Abstract:
The present invention relates generally to systems and methods for cleaning and disinfecting contact lenses. In various respects, the invention is directed to an insulated system that reduces heat loss from catalyzed neutralization of a disinfecting solution resulting in an increased temperature of the disinfection solution during the disinfection process and neutralization of the disinfection solution. The increased temperature increases the kill rate (i.e., better reduction) of microorganisms present on the lenses, and increases the neutralization rate of the disinfection solution. Increase of the kill rate allows better reduction of microorganisms resistant to elimination using previous systems and methods, (e.g.,  Acanthamoeba  cysts), and decreases the amount of time as compared to previous systems and methods necessary to reduce microorganisms to acceptable levels.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims the benefit of U.S. Provisional Application No. 61/897,978, filed on Oct. 31, 2013, which is hereby incorporated by reference herein in its entirety. 
     
    
     INCORPORATION BY REFERENCE 
       [0002]    All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. 
       FIELD 
       [0003]    The present invention relates generally to systems and methods for cleaning and disinfecting contact lenses. In various respects, the invention is directed to an insulated system that reduces heat loss from catalyzed neutralization of a disinfecting solution resulting in an increased temperature of the disinfection solution during the disinfection process and neutralization of the disinfection solution. The increased temperature increases the kill rate (i.e., better reduction) of microorganisms present on the lenses, and increases the neutralization rate of the disinfection solution. Increase of the kill rate allows better reduction of microorganisms resistant to elimination using previous systems and methods, and decreases the amount of time as compared to previous systems and methods necessary to reduce microorganisms to acceptable levels. 
       BACKGROUND 
       [0004]    There are two major classes of contact lens disinfection systems: multipurpose disinfecting solutions (MPDS) and hydrogen peroxide systems. Hydrogen peroxide-based systems are often preferred, due to its better kill of bacteria, yeast, and fungi, preservative-free packaging, low user sensitivity to the active disinfection agent, and neutralization of the disinfection agent to natural by-products, e.g., water and oxygen. 
         [0005]    Literature studies have shown that the contact lens surface typically harbors scores of different microbial species and viruses at the end of a wearing cycle. Of course, the specific species (and numbers of isolates of each species) vary from individual to individual and even between the two eyes. To standardize disinfection testing, the FDA (and industry) have adopted two types of testing; the “stand alone” test and the “regime” test. These two tests use strains of 3 bacterial species ( Staphylococcus aureus, Pseudomonas aeruginosa , and  Serratia marcesens ) and a strain of  Candida albicans  and  Fusarium solani . A minimum reduction in CFU at the end of disinfection time must be achieved for “adequate” disinfection to pass the regulatory test. All approved disinfection systems, including both one-step or two-step hydrogen peroxide systems (described further below), must pass these criteria. More complete killing during the disinfection process of troublesome microorganisms, e.g., yeast, fungi, and amoeba, will provide the consumer a reduced chance of infection (better safety) due to these micro-organisms. 
         [0006]    Two common peroxide disinfection processes exist, so-called one-step and two-step peroxide systems, where the primary difference lies in when the catalyst is introduced into the peroxide solution. In a one-step peroxide system, the catalyst and peroxide are introduced at roughly the same time, whereas in the two-step system the catalyst is introduced much later—towards the end of a disinfection phase, i.e., well after the peroxide is introduced. The two-step system may more completely disinfect, i.e., has a greater kill rate because full strength hydrogen peroxide is present for much longer period of time, but requires the second step of introducing the catalyst to neutralize peroxide to a safe level, and the additional time necessary for neutralization. An additional draw back of the two-step system is a user may forget to introduce the catalyst, and accidently insert a lens with significant amounts of peroxide leading to increased discomfort and potential injury. The one-step system has the benefit of disinfecting and neutralizing at the same time, shortening the time needed before wearing the lenses and removing the potential of forgetting to introduce the catalyst. However, the one-step system does not have as high a kill rate as the two-step system because the one-step system, by design, immediately begins neutralizing the hydrogen peroxide, reducing capacity, over time, to kill bacteria, fungi, and or amoeba. One-step systems effectively reduce fungal microorganisms (e.g.,  C. albicans  and  A. brasiliensis ) much greater than the acceptable level (e.g, ≦1-log kill); however, they may not as effectively reduce other microorganisms (e.g.,  Acanthamoeba ), though there are no standardized acceptable levels at this time. The one-step hydrogen peroxide system is widely used as a lens disinfecting system today, and preferred by many users because of its superior killing efficacy as compared to non-hydrogen peroxide systems. Additional information can be found in C. Hildebrandt, D. Wagner, T. Kohlmann and A Kramer, In vitro analysis of the microbicidal activity of 6 contact lens care solutions, BMC Infectious Diseases 2012 12:241-253. 
       SUMMARY OF THE DISCLOSURE 
       [0007]    The present invention uses a one-step hydrogen peroxide disinfection system and method for soft (hydrophilic) and rigid gas permeable contact lenses that achieves a higher kill rate for known microorganisms than previous one-step systems. Embodiments of the inventive system and methods use a thermally insulated vial to retain the heat of peroxide neutralization, elevating the temperature of the peroxide solution and maintaining an elevated temperature. The elevated temperature has at least the dual benefit of increasing the kill rate of microorganisms, and increasing the rate of neutralization. In alternative embodiments, a heating element may be provided either with or without the thermally insulated vial, where the heating element is used, in addition to the heat from the exothermic peroxide neutralization, to elevate and maintain an elevated temperature. 
