US20230241334A1 - In-line Nasal Delivery Device - Google Patents
In-line Nasal Delivery Device Download PDFInfo
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- US20230241334A1 US20230241334A1 US18/297,601 US202318297601A US2023241334A1 US 20230241334 A1 US20230241334 A1 US 20230241334A1 US 202318297601 A US202318297601 A US 202318297601A US 2023241334 A1 US2023241334 A1 US 2023241334A1
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- junction
- propellant
- compound
- dose
- pump
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- Abandoned
Links
- 150000001875 compounds Chemical class 0.000 claims abstract description 72
- 239000012530 fluid Substances 0.000 claims abstract description 23
- 238000004891 communication Methods 0.000 claims abstract description 22
- 239000003380 propellant Substances 0.000 abstract description 95
- 210000001331 nose Anatomy 0.000 description 13
- 239000007789 gas Substances 0.000 description 11
- 210000003928 nasal cavity Anatomy 0.000 description 9
- 239000007788 liquid Substances 0.000 description 6
- 239000008186 active pharmaceutical agent Substances 0.000 description 4
- 210000003169 central nervous system Anatomy 0.000 description 4
- 238000007906 compression Methods 0.000 description 4
- 230000006835 compression Effects 0.000 description 4
- 238000000151 deposition Methods 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000004033 plastic Substances 0.000 description 4
- 239000002184 metal Substances 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 239000011148 porous material Substances 0.000 description 3
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 230000008021 deposition Effects 0.000 description 2
- 238000006073 displacement reaction Methods 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000007922 nasal spray Substances 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 230000037452 priming Effects 0.000 description 2
- 210000001944 turbinate Anatomy 0.000 description 2
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 description 1
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 229930195733 hydrocarbon Natural products 0.000 description 1
- 150000002430 hydrocarbons Chemical class 0.000 description 1
- 150000005828 hydrofluoroalkanes Chemical class 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000007923 nasal drop Substances 0.000 description 1
- 229940097496 nasal spray Drugs 0.000 description 1
- JCXJVPUVTGWSNB-UHFFFAOYSA-N nitrogen dioxide Inorganic materials O=[N]=O JCXJVPUVTGWSNB-UHFFFAOYSA-N 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 230000036316 preload Effects 0.000 description 1
- 230000001141 propulsive effect Effects 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/08—Inhaling devices inserted into the nose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0618—Nose
Definitions
- olfactory region of the nasal cavity is difficult to accomplish due to the complex architecture of the nasal cavity and the turbinate guided air path for inhaled breath through the nose. These natural structures act to prevent materials from depositing on the olfactory region as a way to protect this entry way into the central nervous system (CNS).
- CNS central nervous system
- Nasal drop or spray devices such as the Pfieffer nasal spray devices (Radolfzell, Germany), are designed to saturate the lower nasal cavity. Drug deposited on the lower nasal cavity is absorbed into the blood stream instead of the CNS, eliminating an advantage of using the nasal route for CNS delivery.
- a device for the intranasal delivery of a compound including a y-junction having a base, a first branch of the y-junction radiating from the base, a second branch of the y-junction radiating from the base, a third branch of the y-junction radiating from the base, and an internal dose loading channel of the y-junction, a metered dose pump in fluid communication with the first branch of the y-junction, a conical spring associated with the second branch of the y-junction, a dose chamber in fluid communication with the third branch of the y-junction, a nozzle associated with the dose chamber, a diffuser compression fit between the internal dose loading channel and the dose chamber, an actuator grip surrounding the y-junction, and a housing, the y-junction residing within the housing.
- the in-line nasal delivery device further includes a propellant canister in fluid communication with the second branch of the y-junction and held by the actuator grip, the conical spring between the propellant canister and the second branch of the y-junction.
- the in-line nasal delivery device further includes a vial in fluid communication with the metered dose pump.
- the in-line nasal delivery device further includes a pump fitment securing the metered dose pump to the vial.
- an in-line nasal delivery device for the intranasal delivery of a compound including a housing, the housing including a tip, an actuator, and a dose chamber, the tip and the dose chamber in fluid communication within the housing, a nozzle at a distal portion of the tip, the nozzle providing an outlet for the compound, and a pump in fluid communication with the dose chamber, the pump to move the compound into the dose chamber.
- the in-line nasal delivery device further includes a propellant canister in communication with the housing, the propellant canister having a propellant valve and in fluid communication with the dose chamber.
- the in-line nasal delivery device further includes a vial of compound cooperative with the pump to move the compound into the dose chamber.
- the in-line nasal delivery device when actuated compresses the pump moving the compound into the dose chamber and actuation of the propellant valve disperses the propellant pushing the compound providing for the compound to exit the device through the nozzle openings.
- FIG. 1 shows a cross section of the in-line nasal delivery device.
- FIG. 2 shows a cross section of the in-line nasal delivery device in the stages of rest and actuation.
- FIG. 2 A shows the in-line nasal delivery device at rest with FIG. 2 B showing the actuation of the pump and FIG. 2 C showing actuation of the propellant valve.
- FIG. 3 shows a cross section of another implementation of the in-line nasal delivery device.
- FIG. 4 shows a cross section of the diffuser as seated within the device.
- FIG. 5 A shows an exploded view of the dose chamber and the y-junction unassembled.
- FIG. 5 B shows an exploded view of the dose chamber and y-junction in cooperation.
- FIG. 6 shows arrows representing both dose and propellant flow.
- FIG. 7 shows the actuator grip and conical spring arrangement.
- FIG. 8 shows a cross section of the optional nose cone and a side elevation of the optional nose cone.
- the in-line nasal delivery device 1 delivers compound into the nasal cavity and deposits compound in the nasal cavity beyond the nasal valve.
- the deposition includes the turbinates and/or the olfactory region.
- the compound delivered is a liquid.
- the compound may be a drug, active pharmaceutical ingredient, or a pharmaceutical formulation.
- the compound delivered may be a dose.
- the in-line nasal delivery device 1 includes a housing 10 , diffuser 20 , tip 35 , nozzle 40 , dose chamber 45 , an actuator 50 , and a pump 25 to move the compound into the dose chamber 45 .
- the in-line nasal device 1 is associated and cooperative with a propellant canister 5 , a propellant valve 15 , and a vial 30 of compound cooperative with the pump 25 to move the compound into the dose chamber 45 .
- the diffuser 20 is a frit 21 .
- the diffuser provides for the conversion of the liquefied propellant in the propellant canister 5 to gas and/or an increase in temperature of the propellant.
- the propellant valve 15 is a metered dose propellant valve 16 .
