Patent Abstract:
An otoscope kit has an otoscope with an attachable ear wax removal device for ear wax removal. A fluid dispensing means which is attachable to the otoscope for ejecting fluid through said ear speculum into the ear canal, the fluid dispensing means being mounted on the gripping body of the otoscope. The fluid dispensing means preferably includes a housing, a fluid supply and dispensing container, a pump, a tube connected to the fluid supply and dispensing container at one end extending and connected to a connector on a speculum cover. The fluid dispensing means is controlled by an actuator switch that is mounted in an opening of said housing wherein the actuation of the fluid dispensing means occurs without blocking the line of sight through the viewing means. The fluid dispensing means further can have a fluid recovery means having a vacuum pump, a fluid and debris recovery container and a tube for connecting the fluid recovery container to a second connector in the speculum cover. The fluid recovery means is controlled by a second actuator switch mounted in an opening of the dispensing housing. The otoscope-come ear wax removal system has the main advantage of removing ear wax under direct vision.

Full Description:
TECHNICAL FIELD  
       [0001]    The present invention relates to a device for removing ear wax or cerumen from the ear canal while providing a means for viewing the ear canal during the wax removal. 
       BACKGROUND OF THE INVENTION  
       [0002]    Cerumen or ear wax is a waxy substance produced in the ear canal. Wax buildup is due to accumulation of cerumen as well as dirt and debris. However, excess production or impaction of cerumen can press painfully against the ear drum and can also impair hearing. Ear wax buildup can also interfere with hearing aids. 
         [0003]    There are several methods of removing excess cerumen. A common method is to syringe the ear canal with warm water flushing the cerumen out with the water. Various solutions of oils, peroxide, glycerine or detergents are also used to flush the ear canal. Cotton swabs are also commonly used, but not recommended as they generally only remove a small amount of wax and push the rest further into the ear canal. 
         [0004]    Physically picking or scraping the earwax out with an ear pick or curette is yet another method of removing ear wax usually performed by a health professional under direct observation with magnification. 
         [0005]    A less common method is ear candling which is the practice of lighting a specially made hollow ear candle and placing the unlit end in the patient&#39;s ear. It is claimed to create a slight vacuum that draws out debris and wax. 
         [0006]    There are some complications or risks associated with these various types of ear wax removal such as damage to the ear drum from excess pressure or physically perforating the ear drum. 
         [0007]    A key limitation in the removal of ear wax or cerumen is the inability to directly observe the ear canal. A device called an otoscope provides a way to see into the ear canal. The otoscope has a handle and a head with a light source and a magnifying lens with a removable ear speculum that attaches to the front. The speculum is inserted into the external ear canal allowing the examiner to look through the lens into the ear canal. Many models have a detachable sliding rear window allowing instruments to be inserted through the speculum into the ear canal that could be used for removing ear wax. The otoscope can only be used to observe the ear canal before or after flushing, but not during actual ear wax removal as a result the physician must repeatedly stop flushing to observe the progress being made. 
         [0008]    An object of the present invention is to be able to visually observe the ear wax removal during flushing or vacuuming of the fluid and dislodged debris from the ear canal. This objective is achieved as are other features by the use of the present invention described as follows. 
       SUMMARY OF THE INVENTION  
       [0009]    An otoscope kit has an otoscope and an attachable ear wax removal device for ear wax removal. The otoscope has an elongated gripping body; a hollow conical ear speculum, having a small outer end with a protective soft collar adapted to be placed in the entrance of the ear canal of a patient, the ear speculum being transversely connected to a top end of the gripping body; a viewing means connected to said top end of the gripping body to provide a line of sight through said ear speculum; a light source which is directed through the ear speculum; and a fluid dispensing means which is removably attached to the otoscope for ejecting fluid through an ear speculum cover into the ear canal, the fluid dispensing means being secured to the gripping body of the otoscope. The attachable ear wax removal device is a fluid dispensing means which preferably includes a dispensing housing, a fluid supply and dispensing container, a pump, a tube connected to the fluid supply and dispensing container at one end extending and connected to an opening in the speculum cover. The fluid dispensing means is controlled by an actuator switch that is mounted in an opening of the dispensing housing wherein the actuation of the fluid dispensing means occurs without blocking the line of sight through the viewing means. 
         [0010]    The speculum is removably attached to the top end of the gripping body. The speculum cover is adapted to fit onto the speculum without blocking the covering opening. The speculum cover has a fluid delivery passageway with a connector for sealingly engaging the tubing to form a fluid path from the fluid supply and dispensing container through the speculum cover for delivering fluid into the ear canal. The speculum cover fluid passageway has an inlet connector end open through the passageway to an outlet end to make a fluid path through the speculum cover. 
