Abstract:
This invention is directed to a medical device and a method of treating mammals, especially humans, to alleviate the symptoms, including pain, of several conditions and symptoms, including hemorrhoids, tissue inflammation and/or yeast infections, and open, draining wounds or incisions.

Description:
1. FIELD OF THE INVENTION 
       [0001]    This invention is directed to a medical device and a method of treating mammals, especially humans, to alleviate the symptoms, including pain, of several conditions and symptoms, including hemorrhoids, vaginal inflammation and/or yeast infections, and open, draining wounds or incisions. 
       2. BACKGROUND OF THE INVENTION 
       [0002]    Prior to the invention disclosed herein, conditions such as hemorrhoids have been treated with topical applications, or suppositories. One of the leading medicaments is phenylephrine (rectal). However, while the relief provided by this medicament is only temporary, it can be contra-indicated if the patient has high blood pressure and/or heart disease, thyroid disease, diabetes, and can lead to side effects, such as skin problems, including acne. Hemorrhoids have also been treated surgically, but of course, that is a much more involved and expensive method of treatment, which many patients are reluctant to undergo. Hemorrhoids may exist in several forms, including external, thrombosed, prolapsed internal, internal or combined (internal and external). 
         [0003]    Thus, there exists a need for temporary treatment and relief of the symptoms of hemorrhoids, without the contra-indications and side effects of phenylephrine (rectal) or the more invasive, expensive surgical treatment. 
       SUMMARY OF THE INVENTION 
       [0004]    In one aspect, the invention provides a medical device that can be used by the consumer who may have one or more of high blood pressure or heart disease, diabetes, thyroid disease or for the relief of tissue inflammation. On the other hand, the medical device of the invention will not cause side effects, such as acne. 
         [0005]    In yet other embodiments of the invention, there is provided a method of treating hemorrhoids, vaginal inflammation and/or yeast infections and draining open wounds or incisions. 
         [0006]    According to one embodiment of the invention, a low cost tubular element, having high heat capacity, which has been chilled, as by refrigeration or other mechanism (e.g., ice bath), can be inserted into the anal canal and/or rectum, vagina, or an open wound or incision of the patient. The chilling effect will bring temporary relief of the symptoms of hemorrhoids, such as the itching, burning sensations, in a non-chemical manner. Thus, there is no likelihood of the inducement of side effects or the contra-indications for patients as those for phenylephrine (rectal) noted above. For use in the treatment of inflammation in the vagina or in draining wounds or incisions, the cooling effect will provide temporary relief of these symptoms/conditions as well. 
         [0007]    The method of use of the medical device includes the chilling (by refrigeration, ice-bath, or otherwise) of the medical device, formed of the high heat capacity materials, and insertion/placement of the chilled medical device into the affected area. 
         [0008]    These and other embodiments of the invention will become apparent when read in light of the following detailed description of the preferred embodiments in conjunction with the appended drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is a schematic representation of typical hemorrhoids; 
           [0010]      FIG. 2  is a schematic representation of the medical device of the invention in its most basic form; 
           [0011]      FIG. 3  is a schematic representation of a medical device of the invention in another embodiment; 
           [0012]      FIG. 4  is a schematic representation of the medical device of the invention with a bail or string to aid in removal of the device after use; 
           [0013]      FIG. 5  is a further schematic representation of the medical device of the invention having a cross-sectional configuration which is triangular; 
           [0014]      FIG. 6  is a schematic representation of a medical device of the invention having at least one protuberance, which could contain an aperture in the form of an eye, to retain the bail or string to assist in removal of the medical device after use; 
           [0015]      FIG. 7  is a further variant having a groove at the proximal (nearer the external) end of the medical device when inserted for use to attach a bail or string to aid in removal of the device; 
           [0016]      FIG. 8  is a still further variant of the shape of the medical device having flared proximal and distal edges; 
           [0017]      FIG. 9  is a still further variant of the medical device of the invention, having an overall frusto-conical shape, but with numerous protuberances and surface striations. 