- the compound is supplied in the form of a sealed vial 30 , e.g., of glass, that contains a quantity of liquid.
- the vial 30 has a neck 31 that is sealed by a removable closure 32 (not shown), for example but not limited to sealed with a plastic cover, crimped metal seal, and rubber stopper (for stability and sterility purposes).
- the vial 30 may contain the active pharmaceutical ingredient.
- the propellant canister 5 is a canister of a compressed gas or a liquefied propellant.
- Compressed gases include but are not limited to compressed air and compressed hydrocarbons. In one aspect, nitrogen or carbon dioxide.
- Liquefied propellants include but are not limited to chlorofluorocarbons and hydrofluoroalkanes.
- the canister 5 will generally be provided with a propellant valve 15 by which the gas flow can be controlled.
- the tip 35 includes a nozzle 40 .
- the nozzle 40 has a plurality of nozzle openings 41 (not shown). Thru the plurality of nozzle openings 41 , the compound and propellant is delivered to the nasal cavity.
- FIG. 2 shows the device 1 at rest ( FIG. 2 A ) and in actuation ( FIGS. 2 B and 2 C ).
- the staging of the device 1 actuation is as follows.
- the housing 10 is compressed to prime the propellant canister 5 .
- an actuator 50 remains stationary in the housing 10 while the propellant canister 5 and the vial 30 move towards the actuator 50 .
- the propellant valve 15 associated with the propellant canister 5 is not actuated by compression.
- the actuator 50 acts upon the pump 25 compressing the pump 25 and the compound from the vial 30 is moved into the dose chamber 45 .
- the actuator 50 acts upon the propellant valve 15 and the propellant valve 15 begins to compress.
- the continued depression of the actuator 50 releases the propellant from the propellant canister 5 .
- the propellant pushes the compound as it exits the device 1 through the nozzle openings 41 of the nozzle 40 located in the tip 35 .
- the actuator 50 provides for first actuation of the pump 25 , then once the pump 25 bottoms out, the continued depression of the actuator 50 provides for release of the propellant from the canister 5 .
- the device 1 does not include a diffuser 20 .
- FIG. 3 shows yet another implementation of the device 100 .
- the device 100 can deliver a single or multiple dose from a vial 30 or other container.
- the device 100 allows for multiple doses to be delivered from the vial 30 , or a single dose.
- the vial 30 may contain a volume of compound for multiple doses, while the user may decide to only deliver a single dose from the vial 30 .
- the compound may be a drug, active pharmaceutical ingredient, or a pharmaceutical formulation.
- the vial 30 may be separate from the rest of the assembled device 100 .
- the device 100 and vial 30 are taken out of their respective packaging.
- the vial 30 will generally be sealed.
- the vial 30 is covered by a plastic cover, metal seal and stopper, the plastic cover and metal seal are pulled away from the top of the vial 30 , and the rubber stopper is removed from the vial 30 .
- the vial 30 may be screwed into a pump fitment 180 located at the base of the device 100 .
- the vial 30 may have female threads which can be screwed into male threads on a pump fitment 180 , or vice versa.
- the vial 30 may contain, for example but not limited to, inclusive of end points, 2-3 ml, in another aspect 2-2.5 ml of compound.
- the device 100 includes a housing 110 .
- the housing 110 contains components of the device 100 including the y-junction 120 .
- the y-junction 120 has three branches radiating from a common base.
- the y-junction and its three branches may be a molded component.
- the y-junction 120 establishes both fluid and gas paths within the device 100 , and connects the metered dose pump 130 , the dose chamber 150 , and the propellant canister 140 when the propellant canister 140 is assembled with the device.
- the user will generally orient the device 100 with the propellant canister 140 assembled and located at the top and the vial 30 assembled and located at the bottom.
- the optional check-valve 160 (attached to the metered dose pump 130 stem) press fits into a receiving hub of a first branch of the y-junction 120 .
- An internal bore provides fluid communication from the metered dose pump 130 , through the optional check-valve 160 and y-junction 120 , to the dose chamber 150 .
- the check valve 160 is an elastomeric component that installs within a plastic housing between the metered dose pump 130 and the y-junction 120 .
- the optional check valve 160 (a) reduces or eliminates dose leakage which could occur through the metered dose pump 130 if the pump stem was depressed and the propellant canister 140 was actuated; (b) allows for improved consistency in dose delivery by the device 100 ; and/or provides that compound is not pushed back down the internal dose loading channel 230 of the y-junction 120 and into the metered dose pump 130 .
- the propellant canister 140 When oriented as to be used in operation, housed within the device's 100 housing 110 , towards the top of the device 100 , the propellant canister 140 press fits into a second branch of the y-junction 120 , establishing the gas path through internal bores, through the diffuser 170 and to the dose chamber 150 .
- the diffuser 170 is annular. As shown in FIG. 4 , the annular diffuser 170 sits inside a bore on the back end of the dose chamber 150 . The external diameter of the annual diffuser 170 is in a compression fit with the dose chamber 150 . An internal dose loading channel 230 which is molded as a portion of the y-junction 120 fits into the inner bore of the annual diffuser 170 when the dose chamber 150 is installed onto the y-junction 120 . The inner diameter of the annular diffuser 170 is in compression with the internal dose loading channel 230 portion of the y-junction 120 . The annular diffuser 170 is seated between the outer wall of the internal dose loading channel 230 and the inner wall of the dose chamber 150 , sealing against both of those surfaces to form the bottom of the dose chamber 150 .
- the diffuser 170 is a frit 171 .
- the diffuser 170 (a) provides for the conversion of the liquefied propellant in the propellant canister 140 to gas; (b) provides an increase in temperature of the propellant; (c) acts to prevent the propellant from flowing back into the device 100 ; (d) acts to prevent the compound from flowing back into the device 100 ; and/or (e) acts to allows gas flow into the dose chamber 150 while preventing the compound from leaking out.
- the diffuser may be made of a porous polymer material.
- the relationship in operation of the device 100 between the compound, the annular diffuser 170 , the inner dose loading tube 230 , the dose chamber 150 and the y-junction 120 are shown at least in FIG. 6 .
- the compound being loaded into the dose chamber 150 takes the less restrictive route, flowing out of the vial 30 and filling the dose chamber 150 rather than loading backwards through the annular diffuser 170 and into the delivery path of the propellant of the y-junction 120 .
- the staging of operation and the amount of time required for operation of the device allows the annular diffuser 170 to restrict compound from flowing back into the y-junction 120 for the period of time needed, as the propellant canister 140 is activated after compound loading.
- the entire actuation of the device 100 is approximately a second or less than a second.
