A tampon for insertion into a subject's nose or ear for administration of a fluid treatment

Abstract

A tampon (1) for insertion into a subject's nose or ear, the tampon comprising a body (10) adapted to fit into a nostril (2) or ear canal (3) of the subject, and a tubular member (20) having a collar (25) arranged substantially inside the body. The tampon is adapted to receive a tip of a syringe (30) for injecting a fluid therapeutic agent through the tubular member for nasal administration or administration to the ear. Also disclosed is a kit comprising the tampon and a syringe, and a method for administering a fluid therapeutic agent to a subject using the tampon.

Description

Technical Field

[0001] This solution relates to an plug for insertion into a subject's nose or ear, more precisely, into the nostril or ear canal. This plug can be used to administer a fluid therapeutic agent to the subject, particularly for, but not limited to, treating conditions affecting the nose or ear. Background Technology

[0002] The human nose is a sensitive organ, used not only for the sense of smell but also for heating, filtering, and humidifying inhaled air. The sinuses also utilize nitric oxide (NO), a gaseous signaling molecule that increases pulmonary blood flow and oxygen uptake. The total usable surface area in this highly vascularized respiratory mucosa is estimated to be approximately 180 cm². 2 .

[0003] Nasal capillaries are specifically designed for fluid to pass rapidly through the vessel walls and dissipate into the dry air of the nose. The amount of blood flowing to this area is considerable, meaning that the blood flow per unit of tissue is greater than that to the brain, liver, or muscles.

[0004] The nasobrain pathway, which crosses the olfactory mucosa, delivers drugs via the nasal cavity directly to the cerebrospinal fluid (CSF) and the brain, resulting in early, concentrated drug action. Other conventional delivery methods, such as intravenous or intramuscular injection, must overcome the blood-brain barrier.

[0005] The nasal mucosa facilitates the direct absorption of medications into the venous circulation. Because the absorption surface is not the intestinal mucosa, for oral or rectal medications, the drugs never enter the hepatic circulation and are not metabolized by the liver, resulting in higher drug absorption and efficacy. Therefore, nasal administration of medical substances offers several advantages compared to injection using a subcutaneous needle.

[0006] One method of nasal application is through the use of nasal sprays. However, the amount of substance that can be applied is limited due to the discomfort caused by introducing too much fluid into the nasal cavity and the difficulty in retaining the substance within it.

[0007] It is also known in the art to provide nasal plugs coated or soaked with, for example, a hemostatic compound to promote blood clotting and stop nosebleeds. Examples of such nasal plugs are disclosed in WO 2018 / 076118A1 and WO 2010 / 085196A1. However, the amount of substance that can be applied by such soaked or coated plugs is similarly limited by the volume or surface area of ​​the plug, and absorption is essentially limited to the portion of the nasal mucosa in contact with the plug.

[0008] Co-pending application WO 2020 / 231317 A1 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 existing technologies. Summary of the Invention

[0010] The purpose of this solution is to at least address some of the aforementioned problems and issues. These and other objectives can be achieved by providing an embolization method according to this disclosure.

[0011] The above embolization can be configured and implemented according to different alternative implementation methods. Further possible features and benefits of this solution will become apparent from the following detailed description.

[0012] In a first aspect of this disclosure, an embolism is provided for insertion into the nose or ear of a subject, the embolism comprising: a body adapted to fit into the nostril or ear canal of the subject, the body including a first end arranged inwardly and a second end arranged outwardly during use; a tubular member disposed within the body and including a first opening inwardly and a second opening outwardly during use, the tubular member being arranged to provide fluid communication between the first opening and the second opening; wherein the tubular member further includes a collar substantially disposed within the body; and wherein the second opening of the tubular member is adapted to receive the tip of a syringe for injecting a fluid therapeutic agent through the tubular member.

[0013] In one embodiment, the embolization further includes a nozzle arranged adjacent to the first opening of the tubular member. The nozzle facilitates the efficient distribution of the fluid therapeutic agent into the nasal cavity or ear.

[0014] In one embodiment, the plug further includes a filter disposed within the tubular member. The filter protects the nose or ear from inhalation, intrusion, penetration, or permeation of particulate matter (e.g., dust, dirt, smoke, pollen, carcinogens, radioactive materials, and other irritants) and / or microorganisms such as bacteria, parasites, amoebas, fungi, and viruses (e.g., those causing influenza, the common cold, and other airborne pandemic respiratory diseases, MERS, SARS-CoV, SARS-CoV-2, etc.).

