Aerosol delivery device and operating method for the aerosol delivery device

Abstract

The invention relates to an aerosol delivery device (10) comprising an aerosol generator (3) for generating an aerosol in the aerosol delivery device (10), a sensor (5) configured to detect a use of the aerosol delivery device (10) for aerosol treatment, and a controller (7) configured to deactivate the aerosol generator (3) if no use of the aerosol delivery device (10) for aerosol treatment is detected by the sensor (5). Further, the invention relates to a method for operating an aerosol delivery device (10), comprising the steps of operating an aerosol generator (3) for generating an aerosol in the aerosol delivery device (10), detecting a use of the aerosol delivery device (10) for aerosol treatment by means of a sensor (5), and deactivating the aerosol generator (3) by means of a controller (7) if no use of the aerosol delivery device (10) for aerosol treatment is detected by the sensor (5).

Claims

1. An aerosol delivery device comprising: an aerosol generator for generating an aerosol in the aerosol delivery device, a sensor configured to detect a use of the aerosol delivery device for aerosol treatment, and a controller configured to deactivate the aerosol generator only if no use of the aerosol delivery device for aerosol treatment is detected by the sensor, wherein the sensor is configured to detect that the aerosol delivery device is not being used for aerosol treatment only if no respiration of a user, including no inhalation and no exhalation, through the aerosol delivery device is sensed by the sensor, wherein the controller is configured to activate the aerosol generator for continuous aerosol generation during use, including during inhalation and exhalation, and to stop aerosol generation in response to detecting no use of the aerosol delivery device and wherein the controller is configured to control the aerosol generator to generate the aerosol for a first period of time after no respiration of the user is detected by the sensor and to deactivate the aerosol generator after the first period of time has lapsed.

2. The aerosol delivery device according to claim 1, wherein the controller is configured to activate the aerosol generator if the use of the aerosol delivery device for aerosol treatment is detected by the sensor.

3. The aerosol delivery device according to claim 1, wherein the aerosol generator is a continuous aerosol generator.

4. The aerosol delivery device according to claim 1, wherein the sensor is configured to detect the use of the aerosol delivery device for aerosol treatment by sensing the presence of a user's respiration on the aerosol delivery device.

5. The aerosol delivery device according to claim 1, wherein the sensor is configured to detect the use of the aerosol delivery device for aerosol treatment by sensing a contact between the aerosol delivery device and a user.

6. The aerosol delivery device according to claim 1, wherein the controller is configured to operate the aerosol generator in a pulsed mode after deactivation of the aerosol generator.

7. The aerosol delivery device according to claim 1, further comprising a monitoring unit configured to monitor an operating ability of the aerosol generator.

8. The aerosol delivery device according to claim 1, wherein the aerosol generator is a vibrating membrane nebuliser.

9. The aerosol delivery device according to claim 1, wherein the first period of time is in a range of 0.1 s to 10 min.

10. The aerosol delivery device according to claim 1, wherein the first period of time is in a range of 1 s to 5 min.

11. The aerosol delivery device according to claim 1, wherein the first period of time is in a range of 2 s to 1 min.

12. The aerosol delivery device according to claim 1, wherein the controller is configured to fully deactivate the aerosol delivery device after a second period of time in which no use of the aerosol delivery device for aerosol treatment has been detected by the sensor, wherein the second period of time is longer than the first period of time.

13. A method for operating an aerosol delivery device, comprising the steps of: operating an aerosol generator for generating an aerosol in the aerosol delivery device, detecting a use of the aerosol delivery device for aerosol treatment by a sensor, and deactivating the aerosol generator by a controller only if no use of the aerosol delivery device for aerosol treatment is detected by the sensor, wherein the sensor detects that the aerosol delivery device is not being used for aerosol treatment only if no respiration of a user, including no inhalation and no exhalation, through the aerosol delivery device is sensed by the sensor, wherein the controller is configured to activate the aerosol generator for continuous aerosol generation during use, including during inhalation and exhalation, and to stop aerosol generation in response to detecting no use of the aerosol delivery device and wherein the aerosol generator is controlled to generate the aerosol for a predetermined period of time after no respiration of the user is detected by the sensor and is deactivated after the period of time has lapsed.

