Abstract:
A simulated cigarette includes a housing having a generally cigarette-like shape and size; a reservoir of inhalable composition within the housing; an actuator controlling the flow of the inhalable composition from the reservoir; an outlet passage from the actuator to an outlet in the housing from which outlet a user inhales the composition; and a chemical heater provided adjacent to the outlet passage and arranged to be activated to undergo an exothermic reaction to heat the inhalable composition as it travels along the outlet passage.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates to a simulated cigarette comprising a housing having a generally cigarette-like shape and size; a reservoir of inhalable composition within the housing; an outlet valve controlling the flow from the reservoir; an outlet passage from the outlet valve to an outlet in the housing from which outlet a user inhales the composition. Such a simulated cigarette will subsequently be referred to as “of the kind described”. 
         [0003]    2. Description of the Related Art 
         [0004]    A simulated cigarette of the kind described is disclosed in our earlier WO 2009/001078 and WO 2009/001082. 
         [0005]    These documents disclose a simulated cigarette device which is refillable in combination with a refill pack which has a size and shape of a cigarette pack. The user removes the simulated cigarette from the pack and holds it against an outlet port in the pack to refill it. This is designed to mimic the action of removing a real cigarette from a pack. By replicating the smoking act, the device is more likely to gain acceptance from a consumer. 
         [0006]    However, the simulated cigarette device disclosed in these applications and, indeed, similar cigarette devices disclosed in other applications such as U.S. Pat. No. 4,393,884 and DE 4030257 are simply cylindrical plastic tubes. 
       SUMMARY OF THE INVENTION 
       [0007]    The present invention aims to provide a simulated cigarette device which more closely resembles the physical feel of a real cigarette. 
         [0008]    According to a first aspect of the present invention, a simulated cigarette of the kind described is characterised in that the housing adjacent to the outlet end has a deformable material at its outer periphery. 
         [0009]    This deformable material is able to be squeezed or flexed by the index finger and thumb of a smoker. This is an important feature for a smoker and part of the behavioural cycle of the smoking ritual. The first aspect of the present invention therefore provides a tactile sense akin to a conventional cigarette. Also, the deformable material provides a more realistic smoking experience for the user when it comes to inhalation. Users typically purse inhalation devices with their lips or teeth so it is advantageous to make the material against which they press deformable accordingly. 
         [0010]    As well as providing increased comfort, the deformable material can also be used to affect the flow characteristics of the inhalable composition. Preferably, the deformable material is configured to be deformable with respect to the outlet passage to change the flow characteristics from the outlet passage. With such a deformable material, the user can disrupt the flow of inhalable material giving rise to vortices that will modify the delivery from the reservoir. This mimics the manner in which smokers modify the delivery of a conventional tobacco cigarette by squeezing the filter to reduce the pore size thereby modifying the flow of the smoke accordingly. This allows the user to modify the flow by narrowing the outlet passage and thereby quickening the velocity of the flow. 
         [0011]    In order to further enhance the control being exercised by a user, the outlet valve is preferably a breath-activated valve which is actuated by a flow of air through the housing in an actuation passage parallel to the flow through the outlet passage and wherein the deformable material is positioned so that it is deformable into the housing to a position in which it affects the flow through at least one of the actuation passage and the outlet passage so as to affect the dosage of inhalable composition that a user receives from the cigarette. 
         [0012]    If the user constricts the actuation passage, the suction force required to open the valve increases while constricting the outlet passage increases the velocity of the flow. This is an important adaptable behavioural mode for smokers since when they desire a deeper inhalation, normally in a spike of craving, they can modify the suction chamber through this action and modestly increase the velocity of the flow, and therefore the speed of uptake to the lung allowing sophisticated control of the flow characteristics. Additionally if the user exerts a lower than usual suction force and constricts the chamber, the device may function in the opposite manner by creating a limitation on the breath force exerted on the breath-activation system and therefore limiting the valve opening and thus the flow rate by the user. Thus by allowing distortion of the flow path, akin to a tobacco cigarette, a more sophisticated control of the flow characteristics is allowed. 