[0015] In one embodiment, the plug further includes an internal device disposed within the tubular member. The internal device can be controlled via an application and can be used, for example, as an alarm clock or in a virtual reality context, emitting specified scents / fragrances, vibrations, acoustic signals, etc., as feedback or to notify the wearer of different situations that may arise and require his / her attention or action.

[0016] In one embodiment, the internal device is an acoustic device selected from hearing aids, loudspeakers, or auditory masking devices. The acoustic device provides the possibility of combining the embolization with a wide range of technological applications, such as audio communication, listening to music, detecting auditory vibrations, acoustic trauma, or suppressing tinnitus by generating sound or noise.

[0017] In one embodiment, the internal device is a sensor configured to detect gases (asphyxiating gases such as nitrogen, carbon dioxide, argon; flammable gases such as gasoline, hydrogen, methane, propane; toxic gases such as hydrogen sulfide, carbon monoxide, nitric oxide), radioactivity, pollen levels, pollution or pathogens, acoustic signals, and / or electromagnetic signals.

[0018] In one embodiment, the sensor is configured to emit pheromones, aphrodisiacs, odors / fragrances, vibrations, and / or acoustic signals in response to the detection of any of the aforementioned substances. This can be used to alert the wearer to harm or danger and prompt the user to take appropriate action.

[0019] Many medications are undetectable to humans and can be life-threatening in various environments. However, by using small sensors in nasal plugs, people can receive immediate notification of their presence (through the emission of different stimuli). Furthermore, many people suffer from some degree of complete loss of smell (olfactory anosmia), and the sensors placed in these plugs have the advantage of being very close to the olfactory region (olfactory receptor area) in the nose, thus enhancing the sense of smell and improving quality of life.

[0020] In one embodiment, the internal device is configured to determine the location, acceleration, and / or orientation of the embolus. Examples of suitable internal devices include positioning or tracking devices, such as markers or beacons that transmit and / or receive electromagnetic signals that can be used to determine the location, gyroscopes, accelerometers, etc.

[0021] In a second aspect of this disclosure, a kit is provided comprising at least one embolism and at least one syringe, the at least one embolism being inserted into the nose or ear of a subject, the at least one syringe being pre-filled with fluid to be injected through the embolism into the nostril or ear canal of the subject, the embolism comprising: a body adapted to fit into the nostril or ear canal of the subject, the body including a first end arranged inwardly and a second end arranged outwardly during use; a tubular member disposed within the body and including a first opening inwardly and a second opening outwardly during use, the tubular member being arranged to provide fluid communication between the first opening and the second opening; wherein the tubular member further includes a collar substantially disposed within the body; and wherein the second opening of the tubular member is adapted to receive the tip of the syringe for injection of a fluid therapeutic agent through the tubular member.

[0022] In one embodiment, the embolism further includes a nozzle arranged adjacent to the first opening of the tubular member.

[0023] In one embodiment, the embolism further includes a filter disposed inside the tubular member.

[0024] In one embodiment, the embolism further includes an internal device disposed within the tubular member. The internal device can be controlled via an application and can be used, for example, as an alarm clock or in a virtual reality context, emitting specified scents / fragrances, vibrations, acoustic signals, etc., as feedback or to notify the wearer of different situations that may arise and require his / her attention or action.

[0025] In one embodiment, the internal device is an acoustic device selected from hearing aids, loudspeakers, or auditory masking devices. The acoustic device provides the possibility of combining the embolization with a wide range of technological applications, such as audio communication, listening to music, detecting auditory vibrations, acoustic trauma, or suppressing tinnitus by generating sound or noise.

[0026] In one embodiment, the internal device is a sensor configured to detect gases (asphyxiating gases, such as nitrogen, carbon dioxide, argon; flammable gases, such as gasoline, hydrogen, methane, propane; toxic gases, such as hydrogen sulfide, carbon monoxide, nitric oxide), detect radioactivity, detect pollen levels, pollution or pathogens, acoustic signals, and / or electromagnetic signals.

[0027] In one embodiment, the sensor is configured to emit pheromones, aphrodisiacs, odors / fragrances, vibrations, and / or acoustic signals in response to the detection of any of the aforementioned substances. This can be used to alert the wearer to harm or danger and prompt the user to take appropriate action.

