Patent Description:
The human nose is a delicate organ not only for the olfaction, the sense of smell, but also for heating, filtration, and humidification of the inhaled air. The nasal sinuses will also "boost" the inhaled air with nitrogen oxide (NO), a gaseous signaling molecule that increases the pulmonary blood flow and oxygen uptake. The total surface area available in this richly vascularized respiratory mucosa is estimated to be about <NUM><NUM>.

Nasal mucosal capillaries are specifically designed for rapid passage of fluids through the vascular wall and out into the dry air in the nose. The amount of blood flow to this area is considerable - it is higher per unit of tissue than the blood flow to the brain, liver, or muscle.

The nose-brain pathway across the olfactory mucosa transports nasally delivered medication directly into the cerebrospinal fluid (CSF) and brain - leading to early effects of centrally acting medications. Other conventionally delivery methods such as intravenous or intramuscular must deal with the blood-brain barrier.

The nasal mucosa easily absorbs medications directly into the venous circulation. Because the absorptive surface is not the intestinal mucosa, as for oral or rectal medications, the drug never enters the liver circulation and is not subjected to hepatic (liver) metabolism - thereby leading to far higher drug absorption and efficacy. Hence, nasal administration of medical substances provides several advantages over injection using hypodermic needles.

One way of nasal administration is by using nasal sprays. However, the amount of substance which may be administered is limited due to discomfort when too much liquid is introduced into the nasal cavity and the difficulty in retaining the substance in the nasal cavity.

It is also well-known in the art to provide nose plugs which are coated or soaked with for instance hemostatic compounds to promote blood clotting and stop nosebleed. <CIT> and <CIT> disclose examples of such nose plugs. However, the amount of substance which may be administered by such soaked or coated plugs is similarly limited by the volume or surface of the plug, and absorption is essentially limited to the part of the nasal mucosa in contact with the plug.

Co-pending application <CIT> discloses a nasal plug for treatment of nosebleed.

<CIT> discloses an atomizing nozzle structured particularly for nasal therapy. The atomizing nozzle is structured to couple with luer-locking structure carried by a syringe. Such an atomizing nozzle includes a nasal stopper and a stem, as well as a distal tip sized for insertion into a nostril of a human child, with a proximal shield portion being structured to resist over-insertion of a discharge orifice into the nostril.

<CIT> discloses a dispenser for liquids comprising an applying nozzle constituted by a bell-shaped body extending along a central axis and provided, at the bottom, with an annular collar and, at the top, with a convex cap. The bell-shaped body has a first axial hole whose cross-section decreases from the collar towards said cap and a valve for nebulizing the solution being housed inside the first hole in a matching manner.

<CIT> discloses a device for delivery of a substance to an external auditory canal and/or nasal cavity which includes a reservoir, an aerosolizing mechanism, a nozzle, and a retaining member.

Thus, there is a need for improved devices and methods for nasal drug administration which overcome the disadvantages of the prior art.

It is an object of the solution to address at least some of the problems and issues outlined above. It is possible to achieve these objects and others by providing a plug according to the present disclosure.

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

According to the present invention, there is provided a plug for insertion into the nose or ear of a subject, comprising: a body adapted to fit into a nostril or ear canal of the subject, the body comprising a first end arranged to face inward and a second end arranged to face outward during use, wherein the body comprises a compressible, resilient foam material adapted to absorb liquid; a tubular member disposed inside the body and comprising a first opening facing inwardly and a second opening facing outward during use, the tubular member being arranged to provide fluid communication between the first and second openings; wherein the tubular member further comprises a cup-shaped collar arranged on an external surface and extending radially outward and disposed substantially inside the body, wherein a substantially concave side of the collar faces towards a first end of the body; and wherein the second opening of the tubular member is adapted to receive a tip of a syringe for injection of a fluid therapeutic agent through the tubular member. The plug further comprises an internal device arranged inside the tubular member.

