Nasal Device for Treatment
20220379101 · 2022-12-01
Inventors
Cpc classification
A61M2205/3337
HUMAN NECESSITIES
A61F5/08
HUMAN NECESSITIES
International classification
Abstract
Herein disclosed are nasal inserts for treatment and/or management of various different ailments. Easy modification of the insert allows for treatment of various ailments that can readily be treated via the nose. The insert can direct air into or out of the nasal cavity and/or deliver medicinal substances and/or non-medicinal substances to the appropriate regions, thereby providing the appropriate therapeutic effect, depending on the ailment being treated.
Claims
1. A nasal insert for insertion into a nasal cavity, comprising: a body comprising a proximal end, at least one distal end configured to be positioned within the nasal cavity, and a sidewall extending between the proximal end and the at least one distal end, wherein at least one portion of the body comprises and/or is coated by at least one component designed to produce a required effect(s) configured to be released from the body to region(s) of the nasal cavity.
2. The nasal insert of claim 1, wherein the proximal end of the body is configured to be positioned proximate to a nostril of the nasal cavity, and wherein the at least one distal end is configured to be positioned within the nasal cavity beyond a nasal valve of the nasal cavity.
3. The nasal insert of claim 1, wherein the sidewall comprises an inner surface defining at least one passageway, an outer surface, and at least one opening through the sidewall, which is configured to be positioned within the nasal cavity.
4. The nasal insert of claim 3, further comprising at least one valve and/or at least one filter in communication with the at least one passageway, wherein the at least one valve permits air and/or other components in one direction in the at least one passageway, and/or wherein the at least one filter is configured to reduce an amount of or prevent particles with selected characteristics from passing through the at least one passageway.
5. The nasal insert of claim 4, wherein the selected characteristics comprise particle size, molecule structure, and/or polarity.
6. The nasal insert of claim 1, wherein, when deployed in the nasal cavity, the body is configured to: direct incoming or outgoing air and/or other components to region(s) of the nasal cavity and/or beyond it; and/or prevent the incoming or outgoing air and/or other components from reaching region(s) in the nasal cavity and/or beyond it; and/or reduce an amount of air and/or other components in region(s) of the nasal cavity and/or beyond it.
7. The nasal insert of claim 1, wherein the body comprises at least one seal extending directly or indirectly from the sidewall of the body configured to (i) reduce or prevent movement of air and/or other components across the at least one seal and/or (ii) deflect air and/or other component flow, and wherein the at least one seal is a total seal, a partial seal, or a selective seal.
8. The nasal insert of claim 1, further comprising at least one hook extending directly or indirectly from an outer surface of the sidewall of the body configured to hold the nasal insert in the nasal cavity.
9. The nasal insert of claim 1, wherein the at least one distal end of the body is positioned in a first region of the nasal cavity, the nasal insert further comprising at least one segment protruding from the sidewall of the body, the at least one segment comprising a proximal end connected to the sidewall of the body, a distal end configured to be positioned proximate to a second region of the nasal cavity, and a segment sidewall extending between the proximal end and the distal end of the segment.
10. The nasal insert of claim 1, wherein the at least one component designed to produce the required effect(s) comprises at least one of: a drug; a medicine; a vaccine; an anti-bacterial agent; an anaesthetization agent; hormone(s); agonists; antagonists; material(s) for shrinking nasal mucus/polyps/tumor(s); material(s) for sanitization, antisepsis, gene therapy, cell targeted therapy, immunotherapy, chemotherapy, electric-based-signal acts/procedures, radiation-based acts, light-based acts; or material(s) for acts/procedures delivered via transdermal, protein-based, electric, ultrasonic, or laser-based technologies.
11. The nasal insert of claim 1, wherein the at least one component designed to produce the required effect(s) is configured to release from the body of the nasal insert in response to a condition or trigger.
12. The nasal insert of claim 1, wherein the body of the nasal insert further comprises a container(s) containing the at least one component designed to produce the required effect(s).
13. The nasal insert of claim 12, wherein the container(s) comprises a biodegradable material configured to degrade from exposure to at least one of temperature/humidity, enzyme(s), pressure, saline, bacteria, radiation, light, electricity, or ultrasound, and wherein degradation of the container(s) releases the at least one component designed to produce the required effect(s) from the container(s) to the nasal cavity.
14. The nasal insert of claim 12, wherein the container(s) comprises a plurality of holes configured to expand to release the at least one component designed to produce the required effect(s) from the container(s).
15. The nasal insert of claim 1, wherein the at least one component designed to produce the required effect(s) comprises a powder embedded in the body of the nasal insert.
16. The nasal insert of claim 1, wherein the at least one portion of the body of the nasal insert comprising and/or coated by the at least one component designed to produce the required effect(s) is removable from other portions of the body of the nasal insert.
17. A method for introducing at least one component designed to produce a required effect(s) to a nasal cavity, the method comprising: inserting the body of the nasal insert of claim 1 into the nasal cavity, such that the at least one distal end of the body is proximate to a first region of the nasal cavity and the proximal end of the nasal insert is proximate to a nostril of the nasal cavity, wherein the nasal insert body is configured to: (1) direct the air and/or any substance/component towards the first region, and/or towards other region(s) of the nasal cavity or beyond it and/or to manipulate the air/any substance in relation to these regions; (2) create a bypass of region(s) in the nasal cavity and/or beyond it; (3) direct air/any substance/component away from region(s) in the nasal cavity and/or beyond it, thereby delaying, blocking, and/or reducing the amount of and/or manipulating the any substance/component from reaching or being in close proximity to region(s) of the nasal cavity and/or beyond; (4) manipulate the first region, and/or other region(s) in the nasal cavity or beyond; (5) provide a component/substance to region(s) in the nasal cavity or beyond it; and/or (6) provide a substance/component to region(s) in the nasal cavity or beyond in a controlled release over time.
