`
`Unlted States Patent [19]
`Gerth et a1.
`
`[11] Patent Number:
`[45] Date of Patent:
`
`4,735,217
`Apr. 5, 1988
`
`[54] DOSING DEVICE TO PROVIDE
`VAPORIZED MEDICAMENT To THE
`LUNGS As A FINE AEROSOL
`[75] Inventors: Donald L. Gerth, Cincinnati; Delmar
`R, Muckenfuhs, Middletown, both of
`Ohio
`
`[73] Assignee= The Procter & Gamble Company,
`Cmcmnat" Ohm
`[21] APPL No-i 898,970
`[22] Filed:
`Aug. 21, 1986
`
`[51] Int. 01.4 ............................................ .. A24K 47/00
`[52] US. Cl. .................................. .. 131/273; 131/ 329;
`128/203.17; l28/203.27; l28/204.17;
`128/204.23
`[58] Field Of Search ..................... .. 131/273, 329, 330;
`123/ 204-17, 203-17, 204-23, 203-27
`References Cited
`
`[56]
`
`U-S- PATENT DOCUMENTS
`239,195 3/1331 Rousseau); ,
`962,617 6/1910 Bucceri .
`1,968,509 7/ 1934 Tiffany .................. ............ .. 219/38
`2,057,353 10/1936 Whimmwe, Jr-
`---- -- 219/38
`gfrggfggk
`128 /200
`2:425:62‘, 8/1947 Lardinois
`128 /2o1
`2’479’002 8/1949 Cepe?y
`" 123/201
`2,702,033 2/1955 pardeman
`1213/2011
`2,721,551 10/1955 Lobl ....... ..
`128/201
`2,764,154 9/1956 Murai
`123/195
`213091634 10/1957 Mum-i
`131/171
`2'830’597 4/1958 Kummh """ "
`128/201
`g’gg’?s 11/1958 B€m°1°me° “
`128/208
`,
`,819 8/1965 Gllbert ....... ..
`151/171
`3,258,015 6/1966 Ellis et al. ...... ..
`131/107
`3,279,476 10/1966 Noznick et a1. ..
`3,313,305 4/1967 Noznick et a1. .................. .. 131/10.7
`3,347,231 10/1967 Chien-Hshuing Chang ..... .. 128/201
`
`3,356,094 12/ 1967 Ellis et al. ......................... .. 131/266
`3,404,692 10/1968 Lampert .... ..
`131/170
`3,683,936 8/1972 O’Neil, Jr.
`...... .. 131/8
`4,149,548 4/1979 Bradshaw
`131/ 170 A
`4,284,089 8/1981 Ray ............ ..
`131/270
`4,340,072 7/1982 Bolt et a1.
`131/273
`4,393,884 7/1983 Jacobs .... ..
`151/273
`4,585,014 4/1986 Fry ......... ..
`131/175
`4,585,015 4/1986 Silberstein ......................... .. 131/339
`Primary Examiner—V. Millin
`Attorney, Agent, or Firm-E. Kelly Linman; John V.
`German; Richard C. Witte
`
`ABSTRACT
`[57]
`A medicament dosing device capable of administering a
`vaporized medicament in the form of tiny aerosol parti
`cles to the mouth and lungs of the user at a substantially
`constant concentration level, In a particularly preferred
`embodiment the dosing device is used to provide nico
`tine to a cigarette smoker in a form and a dose that
`closely mimics a burning cigarette to satisfy the smok
`er’s craving for nicotine, but without subjecting either
`the user or any non-users in the immediate vicinity to
`the tars and carbon monoxide of cigarette smoke. A
`preferred device comprises a battery powered resis
`tance heater housed in a cigarette-shaped tube. A de
`mand-operated switch is employed in the circuit so that
`as the user sucks air through the tube in a manner simi
`lar to puf?ng on a cigarette, energy 15 supplied to the
`resistance heater which vaporizes the nicotine. Because
`the system vaporizes the medicament being adminis
`tered only upon activation of the demand-operated
`switch, the concentration of the medicament will be
`substantially constant each time the user sucks on the
`mouthpiece end of the cigarette-shaped tube, regardless
`.