In one embodiment, the plug further comprises a spray nozzle arranged adjacent the first opening of the tubular member. The spray nozzle facilitates efficient distribution of the fluid therapeutic agent into the nasal cavity or ear.

In one embodiment, the plug further comprises a filter arranged inside the tubular member. The filter protects the nose or ear from inhaled, intruding, infiltrated or penetrating particles such as dust, dirt, smoke, pollen, carcinogens, radioactive substances, and other irritants, and/or microbes such as bacteria, parasites, amoebae, fungi, viruses (e.g., causing flu, common cold, and other airborne pandemic respiratory diseases, MERS, SARS-CoV, SARS-CoV-<NUM> etc.).

In one embodiment, the internal device can be controlled via an app and can, for example, be used as an alarm clock or in virtual reality situations and emit designated scents/fragrances, vibrations, acoustic signals etc. as feedback or to notify the wearer of different situations that might arise and require his/her attention or action.

In one embodiment, the internal device is an acoustic device being selected from a hearing aid, a speaker, or an auditory masking device. The acoustic device provides the possibility to combine the plug with a wide range of technical applications such as audio communication, listening to music, detect auditory vibrations, acoustic trauma or inhibiting tinnitus by producing sound or noise.

In one embodiment, the internal device is a sensor, the sensor being configured to detect gas (suffocating e.g., nitrogen, carbon dioxide, argon, flammable e.g., gasoline, hydrogen, methane, propane, toxic e.g., hydrogen sulfide, carbon monoxide, nitric oxide) detect radioactivity, detect levels of pollen, pollution or pathogens, acoustic signals and/or electromagnetic signals.

In one embodiment, the sensor is configured to emit pheromones, aphrodisiac, scents/fragrances, vibrations and/or acoustic signals in response to the detection of any of the substances described above. This may be used to alert the wearer of hazard or danger and prompt the user to take suitable action.

Many agents cannot be smelled by humans and that can be life threatening in different environments, and with a small sensor in the nose plug one can immediate get notifications (by emitting different stimuli) about it. Also, many people suffer from more or less total loss of smell (anosmia) and a sensor placed in the plug has the advantage of being very close to the olfactory area (area for receptors for smell) up in the nose and can enhance the smell and increase the quality of life.

In one embodiment, the internal device is configured to enable determining a position, acceleration and/or orientation of the plug. Examples of suitable internal devices include positioning or tracking devices such as markers or beacons emitting and/or receiving electromagnetic signals which may be used to determine the position, gyroscopes, accelerometers etc..

In a second aspect of the present disclosure, there is provided a kit comprising at least one plug according to the first aspect and at least one syringe pre-filled with a fluid therapeutic agent to be injected into the nostril or ear canal of the subject through the plug.

The aspects and embodiments described herein are freely combinable with each other.

The solution will now be described, by way of example, with reference to the accompanying drawings, in which:.

In the following, a detailed description of the different embodiments of the solution is disclosed with reference to the accompanying drawings. All examples herein should be seen as part of the general description and are therefore possible to combine in any way in general terms. Individual features of the various embodiments may be combined or exchanged unless such combination or exchange is clearly contradictory to the overall function of the implementation.

Briefly described, the present disclosure relates to a plug <NUM> arranged to be inserted into the nostril <NUM> or ear canal <NUM> of a subject, to serve as a delivery pathway for administration of fluid therapeutic agents, in addition to e.g., stopping a nosebleed. In the context of the present disclosure, the terms 'distal' and 'proximal' when referring to the plug <NUM> and its components should be interpreted from the point of view of a person handling the plug <NUM>, regardless of whether the subject and the person handling the plug <NUM> is the same or different persons.

In <FIG>, perspective and cross-sectional views, respectively, of a plug <NUM> according to the present invention. The plug <NUM> comprises a body <NUM> and a tubular member <NUM> disposed inside the body <NUM>. The body <NUM> comprises a first end <NUM> and a second end <NUM> which substantially coincide or correspond with first and second ends <NUM>, <NUM>, respectively, of the tubular member <NUM> when inserted.