[0028] Many medications are undetectable to humans and can be life-threatening in various environments. However, by using small sensors in nasal plugs, people can be immediately notified of their presence (by emitting different stimuli). Furthermore, many people suffer from some degree of complete loss of smell (olfactory anosmia), and the sensors placed in the plugs have the advantage of being very close to the olfactory region (olfactory receptor area) in the nose, which can enhance the sense of smell and improve quality of life.

[0029] In one embodiment, the internal device is configured to determine the location, acceleration, and / or orientation of the embolus. Examples of suitable internal devices include positioning or tracking devices, such as markers or beacons that transmit and / or receive electromagnetic signals that can be used to determine the location, gyroscopes, accelerometers, etc.

[0030] In one embodiment, the fluid therapeutic agent is selected from analgesics, corticosteroids, antibiotics, decongestants, stem cells, nicotine, vaccines, brain cell inhibitors, disinfectants, astringents, procoagulants, antifungals, and cerium solvents.

[0031] In a third aspect of this disclosure, a method of administering a fluid therapeutic agent to a subject is provided, the method comprising: providing an embolism for insertion into the nose or ear of a subject, the embolism comprising: a body adapted to fit into the nostril or ear canal of the subject, the body including a first end arranged inwardly and a second end arranged outwardly during use; a tubular member disposed within the body and including a first opening inwardly and a second opening outwardly during use, the tubular member being arranged to provide fluid communication between the first opening and the second opening; wherein the tubular member further includes a collar substantially disposed within the body, and wherein the second opening of the tubular member is arranged to receive the tip of a syringe for injecting fluid through the tubular member, inserting the embolism into the nostril or ear canal of the subject; fitting a syringe filled with a fluid therapeutic agent into the second opening of the tubular member; and injecting the fluid therapeutic agent into the nose or ear of the subject through the tubular member.

[0032] Injecting the fluid therapeutic agent into the nose or ear through the embolus facilitates the application of both local and systemic substances, while the embolus seals the nostril or ear canal, allowing the fluid therapeutic agent to remain within the nasal cavity or ear for long-term action and / or absorption.

[0033] In one embodiment, the embolization is provided with a nozzle arranged adjacent to the first opening of the tubular member, such that injection causes the fluid therapeutic agent to be distributed in the area of ​​the subject's nostril or ear canal.

[0034] In one embodiment, the embolization is used to treat a disease affecting the subject's nose or ear, selected from nosebleeds (epistaxis), swimmer's ear (otitis externa), earwax buildup (earwax impaction), and / or fungal infection (otomycosis).

[0035] In one embodiment, the embolization is used for nasal systemic drug delivery or olfactory transmission of the fluid therapeutic agent. The nasal mucosa provides a large surface area for the absorption of the systemic active ingredient. Intranasal delivery provides a practical, non-invasive method for delivering therapeutic agents to the brain and spinal cord, bypassing the blood-brain barrier. The embolization allows drugs that have not crossed the barrier to be delivered to the central nervous system within minutes.

[0036] In one embodiment, the fluid therapeutic agent is selected from analgesics, corticosteroids, antibiotics, decongestants, stem cells, nicotine, vaccines, brain cell inhibitors, disinfectants, astringents, coagulants, antifungals, and / or cerium solvents.

[0037] The aspects and implementation methods described herein can be freely combined with each other. Attached Figure Description

[0038] The solution will now be described by way of example with reference to the accompanying drawings, wherein:

[0039] Figure 1A This is a perspective view of an embolization having a tubular member and a collar according to one embodiment of the present disclosure;

[0040] Figure 1B This is a cross-sectional view of an embolization having a tubular member and a collar according to one embodiment of the present disclosure;

[0041] Figure 2A and Figure 2B This is a cross-sectional view of an embolus soaked in a substance according to one embodiment of the present disclosure, illustrating inhalation and exhalation respectively;

[0042] Figure 3 It is a cross-sectional view of the nasal cavity of a subject, illustrating the nasal administration of a substance using an embolus with a syringe according to one embodiment of the present disclosure.

[0043] Figure 4 This is a cross-sectional view of a subject's ear in the case where an embolus is inserted into the ear canal according to one embodiment of the present disclosure.

[0044] Figure 5This is a cross-sectional view of an embolization according to one embodiment of the present disclosure, having additional components arranged inside a tubular member; and

[0045] Figure 6 This is a graph illustrating the relationship between the comfort experienced by a subject and the compression of the embolization when an embolus according to one embodiment of the present disclosure is inserted into the subject's nostril or ear canal. Detailed Implementation

[0046] The following detailed description of different implementations of the solution is disclosed with reference to the accompanying drawings. All examples herein should be considered part of the general description and can therefore be combined in any way in general terms. Features of the various implementations can be combined or interchanged unless such combination or interchange clearly contradicts the overall functionality of the implementation.

