Patent Grant
11878109
This disclosure relates generally to a drug delivery device, and specifically to a nasal drug delivery device for delivering drugs to the nasal cavity of a user.
Current devices often rely on the patient to coordinate their breath with actuation of the device for proper use. This can be an ineffective means of drug delivery when the patient is inexperienced with the device, or when a caregiver is administering the device to the patient. Further, current devices often require a priming step before use, which can negatively affect device efficacy and proper dosing.
Embodiments relate to a single-use device for delivery of medication into the nasal cavity of a human or other mammal. The nasal cavity is regarded as a useful cavity for absorption of medication. The single-use device enables a single dose of medication to be delivered to a nasal cavity before being disposed of. Further, the device enables medication to be delivered in a reproducible manner while being simple and intuitive for a patient or caregiver to use. For example, using the single-use delivery device, medication is provided to patients using a single actuation step. In addition, the single-use delivery device reduces the chances of inadvertent overdosing or misuse relative to multi-use devices because second dosing is improbable.
In some embodiments, the single-use device utilizes a unit dose container of propellant to push medication into the nasal cavity. Use of a propellant in the device ensures that medication may be administered by a patient and/or caregiver without the need for the patient to coordinate their breath with the actuation of the device. In addition, by using a unit dose container of propellant, the device does not need to be primed, and the amount of propellant used is controlled and consistent on a dose-to-dose basis.
In an embodiment, a nasal delivery device for delivery of a compound includes a propellant canister containing a propellant capable of propelling the compound to a nasal cavity of a user. The propellant canister is displaceable between an unactuated position and an actuated position within a housing body of the device. The device further includes an actuation element. The actuation element includes an actuation lever that is configured to displace the propellant canister from the unactuated position to the actuated position. In the embodiment, the nasal delivery device also includes a puncture element. The puncture element may be positioned to puncture the propellant canister, which causes the release of the propellant from the propellant canister when the propellant canister is driven from the unactuated position to the actuated position by the actuation element. In the embodiment, the device further includes a dose holding chamber containing a unit dose of the compound. The dose holding chamber is positioned such that propellant flows into the dose holding chamber and causes the compound to be propelled from the dose holding chamber to the nasal cavity of the user.
The nasal delivery device may also include a diffuser positioned between the propellant canister and the dose holding chamber such that the diffuser diffuses the propellant upon its release from the propellant canister. The device may also include a nozzle positioned such that the compound flows through the nozzle and out one or more outlet orifices of the nozzle upon being propelled from the dose holding chamber for delivery of the compound to the nasal cavity.
In some embodiments, the actuation lever may be an L-shaped lever. A first member of the L-shaped lever may be positioned to receive a contact force from an actuation button of the actuation element. A second member of the L-shaped lever may be perpendicular to the first member, and may apply a contact force to the propellant canister upon actuation of the actuation button. Further, the actuation element may include a securing latch that is configured to release the actuation lever upon actuation of the actuation element from a mating interface of the securing latch and the actuation lever.
In some embodiments, the actuation element includes an actuation button that, when depressed, drives the propellant canister into the puncture element, thereby puncturing the propellant canister. Further, the actuation element may include a sliding element exposed from the housing body that is slideable between an unactuated position that enables positioning of the propellant canister in the unactuated position and an actuated position that forces the propellant canister to the actuated position. In addition, the device may include a removeable cap that maintains the actuation element in an unactuated position, a lock to maintain the actuation element in an actuated position, and/or a use indicator that provides an indication that the actuation element is in the actuated position.
The figures depict embodiments of the present disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles, or benefits touted, of the disclosure described herein.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art pertinent to the methods and compositions described. As used herein, the following terms and phrases have the meanings ascribed to them unless specified otherwise:
As used herein the specification, “a” or “an” may mean one or more.
A “diffuser” refers to and encompasses a component for dispersing or deflecting a compound in various directions.
A “propellant” shall refer to and encompass a compound that acts as a vehicle for creating propulsion or thrust.