           [0018]      FIG. 10  is a still further variant in which the medical device has a rectangular cross-sectional shape with an aperture therethrough; 
           [0019]      FIG. 11  is a schematic representation of a medical device of the invention having at least one protuberance, which could be in the form of a hook, to retain the bail or string to assist in removal of the medical device after use; and, 
           [0020]      FIG. 12  is a schematic representation of a further embodiment of the invention having a generally cross-sectional shape of a rectangle with curved corners, and further containing surface striations on its external surface, wherein this embodiment further contains a notch facilitating the attachment of a bail or string to aid in removal of the medical device after use. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0021]      FIG. 1  illustrates various forms of hemorrhoids in the human patient. As can be seen from  FIG. 2 , the medical device  2 , in its simplest form can take the shape of a cylindrical tube, have a generally cylindrical outer surface  4 , with an aperture therein. The aperture could be a throughbore  6 , but it is to be understood that the aperture may be drilled or bored through a mass of material, after forming the device, or formed from a combination of boring and broaching, such that non-circular apertures could be formed, or it could be created in other variations, such as elliptical during forming of the material by extrusion, molding and other shaping techniques. Thus, while the term “throughbore” is used to describe the aperture, it should be expressly understood that as used throughout the specification and claims, both circular, flat-sided, and non-circular cross-sections of the aperture are encompassed by the term “throughbore”. The throughbore  6  is most conveniently placed along the center axis of the device  2  as seen in  FIG. 2 , but such placement is not essential and it may occupy a position other than that of a central axis of the device  2  as seen in  FIG. 2 . 
         [0022]      FIG. 3  illustrates a second embodiment of the medical device in which device  12  has a general frusto-conical shaped outer surface  14  with a flared end  15 . As in  FIG. 2 , a throughbore  16  is most conveniently placed along the center axis of the device  12 , but such is not essential as noted above. 
         [0023]      FIG. 4  illustrates a third variant of the medical device  22  of the invention having an aperture having an opening  27  in an end face thereof, with the other end of the opening  28  existing in a lateral surface thereof to accommodate a string  29  (or plastic-coated fine wire or high strength plastic, such as dental floss) to aid in removal of the device  22  after use. As with the embodiments of  FIGS. 2 and 3 , it has a throughbore  26 . 
         [0024]      FIG. 5  is a further variation of the medical device  32  of the invention having an external surface  34  of a shape such that a cross-section thereof is triangular. As with the embodiments of.  FIGS. 2-4 , it has a throughbore  36 . 
         [0025]      FIG. 6  illustrates a further embodiment of the medical device  42 , which includes a protuberance  47  on an outer surface of the device  42 . The protuberance  47  preferably takes the form of a notch therein, or has an aperture  48  therein. The purpose of the aperture  48  (or notch) is to secure a bail  45 , such as a string, plastic coated fine wire, or similar material, such as the plastic used for dental floss, as an aid for removing the used device  42 . 
         [0026]      FIG. 7  is a further variant of the medical device  52  having a groove  53  at the proximal end of the device  52 . The purpose of groove  53  is to secure a bail  54  to aid in removal of the device  52  after use. 
         [0027]      FIG. 8  is a still further variant of the shape of device  62  having flared proximal  64  and distal  66  edges, which may, in some patients, be more comfortable to retain in position while the chilled device  62  engages in heat transfer with the hemorrhoids. The embodiments of  FIGS. 6-8  all have throughbores. 
         [0028]      FIG. 9  is a still further variant of the medical device  72  of the invention, having an overall frusto-conical shape, but with numerous protuberances  75 - 78  and surface striations  79 . As with the other embodiments, the device  72  has a throughbore  73 . Although the surface striations are introduced with this embodiment, it is to be understood that the surface striations may appear in any of the embodiments disclosed herein, even though omitted from some drawing figures for purposes of clarity. The spacing of these surface striations is schematic, and they may take various forms such as being spaced 1/64 of an inch apart. Alternatively the surface striations can be 1/32; 3/64; 1/16; 5/64; 6/64; 7/64; ⅛; 9/64, etc. inches, or other increments, apart. The spacing of the surface striations may also be irregular, such that different spacing exists between adjacent striations. It is also to be understood that the striations may be formed as embossments or bumps (as in  FIG. 9 ) or as grooves (as in  FIG. 12 ). The purpose of these surface striations, which may be in the form of bumps, embossments, grooves or a roughened surface, is to assist with retention of the device in the body of the user or as a carrier for external ointments added thereon. 
