Patent Publication Number: US-2022226572-A1

Title: Plastic Flange for a Medical Container, Medical Container Including This Plastic Flange, and a Method for Manufacturing This Medical Container

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is the United States national phase of International Application No. PCT/EP2020/067527 filed Jun. 23, 2020, and claims priority to European Patent Application No. 19305879.9 filed Jun. 28, 2019, the disclosures of which are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present invention relates to a plastic flange for a medical container, a medical container including this plastic flange, and a method for manufacturing this medical container. 
     Description of Related Art 
     In this application, the distal end of a component or of a device is to be understood as meaning the end furthest from the user&#39;s hand and the proximal end is to be understood as meaning the end closest to the user&#39;s hand. Likewise, in this application, the “distal direction” is to be understood as meaning the direction of injection, with respect to a medical container of the invention, and the “proximal direction” is to be understood as meaning the opposite direction to said direction of injection, that is to say the direction towards the user&#39;s hand holding a container as for an injection operation. 
     Injection devices, for example pre-fillable or prefilled syringes, usually comprise a hollow body or barrel forming a container for a medical product. This body comprises a distal end, usually provided with a needle, and a proximal end, provided with a flange allowing a user to place his or her fingers so as to exert a proximal pressure onto this flange. 
     There is an increasing need for individual traceability of the medical containers, such as injection devices, from the manufacturing process until at least the final use of said medical containers, typically the medical product injection. 
     It is known for example from document WO2017157784 a receptacle having a cylindrical lateral surface surrounded by a sequence of printed machine-readable unique identifier codes. These printed unique identifier codes allow tracking and tracing of each receptacle along a supply chain. However, these unique identifier codes are printed on an external side of the receptacle so that they may be removed or damaged for example during handling or use of the receptacle. Moreover, the unique identifier codes cover a portion of the receptacle so that they may have an impact on a customer visual inspection process. 
     It is further known from document U.S. Pat. No. 8,872,870 a method for glass-marking, wherein an array of readable marks may be formed by a laser on the external surface of a glass tube, for example for tracking purposes. However, the downsides of any laser marking methods are a possible damage to the glass material and an expensive manufacturing process. Besides, the laser-written array of mark requires having a visual access to the glass tube so as to be read, so that the reading operation cannot occur at any time. The laser-written array of mark may further have an impact on a customer visual inspection process. 
     It is further known from document WO2014114938A2 an RFID tag for location inside a tubular base portion of a freestanding cryogenic vial. The document US2011199187A1 discloses an RFID tag inserted into a recess at the bottom of a vial. The document US2010102967A1 discloses a container lid with a removable RFID tag. It is known from document US2008149584A1 a product packaging that comprises a cap on a transparent bottle, where the cap includes an RFID chip and antenna. The document WO2008057150A1 further discloses a container that includes an RFID insert having a disable feature. 
     In this context, an object of the present invention is to provide a plastic flange that alleviates the above-mentioned drawbacks by allowing easy individual identification of a medical container from the first step of the manufacturing step to the final use, typically the injection, or disposal step, with no impact on visual inspection and with few or no risks of being removed or damaged. 
     SUMMARY OF THE INVENTION 
     An aspect of the invention is a plastic flange for a medical container, said plastic flange defining an opening, said opening being surrounded by a peripheral collar, said collar providing a support to a user&#39;s fingers, wherein the flange comprises connecting means for connecting said flange to an external surface of a tubular barrel of the medical container, and wherein the flange further comprises a remotely readable electronic component for remote identification of the medical container, said remotely readable electronic component being at least partially embedded into the plastic flange. 
     By electronic component embedded in the plastic flange it should be understood that the plastic flange fully or at least partially encases the electronic component, so that the electronic component is protected from the external environment and therefore cannot be damaged or removed. 
     By remotely readable electronic component for identification of the medical container it is meant that the electronic component comprises electronically stored information that may be remotely read by a reading machine, such as a RFID reader, enabling identification of the medical container to which the flange of the invention is intended to be assembled. 
