Plug for insertion into a subject's nose or ear and method for administering a fluid therapeutic agent using the plug

Abstract

A plug (1) for insertion into a patient's nose or ear comprises a body (10) adapted to fit into the patient's nostril (2) or ear canal (3), and a tubular member (20) with a collar (25) disposed substantially within the body. The plug is adapted to receive the tip of a syringe (30) through the tubular member for injecting a fluid therapeutic agent for nasal or aural administration. Kits including the plug and syringe, as well as methods for administering a fluid therapeutic agent to a patient using the plug, are also disclosed.

Description

[Technical Field]

[0001] The present solution relates to a plug for insertion into a subject's nose or ear, more precisely into the nostril or ear canal, which is used to administer a fluid therapeutic agent to the subject, particularly, but not exclusively, for the treatment of conditions affecting the nose or ear. [Background technology]

[0002] The human nose is not only the organ for olfaction, the sense of smell, but also a delicate organ for warming, filtering, and humidifying inhaled air. The nasal sinuses also "boost" inhaled air with nitric oxide (NO), a gaseous signaling molecule that increases pulmonary blood flow and oxygen uptake. The total surface area available in this richly vascular respiratory mucosa is approximately 180 cm². 2 It is estimated that...

[0003] The capillaries in the nasal mucosa are specially designed to pump fluid quickly through the blood vessel walls into the dry air inside the nose. Blood flow to this area is so high that the blood flow per tissue is greater than that to the brain, liver, or muscles.

[0004] The nasal-brain pathway through the olfactory mucosa carries nasally delivered drugs directly to the cerebrospinal fluid (CSF) and brain, thereby providing early effects for centrally acting drugs, whereas other conventional delivery methods, such as traditional intravenous or intramuscular administration, require crossing the blood-brain barrier.

[0005] The nasal mucosa allows drugs to be easily and directly absorbed into the venous circulation. Unlike oral or rectal drugs, the absorption surface is not the intestinal mucosa, so the drug does not enter the hepatic circulation and is not metabolized by the liver, resulting in significantly higher drug absorption rates and efficacy. Therefore, nasal administration of medical substances offers several advantages over injections using hypodermic needles.

[0006] Nasal sprays are available as a means of administering the substance into the nasal cavity, but the amount of substance that can be administered is limited by the discomfort caused by introducing large amounts of liquid into the nasal cavity and the difficulty of retaining the substance within the nasal cavity.

[0007] It is also known in the art to provide nasal plugs coated or impregnated with, for example, hemostatic compounds to promote blood clotting and stop nosebleeds. International Publication Nos. WO 2018 / 076118 and WO 2010 / 085196 disclose examples of such nasal plugs. However, the amount of substance that can be administered by such impregnated or coated plugs is similarly limited by the volume or surface of the plug, and absorption is essentially limited to the portion of the nasal mucosa that comes into contact with the plug.

[0008] Co-pending patent application WO 2020 / 231317 discloses a nasal plug for treating nosebleeds.

[0009] Therefore, there is a need for improved devices and methods for nasal drug administration that overcome the shortcomings of the prior art. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] International Publication No. 2018 / 076118 Brochure [Patent Document 2] International Publication No. 2010 / 085196 Brochure [Patent Document 3] International Publication No. 2020 / 231317 Brochure Summary of the Invention [Problem to be solved by the invention]

[0011] It is an object of the present solution to address at least some of the problems and challenges outlined above. These and other objects can be achieved by providing a plug according to the present disclosure. [Means for solving the problem]

[0012] The above plug may be configured and implemented according to different optional embodiments. Further possible features and advantages of this solution will become apparent from the detailed description below.

[0013] In a first aspect of the present disclosure, there is provided a plug for insertion into a subject's nose or ear, the plug comprising: a body adapted to fit within the subject's nostril or ear canal and including a first end arranged to face inward in use and a second end arranged to face outward; and a tubular member disposed within the body and including a first opening facing inward in use and a second opening facing outward, the first opening and the second opening being arranged in fluid communication, the tubular member further including a collar disposed substantially within the body, and the second opening of the tubular member being adapted to receive the tip of a syringe for injecting a fluid therapeutic agent through the tubular member.

[0014] In one embodiment, the plug further comprises a spray nozzle disposed adjacent the first opening of the tubular member to facilitate efficient distribution of the fluid therapeutic agent into the nasal cavity or ear.

