Abstract:
The present disclosure relates to a vial transfer needle assembly including a first molding member and a second molding member. The first molding member includes a hub portion that has a proximal piercing tip and a distal portion. The hub portion defines a lumen that passes therethrough. The second molding member includes a central housing, a proximal skirt, and a distal skirt. The second molding portion is molded at least partially about the first molding portion to form a monolithic structure. The piercing tip is positioned to extend into a first cavity that is defined by the proximal skirt. The distal portion of the first molding member is positioned to extend through a second cavity that is defined by the skirt. The distal skirt is dimensioned to receive a medical device.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present application is a continuation of U.S. patent application Ser. No. 12/892,073, filed on Sep. 28, 2010, the entire contents of which are incorporated by reference herein. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to a vial transfer needle assembly and, more particularly, to a two-piece vial transfer needle assembly. 
         [0004]    2. Description of Related Art 
         [0005]    In the medical field, certain types of solutions (e.g., drugs) are commonly stored in vials that utilize a pierceable cap (e.g., resealable septum) on one end and a plunger that is inserted into the opposite end. It is common for a clinician to use a vial transfer needle assembly that includes a spike or needle on one end and a standard threaded female luer connecter on the other end to fluidly couple the vial to a medical device, e.g., syringe, catheter, hubbed needle, etc. 
         [0006]    Currently vial transfer needle assemblies are manufactured by utilizing a three-piece design, which generally includes a plastic hub portion, a metal needle (e.g., a cannula), and a crimp-on metal insert that is used to capture the needle and seat it within the plastic hub portion. A sheath component may be pressed over the luer taper and serves as a sterile fluid path barrier when the hub is assembled to a vial. 
         [0007]    It would be beneficial to decrease the amount of parts needed for a vial transfer needle assembly and to simplify the assembly process. 
       SUMMARY 
       [0008]    The present disclosure relates to a vial transfer needle assembly including a first molding member and a second molding member. The first molding member includes a hub portion that has a proximal piercing tip and a distal portion. The hub portion defines a lumen that passes therethrough. The second molding member includes a central housing, a proximal skirt, and a distal skirt. The second molding portion is molded at least partially about the first molding portion to form a monolithic structure. The piercing tip is positioned to extend into a first cavity that is defined by the proximal skirt. The distal portion of the first molding member is positioned to extend through a second cavity that is defined by the distal skirt. The distal skill is dimensioned to receive a medical device. 
         [0009]    In embodiments, the vial transfer needle assembly may include a removable sheath that is configured to cover the distal portion of the first molding member. The removable sheath may be molded with the second molding member. The removable sheath may include an annular wall that defines an open proximal portion and a closed distal portion. The removable sheath is configured to cover at least a portion of the first molding member. 
         [0010]    In other embodiments, the closed distal portion of the removable sheath may include a textured configuration to facilitate handling by a user when the removable sheath is removed therefrom. 
         [0011]    In embodiments, the open proximal end of the removable sheath may be formed on to a portion of the distal skirt via a frangible portion such that when the removable sheath is removed the frangible portion is configured to fracture to thereby facilitate removal of the removable sheath. 
         [0012]    The second molding member may be configured to overlay and couple to the first molding member during an injection molding process. The first molding member includes a rigid structure having a higher Shore durometer than the second molding member. Whereas, the second molding member includes a flexible material having a lower Shore durometer than the first molding member to facilitate insertion of the vial when inserted into the proximal skirt. 
         [0013]    In embodiments, the proximal skirt includes an inner wall and a base. The inner wall may include an annular bead that is disposed along an inner periphery of the inner wall. The annular bead is provided to facilitate releasable engagement of a vial when inserted within the first cavity of the proximal skirt. 
         [0014]    In other embodiments, the distal skirt includes an inner wall and a base. The inner wall may have a plurality of threads disposed alongside the inner wall in a helical configuration for reception of the medical device, e.g., a catheter tube, within the second cavity of the distal skirt. Connecting structures other than helical threads are envisioned. 
         [0015]    The vial transfer needle assembly may farther include a cover that is disposed atop of an outer periphery of the proximal skirt to prevent contaminants from entering the cavity of the proximal skirt. 
         [0016]    The present disclosure also relates to a method of manufacturing a vial transfer needle assembly. In an initial step, a first shot of a first material is injected in a form of a first molding member, the first molding member having a hub portion. Subsequently, a second shot of a second material having a lower Shore durometer than the first material is injected. The second shot is configured to at least partially overmold the first molding member. The second molding member may include a hub portion, a proximal skirt, a distal skirt, and a removable sheath. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    Various embodiment of the subject instrument are described herein with reference to the drawings wherein: 
           [0018]      FIG. 1  is a perspective view of a vial transfer needle assembly according to one embodiment of the present disclosure; 
           [0019]      FIG. 2  is a side cross-sectional view of the vial transfer needle assembly of  FIG. 1 ; 
           [0020]      FIG. 3  is an enlarged view of the indicated area of detail of  FIG. 2 ; 
           [0021]      FIG. 4  is a side cross-sectional view of the vial transfer needle assembly shown in  FIG. 1  with a vial having a plunger coupled thereto and a removable sheath shown removed therefrom; 
           [0022]      FIG. 5  is an enlarged view of the indicated area of detail of  FIG. 4 ; 
           [0023]      FIG. 6A  is a perspective view of the vial transfer needle assembly shown in  FIG. 1  with a cover disposed over an opening of the vial transfer needle assembly; 
           [0024]      FIG. 6B  is a perspective view of the vial transfer needle assembly shown in  FIG. 6A  with the cover partially removed therefrom; and 
           [0025]      FIG. 7  is a side cross-sectional view of the vial transfer needle assembly shown in  FIG. 1  connected at one end to a vial and plunger assembly and a second end connected to a catheter tube. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    Embodiments of the presently disclosed vial transfer needle assembly are described in detail with reference to the drawings wherein like reference numerals identify similar or identical elements. As used herein, the term “distal” refers to that portion of the device which is further from a user while the term “proximal” refers to that portion of the device which is closer to a user. 
         [0027]    The present invention is directed to a vial transfer needle. In order to release the solution from the vial, one end of the vial transfer needle assembly is snapped over the pierceable cap such that the spike of the vial transfer needle assembly pierces the septum of the cap. On the opposite end of the vial transfer needle assembly, a medical device is connected to the standard threaded female luer connection. The plunger in the vial is then pressed into the vial to transfer the contents of the vial through the vial transfer needle assembly and into the patient. Alternatively, the medical device, such as a syringe, connected to the threaded female luer connection may withdraw the contents from a vial through the vial transfer needle into the medical device for delivery to the patient. It is understood that the vial transfer needle of the present invention may also be used in conjunction with a plungerless vial, in which the transfer needle may also comprise self-venting features. One example of a self-venting needle is disclosed in U.S. patent application Ser. No. 12/891,885, entitled SELF-VENTING CANNULA ASSEMBLY, and filed on Sep. 28, 2010, the entirety of which is incorporated herein by reference for all purposes. 
         [0028]    Referring initially to  FIGS. 1 and 2 , a transfer needle assembly is shown and generally depicted as  10 . Transfer needle assembly  10  is provided to transfer fluid from a vial  102  having a plunger  104  ( FIGS. 4 and 7 ) to a medical device. The medical device may be any medical device constructed and arranged to receive the contents of the vial and to releasably mate to the transfer needle assembly  10 . For example, the medical device may be a needleless syringe or a catheter. In one embodiment shown in  FIG. 7 , the medical device is a catheter tube  110 . Transfer needle assembly  10  generally includes a first molding member  12  and a second molding member  14  ( FIG. 2 ) that is configured to overlay and couple to first molding member  12  during an injection molding process. In one embodiment, first molding member  12  is injected into a mold during a “first shot” of the injection molding process and, subsequently, second molding member  14  is injected over at least a portion of the first molding member  12  during a “second shot” of the injection molding process. In one embodiment, the first molding member  12  is entirely overmolded with second molding member  14 . The two-shot molding process provides a benefit since it eliminates handling and costs associated with additional pieces and manufacturing steps. 
         [0029]    Referring now to  FIG. 2 , first molding member  12  generally includes a central hub portion  16  having a proximal piercing tip  18  and a distal luer taper  20 . Proximal piercing tip  18  is configured to pierce a pierceable septum of vial  102  ( FIGS. 4 and 7 ). Proximal piercing tip  18  may comprise any desired shape able to pierce the septum of the vial and to transfer the contents of the vial. The piercing tip  18  may be a blunt or sharp tipped. In one embodiment, the piercing tip  18  is constructed and arranged to minimize or prevent coring of the septum during piercing. 
         [0030]    Distal luer taper  20  is configured to be received within the medical device such as a catheter tube  110  (shown in  FIG. 7 ). In embodiments, first molding member  12  is made from a hard material (e.g., a polymer) to provide a rigid structure for the proximal piercing tip  18  and the distal luer taper  20 . In embodiments, different colors may be used to distinguish first molding member  12  from second molding member  14 . For example, first molding member  12  may include one colorant, while second molding member  14  may include a different colorant. In one embodiment, first molding member  12  having a particular piercing tip configuration may be associated with one color, while a first molding member having a different piercing tip configuration may be associated with a different color. In another embodiment, different colorants may be used to identify particular assembly features, such as gage and flow. 
         [0031]    Referring also to  FIG. 2 , central hub portion  16  defines a lumen  30  having proximal portion  30   a  and a distal portion  30   b.  Proximal portion  30   a  of lumen  30  extends to proximal piercing tip  18  and distal portion  30   b  of lumen  30  extends through distal luer taper  20 . In embodiments, lumen  30  tapers from a larger diameter at distal portion  30   b  to a smaller diameter at proximal portion  30   a  ( FIG. 2 ). 
         [0032]    Central hub portion  16  also includes a shoulder  32  extending about its outer periphery to securely abut second molding member  14 . Shoulder  32  includes a flat surface  34  ( FIG. 3 ), a side surface  36  and an angled surface  38 . 
