US20100294269A1 - Nebulizing drug delivery device with an increased flow rate - Google Patents
Nebulizing drug delivery device with an increased flow rate Download PDFInfo
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- US20100294269A1 US20100294269A1 US12/851,049 US85104910A US2010294269A1 US 20100294269 A1 US20100294269 A1 US 20100294269A1 US 85104910 A US85104910 A US 85104910A US 2010294269 A1 US2010294269 A1 US 2010294269A1
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- Prior art keywords
- drug
- drug solution
- barrier
- housing
- reservoir
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- 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
- A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
- A61M11/041—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised using heaters
-
- 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
- A61M11/001—Particle size control
-
- 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
- A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
- A61M2205/3653—General characteristics of the apparatus related to heating or cooling by Joule effect, i.e. electric resistance
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8268—Fuel storage cells
Definitions
- the present invention relates to drug delivery devices, and, in particular, to nebulizers used in an aerosolized drug delivery.
- nebulizing drug delivery devices are configured to deliver drug solutions to a user's lungs via inhalation. But these devices may not be capable of effectively or efficiently nebulizing various types of drug solutions for delivery that are typically delivered directly into a patient's lungs, such as through injection. Thus, typical nebulizing drug delivery devices may not be particularly effective or efficient in delivering drug solutions of a higher viscosity, and/or drug solutions that must be delivered at higher flow rates.
- the valve comprises a float that floats on the portion of drug solution residing on the barrier, the float substantially sealing the reservoir from the barrier when the amount of drug solution residing on the barrier is above the threshold amount.
- the float permitting drug solution to flow from the reservoir to the barrier when the amount of drug solution residing on the barrier is less than the threshold amount.
- the invention in another aspect relates to a nebulizing device comprising a housing having an inlet and an outlet, and a plurality of aerosol generators in communication with a fluid.
- a barrier is disposed between the fluid and a drug solution provided within the housing, the barrier being capable of transmitting acoustic waves in the fluid to the drug solution.
- the plurality of aerosol generators form a corresponding plurality of fountains that generate nebulized particles of the drug solution.
- the plurality of fountains are in communication with the outlet to enable a user to inhale nebulized particles of the drug solution from the plurality of aerosol regions through the outlet.
- FIG. 1 illustrates a perspective view of the nebulizing device in accordance with an embodiment of the invention.
- FIG. 2A is a top plan view of an embodiment of the nebulizing device with a fixed length cord.
- FIG. 2B is a top plan view of an embodiment of the nebulizing device with a cord in a retracted position.
- FIG. 3 is a cross sectional view of the nebulizing device of FIG. 2A , taken along section line 3 - 3 of FIG. 2A , according to an embodiment of the invention.
- FIG. 4 is a sectional view of the nebulizing device similar to FIG. 3 , but illustrating the device with the valves between the barrier chambers and the drug reservoir open.
- FIG. 5 is an exploded perspective view of the nebulizing drug delivery device, in accordance with one embodiment of the invention.
- FIG. 6 is a cross-sectional view of the nebulizing device similar to FIG. 3 , but including an alternative valve arrangement between the barrier chambers and the drug reservoir.
- FIG. 7 is a cross-sectional view of the nebulizing device similar to FIG. 4 , but including a solenoid to operate a valve for opening and closing the drug reservoir.
- FIG. 8 is a cross-sectional view of the nebulizing device similar to FIG. 7 , but illustrating the valve for opening and closing the drug reservoir as being open.
- FIG. 9 is an exemplary illustration of the circuitry of the nebulizing device according to one embodiment of the invention.
- FIG. 10 is an exemplary illustration of a method of controlling the nebulizing device in accordance with an embodiment of the invention.
- FIGS. 11A-11C illustrate a front perspective view, a side plan view, and a rear plan view of the nebulizing drug delivery device, according to one embodiment of the invention.
- FIG. 12 is a sectional view of the nebulizing device of FIG. 11B , taken along section line 12 - 12 of FIG. 11B , in accordance with an embodiment of the invention.
- FIG. 13 is a cross sectional view of the nebulizing device of FIG. 11B , take along section line 13 - 13 FIG. 11B , according to one embodiment of the invention.
- FIG. 1 is a front perspective view
- FIG. 2A is a top view of a nebulizing device 110 , according to an embodiment of the invention.
- Nebulizing device 110 is adapted to nebulize and deliver a drug solution to a user.
- Nebulizing device 110 provides various advantages in nebulizing and/or delivering the drug solution to the user.
- nebulizing device 110 is capable of nebulizing viscous drug solutions such as drug solutions containing a surfactant, or other viscous drug solutions, delivers the drug solution at an enhanced flow rate, and provides other advantages as described herein.
- nebulizing device 110 includes a housing 112 , a gas inlet 114 , a nebulized drug delivery outlet 116 , and a user control interface 118 .
- housing 112 includes a plurality of housing members.
- Housing 112 includes an upper housing portion 120 , a middle housing portion 121 , and a lower housing portion 122 .
- the front surface of upper housing portion 120 has a step region 124 formed thereon.
- upper housing portion 120 has a top surface 126 , an angled surface 128 extending downwardly from top surface 126 , and a longitudinal horizontal ledge surface 130 extending outwardly from the bottom of angled surface 128 .
- top surface 126 and ledge surface 130 are formed as offset parallel planar surfaces with angled surface 128 structurally joining top surface 126 and ledge surface 130 to form step region 124 .
- gas inlet 114 includes one or more inlet ports 132 formed in housing 112 .
- Inlet ports 132 are located at middle housing portion 121 of housing 112 .
- the nebulized drug delivery outlet 116 includes a first outlet port 134 and a second outlet port 136 .
- First outlet port 134 and second outlet port 136 are formed in housing 112 at angled surface 128 .
- first outlet port 134 and second outlet port 136 may be formed as a single outlet port.
- User control interface 118 includes a control knob 138 .
- Control knob 138 is located on housing 112 .
- control knob 138 is located at lower housing portion 122 of housing 112 .
- various other user interfaces could be used without departing from the scope of the present invention such as keypads, touch screens, wirelessly via a memory storage device, sent over a radio frequency, or Infrared communication link.
- FIGS. 3 and 4 are cross sectional views, taken along cross section line 3 - 3 , as illustrated in FIG. 2A , of nebulizing device 110 .
- nebulizing device 110 includes a drug solution reservoir 310 , a first nebulization section 312 , a second nebulization section 314 , control electronics 316 , and a power source/connection 318 .
- Drug solution reservoir 310 is contained in a reservoir housing member 319 , included within housing 112 .
- Drug solution reservoir 310 includes an upper drug solution receiving opening 320 , a drug dispensing opening 322 , a reservoir wall 324 , and a reservoir floor 326 .
- Drug solution reservoir wall 324 is generally cylindrical in shape, or may be otherwise shaped.
- Drug solution receiving opening 322 is defined by the upper periphery of reservoir wall 324 , and is circular, or otherwise shaped.
- Reservoir floor 326 angles from reservoir wall 324 in a downward slope to drug dispensing opening 322 formed within reservoir floor 326 .
- the nebulizing device 110 also includes a heating/sensor unit 327 for heating the drug solution.
- a heating/sensor unit 327 for heating the drug solution. This may be useful with higher viscosity drug solutions, or for increased comfort of a user. For example, to warm the drug solution prior to inhalation in instances when the device and/or drug solution contained therein have been exposed to cold temperatures.
- heating/sensor unit 327 may be annularly disposed about the outer wall 324 that contains drug reservoir 310 . As illustrated in FIG.
- heating/sensor unit 327 may include an annular band member 1022 , with a resistive heating element (or heater) 1024 and a temperature sensor 1026 disposed thereon.
- the temperature sensor 1026 within heating/sensor unit 327 is in functional communication with the heater 1024 , to sense a temperature of the drug solution or the heater 1024 itself.
- Heating/sensor unit 327 is operatively coupled to one or both of control electronics 316 and power source/connection 318 . Heating/sensor unit 327 is controlled via control electronics 316 , and is powered via power source/connection 318 .
- heating/sensor unit 327 maintains the temperature of the heater 1024 in a temperature range between an upper threshold temperature and a lower threshold temperature. Or, heating/sensor unit 327 maintains the temperature of the heater 1024 above a threshold temperature. It is contemplated that heating/sensor unit 327 is configured and/or arranged to heat the drug solution in at least one of drug reservoir 310 , first barrier chamber 332 , second barrier chamber 432 , first reservoir channel 328 , second reservoir channel 330 , first aerosol region 340 , and/or second aerosol region 440 .
- the heater/sensing unit 327 can be separated so that either the heater or the sensor is disposed within the drug solution reservoir 310 , in contact with the drug solution, and the other element (heater or sensor) is in contact with the outer wall 324 that contains drug reservoir 310 .
- the sensor 1026 may be a thermocouple or other temperature sensing element such as a thermistor, resistance thermal detector, bimetallic, or Infrared.
- the heater element 1024 need not be a resistive heater, but can be any suitable heater that can be used to raise the temperature of the drug solution.
- first nebulization section 312 includes a first reservoir channel 328 , a first valve 330 , a first barrier chamber 332 , a first barrier 334 , a first fluid chamber 336 , transmitting fluid 337 , a first aerosol generator 338 , and a first aerosol region 340 .
- First reservoir channel 328 is formed within housing 112 and runs from drug dispensing opening 322 to first valve 330 .
- First valve 330 is positioned outwardly from drug dispensing opening 322 within housing 112 , between first reservoir channel 328 and first barrier chamber 332 .
- first valve 330 includes a first valve opening 342 , and a valve seal 344 .
- First valve opening 342 is formed within housing 112 as an outer opening of first reservoir channel 328 .
- First valve structure 344 is disposed at first valve opening 342 to selectively seal first valve opening 342 .
- first valve structure 344 includes a first float 346 , disposed within first valve 330 at a first float reception cavity 348 .
- First float 346 is composed of a material that enables first float 346 to float in the drug solution, such as, for example, a closed cell foam.
- First float reception cavity 348 is formed in housing 112 between first reservoir channel 328 and first barrier chamber 332 .
- First valve 344 includes a first float/cavity interface 350 that includes corresponding surfaces of first float 346 and first float reception cavity 348 .
- First float 346 seals first valve opening 342 as first float 346 rises to seal first valve opening 342 .
- first float/cavity interface 350 includes corresponding angled surfaces of first float 346 and first float reception cavity 348 .
- floats 346 and 446 include a body 510 and an annular protrusion 512 .
- Annular protrusion 512 surrounds body 510 , and extends outward from body 510 in a direction normal to the surface of body 510 that annular protrusion 512 protrudes from.
- valves 330 and 430 may take the form of one or more electrically operated solenoid valves. Such valves can each be open in response to an associated liquid level detector that detects the amount of drug solution on one of the barriers. When the detector detects that the amount of drug solution is at or below a threshold level, it sends a signal that is used to open the associated valve and permit the drug solution to flow from the associated reservoir to the associated barrier.
- the liquid level detector can optionally be an adjustable detector to enable the threshold level at which the drug solution will be released from the reservoir to the barrier to be adjusted.
- first barrier chamber 332 which communicates with first reservoir channel 328 via first valve 330 is formed within housing 112 between first barrier 334 and first aerosol region 340 .
- First barrier 334 is mounted within housing 112 to a first mounting surface 352 that is formed on an upper surface of first fluid chamber 336 , between first barrier chamber 332 and first fluid chamber 336 .
- First barrier forms a physical separation (i.e., a seal) between first barrier chamber 332 and first fluid chamber 336 .
- First barrier 334 is composed of one or more materials designed to enable first barrier 334 to be capable of transmitting ultrasonic energy therethrough, even under high temperature conditions. For example, polyetheretherketone (PEEK), or other materials may be used.
- PEEK polyetheretherketone
- first fluid chamber 336 is formed within housing 112 between first barrier 334 and first aerosol generator 338 .
- the first aerosol generator 338 is an acoustic wave generator, such as a piezoelectric transducer, and first fluid chamber 336 holds a fluid 337 in communication with first barrier 334 and first aerosol generator 338 .
- Fluid 337 can be selected to be capable of transmitting acoustic waves, such as, for example, water, or other fluids.
- Fluid 337 may include one or more sterilants, such as, alcohol, or other sterilants.
- first aerosol generator 338 is disposed at a first seating portion 354 formed within housing 112 .
- first aerosol generator 338 comprises a piezoelectric transducer, it may be formed to have a concave configuration with a silver electrode.
- First aerosol generator 338 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point, or focal band, that is a focal length from first aerosol generator 338 .
- First seating portion 354 is formed within housing 112 such that the focal point will be within first barrier chamber 332 .
- First aerosol generator 338 is operatively linked to control electronics 316 so that control electronics 316 can control various aspects of acoustic wave generation by first aerosol generator 338 , such as, for instance, activation and deactivation.
- First aerosol generator 338 is operatively linked to power source/connection 318 so that power can be provided to first aerosol generator 338 via this operative link.
- Power source/connection 318 may include a power cord 140 .
- Power cord 140 can be connected to a contemporary household socket to deliver power to the nebulizing device 110 .
- Cord 140 could have a fixed length or could have a mechanism to retract a majority of cord 140 into housing 112 . This feature of the present invention could be used regardless of the aerosol generator being used.
- the present invention contemplates that cord 140 could also be used with a variety of nebulizers including jet nebulizers, traditional planar ultrasonic nebulizers, vibrating mesh nebulizers, vibrating plate nebulizers, or electro spray nebulizers.
- the unique advantage this feature of the present invention provides is that it prevents cord 140 from becoming tangled with objects present in the user's environment when not in use.
- first aerosol region 340 includes a first fountain region 356 , one or more first aerosol region inlets 358 , a first chimney 360 , a first drug delivery region 361 , and a first drug return region 362 .
- First fountain region 356 is formed within housing 112 between first barrier chamber 332 and first chimney 360 .
- First fountain region 356 includes a lower first fountain region 364 and an upper first fountain region 366 .
- Lower first fountain region 364 is open at a first end to first barrier chamber 332 and at a second end to upper first fountain region 366 .
- Lower first fountain region 364 is cylindrical, or may be otherwise shaped.
- Upper first fountain region 366 is open at a first end to lower first fountain region 364 and at a second end to first chimney 360 .
- Upper first fountain region 364 is formed as a funnel with a smaller opening at the first end and a larger opening at the second end, or may be otherwise shaped.
- first aerosol region inlets 358 are formed in housing 112 at first fountain region 356 .
- First aerosol region inlets 358 provide an opening for one or more corresponding inlet channels 368 .
- Inlet channels 368 are formed in housing 112 , and run between first aerosol region inlets 358 and inlet ports 132 .
- first chimney 360 is formed in housing 112 , and opens at a first end to first fountain region 356 .
- a first chimney ceiling 370 is formed within housing 112 at a second end of first chimney 360 .