         [0008]    The following embodiments, aspects and variations thereof are exemplary and illustrative are not intended to be limiting in scope. A thermally insulated contact lens disinfection system may have a lens holder, a thermally insulated vial for receiving peroxide solution, catalyst, and lenses. The thermal insulation may take the form of a void between dual walls from which the vial is constructed, where the void may be under vacuum to reduce thermal conductivity, which may also be occupied, partially or fully, by an insulating material to further reduce the thermal conductivity. Vacuum pressures may be in the range of 0.0001 torr to 1 torr or more preferably 0.1 torr-1 torr. In some embodiments the gas in the void, whether or not partially occupied by insulating material, may be a gas having a thermal conductivity less than that of air (e.g., Ar, Kr or Xe) and could be a mixture of any of these gases with air. In alternative embodiments the vial is constructed directly from suitable thermally insulating materials (without the dual walled structure and insulating void), examples of which may include polystyrene, polypropylene, poly(styrene butadiene), poly(acrylonitrile butadiene styrene), polypropylene, or poly(methyl methacrylate). Preferably the selected thermally insulating material has a thermal conductivity between 0.0001 W/mK-0.05 W/mK, or more preferably 0.003 W/m-K-0.05 W/m-K. 
         [0009]    Additional embodiments of the present invention include one or more method for disinfecting contact lenses. Lenses are placed in or on a contact lens basket, which is then received into a thermally insulated vial into which disinfection solution and a catalyst are added. The thermal insulation retains heat of the exothermic neutralization reaction. The thermal insulation may comprise materials and structured as described above. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: 
           [0011]      FIGS. 1A-1B  illustrate a frontal view a caddy, side view of a cleaning case and a cross section of an insulated vial in accordance with an exemplary contact lens storage system. 
           [0012]      FIGS. 2A-2C  illustrate side views of exemplary thermally insulated vials. 
           [0013]      FIGS. 3A-B  illustrate a side view and a cross sectional side view of a caddy in accordance with another exemplary contact lens storage system. 
           [0014]      FIG. 4  illustrates an exemplary operation flowchart. 
           [0015]      FIG. 5  illustrates another exemplary operational flowchart. 
           [0016]      FIGS. 6A-6B  illustrate a top view and a side view, respectively, of another contact lens storage system. 
           [0017]      FIG. 7A  illustrates a side view of the contact lens cap, lens basket, and platinum catalyst. 
           [0018]      FIG. 7B  illustrates a top perspective view of the contact lens cap showing the main internal components. 
           [0019]      FIG. 8A-B  illustrates kill rate for  C albicans  and  A. brasiliensis  in peroxide over a range of temperatures. 
           [0020]      FIG. 9  illustrates heat retention characteristics for an insulated vial in accordance with an embodiment of the present invention. 
           [0021]      FIG. 10  illustrates a block diagram of an exemplary temperature sensing contact lens cleaning case. 
           [0022]      FIGS. 11A-B  illustrates another exemplary operational flowchart. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    Examples of prior art disinfecting cases including a cap and a vial are well known in the literature and may include other features not shown herein. Examples of such cases can be found in U.S. Pat. Nos. 4,637,919, 4,750,610, 5,186,317, 5,366,078, 5,558,846, 5,609,284, 5,609,837, and 6,148,992. Commercial examples of such cases are found in or included as parts of the AOSEPT® Disposable Cup &amp; Disc (CIBA VISION®) and CLEAR CARE® (CIBA VISION®) systems. 
         [0024]    The present invention uses a one-step hydrogen peroxide disinfection system and method for disinfecting soft (hydrophilic) and rigid gas permeable contact lenses, where the inventive system and method achieves higher kill rates for bacteria, yeast, fungi and amoeba at low concentrations of hydrogen peroxide (e.g., 1%-10%, more preferably 3%-7%) than previous one-step systems and methods. Embodiments of the inventive system and methods use a thermally insulated vial to retain the heat of the exothermic neutralization of peroxide, thereby elevating the temperature of and maintaining an elevated temperature of the peroxide disinfecting solution. The elevated temperature has the benefit of increasing the rate of kill of microorganisms, and simultaneously accelerating the neutralizing of the peroxide solution. A further benefit of embodiments of the present invention is the use of the simpler and quicker one-step system with its associated benefits over a two-step system. In alternative embodiments a heating element is provided to assist in elevating of and maintaining the elevated temperature of the disinfection solution to a desired level, whether the thermally insulated vial is present or not. 
         [0025]    The inventive system and method, in accordance with some embodiments, includes a cap and thermally insulated vial. The thermally insulated vial, in accordance to some embodiments, may include a void or space between a double wall structure, or, alternatively, the material from which the vial wall is constructed has thermal insulating properties, or, alternatively, a combination of a void and thermally insulating material may be used, for example in a sandwich structure. For embodiments using the void to provide thermal insulation, the void may be a substantially evacuated space, contain a gas with a thermal conductivity less than air (e.g., Ar, Kr, and Xe) or a combination of low thermal conductivity gases, which combination may include air, which mixture may also be at reduced or vacuum pressures (e.g., 0.0001 torr-1.5 torr, or more preferably 0.1 torr-1 torr). Alternatively, the material from which the vial is made may have thermal insulating properties (e.g., neoprene rubber, silica aerogel, expanded polystyrene, polyurethane foam, fiberglass, mineral wool). As another alternative a heating element may also be provided, either with a non-insulated vial or with the insulated vial. 