     The plastic flange of the invention thus allows having an individual traceability of each medical container from the manufacturing step to the final use of the medical container or to the disposal of said medical container. Besides, because the electronic component is at least partially encased in the plastic flange, it is protected from removal or external damage that may occur due to the packaging, sterilization, storing, distribution or the use of the medical container. Furthermore, the electronic component being located inside the flange, there is no impact on customer visual inspection process. It is also contemplated that the electronic component permits remote and therefore easy identification of the medical container. The electronic component does not require a direct visual perspective from a reading machine so that the reading may occur at any time without a need to unpackage the medical container. Moreover, the electronic component is integrated inside the flange so that there is advantageously no additional thickness to the medical container barrel, and thus no change is required regarding the packaging or storing of the medical container. Due to the connecting means, the flange of the invention may be advantageously mounted on a glass medical container so that the flange of the invention allows reliable and easy identification of a glass medical container without the drawbacks of the state of the art. 
     In a preferred embodiment, the remotely readable electronic component is selected from the group consisting of a RFID tag, a ultra wide-band real-time location system (RTLS), a wifi RTLS and an infrared RTLS. Advantageously, the remotely readable electronic component is a RFID tag including a RFID chip and a RFID antenna. Preferably, the RFID antenna extends around the opening. 
     Preferably, the plastic flange is connected to the tubular barrel by glueing, screwing or fitting. 
     Preferably, the connecting means comprise a plurality of bumps radially protruding from an inner lateral wall of the flange and configured to abut against the external surface of the tubular barrel. 
     This permits to maintain the flange perpendicular to the tubular barrel. 
     Preferably, the plurality of bumps comprises proximal blocking surfaces configured to abut against a bead of the tubular barrel. 
     This allows preventing movement of the barrel from the flange in a distal direction when the medical device is used for injection of a medical or pharmaceutical composition and thus maintain the barrel secured to the flange. 
     Preferably, the connecting means comprise a distal shoulder configured to receive a proximal end of the tubular barrel and arranged opposite the proximal blocking surfaces. 
     Thus, the tubular barrel is axially blocked relative to the flange. 
     Preferably, adjacent bumps of said plurality of bumps define an axial channel configured to be filled with a glue material. 
     This permits the addition of a glue material between the flange and the tubular barrel in order to prevent any rotational movement of the flange relative to the barrel. 
     Preferably, the connecting means comprise at least one circular channel configured to establish a fluid connection between adjacent axial channels. 
     This permits the glue material to flow in all filling rooms at once in order to perform the glue distribution in a single operation. 
     The circular channel may extend between the distal shoulder and the plurality of bumps. 
     The RFID tag may advantageously be overmolded in the plastic flange. 
     Preferably, the remotely readable electronic component is totally overmolded in the plastic flange. Alternatively, the remotely readable electronic component is embedded between the plastic flange and the glue material. 
     This results in no change in the flange dimensions with regard to standard flange dimensions so as to avoid investment costs. 
     The RFID tag may be molded in a two-shot injection molding process. More particularly, the RFID tag is positioned as an insert into the mold. A first part of the flange is formed by a first injection of a plastic material and partially covers the RFID tag. A second part of the flange, that totally encapuslates the RFID tag together with the first part, is then formed by a second injection step of a plastic material that may be the same plastic material as the first part or a different plastic material. 
     The RFID tag may be substantially arranged at the middle of the plastic flange. 
     Another aspect of the invention is a medical container comprising: 
     a tubular barrel for receiving a medical product, 
     a plastic flange as above described, said plastic flange protruding from an external surface of said barrel so as to provide a user&#39;s fingers support. 
     Preferably, the tubular barrel is made of a glass material. 
     Another aspect of the invention is a method for manufacturing a medical container as above-described, said method comprising the steps of:
         providing a plastic flange as above-described,   providing the tubular barrel,   connecting the plastic to the tubular barrel by means of the flange connecting means.       