[0047] In summary, this disclosure relates to an embolism 1 arranged for insertion into a subject's nostril 2 or ear canal 3 to serve as a delivery channel for the administration of a fluid therapeutic agent, and, for example, to stop a nosebleed. In the context of this disclosure, when referring to the embolism 1 and its components, the terms "distal" and "proximal" should be interpreted from the perspective of the person manipulating the embolism 1, regardless of whether the subject and the person manipulating the embolism are the same person or different persons.

[0048] exist Figure 1A and Figure 1B The figures shown are a perspective view and a cross-sectional view of the embolization 1 according to the present disclosure. The embolization 1 includes a body 10 and a tubular member 20 disposed inside the body 10. The body 10 includes a first end 11 and a second end 12. When the tubular member 20 is inserted, the first end and the second end substantially coincide with or correspond to the first end 23 and the second end 24 of the tubular member 20, respectively.

[0049] The tubular member 20 comprises a generally cylindrical tube having a first opening 21 at its first end 23 and a second opening 22 at its second end 24. Furthermore, the tubular member 20 includes a collar 25 disposed on its outer surface and extending radially outward. In one embodiment, the collar 25 is shaped like a cup, having a generally concave side 26 facing the first end 23 and a generally convex side 27 facing the second end 24. In one embodiment, the collar 25 is oval or elliptical, wherein the width is given by the minor axis and major axis of the ellipse, respectively. That is, the widest lateral extension of the collar 25 corresponds to the major axis of the ellipse, corresponding to... Figure 1B The cross-section shown is illustrated. In one embodiment, the tubular member 20 comprises a flexible material, such as a thermoplastic material, which is flexible but provides a certain degree of stiffness.

[0050] The collar 25 is positioned near the second end 24 of the tubular member 20, but at a distance, such that when the tubular member 20 is arranged inside the body 10 of the plug 1, the collar 25 will be arranged substantially inside the body 10. In this case, as Figure 1B As can be seen, the term "basically inside" should be understood as at least one edge 28 (i.e. the widest part) of the collar 25 being inside the body 10.

[0051] During use, when inserted into the subject's nostril 2 or ear canal 3, the first end 11 of the main body 10 is arranged facing inward. Conversely, during use, the second end 12 is arranged facing outward. Thus, during the use of the embolization 1, the first opening 21 of the tubular member 20 faces inward, while the second opening 22 faces outward.

[0052] The embolization 1 according to this disclosure provides an effective treatment for nasal bleeding, wherein, due to the elastic properties of the body 10, the absorbent body 10 applies direct pressure to the bleeding site and absorbs blood leaving the wound. In the event of excessive and / or prolonged bleeding, the collar 25 forms a stop that effectively prevents blood from escaping from the body 10, thereby preventing dripping from the saturated embolization 1. Furthermore, the collar 25 acts like an umbrella to push the body 10 outward, thereby stabilizing and facilitating the application of pressure to the walls of the nostril 2.

[0053] Meanwhile, the tubular component 20 provides a fluid passage for air, which allows the subject to continue breathing through the nose 5 even when the plug 1 is inserted into the nostril 2.

[0054] In one embodiment, the body 10 includes a compressible, elastic foam material 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, and foam materials based on forestry and agricultural byproducts such as organic cellulose or hemicellulose and specially woven cotton (i.e., so-called cotton foam). In one embodiment, the foam material exhibits micropores.

[0055] refer to Figure 6 The attached figure illustrates the relationship between the comfort experienced by a subject using the plug 1 and the compression when the plug 1 is inserted into the nostril 2 or ear canal 3, i.e., measuring how much pressure the plug 1 exerts on the surrounding walls of the nostril 2 or ear canal 3. Therefore, compression is related to the elasticity and compressibility of the foam material of the plug 1's body 10. On the left side of the graph, the user experiences a high level of comfort with relatively low compression. As the compression of the plug 1 increases, i.e., higher pressure is applied by the plug 1, the level of comfort decreases, eventually reaching a low level of comfort on the right side of the graph where compression is higher.

