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 medical container as for an injection operation.

Basically, medical containers, such as for example syringes, may be made of a glass or plastic material. Preferably, the medical containers are made of glass for its high chemical passivity, its low gas permeability and high transparency, which allows an extended storage and an easy inspection.

The medical containers usually comprise a barrel forming a reservoir for containing a medical product. The barrel has a distal end 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. This connector is typically screwed into the adaptor and engages the distal tip of the medical container to establish a fluid path between the reservoir and said connector.

It is known that the adaptor is strongly fixed to the longitudinal tip of the medical container in order to prevent accidental disengagement, either during connection of the connector onto the longitudinal tip, or caused by the fluid pressures within the drug delivery device and connector.

For example, the document <CIT> discloses that adaptors may be secured around the longitudinal tip of the syringe by snap-fitting or friction force, for example by mechanical attaching means defined onto the longitudinal tip such as a groove or a ring.

The document <CIT> alternatively discloses to provide adaptors with a mounting ring that is shaped and configured such that, when the adaptor is mounted around the longitudinal tip of the drug delivery device, a circumferential space is created between the mounting ring and the longitudinal tip, this circumferential space usually accommodating an adhesive layer in order efficiently to bond the adaptor to the longitudinal tip.

The document <CIT> further discloses an injection device and an adaptor allowing a safe connection of the adaptor on the injection device, in view of further connecting an IV (Intra Venous) connector to this injection device. The document <CIT> discloses a drug delivery device having an end-piece and an adaptor for engaging around the end-piece so as to enable the safe connection of a connector on said end-piece. The document <CIT> discloses an adaptor intended to be used with a drug delivery device having an end-piece, the adaptor having a collar engageable around said-piece and enabling the safe connection of a connector on said collar.

It is however also important that the connector be properly screwed into the adaptor. Therefore, a user has to apply a sufficient torque when screwing the connector into the adaptor in order to get a proper fitting of the connector onto the distal tip of the medical container. Under-screwing or over-screwing of the connector into the adaptor may otherwise lead to a leakage or an ejection of the connector due to internal pressure when transferring a fluid between the container and the connector.

However, some connectors may abut against a distal face of the adaptor when being screwed into said adaptor. When such a contact happens, further rotation of the needle hub relative to the adaptor generates contact between the connector and the adaptor before the proper connection of the connector into the adaptor.

This early contact may give a user the false impression that a sufficient screwing torque is achieved, whereas the connector still does not properly fits onto the distal tip of the medical container. That is, if the user stops screwing, thinking that the connection is completed, the connector does not sufficiently engage the distal tip and a gap remains between the connector and an outer surface of this distal tip. Such a gap may lead to a leakage when transferring a fluid from the reservoir of the medical container to the connector.

There is therefore a need for a medical container preventing the risks of improper fitting and leakage between the connector and the distal tip even though the connector abuts against the distal face of the adaptor when being screwed into said adaptor.

An aspect of the invention is a medical container forming a reservoir for containing a medical product and having a longitudinal distal tip extending along a longitudinal axis A, the distal tip defining a passageway in fluid communication with said reservoir, wherein the distal tip includes.

characterized in that said mounting portion is configured to allow a free longitudinal movement of the adaptor relative to the distal tip when the adaptor is connected to the distal tip.

The medical container of the invention thus permits the adaptor to proximally slide along the distal tip if the connector abuts against a distal face of the adaptor. This prevents the screwing torque from increasing whereas the connector is not enough engaged onto the distal tip. Accordingly, a user will go on screwing the connector until this connector properly fits onto the distal tip of the medical container. As a result, risks of leakage are avoided.

In an embodiment, the mounting portion comprises guiding means configured to guide a translational movement of the adaptor relative to the distal tip and to prevent a rotation of the adaptor relative to the distal tip.

The translational movement is a longitudinal movement along the longitudinal axis A.

In an embodiment, the guiding means comprises at least one longitudinal bump, preferably three longitudinal bumps.

This allows a translational movement of the adaptor along the tip and blocks any rotation of the adaptor around said tip. The mounting portion of the distal tip, that may be made of a glass material or a plastic material, is indeed submitted to high stresses when the connector is secured to the adaptor. A single longitudinal bump is easier to manufacture. Three longitudinal bumps however provide an efficient guiding along the longitudinal direction A and an efficient blocking of any rotation around said longitudinal axis A.