         [0026]    The term “caddy” refers to an apparatus adapted for use with a disinfection solution used to disinfect a medical device, e.g., contact lenses for example. A caddy may be an apparatus into or onto which a separate thermally insulated vial may be removably placed. In other embodiments, a caddy may also be the cleaning vessel (which is thermally insulated). 
         [0027]    The term “disinfection solution” refers to any liquid cleaning or disinfecting solution used to clean medical devices such as contact lenses. Disinfecting solutions may include hydrogen peroxide or other peroxide compounds. Disinfection solutions may also include other ingredients as known to the skilled artisan. Examples of cleaning solutions which may be used in accordance with the systems described herein include, without limitation, AOSEPT® Disinfectant (CIBA VISION®) and CLEAR CARE® (CIBA VISION®). 
         [0028]    The term or “disinfection system” refers to a disinfection solution and accompanying devices, such as a catalyst or other substance used to neutralize the disinfection solution. 
         [0029]    The term “cleaning case” refers to a vial in combination with a cap, a basket in which lenses may be held, and a catalyst or other substance, as more fully explained herein. 
         [0030]    The term “vial” refers to a receptacle for the disinfecting solution, lenses and catalyst or other substance. 
         [0031]    The term “catalyst” refers to a substance that accelerates the neutralization of the disinfection solution. Examples of catalysts, without limitation, include platinum or enzymes such as catalase. As referred to above, it may also be a substance that assists in the chemical reaction transforming the disinfection solution to something substantially benign when placed in a user&#39;s eye. 
         [0032]    The term “property” refers to a physical, chemical, electrical, optical, or other property, as well as a profile of that property over time. 
         [0033]    Unless specifically noted otherwise herein, the definitions of the terms used are standard definitions used in the art of organic synthesis, pharmaceutical, and ocular sciences. Exemplary embodiments, aspects and variations are illustrated in the figures and drawings, and it is intended that the embodiments, aspects and variations, and the figures and drawings disclosed herein are to be considered illustrative and not limiting. 
         [0034]      FIGS. 1A-B  show caddy  150  and cleaning case  110 . Referring to  FIG. 1A , caddy  150  comprises caddy case  151 , indicator  152 , and display panel  154 . Caddy case  151  may be made out of an appropriate material, e.g., a plastic or similar type of material, which is well known in the art. Indicator  152  may be a light or an LED (light emitting diode), and display panel may be an LCD (liquid crystal display) or a similar display panel capable of displaying text and/or graphical images either in color or black/white/grayscale. A display may be an indicator such as a light or an LED or a display panel such as an LCD. These components and structures are also well known in the art. 
         [0035]    In some embodiments, caddy  150  may include a mechanism for providing an audio indication of the solution status, temperature monitoring, and other information. For example, caddy case may include one or more speakers and a controller or processor. The one or more speakers may output audio from an acoustic signal provided by the controller or processor. The controller or processor may receive temperature or other data from one or more sensors. An audio message may be provided based on the data provided by the sensors. For example, the caddy  150  may provide an audio alert indicating the time remaining in the neutralization process, the neutralization process is complete, the caddy is disinfecting the contact lens, disinfection was successful or unsuccessful, the solution is not detected and other messages. Hence, embodiments of the present invention may provide audio alerts in place of or in addition to visual or active alerts to communicate events or conditions related to contact lens, the disinfection solution, and other aspects of the present technology. 
         [0036]    Referring to  FIG. 1B , a separate and partially disassembled cleaning case  110  is shown. Cleaning case  110  may comprise such elements as cap  112 , support beam  114 , basket  116  and catalyst  118 , and thermally insulated vial  120 . In an alternative embodiment cleaning case  110  may also include heating element  113 , which embodiment may include thermally insulated vial  120  or a vial without thermal insulation. Heating element  113  is shown located on beam  114 , but can be placed anywhere (including somewhere in or on the vial) so long as it is immersed in the disinfection solution and wired to a power source, as will be appreciated by the skilled artisan. Contact lenses  117  are also shown. Cleaning case  110  may be fully assembled by reversibly affixing (e.g., by screwing, snapping, form-fitting, friction fitting, etc.) cap  112  onto thermally insulated vial  120 . Thermally insulated vial  120  of the embodiment illustrated in  FIG. 1B  includes threads  115  for affixing cap  112 , but other mechanisms for securing cap  112  will be appreciated by the skilled artisan. Once fully assembled (lenses, disinfection solution, catalyst, cap, etc.), the cleaning case may be removably placed in or on the caddy, or alternatively set on its own. 
         [0037]    Referring to  FIG. 2A-2C  embodiments of thermally insulated vial  120  are shown. In  FIG. 2A  vial  120  has a double wall structure, comprised of inner wall  202 , outer wall  204  and thermally insulating void  206 . Threads  203  or other appropriate attachment mechanisms are provided to secure cap  112  to thermally insulated vial  120 . Thermally insulated void  206  provides the primary thermal insulation for vial  120  in this embodiment. Thermally insulated void  206  has a thermal conductivity less than that of air, which is 26.2 mW/m-K (milliwats per meter kelvin) at ˜300 K, and is, in this embodiment, substantially devoid of solid thermal insulating material. For example, and not by way of limitation, thermally insulated void may comprise one or more gases of low thermal conductivity, such as and not by way of limitation argon, xenon, and krypton. Alternatively, the void may be evacuated to a low pressure of gas, whether air, argon, xenon krypton, other suitable gas or a mixture of gases. Materials used to construct inner and outer walls may also have thermal insulation properties (i.e., low thermal conductivities by virtue of the material, thickness or both), for example and not by way of limitation plastics and glass polystyrene, poly(styrene butadiene), poly(acrylonitrile butadiene styrene), polypropylene, polyethylene, poly(methyl methacrylate). 
