Drug delivery devices, drug delivery systems, and methods for delivering drugs

Abstract

To provide suitable drug delivery devices, drug delivery systems, and methods for delivering drugs. [Solution] This disclosure provides a drug delivery device (1) for the delivery of therapeutic drugs or medications to an individual. The drug delivery device (1) comprises a frame (2) having at least one frame member (4) configured to be received and retained or housed in the nostrils of an individual, and a delivery element (8) provided on and / or carried by the at least one frame member (4) for delivering a drug, preferably in liquid or semi-solid form, or contained in a liquid or gel culture medium. The delivery element (8) is provided on and / or carried by the frame member such that, when the frame member is housed in the nostrils, the delivery element (8) contacts or engages with the inner surface (e.g., tissue) of the nostrils, for example, to deliver the drug to the individual transdermally.

Description

Technical Field

[0001] The present disclosure relates to drug delivery devices, and more particularly to devices, drug delivery systems, and methods for delivering drugs to a user nasally.

Background Art

[0002] The present disclosure has particular application to the delivery of agents or drugs to an individual's nostrils, and it will be convenient to describe the subject matter of the present disclosure in this exemplary context. However, it should be understood that the present disclosure is not limited to this particular application and can also be used for delivering drugs for a range of different purposes.

Summary of the Invention

Means for Solving the Problems

[0003] According to one aspect, the present disclosure provides a drug delivery device for delivering a therapeutic agent or drug to an individual, comprising a substrate configured to be received, retained or stored within an individual's nostril, and a delivery means (e.g., a delivery element) provided on or carried by the substrate for delivering the drug, the drug being preferably in the form of a liquid or gel or contained in a liquid or gel medium, although optionally it can be provided or contained in a film-like form or powder. The delivery means or delivery element is such that when the substrate is retained or stored within the nostril, the delivery means / delivery element contacts or engages the inner wall or surface (e.g., tissue) of the nostril and preferably delivers the drug to the individual transcutaneously, provided on or carried by the substrate.

[0004] Accordingly, the present disclosure provides a drug delivery device comprising a delivery means or delivery element, which may be in the form of a pad or swab, provided on and / or carried on a frame member that is received and retained or housed within an individual's nostrils for delivering a drug thereto. Thus, the pad or swab can be inserted or introduced into the nostrils by the individual themselves. This is highly suitable for use outside of clinical practice or a clinical environment, such as at home, without requiring assistance from another person or a skilled physician.

[0005] It should be noted that the reference to “medicine” is understood to include any active ingredient with pharmacokinetic or therapeutic properties, consisting of, or contained in, a liquid, gel, semi-solid, solid, or powder medium, which can be delivered to an individual, particularly to the individual’s nose (e.g., nasal cavity). Therefore, medicines delivered to an individual will most typically be in the form of a liquid or gel, or contained in or carried in a liquid or gel medium, for delivery to the nose.

[0006] In a preferred embodiment, the substrate forms a frame of a drug delivery device for supporting a delivery means or delivery element provided or supported thereon. Preferably, the frame comprises at least one frame member configured to be received and retained or housed within an individual's nostril, and the delivery means or delivery element is provided on and / or supported thereon. As described above, the substrate is configured to be received and retained in the anterior nasal cavity, e.g., in the external nostril or nasal vestibule, for drug delivery. Thus, the drug delivery device is preferably configured to be worn by an individual.

[0007] In at least one embodiment, the present disclosure therefore provides a drug delivery device for the delivery of therapeutic drugs or medications to an individual. The drug delivery device comprises a frame having at least one frame member configured to be received and retained or housed within the nostrils of an individual, and a delivery element provided on and / or carried by the at least one frame member for delivering a drug, preferably in liquid or semi-solid form, or contained in a liquid or gel culture medium. The delivery element is provided on and / or carried by the frame member such that, when the frame member is housed within the nostrils, the delivery element contacts or engages with the inner surface (e.g., tissue) of the nostrils, for example, to deliver the drug to the individual transdermally. Thus, the drug delivery device has a delivery element provided on and / or carried by the frame member, which is received and retained or housed within the nasal cavity of an individual, for delivering the drug therein at site.

[0008] In a preferred embodiment, at least one frame member, on which a delivery means or delivery element is provided or supported, is configured to be received and retained or housed in the anterior nasal cavity, e.g., the external nostrils or nasal vestibule, for the purpose of delivering a drug to the nasal tissue. In this regard, the scientific literature shows that the external nostrils are effective for the delivery of drugs or medications via nasal swabs. This region of the nose is also directly accessible by the individual themselves, simplifying the introduction and positioning of drug delivery devices into the nostrils.

[0009] In a preferred embodiment, the delivery means / delivery element is impregnated with a therapeutic agent or drug so that when the base material or frame member of the device is secured or housed within the nostril and the delivery means / delivery element comes into contact with or engages with the inner wall or surface (i.e., tissue) of the nostril, the therapeutic agent or drug impregnated on the delivery means or delivery element is delivered to the individual, for example, by transdermal absorption.

[0010] In a preferred embodiment, each delivery element includes a delivery material for holding and delivering the drug. As described above, each delivery element is preferably in the form of a pad or cotton swab. Thus, the delivery material may consist of fibers and / or foams, such as flocked fibers, compressed fibers, fiber sheets, knitted fibers, etc. In the case of a delivery material consisting of fibers, the delivery material may be selected from the group consisting of, for example, cotton, rayon, calcium alginate, polypropylene, and polyethylene (e.g., polyester). In the case of a delivery material consisting of foams, the material may include, for example, urethane foam. In the context of this disclosure, “delivery” of a drug involves the step of carrying or transporting the drug for ingestion by an individual. In this regard, the drug held by the delivery element may be transported to the individual, for example, by the capillary action of the delivery material as the drug is gradually absorbed transdermally.

[0011] As described above, in preferred embodiments, each delivery element may be in the form of a pad of delivery material, such as a pad of compressed fibers, an extruded fiber pad, a pad of knitted fibers, or a foam pad. In alternative embodiments, the delivery element may be in the form of a sleeve of delivery material, such as a sleeve of knitted fibers, a flocked sleeve, an extruded sleeve, or a foam sleeve. Also, as described above, the delivery element may optionally be integrated or integrally formed with a frame member on which it is provided or supported. For example, if the delivery element contains foam material, this may be an outer region or layer of the frame member made of the same foam material. In addition, or alternatively, it or each delivery element may preferably include one or more needles (e.g., microneedles) protruding from its surface for contact and / or engagement with the inner surface or tissue of the nasal cavity, for example, to facilitate transdermal delivery of the drug.

[0012] In a preferred embodiment, at least one frame member on which a delivery means, e.g., a delivery element, is provided and / or supported, is preferably elongated and preferably extending as a rib, capable of following the shape or curvature of the inner surface of the nostril. To this end, the frame member or rib member may be formed to complement the surface shape or curvature of the nasal cavity, which can naturally improve comfort for the wearer and also serve to improve contact between the delivery element and the inner surface or tissue of the nasal cavity. To achieve this goal, the frame member or rib member of the drug delivery device on which the delivery element is provided or supported preferably has a curved or looped configuration. To this end, the elongated frame member (or rib member) may have an arched shape approximating at least a portion of a circle, ellipse, or parabola. This allows the frame member to be comfortably and consistently received and seated within the nostril, which is important for achieving both consistency in use and consistency in drug delivery. The delivery element is typically provided and / or supported on a surface or area of ​​a frame member facing the tissue of the nasal cavity. From the viewpoint of wearer comfort and ease of introduction into the nostrils, the elongated frame member is preferably relatively soft, resilient and flexible, and preferably biased to contact the nostrils so as to engage with the tissue of the nasal cavity when the delivery element is housed therein.

