Abstract:
A method and device delivers a medicament to a selected tissue for treatment of the tissue, plaque and biofilm included. In the device, a first reservoir member is used to connect to a fluid source. Further, a second reservoir member engages the first reservoir member to define a chamber for receiving the medicament. Structurally, the second reservoir member includes an outlet. Attached to the outlet is a tube that extends to a nozzle. When connected, the first reservoir member, second reservoir member, and tube define a passageway from the fluid source to the nozzle. During use, a flow rate for a fluid is established through the passageway to deliver the medicament from the passageway through the nozzle to the selected tissue.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention pertains generally to medication delivery devices and to methods for using such devices. More particularly, the present invention pertains to medication delivery devices that introduce medication to a patient in a stream of fluid. The present invention is particularly, but not exclusively, useful as a fluid delivery device with an inline medication reservoir. 
       BACKGROUND OF THE INVENTION 
       [0002]    Dental diseases, including dental caries and periodontal disease, comprise one of the most common health disorders in man. Further, these dental diseases have been sources for other health disorders that have afflicted man throughout history. It is now well known, these diseases are highly associated with or caused by contagious micro-organisms that are transmitted by various methods. For instance, the transmission of contagious micro-organisms may be air-borne, food-borne, contact-borne, STD-borne, saliva-borne, or through other means. 
         [0003]    Research assays indicate that when micro-organisms enter the body through portals of entry, including the mouth, nose and ears, they may then be transferred into the blood stream. Once in the blood stream, the micro-organisms can move to other systemic areas such as the heart, brain, lungs, stomach, nervous system, uterus, digestive tract, pancreas and other sites where they are able to cause a health disorder. Importantly, the health concerns associated with these disorders cannot be ignored. And, it happens, the mouth is a primary source of concern. At the present time, about forty harmful micro-organisms involved in dental caries and periodontal disease have been identified that can directly cause or contribute to health disorders in other parts of the body. 
         [0004]    While it is known that anti-microbial agents will reduce and help eliminate the contagious micro-organisms in the mouth, there is not yet a completely effective system or method for the delivery of an anti-microbial agent. For instance, tooth brushing and dental flossing do not provide complete and proper delivery of anti-microbial agents to specific infected sites. Furthermore, infected sites harboring different specific species of micro-organisms must typically require the delivery of multiple anti-microbial agents. 
         [0005]    In light of the above, it is an object of the present invention to provide a device for delivering anti-microbial agents to selected tissue sites. Another object of the present invention is to provide a medicament delivery device having an inline reservoir for holding a dissolvable anti-microbial agent. Still another object of the present invention is to provide a device for delivering selected anti-microbial agents to a selected tissue at predetermined concentrations and at predetermined pressures. It is another object of the present invention to provide a method and device for delivering medicaments to selected tissues that is easy to implement, cost effective and simple to use. 
       SUMMARY OF THE INVENTION 
       [0006]    In accordance with the present invention, a device is provided for delivering a medicament, specifically an anti-microbial agent, to a selected oral tissue. Structurally, the device includes a first reservoir member for fluid communication with a fluid source. Further, the device includes a second reservoir member that engages with the first reservoir member to define a chamber. Also, the second reservoir member includes an outlet. Connected to the outlet is a tube that extends to a nozzle. Together, the first and second reservoir members and the tube define a passageway from the fluid source to the nozzle. As constructed, the passageway passes through the chamber. 
         [0007]    For purposes of the present invention, a medicament is positioned in the chamber. In order to prevent the medicament from blocking the outlet of the second reservoir member, the device is provided with a filter at the outlet. Further, the device is provided with a plurality of first and second reservoir members of differing sizes. As a result, different amounts of medicament may be positioned in the chamber formed by the selected reservoir members. 
         [0008]    During operation of the device, the first reservoir member is connected to a fluid source. Also, the medicament is positioned between the first and second reservoir members, and the first and second reservoir members are then engaged with each other. After the tube is connected to the outlet of the second reservoir member, a flow rate for the fluid is established. In this manner, the fluid flows through the chamber, dissolving the medicament, and carrying the medicament through the nozzle to the selected tissue. The operation may be repeated for other desired anti-microbial agents, using different desired amounts and concentrations of the agents. As a result, the selected oral tissue is irrigated with multiple anti-microbial agents to reduce and eliminate targeted disease associated micro-organisms. 
