`Nichols
`
`US006491233B2
`US 6,491,233 B2
`(10) Patent No.:
`Dec. 10, 2002
`(45) Date of Patent:
`
`(54) VAPOR DRIVENAEROSOL GENERATOR
`AND METHOD OF USE THEREOF
`
`(75) Inventor: Walter A. Nichols, Chesterfield, VA
`(US)
`(73) Assignee: Chrysalis Technologies Incorporated,
`Richmond, VA (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(*) Notice:
`
`(21) Appl. No.: 09/742,395
`(22) Filed:
`Dec. 22, 2000
`(65)
`Prior Publication Data
`US 2002/0079377 A1 Jun. 27, 2002
`(51) Int. Cl." ............................. B05B 1/24; B05B 7/16;
`B05B 1/30
`(52) U.S. Cl. ....................... 239/128; 239/134; 239/135;
`239/569
`(58) Field of Search ................................. 239/128, 135,
`239/337, 13, 10, 132, 133, 134, 136, 139,
`569
`
`(56)
`
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`Primary Examiner—Lesley D. Morris
`Assistant Examiner—Davis Hwu
`(74) Attorney, Agent, or Firm—Burns, Doane, Swecker &
`Mathis, LLP
`ABSTRACT
`(57)
`An aerosol generator includes a fluid supply which supplies
`fluid to a fluid passage, a main heater which heats the fluid
`into a gaseous state and a preheater which delivers a volume
`of fluid to the main heater. The preheater can be located in
`or adjacent a metering chamber which receives a predeter
`mined volume of fluid, the preheater heating a portion of the
`fluid so as to form a vapor bubble which ejects the remaining
`fluid from the chamber. An outlet of the aerosol generator is
`arranged to receive the volatilized fluid formed by the main
`heater and direct the volatilized fluid out of the fluid passage.
`The aerosol generator can be used to generate aerosols
`containing medicated materials.
`
`21 Claims, 1 Drawing Sheet
`
`12
`
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`
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`
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`US 6,491,233 B2
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`Copending Application No. 09/742,322 naming Kenneth A.
`Cox, Walter Allen Nichols, F. Murphy Sprinkel, Jr., Douglas
`D. Mcrae and William R. Sweeney as inventor(s) and filed
`on Dec. 22, 2000.
`Notification of Transmittal of International Preliminary
`Examination Report for PCT/US01/44810 dated Sep. 10,
`2002.
`* cited by examiner
`
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`
`
`U.S. Patent
`
`
`
`Dec. 10, 2002
`
`US 6,491,233 B2
`
`Fontem Ex. 2016
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`
`
`1
`WAPOR DRIVEN AEROSOL GENERATOR
`AND METHOD OF USE THEREOF
`
`US 6,491,233 B2
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention relates generally to aerosol genera
`tors and, more particularly, to vapor driven aerosol genera
`tors. The aerosol generators of the invention are able to
`generate aerosols without requiring the use of compressed
`gas propellants. The present invention also relates to meth
`ods for generating an aerosol. The present invention has
`particular applicability to the generation of aerosols con
`taining medicated material.
`2. Description of the Related Art
`Aerosols are gaseous suspensions of fine solid or liquid
`particles and are useful in a wide variety of applications. For
`example, medicated liquids and powders may be adminis
`tered in aerosol form. Such medicated aerosols include, for
`example, materials which are useful in the treatment of
`respiratory ailments, in which case the aerosols may be
`inhaled into a patient’s lungs. Aerosols may also be used in
`non-medicinal applications including, for example, dispens
`ing air fresheners and insecticides and delivering paints
`and/or lubricants.
`In aerosol inhalation applications, it is typically desirable
`to provide an aerosol having an average mass median
`particle diameter of less than 2 microns to facilitate deep
`lung penetration. Most known aerosol generators are inca
`pable of generating aerosols having an average mass median
`particle diameter less than 2 microns. Also, in certain
`applications, it is generally desirable to deliver medicated
`material at high flow rates, for example, above 1 mg per
`second. Most known aerosol generators suited for delivering
`medicated material are incapable of delivering material at
`such high flow rates while maintaining a suitable average
`mass median particle diameter. In addition, most known
`aerosol generators deliver an imprecise amount of aerosol
`compared with the amount of aerosol that is intended to be
`delivered.