[0015] In one embodiment, the plug further comprises a filter disposed within the tubular member that protects the nose or ears from inhalation, entry, penetration, or penetration by particles such as dust, dirt, smoke, pollen, carcinogens, radioactive materials, and other irritants, and / or microorganisms such as bacteria, parasites, amoebas, fungi, and viruses (e.g., those responsible for influenza, colds, and other airborne epidemic respiratory illnesses, MERS, SARS-CoV, SARS-CoV-2, etc.).

[0016] In one embodiment, the plug further comprises an internal device disposed within the tubular member that can be used, for example, as an alarm clock or in a virtual reality situation, and that can emit a specified scent / fragrance, vibration, sound signal, etc. as feedback or to alert the wearer to various situations that may arise that require attention or action.

[0017] In one embodiment, the internal device is an acoustic device selected from a hearing aid, a speaker, or an auditory masking device, which generates sound or noise, thereby enabling the plug to combine a wide range of technical applications such as voice communication, listening to music, detecting auditory vibrations, suppressing acoustic trauma or tinnitus, etc.

[0018] In one embodiment, the internal device is a sensor configured to detect gases (e.g., asphyxiating gases such as nitrogen, carbon dioxide, argon, etc.; flammable gases such as gasoline, hydrogen, methane, propane, etc.; toxic gases such as hydrogen sulfide, carbon monoxide, nitric oxide, etc.); detect radioactivity; detect pollen, pollution, or pathogen levels; or detect acoustic and / or electromagnetic signals.

[0019] In one embodiment, the sensor is configured to emit a pheromone, aphrodisiac, scent / fragrance, vibration, and / or acoustic signal in response to detecting any of the above-mentioned substances, which can be used to alert the wearer to danger or harm and prompt them to take appropriate action.

[0020] Many substances cannot be smelled by humans and can be life-threatening in various environments. Small sensors in nose plugs could provide immediate notification of these substances (by emitting different stimuli). Many people also suffer from a more or less complete loss of smell (anosmia). The sensors placed in the plugs have the advantage of being very close to the olfactory area in the nose (the area of ​​olfactory receptors), enhancing the sense of smell and improving quality of life.

[0021] In one embodiment, the internal device is configured to be able to determine the position, acceleration, and / or orientation of the plug. Examples of suitable internal devices include positioning or tracking devices such as markers or beacons that emit and / or receive electromagnetic signals that can be used to determine position, gyroscopes, accelerometers, etc.

[0022] In a second aspect of the present disclosure, there is provided a kit having at least one plug for insertion into a subject's nose or ear and at least one syringe pre-filled with a fluid for injecting through the plug into the subject's nasal cavity or ear canal, the plug comprising: a body adapted to fit within the subject's nostril or ear canal and including a first end arranged to face inward in use and a second end arranged to face outward; and a tubular member disposed within the body and including a first opening facing inward in use and a second opening facing outward, the first opening and the second opening being arranged in fluid communication, the tubular member further including a collar disposed generally within the body, and the second opening of the tubular member adapted to receive the tip of a syringe for injecting the fluid therapeutic agent through the tubular member.

[0023] In one embodiment, the plug further includes an injection nozzle positioned adjacent the first opening of the tubular member.

[0024] In one embodiment, the plug further includes a filter disposed within the tubular member.

[0025] In one embodiment, the plug further comprises an internal device disposed within the tubular member that can be controlled via an app and can be used, for example, as an alarm clock or in a virtual reality situation, and can emit designated scents / fragrances, vibrations, sound signals, etc. as feedback or to alert the wearer to various situations that may arise that require attention or action.

[0026] In one embodiment, the internal device is an acoustic device selected from a hearing aid, a speaker, or an auditory masking device, which generates sound or noise, thereby enabling the plug to combine a wide range of technical applications such as voice communication, listening to music, detecting auditory vibrations, suppressing acoustic trauma or tinnitus, etc.

[0027] In one embodiment, the internal device is a sensor configured to detect gases (e.g., asphyxiating gases such as nitrogen, carbon dioxide, argon, etc.; flammable gases such as gasoline, hydrogen, methane, propane, etc.; toxic gases such as hydrogen sulfide, carbon monoxide, nitric oxide, etc.); detect radioactivity; detect pollen, pollution, or pathogen levels; or detect acoustic and / or electromagnetic signals.