- the loaded dose in the dose chamber 150 does not have enough time to flow backwards into the y-junction 120 .
- the propellant expels the compound from the device 100 .
- the dose chamber 150 press fits into the y-junction 120 , completing the flow paths for both gas and fluid through the device.
- the angle is 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, inclusive of endpoints and intervening degrees.
- the y-junction 120 may contain engagement ribs (not shown) to help secure and position the assembly within the housing 110 of the device 100 .
- the device 100 includes a pump fitment 180 .
- the pump fitment 180 secures the metered dose pump 130 to the vial 30 and holds both components in place during device 100 use.
- One aspect of the pump fitment 180 is that it consists of engagement ribs that retain it within the housing 110 , provide vertical displacement, and prevent rotation during installation of the vial 30 .
- the device 100 includes a dose chamber 150 .
- the dose chamber 150 receives and stores the compound that has been pushed out of the inner tube of the y-junction 120 .
- the propellant canister 140 is actuated, the y-junction 120 and dose chamber 150 are pressurized and the propellant gas expels the compound out of the dose chamber 150 .
- the dose chamber 150 is press fit into the y-junction 120 .
- the nozzle 190 is installed into the end of the dose chamber 150 opposite where it is press fit into the y-junction 120 .
- the nozzle 190 is installed into the distal end (end opposite where the dose chamber 150 is press fit into the y-junction 120 ) of the dose chamber 150 , forming a liquid and gas-tight seal around the outer diameter.
- propellant evacuates liquid compound from the dose chamber 150 , pushing it out the nozzle 190 .
- the nozzle 190 forms the narrow plume angle (for example, an angle of 1 to 40 degrees, including endpoints and angles intermittent there between; in one aspect the angle is 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees) multi-stream deposition.
- the nozzle 190 and resultant angle of the plume produced promotes delivery of the compound to the olfactory region of the user's nasal cavity.
- the device 100 may include an optional nose cone 200 .
- the external geometries of the nose cone 200 assist in providing proper alignment of the device 100 during insertion into the nose.
- the diametrically opposed flat sides aid with placement against the septum of either naris, with the depth stop providing correct depth of insertion.
- the nose cone 200 adds redundancy to nozzle 190 retention through mechanical interference incorporated into the design.
- there is an opening in the nose cone 200 which aligns with the nozzle 190 .
- the nose cone 200 is not part of the pressurized flow path.
- the housing 110 represents the body of the device 100 .
- the housing 110 includes two different “clamshells” concealing the components of the device 100 and retaining all components to ensure functionality.
- the housing 110 houses the metered dose pump 130 and pump fitment 180 , the actuator grip 210 , the y-junction 120 , the propellant canister 140 , and the dose chamber 150 .
- the nose cone 200 engages onto the outer geometry of the housing 110 .
- the housing 110 is designed to assemble easily through the use of, for example but not limited to, mattel pins, snaps, post or screws, or a combination thereof, molded into the geometry.
- the actuator grip 210 provides for actuation displacement by the user.
- the actuator grip 210 is composed of two parts, actuator grip A and actuator grip B and surround the y-junction 120 and reside within the housing 110 .
- FIG. 7 shows two finger grip notches 215 are designed into the actuator grip 210 to allow the user to engage the device 100 with the fingers, for example but not limited to, the index and middle finger. These finger grip notches 215 allow the user to apply downward movement leading to device 100 actuation.
- the metered dose pump 130 draws compound up from the vial 30 to the y-junction 120 .
- the metered dose pump 130 may utilize a custom pump fitment 180 to promote functionality within the device 100 , and allow attachment of the vial 30 via threads.
- the metered dose pump 130 may deliver, for example but not limited to, volumes, 180 ⁇ l, 200 ⁇ l, or 230 ⁇ l during actuation. Commercially available metered dose pumps 130 can be used.
- the metered dose pump 130 For the device 100 to consistently deliver compound, the metered dose pump 130 must first deliver compound, followed by propellant canister 140 actuation to expel the compound. As shown in FIG. 7 , one manner in which to accomplish this is via a conical spring 220 between the propellant canister 140 and y-junction 120 to create the necessary propellant canister 140 actuation force resulting in the correct order of actuation between the metered dose pump 130 and propellant canister 140 . In one implementation, a conical spring 220 is used, although this force is not limited to being produced by a conical spring 220 as other mechanisms can be used.
- the conical spring 220 has a near zero preload, with a k value of about 25.5 lbf ⁇ in and a maximum load of 3.21 bf. Selection of the spring or mechanism will include the considerations of: (a) providing for proper device 100 staging; (b) physical space in the device 100 ; and/or (c) and user feedback regarding how stiff of a conical spring 220 still allows a variety of users to activate the device 100 .
- the conical spring 220 is installed inline between the propellant canister 140 and y-junction 120 .
- the actuator grip 210 physically holds the propellant canister 140 .
- the user activates the device 100 by, for example, applying an in-line force acting down from the actuator grips 210 , and up from the vial 30 . This force simultaneously acts to activate both the metered dose pump 130 and the propellant canister 140 .
- the conical spring 220 acts in parallel to the internal propellant canister spring, increasing the necessary force required to activate the propellant canister 140 .
- the device 100 By choosing the conical spring 220 such that the necessary force required to actuate the propellant canister 140 is in excess of the maximum necessary force required to completely actuate the metered dose pump 130 , the device 100 provides that dose is loaded into the dose chamber 150 before propellant gas begins to expel compound from the device 100 .
- the metered dose pump 130 draws liquid compound up from the vial 30 at the bottom of the device 100 via the y-junction 120 , through the internal dose loading channel 230 and into the dose chamber 150 .
- the internal dose loading channel 230 provides a clear route for the compound to be loaded ahead of the annular diffuser 170 , without needed to physically pass through the porous material of the annular diffuser 170 .
- small arrow heads represent the flow of the propellant while large arrow heads represent the flow of the compound.
- Priming shots may be required to completely fill the metered dose pump 130 and internal dose loading channel 230 of the y-junction 120 prior to user dosing.
- a dose cap (not shown) may cover the nose cone 200 of the device 100 and captures the priming shots while also providing a means of visual indication to the user that the device is primed.
- the propellant canister 140 releases propellant which enters through the top of the y-junction 120 , following the path shown by open arrow heads in FIG. 6 .
- the propellant flows physically through the porous material of the annular diffuser 170 , which promotions in the vaporization of the propellant.
- the propellant first contacts the compound at the distal (distal being closer to the nozzle 190 , proximal being farther away from the nozzle 190 ) face of the annular diffuser 150 as seated in the device 100 .
