Abstract:
A device for delivering a beneficial agent within a body cavity such as the ear canal. The device preferably includes a soft resilient casing that can be compressed to fit at least partially within the ear canal. Once inserted in the ear canal, the casing expands to form a seal between a boundary defining the ear canal and the device. The soft casing preferably encapsulates the beneficial agent within a reservoir formed inside the soft casing. As the device is squeezed, the beneficial agent is ejected through a release point. The device then maintains the beneficial agent within the ear canal until the beneficial agent has had time to take effect.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application claims the benefit of U.S. Provisional Application No. 60/336,646, filed Dec. 3, 2001, which is hereby incorporated by reference herein in its entirety, including but not limited to those portions that specifically appear hereinafter. 
     
    
     
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
         [0002]    Not Applicable.  
         BACKGROUND OF THE INVENTION  
         [0003]    1. The Field of the Invention.  
           [0004]    The present invention relates generally to devices for delivering beneficial agents into body cavities, and more particularly, but not necessarily entirely, to devices for delivering medical agents into the ear canal.  
           [0005]    2. Description of Related Art.  
           [0006]    It is common practice to place medication into the ear canal of patients suffering from ear aches or infections. For example, children are often afflicted with otitis, or inflamation of the ear, which may be treated by placing medication into the ear canal. A common procedure for placing medication in the ear canal of children involves placing the medication into the ear canal using a dropper. Cotton is commonly placed in the child&#39;s ear to help maintain the medication in place, since movement of the child may cause the medication to become displaced before it has a chance to take effect.  
           [0007]    A drawback of this method is that since cotton is absorbent, it tends to absorb the medication and does not create a seal to maintain the medicine within the ear canal. To help remedy this problem, it is known to wet the cotton with a fluid such as water or the medication prior to inserting it into the ear canal. The wetted cotton is then less able to absorb the medication. However, placing fluid on the cotton is inconvenient and may tend to spread the fluid onto the child or surrounding area.  
           [0008]    Attempts have been made in the prior art to provide alternate devices to assist in administering medication to the ear canal. For example, U.S. Pat. No. 2,737,953 (granted Mar. 13, 1956, to Wiltein) discloses a funnel shaped device having a pair of openings. The device is inserted into the ear canal and the medication is applied through one of the openings. The other opening serves as an air vent so that the medication can flow into the ear canal. The funnel shaped device is configured to create a plug to maintain the medication within the ear canal once it has been administered. The openings are required to be small so that the device can fit within the ear canal, and so that the openings prohibit the medication from flowing back out of the ear canal. However, it may be difficult to administer the medication through the opening due to the viscosity of the medication and the small size of the opening. Furthermore, since the medication is applied to the exterior of the device, the medication is likely to be spread if the user contacts the external portion of the device after the medication has been applied. Moreover, since the medication and the funnel device are separate elements that must be handled, administration of the medication is more cumbersome.  
           [0009]    Another device for introducing medication into the ear canal is disclosed in U.S. Pat. No. 5,674,196 (granted Oct. 7, 1997, to Donaldson et al.) This device includes an ear plug having a pair of conduits. A syringe is attached to one of the conduits to inject medication into the ear canal, and the other conduit serves as an air vent. A drawback of this device is that it requires the use of a syringe, which may not be available in some situations. Furthermore, the need for a syringe increases the cost and complexity of administering the medication.  
           [0010]    The prior art is thus characterized by several disadvantages that are addressed by the present invention. The present invention minimizes, and in some aspects eliminates, the above-mentioned failures, and other problems, by utilizing the methods and structural features described herein.  
         BRIEF SUMMARY OF THE INVENTION  
         [0011]    It is therefore an advantage of the present invention to provide an ear plug medication administration device that is simple in design, manufacture, and use.  
           [0012]    It is another advantage of the present invention to provide such an ear plug medication administration device that maintains the medication within the patient&#39;s ear canal.  
           [0013]    It is a further advantage of the present invention, in accordance with one aspect thereof, to provide an ear plug medication administration device that includes the medication within the device.  
           [0014]    It is an additional advantage of the invention, in accordance with one aspect thereof, to provide an ear plug medication administration device that prevents the spread of the medication and other fluids.  