[0013] In a preferred embodiment, at least one frame member on which a delivery element is provided or supported is configured to be more extensive or wider within its region so as to be located deeper within the nasal cavity or nostril. Thus, the frame member provides a larger surface area for the delivery element provided or supported on it to contact the nasal tissue within the area of ​​the nasal cavity or nostril, which is more likely to provide a larger drug load to be delivered. For similar reasons, at least one frame member may be divided, widened, and opened within its region to provide a larger surface area for supporting the delivery means (e.g., including fibers, particularly flocked fibers), thereby improving the potential drug load.

[0014] In a preferred embodiment, the frame comprises a pair of frame members, each configured to be housed within the individual nostrils of an individual. Thus, the device preferably comprises individual delivery means / delivery elements provided on and / or carried by each of those frame members to contact, compress, or engage with the inner wall or tissue of the individual nostrils and deliver the drug. As will be understood, the delivery device thus preferably comprises frame members and delivery elements designed to be received and housed simultaneously within both nostrils of an individual. This is beneficial, in light of the wider contact area provided by both nostrils, if it is possible for the drug to be delivered through both nostrils simultaneously. It is also preferable that, when deployed or housed within the nostrils, the drug delivery device does not completely obscure or block the nasal passages and still allow the individual to breathe through their nose. Nevertheless, as possible, breathing through the mouth during the use of a drug delivery device may be more comfortable for the individual.

[0015] In a preferred embodiment, the drug delivery device is wearable, i.e., the device is provided on and / or supported by at least one frame member, and is configured to be worn by an individual so that a delivery element is received and retained or stored in the individual's nostrils for an extended period and / or a predetermined duration for drug delivery. In this regard, the drug delivery time is preferably in the range of about 5 minutes to about 8 hours, more preferably in the range of about 10 minutes to about 4 hours. However, depending on the medical condition of the individual to whom the drug is being delivered and the nature of the drug, the delivery time may be shorter, but typically it will be at least about 2 or 3 seconds, preferably at least about 10 to 30 seconds, and more typically at least about 1 or 2 minutes. Longer drug delivery times resulting from or achieved by the “wearability” of the device can improve the “drug loading” delivered by the elements of the device.

[0016] In a preferred embodiment, the drug delivery device includes a timing indicator or means for indicating to the individual or wearer when a predetermined drug delivery time has elapsed. In this regard, the indicator may be provided on a portion of the frame outside the nostril and therefore visible during use of the device. In a particular preferred embodiment, the timing indicator comprises a patch configured to change appearance over time (e.g., change color). For example, the indicator patch may contain a substance selected to react with air and / or light over a predetermined period of time in order to change color over that time. Depending on the commencement of use of the device, the indicator patch may be exposed to air and / or light for the first time (e.g., by removing a protective covering such as an adhesive cover or label). After the predetermined drug delivery time has elapsed, the indicator patch will change color due to exposure to air and / or light, indicating to the user or wearer that the drug delivery device can now be removed. Thus, the device can be designed to achieve consistency in personal use.

[0017] In a preferred embodiment, the drug delivery device comprises a drug source supported on a substrate or frame of the device. In this regard, the source may be arranged to communicate with a delivery means / delivery element for supplying or transporting the drug to it. Thus, as the drug or therapeutic agent is delivered to the individual in the delivery means / delivery element and taken up by it, additional drugs can then be transported from the source to the delivery means / delivery element, thereby replenishing or reloading the delivery means / delivery element. The drug source is preferably configured, or may be configured, as a reservoir for holding a certain amount of the drug, preferably in the form of a liquid or gel. In such a case, the reservoir may be connected to a delivery means or delivery element for transporting the drug from the reservoir to it in fluid communication. The source is preferably configured to hold a predetermined amount of the drug (e.g., for a specific dosage over a given period). Furthermore, the source may preferably be configured to be removable or replaceable on the frame of the device for reloading the drug source. In this context, the supply reservoir may be in the form of a receiver filled with a chemical, and the receiver may be removable or replaceable on the frame of the device. The chemical delivery device may be configured to deliver the chemical passively (e.g., via capillary action) or actively (e.g., via pumping means such as a micropump) from the source to the delivery element. The active delivery or transport of the chemical may be activated by the user / wearer of the device. For example, the device may incorporate pumping means or manual operation by the user / wearer for activation. In this regard, the receiver filled with the chemical may be deformable in response to the manual application of pressure to forcibly transport the chemical from the reservoir to the delivery element.

[0018] In alternative embodiments, each delivery element of a drug delivery device may be designed or adapted to be separated or removed from the frame and resupplied with the drug thereon. For example, in one particular embodiment, it or each delivery element may be configured in the form of a sleeve of delivery material, configured to extend over the outer periphery of a separate frame member on which it is supplied and / or carried. The sleeve of delivery material may therefore be removable from the frame member to resupply the drug thereon (e.g., it may be pulled away or withdrawn from the frame member).

[0019] In another embodiment, the drug delivery device or each delivery element may be integrated or integrally formed with a frame member on which it is provided or supported. In this regard, the delivery element may be made of the same material as the frame member, for example, forming an outer region or layer of the frame member for receiving and applying the drug. Thus, in a certain embodiment, the material of the frame member may potentially play a dual role as a delivery element.

[0020] In a preferred embodiment, the frame of the drug delivery device includes a handle portion for manual handling of the device by an individual. The frame member, or any frame member on which the delivery element is provided or supported, preferably extends from the handle portion. The handle portion thus allows the user to handle the delivery element, for example, before drug delivery, and to operate the drug delivery device by hand without potentially contaminating it. The handle portion may preferably be located between two frame members, arranged in the center of the device and configured to be received and housed within individual nostrils. To better distinguish for individual users which parts of the drug delivery device should be touched by hand and which should not be touched, the device may be color-coded. That is, the handle portion may be clearly marked or colored to identify that manual handling is permitted, while other parts of the device may be marked or colored differently to reflect that manual handling of those parts should be avoided. Timing indicators, as described above, for providing indication of drug delivery time may preferably be provided on the handle portion. The handle portion is optionally removablely connected to the frame or any of its frame members, on which individual delivery means are provided or supported.

[0021] In certain preferred embodiments, the frame of a drug delivery device may include a portion configured or designed to remain outside or adjacent to the nostrils during use. The main portion of the frame preferably incorporates the handle portion described above. The main "external" portion of the frame may interconnect frame members on which individual delivery elements are provided or supported. To achieve this objective, the main "external" portion of the frame may include a substantially U-shaped body, each comprising a pair of leg members that connect to individual frame members with delivery elements. When in use, and therefore the U-shaped body is fitted by an individual, it is positioned to straddle the nasal septum, with the leg members extending to both sides of the septum within each nostril. The distal end regions of the leg members may engage with the septum during use and extend from the posterior septum of the nasal bridge and alar fibroadipose tissue, allowing the frame members on which the delivery elements are carried to extend along the inner wall of the nostrils during use.

