(12) United States Patent
`Cox et al.
`
`111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US006234167Bl
`US 6,234,167 Bl
`May 22,2001
`
`(10) Patent No.:
`(45) Date of Patent:
`
`(54) AEROSOL GENERATOR AND METHODS OF
`l\1AKING AND USING AN AEROSOL
`GENERATOR
`
`(75)
`
`Inventors: Kenneth A. Cox, Midlothian; Timothy
`Paul Beane; William R. Sweeney, both
`of Richmond, all of VA (US)
`
`(73) Assignee: Chrysalis Technologies, Incorporated,
`Richmond, VA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 09/172,023
`Oct. 14, 1998
`
`(22) Filed:
`
`(51)
`
`Int. Cl?
`
`A61J\rl ll/00
`
`(52) U.S. Cl. ................................ 128/200.14; 128/203.17;
`128/203.23
`
`(58) Field of Search ......................... 128/200.14, 200.19,
`128/200.21, 200.22, 200.23, 201.13, 203.17,
`203.23, 203.24, 203.26, 204.17
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`3,431,393
`3,859,398
`3,903,883
`4,060,082
`4,291,838
`4,303,083
`4,575,609
`4,627,432
`4,649,911
`4,682,010
`4,730,111
`4,735,217
`4,744,932
`4,762,995
`4,776,515
`
`3/1969 Katsuda.
`1/1975 Havstad.
`9/1975 Pecina et a!. .
`11/1977 Lindgerg et a!. .
`9/1981 Williams.
`12/1981 Burruss, Jr ..
`3/1986 Fassel eta!. .
`12/1986 Newell eta!..
`~ 3/1987 Knight eta!. ................... 128/200.21
`~ 7/1987 Drapeau et a!. ..................... 219/381
`3/1988 Vestal eta!. .
`4/1988 Gerth eta!. .
`5/1988 Browne.
`8/1988 Browner et a!. .
`10/1988 Michalchik .
`(List continued on next page.)
`
`FOREIGN PATENT DOCUMENTS
`
`354094
`1036470
`0358114
`358114
`0642802A2
`642802
`667979
`168128
`207457
`9503409
`216121
`W094/09842
`
`9/1928 (BE) .
`4/1958 (DE) .
`3/1990 (EP) .
`3/1990 (EP) .
`3/1995 (EP) .
`3/1995 (EP) .
`10/1929 (FR).
`2/1976 (HU) .
`4/1993 (HU) .
`6/1994 (HU) .
`4/1999 (HU) .
`5/1994 (WO) .
`
`OTHER PUBLICATIONS
`
`Aerosol Science and Technology, Yasuo Kousaka et al.,
`"Generation of Aerosol Particles by Boiling of Suspen(cid:173)
`sions", 1994, pp. 236-240.
`Pharmacopeia! Forum, vol. 20, No. 3, "Stimuli To The
`Revision Process", May-Jun. 1994, pp. 7477-7505.
`
`Primary Examiner--Glenn K. Dawson
`(74) Attorney, A.gent, or Firm-Burns, Doane, Swecker &
`Mathis, LLP
`
`(57)
`
`ABSTRACT
`
`An aerosol generator includes a tube having a first and a
`second end, a heater arranged relative to the tube for heating
`the tube, a source of material to be volatilized, the second
`end of the tube being in communication v.rith the source of
`material, a valve operatively located between the source of
`material and the tube, the valve being openable and close(cid:173)
`able to open and close communication between the source of
`material and the first end of the tube, and a pressurization
`arrangement for causing material in the source of material to
`be introduced into the tube from the source of material when
`the valve is in an open position. The aerosol generator
`further includes a source of power for operating the heater
`and the valve, and a control device for controlling supply of
`power from the source of power to the heater and the valve.
`A method of making and a method of using an aerosol
`generator are also disclosed.
`
`68 Claims, 6 Drawing Sheets
`
`53
`
`JTI Exhibit 1004, Page 0001
`
`

`
`US 6,234,167 Bl
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`4,811,731
`4,819,625
`4,848,374
`4,877,989
`4,911,157
`4,935,624
`5,021,802
`5,044,565
`5,056,511
`5,060,671
`5,063,921
`5,133,343
`
`3/1989 Newell et al..
`4/1989 Howe.
`7/1989 Chard et al. .
`10/1989 Drews et al. .
`3/1990 Miller.
`6/1990 Henion et al..
