Patent Publication Number: US-11039983-B2

Title: Cap systems with piercing member for pharmaceutical vials

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of application Ser. No. 15/227,470, filed on Aug. 3, 2016, entitled Cap Systems with Piercing Member for Pharmaceutical Vials, which application is assigned to the same assignee as the subject invention and whose disclosure is specifically incorporated by reference herein. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable 
     INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISK 
     Not Applicable 
     FIELD OF THE INVENTION 
     This invention relates generally to container capping systems and more particularly to systems for capping pharmaceutical vials to provide ready access to the contents of the vials when desired. 
     BACKGROUND OF THE INVENTION 
     For more than sixty years injectable drugs have been packed in glass vials. Such vials typically are formed of glass and have a cylindrical neck terminating in a flanged top or lip, with the opening to the interior of the vial extending through the neck. The neck is sealed by means of a rubber stopper and an aluminum seal or ferrule. When these types of vials are used in lyophilization (freeze drying) the vial is filled with liquid and then the stopper (which is a complex or complicated elastomeric member) is inserted part way into the vial so that the product can be lyophilized. In this regard, the standard stopper and vial combination often rely on a feature called a “blowback” on the inside of the vial&#39;s lip to mate with an indentation on the elastomeric stopper. This action keeps the stoppers from rising up during processing. Once the lyophilization process has occurred the stopper is then fully seated in place, e.g., pushed down, so that it is completely within the neck of the vial during the final stages of the process and a ferrule applied to lock the stopper in place to thereby permanently seal the vial. Needless to say this is a complex operation and requires that the entire operation be accomplished within sterile conditions, e.g., within the freeze drying apparatus. Moreover, the construction of the closures require the use of vials having the blowback feature, thereby limiting the materials that can be used to form the vials to glass, e.g., plastic materials have not proved economically viable for producing vials with a viable blowback feature. 
     In U.S. Pat. No. 8,544,665 (Bogle et al.), which is assigned to the same assignee as this invention and whose disclosure is specifically incorporated by reference herein, there is disclosed and claimed a cap system for permanently sealing a pharmaceutical vial which overcomes the disadvantages of the prior art. That cap system basically comprises an elastomeric stopper, a retainer member and a locking cap member. The cap system of that patent application is particularly to be used on a conventional glass pharmaceutical vial having an interior, an opening to the interior of the vial and a flanged neck surrounding the opening, the flanged neck having an undersurface. The elastomeric stopper of the cap system has a body portion. The retainer member has a top wall and a peripheral sidewall. A plurality of resilient fingers is located about the periphery of the sidewall. The locking cap member comprises a peripheral sidewall including inwardly projecting members and is slidably coupled to the retainer member. The stopper is arranged to be secured to the vial so that its body portion partially closes the opening of the vial. The retainer member is arranged to be secured to the vial with its fingers being arranged to flex over the flanged neck of the vial and then snap into engagement with the undersurface of the flanged neck of the vial and with portions of the top wall of the retainer member in engagement with portions of the stopper to hold the stopper in place on the vial to seal the opening in the vial and prevent removal of said stopper from the vial. The locking cap member is arranged to be slidably secured over the retainer member after the retainer member has sealed the opening in the vial to lock it in a fixed position with respect to the retainer member, whereupon its inwardly projecting members apply an inward force on the fingers of the retainer member to ensure that the vial is permanently sealed. 
     While the cap system of the foregoing patent is eminently suitable for its intended purposes it nevertheless leaves something to be desired from the standpoint of facilitating access to the contents of the vial after the vial has been permanently sealed. 
     The subject invention addresses that need. 
