Claims for Patent: 11,793,953

Summary for Patent: 11,793,953

Title:	Inhalers and related methods
Abstract:	A nasal inhaler for the inhalation of inhalable substances comprise: a canister having an interior reservoir containing pressurised inhalable substances including fluid; a metering valve including a metering chamber and a valve stem defining a communication path between the metering chamber and the interior reservoir, the communication path including an opening configured to permit flow between a transfer space inside the valve stem and the interior reservoir, the interior reservoir being arranged for orientation above the metering chamber whereby gas located within the metering chamber is replaced with liquid from the interior reservoir.
Inventor(s):	Daniel Buck, Paul Prendergast, Declan Walsh
Assignee:	Norton Waterford Ltd
Application Number:	US17/957,079
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,793,953
Patent Claims:	1. A method of preventing gas lock within a medicament inhaler having a metering valve with a metering chamber and a valve stem extending from the metering chamber to an interior reservoir of a canister containing a fluid, the method comprising: allowing atmospheric gas to enter the metering chamber; retracting the valve stem relative to the canister to create a communication path between the metering chamber and the interior reservoir for a time period of about 2 minutes to about 24 hours; and following the time period, altering an orientation of the interior reservoir relative to the metering chamber to cause an amount of fluid sufficient to administer greater than 75% of a labelled claim for a dose to enter the metering chamber and displace the atmospheric gas. 2. The method of claim 1, wherein the fluid is a liquid medicament. 3. The method of claim 2, wherein the liquid medicament has a higher density than a density of the atmospheric gas. 4. The method of claim 1, wherein an amount of atmospheric gas entering the metering chamber is sufficient to create a gas lock within the medicament inhaler. 5. The method of claim 1, wherein the amount of fluid fills the metering chamber when the orientation of the interior reservoir relative to the metering chamber is altered. 6. The method of claim 1, wherein the amount of fluid partially fills the metering chamber when the orientation of the interior reservoir relative to the metering chamber is altered. 7. The method of claim 1, wherein a portion of the displaced atmospheric gas is displaced from the metering chamber to the interior reservoir. 8. The method of claim 1, wherein altering the orientation of the interior reservoir relative to the metering chamber causes placement of the interior reservoir above the metering chamber. 9. The method of claim 1 further comprising: administering the amount of fluid sufficient to administer greater than 75% of the labelled claim for the dose. 10. The method of claim 1, wherein the communication path includes an opening configured to permit flow between a transfer space inside the valve stem and the interior reservoir. 11. The method of claim 10, wherein the opening includes an axially oriented opening portion oriented to face axially along a longitudinal axis of the valve stem into the interior reservoir. 12. The method of claim 10, in which the opening is configured to permit flow in a direction with an axial component along the valve stem directly between the transfer space inside the valve stem and the interior reservoir. 13. The method of claim 10, wherein altering the orientation of the interior reservoir relative to the metering chamber causes the amount of fluid to travel through the opening into the metering chamber. 14. The method of claim 10, wherein causing the amount of fluid to enter the metering chamber and displace the atmospheric gas includes allowing the amount of fluid to flow under pressure through the opening, along the valve stem to a portion of the communication path communicating with the metering chamber. 15. The method of claim 10 further comprising: causing atmospheric gas to flow from the metering chamber, in a direction counter to a direction of the mount of fluid, along the communication path into the interior chamber. 16. The method of claim 10 including providing the opening as an elongated opening. 17. The method of claim 10 including providing a second opening to the communication path diametrically opposed to the opening. 18. The method of claim 1 further comprising: providing the valve stem with an opening having an axially oriented opening portion into the interior reservoir which is oriented facing directly axially along a longitudinal axis of the valve stem into the interior reservoir. 19. The method of claim 1 comprising providing the medicament inhaler as a breath actuated inhaler, and, in response to flow of the atmospheric gas, firing the canister by closing communication between the metering chamber and interior reservoir and opening communication between the metering chamber and atmosphere, the valve stem being held depressed after firing. 20. The method of claim 19 comprising resetting the inhaler to a reset configuration with a reset actuator so as to close communication between the metering chamber and atmosphere and open communication between the metering chamber and the interior reservoir, and by carrying out the altering of the orientation of the interior reservoir above the metering chamber while the inhaler is in the reset configuration. 21. The method of claim 20 comprising providing the reset actuator as dust cap or a mouthpiece cap for the inhaler and in which closing the cap resets the inhaler. 22. The method of claim 1 comprising providing the medicament inhaler as a metered dose inhaler and which includes applying a force to the canister to hold the valve stem depressed; and which includes subsequently releasing the canister to extend the valve stem and carrying out the altering of the orientation of the interior reservoir above the metering chamber. 23. The method of claim 1, wherein the medicament inhaler is configured to provide an inhalable substance including at least one propellant. 24. The method of claim 23 including providing at least one said propellant as a hydrofluoroalkane. 25. The method of claim 1 including providing at least one propellant with a surface tension at 25° C. of about 6 to 10 mN/m, typically about 7 to 9 mN/m, about 8 mN/m being one example. 26. The method of claim 1 including providing inhalable substances as including an active ingredient in suspension or in solution. 27. The method of claim 1, wherein the time period is from about 5 minutes to about 24 hours. 28. The method of claim 1, wherein the time period is from about 30 minutes to about 24 hours. 29. The method of claim 1, wherein orienting the interior reservoir above the metering chamber causes the valves stem to reposition from the retracted position to an extended position. 30. The method of claim 1, wherein 75% to about 110% of the labelled claim for the dose is administered. 31. The method of claim 1, wherein the medicament inhaler includes a mouthpiece and a mouthpiece cap coupled to the mouthpiece, the mouthpiece cap having an open position and closed position, and the mouthpiece cap remaining in the open position from a start of the time period to an end of the time period. 32. The method of claim 1, including venting the metering chamber to atmosphere for a time period which is one hour, more than one hour, 24 hours or more than 24 hours. 33. A method of treating a respiratory disease or disorder to administer a therapeutically effective amount of one or more active ingredients, the method including carrying out the method of claim 27. 34. The method of claim 33, wherein the inhaler is a breath-actuated inhaler and the step of actuating the inhaler comprises inhaling through the inhaler. 35. The method of claim 33, wherein the respiratory disease or disorder is asthma. 36. The method of claim 33, wherein the respiratory disease or disorder is COPD. 37. The method of claim 33, wherein the one or more active ingredients comprise a corticosteroid. 38. The method of claim 33, wherein the one or more active ingredients comprise beclomethasone dipropionate or tiotropium bromide. 39. A method of preventing gas lock within a medicament inhaler having a medicament inhaler having a metering valve with a metering chamber and valve stem extending from the metering chamber to an interior reservoir of a canister: discharging a first metered dose from the medicament inhaler; upon discharge of the first metered dose, retracting the valve stem relative to the canister to create a communication path between the metering chamber and the interior reservoir for a time period of about 2 minutes to about 24 hours, during which the metering chamber stays open and exposed to atmosphere to permit atmospheric gas to enter the metering chamber, wherein the valve stem provides a communication path between the metering chamber and the interior reservoir and is configured to permit flow between the valve stem and the interior reservoir; at an end of the time period, altering an orientation of the interior reservoir relative to the metering chamber to cause an amount of fluid sufficient to enter the metering chamber and displace the atmospheric gas; and actuating the medicament inhaler to discharge a second metered dose including the amount of fluid, the amount of fluid being sufficient to administer greater than 75% of a labelled claim for a dose. 40. The method of claim 39 further comprising: moving a mouthpiece cap from an open position to a closed position causing the valve stem to move from the retracted position to an extended position, the extended position allowing for communication between the metering chamber and interior reservoir. 41. The method of claim 39, wherein orienting the interior reservoir above the metering chamber causes gas to travel through the opening into the interior reservoir. 42. The method of claim 1 further comprising: administering the amount of fluid sufficient to administer greater than 75% of the labelled claim for the dose, wherein the amount of fluid includes a propellant and a therapeutically effective amount of one or more active ingredients for treating a respiratory disease or disorder. 43. The method of claim 1 further comprising: treating a respiratory disease or disorder by administering the amount of fluid sufficient to administer greater than 75% of the labelled claim for the dose, wherein the respiratory disease or disorder is one or more of chronic obstructive pulmonary disease, asthma, cystic fibrosis, exacerbation of airways, allergic rhinitis, sinusitis, pulmonary vasoconstriction, inflammation, allergies, impeded respiration, respiratory distress syndrome, pulmonary hypertension, and pulmonary vasoconstriction. 44. A method of treating a respiratory disease or disorder comprising the method of claim 1, wherein the amount of fluid includes a propellant and a therapeutically effective amount of one or more active ingredients.