`6/1991 Alfred.
`9/1991 Alexander.
`10/1991 Ronge.
`10/1991 Counts et al. .
`11/1991 Howe.
`7/1992 Johnson, IV et al. .
`
`5,134,993 * 8/1992 Van Der Linden et al. ... 128i200.14
`5,217,004 * 6/1993 Blasnik et al. .................. 128/200.23
`5,228,444
`7/1993 Burch.
`5,259,370
`11/1993 Howe.
`5,299,565 * 4/1994 Brown ............................. 128/200.21
`7/1994 Porenski et al. .
`5,327,915
`5,342,180
`8/1994 Daoud.
`5,349,946 * 9/1994 McComb ........................ 128/203.17
`5,474,059 * 12/1995 Cooper ............................ 128i200.22
`5,585,045 * 12/1996 Heinonen et al. .................. 261/72.1
`5,743,251
`4/1998 Howell et al. .
`
`* cited by examiner
`
`JTI Exhibit 1004, Page 0002
`
`

`
`U.S. Patent
`
`May 22,2001
`
`Sheet 1 of 6
`
`US 6,234,167 Bl
`
`Lt')
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`63 _....-.I INDICATOR
`
`DISPLAY
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`35j 165
`
`VALVE
`
`(' -,
`
`OF POWER
`SOURCE
`
`HfATER
`~
`
`~41
`
`I TIMER
`
`DEVICE
`CONTROL
`
`[43
`61
`
`'
`CONTROL
`REMOTE
`
`DffiCTING DEVICE
`
`AIR FLOW
`
`51/
`
`SENSOR
`48 \j PRESSURE
`
`FIG.2
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`I
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`~7 ~--;~Essu~i-oRoP--l
`
`------------------~
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`
`JTI Exhibit 1004, Page 0004
`
`

`
`U.S. Patent
`
`May 22,2001
`
`Sheet 3 of 6
`
`US 6,234,167 Bl
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`JTI Exhibit 1004, Page 0005
`
`

`
`U.S. Patent
`
`May 22, 2001
`
`Sheet 4 of 6
`
`US 6,234,167 Bl
`
`221
`)
`
`25
`
`53
`
`FIG.4
`
`JTI Exhibit 1004, Page 0006
`
`

`
`U.S. Patent
`
`May 22,2001
`
`Sheet 5 of 6
`
`US 6,234,167 Bl
`
`~I
`
`~I
`
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`
`JTI Exhibit 1004, Page 0007
`
`

`
`U.S. Patent
`
`May 22,2001
`
`Sheet 6 of 6
`
`US 6,234,167 Bl
`
`29
`
`29
`
`27
`
`29
`
`27
`
`345o L
`
`L
`
`345o
`
`L
`
`345o
`
`L
`
`345b
`FIG. 6A
`
`345b
`
`345b
`
`FIG. 68
`
`G
`FIG. 6C
`
`339
`
`JTI Exhibit 1004, Page 0008
`
`

`
`US 6,234,167 Bl
`
`1
`AEROSOL GENERATOR AND METHODS OF
`l\1AKING AND USING AN AEROSOL
`GENERATOR
`
`BACKGROUND AND SUMMARY OF THE
`INVENTION
`
`30
`
`2
`generators have wide application for uses such as antiper(cid:173)
`spirant and deodorant sprays and spray paint, their use is
`often limited because of the well-known adverse environ(cid:173)
`mental effects of CFC's and methylchloroform, which are
`s among the most popular propellants used in aerosol genera(cid:173)
`tors of this type.
`In drug delivery applications, it is typically desirable to
`provide an aerosol having average mass median particle
`diameters of less than 2 microns to facilitate deep lung
`10 penetration. Most known aerosol generators are incapable of
`generating aerosols having average mass median particle
`diameters less than 2 to 4 microns. It is also desirable, in
`certain drug delivery applications, to deliver medicaments at
`high flow rates, e.g., above 1 milligram per second. Most
`15 known aerosol generators suited for drug delivery are inca(cid:173)
`pable of delivering such high flow rates in the 0.2 to 2.0
`micron size range.
`U.S. Pat. No. 5,743,251, which is hereby incorporated by
`reference in its entirety, discloses an aerosol generator, along
`20 with certain principles of operation and materials used in an
`aerosol generator, as well as a method of producing an
`aerosol, and an aerosol. The aerosol generator disclosed
`according to the '251 patent is a significant improvement
`over earlier aerosol generators, such as those used as inhaler
`25 devices. It is desirable to produce an aerosol generator that
`is portable and easy to use.
