The United States of America as represented by the Secretary of the Department of Health and Human Services, Centers for Disease Control and Prevention
대리인 / 주소
Klarquist Sparkman, LLP
인용정보
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0인용 특허 :
50
초록▼
Methods and systems for aerosol delivery of agents to a patient are described herein. The present system can be used to administer various types of agents, such as a vaccine or other types of pharmaceutical substances. Certain embodiments of the present system utilize an actuator coupled to a dispos
Methods and systems for aerosol delivery of agents to a patient are described herein. The present system can be used to administer various types of agents, such as a vaccine or other types of pharmaceutical substances. Certain embodiments of the present system utilize an actuator coupled to a disposable aerosolizing element that aerosolizes an agent for delivery to a patient when acted upon by the actuator. The aerosolizing element prevents the agent from contacting the actuator and other non-disposable components of the system so that little or no cleaning or maintenance is required. The present system also can include an aerosolization rate monitor that monitors the rate at which an agent is being aerosolized and provides feedback to the user to ensure that the proper dose is being administered.
대표청구항▼
1. An aerosolizing device, comprising: a housing sized and shaped to be held in a hand of a user;a disposable aerosolizing element coupled to the housing and capable of expelling aerosolized agent, the aerosolizing element comprising a body defining a chamber, agent releasing orifices defined in the
1. An aerosolizing device, comprising: a housing sized and shaped to be held in a hand of a user;a disposable aerosolizing element coupled to the housing and capable of expelling aerosolized agent, the aerosolizing element comprising a body defining a chamber, agent releasing orifices defined in the body and in communication with the chamber, a movable portion positioned opposite the agent releasing orifices, and a fluid inlet for connection to a source of agent, the inlet being in fluidic communication with the chamber; andan actuator disposed in the housing and positioned to exert vibratory oscillations on the movable portion of the disposable aerosolizing element to aerosolize agent from the chamber of the aerosolizing element, the actuator comprising a piezoelectric element and a motion transmitting member that is operable to transmit vibratory motion of the piezoelectric element to the movable portion such that the moveable portion moves toward and away from the orifices such that agent in the chamber is expelled through the orifices when the movable portion moves toward the orifices, and such that agent from the source flows through the inlet and into the chamber when the movable portion moves away from the orifices;wherein the aerosolizing element is configured to prevent agent from contacting the motion transmitting member and the piezoelectric element and to prevent expired particles or contaminants from a patient from contacting the motion transmitting member and the piezoelectric element;wherein the disposable aerosolizing element is removable from the housing for installation and disposal. 2. The device of claim 1, further comprising a patient interface coupled to the aerosolizing element and shaped to deliver aerosolized agent expelled from the disposable aerosolizing element to a patient. 3. The device of claim 2, further comprising air inlet holes positioned to allow entry of atmospheric air into the device to assist in delivery of aerosolized agent through the patient interface. 4. The device of claim 2, wherein the patient interface comprises a disposable mask shaped to fit around the mouth and nose of the patient. 5. The device of claim 4, wherein the mask comprises a material that is porous to air. 6. The device of claim 2, wherein the patient interface comprises a one-way valve that is operable to permit flow from the disposable aerosolizing element to the patient through the patient interface, and to inhibit flow in the reverse direction through the patient interface. 7. The device of claim 6, wherein the one-way valve comprises a duckbill valve. 8. The device of claim 2, wherein the patient interface comprises one or more baffles that shield the disposable aerosolizing element from expired particles. 9. The device of claim 2, wherein the patient interface is a nasal prong. 10. The device of claim 2, wherein a fluid passageway from a source of agent to the patient interface is substantially contained within the aerosolizing element. 11. The device of claim 10, wherein the source of agent is contained within the aerosolizing element. 12. The device of claim 10, wherein the aerosolizing element is shaped for direct connection to the source of agent. 13. The device of claim 1, wherein the motion transmitting member has an end surface that is adhesively secured to the movable portion of the aerosolizing element. 14. The device of claim 13, wherein the motion transmitting member is adhesively secured to the movable portion with double-sided adhesive tape having one side adhesively secured to the end surface of the motion transmitting member and another side adhesively secured to the movable portion. 15. The device of claim 1, wherein the movable portion is deformable, and the movable portion deforms when the vibratory motion is transmitted to the movable portion so as to increase pressure in the chamber, thereby expelling agent from the chamber through the orifices. 16. The device of claim 15, wherein the movable portion comprises a flexible diaphragm. 17. The device of claim 16, wherein the body comprises a rear wall, the rear wall comprising an opening adjacent the flexible diaphragm, and the motion transmitting member extends through the opening in the rear wall. 18. The device of claim 1, further comprising a compressed air source configured to supply compressed air to the device to assist in delivery of aerosolized agent to the patient. 19. The device of claim 18, wherein some of the air conveyed by the compressed air source is directed to cool the actuator. 20. The device of claim 1, wherein the disposable aerosolizing element has an internal chamber at least partially defined by a flexible portion that can be manually squeezed by a user to create a negative pressure within the chamber to assist in filling the chamber with agent. 