     SUMMARY OF THE INVENTION 
     In accordance with one aspect of the invention there is provided a cap system for a pharmaceutical vial having an interior in which a flowable material is disposed, an opening to the interior of the vial and a flanged neck surrounding the opening, with the flanged neck having an undersurface. The cap system comprises an elastomeric stopper, a retainer member, a locking member, a cap member and a piercing member. The elastomeric stopper is arranged to be secured to the vial. The retainer member comprises a sidewall and a plurality of resilient fingers located about the periphery of the sidewall. The retainer member is arranged to be secured to the vial with the fingers of the retainer member being arranged to flex over the flanged neck of the vial and then snap into engagement with the undersurface of the flanged neck of the vial. The locking member is slidably coupled to the retainer member and comprises a peripheral sidewall including inwardly projecting members. The locking member is arranged slid to a fixed position with respect to the retainer member, whereupon the inwardly projecting members of the locking member apply an inward force on the fingers of the retainer member to permanently seal the vial. The cap member is coupled to the locking member and is a hollow member having a socket therein. The piercing member is releasably located in the socket and has a piercing tip. 
     In accordance with one preferred aspect of this invention the cap member is slidably coupled to the locking member to enable the cap member to be slid from a retracted position to an extended position wherein the piercing tip of the piercing member passes through the stopper into the interior of the vial. 
     In accordance with another preferred aspect of this invention the cap member comprises a portion of an assembly additionally comprising a band releasably secured to the cap member. The band is arranged to be removed from the assembly to enable the cap member to be slid from the retracted position to the extended position. 
     In accordance with another preferred aspect of this invention the socket includes an internally threaded portion and wherein the piercing member comprises an externally threaded portion screwed within the internally threaded portion of the socket. The cap member is arranged to be unscrewed from the piercing member after the cap member is in the extended position, whereupon the cap member can be removed from the vial leaving the piercing member in place extending into the interior of the vial. 
    
    
     
       DESCRIPTION OF THE DRAWING 
         FIG. 1  is an isometric view of a conventional glass pharmaceutical vial on which one exemplary embodiment of a cap system constructed in accordance with this invention is disposed; 
         FIG. 2  is an enlarged exploded side elevation view of the vial and the cap system shown in  FIG. 1 ; 
         FIG. 3  is an exploded isometric view of a cap member, a piercing member and a locking member forming a portion of the cap system shown in  FIGS. 1 and 2 ; 
         FIG. 4  is an exploded isometric view of the piercing member and the locking member shown in  FIG. 3 ; 
         FIG. 5  is an enlarged top plan view of the locking member shown in  FIGS. 2-4 ; and 
         FIG. 6  is an enlarged vertical sectional view of the capping system of  FIGS. 1 and 2  shown in place on the vial before the piercing member of the capping system is moved to gain access to the interior of the vial. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown in  FIG. 1  one exemplary embodiment of a capping system  20  constructed in accordance with this invention for use on a conventional glass pharmaceutical vial  22 , such as used for holding an injectable liquid. The capping system basically comprises basically comprises a resilient (e.g., elastomeric) stopper  24 , a retainer member  26 , a locking member  28 , a cap assembly  30  and a piercing member  32 . The details of all of those components and their operation will be described later. Suffice it for now to state that the vial  22 , the stopper  24  and the retainer member  26  are all constructed and arranged like those members disclosed in FIGS. 1-6 of U.S. Pat. No. 8,544,665 (hereinafter referred to as the “&#39;665 patent”), whose disclosure is specifically incorporated by reference herein. Thus, in the interest of brevity the many of the details of the features and operation of those components will not be reiterated. 
     The capping system  20  of this invention is particularly suitable for use on pharmaceuticals vial, such as a glass vial used for injectable drugs, but owing to the construction of the closure assembly it can also be used on vials made of plastic. The vial  22  basically comprises a hollow body  22 A in which a pharmaceutical or other drug or other product to be held in a sterile state is located. The entrance to the interior of the vial&#39;s body is provided via an opening extending through a neck of the vial. The top of the neck of the vial is in the form of a lip or flange, having a generally planar top surface and a somewhat undercut surface. Since the retainer member  26  is constructed in accordance with the teaching of the &#39;665 patent the interior surface of the opening in the neck of the vial need not include a blow-back annular recess, as has characterized prior art vials. Thus, the capping system of this invention enables one to use simpler vials than existing prior art glass vials. In fact, the subject invention enables one to use vials made of plastics as well. 