[0028] In one embodiment, the sensor is configured to emit a pheromone, aphrodisiac, scent / fragrance, vibration, and / or acoustic signal in response to detecting any of the above-mentioned substances, which can be used to alert the wearer to danger or harm and prompt them to take appropriate action.

[0029] Many substances cannot be smelled by humans and can be life-threatening in various environments. Small sensors in nose plugs could provide immediate notification of these substances (by emitting different stimuli). Many people also suffer from a more or less complete loss of smell (anosmia). The sensors placed in the plugs have the advantage of being very close to the olfactory area in the nose (the area of ​​olfactory receptors), enhancing the sense of smell and improving quality of life.

[0030] In one embodiment, the internal device is configured to be able to determine the position, acceleration, and / or orientation of the plug. Examples of suitable internal devices include positioning or tracking devices such as markers or beacons that emit and / or receive electromagnetic signals that can be used to determine position, gyroscopes, accelerometers, etc.

[0031] In one embodiment, the fluid therapeutic agent is selected from an analgesic, a corticosteroid, an antibiotic, a decongestant, a stem cell, a nicotine, a vaccine, a brain cell growth inhibitor, an antiseptic, an astringent, a coagulant, an antifungal, and a keratolytic.

[0032] In a third aspect of the present disclosure, there is provided a method of administering a fluid therapeutic agent to a subject, the method comprising the steps of: preparing a plug for insertion into the subject's nose or ear, the plug comprising: a body adapted to fit within the subject's nostril or ear canal and including a first end disposed to face inward and a second end disposed to face outward in use; and a tubular member disposed within the body and including a first opening facing inward and a second opening facing outward in use, the first and second openings arranged in fluid communication, the tubular member further comprising a collar disposed substantially within the body, the second opening of the tubular member being arranged to receive a tip of a syringe for injecting a fluid through the tubular member; inserting the plug into the subject's nostril or ear canal; fitting a syringe filled with a fluid therapeutic agent into the second opening of the tubular member; and injecting the fluid therapeutic agent through the tubular member into the subject's nose or ear.

[0033] Injecting a fluid therapeutic agent into the nose or ear through the plug facilitates both local and systemic administration of the substance, and the plug seals the nostril or ear canal so that the fluid therapeutic agent remains within the nasal passage or ear for prolonged action and / or absorption.

[0034] In one embodiment, the plug is provided with a spray nozzle positioned adjacent the first opening of the tubular member to distribute the fluid treatment agent over the area of ​​the subject's nostrils or ear canal by spraying.

[0035] In one embodiment, the plug is used to treat a condition affecting the subject's nose or ear, the condition being selected from nosebleeds (epistaxis), swimmer's ear (otitis externa), earwax (cerumen impaction), and / or fungal infection (otomycosis).

[0036] In one embodiment, the plug is used for nasal systemic drug delivery or olfactory transmission of fluid therapeutic agents. The nasal mucosa provides a large surface area for absorption of systemically acting substances. Nasal delivery provides a practical, non-invasive method for bypassing the blood-brain barrier to deliver therapeutic agents to the brain and spinal cord. The plug allows drugs that do not cross this barrier to be delivered to the central nervous system within minutes.

[0037] In one embodiment, the fluid therapeutic agent is selected from an analgesic, a corticosteroid, an antibiotic, a decongestant, a stem cell, a nicotine, a vaccine, a brain cell stimulant, an antiseptic, an astringent, a clotting enhancer, an antifungal, and / or an earwax dissolving agent.

[0038] The aspects and embodiments described herein can be freely combined with each other.

[0039] An example solution will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0040] [Figure 1A] FIG. 1 is a perspective view of a plug having a tubular member and a collar according to an embodiment of the present disclosure. [Figure 1B] FIG. 1 is a cross-sectional view of a plug having a tubular member and a collar according to an embodiment of the present disclosure. [Figure 2A] FIG. 10 is a cross-sectional view of a plug impregnated with a substance, showing air intake, according to one embodiment of the present disclosure. [Figure 2B] 1 is a cross-sectional view of a substance-impregnated plug showing exhalation according to an embodiment of the present disclosure. [Figure 3] 1 is a cross-sectional view of a subject's nasal cavity illustrating nasal administration of a substance using a syringe plug according to one embodiment of the present disclosure. [Figure 4] 1 is a cross-sectional view of a subject's ear with a plug according to an embodiment of the present disclosure inserted into the ear canal. [Figure 5] FIG. 10 is a cross-sectional view of a plug with additional components disposed within a tubular member according to an embodiment of the present disclosure. [Figure 6] FIG. 10 illustrates the relationship between the degree of comfort experienced by a subject when inserted into the subject's nostril or ear canal and the degree of compression of a plug according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0041] The following discloses detailed descriptions of different embodiments of the present solution with reference to the accompanying drawings. All examples in this specification should be considered as part of the overall description and can therefore be combined in any general terms. Individual features in various embodiments can be combined or exchanged as long as the combination or exchange does not obviously contradict the overall function of the embodiment.