[0022] In a preferred embodiment, the frame includes a sensory comforter for enhancing the individual's comfort during use of the device. To achieve this goal, the sensory comforter may include a drug source for inhalation by the individual for enhancing the individual's comfort or user experience. The source is preferably supported on the frame as a pad, which is impregnated with a drug to be inhaled, and on which individual delivery elements are provided or carried, and each frame member is configured to be positioned adjacent to the individual's nostrils when received and stored within the nostrils. Thus, the sensory comforter is preferably provided on an external portion of the frame, for example, on a handle portion of the frame or on a U-shaped body.

[0023] In a preferred embodiment, the frame or each of the at least one frame members forms the substrate of the device and is preferably made of a polymer plastic material selected from the group consisting of polypropylene (PP), polyethylene (PE), polystyrene (PS), polyamide (PA), for example, nylon, and / or styreneethylenebutylene styrene (SEBS). Alternatively, or in addition, the substrate of the device (i.e., the frame and / or each of the at least one frame members) may be made of metal wire.

[0024] In preferred embodiments, the substrate or frame of the drug delivery device preferably comprises a skeletal structure such as an open skeletal structure, which is in the form of, or includes, an array, web, or mesh of stranded elements or filaments. The skeletal structure, or the elements, strands, or filaments of the array, web, or mesh, preferably include or are formed from a polymer plastic material and may be fused or joined together to form the substrate / frame of the drug delivery device. In this regard, the skeletal structure is preferably formed in an additive manufacturing or "3D printing" process. The skeletal structure is preferably relatively soft and flexible in the user's hand.

[0025] In a preferred embodiment, a delivery means or delivery element provided on or supported on a substrate / frame of a drug delivery device for delivering drugs to nasal tissue may preferably comprise an open skeleton formed as, or including, an array, web, or mesh of stranded elements or filaments that may constitute an outer layer or coating on the substrate or frame of the device. The elements, strands, and / or filaments of the open skeleton, array, web, or mesh constituting the delivery means or delivery element are typically formed from polymer plastic material and may be fused or joined together. In this regard, the open skeleton constituting the delivery means or delivery element may be formed in an additive manufacturing or 3D printing process. The open skeleton or array, web, or mesh of strands or filaments within the delivery means or delivery element is preferably very soft and flexible in the hand of an individual user and is very soft to the touch as it is inserted into the nasal cavity. This enhances user comfort during use and avoids the risk of tissue damage. The open skeletal structure of each delivery means or delivery element generates pores or openings for delivering the drug through it to the tissue or mucosa of the nasal cavity. Naturally, they may cover the lower gaps and cavities filled with filaments and / or fibers that form a source or reservoir of the drug to be delivered, in particular a gel or viscous liquid. The filaments or fibers may facilitate "capillary transport," i.e., transport of the drug from the source to the wearer's nasal cavity tissue by capillary action. Thus, the open filamentary skeleton can facilitate improved transport of the drug by the delivery element to the nasal cavity tissue for a predetermined period of time for drug delivery.

[0026] In a preferred embodiment, the drug delivery device comprises a unique identifier for use in the step of recording or registering an individual to whom the drug is delivered using this device. Thus, the unique identifier is designed to assist in the integrity of data and the tracking of the usage status of the device. The unique identifier may be in the form of a numerical value, symbol, code, signal, or any other form suitable for generating a unique identification for this device. Physically, the unique identifier may be provided within or on the device itself, for example, within or on the substrate or frame of the device, or in an associated state with the device, for example, within or on the package.

[0027] In a preferred embodiment, the unique identifier is adapted to be automatically recognized or recorded when registering an individual to whom the drug is delivered using this device. In certain preferred embodiments, the unique identifier is provided in the form of a code (e.g., a QR code (registered trademark)) that can be scanned or read in an automated manner, for example, via QR code (registered trademark) recognition software within a mobile phone application. The code may be provided on the device itself or on a package associated with the device. In another particular preferred embodiment, the unique identifier is provided in the form of a signal, for example, a radio frequency signal via an RFID device, that can be scanned or read in an automated manner. A signal emitter (e.g., RFID) for emitting the unique identifier signal may optionally be provided again within or on the device itself. Once the unique identifier is scanned or read and records a specific drug delivery device, the personal information (e.g., name, address, gender, date of birth, health insurance details, etc.) of the individual to whom the drug was delivered using that device may then be registered in a database.

[0028] According to a further aspect, the present disclosure provides a drug delivery kit comprising a drug delivery device according to any of the embodiments described above for delivering a drug using the nose and, preferably, a drug container for re-supplying the drug to the drug delivery device or each delivery element, which is desirably separated or removed from the frame of the drug delivery device.

[0029] In a preferred embodiment, the drug container holds a source of drug (e.g., a liquid or gel drug) for re-supplying the drug delivery device or each delivery element by dipping the drug delivery device or each delivery element therein.

[0030] According to another aspect, the present disclosure provides a drug delivery system comprising a drug delivery device or kit according to any of the embodiments described above for delivering a drug and a software application for assisting an individual in using the drug delivery device.

[0031] In a preferred embodiment, the software application is accessible or operable via a mobile telecommunications device (hereinafter simply referred to as a “mobile device”), such as a mobile phone or tablet. In this regard, the software application may optionally be downloaded and installed on a mobile device, or alternatively, accessible online via a web browser. The software application typically comprises a computer program or computer software configured to run on a computer processor, such as a microprocessor, as found within a mobile computing device, such as a mobile phone or tablet. Naturally, the computer program or computer software may also be run on a personal computer, such as a personal laptop computer. The software application may be available to the user online (e.g., via a cloud server) as a computer program product to be downloaded, or alternatively, accessible via an internet browser.

[0032] In a preferred embodiment, a software application provides an individual with instructions regarding the correct use of a drug delivery device via a mobile device. The instructions may be available in several languages, such as those selected by the individual, and / or may be provided in a graphically illustrative manner that can be understood regardless of language. The software application may include a timer to provide a means for informing the individual when a predetermined drug delivery time has elapsed. The timer would typically be started after the delivery element of the drug delivery device has been introduced into the individual's nostrils in accordance with the provided instructions. The timer may include an alarm, in which a sound alerts the individual via the mobile device at the end of a predetermined period for drug delivery. This may also operate to record that the individual is complying with the drug delivery process.

[0033] In another aspect, this disclosure relates to a method of delivering medicine to an individual, A drug delivery device comprising: a frame configured such that at least a portion thereof is received and retained within an individual's nostril; and a delivery element provided on and / or supported on the portion of the frame for delivering a drug; The steps include: introducing a delivery element, provided on and / or supported on the portion of the frame, into the nostril of an individual, thereby receiving and retaining within the nostril so that the delivery element contacts or engages with the inner surface or tissue of the nostril and delivers the drug; A step that enables a delivery element provided on and / or supported on the portion of the frame to remain in or reside within the nostril for a predetermined period of time for drug delivery, This provides a method that includes [something].