- first chimney 360 opens to first drug delivery region 361 .
- first drug delivery region 361 is formed within housing 112 to communicate with first chimney 360 , first outlet port 134 , and first drug return region 361 .
- First drug delivery region 361 is open to first drug return region 361 at a first end, and is bounded at a second end by first drug delivery region ceiling 372 .
- First drug delivery region ceiling 372 and first chimney ceiling 370 form a first aerosol region ceiling 374 .
- first drug return region 362 is formed in housing 112 to be open at a first end to drug reservoir 310 .
- First drug return region 362 also communicates with first drug delivery region 361 .
- second nebulization section 312 includes a second reservoir channel 428 , a second valve 430 , a second barrier chamber 432 , a second barrier 434 , a second fluid chamber 436 , a second fluid 437 within second fluid chamber 436 , a second aerosol generator 438 , and a second aerosol region 440 .
- Second reservoir channel 428 is formed within housing 112 and runs from drug dispensing opening 422 to second valve 430 .
- Second valve 430 is positioned outwardly from drug dispensing opening 422 within housing 112 , between second reservoir channel 428 and second barrier chamber 432 .
- first aerosol generator 338 and second aerosol generator 438 may be any device capable of forming aerosol.
- the unique aspects of the present invention can also be used with compressor driven jet nebulizers, traditional planar ultrasonic nebulizers, vibratory mesh nebulizers, vibrating plate nebulizers, or electrospray nebulizers without departing from the teachings of the present invention.
- the second valve 430 includes a second valve opening 442 , and a valve seal 444 .
- Second valve opening 442 is formed within housing 112 as an outer opening of second reservoir channel 428 .
- Second valve seal 444 is disposed at second valve opening 442 to selectively seal second valve opening 442 .
- second valve seal 444 includes a second float 446 , disposed within second valve 430 at a second float reception cavity 448 .
- Second float 446 is composed of materials that enable second float 446 to float in the drug solution.
- Second float reception cavity 448 is formed in housing 112 between second reservoir channel 428 and second barrier chamber 432 .
- Second valve 444 includes a second float/cavity interface 450 that includes corresponding surfaces of second float 446 and second float reception cavity 448 , and is arranged to bias second float 446 against second valve opening 442 as second float 446 rises to seal second valve opening 442 .
- second float/cavity interface 450 includes corresponding angled surfaces of second float 146 and second float reception cavity 448 .
- second barrier chamber 432 which communicates with second reservoir channel 428 via second valve 430 is formed within housing 112 between second barrier 434 and second aerosol region 440 .
- Second barrier 434 is mounted within housing 112 to a second mounting surface 452 that is formed on an upper surface of second fluid chamber 436 , between second barrier chamber 432 and second fluid chamber 436 .
- Second barrier forms a physical separation (i.e., a seal) between second barrier chamber 432 and second fluid chamber 436 .
- Second barrier 434 is composed of one or more materials designed to enable second barrier 434 to be capable of transmitting ultrasonic energy therethrough, even under high temperature conditions. For example, polyetheretherketone (PEEK), or other materials may be used.
- PEEK polyetheretherketone
- second fluid chamber 436 is formed within housing 112 between second barrier 434 and second aerosol generator 438 .
- the aerosol generator 438 in one embodiment, is a concave shaped piezoelectric transducer with a silver electrode.
- the piezoelectric aerosol generator 438 achieves its functionality by generating acoustic waves in the drug solution as described with respect to the first aerosol generator 338 .
- Second fluid chamber 436 holds a fluid in communication with second barrier 434 and second aerosol generator 438 .
- Fluid 337 includes one or more fluids capable of transmitting acoustic waves, such as, for example, water, or other fluids.
- Fluid 337 may include one or more sterilants, such as, alcohol, or other sterilants.
- second aerosol generator 438 is disposed at a second seating portion 454 formed within housing 112 .
- second aerosol generator 438 includes a concave piezoelectric transducer with a silver electrode.
- Second aerosol generator 438 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point, or focal band, that is a focal length from second aerosol generator 438 .
- Second seating portion 454 is formed within housing 112 such that the focal point will be within second barrier chamber 432 .
- Other embodiments of second aerosol generator 438 exist.
- Second aerosol generator 438 is operatively linked to control electronics 316 so that control electronics 316 can control various aspects of acoustic wave generation by second aerosol generator 438 , such as, for instance, activation and deactivation, or other aspects. Second aerosol generator 438 is operatively linked to power source/connection 318 so that power can be provided to second aerosol generator 438 via this operative link.
- the second aerosol region 440 includes a second fountain region 456 , one or more second aerosol region inlets 458 , a second chimney 460 , a second drug delivery region 461 , and a second drug return region 462 .
- Second fountain region 456 is formed within housing 112 between second barrier chamber 432 and second chimney 460 .
- Second fountain region 456 includes a lower second fountain region 464 and an upper second fountain region 466 .
- Lower second fountain region 464 is open at a first end to second barrier chamber 432 and at a second end to upper second fountain region 466 .
- Lower second fountain region 464 is cylindrical, or may be otherwise shaped.
- Upper second fountain region 466 is open at a first end to lower second fountain region 464 and at a second end to second chimney 460 .
- Upper second fountain region 464 is formed as a funnel with a smaller opening at the first end and a larger opening at the second end, or may be otherwise shaped.
- second aerosol region inlets 458 are formed in housing 112 at second fountain region 456 .
- Second aerosol region inlets 458 provide an opening for one or more corresponding inlet channels 468 .
- Inlet channels 468 are formed in housing 112 , and run between second aerosol region inlets 458 and inlet ports 132 .
- second chimney 460 is formed in housing 112 , and opens at a first end to second fountain region 456 .
- a second chimney ceiling 470 is formed within housing 112 at a first end of second chimney 460 .
- second chimney 460 opens to second drug delivery region 461 .
- second drug delivery region 461 is formed within housing 112 to communicate with second chimney 460 , second outlet port 134 , and second drug return region 461 .
- Second drug delivery region 461 is open to second drug return region 461 at a first end, and is bounded at a second end by second drug delivery region ceiling 472 .
- Second drug delivery region ceiling 472 and second chimney ceiling 470 form a second aerosol region ceiling 474 .
- the second drug return region 462 is formed in housing 112 to be open at a first end to drug reservoir 310 . Second drug return region 462 also communicates with second drug delivery region 461 .
- barrier chambers 332 and 432 hold an amount of the drug solution at each of barriers 334 and 434 .
- Fountains are formed at barrier chambers 332 and 432 .
- the fountains create nebulized particles of the drug solution that are delivered to aerosol regions 340 and 440 .
- the nebulized particles of the drug solution are formed by acoustic waves within the drug solution held in barrier chambers 332 and 432 at barriers 334 and 434 .
- the acoustic waves are generated by aerosol generators 338 and 438 .
- the acoustic waves transmitted from aerosol generators 338 and 438 to barrier chambers 332 and 432 via the fluid held in fluid chambers 336 and 436 .
- the transmitted acoustic waves pass from fluid chambers 336 and 436 to barrier chambers 332 and 432 via barriers 334 and 434 .
- the acoustic waves transmitted to barrier chambers 332 and 432 are focused at the focal point.
- the drug solution in barrier chambers 332 and 432 absorbs the ultrasonic energy provided by the focused acoustic waves to create a fountain within each of barrier chambers 332 and 432 .
- the ultrasonic energy delivered by the acoustic waves has a maximum density at or near the focal point of the acoustic waves.
- the fountains shed a portion of the drug solution as particles. Some of these particles are so large they immediately fall out. Some are small enough to pass into drug return regions 362 , 462 before falling out. The remaining particles which are appropriately sized, pass out through first and second outer ports 134 , 136 . In this manner, substantially consistent particle size is achieved.
- the nebulized particles are communicated from barrier chambers 332 and 432 , through aerosol regions 340 and 440 , and to the user via outlet ports 134 and 136 included in outlet 116 . More particularly, the nebulized particles and the larger droplets of the drug solution formed at the fountains are received by aerosol regions 340 and 440 at fluid chambers 364 and 464 , and pass into chimneys 360 and 460 . From chimneys 360 and 460 , the nebulized particles are communicated to the user via drug delivery regions 361 and 461 and outlet ports 134 and 136 .
- the larger droplets may not be communicated to the user, but instead may contact a surface of aerosol regions 340 and 440 , such as aerosol ceilings 372 and 472 , or other surfaces.
- the larger droplets then condense on the contacted surface(s), thereby separating the larger droplets from the nebulized particles prior to delivery to the user.
- the condensed larger droplets are passed back to drug solution reservoir 310 via drug return regions 362 and 462 .
- the nebulization of the drug solution at the fountains is enhanced when the focal point of the acoustic waves coincides (exactly or substantially) with an upper surface of the drug solution in first barrier chamber 332 .
- a flow of the drug solution from drug reservoir 310 to barrier chambers 332 and 432 via reservoir channels 328 and 428 are controlled via valves 330 and 430 by independently sealing and unsealing valve openings 342 and 442 with valve seals 344 and 444 .
- corresponding ones of floats 346 and/or 446 are positioned to seal valve openings 342 and/or 442 by virtue of the buoyancy of floats 346 and 446 with respect to the drug solution.
- the level of the upper surface in one or both of barrier chambers 332 and 432 may drop below the threshold level, which in turn lowers one or both of floats 346 and 446 from valve openings 342 and 442 , thereby opening valves 330 and/or 430 , as is illustrated in FIG. 4 .
- activation of aerosol generators 338 and 438 enable generation of particles of the drug solution to be propelled by the fountains into aerosol regions 340 and 440 .
- the atmosphere within aerosol regions 340 and 440 is disturbed such that intake gas present within inlet channels 368 and 468 is pulled into particle receiving regions 366 and 466 via aerosol region inlets 358 and 458 .
- Pulling air into particle receiving regions 366 and 466 may initiate the flow of intake gas through aerosol regions 340 and 440 to outlet ports 134 and 136 , which may in turn motivate the nebulized particles formed at the fountains toward outlet ports 134 and 136 .
- the atmospheric disturbances that may be caused by the nebulized particles from the fountains, and the resulting flow of intake gas through aerosol regions 340 and 440 may function in a cooperative manner to “drive” the delivery of nebulized particles from the fountains to the user without requiring additional active moving parts such as a pump or compressor.
- FIG. 5 is an exploded view of nebulizing device 110 according to an embodiment of the invention.
- Housing 112 includes an outlet housing member 1010 , a drug return housing member 1012 , a reservoir housing member 319 , a drug reservoir seating member 1016 , a barrier chamber housing member 1018 , and a base housing member 1020 .
- the outlet housing member 1010 is disposed at the upper housing portion 120 of housing 112 .
- Outlet 116 is formed in outlet housing member 1010 .
- FIGS. 3 , 4 , 7 , and 8 illustrating cross sections taken along cross section line 3 show various components of aerosol regions 340 and 440 are formed within outlet housing member 1010 .
- aerosol region ceilings 374 and 474 , and drug delivery regions 361 and 461 are formed within outlet housing member 1010 .
- drug return housing member 1012 may be disposed adjacent outlet housing member 1010 .
- FIGS. 3 , 4 , 7 , and 8 illustrating cross sections taken along cross section line 3 - 3 show various components of aerosol regions 340 and 440 are formed within drug return housing member 1012 .
- chimneys 360 and 460 , and drug return regions 362 and 462 are formed within drug return housing member 1012 .
- Inlet ports 132 of gas inlet 114 , and corresponding inlet channels 368 are partially formed in drug return housing member 1012 .
- heating/sensor unit 327 is disposed around an outer surface of reservoir housing member 319 .
- Drug return housing member 1012 may be adapted to receive heating/sensor unit 327 and reservoir housing member 319 .
- Reservoir housing member 319 is disposed primarily within drug return housing member 1012 , and forms drug reservoir 310 .
- drug reservoir seating member 1016 is disposed adjacent to drug return housing member 1012 .
- a drug reservoir seating portion 1028 is formed on drug reservoir seating member 1016 .
- Drug reservoir seating portion 1028 is configured to receive a seating portion 1030 of reservoir housing member 319 therein.
- Upper fluid chambers 366 and 466 are formed in drug reservoir seating member 1016 .
- Inlet ports 132 of gas inlet 114 , and corresponding inlet channels 368 are partially formed in drug reservoir seating member 1016 . As may be seen in FIGS.
- barrier chamber housing member 1018 is disposed in housing 112 adjacent to drug reservoir seating member 1016 .
- Barrier chambers 332 and 432 , and an upper portion of a plunger channel 618 are formed in barrier chamber housing member 1018 .
- a valve interface 1034 is formed.
- FIGS. 3 , 4 , 7 , and 8 illustrating cross sections taken along cross section line 3 , reservoir channels 328 and 428 , and valves 342 and 442 are formed at valve interface 1034 .
- barrier chamber housing member 1018 includes mounting surfaces 352 and 452 .
- base housing member 1020 is disposed adjacent to barrier chamber housing member 1018 , at lower housing portion 122 of housing 112 , forming a base for housing 112 .
- Base housing member 1020 may form fluid chambers 336 and 436 , solenoid cavity 610 , and a lower portion of plunger channel 618 .
- a solenoid 612 is mounted within solenoid cavity 610 via solenoid bracket 1036 .
- Aerosol generator 338 is seated within base mounting member 1020 at seating portion 354 , formed therein.
- Base mounting member 1020 is adapted to receive user control interface 118 .
- housing 112 including housing members 1010 , 1012 , 319 , 1016 , 1018 , and 1020 are illustrated for exemplary purposes only, and that other embodiments of housing 112 and its various members exist.
- FIGS. 7 and 8 illustrate another embodiment of the invention that enables the drug solution held within housing 112 to be heated prior to, during, and/or after nebulization.
- the drug solution may be heated to enhance a comfort of the user, to lower a viscosity of the drug solution to augment nebulization of the drug solution, increase drug delivery flow rate, or for other purposes.
- nebulizing device 110 includes a solenoid cavity 610 formed in housing 112 .
- a solenoid 612 is mounted in solenoid cavity 610 .
- Solenoid 612 has a solenoid body 613 and a solenoid shaft 616 , which is joined to a movable plunger 614 .
- the solenoid is shown energized, while in FIG. 8 it is de-energized.
- shaft 616 extends from the solenoid body 613 .
- the solenoid could be reconfigured so that when it is energized it retracts into the solenoid body.
- Plunger 614 is joined to the solenoid body 613 at a first end and includes a plunger head 620 at a second end. Plunger head 620 interacts with drug dispensing opening 322 to comprise a reservoir valve 622 . Plunger 614 is actuated between the engaged position (illustrated in FIG. 7 ) and the disengaged position (illustrated in FIG. 8 ) to open and close reservoir valve 622 . In the engaged position, plunger head 620 engages drug dispensing opening 322 of drug solution reservoir 310 such that plunger head 620 seals drug dispensing opening 322 .
