Patent Description:
Various types of connectors for connecting two pieces of medical equipment to each other are known and available. Some known connectors are designed to be connected to a syringe and include a hollow spike for accommodating a syringe needle. The spike has a pointed tip that is used to penetrate a septum of a vial. The spike has a communication port at the tip in such a way that fluid communication is to be established between the internal volume of the vial and that of the syringe for transfer and/or reconstitution of medication to be discharged from the syringe. For example, <CIT> discloses a connector for connecting a medical injection device to a container by screwing a sleeve of the injection device into the connector at one end and connecting the container to the connector at another end.

Prior to use, the spike of such a connector often needs to be covered by a cap. For example, if the connector is used with a prefilled syringe, the communication port of the spike needs to be securely sealed during storage and transportation. Accordingly there is need for a connector assembly that can provide reliable sealing at a communication port formed in a spike.

The present invention has been made in view of the need as described above and thus provides a connector assembly that reliably seals a communication port formed at a tip of a spike.

According to the present invention, there is provided a connector assembly as defined in claim <NUM> of the appended set of claims. Other advantageous embodiments are defined in the corresponding dependent claims.

The present invention also discloses a connector assembly comprising an adaptor and a cap to be connected to each other, wherein the adaptor comprises: a proximal connection portion configured to be removably connectable to a medical injection device; and a spike extending distally from the proximal connection portion and around a central axis, wherein the cap comprises a cap body defining an inner cavity extending around the central axis, the inner cavity being open at a proximal end of the cap body and is closed at a distal end of the cap body, wherein the connector assembly is configured such that the cap is removably connected to the adaptor in such a way that the spike is accommodated within the inner cavity, and wherein the cap is removably connected to the adaptor by press-fit between the spike and the inner cavity.

According to one aspect of the disclosure, the cap may further include threads on an outer circumference of the cap body, the adaptor further including a flange extending distally from the proximal connection portion and radially outward of the spike around the central axis.

According to one aspect of the disclosure, the cap may further include a stopper disposed in a helical groove delimited by the threads, the engaging protrusion being formed with a locking groove configured to receive the stopper when the cap is connected to the adaptor.

According to one aspect of the disclosure, the cap body may have an outer circumference around the central axis, the outer circumference including at least one tooth in the form of a spiral, the adaptor further including a flange extending distally from the proximal connection portion and radially outward of the spike around the central axis.

According to one aspect of the disclosure, the adaptor may further include a rim extending around the central axis at a distance distally away from the flange, the cap further including a collar extending distally from the cap body and radially outward of the cap body around the central axis, the collar being configured to rest on the rim when the cap is assembled with the adaptor.

According to one aspect of the disclosure, the collar may have a ring shape.

According to one aspect of the disclosure, the adaptor may further include at least one retention barb extending proximally from the rim and being slanted toward the central axis, the retention barb being configured to be engageable with a vial that is to be removably connected to the adaptor.

According to one aspect of the disclosure, the cap may further include at least one locking claw configured to be engageable with the retention barb.

According to one aspect of the disclosure, the adaptor may further include at least one retention barb extending distally from the flange and being configured to be engageable with a vial that is to be removably connected to the adaptor.

According to one aspect of the disclosure, the at least one locking claw may have a forked tip. According to one aspect of the disclosure, the adaptor may further include a flange extending distally from the proximal connection portion and radially outward of the spike around the central axis, the flange including on its inner surface at least one support rib protruding radially inwardly.

According to the connector assembly disclosed herein, the secure sealing between the adaptor spike and the cap is maintained for an extended period of time. For use, the cap can be easily removed by rotating the cap around the central axis and then pulling the cap off the adaptor. Thus, handling of the connector assembly is also facilitated.

A variety of examples of connector assemblies will be described in further detail with reference to the accompanying drawings, in which:.