`The related art discloses aerosol generators which employ
`various techniques for delivering an aerosol. A particularly
`useful technique involves volatilizing a fluid and ejecting the
`volatilized fluid into the atmosphere. The volatilized fluid
`subsequently condenses, thereby forming an aerosol. See,
`for example, commonly assigned U.S. Pat. No. 5,743,251,
`the entire contents of which document are hereby incorpo
`rated by reference. Such aerosol generators may eliminate or
`conspicuously reduce some or all of the aforementioned
`problems associated with the known aerosol generators.
`However, since these aerosol generators employ heat
`generating systems, heat resistive material and, in some
`cases, various control devices, pumps and valves, the manu
`facture and assembly of such aerosol generators can be
`complicated and expensive.
`In light of the foregoing, there exists a need in the art for
`the provision of an aerosol generator which overcomes or
`conspicuously ameliorates the above described shortcom
`ings in the related art. Accordingly, it is an object of the
`present invention to provide a vapor driven aerosol genera
`tor which produces an aerosol from a fluid by volatilizing the
`fluid and directing the volatilized fluid therefrom.
`Other objects and aspects of the present invention will
`become apparent to one of ordinary skill in the art upon
`review of the specification, drawings and claims appended
`hereto.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`SUMMARY OF THE INVENTION
`The invention provides an aerosol generator which
`includes a fluid passage having an upstream and a down
`stream end, a heater arranged to heat fluid in the passage into
`a gaseous state, a fluid supply arranged to provide a fluid to
`the upstream end of the passage, a preheater located between
`the fluid supply and the main heater, the preheater including
`a heating element which heats a portion of the fluid in the
`passage into a gaseous state such that fluid in the passage
`downstream of the heating element is driven through the
`passage in a downstream direction.
`The heating element is preferably located in a chamber
`having a predetermined volume and/or the fluid supply
`includes a valve which closes the passage when the heating
`element heats the fluid into a gaseous state. If desired, the
`heating element can be located along an inner wall of a
`metering chamber, the metering chamber being sized to
`receive a predetermined volume of fluid to be emitted as an
`aerosol from the aerosol generator. The passage can be
`located in an organic or inorganic material selected from one
`or more polymer, metal and ceramic materials. For instance,
`the passage can be located in a ceramic laminate wherein the
`passage is defined by a recess in a surface of a first ceramic
`layer and a surface of a second ceramic layer bonded to the
`first ceramic layer. The heating element can comprise a layer
`of resistance heating material located along one or more
`walls of the passage.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`The objects and advantages of the invention will become
`apparent from the following detailed description of the
`preferred embodiments thereof in connection with the
`accompanying drawings, in which:
`FIG. 1 is a schematic diagram of an exemplary aerosol
`generator in accordance with the invention;
`FIG. 2 is a cross section of an exemplary aerosol genera
`tor in accordance with the invention; and
`FIG. 3 is a cross section of another exemplary aerosol
`generator in accordance with the invention.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS OF THE
`INVENTION
`When referring to the drawing figures, like reference
`numerals designate identical or corresponding elements
`throughout the several figures.
`FIG. 1 shows a vapor driven aerosol generator 10 in
`accordance with one embodiment of the invention. As
`shown, the aerosol generator 10 includes a source 12 of
`fluid, a valve 14, a chamber 16, a valve 18, a passage 20, a
`mouthpiece 22, an optional sensor 24 and a controller 26. In
`addition, the aerosol generator 10 includes a preheater 28
`and a main heater 30. The controller 26 includes suitable
`electrical connections and ancillary equipment such as a
`battery which cooperates with the controller for operating
`the valves 14, 18, the sensor 24 and the heaters 28, 30. In
`operation, the valve 14 can be opened to allow a desired
`volume of fluid from the source 12 to enter the chamber 16
`during which time the valve 18 can be closed to prevent the
`incoming fluid from advancing into the passage 20. Filling
`of the chamber 16 can occur prior to or subsequent to
`detection by the sensor 24 of vacuum pressure applied to the
`mouthpiece 22 by a user attempting to inhale aerosol from
`the inhaler 10. Once the chamber 16 contains a predeter
`mined volume of fluid, the controller 26 closes valve 14 and
`
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`3
`opens valve 18 while operating the preheater 28 to drive the
`fluid into the passage 20. While the fluid passes through the
`passage 20, the controller 26 operates the main heater 30 to
`heat the fluid to a suitable temperature for volatilizing the
`fluid therein. The volatilized fluid exits an outlet 32 of the
`passage 20 and the volatilized fluid forms an aerosol which
`can be inhaled by a user drawing upon the mouthpiece 22.