18. A nasal insert for insertion into a nasal cavity, comprising: a body comprising a proximal end, at least one distal end configured to be positioned within the nasal cavity proximate to and/or at a first region of the nasal cavity, and a sidewall extending between the proximal end and the at least one distal end; and at least one segment protruding from the sidewall of the body, the at least one segment comprising a proximal end connected to the sidewall of the body, a distal end configured to be positioned proximate to and/or at a second region of the nasal cavity, and a segment sidewall extending between the proximal end and the distal end of the segment.
19. The nasal insert of claim 18, wherein the first region of the nasal cavity comprises one or more of the following regions of the nasal cavity: nasal floor, vestibule, nasal valve, an inferior meatus, inferior concha, middle meatus, middle concha, superior meatus, superior concha, posterior meatus, upper concha, one or more of sinuses' opening, nasal roof, olfactory area, septum, septum opening, nasal mucosa, nasal cilia, blood vessels, endocrine related areas, lymphatic system, trigeminal nerve/ganglion, nasopharynx, or entrance(s) to an auditory tube or a trachea region(s), and the second region of the nasal cavity comprises one or more of the following other regions of the nasal cavity: nasal floor, vestibule, nasal valve, inferior meatus, inferior concha, middle meatus, middle concha, superior meatus, superior concha, posterior meatus, upper concha, one or more of sinuses' opening, nasal roof, olfactory area, septum, septum opening, nasal mucosa, nasal cilia, blood vessels, endocrine related areas, lymphatic system, trigeminal nerve/ganglion, nasopharynx, or entrance(s) to an auditory tube or a trachea region(s).
20. The nasal insert of claim 18, wherein the at least one segment comprises at least one leaf-like element comprising a flat surface extending from the outer surface of the sidewall of the body, and wherein the at least one leaf-like element is configured to transition between a closed position for insertion of the nasal insert into the nasal cavity and an open position where the at least one leaf-like element leans against a septum or a concha(s) of the nasal cavity with a distal end of the at least one leaf-like element positioned proximate to region(s) of the nasal cavity.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0111] In general all embodiments represent non-limiting examples of different variations to fulfill the same principles, of bringing a treatment to its destination within the nasal cavity or to target areas which are connected to it and leveraging nasal characteristics for it. For clarification, the following figures and their descriptions are provided as non-limiting examples.
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DETAILED DESCRIPTION
[0148] It will be readily appreciated by those skilled in the art that modifications may be made to the invention without departing from the concepts disclosed in the foregoing description. Accordingly, the particular embodiments described in detail herein are illustrative only and are not limiting to the scope of the invention, which is to be given the full breadth of the appended claims and any and all equivalents thereof.
[0149] As described herein, the present insert can include a combination of none, one or more pipe passageways, none, one or more seals, none, one or more threads, none, one or more anchors, none, one or more membranes/valves etc., and none, one or more leafs or sheets, also it may or may not have a head. This present application shows different embodiments but the features of the embodiments may be combined with other embodiments. Further, the shapes of the various embodiments (for example, the seals, threads, leafs, anchors/hooks/holdfasts etc.) are not limited to the shapes depicted by the appending Figures. Rather, any suitable shape may be utilized in order to achieve the intended effect.
[0150] Provided herein are apparatuses for treatment via nasal cavity through efficient drug delivery, or other treatment, or through other manipulation done to or via the nasal cavity. The apparatuses detailed in the present invention may serve for any treatment that can be provided via the nasal cavity. By wearing the nasal insert, the air/molecules/odors/substances/signals/inputs from the outside environment or from inside the body can be manipulated and leveraged for achieving desired affects. The apparatuses may provide access of such particles/signals/materials/etc. to specific areas and/or prevent them from specific areas. The apparatuses detailed herein enable direct and efficient drug and/or other substance(s)/signal(s)/etc. delivery to any desirable area within the nasal cavity or through the nasal cavity, as well to prevent such elements from other areas as needed. The target organ to treat may be located inside the nasal cavity or may be accessed via the nasal cavity, for example: but not limited to the brain, olfactory region, the sinuses, nasal mucosa, lungs, throat, CNS, blood stream, etc.