     Preferably, the method comprises at least one step chosen among the following steps:
         distributing a glue material between the flange and the tubular barrel;   screwing the flange onto the external surface of the tubular barrel; or   snap fitting the flange onto the external surface of the tubural barrel.       

    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
       The invention and the advantages arising therefrom will clearly emerge from the detailed description that is given below with reference to the appended drawings as follows: 
         FIG. 1  is a perpestive view of a medical container having a flange according to the invention, 
         FIG. 2  is a side section view of a flange according to the invention receiving the barrel of a medical container, 
         FIG. 3  is a perspective view of a flange according to the invention, 
         FIG. 4  is a partial perspective view of a flange according to the invention receiving the barrel of a medical container, 
         FIG. 5  is a partial side section view of a flange according to the invention receiving the barrel of a medical container, 
         FIG. 6  is a partial perspective section view of a flange according to the invention receiving the barrel of a medical container, 
         FIG. 7  is a partial perspective section view of a medical container having a flange according to the invention, 
         FIG. 8  is a partial side section view of a medical container having a flange according to the invention. 
     
    
    
     DETAILED DESCRIPTION 
     With reference to  FIGS. 1, 2 and 3  is shown a plastic flange  1  according to the invention. As visible on  FIGS. 1 and 2 , the plastic flange  1  is designed to be mounted on a medical container  2 , such as a syringe. The medical container  2  may comprise a tubular barrel  20  that defines a reservoir for containing a medical product. As shown on  FIG. 1 , the tubular barrel  20  may have a distal end  20   a  including a preferably tapered distal tip  21  defining an axial passageway  22  in fluid communication with the reservoir. The distal tip  21  may allow mounting of an adaptor or a needle thereof. As shown on  FIG. 2 , the tubular barrel  20  includes a proximal end  20   b  that defines an aperture  25  for receiving a plunger rod (not shown). Said proximal end  20   b  may present a circular bead  23  that protrudes from an external lateral surface  24  of said tubular barrel  20 . It should be noted that the flange  1  is made of a plastic material, preferably a hard plastic material such as polycarbonate, polypropylene or cyclic olefin copolymer (COC), while the medical container  2  may be made of a glass material. In an embodiment not shown, the flange  1  may comprise two or more different plastic materials. 
     With reference for example to  FIG. 1 , the plastic flange  1  comprises a remotely readable electronic component  3  for remote identification of the medical container  2  by means of a remote reading machine. Advantageously, the remotely readable electronic component  3  is a RFID tag for identification of the medical container  2 , preferably a passive RFID tag. The RFID tag may be a passive RFID tag. The RFID tag may be read by a RFID reader, without requiring a direct pespective view on the plastic flange  1 . The RFID tag is located within the collar  10  of the plastic flange  1 . The RFID tag may be substantially arranged at the middle of the plastic flange  1  width. The RFID tag includes a RFID chip  31  and a RFID antenna  32 . The RFID chip  31  may at least include a storage unit that stores a unique device identification (UDI), allowing the identification of the medical device. The RFID antenna  32  may extend all around an opening  11  of the plastic flange  10 , as visible on  FIG. 1 . 
     The RFID tag may be partially or completely embedded into the plastic flange  1 , so as to be protected from the outside environment. When assembled to the medical container  2 , the plastic flange  1  preferably completely encases the RFID tag. For example, the RFID tag may be either totally encased in the sole collar  10  of the plastic flange  1  or totally encased by the collar  10  plus a glue material  30  that fixes the plastic flange  1  to the tubular barrel  20 . 
     The RFID tag may advantageously be overmolded within the plastic flange  1 . 
     For example, the RFID tag is molded in a two-shot injection molding process. More particularly, the RFID tag is positioned as an insert into the mold. A first part of the flange is formed by a first injection of a plastic material. A second part of the flange, that encapuslates the RFID tag together with the first part, is then formed by a second injection step of a plastic material that may be the same plastic material as the first part or a different plastic material. 