- the propellant continues to expand, it pushes the compound forward (toward the nozzle 190 ) in the dose chamber 150 , exiting though the nozzle 190 at the end of the dose chamber 150 .
- the propellant canister 140 provides the propulsive energy for the device 100 .
- the stem of the propellant valve seats into the top receiver of the y-junction 120 .
- the user presses down on the actuator grips 210 which pulls the propellant canister 140 body down, actuating the propellant valve. This releases a metered volume of liquid propellant.
- the propellant vaporizes and expands, the compound is forced out of the dose chamber 150 and out through the nozzle 190 .
- the propellant canister 140 uses HFA 134 A as the propellant for the system.
- Other propellants are envisioned.
- the device 100 , the propellant canister 140 , and the vial 30 may all be included or provided together in a kit.
- a device for the intranasal delivery of a compound comprising:
- a y-junction including a base, a first branch of the y-junction radiating from the base, a second branch of the y-junction radiating from the base, a third branch of the y-junction radiating from the base, and an internal dose loading channel of the y-junction;
- a metered dose pump in fluid communication with the first branch of the y-junction
- a dose chamber in fluid communication with the third branch of the y-junction
- the y-junction residing within the housing.
- a propellant canister in fluid communication with the second branch of the y-junction and held by the actuator grip, the conical spring between the propellant canister and the second branch of the y-junction.
- Clause 3 The device of any of clauses 1-11, further comprising a vial in fluid communication with the metered dose pump.
- Clause 4 The device of clause 3, further comprising a pump fitment securing the metered dose pump to the vial.
- Clause 5 The device of any of clauses 1-11, further including a check-valve associated between the metered dose pump and the y-junction.
- Clause 6 The device of any of clauses 1-11, further including a nose cone in engagement with the housing.
- Clause 7 The device of clause 6 further comprising a dose cap covering the nose cone.
- Clause 8 The device of any of clauses 1-11, wherein the third branch of the y-junction is at a 45-degree angle from the base of the y-junction.
- Clause 10 The device of any of clauses 1-11, wherein the diffuser is a porous material.
- a device for the intranasal delivery of a compound comprising:
- the housing including a tip, an actuator, and a dose chamber, the tip and the dose chamber in fluid communication within the housing;
- nozzle at a distal portion of the tip, the nozzle providing an outlet for the compound, the nozzle including a plurality of nozzle openings;
- a pump in fluid communication with the dose chamber, the pump to move the compound into the dose chamber upon actuation of the actuator.
- Clause 13 The device of any of clauses 12-15, further comprising a propellant canister associated with the housing, the propellant canister having a propellant valve for actuation by the actuator, the propellant canister in fluid communication with the dose chamber.
- Clause 14 The device of clauses 12-15, further comprising a vial of compound associated with the pump to move the compound into the dose chamber from the vial.
- Clause 15 The device of clauses 12-15, further including a diffuser.
- a device for the intranasal delivery of a compound to the olfactory region of the nasal cavity comprising:
- the housing including a tip, an actuator, and a dose chamber, the tip and the dose chamber in fluid communication with the housing;
- a nozzle at a distal portion of the tip the nozzle providing an outlet for the compound, the nozzle including a plurality of nozzle openings;
- a pump in fluid communication with the dose chamber, the pump to move the compound into the dose chamber upon actuation of the actuator;
- propellant canister associated with the housing, the propellant canister having a propellant valve for actuation by the actuator, the propellant canister in fluid communication with the dose chamber;
- a vial of compound associated with the pump to move the compound into the dose chamber from the vial wherein the actuator upon actuation of the device compresses the pump moving the compound into the dose chamber and actuation of the propellant valve disperses the propellant pushing the compound providing for the compound to exit the device through the plurality of nozzle openings.
- kits including the device any of clauses 1-16, a propellant canister and a vial.
Abstract
Description
- This application is a continuation of U.S. patent application Ser. No. 17/866,222, filed Jul. 15, 2022, which is a continuation of U.S. patent application Ser. No. 17/585,099, filed Jan. 26, 2022, which is a continuation of U.S. patent application Ser. No. 15/759,447 (now U.S. Pat. No. 11,266,799) which is a National Stage Entry of PCT/US2016/051169 filed Sep. 9, 2016, which claims priority to U.S. Provisional Patent Application No. 62/216,789 filed Sep. 10, 2015, the contents of all of which are hereby incorporated by reference herein in their entirety.
- Depositing drug on the olfactory region of the nasal cavity is difficult to accomplish due to the complex architecture of the nasal cavity and the turbinate guided air path for inhaled breath through the nose. These natural structures act to prevent materials from depositing on the olfactory region as a way to protect this entry way into the central nervous system (CNS). Nasal drop or spray devices, such as the Pfieffer nasal spray devices (Radolfzell, Germany), are designed to saturate the lower nasal cavity. Drug deposited on the lower nasal cavity is absorbed into the blood stream instead of the CNS, eliminating an advantage of using the nasal route for CNS delivery.
- A more elegant approach to the intranasal delivery of compounds or mixtures is needed.
- Shown and described is one implementation of a device for the intranasal delivery of a compound including a y-junction having a base, a first branch of the y-junction radiating from the base, a second branch of the y-junction radiating from the base, a third branch of the y-junction radiating from the base, and an internal dose loading channel of the y-junction, a metered dose pump in fluid communication with the first branch of the y-junction, a conical spring associated with the second branch of the y-junction, a dose chamber in fluid communication with the third branch of the y-junction, a nozzle associated with the dose chamber, a diffuser compression fit between the internal dose loading channel and the dose chamber, an actuator grip surrounding the y-junction, and a housing, the y-junction residing within the housing.
- In one aspect, the in-line nasal delivery device further includes a propellant canister in fluid communication with the second branch of the y-junction and held by the actuator grip, the conical spring between the propellant canister and the second branch of the y-junction.
- In another aspect, the in-line nasal delivery device further includes a vial in fluid communication with the metered dose pump.
- In yet another aspect, the in-line nasal delivery device further includes a pump fitment securing the metered dose pump to the vial.
- In another implementation, shown and described is an in-line nasal delivery device for the intranasal delivery of a compound including a housing, the housing including a tip, an actuator, and a dose chamber, the tip and the dose chamber in fluid communication within the housing, a nozzle at a distal portion of the tip, the nozzle providing an outlet for the compound, and a pump in fluid communication with the dose chamber, the pump to move the compound into the dose chamber.
- In one aspect, the in-line nasal delivery device further includes a propellant canister in communication with the housing, the propellant canister having a propellant valve and in fluid communication with the dose chamber.
- In another aspect, the in-line nasal delivery device further includes a vial of compound cooperative with the pump to move the compound into the dose chamber.
- In another aspect, the in-line nasal delivery device when actuated compresses the pump moving the compound into the dose chamber and actuation of the propellant valve disperses the propellant pushing the compound providing for the compound to exit the device through the nozzle openings.
- The invention will best be understood by reference to the following detailed description of various implementations, taken in conjunction with any accompanying drawings. The discussion below is descriptive, illustrative and exemplary and is not to be taken as limiting the scope defined by any appended claims.
- The foregoing aspects and many of the advantages will be more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
-
FIG. 1 shows a cross section of the in-line nasal delivery device. -
FIG. 2 shows a cross section of the in-line nasal delivery device in the stages of rest and actuation.FIG. 2A shows the in-line nasal delivery device at rest withFIG. 2B showing the actuation of the pump andFIG. 2C showing actuation of the propellant valve. -
FIG. 3 shows a cross section of another implementation of the in-line nasal delivery device. -
FIG. 4 shows a cross section of the diffuser as seated within the device. -
FIG. 5A shows an exploded view of the dose chamber and the y-junction unassembled. -
FIG. 5B shows an exploded view of the dose chamber and y-junction in cooperation. -
FIG. 6 shows arrows representing both dose and propellant flow. -
FIG. 7 shows the actuator grip and conical spring arrangement. -
FIG. 8 shows a cross section of the optional nose cone and a side elevation of the optional nose cone. - When trade names are used herein, applicants intend to independently include the trade name product and formulation, the generic compound, and the active pharmaceutical ingredient(s) of the trade name product.
- For clarity of disclosure, and not by way of limitation, the detailed description is divided into the subsections which follow.
- 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, apparatus and compositions described. As used herein, the following terms and phrases have the meanings ascribed to them unless specified otherwise:
- “A” or “an” may mean one or more.
- In one implementation, the in-line
nasal delivery device 1 delivers compound into the nasal cavity and deposits compound in the nasal cavity beyond the nasal valve. The deposition includes the turbinates and/or the olfactory region. The compound delivered is a liquid. The compound may be a drug, active pharmaceutical ingredient, or a pharmaceutical formulation. The compound delivered may be a dose. - As shown in
FIG. 1 , the in-linenasal delivery device 1 includes ahousing 10,diffuser 20,tip 35,nozzle 40,dose chamber 45, anactuator 50, and apump 25 to move the compound into thedose chamber 45. In one aspect, the in-linenasal device 1 is associated and cooperative with apropellant canister 5, apropellant valve 15, and avial 30 of compound cooperative with thepump 25 to move the compound into thedose chamber 45. - In one aspect, the
diffuser 20 is a frit 21. The diffuser provides for the conversion of the liquefied propellant in thepropellant canister 5 to gas and/or an increase in temperature of the propellant. - In one aspect, the
propellant valve 15 is a metered dose propellant valve 16. - In one aspect, the compound is supplied in the form of a sealed
vial 30, e.g., of glass, that contains a quantity of liquid. In one aspect, thevial 30 has aneck 31 that is sealed by a removable closure 32 (not shown), for example but not limited to sealed with a plastic cover, crimped metal seal, and rubber stopper (for stability and sterility purposes). In one aspect, thevial 30 may contain the active pharmaceutical ingredient. When the closure 32 is removed, thedevice 1 is engaged with thevial 30, in one aspect, by cooperation with theneck 31 of thevial 30. Apump 25 moves the compound into thedose chamber 45. - The
propellant canister 5 is a canister of a compressed gas or a liquefied propellant. Compressed gases include but are not limited to compressed air and compressed hydrocarbons. In one aspect, nitrogen or carbon dioxide. Liquefied propellants include but are not limited to chlorofluorocarbons and hydrofluoroalkanes. Thecanister 5 will generally be provided with apropellant valve 15 by which the gas flow can be controlled. - The
tip 35 includes anozzle 40. In one aspect, thenozzle 40 has a plurality of nozzle openings 41 (not shown). Thru the plurality of nozzle openings 41, the compound and propellant is delivered to the nasal cavity. - Actuation of the
propellant canister 5 is effectively coordinated with actuation of thepump 25 for thevial 30 for the compound. The arrangement may be such that actuation of thevial 30 for the compound causes actuation of thepropellant canister 5.FIG. 2 shows thedevice 1 at rest (FIG. 2A ) and in actuation (FIGS. 2B and 2C ). - As an example, the staging of the
device 1 actuation is as follows. Thehousing 10 is compressed to prime thepropellant canister 5. When thehousing 10 is compressed, anactuator 50 remains stationary in thehousing 10 while thepropellant canister 5 and thevial 30 move towards theactuator 50. At this time, thepropellant valve 15 associated with thepropellant canister 5 is not actuated by compression. The actuator 50 acts upon thepump 25 compressing thepump 25 and the compound from thevial 30 is moved into thedose chamber 45. After a majority of the compound has moved into thedose chamber 45, the actuator 50 acts upon thepropellant valve 15 and thepropellant valve 15 begins to compress. The continued depression of theactuator 50 releases the propellant from thepropellant canister 5. The propellant pushes the compound as it exits thedevice 1 through the nozzle openings 41 of thenozzle 40 located in thetip 35. Theactuator 50 provides for first actuation of thepump 25, then once thepump 25 bottoms out, the continued depression of theactuator 50 provides for release of the propellant from thecanister 5. - In an alternative implementation of the device 1 (not shown), the
device 1 does not include adiffuser 20. -
FIG. 3 shows yet another implementation of thedevice 100. Thedevice 100 can deliver a single or multiple dose from avial 30 or other container. Thedevice 100 allows for multiple doses to be delivered from thevial 30, or a single dose. For example, thevial 30 may contain a volume of compound for multiple doses, while the user may decide to only deliver a single dose from thevial 30. The compound may be a drug, active pharmaceutical ingredient, or a pharmaceutical formulation. - Initially, the
vial 30 may be separate from the rest of the assembleddevice 100. At the time of use, thedevice 100 andvial 30 are taken out of their respective packaging. Prior to use, thevial 30 will generally be sealed. In the aspect where thevial 30 is covered by a plastic cover, metal seal and stopper, the plastic cover and metal seal are pulled away from the top of thevial 30, and the rubber stopper is removed from thevial 30. Thevial 30 may be screwed into apump fitment 180 located at the base of thedevice 100. For example, but not limitation, thevial 30 may have female threads which can be screwed into male threads on apump fitment 180, or vice versa. Thevial 30 may contain, for example but not limited to, inclusive of end points, 2-3 ml, in another aspect 2-2.5 ml of compound. - As shown in
FIG. 3 , thedevice 100 includes ahousing 110. Thehousing 110 contains components of thedevice 100 including the y-junction 120. The y-junction 120 has three branches radiating from a common base. The y-junction and its three branches may be a molded component. The y-junction 120 establishes both fluid and gas paths within thedevice 100, and connects the metereddose pump 130, thedose chamber 150, and thepropellant canister 140 when thepropellant canister 140 is assembled with the device. - As shown in
FIG. 3 , for use of thedevice 100, the user will generally orient thedevice 100 with thepropellant canister 140 assembled and located at the top and thevial 30 assembled and located at the bottom. Housed within the device's 100housing 110, the optional check-valve 160 (attached to the metereddose pump 130 stem) press fits into a receiving hub of a first branch of the y-junction 120. An internal bore provides fluid communication from the metereddose pump 130, through the optional check-valve 160 and y-junction 120, to thedose chamber 150. In one aspect, thecheck valve 160 is an elastomeric component that installs within a plastic housing between themetered dose pump 130 and the y-junction 120. The optional check valve 160: (a) reduces or eliminates dose leakage which could occur through the metereddose pump 130 if the pump stem was depressed and thepropellant canister 140 was actuated; (b) allows for improved consistency in dose delivery by thedevice 100; and/or provides that compound is not pushed back down the internaldose loading channel 230 of the y-junction 120 and into the metereddose pump 130. - When oriented as to be used in operation, housed within the device's 100
housing 110, towards the top of thedevice 100, thepropellant canister 140 press fits into a second branch of the y-junction 120, establishing the gas path through internal bores, through thediffuser 170 and to thedose chamber 150. - In this implementation of the
device 100, thediffuser 170 is annular. As shown inFIG. 4 , theannular diffuser 170 sits inside a bore on the back end of thedose chamber 150. The external diameter of theannual diffuser 170 is in a compression fit with thedose chamber 150. An internaldose loading channel 230 which is molded as a portion of the y-junction 120 fits into the inner bore of theannual diffuser 170 when thedose chamber 150 is installed onto the y-junction 120. The inner diameter of theannular diffuser 170 is in compression with the internaldose loading channel 230 portion of the y-junction 120. Theannular diffuser 170 is seated between the outer wall of the internaldose loading channel 230 and the inner wall of thedose chamber 150, sealing against both of those surfaces to form the bottom of thedose chamber 150. - In one aspect, the
diffuser 170 is a frit 171. The diffuser 170: (a) provides for the conversion of the liquefied propellant in thepropellant canister 140 to gas; (b) provides an increase in temperature of the propellant; (c) acts to prevent the propellant from flowing back into thedevice 100; (d) acts to prevent the compound from flowing back into thedevice 100; and/or (e) acts to allows gas flow into thedose chamber 150 while preventing the compound from leaking out. The diffuser may be made of a porous polymer material. - The relationship in operation of the
device 100 between the compound, theannular diffuser 170, the innerdose loading tube 230, thedose chamber 150 and the y-junction 120 are shown at least inFIG. 6 . In operation, the compound being loaded into thedose chamber 150 takes the less restrictive route, flowing out of thevial 30 and filling thedose chamber 150 rather than loading backwards through theannular diffuser 170 and into the delivery path of the propellant of the y-junction 120. In operation of thedevice 100, the staging of operation and the amount of time required for operation of the device allows theannular diffuser 170 to restrict compound from flowing back into the y-junction 120 for the period of time needed, as thepropellant canister 140 is activated after compound loading. Duringproper device 100 use, the entire actuation of thedevice 100, including metereddose pump 130 andpropellant canister 140, is approximately a second or less than a second. The loaded dose in thedose chamber 150 does not have enough time to flow backwards into the y-junction 120. Immediately after thedose chamber 150 is full, the propellant expels the compound from thedevice 100. - On the third leg of the y-
junction 120 at a 45-degree angle, thedose chamber 150 press fits into the y-junction 120, completing the flow paths for both gas and fluid through the device. In one aspect, the angle is 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, inclusive of endpoints and intervening degrees. - The y-
junction 120 may contain engagement ribs (not shown) to help secure and position the assembly within thehousing 110 of thedevice 100. - The
device 100 includes apump fitment 180. Thepump fitment 180 secures the metereddose pump 130 to thevial 30 and holds both components in place duringdevice 100 use. One aspect of thepump fitment 180 is that it consists of engagement ribs that retain it within thehousing 110, provide vertical displacement, and prevent rotation during installation of thevial 30. - The
device 100 includes adose chamber 150. Thedose chamber 150 receives and stores the compound that has been pushed out of the inner tube of the y-junction 120. When thepropellant canister 140 is actuated, the y-junction 120 anddose chamber 150 are pressurized and the propellant gas expels the compound out of thedose chamber 150. As shown inFIGS. 5A and 5B , thedose chamber 150 is press fit into the y-junction 120. Thenozzle 190 is installed into the end of thedose chamber 150 opposite where it is press fit into the y-junction 120. - The
nozzle 190 is installed into the distal end (end opposite where thedose chamber 150 is press fit into the y-junction 120) of thedose chamber 150, forming a liquid and gas-tight seal around the outer diameter. During actuation of thedevice 100, propellant evacuates liquid compound from thedose chamber 150, pushing it out thenozzle 190. - The
nozzle 190 forms the narrow plume angle (for example, an angle of 1 to 40 degrees, including endpoints and angles intermittent there between; in one aspect the angle is 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees) multi-stream deposition. Thenozzle 190 and resultant angle of the plume produced promotes delivery of the compound to the olfactory region of the user's nasal cavity. - In this implementation, as shown in
FIG. 8 , thedevice 100 may include anoptional nose cone 200. The external geometries of thenose cone 200 assist in providing proper alignment of thedevice 100 during insertion into the nose. The diametrically opposed flat sides aid with placement against the septum of either naris, with the depth stop providing correct depth of insertion. Thenose cone 200 adds redundancy tonozzle 190 retention through mechanical interference incorporated into the design. As shown inFIG. 3 andFIG. 8 , there is an opening in thenose cone 200 which aligns with thenozzle 190. Thenose cone 200 is not part of the pressurized flow path. - The
housing 110 represents the body of thedevice 100. Thehousing 110 includes two different “clamshells” concealing the components of thedevice 100 and retaining all components to ensure functionality. Thehousing 110 houses the metereddose pump 130 andpump fitment 180, theactuator grip 210, the y-junction 120, thepropellant canister 140, and thedose chamber 150. Thenose cone 200 engages onto the outer geometry of thehousing 110. Thehousing 110 is designed to assemble easily through the use of, for example but not limited to, mattel pins, snaps, post or screws, or a combination thereof, molded into the geometry. - The
actuator grip 210 provides for actuation displacement by the user. Theactuator grip 210 is composed of two parts, actuator grip A and actuator grip B and surround the y-junction 120 and reside within thehousing 110.FIG. 7 shows twofinger grip notches 215 are designed into theactuator grip 210 to allow the user to engage thedevice 100 with the fingers, for example but not limited to, the index and middle finger. Thesefinger grip notches 215 allow the user to apply downward movement leading todevice 100 actuation. - The metered
dose pump 130 draws compound up from thevial 30 to the y-junction 120. The metereddose pump 130 may utilize acustom pump fitment 180 to promote functionality within thedevice 100, and allow attachment of thevial 30 via threads. The metereddose pump 130 may deliver, for example but not limited to, volumes, 180 μl, 200 μl, or 230 μl during actuation. Commercially available metered dose pumps 130 can be used. - For the
device 100 to consistently deliver compound, the metereddose pump 130 must first deliver compound, followed bypropellant canister 140 actuation to expel the compound. As shown inFIG. 7 , one manner in which to accomplish this is via aconical spring 220 between thepropellant canister 140 and y-junction 120 to create thenecessary propellant canister 140 actuation force resulting in the correct order of actuation between themetered dose pump 130 andpropellant canister 140. In one implementation, aconical spring 220 is used, although this force is not limited to being produced by aconical spring 220 as other mechanisms can be used. In one aspect, theconical spring 220 has a near zero preload, with a k value of about 25.5 lbf\in and a maximum load of 3.21 bf. Selection of the spring or mechanism will include the considerations of: (a) providing forproper device 100 staging; (b) physical space in thedevice 100; and/or (c) and user feedback regarding how stiff of aconical spring 220 still allows a variety of users to activate thedevice 100. - The
conical spring 220 is installed inline between thepropellant canister 140 and y-junction 120. Theactuator grip 210 physically holds thepropellant canister 140. The user activates thedevice 100 by, for example, applying an in-line force acting down from the actuator grips 210, and up from thevial 30. This force simultaneously acts to activate both the metereddose pump 130 and thepropellant canister 140. Theconical spring 220 acts in parallel to the internal propellant canister spring, increasing the necessary force required to activate thepropellant canister 140. By choosing theconical spring 220 such that the necessary force required to actuate thepropellant canister 140 is in excess of the maximum necessary force required to completely actuate the metereddose pump 130, thedevice 100 provides that dose is loaded into thedose chamber 150 before propellant gas begins to expel compound from thedevice 100. - During
device 100 actuation, the metereddose pump 130 draws liquid compound up from thevial 30 at the bottom of thedevice 100 via the y-junction 120, through the internaldose loading channel 230 and into thedose chamber 150. The internaldose loading channel 230 provides a clear route for the compound to be loaded ahead of theannular diffuser 170, without needed to physically pass through the porous material of theannular diffuser 170. As shown inFIG. 6 , small arrow heads represent the flow of the propellant while large arrow heads represent the flow of the compound. Priming shots may be required to completely fill the metereddose pump 130 and internaldose loading channel 230 of the y-junction 120 prior to user dosing. A dose cap (not shown) may cover thenose cone 200 of thedevice 100 and captures the priming shots while also providing a means of visual indication to the user that the device is primed. - In the second stage of
device 100 actuation, once thedose chamber 150 has been filled, thepropellant canister 140 releases propellant which enters through the top of the y-junction 120, following the path shown by open arrow heads inFIG. 6 . The propellant flows physically through the porous material of theannular diffuser 170, which promotions in the vaporization of the propellant. The propellant first contacts the compound at the distal (distal being closer to thenozzle 190, proximal being farther away from the nozzle 190) face of theannular diffuser 150 as seated in thedevice 100. As the propellant continues to expand, it pushes the compound forward (toward the nozzle 190) in thedose chamber 150, exiting though thenozzle 190 at the end of thedose chamber 150. - The
propellant canister 140 provides the propulsive energy for thedevice 100. The stem of the propellant valve seats into the top receiver of the y-junction 120. During use, the user presses down on the actuator grips 210 which pulls thepropellant canister 140 body down, actuating the propellant valve. This releases a metered volume of liquid propellant. As the propellant vaporizes and expands, the compound is forced out of thedose chamber 150 and out through thenozzle 190. - As an example of propellant, but not limited to, the
propellant canister 140 uses HFA 134A as the propellant for the system. Other propellants are envisioned. There are commerciallyavailable propellant canisters 140. - The
device 100, thepropellant canister 140, and thevial 30 may all be included or provided together in a kit. - The following table provides data on one implementation of the device described herein.
-
Dose Volume [μL] Shot # Device 1 Device 2 Device 3 Device 4 Device 5Device 6 1 190.6 193.7 185.3 199.2 199.2 145.1 185 uL + 10% 203.5 2 181.4 205.5 178.9 167.7 167.7 141.7 185 uL − 10% 166.5 3 183.1 188.5 173.3 165.6 165.6 138.5 185 uL + 15% 212.8 4 183.2 193.3 145.8 164.6 164.6 136.6 185 uL − 15% 157.3 5 183.3 201.5 200.7 162.0 162.0 142.1 6 185.8 207.7 166.3 179.4 179.4 138.9 7 184.3 195.1 180.3 164.8 164.8 140.9 8 183.3 205.4 175.3 164.9 164.9 142.0 9 180.5 178.1 172.0 164.1 164.1 141.8 10 179.7 204.0 178.0 170.6 170.6 143.9 Mean 183.5 197.3 175.6 170.3 170.3 141.2 StDev 3.1 9.3 14.0 11.3 11.3 2.5 Min 179.7 178.1 145.8 162.0 162.0 136.6 Max 190.6 207.7 200.7 199.2 199.2 145.1 - The following clauses described multiple possible embodiments for implementing the features described in this disclosure. The various embodiments described herein are not limiting nor is every feature from any given embodiment required to be present in another embodiment. Any two or more of the embodiments may be combined together unless context clearly indicates otherwise. As used herein in this document “or” means and/or. For example, “A or B” means A without B, B without A, or A and B. As used herein, “comprising” means including all listed features and potentially including addition of other features that are not listed. “Consisting essentially of” means including the listed features and those additional features that do not materially affect the basic and novel characteristics of the listed features. “Consisting of” means only the listed features to the exclusion of any feature not listed.
