Patent Publication Number: US-2003229306-A1

Title: Nasal lavage system and method

Description:
RELATED APPLICATIONS  
     [0001] This application claims the benefit of U.S. Provisional Application No. 60/368,875, filed Mar. 29, 2002, which is incorporated herein by reference. 
    
    
     
       BACKGROUND OF THE INVENTION  
       [0002] 1. Field of the Invention  
       [0003] The present invention relates, in general, to personal hygiene, and, more particularly, to systems, apparatus and methods for performing nasal lavage to cleanse the nasal cavity.  
       [0004] 2. Relevant Background  
       [0005] The human body is presented with an increasingly complex quantity and variety of contaminants. The prevalence of macro-scale contaminants such as dust, soot, and ash is being addressed by environmental regulation, but continue to be a significant health issue. Micro-scale and chemical contaminants are more difficult to detect and regulate and so human exposure continues to increase. Moreover, biological contaminants such as bacteria and viruses, including biotoxins used for military and terrorist purposes, present an increasing health risk worldwide.  
       [0006] The human nasopharyngeal system has evolved to protect the human organism by trapping contaminants such as viruses, bacteria, pollutants and the like. These contaminants are trapped by a system of mucous-lined passageways. Nasal and nasopharyngeal cavities are common places for holding environmental allergens, such as pollen, fungal spores, animal body-originated dustings and volatile chemicals. These harmful agents cause allergic reactions and other health consequences.  
       [0007] The nasopharyngeal system is not, however, completely self-cleaning. As a result, many disease-causing agents exist in the nasal and nasopharyngeal cavities. Exposure to these pathogens may be acute or chronic, but in either case the quantity or proportion of pathogens trapped increases unless the nasopharyngeal system is cleansed. As the loading of these pathogenic agents in the mucous increases to clinically significant levels, health and comfort are negatively impacted. Hence, a need exists for efficient tools and methods for cleaning the nasopharyngeal system as a part of routine personal hygiene.  
       [0008] [refer to Breathing,] 
       [0009] With respect to an individual&#39;s health, even though the nasopharyngeal system may trap contaminants, if they are not removed they can readily lead to health problems. First, local tissues in the sinuses may be impacted resulting in irritation, infection, or more serious consequences. Second, contaminants may progress farther into the human system (i.e., vertical transmission), effectively using the nasopharyngeal system as a launching platform. For example, viruses trapped in the sinuses readily migrate from the upper respiratory tract to the lower respiratory tract of the carrier.  
       [0010] Similarly, trapped viruses also enable spreading of the pathogens to other people through sneezing and/or coughing, for example (i.e., horizontal transmission). Hence, it is beneficial to have a practical system and/or method to remove these disease causing agents from the human body. In a manner similar to brushing one&#39;s teeth, nasal and nasopharyngeal cleaning in the general population will have a number of health benefits.  
       [0011] Several methods have been reported to be useful in cleaning nasal and nasopharyngeal cavities. These generally involve an isotonic saline solution under pressure flowing into one nostril, passing through the sinuses and being discharged from the second nostril. These pressurized systems increase the risk that contaminants will be forced into adjacent areas such as the Eustachian tubes, in effect defeating the purpose of the natural protection mechanisms that exist.  
       [0012] A technique called “neti”, was developed ages ago in India. The device, which has changed little since its conception, is a tea-pot like structure that enables a person to gently run a rinse solution through the nasal passages without pressure. Although this simple device performs well, the conventional design allows reverse flow from the user&#39;s nasal cavity into the reservoir, potentially contaminating the rinse solution. Moreover, the device itself may become contaminated. Further, after each use the device must be carefully cleaned as the device comes into intimate contact with the user&#39;s nostrils and exterior nasal passages. Accordingly, a need exists for a system and method of providing nasal lavage that obtains the benefits of simplicity and un-pressurized operation, while at the same time overcoming the limitations associated with multiple users and contamination of the device and/or lavage solution.  
       SUMMARY OF THE INVENTION  
       [0013] Briefly stated, the present invention involves a nasal lavage device having a reservoir configured to hold a quantity of lavage solution. A spout is coupled to the reservoir operates to conduct the lavage solution from the reservoir to an end of the spout. The lavage system comprises alone or in combination an interchangeable tip assembly and a check valve mechanism. The tip assembly detachably includes a spout-end  203  that couples to the spout  103  and is configured to fit in contact with a user&#39;s nose so as to enable lavage solution to be conducted from the reservoir, through the spout, through the tip to the user&#39;s nose. The check valve is located between the reservoir and the tip and operable to inhibit fluid backflow from the tip to the reservoir.  
       [0014] In another aspect, the present invention involves an interchangeable tip for a nasal lavage system. An exterior sealing surface creates a seal to a user&#39;s nostril. A channel formed in the tip conducts fluid into the user&#39;s nostril. An attachment mechanism located at one end of the interchangeable tip operates to removably attach the tip to a reservoir of lavage fluid. Each interchangeable tip can be associated with a particular user thereby enabling the remaining portions of the lavage system to be hygienically shared amongst several people. The nasal lavage tip may also include a check valve integrated within the tip to prevent backflow of fluid from the nostril into the reservoir through the channel.  
       [0015] In still another aspect, the present invention involves a disposable nasal lavage system using a disposable reservoir operable to hold a quantity of lavage solution. A tip is coupled to the reservoir having a channel formed therein and operable to conduct fluid into the user&#39;s nostril from the reservoir. Preferably, a venting mechanism in the reservoir releases vacuum created by dispensing the lavage solution from the tip. 
     