     Preferably, the RFID tag is totally overmolded in the plastic flange  1 . Alternatively, the RFID tag is partially overmolded in the plastic flange  1  (for example, a portion of the RFID tag may be flush with a surface of the plastic material of the flange  1 ) and then completely embedded into the plastic flange  1  by addition of the glue material  30  that fully covers the RFID tag, the glue material  30  thus directly being in contact with the RFID tag. 
     As shown on  FIG. 3 , the plastic flange  1  comprises a collar  10  that defines the central opening  11 . The collar  10  has a proximal face  10   b  and an opposite distal face  10   a,  as visible on  FIG. 2 . Said distal face  10   a  is designed to provide a support to a user&#39;s fingers when the medical container  2  is being used for example for an injection operation. The collar  10  may have a peripheral rim formed by two parallel edges  10   c  connected by two curved edges  10   d.  In another embodiment (not shown), the peripheral rim may be totally circular. The opening  11  is configured to allow insertion of the tubular barrel  20  of the medical container  2  as will be hereinafter described in further detail. As shown on  FIG. 2 , the opening  11  may be centered around a longitudinal axis A of the medical container  2 . 
     The plastic flange  1  may further define a through-aperture  12  that is configured to be superimposed to the aperture  25  of the tubular barrel  20  so as to allow passage of a plunger rod into the reservoir. The through-aperture  12  and the opening  11  of the flange may be coaxial. The through-aperture  12  may be centered around the longitudinal axis A of the medical container  2 . As shown on  FIG. 3 , the through-aperture  12  may have a lower diameter than the opening  11  of the flange  1 , thereby defining a distal shoulder  14  that separates the opening  11  and the through-aperture  12  of the flange  1 . The through-aperture  12  is proximally located relative to the opening  11  of the flange. The plastic flange  1  may present a proximal bevelled edge  15  that may be provided on the proximal face  10   b  of the collar and that surrounds the through-aperture  12 , as visible for example on  FIG. 2 . 
     The flange  1  comprises connecting means, said connecting means being configured to connect the flange  1  to an external surface of the tubular barrel  20  of the medical container  2 . The connecting means are preferably located inside the opening  11  of the flange  1 . 
     As shown on  FIG. 3 , the connecting means may comprise a plurality of bumps  16  radially protruding from an inner lateral wall  17  of the flange  1 . The inner lateral surface  17  may delimit the opening  11 . The bumps  16  are configured to abut against the external lateral surface  24  of the tubular barrel  20 , as illustrated for example on  FIG. 4 . The bumps  16  may be regularly angularly distributed around the longitudinal axis A and preferably inside the opening  11 . The connecting means comprise at least one, preferably two bumps  16 . In the illustrated embodiment, the connecting means comprise six bumps  16 . They may otherwise comprise three, four, five or more, bumps  16 . 
     As shown on  FIG. 5 , the bumps  16  may include a radial abutment surface  160  that is configured to abut against the external surface  24  of the tubular barrel  20 . The diameter that define said radial abutment surface  160  may be lower than the external diameter of the tubular barrel  20  so that the bumps  16  are configured to exert a radial pressure against the external surface  24  of the tubular barrel  20 . To that end, the flange or the bumps  16  may be made of a resilient material. The radial abutment surfaces  160  may be flat or may preferably have a shape that is complementary to the shape of the external lateral surface  24  of the tubular barrel  20 , such as a cylindrical shape. 
     Still with reference to  FIG. 5 , the bumps  16  may comprise a proximal blocking surface  162  that is configured to block a distal movement of the tubular barrel  20  relative to the flange. For example, the blocking surfaces  162  abut against the bead  23  provided at the proximal end of the end. As visible on  FIG. 5 , the proximal blocking surfaces  162  may be slanted relative to a longitudinal axis A of the medical container  2 . The proximal blocking surfaces  162  are proximally arranged relative to the first radial abutment surfaces  160 . 
