Abstract:
Systems and methods for delivering liquid orally to a mouth of a user are provided. The systems includes a container, a tube coupled to the container, and an oral device positionable in a mouth of a user. Liquid is containable in the container, expellable from the container, through the tube, and to the oral device. From the oral device, the liquid is expelled into a mouth of a user. The container may be an elastomeric pump for expelling liquid therefrom at a constant and predetermined rate. The oral device can be a mouth guard, a night guard, a buccal shield, or dentures. These systems and methods are helpful in treating xerostomia, otherwise known as dry mouth.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to a liquid delivery system and, more particularly, a liquid delivery system for delivering liquids orally to a mouth of a user. 
       BACKGROUND 
       [0002]    Studies show that dry mouth or xerostomia as termed in the medical field plagues as much as 25% of the U.S. population, and many more people around the world. The affected population consists primarily of persons over the age of 65. In fact, current estimates indicate that approximately 30% of persons over the age of 65 are affected by xerostomia. Xerostomia occurs due to a lack of saliva in the mouth and can cause discomfort and difficulty in speech and eating. Some studies have shown xerostomia can lead to halitosis and a dramatic rise in the number of cavities, as the protective effect of saliva is no longer present, and can make the mucosa of the mouth more vulnerable to infection. 
         [0003]    Xerostomia may be a sign of an underlying disease, such as Sjögren&#39;s syndrome, poorly controlled diabetes, or Eaton-Lambert syndrome. Other causes of xerostomia include side effects of drugs, medications, or alcohol, trauma to the salivary glands or their ducts or nerves, dehydration, excessive mouth breathing, previous radiation therapy, and also a natural result of aging. The vast majority of elderly individuals will suffer xerostomia to some degree. Playing or exercising a long time outside on a hot day will often cause the salivary glands to simply dry up as bodily fluids are concentrated elsewhere. 
         [0004]    Xerostomia often has a negative effect on the lifestyle of people suffering therefrom. For example, sufferers of xerostomia are uncomfortable throughout the day and, particularly, during the evening while trying to sleep. Continual dry mouth can cause many sleepless nights. 
         [0005]    Accordingly, a need exists for a treatment for xerostomia that will improve the lifestyle of a person suffering from xerostomia. 
       SUMMARY 
       [0006]    In some aspects, a system for delivering liquid to a mouth of a user is provided. The system includes a container for containing liquid, a tube having a first end and a second end, the first end of the tube being coupled to the container, and an oral device positionable in a mouth of a user, the second end of the tube being coupled to the oral device so that liquid from the container and tube can pass into the mouth of a user. 
         [0007]    In some aspects, a system for delivering liquid to a mouth of a user is provided. The system includes an elastomeric pump including a housing, a bladder supported by and within the housing, an inlet in fluid communication with the bladder, and an outlet in fluid communication with the bladder, a tube having a first end and a second end, the first end of the tube being coupled to the outlet of the elastomeric pump, and an oral device positionable in a mouth of a user and including a coupler, the second end of the tube being coupled to the coupler. 
         [0008]    In some aspects, a method for treating xerostomia is provided. The method includes providing a container, introducing liquid into the container, coupling a tube to the container, coupling the tube to an oral device positionable in a mouth of a user, and expelling liquid from the container, through the tube, and into a mouth of a user. 
         [0009]    Other aspects of the invention will become apparent from consideration of the detailed description and accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a perspective view of a liquid delivery system for delivering liquid to a mouth of a user. 
           [0011]      FIG. 2  is a top perspective view of a liquid container and a portion of a tube of the liquid delivery system shown in  FIG. 1 , the liquid container shown in an empty condition. 
           [0012]      FIG. 3  is a top perspective view of an oral device and a portion of a tube of the liquid delivery system shown in  FIG. 1 , the oral device being a night guard. 
           [0013]      FIG. 4  is a rear view of the oral device shown in  FIG. 3 . 
           [0014]      FIG. 5  is a front view of the oral device shown in  FIG. 3   
           [0015]      FIG. 6  is a top perspective view of the liquid container shown in  FIG. 2  and a liquid injecting device, the liquid container being filled with liquid from the liquid injecting device and shown in a filled condition. 
