Patent Publication Number: US-2011066172-A1

Title: Ear cleaning system and method

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application 61/241,978 to the same inventor, filed Sep. 14, 2009, entitled “Ear Canal Cleaning System and Method”, the entire contents of which are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The invention relates to cleaning of ears, and more particularly the removal of contaminants and cerumen from the ear canal using a liquid and mechanical means. 
     BACKGROUND OF THE INVENTION 
     Normally, the ear canal in humans and many mammals produces a substance called cerumen, and commonly termed “ear wax”. The cerumen may take a predominantly dry or wet form, which has been found to be related to genetics, to an extent. Glands that produce cerumen are located in the outer portion of the ear canal. An amount of cerumen may be removed from the outer portion of the ear canal, in some cases, by wiping a damp cloth in the outer portion of the ear. 
     The ear has a natural ability to clean itself, which causes the migration of excess cerumen towards the end of the ear canal. This natural ability can be impaired in smaller ear canals, or by the presence of mechanical hearing aids, or by inserting other objects into the ear. An accumulation of cerumen may cause discomfort, and can eventually lead to a reduced ability to hear. 
     Additionally, the insertion of elongated objects, such as cotton swabs, endanger the eardrum, raise the potential for infection, and tend to push accumulated cerumen deeper into the ear canal, resulting in hearing impairment. 
     One method of cerumen removal is the use of a standard bulb syringe to direct water into the ear canal. This is often done by a medical professional, particularly when the buildup of cerumen has caused difficulties. 
     The art described in this section is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention, unless specifically designated as such. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 CFR §1.56(a) exists. 
     SUMMARY OF THE INVENTION 
     The invention enables expeditious cleaning of cerumen and or contaminants from the ear and ear canal, without causing injury to ear tissue. In accordance with the invention, a contact member including an expandable material is positioned at a distal end of a device, which swells when exposed to a fluid. In a non-expanded state, the expandable material readily inserts into the ear canal. When swollen or expanded, at least portions of the expandable material contact the wall of the ear canal such that motion, such as rotation or twisting, cleans the ear canal wall. The expandable material can be any material that swells when exposed to an irrigation or therapeutic fluid. 
     A device in accordance with the invention includes a handle adapted to be grasped by the hand of a user. A fluid reservoir and passage is disposed within the handle, operative to contain or conduct fluid. A limiter is connected to an end of the handle, operative to contact the tragus of the ear, thereby preventing insertion of the device too deeply into the ear canal. A support tube extends from the limiter, and is operative to conduct fluid delivered from the passage, through the limiter. An expandable ear canal contacting member is connected to the tube, and includes an expandable material operative to increase in size when exposed to a fluid. 
     In use, the device of the invention is inserted into the ear canal, until a leading face of limiter contacts the tragus, or cartilaginous structure protecting the opening of the ear canal. Once the device is inserted into the ear canal, fluid is passed from the passage, and through or around the limiter, whereupon the fluid exits through one or more apertures disposed in tube. Apertures are oriented to conduct fluid to contact side walls of the ear canal. Accordingly, fluid flow does not directly impact the ear drum, for safety and comfort. 
     The dimensions of the device, and particularly the tube length extending from the limiter, and the size of the expandable material, are advantageously selected to fit a particular ear size, for example a child or an adult of the species being treated. 
     Expandable material of the contact member absorbs fluid expelled through the apertures, and expands to contact side wall portions of the ear canal. In so doing, the expandable material contacts a cerumen accumulation, and mechanically transfers the cerumen to the expandable material with movement of the device. 
     A fluid reservoir may be connected to the device, operative to pass a cleaning or therapeutic fluid to the passage, and ultimately to the apertures and the expandable material. If the reservoir is provided in the form of a dropper bottle, a mating tapered connection at opening may be advantageous. Alternatively, the passage may be sized and shaped to be filled with fluid prior to being provided to the user, and passage may be sealed at a point of manufacture. 
     In another embodiment of the invention, an ampule or other fluid chamber may be positioned within the passage. In this event, the inner chamber is squeezed within the passage and thus broken, releasing a contained fluid within passage. This is advantageous in the event that materials must be mixed just prior to use. In this embodiment, one or more materials to be mixed are placed within the passage, for example a powder or a different liquid, and the remaining elements of a mixture are contained within chamber. 
     Expandable material may be formed into a square or rectangular shape, or any other desired shape. It is advantageous, however, to round or soften any sharp edges, for the comfort and safety of the user. In one alternative embodiment of the invention, at least a portion of an end of tube is opened, or apertures are provided along a portion of the tube, within the expandable material, so that fluid may flow into expandable material. 