[0042] Briefly, the present disclosure relates to a plug 1 that is positioned for insertion into a subject's nostril 2 or ear canal 3 to act as a delivery pathway for administration of a fluid therapeutic agent, for example, in addition to stopping a nosebleed. In the context of the present disclosure, the terms "distal" and "proximal" when referring to the plug 1 and its components should be interpreted as being from the perspective of the person handling the plug 1, whether the subject and the person handling the plug 1 are the same or different persons.

[0043] 1A and 1B are perspective and cross-sectional views, respectively, of a plug 1 according to the present disclosure. Plug 1 comprises a body 10 and a tubular member 20 disposed within body 10. Body 10 includes first and second ends 11 and 12 that generally coincide with or correspond to first and second ends 23 and 24, respectively, of tubular member 20 when inserted.

[0044] Tubular member 20 comprises a generally cylindrical tube having a first opening 21 at first end 23 and a second opening 22 at second end 24. Additionally, tubular member 20 comprises a collar 25 disposed on its exterior surface and extending radially outward. In one embodiment, collar 25 is cup-shaped, having a generally concave side 26 facing toward first end 23 and a generally convex side 27 facing toward second end 24. In one embodiment, collar 25 is elliptical or oval, with a width given by the minor and major axes of the ellipse, respectively. That is, the widest lateral extent of collar 25 corresponds to the major axis of the ellipse, corresponding to the cross-sectional plane shown in FIG. 1B . In one embodiment, tubular member 20 comprises a flexible material, such as a thermoplastic material that provides flexibility while still providing some rigidity.

[0045] Collar 25 is positioned proximally of tubular member 20, i.e., near but spaced from second end 24, such that when tubular member 20 is disposed within body 10 of plug 1, collar 25 is disposed substantially within body 10. In this context, the term "substantially within" should be understood to mean that at least rim 28 (i.e., widest portion) of collar 25 is within body 10, as seen in FIG. 1B.

[0046] The first end 11 of the body 10 is positioned to face inward when inserted into the subject's nostril 2 or ear canal 3 during use. Conversely, the second end 12 is positioned to face outward during use. Thus, during use of the plug 1, the first opening 21 of the tubular member 20 faces inward and the second opening 22 faces outward.

[0047] The plug 1 of the present disclosure effectively treats nosebleeds in that the absorbent body 10 applies pressure directly to the site of the nosebleed and absorbs the blood exiting the wound site due to the elastic properties of the body 10. In the event of excessive and / or prolonged bleeding, the collar 25 forms a stopper that effectively prevents blood from exiting the body 10, thus preventing it from dripping from the saturated plug 1. Furthermore, the collar 25 acts like an umbrella, pushing and stabilizing the body 10 outward and also helping to apply pressure to the walls of the nostril 2.

[0048] At the same time, the tubular member 20 provides a flow path for air that allows the subject to continue breathing through the nose 5 even with the plug 1 inserted in the nostril 2 .

[0049] In one embodiment, the body 10 comprises a compressible, resilient foam adapted to absorb liquid, i.e., blood, from the subject. Examples of suitable materials for the body 10 include polyurethane (PU) foam, polyether foam, (poly)ethylene-vinyl acetate (EVA / PEVA) foam, forestry and agricultural by-product foams based on organic cellulose or hemicellulose, and special woven cotton, so-called cotton foam. In one embodiment, the foam exhibits micropores.

[0050] Referring to FIG. 6, a diagram is shown illustrating the relationship between the level of comfort experienced by a subject using plug 1 and the degree of compression of plug 1 when inserted into nostril 2 or ear canal 3, i.e., a measure of how much pressure plug 1 exerts on the surrounding walls of nostril 2 or ear canal 3. Compressibility, therefore, relates to the elasticity and compressibility of the foam material of body 10 in plug 1. On the left side of the graph, users experience a high level of comfort while the degree of compression is relatively low. As plug 1 becomes more compressible, i.e., as more pressure is exerted by plug 1, the level of comfort decreases, ultimately resulting in a low level of comfort at the right side of the graph when the degree of compression is high.