The tubular member <NUM> comprises a substantially cylindrical tube with a first opening <NUM> in a first end <NUM> and a second opening <NUM> in a second end <NUM> thereof. Additionally, the tubular member <NUM> comprises a collar <NUM> arranged on the external surface and extending radially outward. The collar <NUM> is shaped like a cup, with a substantially concave side <NUM> facing towards the first end <NUM> and a substantially convex side <NUM> facing towards the second end <NUM>. In one embodiment, the collar <NUM> is oval or elliptic, wherein the width is given by the minor and major axes of the ellipse, respectively. , the widest transverse extension of the collar <NUM> corresponds to the major axis of the ellipse, corresponding to the sectional plane shown in <FIG>. In one embodiment, the tubular member <NUM> comprises a flexible material, e.g., a thermoplastic material which is flexible yet provides a certain stiffness.

The collar <NUM> is located near the proximal, second end <NUM> of the tubular member <NUM> but at a distance therefrom such that when the tubular member <NUM> is disposed inside the body <NUM> of the plug <NUM>, the collar <NUM> will be disposed substantially inside the body <NUM>. In this context, the term 'substantially inside' should be understood that at least a rim <NUM> (i.e., the widest part) of the collar <NUM> is inside the body <NUM>, as may be seen in <FIG>.

The first end <NUM> of the body <NUM> is arranged to face inwardly when inserted into the nostril <NUM> or ear canal <NUM> of the subject during use. Conversely, the second end <NUM> is arranged to face outward during use. As such the first opening <NUM> of the tubular member <NUM> faces inwardly and the second opening <NUM> faces outward during use of the plug <NUM>.

The plug <NUM> according to the present disclosure provides an effective treatment of nosebleed in that the absorbent body <NUM> applies direct pressure to the site of the nosebleed due to the resilient properties of the body <NUM> and absorbs the blood exiting the wound site. In cases of excessive and/or prolonged bleeding, the collar <NUM> forms a stop which effectively prevents blood from escaping the body <NUM> and thus avoids dripping from a saturated plug <NUM>. Additionally, the collar <NUM> acts like an umbrella to push the body <NUM> outward to stabilize and aid in applying pressure on the walls of the nostril <NUM>.

At the same time, the tubular member <NUM> provides a fluid passage for air which enables the subject to continue breathing through the nose even with the plug <NUM> inserted in the nostril <NUM>.

The body <NUM> comprises a compressible, resilient foam material adapted to absorb liquid, i.e., blood from the subject. Examples of suitable materials for the body <NUM> include polyurethane (PU) foam, polyether foam, (poly) ethylene-vinyl acetate (EVA/PEVA) foam, foam materials from forestry and agricultural byproducts based on organic cellulose or hemi-cellulose and special woven cotton, so called cotton-foam. In one embodiment, the foam material exhibits micropores.

With reference to <FIG>, there is shown a diagram illustrating the relationship between the comfort experienced by a subject using the plug <NUM> and the compression of the plug <NUM> when inserted into the nostril <NUM> or the ear canal <NUM>, i.e., a measure of how much pressure the plug <NUM> exerts on the surrounding walls of the nostril <NUM> or ear canal <NUM>. The compression is therefore related to the resilience and compressibility of the foam material of the body <NUM> of the plug <NUM>. On the left-hand side of the graph, the user experiences a high level of comfort whereas the compression is relatively low. As the compression of the plug <NUM> increases, i.e., a higher pressure is exerted by the plug <NUM>, the comfort level decreases, eventually reaching a low level of comfort when the compression is high on the right-hand side of the graph.