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
     [0016]FIG. 1 shows an exemplary nasal lavage system in which the present invention is implemented;  
     [0017]FIG. 2 shows the system of FIG. 1 in cross-section;  
     [0018]FIG. 3A through FIG. 3D show various alternative embodiments of interchangeable tip mechanisms in accordance with the present invention;  
     [0019]FIG. 4 illustrates a portion of an exemplary valve used in the embodiment of FIG. 3A;  
     [0020]FIG. 5 illustrates a first disposable implementation of the present invention;  
     [0021]FIG. 6 illustrates a second disposable implementation of the present invention; and  
     [0022]FIG. 7 illustrates a second disposable implementation of the present invention. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
     [0023] In present invention involves a system for providing nasal lavage in which a liquid is introduced into the nasal cavity under a low pressure or gravity feed system to irrigate the nasal cavities and surrounding areas. The dispenser in accordance with the present invention is primarily intended for use by the general public in a program of periodic personal hygiene, but could also be used by health care providers in doctor&#39;s offices, dentist offices, hospitals, and the like.  
     [0024] The present invention is illustrated and described in terms of a lavage system having an interchangeable tip or nose piece such that the portion of the device that comes into contact with any individual is, like a toothbrush, intended for use by a single person. The interchangeable tip may be readily removed, cleaned and stored. Preferably, a valve component is used in combination with the interchangeable nose piece to further inhibit backflow of liquid into the shared components of the system. These features inhibit contamination of shared components of the lavage system.  
     [0025]FIG. 1 and FIG. 2 show an exemplary nasal lavage system in which the present invention is implemented. A reservoir  101  is designed to hold a quantity of lavage solution  202  (shown in FIG. 2) and preferably includes a handle  101  to improve handling and ease of use. A spout  103  provides a channel that conducts lavage solution  202  to a tip end of the spout when reservoir  101  is tilted. Significantly, reservoir  101  is not pressurized and the flow of lavage solution  202  is by gravity feed under the control of a user. A tip  105  having nasal contact surfaces  107  is attached to the tip-end of spout  103 . In use, a person fills reservoir  101  with solution  202 , then places tip  105  in contact with a nostril to make a tight or loose seal with the nostril. Lavage fluid  202  is then conducted into the nostril to wash the nasal cavities and surrounding areas.  
     [0026] One advantage of the various features of the present invention is that much of the nasal lavage system can be hygienically shared by multiple users. This enables a family, for example, to have a single nasal lavage system rather than each person having their own separate system. Specifically, tip  105  is made to be detachable so that each user may have their own tip  105 . Alternatively, tip  105  may be discarded after each use. In some embodiments, an anti backflow valve or check valve is implemented in region  104 . The valve may be implemented in the tip-end of spout  103 , but is more preferably implemented in a tip  105  itself. This feature of the present invention prevents backflow of fluid from tip  105  to spout  101  and/or reservoir  101 .  
     [0027] Reservoir  101  and spout  103  are formed as an integral structure in the exemplary implementation, although this is not required. Alternatively, spout  103  may be made detachable instead of or in addition to tip  105  so that the lavage system can be broken down for thorough cleaning in a dishwasher, for example. Reservoir  101  and spout  103  may be made of metal such as stainless steel, copper, silver, alloys and the like, plastics, ceramics or other water impermeable and hygienic materials.  
     [0028] Reservoir and spout  103  may take on a wide variety of shapes such as the horizontally elongated shape shown in FIG. 1 and FIG. 2, or more upright shapes having a spout that resembles a plant watering cans or pots, or any generally spouted-teapot shaped vessel. The construction may be rigid, semi-rigid, or flexible. In particular, it is contemplated that spout  103  may be formed of a formable tube-like material such as a wire-reinforced plastic or rubber. This allows spout  103  to be shaped and re-shaped to the desires of a user.  
     [0029] Lavage solution  202  typically comprises warm isotonic saline solution. However, many variations are possible. It has been found that buffering the solution with bi-carbonate may increase user comfort. Some believe that slightly acidic solutions comprising citric or tanic acid in very low concentration may improve germ killing capability. It is also contemplated that medicants such as steroids, anti-inflamatories, decongestants, and the like may be included alone or in combination in solution  202  to meet the needs of particular users.  
     [0030] In practice, lavage solution  202  may be supplied in a pre-mixed form that is simply poured into reservoir  101 . Alternatively, a measured quantity of salt and/or medicine and/or buffering agents is mixed with water in reservoir  101  to form the solution each time the lavage system is used. In this case, it may be advantageous to provide a lid or other type of seal for the openings in the top of reservoir  101  and/or the spout  103  so that lavage solution  202  can be easily mixed by agitating reservoir  101  without spilling.  
