Abstract:
A medication delivery device included molded cylindrical barrel having visual marks on the surface of the barrel in the axial direction, a plunger seals the distal opening of the cylindrical barrel, a molded needle hub disposed in the proximal opening of the cylindrical barrel for sealing the needle hub to the barrel. A needle is disposed in the needle hub for communicating liquids by operation of the plunger in the axial direction. The circumferential surface on the flange of the needle hub comprises a colored mark that corresponds to a characteristic of the medication delivery device or its contents.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a divisional of currently pending U.S. patent application Ser. No. 13/442,592, which is hereby incorporated by reference in its entirety, and which was filed on Apr. 9, 2012. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to syringes, and more particularly, to syringes with visually coded needle hubs to designate needle gauge, needle length, syringe type, or the like. 
       BACKGROUND OF THE INVENTION 
       [0003]    One mode of insulin therapy for diabetes is injection of insulin via disposable syringes. Generally, a user removes a safety cap disposed over the needle on the syringe, pierces a cover of an insulin container with the needle, and withdraws a predetermined amount of insulin to prepare the insulin for injection. The user then pierces his or her skin with the needle and injects the insulin. After injecting the insulin, the syringe is discarded. 
         [0004]    Conventional disposable syringes generally include a molded cylindrical barrel, a needle hub fastened to the barrel, and a needle disposed in the needle hub to communicate liquids disposed in the barrel by operation of a plunger. Syringes are marked along the barrel with visual indicators of the volume of liquid disposed within the barrel to allow a user to withdraw and inject the correct volume of medication. Conventional molded needle hubs are not separately marked after assembly, making it difficult to ascertain the properties of the needle. 
         [0005]    In insulin treatment, there are different insulin concentrations available to users. To accommodate the different concentrations of insulin, the markings on the syringe barrel may correspond to units of insulin of a particular insulin concentration. Therefore, if two co-habitating insulin users have different insulin requirements, it may be possible for one of the users to inadvertently use an incorrect syringe and inject an incorrect insulin dosage. 
       SUMMARY OF EMBODIMENTS OF THE INVENTION 
       [0006]    An object of embodiments of the present invention is to substantially address the above and other concerns, and to provide improved insulin injection devices. These and other objects are substantially achieved by providing a molded cylindrical barrel having visual marks on the surface of the barrel in the axial direction, a plunger having a stopper attached to an end of the plunger to seal the distal opening of the cylindrical barrel, and a molded needle hub disposed in the proximal opening of the cylindrical barrel for sealing the cylindrical barrel. 
         [0007]    The needle hub comprises a flange having a circumferential surface that comprises a visually coded mark such as a color. The mark corresponds to a characteristic of the syringe such as needle gauge, needle length, syringe type, medication, or units of medication associated with the visual marks on the surface of the barrel. The circumferential surface of the flange may radially extend beyond the surface of the barrel to allow easy identification of the syringe and its associated characteristics. 
         [0008]    In the exemplary embodiments disclosed herein, a generic needle hub may be manufactured without a needle and specific syringes may be made from the generic needle hub based on production requirements to thereby facilitate manufacturing. In yet other embodiments, a needle is fixed to the needle hub and marked with a visual mark on the needle hub&#39;s surface to identify the characteristics of needle to facilitate manufacturing. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The various objects, advantages and novel features of the exemplary embodiments of the present invention will be more readily appreciated from the following detailed description when read in conjunction with the appended drawings, in which: 
           [0010]      FIG. 1  is a perspective view of a syringe in accordance with an exemplary embodiment of the present invention; 
           [0011]      FIG. 2  is an partial view of the proximal end of the syringe of  FIG. 1  showing the needle hub in more detail; 
           [0012]      FIG. 3  is a side view of a fully assembled syringe of  FIG. 1  with a needle safety shield disposed over the needle; 
           [0013]      FIG. 4  is a perspective view of the needle hub in accordance with an exemplary embodiment of the present invention; 
           [0014]      FIG. 5  is a cross-sectional view of the proximal end of the syringe of  FIG. 1 ; 
           [0015]      FIG. 6  is a flowchart showing an exemplary process for manufacturing the syringe of  FIG. 1 ; 
           [0016]      FIG. 7  is a perspective view of another example syringe in accordance with an exemplary embodiment of the present invention; 
           [0017]      FIG. 8  is a flowchart showing an exemplary process for manufacturing a syringe of  FIG. 7 ; and 
           [0018]      FIG. 9  illustrates an insulin storage container and a retail packaging according to an exemplary embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       [0019]      FIG. 1  illustrates an exemplary embodiment of a medication delivery device such as a plastic disposable syringe  100  having a needle  102  at its proximal end and disposed in a molded needle hub  104 . As will be described below, the needle hub  104  is fastened to an open proximal end of a molded cylindrical barrel  106  and a plunger  108  is disposed at an open distal end of the cylindrical barrel  106 . The plunger  108  includes a stopper  110  that is configured to seal the distal end of the barrel  106 . The stopper  110  may be integral to the plunger  108 . A distal end of the plunger  108  includes a thumb press  111  to provide an interface for a user to move the plunger  108  in the axial direction of the barrel  106 . By pulling or depressing the plunger, a user is able to transfer fluids to and from the syringe  100  at its proximal end via the needle  102 . The outer surface of the barrel  106  includes visual markings  112  to indicate either the volume or the dosage of the liquid disposed within the syringe  100 . For instance, the markings  112  may be associated with a particular insulin concentration so that the user can determine how many units of insulin to withdraw from a corresponding insulin container for injection. That is, the markings  112  may be in insulin units that correspond to a particular insulin concentration. The markings  112  may also be associated with a volume of liquid or any other suitable visual displays associated with the liquid disposed in the syringe  100 . 