In order to achieve the purposes of the present disclosure with respect to the sealing effect to prevent injected fluid substances from escaping the nose or ear, it is vital to have sufficient compression of the plug <NUM>. However, if the pressure exerted by the plug <NUM> is too high, the user is less likely to accept prolonged use of the plug <NUM> which is necessary for some treatments as will be further explained below. Therefore, with the aim to optimize the compression/pressure exerted by the plug <NUM> in relation to the comfort experienced by the user, an optimal comfort-compression zone has been identified as illustrated by the triangular shaped area marked by diagonal lines in <FIG>. The optimal comfort-compression zone is delimited by a horizontal line at approximately one third of the comfort level experienced with no to little compression, a vertical line at approximately half the maximum compression, and the graph representing the relationship between the comfort and compression. It is understood that the comfort level can vary between individuals, which may give rise to slight modifications to location of the optimal comfort-compression zone.

In one embodiment, the body <NUM> is coated or soaked with a hemostatic agent to promote blood clotting and stop bleeding. Examples of suitable hemostatic agents include calcium alginate naturally present in e.g., brown algae (i.e., seaweed extracts), glycine, calcium, kaolin, zeolite, topical microfibrillar collagen, micro-dispersed oxidized cellulose and chitosan derived from shells of shrimp and other sea crustaceans. Other suitable substances include hyaluronic acid for regeneration and botulinum toxin for runny nose (vasomotor rhinitis).

In one embodiment, the body <NUM> is coated or soaked with an aroma compound to be inhaled by the subject. Examples of suitable aroma compounds include menthol, peppermint, lubricating oils such as sesame oil, saline gels, Aloe vera or liquid paraffin which lubricate the mucosa in the nostril to prevent dehydration and formation of cracks or fissures and reduce the risk of rebleeding.

Referring now to <FIG>, when the subject inhales through the plug <NUM>, the air passes through the tubular member <NUM>, illustrated by the solid arrow. As a result, near the first opening <NUM> a local vacuum is formed which acts to draw the substance out from the body <NUM> of the plug <NUM> such that it is mixed with the inhaled air, illustrated by the dashed arrows. With every breath, a small amount of the substance from the soaked micropore foam plug <NUM> is drawn out and added to the inhaled air for prolonged action.

Referring now to <FIG>, when the subject exhales through the plug <NUM>, the air again passes through the first opening of the tubular member <NUM>, illustrated by the solid arrow. Conversely to inhalation, due to the reduced diameter of the tubular member <NUM> compared to the nostril, the pressure in the nostril proximal to the plug <NUM> increases. A small part of the exhaled air together with the substance will enter the body <NUM> of the plug <NUM>, illustrated by the dashed arrows, but the collar <NUM> acts to retain the substance in the body <NUM>. Thus, the collar <NUM> prevents the substance to be inhaled by the subject from exiting the plug <NUM>, but instead retaining the substance in the body <NUM>. This substance-saving feature reduces the amount of substance required for the treatment.

The plug <NUM> and/or body <NUM> may in one embodiment have an oval-shaped transverse cross-section, wherein the width of the plug <NUM> is greater in the transverse extension corresponding to the major axis of the collar <NUM> as shown in <FIG>. In one embodiment, the plug <NUM> and/or body <NUM> is bell-shaped with a substantially cylindrical central portion, wherein the first end <NUM> is substantially hemispherical or dome-shaped and the second end <NUM> is flared outward. In one embodiment, the width of the collar <NUM> corresponding to the major axis of the oval shape is substantially equal to or greater than the width of the body <NUM>. Thus, the collar <NUM> when inserted will stretch and push the body <NUM> outward. Thus, the plug <NUM> exerts a pressure on the nostril <NUM> or ear canal <NUM> to create a seal.

When used to stop nosebleed, the plug <NUM> will brace against the lateral wall of the nostril <NUM> to increase the pressure against the bleed site, e.g., Kiesselbach's plexus. At the same time, the subject can breathe through the tubular member <NUM>. In one embodiment, the total dry weight of the plug is less than <NUM> gram. The absorbing capacity is about <NUM> milliliters of blood, plus expandable extra <NUM>-<NUM> milliliters which is estimated to be more than enough for absorbing the blood leakage during an average anterior nose bleeding.