[0051] To achieve the objectives of this disclosure, which relate to a sealing effect that prevents injected fluid substances from leaking from the nose or ears, sufficient compression of the plug 1 is crucial. However, if the plug 1 exerts too much pressure, the user will find it difficult to tolerate prolonged use of the plug 1, as required for some treatments, as described further below. Therefore, with the goal of optimizing the compression / pressure exerted by the plug 1 in relation to the user's comfort level, an optimal comfort-compression region has been identified, as shown by the triangular area with diagonal lines in FIG. 6. The optimal comfort-compression region is bounded by a horizontal line at approximately one-third of the comfort level experienced when there is little to no compression, a vertical line at approximately half of the maximum compression, and a graph depicting the relationship between comfort and compression. It is understood that comfort levels vary from person to person, and therefore the location of the optimal comfort-compression region may vary slightly.

[0052] In one embodiment, the body 10 is coated or impregnated with a hemostatic agent to promote blood clotting and stop bleeding. Examples of suitable hemostatic agents include calcium alginate, glycine, calcium, kaolin, zeolite, topical microfibrillar collagen, finely dispersed oxidized cellulose, and chitosan, which is obtained from the shells of shrimp and other marine crustaceans, for example, naturally occurring in brown algae (i.e., seaweed extracts). Other suitable substances include hyaluronic acid for regeneration, botulinum toxin for runny noses (vasomotor rhinitis), and the like.

[0053] In one embodiment, the body 10 is coated or impregnated with an aromatic compound to be inhaled by the subject. Examples of suitable aromatic compounds include menthol, peppermint, lubricating oils such as sesame oil, saline gel, aloe vera, or liquid paraffin, which lubricate the mucous membranes within the nostrils to prevent dehydration and the formation of cracks or fissures, and also reduce the risk of rebleeding.

[0054] 2A, when a subject inhales through plug 1, air passes through tubular member 20, as shown by the solid arrow. This creates a localized vacuum near first opening 21, which acts to draw the substance out of body 10 of plug 1 and mix with the inhaled air (shown by the dashed arrow). With each breath, a small amount of the substance is drawn out of impregnated microporous foam plug 1 and added to the inhaled air for prolonged action.

[0055] 2B, when the subject exhales through plug 1, air again passes through the first opening of tubular member 20, as illustrated by the solid arrow. Because the diameter of tubular member 20 is smaller than the nostrils, pressure rises within the nostrils proximal to plug 1, as opposed to inhalation. A small portion of the exhaled air, along with the substance, enters body 10 of plug 1, as indicated by the dashed arrow, but collar 25 acts to retain the substance within body 10. In this way, collar 25 prevents the substance inhaled by the subject from exiting plug 1, instead retaining the substance within body 10. This substance-saving feature can reduce the amount of substance required for treatment.

[0056] In one embodiment, plug 1 and / or body 10 may have an oval cross-section, with the width of plug 1 being greater than the lateral extension corresponding to the major axis of collar 25, as shown in FIG. 1B. In one embodiment, plug 1 and / or body 10 are bell-shaped with a generally cylindrical center, first end 11 being generally hemispherical or dome-shaped, and second end 12 being flared outward. In one embodiment, the width of collar 25, corresponding to the major axis of the oval, is approximately equal to or greater than the width of body 10. Thus, when inserted, collar 25 flares outward, pushing body 10 outward. Thus, plug 1 applies pressure to nostril 2 or ear canal 3 to form a seal.

[0057] When used to stop a nosebleed, plug 1 supports the sidewall of nostril 2, increasing pressure on the bleeding site, e.g., Kiesselbach's plexus. At the same time, the subject can breathe through tubular member 20. In one embodiment, the total dry weight of the plug is less than 1 gram. Its absorption capacity is approximately 2.5 milliliters of blood, plus an additional 0.5 to 1.0 milliliters of expandable capacity, which is estimated to be more than sufficient to absorb the blood leaking during an average anterior nosebleed.

