Abstract:
An ear ailment diagnostic device and method in accordance with the present disclosure generally comprises a pair of earpieces, which both further comprise a light source, a magnification lens, an air conduction channel and a miniature camera. The earpieces may optionally comprise a thermometer and/or tympanometer. Each earpiece is coupled to an air conduction tube, an insufflator and an electrical wiring/data tube which is coupled to a computer. The insufflator may be manually, electronically, or battery powered. In the preferred embodiment the computer comprises a smart phone with data processing capability and wireless communication capability. Any data sent from the device can then be interpreted and diagnosed in a remote location so that an accurate treatment is prescribed.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of 35 U.S.C. §119 and the filing date of provisional application 61/311,813, filed Mar. 9, 2010. 
     
    
     FIELD OF INVENTION 
       [0002]    The present invention relates to the field of medical devices. More specifically, the invention relates to medical devices and methods for the diagnosis of ear ailments. 
       BACKGROUND OF THE INVENTION 
       [0003]    Presently, the standard method of treatment for diagnosing external and middle ear infections requires a live in-person physician appointment and consultation. This is necessary for both the actual examination as well as for the diagnosis and management of a care plan. The patient usually must make an appointment, wait and eventually commute to the doctor&#39;s office; all of which takes a great deal of time and prolongs any potential injury. 
         [0004]    A doctor will usually use an assortment of various test equipment such as thermometers, otoscopes, insufflators and tympanometers to diagnose the ailment. Thermometer readings can indicate if there is increased blood flow to the area due to inflammation or infection. Otoscopes, which typically include a light source and possibly a magnification lens, are commonly used to get a visual of the ear canal as well as test the mobility of the tympanic membrane (eardrum) by shooting a puff of air into the ear. The air can be powered electrically or manually by the use of a small bulb and tubing. Tympanometers or audiometers, which usually include headphones and a hardware circuit, can then be used to measure and diagnose the mobility of the eardrum and ossicles (conductive bones). The sound reflected back to this instrument can be used to diagnose otitis of the middle or external ear. The results of this test can also be graphed as a function of decibels over air pressure. The graphs can then be compared against the norm to reveal potential injuries such as perforation or scarring of the eardrum, buildup of wax or lack of contact between the conduction bones. 
         [0005]    The presently disclosed device allows a patient to benefit from accurate and effective diagnosis of ear ailments through self examination and remote diagnosis. In this way, both time and expense are salvaged and lead to quicker diagnosis, which in effect can lead to faster recovery, healing and/or treatment. 
       SUMMARY OF THE INVENTION 
       [0006]    An ear ailment diagnostic device and method in accordance with the present disclosure generally comprises at least one earpiece, which further comprise a light source, a magnification lens, an air conduction channel and a miniature digital camera, which is capable of taking still or digital images. The earpiece may optionally comprise a thermometer and/or tympanometer. The earpiece is coupled to an air conduction tube, an insufflator and an electrical/data wire which is coupled to a computer. The insufflator may be manually, electronically, or battery powered. The electrical wiring transmits power and video data between the camera and computer, and power and audio data between the tympanometer and computer. In the preferred embodiment the computer comprises a smart phone with data processing capability and wireless communication capability. Broadly, the preferred embodiment of the present disclosure generally provides for a telemedicine integrated compact device for the remote diagnosis and management of an assortment of ear ailments, especially of the external and middle ear. 
         [0007]    One method of using the device comprises the steps of inputting user specific data, inserting at least one earpiece into at least one ear, positioning the earpiece and securing with a clip. Next, the user will set-up and activate the camera to capture an image or video, and transmit that data to a hospital, physician or data center. Any data sent from the device can then be interpreted and diagnosed in a remote location so that an accurate treatment is prescribed and sent back to the user. In another interactive embodiment of the method of using the device, the computer may generate a questionnaire for the user to fill out based on demographics, genetics or past medical history. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  illustrates a perspective view of the preferred embodiment of the present invention. 
           [0009]      FIG. 2  illustrates a front view of the preferred embodiment of the present invention. 
           [0010]      FIG. 3  illustrates a front view of an alternate embodiment of the present invention. 