A “user” or “subject” shall refer to and encompass a human or other animal. For example, the animal may be a primate or a non-primate and may include a rabbit, bovine, equine, pig, rat, mouse, dog or cat.
The device may be used in treatment, prevention, palliative care for humans and veterinary purposes. The device may be used in research and industrial uses. For example, the device may be used to deposit compound in agricultural settings.
In some embodiments, a diameter of the nozzle 110 tapers toward the outlet orifice of the nozzle 110. This configuration may beneficially increase the velocity of the drug compound before it exits the outlet orifice. In addition, this configuration may beneficially decrease the plume width. Decreased plume widths may enable the compound to be propelled further into the nasal cavity and into the upper regions of the nasal cavity (e.g., the middle and superior turbinate regions and/or the olfactory region). In alternative embodiments, the nozzle 110 may be cylindrical or conical in shape.
Further, the design of the nozzle 110 may be optimized for various compounds having different characteristics. For example, the diameter of the nozzle 110, the angle and/or shape of the taper, and/or the diameter of the outlet orifice may be modified (e.g., increased or decreased) to suitably deliver a compound to the upper nasal cavity. As an example, larger nozzles and/or outlet orifices of the nozzles may be used for some drug compounds in powder form to prevent clogging within the nozzle 110. In addition, the number and configuration of outlet orifices in the nozzle 110 may vary to suitably deliver the compound to the upper nasal cavity. For example, the nozzle 110 may include one or more outlet orifices (e.g., one or more outlet orifices, two or more outlet orifices, three or more outlet orifices, four or more outlet orifices, five or more outlet orifices, six or more outlet orifices, seven or more outlet orifices, etc.). In some embodiments, the nozzle 110 is manufactured with a removable seal, such as a metal or plastic seal, to keep the compound in the device 100 until actuation. The removable seal may be in the shape of a pull tab, or may have other suitable geometries for sealing the outlet orifice of the nozzle 110 and providing a portion that a user may grab to remove the removable seal from the nozzle 110.
While the actuation button 115 shown is on the top of the device 100, the actuation button 115 may be placed on the bottom, side, front, and/or back of the device 100. Further, the actuation element may include an electrical motor (e.g., a battery-operated motor), a spring mechanism, and the like. In some embodiments, the device 100 is actuated in a single actuation step. In other embodiments, the device 100 is actuated in one or more actuation steps. For example, the device 100 may require a priming step to load a spring-loaded actuation lever.
As shown in
In some embodiments, the propellant canister 125 is welded together to ensure that the propellant stays within the propellant canister 125 until time of use. A welded seal can require significant force to puncture or break. The actuation lever 120 reduces the amount of force applied by the user on the actuation button 115 to puncture the propellant canister 125 and actuate the device 100 relative to the direct force sufficient to puncture the propellant canister 125. The length of the actuation lever 120 may be designed differently in different embodiments dependent on the desired amount of force from the user intended to be sufficient to actuate the device 100, discussed in detail below with reference to
The actuation lever 120 is a substantially L-shaped lever arm. A first member 145 of the actuation lever 120 is positioned to receive a contact force from the actuation button 115. A second member 150 of the actuation lever 120 is perpendicular to the first member. The second member 150 of the actuation lever 120 applies a contact force to the propellant canister 125 upon actuation of the actuation button 115. The contact force causes the propellant canister 125 to move from an unactuated position to an actuated position, which causes the propellant canister to come into contact with the puncture unit 130. In some embodiments, the first member 145 of the actuation lever 120 and the second member 150 of the actuation lever are of unibody construction together with the actuation button 115. In other embodiments, the first member 145 of the actuation lever 120, the second member 150 of the actuation lever, the actuation button 115, or a combination thereof, may be distinct and separate components. Alternative embodiments of actuations levers are discussed in detail below, with reference to
The propellant contained in the propellant canister 125 is a fluid propellant, such as a liquid propellant or a gaseous propellant. Propellants include pharmaceutically suitable propellants such as hydrofluoroalkane (HFA) including but not limited to HFA, HFA 227, HFA 134a, HFA-FP, HFA-BP and the like HFA's. Additional examples of suitable propellants include nitrogen or choloroflourocarbons (CFC). Additionally, the propellant may be pressurized. For example, propellants may be pressurized air (e.g. ambient air), pressurized nitrogen, pressurized carbon dioxide, or pressurized argon.