`The aerosol generator shown in FIG. 1 can be modified to
`utilize different fluid supply arrangements. For instance, the
`fluid source can comprise a delivery valve which delivers a
`predetermined volume of fluid to the chamber 16 in which
`case the chamber 16 need not be sized to hold a precise
`volume of liquid. Alternatively, the chamber can be sized to
`hold a predetermined volume of fluid and the fluid supply
`can comprise a pressurized source of fluid which fills the
`chamber when valve 14 is opened. The preheater 28 heats
`the fluid in the chamber 16 such that a vapor bubble is
`formed which expands and drives the remaining liquid from
`the chamber 16 into the passage 20. If desired, valves 14, 18
`could be omitted and the fluid source 12 can include a
`delivery arrangement which supplies a predetermined vol
`ume of fluid to the chamber 16. Further, the main heater 30
`can be an individual heater or a plurality of heaters arranged
`to volatilize the liquid in passage 20. In the case of manual
`operations, the sensor 24 can be omitted such as in the case
`where the aerosol generator 10 is operated manually by a
`mechanical switch, electrical switch or other suitable tech
`nique.
`FIG. 2 shows a top cutaway view of a vapor driven
`aerosol generator 40 in accordance with another embodi
`ment of the invention. As shown, the aerosol generator 40
`includes a fluid supply 42, a chamber 44, a passage 46, a
`preheater 48 and a main heater 50. The preheater 48 can be
`arranged on one side of the chamber 44 such that fluid in the
`chamber 44 is heated to form a vapor bubble which expands
`and drives the remaining fluid in the chamber 44 into the
`passage 46. If desired, an additional preheater 52 can be
`provided in the chamber 44 in order to provide additional
`heating of the fluid. The heaters 48, 52 extend horizontally
`along bottom and top walls of the chamber 44. The heaters
`48, 50, 52 are preferably thin films of resistance heating
`material. In order to pass electrical current through the
`heaters, the heaters can be in electrical contact with suitable
`electrical contacts 54. A suitable power source such as a
`battery can be used to deliver sufficient direct current to the
`contacts 54 in order to heat the heaters 48, 50, 52 to desired
`temperatures. Further, operation of the heaters and supply of
`fluid from the fluid source 42 can be controlled by a suitable
`controller as in the case of the first embodiment.
`Like the embodiment shown in FIG. 1, the embodiment
`shown in FIG. 2 can be modified to incorporate different
`fluid supply arrangements and/or heating arrangements.
`However, it is preferred that the chamber 44 include at least
`one preheater therein or associated therewith such that fluid
`in the chamber 44 can be heated to form a vapor bubble
`which drives the fluid in the chamber 44 into the passage 46.
`FIG.3 shows a side view of a third embodiment of a vapor
`driven aerosol generator in accordance with the invention.
`As shown, the aerosol generator 60 includes a fluid supply
`62, a chamber 64, a passage 66, a preheater 68 and a main
`heater 70. The aerosol generator 60 can be formed from solid
`state components such as layers 72, 74, 76 of metal, organic
`or ceramic material such as a polymer material or ceramic
`material. If desired, layers 74 and 76 can comprise a single
`layer which has been machined or etched to form the
`passage 66 and the chamber 64. Alternatively, one or more
`layers can be interposed between the layers 74 and 76 so as
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`to form the passage 66 and the chamber 64. As in the case
`of the embodiment shown in FIG. 2, the heaters 68, 70 can
`be supplied power by contacts 78. The heater 68 is arranged
`to extend vertically along an inner sidewall of the chamber
`64. In arrangements wherein the heater contacts the fluid, it
`is desirable to coat the heater with a material which is
`nonreactive with the fluid, e.g., glass or metal such as
`stainless steel.