[0034] In a preferred embodiment, the predetermined period for drug delivery is at least about 2 to 3 seconds, preferably at least about 10 to 30 seconds, more preferably at least 1 or 2 minutes, and optionally within a range of about 5 minutes to about 8 hours, for example, within a range of about 15 minutes to about 4 hours. In this regard, the individual typically wears the drug delivery device for the predetermined period. Thus, the delivery element is typically introduced into the anterior nasal cavity, for example, into the external nostril or nasal vestibule, and resides there to deliver the drug transnasally over the predetermined period.

[0035] In a preferred embodiment, the method includes the step of supplying or transporting a drug from a source, such as a reservoir, on the frame of the device to its or each delivery element for a predetermined period of time. Thus, the method may include the step of replenishing or reloading each delivery element during use of the device.

[0036] In a preferred embodiment, the method preferably includes the step of accessing and / or operating a software application via a mobile device such as a mobile phone or tablet to assist in the use of a drug delivery device by an individual. In this regard, the software application may be downloaded and installed on the mobile device, or alternatively, it may be accessed online via a web browser.

[0037] In a further aspect, the present disclosure provides a frame for a drug delivery device for delivering a therapeutic drug or medication to an individual. The frame for the drug delivery device includes at least one frame member that is fitted or configured to be received and retained or housed within the nostrils of an individual. The at least one frame member is fitted or configured to carry or support a delivery means, such as a delivery element, for delivering a drug, such that when the frame member is retained or housed within the nostrils, the delivery means / delivery element contacts or engages with the inner wall or surface (e.g., tissue) of the nostril, and preferably delivers the drug to the individual transdermally. The present invention provides, for example, the following: (Item 1) A drug delivery device for delivering a drug, preferably a pharmaceutical or therapeutic agent, to an individual, the delivery device comprising a substrate configured to be received and retained or housed within the nostrils of the individual, and a delivery element provided on and / or carried on the substrate for receiving and delivering the drug, wherein the delivery element is provided on and / or carried on the substrate so that, when the substrate is retained or housed within the nostrils, the delivery element contacts or engages with the tissue of the nostrils and delivers the drug to the individual. (Item 2) The drug delivery device according to item 1, wherein the substrate forms a frame of the device for supporting the delivery element provided and / or supported thereon, the frame preferably comprises at least one frame member configured to be received and retained or housed within the nostrils of the individual, and the delivery element is provided and / or supported thereon. (Item 3) A drug delivery device for delivering a drug, preferably a pharmaceutical, to an individual via the nose, wherein the drug delivery device is A frame having at least one frame member configured to be received and retained or housed within the nostrils of the individual, Preferably, a delivery element provided on and / or carried by the at least one frame member for receiving and delivering the drug in the form of a liquid or gel, Equipped with, A drug delivery device in which the delivery element is provided on and / or carried on the frame member so as to contact and / or engage with the inner surface or tissue of the nasal cavity when the frame member is held or housed within the nostril, and to deliver the drug to the individual. (Item 4) The drug delivery device according to any one of items 1-3, wherein the device is wearable by the individual or configured to be worn so that the delivery element is received and stored in the individual's nostrils for an extended period of time or a predetermined drug delivery time. (Item 5) The drug delivery device according to item 4, wherein the drug delivery time is at least 2 seconds, preferably at least about 30 seconds, and optionally within a range of about 2 minutes to about 8 hours, for example, within a range of about 10 minutes to about 4 hours. (Item 6) A drug delivery device according to any one of items 2-5, wherein the at least one frame member on which the delivery element is provided or supported is configured to be received and retained or housed in the lower nasal cavity, for example, in the nasal vestibule, for delivery of the drug, the at least one frame member is formed to complement the surface shape or curvature of the nasal cavity, and the delivery element is provided or supported on the surface or area of ​​the frame member facing the tissue of the nasal cavity. (Item 7) The drug delivery device according to item 6, wherein the frame member is both elongated and elastic and flexible, and biased to contact the nasal cavity, so that the delivery element compresses and / or engages with the tissue of the nasal cavity when the frame member is housed in the nostril. (Item 8) The drug delivery device according to any one of items 2-7, wherein the frame comprises a pair of frame members, each of which is configured to be housed within an individual nostril of the person, and the device comprises individual delivery elements provided on or carried by each of the frame members, each delivery element configured to compress or engage with the tissue of the individual nostril during use to deliver the drug. (Item 9) The drug delivery device according to any one of items 2-8, wherein the frame member or each frame member has a curved configuration or a loop configuration. (Item 10) The drug delivery device according to any one of items 1-9, wherein the delivery element comprises a delivery material for receiving and delivering the drug, the delivery material preferably consisting of fibers and / or polymer foams with fibers selected from the group consisting of flocked fibers, compressed fibers, fiber sheets and knitted fibers, and the drug is impregnated onto the delivery material for delivery to the individual, for example, by transdermal absorption. (Item 11) The drug delivery device according to item 10, wherein the delivery material consists of fibers selected from the group consisting of cotton, rayon, calcium alginate, polyester, polypropylene, polyamide (nylon), and polyethylene, and / or the delivery material consists of a polymer foam and includes urethane. (Item 12) The drug delivery device according to any one of items 1-11, wherein the delivery element or each delivery element is provided on or supported on the individual frame member and is configured as a pad, preferably in the form of an elongated pad. (Item 13) A drug delivery device according to any one of items 1-12, wherein the delivery element or each delivery element comprises a plurality of microneedles protruding from its surface for, for example, contact with and / or engagement with the inner surface or tissue of the nasal cavity to facilitate transdermal delivery of the drug. (Item 14) A drug delivery device according to any one of items 1-13, comprising a source of the drug on a substrate or frame of the device, wherein the source communicates, preferably fluidly, with the delivery means or delivery element to provide or transport the drug thereto. (Item 15) The drug delivery device according to item 14, wherein the source of the drug preferably includes a reservoir for holding a certain amount of the drug, which may optionally be in the form of a liquid or gel, but optionally in the form of a film or powder, and the reservoir is connected in fluid communication to the delivery means or delivery element for transporting the drug from the reservoir to it. (Item 16) The drug delivery device according to item 15, wherein the reservoir for holding a certain amount of drug is removablely mounted on the frame of the device for (re)loading the source of the drug, and the reservoir is preferably in the form of a receiver such as a capsule filled with the drug. (Item 17) The drug delivery device according to any one of items 1-16, wherein the frame or the at least one frame member is made of a plastic material, for example, polypropylene (PP), polyethylene (PE), polystyrene (PS), polyamide (PA), for example, nylon, or styreneethylenebutylene styrene (SEBS), and / or metal wire. (Item 18) The drug delivery device according to any one of items 1-17, wherein the frame includes a handle portion for manual handling of the drug delivery device by the individual, the frame member or each frame member extending from the handle portion of the frame, and the handle portion preferably being releasably connected to the frame member or each frame member. (Item 19) The drug delivery device according to any one of items 1-18, wherein the frame includes a sensory comforter for enhancing the individual's comfort during use, the sensory comforter comprises a drug source for inhalation by the individual for enhancing the individual's comfort during use, the source being supported on the frame and configured to be positioned adjacent to the nostrils when the delivery elements or each delivery element is housed in the nostrils. (Item 20) The drug delivery device according to any one of items 1-19, wherein the substrate or frame of the device comprises a skeletal structure including an array, web, or mesh of stranded elements or filaments, and the elements, strands, or filaments of the skeletal structure preferably comprise a polymer plastic material and preferably are fused or joined together. (Item 21) The drug delivery device according to item 20, wherein the skeletal structure is formed in an additive manufacturing or 3D printing process. (Item 22) The drug delivery device according to any one of items 1-21, wherein the delivery means or delivery elements provided on or supported on a substrate or frame of the device for receiving and delivering the drug preferably include an open skeleton and / or an array, web, or mesh of stranded elements or filaments constituting an outer layer or covering on the substrate or frame of the device. (Item 23) The drug delivery device according to item 22, wherein the elements, strands, or filaments of the open skeleton, array, web, or mesh constituting the delivery means or the delivery element are formed from a polymer plastic material, preferably formed in an additive manufacturing or 3D printing process. (Item 24) A drug delivery kit comprising a drug delivery device as described in any one of items 1-23, and a source of a drug to be installed on a substrate or frame of the device, wherein the source is configured to be installed in communication with a delivery means or delivery element for supplying or transporting the drug. (Item 25) The drug delivery kit according to item 24, wherein the drug supply source preferably includes a reservoir for holding a certain amount of the drug, which is in the form of a liquid or gel, and the reservoir is adapted to be connected in fluid communication to the delivery means or delivery element for transporting the drug from the reservoir to it. (Item 26) The drug delivery kit according to item 25, wherein the reservoir for holding a certain amount of the drug is in the form of a receiver such as a capsule filled with the drug, and the receiver is configured to be mounted on the frame of the device. (Item 27) The drug delivery kit according to item 25, wherein the reservoir for holding a certain amount of the drug is preferably configured for loading or supplying the drug into the delivery element or each delivery element by immersing the delivery element or each delivery element in the drug. (Item 28) A drug delivery system comprising a drug delivery device for delivering drugs to an individual as described in any one of items 1-23 or a drug delivery kit as described in any one of items 24-27, and a software application for assisting the individual in using the drug delivery device. (Item 29) A method for delivering a drug to an individual via the nose, wherein the method is A step of providing a drug delivery device, the drug delivery device comprising: a frame configured such that at least a portion thereof is received and held within the nostrils of the individual; and a delivery means provided on and / or carried on a portion of the frame for receiving and delivering the drug; The steps include: introducing the delivery means, provided on and / or supported on a portion of the frame, into the nostril of the individual, thereby receiving and retaining within the nostril so that the delivery means contacts or engages with the inner surface or tissue of the nostril and delivers the drug; The steps include enabling the delivery means, provided on and / or supported on a portion of the frame, to remain or reside in the nostril for a predetermined period of time for drug delivery, and Methods that include... (Item 30) The predetermined period for drug delivery is at least about 2 seconds, preferably at least about 30 seconds, optionally within the range of about 5 minutes to about 8 hours, for example, within the range of about 15 minutes to about 4 hours, and / or The drug delivery device will be worn by the individual for the predetermined period of time, and / or The delivery means is in the form of an element and is introduced into the individual's nasal cavity, for example, the external nostril or nasal vestibule, and resides there, delivering the drug over a predetermined period of time. The method described in item 29. [Brief explanation of the drawing]

