Patent Publication Number: US-6669059-B2

Title: System and method for passage rinse

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation application of and claims priority to U.S. application Ser. No. 09/845,759, now U.S. Pat. No. 6,520,384, filed on Apr. 30, 2001, the entirety of which is incorporated herein by reference. 
    
    
     BACKGROUND 
     A sinus is a hollow space within the bones of the face. Humans have several sinuses. The sinuses are lined with delicate membrane called mucosa. The sinuses humidify and warm the air, add to the sense of smell and play a significant role in the quality of human sound. A nasal passage runs from the nostrils to the pharynx and is also lined with mucosa. Sinusitis is an inflammation of the mucosa of various sinuses, which are located around the nasal passages. Rhinitis is an inflammation of the mucosa of a nasal passage. 
     Sinusitis and rhinitis can be caused by cold viruses, allergies to various allergens, smoking, bacterial or fungal infections, nasal polyps, deviated nasal septums and non-allergic hypersensitivities. Symptoms of rhinitis include: stuffy nose, runny or drippy nose, scratchy throat and dry cough. Symptoms of sinusitis are more severe than the symptoms of rhinitis. Acute and chronic sinusitis occurs when the sinuses are inflamed and ostia are blocked. Symptoms include: nasal congestion; runny or stuffy nose; white, yellow or green discharge; headache; night time cough; pain in the upper jaw or teeth; persistent fatigue; fever; loss of sense of smell or taste; and sometimes serious infections like meningitis, brain abscess or ear infections. 
     As indicated above, allergies can cause rhinitis and sinusitis. Allergens are organic particles that attach to the nasal mucosa or respiratory mucosa and lead to the development of an antibody, which subsequently creates a series of chemical reactions leading to symptoms. Every individual&#39;s reaction to allergen exposure is different. Indoor allergens including dust mites, mold, pet dander and cockroaches. Outdoor allergens including pollens, grass and mold. Other substances such as cigarette smoke, perfumes and aerosol sprays are irritants that can worsen allergy and sinus symptoms. 
     There are various methods to treat the symptoms of or to cure sinus disease, including surgery. An effective nasal rinse can significantly reduce or permanently cure the symptoms of nasal allergies and sinus disease. Saline nasal irrigations have been used for many years and have been mentioned in medical textbooks going back hundreds of years. A wide variety of techniques have been described, including swimming in salt water, which often results in some degree of inadvertent nasal salt water irrigation. 
     Nasal rinsing or lavage is a treatment for rhinitis and sinusitis that uses a saline solution dispensed into the nasal passage to cleanse and wash away mucus and allergy creating particles and irritants. Lavaging allows the sinuses to drain normally and reduces the inflammation of the mucus membrane. 
     Prepared saline solution is available for uses including nasal lavage, however a bottle filled with saline solution can be quite expensive. Alternatively, saline solution can be prepared at home using household ingredients. However, there is a concern for cleanliness and contamination and for ensuring the proper concentration level and acidity is achieved. Thus, there is a need for a simple method for preparing a saline solution having a consistent and appropriate concentration that is simple, inexpensive and not easily contaminated. 
     Nasal rinsing equipment currently available includes various types of dispensers that can be filled with a saline solution and which are then injected into the user&#39;s nasal passage. Conventional nasal rinsing equipment can be crude and may only be suitable for user&#39;s having a certain size nostril. For proper use, the dispensing tip should comfortably seal against a user&#39;s nostril. Equipment having a dispenser tip designed for a certain size nostril can be useless for someone with a smaller nostril, in particular children, such as the nasal rinse equipment described in U.S. Pat. No. 5,806,723 for a DEVICE FOR LAVAGING. Thus, there is a need for equipment having a dispenser tip that effectively and comfortably seals against human nostrils of varying sizes, including nostrils of children. 