[0151] The olfactory region concentrates a significant interest for treatment, and is, as explained, hard to reach. In the context of this invention, olfactory is related to not only as nose to brain delivery channel but in a broader aspect. It is known that olfactory cells exist not only in the nose but also in many internal organs, for example in the kidneys in the gut in the heart, and in the blood. These olfactory internal cells are assumed to be functioning as sensors managing “input/output” bodily decisions and other activities. Based on the above, and on other observations, it is my belief that olfactory cells in the nose may serve as the main bio-chemical interface and sensor of the brain and hypothalamus with the environment, including with foods' odors-environmental and in the mouth—that are reaching the nose, and including other environmental inputs. Also the nose olfactory receives many bodily internal inputs via many channels. For example: via throat mouth and digestive system, via the different nerves, via the blood system, the CNS, the respiratory system and maybe via some connectivity to other olfactory cells that is done via different channels. etc. since olfactory serves as a critical bio-chemical sensor of the brain and affecting many bodily processes, manipulating it is expected to have affect over brain and over many bodily cycles. For example, once smelling in the nose is inhibited it may shut down or interfere with the regular metabolic cycle and other cycles in a very acute manner, since it blocks the hypothalamus' sensors from the relayed environmental chemical related inputs metabolic and non-metabolic (food, sex-pheromones, alcohol and many others). In this aspect, the hypothalamus (and brain in general) may then remain with other internal food/metabolic hormonal/other related signals, coming from internal olfactory cells, coming to nose olfactory cells or reaching the brain through other channels to dominate the related functionality. Another example would be that once a specific input is provided to or other manipulation is conducted to olfactory—for example—providing specific molecules and preventing the reach of other specific inputs, then a more sophisticated and accurate manipulation to brain and other bodily mechanisms can be achieved. Meaning, that the ability to manipulate olfactory in general, may provide us with the ability to create a comprehensive change in many bodily mechanisms such as: cycle of hunger and satiation, cycle of sugar level management, sexual attraction and fertility related management, and others, this is in addition and much further beyond simple nose to brain delivery that is hard to achieve and is available via this invention as well. In other words, the role of the apparatuses of this invention is also to specifically serve as olfactory manipulating nasal devices in addition to their ability to deliver treatment to any nasal area or to organs that are connected to it as was explained in relation to target areas.
[0152] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal” and derivatives thereof, shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
[0153] In addition to the nasal inserts described herein, other exemplary nasal inserts and methods that may be used to achieve the methods described herein is described for example in U.S. Pat. Nos. 8,517,026 and 8,839,790, U.S. Design patent Application No. 29/626,909, and U.S. patent application Ser. Nos. 14/480,908 and 16/014,354. Each of these patents/patent applications are incorporated herein by reference.
[0154] Nasal cavity 100, as shown in
[0155] With reference to
[0156] Further, the nasal inserts of the present invention are able to direct both the incoming (inhaled) and outgoing (exhaled) flow of air and/or other components. By air and/or other components, it is meant herein to include air and any other components that might be included in that air, such as, but not limited to particles, smoke, pollutants, chemicals, bacteria, viruses, hormones, odors, electric or other signals, heat/temp, humidity, signals and materials etc. from in-body, from the environment, dedicatedly made or other, etc. The nasal inserts of the present invention are able to provide this functionality by having one or more passageways and other elements as described in this invention.
[0157] The figures are explained in detail below.
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[0159] Provided herein are apparatuses for treatment via nasal cavity through efficient drug delivery, or other treatment, or through other manipulation done to or via the nasal cavity. The apparatuses detailed in the present invention may serve for any treatment that can be provided via the nasal cavity. By wearing the nasal insert, the air/molecules/odors/substances/signals/inputs from the outside environment or from inside the body or from other source as embedded into the device or connected to it can be manipulated and leveraged for achieving desired affects. The apparatuses may provide access of such particles/signals/materials/etc. to specific areas and/or prevent them from specific areas. The apparatuses detailed herein enable direct and efficient drug and/or other substance(s)/signal(s)/etc. delivery to any desirable area within the nasal cavity or through the nasal cavity, as well to prevent such elements from other areas as needed. The target organ to treat may be located inside the nasal cavity or may be accessed via the nasal cavity, for example: but not limited to the brain, olfactory region, the sinuses, nasal mucosa, lungs, throat, Central Nervous System (CNS), blood stream, etc.
[0160] The olfactory region concentrates a significant interest for treatment, and is, as explained, hard to reach. In the context of this invention, olfactory is related to not only as nose to brain delivery channel but in a broader aspect. It is known that olfactory cells exist not only in the nose but also in many internal organs, for example in the kidneys, in the gut, in the heart, and in the blood. These olfactory internal cells are assumed to be functioning as sensors managing “input/output” bodily decisions and other activities. Based on the above, and on other observations, it is believed that olfactory cells in the nose may serve as the main bio-chemical interface and sensor of the brain and hypothalamus with the environment, including with foods' odors-environmental and in the mouth—that are reaching the nose, and including other environmental inputs. Also the nose olfactory receives many bodily internal inputs via many channels. For example: via throat mouth and digestive system, via the different nerves, via the blood system, the CNS, the respiratory system and maybe via some connectivity to other olfactory cells that is done via different channels. etc. since olfactory serves as a critical bio-chemical sensor of the brain and affecting many bodily processes, manipulating it is expected to have affect over brain and over many bodily cycles. For example, once smelling in the nose is inhibited it may shut down or interfere with the regular metabolic cycle and other cycles in a very acute manner, since it blocks the hypothalamus' sensors from the relayed environmental chemical related inputs metabolic and non-metabolic (food, sex-pheromones, alcohol and many others). In this aspect, the hypothalamus (and brain in general) may then remain with other internal food/metabolic hormonal/other related signals, coming from internal olfactory cells, coming to nose olfactory cells or reaching the brain through other channels to dominate the related functionality. Another example would be that once a specific input is provided to or other manipulation is conducted to olfactory—for example—providing specific molecules and preventing the reach of other specific inputs, then a more sophisticated and accurate manipulation to brain and other bodily mechanisms can be achieved. Meaning, that the ability to manipulate olfactory in general, may provide us with the ability to create a comprehensive change in many bodily mechanisms such as: cycle of hunger and satiation, cycle of sugar level management, sexual attraction and fertility related management, and others, this is in addition and much further beyond simple nose to brain delivery that is hard to achieve and is available via this invention as well. In other words, the role of the apparatuses of this invention is also to specifically serve as olfactory manipulating nasal devices in addition to their ability to deliver treatment to any nasal area or to organs that are connected to it as was explained in relation to target areas.