[0038] For a more complete understanding of the present disclosure and its merits, exemplary embodiments of the present disclosure are described in more detail below with reference to the accompanying drawings, in which similar reference numerals indicate similar parts. [Figure 1] Figure 1 is a schematic perspective view of a drug delivery device according to a first preferred embodiment. [Figure 2] Figure 2 is a perspective view of a drug delivery device according to a first preferred embodiment. [Figure 3] Figure 3 is a schematic perspective view of a drug delivery device according to a second preferred embodiment. [Figure 4] Figure 4 is a perspective view of a drug delivery device according to a second preferred embodiment. [Figure 5] Figure 5 is a perspective view of a drug delivery device according to a third preferred embodiment. [Figure 6] Figure 6 is a perspective view of the frame of a drug delivery device according to a fourth preferred embodiment. [Figure 7] Figure 7 is a perspective view of a drug delivery device according to a fifth preferred embodiment. [Figure 8] Figure 8 is a perspective view of a drug delivery device according to a sixth preferred embodiment. [Figure 9] Figure 9 is a schematic perspective view of a drug delivery device according to a seventh preferred embodiment. [Figure 10] Figure 10 is another schematic perspective view of the drug delivery device shown in Figure 9. [Figure 11] Figure 11 is a perspective view of the frame of a drug delivery device according to an eighth preferred embodiment. [Figure 12] Figure 12 is a side view of the drug delivery device according to the embodiment shown in Figure 10. [Figure 13] Figure 13 is a schematic diagram of the drug delivery device shown in Figure 11, in use. [Figure 14] Figure 14 is a schematic perspective view of a drug delivery device according to a ninth preferred embodiment. [Figure 15]Figure 15 is a schematic perspective view of a drug delivery device according to a tenth preferred embodiment. [Figure 16] Figure 16 is a schematic perspective view of a drug delivery device according to an eleventh preferred embodiment. [Figure 17] Figure 17 is another schematic perspective view of the drug delivery device shown in Figure 16. [Figure 18] Figure 18 is a schematic perspective view of a drug delivery device according to a twelfth preferred embodiment. [Figure 19] Figures 19a and 19b are schematic perspective views of the two delivery elements of the drug delivery device according to the embodiment shown in Figure 18. [Figure 20] Figure 20 is a top view of a drug delivery device according to a thirteenth preferred embodiment. [Figure 21] Figure 21 is a side view of the drug delivery device shown in Figure 20. [Figure 22] Figure 22 is a rear view of the drug delivery device shown in Figure 20.

[0039] The accompanying drawings are included and incorporated herein, forming part thereof, to provide a further understanding of this disclosure. The drawings illustrate specific embodiments of this disclosure and, together with the descriptions, serve to illustrate the principles of this disclosure. Many other embodiments and associated advantages will be readily apparent as they become more deeply understood by referring to the detailed description below.

[0040] It should be understood that common and / or more widely understood elements that may be useful or necessary in commercially viable embodiments are not necessarily depicted to facilitate a more abstract representation of the embodiments. Elements in the drawings are not necessarily illustrated to scale relative to one another. It should also be understood that while certain actions and / or steps in certain embodiments of a method may be described or depicted in a particular order of occurrence, a person skilled in the art will understand that such peculiarity with respect to sequence is not actually required. [Modes for carrying out the invention]

[0041] Detailed description of the embodiment Referring first to Figures 1 and 2 of the drawings, a first preferred embodiment of a drug delivery device 1 for delivering drugs, in particular pharmaceuticals or therapeutic drugs, transnasally to an individual, according to the present disclosure is shown in a perspective view. The drug delivery device 1 comprises a frame 2 formed from a polymer plastic material such as, for example, polypropylene (PP), polyethylene (PE), polyamide (PA), nylon, polystyrene (PS), styreneethylenebutylene styrene (SEBS), or equivalent. The frame 2 may be formed by molding, in this case, as an integrated or one-piece component. As is evident from Figures 1 and 2, the frame 2 of the device 1 comprises a central portion 3 and two cantilevered frame members 4 in the form of ribs, which are curved (like "bull horns") and extend laterally outward from the central portion 3 in the opposite direction. The central portion 3 is part of the frame 2, which is configured or designed to remain outside or on the outside of the nostrils, when in use. The central portion 3 comprises a roughly U-shaped body having a tab portion 5 and two frame members 6 in the form of stems or legs that extend substantially parallel to each other from the tab portion 5 toward individual curved rib members 4 to the side and connect with it.