         [0020]      FIGS. 2-4  illustrate the syringe  100  and needle hub  104  in more detail.  FIG. 2  is a partial view of the proximal end of the assembled syringe  100  with the needle hub  104  fastened to the barrel  106 .  FIG. 3  illustrates the assembled syringe  100  with a needle safety shield  114  that is generally disposed over the needle hub  104  to conceal the needle  102  for protective purposes. As illustrated in  FIG. 3 , the needle hub  104  includes a flange  116  that radially extends beyond the circumferential surface of the barrel  106  and interfaces with the needle safety shield  114 , but leaving a circumferential surface of the flange  116  exposed. 
         [0021]    As best illustrated in  FIG. 2 , the needle hub  104  includes a visually coded mark to identify a parameter of the syringe  100 . In this exemplary embodiment, the circumferential surface of the flange  116  includes a visually coded mark  118  so that a user may easily identify the syringe  100  when the safety shield  114  is disposed over the needle  102  for protective purposes. For instance, the mark  118  may be a particular color (e.g., black, red, or blue) on the flange  116  to identify the insulin concentration associated with the barrel  106 . In other exemplary embodiments, the mark  118  may be selectively applied to any portion of the needle hub  104 . For instance, the entire flange  116  may include the mark  118 . In other examples, the needle hub  104  may include a logo, text, or any other suitable distinguishing mark on any surface of the needle hub  104 . The mark  118  may be used to indicate any suitable characteristic of the syringe including, without limitation, needle gauge, needle length, needle type, barrel radius, barrel volume, medication, and so forth. In other exemplary embodiments, the circumferential surface of the flange  116  having the mark  118  may be planar with the surface of the barrel  106 . In yet other embodiments, a circumferential mark on an aspect of the molded barrel could be an equivalent to a mark on the needle hub. 
         [0022]    In one exemplary embodiment, the mark  118  may be applied to needle hub  104  by applying an ultraviolet (UV) resin to the surface of the needle hub  104  and exposing the needle hub to UV light. In such an embodiment, the UV resin reacts to the UV light and creates the mark  118 . For instance, a suitable UV ink by Capex Corporation may be used due to its polymerization initiated by exposure to the UV light. However, any suitable method of applying a visually coded mark may be used to create the mark  118  such as, without limitation, pad printing, dipping, roll printing, laser treating, two-shot molding, and so forth. 
         [0023]      FIG. 4  is a perspective view illustrating the needle hub  104  in more detail. An opening  120  on an end of the needle hub  104  is configured to receive the barrel  106 . The opening  120  includes an inner surface having a recessed surface  122  configured to fasten the needle hub  104  to the barrel  106 . The needle hub  104  also includes a needle base  124  having shape unique to the manufacturer to distinguish it from competitor&#39;s products. In the example of  FIG. 4 , the base  124  is cylindrical having a radius substantially similar to the radius of the barrel  106  and includes a rounded end that tapers to be planar with and expose the needle  102 . As illustrated in  FIG. 4 , the needle  102  axially extends from the needle base  124 . As described above, the needle base  124  is also configured to receive and keep the safety shield  114  in a substantially fixed position. 