     The resilient stopper  24  is best seen in  FIG. 6  and basically comprises a disk-like body  24 A from which a plug  24 B projects. The outer surface of the free end of the plug is tapered to facilitate its entrance into the opening  6  in the vial. The distal surface of the plug includes a hemispherical recess to provide some give to also facilitate entry of the plug into the vial opening. The periphery of the disk-like body  22 A is in the form of a flange having a generally planar undersurface. The central portion of the stopper is arranged to be pierced by a piercing tip  32 A (to be described later) which is a hollow pointed structure forming a portion of the piercing member  32 . The piercing member  32  is, itself, arranged to be coupled to a syringe, catheter or some other instrument (not shown) to provide access to the contents of the vial. 
     As best seen in  FIGS. 2, 3, and 6 , and as will be described in detail later, the piercing member  32  includes an externally threaded hollow portion  32 B which is screwed into a threaded socket (to be described later) forming a portion of the cap assembly  30 . The piercing member also includes a generally planar, circular flange  32 C located between the piercing tip  30 A and the threaded portion  32 B. The flange  32 C serves as a means for connecting the piercing member  32  to the locking member  28  when the piercing tip has pierced the stopper  24  (as will be described later). The flange  32 C includes a plurality of recesses  32 D (also to be described later) in its under surface contiguous with its periphery. The recesses are arranged for cooperation with plural projections or teeth (also to be described later) of the locking member to hold the flange in place on the locking member. That action will be described later. 
     The retainer member  26  is also best seen in  FIG. 6  as well as in  FIG. 2  and basically comprises a top wall  26 A and a peripheral sidewall  26 B. The center portion of the top wall is open, i.e., includes a hole  26 C to provide access to the stopper so that the piercing tip  32 A of the piercing member can be inserted therethrough. The peripheral sidewall  26 B includes a plurality of slots so that the portions of the sidewall between the slots form respective, downwardly extending fingers  26 D ( FIG. 2 ). At least one (and preferably two) internal lugs  26 E project inward from the inner surface of each of the fingers. Each finger also includes a flexible tab  26 F extending inward and upward from the inner surface of the associated finger. The tabs are arranged to flex inward so that the stopper  24  can be inserted and held within the retainer member, with the top surface of the stopper abutting the undersurface of the top wall  26 A. The tabs then snap back into place to engage the undersurface of the stopper and thereby hold the stopper in place. 
     The capping system  20  is arranged to be placed on the neck of a vial so that the top surface of the vial&#39;s neck abuts the inwardly projecting lugs  26 E of the retainer member  26 . In this position the distal end  24 C of the plug portion of the stopper  26  is located within the opening of the vial and will be a slight gap or open interface between the outer surface of the distal end of the stopper and the inner surface of neck of the vial. The gap is in fluid communication with the slots between the fingers  26 D and hence to the ambient atmosphere to enable the lyophilization of the pharmaceutical within the vial (as described in the &#39;665 patent). 
     In order to close the interface and thus temporarily seal the vial, all that is required is to apply a downward force on the retainer member to cause its fingers  26 D to flex outward to ride over the flanged lip of the neck of the vial, so that the top surface of the inwardly projecting lugs  26 E snap into place to engage the undersurface of the neck of the vial. Moreover, the tabs  26 F ride over and tightly engage contiguous portions of the lip of the vial. This action traps the retainer member  26  on the neck of the vial and slightly compresses, e.g., 20% compression, the peripheral flange of stopper  24  between the top wall of the retainer member and the top surface of the neck of the vial, whereupon the drug contents in the vial are sealed off from the ambient atmosphere. 
     The locking member  28  of this invention takes the place of the locking cap member  28  that is shown in FIGS. 12-18 of the &#39;665 patent and is also used to permanently lock the closure assembly in place on the vial. In addition, the locking member  28  of this invention includes a portion (to be described shortly) which cooperates with the cap assembly  30  and the piercing member  32  to enable the piercing member to gain access to the contents of the vial after it has been permanently sealed when such is desired, e.g., when it is desired to withdraw all or a portion of the pharmaceutical from the vial into a syringe or other instrument. 