         [0038]    Referring to  FIG. 2B , showing another embodiment, void  206  may also comprise insulation material  208 , such as and not by way of limitation highly porous material (e.g., fumed silica, aerogel, perlite or glass fiber), where inner wall  202 , outer wall  206  and insulation material  208  form a sandwich structure. Preferably, in this embodiment, void  206  is substantially or partially evacuated of gas (e.g., 0.0001 torr-1.5 torr, or more preferably 0.1 torr-1 torr), where the gas may comprise, for example, those listed above or a mixture thereof. Heat transfer through a volume (e.g., void  206 ) occurs by convection, conduction, and radiation. Reducing gas pressure will substantially reduce or eliminate convection since convection relies on the presence of gas molecules transferring energy by bulk movement through the void. Reduced pressure also reduces conduction as fewer collisions occur between adjacent gas molecules or the walls of the insulation vessel. However, tighter dimensions of the vial walls will cause a relative increase in the conduction component because smaller distances between the walls will increase the number of collisions of gas molecules with the walls. Conduction is more substantially reduced in reduced pressure environments when combined with the presence of solid insulation material in the void, i.e., an evacuated insulation sandwich. The alternative of sandwiching solid insulation material in the void in reduced pressure will substantially reduce the thermal conductivity, without the need of increasing the spacing between the walls. The skilled artisan will appreciate that solid insulation material  208 , if used, may off-gas under reduced pressures, in which case one may use a “getter”, i.e. a chemical in the void to collect or bind the gas from the off-gassing. Examples of thermally insulating materials for the sandwich structure include, without limitation, neoprene rubber, silica aerogel, expanded polystyrene, polyurethane foam, fiberglass, or mineral wool. The materials may be included in the sandwich structure at atmospheric pressures or reduced pressures. 
         [0039]    Referring to  FIG. 2C , showing another embodiment of thermally insulated vial  120 , wall(s)  210  are made from a thermally insulated and sufficiently structurally sound material. Thermally insulated vial  120  is preferably intended for a contact lens disinfection system, using peroxide as the disinfectant. Thus, the thermal insulating material must withstand prolonged exposure to peroxide based lens disinfecting solutions, and be able to withstand the rigors of normal use (e.g., dropping, banging etc.) of a contact disinfection system. In addition the thermal insulating material should have sufficiently low thermal conductivity (e.g., ranging from 0.0001 to 0.05 W/m-K, or alternatively 0.003-0.05 W/m-K) at thicknesses between 1-10 mm in order to achieve desired heat retention from the exothermic neutralization of peroxide and maintain an elevated temperature in thermally insulated vial  120  to increase the kill rate of harmful microorganisms as described herein. Some examples of suitable thermally insulating material include: polystyrene, poly(styrene butadiene), poly(acrylonitrile butadiene styrene), polypropylene, polyethylene, poly(methyl methacrylate). 
         [0040]    Referring to  FIG. 3A , caddy  150  is shown in perspective side view, in which caddy case  151 , indicator  152 , and display panel  154  are also shown.  FIG. 3B  shows a cross-sectional view of caddy  150  and trigger  160 , which are electronically connected to processing device  170 , which is connected to and powered by power source  180 . Processing device  170  is also electronically connected to indicator  152  and display panel  154 . Trigger  160  is positioned such that it is tripped under normal operation when cleaning case  110  is placed in or on caddy  150 . Tripping the trigger advances a counter within the processing device to provide a count. Positing cleaning case  110  in or on caddy  150  may also provide electrical power connections (not shown) to case  110  to power any circuitry or the alternative heating element in or on case  110 . Processing device  170  and any processor may be a logic circuit, integrated circuit chip, or microprocessor, e.g., computing chip, or a plurality or combination thereof. Power source  180  may be a battery, e.g., a rechargeable battery or other type of battery typically used in small electronic devices. In some embodiments, the power source may be a power source external to the caddy, e.g., a household 110 V or similar source. A small transformer, not shown, may also be needed. In embodiments including heating element  113 , it may be preferred to use an outlet source of electric power, as batteries may not provide sufficient charge to provide the necessary heating energy. 
         [0041]    Typically, when hydrogen peroxide is introduced to cleaning case  110  containing catalyst  118 , a chemical reaction occurs in which the catalyst accelerates the neutralization (i.e, reduction) of the peroxide. As described elsewhere the catalyst may be, for example and not by way of limitation, platinum or catalase. Complete neutralization of the peroxide is recommended before inserting a lens into the eye, since even trace amounts of peroxide can be very painful to the eye. The catalyzed neutralization of peroxide is an exothermic reaction. The rate and degree of temperature increase during the reaction and decrease after the reaction can be measured and will be a function of the amount of peroxide in the solution and the amount of available catalyst since catalyst material, commonly a metal such as platinum or an enzyme such as catalase, is also oxidized during the reaction. Thus, in one embodiment, changes in the temperature or temperature profile (i.e., the shape of a temperature vs. time curve) of the cleaning solution can be correlated to changes in the quality of the cleaning solution (e.g., peroxide concentrations) or the catalyst (how much catalyst is still available). A processing device can then be programmed to compare the temperature or temperature profile with a preset value. Thus, different messages can be displayed on the display device depending on whether the temperature sensor measures a temperature profile that falls within or outside of the acceptable temperature profile range. Further details of systems and methods for monitoring the reaction rate and disinfecting efficacy based on temperature and other reaction properties (e.g., pressure) measurements can be found in commonly owned U.S. patent application Ser. No. 13/403,754 (now U.S. Pat. No. 8,851,091), and for sake of brevity will not be further described herein. 
