Abstract:
The present subject matter includes a cannulated delivery device made of an adapter configured to connect to a syringe; a delivery device tip configured to connect to a dosing chamber; an internal chamber of the cannulated delivery device connecting the adapter and to the delivery device tip, and the internal chamber defining a dose pathway and a system and method of use of the device to increase dosage delivery to a patient while maintaining a sterile fluid pathway.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    NONE 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    None. 
       REFERENCE TO SEQUENCE LISTING, A TABLE FOR A COMPUTER PROGRAM LISTING COMPACT DISC APPENDIX 
       [0003]    None. 
       FIELD OF THE INVENTION 
       [0004]    The subject of this invention is a cannulated dose delivery device that is configured to permit internal flushing of a syringe dose chamber 
       BACKGROUND OF THE INVENTION 
       [0005]    In various types of medical applications, a contrast medium or radioactive agent is delivered via a dosing syringe. A dosing syringe is a simple pump made of a plunger that fits tightly in a tube. The plunger can be pulled and pushed along inside a cylindrical tube (called a barrel), allowing the syringe to take in and expel a liquid or gas through an orifice at the open end of the barrel. The open end of the syringe can be fitted with a hypodermic needle, a nozzle, or tubing to help direct the flow into and out of the barrel. In nuclear medicine, injections of various radioactive elements is necessary. By delivering a complete dose to the patient and leaving no residual or very little residual dose is very desirable for many reasons, in order to increase the accuracy of the scan, the dosing syringe, in nuclear medicine applications, is flushed to facilitate the complete delivery of the contrast agent. A need exists in the industry to provide a self-flushing dosing syringe device, 
       SUMMARY OF THE INVENTION 
       [0006]    The present subject matter includes a cannulated dose delivery device. This device is made of a plunger housed in a barrel, wherein the plunger is made, of: a plunger proximal end connector configured to receive a washing agent; a plunger end cap configured to facilitate the washing of a delivery chamber of the barrel; an elongated cylinder having an internal chamber defining a fluid pathway between the plunger proximal end connector and the plunger end cap; wherein the plunger end cap is made of a plurality of slits in the distal end of the plunger end cap. 
         [0007]    This invention further provides a cannulated dose delivery system made of a plunger housed in a barrel, wherein the plunger has a plunger proximal end connector configured to receive a washing agent; a plunger end cap configured to facilitate the washing of a delivery chamber of the barrel; an elongated cylinder having an internal chamber defining a fluid pathway between the plunger proximal end connector and the plunger end cap wherein the plunger end cap is made of a plurality of slits in the distal end of the plunger end cap; a distal connector configured to connect a cannulated dose delivery device to a delivery port: and a saline flush syringe connected to the plunger proximal end connector and a delivery port to a patient. 
         [0008]    This invention further provides method to increase dosage delivery to a patient while maintaining a sterile fluid pathway including the steps of: providing a plunger housed in a barrel, wherein the plunger has; a plunger proximal end connector configured to receive a washing agent; a plunger end cap configured to facilitate the washing of a delivery chamber of the barrel; an elongated cylinder having an internal chamber defining a fluid pathway between the plunger proximal end connector and the plunger end cap; wherein the plunger end cap comprises a plurality of slits in the distal end of the plunger end cap; a distal connector configured to connect a cannulated dose delivery device to a delivery port and a plunger top cap; attaching a needle to the distal end attachment port; connecting a saline flush syringe to the plunger proximal end connector; connecting a delivery port to a patient; delivering a dose of the contrast agent or medication into the delivery chamber; attaching the cannulated dose delivery device distal connector is attached to a patient delivery port; removing the plunger top cap; connecting the saline flush syringe to the cannulated dose delivery device via the plunger proximal connector; and depressing the flush syringe to deliver a washing solution to the dosing chamber to facilitate flushing of a wall of the dosing chamber to increase dosage delivery to a patient. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0009]    The drawing shows schematically a cannulated dose delivery device and method of use according to an example form of the present invention. The invention description refers to the accompanying drawings: 
           [0010]      FIG. 1  shows a perspective front view of an exemplary embodiment of the cannulated dose delivery device. 
           [0011]      FIG. 2  shows a perspective rear view of a portion of an exemplary embodiment of the cannulated dose delivery device 
           [0012]      FIGS. 3A and 3B  shows a sectional view at A-A of an exemplary embodiment of a portion of the cannulated dose delivery device. 