`According to one aspect of the present invention, an
`aerosol generator includes a tube having a first and a second
`end, a heater arranged relative to the tube for heating at least
`a portion of the tube, a source of material to be volatilized,
`the second end of the tube being in communication with the
`source of material, and a valve operatively located between
`the source of material and the tube, the valve being openable
`35 and closeable to open and close communication between the
`source and the first end of the tube. A pressurization arrange(cid:173)
`ment is provided for causing material in the source of
`material to be introduced into the tube from the source of
`material when the valve is in an open position. A source of
`power is provided for operating the heater and for the valve,
`and a control device is provided for controlling supply of
`power from the source of power to the heater and the valve.
`According to a further aspect of the present invention, a
`method of making an aerosol generator is disclosed. Accord-
`45 ing to the method, a heater is arranged relative to a tube for
`heating of the tube, the tube having first and second ends.
`The second end of the tube is connected to a source of
`material to be volatilized. An openable and closeable valve
`is provided between the source of material and the tube. A
`pressurization arrangement is provided for causing material
`in the source of material to be introduced into the tube from
`the source of material when the valve is in an open position.
`The valve is connected to a source of power for opening and
`closing the valve. The heater is connected to the source of
`power. The source of power is connected to a control device
`for controlling a supply of power from the source of power
`to the heater and the valve.
`According to yet another aspect of the present invention,
`a method of using an aerosol generator is disclosed. Accord(cid:173)
`ing to the method, a first signal, indicative of a user's
`intention to use the aerosol generator, is provided to a
`control device. With the control device and in response to
`the first signal, a second signal is sent to a source of power
`to cause the source of power to open an openable and
`closeable valve, the valve being disposed between a source
`of material to be volatilized and a tube, opening of the valve
`permitting material from the source of material to flow from
`
`The present invention relates generally to aerosol genera(cid:173)
`tors and, more particularly, to aerosol generators able to
`generate aerosols without compressed gas propellants and
`methods of making and using such aerosol generators.
`Aerosols are useful in a wide variety of applications. For
`example, it is often desirable to treat respiratory ailments
`with, or deliver drugs by means of, aerosol sprays of finely
`divided particles of liquid and/or solid, e.g., powder,
`medicaments, etc., which are inhaled into a patient's lungs.
`Aerosols are also used for purposes such as providing
`desired scents to rooms, applying scents on the skin, and
`delivering paint and lubricant.
`Various techniques are known for generating aerosols. For
`example, U.S. Pat. Nos. 4,811,731 and 4,627,432 both
`disclose devices for administering medicaments to patients
`in which a capsule is pierced by a pin to release a medica(cid:173)
`ment in powder form. A user then inhales the released
`medicament through an opening in the device. While such
`devices may be acceptable for use in delivering medica(cid:173)
`ments in powder form, they are not suited to delivering
`medicaments in liquid form. The devices are also, of course,
`not well-suited to delivery of medicaments to persons who
`might have difficulty in generating a sufficient flow of air
`through the device to properly inhale the medicaments, such
`as asthma sufferers. The devices are also not suited for
`delivery of materials in applications other than medicament
`delivery.
`Another well-known technique for generating an aerosol
`involves the use of a manually operated pump which draws
`liquid from a reservoir and forces it through a small nozzle
`opening to form a fine spray. A disadvantage of such aerosol
`generators, at least in medicament delivery applications, is
`the difficulty of properly synchronizing inhalation with 40
`pumping. More importantly, however, because such aerosol
`generators tend to produce particles of large size, their use
`as inhalers is compromised because large particles tend to
`not penetrate deep into the lungs.
`One of the more popular techniques for generating an
`aerosol including liquid or powder particles involves the use
`of a compressed propellant, often containing a chloro(cid:173)
`fluoro-carbon (CFC) or methylchloroform, to entrain a
`material, usually by the Venturi principle. For example,
`inhalers containing compressed propellants such as com- 50
`pressed oxygen for entraining a medicament are often oper(cid:173)
`ated by depressing a button to release a short charge of the
`compressed propellant. The propellant entrains the medica(cid:173)
`ment as the propellant flows over a reservoir of the medi(cid:173)
`cament so that the propellant and the medicament can be 55
`inhaled by the user. Since the medicament is propelled by
`the propellant, such propellant-based arrangements are well(cid:173)
`suited for those who might have difficulty inhaling.