[0058] In one embodiment, the first end 23 of the tubular member 20 is positioned proximal to the first end 11 of the body 10 and slightly offset from the body 10 so that the first opening 21 is recessed within the body 10, but the tubular member 20 and the body 10 have approximately equal lengths. In this manner, the first (distal) end 23 of the tubular member 20 is hidden within the body 10 of the plug 1 during insertion, thereby reducing the risk of damaging the nasal mucosa or the epithelium of the ear canal 3. In one embodiment, the tubular member 20 protrudes from the second end 12 of the body 10, i.e., the second (proximal) end 24 of the tubular member 20 extends further proximally than the body 10, thereby providing a handle for handling the plug 1 during insertion and removal from the nostril 2 or ear canal 3.

[0059] Referring now to FIG. 3 , a syringe 30 is shown for use with the plug 1 for delivery of a fluid therapeutic agent to a subject's nasal cavity, i.e., intranasal administration, according to one embodiment of the present disclosure. Here, the plug 1 functions as an adapter for injecting either a locally acting medication, such as a decongestant for cold and allergy treatment, or a systemically acting medication, such as a painkiller, nicotine, or a vaccine, into the nose. A third administration route achieved by the plug of the present disclosure is through olfactory delivery via receptor neurons in the olfactory epithelium, which project into the olfactory bulb of the brain. Olfactory delivery provides a direct connection for delivering drugs to the brain, bypassing the blood-brain barrier. This can be used to deliver drugs such as brain cell growth inhibitors for cancer, drugs for treating Alzheimer's disease and other neurodegenerative disorders, or drugs to suppress AIDS or malaria in the brain via the plug 1.

[0060] In a first step, the plug 1 is compressed and inserted into the nostril 2, expanding the plug 1 to seal against the inner wall of the nostril 2. Next, the syringe 30 is inserted into the proximal opening 22 of the tubular member 20, and the fluid therapeutic agent is injected into the nasal cavity through the plug 1 by depressing the plunger of the syringe 30. For this purpose, the second end 24 may be, for example, tapered or flared outward, or may be provided with a coupling means, such as a thread, for receiving the tip of the syringe 30. Furthermore, the flexibility / elasticity of the tubular member 20 avoids discomfort during insertion and ensures a fluid-tight connection between the syringe tip and the distal end 24 to prevent leakage during medication delivery. The plug 1 and the syringe 30 may be provided together in a prepackaged kit for this purpose. Preferably, the syringe 30 is pre-filled with the fluid therapeutic agent to be delivered to the subject through the plug 1.

[0061] The therapeutic agent may be a pharmaceutical intended for parenteral or topical administration. Examples of suitable therapeutic agents include analgesics such as paracetamol / acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids; corticosteroids such as cortisol, corticosterone, cortisone, and aldosterone; antibiotics such as penicillins, cephalosporins, polymyxins, rifamycins, lipiamycins, quinolones, sulfonamides, macrolides, lincosamides, tetracyclines, cyclic lipopeptides, glycylines, and oxazolidinones; and antibiotics such as pseudoephedrine, phenylephrine, and antihistamines. These include decongestants such as histamine, naphazoline, and oxymetazoline, stem cells, nicotine, vaccines, antivirals, polysaccharide-glycan-based substances, antioxidants, brain cell proliferation inhibitors, drugs for treating Alzheimer's disease and other neurodegenerative diseases, drugs to suppress AIDS or malaria in the brain, disinfectants, astringents such as aluminum acetate (ALSOL) solution and Burow's solution, procoagulants such as aluminum sulfate solution, antifungals such as clotrimazole, and / or keratolytic agents such as olive oil and hydrogen peroxide.

[0062] Over-the-counter non-prescription drugs and therapeutic agents can be delivered and administered by the subject without the need for specialized medical personnel. Higher potency prescription drugs may require the assistance of specialized medical personnel to ensure the correct dosage and to be delivered and administered in accordance with local medical regulations.

[0063] In a further embodiment of the present disclosure, plug 1 is not limited to use within a subject's nostrils, but may also be used to treat ear disorders. The human ear canal is of comparable dimensions to the nostrils, and plug 1 can be inserted into the ear without adjustment and used in a procedure similar to that described above in conjunction with FIG. 3.

[0064] Referring now to FIG. 4, a cross-sectional view of a subject's ear is shown with plug 1 inserted into ear canal 3. In one embodiment, the plug is used to treat otitis externa (also known as swimmer's ear), an inflammation of the ear canal. For this purpose, plug 1 may be impregnated with an antiseptic, decongestant, and / or astringent substance, such as aluminum acetotartrate (ALSOL) solution or concentrate for topical administration to the ear canal. Treating swimmer's ear often requires moistening the ear canal several times a day. Plug 1 may remain inserted in the ear canal, or additional ALSOL solution may be dispensed as needed using syringe 30. Tubular member 20 allows plug 1 and collar 25 to prevent ALSOL solution from dripping out of the ear, while still allowing the subject to hear. All traditional treatments today block the ear canal and impair the subject's hearing.