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[0194] The nasal insert body may also include thread(s)/branch(es) or “spread sheets”/“leaf” like element 9m (see for instance, nasal body 8m of
[0195] In addition, nasal insert body or any part of it may serve as or have special designated sealing/blocking/filtering/reducing/directing member(s) element(s) aimed to manage control and direct air/particles/signals/molecules/bacteria/treatment/etc. flow/reach etc., to bring them to desired area and/or to prevent them from specific areas. See for instance, sealing element 7k in
[0196] Also nasal body or any part of it may further include membrane(s), filter(s) or valve(s) meant to improve and enhance the treatment and the capabilities of the device to better achieve the desired result, and also hold fast(s)/hook(s) to better secure the device in position. See for instance, insert body 8j of
[0197] In general all types of embodiments may have seals/blockers, membrane(s), open(s), filter(s), valve(s), air/treatment/particles/signals/hormones/molecules/substances/drug/other passageway(s), thread(s)/branch(s), sheet like element(s), hook(s), membrane(s) etc. The location, shape, structure and number of them is not meant to be limiting as many embodiments are possible. Also their role may include additional purpose—for example: the seal(s) may be used also to delivery of the treatment or absorbing, or may serve as a holdfast and others, in addition to or instead of blocking/directing. Also it is clarified that the nasal body itself may serve as such elements (seals, leafs, membranes, hooks, etc.) without having them being separated defined parts. For example nasal body can serve as the holdfast and secure the nasal insert in place, or it can create the required seal without having a separated sealing member(s).
[0198] In general, nasal insert body, and all its related element(s) as exist in the specific embodiment, may assume the shape of the nasal cavity, which may be different from its original shape. For example: outside of the nose the nasal insert air passageway's cross section may be an oval shape (or other), and while in the nose the nasal insert air passageway may be more bean-like or a smooth “L” shape or other suitable shape, the exact shape is not meant to be limiting as other shapes may suit for the required purposes. Or for another example: the shape of the passageway itself may be straight line outside the nose and in the nose it may curve to better adapt the cavity, same goes for any other element of the device. Also there is no limitation regarding the length shape, cross section thickness or any other parameters of the passageway (or other part) outside the nose or inside it. Also, because the nose conchas may be periodically expanding and shrinking as the user breathes and as the regular cycle of nasal cavity, the nasal insert body, and its elements accordingly, are flexible enough to change their shape accordingly. Nasal insert body will be rigid enough not to collapse and will maintain an open airway if the specific embodiment includes an air passageway that is needed to stay open all time. The ability of the nasal insert body to compress and expand also minimizes the pressure against the nasal mucosa, providing comfort. Also the ability to compress and then return to its shape allows smooth insertion and positioning in the required location in the nasal cavity. The expansion may occur simply upon releasing the pressure, or due to nose temperature/humidity, or by applying some material to the device—once in the nasal cavity or at any other relevant time. The expansion trigger and mechanism is not meant to be limiting as enormous amount of methods may be applicable for achieving it. Even so, it is clarified that the compression/expansion ability is not a must as in some cases it will not be required in order to achieve the device's purpose. The nasal insert body may be flexible to adapt to the specific shape of the nasal cavity allowing reach and adaptation to the complex nasal shape while minimizing pressure over the nasal internal mucosa through the periodical expansion and reduction of the conchas. The shape and size of the nasal insert body and any part of it are non-limiting and can vary as other shapes and sizes can be used having similar effects including round, bean, “L” shape, convex, straight, rectangular, curved, tapered, bulbous, leaf, sheet, thread many odd shapes or others.
[0199] The nasal insert body of
[0200] The number, length, shape, cross section shapes etc. of air passageway(s) is not meant to be limiting and will be set specifically as will be relevant for each implementation. Air/treatment/other passageway(s) may exist in different locations in different possible embodiments. This embodiment may be used for example (non-limiting) for providing treatment to two/few areas—for example olfactory and middle meatus/sinus opening. It can be the same or different treatment(s). The amount of the passageways and treatments is not meant to be limited. Also a combination of delivery via thread(s)/branch(s) and passageway(s), and sealing(s) body etc. may be leveraged according to the specific treatment(s).
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[0202] Another non-limiting example for delivering dedicated treatment while using passageway(s) 26l is provided in
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[0204] The passageway may also be used for filtering ingredients/molecules/signals etc. For instance, air or other substances may be filtered. For example, the passageway allows exhaled air to flow through it, but filters the active ingredient in order to keep it in the nasal cavity. Or a filter located in a passageway that assist the delivery. In this case, the filter will be used for filtering the inhaled air in order to prevent specific type of particles from being involved in the delivery or reaching the target area for the treatment. Also irritating particles may be prevented.
