Abstract:
A variety of medicinal compounds comprising  crocus sativus  for the treatment of a plurality of medical ailments are described. A method of creating a  crocus sativus  extract is also described. In addition, a variety of embodiments and methods of utilizing inhalation therapeutic delivery mechanisms including nebulizers and vaporizers for the vaporization of  crocus sativus  comprising medicinal compounds and extracts are disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims priority based on U.S. provisional application Ser. No. 61/926,241, filed Jan. 10, 2014. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to herbal mixtures used in the treatment of medical maladies. More specifically, the present invention relates to herbal mixtures and extractions comprising  crocus sativus  used to treat medical maladies. 
         [0004]    2. Prior Art 
         [0005]    A variety of herbal and plant extracts and preparations are available today for treating a variety of medical maladies affecting the mammalian body. Some preparations have been known for literally thousands of years while others are just being scientifically discovered to have curative effects. Effective plant extracts are highly desired as a “natural” way to treat medical maladies. It is believed that “natural” preparations will minimize potential adverse effects as compared to synthetic preparations. For example, U.S. Pat. No. 4,986,895 to Grossman et al., is directed to the use of water-soluble plant extracts for the treatment of virus skin infections. U.S. Pat. No. 5,178,865 to Ho et al., is directed to the use of Chinese herbal extracts for the treatment of HIV related disease. Ho discloses a total of 56 herbal extracts that were screened for anti-HIV activity using various in vitro techniques. 
         [0006]    In particular, the medicinal properties of saffron ( crocus sativus ) have been generally known as the herb has been used for many years in traditional medicine. Today,  crocus sativus  is being scientifically investigated for its many medicinal benefits. The pistil of the crocus flower is composed of a stigma, a style, and an ovary. The stigma has a bright red color and contains many useful components including medicinal constituents, flavoring compounds and pigments. These useful components have been conventionally harvested from the pistils of open crocus flowers. Both the stigma and the petals of the crocus flowers are believed to possess medicinal properties. For example, both the saffron stigma and petals are said to be helpful for depression. 
         [0007]    Saffron ( crocus sativus ) has been the subject of numerous clinical investigations, examples of which are disclosed in articles by M. Agha-Hosseini et al.,  BJOG  2008, 115, p. 515-519; Su Hee Jang et al.,  Complimentary and Alternative Medicine  2014,14:11, p. 1-13; Vijaya Bhargava K,  International Journal of Pharmacy and Pharaceutical Sciences  2011, vol. 3, suppl. 3, p. 22-26; F. I. Abdullaev et al.,  Cancer Detection and Prevention  2004, vol. 28, p. 426-432; and R. Srivastava et al.,  Pharmacogn Rev.  2010, Jul.-Dec., 4(8), p. 200-208, all of which are incorporated by reference herein. These investigations and others have identified the herb to comprise medicinal benefits for numerous medical ailments. Among these scientific studies,  crocus sativus  has been identified as a sedative, a stimulant, in particular, a central nervous system stimulant, an antispasmodic, and a diaphoretic. Saffron, crocins and crocetin have been shown to inhibit breast cancer cell proliferation. It is used for the improvement of digestion and appetite and has been found to be extremely beneficial for providing relief from gas and acidity related problems. Saffron is also used for treating cough and is a known therapeutic for insomnia. 
         [0008]    Saffron is also regularly used to treat many skin problems, for example, dry skin, and is used to lighten skin tone.  Crocus sativus  is used for the treatment of kidney, bladder and liver disorders. It is also believed that saffron helps to improve circulation of the organs of digestion. Saffron is considered by many to be a blood purifier and has been shown to have anti-inflammatory properties as well as help increase the oxygen content of blood, thus aiding in the overall health and well-being of a person. In addition,  crocus sativus  has been used to treat asthma and atherosclerosis. 
         [0009]    In addition, saffron has been used to help relieve inflammation associated with arthritis and also with providing relief from joint pain. It also has been shown to provide relief from lower back pain. Massaging the gums with saffron may help reduce soreness and inflammation of the mouth and the tongue. 
         [0010]    Saffron has also been found to be effective in relieving symptoms of pre-menstrual symptoms (PMS). Saffron is even recommended for use during pregnancy as the herb is used to elevate body temperature. In addition, saffron is thought to be an antioxidant and have anti-cancerous and anti-tumor properties. It also may have a protective effect on the heart. 
         [0011]    Prior art examples that demonstrate some of the medicinal uses of saffron can be found in U.S. Pat. No. 6,607,756 to Rosenstiel which discloses the use of pure powdered saffron to increase blood flow, to relieve pain and minimize skin dryness. U.S. Pat. App. Pub. No. 2003/0086981 to Seiki et al., discloses an ingestible saffron pill composed of a glycerin fatty acid ester that is used in the treatment of pre-menstrual symptoms (PMS). U.S. Pat. App. Pub. No. 2005/0158411 to Vail et al., now U.S. Pat. No. 7,344,740 discloses inhalation of a combination of peppermint oil complemented by saffron and other herbs that may be used to treat nausea induced by cancer chemotherapy treatment. U.S. Pat. No. 8,569,247 to Eidenberger, discloses embodiments of compositions derived from saffron and gardenia for medicinal treatments. 
         [0012]    However, the prior art does not disclose saffron containing medicinal therapeutic mixtures that are designed to be vaporized or nebulized and, thus, provide treatment of these various medical ailments, such as pre-menstrual symptoms (PMS), through inhalation of a saffron comprising therapeutic aerosol. There exists, therefore, a need for a medicinal extract or therapeutic mixture comprising  crocus sativus  to relieve medical ailments that is designed to be delivered through various inhalation methods. In addition, there exists a need for a medicinal extract or therapeutic mixture thereof comprising  crocus sativus  that is designed to be vaporized or nebulized using various apparatus and inhalation methods. 