         [0009]    For instance, topical antiseptics may be used in an initial oral disinfecting process. If resistant infections are encountered, antibiotics may be used in a subsequent process(es) for one to two weeks, depending on the antibiotic, and its combination with other antibiotics (specificity). This method recognizes that viruses are essential cofactors in the periodontal disease process. Before, only bacteria, fungi and protozoans were implicated in these infections. Now, herpes, HPV (human papilloma virus), cytomeglia viruses, and other viruses are being investigated. The sole use of commercially available topical antibiotics as controlled release devices suffer from several potential problems, including insufficient spectrum of antimicrobial activity in some periodontal polymicrobial infections, risks of producing an antibiotic resistant microbiota, and high acquisition costs. The recommended treatment with antimicrobial agents, such as available chemotherapeutics, can provide effective, safe, practical and affordable means of controlling subgingival colonization of periodontal pathogens and various types of periodontal disease. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: 
           [0011]      FIG. 1  is a schematic view of a device for delivering a medicament to a selected tissue in accordance with the present invention; and 
           [0012]      FIG. 2  is a cross sectional view of the reservoir members of  FIG. 1 . 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0013]    Referring initially to  FIG. 1 , a medicament delivery device is shown, and is generally designated  10 . As shown, the device  10  includes a first reservoir member  12  interconnected with a second reservoir member  14 . Structurally, the reservoir members  12 ,  14  define an inner chamber  16 . Further, the first reservoir member  12  forms an inlet  18  to the chamber  16 , while the second reservoir member  14  forms an outlet  20  from the chamber  16 . As shown, the inlet  18  is connected to a fluid source  22  via a tube  24 . Also, a valve  26  is positioned along the tube  24  to control the flow rate of fluid from the fluid source  22 . In  FIG. 1 , it can be seen that the outlet  20  is connected to a nozzle  28  via a tube  30 . As shown, the nozzle  28  may direct fluid  32  from the fluid source  22 , through the chamber  16 , to selected tissue  34 , such as oral tissue, for medical treatment. 
         [0014]    In  FIG. 2 , it can be seen that the chamber  16  defines a chamber axis  36 . Further, the engagement between the tube  24 , reservoir members  12 ,  14 , and the tube  30  is illustrated more clearly. As shown, the device  10  includes an anchor member  38  defining a channel  40  interconnecting the inlet  18  of the first reservoir  12  with the lumen  42  of the tube  24 . Structurally, the anchor member  38  extends axially from a proximal end  44  to a distal end  46 . At its proximal end  44 , the anchor member  38  forms a threaded bore  48  radially spaced from a protrusion  50  extending axially in the proximal direction. Between the threaded bore  48  and the protrusion  50 , the anchor member  38  forms a cylindrical void  52 . As shown in  FIG. 2 , the distal end  54  of the tube  24  is forced into the cylindrical void  52  to connect the lumen  42  of the tube  24  with the channel  40  of the anchor member  38 . As shown, the tube  30  is flexible and is deformed as it engages the anchor member  38 . 
         [0015]    Still referring to  FIG. 2 , it can be seen that the distal end  46  of the anchor member  38  also forms a threaded bore  56  and protrusion  58  that define a cylindrical void  60 . As shown, the inlet  18  of the first reservoir member  12  is received within the cylindrical void  60 . In order to ensure a fluid tight engagement, the inlet  18  is provided with tabs  62  that extend radially outward to engage with the threaded bore  56 . The first reservoir member  12  also includes radially outward extending threads  64  at its distal end  66 . Further, the second reservoir member,  14  includes reciprocating, radially inward extending threads  68  at its proximal end  70 . With this cooperation of structure, the reservoir members  12 ,  14  may be connected and disconnected. In  FIG. 2 , the outlet  20  of the second reservoir member  14  is shown in engagement with the tube  30 . Specifically, the outlet  20  is fit inside the tube  30  to frictionally engage the second reservoir member  14  and the tube  30  and provide fluid communication between the chamber  16  and the lumen  71  of the tube  30 . Because the tube  30  is flexible, it can deform to engage the outlet  20 . 