     It should be pointed out at this juncture that the entire capping system  20  can be preassembled so that the entire assembly can be placed on a vial to be sealed at one time (although the sealing steps are carried out sequentially as described in the &#39;665 patent). Alternatively, the locking cap member  28 , the cap assembly  30  and the piercing member  32  can be preassembled as a unit and that unit can be applied onto a vial that has already been temporarily sealed by the retainer member  26  and the stopper  24 . 
     The locking member  28  is best seen in  FIGS. 4-6  basically comprises a circular sidewall  28 A from which a generally planar ledge  28 B projects inward. The locking member  28 , like each of the retainer member  26 , the cap assembly  30  and the piercing member  32 , can be molded as an integral unit. The center of the ledge  28 B is open, i.e., in the form of a circular hole  28 C. The hole  28 C provides access for the piercing tip  32 A of the piercing member  32  to pass therethrough and then through the hole  26 C in the retainer member  26  to pierce through the underlying stopper  24 . 
     As best seen in  FIGS. 4 and 5 , a plurality of protuberances or teeth  28 D extend upward from the top surface of the ledge about the periphery of the hole  28 C for cooperation with the recesses  32 D of the flange  32 C. In particular, as will be described later the recesses  32 D are shaped to matingly receive the teeth  28 D on the ledge  28 B of the locking member to hold the piercing member in place during removal of a portion of the cap assembly  30 . 
     As best seen in  FIGS. 3 and 4  a plurality of internal lugs  28 E projects inward from the inner surface of the lower end portion of the sidewall  28 A. The lugs  28 E are located slightly above the bottom edge of the locking member  28 . The top surface of the ledge  28 B includes a pair of diametrically opposed tabs  34 , each of which projects upward from the ledge. The teeth  28 D are equidistantly spaced about the periphery of the hole  28 C between the tabs  34  as best seen in  FIG. 5 . Each of the tabs is undercut at  34 A as best seen in  FIG. 4  and each tab is slightly flexible. The top surface of each of the tabs is shaped as a cam surface  34 B ( FIG. 6 ). As will be described later, this arrangement enables the flange  32 C of the piercing member  32  to slide over the cam surfaces to cause the tabs to flex outward to allow the flange to pass between the tabs and be trapped between the top surface of the ledge  28 C and the undercut surfaces  34 A of the tabs. 
     An annular ridge  36  extends about the periphery of the sidewall  28 A. The ridge serves as a means which cooperates with a correspondingly shaped groove or recess in the cap assembly to hold the cap assembly in place on the locking member  28 . 
     The locking member  28  is disposed on the top of the retainer member  26  in the same manner that the locking member of the &#39;665 patent so that a force can be applied to it to cause it to move down with respect to the vial to a temporary sealing position. At this point the stopper  24  will be compressed and locked in place onto the neck of the vial by the inwardly projecting lugs  26 E engaging the undersurface of the lip of the vial as described earlier. In order to permanently seal the vial, all that is required is to apply a further downward force onto the locking cap  28  to cause it to move to the down position shown in  FIG. 6 , whereupon its inwardly projecting lugs  28 E provide an inwardly directed force on the fingers  26 D of the retainer member  26 , thereby ensuring that the vial is permanently sealed. 
     As mentioned above the capping system subject invention is arranged to provide ready access to the contents of the vial via the piercing member  32 . To that end, the piercing member  32  is held in a retracted or up position with respect to the sealed vial by the heretofore identified cap assembly  30  until access to the contents of the vial is desired. The cap assembly is best seen in  FIGS. 1-3 and 6  and basically comprises a cup-shaped hollow cap  38  and a band  40 . The cap  38  includes a threaded socket  38 A for releasably mounting the piercing member therein and holding it in the retracted position like shown in  FIG. 6 . The cap is a hollow member which includes a threaded socket  38 A centered on its longitudinal axis for releasably mounting the piercing member therein and holding it in the retracted position like shown in  FIG. 6 . The band  40  is a ring-like structure that includes an annular recess  40 A extending about its inner periphery adjacent its lower end. The recess  40 A is configured to receive the heretofore identified annular ridge  36  of the locking member  28  to temporarily hold the cap assembly  30  in place on the locking member in the retracted or up state shown in  FIG. 6 . 