14. The method for operating an aerosol delivery device according to claim 13, further comprising the step of activating the aerosol generator by the controller if the use of the aerosol delivery device for aerosol treatment is detected by the sensor.

15. The method for operating an aerosol delivery device according to claim 13, wherein the use of the aerosol delivery device for aerosol treatment is detected by sensing the presence of the user's respiration on the aerosol delivery device.

16. The method for operating an aerosol delivery device according to claim 13, wherein the use of the aerosol delivery device for aerosol treatment is detected by sensing a contact between the aerosol delivery device and the user.

17. The method for operating an aerosol delivery device according to claim 13, further comprising the step of operating the aerosol generator in a pulsed mode after deactivation of the aerosol generator.

Description

BRIEF DESCRIPTION OF HE DRAWINGS

(1) Hereinafter, non-limiting examples of the invention are explained with reference to the drawings, in which:

(2) FIG. 1 shows a schematic longitudinally cut cross-sectional view of an aerosol delivery device according to an embodiment of the present invention;

(3) FIGS. 2(a)-(c) show schematic diagrams of operating modes of the aerosol delivery device shown in FIG. 1, wherein FIG. 2(a) shows an interrupted respiration pattern of a patient, FIG. 2(b) shows a first operating mode of the aerosol delivery device and FIG. 2(c) shows a second operating mode of the aerosol delivery device.

DETAILED DESCRIPTION OF CURRENTLY PREFERRED EMBODIMENTS

(4) FIG. 1 shows a schematic longitudinally cut cross-sectional view of an aerosol delivery device 10 according to a currently preferred embodiment of the present invention.

(5) The aerosol delivery device 10 comprises an aerosol generator 3, which is a vibrating membrane nebuliser, an air inlet 12 for connection with a gas compressor 1 as a source of compressed air, and an adaptation element 14 that is equipped with a mouthpiece (not shown) 16 or optional nasal prongs (not shown) or an optional face mask (not shown) or an optional nosepiece (16) for adaptation to or communication with a user's or patient's respiratory system, nasal cavity etc.

(6) Alternatively, the air inlet 12 may be an open and free air inlet, e.g., allowing for the introduction or entrainment of ambient air into the aerosol delivery device 10.

(7) A fluid container 18 for receiving a fluid to be aerosolised or nebulised is disposed between the air inlet 12 and the adaptation element 14. The fluid container 18 is preferably integrally formed with the body of the aerosol delivery device 10 but, in further embodiments, may be configured such that it is partly or fully detachable from the body.

(8) The body of the aerosol delivery device 10 is preferably made of plastic and preferably manufactured by an injection moulding process. The fluid container 18 may be designed so that it does not directly receive the fluid but rather has an opening element, such as a thorn, a spike, a hollow needle or the like, arranged on its inside that opens a fluid containing vessel, e.g., a vial, a blister, an ampoule, a container, a canister, a reservoir, a cartridge, a pot, a tank, a pen, a storage, a syringe or the like, inserted therein.

(9) In general, any fluid to be aerosolised or nebulised may be received in the fluid container 18 and used for the generation of an aerosol in the aerosol delivery device 10, depending on the condition, diagnosis to be measured or disease to be treated or managed. The fluid composition may comprise one or more active compounds, as has been detailed above.

(10) In the embodiment shown in FIG. 1, the one end of the fluid container 18 can be securely and tightly closed, for example, with a screw cap (not shown). At its other end, opposite the screw cap or the like, the fluid container 18 may have a tapered portion 22 that tapers towards a fluid chamber 24 of the aerosol generator 3. The fluid chamber 24 may he sealed by a sealing lip (not shown) or the like that forms a part of the chamber 24 and is tightly pressed against a membrane 30. The membrane 30 is provided with a plurality of minute openings or holes with diameters in the micrometer range that perforate the membrane 30.

(11) Alternatively, the aerosol delivery device 10 may be configured without the fluid chamber 24. In this case, the fluid container 18 is arranged so that it abuts directly against the membrane 30. Thus, in this configuration, the tapered portion 22 tapers towards the membrane 30.