[0205] Depending on whether a seal is conducted and what is the type of such seal, passageway(s) may or may not serve as the only way out or in of the nasal cavity for exhaled air/particles/etc. moving outwards and for incoming flow. For example a possible seal can be based on sealing members that are directing incoming environmental air and signals to enter the nasal cavity only via a passageway and be directed by passageway accordingly. These sealing members may also prevent air/molecules/etc. from moving around passageways of the way out. On the other hand, those seals can be one-directional collapsible seals—meaning they will collapse and will not prevent particles movement out and by that, or by any other relevant means (for example not limited: filter, one directional filter capabilities. Membrane etc.) will enable such flow also regardless of the passageway. Such seals of-course can control movement on the other way around-meaning enabling flow around the passageway on the way in to the nasal cavity and directing all outward movement to be only or mostly through passageway(s). In this case the passageway may as itself be in a shape or include elements that will reduce/prevent streaming in but will enable streaming out, for example by one directional valve, membrane, filter, tapered shape—more narrow near the nostril opening and wider deeper in the nasal cavity and many other possible implementations that can work. The management of the flow shall be conducted according to the relevant treatment. For example if we would like to leverage/manipulate/use internal signals which are part of the outgoing flow—we may direct it to the relevant area. If we wish to avoid/minimize intranasal air circulation, we may create a seal that will minimize it or if we wish not to have such internal inputs to olfactory or other organs we can then direct outgoing and/or incoming flow to move only or almost only in defined channels and be prevented from others.
[0206] The passageway(s) may contain the releasable/treatment material (also referred to herein as “material able to coact with the body” or as a “component able to create the required effect” of the nasal insert. That material can be present at the passageway prior to insertion, or can be applied to it before or right after insertion, or the material may be inserted and delivered after the apparatus is in its position within the nasal cavity. The passageway can include treatment inside of it to be delivered to a destination located in most cases at the end of the passageway, or it can be on the outer surface of it to be delivered to the nasal mucosa or areas in which the passageway is resting against. For example a treatment on the outer surface may aid in reducing nasal sensitivity due to allergies or congestion, and the passageway itself may aid reduce the contact of irritating airborne or other particles/materials from contacting the mucosa, and by that reduce and ease allergies.
[0207] The apparatuses provided herein may have one or more sealing/directing/blocking/barrier(s)/inhibiting/reducing members extending from the nasal insert body, or from the elongated, flexible, non-collapsible member(s), the branch(s)/thread(s), “leaf(s)” or any other part of the nasal inserts. The sealing member may be in various shapes, depending on the location and the need. The shape of the sealing member is not meant to be limiting and can be of any shape that will support its functionality in the required location. For instance, it may have an oval shape, a leaf shape, or a circular shape or any other shape as relevant. For example:
[0208] Sealing member(s), as indicated, are used for directing air/particle(s)/substance(s)/signal(s)/etc. movement in the nasal cavity, directing a specific drug, treatment or other material inside the nasal cavity, or to block, prevent, or reduce the amount of air, drug, or other material from reaching specific area(s) in the nasal cavity. The sealing member can be located anywhere on the outer surface. In specific embodiments, if a passageway(s) exists, then the sealing member(s) can be located in the passageway. The nasal apparatus body itself can serve as a sealing member without having any additional sealing member(s) extending inside or outside of it.
[0209] The sealing member(s) may also be used for filtering ingredients/particle(s)/etc. For instance, drug or hormone or other substances may be filtered and can be prevented by that from a specific area, or may reach a specific areas after being filtered from other ingredients. The filtration can be based on the size/structure of molecules, or of other characteristics such as polarity, or other as may be relevant for the application and available to use that time. The filter material, can be such as, but not limited to, polypropylene fibers, medical plastic, or silicon materials that are widely used in air-conditioning systems, infusion systems, and/or respiratory systems to prevent the transmission and spread of bacteria. These are only exemplary materials and any relevant material that will prevent the of transmission and spread of bacteria, or other substances/signals/etc. or enable the movement of air/other material back down to nasal cavity through it, but will decrease the amount of the drug, odor or other desired component, may be employed. The type and characteristics of filtering shall be defined according to the needs at a specific treatment or condition and are not meant to be limiting.
[0210] The sealing member(s) may be in a closed/collapsed form during the insertion and can be opened afterwards once located in the nasal cavity. The opening of the sealing/directing member can occur by many means, for example, but not limited to, as a result of the moisture within the nasal cavity, and/or, intra-nasal temperature, for example, the sealing/directing member opens because of the high humidity within the nasal cavity. Alternatively, the sealing/directing member may be spring like, and open based on pressure, or lack thereof. In another example, it can be in a vacuum state through insertion. Once inserted, can be filled with air, or for example, by absorbing internal or external fluids, and therefore, releasing the vacuum state. Alternatively, by inflating, due to a reaction to the presence of specific cells (for example, specific hormone, infection), or any other relevant reaction. In general, the seal may be in a “compressed” state when outside of the nasal cavity, but may be “released” when inserted into a nasal cavity.