     The bumps  16  may define a radial recess  164  configured to receive a corresponding protruding portion of the tubular barrel  20 , such as the bead  23  of said tubular barrel  20 . The recesses  164  have a bottom abutment surface that may be configured to abut against the tubular barrel  20  so as to limit a pivot movement of the tubular barrel  20  relative to the flange  1  around an axis that is orthogonal to the longitudinal axis A. The bottom abutment surfaces may define a diameter that is greater than that defined by the above-described radial abutment surfaces  160 . The recesses  164  may have a shape that is complementary to a shape of the external lateral surface  24  of the tubular barrel  20 . The recesses  164  and their bottom abutment surfaces are proximally located relative to the proximal blocking surfaces  162 . 
     As shown on  FIG. 5 , the proximal end  20   b  of the tubular barrel  20  abuts against the distal shoulder  14  so that the distal shoulder  14  blocks a proximal movement of the tubular barrel  20  relative to the flange  1 . The distal shoulder  14  may be flat and preferably orthogonal to the longitudinal axis A. The distal shoulder  14  faces the proximal blocking surfaces  162  of the bumps  16 . 
     As illustrated on  FIG. 4 or 6 , adjacent bumps  16  may define therebetween an axial channel  18  that is configured to be filled with the glue material  30 . At least one of the axial channels  18  may have a distal open end  180  allowing entry of said glue material  30 . The axial channels  18  may longitudinally extend along the longitudinal axis A and laterally extend around said longitudinal axis A. The axial channel  18  may have a cylindrical shape. The axial channel  18  is indeed delimited by lateral walls  168  of the bumps  16 , the inner lateral surface  17  of the flange  1 , and the external surface  24  of the tubular barrel  20 . 
     The glue material  30  may be chosen between a hol-melt adhesive and glue, for example glue with an acrylate base 
     As shown on  FIGS. 3, 5 and 8 , the connecting means may further comprise at least one circular channel  166  establishing a fluid communication between at least two adjacent axial channels  18 . The circular channels  166  may interconnect the axial channels  18  all together so as to allow the glue material  30  to flow in all spaces located between the external surface  24  of the tubular barrel  20  and the flange  1 . The circular channel  166  may be formed by a groove arranged between the distal shoulder  14  and the bumps  16 , and may be proximally located relative to the recesses  164  of said bumps  16 . For example, the circular channel  166  is a groove defined in the bumps  16  or in the distal shoulder  14  or in the inner lateral surface  17  of the flange  1 . 
     It should be noted that the connecting means may alternatively comprise snap-fit, press-fit or thread elements in order to position or secure the flange to the tubular barrel  20 . The plastic flange  1  may thus be connected to the tubular barrel  20  by gluying, screwing or fitting. 
     The invention also relates to the medical container  2  comprising the tubular barrel  20  for receiving a medical product, and the above-described plastic flange  1  protruding from an external lateral surface of said tubular barrel  20 , wherein the tubular barrel  20  is made of a glass material, the tubular barrel  20  and the plastic flange  1  being secured together by the connecting means. 
     The invention also relates to a method for manufacturing said medical container  2 , wherein the method comprises the steps of providing a plastic flange  1  as above-described which comprises the remotely readable electronic component  3 , providing the tubular barrel  20 , and connecting the plastic flange  1  to the tubular barrel  20  by means of the flange connecting means. 
     The step of providing the plastic flange  1  may include overmolding the remotely readable electronic component  3 , for example during a two-shot injection molding process. 
     The step of connecting the plastic flange  1  to the tubular barrel  20  may include distributing a glue material  30  between the flange  1  and the tubular barrel  20 , or screwing the flange  1  onto the external lateral surface  24  of the tubular barrel  20 , or snap fitting the flange  1  onto the external lateral surface  24  of the tubural barrel  20 .