     In yet another embodiment of the invention, expandable material has the form of a brush of bristles. When not moistened or wet, the brush is sufficiently narrow to be inserted into the ear canal without driving contaminants further into the ear canal. When the bristles have been moisted, the expandable material of the bristles expand to improves a contact of the expandable material with inner sides of the ear canal, and any contaminants or cerumen accumulated within ear canal. 
     The handle, limiter, tube, and other components of a device in accordance with the invention may be formed or molded integrally, or may be joined by any known means, including heat, adhesive, ultrasonic energy, or fasteners. Biocompatible and or biodegradable materials are advantageous used for health and ecological benefits. Accordingly, polymeric materials are advantageous, and may be used to form a device which is economically disposable. Alternatively, devices in accordance with the invention may be formed with metal, glass, or other durable material, whereby the device may be cleaned or sterilized by any known means, and the contacting member may be advantageously replaced for each patient. 
     In one embodiment of the invention, the expandable material is a compressed or uncompressed natural or synthetic material, advantageously provided in a sponge structure, operative to expand when contacted by a fluid, for example water; an alcohol solution; a sodium bicarbonate solution; an antibiotic, antiseptic, or anesthetic solution; or other therapeutic liquid substance. The material is advantageously selected for a rate, force and extent of expansion which is comfortable and safe for the ear, the selection of which, beyond the examples suggested herein, is within the abilities of one skilled in the art. 
     A variety of substances, in accordance with the invention, may be advantageously used to facilitate removal of cerumen and to clean the ear canal. In this regard, 6.5% carbamide peroxide in an anhydrous glycerin base can be used, and is particularly effective for cerumen removal. In one embodiment, a solution containing 70% isopropyl alcohol is used to soften cerumen, as well as to reduce a potential for infection within the ear, and to promote a reduction of moisture within the ear. In another embodiment, 95% isopropyl alcohol is used, for example in an anhydrous glycerin 5% base. A range of alcohol concentrations may advantageously be used for these purposes, including less than 1% to more than 99% alcohol, depending upon the patient&#39;s condition and comfort level, and the therapeutic goals of the practitioner. 
     Alcohol may also be combined with boric acid, for example about 3% boric acid in about 70% alcohol, to treat most bacterial and fungal infections. This solution, or any other solution introduced by the device of the invention into ear canal, may be maintained in place, if desired, by placing ear putty at the opening of ear canal. 
     In one embodiment of the invention, sodium bicarbonate may be placed in an attached fluid chamber, whereby breakage or opening of a fluid chamber internally disposed within the device exposes the sodium bicarbonate to a fluid, for example water within, or introduced into the passage, to hydrate and activate the material, so that it may convey a therapeutic benefit, including for example a reduction in pH, a reduction of an infection or allergic reaction, or for cleaning. Alternatively, a liquid may be contained within the fluid chamber, and sodium bicarbonate may be placed within the passage. In a similar manner, other chemicals may be combined with liquids and or other chemicals, to produce a fresh composition which offers a therapeutic benefit when introduced into the ear canal. 
     The fluid reservoir or tube is squeezed to pass fluid quickly and with sufficient pressure to loosen cerumen and moisten expandable material, but not with such excess pressure that might cause discomfort, or damage to the ear. The cleaning process is repeated until, if desired, the effluent is free of cerumen or contaminants. Optionally, cleaning may be conducted with sufficient frequency, for example weekly, to maintain the ear canal clean, dry, and free of infections. 
     In yet another embodiment of the invention, apertures may be sized sufficiently small to produce a mist when a liquid is driven therethrough at sufficient pressure. Additionally, a sufficient quantity of apertures may be provided to produce a sufficient quantity of mist over a desired area, for example, to mist the a substantial portion of the ear canal. 
     Accordingly, a device of the invention for cleaning the ear canal, comprises: a handle having a distal and a proximal end; a contact member including a material expandable from a first smaller size to a second larger size upon contact with a fluid, the contact member connected to the proximal end of the handle and sized to be smaller than the ear canal when the expandable material has the first smaller size, whereby the expandable material is insertable into the ear canal; a limiter connected to the handle, disposed between the handle distal end and the contact member, the limiter including a face having a diameter greater than an opening to the ear canal, whereby the limiter is operative to limit a depth of insertion of the handle and the contact member; means for passing a fluid through the handle to the contact member when the contact member is disposed within the ear canal, whereby the contact member may be thereby expanded from the first smaller size to the second larger size, whereupon the contact member is sized to contact a wall of the ear canal; wherein the handle is movable together with the connected contact member to thereby dislodge cerumen or contaminants from attachment to a wall of the ear canal. 