         [0033]    Second molding member  14  includes a central hub portion  22 , a proximal skirt  24 , a distal skirt  26  and a removable sheath  28 . Proximal skirt  24  includes an inner wall  40  and a base  42  that define a cavity  44 . Inner wall  40  includes an annular bead  46  that is disposed along an inner periphery of inner wall  40 . Annular bead  46  is provided to facilitate releasable engagement of vial  102  within cavity  44  when the vial  102  is inserted into cavity  44  of proximal skirt  24 . Other types of releasable engagement structures are known and envisioned for use in place of the annular bead. In embodiments, second molding member  14  is made from a softer material, for example, a polymer having a lower Shore durometer than first molding member  12 , to allow for flexible manipulation of second molding member  14  during surgical use. For example, softer material enables proximal skirt  24  to expand when vial  102  is inserted therewithin. 
         [0034]    Distal skirt  26  includes an inner wall  50  and a base  52  that together define a cavity  54 . Inner wall  50  includes a plurality of threads  56  that are disposed alongside inner wall  50  in a helical fashion such that a catheter tube  110  ( FIG. 7 ) or any other type of luer-type connecting conduit may be connected thereto. Connecting structure other than threads  56  is envisioned. 
         [0035]    As discussed above, second molding member  14  includes a removable sheath  23  that is disposed within distal skirt  26 . Removable sheath  28  includes an annular wall  60  defining an open proximal portion  62  and a closed distal portion  64 . Removable sheath  28  is configured to cover distal luer taper  20  of first molding member  12 . In embodiments, closed distal portion  64  of removable sheath  28  may have a textured, and/or ergonomic configuration to facilitate handling by a user when being pulled and/or broken off second molding member  14 . 
         [0036]    Referring to  FIGS. 2 and 3 , during the “second shot” of the injection molding process, open proximal end  62  of removable sheath  28  is releasably secured to base  52  of distal skirt  26  via a frangible portion  66  (e.g., very thin layer). Removable sheath  28  covers the open end of distal luer taper  20 . As briefly discussed above, central hub portion  16  includes a shoulder  32 , which abuts base  52  of distal skirt  26  to provide a firm placement of central hub portion  16  in relation to second molding member  14 . In addition, during the “second shot” of the injection molding process, the softer material is configured to take a form over shoulder  32 . More specifically, an angled surface  68  of proximal portion  62  of removable sheath  28  abuts angled surface  38  of shoulder  32 , while frangible portion  66  surrounds side surface  36  of shoulder  32 . Referring also to  FIGS. 4 and 5 , frangible portion  66  is configured to easily break to facilitate removal of removable sheath  22  from second molding member  14  prior to use of vial transfer needle assembly  10 . 
         [0037]    Referring to  FIGS. 6A and 6B , a cover  70  may be disposed over the opening defined by an outer periphery  48  of proximal skirt  24 . Cover  70  may have a pull tab  72  and is configured to prevent any contaminants from entering cavity  44  of proximal skirt  24  during packaging and before a surgical procedure is performed. Cover  70  may be formed of any conventional material such as a coated paper, laminate or heat sealable film. 
         [0038]    Referring to  FIG. 7 , as it is commonly known in the art, vial  102  may contain a medicinal fluid “M” or any other suitable types of fluids. As it is also commonly known in the art, vial  102  may include a plunger  104 , a neck portion  106 , and a pierceable septum  108  that is positioned within a rim  109  of vial  102 . 
         [0039]    During use, a clinician removes (e.g., peels off) cover  70  from outer periphery  48  of proximal skirt  24  and inserts vial  102  within cavity  44  of proximal skirt  24 . As vial  102  is inserted within cavity  44 , rim  109  of vial  102  is pushed passed annular bead  46  formed on an inner wall of proximal skirt  24  until septum  108  abuts base  42  of the proximal skirt  24 . In this position, annular bead  46  is securely snug around neck portion  106 , thus securing vial  102  within proximal skirt  24 . Also in this position, proximal piercing tip  18  pierces the pierceable septum  108  of vial  102  to thereby allow medicinal fluid “M” to pass through proximal lumen  30   a.    
         [0040]    The clinician may then remove removable sheath  28  by twisting and/or pulling on removable sheath  28 , thus breaking the frangible portion  66 . After removing the removable sheath  28 , the clinician then inserts a connecting structure, e.g., a liter connector, of the cannula tube  110  or other medical device, e.g., syringe, catheter, blabbed needle, etc., into distal skirt  26  into engagement with luer threads  56  such that distal luer taper  20  is disposed within cannula tube  110 . Afterwards, plunger  104  of vial  102  is depressed such that the medicinal fluid “M” travels from vial  102  (as shown by arrow “A”), through central hub portion  16  and distal liter taper  20  (as shown by arrow “B”) via lumen  30 , and ultimately into catheter tube  110  (as shown by arrow “C”). 
         [0041]    It will be understood that various modifications may be made to the embodiments disclose herein. For example, the disclosed removable sheath may be provided after the disclosed second shot molding process. That is, the disclosed removable sheath may be made from a different material other than a polymer, such as, for example, any suitable type of metal. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modification within the scope and spirit of the claims appended hereto.