`.
`.
`°f the lfmgih °f “Fe “me Intervals whlch Pass between
`Successlve mhalatms
`
`20 Claims, 3 Drawing Sheets
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`Apr. 5,1988
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`Sheet 1 0f 3
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`4,735,217
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`Sheet 2 of3
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`'
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`Sheet 3 of3
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`4,735,217
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`‘I
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`Fig. 6
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`72;
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`40
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`[:l/
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`HO
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`1
`
`DOSING DEVICE TO PROVIDE VAPORIZED
`MEDICAMENT TO THE LUNGS AS A FINE
`AEROSOL
`
`10
`
`TECHNICAL FIELD
`The present invention relates to a medicament dosing
`device capable of adminstering a vaporized medicament
`to the lungs of the user at a substantially constant con
`centration level.
`The present invention further relates to such a dosing
`device which will provide nicotine to a cigarette
`smoker in a form and a dose that closely mimics a bum
`ing cigarette to satisfy the smoker’s craving for nicotine,
`but without subjecting either the user or any non-users
`in the immediate vicinity to the tars and carbon monox
`ide of cigarette smoke.
`The present invention has further relation to such a
`device to supply other vaporizable medicaments, such
`as menthol, to the lungs of the user in a very ?ne aerosal
`form at a substantially constant concentration level.
`The present invention has still further relation to such
`a dosing device wherein the medicament being adminis
`tered is vaporized only on demand in response to the
`user drawing a stream of cool air through the device,
`thereby causing the vaporized medicament to condense
`in a very ?ne aerosal with particles which are small
`enough to be dispersed throughout the user’s lungs.
`The present invention has still further relation to a
`self-contained, battery operated medicament dosing
`device which is approximately the size of a conven
`tional cigarette, but which can be automatically actu
`ated to vaporize the medicament without combustion
`by sucking on the mouthpiece end of the device.
`
`4,735,217
`2
`ing process has been initiated with the device as dis
`closed in the U.S. Pat. No. 3,258,015 Ellis et al. patent,
`the nicotine will continue to be vaporized whether or
`not the user is drawing air through the passageway
`containing the nicotine. If the user allows long periods
`of time to elapse between successive inhalations, the
`concentration of nicotine vapor in the passageway can
`build up substantially. Thus the medicament concentra
`tion level encountered by the user with devices of the
`type described in the U.S. Pat. No. 3,258,015 Ellis et al.
`patent will vary greatly from one inhalation to the next,
`depending upon the time intervals between successive
`inhalations.
`U.S. Pat. No. 3,356,094 issued to Ellis et al. on Dec. 5,
`1967 discloses smoking devices somewhat similar to
`those disclosed in the U.S. Pat. No. 3,258,015 Ellis et al.
`patent. However, the devices disclosed in the U.S. Pat.
`No. 3,356,094 Ellis et al. patent require that a portion of
`the by-products of combustion which result from burn
`ing the tobacco surrounding the nicotine-containing
`passageway be drawn into the user’s lungs. The devices
`shown in the U.S. Pat. No. 3,356,094 Ellis et al. patent
`differ from those disclosed in the U.S. Pat. No.
`3,258,015 Ellis et al. patent in that they allow the user
`to better control the concentration level of the nicotine,
`i.e. drawing air through the tobacco containing portion
`of the device will accelerate its rate of combustion and
`hence the rate of vaporization of the nicotine in the
`central passageway. However, even the device dis
`closed in the U.S. Pat. No. 3,356,094 Ellis et al. patent
`does not give the user complete, on demand control
`over the concentration of vaporized nicotine developed
`in the interior pasageway. Furthermore, it suffers the
`disadvantage that it requires the user to inhale some of
`the harmful products of combustion in order to in?u
`ence the rate of vaporization of the nicotine. This
`would certainly be undesirable in situations where the
`medicament in question is being administered to a
`person suffering from respiratory dif?culties.
`U.S. Pat. No. 3,200,819 issued to Gilbert on Aug. 17,
`1965 discloses a smokeless, non-tobacco cigarette
`wherein a heating element, characterized as a vacuum
`tube, is energized by a small battery so as to heat ?a
`vored air as it passes from a flavor-containing cartridge
`20 located at the outermost tip of the device to its
`mouthpiece end. However, the ?avor-containing car
`tridge is not heated by the heating element and no
`means are provided for energizing and de-energizing
`the heat source on demand. Therefore the device dis
`closed in the patent to Gilbert would not function to
`administer a substantially constant concentration of a
`medicament which must be vaporized by the addition of
`heat.
`U.S. Pat. No. 1,968,509 issued to Tiffany on July 31,
`1934 and U.S. Pat. No. 2,057,353 issued to Whittemore,
`Jr. on Oct. 13, 1936 both disclose vaporizing units for
`liquid medicaments. These devices employ a resistance
`wire heating element energized by a battery which is
`activated by a manual switch. The device disclosed by
`Whittemore, Jr. further shows a wicking means to de
`liver the liquid medicament to the resistance heating
`wire. Neither of these device appears to be well suited
`for use in the user’s mouth in the manner of a cigarette.
`In essence, they are portable vaporizing units powered
`by ?ashlight batteries which are controlled by manually
`operated “on/off” switches. Accordingly, the concen
`tration of medicament vapor for any given inhalation by
`
`40
`
`25
`
`35
`
`45
`
`55
`
`60
`
`65
`
`BACKGROUND OF THE INVENTION
`Inhalation devices for closing various medicaments,
`including nicotine, are generally known in the art.
`U.S. Pat. No. 3,258,015 issued to Ellis et al. on June
`28, 1966 discloses a number of embodiments for a smok
`ing device intended to provide dosing of nicotine with
`out the inhalation of products of combustion normally
`encountered when smoking cigarettes. In most of the
`disclosed embodiments, an outer wrap of tobacco or
`similar combustible material is utilized to vaporize nico
`tine contained within a continuous passageway extend
`ing from the outermost end of the cigarette-like device
`to the mouthpiece end.
`Most of the disclosed embodiments, while not requir
`ing inhalation of smoke by the user, do require combus
`tion of the outer wrap to provide the heat needed to
`vaporize the nicotine. However, the FIG. 9 embodi
`ment of Ellis et al. discloses a smoking device utilizing
`a centrally located heating material comprised of pyro
`phorous material such as ?nely divided iron, nickel,
`zinc or lead of moderate activity. The centrally located
`tubular member is sealed to the atmosphere until such
`time as the user desires to operate the device. At this
`point a plug 64 is removed to expose the pyrophorous
`material to the atmosphere, thereby generating heat
`sufficient to vaporize nicotine contained in a nicotine
`releasable material 60 disposed outside the tubular
`member 61. The innermost end of the pyrophorous
`material containing tube is sealed by an impermeable
`disc 63 to prevent inhalation, while the user is allowed
`to draw the nicotine containing vapor from the concen
`tric overwrap through the permeable disc 66 located
`near the mouthpiece end'of the device. Once the heat
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`constant each time the user sucks on the cigarette
`shaped tube, regardless of the time intervals which pass
`between successive inhalations. Furthermore, because
`vaporization occurs only as air is being drawn across
`the medicament, nearly all of the vaporized medicament
`is effectively utilized by the user rather than merely
`re-condensing inside the device without reaching the
`user’s lungs.
`In a particularly preferred embodiment, the electrical
`air-?ow actuated switch comprises a vane-type switch
`which is actuated by a resilient diaphragm located at the
`exterior end of the device. One or more air inlet ori?ces
`located about the periphery of the device near its dia
`phragm end allow the user to draw the incoming air
`across the vaporized medicament on its way to the
`user’s mouth and lungs. The reduced pressure created
`inside the device when the user sucks on the mouth
`piece end causes inward movement of the resilient dia
`phragm which contacts and closes the vane-type elec
`trical switch against the battery. This completes the
`electrical circuit, thereby energizing the resistance
`heater on which the medicament is placed. Thus the
`medicament is vaporized only when air is drawn across
`its surface. While in the relatively cooler air stream, the
`vaporized medicament condenses to form tiny aerosal
`particles which are small enough to enter the user’s
`lungs and be distributed throughout the alveolae
`thereof. Thus the medicament is effectively adminis
`tered to the user’s body through the lungs.
`
`4,735,217
`3
`the user will depend upon: (a) how long the unit has
`been left in the “on” position immediately prior to inhal
`ing the vapor; and (b) how long a period of time has
`passed since the preceding inhalation.
`US. Pat. No. 2,809,634 issued to Murai on Oct. 15,
`1957, U.S. Pat. No. 2,830,597 issued to Kummli on April
`15, 1958 and US. Pat. No. 4,393,884 issued to Jacobs on
`July 19, 1983 all disclose inhalation devices which are
`automatically actuated by suction or manual pressure.
`However, the material to be inhaled from these devices
`is maintained in a pressurized form, usually as an
`aerosal. These devices would not function with non
`aerosal medicaments which require the addition of heat
`for vaporization to occur.
`While the aforementioned prior art devices have
`solved some of the problems associated with dosing of a
`vaporized or vaporizable medicament, none have simul
`taneously solved all of the dif?culties normally encoun
`tered. Furthermore, none of these prior art devices have
`achieved a signi?cant level of commercial acceptance,
`particularly as substitutes for conventional nicotine
`containing cigarettes.
`Accordingly, it is an object of the present invention
`to provide a dosing device for a vaporizable medica
`ment which operates only on demand when the user
`draws air through the device.
`It is another object of the present invention to pro
`vide such a dosing device which includes a self-con
`tained power source and a heating element capable of
`v‘ vaporizing a medicament by the addition of heat only
`30
`1 when the user draws air through the device.
`It is another object of the present invention to pro—
`v"vide such a device which is capable of delivering the
`" vvaporized medicament to the user in ?ne aerosal form at
`an approximately constant concentration level, regard
`less of the time interval which passes between succes
`sive inhalations.
`It is still another object of the present invention to
`provide such a device which is combustion free,
`whereby neither the user nor any non-users in the im
`Ymediate vicinity need inhale the harmful by-products of
`Jaé-‘combustion in order to vaporize the medicament.
`
`35
`
`DISCLOSURE OF THE INVENTION
`The present invention comprises a medicament dos
`ing device capable of administering a vaporized medica
`ment to the lungs of a user at a substantially constant
`concentration level. In a particularly preferred embodi
`ment the dosing device is used to provide nicotine to a
`cigarette smoker in a form and a dose that closely mim
`ics a burning cigarette to satisfy the smoker’s craving
`for nicotine, but without subjecting either the user or
`any non-smokers in the immediate vicinity to the tars
`and carbon monoxide of cigarette smoke. The device
`preferably comprises a battery powered resistance
`heater housed in a cigarette-shaped tube. A demand
`operated electrical switch is employed in the heating
`circuit so that as the user sucks air through the tube in
`a manner similar to puffing on a cigarette, energy is
`supplied to the resistance heater which vaporizes the
`nicotine. The vaporized nicotine condenses as a very
`?ne aerosol in the cool air drawn through the device,
`thereby allowing tiny particles of the medicament to
`reach the alveolae of the user’s lungs along with the air
`drawn through the device. Because the system vapor
`izes the medicament being administered only upon acti
`vation of the demand-operated electrical switch, the
`concentration of the medicament will be substantially
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`While the speci?cation concludes with claims partic
`ularly pointing out and distinctly claiming the present
`invention, it is believed the present invention will be
`better understood from the following description in
`conjunction with the accompanying drawings in which:
`FIG. 1 is a simpli?ed enlarged perspective illustration
`of a medicament dosing device of the present invention
`shown prior to insertion of the medicament pellet;
`FIG. 2 is a view generally similar to that of FIG. 1,
`but showing the device after the medicament pellet has
`been inserted and the cylindrical restraining ring has
`'been advanced along the axis of the device to cover the
`ori?ce through which the medicament pellet is inserted;
`45
`FIG. 3 is a view generally similar to that of FIGS. 1
`and 2, but showing the condition of the resilient dia
`phragm in the end of the device when air is being drawn
`through the mouthpiece end;
`FIG. 4 is a greatly enlarged simpli?ed cross-section
`of the device generally shown in FIG. 2 taken along
`section line 4-4 of FIG. 2;
`FIG. 5 is a greatly enlarged simpli?ed cross-section
`of the device generally shown in FIG. 3 taken along
`section line 5-5 of FIG. 3; and
`FIG. 6 is an electrical schematic of an alternative
`embodiment of the present invention.
`
`50
`
`55
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`FIGS. 1-5 disclose a particularly preferred medica
`ment dosing device 10 of the present invention. In the
`illustrated embodiment, the dosing device 10 comprises
`a cylindrical body portion 15 joined to the mouthpiece
`end 25 by means of a conical section 20. The cylindrical
`body portion 15, the mouthpiece end 25 and the conical
`section 20 may be comprised of nearly any desired ma
`terial, molded plastic being particularly preferred.
`
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`5
`As can best be seen from the cross-sections of FIGS.
`4 and 5, the cylindrical body portion 15 has its exterior
`end closed by means of a resiliently deformable dia
`phragm member 55 which is preferably secured about
`the periphery of the cylindrical body portion 15 of the
`device. The diaphragm 55 preferably includes a cen
`trally located deformable portion 60 which is substan
`tially impermeable to the passage of air.
`The cylindrical body portion 15 also includes at least
`one air inlet ori?ce 30 located near the exterior end of
`the device. As will be appreciated by those skilled in the
`art, a multiplicity of such ori?ces may, if desired, be
`employed. The resistance to air ?ow through ori?ce 30
`is preferably adjustable by means of a sealing ring 45
`which is axially slidable along the length of body por
`tion 15. In the embodiment illustrated in FIGS. 1—5, the
`sealing ring 45 is not functioning to restrict air flow
`through ori?ce 30. However, depending upon the resis
`tance desired by the user, the ori?ce 30 may be re
`stricted by axially sliding sealing ring 45 in the direction
`of the exterior end of the device 10 to block at least a
`portion of ori?ce 30.
`A second ori?ce 35, also located in body portion 15,
`is preferably used for inserting a cylindrical pellet of
`vaporizable medicament 40 into position in the dosing
`device 10, as generally shown in FIGS. 1, 4 and 5. The
`pellet of vaporizable medicament 40 is preferably held
`in place by means of a restraining ring 50 generally
`similar to sealing ring 45, the restraining ring also being
`slidable along the axis of cylindrical body portion 15 of
`the dosing device 10. In the condition illustrated in
`FIG. 1, the restraining ring 50 is slid toward the mouth
`piece end 25 to allow exposure of ori?ce 35 and inser
`tion of the pellet of medicament 40. In the condition
`illustrated in FIGS. 2-5, the restraining ring 50 has been
`- advanced to a position which blocks ori?ce 35, thereby
`preventing the pellet of vaporizable medicament 40
`from being dislodged from the device 10.
`Inside the cylindrical body portion 15 of the device
`there is also provided a self-contained electrical power
`40
`source, as represented by battery 65. The positive end
`66 of the battery 65 is ?tted with a cylindrical metallic
`ring 68 having a deformable metallic vane or arm 69 in
`electrical contact with metallic ring 68. The negative
`end 67 of batter 65 is ?tted with a similar metallic ring
`70 having a spring tensioned metallic arm 71 maintained
`in electrical contact therewith. Metallic rings 68 and 70
`are placed in electrical contact with one another by
`means of a resistance heating element 72 which has its
`opposite ends secured to metallic rings 68 and 70 so as
`to establish electrical continuity therebetween. The
`battery 65, metallic rings 68 and 70 and heating element
`72 are secured within tubular body portion 15 of the
`device 10 by means well known in the art and therefore
`not shown (e.g. an adhesive). As can be seen from
`FIGS. 4 and 5, the heating element 72 is radially aligned
`with ori?ce 35, and the pellet of vaporizable medica
`ment 40 has a height suf?cient to cause slight deforma
`tion of heating element 72 when restraining ring 50 is
`advanced into the position shown in FIGS. 4 and 5.
`This ensures good contact between the medicament 40
`and the heating element 72.
`The cross-section of FIG. 4 shows the de-energized
`condition of the electrical circuit when no air is being
`sucked through the mouthpiece end 25 of the device 10.
`Because there is no contact between metallic arm 69
`and the positive end 66 of battery 65, the electrical
`circuit which includes the resistance heating element 72
`
`4,735,217
`6
`is in an “open” condition. Accordingly, no current
`?ows through resistance heating element 72 and there is
`no melting or vaporization of the pellet of medicament
`40.
`The cross-section of FIG. 5 depicts the condition
`which exists when the user sucks air through the mouth
`piece end 25 of the device. In particular, air is drawn in
`through ori?ce 30 in cylindrical body portion 15 of the
`device. This air travels along the interior passageway of
`cylindrical body portion 15, around the pellet of medi
`cament 40, through conical section 20 and mouthpiece
`end 25 and into the user’s mouth and lungs, as generally
`shown by the arrows in FIG. 5. Sucking on the mouth
`piece end 25 of the device also reduces the pressure
`existing within the device relative to the surrounding
`atmosphere. When this occurs, the deformable dia
`phragm 55 is acted upon by the surrounding atmo
`spheric pressure so that its movable portion 60 is caused
`to exhibit an inwardly concave conformation, as gener
`ally shown in FIG. 5. This inward movement of portion
`60 of diaphragm 55 causes movable metallic arm 69 to
`move into contact with the positive end 66 of battery
`65. This completes or “closes” the electrical circuit
`which includes the resistance heating element 72 shown
`generally in FIGS. 4 and 5. It is, of course, recognized
`that different types of air ?ow actuated switches could
`be used in lieu of the diaphragm actuated switch illus
`trated in the Drawing Figures e.g, a vane switch. The
`particular switch selected is unimportant so long as it
`reliably actuates in response to the ?ow of air through
`the device.
`The heat produced by resistance heating element 72
`elevates the temperature of the pellet of medicament 40
`suf?ciently to cause at least some vaporization of the
`medicament. Because the relatively cool air being
`drawn through ori?ce 30 is being drawn across the
`pellet of medicament 40 on its way to the user’s mouth,
`a substantial portion of the vaporized medicament is
`picked up by the moving air stream and carried to the
`mouthpiece end 25 of the device and ultimately into the
`user’s mouth and lungs. While in the relatively cooler
`air stream, the vaporized medicament condenses to
`form tiny aerosol particles which are small enough to
`enter the user’s lungs and be distributed to the alveolae
`thereof. This is a necessary condition for the medica
`ment to be effectively administered to the user’s body
`through the lungs. Without the moving airstream, the
`vaporized medicament will merely condense inside the
`device and will never reach the user’s lungs.
`As will be appreciated by those skilled in the art,
`when the air ceases to ?ow through the device 10, i.e.,
`when the user stops sucking on the mouthpiece end 25,
`the movable portion 60 of resiliently deformable dia
`phragm 55 will return to its substantially undistorted
`condition, as generally shown in FIG. 4. This allows the
`spring loaded metallic arm 69 to return to its normal at
`rest position as generally shown in FIG. 4, thereby
`breaking or “opening” the electrical circuit which in
`cludes resistance heating element 72. Accordingly, the
`resistance heating element 72 immediately begins to
`cool and vaporization of the pellet of medicament 40
`ceases as soon as its temperature has dropped below the
`vaporization temperature of the particular medicament
`being administered. This prevents the vapor concentra
`tion from building up inside the device during the time
`intervals which elapse between successive inhalations
`from the mouthpiece end 25 of the device.
`
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`FIG. 6 is a simpli?ed electrical schematic of an alter
`of 1.5 volts DC and capable of delivering a current of
`native embodiment 110 of the present invention. Em
`about 2.0 amps during each 2_ second puff on the device
`bodiment 110 can be very similar to embodiment 10
`was utilized as the power source. The heating element
`shown in FIGS. 1-5 with the exception that a normally
`comprised a Nichrome ® (241 alloy) segment, as avail
`“open” pressure actuated switch 115 is added to the
`able from Driver-Harris Co. of Harrison, NJ. It mea
`mouthpiece end of the device. If the user wishes to keep
`sured approximately one inch long by Q inch wide by
`the device 110 in his or her mouth without inhaling
`0.001 inches thick and exhibited a resistance of approxi
`vaporized medicament with each breath of air drawn
`mately 0.50 ohms. The opposite ends of the heating
`through the device, the pressure responsive switch 115
`element were soldered to metallic rings 68 andv69. '
`is actuated by pressure applied by the user’s mouth or
`The con?guration and orientation of the battery 65,
`lips, as generally shown in the electrical schematic of
`the metallic rings 68 and 70, the metallic arms 69 and 71
`FIG. 6. Such a pressure actuated switch 115 could be
`and the resistance heating element 72 were essentially as
`calibrated to permit the heating circuit to be turned
`shown in the cross-sections of FIGS. 4 and 5. The dia
`“on” only when the user’s lips apply a predetermined
`phragm 55 comprised a resilient ?ngertip cut from a
`threshold pressure suf?cient to close switch. The nor
`rubber glove and secured about the periphery of the
`mally open pressure actuated switch 115 must, of
`large diameter plastic tubing, as generally shown in
`course, be connected in series with the air ?ow actuated
`FIGS. 4 and 5. The air intake ori?ce 30 measured ap
`switch 69 and battery 65 so that both switches must be
`proximately 0.8 millimeters in diameter, and the ori?ce
`closed before vaporization of the medicament 40 can
`35 utilized to load the medicament pellet 40 measured
`occur. Thus, pressure must be applied to the pressure
`approximately 4 millimeters in diameter.
`20
`actuated switch 115 and air must ?ow through the de~
`The test medicament was comprised of a menthol
`vice to close the air ?ow actuated switch 69 before any
`pellet measuring approximately 3.9 millimeters in diam
`power is supplied to the heating element 72. So long as
`eter by 5 millimeters in height.
`the pressure actuated switch 115 remains “open”, the
`The exemplary device was user activated by sucking
`user can draw non-medicated air through the device
`on the mouthpiece end. An inhalation of approximately
`and into his or her lungs without energizing the heating
`35 milliliters volume over a two second duration, was
`element.
`utilized to test the device. The medicament pellet com
`Since vaporization of medicament 40 occurs only
`prised of menthol having a melting point of 108° F. and
`.1 upon a demand for air through dosing devices of the
`a boiling point of 218° F. emitted vapor as the Nichrome
`present invention, the vapor concentration level in the
`heating element 72 achieved a temperature in the range _
`~ air stream drawn into the user’s mouth and lungs remain
`of l90°-220° F. within the 2 second duration. Based on
`:substantially constant for any given air ?ow rate
`organoleptic perception of the user, the device ap
`through the device, regardless of the interval of time
`peared to provide a substantially constant concentration
`' which passes between successive draws. This not only
`of menthol vapor in the air drawn across the heated
`'
`waste of the medicament pellet 40, but also
`menthol pellet over the life of the device. The particular
`battery tested was capable of providing heating element
`enables the user to administer the medicament within a
`substantially given concentration range. In a particu
`temperatures in the 200° F. range for about 5 cycles,
`i‘? larly preferred embodiment, the vapor concentration
`each cycle having an overall duration of approximately
`‘level of the medicamentcan be adjusted upwardly or
`ten minutes. Each ten minute cycle was carried out
`v‘fdownwardly as desired by increasing or decreasing the
`using a continuously repeating pattern of two seconds
`40
`?ow through ori?ce 30 via movement of sealing ring
`“on” and 58 seconds “off” in an attempt to emulate the
`345 along the tubular body portion 15 of the device. This
`behavior of a cigarette smoker.
`ability to control vapor concentration level may be
`Although the exemplary device described in the pre
`particularly important for medicaments which are ef
`ceding paragraphs was tested only with menthol, it is
`fective for their intended purpose only when adminis
`believed that similar results can be obtained working
`with nicotine-containing compounds. For example, it is
`tered within a predetermined concentration range or
`which, for one reason or another, may be harmful to the
`believed that liquid nicotine base (C10H14N2), which is
`user if a certain maximum concentration level is ex
`colorless and volatile and which turns brown and ac
`ceeded.
`quires a tobacco-like odor upon exposure to air, could
`be mixed with a solid such as menthol to form a pellet of
`nicotine-containing medicament 40. Alternatively, a
`nicotine tartrate or a mixture of nicotine and citric acid
`could be produced as a solid or semi-solid and used in a
`manner similar to the menthol pellet described above to
`provide dosing of nicotine at safe levels comparable to
`those experienced when smoking a cigarette, but with
`out the harmful by-products of combustion. It is also
`believed feasible to coat the heating element 72 with a
`nicotine-containing compound in lieu of using a vapor
`izable pellet 40. Such easily replaceable, coated heating
`elements could be used as an alternative to vaporizable
`pellets and a non-disposable heating element, as dis
`closed herein.
`While particular embodiments of the present inven
`tion have been illustrated and described, it will be obvi
`ous to those skilled in the art that various changes and
`modi?cations can be made without departing from the
`spirit of the scope of the invention. It is intended to
`
`EXAMPLE
`An exemplary dosing device of the present invention
`was made utilizing transparent acrylic plastic tube
`stock. The body portion of the device had an exterior
`diameter of approximately 2.5 centimeters and overall
`length of approximately 8 centimeters. The inside diam
`eter of the body portion was approximately 1.9 centime
`ters.
`The mouthpiece end of the device comprised a simi
`lar piece of plastic tube stock measuring approximately
`1.9 centimeters in outside diameter by approximately 3
`centimeters long. The inside diameter of the mouth
`piece end measured approximately 1.2 centimeters in
`diameter. The smaller mouthpiece end was forced in
`side the large body portion tube and secured in substan
`tially sealed relation thereto by the resultant interfer
`ence ?t. An EverReady ® alkaline type E91 (AA) bat
`tery, as available from Union Carbide, having a rating
`
`35
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`45
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`50
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`60
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`Fontem Ex. 2007
`Nu Mark LLC v. Fontem Holdings 1 B.V. IPR2016-01303
`Page 8 of 11
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`9
`cover in the appended claims all such modi?cations that
`a