     Alternatives of the device in accordance with the invention further include one or more embodiments wherein: a support extension disposed between the limiter and the contact member is operable to support the contact member within the ear canal, and to conduct a fluid; one or more apertures disposed between the limiter and the contact member, operative to direct fluid to a wall of the ear canal and to the contact member; apertures direct fluid to a wall of the ear canal at an angle less than 90 degrees with respect to an angle of a wall of the ear canal; apertures direct fluid into an interior portion of the expandable material; the handle includes a fluid passage operative to contain a fluid and pass the fluid from a distal portion of the handle to a proximal portion of the handle; the handle includes a fluid passage operative to contain a fluid and pass the fluid, from a distal portion of the handle to the ear canal, under pressure; the second larger size of the contact member has a diameter greater than a diameter of the ear canal; the handle and the contact member are not provided with a means for mutual relative disengagement; the expandable material is selected from the group consisting of: sponge, cellulosic material, polyvinyl acetate, Merocel, polymer, natural fiber, synthetic fiber; the expandable material has a textured or roughened exterior surface; a reservoir is disposable within the handle, the reservoir operable to be ruptured to release a first material into an interior in the handle; the interior in the handle is configured to contain a second material, and wherein a combination of the first material and the second material produces a therapeutic substance; a reservoir is connectable to the handle, operative to introduce a material into the fluid passage when the reservoir is connected to the handle; the expandable material has the form of a brush; the handle and the limiter are not provided with a means for mutual releasable engagement; the expandable material is compressed when having the first smaller size; and, the fluid is selected from the group consisting of: alcohol, isopropyl alcohol solution, an isopropyl alcohol and water solution, water, sodium bicarbonate solution, an antibiotic in solution, an antiseptic in solution. 
     In a further embodiment of the invention, a device for cleaning the ear canal, comprises: a handle having a distal and a proximal end; a contact member including a material expandable from a first smaller size to a second larger size upon contact with a fluid, the contact member connected to the proximal end of the handle and sized to be smaller than the ear canal when the expandable material has the first smaller size, whereby the expandable material is insertable into the ear canal; a limiter connected to the handle, disposed between the handle distal end and the contact member, the limiter including a face having a diameter greater than an opening to the ear canal, whereby the limiter is operative to limit a depth of insertion of the handle and the contact member; a support extension extending between the limiter and the contact member, provided with apertures operative to direct a fluid in a direction of the ear canal when at least a portion of the support extension is disposed within the ear canal, whereby the contact member may expanded, by contact with a fluid, from the first smaller size to the second larger size, whereupon the contact member is sized to contact opposing walls of the ear canal; wherein the handle is movable together with the connected contact member to thereby dislodge cerumen or contaminants from attachment to a wall of the ear canal. 
     In yet another embodiment of the invention, a device for cleaning the ear canal, comprises a handle having a distal and a proximal end; a contact member including a material expandable from a first smaller size to a second larger size upon contact with a fluid, the contact member connected to the proximal end of the handle and sized to be smaller than the ear canal when the expandable material has the first smaller size, whereby the expandable material is insertable into the ear canal; a limiter connected to the handle, disposed between the handle distal end and the contact member, the limiter including a face having a diameter greater than an opening to the ear canal, whereby the limiter is operative to limit a depth of insertion of the handle and the contact member; a support extension extending between the limiter and the contact member, provided with at least one aperture operative to direct a fluid in a direction of the ear canal when at least a portion of the support extension is disposed within the ear canal, whereby the contact member may expanded, by contact with a fluid, from the first smaller size to the second larger size, whereupon the contact member is sized to contact opposing walls of the ear canal; a reservoir connectable with the handle, operative to contain a fluid and pass the fluid to the at least one aperture; wherein the handle is movable together with the connected contact member to thereby dislodge cerumen or contaminants from attachment to a wall of the ear canal. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which: 
         FIG. 1  illustrates an ear cleaning device in accordance with the invention; 