[0211] The nasal insert body may further include an enlarged bulbous-shaped head/proximate end (see for instance,
[0212] The nasal insert body may be flexible to adapt to the specific shape of the nasal cavity if this is required for the specific application and embodiment. The nasal insert body further extends into the nasal cavity to one or several directions according to the specific application and embodiment. For example in embodiment
[0213] Further, the nasal insert body can also have a slanted or tapered or other tail or a bulbous shaped tail as shown in
[0214] In a different another example shown in
[0215] The apparatuses described herein can be made of smooth, yet rigid material, to avoid discomfort or injury while enabling the insertion of the apparatus into the nasal cavity all the way to the target area of treatment without collapsing. This may be achieved by using one material or more materials, in a suitable combination. Examples of some materials are listed below. For example, a combination of materials that provide a rigid internal “bone”-like structure covered with softer material. For example, the “bone”-like material can be made of Teflon or from plastic and the soft material can be made from rubber, soft plastic. In other words, the device shall be made from a soft, flexible material, that yet has sufficient rigidity, in order to enable smooth and pleasant insertion into the nasal cavity. Further, the nasal insert device may have the characteristic of being easily adapted and molded to the nasal cavity's unique, gentle structure and tissue, while maintaining the device's unique shape and delivery capabilities. The outer surface of the device can be soft enough to be inserted and to be in touch and direct contact with the nasal tissue, while the internal part may provide the rigidity necessary to maintain the overall structure of the nasal insert device. The right composition of rigidity together with flexibility and softness may be achieved in many other ways as well, and is not limited to the above. For example it can be achieved by having different thicknesses or, some layers etc. Example for suitable materials include: FDA approved carbon based substances, (e.g. polyglycol-glycerol-sebacate)), a shape-memory polymer (SMP) (e.g. PET cross linked with Glycerol/dimethyl 5-sulfoisophthalate), or silicon based materials (e.g. polydimethylsiloxane), these materials may or may not be biodegradable. Or suitable plastics such as TPE, SEBS or others. Additionally metals, either elementary, as an alloy, compounded or metal ions may be used, these metals may include, but are not limited to, titanium, stainless steel, platinum, iridium. The materials are not meant to be limiting as any material that is suitable can be used for it, existing or future developed material.
[0216] Also, these and other substances may be also used in combination with (or as) powder and/or as nanoparticles embedded in the matrix of the device material or as a coat to the device or part of it in order to facilitate the functionality of the device or to provide it with additional functionality, or may be provided or connected in other relevant manner (see for instance,
[0217] The nasal insert body or part of it (for example the sealing member, or branch) may consist of one layer or more with no limitation. Further, the apparatus body, or part of it, may also be made from a material that will enable the user to adapt its shape (like in plasticine work) to fully suit a specific anatomy or use, for example to bend a specific portion, or to have a specific portion be narrow, while preserving the overall shape of the apparatus. Additional materials that the apparatus may include are mesoporous materials, allowing for drug delivery of any type, amino-acid based drug delivery systems, other relevant drug delivery technologies, materials and mechanism. Further, the apparatus may include several releasable materials to be released each at specific times. In one example, the apparatus may include an anaesthetization material, such as, a combination of lidocaine and epinephrine, or any other acceptable anaesthetization. Such materials may be also released during the entire stay of the device in the nasal cavity, while other materials are being released at specific time/s or continually.
[0218] One possible feature of the invention is to provide the device, or part of the device, with a drug, odor, or suitable therapeutic agent. In other words, the apparatuses provided herein may include one or more releasable ingredient(s). The releasable ingredient(s), also referred to herein as active agent, active ingredient, or therapeutic agent, can be of any kind, suitable for any purpose, in any suitable form. The releasable ingredient may be, for example, but not limited to: drug, medicine, vaccination, physiological water, watery material, oily material, anti-bacterial, gas, solid, liquid, paste, ointment, anaesthetization, medical soap, hormone(s), agonists, antagonists, peptides, enzymes, odors, materials to shrink nasal mucus/polyps/tumor(s), sanitization and antisepsis, proteins and other biological/genetic molecules, gene therapy, cell targeted therapy, immunotherapy, chemotherapy, electric signals/therapy, radiation based treatment, light therapy, and any other relevant existing or future, molecule/treatment/other.
[0219] The releasable ingredient may be provided in combination with other diagnostic/treatment methods and/or devices, in order to enhance diagnoses and treatment of ailments. For example, the releasable ingredients may include elements that allow for use in diagnostic/treatment methods, such as intra-body imaging, or various relevant nanotechnology-related. Use of the herein devices may allow for more efficient diagnoses and/or treatment of ailments when used in combination with various other diagnostic/treatment methods. For example, the releasable ingredient may be provided via a transdermal materials based technology, a protein-based therapy, a vaccine therapy, via electric, ultrasonic, or laser-based technologies, or any other relevant technology or method. Alternatively, as indicated, the herein provided devices may be coupled with mechanisms for providing a treatment, such as, some remote controlled mechanism, mechanisms that have recording capability or transmission capabilities, or any other type of material or technology that may be suitable for such implementation. Further, the herein provided devices may be coupled with any combination of materials and technologies, in the form of liquid or solid or gas or light or power or other or combination of all or part of the above or any other technology or capability.
[0220] In some non-limiting examples, the nasal insert may include anaesthetization material and a substance that shrinks the mucus, in order to ease the insertion of the nasal insert and/or additionally, to maintain the position of the nasal insert within sensitive areas of the nasal cavity. Sensitive areas of the nasal cavity include areas, such as, the superior meatus. The nasal insert may additionally contain for example the hormone, Leptin to be released once in position, near olfactory region. The Leptin may be delivered in a form of targeted nanomedicine or in other form, in order to promote targeting of the leptin to the leptin receptors in the olfactory region, and also in the brain, through the trigeminal nerve or blood system or directly through olfactory. The Leptin can also be directed to targeted peripheral body organs/cells using nanomedicine technology. It can be, for example, transmitted through absorption to the blood system or via transdermal technology, through simple contact through nasal lining. Specifically, in one non-limiting embodiment, the active ingredient may be provided in the form of gas, which will be absorbed through the nasal lining.