         [0013]    The deformable material may be elastomeric, or may be a flexible skin containing a fluid or gel. 
         [0014]    When the deformable material includes liquid or a gel, as a further enhancement of the invention, this may be supersaturated and arranged to come into contact with nucleation sites upon tapping of the cigarette, to form crystals and undergo an exothermic reaction. 
         [0015]    This can produce a warming sensation at the tip of the cigarette which a user will find pleasant and again replicates the heating effect in a real cigarette of drawing smoke through the filter. 
         [0016]    As the cigarette device is designed to be refilled a number of times, there are preferably a plurality of compartments containing liquid or gel which are separately actuatable to produce an exothermic reaction. 
         [0017]    In addition to, or as an alternative to, using the exothermic reaction to provide a warm sensation adjacent to a mouthpiece of a cigarette, the cigarette may be configured to direct the heat produced inwardly, so as to heat the inhalable composition in the outlet passage. 
         [0018]    This forms a second aspect of the present invention which may be defined, in the broadest sense, as a simulated cigarette of the kind described further comprising a chemical heater provided adjacent to the outlet passage and arranged to be activated to undergo an exothermic reaction to heat the inhalable composition as it travels along the outlet passage. 
         [0019]    The generation of heat in a simulated cigarette is known, for example, in EP 1 618 803 and in WO 2009/155957. However, in these cases, the heat is used to vaporize the composition. In this second aspect of the present invention, the inhalable composition is released from a reservoir and is subsequently heated by a heater. 
         [0020]    The inhalable composition is released from the reservoir will generally be cold. It is warmed, to some extent, by the surrounding housing as it travels around the outlet passage and, if present, by dilution of air from the actuation passage. However, if the device is used repeatedly, the mouthpiece itself can become cold to touch. This can be avoided by heating the mouthpiece, which also has a beneficial effect on the temperature of the inhalable composition flowing through the mouthpiece. 
         [0021]    Preferably, the outlet valve is at least 4 mm from the outlet. This allows sufficient time for the inhalable composition to mix with ambient air to allow the warming effect referred to above. This allows sufficient time for the inhalable composition to mix with ambient air to allow the warming effect referred to above. 
         [0022]    Preferably, the heater is provided by a gel or liquid which is supersaturated and which is arranged to come into contact with nucleation sites upon tapping of the cigarette, to form crystals and undergo an exothermic reaction. 
         [0023]    As the cigarette device is designed to be refilled a number of times, there are preferably a plurality of compartments containing liquid or gel which are separately actuatable to produce an exothermic reaction. These components are preferably provided by rupturable microcapsules. 
         [0024]    According to a third aspect of the present invention, a simulated cigarette of the kind described is wrapped in a wrap comprising an adhesive layer to stick to the housing, a paper or paper-like layer and a polymer film to cover and protect the paper or paper-like layer. 
         [0025]    In the prior art referred to above, all simulated cigarettes of this type have only a plastic housing as they are designed to be durable. US 2004/0003820 discloses a cigarette substitute with a chamber lined with a scratch-releasable-coated paper which is scratched with a wire brush to release a cigarette-like aroma. This document discloses that the vessel is coated or lined with a white, paper-like material for improved realism but there is no indication of the underlying material of the housing, or how this is implemented. JP2010/35663 discloses an inhaler containing a string of capsules. These are crushed by a user&#39;s fingers to release their contents for inhalation. The device is covered in a paper-like material as it is required to be deformable to crush the capsules. 
         [0026]    The third aspect of the present invention replicates more closely the feel of a real cigarette. Further, it is suited to the arrangement described in WO 2009/001078 which is designed to be refilled only a relatively small number of times such that longevity is less of an issue. The polymer film is able to protect the paper as the time for which it is used, while for less than the prior art above, is still significantly longer than a real cigarette or the devices of US 2004/0003820 and JP 2010/035663. 
