Abstract:
An inhaler having a housing containing a low temperature material. Positioned in the housing is a coil or other pathway isolated from the housing and defining an airflow passageway. The coil and the air inside the coil are cooled by the low temperature material when activated. The low temperature material is normally in an inactive state, and requires activation in order to cool. Activation can be initiated immediately prior to use by flexing a flexible or collapsible member in which an activating agent is stored. Also disclosed is a method of activating a low temperature material by causing the low temperature material to contact an activating agent, and inhaling (or forcing manually or automatically) cool air from the device to cause cool air to enter the airways of a patient.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates to inhalation apparatus for the relief from symptoms of various respiratory illnesses or distresses, including postoperative distress, and to methods of treating such symptoms. 
         [0002]    There are a number of diseases and conditions that may cause upper respiratory tract symptoms that result in considerable discomfort. Exemplary diseases and conditions include the common cold, croup, laryngitis, Laryngotracheobronchitis, bronchitis, strep throat, mononucleosis, whooping cough (pertussis), respiratory tract infections, respiratory syncytial virus (RSV), flu, pneumonia, allergies, asthma, tonsillitis, etc. Exposure to severe environmental conditions, such as excessive heat during a fire or exposure to toxic gases may result in similar symptoms and cause similar discomfort. In addition, such discomfort may be present after surgery, particularly where anesthesia is involved, or may manifest itself as a consequence of sleep apnea. 
         [0003]    Various remedies that attempt to reduce or alleviate such discomfort are available, including vapor rubs, cough drops and lozenges, humidifiers, vaporizers, etc. These remedies, however, suffer from various disadvantages. For example, humidifiers, cool mist vaporizers or ultrasonic nebulizers require confining the patient to a relatively small area, as does the use of a hot shower, which confines the patient to a space that is relatively small and that can be very uncomfortable. Bacteria and fungi can grow in the filters and water tanks of portable and console humidifiers, and can be aerosolized and distributed throughout the room. Cough drops and lozenges can have high sugar content and can be high in calories. 
         [0004]    It would therefore be desirable to provide a device that is inexpensive and convenient to use, and that reduces or eliminates the foregoing discomforts without suffering from the drawbacks of the prior art. 
       SUMMARY OF THE INVENTION 
       [0005]    The problems of the prior art have been overcome by the present invention, which provides portable, recyclable or disposable inhaler device and a method of treating various symptoms associated with the airway and/or throat and/or respiratory system of a patient by cooling the airway and/or throat. The device is particularly designed to reduce swelling and inflammation of, and/or relieve symptoms associated with the swelling and inflammation of the larynx and or upper respiratory track, such as swelling and/or inflammation that result from croup, laryngitis&#39;s, laryngotracheobronchitis, sleep apnea, anesthesia, and other diseases and conditions including those mentioned above. The device does not require that the user wear a mask. 
         [0006]    In certain embodiments, the device is disposable after a single use, and includes a housing containing a low temperature material. Positioned in the housing is a coil or other pathway isolated from the housing and defining an airflow passageway. The coil, and therefore the air inside the coil, is cooled by the low temperature material. When a patient inhales from the device, air in the airflow passageway cooled (and/or humidified) by the low temperature material flows into the patient&#39;s airways. 
         [0007]    In certain embodiments, the low temperature material is normally in an inactive state, and requires activation in order to function as a low temperature material. Activation is typically initiated immediately prior to use. 
         [0008]    In certain embodiments, an activating agent is stored in a flexible member in fluid communication with the low temperature material. Upon flexing of the flexible member (such as by compression, stretching or twisting), the activating agent is released and comes into contact with the low temperature material, causing an endothermic reaction with the low temperature material. 
         [0009]    In its method aspects, the present invention includes activating a low temperature material by causing the low temperature material to contact an activating agent, and inhaling (or forcing manually or automatically) cool and/or moist air from the device to cause cool and/or moist air to enter the airways of a patient. 
         [0010]    The device can be hand-held, and is generally suitable for a single one-time use, after which it can be recycled or disposed of. 