           [0016]      FIG. 7  is a top view of an alternative embodiment of an oral device of the liquid delivery system, the oral device being a buccal shield. 
           [0017]      FIG. 8  is a top perspective view of an alternative embodiment of an oral device, the oral device being a top portion of a denture. 
           [0018]      FIG. 9  is a top perspective view of an alternative embodiment of an oral device, the oral device being a bottom portion of a denture. 
           [0019]      FIG. 10  is a top perspective view of an alternative embodiment of a connection between a tube and an oral device of a liquid delivery system for delivering liquid to a mouth of a user. 
           [0020]      FIG. 11  is a top perspective view of another alternative embodiment of a connection between a tube and an oral device of a liquid delivery system for delivering liquid to a mouth of a user. 
           [0021]      FIG. 12  is a perspective view of a liquid delivery system for delivering liquid to a mouth of a user, the system including a restrictor. 
           [0022]      FIG. 13A  is a top view of the restrictor of  FIG. 12 , the restrictor shown in a first condition for facilitating a first flow rate. 
           [0023]      FIG. 13B  is a top view of the restrictor of  FIG. 12 , the restrictor shown in a second condition for facilitating a second flow rate. 
       
    
    
       [0024]    Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. 
       DETAILED DESCRIPTION 
       [0025]    With reference to  FIG. 1 , a liquid delivery system  20  is illustrated and is operable to deliver a controlled flow of liquid to a mouth of a user. Such liquid delivery is valuable for people suffering from dry mouth or xerostomia, for example. Many types of liquids can be delivered orally by the liquid delivery system  20 , such as, for example, water, nutrient enriched liquids, medicines, or any other ingestible liquids. The liquid delivery system  20  includes a liquid container  24 , a tube  28 , and an oral device  32 . 
         [0026]    With continued reference to  FIG. 1  and additional reference to  FIG. 2 , the liquid container  24  is operable to contain a liquid and deliver the liquid from the container  24  at a constant and predetermined rate. In the illustrated embodiment, the container  24  is an elastomeric pump capable of containing liquid and expelling liquid at a constant and predetermined rate. Alternatively, the container  24  can be other devices capable of containing liquid and expelling liquid therefrom. The container  24  includes a housing  36 , a cover  40  for covering an open end of the housing  36 , an elastomeric bladder  44  supported by and disposed within the housing  36 , an inlet  48  positioned at a top of the housing  36  and in fluid communication with the bladder  44 , and an outlet  52  positioned at the top of the housing  36  and in fluid communication with the bladder  44 . Liquid is introduced into the bladder  44  via the inlet  48  by any appropriate device. For example, with reference to  FIG. 6 , a syringe  56  is used to inject liquid into the bladder  44  through the inlet  48 .  FIGS. 1 and 2  illustrate the liquid container  24  in an empty condition, in which no liquid is positioned in the bladder  44 , and  FIG. 6  illustrates the liquid container  24  in a filled condition, in which a sufficient amount of liquid has been injected into the bladder  44  causing the bladder  44  to deform and expand. The expanded bladder  44  applies a constant and predetermined force on the liquid therein, thereby forcing the liquid out of the bladder  44  and through the outlet  52  at a substantially constant and predetermined volume over time (“rate”). In some embodiments, the liquid container  24  is an Infusor™ manufactured by Baxter Healthcare Corporation located in Deerfield, Ill. However, other types of liquid containers can be utilized to deliver liquid at a substantially constant and predetermined rate. 