The tubular member <NUM> and the body <NUM> have substantially equal length, although in one embodiment the tubular member <NUM> is slightly offset from the body <NUM> such that the first end <NUM> of the tubular member <NUM> is arranged proximal to the first end <NUM> of the body <NUM>, and the first opening <NUM> is sunk into the body <NUM>. In this way, the first (distal) end <NUM> of the tubular member <NUM> is shielded inside the body <NUM> of the plug <NUM> during insertion, to reduce the risk of damaging the nasal mucosa or epithelium of the ear canal <NUM>. In one embodiment, the tubular member <NUM> protrudes from the second end <NUM> of the body <NUM>, i.e., the second (proximal) end <NUM> of the tubular member <NUM> extends further proximally than the body <NUM> to provide a grip when handling the plug <NUM> during insertion into and removal from the nostril <NUM> or ear canal <NUM>.

Referring now to <FIG>, there is shown a syringe <NUM> to be used in conjunction with the plug <NUM> for delivery of fluid therapeutic agents to the nasal cavity of a subject according to one embodiment of the present disclosure, i.e., nasal administration. Here, the plug <NUM> acts as an adapter for injecting substances into the nose, either for topical administration of locally acting drugs, e.g., decongestants for cold and allergy treatment, or for systemic administration of systemically acting drugs, e.g., analgesics, nicotine, or vaccines. A third route of administration achieved by the plug of the present disclosure is through olfactory transfer via the receptor nerve cells of the olfactory epithelium which project into the olfactory bulb of the brain. This provides a direct connection for delivery of drugs to the brain, bypassing the blood-brain barrier. This may be used to deliver drugs such as cerebral cytostatic for cancer, medicines for Alzheimer's disease and other neurodegenerative diseases, or inhibiting agents for cerebral AIDS or malaria by means of the plug <NUM>.

In a first step, the plug <NUM> is compressed and inserted into the nostril <NUM> and allowed to expand such that it seals against the walls of the nostril <NUM>. Next, the syringe <NUM> is inserted into the proximal opening <NUM> of the tubular member <NUM> and the fluid therapeutic agent is injected through the plug <NUM> into the nasal cavity by depressing the plunger of the syringe <NUM>. To this end, the second end <NUM> may e.g., be tapered or flared outwardly, or provided with interfacing means such as threads to receive the tip of the syringe <NUM>. In addition, flexibility/resilience of the tubular member <NUM> will avoid discomfort during insertion and ensure a fluid-tight connection between the syringe tip and the second end <NUM> to prevent leaking during drug delivery. The plug <NUM> and the syringe <NUM> may be provided together in a pre-packaged kit for this purpose. Preferably, the syringe <NUM> is pre-filled with a fluid therapeutic agent to be delivered to the subject through the plug <NUM>.

The therapeutic agent may be a pharmaceutical drug intended for parenteral or topical administration. Examples of suitable therapeutic agents include analgesics such as paracetamol/acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids; corticosteroids such as cortisol, corticosterone, cortisone, aldosterone; antibiotics such as penicillin, cephalosporin, polymyxin, rifamycin, lipiarmycin, quinolones, sulfonamides, macrolides, lincosamides, tetracyclines, cyclic lipopeptides, glycylcyclines, oxazolidinones,; decongestants such as pseudoephedrine, phenylephrine, antihistamines, naphazoline, oxymetazoline; stem cells; nicotine; vaccines; anti-viral agents; polysaccharide-glycan-based-substances, antioxidants; cerebral cytostatic; medicines for Alzheimer's disease and other neurodegenerative diseases; inhibiting agents for cerebral AIDS or malaria; disinfectants; astringents such as aluminum acetotartrate (ALSOL) solution, Burow's solution; procoagulants such as aluminum sulfate solution; antifungals such as clotrimazole and/or cerumenolytics such as olive oil, hydrogen peroxide.

Non-prescription drugs and therapeutic agents sold over the counter may be delivered and administered by the subject without the need for professional health care workers. More potent prescription drugs may require assistance from professional health care workers for delivery administration according to local health care regulations, to ensure correct dosage.