     
    
     
       BRIEF DESCRIPTION OF THE INVENTION 
         [0011]      FIG. 1  is a perspective view of a device in accordance with certain embodiments; 
           [0012]      FIG. 2  is a cross-sectional view of a device in accordance with certain embodiments; 
           [0013]      FIG. 3  is a side view of a device in accordance with certain embodiments; 
           [0014]      FIG. 4  is a cross-sectional view taken along line  4 - 4  of  FIG. 3 ; 
           [0015]      FIG. 5  is a top view of a device in accordance with certain embodiments; 
           [0016]      FIG. 6  is a cross-sectional view of a mouthpiece in accordance with certain embodiments; 
           [0017]      FIG. 7  is an exploded view of a device in accordance with certain embodiments; and 
           [0018]      FIG. 8  is an exploded view of a device in accordance with other certain embodiments. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0019]    Turning first to  FIGS. 1-5  and  7 - 8 , there is shown a device  10  in accordance with certain embodiments of the present invention. The device  10  includes a housing  12  that is shown in the shape of a cylinder. Those skilled in the art will appreciate that other shapes, including rectangles and irregular polygons are suitable and are within the scope of the invention. Preferably the housing  12  is rigid, liquid impervious, and is durable. Suitable materials include plastics, polypropylene, polyvinyl chloride, polytetrafluoroethylene (TEFLON), polyethylene, polycarbonate, Styrofoam, polystyrene, acrylic, metal, glass, etc. The most preferred material is FDA approved low-density polyethylene or high-density polyethylene. The housing  12  can be made to have antimicrobial and/or antibacterial properties, such as by coating or embedding an antimicrobial and/or antibacterial agent therein. The housing  12  defines a volume or chamber that is sized to accommodate, when the device  10  is in its assembled condition, an airflow pathway  20  (best seen in  FIG. 2 ), such as a coil, and a low temperature material or a material adapted to become a low temperature material upon activation. 
         [0020]    The airflow pathway  20  is preferably isolated from the air in the remainder of the volume defined by the housing  12 , such that air within the pathway  20  does not mix or commingle with air (or liquid) within the remainder of the housing  12 . Although a coil is the preferred structure defining the pathway  20 , which coil provides a large surface area that is exposed to the low temperature material that is contained in the housing  12 , other shapes are within the scope of the present invention. The pathway  20  has a smaller outer diameter than the inner diameter of the housing  12 , such that the housing can contain the structure defining the pathway  20 , when the device  10  is assembled, and preferably such that a gap  30  between the inner wall of the housing  12  and the structure defining the pathway  20  is maintained ( FIG. 2 ). The pathway  20  preferably has a length similar to the length of the housing  12 . 
         [0021]    The pathway  20  is defined by a coil that can be made out of a thermally conductive material, such as stainless steel, so that the air inside the coil is quickly and efficiently cooled by the low temperature material contained in the housing  12 . The coil shape provides a large surface area for cooling of the air in the pathway  20 . Other materials of construction for the coil such as a thermoplastic, or a metal-coated thermoplastic, may be preferred due to their relatively low cost, particularly in view of the disposable nature of the device. 
         [0022]    The interior volume or chamber of the housing  12  is configured to hold a low temperature material or coolant (i.e., a material having a lower temperature than the ambient air, preferably at least 10-20° lower, although about 30° lower is acceptable). In the preferred embodiment, the interior volume holds ammonium nitrate that, upon activation, mixes with a fluid to initiate an endothermic reaction, creating a low temperature material. That is, preferably the low temperature material is a material that is normally at room temperature, and that can be caused to lower in temperature by some positive act, such as by mixing with a fluid such as water. Thus, the term “low temperature material” as used herein includes materials that are not initially at a temperature significantly lower than the temperature of the air in the pathway  20  or the ambient, but can be made to have (and preferably retain for at least several minutes) a low temperature relative to the temperature of the air in the pathway  20  or the ambient. Preferably the low temperature material is located in the vicinity of the structure defining the pathway  20 , surrounding as much of the surface area of the structure defining the pathway  20  as possible, to enhance the transfer of heat between the structure and the low temperature material. Most preferably, the low temperature material comprises ammonium nitrate crystals. The effective amount of ammonium nitrate crystals (and activating agent) used can be readily determined by those skilled in the art in order to obtain a temperature lowering to about 50-65° F. for about 15-30 minutes. 