`Nonetheless, aerosols generated by propellant-based
`arrangements have particles that are too large to ensure deep 60
`lung penetration.
`In propellant-based arrangements, however, a medica(cid:173)
`ment may not be properly delivered to the patient's lungs
`when it is necessary for the user to time the depression of an
`actuator such as a button with inhalation. Moreover, such 65
`arrangements tend to be poorly suited for delivery of mate(cid:173)
`rials in large quantities. Although propellant-based aerosol
`
`JTI Exhibit 1004, Page 0009
`
`

`
`US 6,234,167 Bl
`
`3
`the source of material and into the tube. Material from the
`source of material is caused to flow from the source of
`material and into the tube. With the control device and in
`response to the first signal, a third signal is sent to the source
`of power to supply power to a heater disposed relative to the
`tube to heat the tube. Material from the source of material is
`heated in the tube with the heater to a vaporization tem(cid:173)
`perature such that the material volatilizes and expands out of
`an open end of the tube.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The features and advantages of the present invention are
`well understood by reading the following detailed descrip(cid:173)
`tion in conjunction with the drawings in which like numerals
`indicate similar elements and in which:
`FIG. 1 is a schematic, partially broken, side view of an
`aerosol generator according to an embodiment of the present
`invention;
`FIG. 2 is a logic diagram of powered components of an
`aerosol generator according to an embodiment of the present
`invention;
`FIG. 3 is a schematic, partially broken, side view of an
`aerosol generator according to a second embodiment of the
`present invention;
`FIG. 4 is a schematic, partially broken, side view of an
`aerosol generator according to a third embodiment of the
`present invention;
`FIG. 5 is a schematic, partially broken, side view of an
`aerosol generator according to a fourth embodiment of the
`present invention;
`FIGS. 6A-6C show steps according to a method, accord(cid:173)
`ing to a further aspect of the present invention, of manu(cid:173)
`facturing an aerosol generator according to the fifth embodi(cid:173)
`ment of the present invention.
`
`DETAILED DESCRIPTION
`An aerosol generator 21 according to the present inven(cid:173)
`tion is shown in FIG. 1. The principles of operation of the
`aerosol generator 21 and, where applicable, materials used
`in the aerosol generator are preferably similar to the prin(cid:173)
`ciples of operation and materials used in the aerosol gen(cid:173)
`erator disclosed in U.S. Pat. No. 5,743,251, which is hereby
`incorporated by reference in its entirety.
`A preferred application for the aerosol generator 21 is as
`an inhaler device, such as an inhaler for medicaments, such
`as asthma medication and pain killers. The aerosol generator
`21 preferably includes a first component 23, which prefer(cid:173)
`ably includes, for example, the material to be turned into an 50
`aerosol and which is preferably disposable after one or a
`predetermined plurality of uses, removably attached to a
`second component 25, which preferably includes, for
`example, power source and logic circuitry structures and
`which is preferably permanent in the sense that it is reusable 55
`\vith successive ones of the first components. The first and
`second components 23 and 25 can be attachable to one
`another in end to end or side by side relationships. If desired
`or necessary, however, the aerosol generator can be a
`one-piece device.
`The first component 23 preferably includes a tube 27
`having a first and a second end 29, 31, and a heater 33
`arranged relative to the tube for heating the tube. A valve 35
`is provided either on the tube 27 or between the second end
`31 of the tube and a source 37 of material, the valve 65
`preferably being openable and closeable to open and close
`communication between the first end 29 of the tube and the
`
`10
`
`25
`
`4
`source of material. The valve 35 may define the second end
`31 of the tube. The valve 35 is preferably electronically
`openable and closeable, preferably a solenoid-type valve.
`The first component 23 preferably further includes the
`s source 37 of material to be volatilized. The first component
`23 preferably also includes a pressurization arrangement 39
`for causing material in the source 37 of material to be
`introduced into the tube 27 from the source of material when
`the valve 35 is in an open position.
