Patent Description:
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's hand and the proximal end is to be understood as meaning the end closest to the user'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's hand holding a container as for an injection operation.

Medical devices, for example injection devices such as pre-fillable or prefilled syringes, usually comprise a hollow body or barrel forming a container for a medical product. This body comprises 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, and a distal end, usually provided with a needle, said distal end being in the form of a longitudinal tip defining an axial passageway through which the medical product is expelled from the container. However, this longitudinal tip does not allow parenteral administration by itself and must either comprise a staked needle or an adaptor allowing the connection of the syringe to a connector such as a needle hub or an intravenous (IV) line. Basically, adaptors may be secured around the longitudinal tip of the syringe by gluing, screwing, snap-fitting or friction force. The connector is then mounted on the adaptor, for example by screwing.

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 <CIT>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 <CIT> 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.

Document <CIT> further discloses an injection site information cap. Document <CIT> discloses a medical device hose connector, for connecting a respiration hose to a respiration device, that has electronic data storage element embedded between plastic parts that are cast together.

In this context, an object of the present invention is to provide an adaptor 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.

An aspect of the invention is an adaptor for a medical container having a distal tip, said adaptor comprising:.

By electronic component embedded in the adaptor it should be understood that the material of the adaptor 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 configured to allow remote 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 adaptor of the invention is intended to be assembled.

The adaptor of the invention thus allows having an individual traceability of each medical container from the first steps of 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 adaptor, 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 adaptor, 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 adaptor so that there is advantageously no additional thickness to the usually used adaptor or to the medical container barrel, and thus none change is required regarding the packaging or storing of the medical container.

According to the invention, the remotely readable electronic component is a RFID tag. Other technical solutions which are not claimed, are an ultra wide-band real-time location system (RTLS), a wifi RTLS and an infrared RTLS. According to the invention, the remotely readable electronic component is a RFID tag including a RFID chip and a RFID antenna, said RFID antenna preferably extending around a through-opening of the adaptor.

According to the invention, the remotely readable electronic component is flush with an inner surface of the adaptor, specifically with an inner surface of the proximal part of the adaptor.

This limits the risks that the remotely electronic component be damaged by the outside environment before adding the glue material. This also enables to mold the adaptor by one-shot molding.

The proximal part has an inner surface that defines at least one annular space configured to accommodate a glue material, and said remotely readable electronic component is arranged so as to be covered by said glue material.

As a result, the remotely readable electronic component is embedded between the adaptor and the glue material. This enables to reduce manufacturing costs while efficiently protecting the remotely readable electronic component.

Accordingly, the adaptor is configured to be secured to the medical container by gluing.

Preferably, the remotely readable electronic component is completely located within the proximal part of the adaptor.

Preferably, the inner surface of the proximal part is provided with protrusions, and the RFID chip is located between two of said protrusions.

This limits the risk that the RFID chip be broken due to the pressure during the injection process.

The protrusions may divide the at least one annular space into several cavities.

The proximal part comprises an annular ring, and the RFID antenna is located in this annular ring.

The annular ring may be provided at a distal end of the at least one annular space.

The remotely readable electronic component is fully embedded in the adaptor.

This results in no change in the adaptor dimensions with regard to standard adaptor dimensions so as to avoid investment costs. In this embodiment, the adaptor is molded via a two-shot injection molding process.

When the remotely readable electronic component is fully embedded in the adaptor, said adaptor is configured to be secured to the medical container by gluing, press-fitting screwing or snap-fitting.

Another aspect of the invention is a medical container comprising a distal tip and an adaptor as above-described, said adaptor being mounted onto the distal tip of said medical container.

Preferably, the adaptor is secured to said distal tip by means of a glue material and the remotely readable electronic component of the adaptor is embedded between the adaptor and said glue material.

Alternatively, the adaptor is secured to said distal tip by press-fit, snapping or screwing means and the remotely readable electronic component of the adaptor is fully embedded within the adaptor.

Another aspect of the invention is a method for manufacturing a medical container as above-described, said method comprising the steps of:.

Preferably, the method comprises at least one step chosen among the following steps:.

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:.