           [0013]      FIG. 4A and 4B  show exemplary embodiments of the plunger end cap of the cannulated dose delivery device. 
           [0014]      FIG. 5A and 5B  shows a side view of an exemplary embodiment of the plunger end cap of the exemplary embodiment of the cannulated dose delivery device system. 
           [0015]      FIG. 6  shows an exemplary embodiment of delivery system including the cannulated dose delivery device. 
           [0016]      FIG. 7  shows an exemplary embodiment of a plurality of cannulated dose delivery devices in a sterile package. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0017]    The present invention may be understood more readily by reference to the following detailed description of the invention. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Also, as used in the specification including the appended claims, the singular forms “a,” “an” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. 
         [0018]    These and other aspects, features and advantages of the invention will be understood with reference to the detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description of the invention are exemplary and explanatory of preferred embodiments of the inventions, and are not restrictive of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. 
         [0019]    One of the objectives of the current technology is to provide a complete delivery of agents to a subject, such as a patient, by flushing the syringe, without compromising the sterility of the injection. Turning to  FIG. 1 , a cannulated dose delivery device  100  is shown. The cannulated dose delivery device  100  is an assembly of a number of components including a plunger  200  housed in barrel  202 . The plunger  200  is configured to connect to a syringe (not shown) via a plunger proximal end connector  210 , to receive a washing agent. The cannulated dose delivery device  100  includes a plunger end cap  250 . The plunger end cap  250  is configured to facilitate washing the walls  262  of the drug or agent delivery chamber  260  to provide a more complete dose into the patient&#39;s intravenous connection. The cannulated dose delivery device  100  is configured to connect to a patient delivery port  340  ( FIG. 6 ) such as a patient&#39;s IV connector through a distal end connector  280 . 
         [0020]    Now referring to  FIGS. 2, 3A, and 3B , in this exemplary embodiment, a plunger  200  subassembly is shown. The plunger  200  includes a plunger top cap  205 . The plunger top cap  205  is configured to fit on and seal the plunger proximal end connector  210 . In the exemplary embodiment, the plunger proximal end connector  210  is a luer-lock A luer-lock is a dose connection that can be easily released, but maintains sterility of the connection between devices. The main feature of a luer-lock is a bayonet lock, a tapered joint and when connected is leak tight, but easily separated by hand. A typical luer-lock includes two bayonet projections  213  to allow a plunger top cap  205  to be twisted on, pulling the tapered joint tight and preventing accidental separation of the components. When the plunger top cap  205  is removed, the plunger proximal end connector  210  is configured to be attached a saline syringe (not shown) for flushing of a dosing chamber. A flange  215  is provided to facilitate the manipulation of the plunger  200 , to aid in providing a dose to the patient. 
         [0021]    The middle section  220  of the cannulated dose delivery device  100  forms an elongated barrel and includes an internal chamber  230  sized to allow the flow of liquid through the plunger end cap  250 . For nuclear medicine applications, the diameter of the internal chamber  230  varies based on type of injection being provided to the patient. The internal chamber  230  connects to the plunger proximal end connector  210  and to the distal plunger connector  240  to define a fluid pathway in cannulated dose delivery device  100 . 
         [0022]    The distal end of the plunger  200  of the cannulated dose delivery device  100  includes a distal plunger connector  240  having a retaining member  245 . The retaining member  245  projects from the distal plunger connector  240  and forms a generally “T” shaped retaining member in an exemplary embodiment. This portion of the cannulated dose delivery device  100  can be constructed of a biocompatible, pharmacologically inert sterilizeable clear plastic, such as, polyvinyl chloride, high-density polyethylene (“HDPE”) or polypropylene or the like. 
         [0023]    Now referring to  FIGS. 4A and 4B, 5A and 5B , a plunger end cap  250  is shown. The plunger end cap  250  includes an external groove  253  that is configured to prevent leakage of fluid agents. The plunger end cap  250 , in an exemplary embodiment, is made from a thermoplastic elastomeric or similarly deformable and sterilizable materials. The plunger end cap  250  provides two functions: it facilitates the fluid connection to the internal chamber  230  and is sized to allow the flow of liquid through the cannulated dose delivery device  100  and the plunger end cap  250  is configured to facilitate washing the walls  262  of the drug or agent delivery chamber  260  to provide a more complete dose into the patient&#39;s intravenous connection. 
         [0024]    Now referring to  FIGS. 5A and 5B , this exemplary embodiment, a section of the thermoplastic elastomeric plunger end cap  250  is peeled back or deformed to allow the plunger retaining member  245 , to be inserted into a conforming receiving section  255  in the proximal end  254  of the plunger end cap  250  to form the fluid resistant seal. 
         [0025]    Now referring to  FIGS. 4A and 4B  exemplary embodiments of the plunger end cap  250  of the cannulated dose delivery device  100  are shown. In embodiment,  4 A, the plunger end cap  250  includes a plurality of horizontal slits  251  in the distal end  256  projecting away from the cannulated dose delivery device  100 . The plurality of horizontal slits  251  in the plunger end cap  250  are to a moderate extent parallel with the distal end  256  and can be either straight or curved, 
         [0026]    The function of these horizontal slits  251  is to wash the walls  262  of a drug or agent deliver chamber  260  to provide a more complete dose into the patient&#39;s intravenous connection (not shown). In this exemplary embedment, a plurality of horizontal slits  251  are arranged at about 120 degree angles relative to each other. Upon the application of fluid pressure, the horizontally located slits  251  open and direct, the wash upon the walls  262  of the dosing chamber  260 . The fluid pressure of wash solution, in particular, the added saline, facilitates the washing of the chamber walls  262  of a dosing chamber  260  to facilitate the internal flushing of a syringe dose chamber  260 . 
         [0027]    in embodiment  4 B the plunger end cap  250  includes a plurality of vertical slits  252  in the distal-end  256  projecting away from the cannulated dose delivery device  100 . The plurality of vertical slits  252  of the plunger end cap  250  function to provide a more complete dose into the patient&#39;s intravenous connection (not shown). In an exemplary embodiment, plurality of vertical slits  252  do not bisect each other to increase the rigidity of the plunger end cap  250 . The plurality of vertical slits  252  of the plunger end cap  250  are to a moderate extent perpendicular with the distal end  256  and can be straight or curved as desired by one skilled in the art. 
         [0028]    The terms horizontal slits  251  and vertical slits  252  are intended to cover any equivalent orientation of slits covering the range from perpendicular to parallel that facilitate the internal flushing of a syringe dose chamber  260 . The fluid pressure of wash solution, in particular the added saline, facilitates the washing of the chamber walls  262  of a dosing chamber  260 . 
         [0029]    Now referring to  FIG. 6 , saline flush syringe  310  is attached to the plunger proximal end connector  210  on the proximal end of the cannulated dose delivery device  100 . The saline solution is administered through the middle section  220  of the cannulated dose delivery device  100  that includes an internal chamber  230 , which allows flow of the saline solution into the dosing chamber  260  via the plurality of slits  252  in the plunger end cap  250 . This allows the walls  262  of the dosing chamber  260  to be rinsed to complete the dose to be delivered while maintaining the sterile dose pathway. 
         [0030]    Now referring to  FIG. 7 , sterilized cannulated dose delivery devices  100  are packaged in a container  350 , such as a perforated  352  blister pack, that can be separated to form one sterilized unit  351 . The packaged cannulated dose delivery device  100  can be sterilized by gaseous or radiation means known to one skilled in the art, and provide an integral system to flush a dosing chamber  260 . 
         [0031]    In a medical procedure, one sterilized unit  351  is detached from the package  350  by separating the perforation  251 . The sterilized unit  351  is opened to provide the cannulated dose delivery device  100 . A needle is attached to the distal end attachment port  280  of the cannulated dose delivery device  100  and a dose of the contrast agent or medication is drawn into the delivery chamber  260 . The cannulated dose delivery device distal connector  280  is attached to a patient delivery port  340  such as a patient&#39;s IV. The plunger top cap  205  is removed. The saline flush syringe  310  is connected to the cannulated dose delivery device  100  via the plunger proximal connector  210 . The saline flush syringe  310  is depressed releasing the wash fluid into the syringe  200 . The washing agent flows through the plunger end cap  250  and into the dosing chamber  260 . The dosing chamber  260  is rinsed and the patient receives a complete dose of the agent/drug plus the saline, without compromising the sterility of the injection. 
         [0032]    While the invention has been described with reference to preferred and example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims.