Liquid drug cartridges and associated dispenser

• US 10,307,550 B2
• Filed: 06/05/2015
• Issued: 06/04/2019
• Est. Priority Date: 06/09/2014
• Status: Active Grant

• Current Assignee: Aerami Therapeutics, Inc. (Dance Biopharm Holdings, Inc.)
• Original Assignee: Dance BioPharm Incorporated (Dance Biopharm Holdings, Inc.)
• Inventors: Stedman, Benjamin, Fink, Jim, Molloy, Lisa, Sander, Matt
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US14/732,446
• Publication Number:
  US 20150352297A1
• Time in Patent Office: 1,460 Days
• Field of Search: 12820014, 12820016, 2225411, 604110, 604162, 60416408, 604181, 604190, 604192, 604200, 604212, 604263
• CPC Class Codes: A61M 11/003 by passing the aerosol trough sieves or filters
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/006 operated by applying mechanical pressure to the liquid to be sprayed or atomised
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 15/001 using ultrasonic means
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0033 Details of the piercing or cutting means
• CPC Class Codes: A61M 15/0035 Piercing means
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2205/053 ultraviolet
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2209/10 : Equipment for cleaning
• CPC Class Codes: A61M 5/3145 : Filters incorporated in syringes
• CPC Class Codes: B05B 17/0646 : Vibrating plates, i.e. plates being directly subjected to the vibrations, e.g. having a piezoelectric transducer attached thereto
• CPC Class Codes: B05B 17/0684 : Wicks or the like

Abstract

Liquid drug cartridges and an associated inhaler are used to deliver one more separate doses of an aerosolized liquid drug. A cartridge includes a container for storing the liquid drug, an end cap having an ejection opening, a filter element, and a piston that is repositionable relative to the container to selectively eject a volume of liquid drug from the ejection opening. The filter element filters the liquid drug prior to ejection from the ejection opening. The liquid drug cartridge can be coupled with an inhaler that includes an aerosol generator. The aerosol generator includes a vibratable membrane onto which the liquid drug is ejected. The liquid drug is aerosolized by the vibration of the membrane for inhalation by a user.

Claims

1. A liquid drug cartridge, comprising:

a container configured to store a liquid drug;

an end cap coupled with a first end of the container, the end cap having an ejection opening from which a volume of the liquid drug from the container can be selectively ejected;

a removable cap configured to interface with the end cap such that the ejection opening is closed by the removable cap so as to block flow of the liquid drug through the ejection opening any time the removable cap is coupled with the end cap;

a filter element positioned between the container and the ejection opening, the filter element being configured to filter the liquid drug prior to ejection from the ejection opening;

a check valve disposed between the end cap and the container and configured to permit only one-way flow in an outward direction from the container to the ejection opening to block microbial ingress into the container from the ejection opening; and

a piston that extends an entire distance between opposing sidewalls of the container, the piston being solid so as to prevent the liquid drug from passing through and/or beyond the piston, the piston sealing a second end of the container that is spaced apart from the first end, the piston being repositionable relative to the container so as to selectively eject a volume of the liquid drug from the container via the ejection opening.

2. The cartridge of claim 1, wherein the end cap has a protruding portion in which the ejection opening is disposed.

3. The cartridge of claim 1, wherein the end cap comprises a conduit in fluid communication with the ejection opening for delivery of the liquid drug to the ejection opening, the conduit being coated to inhibit microbial ingress into the container.

4. The cartridge of claim 3, wherein the conduit is coated with silver.

5. The cartridge of claim 1, wherein the end cap comprises a conduit in fluid communication with the ejection opening for delivery of the liquid drug to the ejection opening, the conduit being configured to inhibit escape of any amount of the liquid drug from the container absent repositioning of the piston relative to the container.

6. The cartridge of claim 5, wherein the conduit is coated to inhibit microbial ingress into the container.

7. The cartridge of claim 1, wherein the filter is configured to inhibit microbial ingress into the container.

8. The cartridge of claim 1, wherein the cartridge is configured to inhibit escape of any amount of the liquid drug from the container absent repositioning of the piston relative to the container.

9. The cartridge of claim 8, wherein the filter element is configured to inhibit escape of any amount of the liquid drug from the container absent repositioning of the piston relative to the container.

10. The cartridge of claim 1, wherein fluid is ejected from the cartridge in controlled doses by controlled movement of the piston.

11. The cartridge of claim 10, wherein the size of each of the controlled doses is set via an external control.

12. The cartridge of claim 10, wherein the cartridge contains a plurality of doses of medication and the medication can be delivered from the cartridge in a plurality of individual doses.

13. A liquid drug cartridge, comprising:

a container defining a chamber that is configured to store a liquid drug;

an end cap coupled with a first end of the container, the end cap having an ejection opening from which a volume of the liquid drug from the container can be selectively ejected;

a filter element positioned between the container and the ejection opening, the filter element being configured to filter the liquid drug prior to ejection from the ejection opening;

a check valve disposed between the end cap and the chamber configured to permit only one way flow from the container to the ejection opening to block microbial ingress into the container from the ejection opening; and

a piston that extends an entire distance between opposing sidewalls of the container, the piston being solid so as to prevent the liquid drug from passing through and/or beyond the piston, the piston sealing a second end of the container that is spaced apart from the first end, the piston being repositionable relative to the container so as to selectively eject a volume of the liquid drug from the container via the ejection opening.

14. An aerosolization system, comprising:

a liquid drug cartridge, comprising;

a container defining a chamber that is configured to store a liquid drug;

an end cap coupled with a first end of the container, the end cap having an ejection opening from which a volume of the liquid drug from the container can be selectively ejected;

a filter element positioned between the container and the ejection opening, the filter element being configured to filter the liquid drug prior to ejection from the ejection opening; and

a piston sealing a second end of the container, the piston being repositionable relative to the container so as to selectively eject a volume of the liquid drug from the container via the ejection opening

an aerosol generator including a vibratable membrane having a front face and a rear face, and a vibratable element used to vibrate the membrane;

a housing defining a mouthpiece, the housing including a receptacle configured to at least partially receive the liquid drug cartridge and interface with the liquid drug cartridge to position the ejection opening of the liquid drug cartridge to dispense liquid drug directly onto the rear face of the vibratable membrane to be aerosolized by controlled vibration of the vibratable element, wherein the rear face of the vibratable membrane faces the ejection opening and the front face faces away from the ejection opening, and wherein the vibratable membrane is configured to deliver the aerosolized liquid drug from the front face; and

an actuator configured to reposition the piston of the liquid drug cartridge to dispense a dosage of the drug via the ejection opening to the rear face of the vibratable membrane.

15. The system of claim 14, wherein the housing further includes:

a mixing chamber in fluid communication with the front face of the vibratable membrane and the mouthpiece; and

one or more air inlets in fluid communication with the mixing chamber and configured to inlet air into the mixing chamber in response to a user inhaling via the mouthpiece.

16. The system of claim 15, further comprising an air flow restrictor array having greater resistance to air flow than the one or more air inlets and placing the mixing chamber in fluid communication with the one or more air inlets.

17. The system of claim 16, wherein air flowing through the mixing chamber in response to the user inhaling via the mouthpiece is laminar and surrounds a dosage of the drug aerosolized via the vibratable membrane so as to inhibit contact between the aerosolized drug and surrounding surfaces of the mixing chamber.

18. The system of claim 17, further comprising a pressure port connected to a pressure sensing system, wherein a patient'"'"'s inhalation is detected via the pressure port.

19. The system of claim 16, wherein the airflow restrictor array comprises a plurality of orifices disposed in an annular arrangement.

20. The system of claim 14, further comprising:

one or more processors;

a tangible memory storing non-transitory instructions that, when executed by the one or more processors, cause the one or more processors to control the actuator to reposition the piston relative to the cartridge until a drop of the liquid drug is ejected from the ejection opening.

21. The system of claim 20, wherein the instructions, when executed by the one or more processors, cause the one or more processors to determine that a drop of the liquid drug has been ejected from the ejection opening by detecting when the vibratable membrane has been wetted by the ejected drop of the liquid drug.

22. The system of claim 14, wherein the cartridge is configured to be removed at any time to enable more thorough cleaning of the dispenser.

23. The system of claim 14, wherein:

the cartridge includes a removable cap configured to interface with an end cap coupled with a first end of the cartridge so as to block flow of the liquid drug through the ejection opening; and

the removable cap is configured such that the cartridge cannot be inserted into the receptacle until the removable cap is removed from the cartridge.

24. The system of claim 14, wherein the vibratable membrane is coupled with the housing via elastomeric isolators configured to enhance efficiency of the aerosol generator.

25. The system of claim 14, further comprising an ultraviolet light configured to provide microbial control between doses.

26. The system of claim 14, wherein:

the housing forms a pressurizable vessel in which the cartridge is disposed; and

the actuator pressurizes the vessel to reposition the piston relative to the cartridge to dispense a dosage of the drug via the ejection opening to the rear face of the membrane.

27. The system of claim 14, wherein the actuator mechanically displaces the piston relative to the cartridge so as to dispense a predetermined desired amount of the liquid drug via the ejection opening.

28. The system of claim 27, wherein the actuator further comprising an adjustable metering mechanism that is operable to permit only selectable amounts of repositioning of the piston relative to the cartridge so that a selectable dosage of the liquid drug is dispensed.