     Another problem with current lavaging equipment is that the configuration of the dispensing tip can cause the saline solution to be dispensed into the nasal passage without sufficiently dispersing before reaching the back of the nasal passage, resulting in an uncomfortable or painful sensation for the user. There is a need for a dispenser tip configured to allow the saline solution to disperse sufficiently before reaching the back of the nasal passage. 
     Conventional lavaging equipment includes dispenser tips that are compatible with power operated oral irrigators. However, the dispenser tips are typically only compatible with a certain model of oral irrigator, such as the dispenser tip described in U.S. Pat. No. 3,847,145 for a NASAL IRRIGATION SYSTEM. There is a need for a dispenser tip that is compatible with most commercially available oral irrigators. 
     For the foregoing reasons, there is a need for an apparatus and system for preparing and dispensing a saline solution that is simple to use, capable of being prepared and administered in most any location, relatively inexpensive and suitable for use by persons having nostrils of varying sizes, including children. 
     SUMMARY 
     The present invention is directed to an apparatus and method for preparing and dispensing a saline solution into a nasal passage. An apparatus for dispensing a liquid into a human nostril comprises a container and a removable cap. The cap has a cylindrical lower portion, a rounded convex upper portion curving away from an axially aligned opening located in the uppermost surface of the upper portion, an open lower end and a tubular conduit connected to the uppermost interior surface of the upper portion and having a hollow center axially aligned with the opening located in the upper portion. The container has flexible sidewalls and an axially aligned neck configured to connect to the cap with a liquid tight connection. The conduit of the cap can extend into the container when the cap and container are joined together, or a flexible tube can be connected to the conduit, which flexible tube extends into the container. 
     The saline solution comprises sodium chloride and sodium bicarbonate dissolved in water to form an isotonic and pH balanced solution. The water can be distilled and lukewarm. 
     A method for rinsing a nasal passage comprises preparing the saline solution by emptying the contents of a packet containing a measured amount of sodium chloride and sodium bicarbonate into a container filled with a measured amount of water and dissolving the sodium chloride and sodium bicarbonate in the water, connecting the cap and tube assembly (or cap having an extended conduit) to the container, pressing the cap against a nostril for an effective seal, and compressing the sidewalls of the container to urge the saline solution out of the container and into a nasal passage through the nostril. 
     Another aspect of the invention includes connecting the cap and tube (or cap having an extended conduit) to a power operated oral irrigator having a reservoir containing the saline solution and operating the oral irrigator to drive the saline solution into a nasal passage. 
     Advantages of the invention include one or more of the following. A nasal rinse apparatus is provided that can be used by children as well as adults. The apparatus includes a cap design that will provide an effective seal against the nostril of a child or adult. 
     The cap can be used in conjunction with a power driven oral irrigator for performing a nasal rinse. A flexible tube is provided that can be connected to most commercially available oral irrigators. 
     A nasal rinse can be performed without having to bend the neck back and look upwards, as is the case in nasal irrigation systems that rely on gravity to dispense the solution. This feature is particularly advantageous to persons who experience dizziness in this position, in particular elderly persons. 
     The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. 
    
    
     DESCRIPTION OF DRAWINGS 
     FIG. 1 is a side view of a dispenser assembly. 
     FIG. 2 is a side view of the dispenser assembly of FIG. 1 with the cap partially removed. 
     FIG. 3 is a cross-sectional view of the dispenser assembly of FIG.  1 . 
     FIG. 4 is a cross-sectional view of the cap of FIG.  1 . 
     FIG. 5 is a cross-sectional view of a cap with an extended conduit. 
     Like reference symbols in the various drawings indicate like elements. 
    
    
     DETAILED DESCRIPTION 
     Referring now to FIG. 1, an apparatus for performing a nasal rinse using a saline solution is shown. A dispenser assembly  10  includes a container  30 , a cap  20  and a tube  35  connected to the interior portion of the cap  20  and extended into the container  30 . The cap  20  can be removed from the container  30  by rotating the cap  20  (e.g., counter-clockwise), to allow the container  30  to be filled with a saline solution  40 . 
     Referring now to FIGS. 2 through 4, the apparatus will be described in greater detail. The container  30  has flexible sidewalls that can be easily compressed by a hand to force the saline solution  40  through the tube  35  and through an opening  15  at the top of the cap  20 , when the cap  20  is secured to the container  30 . The uppermost portion of the container  30  includes a neck  45  that can include threads  50  to provide a tight connection to the cap  20  to prevent the escape of saline solution  40 . However, attachment of cap  20  to container  30  can be accomplished in any convenient fashion that allows for removability and which maintains a liquid tight seal. Other methods for attachment can include a ring and groove assembly, a compression-fitting cap, exterior clamps or the like. The container  30  can include a marking  32  to indicate a liquid level. The marking  32  can be in any convenient form such as a printed line, a groove, a ring or the like. The container  30  can be made of a transparent material, such as a low-density polypropylene, so the amount of saline solution  40  is visible and the container  30  can be inspected for cleanliness. The container  30  should be able to withstand the heat of lukewarm to hot water and should be microwave safe to allow convenient heating of the contents of the container  30 . 
     The cap  20  is hollow. The exterior of cap  20  has a cylindrically shaped lower portion and a conically shaped upper portion. The cap  20  has a lower opening  75  to secure cap  20  onto container  30  and an upper opening  15  at the apex of the conically shaped upper portion for expulsion of the saline solution  40  from the cap  20 . The cylindrical lower portion of the exterior surface of cap  20  can include rounded, vertical ridges  25  to allow a user to grip the cap  20  when either securing the cap  20  onto, or removing the cap  20  from, the neck  45  of the container  30 . The conical upper portion of the exterior surface of cap  20  includes a smooth finish to allow a comfortable and effective seal against a user&#39;s nostril. 
     The exterior of the conical upper portion of cap  20  immediately slopes downward from opening  15  to the ridges  25 . The exterior shape of a longitudinal cross-section of the upper portion of cap  20  can be a curve formed by the combination of at least three arcs. The uppermost portion of the curve can be an arc that is a portion of a circle having a first radius and the side portions of the curve can be arcs that are portions of a circle having a second radius. In the example of a cap  20  having a total height of approximately 40 mm and an exterior diameter at its widest point of approximately 29 mm, the first radius is approximately 10 mm and the second radius is approximately 30 mm. In another implementation, the exterior shape of a longitudinal cross-section of the upper portion of cap can be elliptical. 
     The conical shape of the upper portion of cap  20  allows the cap  20  to be inserted into and sealed against the nostril of either a child or an adult, even though an adult typically has a relatively larger nostril. In the case of an adult, the cap  20  is inserted slightly further into the nasal passage before an effective seal is achieved. 
     The interior of cap  20  can form a first cylinder  52  extending from the lower surface of cap  20  to a height approximately one half of the total height of cap  20 . The surface of approximately the lower quarter of the first cylinder  52  is smooth and the surface of the remainder of the first cylinder  52  can have threads  60  to permit a tight, threaded connection to the neck  45  of the container  30 . The interior of cap  20  can form a second cylinder  54  extending from the top of the first cylinder  52  to a height approximately one quarter of the total height of cap  20 . The second cylinder  54  has a smaller diameter than the first cylinder  54 , thereby forming a lower surface  80  of the second cylinder  54 , which lower surface  80  abuts the upper surface of the neck  45  of the container  30  when the cap  20  is secured onto container  30 . The interior of cap  20  further forms a cavity having interior walls  56  slanting or curving from the top of the second cylinder  54  to the top of the exterior of a conduit  55  extending vertically downwards from opening  15 . 