-
Clause 1. A device for the intranasal delivery of a compound comprising: - a y-junction including a base, a first branch of the y-junction radiating from the base, a second branch of the y-junction radiating from the base, a third branch of the y-junction radiating from the base, and an internal dose loading channel of the y-junction;
- a metered dose pump in fluid communication with the first branch of the y-junction;
- a conical spring associated with the second branch of the y-junction;
- a dose chamber in fluid communication with the third branch of the y-junction;
- a nozzle associated with the dose chamber;
- a diffuser between the internal dose loading channel and the dose chamber;
- an actuator grip surrounding the y-junction; and
- a housing, the y-junction residing within the housing.
- Clause 2. The device of any of clauses 1-11, further comprising:
- a propellant canister in fluid communication with the second branch of the y-junction and held by the actuator grip, the conical spring between the propellant canister and the second branch of the y-junction.
- Clause 3. The device of any of clauses 1-11, further comprising a vial in fluid communication with the metered dose pump.
- Clause 4. The device of clause 3, further comprising a pump fitment securing the metered dose pump to the vial.
-
Clause 5. The device of any of clauses 1-11, further including a check-valve associated between the metered dose pump and the y-junction. - Clause 6. The device of any of clauses 1-11, further including a nose cone in engagement with the housing.
- Clause 7. The device of clause 6 further comprising a dose cap covering the nose cone.
- Clause 8. The device of any of clauses 1-11, wherein the third branch of the y-junction is at a 45-degree angle from the base of the y-junction.
- Clause 9. The device of any of clauses 1-11, wherein the diffuser is annular.
-
Clause 10. The device of any of clauses 1-11, wherein the diffuser is a porous material. - Clause 11. The device of any of clauses 1-11, wherein the diffuser forms the bottom of the dose chamber.
- Clause 12. A device for the intranasal delivery of a compound, the device comprising:
- a housing, the housing including a tip, an actuator, and a dose chamber, the tip and the dose chamber in fluid communication within the housing;
- a nozzle at a distal portion of the tip, the nozzle providing an outlet for the compound, the nozzle including a plurality of nozzle openings; and
- a pump in fluid communication with the dose chamber, the pump to move the compound into the dose chamber upon actuation of the actuator.
- Clause 13. The device of any of clauses 12-15, further comprising a propellant canister associated with the housing, the propellant canister having a propellant valve for actuation by the actuator, the propellant canister in fluid communication with the dose chamber.
- Clause 14. The device of clauses 12-15, further comprising a vial of compound associated with the pump to move the compound into the dose chamber from the vial.
-
Clause 15. The device of clauses 12-15, further including a diffuser. - Clause 16. A device for the intranasal delivery of a compound to the olfactory region of the nasal cavity, the device comprising:
- a housing, the housing including a tip, an actuator, and a dose chamber, the tip and the dose chamber in fluid communication with the housing;
- a nozzle at a distal portion of the tip, the nozzle providing an outlet for the compound, the nozzle including a plurality of nozzle openings;
- a pump in fluid communication with the dose chamber, the pump to move the compound into the dose chamber upon actuation of the actuator;
- a propellant canister associated with the housing, the propellant canister having a propellant valve for actuation by the actuator, the propellant canister in fluid communication with the dose chamber; and
- a vial of compound associated with the pump to move the compound into the dose chamber from the vial wherein the actuator upon actuation of the device compresses the pump moving the compound into the dose chamber and actuation of the propellant valve disperses the propellant pushing the compound providing for the compound to exit the device through the plurality of nozzle openings.
- Clause 17. A kit including the device any of clauses 1-16, a propellant canister and a vial.
- The present invention is not to be limited in scope by the specific implementations described herein. Indeed, various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and accompanying figures. Such modifications are intended to fall within the scope of the appended claims.
Claims (1)
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US18/538,917 US20240115819A1 (en) | 2015-09-10 | 2023-12-13 | In-Line Nasal Delivery Device |
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US201815759447A | 2018-03-12 | 2018-03-12 | |
US202217585099A | 2022-01-26 | 2022-01-26 | |
US17/866,222 US20230095719A1 (en) | 2015-09-10 | 2022-07-15 | In-line Nasal Delivery Device |
US18/297,601 US20230241334A1 (en) | 2015-09-10 | 2023-04-08 | In-line Nasal Delivery Device |
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CN110831578A (en) | 2017-07-02 | 2020-02-21 | 瑞迪博士实验室有限公司 | Nasal formulation of dihydroergotamine |
JP7317020B2 (en) | 2018-01-05 | 2023-07-28 | インペル ファーマシューティカルズ インコーポレイテッド | Intranasal delivery of dihydroergotamine by a precision olfactory device |
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2016
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- 2016-09-09 MA MA042708A patent/MA42708A/en unknown
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- 2016-09-09 KR KR1020187009528A patent/KR20180052662A/en not_active Application Discontinuation
- 2016-09-09 JP JP2018513344A patent/JP6753927B2/en active Active
- 2016-09-09 MX MX2018002895A patent/MX2018002895A/en unknown
- 2016-09-09 CN CN201680060459.8A patent/CN108601916B/en active Active
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- 2016-09-09 EP EP16845229.0A patent/EP3341059B1/en active Active
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2020
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2022
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AU2016321345B2 (en) | 2020-12-10 |
JP7001777B2 (en) | 2022-02-10 |
MA42708A (en) | 2018-07-04 |
US20230095719A1 (en) | 2023-03-30 |
US11266799B2 (en) | 2022-03-08 |
IL257845A (en) | 2018-04-30 |
JP2020185475A (en) | 2020-11-19 |
JP2018527099A (en) | 2018-09-20 |
AU2016321345A1 (en) | 2018-04-19 |
JP6753927B2 (en) | 2020-09-09 |
IL257845B (en) | 2022-07-01 |
ZA201801543B (en) | 2022-08-31 |
CN108601916A (en) | 2018-09-28 |
NZ741171A (en) | 2022-01-28 |
EP3341059A4 (en) | 2019-05-08 |
KR20180052662A (en) | 2018-05-18 |
HK1252257A1 (en) | 2019-05-24 |
CN108601916B (en) | 2021-07-09 |
US20240115819A1 (en) | 2024-04-11 |
EP3341059B1 (en) | 2022-03-02 |
US20180256836A1 (en) | 2018-09-13 |
WO2017044897A1 (en) | 2017-03-16 |
MX2018002895A (en) | 2018-07-06 |
CA2998182A1 (en) | 2017-03-16 |
EP3341059A1 (en) | 2018-07-04 |
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