         [0042]    Referring to  FIGS. 4-5 , various aspects of operation of certain embodiments of a contact lens disinfection system and method  400  are provided. At step  402  a user inserts the lenses into baskets  116 . The baskets with lenses are then placed into thermally insulated vial at step  404 , and a catalyst is also inserted at step  406 . The skilled artisan will appreciate that the catalyst may be integrated into the basket structure, as in catalyst  118  on case  110 , or it may be provided in any other manner known to the skilled artisan (e.g., dropping catalyst into vial, making catalyst part of the vial, etc.). Disinfection solution is added to thermally insulated vial  120  at step  408 . But, it will be appreciated that the disinfection solution may be added to the vial prior to receiving the contact lenses and catalyst, and that the order of the method is not particularly important, except to note that the catalyst should contact the disinfection solution at approximately the same time or shortly after the lenses are immersed in the disinfection solution, otherwise the catalyzed neutralization will diminish the disinfection properties (e.g., lower peroxide concentrations) of the solution prior to insertion of the lenses. Cap  112  is secured to thermally insulated vial at step  410 . 
         [0043]    Referring now to  FIG. 5 , case  110  is inserted into/onto caddy  15  at step  502 . A trigger (e.g., trigger  160 ,  FIG. 3B ) and the processing device to which it is connected can be used to determine if the contact lens case has been placed into the base unit at step  504 . If a cleaning case has been placed therein, a message such as “Disinfecting” can be displayed on a display panel (e.g., display panel  154 ,  FIG. 1A ) at step  506 . If no cleaning case has been placed in the base unit, the display panel can display a message such as “Standing By” at step  507  and the base unit can be said to be in “standby mode”. After the trigger has been tripped, the temperature profile of the disinfection solution can be measured to determine if it falls within an acceptable temperature profile range at step  508 , meaning that a sufficient temperature (or pressure or other reaction property) increase with respect to time is measured to assure that the disinfection solution is sufficiently strong or the catalyst is sufficiently active to assure disinfection. If “No” then a message such as “Disinfection unsuccessful. Please replace case and solution.” can be displayed at step  510 , after which the case can be removed at step  512  and the “Standing By” message can be displayed at step  507 . If the temperature is found to be increasing within an acceptable range, then a timer can begin counting to a preset minimum disinfection time (“MDT”) time for normal disinfection of a pair of contact lenses at step  512 . At step  514  the method determines if the desired temperature is reached to achieve increased kill rates (as described herein). If such minimum temperature not reached, the method alternatively activates heating element  113  to elevate temperature to minimum at step  516 . The temperature is preferably checked over time to ensure the minimum temperature is maintained or exceeded for a preset time at step  517 . At this time, a “Disinfection working properly” message can be displayed at step  518 . This message can remain displayed as long as long as the elapsed time is not greater than the minimum disinfection time and the temperature did not drop below the minimum temperature for the preset amount of time at step  520 . The preset amount of time will be determined based on the time needed to achieve increased kill rates. It will be appreciated that the time to achieve increased kill rates at elevated temperatures will be less than the amount of time to achieve full neutralization. Once the elapsed time (“ET”) equals the minimum time to achieve a neutralized solution at step  520 , a “Safe to Wear Lenses” or “Disinfection Complete” message may be displayed at step  522 . For example, the minimum disinfection time can be set at 6 hours. Other minimum disinfection times can be set according to factors such as how long it takes to measure the temperature profile, the size and shape of the lens case and catalyst, and the recommended minimum time of disinfection specified by the cleaning system (e.g., CLEAR CARE®, etc.), etc. If the case is then removed at step  512 , the base unit is returned to standby mode. If the case is not removed at step  524 , then the timer continues to count. When the elapsed time measured by the timer reaches a preset upper limit of safe storage time (“SST”) at step  526 , a message such as “Please restart the disinfection process” can be displayed at step  528 ; if not, the “Safe to Wear Lenses” message can remain displayed. For example, the upper limit of SST may be about 18 hours, about 24 hours, about 7 days, or another time depending on the cleaning system used. Since after this time the risk of re-infection may increase, it may be advisable to remove the lenses from the cleaning case before this time. As will be appreciated by persons having ordinary skill in the art, the processing device, which can include one or more memory units, can store the values such as the elapsed time, the safe storage time, etc. and can perform the above-described comparisons and calculations. 
         [0044]    Referring to  FIGS. 6A-B , an embodiment where the caddy itself receives the cleaning solution (i.e., where there is no separate cleaning case) is shown. Referring to  FIG. 6A , caddy  600  in top view is shown, including thermally insulated caddy case  651 , made of plastic or some other suitable material described in more detail herein, indicator  652 , control buttons  653 A and  653 B, display  654 , reservoirs  620 A and  620 B, and caps  612 A and  612 B, which may be reversibly affixed (e.g. by screwing, snapping, form-fitting, friction fitting, etc.) to thermally insulated caddy case  651 . Certain of these components are shown in side view in  FIG. 6B . Referring only to reservoir  620 A side and  FIG. 6B , insulated caddy case has internal wall  602 , external wall  604 , with void  603  therebetween. As will be appreciated by the skilled artisan, thermally insulated caddy case  651  and reservoirs  620 A and  620 B are the equivalent to thermally insulated vial  120  described above, and may have a similar double walled construction with void  603  serving to insulate, or may be constructed of insulating material, a combination of both, or may be an evacuated insulation material sandwich structure described herein. A heating element may also be provided (not shown) in this embodiment, either alone or in combination with insulating the reservoirs. 
         [0045]    This caddy may include features illustrated in the other embodiments, and not explicitly shown here, such as a trigger, a timer, a processing device or a power source. The caddy shown in  FIGS. 6A-B  may also include sensors such as a temperature sensor, an electronic sensor, a pressure sensor, a sound sensor, or a gas sensor. For example, caddy  800  may include a temperature sensor in caps  612 A-B. These sensors may, among other things, be used to determine the progress of disinfection and neutralization as more thoroughly described in co-owned U.S. Pat. No. 8,851,091, and may be used to ensure temperatures are adequately elevated for specified periods of time to achieve increased kill rates as described herein. The caddy may also include buttons or tabs under a portion of where the caps are placed which are depressed when the caps have been reversibly affixed to the case. When depressed, a signal can then be sent to the processing device to begin a timer or display a message, similar to the trigger described above. 
         [0046]      FIG. 7A-B  illustrates a side view of case  110 , including contact lens cap  112 , lens basket  116 , and platinum catalyst  118 , though vial  120  is not shown. Vial  120  (not shown) uses threads to secure lens cap  112  to vial  120 . Solution temperature sensor  5  monitors the temperature of the solution over time during the peroxide neutralization process. Heating element  113  may be provided on beam  114  or directly in vial  120  (not shown). Preferably, if provided, heating element  113  will be on beam  114  and be electrically connected to caddy  150  via wiring (not shown) in lens cap  112 . The electrical connection to the heating element is provided by way of example, not limitation. The skilled artisan will appreciate many ways to electrically power the heating element without exceeding the boundaries of the present invention. In various embodiments, the solution temperature sensor  5  may be a thermistor or a thermocouple. Using a solution sensor  121 , the microcontroller (not shown) senses that the contact lenses are immersed into the disinfection solution and initiates the monitoring process. The solution sensor  121  may include two electrodes, one of which is shown on support beam  114  of  FIG. 7 . Solution sensor  121  may be located adjacent or near a top portion of lens basket  116 . The solution sensor may be a pair of conductivity electrodes. 
         [0047]    A pair of contact lens baskets  116  holds the lenses in place during the disinfection process. Platinum catalyst  118  neutralizes the hydrogen peroxide solution, an exothermic process. The basket hinge  119  allows the contact lens basket  7  to open, which allows the contacts to be attached or removed. 
         [0048]      FIG. 7B  illustrates a top view of lens cap  112  showing some internal components. These may include a microcontroller  11 , a sensor such as an external temperature sensor  13 , a battery  12 , or other electrical power source (e.g., connection to the caddy or alternatively a DC or AC source). The capacitive touch sensor  10  wakes the microcontroller  11  from low-power sleep mode. The capacitive touch sensor  10 , commonly used in many hand-held devices such as cell phone capacitive touch screens, may communicate with the microcontroller  11  to identify hand touch. 
         [0049]    The external temperature sensor  13  measures the temperature of the air around the cup  1  and corrects for external heating or cooling of the solution. In various embodiments, the external temperature sensor  13  may be a thermistor or a thermocouple. An example how the microcontroller  11  may measure temperature through the use of a thermistor, is with the use of an RC circuit. These temperatures can be used by the microcontroller to determine when disinfection and neutralization are complete when combined with temperature data from inside the vial during disinfection and neutralization. These processes are described more thoroughly in co-owned U.S. Pat. No. 8,851,091. 
       Increased Kill Rates of Microorganisms at Elevated Temperatures in a Peroxide System 
       [0050]    Kill rates of commonly known microorganisms on contact lenses in a peroxide system are increased at elevated temperatures as illustrated by the data below and graphical representation thereof in  FIG. 8A-B   
         [0051]    In the first test, 0.05% H 2 O 2  was tested against Aspergillus brasiliensis ATCC 16404 at varying temperatures to determine if temperatures affect the kill rate in the presence of peroxide. 3% H 2 O 2  was diluted into phosphate buffered saline and immediately inoculated with 5 loopfuls of  A. brasiliensis  spores. 1 mL aliquots were added to microcentrifuge tubes and incubated at room temperature, 30° C., 40° C. and 50° C. for time intervals of 0.5, 1 and 3 hours. Controls without H 2 O 2  were also tested.  A. brasiliensis  spore stock was prepared to achieve approximately 1×10 6  CFU/mL, confirmed by bactiter. At each time point, 100 μL was removed, diluted and spread on to SDA plates (triplicate). The plates were then incubated in 30° C. for optimal growth. 
         [0052]    Table 1 and  FIG. 8A  show increased kill rate for  A. brasiliensis  in 0.05% H 2 O 2  with elevated temperature in the presence of peroxide. Complete kill (down to the limit of detection) was achieved by 3 hours at 50° C. It is noted that there is a reduction of CFUs in the control by 3 hours at 50° C. (Table 2). 
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                   A. brasiliensis  in 0.05% H 2 O 2   
               
             
          
           
               
                 Hours 
                 Room Temp. 
                 30° C. 
                 40° C. 
                 50° C. 
               
               
                   
               
             
          
           
               
                 0 
                 1.67 × 10 6   
                 1.67 × 10 6   
                 1.67 × 10 6   
                 1.67 × 10 6   
               
               
                 0.5 
                 3.33 × 10 6   
                 3.33 × 10 6   
                 4.44 × 10 6   
                 4.44 × 10 6   
               
               
                 1 
                 3.33 × 10 6   
                 1.33 × 10 6   
                 2.22 × 10 6   
                 1.11 × 10 6   
               
               
                 3 
                 1.44 × 10 6   
                 1.89 × 10 6   
                 1.56 × 10 6   
                 ≦5 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
             
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                   A. brasiliensis  grown in control 
               
             
          
           
               
                   
                 Hours 
                 50° C. 
               
               
                   
                   
               
             
          
           
               
                   
                 0 
                 3.33 × 10 6   
               
               
                   
                 0.5 
                 4.44 × 10 6   
               
               
                   
                 1 
                 6.67 × 10 5   
               
               
                   
                 3 
                 1.89 × 10 4   
               
               
                   
                   
               
             
          
         
       
     
         [0053]    In a second test, 0.01% H2O2 was tested against  Candida albicans  ATCC 10231 at varying temperatures to determine if temperatures affect the kill rate in the presence of peroxide. 3% H2O2 was diluted into sterile saline and 0.5 mL aliquots added to microcentrifuge tubes. Controls without H2O2 were also tested.  C. albicans  stock was prepared and inoculated into each microcentrifuge tube to achieve approximately 1×105 CFU/mL, confirmed by bactiter. The tubes were incubated at room temperature, 30° C., 40° C. and 50° C. for time intervals of 0.5, 1 and 3 hours. At each time point, 100 uL was removed, diluted and spread on to SDA plates. The plates were then incubated in 30° C. for 2 days for optimal growth. This was performed in duplicate. It is noted that 50° C. plates contained no viable  C. albicans  colonies in either the testing agent or the control plates at all time points (Tables 3 and 4). It is therefore concluded that  C. albicans  does not survive 50° C. incubation period. 
         [0054]    Tables 3, 4 and  FIG. 8B  show increased kill rate of  C. albicans  in 0.01% H2O2 at elevated temperatures. Complete kill (down to the limit of detection) was achieved by 3 hours at 40° C. 
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                   C. albicans  (average CFU/mL) in 0.01% H 2 O 2   
               
             
          
           
               
                 Hours 
                 Room Temp. 
                 30° C. 
                 40° C. 
                 50° C. 
               
               
                   
               
             
          
           
               
                 0 
                 1.33 × 10 5   
                 1.33 × 10 5   
                 1.33 × 10 5   
                 1.33 × 10 5   
               
               
                 0.5 
                 1.22 × 10 5   
                 1.11 × 10 5   
                 1.34 × 10 5   
                 &gt;5 
               
               
                 1 
                 1.64 × 10 5   
                 1.07 × 10 5   
                 3.78 × 10 4   
                 &gt;5 
               
               
                 3 
                 4.33 × 10 4   
                 2.17 × 10 5   
                 &gt;5 
                 &gt;5 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 4 
               
             
             
               
                   
               
               
                   C. albicans  (average CFU/mL) grown in control 
               
             
          
           
               
                 Hours 
                 Room Temp. 
                 30° C. 
                 40° C. 
                 50° C. 
               
               
                   
               
             
          
           
               
                 0 
                 1.33 × 10 5   
                 1.33 × 10 5   
                 1.33 × 10 5   
                 1.33 × 10 5   
               
               
                 0.5 
                 3.28 × 10 4   
                 2.78 × 10 4   
                 9.56 × 10 4   
                 &gt;5 
               
               
                 1 
                 5.00 × 10 4   
                 3.89 × 10 4   
                 1.61 × 10 4   
                 &gt;5 
               
               
                 3 
                 7.78 × 10 4   
                 8.06 × 10 4   
                 3.39 × 10 4   
                 &gt;5 
               
               
                   
               
             
          
         
       
     
         [0055]    These data clearly demonstrate an increased kill rate for at least two fungal species in the presence of hydrogen peroxide at elevated temperatures. 
         [0000]    Temperature Profiles of Peroxide Solution with Platinum in Thermally Insulated Vial 
         [0056]      FIG. 9  shows plots of temperature versus time of thermally insulated vials in accordance with embodiments of the present invention. The thermally insulated vials were of dual walled plastic construction with the void filled with expanded polyurethane foam, but not evacuated. The wall thickness, including the expanded polyurethane foam, was approximately 2 cm. Also shown are plots of temperature versus time for an uninsulated vials. The system tested was 3% and 7% peroxide solutions in the presence of a platinum catalyst. The data demonstrated the heat from the exothermic reaction increased the temperature of the peroxide solutions. The peak temperature reached in the insulated vials was higher than in the uninsulated vials, and the temperature of the insulated vials remained higher than in the uninsulated vials. These data strongly suggest that the idea of using a thermally insulated vial will provide a mechanism for achieving and maintaining an elevated temperature in the peroxide solution solely based on heat from the exothermic neutralization reaction. 
         [0057]      FIG. 10  illustrates a block diagram of an exemplary temperature sensing contact lens cleaning case  706 . The cleaning case  706  has a microcontroller  708  that is powered by the power supply  713 . The microcontroller  708  monitors the solution sensor  711  to sense when solution is present. When the microcontroller  708  determines that solution is present, readings from air temperature sensor  709  and solution temperature sensor  710  are obtained. These readings, combined with calibration data stored in the memory  712 , are converted to temperature measurements by the microcontroller  708 . The microcontroller  708  then stores these historical temperature measurements in the memory  712  for later retrieval. After a specific duration, the temperature measurements are recalled from the memory  712  by the microcontroller  708 . The microcontroller  708  determines what signals should be sent to display  707 . 
         [0058]      FIGS. 11A-B  illustrates an example of an operational flow chart for using a three light LED display configuration. The flow of operation described herein is for illustrative purposes and is not intended to be limiting. In various embodiments, the process begins at step  720  when the cleaning case (e.g. case  110  with thermally insulated vial  120 ) is powered on. In some embodiments, the device is normally in low-power sleep mode at step  721  to preserve limited battery life, though AC power may alternatively be provided. The device may wake up from low-power sleep mode every 1 to 3 seconds for a period of a few microseconds to sense if cleaning solution has been added to the device at step  722 . If no solution is detected, the device goes back into sleep mode. If solution is detected, the device blinks the yellow LED quickly at step  723 . For example, the device LED may blink twice per second. Quick blinking may indicate the device is determining if the cleaning solution and system are functioning properly. The device delays 5 to 15 seconds before taking a baseline temperature measurement at step  724 , to allow for temperature equilibration of the cleaning solution, vial, and cap. After equilibration, initial solution and atmospheric temperature measurements are taken at step  725 . The solution temperature is used as a reference point, from which future solution temperature rates can be determined. The device routinely detects if the cap is continuously immersed in solution at step  726 . 
         [0059]    If no solution is detected at step  726 , the LED will blink red at step  730 , indicating that the cleaning process has been interrupted and that it is unsafe to place the contact lenses into the eye. The red blinking LED continues to blink for 30 seconds, followed by return to low-power sleep mode at the start of the sequence. If solution is detected, the microcontroller delays for 30 seconds at step  727 . Solution and atmospheric temperature measurements are re-sampled or taken at step  728 . The device routinely detects if the cap is continuously immersed in solution at step  729 , and the process proceeds if solution is detected. 
         [0060]    Referring to  FIG. 11B , if the actual temperature has reached the desired minimum temperature (e.g. 40° C.) at step  733 , then the device blinks the yellow LED slowly at step  734 , for example once per 2 to 3 seconds. The purpose of the slowly blinking is to indicate that the device has determined that the cleaning solution and system are functioning properly, and the device is cleaning the contact lenses. The device detects if the cap is continuously immersed in solution at step  735 . If solution is detected, the device proceeds to determine if the temperature is at or above the minimum temperature for a preset period of time at step  745 . If both steps  735  and  745  are true, then the device goes on to allow 6 hours (or a preset period of time) for the cleaning solution to complete the cleaning/neutralization cycle at step  736 . If either  735  or  745  are false the device blinks red indicating an error has occurred, and step  742  will check to see if a solution remains present and continue to blink red until the solution is removed returning the system back to start. If 6 hours has elapsed, the device blinks the green LED slowly at step  737 , which indicates to the user that the device has finished the cleaning/neutralization cycle, and the contact lenses are safe to insert into the eye. The device continues to blink the green LED until no solution is detected at step  738  (user removed lenses, dumped solution), where it returns to the start at step  743 . If solution continues to be detected at step  738 , and 7 days (for example) has elapsed at step  739 , then the LED blinks red at step  740  to indicate that it is no longer safe to insert the contact lenses into the eye. This is due to a possibility that microbes may have re-infected the sterile solution. The red LED will continue to blink until no solution is detected at step  744 . 
         [0061]    The examples above describe in detail embodiments in which the vial or vessel into which the lenses are placed is thermally insulated to retain heat from the exothermic peroxide neutralization, where the insulation is used to achieve and maintain an elevated temperature of the disinfection solution so as to increase the kill rate of microorganisms present on the lenses. However, this disclosure encompasses additional embodiments wherein other ways of insulating and/or increasing and maintaining an elevated temperature may be used. Such as, for example and without limitation, a heating element, or an evacuated sandwich structure. 
         [0062]    While a number of exemplary embodiments, aspects and variations have been provided herein, those of skill in the art will recognize certain modifications, permutations, additions and combinations and certain sub-combinations of the embodiments, aspects and variations. It is intended that the following claims are interpreted to include all such modifications, permutations, additions and combinations and certain sub-combinations of the embodiments, aspects and variations are within their scope.