(12) The membrane 30 can be vibrated or oscillated, for example, with the use of a piezoelectric element (not shown), such that the direction of the vibration is substantially perpendicular to the plane of the membrane 30. A controller 7 configured to supply electrical power to the aerosol generator 3 and to activate and deactivate the aerosol generator 3 is connected to the aerosol generator 3.

(13) By inducing such vibrations of the membrane 30, fluid contained in the fluid chamber 24 is passed through the minute openings or holes of the membrane 30 and nebulised into a mixing chamber 32, e.g., an aerosol chamber or a nebuliser chamber, formed at the other side of the membrane 30 opposite to the fluid chamber 24, thereby generating an aerosol in the aerosol delivery device 10. In this way, the fluid chamber 24 and the membrane 30 together form a vibrating membrane nebuliser, i.e., the aerosol generator 3. A detailed description of this concept is presented, for example, in U.S. Pat. No. 5,518,179.

(14) The aerosol generator 3 is a continuously operated nebuliser, continuously generating an aerosol in the aerosol delivery device 10 during the operation of the device 10.

(15) The controller 7 comprises a computer and a control element (not shown), such as a transistor, that is connected to the membrane 30 for stopping and starting the membrane vibration and hence the aerosol generation by the aerosol generator 3.

(16) A flow passage 36 is formed between the membrane 30 and the body of the aerosol delivery device 10 which allows for the passage of a gas, i.e., air in the present embodiment, supplied from the compressor 1 through the air inlet 12 and/or entrained by the patient's respiration through the air inlet 12.

(17) Further, the aerosol delivery device 10 comprises a sensor 5 configured to detect a use of the aerosol delivery device 10 for aerosol treatment by sensing the presence of a patient's respiration through the aerosol delivery device 10, in particular, through the adaptation element 14. The sensor 5 is connected to the controller 7 and transmits a detection signal to the controller 7, indicating whether or not the aerosol delivery device 10 is being used for aerosol treatment, i.e., whether or not the user's or patient's respiration through the aerosol delivery device 10 is present.

(18) The controller 7 is configured to deactivate the aerosol generator 3 if no use of the aerosol delivery device 10 for aerosol treatment is detected by the sensor 5 and to activate the aerosol generator 3 if the use of the aerosol delivery device 10 for aerosol treatment is detected by the sensor 5.

(19) For example, the sensor 5 may be configured as a flow sensor for sensing a fluid flow through the device and/or a temperature sensor for sensing a temperature or temperature gradient in the device and/or an acoustic sensor, e.g., a sound sensor, for sensing an acoustic level, such as a sound or noise level, in the device and/or a pressure sensor detecting pressure differences, pressure drop or pressure fluctuations during use of the device.

(20) The controller 7 may be configured to operate the aerosol generator 3 in a pulsed mode after deactivation of the aerosol generator 3.

(21) In the following, two different examples of the operation of the aerosol delivery device 10 shown in FIG. 1, using two different configurations of the controller 7, will be explained with reference to FIGS. 1 and 2.

(22) FIG. 2(a) shows a schematic diagram of the gas flow, i.e., air flow, through the adaptation element 14 for an interrupted regular respiration pattern of a user or patient, respiring through the aerosol delivery device 10. As can be seen from FIG. 2(a), the respiration pattern includes regular respiration, including inhalation and exhalation periods, through the aerosol delivery device 10 in the time interval from 0 to t1, an interruption of the respiration through the device 10 in the time interval from t1 to t2, e.g., due to the user or patient removing the nose piece (16), face mask (not shown), or mouthpiece (not shown) from his mouth, or face, or nose, and regular respiration, including inhalation and exhalation periods, through the device 10 in the time interval starting from t2.

(23) FIGS. 2(b) and (c) show schematic diagrams of two different modes of operating the aerosol delivery device 10 of FIG. 1, using two different configurations of the controller 7, wherein FIG. 2(b) shows a continuous operation mode with subsequent permanent shut-off in the interruption period and FIG. 2(c) shows a pulsed operation mode in the interruption period.