[0056] To achieve the sealing effect of this disclosure regarding preventing the leakage of injected fluid substances from the nose or ear, sufficient compression of the embolus 1 is essential. However, if the pressure applied by the embolus 1 is too high, the user is unlikely to tolerate prolonged use of the embolus 1, which is necessary for some treatments, as will be further explained below. Therefore, to optimize the compression / pressure applied by the embolus 1 in relation to user comfort, such as... Figure 6 The triangular area marked with a diagonal line in the diagram shows the optimal comfort compression zone, which has been determined. The optimal comfort compression zone is defined by a horizontal line at approximately one-third of the comfort level experienced with no or little compression, a vertical line at approximately half of the maximum compression, and a graph representing the relationship between comfort and compression. It is understood that comfort levels can vary between individuals, which may result in slight modifications to the location of the optimal comfort compression zone.

[0057] In one embodiment, the body 10 is coated or impregnated with a hemostatic agent to promote blood clotting and hemostasis. Examples of suitable hemostatic agents include calcium alginate, glycine, calcium, kaolin, zeolite, localized microfibrillary collagen, microdispersed oxidized cellulose, and chitosan derived from shrimp shells and other marine crustaceans, all naturally occurring in brown algae (i.e., seaweed extracts). Other suitable substances include hyaluronic acid for regeneration and botulinum toxin for runny nose (vasomotor rhinitis).

[0058] In one embodiment, the body 10 is coated or impregnated with an aromatic compound that is 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 in the nostrils to prevent dehydration and the formation of cracks or fissures, and reduce the risk of rebleeding.

[0059] For reference Figure 2A As illustrated by the solid arrow, when the subject inhales through the embolus 1, air passes through the tubular member 20. As a result, as shown by the dashed arrow, a local vacuum is created near the first opening 21. This local vacuum is used to extract the substance from the body 10 of the embolus 1, allowing it to mix with the inhaled air. With each breath, a small amount of substance is extracted from the soaked microporous foam embolus 1 and added to the inhaled air to prolong the duration of action.

[0060] For reference Figure 2BAs indicated by the solid arrow, when the subject exhales through the embolus 1, air again passes through the first opening of the tubular member 20. Conversely, due to the reduced diameter of the tubular member 20 compared to the nostrils, the pressure in the nostrils near the embolus 1 increases. As indicated by the dashed arrow, a small portion of the exhaled air, along with the substance, enters the body 10 of the embolus 1, but the collar 25 is used to retain the substance within the body 10. Therefore, the collar 25 prevents the substance inhaled by the subject from leaving the embolus 1, but retains it within the body 10. This substance-saving feature reduces the amount of substance required for treatment.

[0061] In one embodiment, the plug 1 and / or the body 10 may have an elliptical transverse cross-section, wherein, as shown in the figure... Figure 1B As shown, the width of the plug 1 is greater in its lateral extension corresponding to the long axis of the collar 25. In one embodiment, the plug 1 and / or the body 10 is bell-shaped with a generally cylindrical central portion, wherein the first end 11 is generally hemispherical or dome-shaped, and the second end 12 is flared outwards. In one embodiment, the width of the collar 25 corresponding to the elliptical long axis is substantially equal to or greater than the width of the body 10. Therefore, the collar 25 stretches and pushes the body 10 outwards when inserted. Thus, the plug 1 applies pressure to the nostril 2 or ear canal 3 to form a seal.

[0062] When used to stop nosebleeds, the plug 1 will be pressed against the side wall of the nostril 2 to increase resistance to pressure at the bleeding site (e.g., Kernig's area). Simultaneously, the subject can breathe through the tubular member 20. In one embodiment, the total net weight of the plug is less than 1 gram. The absorption capacity, plus an additional 0.5-1.0 ml that can expand, is approximately 2.5 ml of blood, which is estimated to be sufficient to absorb blood leakage during average anterior nasal bleeding.

[0063] The tubular member 20 and the body 10 have substantially equal lengths, although in one embodiment, the tubular member 20 is slightly offset from the body 10 such that the first end 23 of the tubular member 20 is arranged close to the first end 11 of the body 10, and the first opening 21 is recessed into the body 10. In this way, during insertion, the first (distal) end 23 of the tubular member 20 is shielded within the body 10 of the plug 1 to reduce the risk of damage to the nasal mucosa or the epithelial tissue 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 more proximally than the body 10 to provide gripping during insertion and removal of the plug 1 into the nostril 2 or ear canal 3.

