Abstract:
A medical delivery or extraction system comprising a needle assembly having a needle and a hub coupled to the needle. The hub includes a verification region or component. A syringe body rotatably coupled to the needle assembly includes at least one indicia on the outer surface thereof. When the indicia corresponds to the verification region, the user is provided with an indication that the se body is properly connected to the needle assembly.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention is directed to medical delivery/extraction systems. More particularly, the present invention is related to a medical delivery/extraction system with a built-in indicator of whether individual components of the system are properly connected to each other.  
         BACKGROUND OF THE INVENTION  
         [0002]    Syringe and needle assemblies have been used for a number of years for the purpose of injecting fluids into or withdrawing fluids from a body. These fluids may include medicine, blood or other types of biological materials. Due to the multitude of infectious diseases which may be carried by bodily fluids such as blood, it is extremely important that any potential leakage of fluid during an injection or withdrawal process be kept to an absolute minimum.  
           [0003]    One location in a delivery/extraction system where bodily fluids and/or other substances may leak from the system is the connection area between the syringe and the needle assembly. Because syringes and needle assemblies are often marketed and/or manufacture separately, a doctor, nurse or other technician is required to properly connect the needle assembly to the syringe. If the needle assembly is not properly connected to the syringe, the possibility of a poor connection and accidental leakage of biological materials increases significantly. This correspondingly increases the risk of exposure to hazardous materials.  
           [0004]    The type of media being delivered out of the syringe may also contain materials, components, or ingredients that can separate at a poor connection when exposed to the injection pressures developed in the syringe. The material separation can cause further problems of injecting or extracting the full contents of the syringe through the needle. A properly connected needle assembly to the syringe would significantly reduce the possibility of material, component, or ingredient separation from occurring.  
           [0005]    A variety of mechanisms have been developed to securely fasten needle assemblies to syringes, but each have their drawbacks. For example, a number of conventional mechanisms include a linear connection between the syringe and the needle assembly in the form of a track or groove, in which the needle assembly slides onto the syringe. Systems with linear connections often include o-ring type seals that are located a certain distance from the path of the fluid material. This distance between the seal and the material pathway may cause delivery and/or extraction problems for certain types of materials. Other types of conventional systems involve a rotational fitting between the needle assembly and the syringe. These systems allow for a line-to-line seal that is integral to the material path, but the systems are somewhat limited in their ability to indicate to the user when an adequate or proper connection has been achieved. Furthermore, some of these systems may be prone to being “overtightened” which can affect the functionality and/or safety of the completed assembly. Also, it can often be difficult to determine whether the needle assembly is properly connected to the syringe. In either case, an improperly made connection between the needle assembly and the syringe can have hazardous results and/or functional/operational problems.  
         SUMMARY OF THE INVENTION  
         [0006]    It is therefore an object of the invention to provide an improved delivery or extraction system that provides a simple mechanism for ensuring a proper connection between components.  
           [0007]    It is another object of the invention to provide an improved delivery or extraction system that includes a mechanism to indicate to a user that a proper connection has been achieved.  
           [0008]    It is still another object of the invention to provide an improved delivery or extraction system that minimizes the incidence of fluids escaping from the system.  
           [0009]    It is yet another object of the present invention to provide an improved delivery and extraction system that provides a visual indication of whether an adequate or proper connection has been made in the system.  
           [0010]    It is another object of the present invention to provide an improved delivery and extraction system that is simple to use while still maintaining a high degree of safety.  
           [0011]    It is finally another object of the present invention to provide an indicator means that provides accurate and concurrent positioning of both linear and angular orientation, ensuring indication of a proper connection.  
