an actuator, the canister being configured to store coolant and compressed air, and dispensing the coolant and compressed air when actuated; as well as Intranasal catheter, the intranasal catheter comprising: Manifold, the manifold having: A pair of inlet channels, the pair of inlet channels being configured to receive the coolant and the compressed air; and Two pairs of outlet channels, the two pairs of outlet channels being configured to output the coolant and the compressed air; A pair of tubular nostril inserts extending away from the manifold; A pair of tubular nasal inserts, the pair of tubular nasal inserts extending distally from a nostril insert, each of the tubular nasal inserts including a nozzle plate at an outlet distal to the nostril insert; and Two pairs of delivery channels, each pair of delivery channels extending through the interior of each of the tubular nasal insert and the nasal cavity insert, a first end of each of the delivery channels being connected to one of the outlet channels, and a second end of each of the delivery channels being close to one of the nozzle plates, forming a mixing chamber in the intermediate space between the second end of the delivery channel and the nozzle plate inside the nasal cavity insert.

2. The device according to claim 1, wherein, The nostril insert has a length of approximately 3 cm.

3. The device according to claim 1, wherein, The nasal cavity insert extends approximately 1 cm beyond the nostril insert.

4. The device according to claim 1, wherein, The coolant is perfluorocarbon.

5. The device according to claim 2, wherein, The coolant is perfluorohexane.

6. The device according to claim 1, wherein, The coolant is at least one of carbon dioxide and nitrogen.

7. Use of the device according to claim 1 for treating migraines.

8. The use of the device according to claim 1 for treating heatstroke.

9. The device according to claim 1, wherein, The actuator includes an actuation mechanism configured to dispense a dose of the coolant and the compressed air for approximately 30 seconds.

10. A nasal catheter, the nasal catheter comprising: Manifold, the manifold having: A pair of inlet channels, the pair of inlet channels being configured to receive two different fluids; as well as Two pairs of outlet channels, which are configured to output the two different fluids; A pair of tubular nostril inserts extending away from the manifold; A pair of tubular nasal inserts, the pair of tubular nasal inserts extending distally from a nostril insert, each of the tubular nasal inserts including a nozzle plate at an outlet distal to the nostril insert; and Two pairs of delivery channels, each pair of which extends through the interior of the tubular nasal insert and each of the nasal cavity inserts, a first end of each delivery channel being connected to an outlet channel of the outlet channels, and a second end of each delivery channel being close to a nozzle plate of the nozzle plate, forming a mixing chamber in the intermediate space between the second end of the delivery channel and the nozzle plate inside the nasal cavity insert.

11. The nasal cannula according to claim 10, wherein, The length of the nostril insert is approximately 3 cm.

12. The nasal cannula according to claim 10, wherein, The nasal cavity insert extends approximately 1 cm beyond the nostril insert.

13. Use of the nasal catheter according to claim 10 as part of a cryotherapy device for treating migraines.

14. Use of the nasal catheter according to claim 10 as part of a cryotherapy device for treating heatstroke.

15. An intranasal cryotherapy device, the intranasal cryotherapy device comprising: A canister having an actuator cover, the canister being configured to separately store coolant and compressed air, and to dispense a mixture of coolant and compressed air when the actuator cover is actuated; as well as Intranasal catheter, the intranasal catheter comprising: manifold; A cap flow channel, the cap flow channel being fluidly connected to the manifold, the cap flow channel being configured to connect the intranasal catheter to the actuator cap of the intranasal cryotherapy device; and Two nasal inserts are fluidly connected to the manifold, the nasal inserts are configured to be inserted into the user's nose, and when the actuator cover is actuated, deliver the mixture of coolant and compressed air to the user.

16. The intranasal cryotherapy device according to claim 15, wherein, Each of the nasal inserts includes a nostril insertion portion and a nasal cavity insertion portion.

17. The intranasal cryotherapy device according to claim 15, wherein, The intranasal cannula also includes a set of channels to regulate and guide the mixture of coolant and compressed air through the nasal cannula.

18. The intranasal cryotherapy device according to claim 17, wherein, The set of flow channels includes: at least one flow channel that guides the mixture of coolant and compressed air from the cover flow channel to each of the nose inserts; and at least one additional flow channel that guides additional fluid to the nose inserts.

19. The intranasal cryotherapy device according to claim 18, further comprising: A storage unit for the additional fluid, the storage unit being fluidly connected to the at least one additional flow channel.

20. Use of the device according to claim 15 for treating at least one of migraine and heatstroke.

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