[0064] Now for reference Figure 3The illustration shows a syringe 30 according to one embodiment of the present disclosure, which is used in conjunction with an embolus 1 for delivery of a fluid therapeutic agent into the nasal cavity of a subject, i.e., nasal administration. Here, the embolus 1 serves as an adapter for injecting substances into the nose, or for the local administration of a locally acting drug, such as a decongestant for the treatment of colds and allergies, or for the systemic administration of a systemically acting drug, such as analgesics, nicotine, or vaccines. A third route of administration achieved by the embolus of the present disclosure is via olfactory transmission through receptor neurons of the olfactory epithelium projecting into the olfactory bulb of the brain. This provides a direct connection for delivering drugs to the brain by bypassing the blood-brain barrier. This can be used to deliver drugs via the embolus 1, such as brain cell inhibitors for treating cancer, drugs for treating Alzheimer's disease and other neurodegenerative diseases, or inhibitors for treating brain AIDS or malaria.

[0065] In the first step, the embolus 1 is compressed and inserted into the nostril 2, allowing it to expand and seal against the wall of the nostril 2. Next, the syringe 30 is inserted into the proximal opening 22 of the tubular member 20, and a fluid therapeutic agent is injected into the nasal cavity through the embolus 1 by pressing the plunger of the syringe 30. For this purpose, the second end 24 can be, for example, tapered or flared outwards, or provided with a threaded interface device to receive the tip of the syringe 30. Furthermore, the flexibility / elasticity of the tubular member 20 will avoid discomfort during insertion and ensure a fluid-tight connection between the syringe tip and the distal end 24 to prevent leakage during drug delivery. For this purpose, the embolus 1 and syringe 30 can be packaged together in a pre-packaged kit. Preferably, the syringe 30 is pre-filled with a fluid therapeutic agent for delivery to the subject through the embolus 1.

[0066] Therapeutic agents can be medications administered parenterally or topically. Examples of suitable therapeutic agents include: analgesics such as acetaminophen / paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids; corticosteroids such as cortisol, corticosteroids, cortisone, and aldosterone; antibiotics such as penicillin, cephalosporins, polymyxins, rifamycin, lipomycin, quinolones, sulfonamides, macrolides, lincosamides, tetracyclines, cyclic lipopeptides, glycylcyclines, and oxazolidinones; and decongestants such as pseudoephedrine and benzylpyridinium chloride. Adrenaline, antihistamines, naproxen, oxymetazoline; stem cells; nicotine vaccines; antiviral drugs; polysaccharides, antioxidants; brain cell inhibitors; drugs for treating Alzheimer's disease and other neurodegenerative diseases; inhibitors of encephalopathy or malaria; disinfectants; astringents such as aluminum acetylated tartrate (ALSOL) solution, Burow's solution; coagulants such as aluminum sulfate solution; antifungal drugs such as clotrimazole and / or solvents such as olive oil, hydrogen peroxide.

[0067] Over-the-counter medications and treatments can be delivered and administered by the patient without the need for a medical professional. More potent prescription medications may require delivery and administration with the assistance of a medical professional, depending on local healthcare regulations, to ensure the correct dosage.

[0068] In another embodiment of this disclosure, the plug 1 is not limited to use in the nostrils of the subject, but can also be used to treat ear diseases. The size of the human ear canal is comparable to the size of the nostrils, and the plug 1 can be inserted into the ear without any adjustment and bonded thereto. Figure 3 Used in similar programs as described.

[0069] For reference Figure 4 The image shows a cross-sectional view of a subject's ear, including an plug 1 inserted into the 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, the plug 1 can be soaked in a disinfectant, decongestant, and / or astringent such as aluminum acetylated tartrate (ALSOL) solution or a fluid for topical application into the ear canal. Treatment of swimmer's ear typically requires soaking the ear canal several times a day. The plug 1 can remain inserted in the ear canal, and a syringe 30 can be used to deliver additional ALSOL solution as needed. A tubular member 20 allows the subject to still hear, while the plug 1 and the collar 25 prevent ALSOL solution from dripping from the ear. Conventional treatments today often block the ear canal and damage the subject's hearing.

[0070] In one embodiment, the plug 1 can be used to treat earwax impaction, i.e., excessive earwax blocking the ear canal. For this purpose, the plug 1 is inserted into the ear canal 3, and a cerium-dissolving substance is injected through the tubular member 20 using a syringe 30. After injection, the proximal end 24 of the tubular member 20 is closed, for example, using a small rubber or plastic stop (not shown), and the plug 1 is left in the ear canal 3 for an extended period, such as overnight, allowing the cerium-dissolving substance to soften and loosen the earwax for easy removal. The cerium-dissolving substance can be, for example, selected from mineral oils or vegetable oils (e.g., olive oil, almond oil, baby oil), glycerin, docusolate, triethanolamine peptides. After sufficient time, the stop is removed, and the syringe 30 is used to aspirate any remaining cerium-dissolving substance and softened earwax while the plug 1 is slowly removed. Compared to conventional urea peroxide irrigation, which can cause trauma, dizziness, pain, and even inflammation to the ear canal and tympanic membrane, this technique is a much gentler method of earwax removal, especially for children and the elderly.