         [0023]    The structure defining the pathway  20  has a first open end  15  and a spaced second open end  16 . The first open end  15  allows for the ingress of air into the passageway  20 , such as from the ambient. The second open end  16  allows for the egress of air from the passageway into or in the vicinity of the user&#39;s mouth and/or nose. Preferably the first and second open ends are located on the same side of the structure defining the passageway  20 , most preferably such that when the structure is contained in the outer housing  12 , the first and second open ends are at or near the top of the housing  12  such that they can be in respective fluid communication with an intake port and an outtake port in end cap or cover  60 . 
         [0024]    Preferably the cover  60  includes an intake port  64  and an outtake port  63 . The intake port  64  is in fluid communication with the first open end of the structure defining pathway  20 , and the outtake port  63  is in fluid communication with the second open end of the structure defining pathway  20 . Accordingly, an airflow loop is defined between the intake port  63 , the outtake port  63 , and the structure defining the pathway  20 . A mouthpiece  90  suitable for use with the device of the invention can be coupled to the outtake port  63 . Preferably the mouthpiece  90  is made out of a polyolefin, most preferably polypropylene. One suitable mouthpiece is commercially available from Teleflex Incorporated. Such a mouthpiece  90  has a cylindrical portion  91  having an open end  92 . The mouthpiece  90  can be inserted onto the outtake port  63  and fits snuggly thereon by frictional engagement unless it is forceably (such as by manually pulling on the mouthpiece) removed therefrom. The mouthpiece can be removable from the outtake port and can be substituted with a different mouthpiece, depending upon the particular needs of the user. 
         [0025]    The distal end of the mouthpiece  90  has an oval shaped opening  94  shaped to the average general contour of a person&#39;s mouth ( FIG. 6 ), defined by an outwardly extending flange portion  95  adapted to fit into the patient&#39;s mouth and around which the lips of the patient can be positioned so comfortably position and maintain the mouthpiece in the patient&#39;s mouth. 
         [0026]    Mouthpiece  90  preferably has an internal filter assembly  96 , integrally molded therein. In the embodiment shown, the filter assembly  96  includes a front checkerboard grate  97 , and opposite side filters  98  tapering outwardly as they extend towards the end  92  of the mouthpiece  90 . The filter assembly  96  helps ensure that no particular matter enters the patient&#39;s mouth during use of the device, and is shaped to direct the airflow towards the center of the mouthpiece. Those skilled in the art will appreciate that other filter assemblies could be used without departing from the spirit and scope of the invention. 
         [0027]    In an alternative embodiment, the mouthpiece  90  can be attached to suitable flex medical tubing (not shown), which tubing is then attached to the device. This allows the device  10  to be positioned further away from the patient&#39;s mouth if desired. In yet a further alternative embodiment, a facemask can be placed in fluid communication with the device and can be worn by the user to cover the user&#39;s mouth, nose or both. Alternatively still, a nasal cannula can be positioned in fluid communication with the outtake port  63  to direct air into the nose of the patient. 
         [0028]    The device  10  includes a flexible member such as a compressible bellows  25  having an internal volume that contains an activating agent, preferably water. Preferably the activating agent is stored in a piercable housing  28 , such as a plastic bag. The internal volume of the flexible member is in fluid communication, or can be caused to be in fluid communication, with the internal volume of the housing  12 . Compression, twisting, stretching, squeezing or bending of the flexible member, which can be carried out manually, compresses the piercable housing, which breaks the housing and expels the fluid therein. Such manipulation of the bellows also forces the expelled fluid to flow into the housing  12 , where it contacts the low temperature material (e.g., ammonium nitrate), causing the material to cool. The bellows  25  is preferably made of a compressible plastic material, such as a low or high density polyolefin, e.g., low or high density polypropylene or low or high density polyethylene, and can include a bottom cap  26  as shown in  FIGS. 1 and 4 . As best seen in  FIG. 4 and 5  and  7  and  8 , plastic baffle  3  with a plurality of perforations can be positioned between the housing  12  and the bellows to prevent the ammonium nitrate from displacing from the interior volume of the housing  12  into the interior volume of the bellows. The baffle also serves as a barrier against which the plastic bag in the bellows is compressed upon compression of the bellows. A vent or exhaust port (not shown) or a microfilter  40   FIG. 8 ) can be located in the device, such as in cover  60 , to expel excess air that is forced out of the flexible member  25  upon compression, twisting, stretching or squeezing. 
         [0029]      FIG. 8  illustrates an embodiment where the bottom cap  26  is locked onto the device to prevent disassembly or leakage. In the embodiment shown, the bottom cap  26  includes longitudinally extending arms  29 ,  29 ′that terminate in respective notched ends  31 ,  31 ′. The notched ends  31 ,  31 ′ are configured to receive corresponding protrusions  32 ,  32 ′ (only one shown) located on the surface of the housing  12  in locking engagement to secure the bottom cap  26  in place. 
         [0030]    In use in a first mode of operation, an effective amount of a low temperature material, such as ammonium nitrate, is placed in the interior of the housing  12 , and an effective amount of activating agent, such as water, is placed in the interior of the flexible member. The amount of low temperature material is not particularly limited, but should be present in a sufficient amount that upon activation, it cools the airflow passageway (and thus air in that passageway) to a sufficient degree (a cooling of about 10-20 degrees less than ambient) quickly and for a sufficient amount of time, preferably at least about 15-30 minutes. The ammonium nitrate is activated, such as by breaking an inner bag or container within the compressible member (e.g., bellows  25 ) by flexing the flexible member such as by compression, causing the fluid in the bag to flow into the housing  12  and react with the ammonium nitrate therein. The activation of the low temperature material is preferably carried out just prior to use of the device by the patient. The now cool solution of ammonium nitrate and water flows around the airflow passageway and cools the same. Agitation of the device optionally can be carried out to enhance the cooling. The patient then places his mouth about the mouthpiece  90 , and inhales. The inhalation is a driving force that draws ambient air into the device  10  through the intake opening  64 , through the pathway  20 , where the air in the pathway  20  is cooled by the low temperature material. The now cool air exits the pathway  20  and enters the mouthpiece  90 , from which it enters the mouth of the patient, where it cools the throat, larynx, upper respiratory tract, etc. of the patient, providing soothing relief thereto. The intake opening and outtake opening, although in fluid communication via the pathway  20 , are segregated; intake air must flow through the pathway  20  (and thus be cooled by the low temperature material) prior to reaching the outtake. The patient may then remove his mouth from the mouthpiece  90  and exhale into the ambient environment. Once the low temperature material is no longer cool relative to the ambient, the apparatus can be properly disposed of. 
         [0031]    In an alternative mode of operation, particularly applicable for use with small children (e.g., under 3 years of age), infants or the elderly, an air assist can be provided. In this mode, a driving force, such as a manually operated air bulb, pump or fan, is then placed in fluid communication with the intake opening (such as through suitable tubing (not shown)), and is actuated such that air is forced into the pathway  20 , where the air contacts the low temperature material which effectively lowers the temperature of the air. The now cool air exits the pathway  20 , flowing through the mouthpiece  90  and into the mouth of the patient. It should be noted that the mouthpiece need not be positioned inside the mouth of the patient; it is sufficient to place the mouthpiece or outtake in proximity to the mouth and/or nose of the patient (e.g., within about 3 inches thereof) to effectively cool the air that the patient is breathing. Indeed, this allows the patient to breath normally without forcing too much cool air into the respiratory system of the patient. It should be noted that the mouthpiece can be omitted entirely in this mode. Alternatively still, a nosepiece such as a nasal cannula (not shown) can be used and can be inserted into the nose of the patient or placed in proximity thereto. The air assist as the driving force for air circulation through the device can be provided alone or in addition to inhalation by the patient.