[0042] Referring to Figures 1 and 2 of the drawings, the drug delivery device 1 further comprises delivery elements 8, which are provided on each of the curved rib members 4 and are in the form of pads of fibrous delivery material carried thereby. Each delivery pad 8 is made of, for example, cotton, rayon, calcium alginate, polyester, polypropylene, or polyethylene and is typically designed to hold and deliver liquid or gel drugs percutaneously through contact with nasal tissue or mucosa. Each delivery pad 8 is mounted or connected to an individual rib member 4 at a connection point 9 by a connecting element such as a joint, fuse, or pin connector. Furthermore, each pad 8 extends along the surface or side surface 10 of the rib member 4, which is configured to face the tissue of the nasal cavity when in use.

[0043] In this regard, it should be understood that the rib members 4 and their individual delivery pads 8 are configured to be inserted or introduced into an individual's nostrils to deliver medication. To achieve this goal, the rib members 4 are designed to be relatively soft and resilient, flexible or "elastic," to facilitate their easy insertion into the nostrils. Similarly, the delivery pads 8 are relatively soft to enhance user comfort. The tab portion 5 of the central portion 3 forms a handle for the individual to grasp and manipulate the device 1 during insertion of the rib members 4 and delivery pads 8 into the nose. As will be understood, it is desirable to avoid the user touching the delivery pads 8 with their hands and thus avoid any potential contamination of the medication. The individual therefore grasps the device through the tab portion 5 of the central portion 3, which may include a curved recess 11 to facilitate grasping with fingers or thumb. The stalk or leg member 6 and the gap 12 between the leg members 6, extending from the tab portion 5, allow the individual rib members 4 and delivery pad 8 to be inserted into the nostrils on both sides of the septum. In this way, the rib member 4 and delivery pad 8 can be positioned and retained or housed in the lower nasal cavity for drug delivery via the pad 8. Provided on the flexible rib member 4, the delivery pad 8 conforms to and complements the surface contour or curvature of the nasal cavity.

[0044] When in use, the U-shaped body of the central portion 3 of the drug delivery device 1 is positioned to straddle the nasal septum when the individual wears it with the leg members 6 extending into each nostril on both sides of the septum. The leg members 6 may be slightly inclined relative to each other to accommodate the nasal bridge when worn by the individual, with a relatively longer distance provided between the leg members 6 in the tab portion 5. The distal end region of the leg members 6 may be positioned to engage with the septum when in use and extend from the septum behind the nasal bridge and alar fibroadipose tissue, thereby allowing the delivery element 8 to be carried on it, and to extend along the individual nostrils to the inner wall of the nostril when in use.

[0045] After the rib members 4 and delivery pads 8 of the drug delivery device 1 are introduced and stored in the individual's nostrils, they remain there or reside there for a predetermined drug delivery time of a long period or at least a few seconds, preferably at least about 30 seconds, more typically 1 or 2 minutes to about 15 minutes, up to several hours. For example, an individual may wear the drug delivery device during the day or at night (e.g., while sleeping) for the delivery of drugs via the pads 8. After the predetermined period for drug delivery has elapsed, the user may remove the rib members 4 and delivery pads 8 from the nose by grasping the handle or tab portion 5 and gently pulling those parts of the device 1 out of the nostrils.

[0046] Referring here to Figures 3 and 4, a second preferred embodiment of the drug delivery device 1 for delivering drugs nasally to an individual according to the present disclosure is shown in perspective view. The general structure of the drug delivery device 1 of this embodiment is essentially identical to that of the first embodiment, and therefore another description of its structure will not be repeated, although similar reference symbols in the drawings will identify similar parts. However, the difference of this second embodiment relates to the delivery element 8, which is provided in the form of a tubular sleeve that surrounds or accommodates a curved rib member 4 instead of the pad shown in Figures 1 and 2. In this embodiment, the delivery sleeve 8 may be a knitted sleeve made of, for example, cotton, rayon, calcium alginate, polyester, polypropylene, or polyethylene fibers, or it may also be a foamed sleeve element made of, for example, urethane foam. The delivery sleeve 8 may be morph-fitted or friction-fitted onto the flexible rib member 4, or they may optionally be connected to the rib member 4 again via connection points 9 by connecting elements such as joints, fusions, or pin connectors. The use and operation of the drug delivery device 1 in the second embodiment correspond to the use and operation described above with respect to the first embodiment.

[0047] Figures 5, 6, and 7 illustrate several alternative embodiments of the drug delivery device 1, exhibiting differences in the configuration of the frame 2. However, it should be noted again that the general use of these drug delivery devices 1 corresponds to the use described above with respect to the first embodiment. In the third embodiment of Figure 5, the frame member 4, on which the delivery element 8 is provided or supported, is in the form of a closed loop. Similar to the second embodiment of Figures 3 and 4, the delivery element 8 is provided in the form of a sleeve surrounding or housing the loop member 4. In the fourth embodiment of Figure 6, the frame member 4, on which an individual delivery element (not shown) will be supported, is provided in the form of a series of interconnected loops or rings 13 forming a cage structure. The delivery element may in this case be provided in the form of a cylindrical or conical sheath or sleeve to cover the outer periphery of the cage structure. This structure, when used, results in a delivery element (not shown) that extends more farther or deeper into the nasal cavity. In this embodiment, the tab portion 5 is also omitted, and the central portion 3 is provided with a simple band 14 that interconnects the leg members 6.

[0048] In the fifth embodiment shown in Figure 7, the drug delivery device 1 includes a frame 2 having a configuration very similar to that of the first embodiment. The delivery element 8 is also provided in the form of a pad, as in the first embodiment. However, in this fifth embodiment, each rib member 4 includes an adjuster 15 for setting or adjusting the radial position of the delivery pad 8. In this regard, the adjuster 15 preferably comprises a mechanism, such as a ratchet mechanism, for setting or adjusting the curvature or radial range of the individual rib member 4, and therefore also the associated delivery pad 8. In this embodiment, for example, each adjuster mechanism 15 comprises a pin 16 and a socket 17 arranged to receive and engage with the pin 16. To prevent the pin from being pulled out of the socket 17, an enlarged portion or head may be provided at the end of the pin 16. In this regard, a shoulder portion provided inside the socket 17 may be configured to engage with the enlarged portion or head of the pin 16 and prevent the pin from being pulled out of the socket. This may allow for some pre-adjustment of the shape and / or position of the rib member 4 and the delivery pad 8 prior to the insertion of those parts of the device 1 into the individual's nostrils for drug delivery. Furthermore, this embodiment includes a timing indicator 19 for informing the individual or wearer when a predetermined period for drug delivery has elapsed. The indicator 19 is provided on a tab portion 5 of the frame 2, which remains outside the nostrils and is therefore visible during use of the device 1. The timing indicator 19 comprises a patch configured to change its appearance (color) over time. In this regard, the indicator patch 19 contains a substance selected to react with air and / or light over a predetermined period of time to change its color over that time. In accordance with the start of use of the device 1, the indicator patch 19 is exposed to air and / or light for the first time by removing the protective cover or label 19'. After the predetermined time for drug delivery has elapsed, the indicator patch 19 will change its color due to exposure to air and / or light, indicating to the user or wearer that the drug delivery device 1 can now be removed.Thus, device 1 is designed to achieve consistency in use by the individual inspecting it. This feature of the timing indicator 19 may be included in any of the other embodiments.