     The opening  15  leads into a conduit  55  that extends vertically from opening  15  downwards into the interior of cap  20 . The exterior diameter of the conduit  55  gradually tapers from the diameter at the top of conduit  55  (closest to opening  15 ) to a lesser diameter at the bottom of conduit  55 . The interior diameter remains substantially constant the entire length of the conduit  55 . The tapered exterior of conduit  55  allows tube  35  to be forced over the top of the exterior of conduit  55  to form a snug fit. However, attachment of tube  35  to conduit  55  can be accomplished in any convenient fashion, including the addition of a ring (not shown) around the exterior of conduit  55  to effectively lock tube  35  onto conduit  55  once tube  35  is forced over the ring. 
     The diameter of opening  15  affects the flow rate of the saline solution  40  out of the cap  20 . If the opening  15  is too small, the saline solution  40  will enter a user&#39;s nasal passage at such a velocity that the stream of saline solution  40  will not sufficiently disperse before reaching the rear wall of the user&#39;s nasal cavity and the force at which the saline solution  40  impacts the rear wall of the user&#39;s nasal cavity will cause a jabbing sensation. If the opening  15  is too large, the saline solution  40  will not exit the cap  20  with enough force to reach the rear wall of a user&#39;s nasal cavity. In one implementation, the diameter of opening  15  is made to be no larger than approximately 4.25 mm and no smaller than approximately 2.5 mm to allow the saline solution  40  to exit the cap  20  with enough force both to fully irrigate the nasal passage and to sufficiently disperse before reaching the rear wall of the user&#39;s nasal cavity to minimize any user discomfort. The conical shape of the upper portion of cap  20  allows an effective seal to be formed against a nostril being at least as large as the opening  15 . The diameter of opening  15  is sized such that an effective seal can be formed against the nostril of a child as well as an adult. 
     The cap  20  can be constructed from a rigid plastic such as low-density polypropylene. Alternatively, cap  20  can be constructed from any other non-toxic rigid substance, including stainless steel. The cap  20  can be approximately 40 mm in height and have an exterior diameter at its widest point of approximately 29 mm. 
     When dispenser assembly  10  is fully assembled, tube  35  is connected to conduit  55  and cap  20  is secured to container  30 . Tube  35  extends into the interior of container  30 , the lower surface of tube  35  being approximately half an inch above the base  70  of container  30 . The tube can be made of a latex free, non-toxic, strong and flexible material such as polyurethane. 
     Referring now to FIG. 5, in another implementation, the cap and tube assembly can be a single unit. Cap  90  is similar in shape to cap  20 , but modified such that conduit  56  extends a length comparable to the length of tube  35 . The cap  90  can be made of a rigid plastic such as a low density polyethylene. Cap  90  can be connected to container  30  in the same manner as described above with reference to cap  20 . 
     The dispenser assembly  10  can also include a plug or stopper (not shown) that fits into conduit  55  or conduit  56  through opening  15 , to retain the saline solution  40  in the container  30  to permit transporting of the dispenser assembly  10  without leakage of the saline solution  40 . The connection of the plug to cap  20  or cap  90  could be by any convenient means including a compression-fit or threaded connection. 
     The saline solution  40  can be prepared by dissolving sodium chloride (NaCl) and sodium bicarbonate (NaHCO 3 ) in water. Preferably distilled water is used, but purified or clean tap water can also be used. Packets containing a mixture of NaCl and NaHCO 3  for preparing a pH balanced, isotonic saline solution are available from NeilMed™ Products located in Santa Rosa, Calif. One size packet available contains an approximately 2.16 gram mixture of approximately 39 parts NaCl and 1 to 2 parts NaHCO 3 , and can be used to prepare an isotonic saline solution having a concentration of approximately 0.9% to 1%, by dissolving the contents of the packet into 8 ounces of distilled water. A hypertonic saline solution can be prepared by dissolving two or three packets of the NaCl/NaHCO 3  mixture in 8 ounces of distilled water. The packets contain all natural and iodine free ingredients to form a pH balanced, isotonic saline solution that is compatible with the human nasal and sinus mucosa to prevent burning or stinging during nasal lavage, which negative sensations could be caused by a saline solution prepared using home ingredients, such as table salt. Preparing a saline solution using only table salt, and therefore without NaHCO 3 , results in a more acidic solution that can cause burning when used to a rinse a nasal passage. An aluminum lining can be used inside the packets to protect the contents from moisture, which can adversely affect the ease with which the NaCl/NaHCO 3  dissolves in the water. A dotted line is marked on the exterior of the packet to provide a guide for cutting open the packet. 