         FIG. 2  illustrates the ear cleaning device of  FIG. 1 , after exposure to a liquid; 
         FIG. 3  illustrates the ear cleaning device of  FIG. 1 , positioned proximate an ear; 
         FIG. 4  illustrates the ear cleaning device of  FIG. 1 , a portion of which inserted into an ear canal; 
         FIG. 5  illustrates an enlarged view of the ear cleaning device of  FIG. 1 , further illustrating fluid passages within an expandable ear canal contacting member of the invention; 
         FIG. 6  illustrates the contacting member of  FIG. 5 , expanded within the ear; 
         FIG. 7  illustrates an embodiment of the invention in which a fluid is introduced into a device of the invention, through an aperture at an end of the device, through a connection with a fluid reservoir; 
         FIG. 7A  illustrates a fluid reservoir and internal tube in accordance with the invention; 
         FIG. 8  illustrates a fluid container within a device in accordance with the invention, and a sealing member; 
         FIG. 9  illustrates a perspective view of a device in accordance with the invention, including an ear contacting member in the form of a pad; 
         FIG. 10  illustrates a reverse view of the device of  FIG. 9 ; 
         FIG. 11  illustrates a contacting member stiffening device, in the form of a flexible pin within the contacting member; 
         FIG. 12A  illustrates a contacting member having the form of a brush; 
         FIG. 12B  illustrates the brush of  FIG. 12A , expanded by exposure to a liquid; 
         FIG. 13  illustrates the brush of  FIG. 2  with an aperture for release of fluids only within an expandable material; and 
         FIG. 14  illustrates the brush of  FIG. 2 , with a single aperture at a tube end within the expandable material. 
     
    
    
     All dimensions shown in the figures or discussed in this specification are illustrative only, are not to scale, and should not be considered limiting, as the present invention contemplates various configurations. 
     DETAILED DESCRIPTION OF THE INVENTION 
     The invention enables expeditious cleaning of cerumen and or contaminants from the ear and ear canal  44 , without causing injury to ear tissue, including the ear canal  44  and ear drum  48 . In accordance with the invention, a contact member  20  including an expandable material  22  is positioned at a distal end of device  10 , and swells when exposed to a fluid. In a non-expanded state, expandable material  22  readily inserts into ear canal  44 . When swollen or expanded, at least portions of the expandable material  22  contact the wall of the ear canal such that motion, such as rotation or twisting, cleans the ear canal wall by transferring the cerumen or contaminants to the expandable material, or loosening the cerumen so that it may be flushed from the ear. Examples of flushing material from the ear may be found in U.S. Patent Application Publication 2010/0179490 to Connely, et al., and U.S. Provisional Application 61/241,978 to the instant inventor, each of which is incorporated herein by reference. It is advantageous if expandable material  22  expands sufficiently in order to contact opposing wall surfaces of ear canal  44 , thereby enabling a force to be applied by the expandable material against cerumen or contaminants attached to or adhered to the ear canal wall, thereby facilitating dislodging the cerumen or contaminants, or transfer of same to the expandable material  22 . 
     Although any suitable geometry for the expandable member can be used, a cylindrical geometry is advantageous as it mimics the general shape of the ear canal. The composition of expandable material  22  can be any material that swells when exposed to an irrigation or therapeutic fluid. Examples include polyvinyl acetate, Merocel (a polyvinyl alcetal surgical sponge material which is a registered trademark of Medtronic Xomed, Inc., a Delaware Corporation), cellulose or cellulose based material, collagen, or any other biocompatible material that swells when exposed to the intended therapeutic fluid. 
     Referring to  FIG. 1 , a device  10  in accordance with the invention includes a handle  12  adapted to be grasped by the hand of a user. In the illustration, handle  12  has the form of a tube, however any form which is advantageously grasped and manipulated by a hand is contemplated within the spirit and scope of the invention. A fluid reservoir and passage  14 ′ is disposed within handle  12 , operative to contain or conduct fluid. In an embodiment of the invention, an opening  16  is provided at an end of handle  12 . A limiter  18  is connected to an end of handle  12 , and is operative to contact the tragus  42  of the ear, thereby preventing insertion of device  10  too deeply into the ear canal  44 , as explained further below. A support tube  14  extends from limiter  10 , on a side opposite handle  12 , and is operative to conduct fluid delivered from passage  14 ′, through limiter  10 . An expandable ear canal contacting member  20  is connected to tube  14 , and includes an expandable material  22  operative to increase in size when exposed to a fluid. Support tube  14  may extend into handle  12  to form passage  14 ′, or may be connected to limiter  18  and or tube  12  to establish fluid communication with passage  14 ′. 