In an embodiment, the mounting portion has a cylindrical shape.

The mounting portion thus guides the adaptor all along the mounting portion with reduced friction forces. The mounting portion has a constant outer diameter.

By cylindrical shape, it is meant that the mounting portion has the shape of any right cylinder, whose base may be a circle or a polygon, a square, an ellipse or any other non-circular geometrical shape. A mounting portion having a non-circular cross-section permits to guide the adaptor in the longitudinal direction while blocking a rotation of the adaptor around the distal tip. Such a mounting portion with a non-circular shape may form the guiding means in lieu of the at least one longitudinal bump. However, a mounting portion having a circular cross-section is easier to manufacture.

In an embodiment, the medical container comprises blocking means configured to limit the free longitudinal movement of the adaptor relative to the distal tip.

In an embodiment, the blocking means comprises a distal abutment surface and a proximal abutment surface.

The distal abutment surface prevents the removing of the adaptor from the distal tip of the medical container, and helps maintaining a closure cap of the medical container by blocking the adaptor in a distal-most position. The proximal abutment surface blocks the adaptor in a proximal-most position, thereby preventing the fact that the adaptor is too further engaged on the distal tip. In that case, it would not be possible anymore to engage the external thread of the connector into the inner thread of the adaptor.

In an embodiment, the distal abutment surface and the proximal abutment surface are respectively provided on a bump.

The adaptor is free to move relative to the distal tip along a predetermined amplitude a along the longitudinal axis A. By free longitudinal movement it is meant that the adaptor slides along the tip as soon as the adaptor is simply pushed proximally or distally in the axial direction. This predetermined amplitude a is comprised between <NUM> and <NUM>, preferably around <NUM>, along the longitudinal axis A. In other words, the blocking means may be configured so that the amplitude a of the adaptor free longitudinal movement is comprised between <NUM> and <NUM>, and is preferably around <NUM>. The greater the tip external diameter, the lower amplitude a needs to be. Conversely, the lower the tip external diameter, the greater amplitude a needs to be.

Another aspect of the invention is an adaptor for connecting the aforementioned medical container, said adaptor having connecting means configured to cooperate with complementary connecting means provided on a connector, and a mounting ring for mounting the adaptor onto the distal tip of the medical container, said mounting ring being configured to slidably engage the mounting portion of the distal tip.

In an embodiment, the mounting ring defines a through opening whose diameter is at least equal to or preferably greater than an outer diameter of the mounting portion of the distal tip.

There is thus no radial compression exerted by the mounting ring against the mounting portion of the distal tip.

Preferably, the difference between the diameter of the through opening and the outer diameter of the mounting portion is comprised between <NUM> and <NUM>, typically <NUM>.

In an embodiment, the mounting ring is in the form of a frustoconical disc.

The disc is distally inclined relative to a tubular wall of the adaptor. This reduces the insertion force while increasing the adaptor pull out force.

Another aspect of the invention is a drug delivery device comprising the aforementioned medical container and the aforementioned adaptor, wherein the adaptor is slidably mounted onto the mounting portion of the distal tip.

The adaptor is free to move relative to the distal tip along a predetermined amplitude, said predetermined amplitude being preferably comprised between <NUM> and <NUM> along the longitudinal axis A.

In an embodiment, the drug delivery device further includes a needle hub having an inner conduit configured to fit onto the distal tip and outer wings configured to engage an inner thread of the adaptor, said needle hub including a ramp for guiding a user's finger towards a pivoting arm in order to move the pivoting arm back towards a safety position wherein the pivoting arms covers a needle.

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 a medical container <NUM>, an adaptor <NUM> and a drug delivery device <NUM> according to an embodiment of the invention. The drug delivery device <NUM> is intended to cooperate with a connector such as a needle hub <NUM> as shown on <FIG>.

As illustrated on <FIG>, the medical container <NUM> comprises a barrel <NUM> defining a reservoir for containing a medical product. A distal tip <NUM> defining a passageway in fluid communication with the reservoir longitudinally extends along a longitudinal axis A of the medical container <NUM>. The medical container <NUM> may be made of a glass material or a plastic material. The distal tip <NUM> may consequently be made either by glass forming or by injection molding.