`The second component 25 is preferably attachable and
`detachable to the first component 23 and includes a source
`41 of power for the heater 33 and for the valve 35, and a
`control device 43, such as a microchip, for controlling
`supply of power from the source of power to the heater and
`15 the valve. The source 41 of power is preferably a battery,
`more preferably a rechargeable battery, however, the source
`of power may, if desired or necessary, be a non-depleting
`source of power, such as a conventional power line. Inter(cid:173)
`national Publication No. WO 98/17131 discloses a power
`20 controller and a method of operating an electrical smoking
`system that discloses a power source and a control device,
`particularly for heaters, the principles of operation and
`features of which are transferrable to the present invention,
`and is hereby incorporated by reference.
`General operation of the aerosol generator 21 involves a
`user providing a signal, such as by compressing a button or
`performing some other action such as inhaling near the first
`end 29 of the tube 27 to actuate a flow sensing detector or
`a pressure drop sensing detector, which is received by the
`30 control device 43. In response to the signal, the control
`device 43 preferably controls the supply of power from the
`power source 41 such that the valve 35 is opened and power
`is supplied to the heater 33 to cause it to heat up to its desired
`operating temperature. It may be desired or necessary,
`35 depending upon the application and the equipment
`employed, to open the valve 35 before or after supplying
`power to the heater 33.
`Upon opening the valve 35, the pressurization arrange-
`40 ment 39 causes material in the source 37 of material to be
`introduced into the tube 27. The material in the tube 27 is
`heated to a vaporization temperature in the tube, volatilizes,
`and expands out of the free first end 29 of the tube. Upon
`exiting the tube 27, the volatilized material contacts cooler
`45 air and condenses to form an aerosol. Preferably, after a
`predetermined period of time, the control device 43 auto(cid:173)
`matically closes the valve 35 and shuts off the supply of
`power to the heater 33. After one or a plurality of uses, the
`first component 23 is preferably separated from the second
`component 25 and is disposed of, and a new first component
`is attached to the second component for further use.
`Because presently preferred applications for the aerosol
`generator 21 include use as an inhaler, the aerosol generator
`is preferably as small as possible. The valve 35 is preferably
`a microvalve. More preferably, the valve 35, the heater 33,
`and the tube 27 are a single micoelectronic machine formed
`on a single chip. To the extent that other components of the
`aerosol generator 21 disclosed in the present application are
`subject to production as microelectronic devices, they may
`60 also be formed on a single chip with the valve 35, the heater
`33, and the tube 27, or on another chip.
`According to the preferred embodiment, the source 37 of
`material includes a flexible container 45, and the pressur(cid:173)
`ization arrangement 39 includes a chamber 47 in which the
`flexible container is disposed. A pressurized gas G is pref(cid:173)
`erably sealed in the chamber 47 and surrounds the flexible
`container 45. The pressurization arrangement 39 is prefer-
`
`JTI Exhibit 1004, Page 0010
`
`

`
`US 6,234,167 Bl
`
`5
`ably a so-called sepra container of the type used for
`dispensing, for example, gel shaving creams, caulking
`compounds, and depilatories, although other pressurization
`arrangements for delivering the material, such as propellants
`and manual or automatic pumps, may be used if desired or
`necessary. The sepra container pressurization system is
`particularly preferred, however, particularly due to its capac(cid:173)
`ity for resistance to surrounding temperature variations, as
`well as to variations in pressure of the gas G because the gas
`is not depleted. When it is desired to dispense material from
`the source 37 of material, and the valve 35 is opened, the
`pressure of the gas G, which is preferably about two
`atmospheres (about 30 psi) greater than ambient pressure,
`compresses the flexible container 45, causing material to
`enter the tube 27 through the second end 31 of the tube in
`communication with the source of material. A preferred gas
`G is nitrogen because of its ready availability and compara(cid:173)
`tively low cost, although various other gases are also suit(cid:173)
`able and may be preferred for particular applications.
`Displacement of material from the flexible container 45
`means that there is more room in the chamber 47, which
`means that the gas G enclosed in the chamber occupies a
`greater volume. Preferably, the size of the flexible container
`45 relative to the size of the chamber 47 is selected such that
`pressure of the gas G is about ten percent lower when the
`flexible container is empty than when the flexible container
`is full.
`A pressure sensor 48 may be provided to sense the
`pressure of the gas Gin the chamber 47. As seen in FIG. 2,
`the pressure sensor 48 is preferably arranged to send a signal
`representative of the pressure in the chamber 47 to the
`control device 43. The control device 43, in tum, is prefer(cid:173)
`ably arranged to control the power source 41 to adjust a
`length of time that power is supplied to the valve 35, and if
`desired or necessary, to the heater 33, in response to the
`signal from the pressure sensor. In this way, pressure drops
`in the chamber 47, which may result in a decrease in the rate
`at which material in the flexible container 45 is dispensed,
`can be compensated for by dispensing material for some(cid:173)
`what longer periods of time, i.e., by keeping the valve 35
`open longer and, if desired or necessary, maintaining a
`supply of power to the heater 33.
