Patent Publication Number: US-6210358-B1

Title: Ear irrigation device

Description:
FIELD OF THE INVENTION 
     The present invention relates to an earpiece that can be used for cleaning wax and other matter from the ear canal of a patient and in particular the external auditory canal. 
     BACKGROUND OF THE INVENTION 
     Accumulation of wax in the external auditory canal can cause reduced hearing, tinnitus (ie. ringing in the ears) and some discomfort, as well as predisposing the ear to infection. 
     The current typical practice for removing the build-up of ear wax involves the introduction of a cleaning fluid, such as water, into the canal using a syringe. The introduced fluid circulates in the canal and then drains out of the ear carrying with it the wax and any other foreign matter present in the canal. The fluid, wax and/or foreign matter draining from the ear is typically collected in a dish or other vessel which is held below the ear. 
     Some problems with the current method are that it is messy, not very effective and that there is a high incidence of perforation of the eardrum. This latter problem results from the injected fluid or in some instances the syringe being introduced too far into the canal and inadvertently directly striking the delicate structures of the eardrum. 
     It would be desirable to have an apparatus for cleaning wax and other foreign matter from the ear canal which presented a decreased risk of damaging the eardrum. 
     SUMMARY OF THE INVENTION 
     According to a first aspect, the present invention comprises an earpiece having a longitudinal axis and arranged to allow at least partial visualisation of an ear canal when the earpiece is in the ear canal, the earpiece having a fluid outlet through which fluid may be directed into the ear canal and which is adapted to direct the fluid passing through the outlet at an oblique angle to the longitudinal axis and against the surface of an ear canal into which the earpiece has been introduced. 
     The earpiece can be used to direct a cleaning fluid into the ear canal to clean wax and other matter therefrom while allowing simultaneous visualisation of the canal. The earpiece can also be used to deliver a therapeutic agent, such as ear drops, into the ear canal. 
     A fluid delivery means is preferably connected to the fluid outlet of the earpiece. The delivery means can comprise a tube having one end connected to the fluid outlet of the earpiece. The tube can be integral with the earpiece. The other end of the tube can be connected to any suitable fluid supply means. The fluid supply means can comprise a tap, bag or syringe and the fluid will typically be water or a therapeutic agent as requirements dictate. The diameter of the tube is preferably kept relatively small to eliminate high pressure jets of water entering the ear canal and so damaging the eardrum. 
     The earpiece can be fabricated in one piece. The earpiece preferably has a first portion arranged to at least partially enter the ear canal and a second ear abutment portion. The first portion preferably tapers from a first end to a second distal end arranged to be disposed within the ear canal, The taper of the first portion is arranged such that one may still view the ear canal when the first portion is disposed in the ear canal. 
     The fluid outlet is preferably disposed proximate the distal end of the first portion and can comprise an orifice in the wall of the first portion. 
     The second ear abutment portion can comprise a cylindrical ring or tapering member of larger diameter than the first portion. The second portion preferably partially overlaps the first end of the first portion. This sets a maximum distance that the first portion may enter the ear canal so reducing the likelihood of damage to the eardrum by insertion of the irrigation device into the ear. The outer end of the second portion preferably has a standard fitting to allow its connection to an auroscope or like device. Either between or during flushing of the ear canal, the auroscope can be mounted to the earpiece so allowing the physician an opportunity to view whether cleaning of the canal or application of the therapeutic agent is complete. 
     The second portion can also act as a drain for fluid leaving the ear. The second portion preferably has an outlet port through which the fluid and entrained wax or other matter may drain or be suctioned from the ear. 
     The first and second portions of the earpiece are preferably joined by a plurality of ribs that extend from proximate the first end of the first portion to the overlying second portion. 
     The earpiece is preferably fabricated from a plastics material, silicone or a combination thereof and can be disposable. 
     According to a further aspect, the present invention comprises a method for cleaning wax and other matter from an ear canal comprising the steps of inserting the earpiece as defined herein into the ear canal, and directing fluid through the fluid outlet and into the ear canal. 
     According to a still further aspect, the present invention comprises a method for delivering a quantity of a therapeutic agent in the form of a fluid into all ear canal comprising the steps of inserting the earpiece as defined herein into the ear canal, and directing fluid through the fluid outlet and into the ear canal. 
     Either of the further aspects can also include the step of visualising the ear canal before, during and/or after the step of directing the fluid through the fluid outlet. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Hereinafter by way of example only, preferred embodiments of the invention are described with reference to the accompanying drawings, in which: 
     FIG. 1 is a perspective view of one embodiment of an earpiece according to the present invention; 
     FIG. 2 is a perspective view of the first portion of the earpiece of FIG. 1; 
     FIG. 3 is a perspective view of the second portion of the earpiece of FIG. 1; 
     FIG. 4 is an end view of the earpiece of FIG. 1; and 
     FIG. 5 is an enlarged cross-sectional view of an alternative embodiment of the distal end of the first portion of the earpiece. 
    