     In use, device  10  is inserted into the ear canal in need of cleaning, in the orientation shown in  FIG. 3 . A leading face  24  of limiter  18  contacts the tragus, or cartilaginous structure protecting the opening of the ear canal, and other tissue at the opening of ear canal  44 , thereby limiting an extent to which device  10  can be inserted into the ear canal. Once device  10  is inserted into the ear canal, fluid is passed from passage  14 ′, through or around limiter  18 , whereupon the fluid exits through one or more apertures  26 , disposed through an outer periphery of tube  14 . In an embodiment of the invention, apertures  26  are angled to direct flow against ear canal  44  side walls at an angle, although in accordance with the invention, fluid may also be directed perpendicular to the walls. Apertures  26  are oriented to conduct fluid angularly with respect to an orientation of device  10  within ear canal  44 . In this manner, fluid flows against against inner side portions  46  of ear canal  44 . Accordingly, fluid flow is not initially directed against ear drum  48 , thereby avoiding creating noise and pressure against ear drum  48 , increasing safety for the ear, and maintaining comfort for the individual. Apertures  26  are positioned to direct fluid flow under pressure against ear side portions  46 , and therefore advantageously have an unobstructed path thereto. Apertures  26  may also be positioned beneath or within expandable material  22 , as described further below. 
     With further reference to  FIG. 3 , dimensions “X”, “Y”, and “Z” are advantageously selected to fit a particular ear size, for example a child or an adult of the species being treated. Dimension “X” is advantageously selected to be sufficiently small to enable contacting member  20  to be inserted into the ear with a low probability of pushing cerumen further into the ear. The “Z” dimension is selected to ensure device  10  cannot be inserted too far into the ear. Dimension “Y” is selected to be sufficiently long to efficaciously remove excess cerumen. In adult human, the “X”, “Y”, and “Z” dimensions have been determined to advantageously be about ⅛th, ⅜ths, and ⅝ths of an inch (3.2, 9.5, and 15.9 mm), respectively. Limiter  18  has advantageously been determined to be about 9/16ths of an inch (14.3 mm) high. These values correspond, typically, to an inner ear  44  having portions with a height of about ¼ inch (6 mm) in diameter, and an ear canal  44  length of about 1 inch (25.4 mm), for example. These dimensions are merely exemplary, however, and it should be understood that dimensions are selected to fit a user&#39;s ear, and to facilitate usage of the device  10  of the invention. The dimensions of contact member  20 , for example, may be smaller, while still enabling efficacious use of device  10 . 
     Referring now to  FIG. 4 , device  10  has been inserted into an ear, with leading face  24  of limiter  18  contacting tragus  42 , and contacting member  20 , supported on tube  14 , disposed within ear canal  44 . Expandable material  22  is positioned to overlap at least a portion of cerumen accumulation  40 . In an adult human, the distance from tragus  42  to the beginning of ear canal  44 , has been found to typically be about ½ inch (12.7 mm), for example. The positioning of contact member  20  with respect to limiter  18  is accordingly selected to locate expandable material  22  within ear canal  44  when limiter  18  contacts tragus  42 . Once such positioning has taken place, fluid may be admitted into ear canal  44 . As shown in  FIG. 5 , admitted fluid exits through apertures  26 , in the general direction of the dashed arrows, which indicate an advantageously angular trajectory towards a side wall of ear canal  44 , and not directly against ear drum  48 . It should be understood, however, that fluid may be directed at an angle perpendicular to the walls of ear canal  44 . In  FIG. 5 , additional, optional apertures  26  are illustrated underneath, or within, expandable material  22 , provided to hasten moistening of expandable material  22 . It should be understood, however, that expandable material  22  may be sufficiently moistened, in some embodiments of the invention, from fluid directed against side walls of ear canal  44 . Alternatively, as shown in  FIG. 13 , apertures  26  may be provided only within expandable material  22 , or as shown in  FIG. 14 , an additional aperture  26  may be provided at the end of support tube  14 , either with or without other apertures  26  within expandable material  22 , or elsewhere upon support tube  14 . In accordance with the foregoing, any combination of aperture  26  locations may be used with any of the various embodiments of the invention. 