[0049] Referring here to Figure 8 of the drawings, a sixth embodiment of the drug delivery device 1 is illustrated. This sixth embodiment substantially corresponds to the embodiment of Figure 7, except that instead of a timing indicator 19, it includes a sensory comforter 18 for enhancing sensory comfort during drug delivery. The sensory comforter 18 comprises a pad impregnated with a drug for inhalation by the individual. The drug preferably provides a pleasant aroma to mask or counteract the drug delivered on the delivery pad 8, thereby enhancing the user's comfort. Thus, the pad 18 provides a sensory comforter source supported on a central portion 3 of the frame 2, which is positioned adjacent to the individual's nostrils when the rib member 4 and individual delivery pads 8 are stored or held in the nostrils during use. In response to inhalation, the sensory comforter 18 releases the drug, in the form of a smoke, vapor, or volatile substance V, which acts to enhance a pleasant sensory experience for the user and thus counteract or mask any unpleasant sensory experience from the drug itself during the delivery period. This feature of the sensory comfort device 18 may be included in any of the other embodiments.

[0050] Referring further to Figures 9 and 10 of the drawings, a seventh preferred embodiment of the drug delivery device 1 is schematically shown. In this embodiment, the frame 2 of the device 1 consists of a metal wire. The wire is shaped to provide a U-shaped central portion 3 and a pair of frame members 4 in the form of ribs, which are curved and extend laterally outward from the central portion 3 in opposite directions. Again, the rib members 4 are elastic, flexible and "resilient" for easy adaptation to the size and shape of an individual's nasal cavity, thereby promoting wearer comfort. In this embodiment, the delivery element 8 is again provided in the form of a sleeve that surrounds or houses the rib members 4. The central portion 3 in this embodiment includes a removable tab portion or handle 5, preferably formed from plastic, which is designed to clip onto two substantially parallel extending wire leg members 6 and a connecting wire band 14 of the central portion 3 that interconnects the two rib members 4. The fact that the tab portion or handle 5 is removable makes the drug delivery device 1 less obtrusive when worn by the user, for example, while sleeping.

[0051] Referring here to Figures 11-13, an eighth preferred embodiment of the drug delivery device 1 is illustrated. As can be seen in Figure 11, the central portion 3 of the frame 2 is configured very similarly to the previously described embodiment and includes a substantially U-shaped body having a tab portion 5 that forms a handle, and a pair of leg members 6 extending therefrom. However, the rib members 4 of this embodiment are slightly different. Each elongated rib member 4 approximates an ellipse and has a loop-shaped outer shape that allows the rib member 4 to be comfortably and consistently received and seated in the nostril within the nasal vestibule, as seen in Figure 13, which is important for achieving consistency both during use and during drug delivery. Furthermore, the delivery means 8 provided / carried on thereon in the form of a layer of fibers, particularly flocked fibers, is configured to be more extensive or wider within its region B so that each rib member 4 is located more deeply within the nasal cavity or external nostril. Thus, the rib member 4 provides a larger surface area for the delivery means 8 supported thereon to contact the surface of the external nostril or nasal cavity, which is likely to provide more drug loading delivery. For similar reasons, the rib member 4 is open, spread out, or divided into riblets 4' within this region to support the fibers of the delivery means 8, such as flocked fibers, and provide a larger surface area to improve potential drug loading.

[0052] Referring here to Figure 14 of the drawings, a ninth embodiment of the drug delivery device 1 is shown in a schematic perspective view. In this embodiment, the frame 2, in particular the rib members 4 having adjusters 15 for setting or adjusting the radial position of each delivery pad 8 of the device 1, is very similar to the embodiments shown in Figures 7 and 10. However, it should be noted that in this case, the delivery pads 8 do not extend across the entire surface or side surface 10 of the rib members 4, but rather are localized to the enlarged end region of each rib member 4. The delivery pads 8 themselves consist of a porous and relatively soft, spongy foam material. Another difference in this embodiment lies in the configuration of the central portion 3 of the frame 2. The central portion 3 again has a substantially U-shaped body with a gap 12 between the leg members 6 to allow the individual ribs 4 and delivery pads 8 to be inserted into the wearer's nostrils on both sides of the septum, but the front end of the central portion in this embodiment is not formed as a flat tab. Instead, the front end of the central portion 3 incorporates a receiver 20 that forms a source or reservoir for the liquid. A tube or fluid line 21 provides fluid communication between the receiver or reservoir 20 and the spongy delivery pad 8. Furthermore, the receiver 20 is formed from a flexible and deformable material (e.g., a polymer plastic material) and is mounted within the central portion 3 of the frame 2 in a recess 22, allowing access to the receiver 20 by the thumb or fingers of the wearer or user of the device 1. When the device 1 of Figure 14 is used for the first time, the liquid may be sealed inside the capsule-like receiver 20. The drug may be released and flow from the receiver 20 toward the delivery pad 8 by, for example, inserting the end of the fluid line 21 through the side opening 23 of the central portion 3 so as to penetrate the capsule-like receiver 20. Microtubules (e.g., microtubules) of the fluid line 21 may in any case facilitate the transport of the liquid from the receiver 20 via capillary action. By applying manual pressure (for example, by a thumb or finger) to the flexible receiver 20, the liquid can also be pushed along the fluid line 21 to the delivery pad 8.In an alternative embodiment, the pipes or fluid lines 21 may be fixed in fluid communication with the capsule-like receiver 20, and applying pressure to the reservoir or compressing it through the recess 22 may break the internal seal (not shown) and allow the liquid to flow to the delivery pad 8.

[0053] Referring to Figure 15, a tenth embodiment of the drug delivery device 1 is illustrated, which may incorporate any of the features of the embodiments described above. In this case, the delivery element 8 is again provided as a pad in the distal end region 7 of the rib member 4, but the delivery pad 8 has a recessed area for receiving and / or absorbing the drug. This embodiment also includes a protective cover or film layer 24 which will be removed (e.g., peeled off) by the individual before using the device 1.