     The dispenser assembly  10  and saline solution  40  can be used to perform a nasal rinse. Using the method described below, a user of the dispenser assembly  10  can irrigate the nasal passage to removed mucus, allergens and irritants. Starting with the cap  20  removed from the container  30 , the container  30  is filled with eight ounces of distilled water. A dashed line marked on the exterior of container  30  indicates to a user when eight ounces of fluid has been poured into the container  30 . The water can then be warmed in a microwave oven. It is recommended to warm the water using five second increments to avoid excessive heating. If the water is heated to hotter than lukewarm, it is recommended to allow the water to cool before proceeding. Alternatively, the water can be warmed before pouring it into container  30  or does not have to be warmed at all. 
     A packet containing the NaCl/NaHCO 3  mixture is cut open along the dotted line and emptied into the container  30 . The cap  20  having the tube  35  connected to the conduit  55  is secured onto the container  30  by aligning the threads  60  of cap  20  with the threads  50  of neck  45  and screwing the cap  20  onto the neck  45  by gripping the ridges  25  and rotating the cap  20  clockwise until fully tightened. The dispenser assembly  10  is shaken until the NaCl/NaHCO 3  mixture is fully dissolved in the distilled water. 
     The user bends forward to a comfortable level, tilting the head slightly down and applies the cap  20  snugly against the left nostril with opening  15  directed into the left nasal passage. The container  30  is squeezed to force the saline solution  40  to enter the left nasal passage. The process is repeated applying the cap snugly against the right nostril. The saline solution  40  that was injected into the nasal passages will drain from the nasal passages or the mouth and should not be swallowed by the user. The user then gently blows the nose. Any unused portion of the saline solution  40  is discarded and the dispenser assembly  10  is cleaned. A nasal rinse can be performed once or twice a day or as recommended by a qualified physician. 
     The cap  20 , tube  35  and container  30  should be thoroughly cleaned after each nasal rinse usage. The cap  20  can be sterilized by submersing it briefly in boiling water. The tube can be cleaned by rinsing the tube thoroughly with water and using a narrow brush to clean the interior, such as the type of brush commercially available for cleaning baby bottles. The container  30  can similarly be cleaned by rinsing the container  30  with water and using an appropriately-sized brush. A vinegar and water solution can also be used to clean the dispenser assembly  10 . 
     An alternative ravaging technique includes using a power operated water jet dispenser designed for oral irrigation attached to a dispenser tip suitable for nasal irrigation. An oral irrigator such as the Waterpik® Oral Irrigator manufactured by The Waterpik Technologies Personal Healthcare Products Division of Water Pik Technologies, Inc., based in Fort Collins, Colo., can be used in conjunction with cap  20  and tube  35  to perform a nasal lavage. Tube  35  has an inner diameter such that it can form a snug fit connection to a water tube (not shown) forming part of the oral irrigator. The flexibility of tube  35  permits compatibility to most commercially available oral irrigators. The water reservoir element of the oral irrigator is filled with a saline solution that can be prepared using the method described above. The oral irrigator can then be operated to drive the saline solution through the water tube into tube  35  and out of opening  15  into a user&#39;s nasal passage. 
     Cap  90  can also be used in conjunction with an oral irrigator as described above. A length of flexible tubing (not shown) can be used as a coupling between conduit  56  and a water tube forming part of the oral irrigator. 
     A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.