- Solenoid 612 is operatively coupled to control electronics 316 and power source/connection 318 . Solenoid 612 is controlled via control electronics 316 . Solenoid 612 is powered via power source/connection 318 .
- FIG. 9 is an exemplary illustration of circuitry 626 that may be used in nebulizing device 110 according to an embodiment of the invention.
- control electronics 316 are operatively linked with various components of nebulizing device 110 , such as, for example, user control interface 118 , power source/connection 318 , aerosol generators 338 and 438 , reservoir valve 622 , heating/sensor unit 327 , and/or other components.
- FIG. 10 is an exemplary illustration of a method 910 of controlling a nebulizing device according to one embodiment of the invention.
- Method 910 is commenced from a state in which the device is deactivated. In this state, a drug solution is held in drug reservoir 310 with closed valve 622 , the heater/sensing unit 327 associated with the device is at room temperature, and aerosol generators 338 and 438 associated with the device are deactivated.
- An activation command is conveyed from the user to the device at an operation 912 .
- the activation commend is input via user control interface 138 , or otherwise conveyed from the user to the device.
- Method 910 includes an operation 914 , at which a first threshold temperature and a second threshold temperature is determined.
- the first threshold temperature and/or the second threshold temperature is determined, in non-limiting examples, according to an input from the user, determined based on a default setting, determined automatically based on one or more measured variables, and/or otherwise determined.
- the inventors presently contemplate that the preferred operating temperature is 37 degrees Celsius or between 33 degrees to 41 degrees Celsius.
- delivery temperatures outside this range could also be used without departing from the scope of the present invention as dictated by the requirements of the particular drug being delivered and/or user preferences.
- Method 910 includes an operation 916 , at which the heater in heater/sensing unit 327 associated with the nebulizing device 110 is activated. Activating the heater includes transmitting power to the heater. Activation causes the temperature of the heater to rise.
- method 910 includes an operation 918 , at which the temperature of the heater associated with heater/sensing unit 327 is sensed to determine if the temperature is above the first temperature threshold. If the temperature of the heater is below the first threshold temperature, method 910 returns to operation 916 .
- method 910 proceeds to an operation 920 .
- the drug solution is released from the drug reservoir 310 for nebulization.
- the drug solution is released to barriers 334 and 434 by opening valve 622 .
- Method 910 includes an operation 922 , at which aerosol generators 338 and 438 are activated.
- the acoustic waves generated by the activated aerosol generators 338 and 438 are delivered to the drug solution to form nebulized particles from the drug solution at corresponding ones of barriers 334 and 434 .
- Method 910 includes an operation 924 , at which the temperature of the heater is sensed by the temperature sensor to determine if the temperature is between the first temperature and the second temperature. If the temperature of the heater is determined to be below the first temperature, method 910 proceeds to an operation 926 .
- the flow of the drug solution from the drug reservoir 310 to the barriers 334 and 434 are sealed (or substantially sealed), effectively stopping the delivery of the drug solution from the drug reservoir 310 to the barriers 334 and 434 .
- the flow of the drug solution is sealed by closing valve 622 .
- the aerosol generators 338 and 438 are deactivated. From operation 926 , method 910 may return to operation 916 .
- method 910 proceeds to an operation 928 , at which the heater is deactivated. This causes the heater to stop producing heat.
- the flow of the drug solution from the drug reservoir 310 to the barriers 338 and 438 is sealed (or substantially sealed), effectively stopping the delivery of the drug solution from the drug reservoir 310 to the barriers 334 and 434 , and the aerosol generators 338 and 438 are deactivated.
- the delivery of the drug solution from the drug reservoir 310 to the barriers 334 and 434 is continued and the aerosol generators 338 and 438 are deactivated. From operation 928 , method 910 returns to operation 924 .
- method 910 proceeds to an operation 930 .
- operation 930 it is determined if a treatment session with the nebulizing device 110 has been completed. The completion of a treatment session includes, among other things, receiving a deactivation command from the user, completing nebulization of a predetermined or threshold amount of the drug solution, nebulizing the drug solution for a predetermined or threshold amount of time, or otherwise completing the treatment session. If the treatment session is not completed, method 910 returns to operation 924 . If the treatment session is completed, method 910 proceeds to an operation 932 .
- the nebulizing device 110 is deactivated.
- Deactivating the nebulizing device 110 includes, among other things, deactivating the aerosol generators 338 and 438 , closing the valve 622 , and/or otherwise deactivating the nebulizing device 110 .
- FIGS. 11A-11C and 12 are exemplary illustrations of a handheld nebulizing device 1110 in accordance with another embodiment.
- device 1110 includes a housing 1112 , an inlet 1114 , an outlet 1116 , and a user control interface 1118 .
- Housing 1112 includes mouthpiece module 1120 , an intermediate module 1122 , and a base module 1124 .
- Modules 1120 , 1122 , and 1124 are selectively coupled to each other, and may be coupled and uncoupled to each other by the user.
- inlet 1114 includes an inlet port 1121 formed in housing 1112 , and particularly in mouthpiece module 1120 .
- outlet 1116 includes an outlet port 1126 formed in housing 1112 at mouthpiece module 1120 .
- Outlet port 1126 is configured for engagement by the user's mouth.
- user control interface 1118 includes a control knob 1128 .
- Control knob 1128 is located on the front of housing 1112 at base module 1124 .
- Intake gas such as air from the atmosphere
- Intake gas is received into inlet 1114 .
- outlet 1116 nebulized particles of the drug solution are communicated from device 1110 to the user.
- the user may control various aspects of operation of device 1110 via control interface 1118 .
- device 1110 includes a power receiving connector 1130 .
- Power connector 1130 is provided in housing 1112 at base module 1124 .
- Power is provided to device 1110 via power connection 1130 .
- power may be provided to device 1110 via an internal power source, such as a battery, a fuel cell, or other power source.
- FIG. 12 is a cross sectional view, taken along cross section line 12 - 12 in FIG. 11B .
- device 1110 includes a drug solution reservoir 1310 , a first nebulization section 1312 , a second nebulization section 1314 , and control electronics 1316 .
- Drug solution reservoir 1310 includes a drug solution receiving opening 1320 , a drug dispensing opening 1322 , a reservoir wall 1324 , and a reservoir floor 1326 .
- Drug solution reservoir 1310 is generally cylindrical in shape, or may be otherwise shaped.
- Drug solution receiving opening 1322 is formed by reservoir wall 1324 , and is circular, or otherwise shaped.
- Reservoir floor 1326 angles from reservoir wall 1324 in a downward slope to drug dispensing opening 1322 , which is formed by reservoir floor 1322 .
- First nebulization section 1312 includes a first reservoir channel 1328 , a first valve 1330 , a first barrier chamber 1332 , a first barrier 1334 , a first fluid chamber 1336 , a first aerosol generator 1338 , and a first aerosol region 1340 .
- First reservoir channel 1328 is formed within housing 112 and runs from drug dispensing opening 1322 to first valve 1330 .
- First valve 1330 is positioned outwardly from drug dispensing opening 1322 within housing 112 , between first reservoir channel 1328 and first barrier channel 1332 .
- first valve 1330 includes a first valve opening 1342 , and a valve seal 1344 .
- First valve opening 1342 is formed within housing 1112 as an outer opening of first reservoir channel 1328 .
- First valve seal 1344 is disposed at first valve opening 1342 to selectively seal first valve opening 1342 .
- First valve seal 1344 may include a first float 1346 disposed within first valve 1330 at a first float reception cavity 1348 .
- First float 1346 is composed of a material that enables first float 1346 to float in the drug solution, such as a closed cell foam.
- First float reception cavity 1348 is formed in housing 1112 between first reservoir channel 1328 and first barrier chamber 1332 .
- First valve 1344 includes a first float/cavity interface 1350 that includes corresponding surfaces of first float 1346 and first float reception cavity 1348 .
- First float 1346 is forced against first valve opening 1342 as first float 1346 rises to seal first valve opening 1342 .
- first float 1346 includes a first protruding center portion 1345 and first sloping lateral portions 1347 .
- First protruding center portion 1345 protrudes from first sloping lateral portions 1347 , which slope away from first protruding center portion 1345 .
- First float reception cavity 1348 includes a first vertical channel 1349 and first lateral sloping surfaces 1351 , arranged such that first protruding center portion 1345 is constantly positioned in first vertical channel 1349 even when first float 1346 is not sealing first valve opening 1342 to maintain the orientation of first float 1346 . Maintaining the orientation of first float 1346 ensures that first sloping lateral portions 1347 will contact sloping lateral surfaces 1351 to seal first valve 1330 when first float rises due to its buoyancy.
- first barrier chamber 1332 which communicates with first reservoir channel 1328 via first valve 1330 , is formed within housing 1112 between first barrier 1334 and first aerosol region 1340 .
- First barrier 1334 is mounted within housing 112 to a first mounting surface 1352 that is formed on an upper surface of first fluid chamber 1336 , between first barrier channel 1332 and first fluid chamber 1336 .
- First barrier forms a physical separation (i.e., a seal) between first barrier channel 1332 and first fluid chamber 1336 .
- First barrier 1334 is composed of one or more materials designed to enable first barrier 1334 to be capable of transmitting ultrasonic energy therethrough, even under high temperature conditions. For example, polyetheretherketone (PEEK), or other materials may be used.
- PEEK polyetheretherketone
- first fluid chamber 1336 is formed within housing 1112 between first barrier 1334 and first aerosol generator 1338 .
- First fluid chamber 1336 holds a fluid 1339 in communication with first barrier 1334 and first acoustic wave aerosol generator 1338 .
- Fluid 1339 includes one or more fluids capable of transmitting acoustic waves, such as, for example, water, or other fluids.
- Fluid 1339 may include one or more sterilant, such as, alcohol, or other sterilants.
- first aerosol generator 1338 is disposed at a first aerosol generator seating portion 1354 formed within housing 112 .
- first aerosol generator 1338 includes a concave piezoelectric transducer with a silver electrode.
- First aerosol generator 1338 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point, or focal band, that is a focal length from first aerosol generator 1338 .
- First aerosol generator seating portion 1354 is formed within housing 112 such that the focal point will be within first barrier chamber 1332 .
- Other embodiments of first aerosol generator 1338 exist.
- First aerosol generator 1338 is operatively linked to control electronics 1316 so that control electronics 1316 can control various aspects of acoustic wave generation by first aerosol generator 1338 , such as, for instance, activation and deactivation, or other aspects.
- First aerosol generator 1338 is operatively linked to power receiving connection 1130 so that power can be provided to first aerosol generator 1338 via this operative link.
- first aerosol region 1340 includes a first fountain region 1356 , one or more first aerosol region inlets 1358 , a first chimney 1360 , and a first drug return region 1362 .
- First fountain region 1356 is formed within housing 1112 between first barrier chamber 1332 and first chimney 1360 .
- First fountain region 1356 is open at a first end to first barrier chamber 1332 and at a second end to first chimney 1360 .
- First fountain region 1356 is formed as a funnel with a smaller opening at the first end and a larger opening at the second end, or may be otherwise shaped.
- the first aerosol region inlet 1358 is formed in housing 1112 at first fountain region 1356 .
- First aerosol region inlet 1358 is in communication with inlet port 1132 .
- first chimney 1360 is formed in housing 1112 , and opens at a first end to first fountain region 1356 .
- a first aerosol region ceiling 1374 is formed at a second end of first chimney 1360 .
- First chimney 1360 provides operable communication between first fountain region 1356 and outlet 1116 .
- first drug return region 1362 is formed in housing 1112 .
- First drug return region 1362 is open at a first end to drug reservoir 1310 .
- First drug return region 1362 communicates with first chimney 1360 .
- second nebulization section 1314 includes a second reservoir channel 1428 , a second valve 1430 , a second barrier chamber 1432 , a second barrier 1434 , a second fluid chamber 1436 , a second aerosol generator 1438 , and a second aerosol region 1440 .
- Second reservoir channel 1428 is formed within housing 1112 and runs from drug dispensing opening 1422 to second valve 1430 .
- Second valve 1430 is positioned outwardly from drug dispensing opening 1422 within housing 1112 , between second reservoir channel 1428 and second barrier chamber 1432 .
- second valve 1430 includes a second valve opening 1442 , and a valve seal 1444 .
- Second valve opening 1442 is formed within housing 1112 as an outer opening of second reservoir channel 1428 .
- Second valve seal 1444 is disposed at second valve opening 1442 to selectively seal second valve opening 1442 .
- second valve seal 1444 includes a second float 1446 , disposed within second valve 1430 at a second float reception cavity 1448 .
- Second float 1446 is composed of materials that enable second float 1446 to float in the drug solution.
- Second float reception cavity 1448 is formed in housing 1112 between second reservoir channel 1428 and second barrier chamber 1432 .
- Second valve 1444 includes a second float/cavity interface 1450 that includes corresponding surfaces of second float 1446 and second float reception cavity 1448 , and is arranged to bias second float 1446 against second valve opening 1442 as second float 1446 rises to seal second valve opening 1442 .
- second float/cavity interface 1450 is structured similarly to first float/cavity interface 1350 .
- valves 1330 and 1430 include, for example, one or more electrically operated solenoid valves that are actuated to open and/or close second valve 1430 .
- second barrier chamber 1432 which communicates with second reservoir channel 1428 , via second valve 1430 is formed within housing 1112 between second barrier 1434 and second aerosol region 1440 .
- Second barrier 1434 is mounted within housing 1112 to a second mounting surface 1452 that is formed on an upper surface of second fluid chamber 1436 , between second barrier chamber 1432 and second fluid chamber 1436 .
- Second barrier forms a physical separation (i.e., a seal) between second barrier chamber 1432 and second fluid chamber 1436 .
- Second barrier 1434 is composed of one or more materials designed to enable second barrier 1434 to be capable of transmitting ultrasonic energy therethrough, even under high temperature conditions. For example, polyetheretherketone (PEEK), or other materials may be used.
- PEEK polyetheretherketone
- the second fluid 1436 is formed within housing 1112 between second barrier 1434 and second aerosol generator 1438 .
- Second fluid 1436 holds an fluid 1439 in communication with second barrier 1434 and second aerosol generator 1438 .
- Fluid 1439 includes one or more fluids capable of transmitting acoustic waves, such as, for example, water, or other fluids.
- Fluid 1439 may include one or more sterilant, such as, alcohol, or other sterilants.
- Second aerosol generator 1438 is disposed at a second aerosol generator seating portion 1454 formed within housing 1112 .
- second aerosol generator 1438 includes a concave piezoelectric transducer with a silver electrode.
- Second aerosol generator 1438 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point, or focal band, that is a focal length from second aerosol generator 1338 .
- Second aerosol generator seating portion 1454 is formed within housing 1112 such that the focal point will be within second barrier chamber 1432 .
- Second aerosol generator 1438 is operatively linked to control electronics 1316 so that control electronics 1316 can control various aspects of acoustic wave generation by second aerosol generator 1438 , such as, for instance, activation and deactivation, or other aspects. Second aerosol generator 1438 is operatively linked to power connection 1130 so that power can be provided to second aerosol generator 1438 via this operative link.
- Second aerosol region 1440 includes a second fountain region 1456 , one or more second aerosol region inlets 1458 , a second chimney 1460 , and a second drug return region 1462 .
- Second fountain region 1456 is formed within housing 1112 between second barrier chamber 1432 and second chimney 1460 .
- Second fountain region 1456 is open at a first end to second barrier chamber 1432 and at a second end to second chimney 1460 .
- Second fountain region 1456 is formed as a funnel with a smaller opening at the first end and a larger opening at the second end, or may be otherwise shaped.
- second aerosol region inlet 1458 is formed in housing 1112 at second fountain region 1456 . Second aerosol region inlet 1458 is in communication with inlet port 1132 .
- second chimney 1460 is formed in housing 1112 , and opens at a first end to second fountain region 1456 .
- a second aerosol region ceiling 1474 is formed at a second end of second chimney 1460 .
- Second chimney 1460 provides operable communication between second fountain region 1456 and outlet 1116 .
- second drug return region 1462 is formed in housing 1112 .
- Second drug return region 1462 is open at a first end to drug reservoir 1310 .
- Second drug return region 1462 communicates with second chimney 1460 .
- the barrier chambers 1332 and 1432 hold an amount of the drug solution at each of barriers 1334 and 1434 .
- Nebulized particles of the drug solution are formed by the fountains and are delivered to aerosol regions 1340 and 1440 .
- the fountains are formed by acoustic waves within the drug solution held in barrier chambers 1332 and 1432 at barriers 1334 and 1434 .
- the acoustic waves are generated by aerosol generators 1338 and 1438 .
- the acoustic waves transmitted from aerosol generators 1338 and 1438 to barrier chambers 1332 and 1432 via the fluid held in fluid chambers 1336 and 1436 .
- the transmitted acoustic waves pass from fluid chambers 1336 and 1436 to barrier chambers 1332 and 1432 via barriers 1334 and 1434 .
- the acoustic waves transmitted to barrier chambers 1332 and 1432 are focused at the focal point.
- the drug solution in barrier chambers 1332 and 1432 absorbs the ultrasonic energy provided by the focused acoustic waves to create a fountain within each of barrier chambers 1332 and 1432 .
- the ultrasonic energy delivered by the acoustic waves has a maximum density at or near the focal point of the acoustic waves.
- the fountains shed a portion of the drug solution as particles. Some of these particles are so large they immediately fall out. Some are small enough to pass into drug return regions 1362 , 1462 before falling out. The remaining particles which are appropriately sized, pass out through first to second outlet 1116 . In this manner, substantially consistent particle size is achieved.
- the nebulized particles are communicated from barrier chambers 1332 and 1432 , through aerosol regions 1340 and 1440 , and to the user via outlet 1116 . More particularly, the nebulized particles and the larger droplets of the drug solution formed at the fountains are received by aerosol regions 1340 and 1440 at fluid chambers 1364 and 1464 , and pass into chimneys 1360 and 1460 . From chimneys 1360 and 1460 , the nebulized particles are communicated to the user via outlet 1116 .
- the larger droplets may not be communicated to the user, but instead may contact a surface of aerosol regions 1340 and 1440 , such as aerosol region ceilings 1374 and 1474 , or other surfaces.
- the larger droplets then condense on the contacted surface(s), thereby separating the larger droplets from the nebulized particles prior to delivery to the user.
- the drug solution contained in the condensed larger droplets are passed back to drug solution reservoir 1310 via drug return regions 1362 and 1462 .
- the nebulization of the drug solution by the fountains is enhanced when the focal point of the acoustic waves coincides (exactly or substantially) with an upper surface of the drug solution in first barrier chamber 1332 .
- an amount of the drug solution at barriers 334 and 434 is controlled by manipulating a flow of the drug solution from drug reservoir 1310 to barrier chambers 1332 and 1432 via reservoir channels 1328 and 1428 are controlled via valves 1330 and 1430 by independently sealing and unsealing valve openings 1342 and 1442 with valve seals 1344 and 1444 .
- corresponding one of floats 1346 and/or 1446 are positioned to seal valve openings 1342 and/or 1442 by virtue of the buoyancy of floats 1346 and 1446 with respect to the drug solution.
- valves 330 , and 430 may drop below the threshold level, which in turn lowers one or both of floats 1346 and 1446 from valve openings 1342 and 1442 , thereby opening valves 1330 and/or 1430 .
- This functionality is illustrated with respect to valves 330 , and 430 in FIGS. 3 , and 4 .
- activation of aerosol generators 1338 and 1438 enable generation of particles of the drug solution to be propelled by the fountains into aerosol regions 1340 and 1440 .
- the atmosphere within aerosol regions 1340 and 1440 is disturbed such that intake gas is pulled into particle receiving regions 1366 and 1466 via aerosol region inlets 1358 and 1458 .
- Pulling air into particle receiving regions 1366 and 1466 may initiate the flow of intake gas through aerosol regions 1340 and 1440 to outlet 1116 , which may in turn motivate the nebulized particles formed at the fountains toward outlet 1116 .
- the atmospheric disturbances that may be caused by the nebulized particles from the fountains, and the resulting flow of intake gas through aerosol regions 1340 and 1440 may function in a cooperative manner to “drive” the delivery of nebulized particles from the fountains to the user without requiring additional active moving parts.
- FIG. 13 is an exemplary cross sectional view of the handheld nebulizing device 1110 , taken along cross section line 13 - 13 , in accordance with another embodiment of the invention.
- device 1610 includes a first nebulization section 1612 , a second nebulization section 1614 , and control electronics 1616 .
- first nebulization section 1612 includes a first aerosol generator 1618 , a first fluid 1620 , a first barrier 1622 , a first barrier chamber 1624 , a first guide tube 1626 , and a first separator structure 1628 .
- First aerosol generator 1618 may include a concave piezoelectric transducer with a silver electrode.
- First aerosol generator 1618 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point that is a focal length from first aerosol generator 1618 .
- Device 1110 is arranged such that the focal point is within first barrier chamber 1624 .
- aerosol generator 1618 may be a jet type nebulizer, a vibrating mesh nebulizer, a vibratory plate nebulizer, a traditional planar ultrasonic nebulizer, or an electrospray nebulizer.
- first aerosol generator 1618 is seated in a first aerosol generator seating portion 1630 within intermediate module 1122 .
- First aerosol generator seating portion 1630 is defined by an upper surface of a first seating portion wall 1632 that extends upward from a bottom plane of intermediate module 1122 .
- first fluid 1620 is formed adjacent to aerosol generator seating portion 1630 such that first aerosol generator 1618 forms a portion of a lower surface of first fluid 1620 .
- a first barrier mounting surface 1634 is located at an upper surface of first fluid 1620 .
- First barrier mounting surface 1634 defines a first barrier opening 1636 .
- First barrier opening 1636 enable communication between first fluid 1620 and first barrier chamber 1624 .
- First barrier 1622 is mounted to first barrier mounting surface 1634 , effectively sealing first fluid 1620 from first barrier chamber 1624 .
- first barrier chamber 1624 is formed by a first barrier chamber wall 1638 and a first barrier chamber floor 1640 .
- First barrier chamber floor 1640 is sloped such that first barrier opening 1636 is a lowest point within first barrier chamber 1624 .
- first guide tube 1626 is provided over first barrier 1622 such that a first end of first guide tube 1626 extends down into first barrier chamber 1624 and a second end of first guide tube 1626 extends out of first barrier chamber 1624 .
- First guide tube 1626 is held in position over first barrier 1622 by a first guide tube collar 1638 associated with first separator structure 1628 .
- First guide tube collar 1638 holds first guide tube 1626 in position such that the second end of first guide tube 1626 extends up into first separator structure 1628 .
- First separator structure 1628 provides communication between the second end of first guide tube 1626 and outlet 1116 .
- first aerosol generator 1618 may be activated by control electronics 1616 to generate acoustic waves that are introduced into first fluid 1620 .
- First fluid 1620 contains a fluid 1629 that is capable of transmitting the received acoustic waves.
- the transmitting fluid 1629 may include water, or other fluids.
- a sterilant such as alcohol, or another sterilant, may be added to the transmitting fluid.
- the second nebulization section 1614 includes a second aerosol generator 1718 , a second fluid 1720 , a second barrier 1722 , a second barrier chamber 1724 , a second guide tube 1726 , and a second separator structure 1728 .
- Second aerosol generator 1718 may include a concave piezoelectric transducer with a silver electrode. Second aerosol generator 1718 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point that is a focal length from second aerosol generator 1718 . Device 1110 is arranged such that the focal point is within second barrier chamber 1724 . Other embodiments of aerosol generator 1718 exist.
- second aerosol generator 1718 is seated in a second aerosol generator seating portion 1630 within intermediate module 1122 .
- Second aerosol generator seating portion 1630 is defined by an upper surface of a second seating portion wall 1632 that extends upward from a bottom plane of intermediate module 1122 .
- second fluid 1720 is formed adjacent to aerosol generator seating portion 1630 such that second aerosol generator 1718 forms a portion of a lower surface of second fluid 1720 .
- a second barrier mounting surface 1634 is located at an upper surface of second fluid 1720 .
- Second barrier mounting surface 1634 defines a second barrier opening 1636 .
- Second barrier opening 1636 enable communication between second fluid 1720 and second barrier chamber 1724 .
- Second barrier 1722 is mounted to second barrier mounting surface 1634 , effectively sealing second fluid 1720 from second barrier chamber 1724 .
- the second barrier chamber 1724 is formed by a second barrier chamber wall 1638 and a second barrier chamber floor 1740 .
- Second barrier chamber floor 1740 is sloped such that second barrier opening 1636 is a lowest point within second barrier chamber 1724 .
- second guide tube 1726 is provided over second barrier 1722 such that a first end of second guide tube 1726 extends down into second barrier chamber 1724 and a second end of second guide tube 1726 extends out of second barrier chamber 1724 .
- Second guide tube 1726 is held in position over second barrier 1722 by a second guide tube collar 1738 associated with second separator structure 1728 .
- Second guide tube collar 1728 holds second guide tube 1726 in position such that the second end of second guide tube 1726 extends up into second separator structure 1728 .
- Second separator structure 1728 provides communication between the second end of second guide tube 1726 and outlet 1116 .
- second acoustic wave aerosol generator 1718 may be activated by control electronics 1716 to generate acoustic waves that are introduced into second fluid 1720 .
- Second fluid 1720 contains a fluid 1729 that is capable of transmitting the received acoustic waves.
- the fluid 1729 may include water, or other fluids.
- a sterilant such as alcohol, or another sterilant, may be added to the transmitting fluid.
- the acoustic waves introduced to fluids 1620 and 1720 are transmitted from fluids 1620 and 1720 to barrier chambers 1624 and 1724 via barriers 1622 and 1722 .
- the acoustic waves transmitted to barrier chambers 1624 and 1724 are focused at the focal points of aerosol generators 1618 and 1718 .
- Pools of drug solution held within barrier chambers 1624 and 1724 absorb the ultrasonic energy provided by the focused acoustic waves, thereby energizing the drug solution to create a fountain at the top of guide tubes 1626 , 1726 .
- the fountains shed a portion of the drug solution as particles. Some of these particles are so large they immediately fall out. The remaining particles, which are appropriately sized, pass out of barrier chambers 1624 , 1724 . In this manner, a substantially consistent particle size is achieved.
- the nebulization of the drug solution by the fountains is enhanced when the focal point of the acoustic waves coincides (exactly or substantially) with a surface of the drug solution in barrier chambers 1624 and 1724 . This may require a level of the surface to be controlled with some particularity to enhance the operation of the fountain.
- the fountains are formed at the top of guide tubes 1626 and 1726 .
- the drug solution within guide tubes 1626 and 1726 is propelled toward the second ends of guide tubes 1626 and 1726 by the ultrasonic energy from the acoustic waves.
- ultrasonic energy received by guide tubes 1626 and 1726 from the acoustic waves are transmitted to the drug solution propelled up from first ends of guide tubes 1626 and 1726 , and is delivered to the drug solution at the second ends of guide tubes 1626 and 1726 to form the nebulized particles of the drug solution.
- guide tubes 1626 and 1726 enhance the formation of the nebulized particles of the drug solution within the fountains by energizing the drug solution within guide tubes 1626 and 1726 to nebulize drug solution that is not located at the respective focal points of the acoustic waves.
- the guide tubes are 2 mm-3 mm in diameter.
- the particles discharged from guide tubes 1626 , 1726 can be adjusted by adjusting the size of the guide tubes 1626 , 1726 .
- pulmonary surfactants mainly consist of phosphelipids and surfactants proteins that are used to replace deficient endogenous surfactants in patient's lungs.
- surfactant medications available such as natural human surfactants (obtained from amniotic fluid or a bio-synthetic material), natural animal surfactants (obtained from bovine lung extracts, porcine lung extracts, or a bio-synthetic material), or synthetic preparations.
- natural human surfactants obtained from amniotic fluid or a bio-synthetic material
- natural animal surfactants obtained from bovine lung extracts, porcine lung extracts, or a bio-synthetic material
- synthetic preparations What makes pulmonary surfactants particularly difficult to delivery in aerosol form is that they are highly viscous. Accordingly using one or more of the above described features of the present invention permits high speed delivery of viscous drugs such as pulmonary surfactants.
- the novel aspects of the present invention can also be used with a variety of other drug formulations.
Abstract
The present invention provides a nebulizing drug delivery system for delivering an aerosolized drug to a user having various features to increase the capacity of the drug delivery device. The drug delivery system includes a heater to increase the viscosity of the drug, a double aerosolizing system to double the capacity of the device, and a valve system to continuously replenish drug to the aerosol generator thereby providing a high speed delivery.
Description
- This application claims priority under 35 U.S.C. §119(e) from provisional U.S. Patent Application No. 60/659,919 filed Mar. 9, 2005; and U.S. application Ser. No. 11/367,649 filed Mar. 3, 2006, entitled “Nebulizing Drug Delivery Device with an Increased Flow Rate” the contents of which are incorporated herein by reference.
- 1. Field of the Invention
- The present invention relates to drug delivery devices, and, in particular, to nebulizers used in an aerosolized drug delivery.
- 2. Description of the Related Art
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- Nebulizing drug delivery devices that use ultrasonic energy to nebulize a drug solution are generally known. Such devices typically include an acoustic wave generator to generate acoustic waves that are transmitted to a drug solution. The ultrasonic energy transmitted to the drug solution in the form of the acoustic waves energizes the drug solution such that nebulized particles of the drug solution are formed. The ultrasonic energy may be delivered with a maximum density at a focal point of the acoustic waves, and nebulization efficiency of the drug solution may be enhanced when an upper surface of a pool of the drug solution is located at or near the focal point of the acoustic waves. However, the ability to take advantage of enhanced nebulization efficiency in this manner has been limited by the fact that the upper surface of the drug solution lowers during nebulization as the amount of drug solution in the device is depleted.
- It should be appreciated that several conventional nebulizing drug delivery devices are configured to deliver drug solutions to a user's lungs via inhalation. But these devices may not be capable of effectively or efficiently nebulizing various types of drug solutions for delivery that are typically delivered directly into a patient's lungs, such as through injection. Thus, typical nebulizing drug delivery devices may not be particularly effective or efficient in delivering drug solutions of a higher viscosity, and/or drug solutions that must be delivered at higher flow rates.
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- In accordance with the broad teachings of the invention, one aspect of the invention relates to a nebulizing device comprising a housing including an outlet and a drug reservoir for receiving a drug solution within the housing. An aerosol generator is disposed in communication with a fluid, and a barrier separates the fluid from a portion of the drug solution residing on the barrier. The barrier is capable of transmitting acoustic waves in the fluid to the portion of drug solution residing thereon. The acoustic waves in the drug solution operate to form nebulized particles from the portion of drug solution residing on the barrier to enable nebulized particles of the drug solution to be communicated to a user through the outlet. A valve permits drug solution within the reservoir to replenish the portion of drug solution residing on the barrier when the portion is less than a threshold amount.
- In one embodiment, the valve comprises a float that floats on the portion of drug solution residing on the barrier, the float substantially sealing the reservoir from the barrier when the amount of drug solution residing on the barrier is above the threshold amount. The float permitting drug solution to flow from the reservoir to the barrier when the amount of drug solution residing on the barrier is less than the threshold amount.
- In another aspect the invention relates to a nebulizing device comprising a housing having an inlet and an outlet, and a plurality of aerosol generators in communication with a fluid. A barrier is disposed between the fluid and a drug solution provided within the housing, the barrier being capable of transmitting acoustic waves in the fluid to the drug solution. The plurality of aerosol generators form a corresponding plurality of fountains that generate nebulized particles of the drug solution. The plurality of fountains are in communication with the outlet to enable a user to inhale nebulized particles of the drug solution from the plurality of aerosol regions through the outlet.
- These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. As used in the specification and in the claims, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
- A specific embodiment of the invention is now described with reference to the accompanying drawings, wherein:
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FIG. 1 illustrates a perspective view of the nebulizing device in accordance with an embodiment of the invention. -
FIG. 2A is a top plan view of an embodiment of the nebulizing device with a fixed length cord. -
FIG. 2B is a top plan view of an embodiment of the nebulizing device with a cord in a retracted position. -
FIG. 3 is a cross sectional view of the nebulizing device ofFIG. 2A , taken along section line 3-3 ofFIG. 2A , according to an embodiment of the invention. -
FIG. 4 is a sectional view of the nebulizing device similar toFIG. 3 , but illustrating the device with the valves between the barrier chambers and the drug reservoir open. -
FIG. 5 is an exploded perspective view of the nebulizing drug delivery device, in accordance with one embodiment of the invention. -
FIG. 6 is a cross-sectional view of the nebulizing device similar toFIG. 3 , but including an alternative valve arrangement between the barrier chambers and the drug reservoir. -
FIG. 7 is a cross-sectional view of the nebulizing device similar toFIG. 4 , but including a solenoid to operate a valve for opening and closing the drug reservoir. -
FIG. 8 is a cross-sectional view of the nebulizing device similar toFIG. 7 , but illustrating the valve for opening and closing the drug reservoir as being open. -
FIG. 9 is an exemplary illustration of the circuitry of the nebulizing device according to one embodiment of the invention. -
FIG. 10 is an exemplary illustration of a method of controlling the nebulizing device in accordance with an embodiment of the invention. -
FIGS. 11A-11C illustrate a front perspective view, a side plan view, and a rear plan view of the nebulizing drug delivery device, according to one embodiment of the invention. -
FIG. 12 is a sectional view of the nebulizing device ofFIG. 11B , taken along section line 12-12 ofFIG. 11B , in accordance with an embodiment of the invention. -
FIG. 13 is a cross sectional view of the nebulizing device ofFIG. 11B , take along section line 13-13FIG. 11B , according to one embodiment of the invention. -
FIG. 1 is a front perspective view, andFIG. 2A is a top view of a nebulizingdevice 110, according to an embodiment of the invention. Nebulizingdevice 110 is adapted to nebulize and deliver a drug solution to a user. Nebulizingdevice 110 provides various advantages in nebulizing and/or delivering the drug solution to the user. For example, nebulizingdevice 110 is capable of nebulizing viscous drug solutions such as drug solutions containing a surfactant, or other viscous drug solutions, delivers the drug solution at an enhanced flow rate, and provides other advantages as described herein. As shown, nebulizingdevice 110 includes ahousing 112, agas inlet 114, a nebulizeddrug delivery outlet 116, and auser control interface 118. - In one embodiment of the invention,
housing 112 includes a plurality of housing members.Housing 112 includes anupper housing portion 120, amiddle housing portion 121, and alower housing portion 122. The front surface ofupper housing portion 120 has astep region 124 formed thereon. Specifically,upper housing portion 120 has atop surface 126, anangled surface 128 extending downwardly fromtop surface 126, and a longitudinalhorizontal ledge surface 130 extending outwardly from the bottom ofangled surface 128. Thus,top surface 126 andledge surface 130 are formed as offset parallel planar surfaces withangled surface 128 structurally joiningtop surface 126 andledge surface 130 to formstep region 124. - According to one embodiment of the invention,
gas inlet 114 includes one ormore inlet ports 132 formed inhousing 112.Inlet ports 132 are located atmiddle housing portion 121 ofhousing 112. - The nebulized
drug delivery outlet 116 includes afirst outlet port 134 and asecond outlet port 136.First outlet port 134 andsecond outlet port 136 are formed inhousing 112 atangled surface 128. In an alternate embodiment,first outlet port 134 andsecond outlet port 136 may be formed as a single outlet port. -
User control interface 118 includes acontrol knob 138.Control knob 138 is located onhousing 112. In a non-limiting example,control knob 138 is located atlower housing portion 122 ofhousing 112. Of course, various other user interfaces could be used without departing from the scope of the present invention such as keypads, touch screens, wirelessly via a memory storage device, sent over a radio frequency, or Infrared communication link. -
FIGS. 3 and 4 are cross sectional views, taken along cross section line 3-3, as illustrated inFIG. 2A , ofnebulizing device 110. Referring toFIG. 3 ,nebulizing device 110 includes adrug solution reservoir 310, afirst nebulization section 312, asecond nebulization section 314,control electronics 316, and a power source/connection 318. -
Drug solution reservoir 310 is contained in areservoir housing member 319, included withinhousing 112.Drug solution reservoir 310 includes an upper drugsolution receiving opening 320, adrug dispensing opening 322, areservoir wall 324, and areservoir floor 326. Drugsolution reservoir wall 324 is generally cylindrical in shape, or may be otherwise shaped. Drugsolution receiving opening 322 is defined by the upper periphery ofreservoir wall 324, and is circular, or otherwise shaped.Reservoir floor 326 angles fromreservoir wall 324 in a downward slope todrug dispensing opening 322 formed withinreservoir floor 326. - In one embodiment of the invention, the
nebulizing device 110 also includes a heating/sensor unit 327 for heating the drug solution. This may be useful with higher viscosity drug solutions, or for increased comfort of a user. For example, to warm the drug solution prior to inhalation in instances when the device and/or drug solution contained therein have been exposed to cold temperatures. As shown in the embodiments ofFIGS. 3-8 and as can be particularly appreciated from the exploded view of the embodiment ofFIG. 5 , heating/sensor unit 327 may be annularly disposed about theouter wall 324 that containsdrug reservoir 310. As illustrated inFIG. 5 , heating/sensor unit 327 may include anannular band member 1022, with a resistive heating element (or heater) 1024 and atemperature sensor 1026 disposed thereon. Thetemperature sensor 1026 within heating/sensor unit 327 is in functional communication with theheater 1024, to sense a temperature of the drug solution or theheater 1024 itself. Heating/sensor unit 327 is operatively coupled to one or both ofcontrol electronics 316 and power source/connection 318. Heating/sensor unit 327 is controlled viacontrol electronics 316, and is powered via power source/connection 318. - The heater is operable in response to the
temperature sensor 1026. In some instances, heating/sensor unit 327 maintains the temperature of theheater 1024 in a temperature range between an upper threshold temperature and a lower threshold temperature. Or, heating/sensor unit 327 maintains the temperature of theheater 1024 above a threshold temperature. It is contemplated that heating/sensor unit 327 is configured and/or arranged to heat the drug solution in at least one ofdrug reservoir 310,first barrier chamber 332,second barrier chamber 432,first reservoir channel 328,second reservoir channel 330,first aerosol region 340, and/orsecond aerosol region 440. - In another embodiment, the heater/
sensing unit 327 can be separated so that either the heater or the sensor is disposed within thedrug solution reservoir 310, in contact with the drug solution, and the other element (heater or sensor) is in contact with theouter wall 324 that containsdrug reservoir 310. Thesensor 1026 may be a thermocouple or other temperature sensing element such as a thermistor, resistance thermal detector, bimetallic, or Infrared. - It is further contemplated that the
heater element 1024 need not be a resistive heater, but can be any suitable heater that can be used to raise the temperature of the drug solution. - According to various embodiments of the invention,
first nebulization section 312 includes afirst reservoir channel 328, afirst valve 330, afirst barrier chamber 332, afirst barrier 334, a firstfluid chamber 336, transmittingfluid 337, afirst aerosol generator 338, and afirst aerosol region 340.First reservoir channel 328 is formed withinhousing 112 and runs fromdrug dispensing opening 322 tofirst valve 330.First valve 330 is positioned outwardly fromdrug dispensing opening 322 withinhousing 112, betweenfirst reservoir channel 328 andfirst barrier chamber 332. - In one embodiment, seen best in
FIG. 4 ,first valve 330 includes afirst valve opening 342, and avalve seal 344.First valve opening 342 is formed withinhousing 112 as an outer opening offirst reservoir channel 328.First valve structure 344 is disposed at first valve opening 342 to selectively sealfirst valve opening 342. In one embodiment,first valve structure 344 includes afirst float 346, disposed withinfirst valve 330 at a firstfloat reception cavity 348.First float 346 is composed of a material that enablesfirst float 346 to float in the drug solution, such as, for example, a closed cell foam. Firstfloat reception cavity 348 is formed inhousing 112 betweenfirst reservoir channel 328 andfirst barrier chamber 332.First valve 344 includes a first float/cavity interface 350 that includes corresponding surfaces offirst float 346 and firstfloat reception cavity 348. First float 346 seals first valve opening 342 asfirst float 346 rises to sealfirst valve opening 342. For example, as is illustrated inFIGS. 3 , and 4, first float/cavity interface 350 includes corresponding angled surfaces offirst float 346 and firstfloat reception cavity 348. - Referring to
FIG. 6 , an exemplary illustration ofnebulizing device 110 provides an alternate configuration forvalves FIG. 6 , floats 346 and 446 include abody 510 and anannular protrusion 512.Annular protrusion 512 surroundsbody 510, and extends outward frombody 510 in a direction normal to the surface ofbody 510 thatannular protrusion 512 protrudes from. Asfloats cavity interfaces bodies 510 offloats float cavities annular protrusions 512 effectively sealvalve openings valves - In other embodiments,
valves - In the embodiment illustrated in
FIGS. 3 , and 4,first barrier chamber 332, which communicates withfirst reservoir channel 328 viafirst valve 330 is formed withinhousing 112 betweenfirst barrier 334 andfirst aerosol region 340.First barrier 334 is mounted withinhousing 112 to a first mountingsurface 352 that is formed on an upper surface of firstfluid chamber 336, betweenfirst barrier chamber 332 and firstfluid chamber 336. First barrier forms a physical separation (i.e., a seal) betweenfirst barrier chamber 332 and firstfluid chamber 336.First barrier 334 is composed of one or more materials designed to enablefirst barrier 334 to be capable of transmitting ultrasonic energy therethrough, even under high temperature conditions. For example, polyetheretherketone (PEEK), or other materials may be used. - According to one embodiment of the invention, first
fluid chamber 336 is formed withinhousing 112 betweenfirst barrier 334 andfirst aerosol generator 338. In one embodiment, thefirst aerosol generator 338 is an acoustic wave generator, such as a piezoelectric transducer, and firstfluid chamber 336 holds a fluid 337 in communication withfirst barrier 334 andfirst aerosol generator 338.Fluid 337 can be selected to be capable of transmitting acoustic waves, such as, for example, water, or other fluids.Fluid 337 may include one or more sterilants, such as, alcohol, or other sterilants. - In one embodiment of the invention,
first aerosol generator 338 is disposed at afirst seating portion 354 formed withinhousing 112. In embodiments wherefirst aerosol generator 338 comprises a piezoelectric transducer, it may be formed to have a concave configuration with a silver electrode.First aerosol generator 338 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point, or focal band, that is a focal length fromfirst aerosol generator 338.First seating portion 354 is formed withinhousing 112 such that the focal point will be withinfirst barrier chamber 332.First aerosol generator 338 is operatively linked to controlelectronics 316 so thatcontrol electronics 316 can control various aspects of acoustic wave generation byfirst aerosol generator 338, such as, for instance, activation and deactivation.First aerosol generator 338 is operatively linked to power source/connection 318 so that power can be provided tofirst aerosol generator 338 via this operative link. - Power source/
connection 318 may include apower cord 140.Power cord 140 can be connected to a contemporary household socket to deliver power to thenebulizing device 110.Cord 140 could have a fixed length or could have a mechanism to retract a majority ofcord 140 intohousing 112. This feature of the present invention could be used regardless of the aerosol generator being used. The present invention contemplates thatcord 140 could also be used with a variety of nebulizers including jet nebulizers, traditional planar ultrasonic nebulizers, vibrating mesh nebulizers, vibrating plate nebulizers, or electro spray nebulizers. The unique advantage this feature of the present invention provides is that it preventscord 140 from becoming tangled with objects present in the user's environment when not in use. - According to an embodiment of the invention,
first aerosol region 340 includes afirst fountain region 356, one or more firstaerosol region inlets 358, afirst chimney 360, a firstdrug delivery region 361, and a firstdrug return region 362.First fountain region 356 is formed withinhousing 112 betweenfirst barrier chamber 332 andfirst chimney 360.First fountain region 356 includes a lowerfirst fountain region 364 and an upperfirst fountain region 366. Lowerfirst fountain region 364 is open at a first end tofirst barrier chamber 332 and at a second end to upperfirst fountain region 366. Lowerfirst fountain region 364 is cylindrical, or may be otherwise shaped. Upperfirst fountain region 366 is open at a first end to lowerfirst fountain region 364 and at a second end tofirst chimney 360. Upperfirst fountain region 364 is formed as a funnel with a smaller opening at the first end and a larger opening at the second end, or may be otherwise shaped. - As is illustrated in
FIGS. 3 , and 4, firstaerosol region inlets 358 are formed inhousing 112 atfirst fountain region 356. Firstaerosol region inlets 358 provide an opening for one or morecorresponding inlet channels 368.Inlet channels 368 are formed inhousing 112, and run between firstaerosol region inlets 358 andinlet ports 132. - In one embodiment,
first chimney 360 is formed inhousing 112, and opens at a first end tofirst fountain region 356. Afirst chimney ceiling 370 is formed withinhousing 112 at a second end offirst chimney 360. At a side offirst chimney 360, proximate tofirst chimney ceiling 370,first chimney 360 opens to firstdrug delivery region 361. - According to an embodiment of the invention, first
drug delivery region 361 is formed withinhousing 112 to communicate withfirst chimney 360,first outlet port 134, and firstdrug return region 361. Firstdrug delivery region 361 is open to firstdrug return region 361 at a first end, and is bounded at a second end by first drugdelivery region ceiling 372. First drugdelivery region ceiling 372 andfirst chimney ceiling 370 form a firstaerosol region ceiling 374. - In one embodiment of the invention, first
drug return region 362 is formed inhousing 112 to be open at a first end todrug reservoir 310. Firstdrug return region 362 also communicates with firstdrug delivery region 361. - According to the embodiment of the invention shown in
FIGS. 3 , 4,second nebulization section 312 includes asecond reservoir channel 428, asecond valve 430, asecond barrier chamber 432, asecond barrier 434, a secondfluid chamber 436, asecond fluid 437 within secondfluid chamber 436, asecond aerosol generator 438, and asecond aerosol region 440.Second reservoir channel 428 is formed withinhousing 112 and runs from drug dispensing opening 422 tosecond valve 430.Second valve 430 is positioned outwardly from drug dispensing opening 422 withinhousing 112, betweensecond reservoir channel 428 andsecond barrier chamber 432. - The invention contemplates that
first aerosol generator 338 andsecond aerosol generator 438 may be any device capable of forming aerosol. For instance, the unique aspects of the present invention can also be used with compressor driven jet nebulizers, traditional planar ultrasonic nebulizers, vibratory mesh nebulizers, vibrating plate nebulizers, or electrospray nebulizers without departing from the teachings of the present invention. - The
second valve 430 includes a second valve opening 442, and avalve seal 444.Second valve opening 442 is formed withinhousing 112 as an outer opening ofsecond reservoir channel 428.Second valve seal 444 is disposed at second valve opening 442 to selectively sealsecond valve opening 442. In some instances,second valve seal 444 includes asecond float 446, disposed withinsecond valve 430 at a secondfloat reception cavity 448.Second float 446 is composed of materials that enablesecond float 446 to float in the drug solution. Secondfloat reception cavity 448 is formed inhousing 112 betweensecond reservoir channel 428 andsecond barrier chamber 432.Second valve 444 includes a second float/cavity interface 450 that includes corresponding surfaces ofsecond float 446 and secondfloat reception cavity 448, and is arranged to biassecond float 446 against second valve opening 442 assecond float 446 rises to sealsecond valve opening 442. For example, as is illustrated inFIGS. 3 , and 4, second float/cavity interface 450 includes corresponding angled surfaces of second float 146 and secondfloat reception cavity 448. - According to an embodiment of the invention,
second barrier chamber 432, which communicates withsecond reservoir channel 428 viasecond valve 430 is formed withinhousing 112 betweensecond barrier 434 andsecond aerosol region 440.Second barrier 434 is mounted withinhousing 112 to asecond mounting surface 452 that is formed on an upper surface of secondfluid chamber 436, betweensecond barrier chamber 432 and secondfluid chamber 436. Second barrier forms a physical separation (i.e., a seal) betweensecond barrier chamber 432 and secondfluid chamber 436.Second barrier 434 is composed of one or more materials designed to enablesecond barrier 434 to be capable of transmitting ultrasonic energy therethrough, even under high temperature conditions. For example, polyetheretherketone (PEEK), or other materials may be used. - In accordance with the embodiment of the invention illustrated in
FIGS. 3 , and 4, secondfluid chamber 436 is formed withinhousing 112 betweensecond barrier 434 andsecond aerosol generator 438. Theaerosol generator 438, in one embodiment, is a concave shaped piezoelectric transducer with a silver electrode. Thepiezoelectric aerosol generator 438 achieves its functionality by generating acoustic waves in the drug solution as described with respect to thefirst aerosol generator 338.Second fluid chamber 436 holds a fluid in communication withsecond barrier 434 andsecond aerosol generator 438.Fluid 337 includes one or more fluids capable of transmitting acoustic waves, such as, for example, water, or other fluids.Fluid 337 may include one or more sterilants, such as, alcohol, or other sterilants. - In one embodiment of the invention,
second aerosol generator 438 is disposed at asecond seating portion 454 formed withinhousing 112. In some instances,second aerosol generator 438 includes a concave piezoelectric transducer with a silver electrode.Second aerosol generator 438 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point, or focal band, that is a focal length fromsecond aerosol generator 438.Second seating portion 454 is formed withinhousing 112 such that the focal point will be withinsecond barrier chamber 432. Other embodiments ofsecond aerosol generator 438 exist.Second aerosol generator 438 is operatively linked to controlelectronics 316 so thatcontrol electronics 316 can control various aspects of acoustic wave generation bysecond aerosol generator 438, such as, for instance, activation and deactivation, or other aspects.Second aerosol generator 438 is operatively linked to power source/connection 318 so that power can be provided tosecond aerosol generator 438 via this operative link. - The
second aerosol region 440 includes asecond fountain region 456, one or more secondaerosol region inlets 458, asecond chimney 460, a seconddrug delivery region 461, and a seconddrug return region 462.Second fountain region 456 is formed withinhousing 112 betweensecond barrier chamber 432 andsecond chimney 460.Second fountain region 456 includes a lowersecond fountain region 464 and an uppersecond fountain region 466. Lowersecond fountain region 464 is open at a first end tosecond barrier chamber 432 and at a second end to uppersecond fountain region 466. Lowersecond fountain region 464 is cylindrical, or may be otherwise shaped. Uppersecond fountain region 466 is open at a first end to lowersecond fountain region 464 and at a second end tosecond chimney 460. Uppersecond fountain region 464 is formed as a funnel with a smaller opening at the first end and a larger opening at the second end, or may be otherwise shaped. - In one embodiment of the invention, second
aerosol region inlets 458 are formed inhousing 112 atsecond fountain region 456. Secondaerosol region inlets 458 provide an opening for one or morecorresponding inlet channels 468.Inlet channels 468 are formed inhousing 112, and run between secondaerosol region inlets 458 andinlet ports 132. - In one embodiment,
second chimney 460 is formed inhousing 112, and opens at a first end tosecond fountain region 456. Asecond chimney ceiling 470 is formed withinhousing 112 at a first end ofsecond chimney 460. At a side ofsecond chimney 460, proximate tosecond chimney ceiling 470,second chimney 460 opens to seconddrug delivery region 461. - According to the embodiment of the invention shown in
FIGS. 3 , and 4, seconddrug delivery region 461 is formed withinhousing 112 to communicate withsecond chimney 460,second outlet port 134, and seconddrug return region 461. Seconddrug delivery region 461 is open to seconddrug return region 461 at a first end, and is bounded at a second end by second drugdelivery region ceiling 472. Second drugdelivery region ceiling 472 andsecond chimney ceiling 470 form a secondaerosol region ceiling 474. - The second
drug return region 462 is formed inhousing 112 to be open at a first end todrug reservoir 310. Seconddrug return region 462 also communicates with seconddrug delivery region 461. - According to an embodiment of the invention,
barrier chambers barriers barrier chambers aerosol regions barrier chambers barriers generators aerosol generators barrier chambers fluid chambers fluid chambers barrier chambers barriers - In accordance with the embodiment of the invention illustrated in
FIGS. 3 , and 4, the acoustic waves transmitted tobarrier chambers barrier chambers barrier chambers drug return regions outer ports - In one embodiment of the invention, the nebulized particles are communicated from
barrier chambers aerosol regions outlet ports outlet 116. More particularly, the nebulized particles and the larger droplets of the drug solution formed at the fountains are received byaerosol regions fluid chambers chimneys chimneys drug delivery regions outlet ports aerosol regions aerosol ceilings drug solution reservoir 310 viadrug return regions - The nebulization of the drug solution at the fountains is enhanced when the focal point of the acoustic waves coincides (exactly or substantially) with an upper surface of the drug solution in
first barrier chamber 332. This requires a level of the upper surface to be controlled with some particularity to enhance the operation of the fountains. To control the level of the upper surface, a flow of the drug solution fromdrug reservoir 310 tobarrier chambers reservoir channels valves valve openings valve seals barriers 334 and/or 434 reaches a threshold level at or near the focal point of the acoustic waves, corresponding ones offloats 346 and/or 446 are positioned to sealvalve openings 342 and/or 442 by virtue of the buoyancy offloats barrier chambers floats valve openings valves 330 and/or 430, as is illustrated inFIG. 4 . - Referring to
FIG. 3 , in some embodiments of the invention, activation ofaerosol generators aerosol regions aerosol regions aerosol regions inlet channels particle receiving regions aerosol region inlets particle receiving regions aerosol regions outlet ports outlet ports aerosol regions -
FIG. 5 is an exploded view ofnebulizing device 110 according to an embodiment of the invention.Housing 112 includes anoutlet housing member 1010, a drugreturn housing member 1012, areservoir housing member 319, a drugreservoir seating member 1016, a barrierchamber housing member 1018, and abase housing member 1020. - The
outlet housing member 1010 is disposed at theupper housing portion 120 ofhousing 112.Outlet 116 is formed inoutlet housing member 1010. As may be seen inFIGS. 3 , 4, 7, and 8 illustrating cross sections taken alongcross section line 3, show various components ofaerosol regions outlet housing member 1010. For example,aerosol region ceilings drug delivery regions outlet housing member 1010. - According to one embodiment of the invention, drug
return housing member 1012 may be disposed adjacentoutlet housing member 1010. As may be seen in theFIGS. 3 , 4, 7, and 8 illustrating cross sections taken along cross section line 3-3, show various components ofaerosol regions return housing member 1012. For example,chimneys drug return regions return housing member 1012.Inlet ports 132 ofgas inlet 114, andcorresponding inlet channels 368, are partially formed in drugreturn housing member 1012. - In the embodiment illustrated in
FIG. 5 , heating/sensor unit 327 is disposed around an outer surface ofreservoir housing member 319. Drugreturn housing member 1012 may be adapted to receive heating/sensor unit 327 andreservoir housing member 319.Reservoir housing member 319 is disposed primarily within drugreturn housing member 1012, and formsdrug reservoir 310. - According to various embodiments of the invention, drug
reservoir seating member 1016 is disposed adjacent to drug returnhousing member 1012. A drugreservoir seating portion 1028 is formed on drugreservoir seating member 1016. Drugreservoir seating portion 1028 is configured to receive aseating portion 1030 ofreservoir housing member 319 therein. Upperfluid chambers reservoir seating member 1016.Inlet ports 132 ofgas inlet 114, andcorresponding inlet channels 368, are partially formed in drugreservoir seating member 1016. As may be seen inFIGS. 3 , 4, 7, and 8 illustrating cross sections taken along cross section line 3-3, when drugreservoir seating member 1016 is disposed adjacent to drug returnhousing member 1012,inlet ports 132 ofgas inlet 114, and thecorresponding inlet channels 368 are formed inhousing 112 at aninlet interface 1032 between drugreturn housing member 1012 and drugreservoir seating member 1016. - As is illustrated in
FIG. 5 , barrierchamber housing member 1018 is disposed inhousing 112 adjacent to drugreservoir seating member 1016.Barrier chambers plunger channel 618 are formed in barrierchamber housing member 1018. When barrierchamber housing member 1018 is disposed inhousing 112 adjacent to drug reservoir seating member 1016 avalve interface 1034 is formed. As may be seen inFIGS. 3 , 4, 7, and 8 illustrating cross sections taken alongcross section line 3,reservoir channels valves valve interface 1034. Also illustrated inFIGS. 3 , 4, 7, and 8, barrierchamber housing member 1018 includes mountingsurfaces - Returning to
FIG. 5 ,base housing member 1020 is disposed adjacent to barrierchamber housing member 1018, atlower housing portion 122 ofhousing 112, forming a base forhousing 112.Base housing member 1020 may formfluid chambers solenoid cavity 610, and a lower portion ofplunger channel 618. Asolenoid 612 is mounted withinsolenoid cavity 610 viasolenoid bracket 1036.Aerosol generator 338 is seated withinbase mounting member 1020 atseating portion 354, formed therein.Base mounting member 1020 is adapted to receiveuser control interface 118. - It will be appreciated that the configurations of
housing 112 shown, includinghousing members housing 112 and its various members exist. -
FIGS. 7 and 8 illustrate another embodiment of the invention that enables the drug solution held withinhousing 112 to be heated prior to, during, and/or after nebulization. The drug solution may be heated to enhance a comfort of the user, to lower a viscosity of the drug solution to augment nebulization of the drug solution, increase drug delivery flow rate, or for other purposes. - As illustrated in
FIGS. 7 and 8 ,nebulizing device 110 includes asolenoid cavity 610 formed inhousing 112. Asolenoid 612 is mounted insolenoid cavity 610.Solenoid 612 has asolenoid body 613 and asolenoid shaft 616, which is joined to amovable plunger 614. InFIG. 7 , the solenoid is shown energized, while inFIG. 8 it is de-energized. When thesolenoid 612 is actuated,shaft 616 extends from thesolenoid body 613. Of course one of ordinary skill in the art can best appreciate that the solenoid could be reconfigured so that when it is energized it retracts into the solenoid body. -