`The fluid may include any material capable of volatiliza
`tion by the aerosol generator. In a preferred embodiment, the
`fluid does not decompose when exposed to the heat required
`for volatilization thereof. The fluid preferably includes a
`medicated material such as, for example, a material that is
`useful in the treatment of respiratory ailments. In such
`applications, the generated aerosol may be inhaled into a
`user’s lungs. Alternatively, the fluid may include a non
`medicated material.
`In the foregoing embodiments, the fluid passage can be
`defined by a capillary tube or a channel in a multi-layered
`arrangement wherein the layers are formed from a heat
`resistant material that is preferably capable of withstanding
`the temperatures and pressures generated in the fluid pas
`sage. The heat-resistant material is more preferably capable
`of withstanding repeated heating cycles. Also, the heat
`resistant material preferably does not react with the fluid
`contained in the fluid passage. The heat-resistant material
`may include, for example, alumina, zirconia, silica, alumi
`num silicate, titania, yttria-stabilized zirconia or mixtures
`thereof, preferably alumina. The layers may be of any size
`suitable for aerosol generation. According to a preferred
`embodiment, each layer can have a length of from about 1
`to 100 mm, more preferably about 15 mm; a width of from
`about 1 to 100 mm, more preferably about 15 mm; and a
`thickness of from about 0.001 to 10 mm, more preferably
`about 0.076 mm.
`The layers can be configured to at least partially define the
`fluid passage. In an exemplary embodiment of the present
`invention, a channel is in a layer or the channel can be
`defined by adding one or more layers of material between
`first and second layers. The layers can be attached together,
`thereby enclosing the channel therebetween. In this manner,
`the channel defines the fluid passage.
`The layers may be attached together using various
`techniques, including, for example, adhesive bonding. The
`adhesive material used to attach the layers is preferably
`capable of withstanding repeated heating cycles and may
`include, for example, a metal, a cement, an epoxy, an acrylic,
`a cyanoacrylic or mixtures thereof, preferably an acrylic
`cement. Alternatively, other techniques may be used to
`attach the layers together such as, for example, mechanical
`or metallurgical bonding such as a brazing material.
`The fluid passage is preferably linear to facilitate the flow
`of the fluid therethrough. Alternatively, the fluid passage can
`be non-linear in two or three dimensions such as in the case
`where the direction of fluid flow through the passage con
`tains at least one turn. An outlet at the downstream end of the
`fluid passage can be sized to achieve a desired aerosol
`particle size distribution. In a preferred embodiment, the
`outlet is circular and has a diameter of about from 0.01 to 5
`mm, more preferably about 0.1 mm.
`The outlet may be disposed at an angle, for example, 10
`to 160°, with respect to the axis of fluid flow within the fluid
`passage, to direct the flow of the volatilized fluid out of the
`fluid passage in a desired direction. According to an alter
`native embodiment, the fluid passage can extend through a
`side wall of the layers, and the outlet can be defined by the
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`Nu Mark LLC v. Fontem Holdings 1 B.V. IPR2016-01288
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`furthest downstream portion of the fluid passage. A conduit
`(not shown) may be connected to receive the volatilized
`fluid from the outlet to further direct the flow of volatilized
`fluid in a desired direction. Such a conduit can have a
`diameter of from about 0.01 to 5 mm.
`In a preferred embodiment, a valve and/or a pump can be
`used to control the flow of fluid from the fluid supply to the
`fluid passage. The valve and/or the pump may be manually
`operated or a controller may manipulate the valve and/or the
`pump based on various parameters including, for example,
`the amount of time the valve remains in the open position,
`or the volumetric amount of fluid that is supplied to the fluid
`passage. In this manner, the valve and/or the pump may
`enable the liquid supply to deliver a predetermined volume
`of fluid in liquid phase to the fluid passage. In an alternative
`embodiment, the fluid in liquid phase can be contained in a
`chamber, and the fluid can be delivered by compressing the
`fluid in the chamber using a piston.
`The fluid supply provides the fluid to be volatilized in
`fluid phase to the fluid passage. The fluid in liquid phase may
`be stored in the liquid supply at a pressure above atmo
`spheric to facilitate delivery of the fluid to the fluid passage.
`In an exemplary embodiment, the fluid supply comprises a
`refillable storage chamber formed of a material suitable for
`containing the fluid to be volatilized. Alternatively, the fluid
`supply comprises a disposable storage chamber which, upon
`exhaustion of the fluid, is discarded and replaced by a new
`storage chamber.
`The fluid passage may contain any amount of fluid in
`liquid phase which is capable of being volatilized by the
`heater of the aerosol generator. For example, the fluid
`passage may have a liquid volumetric capacity of from about
`1×107° ml to 0.005 ml. Alternatively, the fluid passage may
`have a liquid volumetric capacity of greater than about 0.005
`ml, preferably from about 0.1 ml to 1.0 In aerosol inhalation
`applications, the fluid passage may have a liquid volumetric
`capacity which is sufficient for containing a predetermined
`amount of fluid that comprises a metered quantity of fluid.
`The main heater for heating the fluid passage and the
`preheater for heating the chamber preferably include a film
`forming an electrically resistive heating material which is
`different from the heat-resistant material used to form the
`layers of the aerosol generator. For example, the resistive
`material may include a pure metal, metal alloy or metal
`compound such as platinum, titanium nitride, stainless steel,
`nickel chromium or mixtures thereof. Additional resistive
`materials include composite layers such as self-regulating
`heater materials. The main heater may be sized to be capable
`of generating a sufficient amount of heat to vaporize the fluid
`present in the fluid passage. In a preferred embodiment, the
`main heater has a length of from about 1 to 100 mm, more
`preferably about 10 mm; a width of from about 0.1 to 10
`mm, more preferably about 0.5 mm; a thickness of from
`about 1 to 10 microns, more preferably about 3 microns; and
`an electrical resistance of from about 0.1 to 10 ohms, more
`preferably about 0.65 ohm.
`Using a material for forming the heaters which is different
`from the material used to form the layers allows the resis
`tance through the heaters to be easily adjusted by varying
`various parameters including, for example, the dimensions
`and amount of heat produced by the heaters may be adjusted
`for various applications. the material of the heaters. In this
`manner, the resistance of the heaters and the
`The resistive material of the heaters may be attached to
`the layers using various techniques. For example, the resis
`tive material may be sputtered, printed, bonded or coated
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`upon the layers. Deposition by sputtering includes, for
`example, DC magnetron sputter deposition. Deposition by
`bonding includes, for example, eutectically bonding the
`resistive material using sputtered material including, for
`example, copper or copper sheet material. Alternatively,
`vacuum evaporation, chemical deposition, electroplating
`and chemical vapor deposition may be used to deposit the
`resistive material.
`Various factors contribute to the stability of the bond
`between the heater and the layers. For example, to enhance
`bonding, the arithmetic average of the surface roughness of
`the surface upon which the resistive material is disposed
`preferably is greater than or equal to about 1 microinch,
`more preferably from about 1 to 100 microinches, and most
`preferably from about 12 to 22 microinches. In addition, the
`heat-resistant material of the layers and the resistive material
`of the heater preferably have comparable coefficients of
`thermal expansion to minimize or prevent thermally induced
`delamination.
`In a preferred embodiment, the heater is in electrical
`contact with first and second contacts which pass an elec
`trical current through the heater. In this embodiment, the
`power supply which provides the electrical current to the
`heater is in electrical contact with the first and second
`COntacts.
`The first and second contacts of the heater are preferably
`formed from a material which has a lower resistance than
`that of the resistive material of the heater. For example, the
`first and second contacts typically include copper or a
`copper alloy such as, for example, phosphor bronze and Si
`bronze, and preferably copper or a copper alloy comprising
`at least 80% copper. Use of such materials prevents or
`reduces the heating of the contacts prior to the heating of the
`heater. The contacts are sized to be capable of passing an
`electrical current through the heater. The contacts may be
`attached to the layers and/or heater using any of the tech
`niques used to attach the resistive material to the layers, as
`discussed above.
`In each of the above embodiments, a single heater or
`multiple heaters may be used for the main heater or pre
`heater. The use of multiple heaters for the main heater in the
`aerosol generator may enable a more uniform distribution of
`heat within the fluid passage. Alternatively, the use of
`multiple heaters may enable different zones of the fluid
`passage to be maintained at different temperatures. Such
`differing temperature zones in the fluid passage may be
`useful in fluid temperature control devices, as discussed in
`U.S.