`A signal to the control device 43 to supply power to the
`valve 35 and the heater 33 and, where provided, other
`features of the aerosol generator 21, is preferably provided
`by a user of the aerosol generator. While the signal may be
`provided by, for example, pressing a button, turning a knob,
`or switching a switch, a preferred arrangement for providing
`a signal is based on a user causing some manner of air flow
`in the proximity of the free first end 29 of the tube 27, such
`as by inhaling on a mouthpiece section 49 of the aerosol 50
`generator. The aerosol generator 21 preferably includes an
`air flow detecting device 51 for determining when a prede(cid:173)
`termined air flow rate exists proximate the first end 29 of the
`tube 27. The air flow detecting device 51 is preferably
`arranged to send a signal to the control device 43 to indicate 55
`that the predetermined air flow rate exists, which may be
`indicative that a user is drawing on the open end 53 of the
`mouthpiece 49 section, and the controller is preferably
`arranged to control the power source to supply power to the
`valve 35 and the heater 33, and any other components, in 60
`response to the signal from the air flow detecting device. As
`seen in FIG. 1, the air flow detecting device 51 is preferably
`disposed transversely to and upstream of the first end 29 of
`the tube 27 so that the air flow detecting device will assist
`in ensuring that an adequate supply of air flow exists to 65
`produce and effectively deliver an aerosol from the volatil(cid:173)
`ized material as it expands out of the first end of the tube.
`
`6
`Where the aerosol generator 21 is a multi-piece device,
`the air flow detecting device 51 is preferably permanently
`attached to the second component 25 and is, thus, preferably
`a permanent component, i.e., it is not disposed of. If desired
`5 or necessary, however, the air flow detecting device 51 can
`be a disposable component forming part of the first com(cid:173)
`ponent 23 and can be removably connected, such as through
`an electrical connection, to the control device 43.
`The mouthpiece section 49 preferably has an open end 53.
`10 The tube 27 is preferably disposed in the mouthpiece section
`49 and the first end 29 of the tube is preferably disposed
`inside of the mouthpiece section at a distance from the open
`end 53 to permit complete mixing of volatilized material
`expanding out of the first end of the tube with surrounding
`15 air to form an aerosol. To ensure an adequate supply of air
`for mixing with the volatilized material, as well as to ensure
`an adequate supply of air for permitting a user to draw on the
`mouthpiece section and actuate the air flow detecting device
`51, the mouthpiece section 49 preferably has a plurality of
`20 vent holes 55. To facilitate the flow of air past the first end
`29 of the tube 27 and thereby facilitate formation of an
`aerosol, the first end of the tube is preferably disposed in the
`mouthpiece section 49 between the vent holes 55 and the
`open end 53 of the mouthpiece section. The vent holes 55 are
`25 preferably located relative to the tube 27, preferably close to
`the end 29, such that air passing through the vent holes has
`no or minimal cooling effect on the tube. The tube 27 may,
`of course, be insulated from air flowing through the vent
`holes 55, such as by providing insulation material or a
`30 concentric tube 56 (shown in phantom) or the like around the
`tube to channel air away from the tube.
`As an alternative to, or in addition to, using an air flow
`detecting device 51 to send a signal to the control device 43,
`as seen in FIG. 2 in phantom, a pressure drop detecting
`35 device 57 for determining when a predetermined pressure
`drop occurs proximate the first end 29 of the tube 27 may be
`used. The pressure drop detecting device 57 is preferably
`arranged to send a signal to the control device 43 to indicate
`that the predetermined pressure drop is occurring, which
`40 may be indicative of a user drawing on the open end 53 of
`the mouthpiece section 49, and the control device is
`arranged to control the power source 41 to supply power to
`the valve 35 and the heater 33, and any other electrically
`powered components, in response to the signal from the
`4s pressure drop detecting device.