         [0011]    The fluid dispensing means further can have a fluid recovery means having a vacuum pump, a fluid and debris recovery container and a tube for connecting the fluid recovery container to a second connector in the speculum cover. The fluid recovery means is controlled by a second actuator switch mounted in an opening of the dispensing housing. The speculum cover has a second vacuum fluid passageway open to a second suction opening in the speculum cover and extending through the speculum cover to the second vacuum connector for attachment of a vacuum tube which is connected to the fluid and debris recovery container to form a fluid and debris recovery passageway for recovering fluid and debris from the ear canal into the fluid recovery container. The second vacuum passageway preferably is formed as a large channel open to the ear canal of the patient and extending back to a bowl shaped trap portion to which an ear wax debris container is connected to the speculum cover on a lower side of the speculum cover. In this way ear wax is drawn into the container under vacuum and falls into the debris container as the fluid is sucked out of the ear canal into the second vacuum passageway and tubing back into the fluid recovery container. The speculum cover when attached to the speculum seals the second vacuum passageway channel internally near the debris container. 
         [0012]    Preferably, the fluid delivery passageway is positioned on an external surface of the speculum cover and the fluid and debris recovery passageway is positioned on a lower internal surface of the speculum cover. The otoscope has a power source for operating the otoscope. The power source can be an electrical cord connected to the gripping body for connecting a plug into an electrical outlet. Alternatively, the power source can be one or more batteries stored in the gripping body and fluid dispensing means and the otoscope can also include a recharging base for recharging the batteries. The speculum cover can be disposable for replacement after each use as can be the fluid supply and dispensing container and the fluid recovery container and tubing or alternatively can be reused after cleaning and disinfecting. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0013]    The invention will be described by way of example and with reference to the accompanying drawings in which: 
           [0014]      FIG. 1  is a perspective view of the otoscope kit of the present invention. 
           [0015]      FIG. 2  is a perspective front view of the otoscope of the present invention. 
           [0016]      FIG. 3  is a perspective rear view of the otoscope of the present invention. 
           [0017]      FIG. 4  is an exploded perspective view of the fluid dispensing means for attachment to the otoscope of the present invention. 
           [0018]      FIG. 5  is an exploded perspective view of the entire fluid dispensing means for attachment to the otoscope of the present invention. 
           [0019]      FIG. 6  is a cross sectional view of the tube attachment to the speculum cover for the fluid dispensing means of the present invention. 
           [0020]      FIG. 7  is a longitudinal cross sectional view of the speculum cover and tube attachment for the fluid dispensing means of the present invention. 
           [0021]      FIG. 8  is a plan view of the end of the speculum cover with fluid passageway and secondary vacuum passageway openings according to the present invention. 
           [0022]      FIG. 9  is a perspective exploded view showing the recommended attachment of the fluid dispensing means prior to attachment to the otoscope according to the present invention. 
           [0023]      FIG. 10  is a perspective view showing the fluid dispensing means attached to the otoscope according to the present invention. 
           [0024]      FIG. 11  is a perspective view of an alternative embodiment of the present invention showing a direct attachment to a faucet and drainage into sink. 
           [0025]      FIG. 12  is a cross sectional view of the otoscope with attached fluid dispensing means being used in a patient&#39;s ear canal. 
           [0026]      FIG. 12A  shows the removal of ear wax through the vacuum recovery means. 
           [0027]      FIG. 13  is a cross sectional view of the otoscope with attached fluid dispensing means according to the present invention. 
           [0028]      FIGS. 14A and 14B ,  14 A shows the fluid supply and recovery assembly prior to being filled,  14 B shows the fluid supply and dispensing container being filled. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0029]    With reference to  FIG. 1 , an otoscope kit  100  of the present invention is shown. The otoscope kit  100  includes an attachable ear wax removal device hereinafter referred to as a fluid dispensing means  40  that can be physically attached to an otoscope  10 . In addition, the kit  100  includes several removable ear speculum covers  40 A all contained in a box  102 . 
         [0030]    As further illustrated in  FIGS. 2 and 3 , the otoscope has an elongated gripping body  12  and a hollow conical ear speculum  22  having a small outer end adapted to be placed in the ear canal of the patient. The ear speculum  22  is transversely connected to a top end  20  rotatably attached to the otoscope gripping body  12 . A viewing means or window  21  is connected to the top end  20  of the otoscope  10  to provide a line of sight through the ear speculum  22  directly into an ear canal. As further shown in  FIG. 13 , a light source  30 L is provided internal of the otoscope  10  which directs light through the ear speculum  22 . This light source  30 L impinges upon a lens internal of an otoscope  10  such that the observer can see a view of the inner ear canal  4  through the viewing window  21 . As shown, the viewing window or means  21  along with the top  20  can be pivotally rotated about the gripping body  12 . On the upper surface of an end cap  24  of the otoscope  10  is provided a switch  25  upon which the light  30 L can be energized from an internal battery  28  inside of the otoscope. This is illustrated in  FIG. 13 . The ability to rotate the viewing window or means  21  relative to the gripping body  12  enables the unit to be moved in any particular fashion. Also, the light intensity can be adjusted by rotation of this viewing window if so desired. The otoscope  10  can be powered by a battery  28 , the battery preferably is rechargeable and can be connected to an outlet through the connector  128  and wires  126  and  124  as shown in phantom or dashed lines. 
         [0031]    The otoscope  10  as illustrated in  FIGS. 2 and 5 , provides a means for viewing the inner ear canal and enables the viewer to slide the viewing means or window  21  over slightly to insert tools or utensils into an opening and through the speculum  22  into the ear canal if so desired. These principles are typically known and this otoscope is conventionally considered somewhat standard relative to existing otoscopes. In addition to the otoscope  10 , the kit  100  includes a unique fluid dispensing means  40  that can be removably attached to the gripping body  12  of the otoscope. Alternatively, this fluid dispensing means  40  can be sold separately and can be used with available otoscopes. This fluid dispensing means  40 , illustrated in  FIGS. 4 ,  5 ,  9  and  10  as well as  FIG. 13 , provides a unique system that enables the physician to look into an ear canal  4  of a patient  2  and to deliver fluid  7  and remove fluid  7  and ear wax  6  from the ear canal  4  in an attempt to remove cerumen or ear wax  6  from the patients inner ear as shown in  FIGS. 12 and 12A . As shown in  FIG. 4 , the fluid dispensing means  40  includes a housing  42 , with a semicircular recess  43  extending longitudinally along the housing in such a fashion that it is possible to snap the entire fluid dispensing means  40  onto the otoscope gripping body  12 . The housing  42  further includes two large cavities  44 ,  46  into which a fluid supply and recovery assembly  30  can be inserted into the housing body cavities  44  and  46 . As shown, the assembly  30  includes a fluid supply and dispensing container  32  and a compressed but expandable fluid recovery container  34  both of which are connected to a plastic end plate  36 . The plastic end plate  36  includes tubing connections  37  and  38 . The tubing connection  37  is connected to the fluid supply and dispensing container  32  and the fluid connector  38  is connected to fluid recovery container  34 . The recovery container  34  fits into the opening  46  where the fluid container  32  inserts directly into the opening  44 , once these are inserted into the openings  44  and  46 , the cover plate  36  is pushed firmly into place and compresses elastomeric seals  60 ,  62  when end caps  48  and  49  are respectively rotated into the slots  48 A and  49 A respectively to a closed position creating a sealed closure of the device. 
         [0032]    With reference to  FIG. 5 , these components are shown in an exploded view wherein the housing  42  further includes a switch mechanism  50  which includes a first button  51  and a second button  52 . These buttons or switches enable either a fluid pump motor  82  to be activated or a vacuum pump motor  84  to be activated that will be discussed later. In addition, the assembly  30  prior to being inserted into the housing  42  has the outer plate  36  resting over two “o” rings  60  and  62  as illustrated. Therefore, once the assembly  30  is inserted into the housing the top plate  36  rests upon the seals  60  and  62 . Threaded fasteners  70  and  72  are inserted into the threaded openings  71  and  73  respectively to secure the end closures  48  and  49 . Once the assembly  30  is inserted into the housing  42 , the end closures  48  and  49  are rotated into position into the slots  48 A and  49 A respectively which forces the plate  36  into an airtight seal against seals  60 ,  62  in the container housing  42 . A bottom plate  43  is attached to the housing  42 . The bottom plate  43  includes recesses  80  and  81  into which a fluid dispensing pump  82  and a vacuum pump  84  and can be inserted. Directly above the fluid pump  82  and the vacuum pump  84  are seal “o” rings  86  and  88 . Upon assembly these pumps and seals will press against an internal portion of the housing  42  through a pair of holes  41  ( FIG. 13 ) through which the pump ends  82 N and  84 N project into and are open to the openings  44  and  46  at the lower end of the housing  42  which is open to the fluid supply and dispensing container  32  and the vacuum recovery container  34  upon assembly as shown in  FIG. 13 . These pumps can, in the case of the fluid pump  82  deliver compressed air into the opening  44  thus collapsing the fluid filled container  32  as the fluid is pumped into the ear canal  4 . The vacuum pump  84  sucks air through the other hole  41  out of the opening  46  causing the collapsed fluid recovery container  34  to expand by creating a vacuum to draw fluid and ear wax debris from the ear canal during the ear wax removal procedure. 
         [0033]    To operate the pump and vacuum motors a pair of batteries  90  is provided. The batteries  90  are connected electrically by connectors  91  and  92  at both ends. A pair of coil springs  94  is provided to ensure adequate electrical connection forces. The fluid dispensing means  40  can be powered in such a fashion that the pumps  82 ,  84  can be activated independently by the switches  51  and  52 . Alternatively, both switches  51  and  52  can be depressed and activate both the fluid pump  82  and vacuum pump  84  simultaneously, if so desired. The bottom plate  43  is physically attached to the housing using threaded fasteners  45  and has a fit that allows the air to vent out of the bottom plate  43  as a vacuum is produced in the fluid recovery opening  46 . 
         [0034]    With reference to  FIG. 9 , an exploded view of the otoscope  10  with the fluid dispensing means  40  not yet attached to the otoscope  10  is illustrated. The figure also shows a pair of tubes  106  and  108  extending on one side of the otoscope  10  toward an ear speculum cover  40 A. The tubing  106  and  108  are adapted to connect to tubing connections  37  and  38  as illustrated and further to connect to the ear speculum cover  40 A as further illustrated in  FIGS. 6 ,  7  and  8 . 
         [0035]    With reference to  FIG. 6 , the ear speculum cover  40 A has a pair of tubing connections  67  and  68  to which the tubing  106  and  108  can be attached. Extending from the tubing connections  67  and  68  are a pair of passages  110  and  112 . The passages  110  and  112  extend from the connections  67  and  68  to the end of the speculum cover  40 A as illustrated in  FIG. 8 . These openings or passages  110 ,  112  extend to and terminate at the smaller end of the speculum cover  40 A to provide a clear passageway directly into and out of the ear canal. As further illustrated in  FIG. 6 , an upper portion of the ear speculum cover  40 A is a protrusion  120 . This protrusion  120  will fit into a slot  122  on the ear speculum  22  of the otoscope  10 . In this fashion the ear speculum cover  40 A can be snap fit onto the ear speculum  22  of the otoscope  10  and make a secure attachment as shown in  FIG. 13 . As shown in  FIGS. 6 ,  7  and  8 ; the ear speculum cover  40 A is open and hollow, forming a conical opening  40 B to fit onto the ear speculum  22  of the otoscope  10 , however slightly more elongated. This cover  40 A can extend directly into an ear canal and be open such that the viewing source  21  is totally unobstructed by the cover  40 A leaving an open viewing path through the opening  40 B so that the doctor can see directly into the patient&#39;s ear canal. 
         [0036]    An important aspect of the ear wax removal device is the shape of the passageways  110  and  112 . The small circular opening of passageway  110  delivers a jet or stream of fluid into the ear which can be directed to dislodge ear wax from an upper side of the speculum cover  40 A. The second vacuum passageway  112  is shaped as an open channel of much larger area to allow loosened ear wax to be sucked along the channel back to a trap or opening  115  for capturing ear wax  6  into a debris container  117  as the fluid is withdrawn as shown in  FIG. 12A  excess fluid is vacuumed into the passageway back to the debris and fluid recovery container  34 . The passageway channel deepens and widens as it approaches the trap  115 . The speculum of the otoscope closes the open top of the channel directly above the trap  115 . 
         [0037]    When completely assembled, the dispensing means  40  is snapped onto the gripping body  12  of the otoscope  10  as illustrated in  FIG. 10 . The tubing  106  and  108  are connected at both ends to tubing connections and directly attached to the removable ear speculum cover  40 A. Once this assembly of the dispensing means  40  to the otoscope  10  is complete, as illustrated in  FIG. 10 , the patient&#39;s ear canal can be observed and ear wax or cerumen can be removed. In  FIG. 12 , the device according to the present invention is shown whereby the viewing source  21  of the otoscope  10  is shown wherein the lamp or light source  30 L is illuminating into the inner ear canal  4  wherein the inner ear canal  4  is shown having fluid  7  sprayed under required pressure onto the wax  6 , preferably the fluid  7  is a suitable warmed liquid and is delivered by pressing on the switch  52  which activates the pump  82  such that the fluid supply and dispensing container  32  is pressurized by air pressing against the flexible fluid supply and dispensing container  32  such that the fluid  7  is being pushed through the passageway  110  directly into the inner canal  4 . An ear seal  27  is shown affixed at the small end or tip of the speculum cover  40 A to create a seal in the ear canal  4  of the patient  2 . As the ear wax  6  is softened or loosened either into small chunks of debris or preferably into a liquid form, a second switch  51  can be activated which will activate the vacuum pump  84  as shown in  FIG. 12A . Upon activating the vacuum pump  84 , the fluid  7  and wax debris  6  are drawn from the ear by the fluid vacuum pump  84  a debris container  117  and into the fluid recovery container  34  via the vacuum opening or passageway  112 . Accordingly, as this wax debris  6  and fluid  7  are removed, additional fluid  7  can be added to the ear canal  4 . All of this can be accomplished while viewing through the otoscope  10  in a normal fashion. This greatly facilitates the physician&#39;s ability to direct the fluid path most efficiently into the portions of the inner ear canal  4  where the most wax buildup is observed. Accordingly, this fluid dispensing means  40  enables the physician to directly remove the ear wax  6  while observing his activity of wax removal. 
         [0038]    As illustrated, the fluid supply and dispensing container  32  preferably is a plastic flexible bag as is the vacuum fluid recovery container  34 . These bags  32 ,  34  are provided in such a fashion that the activation of either the fluid pump  82  or the vacuum pump  84  can create a pressurization onto the container to press fluid out of the fluid supply and dispensing container  32  or create a vacuum on the vacuum fluid recovery container  34  of the fluid dispensing means  40  such that the bag  34  can be expanded internally to withdraw the excess fluid  7  from the ear canal  4  along with the ear wax  6  into the fluid recovery container  34 . Once the wax removal procedure is completed, the entire fluid dispensing means  40  can be shut down, the ends  48  and  49  opened and the assembly  30  having both the fluid supply and dispensing container  32  basically depleted and the vacuum fluid recovery container  34  basically filled with the debris and fluid removed and then discarded, along with the tubing  108  and  106  and the ear speculum cover  40 A. In this way, all bodily contaminated fluids coming from the ear canal can be safely discarded in biologically safe techniques known in art. This creates a hygienically clean assembly such that the fluid dispensing means  40  can remove all contaminated components which can simply be discarded and replaced with new components for use on the next patient. 
         [0039]    In  FIGS. 14A and 14B , the fluid supply and recovery assembly  30  is shown. The supply and dispensing container  32  as well as the recovery container  34  are empty and the assembly  30  can be supplied as a replaceable component. As shown in  FIG. 14B , the supply and dispensing container  32  can be filled in the doctor&#39;s office using an ear wax removal device such as a syringe  130  with a needle  132  connected to the fitting  37 . The ear wax removal device preferably is filled with a suitable warmed solution  7 . As shown, the container  32  holds approximately 57 cc of fluid. The recovery container  34  remains unfilled and has a similar fluid holding capacity of 57 cc. Once filled, the assembly  30  is inserted into the dispensing means  40  for use. Once used, the assembly  30  and the speculum cover  40 A and tubing  106 ,  108  can be discarded. 
         [0040]    In  FIG. 11  an alternative embodiment of the present invention is shown wherein the fluid dispensing device  40  has been modified with connectors  37 A and  38 A that enable fluid supply tubing  106 A to be connected to a water supply faucet  109  in a sink  107  forming a way to supply water directly to the fluid dispensing device  40 . This provides the doctor with a virtually endless supply of warm or cold water. To recover this water, the fluid recovery side of the device  40  has drainage tubing  108 A connected to the fitting  38 A which has an end placed in the drain  111  of the sink  107 . This enables the device to operate just as described previously but with the advantage of much increased fluid available for the procedure. As shown, the fluid supply connected to the faucet has a valve  39  which enables the flow to be regulated or turned on and off as desired. 
         [0041]    As a further alternative, the tubing  106 A and  108 A can be directly attached to the fittings  67  and  68  of the speculum cover  40 A and the entire device  40  can be eliminated if so desired. The advantage of this embodiment is greatly reduced cost. The main disadvantage is the lack of pump-driven fluid delivery actuated by a switch and the lack of vacuum power as the only vacuum created is a siphoning effect through the tubing  106 A. 
         [0042]    Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described which will be within the full intended scope of the invention as defined by the following appended claims.

Technology Classification (CPC): 0