In a further embodiment of the present disclosure, the plug <NUM> is not limited to use in the nostril of a subject but may also be used to treat disorders of the ear. The human ear canal is of comparable dimension to the nostril and the plug <NUM> can, without any adjustments, be inserted into the ear and used in a similar procedure as described above in conjunction with <FIG>.

Referring now to <FIG>, there is shown a cross-sectional view of the ear of a subject, including a plug <NUM> inserted into the ear canal <NUM>. In one embodiment, the plug is used in treatment of otitis externa, also known as swimmer's ear, which is an inflammation of the ear canal. To this end, the plug <NUM> can be soaked with disinfectant, decongestant and/or astringent substances like aluminum acetotartrate (ALSOL) solution or liquor for topical administration in the ear canal. Treatment of swimmer's ear often requires soaking of the ear canal several times per day. The plug <NUM> may remain inserted in the ear canal, and a syringe <NUM> may be used to deliver additional ALSOL solution as needed. The tubular member <NUM> allows the subject to still hear while the plug <NUM> and collar <NUM> prevent the ALSOL solution from dripping out of the ear. Traditional treatment of today all block the ear canal and impair the hearing for the subject.

In one embodiment, the plug <NUM> may be used in treatment of cerumen impaction, i.e., excess earwax which blocks the ear canal. To this end, the plug <NUM> is inserted into the ear canal <NUM> and a cerumenolytic substance is injected through the tubular member <NUM> by means of a syringe <NUM>. After injection, the proximal end <NUM> of the tubular member <NUM> is closed, e.g., with a small rubber or plastic stopper (not shown), and the plug <NUM> is left in the ear canal <NUM> for an extended time period, e.g., overnight, allowing the cerumenolytic substance to soften and loosen the earwax to facilitate removal. The cerumenolytic substance may for instance be selected from mineral or vegetable oils (e.g., olive oil, almond oil, baby oil), glycerin, docusate, triethanolamine polypeptide. After sufficient time has passed, the stopper is removed and the remaining cerumenolytic substance and softened earwax is aspirated using a syringe <NUM> whilst simultaneously slowly removing the plug <NUM>. This technique is a much gentler way of removing cerumen, especially for children and elderly, compared to conventional carbamide peroxide irrigation which can cause trauma to the ear canal and ear drum, vertigo, and pain or even inflammation.

Referring now to <FIG>, there is shown another embodiment of the plug <NUM> according to the present disclosure. In this embodiment, the plug <NUM> comprises one or more additional components arranged inside the tubular member <NUM>. Adjacent the first, distal end <NUM> of the tubular member <NUM>, there is arranged a spray nozzle <NUM>. The spray nozzle <NUM> may in its simplest form be a single-fluid plain-orifice nozzle, but other configurations such as shaped-orifice nozzles and surface-impingement nozzles are also foreseen depending on the spray characteristics desired, as known in the art. Common for all types of single-fluid spray nozzles is that the fluid is passed through a small orifice which causes the fluid to break up into droplets, i.e. atomization, which are then distributed over a surface area, the nasal cavity in the case of nasal administration and the ear canal in the case of administration into the ear. The spray nozzle <NUM> is preferably configured to produce a cone-shaped spray with a spray angle as shown in <FIG>. The spray nozzle <NUM> is further arranged proximal to the first, distal end <NUM> of the tubular member <NUM> such that the spray nozzle <NUM> does not rub against the nasal mucosa or epithelium of the ear canal <NUM>.

Additionally, or alternatively, a filter <NUM> is arranged inside the tubular member <NUM>. The filter <NUM> exhibits a plurality of openings or pores with a pore size adapted to prevent inhaled, intruding, infiltrated or penetrating particles such as dust, dirt, smoke, pollen, carcinogens, radioactive substances, and other irritants and/or microbes such as bacteria, parasites, amoebae, fungi, viruses (e.g. causing flu, common cold, and other airborne pandemic respiratory diseases, MERS, SARS-CoV, SARS-CoV-<NUM> etc.) from passing through the filter <NUM>. In that way the nose or ear is protected from exposure to e.g., pathogens whilst allowing air to pass through the plug <NUM> to enable breathing or hearing, as opposed to known plugs which completely block the nostril <NUM> or ear canal <NUM>.