Plunger 614 is joined to thesolenoid body 613 at a first end and includes aplunger head 620 at a second end.Plunger head 620 interacts withdrug dispensing opening 322 to comprise areservoir valve 622.Plunger 614 is actuated between the engaged position (illustrated inFIG. 7 ) and the disengaged position (illustrated inFIG. 8 ) to open andclose reservoir valve 622. In the engaged position,plunger head 620 engagesdrug dispensing opening 322 ofdrug solution reservoir 310 such thatplunger head 620 sealsdrug dispensing opening 322. Sealingdrug dispensing opening 322 keeps the drug solution indrug solution reservoir 310 from flowing tobarrier chambers reservoir chambers plunger head 620 is withdrawn fromdrug dispensing opening 322 to enable the drug solution held indrug solution reservoir 310 to flow tobarrier chambers Solenoid 612 is operatively coupled to controlelectronics 316 and power source/connection 318.Solenoid 612 is controlled viacontrol electronics 316.Solenoid 612 is powered via power source/connection 318. It can be appreciated that while at rest, thesolenoid 612 is positioned to seal theopening 322 and activated to unseal it, the opposite arrangement can alternatively be provided so that thesolenoid 612 is activated to seal the opening and deactivated to unseal theopening 322 -
FIG. 9 is an exemplary illustration ofcircuitry 626 that may be used innebulizing device 110 according to an embodiment of the invention. As shown,control electronics 316 are operatively linked with various components ofnebulizing device 110, such as, for example,user control interface 118, power source/connection 318,aerosol generators reservoir valve 622, heating/sensor unit 327, and/or other components. -
FIG. 10 is an exemplary illustration of amethod 910 of controlling a nebulizing device according to one embodiment of the invention.Method 910 is commenced from a state in which the device is deactivated. In this state, a drug solution is held indrug reservoir 310 withclosed valve 622, the heater/sensing unit 327 associated with the device is at room temperature, andaerosol generators - An activation command is conveyed from the user to the device at an
operation 912. For example, the activation commend is input viauser control interface 138, or otherwise conveyed from the user to the device. -
Method 910 includes anoperation 914, at which a first threshold temperature and a second threshold temperature is determined. The first threshold temperature and/or the second threshold temperature is determined, in non-limiting examples, according to an input from the user, determined based on a default setting, determined automatically based on one or more measured variables, and/or otherwise determined. The inventors presently contemplate that the preferred operating temperature is 37 degrees Celsius or between 33 degrees to 41 degrees Celsius. Of course, delivery temperatures outside this range could also be used without departing from the scope of the present invention as dictated by the requirements of the particular drug being delivered and/or user preferences. -
Method 910 includes anoperation 916, at which the heater in heater/sensing unit 327 associated with thenebulizing device 110 is activated. Activating the heater includes transmitting power to the heater. Activation causes the temperature of the heater to rise. - As is shown in
FIG. 10 ,method 910 includes anoperation 918, at which the temperature of the heater associated with heater/sensing unit 327 is sensed to determine if the temperature is above the first temperature threshold. If the temperature of the heater is below the first threshold temperature,method 910 returns tooperation 916. - If the temperature of the heater is above the first threshold temperature,
method 910 proceeds to anoperation 920. Atoperation 920, the drug solution is released from thedrug reservoir 310 for nebulization. For example, the drug solution is released tobarriers valve 622. -
Method 910 includes anoperation 922, at whichaerosol generators aerosol generators barriers -
Method 910 includes anoperation 924, at which the temperature of the heater is sensed by the temperature sensor to determine if the temperature is between the first temperature and the second temperature. If the temperature of the heater is determined to be below the first temperature,method 910 proceeds to anoperation 926. Atoperation 926, the flow of the drug solution from thedrug reservoir 310 to thebarriers drug reservoir 310 to thebarriers valve 622. Atoperation 926, theaerosol generators operation 926,method 910 may return tooperation 916. - As is illustrated in
FIG. 10 , atoperation 924, if the temperature of the heater is above the first threshold and the second threshold,method 910 proceeds to anoperation 928, at which the heater is deactivated. This causes the heater to stop producing heat. In some instances, the flow of the drug solution from thedrug reservoir 310 to thebarriers drug reservoir 310 to thebarriers aerosol generators drug reservoir 310 to thebarriers aerosol generators operation 928,method 910 returns tooperation 924. - At
operation 924, if the temperature of the heater is between the first temperature threshold and the second temperature threshold,method 910 proceeds to an operation 930. At operation 930, it is determined if a treatment session with thenebulizing device 110 has been completed. The completion of a treatment session includes, among other things, receiving a deactivation command from the user, completing nebulization of a predetermined or threshold amount of the drug solution, nebulizing the drug solution for a predetermined or threshold amount of time, or otherwise completing the treatment session. If the treatment session is not completed,method 910 returns tooperation 924. If the treatment session is completed,method 910 proceeds to anoperation 932. - At
operation 932, thenebulizing device 110 is deactivated. Deactivating thenebulizing device 110 includes, among other things, deactivating theaerosol generators valve 622, and/or otherwise deactivating thenebulizing device 110. -
FIGS. 11A-11C and 12 are exemplary illustrations of ahandheld nebulizing device 1110 in accordance with another embodiment. In this embodiment,device 1110 includes ahousing 1112, aninlet 1114, anoutlet 1116, and auser control interface 1118. -
Housing 1112 includesmouthpiece module 1120, anintermediate module 1122, and abase module 1124.Modules - As is illustrated in the rear plan view of
FIG. 11C ,inlet 1114 includes aninlet port 1121 formed inhousing 1112, and particularly inmouthpiece module 1120. - As shown in the front plan view of
FIG. 11A ,outlet 1116 includes anoutlet port 1126 formed inhousing 1112 atmouthpiece module 1120.Outlet port 1126 is configured for engagement by the user's mouth. - In some embodiments,
user control interface 1118 includes a control knob 1128. Control knob 1128 is located on the front ofhousing 1112 atbase module 1124. - Intake gas, such as air from the atmosphere, is received into
inlet 1114. Atoutlet 1116, nebulized particles of the drug solution are communicated fromdevice 1110 to the user. The user may control various aspects of operation ofdevice 1110 viacontrol interface 1118. - As is illustrated in
FIG. 11C ,device 1110 includes apower receiving connector 1130.Power connector 1130 is provided inhousing 1112 atbase module 1124. Power is provided todevice 1110 viapower connection 1130. Alternatively, power may be provided todevice 1110 via an internal power source, such as a battery, a fuel cell, or other power source. -
FIG. 12 is a cross sectional view, taken along cross section line 12-12 inFIG. 11B . In some instances,device 1110 includes adrug solution reservoir 1310, afirst nebulization section 1312, asecond nebulization section 1314, andcontrol electronics 1316. -
Drug solution reservoir 1310 includes a drugsolution receiving opening 1320, adrug dispensing opening 1322, areservoir wall 1324, and areservoir floor 1326.Drug solution reservoir 1310 is generally cylindrical in shape, or may be otherwise shaped. Drugsolution receiving opening 1322 is formed byreservoir wall 1324, and is circular, or otherwise shaped.Reservoir floor 1326 angles fromreservoir wall 1324 in a downward slope todrug dispensing opening 1322, which is formed byreservoir floor 1322. -
First nebulization section 1312 includes afirst reservoir channel 1328, afirst valve 1330, afirst barrier chamber 1332, afirst barrier 1334, a first fluid chamber 1336, afirst aerosol generator 1338, and afirst aerosol region 1340.First reservoir channel 1328 is formed withinhousing 112 and runs fromdrug dispensing opening 1322 tofirst valve 1330.First valve 1330 is positioned outwardly fromdrug dispensing opening 1322 withinhousing 112, betweenfirst reservoir channel 1328 andfirst barrier channel 1332. - In some embodiments of the invention,
first valve 1330 includes afirst valve opening 1342, and avalve seal 1344.First valve opening 1342 is formed withinhousing 1112 as an outer opening offirst reservoir channel 1328.First valve seal 1344 is disposed atfirst valve opening 1342 to selectively sealfirst valve opening 1342.First valve seal 1344, in one embodiment, may include afirst float 1346 disposed withinfirst valve 1330 at a firstfloat reception cavity 1348.First float 1346 is composed of a material that enablesfirst float 1346 to float in the drug solution, such as a closed cell foam. Firstfloat reception cavity 1348 is formed inhousing 1112 betweenfirst reservoir channel 1328 andfirst barrier chamber 1332.First valve 1344 includes a first float/cavity interface 1350 that includes corresponding surfaces offirst float 1346 and firstfloat reception cavity 1348.First float 1346 is forced againstfirst valve opening 1342 asfirst float 1346 rises to sealfirst valve opening 1342. - In the embodiment illustrated in
FIG. 12 ,first float 1346 includes a firstprotruding center portion 1345 and firstsloping lateral portions 1347. First protrudingcenter portion 1345 protrudes from first slopinglateral portions 1347, which slope away from firstprotruding center portion 1345. Firstfloat reception cavity 1348 includes a firstvertical channel 1349 and firstlateral sloping surfaces 1351, arranged such that firstprotruding center portion 1345 is constantly positioned in firstvertical channel 1349 even whenfirst float 1346 is not sealingfirst valve opening 1342 to maintain the orientation offirst float 1346. Maintaining the orientation offirst float 1346 ensures that firstsloping lateral portions 1347 will contact slopinglateral surfaces 1351 to sealfirst valve 1330 when first float rises due to its buoyancy. - According to an embodiment of the invention,
first barrier chamber 1332, which communicates withfirst reservoir channel 1328 viafirst valve 1330, is formed withinhousing 1112 betweenfirst barrier 1334 andfirst aerosol region 1340.First barrier 1334 is mounted withinhousing 112 to afirst mounting surface 1352 that is formed on an upper surface of first fluid chamber 1336, betweenfirst barrier channel 1332 and first fluid chamber 1336. First barrier forms a physical separation (i.e., a seal) betweenfirst barrier channel 1332 and first fluid chamber 1336.First barrier 1334 is composed of one or more materials designed to enablefirst barrier 1334 to be capable of transmitting ultrasonic energy therethrough, even under high temperature conditions. For example, polyetheretherketone (PEEK), or other materials may be used. - According to one embodiment of the invention, first fluid chamber 1336 is formed within
housing 1112 betweenfirst barrier 1334 andfirst aerosol generator 1338. First fluid chamber 1336 holds a fluid 1339 in communication withfirst barrier 1334 and first acousticwave aerosol generator 1338.Fluid 1339 includes one or more fluids capable of transmitting acoustic waves, such as, for example, water, or other fluids.Fluid 1339 may include one or more sterilant, such as, alcohol, or other sterilants. - In the embodiment of the invention illustrated in
FIG. 12 ,first aerosol generator 1338 is disposed at a first aerosolgenerator seating portion 1354 formed withinhousing 112. In some instances,first aerosol generator 1338 includes a concave piezoelectric transducer with a silver electrode.First aerosol generator 1338 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point, or focal band, that is a focal length fromfirst aerosol generator 1338. First aerosolgenerator seating portion 1354 is formed withinhousing 112 such that the focal point will be withinfirst barrier chamber 1332. Other embodiments offirst aerosol generator 1338 exist.First aerosol generator 1338 is operatively linked to controlelectronics 1316 so thatcontrol electronics 1316 can control various aspects of acoustic wave generation byfirst aerosol generator 1338, such as, for instance, activation and deactivation, or other aspects.First aerosol generator 1338 is operatively linked topower receiving connection 1130 so that power can be provided tofirst aerosol generator 1338 via this operative link. - According to an embodiment of the invention,
first aerosol region 1340 includes afirst fountain region 1356, one or more firstaerosol region inlets 1358, afirst chimney 1360, and a first drug return region 1362.First fountain region 1356 is formed withinhousing 1112 betweenfirst barrier chamber 1332 andfirst chimney 1360.First fountain region 1356 is open at a first end tofirst barrier chamber 1332 and at a second end tofirst chimney 1360.First fountain region 1356 is formed as a funnel with a smaller opening at the first end and a larger opening at the second end, or may be otherwise shaped. - The first
aerosol region inlet 1358 is formed inhousing 1112 atfirst fountain region 1356. Firstaerosol region inlet 1358 is in communication with inlet port 1132. - In one embodiment,
first chimney 1360 is formed inhousing 1112, and opens at a first end tofirst fountain region 1356. A firstaerosol region ceiling 1374 is formed at a second end offirst chimney 1360.First chimney 1360 provides operable communication betweenfirst fountain region 1356 andoutlet 1116. - In some embodiments of the invention, first drug return region 1362 is formed in
housing 1112. First drug return region 1362 is open at a first end todrug reservoir 1310. First drug return region 1362 communicates withfirst chimney 1360. - In accordance with an embodiment of the invention shown in
FIG. 12 ,second nebulization section 1314 includes asecond reservoir channel 1428, asecond valve 1430, asecond barrier chamber 1432, asecond barrier 1434, asecond fluid chamber 1436, asecond aerosol generator 1438, and asecond aerosol region 1440.Second reservoir channel 1428 is formed withinhousing 1112 and runs from drug dispensing opening 1422 tosecond valve 1430.Second valve 1430 is positioned outwardly from drug dispensing opening 1422 withinhousing 1112, betweensecond reservoir channel 1428 andsecond barrier chamber 1432. - In the embodiment shown,
second valve 1430 includes asecond valve opening 1442, and avalve seal 1444.Second valve opening 1442 is formed withinhousing 1112 as an outer opening ofsecond reservoir channel 1428.Second valve seal 1444 is disposed atsecond valve opening 1442 to selectively sealsecond valve opening 1442. In some instances,second valve seal 1444 includes asecond float 1446, disposed withinsecond valve 1430 at a secondfloat reception cavity 1448.Second float 1446 is composed of materials that enablesecond float 1446 to float in the drug solution. Secondfloat reception cavity 1448 is formed inhousing 1112 betweensecond reservoir channel 1428 andsecond barrier chamber 1432.Second valve 1444 includes a second float/cavity interface 1450 that includes corresponding surfaces ofsecond float 1446 and secondfloat reception cavity 1448, and is arranged to biassecond float 1446 againstsecond valve opening 1442 assecond float 1446 rises to sealsecond valve opening 1442. For example, second float/cavity interface 1450 is structured similarly to first float/cavity interface 1350. - In other embodiments,
valves second valve 1430. - According to one embodiment of the invention,
second barrier chamber 1432, which communicates withsecond reservoir channel 1428, viasecond valve 1430 is formed withinhousing 1112 betweensecond barrier 1434 andsecond aerosol region 1440.Second barrier 1434 is mounted withinhousing 1112 to asecond mounting surface 1452 that is formed on an upper surface ofsecond fluid chamber 1436, betweensecond barrier chamber 1432 andsecond fluid chamber 1436. Second barrier forms a physical separation (i.e., a seal) betweensecond barrier chamber 1432 andsecond fluid chamber 1436.Second barrier 1434 is composed of one or more materials designed to enablesecond barrier 1434 to be capable of transmitting ultrasonic energy therethrough, even under high temperature conditions. For example, polyetheretherketone (PEEK), or other materials may be used. - The
second fluid 1436 is formed withinhousing 1112 betweensecond barrier 1434 andsecond aerosol generator 1438.Second fluid 1436 holds an fluid 1439 in communication withsecond barrier 1434 andsecond aerosol generator 1438.Fluid 1439 includes one or more fluids capable of transmitting acoustic waves, such as, for example, water, or other fluids.Fluid 1439 may include one or more sterilant, such as, alcohol, or other sterilants. -