[0054] Referring to Figures 16 and 17, an eleventh embodiment of the drug delivery device 1 is shown in a schematic perspective view. In this case, the drug delivery device 1 is similar to the embodiment in Figure 14. The delivery pads 8 are again provided to the end regions 7 of the curved rib members 4, but extend slightly further along the outside 10 of those rib members 4. Furthermore, the drug delivery device 1 of this embodiment again includes a source of liquid that communicates with the delivery pads 8, but the source is not incorporated into the central portion 3 of the frame 2. Rather, the central portion of the frame 2 merely constitutes a U-shaped body with legs 6 interconnected by bands 14. Instead, the drug delivery device 1 has separate capsule-like receivers 20 for connection to each rib member 4 that fluidly communicates with individual delivery pads 8 on its rib members 4. In this regard, each rib member 4 preferably includes a hollow pin or spike 25 having a pointed, optionally barbed end 26 for penetrating and receiving individual capsule-like receivers 20, as indicated by the arrows in Figure 17. In this regard, each capsule-like receiver 20 comprises a relatively thin plastic shell filled with a liquid to be delivered to the individual. By mounting the capsule 20 on the hollow pin or spike 25, the liquid may flow through the hollow pin or spike into adjacent pads 8, which are connected to fluidly communicate using it. The main flow of the drug to soak into or impregnate each delivery pad 8 can be assisted by the user gently squeezing the individual capsule-like receiver after it has been mounted on the pin or spike 25. The capsules 20 may be disposable or replaceable on the device 1 after the contents of the first pair of capsules 20 have been fully delivered to the user.

[0055] Furthermore, referring to Figures 18, 19a, and 19b, a twelfth embodiment of the drug delivery device 1 is shown. In this embodiment, the delivery element 8 of the device 1, provided in the end region 7 of the rib member 4, is in the form of a replaceable cartridge element. In particular, these cartridge delivery elements 8 contain, for example, a source of drug to be delivered into a built-in receiver or chamber, and provide an interface 8' for contact with the inner surface of the nostril, at which the transport or delivery of the drug to the user occurs. The interface 8' may again comprise a pad or layer of porous foam or fibrous material impregnated with the drug for delivery of the drug to the wearer. Alternatively, or in addition, the interface 8' may include an array of microneedles 27 for skin surface penetration for improved drug delivery by transdermal absorption. The microneedles may be designed to decompose slowly upon contact with the skin. The interface 8' is preferably covered by a protective cover or film layer 24, which will be removed before use. As can be seen in Figure 18, each end region 7 of the rib member 4 is equipped with a retainer 28, such as a clip, for releasably mounting an individual cartridge delivery element 8. Similar to the capsule 20 in the embodiments of Figures 16 and 17, the cartridge 8 may be disposable and replaceable on the device 1 after the contents of the first pair of cartridges 8 have been fully delivered to the user / wearer.

[0056] Referring to Figures 20-22, a thirteenth embodiment of the drug delivery device 1 will be described here. The shape of the device 1 in this embodiment basically corresponds to the embodiments in Figures 5 and 11 and 12, although in this case it does not involve the tab portion 5. The substrate or frame 2 of the device 1 in this embodiment has a skeletal structure which can be produced by additive manufacturing or 3D printing processes and which can offer several advantages. For example, the skeletal structure can provide good strength properties with light weight and low material consumption, and additive manufacturing or 3D printing processes can avoid expensive die-making steps in the production process. In this embodiment, the frame 2 is preferably formed from a polymer plastic material such as polyamide (PA) (e.g., nylon), but polyethylene (PE), polystyrene (PS), and styrene-ethylene-butylene-styrene (SEBS) may also be suitable. The nylon of the skeleton is formed as an array or mesh of stranded wires or filaments which are fused or joined together during the 3D printing process. What is inside the outer covering seen in Figure 20-22 is the inner structure or frame 2 which supports the outermost layer.

[0057] The frame 2 of this embodiment has many of the same basic features as the other embodiments described above, including a central portion 3 in the general form of a U-shaped body, with two elongated stems or leg members 6 extending substantially parallel to each other and interconnected by a central band 14. Each stem or leg member 6 connects to an individual loop-shaped frame member or rib member 4 that extends behind the central band 14 and project or extends rearward and laterally to the opposite side of the central portion 3. Each loop-shaped frame member or rib member 4 is provided with an outer covering formed by an intricate mesh-like structure of filaments interconnected in an open skeleton. This forms a three-dimensional array of filaments for delivering drugs as a delivery means / delivery element 8 that covers the inner rib member 4. Because the strands or filaments within the delivery means / delivery element 8 are very soft and flexible, the delivery element covering 8 they form enhances user comfort and avoids irritation. Naturally, the delivery element 8 may cover a lower space or void filled with filaments and / or fibers, forming a source or reservoir for the drug to be delivered, particularly for gels or viscous liquids. The filaments or fibers may facilitate "capillary transport," i.e., transport of the drug from the source to the wearer's nasal tissue by capillary action. Thus, the open filamentary skeleton and large openings and pores or cavities within its structure facilitate the transport of the drug by the delivery element 8 to the tissues within the nose. It should be noted that the central band 14 may function as a handle or gripping portion for the individual to grasp, hold, and / or manipulate the device 1 during use. However, the drug delivery device 1 may be produced with a tab portion 5 similar to those described above in other embodiments instead of the band 14, providing a larger handle portion for better manual handling by the user.

[0058] While specific embodiments of the Disclosure are illustrated and described herein, it will be understood by those skilled in the art that various alternatives and / or equivalent implementations exist. It should be understood that each exemplary embodiment is merely an example and is not intended to limit in any way its scope, availability, or configuration. Rather, the foregoing summary and detailed description provide to those skilled in the art a convenient roadmap for implementing at least one exemplary embodiment, which will be understood to be made in a variety of ways, without departing from its scope, in the array of functions and elements described in the exemplary embodiments as stated in the appended claims and their legal equivalents. In general, this application is intended to cover any adaptable or modified examples of the specific embodiments discussed herein.

[0059] It should also be understood that the terms “comprise,” “comprising,” “include,” “including,” “contain,” “containing,” “have,” “having,” and any variations thereof used herein are intended to be understood in an inclusive (i.e., non-exclusive) sense, so as to be understood, that the processes, methods, devices, apparatus, or systems described herein are not limited to the listed functions, integers, parts, elements, or steps, and may include other features, integers, parts, elements, or steps that are not expressly listed and / or are not specific to such processes, methods, devices, apparatus, or systems. Furthermore, the terms “a” and “an” used herein are intended to be understood as “one or more” unless expressly stated otherwise. In addition, terms such as “first,” “second,” “third,” etc., are used merely as indicators and are not intended to impose or establish numerical requirements for the importance of those objects. In addition, the references to positional terms such as "lower" and "upper" used in the above description should be understood within the context of the embodiments depicted in the figures, and this disclosure should not be limited to a literal interpretation of the terms, but rather should be understood in a manner that would be understood by those skilled in the art in the appropriate context.

[0060] Nothing discussed in this disclosure regarding the background technology should be considered in any way to permit such background to be prior art, well known, or to form part of common general knowledge, either within Australia or in any other national field worldwide.

Claims

[Claim 1] A drug delivery device for delivering a drug, preferably a pharmaceutical or therapeutic agent, to an individual, the delivery device comprising a substrate configured to be received and retained or housed in the nostrils of the individual, and a delivery element provided on and / or carried on the substrate for receiving and delivering the drug, wherein the delivery element is provided on and / or carried on the substrate so that, when the substrate is retained or housed in the nostrils, the delivery element contacts or engages with the tissue of the nostrils and delivers the drug to the individual.

Images