     With reference to  FIG. 6 , it can be seen that expandable material  22  of contact member  20  has absorbed fluid expelled through apertures  26 , and has expanded to contact side wall portions of ear canal  44 . In so doing, expandable material contacts cerumen accumulation  40 . Accordingly, device  10  may be moved longitudinally with respect to an axis of ear canal  44 , as shown by arrow “B”, or may be rotated within ear canal  44 , as shown by arrow “C”, to transfer cerumen to contact member  20 . The cerumen has been loosened by the action of the fluid expelled through apertures  26 , or a mechanical wiping of expandable material  22 , or a combination of each, whereby some or all of cerumen  40  transfers to expandable material  22 , to be removed as device  10  is withdrawn from the ear. The process of inserting device  10  into ear canal  44 , optionally expelling additional fluid through apertures  26 , and mechanically wiping cerumen may be repeated until the ear canal is satisfactorily cleaned of cerumen  40  and or other contaminants. 
       FIG. 7  illustrates one embodiment of the invention, in which fluid is introduced to passage  14 ′ through opening  16 . In this embodiment, a fluid reservoir  50  threadably fastens, as by thread  54 ,  54 ′, to passage  14 ′, although other means of attachment may be used, including a friction fit, or other known method of fluid connection or coupling. Fluid  52  may be transferred to passage  14 ′, and fluid reservoir  50  removed prior to use, or reservoir  50  may remain connected during use. In the latter circumstance, it may be advantageous if reservoir  50  may be squeezed, in order to provide pressure for fluid flow through apertures  26 . If reservoir  50  is to be removed prior to use, a cap, such as threadable cap  56  of  FIG. 8  may be used, or other suitable seal. In this event, it may be advantageous if passage  14 ′ can be squeezed to create pressure. Passage  14 ′ may also be filled and sealed in any known manner, and a funnel may be used to facilitate filling. If reservoir  50  is provided in the form of a dropper bottle, a mating tapered connection at opening  16  may be advantageous, although any of a variety of shaped openings of sufficient size may be used, as understood by one skilled in the art. 
     With reference to  FIG. 7A , Reservoir  50  may be provided with an internal tube  60 , operative to conduct fluid  52  from reservoir  50 , whereby pressure within reservoir  50  causes fluid to be driven through internal tube  60  to outside of reservoir  50 , for example through opening  16 . Pressure may be provided in the form of an internal propellant  62 , or by a user squeezing a flexible reservoir  50 . Internal tube  60  may optionally be bent or angled to enable maintenance of reservoir  50  in an upright position when connected to opening  16 , when device  10  is disposed within the ear. Various connectors  64  may be provided to connect reservoir  50  to device  10 , and may include adapters or be adapted to fit industry standard fluid vessels. If internal propellant  62  is used, a trigger  64 A is advantageously provided to control fluid flow from reservoir  50 . Pressure provided by propellant  62  may be advantageously determined to be appropriate for a particular application, dependent upon fluid viscosity, species, and ear size, for example. Internal tube may be provided with a taper  66  at an outlet end, to facilitate fluid sealing coupling to opening  16 , which may be provided with a mating taper. 
     Alternatively, passage  14 ′ may filled with a therapeutically beneficial amount of fluid  52  prior to being provided to the user, and passage  14 ′ may be sealed at a distal and or proximal end of passage  14 ′, advantageously during manufacturing, and prior to shipment of the device to a user. Passage  14 ′ is accordingly sized and shaped to contain a suitable amount of fluid  52 . Means may be provided to unseal an end of passage  14 ′ to form a fluid coupling to tube  14 , for example a twist lock, pressure sensitive seal, puncturing device, or other method known in the art. 
     In  FIG. 8 , an ampule or other fluid chamber  58  may be positioned within passage  14 ′. In this event, chamber  58  may be squeezed within passage  14 ′ and thus broken, separated or ruptured, releasing a contained fluid within passage  14 ′. This is advantageous in the event that materials must be mixed just prior to use, as explained further below. In this embodiment, one or more materials to be mixed are placed within passage  14 ′, and the remaining elements of a mixture are contained within chamber  58 . 
     In accordance with another embodiment of the invention, a kit may be formed of any or all of the elements of the invention disclosed herein. For example, a kit may be formed with quantities of one or more, optionally in different sizes where applicable, of any of the following: contacting members  20 ; handle  12 ; limiter  18 ; fluid reservoir  50 ; fluids, optionally of different types; cap  56 ; propellant  62 ; connectors  64 ; cleaning supplies; instructions on paper or audio-visual media; and containers. 