         [0016]    When the lumen  42 , channel  40 , chamber  16  and lumen  71  are interconnected, a passageway  72  from the fluid source  22  to the nozzle  28  (both shown in  FIG. 1 ) is created. Further, when the reservoir members  12 ,  14  are connected, as in  FIG. 2 , the chamber  16  formed is able to hold medicaments. Structurally, the volume of the chamber  16  increases diametrically from the inlet  18  toward the distal end  66  of the first reservoir member  12 . Then, the volume of the chamber  16  decreases diametrically from the proximal end  70  of the second reservoir member  14  to the outlet  20 . In  FIG. 2 , shown positioned in the chamber  16  is a medicament  74 , specifically, a selected anti-microbial agent. For the present invention, the anti-microbial agents  74  may be in different physical forms, including pills, capsules, gels, and powders, and may be bacteriocidal or bacteriostatic. More specifically, the anti-microbial agents  74  may include metallic salts (sodium chloride, bicarbonate or soda, povidone iodine, sodium hypochlorite, or other anti-microbial agents effective against  Porphyromonas gingivalis, Prevotella intermedia, Bacteroides forsythus, Fusobacterium, Selenomonas, Centipeda periodontii, Spirochetes, Peptostreptococcus micros, Eubacterium, Actinobacillus actinomycetemcomitans, Eikenella corrodens, Capnocytophaga, Campylobacter rectus, Enteric rods/pseudomonads, Staphylococcus, Enterococcus faecalis, Candida, Protozoans  ( Amoebae  and  Trichomonads ), and viruses. As further shown in  FIG. 2 , a filter  76  is positioned adjacent to the outlet  20  to prevent the medicament  74  from blocking the outlet  20 . Also, in order to seal the components of the device  10 , each interface between device components may be provided with resilient O-rings  78 . 
         [0017]    For purposes of the present invention, the first reservoir member  12  and the second reservoir member  14  are selected from a plurality of reservoir members  12  and  14 . For instance, a small chamber  16  formed by a first reservoir member  12  and a second reservoir member  14  may have an axial length of 1¾ inches (1.75 in.) and a maximum diameter of ⅝ inches (0.616 in.). Further, a medium chamber  16  may have an axial length of 2⅜ inches (2.745 in.) and a maximum diameter of 1 inch. Also, a large chamber  16  may have a length of 2⅛ inches (2.116) and a maximum diameter of 1¼ inches (1.30 in.). For each reservoir member  12 ,  14 , the diameter of the inlet  18  and the diameter of the outlet  20  may be selectively varied as well, though the diameter of the inlet  18  is preferably ¼ inch ( 0 . 30  in.) and the diameter of the outlet  20  is preferably 3/24 inches (0.2675 in.). Further, for each reservoir member  12 ,  14 , the length of the outlet  20  may be selectively varied. 
         [0018]    With the provision of reservoir members  12 ,  14  having chambers  16 , inlets  18  and outlets  20  (and tubes) of varying diameters and lengths, a range of flow rates through the passageway  72  can be provided. For instance, given a flow rate from the fluid source  22 , the selected length and diameters of the inlet  18 , reservoir members  12 ,  14 , and outlet  20  can determine a maximum flow rate through the passageway  72 . As a result, the device  10  provides for proper treatment of selected tissue  34  with any desired medicament  74 . For instance, proper treatment with metallic salts, iodine, etc. may require the application of these various agents over a period of time no longer than five minutes and at appropriate concentrations. After the dissolving rate of the topical agents is determined, and with the volume of the medicament  74 , the maximum concentration of the medicament  74 , and the period of application for the medicament  74  known, reservoir members  12 ,  14  having a properly dimensioned chamber  16 , inlet  18  and outlet  20  may be selected. In this manner, the device  10  provides for the proper application of a wide range of medicaments  74 . 
         [0019]    In operation, the micro-organisms are identified, and a treatment plan is identified and implemented. Specifically, the medicament  74  is identified, the amount of medicament  74  is chosen, and the amount of time for the application of the medicament  74  is selected. As a result, an optimal flow rate for the fluid  32  is ascertained. In view of these determinations, the appropriate first reservoir member  12  and second reservoir member  14  are selected. After the components of the device  10  are interconnected, and the medicament  74  is positioned in the chamber  16 , the water source  22  is activated to flow the water  32  through the passageway  72 . The valve  26  and fluid source  22  may be manipulated to achieve the desired flow rate in view of the selected reservoir members  12 ,  14 . As the water  32  passes the medicament  74 , it dissolves or otherwise picks up some of the medicament  74  and carries the medicament  74  out of the nozzle  28  to irrigate the selected tissue  34 . After the treatment is performed, the water source  22  is turned off. Then another medicament  74  may be positioned in the chamber  16  of the same reservoir members  12 ,  14 , or in the chamber  16  of different sized reservoir members  12 ,  14 , and the device components reconnected. When the device  10  is ready, the water source  22  is again activated and the water is adjusted to a desired flow rate. This process may be repeated for multiple medicaments  74 , as desired. While  FIG. 1  illustrates the use of the device  10  on oral tissue  34 , the device  10  may be used on any type of tissue infected with micro-organisms. 
         [0020]    While the particular Dental/Medical Oral Irrigation System as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.