     [0031]FIG. 3A through FIG. 3D show various alternative embodiments of interchangeable tip mechanisms in accordance with the present invention. In FIG. 3A a valve member  202  comprises a shaped plastic, rubber, metal, or other rigid or semi-rigid material. The valve member  201  is shown in greater detail in FIG. 4. When tipped forward, fluid can spill around the base  401  which is restrained from making a sealing contact with the body of tip  105  by several projections  403 . When tipped backward, or under the influence of reverse flow, sealing surface  402  of valve member  201  seals back against a spout-end of tip  105  sealing surface  402  may be flat or tapered to make an adequate seal, or may have an outside diameter that is less than the inside diameter of spout-end  203  of tip  105 .  
     [0032]FIG. 3B illustrates an alternative valve arrangement using a hinged flap  301  to provide unidirectional flow. Flap  301  may comprise a membrane of the same material used to form tip  105 , or may comprise a sheet or membrane of almost any material that can be attached to tip  105  in a manner that enables hinged action. FIG. 3C illustrates a modification in which valve  302  is formed by a membrane having a slit or similar self-closing opening formed therein. In yet another alternative, FIG. 3D illustrates a valve mechanism  303  that can be mounted on the spout-end of tip  105 . For example, valve mechanism  303  could be readily attached to or inserted in a formed tip  105  and may form a part of the mechanism that attaches tip  105  to spout  103 . A wide variety of valve types and configurations are known, and many variations and equivalents to the specific teachings herein will be appropriate for particular applications.  
     [0033] A disposable implementation is expected to be particularly valuable for use in office first aid kits, vending machine applications, and by travelers. FIG. 5 illustrates a first disposable implementation of the present invention. A disposable reservoir  501  may be formed of a plastic or paperboard box as is often used for disposable drink containers. Such containers are easily sealed to protect the sterility of the lavage solution contained therein. A shaped tip  502  is attached at one end of reservoir  501  and may or may not include a valve mechanism as described hereinbefore. Preferably, a vent such as screw-top sealable vent  503  is used to relieve vacuum build up during use. Alternatively, vent  503  may be implemented with a simple pull-tab type device that allows the user to regulate the flow of liquid by selectively blocking vent  503  with a thumb or finger.  
     [0034]FIG. 6. illustrates a second disposable implementation of the present invention using a collapsible bag dispenser. Reservoir  601  is implemented with a collapsible paper or mylar bag and preferably comprises a material that is deformable, but not elastic. In this manner, lavage solution within reservoir  601  is under little or no pressure during use. A tip  602  is coupled to reservoir  601  and operates in a manner similar to that described above. A sealable flap  604  is preferably included that envelops tip  602  during shipping and handling. A user may release tip  602  by pulling the sealed tabs  604  apart to expose the sterile tip  602 . A vent, such as vent  503  shown in FIG. 5, may also be included in the design shown in FIG. 6.  
     [0035]FIG. 7 illustrates a third disposable implementation of the present invention using a collapsible bag dispenser. Reservoir  701  is implemented with a collapsible paper bag, plastic bag, mylar bag, or the like and preferably comprises a material that is deformable, but not elastic. In this manner, lavage solution within reservoir  701  is under little or no pressure during use as in the case of the embodiment shown in FIG. 6. A tip  702  is coupled to reservoir  701  and operates in a manner similar to that described above. A vent tube  703  has one end that couples to an area on or near tip  702  and leads inside reservoir  701 . Another end of vent tube  703  is located near a bottom of reservoir  701 . In operation, when reservoir  701  is tipped sideways or upside down to dispense the lavage solution contained in reservoir  701 , vent tube  703  provides a conduit for pressure equalization within reservoir  701 . Preferably, a cap or sealing device (not shown) provides a sanitary seal for both the exit portion of tip  702  and vent tube  703  so that the device shown in FIG. 7 is readily shipped and handled while maintaining the contents of reservoir  701  in a sanitary condition. Vent tube  703  may exit reservoir  701  at any convenient location and may be provided as, for example, a straw that is inserted through a wall of reservoir  703  just prior to use.  
     [0036] In an alternative mode of operation, disposable reservoirs  501  and  601  may be shipped with a pre-measured quantity of dry salt, medicines, or other materials used in lavage solution  202 . A user will then add warm water and mix the solution before use. In one example, vent  501  can be used as a means for adding water to reservoir  601 , then sealed. The sealed reservoir  501 / 601  can then be agitated to mix the solution before use. It is contemplated that a variety of lavage solution mixtures may be provided, each in a different labeled container so as to be readily identified by a user. By supplying the lavage solution  202  in a pre-measured, dehydrated form, the package is convenient to transport and use.  
     [0037] Although the invention has been described and illustrated with a certain degree of particularity, it is understood that the present disclosure has been made only by way of example, and that numerous changes in the combination and arrangement of parts can be resorted to by those skilled in the art without departing from the spirit and scope of the invention, as hereinafter claimed.