         [0029]      FIG. 10  is a still further variant in which the medical device  82  has a generally rectangular cross-sectional shape with rounded edges and is provided with a throughbore  86 . 
         [0030]      FIG. 11  is a schematic representation of a medical device  92  of the invention having at least one protuberance, which could be in the form of a hook  95 , to retain the bail or string (not shown) to assist in removal of the medical device after use. As with the other devices, device  92  has a throughbore  96 . 
         [0031]      FIG. 12  is a schematic representation of a still further embodiment of the invention, where the medical device  102  of the invention has a generally rectangular cross-sectional shape with rounded corners. A groove  105  is provided along one rounded edge of the device to receive a bail, string, plastic coated fine wire, or other element, such as dental floss to aid in removal of the device  102  from the user. Similar to other embodiments of the invention, the device  102  contains an aperture  106 . A series of intersecting surface striations  108  covers at least opposed portions, but preferably all portions of outer surface of device  102 . As described above, the spacing between surface striations is shown schematically in the drawings but can be selected from the group consisting of 1/64; 1/13; 3/64; 1/16; 5/64; 6/64 ; 7/64, ⅛; 9/64, etc. inches, or other increments, apart. In this embodiment of the invention, the outer surface of the body  102  has surface striations, cross-hatching or roughened surface  108 . The purpose of the modified surface  108  on device  102  can accommodate various surface agents, such as lubricants, local anesthetics, antibiotics, astringents, or medically active substances, such as vinegar (for treating yeast infections). 
         [0032]    In addition to the cylindric, frusto-conical, flared, triangular shapes illustrated herein, the shapes can be generally rectangular with rounded edges, or irregular in shape. 
         [0033]    The dimensions of the outer diameter and length of the invention will vary according to the specific method of treatment but typically may be as small as ½ inch outer diameter and 2-7 inches in length. 
         [0034]    In the most preferred use, the medical device of the invention is chilled (by refrigeration, ice bath or other techniques) to lower the temperature of the medical device. As heretofore described, the medical device is preferable formed from a high heat capacity material. Suitable material include artificial materials comprising a combination of hardened calcium carbonate/sodium carbonate materials, such as described in my previous U.S. Pat. Nos. 6,264,740 and 6,913,645 (each incorporated by reference in its entirety); natural materials, such as stone and jade; ceramics; rubbers; geo-polymers (such as described in U.S. Pat. No. 8,202,363, hereby incorporated by reference in its entirety); some composites of plastics/fillers; plastics/metals and metals and alloys. The hardened calcium carbonate/sodium carbonate materials with a high sodium carbonate component have the advantage of breaking down in sewer/septic systems, and therefore are considered to be a preferred material for this invention. 
         [0035]    In order to obtain the maximum effective time of use, the chilling should be to or at 32° F. (0° C.), or slightly above. Temperatures below the freezing point of water might induce thermal damage to the tissues surrounding the medical device of the invention and therefore should be avoided. 
         [0036]    Chilling could be effective by placing a plurality of devices in a container having a fluid therein to simultaneously chill a plurality of the medical devices of the invention. The fluid can be vinegar, alcohol, wine, brine, an ice bath, witch hazel, and mixtures thereof, or other suitable liquid which does not freeze at the freezing point of water. Once properly chilled, a single device is selected and inserted, either by the patient or a medical practitioner, to provide immediate relief from the symptoms/conditions mentioned herein. 
         [0037]    Alternatively, the medical devices of the invention could be individually packaged in foil packages surrounded by one of the fluids mentioned above, or in a material such as Benadryl, a lubricant, an astringent, a local anesthetic, an antibiotic, or other material, which packages can be chilled individually or as a group. 
         [0038]    It will be understood that other variations, and uses, of the medical device of the present invention will be envisioned by those skilled in the art reading the present disclosure or viewing the drawings herein, and it is to be understood that all uses of the medical device of the invention are within the scope of the invention as defined by the appended claims.