           [0015]    The above advantages and others not specifically recited are realized in a specific illustrative embodiment of an ear plug medication administration device. The device preferably includes a soft resilient casing which can be compressed to fit at least partially within the ear canal. Once inserted in the ear canal, the casing expands to form a seal between the ear canal and the device. The soft casing preferably encapsulates the beneficial agent within a reservoir formed inside the soft casing. The device may include an impervious liner between the soft casing and the beneficial agent. As the device is squeezed, the beneficial agent is ejected through a release point. The device then retains the beneficial agent within the ear canal until the beneficial agent has had time to take effect. A cord may be attached to the device to facilitate removal from the ear canal.  
           [0016]    Additional advantages of the invention will be set forth in the description that follows, and in part will be apparent from the description, or may be learned by the practice of the invention without undue experimentation. The advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]    The above features and advantages of the invention will become apparent from a consideration of the subsequent detailed description presented in connection with the accompanying drawings in which:  
         [0018]    [0018]FIG. 1 is a perspective view of an ear plug medication administration device in accordance with the principles of the present invention;  
         [0019]    [0019]FIG. 2 is a side, cross-sectional view of an ear plug medication administration device of FIG. 1;  
         [0020]    [0020]FIG. 3 is a side, break-away cross-sectional view of an ear plug medication administration device being inserted in a patient&#39;s ear canal; and  
         [0021]    [0021]FIG. 4 is a side, cross-sectional view of an alternative embodiment ear plug medication administration device.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0022]    For the purposes of promoting an understanding of the principles in accordance with the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications of the inventive features illustrated herein, and any additional applications of the principles of the invention as illustrated herein, which would normally occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the invention claimed.  
         [0023]    Referring now to FIG. 1, there is shown is a perspective view of an ear plug medication administration device, designated generally at  10 , in accordance with the principles of the present invention. The ear plug medication administration device  10  shown in FIG. 1 is configured in size and shape to fit within a body cavity such as the ear canal. However, it will be appreciated that the device  10  may be sized and shaped in various different configurations within the scope of the present invention for use in the ear canal and other body cavities, such as the nostrils for example.  
         [0024]    The device  10  may include a casing  12 , which is preferably formed of a soft resilient material, such as foam rubber for example. It will be appreciated that other materials may be used to form the casing  12  within the scope of the present invention. The material forming the casing  12  is preferably compressible and has an elastic memory such that when a compressive force is applied to the casing  12 , the volume of the casing  12  is reduced so that the casing  12  can fit within a body cavity. After the compressive force is removed, the casing  12  preferably expands such that the volume is increased to substantially its original condition. This allows the casing  12  to form a seal within the body cavity.  
         [0025]    A handle or safety cord  14 , may be attached to an end of the device  10  for facilitating grasping of the device  10  to extract the device  10  from the body cavity. The safety cord  14  is illustrated as a flexible strand. However, it will be appreciated that the safety cord  14  may be configured as a tab or flange, for example, and may be formed as an integral part of the casing  12 .  
         [0026]    As shown in FIG. 2, which presents a side, cross-sectional view of an ear plug medication administration device  10 , the casing  12  preferably encapsulates a reservoir  16  wherein a beneficial agent  18  may be contained. The reservoir  16  may be sized to contain a single dose of the beneficial agent  18 . The beneficial agent  18  may include any variety of substances desired to be administered within the body cavity for a variety of different types of treatments. For example, the beneficial agent  18  may include medications such as antipyrine/benzocaine liquid for the treatment of otitis. Similarly, other examples of conditions and beneficial agents  18  in which the device  10  may be beneficial include: 1) otitis externa, an infection of the external ear canal in which antibiotic and/or anti-inflammatory medication would be administered to eradicate the infection and/or reduce discomfort; 2) otitis media without perforation, an infection of the middle ear space, in which an anesthetic medication would be administered to relieve pain; and 3) otitis media with perforation (such as with pressure equalization tubes) in which antibiotic medication would be administered to eradicate the infection behind the tympanic membrane  28  (as shown in FIG. 3). It will be appreciated, however, that the beneficial agent  18  may include any of a variety of suitable substances for treatment of various conditions, within the scope of the present invention.  
         [0027]    The reservoir  16  may be lined with an impermeable liner  20  to contain the beneficial agent  18  within the reservoir  16 , and keep it from migrating into the casing  12 . “Impermeable” as referred to herein is defined as a characteristic of preventing the flow of a fluid. Thus, the impermeable liner  20  may be formed of any suitable material that is substantially impervious to the beneficial agent  18 , such as a plastic material for example.  
         [0028]    A release point  22  is preferably formed in an end of the device  10 . The release point  22  is the location where the beneficial agent  18  is ejected from the device  10 . The release point  22  may be formed as an exposed portion of the liner  20 , a thin or weakened portion of the casing  12 , or a type of plug sealing the reservoir  16 , for example. The material at the release point  22  is formed such that when the device  10  is compressed, the increased pressure of the beneficial agent causes the reservoir  16  to be ruptured at the release point  22  so the beneficial agent may be ejected at the release point  22 .  
         [0029]    Use of the device  10  is now explained with reference to FIG. 3 which shows a side, break-away cross-sectional view of an ear plug medication administration device  10  being inserted in a patient&#39;s ear canal  24 . The device  10  is squeezed, as indicated by the reference numerals  26 , to compress the soft casing  12  so that the device can fit within the ear canal  24 . As the device  10  is squeezed, the pressure on the beneficial agent  18  increases and forces the release point  22  to be opened. The beneficial agent  18  is then ejected into the ear canal  24  for treatment of the tympanic membrane  28 , or the middle ear space behind the tympanic membrane  28 , or the ear canal  24  itself. Once inserted, the casing  12  expands to form a seal between the device  10  and the ear canal  24  so that the beneficial agent  18  is maintained within the ear canal  24 . After sufficient time has passed to allow the beneficial agent  18  to take effect, the device  10  may be removed by grasping the safety cord  14  and pulling the device  10  from the ear canal  24 .  
         [0030]    Reference will now to made to FIG. 4 to describe a second embodiment of the present invention. As previously discussed, the presently preferred embodiments of the invention illustrated herein are merely exemplary of the possible embodiments of the invention, including that illustrated in FIG. 4.  
         [0031]    It will be appreciated that the second embodiment of the invention illustrated in FIG. 4 contains many of the same structures represented in FIGS.  1 - 3  and only the new or different structures will be explained to most succinctly explain the additional advantages which come with the embodiments of the invention illustrated in FIG. 4.  
         [0032]    [0032]FIG. 4 shows a side, cross-sectional view of an alternative embodiment ear plug medication administration device  10  which is similar to that of FIG. 2 except that the casing  12  is impermeable to the beneficial agent  18 , thus eliminating the need for the liner  20 .  
         [0033]    In view of the foregoing description, those skilled in the art of forming products of foam-like materials will understand how to make the device in accordance with the principles of the present invention.  
         [0034]    In accordance with the features and combinations described above, a preferred method of administering a beneficial agent to a patient&#39;s ear canal includes the steps of:  
         [0035]    (a) obtaining a device containing said beneficial agent therein;  
         [0036]    (b) squeezing said device to cause said device to compress and eject said beneficial agent into said ear canal;  
         [0037]    (c) inserting said device into said ear canal;  
         [0038]    (d) allowing said device to expand to seal said ear canal to maintain said beneficial agent within said ear canal;  
         [0039]    (e) leaving said device within said ear canal for a period of time to allow said beneficial agent to take effect; and  
         [0040]    (f) pulling on a handle attached to said device to remove said device from said ear canal.  
         [0041]    In view of the foregoing, it will be appreciated that the present invention provides an ear plug medication administration device which is simple in design, manufacture, and use, and which contains the medication within the device. The present invention also provides an ear plug medication administration device that maintains the medication within the patient&#39;s ear canal and prevents the spread of the medication and other fluids.  
         [0042]    It is to be understood that the above-described arrangements are only illustrative of the application of the principles of the present invention. Numerous modifications and alternative arrangements may be devised by those skilled in the art without departing from the spirit and scope of the present invention and the appended claims are intended to cover such modifications and arrangements. Thus, while the present invention has been shown in the drawings and fully described above with particularity and detail in connection with what is presently deemed to be the most practical and preferred embodiments of the invention, it will be apparent to those of ordinary skill in the art that numerous modifications, including, but not limited to, variations in size, materials, shape, form, function, and manner of operation, assembly, and use may be made without departing from the principles and concepts set forth herein.