Referring to <FIG>, a connector assembly <NUM> according to one aspect of the disclosure will be explained. <FIG> is an exploded perspective view showing the connector assembly <NUM> together with a medical injection device <NUM>. <FIG> is a perspective view showing the connector assembly <NUM> connected to the injection device <NUM>.

The connector assembly <NUM> is configured to be removably connected to the injection device <NUM>. For example, the connector assembly <NUM> may be screwed into a barrel <NUM> of the injection device <NUM>. The connector assembly <NUM> may be used to cover a needle <NUM> of the injection device <NUM> in order to prevent possible contamination and/or needlestick injury. The injection device <NUM> may be any type of injection devices available, including but not being limited to a medical syringe, in particular a prefilled syringe.

As shown in <FIG>, when the connector assembly <NUM> and the injection device <NUM> are connected to each other, the connector assembly <NUM> and the injection device <NUM> are in axial alignment so as to extend around a common axis C (see <FIG> and <FIG>, for example). The common axis C is herein referred to as a "central axis" C. Herein, a direction pointing from the central axis C to its circumference is referred to as "radially outward" and a direction opposite to the radially outward is referred to as "radially inward".

The expression "proximal" or "proximally" refers to a point or a portion closer to the end of the connector assembly <NUM> where the injection device <NUM> is to be connected. The expression "distal" or "distally" refers to a point or a portion closer to another end of the connector assembly <NUM>.

The connector assembly <NUM> includes a cap <NUM> and an adaptor <NUM>. The adaptor <NUM> serves as a luer fitting adaptor configured to connect the injection device <NUM> to another medical equipment. The cap <NUM> serves as a luer fitting cap to be connected to the adaptor <NUM> to provide sealing. The adaptor <NUM> and the cap <NUM> are made of a plastic material suitable for injection molding, respectively. The adaptor <NUM> and the cap <NUM> may be made of the same material or of different materials. The material of which the adaptor <NUM> and/or the cap <NUM> is/are made may include, but is not limited to, polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS) or acrylic.

<FIG> and <FIG> show the adaptor <NUM> in different views rotated by <NUM> degrees around the central axis C. The adaptor <NUM> may include a proximal connection portion <NUM>, a flange <NUM>, a skirt <NUM> and a drug transfer channel such as a spike <NUM>.

The proximal connection portion <NUM> is formed at a proximal end of the adaptor <NUM> where the adaptor <NUM> is to be connected to the injection device <NUM>. The proximal connection portion <NUM> may be a generally tubular element extending around the central axis C and configured to be removably connected to the injection device <NUM>. The proximal connection portion <NUM> may be configured to be sealingly fitted onto a tip of the barrel <NUM> of the injection device <NUM>. For example, the proximal connection portion <NUM> may be threaded so as to be screwed onto the barrel <NUM> of the injection device <NUM>, said injection device <NUM> comprising a corresponding thread. The thread provided on the proximal connection portion <NUM> is provided on the outer surface of the proximal connection portion <NUM> of the adaptor <NUM>. The fitting between the adaptor <NUM> and the injection device <NUM> is preferably configured as luer-fitting.

The spike <NUM> extends distally from the proximal connection portion <NUM> around the central axis C. The spike <NUM> may have a generally cylindrical base and a generally conical tip extending distally from the cylindrical base. The spike <NUM> defines an inner channel <NUM> extending around the central axis C, adapted to accommodate the needle <NUM> of the injection device <NUM>. The spike <NUM> has a communication port <NUM> at or near its pointed distal tip, through which fluid communication with the internal volume of the injection device <NUM> is made possible. The spike <NUM> is connected to the proximal connection portion <NUM>.

The flange <NUM> may extend distally from the proximal connection portion <NUM> and radially outward of the spike <NUM>. The flange <NUM> may define a circular opening in such a way that the flange <NUM> and the spike <NUM> together define an annular gap <NUM> around the central axis C (see also <FIG>) where the cap <NUM> is to be received. The flange <NUM> may include a pair of opposite walls <NUM> and <NUM> whose outer surfaces diverge radially outward along the central axis C. The flange <NUM> may be open over a part of its circumference around the central axis C, i.e. having no wall over a part of the circumference. Alternatively, the flange <NUM> may also form a continuous wall all around the axis C.

The flange <NUM> may include engaging protrusions <NUM> protruding radially inward from the respective inner surfaces <NUM> of the opposite walls <NUM> and <NUM>. The engaging protrusion <NUM> may be formed with a locking groove (not shown). The flange <NUM> may include an undulating portion <NUM> on the outer surfaces of the opposite walls <NUM> and <NUM>. The undulating portion <NUM> may be ergonomically designed to provide a firm grip by a user who handles the adaptor <NUM>.

The skirt <NUM> may extend distally from the flange <NUM> and around the central axis C. At its distal end, the skirt <NUM> may include a rim <NUM> that defines a distal end of the adaptor <NUM>. The skirt <NUM> may include a plurality of columns <NUM> connecting the flange <NUM> and the rim <NUM> to each other. Accordingly between the columns <NUM> through holes are provided onto the skirt <NUM>.

The rim <NUM> delimits a circular opening <NUM> around the central axis C (see <FIG>, for example). The circular opening <NUM> is configured to be fitted onto a corresponding portion of the cap <NUM> when the cap <NUM> is assembled with the adaptor <NUM>; or to a corresponding portion of a vial when a vial is assembled with the adaptor <NUM>. The rim <NUM> may be situated at a position distally farther from the spike <NUM> to protect the needle <NUM> within the inner channel <NUM> of the spike <NUM>.

The skirt <NUM> may include at least one retention barb <NUM> extending proximally from the rim <NUM>. The retention barb <NUM> is slanted with respect to the central axis C so as to be oriented radially inward. The retention barb <NUM> is configured to be snap-fitted onto a vial that is to be connected with a medical device via the adaptor <NUM>, as described later in details. The skirt <NUM> may include two or more retention barbs <NUM> over its circumference around the central axis C.

The skirt <NUM> may also include at least one audible barb <NUM>. Similar to the retention barb <NUM>, the audible barb <NUM> extends proximally from the rim <NUM> and is slanted so as to be oriented radially inward. The audible barb <NUM> is thinner and longer than the retention barbs <NUM>. The audible barb <NUM> may extend farther toward the central axis C than the retention barb <NUM>. The audible barb <NUM> is configured to produce a sharp sound when the corresponding vial is fully inserted to the adaptor <NUM> as described later in details. The skirt <NUM> may include two or more audible barbs <NUM> over its circumference around the central axis C. The retention barbs <NUM> may be arranged alternately with the audible barbs <NUM> around the central axis C.

Turning to <FIG> and <FIG>, the cap <NUM> will be explained. <FIG> and <FIG> respectively show the cap <NUM> in different views rotated by <NUM> degrees around the central axis C. The cap <NUM> may include a cap body <NUM>, a collar <NUM> and a tab <NUM>.

The cap body <NUM> is formed with an inner cavity <NUM> extending around the central axis C (see <FIG>). The cavity <NUM> opens at a proximal end of the cap body <NUM> and configured to accommodate the spike <NUM> of the adaptor <NUM> when the cap <NUM> is connected to the adaptor <NUM>. The cavity <NUM> is closed at the opposite end, thereby allowing the communication port <NUM> to be sealed and preventing contamination of the needle <NUM> of the injection device.

The cap body <NUM> may have threads <NUM> at the proximal end of the cap <NUM>. The cap body <NUM> may be formed with a stopper <NUM> in the form of a protrusion disposed in a helical groove delimited by the threads <NUM>. The stopper <NUM> may be configured to be engaged with a locking groove of the adaptor <NUM>, e.g. a small recess formed on the engaging protrusion <NUM>, in order to prevent slipping off of the cap <NUM> from the connected position.

The collar <NUM> is configured to be engaged with the rim <NUM> of the adaptor <NUM>. The collar <NUM> may have a generally disk shape extending around the central axis C. The collar <NUM> has a greater diameter than the cap body <NUM>. The collar <NUM> may be delimited by a tapered circumference having a diameter that gradually decreases toward the proximal end.

The tab <NUM> may extend distally from the collar <NUM>. The tab <NUM> may be a generally flat, rectangular parallelepiped element. The tab <NUM> may be ergonomically designed to allow a user to firmly hold the cap <NUM> by two fingers.

Hereafter the process of connecting the cap <NUM> with the adaptor <NUM> to form the connector assembly <NUM> will be described.

As shown in <FIG>, the cap <NUM> and the adaptor <NUM> are brought in alignment around the central axis C. The cap <NUM> is then moved toward the adaptor <NUM> along the central axis C, or vice versa, whereby the cap body <NUM> is inserted into the adaptor <NUM> through the circular opening <NUM>. The cap <NUM> further advances so that the spike <NUM> enters the inner cavity <NUM> of the cap body <NUM> and the cap body <NUM> passes through the annular gap <NUM> around the spike <NUM>. Since the inner cavity <NUM> is designed to have a slightly smaller diameter than the outer diameter of the spike <NUM>, the cap body <NUM> is moved proximally with pushing force against friction.

Once the proximal end of the cap <NUM> reaches the engaging protrusions <NUM> of the adaptor <NUM>, the cap <NUM> is pushed farther and rotated around the central axis C in such a way that the advancement of the cap <NUM> is guided by engagement between the threads <NUM> and the engaging protrusions <NUM>. At the end of the insertion, the stoppers <NUM> of the cap <NUM> are received by the respective locking grooves of the engaging protrusions <NUM>, whereby the connection process of the cap <NUM> and the adaptor <NUM> is complete. The stoppers <NUM> and the corresponding locking grooves serve as a turn limit for preventing excessive rotation of the cap <NUM> and provides anti-slipping function. When the cap <NUM> is fully inserted into the adaptor <NUM>, the collar <NUM> of the cap <NUM> rests on the rim <NUM> of the adaptor <NUM> (see <FIG>).

When the cap <NUM> is taken apart from the adaptor <NUM>, the cap <NUM> is rotated around the central axis C, disengaging the stopper <NUM> from the locking groove. By further rotating the cap <NUM>, the engaging protrusion <NUM> is disengaged from the threads <NUM>. After that, the cap <NUM> can be simply pulled away from the adaptor <NUM>.

According to the connector assembly <NUM> as described above, the spike <NUM> is press-fitted into the inner cavity <NUM> of the cap body <NUM>. Thus, any leakage of the liquid content of the injection device <NUM> through the interface between the cap <NUM> and the adaptor <NUM> is prevented. Further, in the embodiment where the cap <NUM> and the adaptor <NUM> are respectively made of a plastic material, the sealing between the two parts can be maintained over a longer period of time. In comparison, if the cap is made of an elastic material such as rubber, the sealing effect may be lost over time due to stress relaxation or deformation of the rubber cap.

Moreover, thanks to the press-fit in combination with the engagement between the threads <NUM> and the engaging protrusion <NUM>, inevitable individual variation of the parts can be compensated by self-adjustment. Consequently, secure sealing between the spike <NUM> and the internal cavity <NUM> is obtained. With the optional turn limit and anti-slipping feature, excessive rotation of the cap <NUM> can be prevented and unintended slipping of the cap <NUM> relative to the adaptor <NUM> can be prevented.

Furthermore, while the fluid-tight sealing between the spike <NUM> and the inner cavity <NUM> is maintained, the cap <NUM> can be easily removed from the adaptor <NUM> by rotational movement around the central axis C.

With the optional open design of the flange <NUM> of the adaptor <NUM> around the central axis C, the engaging protrusion <NUM> can be easily produced by injection molding with simpler molding tools.

Referring to <FIG>, a process of connecting the medical injection device <NUM> to a vial <NUM> via the adaptor <NUM> will be explained. In <FIG> and <FIG>, the injection device <NUM> is omitted for the sake of better visibility.

The vial <NUM> may have a generally cylindrical vial body <NUM>. The vial <NUM> may have a lip <NUM> defining an opening covered by a septum <NUM>. A neck <NUM> is formed between the vial body <NUM> and the lip <NUM>. The vial <NUM> has a smaller diameter at the neck <NUM> than those of the body <NUM> and the lip <NUM>.

When moving the vial <NUM> toward the adaptor <NUM> or vice versa, the lip <NUM> of the vial <NUM> makes contact with the rim <NUM> of the adaptor <NUM>. Since the rim <NUM> is designed to diverge radially outward, the vial <NUM> is easily aligned with the adaptor <NUM> around the central axis C.

As the vial <NUM> advances through the circular opening <NUM>, the lip <NUM> pushes and elastically deforms the audible barbs <NUM> substantially radially outward (see <FIG>). As the vial <NUM> further advances, the retention barbs <NUM> are also subjected to elastic deformation.

When the vial <NUM> is fully inserted into the adaptor <NUM>, the retention barbs <NUM> are disengaged from the lip <NUM> and rebound to be snap fitted onto the neck <NUM> of the vial <NUM>. Almost simultaneously or shortly thereafter (for example, several milliseconds later), the audible barbs <NUM> rebound and snap fit onto the neck <NUM> of the vial <NUM>. As compared to the thicker and shorter retention barbs <NUM> which deform slowly and to a lesser degree, the audible barbs <NUM> make a sudden contact with the vial neck <NUM> with stronger restoration force, thereby producing a sharp noise. The specific design of the audible barbs <NUM> can be optimized by taking into account various factors, including but not being limited to, the rigidity of materials of which the audible barbs <NUM> and/or the vial <NUM> is/are made of, the sizes of the lip <NUM> and the neck <NUM> of the vial <NUM>.

The sharp noise resulting from the contact between the audible barbs <NUM> and the vial neck <NUM> serves as indication of full insertion of the vial <NUM> into the adaptor <NUM>, i.e. the spike <NUM> penetrating the septum <NUM> of the vial <NUM>. Thus, the user will be made aware that the vial <NUM> and the injection device <NUM> are in fluid communication and ready for transfer and/or reconstitution of the medication. In this way, the risk of any leakage between the via <NUM> and the adaptor <NUM> can be prevented.

<FIG> shows another example of the cap <NUM>. The cap <NUM> in this example has the same configuration and functions as the cap <NUM> described above, except that the cap <NUM> has at least one tooth <NUM> at its proximal end. The tooth <NUM> may be generally in the form of a spiral. If more than one tooth <NUM> are provided, the teeth <NUM> may be opposite to one another with respect to the central axis C. As shown in <FIG> by way of example, the teeth <NUM> are configured to be engaged with corresponding ribs <NUM> formed on the inner surface <NUM> of the flange <NUM>. The number of teeth <NUM> is not limited. The spike <NUM> and the cap body <NUM> are connected to each other by press-fit.

The cap <NUM> may have three or more teeth. The teeth <NUM> and/or the ribs <NUM> may have a ramp angle with respect to the circumference around the central axis C. With this design, the connector assembly <NUM> provides self-adjustment functioning in order to compensate individual variation of the parts. The teeth <NUM> and the ribs <NUM> are easily disengaged by rotational movement. Thus, the cap <NUM> is easily removed from the adaptor <NUM> in the same manner as the example described above, by rotating the cap <NUM> around the central axis C and subsequent pulling action along the central axis C.

The cap <NUM> shown in <FIG> may be made by molding that involves a side slider. In order to simplify the molding process, the collar <NUM> of the cap <NUM> may be in the form of a ring, as illustrated in <FIG>. In this example, the molded cap <NUM> can be released in an axial direction, i.e. parallel to the central axis C, thereby facilitating the manufacturing process.

Another example of the connector assembly <NUM> includes a cap <NUM> having the same configuration and the functions as described above, except that the cap <NUM> includes no threads <NUM> nor teeth <NUM>. As shown in <FIG>, the cap <NUM> has a cylindrical cap body <NUM>. The cap <NUM> is configured to be connectable to the adaptor <NUM> (not shown in <FIG>) by press-fit of the spike <NUM> into the internal cavity <NUM> of the cap <NUM>.

According to one example, the adaptor <NUM> may be formed with at least one support rib <NUM>, as shown in <FIG>. The support rib <NUM> protrudes radially inward from the inner surface <NUM> of the flange <NUM> and extends parallel to the central axis C. With this optional support rib <NUM> formed on the adaptor <NUM>, vibration of the cap <NUM> can be prevented during storage and/or transportation, for example. Two or more support ribs <NUM> may be provided.

The adaptor <NUM> according to another example may include at least one retention barb <NUM> extending distally from the flange <NUM> and having a tip pointed radially inward, as shown in <FIG>. Similar to the retention barb <NUM> extending proximally from the rim <NUM>, the retention barb <NUM> is also configured to be snap-fitted with the vial neck <NUM>. The retention barb <NUM> may be employed together with the at least one audible barb <NUM> as described above with reference to the previous example.

The cap <NUM> according to yet another example may include at least one locking claw <NUM> as shown in <FIG>. The locking claw <NUM> extends proximally from the collar <NUM> and has a tip pointed radially outward. The locking claw <NUM> is configured to be engaged with the corresponding retention barbs <NUM> of the adaptor <NUM> as illustrated in <FIG>. When the cap <NUM> is connected to the adaptor <NUM> as a result of axial translation along the central axis C, the retention barb <NUM> is to be snap fitted with the locking claw <NUM> (see <FIG>). The engagement between the retention barb <NUM> and the locking claw <NUM> also assists in maintaining the tight connection between the cap <NUM> and the adaptor <NUM> and therefore the secure sealing between the spike <NUM> and the inner cavity <NUM>. According to another example, the locking claw <NUM> may be configured to be engaged with the retention barb <NUM>. It is to be noted that the rotational movement of the cap <NUM> around the central axis C also results in disengagement of the locking claw <NUM> from the retention barb <NUM> or from the retention barb <NUM>. Therefore, easy removal of the cap <NUM> from the adaptor <NUM> is ensured.

Claim 1:
A connector assembly (<NUM>) comprising an adaptor (<NUM>) and a cap (<NUM>) to be connected to each other,
wherein the adaptor (<NUM>) comprises:
- a proximal connection portion (<NUM>) configured to be removably connectable to a medical injection device (<NUM>); and
- a spike (<NUM>) extending distally from the proximal connection portion (<NUM>) and around a central axis (C),
wherein the cap (<NUM>) comprises a cap body (<NUM>) defining an inner cavity (<NUM>) extending around the central axis (C), the inner cavity (<NUM>) being open at a proximal end of the cap body (<NUM>) and is closed at a distal end of the cap body (<NUM>),
wherein the connector assembly (<NUM>) is configured such that the cap (<NUM>) is removably connected to the adaptor (<NUM>) in such a way that the spike (<NUM>) is accommodated within the inner cavity (<NUM>),
the assembly (<NUM>) being characterized in that
the adaptor and the cap are made of a plastic material suitable for injection molding and the cap (<NUM>) is removably connected to the adaptor (<NUM>) by press-fit between the spike (<NUM>) and the inner cavity (<NUM>).