           [0011]      FIG. 4  illustrates a front view of yet another embodiment of the present invention. 
           [0012]      FIG. 5  illustrates a process flow diagram of the preferred embodiment of the method of using the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0013]    In the following description of the various embodiments, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration, various embodiments in which the invention may be practiced. It is to be understood that other embodiments may still be utilized and structural and functional modifications may be made without departing from the scope and spirit of the present invention. 
         [0014]    Referring to  FIG. 1 , a perspective view of the preferred embodiment of an ear ailment diagnostic device  10  is shown. In this preferred embodiment of ear diagnostic device  10 , left earpiece  12  and right earpiece  14  are bulbous containers which house smaller components. Each earpiece,  12 ,  14  could alternatively take other similarly functional shapes but must comprise at least one tip  30  which is capable of fitting into the exterior of an ear canal. Both the earpieces,  12 ,  14  and tips  30  may swivel or pivot or be maneuverable, extendable, flexible or moldable so as to reach different areas and/or make a more secure connection. Each may further comprise a small protective shield which may be used to focus the light emanating from light source  32 , which preferably is opposite tips  30  on earpieces  12 ,  14 . Besides acting as visible conduit into the ear, tips  30  also comprise air tubes  36 . Air tubes  36  may be straight down the middle of tips  30  or alternatively may be ring-shaped just inside the circumference edges of tips  30 . In this latter shape they can function without impinging upon visibility and sound transmission. Each earpiece,  12 ,  14  will also comprise a miniature camera  34 , preferably located inside the bulbous or spherical structure. Cameras  34  may be directly connected to earpieces  12 ,  14  or may form an extension of device  10  in some embodiments of the disclosure. Each camera may be adjustable so that it may focus on different areas within the first five millimeters of an ear canal. It may further include servos to remotely control its position, focus, magnification, aperture speed and independent lighting source for constant or flash lighting. Camera  34  may use any light source known in the art which is deemed appropriate for high quality still or motion pictures. A short motion picture or video clip, typically no more than fifteen seconds, may be stored on digital memory. Ear device  10  additionally comprises power button and LED power indicator lights  46 , which may be located directly on earpieces  12 ,  14  as shown in  FIG. 1 , on any other part of device  10 , or in a foreign location such as a remote controller. 
         [0015]    Now referring to  FIG. 2 , left ear tube  16  and right ear tube  18  may be seen extending downward from their respective earpieces,  12 ,  14  in a general conical or C-shape. It is important for these tubes  16 ,  18  to be constructed of a flexible material, which include large percentages of rubber, cloth and/or plastics. Tubes  16 ,  18  serve to conduct air up to air tubes  36  as well to conduct electrical power, audio, video and data feeds downward through optional nexus juncture  20 . Additionally, tubes  16 ,  18  further comprise clips  28 , which may fasten the device in place when in use or keep it locally secure when not in use. From nexus juncture  20 , combined tube  22  carries all merged wires, tubes and lines through insufflator  24 . Insufflator  24 , which can be mechanically or electrically powered through a battery or wall circuit, provides bursts of increased air pressure through device  10  and into the ear canal, so that changes to the eardrum can be visually measured. In the preferred embodiment of device  10 , earpieces  12 ,  14  further comprise a tympanometer (not shown) which can generate bursts of sound through tiny speakers near tips  30 . The sound that is reflected back from the eardrum can then be measured through miniature audio sensors within the tympanometer and transmitted downward past insufflator  24 . Results from the tympanometer are usually graphed by a software program to indicate potential ailments to the eardrum and/or surrounding location. Finally, earpieces,  12 ,  14  may further comprise any variety of digital thermometer known in the art, which are capable of measuring and sending readings down tube  26 . Tube  26  can be seen exiting insufflator  24  and entering handheld computer  40  through port  38 . 
         [0016]    In the preferred embodiment, handheld computer  40  will be a smart phone with various software applications as well as wireless data communication capability, but could easily be envisioned to be a custom dedicated device or other similar functioning device known in the art. Computer  40  comprises a monitor or screen and a virtual or tactile keypad. Alternate embodiments also comprise a speaker, microphone, camera, mouse, output port  42 , touch-pad or joystick  44 , camera button  50  and light control button  52 . Device  10  may optionally have other controls used for operating the thermometer, tympanometer, cameras, data I/O, screen, and/or any associated software. 