     The band  40  is removable (i.e., releasably secured to the cap  38 ) so that once the band is removed the cap  38  can be moved (e.g., pushed) from the up or retracted position shown in  FIG. 6  to a down or extended position (not shown) wherein the piercing tip  32 A of the piercing member has pierced through the stopper  24 . To that end, as best seen in  FIGS. 1, 2, 3 and 6  the band  40  is releasably secured to the bottom of the cap  38  by frangible (e.g., perforated) line  42  extending about the entire periphery of the cap. The lower edge of the band  40  is in the form of a downwardly projecting tab  44  ( FIGS. 1-3 ). A second frangible (e.g., perforated) line  46  extends perpendicularly to the frangible line  42  from the lower edge of the band  40  to the frangible line  42  immediately beside the tab  44 . Hence one can grasp and pull on the tab  44  to cause the frangible lines  46  and  42  to break, thereby removing the band  40  from the cap  38 . 
     As best seen in  FIG. 6 , the top edge  28 F of the sidewall  28 A of the locking member is slightly bulbous and is received within a correspondingly shaped recess  38 B in the inner periphery of the cap  38 . The recess  38 B is located at approximately the mid-height of the cap assembly  30 . Accordingly, after the band  40  is removed the cap  38  is still held in the retracted position by the bulbous edge  28 F received with the recess  38 B such as shown in  FIG. 6 . However, the application of a force onto the top of the cap  38  will cause the sidewall of the cap  38  to bow slightly outward whereupon the recess  38 A will release the ridge, thereby enabling the cap to be moved downward towards the retainer member to the extended position. In that position or state (not shown) the piercing member pierces the stopper  24  so that its tip  32 A is within and in fluid communication with the interior  22 A of the vial  22 . 
     As mentioned earlier the piercing member  32  is held within the cap by means of its threaded portion  32 B being screwed into the socket  38 A. When the cap  38  is moved downward to the extended position the flange  32 C of the piercing member slides over the cam surfaces at the top of the tabs  34 , whereupon the tabs flex outward to allow the periphery of the flange to pass thereover and into the undercut portions of the tabs, whereupon the tabs flex back to trap the flange between them and the upper surface of the ledge  28 B with the teeth  28 D of the ledge  28 B being received within corresponding recesses  32 D of the flange. This action holds the piercing member in place so that its hollow piercing tip extends into the interior of the vial to provide access to the vial&#39;s contents. Once that action has occurred it is necessary to remove the cap  38  from the system  20  to provide access to the hollow interior of the threaded portion  32 B of the piercing member so that a syringe (not shown) or some other instrument, e.g., a catheter, (not shown) can be connected to the piercing member to withdraw the contents of the vial into that syringe or other instrument through the piercing member. 
     The removal of the cap is achieved by unscrewing it with respect to the piercing member. The disposition of the teeth  28 D of the locking member within the recesses  32 D in the flange prevent the rotation of the piercing member as the cap is unscrewed from the piercing member. Thus, the cap can be unscrewed from the piercing member, while the piercing member is held stationary with respect to the locking member and hence with its piercing tip within the interior of the vial. 
     The hollow interior of the piercing member at the portion  32 B can be in the form of a Luer fitting or some other conventional connector to enable a syringe or other instrument to be connected to the piercing member. As mentioned earlier the piercing tip is a hollow pointed member. Thus, after the syringe or other instrument has been connected to the piercing member and operated the flowable contents of the vial can flow (i.e., be withdrawn) into the open end of the piercing tip, through its hollow interior and into the interior of the threaded portion  32 B from whence the contents can flow into the syringe or other instrument. 
     It should be pointed out at this juncture that the capping system of this invention can be used in the same ways as described in the prior application. In addition, since the capping system of this invention in and of itself provides a means for gaining access to the sealed vial&#39;s contents it offers additional advantages to the pharmaceutical and medical fields. 
     It should also be pointed out that the capping system subject invention can be used for liquid fills, as well as freeze dried applications, allowing the closed container to leave a sterile environment with proven seal integrity and be handled in a non-classified environment. It could be made available in various finish sizes and the piercing member could be designed to fit with a variety of devices for administration. 
     Without further elaboration the foregoing will so fully illustrate my invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.