    
     PREFERRED MODE OF CARRYING OUT THE INVENTION 
     An earpiece for use as an irrigation device or for the delivery of a therapeutic agent, such as ear drops, according to the present invention is generally depicted as  10  in the drawings. 
     The earpiece  10  comprises a first portion  11 , an ear abutment portion  12  and a fluid delivery tube  13 . 
     The first portion  11  tapers from a first end  14  to a truncated inner end  15 . A diameter of the inner end  15  is such that the ear canal can still be visualised when the earpiece  10  is placed in the ear canal. 
     Proximate the inner end  15  is an outlet  16  to which is connected the tube  13  (partially depicted in phantom in FIGS.  1  and  2 ). The outlet  16  is disposed at an oblique angle to the longitudinal axis  21  of the earpiece  10  such that fluid entering the ear canal firstly strikes and then spirals along the wall surfaces of the ear canal before reaching the eardrum. The other end of the tube is removably connected to a fluid supply means such as a syringe. bag or tap. The small diameter of the tube  13  serves to minimise the maximum pressure of the fluid entering the ear canal so further reducing the risk to the eardrum. 
     Disposed around the first end  14  of the first portion  11  is the second portion  12  of the earpiece  10 . The second portion  12  is tapered with its outer  10  end  17  being adapted to connect to an auroscope or like device via a connection means  24 . The second portion  12  is connected to the first portion by four ribs  18  best depicted in FIG.  4 . Disposed in the wall of the second portion is an outlet port  19  through which fluid and entrained wax or other matter may be drained from the ear to a waste storage means for later disposal. 
     In use, the earpiece  10  with tube  13  in place will be placed in a patient&#39;s ear with the second portion  12  in abutment with the outer surfaces of the ear. The fluid supply is then connected to the tube  13  and is directed into the ear canal through the tube  13 . The position of the outlet  16  serves to direct the fluid into and spirally along the wall of the ear canal. This action is useful for cleaning the ear canal as it removes the wax or other matter disposed in the canal. It also allows for the precise delivery of ear drops into ear canal where desired. The motion of the fluid along the wall surfaces of the ear canal also reduces the risk of perforation of the eardrum which can potentially arise from the introduction of a fluid jet entering the ear canal. 
     The fluid with any entrained wax or matter or excess ear drops can exit the ear through the second portion  12  and out the outlet port  19 . 
     An auroscope can be readily mounted to the outer end  17  of the second portion  12  so allowing visualisation of the ear canal either during or after injection of the fluid into the ear canal. 
     The arrangement of the earpiece  10  serves to allow cleaning of the ear canal or the placement of ear drops and visualisation of the ear canal without the necessity of repositioning the earpiece  10  following inspection of the ear canal. 
     FIG. 5 depicts an alternative arrangement for the region proximate the inner end  15  of the first portion  11 . In this embodiment, a lumen  23  is formed integrally in the first portion  11  with the outlet  16  being disposed adjacent the inner end  15 . In use, fluid can be directed down the lumen  23  where it strikes the end wall  22  and is directed out through the outlet  16  and into the ear canal. 
     It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.