         [0013]    Vaporization offers a means to extract and concentrate therapeutic agents, such as those separated from a naturally occurring plant, through a pure aerosol vapor mist. In an embodiment of the present invention, vaporization of plants, herbs, their extracts, and combinations thereof, is provided. In one such embodiment, the vaporization of  crocus sativus  is provided. In the embodiment, the vaporization method utilizes different solvents and temperatures to modify and/or concentrate the therapeutic substance, for example, but not limited to, the saffron stigma, the saffron petals, dried saffron threads and powders. “Saffron threads” are generally known to be dried stigmas of the saffron plant. 
         [0014]    An alternate delivery method is to inhale smoke resulting from the burning of a plant, herb or combination thereof. However, the burning process may create potentially toxic materials or compounds such as tars, which are generally not desirable. Hence, inhalation of vaporized saffron is preferred. Furthermore, the vaporizing process may be used to concentrate the therapeutic delivery agent. The separated agent from the naturally occurring plant may be also be otherwise concentrated using traditional processes such as, but not limited to, distillation. The concentrated end product may further be embodied in a delivery media or complemented by other therapeutic agents to enhance delivery and efficacy of therapy. 
         [0015]    In the present application, embodiments and methods of preparing various medicinal compounds comprising  crocus sativus,  infusions, extracts, and combinations thereof are provided. In addition, various means of vaporizing these medicinal extracts, infusions and compounds are provided. One such method of vaporizing and delivering a therapeutic compound to a patient is through the use of a nebulizer or inhaler. 
         [0016]    Nebulizers and inhalers deliver a mist of the extraction or infusion of the therapeutic agent separated from a naturally occurring saffron plant, such as  crocus sativus.  Nebulizers and inhalers are typically small devices that are used to administer various aerosol media through a traditional mouthpiece. Nebulizers generally operate by converting a therapeutic liquid medium into aerosol droplets that are inhaled by a user to provide therapy. Nebulizers typically use a gas, such as oxygen, or compressed air to “break up” a therapeutic solution or suspension into aerosol droplets that can be directly inhaled through a mouthpiece of the device. In addition, an ultrasonic transducer may also be provided that aids in the creation of the aerosol droplets. The term “aerosol” is defined herein as a mixture of gas and liquid particles. An example of an aerosol is mist, a mixture of vaporized water particles that are mixed with hot ambient air that cools down and condenses into a cloud of visible airborne water droplets. 
         [0017]    There are generally two types of nebulizers, a jet nebulizer and an ultrasonic wave nebulizer. Both types of nebulizers are designed to administer a therapeutic medium to an individual via inhalation through a mouthpiece or a mask. It will be obvious to those skilled in the art that extended options for the final product achieved for vaporization also apply to nebulization. 
         [0018]    A jet nebulizer or atomizer generally utilizes a compressor that causes a compressed gas, such as air or oxygen to flow at high velocity through a therapeutic liquid to convert the liquid into an aerosol. This aerosol is then inhaled by a patient. An ultrasonic wave nebulizer utilizes an electronic oscillator that generates a high frequency ultrasonic wave that causes the mechanical vibration of a piezoelectric element within the transducer. The transducer with it vibrating element is generally positioned within the therapeutic medium. The high frequency of the vibrating oscillator is generally sufficient to produce a vapor mist that is then inhaled. 
         [0019]    In addition to a nebulizer, an inhaler may also be used to deliver the therapeutic medium to a patient. An inhaler typically comprises a sealed container having a release valve that is generally filled with a therapeutic medium such as a solvent or liquid extract. The therapeutic medium is typically housed under pressure within the container such that when the release valve is actuated, pressure from within the container causes the therapeutic medium to exit the container at a high velocity. A propellant may also be contained therewithin to aid in the expulsion of the therapeutic medium from the container. The propellant mixes with the therapeutic medium inside the container such that when the contents therewithin are released by the valve, an aerosol mixture of the therapeutic medium and propellant is expelled at a high velocity in an aerosol form. The container is received within an inhaler housing that comprises an activation mechanism capable of activating the release of the contents. The inhaler housing generally comprises a mouthpiece that directs the aerosol mixture into a patient. These and other embodiments will be disclosed in the specification and drawings of the present application. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]      FIG. 1  is a flow chart of a preferred  crocus sativus  extraction process of the present invention. 
           [0021]      FIG. 2  illustrates a cross-sectional view of an embodiment of an inhaler device that may be used to deliver the  crocus sativus  extract or therapeutic mixture thereof. 
           [0022]      FIG. 3A  shows a cross-sectional view of an embodiment of a jet nebulizer that may be used to deliver the  crocus sativus  extract or therapeutic mixture thereof. 
           [0023]      FIG. 3B  is a cross-sectional view of an embodiment of an ultrasonic nebulizer that may be used to deliver the  crocus sativus  extract or therapeutic mixture thereof. 
           [0024]      FIG. 4  illustrates a cross-sectional view of an embodiment of a portable inhaler that may be used to deliver the  crocus sativus  extract or therapeutic mixture thereof. 
           [0025]      FIG. 5  is a cross-sectional view of an embodiment of an electronic cigarette which may be used to deliver the  crocus sativus  extract or therapeutic mixture thereof. 
       
    
    
     SUMMARY OF THE PRESENT INVENTION 
       [0026]    The present invention is directed to the use of saffron ( crocus sativus ) in the treatment of various medical maladies affecting the mammalian body.  Crocus sativus,  commonly known as saffron, is a perennial stemless herb that is widely cultivated in different parts of the world, particularly Greece, India, Iran, and Spain. Saffron has been known to be used in traditional medicine as an anodyne, antidepressant, sedative, respiratory decongestant, anticatarrhal, expectorant, antispasmodic, eupeptic, stomachic, carminative, diaphoretic, gingival sedative, aphrodisiac, and emmenagogue. 
         [0027]    In view of its wide range of medical uses, saffron has undergone extensive phytochemical and biochemical studies with a variety of biologically active constituents being isolated (Srivastava, R.). Chemical studies of  crocus sativus  stigmas appear to indicate that it possesses medically beneficial carotenoids such as crocetin (also called α-crocetin or crocetin-I), its glycosidic forms being digentiobioside (crocin), gentiobioside, glucoside, gentioglucoside and diglucoside, γ-crocetin (monomethyl ester), γ-crocetin (dimethylester), trans crocetin isomer, 13-cis-crocetin, α-carotene, β-carotene, lycopene, zeaxanthin and mangicrocin, a xanthone-carotenoid glycosidic conjugate (Bhargava, V. K.). These carotenoids and other constituents contained within  crocus sativus  are currently being investigated for a number of medical ailments, such as the treatment of Alzheimer&#39;s disease, respiratory disorders, Parkinson&#39;s disease seizures, diabetes, blood pressure disorders and cancer (Bhargava, V. K. and Abdullaev, F. I.). In addition, studies by M. Agha-Hosseini et al, have shown  crocus sativus  to be particularly beneficial in the treatment of pre-menstrual symptoms. 
         [0028]    The present invention, therefore, provides methods and embodiments for optimization of the medicinal benefits of saffron. Specifically, embodiments of  crocus sativus  comprising extracts, compounds and mixtures are provided for use in the treatment of various medical ailments, particularly for the treatment of pre-menstrual symptoms. 
         [0029]    In addition, embodiments and methods are provided for use of  crocus sativus  comprising extracts, compounds and mixtures for use with various inhalation apparatus and methods such as vaporization and nebulization. 
       DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0030]    Before saffron can be used for its medicinal properties, it is first modified to extract, modify and concentrate the carotenoids comprised within the  crocus sativus.    FIG. 1  is a flow chart that illustrates a preferred embodiment of the  crocus sativus  extraction process of the present invention. In the embodiment, a constituent mixture comprising  crocus sativus  is steeped in a heated solvent or liquid to extract and concentrate the  crocus sativus  therewithin. The steeped  crocus sativus  extract may then be mixed with other solvents and/or chemicals to further modify the medicinal mixture. This modification process preferably utilizes a steeping of the  crocus sativus  combined with other optional herbs and extracts in a heated solvent. The steeping process preferably extracts and concentrates the carotenoids comprised within the  crocus sativus.    
         [0031]    In a first step of the preferred process, a solvent, such as water is heated to a desired temperature. In step  2 , the constituents comprising  crocus sativus  are added to the heated solvent and are allowed to steep in the solvent for a period of time to thereby extract and concentrate the medicinal properties of the  crocus sativus.  In the following step, the extract constituents are removed from the solvent and the extract is cooled, for example, to room temperature. The  crocus sativus  concentrated extract is now ready to be utilized for therapeutic applications, particularly with an inhalation delivery device. 
         [0032]    In addition, other constituents may also be added to the saffron and steeped together. Examples of additional non-limiting constituents that may be added to the mixture include herbs and spices such as turmeric, lavender, cinnamon, various mints, flavorings, vitamins, aromatics or other organic materials. In a preferred embodiment, at least one of the constituents may be soluble in water, ethyl alcohol or a mixture thereof. 
         [0033]    In a preferred embodiment,  crocus sativus  is added to water, such as distilled water. Other liquids or solvents such as, but not limited to, hydrocarbons, oils such as hemp and vegetable oils, alcohols such as ethyl alcohol, vegetable glycerins, tinctures, vinegar, glycerol, ether, infused liquids or combinations thereof, may be used as a steeping solvent. For the purpose of the present invention, the term “steep” is defined as soaking in a liquid such as water to soften, cleanse, extract or infuse a constituent. The term “extract” is defined herein as a preparation containing the active ingredient of a substance in concentrated form. The term “infusion” is defined herein as the extraction of an active substance through the use of steeping. The term “tincture” is defined herein as an extract from a plant or animal. Tinctures may comprise a variety of solvents including but not limited to ethyl alcohol, vinegar, glycerol, ether and propylene glycol. A tincture comprising  crocus sativus  may be placed directly in the mouth, such as on the tongue or alternatively may be positioned within an inhaler, nebulizer, vaporizer or container thereof. 
         [0034]    In a preferred embodiment, the solvent, such as water is first heated to about 100° C. (212° F.) at which point the solvent is removed from the heat source. Saffron is then added to the heated solvent, i.e., water, to extract and concentrate the  crocus sativus.  The saffron may comprise any commercially available form. Non-limiting examples are as dried “threads”, as a powder or combination thereof. In addition, the saffron may be contained within a fabric, a paper envelope or package such that the solvent and the  crocus sativus  extract is able to permeate therethrough. The form of the package is non-limiting and may comprise a pouch, a pillow, a bag, or similar container. 
         [0035]    Alternatively, the saffron may be added directly into the solvent without being placed within a separate package or container. The steeped medium may be prepared in advance and may be bottled for future use. 
         [0036]    The saffron may be steeped using a non-limiting combination of time intervals and solvent temperatures. For example, saffron may be steeped for a longer period of time in a solvent (i.e., water) having a temperature of 10° C. (50° F.) as compared to steeping in a solvent having a temperature of about 96° C. (205° F.). Table 1 shown below, illustrates an embodiment of the relationship between solvent temperature and steeping time. In a preferred embodiment, steeping time may range from about 30 seconds to about 15 minutes. However, a preferred steeping time ranges from about 1 minute to about 5 minutes. 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                 TABLE 1 
               
               
                   
                   
               
               
                   
                 Solvent Temperature 
                 Steeping Time 
               
               
                   
                 (° C.) 
                 (minutes) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 10 
                 15 
               
               
                   
                 35 
                 10 
               
               
                   
                 60 
                 5 
               
               
                   
                 85 
                 3 
               
               
                   
                 100 
                 1 
               
               
                   
                   
               
             
          
         
       
     
         [0037]    In addition, the amount of saffron added to the solvent also affects the optimal steeping time interval. In general, the more saffron added to the solvent, a longer steeping time is required to extract an effective therapeutic amount of  crocus sativus.  A preferred steeping temperature is about 65° C. (150° F.) for a period of time commensurate with the amount of saffron added. Table 2 shown below, illustrates preferred steeping times for different amounts of saffron. These time intervals should be added to the previously given time intervals based on liquid temperature. For example, when steeping about one gram of saffron at 60° C., the total preferred steeping time is about 7 minutes, 5 minutes for 60° C. solvent (Table 1) and an additional 2 minutes for the additional 0.75 g of saffron. 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                 TABLE 2 
               
               
                   
                   
               
               
                   
                 Amount of Saffron 
                 Additional Steeping Time 
               
               
                   
                 (g) 
                 Interval (minutes) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 0.25 
                 0 
               
               
                   
                 0.50 
                 1 
               
               
                   
                 1.0 
                 2 
               
               
                   
                 2.0 
                 4 
               
               
                   
                 3.0 
                 6 
               
               
                   
                   
               
             
          
         
       
     
         [0038]    Color of the steeped solvent may be used as an indicator to determine the concentration level of extraction. The concentration level of extraction is important, as the darker the infused solvent appears, typically the more concentrated the  crocus sativus  extract. Thus, concentration of the extract can be controlled by analysis of the color and hue of the appearance of the extract. Color intensity may range from a light yellow to a darker orange color. The longer the time interval the saffron is steeped at a given temperature, generally the deeper and darker the extract color and, subsequently, the more concentrated the infusion or extract. Also affecting color and infusion or extract concentration is the amount of saffron being steeped. In general, the greater the amount of saffron being steeped, the deeper and darker the color and, subsequently, the more concentrated the infusion or extract. Therapeutic saffron steep levels will vary from individual to individual. In a preferred embodiment, the concentration of  crocus sativus  in the solvent is at least about 0.01 mg/ml. In a more preferred embodiment, the concentration of the  crocus sativus  in the ranges from about 0.01 mg/ml to about 10 mg/ml. The solvent may comprise water, ethyl alcohol, or combinations thereof. 
         [0039]    Once the saffron is steeped, the infused solvent may either be placed in a steamer or humidifier, a nebulizer, an aerosol delivery device, such as an inhaler or similar vaporizing or humidifying apparatus. Other therapeutic agents may be added to the infused solvent. Delivery of the vapor or mist may be assisted using oxygen, compressed air, or ultrasonic power. 
         [0040]    A non-limiting example for preparing a steeped inhalation medium is as follows. Heat about 235 ml or about 235 g of water, preferably distilled water, to a temperature of about 100° C. Remove the water from the heat and allow the water to cool to a temperature of about 65° C. (150° F.) It is important to allow any solvent being used to steep saffron to cool to at least 65° C. (150° F.) before steeping, otherwise the therapeutic advantage of the steeped agent may be significantly diminished, and might even be rendered ineffective. 
         [0041]    After the solvent reaches the desired temperature, about 0.25 g of the  crocus sativus  stigma or other saffron form is added to the heated solvent and allowed to steep from about 5 to about 10 minutes, depending upon the desired concentration strength. After the concentration of the  crocus sativus  is achieved, the steeping constituents are removed from the infused solvent, for example by a straining process. The extract is then cooled to about 25° C. at which it is then placed within a container or chamber for inhalation therapy. 
         [0042]    The mixture comprising the solvent and  crocus sativus  is preferably stirred until the desired concentration is achieved, as evidenced by the preferred color change of the steeped mixture. In a preferred embodiment, the mixture of the  crocus sativus  and solvent is steeped such that the color of the mixture changes to an orange color having a Pantone® identification number of 144C. Typically, the steeping mixture changes from a brown color, having a Pantone® identification number ranging from 127C to 129C, to a darker brown, having a Pantone® identification number ranging from 135C to 137C or in the Pantone® identification number 1375 color family, and then finally to an orange color, having a Pantone® identification number of 144C. 
         [0043]    The Pantone® Color Matching System is a standardized color reproduction system that may be used to accurately reproduce the intensity and hue of a color. The system uses standardized color mixtures to accurately replicate various shades and intensity of colors. The Pantone® Matching System may be used as a means by which to assess readiness of the steeped medium for use in inhalation therapy. Pantone Guides provide a number of color swatches for color matching. “Pantone” is a registered trademark of Pantone LLC, of Carlstadt, N.J. 
         [0044]      FIG. 2  illustrates an embodiment of an inhaler  10  that may be used to deliver the  crocus sativus  infusion or medicinal extract. In a preferred embodiment, the inhaler  10  comprises a housing  12  having an opening  14  that extends to a mouth piece  16 . In a preferred embodiment, a distal end  18  of the opening  14  is designed to receive an inhaler container or vessel  20 , such as a sealed inhaler canister and an opening proximal end  22  that comprises the inhaler mouth piece  16 . The inhaler mouth piece  16  is designed to channel the released therapeutic aerosol comprising the  crocus sativus  mixture to a patient. In addition, the inhaler  10  comprises an actuation mechanism  24 . The actuation mechanism  24  activates the release of a therapeutic aerosol  26  from within the inhaler container or canister  20 . 
         [0045]    In a preferred embodiment, the actuation mechanism  24  comprises a moveable mechanism member  28  that operates a container release valve  30  that enables the contents within the container to expel out. In a preferred embodiment illustrated in  FIG. 2 , the moveable mechanism member  28  compresses against a distal end  32  of the release valve  30 . When compressed, the contents contained within the inhaler container  20  expel out through the valve  30 . The movable mechanism member  28  may comprise a moveable portion of a sidewall  34  of the housing  12  or may comprise an actuation button  36  that when depressed, causes the release of the contents contained within the inhaler container  20 . 
         [0046]    In a preferred embodiment, a medicinal therapeutic mixture  38  comprising the  crocus sativus  extract, infusion or combination thereof, is contained within the sealed inhaler container or canister  20 . In addition to the  crocus sativus  extract, other solvents or medicinal compounds such as ethyl alcohol, glycerin and tinctures may be mixed with the  crocus sativus  and contained within an interior  40  of the container  20 . In addition, a propellant such as a chlorofluorocarbon or a hydrofluoroalkane may be comprised within the container  20 . The propellant is preferably mixed with the medicinal therapeutic mixture  38  comprising the  crocus sativus  extract. In addition, the propellant provides an aerosol medium with which the  crocus sativus  extract or infusion mixture thereof is expelled from within the container  20 . Once expelled from the container  20 , the aerosol  crocus sativus    26  travels through the mouth piece  16  of the inhaler  10 , where it is thus inhaled by a patient. 
         [0047]      FIG. 3A  illustrates a generalized embodiment of a jet nebulizer  42  that may be used to create an aerosol  44  of the medicinal therapeutic mixture  38  comprising the  crocus sativus  extract. In a preferred embodiment, the jet nebulizer  42  comprises a reservoir  46  within which the therapeutic mixture  38  comprising the  crocus sativus  extract or infusion may reside. In addition, the jet nebulizer  42  comprises a housing  48  having first and second openings  50 ,  52 . In a preferred embodiment, the first opening  50  extends to a mouth piece  54  that interfaces with a patient. The second opening  52  comprises a gas intake end  56 . In a preferred embodiment, ambient air enters through the gas intake end  56 . As shown in the figure, a compressed gas carried by a tube  58  is introduced into the reservoir  46 . The compressed gas forces the medicinal therapeutic mixture  38  comprising the  crocus sativus  through a baffle  60  at which pressure from the air intake end  56  creates the aerosol mist  44  comprising the  crocus sativus.  The aerosol mist  44  is then inhaled by a patient through the mouthpiece  54 . In a preferred embodiment, the compressed gas may comprise ambient air, oxygen, an inert gas, or combinations thereof. 
         [0048]      FIG. 3B  illustrates a generalized embodiment of an ultrasonic nebulizer  62  which may be used to produce a therapeutic aerosol  64  of the therapeutic mixture  38  comprising the  crocus sativus  extract or infusion thereof. As previously mentioned, the ultrasonic nebulizer  62  utilizes an oscillating or vibrating transducer  66  that creates the aerosol particles  64 . In this case the aerosol particles  64  comprise the infused  crocus sativus  mixture. As shown, the ultrasonic nebulizer  62  comprises a housing  68  having a reservoir portion  70 . In a preferred embodiment, the  crocus sativus  infusion mixture  38  resides within the reservoir portion  70 . In addition, the transducer  66 , such as a piezoelectric transducer, is submerged within the  crocus sativus  infusion mixture. In a preferred embodiment, the transducer  66  is positioned on an interior surface  74  of a bottom sidewall  76  of the reservoir  70 . Vibration of the transducer  66  within the therapeutic mixture  38  comprising the  crocus sativus  infusion mixture creates a plurality of aerosol particles  64  which escape from the reservoir container  70 . As shown, electrical power is supplied to the transducer  66  through an electrically connected power source  72 . 
         [0049]    In addition, as shown, the nebulizer  62  has a first opening  76  that extends through a sidewall  78  of the housing  68 . The first opening  76  extends to a mouth piece  80  that interfaces with a patient. A second opening  82  opposed from the first opening  76 , extends through a second portion  84  of the housing sidewall  78 . The second opening  82  comprises an air intake designed to receive a gas such as compressed air, oxygen, an inert gas or combinations thereof. Pressure created by the air or gas entering the intake opening  82  forces the aerosol  64 , created by the transducer  66 , out through the mouthpiece  80  where it is inhaled by a patient. 
         [0050]    In another embodiment, a portable inhaler device  86  such as the embodiment shown in  FIG. 4  may be used as a vehicle in which a therapeutic mixture  88  comprising the  crocus sativus  is inhaled. The inhaler  86  comprises a housing  90  having an elongated length  92  that extends between opposing first and second housing ends  94 ,  96 . In a preferred embodiment, the inhaler housing  90  comprises an enclosure formed in an elongated tubular form. In a preferred embodiment, the inhaler housing  90  extends to an annular opening  98  at the second housing end  96 . The opening  98  extends through a housing sidewall  100  and provides access to an interior housing region  102 . In addition, the opening  98  acts as the interface to the patient. In a preferred embodiment, the inhaler  86  shown in  FIG. 4 , is positionable within a nose of a patient, wherein the medical therapeutic mixture  88  therewithin is inhaled. Alternatively, the opening  98  of the inhaler  86  may be positioned within the patient&#39;s mouth to facilitate inhalation of the  crocus sativus  extract. 
         [0051]    In a preferred embodiment, the therapeutic mixture  88  comprising the  crocus sativus  extract, infusion mixture or compound thereof resides within the interior region  102  of the inhaler  86 . In addition, a mixture comprising ethyl alcohol, a wax, petroleum jelly, polymeric material or combinations thereof may be mixed with the  crocus sativus  to thus form a therapeutic compound  104  that is positionable within the interior  102  of the inhaler housing  90 . A wick  106  or a fillable packaging  108  may reside within the inhaler housing  90 . Preferably at least a portion of the wick  106  may reside within the  crocus sativus  comprising mixture  88  or compound  104 . The wick  106  may be made of cotton or other absorbent material. The wick  106  may also be soaked in the saffron infusion or extract or may be added by droplets to the wick  106  (from 5 to 30 or more) and then assembled for inhaling. 
         [0052]    A cap  110  may be positioned over the opening  98  to prevent evaporation or contamination of the therapeutic mixture  88  or compound  104  residing within the housing  90 . The inhaler housing  90  may be made of a polymer, plastic, metal, cardboard, glass, composite or other such structural material. 
         [0053]    In another embodiment, the inhaler  86  may house commercially available saffron that may be packaged within the fillable packing or secondary container  108  such as, but not limited to, a cotton pillow, a woven or non-woven fabric, or an absorbent paper pouch, that resides within the nose inhaler housing  90 . In a preferred embodiment, the saffron within the secondary container  108  may be activated with water (or other solvent such as ethyl alcohol). Individuals may conduct repeated periodic inhalation until therapeutic relief is achieved. 
         [0054]    In a preferred embodiment, the secondary container  108  may comprise a pouch, bag or a pillow that encloses an amount of  crocus sativus.  The secondary container  108  may be constructed by enclosing an amount of an extract constituent, such as  crocus sativus  within about a 3 cm to 4 cm by a 1 cm to 2 cm area of material on three sides. The secondary container  108  is formed by, for example but not limited to, folding or sealing three of the sides of the material together. In a preferred embodiment, about 0.5 g to about 3 g of  crocus sativus  stigma or other saffron form is inserted into this 3 sided sealed package. After the saffron is positioned inside the container  108 , the fourth side of the material is sealed along with the other three sides. The secondary container  108 , comprising the extract constituent is then placed within the housing  90  of the inhaler  86 . About 3 ml to 9 ml of distilled water, preferably having a temperature greater than 10° C. is then poured onto the filled secondary package  108 . 
         [0055]    In addition to vaporizing the  crocus sativus  infusion or extract into an aerosol mist, as previously described, a concentrated form of a medicinal compound  104  may be made by combining the  crocus sativus  with a variety of non-limiting oils, waxes, gels, petroleum jelly, ethyl alcohol, or other solvents. In this embodiment, the  crocus sativus  may be mixed with a combination of these oils, waxes, and/or alcohols to create a concentrated hardened medicinal compound of  crocus sativus.  In an embodiment, the medicinal compound  104  may be positioned within the inhaler  86  illustrated in  FIG. 4 . In addition to vaporizing the hardened medicinal  crocus sativus  compound, it is further contemplated that the medicinal compound  104  may be ingested. Such an ingestible  crocus sativus  comprising compound may contain ingestible materials such as, but not limited to ingestible oils, waxes, ethyl alcohol, flavorings, herbs such as cinnamon, turmeric, mint as well as vitamins, water and alcohol soluble additives and/or hardeners. Furthermore, it is contemplated that the  crocus sativus  extract or infusion mixture may be ingested itself or applied to the skin. Such a mixture for topical applications may also comprise a cream or oil designed for application to the skin. 
         [0056]    In an embodiment, vaporization of the medicinal therapeutic mixture  38  comprising the  crocus sativus  infusion, and/or the  crocus sativus  comprising medicinal compound  104 , may be accomplished through contact with a heat source (not shown) such as a heated surface. A heated or non-heated forced air source (not shown) may also be used in combination with the heat source to facilitate vaporization of the  crocus sativus  comprising mixture. The emanation of such a vapor resulting from the heating of the medicinal compound  104  or mixture  38  may be directly inhaled from a vaporization device such as a humidifier (not shown), through a connector device (not shown), such as but not limited to a mask, a tube, a balloon or a nose piece that is connectable to the vaporization device (not shown). The  crocus sativus  medicinal compound or infusion is preferably deposited within a chamber of the vaporization device such that it is in contact with the heat source. 
         [0057]    Vaporizers typically reach temperatures between about 680° C. (360° F.) and 806° C. (430° F.) which is a temperature capable of vaporizing the  crocus sativus  infusion mixture  38  or medicinal compound  104 . Digitally controlled vaporizers may be used by individuals preferring to set specific vaporization temperatures. Generally, temperatures less than 842° C. (450° F.) are used as organic matter burns above that temperature, potentially contaminating the vapors with toxic materials. 
         [0058]    In another embodiment, a humidifier (not shown) containing the infused saffron  38  or medicinal compound  104  may be placed in a room without the aid of a connector device (not shown). In this embodiment, the vaporized  crocus sativus  comprising infusion mixture  38  or medicinal compound  104  is emanated through the air surrounding the humidifier. Inhalation of the saffron infused steam may be achieved by the individual&#39;s presence within the room being humidified. Inhalation can occur while sleeping, working, or other activity being conducted within a room to provide treatment of a medical ailment, such as reducing pre-menstrual symptoms. 
         [0059]    In another embodiment, the  crocus sativus  extract  38  and/or medical compound  104  may be vaporized using an electric cigarette  112  as shown in  FIG. 5 . The electronic cigarette  112  typically comprises a heating element  114 , i.e., an atomizer that heats a liquid or material contained within an electronic cigarette container or cartridge  116  until it reaches its vaporization point. The mixture  38 , in this case, the  crocus sativus  comprising extract or infusion mixture or compound  104 , as previously discussed, is contained within the electronic cigarette container or cartridge  116  that resides within an electronic cigarette housing  118 . A micro-controller  120  connected to an electrical power source  122  may be used to activate the atomizer  114  and vaporize the  crocus sativus  extract contained therewithin. An operating indicator  130  such as a light emitting diode (LED) or other light source may be controller by the micro-controller  120  to indicate that the heating element  114  is operating. 
         [0060]    In a preferred embodiment, heat emanating from the heating element  114  heats the electronic cigarette container  116 , converting the therapeutic mixture  38  comprising the  crocus sativus  extract or infusion mixture into an aerosol particle vapor  124  that is inhaled by a user. Alternatively, the heating element  114  may also heat the  crocus sativus  comprising compound  104  which may be contained therewithin, thus converting it into aerosol particle vapor  124 . The aerosol vapor particles  124  are delivered through an opening  126  of the housing  118  which serves as a mouth piece  128  through which a user may inhale, thus forcing the vapor  124  into the lungs of the user. The electronic cigarette delivery concept provides a vapor, or steam comprising  crocus sativus  that may be inhaled into the lungs to provide instantaneous therapy and relief of the various medical ailments previously discussed. The above detailed description and examples are intended for purposes of illustrating the invention and are not to be construed as limited.