According to the present invention, an internal device <NUM> is arranged inside the tubular member <NUM>. The internal device <NUM> can be controlled via an app and can, for example, be used as an alarm clock or in virtual reality situations and emit designated scents/fragrances, vibrations, acoustic signals etc. as feedback or to notify the wearer of different situations that might arise and require his/her attention or action.

The internal device <NUM> may be a sensor for detecting gas (suffocating e.g., nitrogen, carbon dioxide, argon, flammable e.g., gasoline, hydrogen, methane, propane, toxic e.g., hydrogen sulfide, carbon monoxide, nitric oxide) or radioactivity, detect levels of pollen, pollution or pathogens and respond to those stimuli in different ways, and to emit pheromones, aphrodisiac, scents/fragrances and enhance smell. Many agents cannot be smelled by humans and that can be life threatening in different environments, and with a small sensor in the nose plug one can immediate get notifications (emitting different stimuli) about it. Also, many people suffer from more or less total loss of smell (anosmia) and a sensor placed in the plug has the advantage of being very close to the olfactory area (area for receptors for smell) up in the nose and can enhance the smell and increase the quality of life.

In another embodiment, the internal device <NUM> may be an acoustic device such as a hearing aid, a speaker, or an auditory masking device. The acoustic device provides the possibility to combine the plug with a wide range of technical applications such as audio communication, listening to music, detect auditory vibrations, acoustic trauma or inhibiting tinnitus by producing sound or noise.

In one embodiment, the internal device <NUM> is configured to enable determining a position, acceleration and/or orientation of the plug <NUM>. Examples of suitable internal devices include positioning or tracking devices such as markers or beacons emitting and/or receiving electromagnetic signals which may be used to determine the position. For instance, the tracking device may be used to determine position in conjunction with global navigation satellite systems such as GPS or local positioning systems using cellular base stations, Wi-Fi access points, and radio broadcast towers. Other examples of suitable devices include gyroscopes and accelerometers.

It is understood that although <FIG> illustrates the plug <NUM> with the spray nozzle <NUM>, the filter <NUM> and the internal device <NUM> in combination, the plug <NUM> may comprise one or two or more of the additional components in different combinations, depending on the desired configuration, medical indication and use of the plug <NUM>.

In one embodiment, the tubular member <NUM> is permeable to fluids or gases and/or selected substances therein. For instance, the tubular member <NUM> may comprise a plurality of small perforations or a lattice or grating with small apertures along its length inside the body <NUM>. This will allow the therapeutic agent to also be transmitted into the body <NUM> of the plug <NUM> through the openings in the tubular member <NUM> during delivery.

Claim 1:
A plug (<NUM>) for insertion into the nose or ear of a subject, comprising:
a body (<NUM>) adapted to fit into a nostril (<NUM>) or ear canal (<NUM>) of the subject, the body comprising a first end (<NUM>) arranged to face inward and a second end (<NUM>) arranged to face outward during use, wherein the body comprises a compressible, resilient foam material adapted to absorb liquid;
a tubular member (<NUM>) disposed inside the body and comprising a first opening (<NUM>) facing inwardly and a second opening (<NUM>) facing outward during use, the tubular member being arranged to provide fluid communication between the first and second openings;
wherein the second opening of the tubular member is adapted to receive a tip of a syringe (<NUM>) for injection of a fluid therapeutic agent through the tubular member,
characterised in that the tubular member further comprises a cup-shaped collar (<NUM>) arranged on an external surface and extending radially outward and disposed substantially inside the body to push the body outward, wherein a substantially concave side (<NUM>) of the collar faces towards the first end (<NUM>) of the body (<NUM>); and
wherein the plug further comprises an internal device (<NUM>) arranged inside the tubular member.