[0065] In one embodiment, plug 1 can be used to treat earwax blockage, i.e., excess earwax blocking the ear canal. To this end, plug 1 is inserted into ear canal 3, and an earwax-dissolving substance is injected through tubular member 20 using syringe 30. After injection, proximal end 24 of tubular member 20 is closed, e.g., with a small rubber or plastic stopper (not shown), and plug 1 is left in ear canal 3 for an extended period of time, e.g., overnight, allowing the earwax-dissolving substance to soften and dissolve the earwax, making it easier to remove. The earwax-dissolving substance can be selected from, e.g., mineral oil or vegetable oil (e.g., olive oil, almond oil, baby oil), glycerin, docusate, and triethanolamine polypeptide. After a sufficient amount of time has passed, plug 1 is removed, and the remaining earwax-dissolving substance and softened earwax are aspirated using syringe 30 while plug 1 is slowly removed. This method is a much gentler method of earwax removal, especially for children and the elderly, compared to traditional carbamide peroxide irrigation, which can cause trauma to the ear canal and eardrum, dizziness, and even pain or irritation.

[0066] Referring now to FIG. 5, another embodiment of a plug 1 according to the present disclosure is shown. In this embodiment, the plug 1 includes one or more additional components disposed within the tubular member 20. A spray nozzle 50 is disposed adjacent to the first (distal) end 21 of the tubular member 20. In its simplest form, the spray nozzle 50 may be a single-fluid plain-orifice nozzle; however, as known in the art, other configurations, such as shaped-orifice nozzles and surface-impingement nozzles, are also envisioned depending on the desired spray characteristics. Common to all types of single-fluid spray nozzles is that the fluid passes through a small orifice, which breaks up the fluid into droplets, i.e., atomizes them, and distributes the atomized droplets over a surface area—for example, over the nasal cavity in the case of nasal administration, or over the ear canal in the case of otic administration. The spray nozzle 50 is preferably configured to produce a cone-shaped spray with a spray angle as shown in FIG. 5. Furthermore, the spray nozzle 50 is positioned proximal to the first (distal) end 21 of the tubular member 20 so that the spray nozzle 50 does not scrape the nasal mucosa or the epithelium of the ear canal 3 .

[0067] Additionally or alternatively, a filter 60 is disposed within the tubular member 20. The filter 60 exhibits a plurality of openings or pores having a pore size adapted to prevent particles, such as dust, dirt, smoke, pollen, carcinogens, radioactive materials, and other irritants, and / or microorganisms, such as bacteria, parasites, amoebas, fungi, viruses (e.g., those causing influenza, colds, and other airborne epidemic respiratory illnesses, MERS, SARS-CoV, SARS-CoV-2, etc.), from inhaling, entering, penetrating, penetrating, or passing through the filter 60. In that way, in contrast to known plugs that completely block the nostrils 2 or ear canals 3, the nose or ear is protected from exposure to, for example, pathogens while still allowing air to pass through the plug 1 to allow breathing or hearing.

[0068] Additionally or alternatively, an internal device 70 is disposed within the tubular member 20. The internal device 70 can be controlled via an app and can be used, for example, as an alarm clock or in a virtual reality situation, and can emit designated scents / fragrances, vibrations, sound signals, etc. as feedback or to alert the wearer to various situations that may arise requiring attention or action.

[0069] The internal device 70 may be a sensor that detects gases (e.g., asphyxiating gases such as nitrogen, carbon dioxide, argon, etc.; flammable gases such as gasoline, hydrogen, methane, propane, etc.; or toxic gases such as hydrogen sulfide, carbon monoxide, nitric oxide, etc.) or radioactivity; detects levels of pollen, pollution, or pathogens and responds differently to these stimuli; or it may be a sensor that emits pheromones, aphrodisiacs, or scents / fragrances to enhance the sense of smell. Many pathogens cannot be smelled by humans and can be life-threatening in various environments. A small sensor in a nose plug could provide immediate notification about pathogens (by emitting different stimuli). Many people also suffer from more or less complete loss of smell (anosmia). A sensor placed in the plug has the advantage of being very close to the olfactory region (the area of ​​olfactory receptors) in the nose and can enhance the sense of smell to improve quality of life.

