Abstract:
A flavored covering for an oral medical instrument. The covering may be constructed of multiple layers of impervious material joined together, or a single piece of molded impervious material. The covering is flavored with a thin coating of a flavoring agent or a candied flavoring, or the flavoring is impregnated into the cover material. The flavoring encourages the cooperation of a child during the use of an oral medical instrument.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to a disposable cover for oral medical instruments.  
         DESCRIPTION OF THE RELATED ART  
         [0002]    Disposable thermometer covers have been available for some time. For example, see U.S. Pat. No. 4,136,776 (Poncy). The benefit of disposable thermometer covers is to supply a sterile thermometer for each patient without the necessity of sterilizing the thermometer between uses.  
           [0003]    Most thermometer covers, however, are constructed of plastic and leave the patient with a feeling of a tasteless medical instrument placed in his or her mouth.  
         SUMMARY OF THE PRESENT INVENTION  
         [0004]    The present invention overcomes the problems and disadvantages of the prior art by providing a cover for an oral medical instrument, with an inner surface adapted to fit the oral medical instrument and having an outer surface opposite the inner surface, wherein the cover is flavored, and a package contains the cover. Such flavoring provides a device for encouraging the cooperation of a child during the use of an oral medical instrument, and provides a pleasing flavor for both children and adults. In one embodiment the oral medical instrument is a temperature sensing device. The covering is preferably constructed of sterile, multi-layered, thermoplastic films. The package for the covering is preferably made of an impervious, sterile material. The covering is preferably flavored using a thin coating of a flavoring agent, which is applied on the outer surface of the cover. The cover may be textured to provide an adhesion surface for the flavoring agent. Alternatively, the cover can be flavored by impregnating a flavoring agent into the cover. Alternatively, in an embodiment where the cover is constructed of sterile, multi-layered thermoplastic films, the outer layer is preferably impregnated with a flavoring agent.  
           [0005]    In another embodiment, the oral instrument cover comprises a one-piece tubular member having a thin side wall, wherein the tubular member is adapted to closely fit an oral medical instrument, wherein the tubular member is flavored, and the cover has a sterile package. The oral medical instrument can be a temperature sensing device. The tubular member may be flavored with a thin coating comprising a flavoring agent, wherein the thin coating is applied to the outer surface of the cover, which may be textured. Alternatively, the tubular member may be flavored with a flavoring agent impregnated into the plastic.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0006]    The accompanying drawings illustrate an embodiment of the invention, and together with the specification serve to explain the principles of the invention.  
         [0007]    [0007]FIG. 1 is a plan view of a packaged oral medical instrument cover, showing the cover within it.  
         [0008]    [0008]FIG. 2 is a cross-section of a packaged oral medical instrument cover, showing the bonding of the end seal of the cover and the outer paper packaging.  
         [0009]    [0009]FIG. 3 is oblique view of an oral medical instrument cover, with an oral medical instrument inserted, and the package and excess impervious material being peeled away.  
         [0010]    [0010]FIG. 3A is an oblique view of an oral medical instrument cover, with dimples on the plastic cover.  
         [0011]    [0011]FIG. 3B is an oblique view of an oral medical instrument cover, with striations on the plastic cover.  
         [0012]    [0012]FIG. 3C is an oblique view of an oral medical instrument cover, with perforations on the outermost impervious layer of the plastic cover.  
         [0013]    [0013]FIG. 4 is a cross section of an outer layer the impervious material of an oral medical instrument cover with a thin coating of flavoring between the cover and the paper packaging.  
         [0014]    [0014]FIG. 5 is a cross section of a thermoplastic film impregnated throughout with a flavoring agent.  
         [0015]    [0015]FIG. 6 is a cross section of a thermoplastic film where a portion of the film is impregnated with a flavoring agent.  
         [0016]    [0016]FIG. 7 is a plan view of an injection molded plastic oral medical instrument cover.  
         [0017]    [0017]FIG. 8 is an end view of an injection molded plastic oral medical instrument cover. 
     
    
     DETAILED DESCRIPTION  
       [0018]    Reference will now be made to the presently preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings. Whenever possible the same reference numbers will be used throughout the drawings to refer to the same or like parts.  
         [0019]    [0019]FIG. 1 depicts a plan view of the exterior of a packaged oral medical instrument cover  1 . An oral medical instrument cover  3  is concealed within a package  9 . The outline of the cover  3  is shown by the seal line  4 , and the shape is adapted to fit a particular medical instrument, preferably a thermometer. In the packaged state, the inner surface  17  of the cover  3  (shown in FIG. 2) is exposed at the flared open end  10  of the cover  3 . The outer surface  1   8  of the cover  3  is flavored, and is protected prior to use by the paper  12  packaging. FIG. 3 depicts the cover  3  when the package  9  is removed.  