`A suitable pressure drop detecting device is a puff(cid:173)
`actuated sensor in the form of a Model163PC01D35 silicon
`sensor, manufactured by MicroSwitch division of
`Honeywell, Inc., Freeport, Ill., or an SLP004D 0-4" H 20
`Basic Sensor Element, manufactured by SenSym, Inc.,
`Milpitas, Calif. Other known flow-sensing devices, such as
`those using hot-wire anemometry principles, are also
`believed to be suited for use with the aerosol generator 21.
`The use of an air flow detecting device 51, as compared to
`a pressure drop detecting device, is presently preferred for
`inhaler-type applications because it is anticipated that an air
`flow detecting device will be easier for users to actuate as
`compared to a pressure drop detecting device.
`Presently anticipated applications for the aerosol gener(cid:173)
`ating device 21 include drug delivery applications. For such
`applications, as well as in other applications to which the
`aerosol generating device 21 might be applied, the control
`device 43 may include a timer 59 for controlling a frequency
`with which the control device controls the power supply 41
`to supply power to the valve 35 and the heater 33 and other
`components. In this way, the aerosol generating device 21
`can automatically limit the frequency with which a user can
`
`JTI Exhibit 1004, Page 0011
`
`

`
`US 6,234,167 Bl
`
`7
`operate the aerosol generating device, thereby facilitating in
`preventing accidental misuse and overdosages. Moreover, to
`assist caregivers in treating their patients, the aerosol gen(cid:173)
`erator 21 can be associated with a remote control device 61
`remote from the control device 43. The remote control 5
`device 61 is preferably capable of adjusting the timer 59 to
`adjust the frequency with which the control device 43
`controls the power supply 41 to supply power to the valve
`35 and the heater 33, and other components. In this way,
`when a caregiver desires to increase or decrease the fre- 10
`quency with which the user is able to operate the aerosol
`generator, the caregiver can do so in situations where the
`caregiver and the user are separated by some distance. In this
`way, users who might otherwi<;e be required to personally
`see their caregivers to have their treatment schedules 15
`adjusted have greater mobility.
`The control device 43 and, if provided, the remote control
`device 61, may also be configured to permit adjustment or
`remote adjustment of other powered components of the
`aerosol generator 21, such as the length of time that the valve 20
`35 is open, and the length of time that power is supplied to
`the heater from the power source 41. In this manner, it is
`possible to adjust dosages up or down, as well as to adjust
`operating conditions of the aerosol generator 21 to maintain
`the same operation where, for example, pressure of the gas 25
`G in the chamber 47 drops or the rate at which power is
`supplied from the power source 41 reduces, such as where
`the aerosol generator is used in different temperatures,
`material in the flexible container 45 is used up, or the charge
`of a battery forming the power source diminishes.
`The timer 59 of the control device preferably is associated
`with an indicator 63, such as a beeper or light forming part
`of the timer or, for example, electrically connected to the
`timer, for indicating that the control device 43 is available to
`control the power supply 41 to supply power to the valve 35 35
`and the heater 33 and other components. Where, for
`example, the aerosol generator 21 is used to dispense
`medication, the indicator 63 serves to remind the user that it
`is time for the medication. The indicator 63 may also, if
`desired or necessary, be operable by the remote control 40
`device 61. The indicator 63 may also be used to indicate to
`a user a length of time since the aerosol generator 21 was
`actuated, such as where the aerosol generator is used as an
`inhaler, and the user is supposed to hold his or her breath for
`a length of time after inhaling, with the indicator 63 indi- 45
`eating when a period of time has elapsed.
`The aerosol generator 21 may also include a display
`device 65, such as an LCD display, for displaying informa(cid:173)
`tion such as a number of times that the control device 43
`controls the power supply 41 to supply power to the valve 50
`and the heater. The display device 65 may display, for
`example, a number of times that the aerosol generator 21 has
`been operated, e.g., 1 or 2 or 3, or a number of operations
`remaining, which may be based on, for example, the size of
`the source 37 of material and the amount of material 55
`dispensed each time that the valve 35 is opened and closed,
`or the life of the power supply 41, such as the remaining life
`of a battery. The same or additional display devices can be
`provided to display other information, such as pressure in
`the pressure chamber 47 and power level of the power 60
`source 41. Further, the aerosol generator 21 may be
`equipped with various sensors and displays to provide
`feedback to be displayed in a display device 65 to, for
`example, assist a user in learning how to use the aerosol
`generator properly as an inhaler, such as sensors to measure 65
`the volume and duration of an inhalation after completion of
`an inhalati