[0071] For reference Figure 5This illustrates another embodiment of the plug 1 according to the present disclosure. In this embodiment, the plug 1 includes one or more additional components disposed within a tubular member 20. A nozzle 50 is disposed adjacent to a first distal end 21 of the tubular member 20. The nozzle 50 can be in its simplest form a single fluid planar orifice nozzle, but other configurations such as shaped orifice nozzles and surface impact nozzles are also foreseeable based on desired spray characteristics known in the art. The common feature of all types of single fluid nozzles is that fluid passes through an orifice that breaks the fluid into droplets, i.e., atomizes it, and then distributes the droplets over a surface area, onto the nasal cavity in the case of nasal application, and onto the ear canal in the case of ear application. Figure 5 As shown, the nozzle 50 is preferably configured to produce a conical spray with a spray angle. The nozzle 50 is further arranged close to the first distal end 21 of the tubular member 20, such that the nozzle 50 does not rub against the nasal mucosa or the epithelial tissue of the ear canal 3.

[0072] Additionally or alternatively, filter 60 is arranged inside tubular member 20. Filter 60 presents multiple openings or holes, wherein the hole size is adapted to prevent inhalation, intrusion, penetration, or permeation of particulate matter such as dust, dirt, smoke, pollen, carcinogens, radioactive substances, and other irritants, and / or microorganisms such as bacteria, parasites, amoebas, fungi, and viruses (e.g., those causing influenza, the common cold, and other airborne pandemic respiratory diseases, MERS, Severe Acute Respiratory Syndrome Coronavirus, Severe Acute Respiratory Syndrome Coronavirus Type 2, etc.) through filter 60. In this way, unlike known plugs that completely block the nostrils 2 or ear canals 3, the nose or ears are protected from exposure to pathogens, while allowing air to pass through plug 1 for breathing or hearing.

[0073] Additionally or alternatively, the internal device 70 is disposed inside the tubular member 20. The internal device 70 can be controlled via an application, for example, used as an alarm clock or in a virtual reality context, and emits specified scents / fragrances, vibrations, acoustic signals, etc., as feedback, or notifies the wearer of different situations that may occur and require his / her attention or action.

[0074] The internal device 70 can be a sensor for detecting gases (asphyxiating gases, such as nitrogen, carbon dioxide, argon; flammable gases, such as gasoline, hydrogen, methane, propane; toxic gases, such as hydrogen sulfide, carbon monoxide, nitric oxide) or radioactivity, detecting pollen levels, pollution, or pathogens, and responding to these stimuli in different ways, emitting pheromones, aphrodisiacs, odors / fragrances, and enhancing the sense of smell. Many agents are undetectable to humans and can be life-threatening in different environments, but by using a small sensor in the nasal plug, people can be immediately notified of them (emitting different stimuli). Furthermore, many people suffer from more or less complete loss of smell (anosmia), and the sensor placed in the plug has the advantage of being very close to the olfactory region (olfactory receptor region) on the nose, and can enhance the sense of smell and improve quality of life.

[0075] In another embodiment, the internal device 70 may be an acoustic device, such as a hearing aid, a speaker, or an auditory masking device. Acoustic devices offer the possibility of combining embolism with a wide range of technological applications, such as audio communication, listening to music, detecting auditory vibrations, acoustic trauma, or suppressing tinnitus by generating sound or noise.

[0076] In one embodiment, the internal device 70 is configured to determine the position, acceleration, and / or orientation of the embolus 1. Examples of suitable internal devices include positioning or tracking devices, such as markers or beacons that transmit and / or receive electromagnetic signals that can be used to determine the position. For example, a tracking device may be used in conjunction with a global navigation satellite system (e.g., GPS) or a local positioning system using cellular base stations, Wi-Fi access points, and radio towers to determine the position. Other examples of suitable devices include gyroscopes and accelerometers.

[0077] Understandable, although Figure 5 An example of an embolization 1 is shown having a combination of nozzle 50, filter 60 and internal device 70, but embolization 1 may include one or two or more additional components in different combinations, depending on the required configuration, medical indication and use of embolization 1.