[0070] In another embodiment, internal device 70 may be an acoustic device such as a hearing aid, a speaker, or an auditory masking device that generates sound or noise to combine with a wide range of technical applications such as voice communication, listening to music, detecting auditory vibrations, suppressing acoustic trauma or tinnitus, etc.

[0071] In one embodiment, internal device 70 is configured to be able to determine the position, acceleration, and / or orientation of plug 1. Examples of suitable internal devices include positioning or tracking devices, such as markers or beacons that emit and / or receive electromagnetic signals that can be used to determine location. For example, tracking devices may be used to determine location in conjunction with a global positioning satellite system, such as GPS, or local positioning systems that utilize cell towers, Wi-Fi access points, and radio broadcast towers. Other examples of suitable devices include gyroscopes and accelerometers.

[0072] While FIG. 5 shows plug 1 combining spray nozzle 50, filter 60 and internal device 70, it will be understood that plug 1 may include one or more additional components in different combinations depending on the desired configuration, medical application and use of plug 1.

[0073] In one embodiment, the tubular member 20 is permeable to fluids or gases and / or selected substances present within the tubular member 20. For example, the tubular member 20 may include a lattice or grid with a plurality of small perforations or openings along its length and within the body 10, such that the therapeutic agent is delivered through the openings in the tubular member 20 and into the body 10 of the plug 1 during delivery.

[0074] While the above description includes multiple specific examples, these should not be construed as limiting the scope of the concepts described herein, but merely as providing illustrations of some exemplary embodiments of the concepts described. It will be understood that the scope of the presently described concepts fully encompasses, and is not limited by, other embodiments that will become apparent to those skilled in the art. Reference to an element in the singular is not intended to mean "one and only one," but rather "one or more," unless explicitly stated. Furthermore, it is not necessary for a device or method to address each and every problem sought to be solved by the presently described concepts to be encompassed herein.

Claims

1. A plug (1) for insertion into the nose or ear of a subject, a body (10) adapted to fit into the subject's nasal cavity (2) or ear canal (3) and including a first end (11) arranged to face inward in use and a second end (12) arranged to face outward, the body (10) comprising a compressible, resilient foam material adapted to absorb liquid; and a tubular member (20) disposed within the body and including, in use, a first opening (21) facing inward and a second opening (22) facing outward, the first opening (21) and the second opening (22) being arranged in fluid communication; Equipped with the second opening of the tubular member is adapted to receive the tip of a syringe (30) for injecting a fluid therapeutic agent through the tubular member; The tubular member further comprises a cup-shaped collar (25) disposed on the outer surface of the tubular member, extending radially outward, and disposed substantially inside the body so as to press the body outward, the substantially concave side (26) of the collar (25) facing toward the first end (11) of the body (10).

2. 2. The plug of claim 1, further comprising an injection nozzle (50) disposed adjacent the first opening of the tubular member.

3. The plug of claim 1 or 2, further comprising a filter (60) disposed within the tubular member.

4. The plug according to any one of claims 1 to 3, further comprising an internal device (70) disposed inside the tubular member, the internal device being an acoustic device selected from a hearing aid, a speaker, or an auditory masking device.

5. The plug according to any one of claims 1 to 3, further comprising an internal device (70) disposed inside the tubular member, the internal device being a sensor configured to detect gases, radioactivity, pollen levels, pollution, pathogens, acoustic signals and / or electromagnetic signals.

6. 6. The plug of claim 5, wherein the sensor is configured to emit a pheromone, an aphrodisiac, a scent / fragrance, a vibration, and / or an acoustic signal in response to the detection.

7. The plug according to any one of claims 1 to 3, further comprising an internal device (70) disposed within the tubular member, the internal device configured to be able to determine a position, acceleration and / or orientation of the plug.

8. A kit comprising at least one plug (1) for insertion into the nose or ear of a subject as described in any one of claims 1 to 7, and at least one syringe (30) pre-filled with a fluid for injection through the plug into the subject's nasal cavity (2) or ear canal (3).

9. 9. The kit of claim 8, wherein the fluid treatment agent is selected from an analgesic, a corticosteroid, an antibiotic, a decongestant, a stem cell, a nicotine, a vaccine, a brain cell growth inhibitor, an antiseptic, an astringent, a coagulant, an antifungal, and / or a keratolytic.

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