Second aerosol generator 1438 is disposed at a second aerosolgenerator seating portion 1454 formed withinhousing 1112. In one embodiment,second aerosol generator 1438 includes a concave piezoelectric transducer with a silver electrode.Second aerosol generator 1438 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point, or focal band, that is a focal length fromsecond aerosol generator 1338. Second aerosolgenerator seating portion 1454 is formed withinhousing 1112 such that the focal point will be withinsecond barrier chamber 1432.Second aerosol generator 1438 is operatively linked to controlelectronics 1316 so thatcontrol electronics 1316 can control various aspects of acoustic wave generation bysecond aerosol generator 1438, such as, for instance, activation and deactivation, or other aspects.Second aerosol generator 1438 is operatively linked topower connection 1130 so that power can be provided tosecond aerosol generator 1438 via this operative link. -
Second aerosol region 1440 includes asecond fountain region 1456, one or more secondaerosol region inlets 1458, asecond chimney 1460, and a second drug return region 1462.Second fountain region 1456 is formed withinhousing 1112 betweensecond barrier chamber 1432 andsecond chimney 1460.Second fountain region 1456 is open at a first end tosecond barrier chamber 1432 and at a second end tosecond chimney 1460.Second fountain region 1456 is formed as a funnel with a smaller opening at the first end and a larger opening at the second end, or may be otherwise shaped. - In some embodiments of the invention, second
aerosol region inlet 1458 is formed inhousing 1112 atsecond fountain region 1456. Secondaerosol region inlet 1458 is in communication with inlet port 1132. - In the embodiment of
FIG. 12 ,second chimney 1460 is formed inhousing 1112, and opens at a first end tosecond fountain region 1456. A secondaerosol region ceiling 1474 is formed at a second end ofsecond chimney 1460.Second chimney 1460 provides operable communication betweensecond fountain region 1456 andoutlet 1116. - In one embodiment of the invention, second drug return region 1462 is formed in
housing 1112. Second drug return region 1462 is open at a first end todrug reservoir 1310. Second drug return region 1462 communicates withsecond chimney 1460. - The
barrier chambers barriers aerosol regions barrier chambers barriers aerosol generators aerosol generators barrier chambers fluid chambers 1336 and 1436. The transmitted acoustic waves pass fromfluid chambers 1336 and 1436 tobarrier chambers barriers - According to various embodiments of the invention, the acoustic waves transmitted to
barrier chambers barrier chambers barrier chambers second outlet 1116. In this manner, substantially consistent particle size is achieved. - In one embodiment of the invention, the nebulized particles are communicated from
barrier chambers aerosol regions outlet 1116. More particularly, the nebulized particles and the larger droplets of the drug solution formed at the fountains are received byaerosol regions chimneys chimneys outlet 1116. In contrast, due to size and/or weight, the larger droplets may not be communicated to the user, but instead may contact a surface ofaerosol regions aerosol region ceilings drug solution reservoir 1310 via drug return regions 1362 and 1462. - The nebulization of the drug solution by the fountains is enhanced when the focal point of the acoustic waves coincides (exactly or substantially) with an upper surface of the drug solution in
first barrier chamber 1332. This requires a level of the upper surface to be controlled with some particularity to enhance the operation of the fountains. To maintain the level of the upper surface, an amount of the drug solution atbarriers drug reservoir 1310 tobarrier chambers reservoir channels valves valve openings valve seals barriers 1334 and/or 1434 reaches a threshold level at or near the focal point of the acoustic waves that corresponds to a threshold amount of the drug solution being present on one ofbarriers floats 1346 and/or 1446 are positioned to sealvalve openings 1342 and/or 1442 by virtue of the buoyancy offloats barrier chambers floats valve openings valves 1330 and/or 1430. This functionality is illustrated with respect tovalves FIGS. 3 , and 4. - Referring to
FIG. 12 , activation ofaerosol generators aerosol regions aerosol regions aerosol regions aerosol region inlets aerosol regions outlet 1116, which may in turn motivate the nebulized particles formed at the fountains towardoutlet 1116. Thus, the atmospheric disturbances that may be caused by the nebulized particles from the fountains, and the resulting flow of intake gas throughaerosol regions -
FIG. 13 is an exemplary cross sectional view of thehandheld nebulizing device 1110, taken along cross section line 13-13, in accordance with another embodiment of the invention. In the embodiment illustrated inFIG. 13 , device 1610 includes afirst nebulization section 1612, asecond nebulization section 1614, andcontrol electronics 1616. - In the embodiment of
FIG. 13 ,first nebulization section 1612 includes a first aerosol generator 1618, afirst fluid 1620, afirst barrier 1622, afirst barrier chamber 1624, afirst guide tube 1626, and a first separator structure 1628. First aerosol generator 1618 may include a concave piezoelectric transducer with a silver electrode. First aerosol generator 1618 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point that is a focal length from first aerosol generator 1618.Device 1110 is arranged such that the focal point is withinfirst barrier chamber 1624. Other embodiments of aerosol generator 1618 exist. The inventors contemplate that various other aerosol generators could be employed with the teachings of the present invention. For instance, the aerosol generator may be a jet type nebulizer, a vibrating mesh nebulizer, a vibratory plate nebulizer, a traditional planar ultrasonic nebulizer, or an electrospray nebulizer. - According to one embodiment of the invention, first aerosol generator 1618 is seated in a first aerosol
generator seating portion 1630 withinintermediate module 1122. First aerosolgenerator seating portion 1630 is defined by an upper surface of a first seating portion wall 1632 that extends upward from a bottom plane ofintermediate module 1122. - In this embodiment of the invention,
first fluid 1620 is formed adjacent to aerosolgenerator seating portion 1630 such that first aerosol generator 1618 forms a portion of a lower surface offirst fluid 1620. - A first
barrier mounting surface 1634 is located at an upper surface offirst fluid 1620. Firstbarrier mounting surface 1634 defines afirst barrier opening 1636.First barrier opening 1636 enable communication between first fluid 1620 andfirst barrier chamber 1624.First barrier 1622 is mounted to firstbarrier mounting surface 1634, effectively sealing first fluid 1620 fromfirst barrier chamber 1624. - According to the embodiment illustrated in
FIG. 13 ,first barrier chamber 1624 is formed by a firstbarrier chamber wall 1638 and a firstbarrier chamber floor 1640. Firstbarrier chamber floor 1640 is sloped such thatfirst barrier opening 1636 is a lowest point withinfirst barrier chamber 1624. - In one embodiment of the invention,
first guide tube 1626 is provided overfirst barrier 1622 such that a first end offirst guide tube 1626 extends down intofirst barrier chamber 1624 and a second end offirst guide tube 1626 extends out offirst barrier chamber 1624.First guide tube 1626 is held in position overfirst barrier 1622 by a firstguide tube collar 1638 associated with first separator structure 1628. Firstguide tube collar 1638 holdsfirst guide tube 1626 in position such that the second end offirst guide tube 1626 extends up into first separator structure 1628. First separator structure 1628 provides communication between the second end offirst guide tube 1626 andoutlet 1116. - According to an embodiment of the invention, first aerosol generator 1618 may be activated by
control electronics 1616 to generate acoustic waves that are introduced intofirst fluid 1620. First fluid 1620 contains a fluid 1629 that is capable of transmitting the received acoustic waves. For example, the transmitting fluid 1629 may include water, or other fluids. In some instances, a sterilant, such as alcohol, or another sterilant, may be added to the transmitting fluid. - The
second nebulization section 1614 includes asecond aerosol generator 1718, asecond fluid 1720, a second barrier 1722, asecond barrier chamber 1724, asecond guide tube 1726, and asecond separator structure 1728.Second aerosol generator 1718 may include a concave piezoelectric transducer with a silver electrode.Second aerosol generator 1718 generates acoustic waves at a generator frequency, such as, for example, 2.5 MHz, or another frequency. The acoustic waves are focused at a focal point that is a focal length fromsecond aerosol generator 1718.Device 1110 is arranged such that the focal point is withinsecond barrier chamber 1724. Other embodiments ofaerosol generator 1718 exist. - According to one embodiment of the invention,
second aerosol generator 1718 is seated in a second aerosolgenerator seating portion 1630 withinintermediate module 1122. Second aerosolgenerator seating portion 1630 is defined by an upper surface of a second seating portion wall 1632 that extends upward from a bottom plane ofintermediate module 1122. - In the embodiment of the invention shown in
FIG. 13 ,second fluid 1720 is formed adjacent to aerosolgenerator seating portion 1630 such thatsecond aerosol generator 1718 forms a portion of a lower surface ofsecond fluid 1720. - In this embodiment, a second
barrier mounting surface 1634 is located at an upper surface ofsecond fluid 1720. Secondbarrier mounting surface 1634 defines asecond barrier opening 1636.Second barrier opening 1636 enable communication between second fluid 1720 andsecond barrier chamber 1724. Second barrier 1722 is mounted to secondbarrier mounting surface 1634, effectively sealing second fluid 1720 fromsecond barrier chamber 1724. - The
second barrier chamber 1724 is formed by a secondbarrier chamber wall 1638 and a second barrier chamber floor 1740. Second barrier chamber floor 1740 is sloped such thatsecond barrier opening 1636 is a lowest point withinsecond barrier chamber 1724. - In accordance with one embodiment of the invention,
second guide tube 1726 is provided over second barrier 1722 such that a first end ofsecond guide tube 1726 extends down intosecond barrier chamber 1724 and a second end ofsecond guide tube 1726 extends out ofsecond barrier chamber 1724.Second guide tube 1726 is held in position over second barrier 1722 by a second guide tube collar 1738 associated withsecond separator structure 1728. Secondguide tube collar 1728 holdssecond guide tube 1726 in position such that the second end ofsecond guide tube 1726 extends up intosecond separator structure 1728.Second separator structure 1728 provides communication between the second end ofsecond guide tube 1726 andoutlet 1116. - According to an embodiment of the invention, second acoustic
wave aerosol generator 1718 may be activated by control electronics 1716 to generate acoustic waves that are introduced intosecond fluid 1720.Second fluid 1720 contains a fluid 1729 that is capable of transmitting the received acoustic waves. For example, the fluid 1729 may include water, or other fluids. In some instances, a sterilant, such as alcohol, or another sterilant, may be added to the transmitting fluid. - In one embodiment, the acoustic waves introduced to
fluids fluids barrier chambers barriers 1622 and 1722. The acoustic waves transmitted tobarrier chambers aerosol generators 1618 and 1718. Pools of drug solution held withinbarrier chambers guide tubes barrier chambers - In the embodiment of
FIG. 13 , the nebulization of the drug solution by the fountains is enhanced when the focal point of the acoustic waves coincides (exactly or substantially) with a surface of the drug solution inbarrier chambers - In the illustrated embodiment, the fountains are formed at the top of
guide tubes guide tubes guide tubes guide tubes guide tubes guide tubes guide tubes tubes guide tubes guide tubes guide tubes - The above described systems are particularly well suited for delivering drugs to patients that have previously been difficult to administer. For instance, one such drug that has been difficult to deliver in an aerosolized form is pulmonary surfactants. Surfactants mainly consist of phosphelipids and surfactants proteins that are used to replace deficient endogenous surfactants in patient's lungs. There are a variety of surfactant medications available such as natural human surfactants (obtained from amniotic fluid or a bio-synthetic material), natural animal surfactants (obtained from bovine lung extracts, porcine lung extracts, or a bio-synthetic material), or synthetic preparations. What makes pulmonary surfactants particularly difficult to delivery in aerosol form is that they are highly viscous. Accordingly using one or more of the above described features of the present invention permits high speed delivery of viscous drugs such as pulmonary surfactants. Of course, the novel aspects of the present invention can also be used with a variety of other drug formulations.
- Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims.
Claims (10)
1. A nebulizing drug delivery device, comprising:
a housing having an inlet and an outlet;
an aerosol generator in communication with a fluid;
a temperature sensor that senses a temperature of the drug solution; and
a heater in functional communication with the temperature sensor, the heater being operable in response to the temperature sensor to maintain the temperature of the drug solution above a threshold temperature.
2. A nebulizing drug device according to claim 1 , wherein the threshold temperature can be adjusted.
3. A nebulizing device according to claim 1 , wherein the heater is positioned to heat the drug solution.
4. A nebulizing device according to claim 1 , further comprising a drug solution reservoir in the housing, and a valve that can be opened to supply the drug solution from the reservoir, wherein the heater is positioned to heat the drug solution in the reservoir.
5. A nebulizing device according to claim 4 , wherein the valve comprises an electrically operated solenoid, the solenoid being in communication with the temperature sensor, the solenoid being operated to open the valve and enable the drug solution to flow from the reservoir to the barrier in response to the temperature sensor indicating that the temperature of the drug solution is above the threshold level.
6. A nebulizing device according to claim 5 , wherein the solenoid remains open until the device is turned off.
7. A nebulizing device according to claim 1 , wherein the temperature sensor turns the heater on and off to maintain the drug solution with a range.
8. A nebulizing device according to claim 1 , wherein the heater is turned off in response to the temperature sensor determining that the drug solution is above an upper threshold level, and wherein the heater is turned off and on to maintain the drug solution within a temperature range.
9. A nebulizing device comprising:
a housing having an inlet and an outlet;
an aerosol generator;
a temperature sensor that senses a temperature of the drug solution; and
a heater in functional communication with the temperature sensor, the heater being operable in response to the temperature sensor to maintain the drug above a threshold temperature; wherein the drug solution is a surfactant.
10. The nebulizing device as recited in claim 9 wherein the threshold temperature is approximately about 37 degrees Celsius.
Priority Applications (1)
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US12/851,049 US20100294269A1 (en) | 2005-03-09 | 2010-08-05 | Nebulizing drug delivery device with an increased flow rate |
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US11/367,649 US7814901B2 (en) | 2005-03-09 | 2006-03-03 | Nebulizing drug delivery device with increased flow rate |
US12/851,049 US20100294269A1 (en) | 2005-03-09 | 2010-08-05 | Nebulizing drug delivery device with an increased flow rate |
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US12/851,049 Abandoned US20100294269A1 (en) | 2005-03-09 | 2010-08-05 | Nebulizing drug delivery device with an increased flow rate |
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WO2021080411A1 (en) * | 2019-10-25 | 2021-04-29 | Bioactivos Y Nutracéuticos De México, S.A. De C.V. | Ultrasound-mediated drug dispenser |
Also Published As
Publication number | Publication date |
---|---|
WO2006096658A2 (en) | 2006-09-14 |
EP1855746A2 (en) | 2007-11-21 |
US7814901B2 (en) | 2010-10-19 |
US20060201502A1 (en) | 2006-09-14 |
WO2006096658A3 (en) | 2007-05-24 |
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