21. The device of claim 1, further comprising: a power source for the device comprising one or more batteries. 22. The device of claim 21, further comprising an air pump and an air conduit fluidly connecting the air pump to the housing, the air pump being operable to supply compressed air to the housing to assist in delivery of aerosolized agent to the patient. 23. The device of claim 1, further comprising a counting device that is operable to record the number of doses that are administered by the device. 24. The device of claim 1, further comprising an aerosolization rate monitor that is operable to detect the rate at which agent is aerosolized by the aerosolizing element. 25. The device of claim 24, wherein the aerosolization rate monitor comprises a light source operable to project a light beam that extends through aerosol droplets being expelled by the aerosolizing element and a light detector operable to detect the obscuration of the light beam caused by the aerosol droplets. 26. The device of claim 25, wherein the aerosolization rate monitor comprises a controller and a visual indicator, wherein the controller receives the signal from the light detector and determines an aerosolization rate based on the signal, and the visual indicator provides a visual indication regarding the aerosolization rate. 27. The device of claim 25, wherein the aerosolizing element comprises first and second reflective surfaces, the first reflective surface being positioned to reflect the light beam from the light source to extend in a first direction through the aerosol droplets, the second reflective surface being positioned to reflect the light beam extending through the aerosol droplets to extend in a second direction toward the light detector. 28. The device of claim 1, wherein the aerosolizing element is pre-filled with a volume of agent for providing at least one dose to the patient. 29. The device of claim 28, wherein the volume of agent is sufficient for delivery of multiple single doses. 30. The device of claim 1, further comprising a vial containing agent for direct coupling to the aerosolizing element. 31. The device of claim 1, further comprising projections disposed in the chamber of the aerosolizing element, the projections configured to maintain a minimum spacing in the chamber between the orifices and the movable portion. 32. The device of claim 31, wherein the projections are disposed on the movable portion. 33. The device of claim 1, wherein a pathway for the aerosolized agent from the aerosolizing element to the patient is entirely outside of the housing. 34. The device of claim 1, wherein the motion transmitting member comprises first and second ends, the movable portion of the aerosolizing element being connected to the first end of the motion transmitting member, the piezoelectric element being connected to the second end of the motion transmitting member, such that the vibratory motion of the piezoelectric element causes the motion transmitting member to reciprocate toward and away from the aerosolizing element in first and second opposing directions, the first direction extending from the second end to the first end of the motion transmitting member and the second direction extending from the first end to the second end of the motion transmitting member, and wherein the movable portion is secured to the first end of the motion transmitting member such that the reciprocating motion of the motion transmitting member causes corresponding movement of the movable member toward and away from the orifices in the first and second directions. 35. An aerosolizing device, comprising: a housing sized and shaped to be held in a hand of a user;a disposable aerosolizing element disposed in the housing and capable of expelling aerosolized agent, the aerosolizing element comprising a body defining a chamber, agent releasing orifices defined in the body and in communication with the chamber, a movable portion positioned opposite the agent releasing orifices, and a fluid inlet for connection to a source of agent, the inlet being in fluidic communication with the chamber; andan actuator disposed in the housing and positioned to exert vibratory oscillations on the movable portion of the disposable aerosolizing element to cause the moveable portion to move toward and away from the orifices, such that the motion of the moveable portion toward the orifices causes agent in the chamber to be expelled through the orifices and the motion of the movable portion away from the orifices is effective to cause agent from the source to flow through the inlet and into the chamber;wherein the aerosolizing element is configured to prevent agent from contacting the actuator and to prevent expired particles from a patient from contacting the actuator;wherein a pathway for the aerosolized agent from the aerosolizing element to the patient is entirely outside of the housing. 36. The device of claim 35, wherein the disposable aerosolizing element is removable from the housing and replaceable with a new aerosolizing element for use of the device with a different patient without cleaning the actuator. 37. The device of claim 35, wherein the actuator comprises a vibratory element that generates vibratory oscillations and a motion transmitting member having first and second opposite ends, the first end of the motion transmitting member being secured to the movable portion of the aerosolizing element and the second end of the motion transmitting member being secured to the vibratory element, such that the vibratory motion of the vibratory element causes the motion transmitting member to reciprocate toward and away from the aerosolizing element in first and second opposing directions, the first direction extending from the second end to the first end of the motion transmitting member and the second direction extending from the first end to the second end of the motion transmitting member, and wherein movement the motion transmitting member in the first direction causes the movable portion to flex toward the orifices and movement of the motion transmitting member in the second direction causes the movable portion to flex away from the orifices.
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