         [0024]      FIG. 5  is a cross-sectional view of the proximal end of the syringe  100  in the axial direction of the needle  102  that illustrates the recessed surface  122  of the opening  120  engages a tapered notch  128  on an outer surface of the barrel  106 . In this exemplary embodiment, when the opening  120  of the needle hub  104  axially receives the barrel  106  during assembly, the tapered notch  128  becomes biased by the inner surface of opening  120 . When the tapered notch  128  is displaced adjacent to the recessed surface  122 , the tapered notch  128  unbiases into the recessed surface  122  to fasten the needle hub  104  to the barrel  106 . That is, the recessed surface  122  and the tapered notch  128  implement a latching mechanism to fix the needle hub  104  to the barrel  106 . The latching mechanism of the syringe  100  can be formed by any suitable arrangement that keeps the needle hub  104  fastened to the barrel  106  (e.g., a luer lock, etc.). In other examples, the needle hub  104  and the cylinder  106  may be molded as a single device. 
         [0025]      FIG. 6  illustrates an exemplary process  130  that may be implemented to manufacture the syringe  100 . The exemplary process  130  starts by using a polymer to mold a generic barrel and a generic needle hub at step  131 . At step  131 , any suitable mark may be formed on the surface of the barrel to indicate volume or units of medication. After any marks are formed on the barrel, the stopper and plunger are assembled and placed into the distal opening of the barrel at step  132 . 
         [0026]    At step  133 , a mark is selected for the needle hub associated with the visual marks on the cylindrical barrel. In other exemplary embodiments, the exemplary process  130  may begin by selecting a mark associated with a needle length, needle gauge, or any other syringe characteristic. A UV resin associated with the selected mark is applied to a needle hub corresponding to the barrel at step  134 . In one example, the UV resin is applied to the circumferential surface on the flange of the needle hub. In other exemplary embodiments, the UV resin may be applied to the entire needle hub or patterns of UV resin may be selectively applied to any surface of the needle hub as described above. After applying the UV resin to the needle hub, the needle hub is exposed an UV light source to cure the resin and polymerize the resin to the needle hub to create the mark on the needle hub at step  136 . In one example, the ultraviolet resin may cause the needle hub flange to be black, red, or blue. However, any color or combination of colors or patterns (e.g., a stripe, a dashed line, etc.) may be used. 
         [0027]    After curing the resin, a needle is fastened to the needle hub at step  138  by any suitable means (e.g., epoxy, etc.). The exemplary process  130  continues placing a needle safety shield over the needle hub at step  140 . The needle hub is then fastened to the barrel at step  142  by placing barrel  106  into an opening of the needle hub as described above. 
         [0028]    The above-described exemplary embodiments allow a generic needle hub to be molded and fitted with any suitable needle, thereby requiring only one generic needle hub for each barrel radius. Further, the mark on the needle hub is always exposed, even with a needle safety shield  114  in place, and provides a visual indicator of the content (e.g., insulin concentration, medication, etc.) or other characteristic of the syringe (needle gauge, needle length, barrel volume, barrel radius, etc.). Because the colored mark on the flange extends from the circumferential surface of the barrel, it can be easily seen from any angle. In other examples, the needle hub may be fabricated with the needle already fixed in place prior to creating the mark with the UV resin. Another exemplary embodiment may further comprise filling the assembled syringe  100  with a medication such as insulin. In such an example, the insulin concentration in the syringe is associated with the colored mark on the syringe. Other exemplary embodiments may further comprise a safety syringe having the mark as described above. 
         [0029]      FIG. 7  illustrates another example of the syringe  100  with the needle hub  104 . In the example of  FIG. 7 , a mark  146  is selectively placed on the circumferential surface of the base  124  and/or flange  116  via laser marking. As an example, the mark  146  is an arcing line around the circumference of the base  124  as illustrated in  FIG. 7 . Any suitable line, pattern, a sawtooth wave, a sinusoidal line, or a graphic may be implemented such as, for example, a helical line, a logo, and so forth. Further, the needle hub  104  and/or barrel  106  may be selectively laser treated to create a color shade on the needle hub  104  and/or barrel  106  over the entire surface. In other examples, the surface of the needle hub  104  may be selectively treated in a stipple pattern via the laser marking to create a tinted region. For example, the region between the mark  146  and the flange  116  may be selectively treated by the laser to create a shaded region on the needle hub  104 . In such an exemplary embodiment, the selective laser treatment may be in black only, or in other colors envisioned. The laser marking affects the surface and sub-surface of the molded plastic, resulting in a more permanent mark without substantial thermal damage to the surface of the syringe. Further, the amount of laser making dye can be altered to alter the color shade. 
         [0030]      FIG. 8  illustrates an exemplary process  150  to make the syringe  100  of  FIG. 7 . At step  152 , the exemplary process  150  begins by adding a laser marking dye to a polymer (e.g., polyethylene). One example laser marking dye is an OnCap™ Fast Mark™ laser marking additive, which absorbs the light to generate heat, thereby causing the surface of the polymer to carbonize at the exposed location. The polymer is then used to mold a generic barrel and a generic needle hub at step  154 . At step  154 , any suitable mark may be formed on the surface of the barrel to indicate volume or units of medication. The stopper and plunger are assembled and placed into the distal opening of the barrel at step  156   
         [0031]    The barrel is then selectively exposed to a laser source, which reacts with the laser marking dye to create a mark at step  158 . At step  158 , to prevent substantial damage to the plastic of the barrel, the laser source selectively exposes portions of the surface of the barrel at fine intervals to create a color shade on a region of the barrel without creating substantial thermal damage on its surface. The needle hub is then selectively exposed to the laser source to create a fine pattern to create a color shaded on its surface at step  160 . In the exemplary process  150  at step  162 , the needle hub may also be selectively exposed to create a solid line, a pattern, a logo, or other text at step  162  (e.g., an arcing line similar to the mark  146 ). 
         [0032]    After laser marking the needle hub and/or barrel, the needle is fastened to the needle hub at step  164  by any suitable means (e.g., epoxy, etc.). A needle safety shield is placed over the needle and needle hub at step  165 . The needle hub is fastened to the barrel at step  166  by, for example, placing the barrel into the opening of the needle hub and then applying a force to cause the fastener to latch to the barrel as described above. 
         [0033]    The above-described examples allow a selectively color shaded needle hub with a mark and/or a shaded barrel. The shaded barrel and/or shaded needle hub can be used in conjunction to identify multiple syringe characteristics. For instance, the needle hubs may have no shade if the needle length is less than 6 millimeters (mm) and a light shade if greater 6 mm. In such an example, the flange of the needle hub may be marked with a color by a UV cure process as described above to indicate additional syringe characteristics. In other examples, the shade of the needle hub, the shade of the barrel, a color mark on the base, and a color mark on the flange may be a visual indicator of the content (e.g., insulin concentration, medication) and/or other parameters of the syringe (needle gauge, needle length, barrel volume, barrel radius, etc.). The shade of the mark can be adjusted by, for example, adjusting the amount of laser marking dye added to the polymer. 
         [0034]    The color of the mark  118  may also be disposed on additional materials that are associated with the syringe  100  for a user&#39;s convenience. For instance, as illustrated in  FIG. 9 , an insulin container  168  may include a cap  170  having a substantially similar color to the mark  118 . In such an example, the syringe  100  pierces a septum  172  disposed on the cap to withdraw insulin from the insulin storage container  168  into the syringe  100 . The insulin container  168  may also have a label  174  having a display visual indicator  176  having a substantially identical color of the mark  118  so that the user can easily identify the correct syringe. The substantially matching colors of the mark  118  on the syringe  100 , the cap  170 , and the label  174  provide a visual indication to the user that he or she is withdrawing the correct insulin to be used in the syringe  100 . In yet another exemplary embodiment, several syringes  100  may be prefilled with the insulin and provided to the user in a retail package  178 . In such an embodiment, an exterior surface of the package may display visual indicator  180  having a substantially identical color of the mark  118  so that the user can easily identify the correct syringe. 
         [0035]    In each of the embodiments disclosed herein and in other alternative embodiments, the syringe molded components can be made of polypropylene, polyethylene, polyethylene terephthalate, and/or bio-derived resins such as polylactide, starch-filled polypropylene, or polyhydroxyalkanoates. Alternatively, bio-degradable resins may be used to form the syringe molded components. The needle on the needle hub can be fixed to the needle hub either before or after the marking is placed on the needle hub. As described above, when provided to the user, the syringe can be filled with medication (e.g., insulin) or may be empty so a user can withdraw the medication from a corresponding container. The user may retrieve the syringe from packaging that is also marked with the substantially identical color, thereby providing the user multiple notifications as to the insulin concentration that will be injected. This ensures the user will use the correct amount of insulin by implementing multiple warnings using a visual indicator such as a particular color, pattern, and so forth. 
         [0036]    Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of the appended claims and their equivalents.