With reference to <FIG> is shown an adaptor <NUM> according to an embodiment of the invention. The adaptor <NUM> is intended to be mounted onto a distal tip <NUM> of a medical container <NUM>, as shown on <FIG>, more precisely onto an outer surface <NUM> of said distal tip <NUM>. The outer surface <NUM> may be either cylindrical or distally tapered.

The adaptor <NUM> comprises a proximal part <NUM>, which may be in the form of a mounting ring, configured to be secured to the medical container <NUM>, and a distal part <NUM>, which may be in the form of a connecting ring, configured to receive a connector (not shown), such as a needle hub or an intravenous (IV) line, in order to establish a reliable fluid communication between a passageway <NUM> of the distal tip <NUM> and said connector. The distal part <NUM> thus includes connecting means, such as an internal thread <NUM>, in order to secure the connector to the distal tip <NUM>. The connecting means may alternatively comprise a bayonet element, a snapping element or a press-fit element.

With reference to <FIG>, the adaptor <NUM> comprises a remotely readable electronic component <NUM> for remote identification of the medical container <NUM> by means of a remote reading machine. The remotely readable electronic component is a RFID tag <NUM>, preferably a passive RFID tag <NUM>. The RFID tag <NUM> may be read by a RFID reader, without requiring a direct pespective view on the adaptor <NUM>.

With reference to <FIG>, the RFID tag <NUM> includes a RFID chip <NUM> and a RFID antenna <NUM>. The RFID chip <NUM> may include at least a storage unit that stores a unique device identification (UDI), allowing the identification of the medical container <NUM>.

The RFID tag <NUM> may have some or all of the following dimensions: an overall height H comprised between <NUM> and <NUM>, for example of about <NUM>; an antenna height h comprised between <NUM> and <NUM>, for example of about <NUM> ; an antenna width w comprised between <NUM> and <NUM>, for example of about <NUM> ; an antenna outside diameter comprised between <NUM> and <NUM>, for example of about <NUM> ; a RFID chip comprised between <NUM> x <NUM> and <NUM> x <NUM>, for example of about <NUM> x <NUM>.

The remotely readable electronic component <NUM> is overmolded in the adaptor <NUM>.

The remotely readable electronic component <NUM> is at least partially embedded into the adaptor <NUM>.

In a first embodiment, the remotely readable electronic component <NUM> is partially embedded in a material of the adaptor <NUM>, for example during a one shot injection process. In this first embodiment, the remotely readable electronic component <NUM> is intended to be then covered by a glue material <NUM>. As a result, the remotely readable electronic component <NUM> is thus partially embedded in the material of the adaptor <NUM>, but howeverfully embedded between the adaptor <NUM>, the glue material <NUM>, and if needed the distal tip <NUM> of the medical container <NUM>. According to this embodiment, the remotely readable electronic component <NUM> is preferably completely located in the proximal part <NUM> of the adaptor <NUM>. Advantageoulsy, when the remotely readable electronic component <NUM> is a RFID tag <NUM> comprising a RFID chip <NUM> and an antenna <NUM>, the chip <NUM> is fully embedded between the adaptor <NUM> and the glue material <NUM>, while the antenna <NUM> may be left uncovered by the glue material <NUM>, so that the antenna <NUM> contacts the distal tip <NUM> of the medical container <NUM> and is thus embedded between the adaptor <NUM> and the distal tip <NUM> of the medical container <NUM> when the adaptor <NUM> is mounted onto said distal tip <NUM>. The antenna <NUM> may or may not be in contact with the glue material <NUM>.

The glue material may be chosen between a hol-melt adhesive and glue, for example glue with an acrylate base.

In a second embodiment, the remotely readable electronic component <NUM> is fully embedded into the material of the adaptor <NUM>. For instance, the remotely readable electronic component <NUM> may be overmolded in a two-shot injection process. More particularly, the remotely readable electronic component <NUM> is positioned as an insert into the mold. A first part of the adaptor <NUM> is formed by a first injection of a material and covers partially the remotely readable electronic component <NUM>. A second part of the adaptor <NUM>, that encapuslates totally the remotely readable electronic component <NUM> together with the first part, is then formed by a second injection step of a material that may be the same material as the first part or a different material. According to this embodiment, the remotely readable electronic component <NUM> may be located into the proximal part <NUM> and/or the distal part <NUM> of the adaptor <NUM>.