[0221] As discussed, the nasal insert can include the releasable ingredient. The releasable ingredient may be impregnated in the material in of the nasal insert homogeny or non-homogeny manner, it may be located in sacks/containers, anywhere on the device, for example (non-limiting): inside the material, or layer/layers of it, or on the body surface of it, may be located only on the branches members or inside of it or at the most remote point of them, in proximity to the TA or on the external walls of the device, or in the internal passage of the device, on the sealing members, or it may be located in certain portions of the nasal insert. It in can be located on the outer layer of it or inner or can be a layer of the materials of the nasal insert. Another option is that the nasal insert body itself or part of it will be made of the releasable/active material. Also several therapeutic solutions for same or different diseases/conditions may be provided by same device. Additional option is that the nasal insert will be vehicle or the transmitter of an external source of active ingredient.
[0222] As described herein, the drug or treatment relating to a specific condition(s), purpose, and/or a specific ailment, may be provided by a variety of methods. The following provide additional non-limiting examples.
[0223] In some embodiments, a releasable, therapeutic, ingredient may be coated on any part of the nasal insert device, may be integrated into the material of the device, or may be provided/connected differently. Alternatively, it can be applied to portions of the nasal insert device through an external applicator, or the device can be soaked in a solution prior to insertion or any other means and methods can be used for having the device carrying and delivering a required substance material. The required substance may be in any relevant form, for example solid, liquid, ointment, gas etc. and may be located directly or indirectly on the nasal insert device (see discussion above with respect to releasable/therapeutic agents). Also, the therapeutic agent may impregnated in the nasal insert device. The therapeutic agent may be released from the nasal insert device as a consequence of some intra-nasal condition, trigger, or other reaction. For example, the temperature in the nasal cavity, and/or moisture or the presence of an enzyme, hormone, bacteria etc. in the nasal cavity may promote the release of the therapeutic agent. Other initiators for release can be applicable, intranasal, external and others. some examples for that may be: external pressure applied to the nose, ultrasound, radiation, radio, electromagnetic, applying initiating material to the nasal, and any other method as will be relevant. Also, the active ingredient/s may be contained in a small container/s, sack/s, or cover on the nasal insert device. The small container, sack, or cover may be made from the same material of the device, optionally in a much thinner thickness. The small container, sack, or cover may alternatively be made from other material, for example, a material that can melt or disconnect due to temperature/humidity enzyme, bacteria and alike within the nasal cavity, or as a result of another mechanism internal or external that results in the release/activation of the active ingredient.
[0224] The container, sack, cover, or equivalent permits delivery of the drug in a variety of ways. For example, but not limited to the following: the container, sack, cover, or equivalent may contain small holes that expand due to intra-nasal temperature and/or moisture/humidity or due to other intranasal or external mechanism. As a result of the expanding, the drug/odor/therapeutic agent are released, allowing it to be delivered to the intended location. In another example, the sack, cover, impregnated etc. material or equivalent may contain a component, such as, for example, a biological, or a nano-technological component, that will cause the release of the material as a result of the reaction to a defined situation. For example, by reaction to the presence of specific cells, specific hormones, an infection or purulence, specific proteins, for example by using artificial nanodevices, such as biomolecular sensors and artificial cells or any other relevant reaction or in any other suitable manner, allowing the drug, odor, material alike to exit the sack/the device and be delivered. Alternatively, the container, sack, cover, or equivalent, or some part of it, may melt or open up, thus allowing for the release and delivery of the therapeutic agent. In another example, the sack, cover, or equivalent is made of a material that allows for controlled transdermal/trans-mucosal fast and slow release immediate or delayed or spread over time or at once, of the releasable substance, for example, Eluting Bandage. In another example, the container, sack, cover, or equivalent may be opened by the act of insertion of the device into the nasal cavity, or right before or right after the insertion. The drug, odor, or any therapeutic agent may be released all at once, gradually, or at specific intervals, depending on and according to the requirements of the specific ailment being treated. The drug, odor, or suitable therapeutic agent may reach its destination through inhalation/exhalation, by absorption, by dissolution, by direct needle-free transdermal solution such as the Eluting Bandage or other, by cell targeted technology, or by other means.
[0225] In another example, the device or part of it or a carrier of the therapeutic agent may be “glued” to the nasal cavity in the relevant area through use of bioadhesives, such as, fibrin glue, cryoprecipitate glue, containing gelatin-resorcinol-formaldehyde-glutaraldehyde, high molecular weight polydimethylsiloxane adhesives and/or other suitable equivalent materials. The device can deliver and connected the relevant part to the required location in the nasal cavity and then be removed—while the glued part stays in the nasal cavity. The device or part of it can then stay in the nasal cavity until they shall be removed or can be biodegradable.
[0226] Also it is important to emphasize that the apparatuses of this invention may act without having any active/releasable therapeutic ingredient. They can provide aid by acting purely based on their structure and mechanical characteristics.
[0227] The herein described apparatuses may additionally have an absorbing capability. Specifically, the apparatus of this invention can be used for opening, cleaning, draining, absorbing, or like functions, intranasal target areas or other areas. For example, reaching a sinus opening and delivering for example saline water thereto, or rather than saline, any other suitable, purification material, washing material, medication, or shrinking material such as adrenalin based materials to shrink the lining of the sinus opening in order to open it and drain it. Further, maintaining the nasal insert, which includes absorbing material, in position in order to absorb mucus, purulence, and or any other secreted substance; and additionally wherein the nasal insert includes material for cleaning, opening, removing (for example from sinus opening), enabling the drainage of the sinus or other relevant area and absorbing it or enabling its content to flow out to the nasal cavity, or for any other purpose. For example (non-limiting), the device may be made of, or include parts made of, but not limited to, polycaprolactone, poly(ethylene glycol), maltodextrin modified by fatty acids, silicone, Tygon®, hydro-gels, cotton, Merocell®, silicon, polyurethanes, polyvinylchloride, dimethylpolysiloxan, silicic acid, azodiacarbonamide, reticulated foam, polyethers, polyesters, polysiloxanes, polycarbonate, polyolefins, polybutyrate, polyethylene teraphtalate (PET), Polymides, polyethylene glycol, charcoal (activated carbon), biodegradable material, anti-microbial agents, plastic materials, silver, bamboo, antimony, aluminum, metal materials, polymers, wood, resins, carbon based materials, carbon nanotubes (CNT), esters.