(24) In order to perform an aerosol treatment using the aerosol delivery device 10 schematically shown in FIG. 1, the fluid container 18 is first filled, for example, with 2 ml of an aerosolisable fluid that comprises an active compound, such as an antibiotic drug or the like, and tightly sealed with the screw cap (not shown). Then, the mouthpiece (not shown) a face mask (not shown) or a nose piece (16), of the adaptation element 14 is inserted into the nose, on the face or into the mouth of a user or patient having a medical condition to be treated.

(25) The user or patient starts breathing through the mouthpiece (not shown), a face mask (not shown) or a nose piece (16), thereby inducing an air flow or pressure drop in the adaptation element 14, This air flow or pressure drop is sensed by the sensor 5. The sensor 5 thus generates a detection signal, indicating that the aerosol delivery device 10 is being used for aerosol treatment, and transmits this signal to the controller 7. In response to this signal, the controller 7 activates the aerosol generator 3 in order to generate an aerosol in the aerosol delivery device 10.

(26) The aerosol generation by the aerosol generator 3 is started by vibrating or oscillating the membrane 30 so that it continuously nebulises or aerosolises the fluid supplied from the fluid container 18 and received in the fluid chamber 24 into the mixing chamber 32, so that the aerosol thus generated is made available for a user or patient and may be inhaled from the mixing chamber 32 via the mouthpiece (not shown), a face mask (not shown) or a nose piece (16), like nasal prongs. At the same time, a constant transport flow of gas, i.e., air in this embodiment, may be supplied, for example, at a flow rate of 0.5 to 5 L/min, preferably at a flow rate of 0.5 to 3 L/min, by the gas compressor 1.

(27) Alternatively, as has been detailed above, the aerosol delivery device 10 may be configured without the fluid chamber 24. In this case, the fluid container 18 is arranged so that it abuts directly against the membrane 30 and the vibrating or oscillating membrane 30 directly nebulises or aerosolises the fluid supplied from the fluid container 18.

(28) As is shown in FIG. 1, the plane of the membrane 30 is substantially perpendicular to the direction of aerosol transport (direction of arrow A in FIG. 1) towards the adaptation element 14, so that the risk of any aerosol loss at the walls of the aerosol delivery device 10 due to impaction is minimised. The air supplied by the compressor 1 and/or the air entrained via the air inlet 12 flows around the membrane 30 through the flow passage 36 and mixes with the nebulised or aerosolised fluid in the mixing chamber 32.

(29) At the point of time t1, the respiration of the user or patient through the aerosol delivery device 10, i.e., the aerosol treatment, is interrupted, as is schematically shown in FIG. 2(a). At this point of time, the sensor 5 senses that no respiration through the aerosol delivery device 10 is present and generates a detection signal, indicating that the aerosol delivery device 10 is not being used for aerosol treatment by the user or patient. This detection signal is transmitted to the controller 7. In response to this signal, the controller 7 deactivates the aerosol generator 3, thus stopping the generation of aerosol in the aerosol generator 3, as is schematically shown in FIGS. 2(b) and (c).

(30) At the point of time t2, the sensor 5 senses the presence of the user's or patient's respiration through the aerosol delivery device 10 and generates a detection signal, indicating that the aerosol delivery device 10 is being used for aerosol treatment. This detection signal is transmitted to the controller 7. In response to this signal, the controller 7 activates the aerosol generator 3, in order to start the continuous generation of aerosol in the aerosol generator 3, as is schematically shown in FIGS. 2(b) and (c).

(31) In the embodiment shown in FIG. 2(b), the controller 7 is configured to deactivate the aerosol generator 3 if no use of the aerosol delivery device 10 for aerosol treatment is detected by the sensor 5 and to activate the aerosol generator 3 only if the use of the aerosol delivery device 10 for aerosol treatment is detected by the sensor 5. During the interruption of the aerosol treatment, i.e., in the time interval from t1 to t2, the aerosol generator 3 remains permanently switched off or deactivated, so that no aerosol is generated in the aerosol delivery device 10, as is schematically shown in FIG. 2(b). In this way, aerosol losses during the interruption of the aerosol treatment can be minimised.