     Referring now to  FIGS. 9 and 10 , a device  10  in accordance with an alternative embodiment of the invention includes contacting member  20 , including expandable material  22  formed into a pad connected to support tube  14 . Expandable material  22  may be formed into a square or rectangular shape, or any other desired shape. It is advantageous, however, to round or soften any sharp edges, for the comfort and safety of the user. In the embodiment of  FIGS. 9 and 10 , tube  14  extends into expandable material  22 , and may be flattened or otherwise shaped to better insert or fit within expandable material  22 , for example, by flattening or shaping an end of tube  14 . Alternatively, expandable material  22  may be connected to tube  14  by any known means, including adhesives or fasteners. It is advantageous, however, for there to be no sharp edges or corners which could be injurious to the delicate tissues of the ear and ear canal  44 . In one alternative embodiment of the invention, at least a portion of an end of tube  14  is opened, so that fluid may flow into expandable material  22 . In this embodiment, apertures  26  may be present, or may be eliminated. 
     While expandable material  22  is shown in  FIGS. 9 and 10  as biased towards a side of tube  14 , it should be understood that tube  14  may be contained entirely within expandable material  22 , so that no portion of tube  14  is positionable to contact inner ear  44 , and or so that as expandable material  22  expands, all sides of inner ear  44  are contacted with even pressure. 
     As may be seen in  FIGS. 10 and 11 , an additional support member  28  may be provided, positionable or positioned within expandable material  22 , operative to further stiffen expandable material  22 , should this be deemed therapeutically advantageous. 
     With reference to  FIGS. 12A and 12B , an alternative form of expandable material  22  is shown, having the form of a brush of bristles. In  FIG. 12 , expandable material  22  is not moistened or wet, and is accordingly sufficiently narrow to be inserted into ear canal  44  without driving contaminants further into ear canal  44 . In  FIG. 12B , the bristles of expandable material  22  have been moistened, as by fluid passed through apertures  26 , or from contact with fluid applied to inner ear  44  by apertures  26 , and have thus expanded to a configuration which improves a contact of expandable material  22  with inner sides of ear canal  44  and contaminants or cerumen  40 , accumulated within ear canal  44 . 
     It should be understood that handle  12 , limiter  18 , and tube  14 , and other components of a device in accordance with the invention, may be formed or molded integrally, or may be joined by any known means, including heat, adhesive, ultrasonic energy, or fasteners. Biocompatible materials are advantageously used, particularly in the event that any portion of the device is inadvertently detached and left inside the ear. Biodegradable materials are additionally advantageous for the same reason, and further promote disintegration within landfills. Accordingly, polymeric materials are advantageous, and may be used to form a device which is economically disposable. Alternatively, device  10  may be formed with metal, glass, or other durable material, whereby the device may be cleaned or sterilized by any known means, and contacting member  20 , at least, may be advantageously replaced for each patient, connectable to the remainder of the device by screws, fasteners, threads, adhesive, or other means which would be apparent to one skilled in the art. 
     In one embodiment of the invention, expandable material  22  is a compressed or uncompressed natural or synthetic material, advantageously provided in a sponge structure, operative to expand when contacted by a fluid, for example water, or solutions of alcohol, sodium bicarbonate, one or more antibiotics, one or more antiseptics, or one or more anesthetics. Other therapeutic fluid substances are contemplated within the scope of the invention, as would be understood by one skilled in the art. A wide variety of natural and synthetic materials which are non-injurious to the body, and which are sufficiently soft in both a dry and or compressed form, and in a fluid expanded form, may be advantageously used for expandable material  22 , in accordance with the invention. Examples of materials usable for expandable material  22  include cellulosic material, polyvinyl acetate, or Merocel, natural fiber, or synthetic fiber, although many more alternatives would be understood to be usable by one skilled in the art. It is advantageous if the expanded material has an outer surface with a textured or roughened exterior surface, to facilitate removal of cerumen or contaminants attached or adhered to a wall of the ear canal, or to facilitate a transfer of cerumen or contaminants from the ear canal to the expandable material. 
     The material is advantageously selected for a rate, force and extent of expansion which is comfortable and safe for the ear, the selection of which, beyond the examples suggested herein, is within the abilities of one skilled in the art. In accordance with one embodiment of the invention, an expansion of expandable material  22  from ¼ inch (6.3 mm) to ½ (12.7 mm) inch has been found to be advantageous, or about double in size, although other ratios are contemplated within the invention, particularly where the expanded size may be comfortably compressed by the ear canal to a dimension which conforms thereto. The expandable material  22  may be contained within a sleeve or other container, not shown, until ready for use, particularly if expandable material  22  must be maintained compressed until use. 