           [0012]    In accordance with the above objects, a medical delivery and extraction system is provided. The system comprises a needle assembly including a needle with a hub formed therein. A syringe body is rotatably coupled to the needle assembly. The syringe body includes at least one indicia on a portion of the body, and the needle hub includes a verification region an a portion thereof. The indicia and verification region are arranged on the syringe body and needle hub, respectively, such that when the syringe body is properly fastened to the needle assembly, the indicia aligns with the verification region, giving the user an indication that the needle assembly is properly connected to the syringe body. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]    The foregoing advantages and features of the invention will become apparent upon reference to the following detailed description and the accompanying drawings, of which:  
         [0014]    [0014]FIG. 1 is a side view of a medical delivery system according to one embodiment of the invention;  
         [0015]    [0015]FIG. 2 is a detailed side view of a syringe according to one embodiment of the present invention;  
         [0016]    [0016]FIG. 3 is a detailed side view of a needle assembly for mating with the syringe of FIG. 2;  
         [0017]    [0017]FIG. 4 is a detailed side view of a portion of the needle assembly of FIG. 3 rotated ninety degrees;  
         [0018]    [0018]FIG. 5 is a side view of a needle assembly and syringe before being fastened;  
         [0019]    [0019]FIG. 6 is a side view rotated ninety degrees of the needle assembly and syringe of FIG. 5;  
         [0020]    [0020]FIG. 7 is a side view rotated ninety degrees of the needle assembly and syringe of FIG. 5 as the needle assembly is partially fastened to the syringe;  
         [0021]    [0021]FIG. 8 is a side view of the needle assembly and syringe of FIG. 5 as the needle assembly is properly connected to the syringe;  
         [0022]    [0022]FIG. 9 is a side view rotated ninety degrees of the needle assembly and syringe of FIG. 8 as the needle assembly is properly connected to the syringe;  
         [0023]    [0023]FIG. 10 is a side view of a luer connection according to another embodiment of the invention;  
         [0024]    [0024]FIG. 11 is another side view of the luer connection of FIG. 10;  
         [0025]    [0025]FIG. 12 is a side view of a modified luer connection according to still another embodiment of the invention;  
         [0026]    [0026]FIG. 13 is a side view of a modified luer connection according to yet another embodiment of the invention;  
         [0027]    [0027]FIG. 14 is a side view of a modified luer connection according to still another embodiment of the invention;  
         [0028]    [0028]FIG. 15 is a side view of an unfastened medical delivery system including a protective sheath;  
         [0029]    [0029]FIG. 16 is a side view rotated ninety degrees of an unfastened medical delivery/extraction system including a cannula;  
         [0030]    [0030]FIG. 17 is a side view rotated ninety degrees of the medical delivery system of FIG. 16 during the securing process;  
         [0031]    [0031]FIG. 18 is a side view rotated ninety degrees of the medical delivery system of FIG. 17 when properly connected; and  
         [0032]    [0032]FIG. 19 is a side view of the medical delivery system of FIG. 16 when properly connected. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0033]    A medical delivery or extraction system is shown generally at  100  in FIGS.  1 - 4 . The medical delivery or extraction system  100  comprises a syringe  102  and a needle assembly  104 . The syringe  102  comprises a syringe body  110  coupled to an end-piece  112  (see FIG. 2). The syringe body  110  includes a plunger receiving end  114  and a needle assembly receiving end  116 . The plunger receiving end  114  is open such that it may accept a plunger  128  that is used to force fluid into or out of the syringe  102 . The syringe body  110  also includes a plurality of volume indicia  118  for measuring the amount of fluid inside the syringe  102  at any given moment.  
         [0034]    The syringe  102  also includes an inner body  122  on the inside of the syringe  102 . The inner body  122  comprises a passageway through which the fluid primarily flows. The inner body  122  terminates at a connection portion  124 . In the area around the connection portion  124 , there are a plurality of threads  126  formed on the inside of the syringe body  110 .  
         [0035]    An indicator mark  120  is also included at the needle assembly receiving end  116  of the syringe  102 . The indicator mark  120  is used to determine whether the syringe  102  is properly connected to the needle assembly  104 . The indicator mark  120  may take a variety of forms. In a preferred embodiment of the invention, the indicator mark  120  comprises a colored dot which is visible by a user. The indicator mark  120  can take a variety of other forms, however, including lines, figures, numbers, colored bands, etc. and a variety of indicating methods including aligning lines or figures, compression rings, etc. Additionally, it is also possible for the indicator mark simply to be a color opposite that of the surrounding portion of the syringe body  110  or to be reverse printed from that described in this embodiment. Furthermore, it is possible to have multiple color bands or other mechanisms for indicating varying degrees of making the connection. The indicator mark  120  can be imprinted on the outer surface of the syringe body  110  or can be imbedded inside the syringe body  110 . Furthermore, the indicator mark  120  can comprise a depression, ridge, or groove which mates with the needle assembly  104 .  
         [0036]    The needle assembly  104  comprises a needle  130  (shown in phantom in FIGS. 3 and 4) coupled to a luer connection  132 . The luer connection  132  includes a hub  134  formed on the inside thereof. The hub  134  is hollow and runs from a first end  136  to a second end  138 . The hub  134  is sized to accept the needle  130  in a snug relationship. The hub  134 , in one embodiment of the invention, also includes a hub ridge  142  at the second end  138 . Alternatively, the hub  134  may include a plurality of hub threads  170 , shown best in FIGS.  10 - 14 . As shown in FIGS.  1 - 4 , the hub ridge  142  and/or the hub threads  170  are used to mate the needle assembly  104  with the syringe  102 . The luer connection  132  also includes a gripping portion  146 . The gripping portion  146  may be used by a user to fasten and unfasten the needle assembly  104  from the syringe  102 .  
         [0037]    The luer connection  132  also includes a viewing region  144 . In a preferred embodiment of the invention, the viewing region  144  comprises a circular opening. It is also possible for the viewing region  144  to comprise a transparent material. The viewing region is used by the user to determine if the needle assembly  104  is properly connected to the syringe  102 . As is explained herein, when the indicator mark  120  of the syringe  102  is clearly visible through the viewing region  144 , then it is understood that the syringe  102  is properly connected to the needle assembly  104 .  
         [0038]    FIGS.  10 - 14  show various types of threaded sealing connections that may be incorporated into the present invention. FIGS. 10 and 11 show a standard threaded luer connection  232 , including a stain relief portion  148  and a luer end  170 . FIGS.  12 - 14  disclose modified luer connections  132 , including modified luer connections with straight lead-ins but having a smaller diameter than the luer  232  in FIGS. 10 and 11 (FIG. 12), a modified luer connector with a straight lead with the initial outer thread removed (FIG. 13); and a modified luer connection with a straight lead with the outer thread remaining in place and the end tapered, shown in FIG. 14. A variety of types of connections could also be used as would be understood by one of ordinary skill in the art.  
         [0039]    Depending upon the nature and type of threads  126 , the number of indicator marks  120  on the syringe body  110  may also vary. For example, if a single lead thread is used, only one indicator mark  120  is required on the syringe. If a double lead thread is used, however, two of the indicator marks  120  must be incorporated onto the syringe body  110 , each being approximately 180° from the other. In this case, the medical delivery or extraction system  100  would be properly connected when either of the indicator marks  120  is aligned with the viewing region  144 . If a triple lead thread is used, three indicator marks  120  would be used with each of the indicator marks  120  being approximately 120° from the other indicator marks  120 . In general, the number of indicator marks needed would correlate to the number of thread leads used.  
         [0040]    The operation of the medical delivery or extraction system  100  is generally as follows. As shown in FIGS. 5 and 6, the needle assembly  104  is separable from the syringe  102 . If the user desires to couple the noodle assembly  104  to the syringe  102 , the user brings the second end  138  of the luer connection  132  towards the needle assembly receiving end  116  of the syringe body  110 . When the second end  138  of the luer connection  132  comes into contact with the needle assembly receiving end  116  of the syringe body  110 , the user either twists the gripping portion  146  of the luer connection  132  or grips the gripping portion  146  of the luer connection  132  and twists the syringe body  110 . The mating action of the threads  126  with hub threads  170  causes the luer connection  132  to couple to the syringe body  110 . As is shown in FIGS.  7 - 9 , the connection between the luer connection  132  and the syringe body  110  becomes more pronounced as the luer connection  132  is twisted relative to the syringe body  110 . As is shown in FIG. 7, when the luer connection  132  is only partially upon the syringe body  110 , the indicator mark  120  is not yet visible through the viewing region  144 . As the user continues to twist the luer connection  132 , the indicator mark  120  ultimately aligns with the viewing region  144 , as best shown in FIG. 9. At this position a proper connection has been achieved between the needle assembly  104  and the syringe  102 , and the user is given an indication that additional tightening is not necessary. The user is then able to perform the particular procedure using the medical delivery or extraction system  100 . When the user desires to remove the needle assembly  104  from the syringe  102 , the user simply rotates the luer connection  132  in the opposite direction using the gripping portion  146 .  
         [0041]    The delivery or extraction system  100  of the present invention can be used in virtually any situation that requires an indication and assurance of a proper connection for rotationally connected medical delivery or extraction devices. Such environments range from sterile hospital suites to non-sterile doctors&#39; offices. The system  100  could be used at ambient conditions in addition to hot or below freezing conditions and dry or humid conditions. The system  100  can also be packaged and sterilized using conventionally known methods and can be provided and used for non-sterile applications. The individual components can all be manufactured using conventionally known techniques resulting in a relatively low cost.  
         [0042]    As mentioned previously, a variety of indicia can be used for indicating that the syringe  102  is properly connected to the needle assembly  104 . For example, a variety of visual indicators could be used, and it is also possible to have an audible indication of a proper connection. This can be accomplished using a form of snap fitting in a mechanical design, an electronic computer chip in an electrical design, or other design systems. A combination of visual and audio indications could also be used. Furthermore, a number of the individual components can be replaced and/or modified depending upon the particular needs. For example, the syringe  102  could be in the form of a container such as a cartridge, vial or bottle, while the needle assembly  104  could be replaced with a different type of mechanism or device. Different types of seal interfaces, such as tapered seals, face seals, etc., could be used to ensure a secure connection, and connections other than luer connections could be used. For example, a variety of types of threads or a twist locking mechanism could be incorporated into the system  100 .  
         [0043]    It should be understood that the above description of the invention and specific examples and embodiments, while indicating the preferred embodiments of the present invention, are given by demonstration and not limitation. Many changes and modifications within the scope of the present invention may therefore be made without departing from the spirit thereof and the present invention includes all such changes and modifications.