         [0020]    As show in FIG. 2, one embodiment of the packaged oral medical instrument cover  1  comprises several sterilizable layers of impervious material  14 ,  15 ,  16 , which are preferably thin films or sheets of thermoplastic. The number of layers may be varied as needed. Impervious material  14 ,  15 ,  16  may be joined by heat sealing. In order to package the cover  3  for shipment and to keep the cover  3  sterile while in storage, sheets of paper  12  may be placed on either side of the impervious material  14 ,  15 ,  16  and bonded to them. Paper  12  is preferably glassine, but need not be glassine, and could be any suitable impervious material that is capable of forming a durable package  9  that can maintain the sterility of the enclosed cover  3 .  
         [0021]    In a preferred embodiment, layers of impervious materials  14 ,  15 ,  16  may be sealed or welded together to each other as shown in FIGS. 1 and 2. The cover  3  may have a closed end formed by the end seal  5  and an open end  10  for easy insertion of the oral medical instrument  7  into the cover  3 . The cover  3  may be formed and sealed in an electronic die (not shown) in a high frequency heat sealing press (not shown) that seals the impervious material  14 ,  15 ,  16  together along a seal line  4  to form the enclosed cover  3 . Such a die also lightly bonds the paper  12  to the exterior surface  18  of the cover  3  so that it can be maintained in a sterile condition until the paper  12  is pulled away by the user (see FIG. 3).  
         [0022]    In a preferred embodiment, the impervious material  14 ,  15 ,  16  is comprised of layers of thermoplastic films, and the electronic die has the effect of weakening the impervious material  14 ,  15 ,  16  along the seal line  4  formed by the die. This weakened zone of impervious materials  14 ,  15 ,  16  along the seal line  4  allows the portions thereof outside the boundary of the cover  3  to be torn away from the portions of the impervious material  14 ,  15 ,  16  that adhered along the edge of the seal line  4 . The paper  12  on both sides of the impervious material  14 ,  15 ,  16  act as buffers between the die and the bed of the press, and to some extent prevent total destruction of the impervious material  14 ,  15 ,  16  by the heat of the press, and actually become part of the cover package  9  itself. As a result of this bonding, all the impervious material  14 ,  15 ,  16  outside the seal line  4 , and all of the paper  12  will be torn away when the packaging is separated from the cover  3  (see FIG. 3), collectively referred to as a “tear-away”  2 . An optional coating (not shown) on the paper  12  may also form a protective surface or barrier against cover  3  contamination, which might possibly occur due to any porosity in the paper  12 . The impression made into the paper  12  at the seal line  4  serves as a visual guide for the insertion of the oral medical instrument  7  into the cover  3  prior to the removal of the packaging.  
         [0023]    Flavoring may be added to the cover in a variety of ways. As shown in FIG. 4, in one embodiment, the flavoring  20  can be placed as a thin coating atop the outermost layer of the impervious material  14  prior to placing the paper  12  over the impervious material  14 ,  15 ,  16  and assembling the covers in the electronic die. Alternatively, the cover  3  could be assembled in an electronic die without paper  3 , and the cover  3  could then be coated with the flavoring  20 , and subsequently packaged.  
         [0024]    The flavoring  20  may be comprised of a candied flavoring, such as a sticky, soft candy, or candy substitute, which can be sweetened with one or more sugar substitutes, such as aspartame, polydextrose, or other suitable sugar substitutes, and may further contain caprenin, vitamins, and/or or organic ingredients. The candied flavoring could contain caramel, chocolate or fruit flavors. Between 1 and 100 grams of candied flavoring could be spread evenly over one-fifth to one-half of the cover  3  proximal to the end seal  5 . Alternatively, the cover could be free of the candied flavoring between the end seal  5  and some distance along the cover  3  to assure that the sensing mechanism of the oral medical instrument  7  obtains accurate measurements. To allow the candied flavoring to adhere to the cover  3 , the cover  3  may be textured (FIGS.  3 A- 3 C), such as with dimples  40  or striations  42 , or the outermost layer of the impervious material  14  could be perforated  44 , so long as there remains at least one layer of impervious material  15 ,  16  beneath. A substantial portion of the candied flavoring may have a melting point between approximately 98 and 101 degrees Fahrenheit.  
         [0025]    In another embodiment, the flavoring of the covers may be accomplished by impregnating the outer layer of impervious material  14  with a flavoring agent  22  (FIG. 5). The flavoring agent  22  may be added to the impervious material  14  prior to the formation of the film.  
         [0026]    Sterilization of the outer surface  18  of the cover  3  may preferably be accomplished by subjecting the impervious materials  14 ,  15 ,  16  and the paper  12  to ultraviolet exposure until they are joined together during assembly. Sterilization may alternatively be accomplished during the manufacturing process as described or after the package  9  has been completely fabricated. Multiple types of sterilization may be used if so desired.  
         [0027]    In a preferred embodiment, when the multiple sheets of impervious material  14 ,  15 ,  16  are placed in the die to form the cover, shown in FIGS. 1 and 2, the result is that the cover  3  is fully enclosed in a sterile atmosphere. Only the interior surfaces  17  of the cover are exposed to the atmosphere at the open end  10  of the cover, with the exterior surfaces  18  are covered in the paper  12  and sealed from the atmosphere. The material of the facing coating (not shown) on the paper  12  and the impervious material of the cover  14 ,  15 ,  16  itself may be of any suitable impervious material, but preferably a thermoplastic.  
         [0028]    After the packaged oral medical instrument cover  1  is assembled with the die, the cover  3  may be handled freely without any special precautions as to the outer surfaces  18 , as they are wholly-enclosed within the sterile surface  19  of the paper  12 . This paper  12  may be kept in place until just before the oral medical instrument  7  is inserted and used. Due to the thinness of the layers of the impervious material  14 ,  15 ,  16 , the cover  3  provides negligible insulation against heat transfer, yet has sufficient strength for the intended purpose and permits an accurate reading of a thermometer. After a single use, the cover  3  can be stripped from the thermometer and simply discarded.  
         [0029]    Any number of oral medical instruments can be covered with an appropriately formed cover adapted to the shape of the instrument. Such instruments can include tongue depressors and dental instruments.  
         [0030]    In use, the packaged oral medical instrument cover  1  may be grasped by a tab  8  along either side, and the thermometer or other oral medical instrument  7  may be inserted into the open end  10  of the cover  3  and pushed inwardly until it fully occupies the cover  3  and is stopped by the end-seal  5 . Of course, a thermometer is usually inserted by the sensing end first, whether it is a mercury or an electronic thermometer. The tear-away  2  may be then stripped or peeled away from the cover against the friction afforded by the inserted instrument  2 , by gripping and pulling the tab  6  at the opposite end, separation taking place along the tear seal line  4 , leaving the sterile exterior surfaces  18  of the cover exposed.  
         [0031]    Thus, the oral medical instrument  7  is covered with a transparent cover  3 , which is entirely sterile on the exposed surface  18  to avoid transmission of disease or infection. If the instrument  7  is a classic thermometer, graduations on the thermometer may be read through the cover  3 , or the cover  3  may be pulled off of the thermometer to read the temperature. After use, the cover  3  is slipped off of the instrument  7  and disposed, and the instrument is immediately available for reuse by insertion into another cover package  9  and stripping away the outer cover.  
         [0032]    In another embodiment, shown in FIGS. 7 and 8, the cover has an elongated hollow body or tube  30  made of a one-piece plastic tubular member with a thin, preferably cylindrical side wall  34 , and can be made from polypropylene, polyethylene, or other suitable plastics. Tube  30  may be a flexible and elastic plastic, so the side wall  34  can be longitudinally and circumferentially stretched. The plastic is preferably smooth, compatible with body tissue, and resistant to body fluids. The side wall  34  may be easily deformed by the mouth of the patient to minimize movement of the Tube  30  and the instrument (not shown) in the patient&#39;s mouth. The shape of the Tube  30  is adapted to the particular oral medical instrument (not shown), and need not be cylindrical or tubular. It can be made by injection molding or any suitable process. Tube  30  is then placed in a package (not shown) that is standard in the medical industry for sterile disposable items.  
         [0033]    In Tube  30 , the cover can be flavored by coating it with a flavored gel, which will withstand sterilization techniques and have a sufficient shelf life, as well as being compatible with the plastic used for the cover. The cover may also be textured to provide an adhesion surface for the flavored gel.  
         [0034]    Another method of flavoring Tube  30  is after the material is injected into the mold, a flavored gel is injected prior to the final curing of the plastic, which impregnates the cover with a flavoring agent.  
         [0035]    Similar sterilization techniques can be used as described above and packaging techniques could be utilized as are common in the medical industry.  
         [0036]    Other embodiments of the invention will be apparent to those skilled in the art. It is intended that the specification and examples be considered as exemplary only.