(32) In the embodiment shown in FIG. 2(c), the controller 7 is configured to deactivate the aerosol generator 3 if no use of the aerosol delivery device 10 for aerosol treatment is detected by the sensor 5, to operate the aerosol generator 3 in a pulsed mode after deactivation of the aerosol generator 3 and to activate the aerosol generator 3 so as to continuously generate aerosol if the use of the aerosol delivery device 10 for aerosol treatment is detected by the sensor 5. Hence, the controller 7 is configured to operate the aerosol generator 3 in the pulsed mode during the interruption of the aerosol treatment, i.e., in the time interval from t1 to t2.

(33) In this way, the mixing chamber 32 is filled with aerosol during the interruption of the aerosol treatment, so that it can be ensured that a sufficient amount of aerosol is present in the mixing chamber 32 for the subsequent aerosol inhalation starting at the point of time t2. Moreover, the operation of the aerosol generator 3 in the pulsed mode indicates to the user or patient that the aerosol delivery device 10 is in a fully functional or operable state.

(34) The pulses in the pulsed mode are spaced at regular time intervals in the range of 0.01 s to 5 s, more preferably in the range of 0.5 s to 5 s or, even more preferably in the range of 1 s to 3 s. In an embodiment, the regular time intervals are in the range of 0.1 s to 3 s or, even more preferably in the range of 0.3 s to 2 s. All of the pulses have the same pulse duration which lies in the range of 10 ms to 3000 ms or, more preferably in the range of 100 ms to 2000 ms or, even more preferably in the range of 300 ms to 1000 ms. Thus, the aerosol losses induced by the operation of the aerosol generator 3 in the pulsed mode are minimised and re-filling of the mixing chamber with aerosol for the continuation of the aerosol treatment is secured.

(35) In the embodiments shown in FIGS. 2(b) and (c), the controller 7 is configured to deactivate the aerosol generator 3 immediately upon detection that the aerosol delivery device 10 is not being used for aerosol treatment. However, in other embodiments, the controller 7 may be configured to deactivate the aerosol generator 3 after the lapse of a period of time, e.g., a preset or predetermined period of time, if no use of the aerosol delivery device 10 for aerosol treatment is detected by the sensor 5, as has been detailed above.

(36) This period of time may, for example, start from the beginning of the last exhalation period of the patient before the interruption of the aerosol treatment or from the detection of the interruption of the aerosol treatment, i.e., the point of time t1. In this case, the aerosol generator 3 is not deactivated at the point of time t1, as shown in FIGS. 2(b) and (c), but at a later point of time between t1 and t2.

(37) While the aerosol generator 3 of the embodiment shown in FIG. 1 is a vibrating membrane nebuliser, any type of aerosol generator may be used for the aerosol delivery device of the present invention, as has been de tailed above. The aerosol generator maybe a nebuliser, an atomiser, such as a humidifier, a pneumatic nebuliser, an electronic nebuliser, an ultrasonic nebuliser, an electro-hydrodynamic nebuliser, an electrostatic nebuliser, a jet nebuliser, a humidifier-nebuliser for ventilation devices or the like.

(38) In particular, the aerosol generator may be a jet nebuliser employing pressurised air and/or a compressor, such as those disclosed in U.S. Pat. No. 5,957,389, US-A-2007/0068513, DE-A-100 22 795 and DE-A-102 26 334.

(39) Further, while the aerosol delivery device 10 of the embodiment shown in FIG. 1 comprises a nose piece (16), face mask (not shown) or mouthpiece (not shown) for adaptation to or communication with a user's or patient's nose, face or mouth, the aerosol delivery device of the present invention may comprise nasal prongs, a nosepiece or a face mask, e.g., for adaptation to or communication with a user's or patient's body cavities, abdomen, eyes, intestine, stomach, nose, nasal cavities, sinuses, osteomeatal complex, trachea, lungs, bronchi, bronchioles, alveoli and/or respiratory tract.

(40) In particular, an aerosol comprising an active compound which is useful for the prevention, management, diagnosis or treatment of any disease, symptom or condition affecting the paranasal sinuses may be generated and transported to the paranasal sinuses using an aerosol delivery device comprising a nosepiece and an aerosol generator such as that disclosed in U.S. Pat. No. 7,980,247.