[0078] In one embodiment, the tubular member 20 may be permeable to a fluid or gas and / or selected substances therein. For example, the tubular member 20 may include a plurality of small perforations or a grid or mesh with small apertures along its length within the body 10. This would allow the therapeutic agent to also be delivered to the body 10 of the embolus 1 through the openings in the tubular member 20 during delivery.

[0079] While the foregoing description contains several specificities, these specificities should not be construed as limiting the scope of the concepts described herein, but rather as providing illustrations of some exemplary embodiments of the described concepts. It should be understood that the scope of the concepts currently described fully encompasses other embodiments that may become apparent to those skilled in the art, and therefore, the scope of the concepts currently described is not limited. Unless explicitly stated otherwise, elements referred to in the singular form do not mean "one and only one," but rather "one or more." Furthermore, the apparatus or method need not solve every problem sought to be addressed by the concepts currently described, and are therefore included herein.

Claims

1. An embolism (1) for insertion into the nose or ear of a subject, the embolism comprising: A body (10) adapted to fit into the nasal cavity (2) or ear canal (3) of the subject, the body including a first end (11) arranged inward and a second end (12) arranged outward during use, wherein the body includes a compressible elastic foam material adapted to absorb liquid; A tubular member (20) is disposed inside the body and includes an inwardly facing first opening (21) and an outwardly facing second opening (22) during use, the tubular member being arranged to provide fluid communication between the first opening and the second opening; 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 is characterized in that it further includes a cup-shaped collar (25) arranged on the outer surface and extending radially outward and substantially arranged inside the body to push the body outward, wherein the substantially concave side (26) of the collar faces the first end (11) of the body (10).

2. The embolization according to claim 1, the embolization further comprising a nozzle (50) arranged adjacent to the first opening of the tubular member.

3. The embolization according to claim 1 or 2, wherein the embolization further comprises a filter (60) disposed inside the tubular member.

4. The embolization according to claim 1 or 2, wherein the embolization further comprises an internal device (70) disposed within the tubular member.

5. The embolization according to claim 4, wherein, The internal device is an acoustic device selected from hearing aids, loudspeakers, or auditory masking devices.

6. The embolization according to claim 4, wherein, The internal device is a sensor configured to detect gases, radioactivity, pollen levels, pollution, pathogens, acoustic signals, and / or electromagnetic signals.

7. The embolization according to claim 4, wherein, The internal device is configured to determine the location, acceleration, and / or orientation of the embolus.

8. A kit comprising at least one embolism (1) and at least one syringe (30), the at least one embolism being inserted into the nose or ear of a subject, the at least one syringe being pre-filled with fluid to be injected into the nasal cavity (2) or ear canal (3) of the subject through the embolism, the embolism comprising: A body (10) adapted to fit into the nostril or ear canal of the subject, the body including a first end (11) arranged inward and a second end (12) arranged outward during use, wherein the body includes a compressible elastic foam material adapted to absorb liquid; A tubular member (20) is disposed inside the body and includes an inwardly facing first opening (21) and an outwardly facing second opening (22) during use, the tubular member being arranged to provide fluid communication between the first opening and the second opening; 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 is characterized in that it further includes a cup-shaped collar (25) arranged on the outer surface and extending radially outward and substantially arranged inside the body to push the body outward, wherein the substantially concave side (26) of the collar faces the first end (11) of the body (10).

9. The kit according to claim 8, wherein, The embolism also includes a nozzle (50) arranged adjacent to the first opening of the tubular member.

10. The kit according to claim 8 or 9, wherein, The embolism also includes a filter (60) disposed inside the tubular member.

11. The kit according to claim 8 or 9, wherein, The embolism also includes an internal device (70) disposed inside the tubular member.

12. The kit according to claim 11, wherein, The internal device is an acoustic device selected from hearing aids, loudspeakers, or auditory masking devices.

13. The kit according to claim 11, wherein, The internal device is a sensor configured to detect gases, radioactivity, pollen levels, pollution, pathogens, acoustic signals, and / or electromagnetic signals.

14. The kit of claim 11, wherein, The internal device is configured to determine the location, acceleration, and / or orientation of the embolus.

15. The kit according to claim 8 or 9, wherein, The fluid therapeutic agent is selected from analgesics, corticosteroids, antibiotics, decongestants, stem cells, nicotine, vaccines, brain cell inhibitors, disinfectants, astringents, coagulants, antifungals, and / or cerium solvents.

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