[0228] The apparatuses of this invention may also include small camera with ability to transmit a picture. Such functionality may ease the navigation in the nasal cavity to reach the desired location and also may enable to better understand the exact status. This could replace or serve as or be an extension of the endoscope.
[0229] Examples for methods of use: the below detailed methods are few among endless possibilities of use and are provided here in order to a bit elaborate, clarify and demonstrate the some of the practical useful potential of use for the devices of this invention. These examples are not meant to be limiting in any manner.
[0230] To use the nasal inserts illustrated in
[0231] The seals of this embodiment leads to the formation of an airlock in the nasal cavity-marked as 7w in
[0232] Another method of use, that can be combined in many treatments—including for example without limitation, with the Leptin based example herein above, but with many other treatments as well, whether including actual active ingredient or are based on the mechanical characteristics of the apparatus is as follows: as mentioned before, signals from both outside the body and inside the body are reaching olfactory and brain and affecting the management of processes and mechanisms of the body. In this example we would like to provide a non-limiting example for leveraging signals from inside the body in order to affect bodily processes. Enhancing the affect and effect of intra-bodily inputs may be achieved by “trapping” them or manipulating them and directing them to olfactory. (by manipulating them we can for non-limiting example filter them and direct only specific part of them to reach olfactory, or we may enhance them, or we may connect additional molecule to part of them and change them etc. without limitation) Also further enhancement may be achieved by reducing external inputs. In addition, in order to magnify a specific input other additional treatment can be provided, for example some antagonist to block and prevent the excitation of “opposite acting” receptors. For such use a device similar to
[0233] Also it is easily understood that the apparatuses of this invention can be leveraged for prevention/manipulation/direction of internal body signals/molecule/etc. all or part/specific ones from olfactory or from other areas or to them, and affect the brain and body by that.
[0234] Such abilities of the device are currently almost impossible to do by other means. It can be leveraged for many treatments and may lead to an acute change in the regular cycles of the body and for efficient treatment or treatment aid.
[0235] Another non-limiting example for use of the devices of this invention would be to deliver smoking cessation air drug to olfactory. in this case the active ingredient maybe Chantix or other medication that can connect to and block nicotine receptors in olfactory organ and brain- to assist in smoking cessation, and to avoid the first digestive tract in the liver and digestive system that leads to side effects and to reduced effectiveness
[0236] Example to another method would be: treating the maxillary sinus. Using nasal insert of embodiment 1
[0237] Another option would be to use a different type of nasal insert to deliver the medication—for example embodiments as depicted in
[0238] Additional method would be to deliver medication to lungs while preventing it from the nasal cavity mucosa/blood system/olfactory.
[0239] Furthermore the methods outlined above may also include wearing the nasal insert for a period of time, for example 12 hours, or 1 hour, or anything else with no limitation according to the treatment, and then taking it out for a period of time, for example 3 hours or other periods of time according to instructions, allowing the nose mucosa to recover, as well as for other reasons. After this period, the user may wear the nasal insert again for a period of time, remove it again for a period of time, and so on. Alternatively it can be used for few minutes/defined time/defined outcome/other sign to deliver the active ingredient and then removed until the next treatment. It can be also used to position a treatment and then removed while the treatment is continuously provided via a delayed slow release methods or other. In addition, in case of use of a re-usable nasal insert, the method also may include washing or cleaning the nasal insert prior to re-using it, and/or soaking it in odor/medication or re-filling it. In the case of a disposable nasal insert, the user may insert a new nasal insert for each use. The method may also include using the nasal insert continuously, or using the nasal insert only for selected periods of time.
[0240] The nasal inserts of the current invention meet the described above need of providing better and more efficient modes of drug and/or therapeutic agent delivery, through unique structure, materials and compatibility with nasal characteristics. In order to benefit the remedy that such nasal device may provide, a user will use the nasal device according to the specific treatment oriented instructions. As such, non-limiting embodiments of the present invention are directed to nasal devices coupled with specific instructions for a specific treatment of specific ailments. For example, in one non-limiting embodiment, a user may be asked to insert the relevant nasal device into one or both nasal cavities and to keep the nasal device inserted for a period of time according to instructions as dictated by the ailment that requires treatment. For instance, suitable time frames may include, but are not limited to, few minutes, few hours, or few days etc. Additionally, instructions may include a variety of steps and procedures for proper use of the nasal insert device, for example, but not limited to: inserting the nasal insert into one nostril and doing so while blocking the other nostril opening, or by inserting the nasal insert into one or both nostrils coupled with inhaling through the nostril and exhaling through the mouth, alternatively or in combination, by keeping the nasal device inserted overnight or for any other prolonged time periods.
[0241] It will be readily appreciated by those skilled in the art that modifications may be made to the invention without departing from the concepts disclosed in the foregoing description. Accordingly, the particular embodiments described in detail herein are illustrative only and are not limiting to the scope of the invention, which is to be given the full breadth of the appended claims and any and all equivalents thereof.