     A variety of substances, in accordance with the invention, may be advantageously used to facilitate removal of cerumen and to clean ear canal  44 . A fluid substance is advantageously selected to avoid injury to the ear canal skin and ear drum. In one embodiment, a solution containing 70% isopropyl alcohol is used to soften cerumen, as well as to reduce a potential for infection within the ear, and to promote a reduction of moisture within the ear. In another embodiment, 95% isopropyl alcohol is used, for example in an anhydrous glycerin 5% base. A range of alcohol concentrations may advantageously be used for these purposes, including less than 1% to more than 99% alcohol, depending upon the patient&#39;s condition and comfort level, and the therapeutic goals of the practitioner. 
     A further advantage of an alcohol solution includes use of a device  10  of the invention for drying ear canal  44  after swimming, for example. Moreover, alcohol is antimicrobial, and its use reduces the potential for infection. As understood by practitioners in the art, however, the use of alcohol should be discontinued if there is a burning sensation when used, which may indicate an infection, open wound or sore, or a perforation of ear drum  48 . Although there may be temporary discomfort, this is normally transient and not damaging to the ear or hearing. 
     Alcohol may also be combined with boric acid, for example about 3% boric acid in about 70% alcohol, to treat most bacterial and fungal infections. Of course, the concentrations of boric acid and alcohol may be varied considerably, as would be understood by those skilled in the art. This solution, or any other solution introduced by device  10  into ear canal  44 , may be maintained in place, if desired, by placing ear putty at the opening of ear canal  44 . Although initially causing discomfort in some individuals, ear putty typically becomes more tolerable over time, and may be maintained for a sufficient period to provide therapeutic benefit, for example, the reduction of an infection. 
     In one embodiment of the invention, sodium bicarbonate may be placed in fluid chamber  58 , whereby breakage or opening of fluid chamber  58  exposes the sodium bicarbonate to a fluid, for example water within, or introduced into, passage  14 ′, to hydrate and activate the material so that it may be passed into ear canal  44 , thereby operative to convey a therapeutic benefit to the ear, including for example a reduction in pH, a reduction of an infection or allergic reaction, or for cleaning. Alternatively, a liquid may be contained within fluid chamber  58 , and sodium bicarbonate may be placed within passage  14 ′. In a similar manner, other chemicals may be combined with liquids and or other chemicals, to produce a fresh composition which offers a therapeutic benefit when introduced into ear canal  44 . 
     In one embodiment of the invention, a temperature gauge or indicator, for example a temperature indicating strip, not shown, may be applied to or incorporated into device  10 , in order to indicate whether a fluid to be introduced into the ear is at a comfortable or efficacious temperature, before application. 
     When sufficient fluid has been introduced into the ear, effluent, advantageously including removed cerumen, will pass out of ear canal  44 , and is advantageously collected by a container, such as a kidney basin or similar collector, which may be eliminated if the user is in a suitable environment, for example, a shower. To promote retention of fluid within ear canal  44 , a user&#39;s head may be tilted slightly backward and towards the nearest shoulder, which further reduces the likelihood of the fluid entering an eye of the user. 
     Reservoir  50  or tube  14  is squeezed to pass fluid quickly and with sufficient pressure through apertures  26  to loosen cerumen and moisten expandable material  22 , but not with such excess pressure that might cause discomfort, or damage ear canal  44  or ear drum  48 . The cleaning process is repeated until, if desired, the effluent is free of cerumen or contaminants. Optionally, cleaning may be conducted with sufficient frequency, for example weekly, to maintain ear canal  44  clean, dry, and relatively free of infections, and substantially free of cerumen, although a minor quantity of cerumen may be therapeutically beneficial. 
     Device  10  of the invention is advantageously used, for example, by individuals; medical practitioners, including ear nose and throat specialists, general practitioners, audiologists, and veterinarians; and athletes, including swimmers. 
     In yet another embodiment of the invention, apertures  26  may be sized sufficiently small to produce a mist when a liquid is driven therethrough at sufficient pressure. Additionally, a sufficient quantity of apertures  26  may be provided to produce a sufficient quantity of mist over a desired area, for example, to mist the a substantial portion of ear canal  44 . A mist promotes an even coating of ear canal  44  with a minimum of fluid. The mist may be maintained within ear canal  44 , if desired, by using ear putty, for example. 
     It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention. 
     All references cited herein are expressly incorporated by reference in their entirety. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. There are many different features to the present invention and it is contemplated that these features may be used together or separately. Thus, the invention should not be limited to any particular combination of features or to a particular application of the invention. Further, it should be understood that variations and modifications within the spirit and scope of the invention might occur to those skilled in the art to which the invention pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention.