Abstract:
An apparatus for treatment of sinus problems includes a single-use container with hypertonic saline solution. The concentration of Sodium chloride within the saline solution may fall within the range of 0.9% to 3.0%. The single-use container may be an ampule, or resilient, flexible bottle, for example. A package containing a plurality of single-use containers allows for several single-use applications of the hypertonic saline solution.

Description:
FIELD OF THE INVENTION  
       [0001]     The invention relates to the treatment of nasal congestion and, in particular, to a method and apparatus for the convenient delivery of a solution to the sinuses for irrigation of the sinuses.  
       BACKGROUND OF THE INVENTION  
       [0002]     Millions of people are stricken with the symptoms of colds, nasal congestion, allergies and nasal congestion on a daily basis. Such ailments may be accompanied by labored breathing, fatigue, and severe headaches, and may also be associated with serious medical complications, such as loss of hearing. The symptoms are particularly acute in the case of infants; infants are obligate nasal breathers and cannot feed if they are congested. Various treatments for colds nasal congestion, allergies and sinusitis exist and are employed with varying degrees of success. Many treatments include substances that may have deleterious side effects, many of the available treatments are not directed toward juvenile sinusitis, nasal congestion, and colds, and many treatments are not packaged in a convenient form.  
         [0003]     An apparatus and method for the treatment of colds, nasal congestion, sinusitis, and allergies, particularly in infants would therefore be highly desirable.  
       SUMMARY  
       [0004]     In accordance with the principles of the present invention, hypertonic saline may be employed for the irrigation of sinuses in the treatment of colds, chronic nasal congestion and allergies, particularly for infants from approximately one month to six years of age. In an illustrative embodiment, the saline may range from greater than 0.9% to 3.0% and a volume of approximately 1 ml to 60 ml may be employed to irrigate the affected sinuses. In operation, a patient&#39;s head is tilted back and the hypertonic saline is introduced into one, or both, of the patient&#39;s nostrils and allowed to flow into the sinuses. Isotonic saline may also be employed in accordance with the principles of the present invention.  
         [0005]     In accordance with another aspect of the invention, a sterile package contains sufficient hypertonic saline for a single application (a range of approximately 1 ml to 60 ml). Single-use packages ensure that the contents remain sterile until use and provide for convenient delivery of the appropriate amount of solution. The package may take any one of many forms, including various configurations of ampule, syringe, or squeeze bottle, for example. Additionally, a kit including a plurality of single-use packages may be employed for a course of treatment. The single-use packages within such a kit may be of the same or differing volumes and may contain the same or different concentrations of hypertonic saline.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0006]     The above and further features, aspects, and advantages of the invention will be apparent to those skilled in the art from the following detailed description, taken together with the accompanying drawings in which:  
         [0007]      FIG. 1  is a flow chart that depicts the basic steps involved in a treatment in accordance with the principles of the present invention;  
         [0008]      FIG. 2  is a schematic diagram of a container for use in a treatment in accordance with the principles of the present invention;  
         [0009]      FIG. 3  is a schematic diagram of another container for use in a treatment in accordance with the principles of the present invention;  
         [0010]      FIG. 4  is a schematic diagram of another container for use in a treatment in accordance with the principles of the present invention;  
         [0011]      FIG. 5  is a schematic diagram of another container for use in a treatment in accordance with the principles of the present invention; and  
         [0012]      FIG. 6  is a conceptual block diagram of a kit that includes a plurality of single-use hypertonic saline solution containers in accordance with the principles of the present invention.  
     
    
     DETAILED DESCRIPTION  
       [0013]     The flow chart of  FIG. 1  illustrates a process in accordance with the principles of the present invention by which sinuses are irrigated using a hypertonic saline solution. The process begins in step  100  and proceeds from there to step  102 , where hypertonic saline is introduced into one nostril of an affected individual. In an illustrative embodiment, the affected individual is a child between the ages of one month and six years. In this illustrative embodiment the child&#39;s head is tilted back to allow gravity to aid in the distribution of the saline.  