         [0027]    With reference to  FIGS. 1-3 , the tube  28  includes a first end  60  coupled to and in fluid communication with the outlet  52  of the liquid container  24  and a second end  64  coupled to the oral device  32 . The tube  28  is hollow and enables liquid to travel from the outlet  52  of the liquid container  24  to the oral device  32 . In the illustrated embodiment, the second end  64  of the tube  28  passes completely through a tube coupler  68  such that it extends beyond an outlet  76  of the tube coupler  68  and is blocked from further liquid flow, such as by knot  80  at the second end  64 . In addition to the knot  80  blocking liquid flow, the knot  80  also prevents the tube  28  from being pulled back through the tube coupler  68  and disconnecting from the oral device  32 . Alternatively, the tube  28  may be blocked and prevented from disconnecting from the oral device  32  in manners other than that described and illustrated. The tube  28  has a tube aperture  84  near the knot  80  and preferably to the rear of the oral device  32 . In this embodiment, the liquid remains in the tube  28  until reaching the tube aperture  84 , where liquid leaks through the tube aperture  84  and into a user&#39;s mouth. The tube  28  can be a large variety of types and sizes of tubes as long as liquid is delivered from the liquid container  24  to the oral device  32  at an acceptable rate. In some embodiments, the tube  28  is a Surflo winged infusion tube (product no. SV23BLK) manufactured by Terumo Corporation of Tokyo, Japan (U.S. headquarters in Somerset, N.J.) that has an inner diameter of 1 millimeter and an outer diameter of 2 millimeters. 
         [0028]    With particular reference to  FIG. 1 , a fitting or Luer Lok®  66  is disposed along the tube  28 . In the illustrated embodiment, the tube  28  is separated into two portions. The fitting  66  joins the two portions of the tube together and acts as a valve to assist in controlling the flow of liquid from one portion of the tube to the other and, ultimately, to control the flow of liquid from the container  24  to the oral device  32 . In some embodiments, the fitting  66  controls the flow of liquid from the container  24  to the oral device  32  at a single, constant rate. Liquid delivery rates of 2 cubic centimeters (cc) or 5 cubic centimeters per hour are thought to be helpful for some users. Alternatively, the rate at which the liquid is delivered from the bladder  44  can be another desired rate, depending on the liquid demand or needs of the patient. In other embodiments and with reference to  FIGS. 12 ,  13 A, and  13 B, the system can include a restrictor  67  for adjusting the flow of liquid from the container  24  to the oral device  32 . The restrictor  67  can be connected to or unitary with the fitting  66 , or can be separate from the fitting  66  and disposed along the tube  28  at a distance from the fitting  66  (as shown in the illustrated embodiment). In embodiments where the system  20  includes a restrictor  67  to control liquid flow rate, the fitting  67  does not assist in controlling liquid flow rate. Rather, the fitting  67  is used solely to couple the first and second portions of the tube  28  together. The restrictor  67  includes a housing  69 , a restrictor inlet  70 , a restrictor outlet  71 , a rotatable dial  73 , and indicia  74  associated with various liquid flow rates. A user rotates the dial  73  to the desired flow rate and ceases rotation of the dial  73  when the desired indicium  74  is in the dial window  75 .  FIG. 13A  shows a 3 cc per hour condition, which allows 3 cc of liquid per hour to flow from the container  24  to the oral device  32 .  FIG. 13B  shows a 5 cc per hour condition, which allows 5 cc of liquid per hour to flow from the container  24  to the oral device  32 . The restrictor  67  can include numerous additional settings than the two settings illustrated and described in order to facilitate greater adjustability of flow rates. Additionally, the restrictor  67  can have other flow rate values from those illustrated and described. In some embodiments, the system  20  may not include a fitting positioned along the tube  28  and may only include a restrictor  67 . In other embodiments, the system  20  may not include a fitting or a restrictor, in which case the tube  28  may be a single, continuous tube extending between the container  24  and the oral device  32 . 
         [0029]    With reference to FIGS.  1  and  3 - 5 , an oral device  32  is illustrated and includes a pair of tube couplers  68  through respective portions of the oral device  32 . In this case, the oral device  32  is a mouth guard and the couplers are apertures opposite each other and located at the rear ends of the mouth guard. Alternatively, the apertures may be located elsewhere on the oral device  32 , and the oral device  32  may include only one coupler  68 . Each aperture  68  includes an oral inlet  72  and an oral outlet  76 . The second end  64  of the tube  28  can be coupled to either one of the apertures  68  to deliver liquid to the selected aperture  68 . Preferably, the outlets  76  are located further from the lips than the inlets  72 . Liquid delivered from the container  24  to the oral device  32  moistens the interior of the user&#39;s mouth, thereby relieving some or all of the discomforts of dry mouth. 
