Patent Publication Number: US-2011066102-A1

Title: Irrigation Device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Patent Application No. 61/241,956, filed Sep. 13, 2009. The contents of that application are incorporated by reference herein in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates generally to the field of devices for irrigating and cleaning body cavities, and more particularly, to devices for cleaning and irrigating the ear canal. 
     2. Description of Related Art 
     Ear wax, also called cerumen, is secreted by the human ear canal and provides protection, cleaning, and lubrication for the structures within the ear. However, build-up of ear wax can also put pressure on the structures within the ear and can impede hearing. Several techniques are known for removing ear wax, including techniques using metal scraping tools (e.g., curettes and ear picks), and techniques using liquid-filled syringes, which are used to inject streams of liquid into the ear to clear the wax. Each of these methods has its disadvantages: using metal scraping tools, it is possible to damage the structures of the ear; using a syringe, control of the liquid stream may be awkward or difficult, and the stream will not be accurately aimed or caused to oscillate. 
     U.S. Pat. No. 5,833,675 to Teddy Garcia, which is incorporated by reference in its entirety, discloses an alternate solution. In the Garcia patent, a hand pump with a liquid reservoir is used to generate a pressurized stream of liquid, which is directed into a relatively long tube that is connected to a soft end tube of a smaller bore. The material of the end tube is flexible enough to oscillate when water is pumped through it. Although this device may function well in producing an oscillatory stream of fluid to the ear, the device itself may be difficult for a single person to manipulate and use. 
     SUMMARY OF THE INVENTION 
     One aspect of the invention relates to an irrigation device for irrigating a body cavity, such as an ear canal. The irrigation device comprises a hand-held pumping device and an irrigating tip. The hand-held pumping device includes a liquid reservoir and a pumping mechanism, which may be in the form of a spray bottle with a squeeze trigger. The outlet of the pumping mechanism is directly connected to the irrigating tip. The irrigating tip includes a connector and a short end or irrigation tube that is made of a flexible material and has inner and outer dimensions and a length suitable for insertion into the ear canal. When liquid is drawn from the reservoir and propelled through the irrigating tip, the irrigating tip oscillates as the fluid passes through it and into the ear canal. 
     Other aspects, features, and advantages of the invention will be set forth in the description that follows. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING FIGURES 
       The invention will be described with respect to the following drawing figures, in which like reference numerals refer to like features throughout the figures, and in which: 
         FIG. 1  is a side elevational view of a portion of an irrigator according to one embodiment of the invention; 
         FIG. 2  is a top plan view of the irrigator of  FIG. 1 ; 
         FIG. 3  is an exploded (disassembled) view of the outlet and irrigating tip of the irrigator; 
         FIG. 4  is a side elevational view of a portion of an irrigator according to another embodiment of the invention; and 
         FIG. 5  is a perspective view of an irrigation kit according to yet another embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  and  FIG. 2  are side elevational and top plan views of an irrigator, generally indicated at  10 , according to one embodiment of the invention. The irrigator  10  comprises a liquid reservoir  12  connected to a mechanical pumping mechanism  14  that is coupled to the reservoir  12  and arranged such that when actuated, liquid is drawn from the reservoir  12  and expelled from the outlet  16  of the pumping mechanism  14 . In the embodiment of  FIGS. 1 and 2 , the pumping mechanism  14  is a manual pump that has the form and attributes of a conventional spray bottle with a squeeze trigger  30 , although pumping mechanisms having other forms and attributes may be used in other embodiments of the invention. 
     At the outlet  16  of the pumping mechanism  14 , an irrigating tip  18  is connected. The irrigating tip  18  comprises a connector  28  and an end or irrigation tube  22  that in most embodiments is fixedly attached to the connector  28 , such that the two components may be removed and replaced together, allowing the irrigator  10  to be used with multiple patients. The connector  28  connects on one end with the outlet  16  of the pumping mechanism  14  through an adapter  20  to place the end tube  22  in fluid communication with the pumping mechanism  14  and reservoir  12 , so that liquid expelled from the outlet  16  is propelled through the end tube  22 . The connection between the adapter  20  and the outlet  16  may, for example, be a threaded connection, and a first sealing structure  24 , such as an O-ring, may be used to seal the connection between the two components  16 ,  20  and prevent leakage. If the pumping mechanism  14  is a conventional spray bottle, a second sealing structure  26 , such as another, larger O-ring, may be used between the outlet  16  and the main body of the pumping mechanism  14  to maintain the outlet  16  in an open condition (if the outlet  16  is movable and has both open and closed positions) and to prevent leakage between the outlet  16  and the main body of the pumping mechanism  14 . 
     The end tube  22  is generally comprised of a flexible tubing material of an outer diameter small enough to fit within the ear canal. The material of which the end tube is made would generally be a plastic or rubber, and may be flexible enough so that when liquid is expelled through the end tube  22 , the end tube  22  oscillates as illustrated in U.S. Pat. No. 5,833,675. In general, any biocompatible tubing of appropriate size and compliance may be used. The end tube  22  may, for example, be made of polyvinyl chloride (PVC), while the connector  28  may be made of polypropylene. The end tube  22  may have a length on the order of about 0.5 inches to about 1 inch, and, for example, an outer diameter of ⅛ inch and an inner diameter of 1/16 inch. 