The propellant canister 125 may have a capacity for distributing propellant for a certain number of doses. In some embodiments, the propellant canister 125 is a unit dose propellant canister 125 such that the device 100 may be a single-use device. In these embodiments, the device 100 may be disposed of after a single dosing, and/or the propellant canister 125 may be replaced with a new canister. In some embodiments, the propellant canister 125 may include propellant for multiple actuations of the device. The amount of propellant released upon actuation may be between about 5 μl and 250 μl, inclusive of endpoints, of propellant.
The puncture unit 130 is designed to puncture the propellant canister 125 to create an opening in the propellant canister 125. The puncture unit 130 may comprise a sharp point, a sharp angle, a blade-like edge, or other suitable geometries for puncturing the propellant canister 125. The puncture unit 130 may be configured to puncture a puncture area of the propellant canister 125, such as a dimple of the propellant canister 125. In some embodiments, the device 100 includes multiple puncture units that are each suitable for puncturing the propellant canister 125 upon actuation. Alternatively, or additionally, the device may include one or more additional puncture units designed to puncture the dose holding chamber 140. For example, an additional puncture unit may puncture a distal end of the dose holding chamber 140 upon actuation. As another example, an additional puncture unit may puncture a proximal end of the dose holding chamber 140 upon actuation.
The diffuser 135 diffuses propellant released from the propellant canister 125. In one aspect, a majority of the propellant is diffused via the diffuser 135. In another aspect, a minority of the propellant is diffused via the diffuser 135. In some embodiments, the diffuser 135 is a porous member. An example of a diffuser 135 includes a frit, a plurality of frits, or a diffuser member or combinations thereof.
The diffuser 135 may act as a one-way check-valve to keep a liquid or dry compound in the dose holding chamber 140 from coming into contact with the propellant canister 125. For example, the diffuser 135 may prevent the compound from travelling into the propellant canister 125, while allowing the propellant to travel through the diffuser and push the compound in the opposite direction towards the nozzle. The diffuser 135 may also serve to reduce the velocity and/or pressure of the propellant exiting the propellant canister 125. The diffuser 135 may also serve to increase the temperature of the propellant exiting the propellant canister 125. Additionally, or alternatively, the diffuser 135 may convert propellant from a liquid to a gas. For example, the diffuser 135 may expand the propellant from a liquid state to a gaseous state. The gaseous propellant may aerosolize the compound and propel the aerosolized compound through the dose holding chamber 140 and out of the nozzle 110. In some embodiments, the device 100 does not include a diffuser. In these embodiments, the propellant flows from the propellant canister 125, through the dose holding chamber 140, and out of the nozzle 110, propelling the compound out of the nozzle 110 in the process.
The dose holding chamber 140 contains one or more unit doses of a compound. The compound may treat a variety of conditions, including but not limited to migraines, epilepsy, pain, agitation, Parkinson's disease, opioid overdose, addiction, narcolepsy, and/or sleeping disorders. Examples of the compound may include, but are not limited to olanzapine, levodopa, dihydroergotamine, sumatriptan, zolmitriptan, diazepam, midazolam, naloxone, dexameditimodine, morphine, and/or fentanyl. Alternative or additional compounds may be used in alternative embodiments.
In some embodiments, the device 100 may include a tip 155 that houses the nozzle 110, diffuser 135, and dose holding chamber 140.
The device 200 may further include a lock (not shown), such as a ratcheting lever lock, to lock the actuation lever 120 in an actuated (or partially actuated) position after the actuation lever 120 has rotated by a predetermined distance in an inward direction during actuation. The lock locks the actuation lever 120 in place after the device 200 has been actuated, preventing further actuation of the device 200. The lock may be placed along various locations of actuation lever 120. For example, the lock may comprise a ratcheting mechanism placed on the pivot point of the actuator lever 120 to enable rotation from an unactuated to an actuated position but to prevent rotation of the actuation lever 120 in a reverse direction. Thus, following actuation, the lock maintains the actuation lever 120 in the actuated position. Alternatively, or additionally, a lever lock may be placed near the actuation button 115 end of the actuation lever 120. In these embodiments, once the actuation button 115 is depressed, the lock latches over the depressed actuation button 115 to prevent the actuation lever 120 from lifting back up and therefore locks the actuation lever in the actuated position. Further, the device 200 may include a use indicator (not shown). The use indicator provides a visual indication that the device 200 has been actuated. Examples of use indicators include a cutout in the housing body 105 and/or a physical feature that protrudes from the housing body 105, each of which may display one color before the device has been actuated and a different color after the device has been actuated. The use indicator may be colored metal, colored plastic, an LED, and the like. Alternatively, the use indicator may be any suitable visual indicator that provides an indication the device 200 has been actuated.
Some of the components in the device 300 shown have a different form factor than the devices shown in
In the device 400 shown, the actuation button 440 is a slideable element that includes a securing latch 450, and the actuation lever 405 is spring 415 loaded. The actuation button 440 is connected to the actuation lever 405, which is contained within the housing body 410. When the actuation lever 405 is pushed by the compressed spring 415, the actuation lever 405 is also being held in place by the actuation button 440 at the interface of the actuation lever 405 and the securing latch 450.
When a user slides the actuation button 440 in a direction away from the nozzle 445, the actuation button 440 physically releases the actuating lever 405 at the mating interface of the actuation lever 405 and the securing latch 450. The spring force then drives the actuator lever 405 against the propellant canister 420, which forces propellant canister against the puncture unit 425. The puncture unit 425 punctures the propellant canister 420, which releases the propellant contained in the propellant canister 420.
The released propellant flows towards and through a diffuser 430, into the dose holding chamber 435, and out of the nozzle 445 (e.g., through one or more outlet orifices of the nozzle 445). Once the propellant enters the dose holding chamber 435, the propellant pushes the compound contained in the dose holding chamber 435 out through the nozzle 445 itself.
Similar to the devices shown in
In addition, the diffuser 430 may act to keep a liquid or dry compound in the dose holding chamber 430, serve to reduce the velocity and/or pressure of the propellant exiting the propellant canister 420, serve to increase the temperate of the propellant exiting the propellant canister 420, and/or convert propellant from a liquid to a gas.
In some embodiments, the actuation button 440 is configured such that the device 400 is actuated by depressing the actuation button 440 in a direction towards the housing body. Upon depression of the actuation button 440, the actuation lever 405 is released from an unactuated position to an actuated position. This causes the propellant canister 420 to contact the puncture unit 425, which punctures the propellant canister 420. In these embodiments, the actuation lever 405 may be spring loaded. While the actuation button 440 shown is on the top of the device 400, the actuation button 440 may be placed on the bottom, side, front, and/or back of the device 400. Further, in some embodiments, the device 400 is actuated in a single actuation step. In other embodiments, the device 400 is actuated in one or more actuation steps. For example, the device 400 may require a priming step to load the spring 415.
Additional Configuration Information
The foregoing description of the embodiments of the disclosure has been presented for the purpose of illustration; it is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Persons skilled in the relevant art can appreciate that many modifications and variations are possible in light of the above disclosure.
The language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the disclosure be limited not by this detailed description, but rather by any claims that issue on an application based hereon. Accordingly, the disclosure of the embodiments is intended to be illustrative, but not limiting, of the scope of the disclosure, which is set forth in the following claims.
This application claims the benefit of provisional U.S. Patent Application No. 62/849,735, filed on May 17, 2019, which is incorporated by reference herein in its entirety for all purposes.
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| Number | Date | Country | |
|---|---|---|---|
| 20200360627 A1 | Nov 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62849735 | May 2019 | US |