         [0014]     After introducing the saline into the child&#39;s nostril, in step  104  a caregiver blocks that nostril in a manner that prevents the hypertonic saline solution from escaping through the opening in the nostril. Then, in step  106 , the caregiver tilts the child&#39;s head in the direction opposite the nostril that received the hypertonic saline solution. That is, if, for example, the solution has been introduced to the child&#39;s left nostril, the caregiver tilts the child&#39;s head to the right. The solution is allowed to travel, on an interior path from the nostril into which the solution was introduced to the child&#39;s other nostril. In step  108 , the caregiver returns the child&#39;s head to a neutral position (i.e., head tilted back, but tilted to neither the left or the right) and cleans the child&#39;s nostril, for example, using a suction bulb or syringe to suction fluid from the nostril that has had the hypertonic saline solution introduced.  
         [0015]     The caregiver then, in step  110 , again introduces hypertonic saline into and in step  112  blocks the child&#39;s nostril, as before. The caregiver then tilts the child&#39;s head in step  114  to the same side as the nostril into which they have just placed the hypertonic solution in order to irrigate the sinuses on that side of the child&#39;s head. In step  116  the caregiver again returns the child&#39;s head to the neutral position and cleans the child&#39;s nostril. In step  118 , the illustrative irrigation process proceeds on the child&#39;s other nostril, with the caregiver introducing hypertonic saline is introduced into the child&#39;s other nostril.  
         [0016]     After introducing the saline into the child&#39;s nostril, in step  120  the caregiver blocks the nostril to prevent the hypertonic saline solution from escaping through the opening in the nostril. Then, in step  122 , the caregiver tilts the child&#39;s head in the direction opposite the side of the nostril into which she has introduced the hypertonic saline. That is, if the solution has been introduced to the child&#39;s right nostril, the caregiver tilts the child&#39;s head to the left. The solution is allowed to travel, on an interior path, from the nostril into which the solution was introduced to the child&#39;s other nostril. In step  124 , the caregiver returns the child&#39;s head to a neutral position (i.e., head tilted back, but tilted to neither the left or the right) and cleans the child&#39;s nostril, for example, using a suction bulb or syringe to suction fluid from the nostril that has had the hypertonic saline solution introduced.  
         [0017]     The caregiver then, in step  126 , again introduces hypertonic saline into and in step  128  blocks the child&#39;s nostril, as before. The caregiver then tilts the child&#39;s head in step  130  to the same side as the nostril into which they have just placed the hypertonic solution in order to irrigate the sinuses on that side of the child&#39;s head. In step  132  the caregiver again returns the child&#39;s head to the neutral position and cleans the child&#39;s nostril. The process is repeated as necessary, then ends in step  134 . In an alternative embodiment, the child&#39;s head may be tilted backwards. A caregiver then introduces hypertonic saline into one or both nostrils and maintains the child&#39;s head in the tilted position long enough to allow gravity to drain the solution through the nares, down the posterior oropharyncx and on its way through the esophagus and into the stomach.  
         [0018]     In another aspect of the invention, a sterile package of hypertonic saline contains a sufficient volume of hypertonic saline for a single use. In an illustrative embodiment, the saline is greater than 0.9% and less than 3.0% sodium chloride and each package contains between approximately 1 ml and 60 ml. Single-use packages in accordance with the principles of the present invention ensure that the contents remain sterile until use and provide for convenient delivery of the appropriate amount of solution. Such packages may take any of many forms, including various configurations of ampule, syringe, or squeeze bottle, for example. A syringe or squeeze bottle provides the advantage of allowing the operator to apply a controlled volume of the solution at a controlled rate. Additionally, the package may be made of any of a variety of materials, such as glass, plastic or rubber, for example. Ampules are known and discussed, for example, in U.S. Pat. No. 6,846,469, issued to Snedden, entitled, RESILIENT DISPERSING AMPULE AND PROCESS FOR FORMATION THEREOF, in U.S. Pat. No. 3,917,120, issued to Larenz et al, entitled, SINGLE USE CONTAINER FOR LIQUID PHARMACEUTICAL COMPOSITIONS, and in U.S. Pat. No. 5,320,257, issued to Snedden, entitled, RESILIENT AMPULE WITH ARTICULATING LINKAGE AND ELONGATE SPOUT, all of which are hereby incorporated by reference in their entirety. A wide variety of other single-use containers, such as syringes and squeeze bottles are also known.  