       FIG. 3  is an exploded view of the outlet  16 , the adapter  20 , the connector  28 , and a portion of the end tube  22 , showing how the components fit together. The rearward portion  31  of the adapter  20  that faces the outlet  16  has male, exterior threads, carries the first sealing structure or O-ring  24 , and makes a threaded connection with the outlet  16 , which has complementary female threads. At its forward end  34 , the adapter  20  forms a tubular portion of a smaller diameter that has threads or other appropriate connecting structure and is thus adapted to connect with the rearward portion  32  of the connector  28 , which features an appropriately sized complementary threaded tubular connector. 
     The outlet  16  and adapter  20  are separable components in the illustrated embodiment, which is advantageous in that it allows the irrigating tip  18  to be attached easily to an existing pumping mechanism. However, in some embodiments, the outlet  16  and adapter  20  may be molded or otherwise formed as a single component. In yet other embodiments, the outlet itself may be formed so that it provides an attachment point suitable for the direct attachment of an irrigating tip  18 . 
     As those of skill in the art will appreciate, although male threads are shown on some components and female threads on others, the sense of the threads may be reversed. Moreover, any form of connection may be used between the components, including, for example, luer-type connectors, especially between the irrigating tip  18  and the outlet  16  or adapter  20 . 
     In the irrigator  10 , there is no tubing or other flexible conduit between the outlet  16  of the pumping mechanism  14  and the irrigating tip  18 . At least in part for that reason, the irrigator  10  can easily be operated by a single person using only one hand, with the end tube  22  inserted directly into the ear canal or other body cavity requiring irrigation and the rest of the irrigator  10  just outside and immediately proximate. The reservoir  12 , pump mechanism  14  and other components may be particularly sized or adapted for one-handed usage in some embodiments. 
       FIG. 4  is a side elevational view of an irrigator  100  according to another embodiment of the invention. The irrigator  100  has a reservoir  12  and a pump mechanism  14  similar to those of the irrigator  10 , and other features not described here may also be assumed to be substantially similar to those of the irrigator  10 . As was noted above, in some embodiments, the outlet  16  and adapter  20  may be made integral, as they are in the irrigator  100 . Specifically, a unitary outlet member  102  in the irrigator  100  tapers from a pump-interfacing portion  104  of greater diameter to an irrigating tip interfacing portion  106  of somewhat lesser diameter, although not all embodiments need taper or change diameter. The unitary outlet member  102  may be formed in a single piece, e.g., using injection molding, and eliminates the need for a sealing member  24 . 
     Interchangeable irrigating tips  18  would generally connect with the irrigating tip interfacing portion  106  in the same way as with the irrigator  10 . Specifically, the inside diameter of the irrigating tip interfacing portion  106  may have threads or ridges that engage the connector  28  of the irrigating tip  18 . 
     Irrigators  10 ,  100  according to embodiments of the invention may be sold as parts of a kit.  FIG. 5  is a perspective view of a kit, generally indicated at  200 , according to one embodiment of the invention. The kit  200  includes an irrigator, which in this case is irrigator  100 , though any irrigator  10 ,  100  according to embodiments of the invention may be used. In addition to the irrigator  100 , the kit  200  comprises one or more irrigating tips  18 , and would generally include a plurality of irrigating tips  18 , each made to be disposable. In addition, the kit  200  may include a basin  202 , which may be shaped, contoured, and otherwise adapted to be placed just under the external portion of the ear to catch solution as it leaves the ear during and after the washing process. The basin  202  may be disposable or reusable and sterilizable by a standard process, such as by autoclaving. 
     The kit  200  may also include a bracket or holder  204  which is configured and adapted to hold the irrigator  10 ,  100  and may also include mounting hardware for mounting on a wall or in another such convenient location. In the illustrated embodiment, the bracket  204  is a straight-backed sheet of material that is bent at appropriate locations to define a back wall, a bottom, and a front wall. The ends of the bracket  204  are contoured to match the contours of the irrigator  10 ,  100 , so as to provide a receptacle for the irrigator  10 ,  100 . The bracket  204  may be made of a plastic, such as PLEXIGLAS®, a metal, or any other suitable material. 
     Any number of solutions may be used with irrigators  10 ,  100  according to embodiments of the invention. For example, a solution of 1 part 3% hydrogen peroxide solution and 4 parts water may be suitable. A minor portion (e.g., a few drops) of a surfactant or detergent, such as a conventional shampoo, may also be added. More dilute solutions, such as 1 part 3% hydrogen peroxide to  9  parts water, may be used. Other suitable solutions will be known to those of skill in the art. 
     The irrigators  10 ,  100  themselves may be disinfected by loading the reservoir  12  with a disinfectant solution and pumping it through the irrigator  10 ,  100  and by wiping the exterior with a disinfectant solution. 
     Although the invention has been described with respect to certain exemplary embodiments, the description is intended to be illuminating, rather than limiting. Modifications and changes may be made within the scope of the invention, which is defined by the appended claims.