         [0027]    Preferably, the wrap is hydrophobic so that it does not absorb moisture from the user&#39;s mouth, from the ambient environment or from the filling process. The wrap is preferably a wipe-clean paper. It is preferably also fire retardant in case of hazard or mistaken ignition. Preferably, the wrap is provided with a flavour (e.g. menthol) and/or an antibacterial agent. 
         [0028]    Such an example of a wrap is a co-extruded biaxially orientated corona treated polyproplyene situated with an acrylic based adhesive. The adhesive is a water-borne acrylic based adhesive comprising acrylic esters copolymerised with acrylic acid. 
         [0029]    This is laminated over a supercalendered glassine paper, which gives the image and texture of a paper wrap, where the transparency is around 30-60%, most preferably 45%. A compatible ink, preferably a raw material consisting of an acrylate mixture, which in its finished cured form in a acrylate polymer contains very little residual monomer such to improve the chemical stability of the system. Such a system can also be impregnated with Silver Ion spray coating on top of the glassine paper to limit any microbial activitiy over continued use, and the end tip can be sprayed with a compatible fire retardent material before the adhesive layer and extruded polyproplyene applied. 
         [0030]    Additionally a laminate is layered over the system to improve stability and use duration. A higher strength acrylic adhesive is employed to attach the laminate underlay of the glassine paper to the plastic chassis tubing of the inhaler, such that it will remain in fixed position without uncurling or unwrapping over the alotted shelf life. Such a system should incorporate as low a density co-extruded biaxially orientated corona treated polyproplyene as possible without compromising resistance, in order to improve the fixation stability of the wrap. 
         [0031]    The system should comply with the guidelines laid down under ISO 10993 when relating to component biocompatibility. As such, plastic coating should comply with a material safety test guidance under the European Pharmacopiea in order to ensure compatibility with transient oral mucocal contact, with adhesive layers ensuring compatibility with the European food directive legislations, FDA 175.105 and the German recommendations XIV as published by BfR. This construction should also be classed as a safe product in accordance with the material description as given by EC directive 92/59, article 2(b) which will ensure safety for repeated use. 
         [0032]    The wrap may be used in its own right, but is particularly advantageous when used in combination with the deformable material of the first aspect of the present invention and/or the heater of a second aspect of the present invention, as the overall effect most closely resembles a real cigarette. 
         [0033]    In all aspects of the invention, the reservoir is preferably pressurized and is preferably refillable. The refill is preferably carried out through a refill valve at the end of the cigarette opposite to the outlet. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0034]    So that the manner in which the above recited features of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may be had by reference to embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments. 
           [0035]    Examples of a simulated cigarette in accordance with the various aspects of the present invention will now be described with reference to the accompany drawings, in which: 
           [0036]      FIG. 1  is a cross-section of a simulated cigarette; 
           [0037]      FIG. 2  is an exploded view of the simulated cigarette; 
           [0038]      FIGS. 3A to 3C  are perspective views of alternative deformable members; and 
           [0039]      FIG. 4  is a cross-section of the  FIG. 3A  example. 
       
    
    
     DETAILED DESCRIPTION 
       [0040]    The device has a housing  1  made up of a main chassis  2  and a closure element  3  as shown in  FIG. 2 . This is held in place by label  4 . Within the housing, there is a reservoir  5  containing the inhalable composition. This is preferably pressurised but could also work with a non-pressurised reservoir in combination with a Venturi nozzle to generate an enhanced suction force on the reservoir. It may be refillable as described in WO 2009/001082 through the filling valve  6 , or the device may be a single use device, or may be arranged so that the reservoir  5  is a replaceable component. 
         [0041]    The breath-activated valve  7  is positioned between an outlet end  8  and the reservoir  5 . The breath-activated valve is arranged so that, when a user sucks on the outlet end  8 , the breath-activated valve  7  opens to allow the inhalable composition from the reservoir  5  to be inhaled. 
         [0042]    The housing downstream at the valve  7  has two passages. The first of these is the suction passage  9  which communicates with a chamber  10  as will be described in greater detail below and the second is a composition passage  11  from which the inhalable composition is dispensed. This is also described in more detail below. The suction passage and composition passage meet at outlet passage  13  which leads to outlet end  8 . 
         [0043]    A deformable tubular nozzle  14  is provided between the reservoir  5  and composition passage  11 . The element is selectively deformable between open and closed configurations by a mechanism as described below. 
         [0044]    This mechanism comprises a pivotally mounted vane  15  and a membrane  16 . The pivotally mounted vane has a pivot  17  at the end closest to the outlet end  8  and a central reinforcing rib  18  running along its length and tapering away from the outlet end. At around the midpoint, the vane  15  is provided with a recess  19  for receiving a spring  20  which biases it into the closed position shown in  FIG. 1 . Below the recess  19  is a jaw  21  having a triangular cross-section which is configured to apply the force provided from the vane  15  to the nozzle  14  over a narrow area (although the nozzle is shown in  FIG. 1  in its uncompressed, open state, whereas in use, with the vane in this position it would deform the nozzle to seal the reservoir). The vane  15  is supported by the diaphragm  16  which is sealed to the housing at its ends  22 ,  23 . 
         [0045]    An inlet  24  is provided into the chamber  10 , while the underside of the membrane  16  is open to atmospheric pressure as a leakage path exists through the housing  1  which is not shown in the drawings as it is not shown in the plane of  FIGS. 1 and 2 . 
         [0046]    When a user sucks on the outlet end  8  air is sucked through inlet  24  through chamber  10  and out of suction passage  9  thereby lowering the pressure in the chamber  10 . This causes the vane  15  to be lifted against the action of the spring  20  deforming the diaphragm and lifting the jaw  21  to allow the deformable nozzle  14  to open, thereby allowing the inhalable composition from the reservoir  5  along composition passage  11  into the outlet passage  13  where it mixes with the suction air. The degree of suction applied by the user will determine the extent to which the vane  15  moves and therefore the amount of composition that the user receives. As soon as a user stops sucking, atmospheric pressure will return to the chamber  10  and the spring  20  will push the vane down thereby pinching the nozzle  14  closed. 
         [0047]    The simulated cigarette described to date is generally as described in WO 2011/015825. 
         [0048]    The housing  1  is provided at the outlet end with a generally annular recess  30  surrounding the outlet passage  13 . Within this annular recess is a deformable member  31  which, in situ, is flush with the surface of the housing  1  as shown in  FIG. 1 . The deformable member  31  may be an elastomeric member, or may be a thin-walled capsule containing a liquid or gel which is described in more detail below. An annular lip  32  is present at the outlet end of the cigarette. This may be thinner than the illustrated lip, or may not be present at all. 
         [0049]    The deformable member  31  is generally positioned in the area that would be occupied by the filter of a conventional cigarette. Thus, the user is able to squeeze the end of the cigarette in the manner that they would squeeze the filter of a cigarette, and hold this end of the cigarette in their mouth and, in both cases, obtain a tactile sensation comparable to that of a real cigarette. 
         [0050]    Further, the housing  1  in the vicinity of the outlet passage  31  is provided with a pair of diametrically opposed openings  33  and, as shown in  FIG. 1 , the deformable member  31  is arranged to bulge through these to project into the outlet passage  13 . As the user presses on the deformable member, the degree to which the deformable member bulges into the passage  13  is varied. If the user presses on the top of the deformable member  31  (with reference to the orientation shown in  FIG. 1 ), they will restrict the flow through the suction passage  9  with the effect that the user will need to suck harder on the device to achieve the desired inhalation profile. If they press on the lower part of the deformable member  31 , they will restrict the flow through the composition passage  11  with the effect that if the valve is fully open, the velocity of the flow will increase and quicken the route of delivery. Pressing on the top and bottom of the deformable member  31  simultaneously will increase the resistance and necessatitate sucking harder on the device but also by nature of construction of the composition passage  11 , quicken the flow and speed of delivery. This is a useful feature for smokers who wish to quicken the rate of absorption when undergoing a spike in craving. Thus a user is able to self-regulate the flow of inhalable composition from the cigarette, much as they are able to do with a conventional cigarette by squeezing on the filter. 
         [0051]    As well as providing tactile benefits, and the ability to regulate the flow, the deformable member  31  may also be designed as a heater. 
         [0052]    As mentioned above, the deformable member  31  may contain liquid or gel. This may be an acetate, and preferably sodium acetate that is super saturated. This may be encapsulated into microcapsules having a polymeric or celluostic casing. If there are around  20  such microcapsules, the device can be re-used a number of times, each time breaking a small number of the capsules. Inside the deformable member  31  and surrounding the inner wall is a layer, disc or film of ferrous metal or other that have been coursed to provide a greater reactive surface area. When the user taps the outer wall of the deformable element  31 , such as a smoker is accustomed to do to release ash that has built-up on the tip of the cigarette, crystals of sodium acetate are released into the solution which then act as nucleation sites. This causes the solution to crystallise suddenly, releasing energy and thereby creating a heating effect to the surrounding material, which the user can perceive. This heat can be controlled to ensure that the temperature is pleasant and warming and does not approach higher temperatures that may impact on the integrity of the device. In order to last over several refills of the device, the deformable member  31  may be composed of multiple layers or compartments  34 , each connected individually to separate solutions and ferrous metals. It is possible that the outer wall of the deformable member  31  may be a good insulator which allows minimal heat to be conducted out of the device so that the heat is, instead, directed inwardly to heat the flow through the upper passage  13 . 
         [0053]    Alternative designs of deformable element  31  are shown in  FIGS. 3A-3C  and  4 . In  FIGS. 3A and 4 , a plurality of frangible balls  35  containing acetate are each positioned on a ferrous disc  36  which provides the nucleation sites. Pressure on the outer wall of the deformable member breaks some of the frangible balls so that the acetate comes into contact with the ferrous disc initiating nucleation and causing an exothermic reaction. 
         [0054]    In  FIG. 3B , the compartments  34  are filled with calcium powder and frangible balls  37  containing water are arranged along the length of each compartment. Again, pressure on the deformable member  31  breaks the balls  37  and the water and calcium chloride react exothermically. 
         [0055]    In  FIG. 3C , each compartment  34  contains an elongate ferrous disc  38 , the compartment filled with acetate. In this case, pressure on the deformable member  31  causes a sudden “snap” deformation of a disc  38  to trigger nucleation. 
         [0056]    Other chemical heating sources for example can include, but not limited to, utilising an in situ combination of calcium chloride and reservoir containing pure distilled water. The calcium chloride is separated from water by a the film or a diaphragm which when tapped or pushed, loses the integrity of its casing and allows the water to dissipate and therefore causing an exothermic reaction to take place. For use in a multi-phase manner, the distilled water can be manufactured into microcapsules, pellets or spheres encompassed either a polymeric or cellulosic casing that are no more than  2  mm in diameter. These microcapsules can be located within the chamber and distributed evenly around a surrounding layer of finely milled calcium chloride powder. When a user squeezes the deformable member  31 , element of the mouthpiece, pressure is applied to the microcapsules such that they casing ruptures and releases its containment of the distilled water. There can be arranged around  20  microspheres within the deformable chamber such that there scope for multi-activation during the use of the cigarette device. 
         [0057]    As can be seen in  FIG. 1 , the jaw  21  which represents the effective outlet from the reservoir  5  is positioned some considerable distance from the outlet end  8 . This distance is preferably greater than 10 mm. This means that the composition has to flow a reasonable distance through the device before it is inhaled by the smoker. Thus, it can be warmed by the housing surrounding the composition passage  11  and outlet passage  13 . It is diluted and warmed by the air from the suction passage  9  and is also heated by the heat generated in the deformable member  31  if this is designed as the exothermic element described above. The smoker therefore inhales composition which is warmed to a degree ideally replicating the temperature of smoke from a real cigarette, but at least warmed to a degree so as not to cause discomfort. 
         [0058]    The label  4  is an overwrap that surrounds substantially the entire curved surface of the simulated cigarette. As shown in  FIG. 2 , it is divided into two sections  40  and  41  which are coloured and patterned to resemble a conventional cigarette with a filter tip. In combination with the deformable member  31 , the outlet end of the cigarette both looks and feels like the filter of a conventional cigarette. The label has at least one hole laser drilled so as not to obstruct inlet  24 . 
         [0059]    The coatings applied to the label  4  demonstrate hydrophobic properties, but also create a lipophobic and oleophobic surface to repel water, dirt on surfaces and any formulation that may be spilled or accidentally emitted during the refilling process. This makes sure that the cigarette paper does not tear or blemish as the formulation may contain propylene glycol, PEG or aromatic oils which will lead to quick discolouration of the paper, and reduce its structural integrity. As such coatings can be used such as a phosphonate based application, and applied in a monolayer. This can be provided by for example Aculon Inc. This will also impart an additional wipe clean quality, so that the dirt does not build up on the mouthpiece. Since the device is intended to be disposable, a coating can be applied solely to the mouthpiece and to the distal end where the refill valve is, to reduce the likelihood of dirt ingress and paper tear. This also provides an enhanced consumer response so that users can clean the mouthpiece end easily without fear or paper or fabric tear, for example if lipstick is accidentally applied. 
         [0060]    Additionally fluropolymers can be used, either applied directly to the paper or fabric coating as a powder or spray and provide necessary oil-repellant/water-repellant properties. These can include PTFE (polytetrafluoroethylene), PFA (perfluoroalkoxy polymer resin), FEP (fluorinated ethylene-propylene) and ETFE polyethylenetetrafluoroethylene but not limited to these types of fluoropolymers. Care is taken when choosing a coating that they demonstrate suitable biomaterial compatibility especially if in frequent contact with the skin. 
         [0061]    The wrap may be paper-like material such as a tightly woven cotton, or other fabric and a coating of silica or titania particles can be used to provide hydrophobic properties on devices where the oleophobic property is not needed due to a different composition of formulation. 
         [0062]    Preferably a material is used that contains a hydrophobic, lipophobic and oleophobic property but also has a fire retardant capability. This is to protect the device in case it unduly exposed to fire or naked flame. Such coatings can include Aluminium Trihydride (ATH), Antimony Trioxide (Sb2O3) and Zinc Borate. Zinc Oxides can also be used at a pharmaceutical grade specifications for use in this respect. 
         [0063]    A specialty chemical, MP Protect, available at TSC Ltd, can also be applied which incorporates a fire retardant system for cellulose rich substrates, such as wood, paper cotton and certain textile applications. This will allow it to be capable of withstanding flames in accordance with the DIN 53438 standard burn test, but also has a property to impart an anti-bacterial quality which can destroy micro-organisms such as influenza, salmonella and Legionella. This can be an important attribute to the device if shared routinely in social situations. 
         [0064]    An anti-bacterial coating on the mouthpiece may be especially advantageous as part of one coating or in addition to several coatings but locally applied on the mouthpiece. Such coatings can include a thin layer of silver, Ionizable silver incorporated into fabric, silver alloy or oxide which will help in reducing the bacteria spread and have been approved for use in respiratory devices such as endotracheal breathing tubes by the FDA. This will offer an improved hygienic aspect to the device if used multiple times before it is eventually disposed of.