         [0019]     The schematic diagram of  FIG. 2  illustrates one form of ampule  200  that may be employed, in accordance with the principles of the present invention, as a single-use container for hypertonic saline solution. The ampule  200  includes neck  202  and reservoir  204  portions. Access to hypertonic saline solution contained within the reservoir  204  portion may be obtained by cutting or breaking the neck  202  portion off from the reservoir  204  portion. Some ampules provide a frangible area between the neck  202  and reservoir  204  portions to allow for relatively easy separation of the portions and access to the fluids contained within the reservoir.  
         [0020]     The schematic diagram of  FIG. 3  illustrates another type of ampule  300  that may be employed in accordance with the principles of the present invention. The ampule  300  includes neck  302  and reservoir  304  portions and a top  306  portion designed to twist off, thereby providing access to the contents of the reservoir  304 .  
         [0021]     Another type of ampule suitable for single-use delivery of hypertonic saline solution in accordance with the principles of the present invention is illustrated in the schematic diagram of  FIG. 4 . The ampule  400  includes cap  402  and reservoir  404  portions and a frangible area  406  separating the two. In this illustrative embodiment a plunger mechanism  408  is included to allow the ampule  400  to act as a syringe, once opened.  
         [0022]     A bulb dispenser  500  suitable for single-use delivery of hypertonic saline solution in accordance with the principles of the present invention is illustrated in the schematic diagram of  FIG. 5 . The bulb  502  form a reservoir for holding hypertonic saline solution. The neck  504  may be inserted into a nostril, of an infant, for example, for irrigation of the infant&#39;s sinuses in accordance with the principles of the present invention. The bulb dispenser  500  may include a cap  506  that is removable for use, or the neck  504  may be sealed, requiring a user to sever a top portion  508  of the neck  504  in order to dispense the hypertonic saline solution contained within the dispenser  500 .  
         [0023]     Any of the forgoing ampules may include a plunger mechanism that permits the ampule to operate as a syringe once the ampule is opened, by breaking a frangible area, or twisting off a cap, for example. Syringes and their operation are known.  
         [0024]     The conceptual block diagram of  FIG. 6  illustrates a kit  600  of single-use hypternonic saline solution packages  602 , in accordance with the principles of the present invention. Each of the packages  602  contains sufficient hypertonic saline for a single application. The concentration of hypertonic solution may differ from single-use package to single-use package within the kit  600  and the entire kit  600  may contain a sufficient number of packages  602  for a full course of treatment. That is, for example, a kit  600  may contain seven packages  602  of hypertonic saline, one per day for a one-week course of treatment, with the concentration of hypertonic saline decreasing from the concentration of the saline within the package to be used on the first day of treatment. Longer-term treatment is contemplated in accordance with the principles of the present invention. The kit  600  may, for example, include sufficient packages for a five week course of treatment, for example. Additionally, the containers  602  may include a threaded lid.  
         [0025]     The foregoing description of specific embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed, and many modifications and variations are possible in light of the above teachings. The embodiments were chosen and described to best explain the principles of the invention and its practical application, and to thereby enable others skilled in the art to best utilize the invention. It is intended that the scope of the invention be limited only by the claims appended hereto.