         [0030]    With continued reference to FIGS.  1  and  3 - 5 , the oral device  32  is a mouth guard typically worn by users during sleep. Such mouth guards inhibit teeth grinding, cheek biting, and other issues that arise during sleep. These types of mouth guards are commonly referred to as night guards and are made by a variety of manufactures. 
         [0031]    With reference to  FIG. 7 , an alternative embodiment of an oral device  32  is illustrated. In this embodiment, the oral device  32  is a buccal shield. Similarly to the mouth guard, the buccal shield includes two couplers or apertures  68 , one on each side, for receiving the second end  64  of the tube  28 . Alternatively, the apertures  68  may be located elsewhere on the buccal shield, and the buccal shield may include only one coupler. 
         [0032]    Referring now to  FIGS. 8 and 9 , another alternative embodiment of the oral device  32  is illustrated. In this embodiment, the oral device  32  is dentures.  FIG. 8  shows a top denture and  FIG. 9  shows a bottom denture. Either or both the top and the bottom dentures can include a coupler or aperture  68  for receiving the second end  64  of the tube  28 . Also, either or both sides of the top denture and either or both sides of the bottom denture can include a coupler or aperture  68  for receiving the second end  64  of the tube  28 . 
         [0033]    With reference to  FIGS. 1 and 6 , operation of the liquid delivery system  20  will be described. A user first fills an injecting device  56  (a syringe as illustrated) with a desired liquid. The syringe  56  is then inserted into the inlet  48  of the liquid container  24  and the plunger of the syringe  56  is depressed to inject the liquid into the bladder  44  of the liquid container  24 . This step is repeated until the bladder  44  contains the desired amount of liquid. A user then inserts the oral device  32  into his/her mouth. The liquid container  24  and fitting  66  are configured to deliver liquid to the oral device  32  at a substantially constant and predetermined rate. The liquid is expelled from the bladder  44  through the outlet  52  of the liquid container  24  and travels into and through the tube  28  and fitting  66  to the oral device  32 . From the oral device  32 , liquid enters and moistens the user&#39;s mouth. A person can use the liquid delivery system  20  while awake or sleeping. 
         [0034]    With reference to  FIG. 10 , an alternative manner of coupling the tube  28  to the oral device  32  is illustrated. In this embodiment, the tube  28  is coupled to the oral device  32  by inserting end  64  of the tube  28  into the inlet  72  of the aperture  68  and press-fitting, friction-fitting, or interference-fitting the tube  28  in the aperture  68 . The liquid container  24  delivers liquid therefrom and the liquid travels through the tube  28 , into the inlet  72  of the aperture  68 , and out of the outlet  76  of the aperture  68 . From the outlet  76  of the aperture  68 , the liquid is introduced into a mouth of a user. 
         [0035]    With reference to  FIG. 11 , another alternative manner of coupling the tube  28  to the oral device  32  is illustrated. In this embodiment, a hollow needle or pipe  88  is used to couple the tube  28  to the oral device  32 . The pipe  88  has an inner passage  90  to allow liquid to pass there through, a first end  92  coupled to the second end  64  of the tube  28 , and a second end  94  coupled to the oral device  32 . The second end  64  of the tube  28  can be slid over the first end of the pipe  88  and secured via a press-fit, friction-fit, interference-fit, or the like. Liquid travels through the tube  28 , into and through the pipe  88 , into the aperture  68 , and out of the outlet  76  of the aperture into a user&#39;s mouth. 
         [0036]    The various oral devices shown and described herein are only a sample of the oral devices useable in the liquid delivery system. The liquid delivery system can utilize any type of oral device appropriate for receiving a tube and liquid flowing from the tube. Accordingly, the present invention is not meant to be limited to those oral devices specifically disclosed herein, but, rather, to include other types of oral devices appropriate for use with the liquid delivery system. 
         [0037]    It should be understood that a large variety of alternatives and variations exist to the embodiments discussed above and illustrated in the drawings. One of ordinary skill in the art will be able to recognize such alternatives and variations from the disclosure herein and, therefore, such alternatives and variations are within the spirit and scope of the present invention.