         [0017]    Now referring to  FIG. 3 , an alternate embodiment of the present disclosure is shown. Device  10  is connected and assembled in a manner so that nexus juncture  20  is absent and tubes,  16 ,  18  continue straight, but individually to insufflator  24 . Tubes,  16 ,  18  may be intertwined or secured together in some fashion. This construct may allow more flexibility in the operation of device  10 . Additionally, insufflator  24  may be attached by separate wire and tubing (not shown) and independently connect tube  26 , instead of being positioned between tubes  16 ,  18  and tube  26 . 
         [0018]    Now referring to  FIG. 4 , another alternate embodiment of the present disclosure is shown with insufflator  24  and tubing  16 ,  18  opposite computer  40 . This version simply shows that tubing (ie. for air) can be kept separate from electrical/data wiring  22 . In this configuration, clips  28  can then be placed in alternate locations, such as on electrical/data wiring  22 . 
         [0019]    The presently disclosed device has a broad range of functionality due to its multiple components. It can provide a visual inspection of a patient&#39;s inner ear due to the tips, light source and cameras. It can provide a tactile response in conjunction with the visual inspection due to the insufflator and air tubing. It can also provide a more electronically sensed response due to tiny speakers which emit sound waves and sense reflected sound waves form the tympanometer. This data can only be captured and recorded due to the orientation and construction of the wiring which directly connects to a computerized unit. Finally, temperature within the ear or ears can be simultaneously measured and recorded while any of the previously mentioned tests are being performed. The tests can then be used to diagnose ailments ranging from a build-up of earwax, to an infection to a small perforation in the eardrum or even a misalignment of the ossicles. The versatility of the device eliminates the need for multiple instrumentation. Additionally, the simplicity of the device allows for a user or patient with almost any level of skill, such as a child, to be able to operate the device. The ability to take the various measurements and, in essence, thoroughly examine an ear eliminates the need for a patient to travel to a hospital or be in the presence of a doctor. Instead, a medical practitioner may conduct the diagnosis and prescribe treatment from any remote location. 
         [0020]    Now referring to  FIG. 5 , a process flow diagram of the preferred method of using the presently disclosed device is shown. First, a user will input family, genetic, demographic and/or past medical record history into the miniature computer. In one embodiment, the computer may then provide an appropriate questionnaire based on this information, which may be helpful in ascertaining additional pertinent information. The user will then fill out this questionnaire, if provided. The user may also take a picture of the outside of the ear and profile of the head. The user will then place at least one tip  30  of earpieces  12 ,  14  into the external ear canal of their ears. In some circumstances, only one earpiece may be used. In one embodiment of the presently disclosed method, the earpieces may also comprise small speakers which play audio instructions for proper fit of device  10 . In the preferred embodiment, the user will also use clips  28  on the pinnea (ear lobe) or external ear in order to ensure the best picture position. The best position can be confirmed via audio or visual display. Once earpieces,  12 ,  14  are in place, the user may press camera button  50  to activate the cameras to take a picture or video clip. Either the same button, or another button may then be used to adjust the camera settings, including lighting, aperture, focus, and magnification, and “snap” the picture. Additionally, a short video make also be taken. Any number of pictures and video icons will appear on the screen of mini-computer  40 . The screen may also display other pictures, data and icons representing all data sets from various tests, various time frames and even various users. The user then sends the pictures and data to a medical practitioner. The medical practitioner makes a diagnosis and recommends a treatment, which is transferred back to the user. In a more sophisticated embodiment of the present device and method, software within the device or located at a remote data center will make the diagnosis and recommend a treatment. 
         [0021]    The present invention includes any novel feature or combination of features disclosed herein either explicitly or any generalization thereof. While the invention has been described with respect to specific examples including presently preferred modes of carrying out the invention, those skilled in the art will appreciate that there are numerous variations and permutations of the above described apparatus. Thus, the spirit and scope of the invention should be construed broadly as set forth in the previous specification or appended claims.