Finally, in both of said first and second embodiments, when the adaptor <NUM> is mounted onto the distal tip <NUM> of the medical container <NUM>, the remotely readable electronic component <NUM>, especially the chip <NUM> of the RFID tag <NUM>, is fully embedded, either between the adaptor <NUM>, the glue material <NUM> and/or the distal tip <NUM> of the medical container <NUM>, or in the sole adaptor <NUM>. The remotely readable electronic component <NUM> is thus protected from the outside environment. For instance, the adaptor <NUM> or medical container <NUM> may therefore be submitted to a sterilization process without damaging the remotely readable electronic component <NUM>.

The adaptor <NUM> defines a central through-opening <NUM> extending through the proximal and distal parts <NUM>, <NUM> along a longitudinal axis A. Said through-opening <NUM> defines a proximal portion and a distal portion, the proximal portion being configured to receive the distal tip <NUM>, and the distal portion being configured to receive both the distal tip <NUM> and the connector connected around the distal tip <NUM>. Therefore, the distal portion has a greater diameter than that of the proximal portion.

As shown on <FIG> and <FIG>, the RFID antenna <NUM> preferably extends around the through-opening <NUM> of the adaptor <NUM>. As visible on <FIG>, the RFID antenna <NUM> extends all around the through-opening <NUM>.

With reference to <FIG>, the proximal part <NUM> comprises an annular ring <NUM> provided at a distal end of said proximal part <NUM>. The annular ring <NUM> protrudes radially inwardly. Said annular ring <NUM> may define a distal shoulder <NUM> that separates the proximal and distal parts <NUM>, <NUM>. As shown on <FIG>, the annular ring <NUM> may further define a proximal shoulder <NUM> which is intended to serve as a stop for a glue material as will be described in further detail below.

As shown on <FIG> or <FIG>, the RFID antenna <NUM> is located in this annular ring <NUM>.

The proximal part <NUM> comprises an inner surface <NUM> that may be provided with securing means in order to secure said proximal part <NUM> onto the outer surface <NUM> of the distal tip <NUM>.

The securing means may comprise an annular space <NUM> configured to receive a glue material <NUM> in order to bond the adaptor <NUM> to the distal tip <NUM>. The annular space <NUM> is delimited by the inner surface <NUM> of the proximal part <NUM>, the annular ring <NUM>, especially its proximal shoulder <NUM>, and the outer surface <NUM> of the distal tip <NUM> when the adaptor <NUM> is mounted on the medical container <NUM>. The annular space <NUM> may have an open proximal end to let in the glue material <NUM>, while having a distal end which may be closed by the annular ring <NUM>.

Preferably, the remotely readable electronic component <NUM>, more precisely the RFID chip <NUM>, partly delimits the annular space <NUM>. The remotely readable electronic component <NUM> is substantially flush with the inner surface <NUM> of the proximal part <NUM>, as illustrated on <FIG>. By a remotely readable electronic component <NUM> that is flush with the inner surface <NUM> it is meant that a part of said electronic component <NUM> is arranged at the same level as the inner surface <NUM> or may slightly protrude or form a recess with regard to said inner surface <NUM>. The readable electronic component <NUM> is thus arranged so as to be covered the said glue material <NUM> received in the annular space <NUM>.

The securing means may comprise one or several protrusions that may be in the form of longitudinal ribs <NUM> which may extend parallel to the longitudinal axis A. the longitudinal ribs <NUM> may be regularly distributed around on the circumference inner surface <NUM>. The longitudinal ribs <NUM> may extend, preferably continuously, on the whole length of the inner surface <NUM>. The longitudinal ribs <NUM> may contact the annular ring <NUM> or may be spaced from the annular ring <NUM>. At least one of the longitudinal ribs <NUM> and the annular ring <NUM> may be in contact with the outer surface <NUM> of the distal tip <NUM> in order to increase the interference between the proximal part <NUM> of the adaptor <NUM> and said distal tip <NUM>. The longitudinal ribs <NUM> may divide the annular space <NUM> into several cavities. For example, as illustrated on <FIG>, the proximal part <NUM> of the adaptor <NUM> comprises only three longitudinal ribs <NUM> in order to have an isostatic centering of the adaptor <NUM> onto the distal tip <NUM> of the medical container <NUM>. The three longitudinal ribs <NUM> divide the annular space <NUM> in three cavities. It should be noted that at least one of these cavities, preferably each cavity, has an open proximal end so as to let in the glue material <NUM>, while having a distal end which may be closed by the annular ring <NUM>.

With reference to <FIG>, the RFID chip <NUM> is preferably located between two of said longitudinal ribs <NUM>. The RFID chip <NUM> is thus preferably not embedded behind one of said protrusions. The RFID chip <NUM> may partly delimit one of the cavities formed by the longitudinal ribs <NUM>.

The adaptor <NUM> may be made of a plastic material, more precisely of any rigid polymer adapted to medical use, such as high density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and combinations thereof. Preferably, the adaptor <NUM> is made of polcarbonate (PC). To simplify its manufacturing, the adaptor <NUM> is preferably made of a single piece of material. The adaptor <NUM> may however comprise two different material, for example when the adaptor <NUM> is made in a two-shot injection process. Preferably, the adaptor <NUM> is made of a light-transmitting material.

With reference to <FIG>, the invention also relates to the medical container <NUM> which may be a syringe. Said medical container <NUM> comprises a tubular barrel <NUM> that defines a reservoir for a medical product. The tubular barrel <NUM> is provided with the distal tip <NUM> that may protrude from a distal shoulder <NUM>. The distal tip <NUM> may be cylindrical or distally tapered. The distal tip <NUM> includes an internal passageway <NUM> in communication with the reservoir. The tubular barrel <NUM> and the distal tip <NUM> are preferably made of glass. The medical container <NUM> may be provided with a piston and a plunger rod (not shown) so as to expel the medical product from the reservoir and through the passageway <NUM>.

The medical container <NUM> also comprises an adaptor <NUM> having some or all of the above-described features. The adaptor <NUM> has its proximal part <NUM> mounted onto the distal tip <NUM>.

In a preferred embodiment, the proximal part <NUM> of the adaptor <NUM> is secured to said distal tip <NUM> by means of the glue material <NUM>. The remotely readable electronic component <NUM> is accordingly embedded between the adaptor <NUM> and said glue material <NUM>. Due to this adhesive layer of glue material <NUM>, the adaptor <NUM> may be bonded around the distal tip <NUM> without any need for a groove or a ring on the outer surface <NUM> of the distal tip <NUM>. The distal tip <NUM> is thus devoid of such a groove or ring.

In another preferred embodiment, the proximal part <NUM> of the adaptor <NUM> may be secured to the distal tip <NUM> by press-fit, snapping or screwing means. The remotely readable electronic component <NUM> may be accordingly fully embedded within the adaptor <NUM>.

The invention also relates to a method for manufacturing this medical container <NUM>. The method comprises the steps of:.

As shown on <FIG>, the adaptor <NUM> may be connected onto the outer surface <NUM> of the distal tip <NUM>.

Besides, the step of connecting the adaptor <NUM> to the distal tip <NUM> may comprise at least one step chosen among the following ones:.

Claim 1:
An adaptor (<NUM>) for a medical container (<NUM>) having a distal tip (<NUM>), said adaptor (<NUM>) comprising:
- a proximal part (<NUM>) comprising an inner surface (<NUM>) configured to be secured onto an outer surface (<NUM>) of the distal tip (<NUM>) of the medical container (<NUM>),
- a distal part (<NUM>) configured to receive a connector,
- a glue material (<NUM>), and
- a remotely readable electronic component (<NUM>) which is a RFID tag (<NUM>), including a RFID chip (<NUM>) and a RFID antenna (<NUM>),
configured to allow remote identification of the medical container (<NUM>) when said adaptor (<NUM>) is secured to the medical container (<NUM>), said RFID tag (<NUM>) being overmolded with the adaptor (<NUM>) so as to be embedded into the adaptor (<NUM>), characterised in that the inner surface (<NUM>) defines at least one annular space (<NUM>) configured to accommodate the glue material (<NUM>), and said remotely readable electronic component (<NUM>) is flush with the inner surface (<NUM>) so as to be covered by said glue material (<NUM>), and wherein the proximal part (<NUM>) comprises an annular ring (<NUM>), the RFID antenna (<NUM>) being located in this annular ring (<NUM>).