Abstract:
A middle ear insufflation device to relieve pressure differential across the tympanic membrane resulting from rapid changes in altitude or intrinsic Eustachian Tube Dysfunction, the device having a compressible bladder member and an ear canal sealing member such that the bladder member can be compressed and released to reduce or increase pressure within the ear canal that is then translated across the tympanic membrane affecting internal pressure within the middle ear space, thereby helping to facilitate normalization of middle ear pressure through the Eustachian Tube.

Description:
[0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/192,756, filed Sep. 22, 2008. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    This invention relates generally to the field of devices and methods used to equalize air pressure differentials between the middle ear and the external ear canal resulting from rapid changes in altitude, such as occur during take off and landing of an airplane, or with primary Eustachian Tube Dysfunction as is commonly encountered in children. 
         [0003]    As an airplane rises to cruising altitude the air pressure within the ear canal, the region exterior to the tympanic membrane, drops rapidly, while the air pressure within the middle ear remains higher unless equalization occurs. During landing the opposite situation occurs, with the external air pressure now being greater than the internal air pressure. In most cases, sufficient air passes from inside the upper throat through the Eustachian Tubes into the middle ear to equalize the air pressure within a brief amount of time. In other cases, however, the Eustachian Tubes may not open sufficiently or may be blocked, as for example when a person is suffering from a cold or with young children whose Eustachian Tubes have not fully matured, with the pressure differential across the tympanic membrane resulting in discomfort or pain. Yawning, chewing gum, or “popping” the ears by closing the nostrils and mouth while expelling air from the lungs are techniques often utilized. These techniques do not always work, and in the case of infants and young children, the child may not understand the parent&#39;s instructions. 
         [0004]    Devices and techniques addressing this problem in the past have usually been based on the Politzer method, wherein air is forced through the nasal cavity. The original method required a high pressure burst administered simultaneously with swallowing, which proved difficult to properly time. In addition, the early systems lacked safeguards against the administration of excessive pressure. The devices were often designed only to increase pressure within the Eustachian tube internal to the middle ear, and thus were not useful in circumstances where the external pressure is less than the internal pressure. Even with improved devices, alleviating the discomfort and pain in young children and infants was hindered by the natural aversion to having air forced into the nasal cavity. 
         [0005]    Thus there is a need for a simple device and method that can be utilized to quickly alleviate discomfort and pain caused by unequalized, sometimes rapid, air pressure differentials encountered during both take-off and landing, as well as in instances of primary Eustachian Tube Dysfunction or other conditions resulting in discomfort or pain. There is a further need for a relatively simple device and method that can be easily administered to young children and infants, and one that does not present a danger of excessive pressure or suction. 
       SUMMARY OF THE INVENTION 
       [0006]    The invention is an external middle ear insufflation device that rapidly equalizes pressure differentials between the external ear canal and the middle ear to alleviate the resulting discomfort and pain, and its method of use. The device comprises in general a compressible bladder member of relatively small volume, the bladder member having a main body and a single opening for suction and expulsion of air into and from the interior of the bladder member. An ear canal sealing member, that may be mounted onto or connected to the bladder member or alternatively formed as a unitary body with the bladder member, forms a seal against the ear canal of the person being treated. The ear canal sealing member comprises an internal bore in communication with the opening of the bladder member, and may further comprise an annular sealing portion of relatively large diameter that transitions into a smaller end member. 
         [0007]    When air pressure differentials are encountered, the ear canal sealing member of the device is inserted into the ear canal so as to effectively block passage of air between the ear canal and the environment. When the external air pressure is greater than the air pressure in the middle ear, the bladder member is first squeezed to expel air within its interior, the ear canal sealing member is then inserted into the ear canal, and the bladder member is allowed to expand to pull air from the ear canal into the bladder member, thereby decreasing pressure within the ear canal, which is translated to the middle ear as the tympanic membrane responds by moving in a normal piston-like manner resulting in corresponding changes in the middle ear pressure. When the external air pressure is less than the air pressure in the middle ear, the bladder member is inserted in its expanded state and then squeezed using the fingers and thumb in order to increase pressure in the ear canal against tympanic membrane. In certain circumstances, repetitive pumping of the device by squeezing and releasing the bladder member may be needed to equalize the atmospheric air pressure differential by promoting air entry into the middle ear through the Eustachian Tube as the tympanic membrane moves back and forth, thereby relieving the pain and discomfort from pressure imbalance. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is a view of an embodiment showing the compressible bladder member and the ear canal sealing member. 
           [0009]      FIG. 2  is a cross-sectional view of the embodiment of  FIG. 1  showing the compressible bladder member and the ear canal sealing member. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0010]    With reference to the drawings, the invention will now be described in detail with regard for the best mode and the preferred embodiment. In general, the invention is an external middle ear insufflation device and its method of use that rapidly equalizes pressure differentials between the external ear canal and the middle ear, such as would be encountered for example during the take off and landing phases of air travel, or with certain medical conditions. The device allows an individual to address pain and discomfort in his or her own ears, as well as addressing pain and discomfort in the ears of an infant or young child incapable of operating the device. The device transfers a relatively small, controlled amount of air within the ear canal during suction or expulsion operations. 
         [0011]    As shown in the figures illustrating a representative embodiment of the invention, the middle ear insufflation device comprises a compressible bladder member  10  and an ear canal sealing member  20 . The bladder member  10  and ear canal sealing member  20  may be formed as a unitary member, but preferably comprise separate elements with the ear canal sealing member  20  mounted onto or connected to the bladder member  10 . The bladder member  10  is a thin-walled member composed of a relatively soft plastic, but the walls must be of sufficient rigidity that the bladder member  10  maintains an expanded configuration defining an interior volume when the bladder member  10  is not placed under compressive force. i.e., when the bladder member  10  is in a neutral status. Preferably the bladder member comprises a generally elongated main body  11  with a closed end  15 , the other end of the main body comprising a short tube member  12  defining a single opening  14  into the interior of the main body  11 , the opening  14  being of relatively small diameter. A transition shoulder  13  may be provided between the main body  11  and the tube member  12 . 
         [0012]    The ear canal sealing member  20  is preferably composed of a relatively soft and flexible plastic, and in the embodiment shown comprises an annular sealing portion  21  sized to seal off the ear canal such that air cannot pass between the ear canal and the environment when the device is in use. The sealing portion  21  may be provided with one or more annular rib members  25  to more effectively seal the ear canal. A generally conical shaped transition portion  22  extends outwardly from the sealing portion  21 , and an internal bore  24  receives and communicates with the tube member  12  of the bladder member  10  such that air can be transferred into and out of the device. A cushioning end member  23  may be positioned at the free end of the transition portion  22 . Alternative constructions for the ear canal sealing member  20  may comprise similar structures that effectively seal the external ear canal. 
         [0013]    In the embodiment wherein the ear canal sealing member  20  is a separate member joined to the bladder member  10 , such as shown in the figures with the annular sealing portion  21  of the ear canal sealing member  20  mounted onto the tube member  12  of the bladder member  10 , varying sizes of ear canal sealing members  20  can be chosen as needed, to best fit the size of the external auditory canal, or if there is need for the ear canal sealing member  20  to be replaced if it becomes damaged or soiled. 
         [0014]    Without the intention of being limited to the dimensions as now set forth, suitable representative dimensions for the middle ear insufflation device may consist of, with all dimensions being approximations, a bladder member  10  having a main body  11  thirteen mm in diameter and four cm in length, a shoulder  13  eight mm in length, and a tube member  12  eight mm in length and five mm in diameter. The ear canal sealing member  20  may be seventeen mm in length and have a sealing portion  21  with a diameter of one cm and a length of three mm, a transition portion one cm in length and an end member  23  three mm in length. The volume of the bladder member  10  is approximately 5 milliliters, but may be slightly larger or smaller provided the characteristics of the device are not excessively altered. 
         [0015]    The method of using the middle ear insufflation device is straightforward. When middle ear—tympanic membrane air pressure differentials are encountered, the ear canal sealing member  20  inserted into the ear canal to the point where the annular sealing portion  21  effectively blocks passage of air between the ear canal and the environment creates a controlled system. When the external air pressure is less than the air pressure in the middle ear, the bladder member  10  is then squeezed using the fingers and thumb in order to increase pressure in the ear canal against tympanic membrane. When the external air pressure is greater than the air pressure in the middle ear, the bladder member  10  is first compressed to expel air within its interior, the ear canal sealing member  20  is then inserted into the ear canal, and the bladder member  10  is allowed to expand to pull air from the ear canal into the bladder member  10 , thereby decreasing pressure within the ear canal. In certain circumstances repetitive pumping by compressing and releasing the bladder member  10  may be needed to equalize the middle ear air pressure differential to relieve the pain and discomfort. This pumping action results in normal repetitive piston-like movement of the tympanic membrane and assists in the transfer of air through the Eustachian Tube into the middle ear, thereby normalizing the pressure differential across the tympanic membrane. Because of the relatively small volume of the bladder member  10 , relatively small changes in pressure on the order of 50 to 400 mm of water are achieved during usage, thereby insuring that suction or increased pressure on the tympanic membrane is not harmful. 
         [0016]    It is understood that equivalents and substitutions for certain elements set forth above may be obvious to those of ordinary skill in the art, and thus the true scope and definition for the invention is to be as set forth in the following claims.