The distal tip <NUM> of the medical container <NUM> has a mounting portion <NUM>. The mounting portion <NUM> is configured to receive a mounting ring <NUM> of the adaptor <NUM> for connecting the adaptor <NUM> onto the tip <NUM>, as illustrated on <FIG>. The mounting portion <NUM> preferably extends in a proximal region of the distal tip <NUM>. More specifically, the mounting portion <NUM> may be closer to a distal shoulder <NUM> of the barrel <NUM> than a distal face <NUM> of the longitudinal tip <NUM>. Typically, the mounting portion <NUM> is disposed in the proximal-most third of the distal tip <NUM> if said distal tip <NUM> is divided into three equal thirds.

The distal tip <NUM> further comprises a fitting portion <NUM>. The fitting portion <NUM> distally extends from the mounting portion <NUM>. Said fitting portion <NUM> is configured to fit with an inner conduit of the needle hub <NUM> so as to establish a fluid path from the reservoir of the medical container <NUM> to a needle (not shown) of the needle hub <NUM>. The fitting portion <NUM> preferably has a frustoconical shape.

According to the invention, the mounting portion <NUM> of the distal tip <NUM> comprises guiding means for guiding a longitudinal sliding movement of the adaptor <NUM> along the longitudinal axis A and for blocking a rotational movement of the adaptor <NUM> relative to the distal tip <NUM> around said longitudinal axis A.

As a result, the adaptor <NUM> is free to move relative to the distal tip <NUM> along a predetermined amplitude a. The predetermined amplitude a is defined by the difference between the length L of the mounting portion <NUM> and the thickness of the mounting ring <NUM>, as illustrated in <FIG>. This predetermined amplitude a may be comprised between <NUM> and <NUM>, preferably around <NUM>, along the longitudinal axis A. The adaptor <NUM> is free to slide along the longitudinal axis A within the predetermined amplitude a, i.e. between the distal-most position and the proximal-most position of the adaptor <NUM> when said adaptor <NUM> is mounted onto the distal tip <NUM>.

This longitudinal movement of the adaptor <NUM> relative to the tip <NUM> permits to vary the distance d between the distal face <NUM> of the tip <NUM> and a distal face <NUM> of the adaptor <NUM> as visible on <FIG>. As a result, the adaptor <NUM> may be pushed in a proximal direction, thereby increasing the distance d, by the needle hub <NUM> abutting against a distal face <NUM> of the adaptor <NUM>. This allows the distal tip <NUM> to properly fit into an inner conduit of the needle hub <NUM>. Risks of leakage due to an insufficient screwing of the needle hub <NUM> into the adaptor <NUM> because of a contact between the needle hub <NUM> and the distal face <NUM> of the adaptor <NUM> are thus avoided.

With reference to <FIG>, the guiding means may comprise at least one longitudinal bump <NUM>. The least one longitudinal bump <NUM> extends in a straight direction parallel to the longitudinal axis A. Having a bump, that protrudes from an outer wall of the mounting portion <NUM>, instead of a longitudinal groove that would form a recess with regard to said outer wall, has the advantage of strengthening, not weakening, said mounting portion <NUM> and said tip <NUM>.

It should be noted that the outer diameter of the mounting portion <NUM>, without bumps <NUM>, <NUM>, <NUM>, is equal to or lower than, preferably equal to, the greatest outer diameter of the fitting portion <NUM> of the distal tip <NUM>. In other words, the mounting portion <NUM> of the distal tip <NUM> is preferably no thinner than the rest of the tip <NUM>. As a result, the mounting portion <NUM> is devoid of any groove or recess. This limits the risk of breakage, especially when the medical container <NUM> is made of glass.

As shown on <FIG>, the at least one longitudinal bump <NUM> may be in the form of an longitudinal rib extending all along the mounting portion <NUM>.

The at least one longitudinal bump <NUM> may have a rounded shape, as illustrated on <FIG>. The at least one bump <NUM> may define recessed lateral edges <NUM>.

Preferably, the guiding means may comprise three longitudinal bumps <NUM>. Having three longitudinal bumps <NUM> offers a satisfactory repartition of the screwing torque around the tip <NUM> in order to avoid breakage without complicating the manufacturing process, especially when the tip <NUM> is made of glass. The three longitudinal bumps <NUM> may be regularly distributed around the mounting portion <NUM>. The guiding means may however have less or more than three longitudinal bumps <NUM>.

The mounting portion <NUM> preferably has cylindrical shape. Alternatively or complementarily to the at least one longitudinal bump <NUM>, the guiding means may comprise the mounting portion <NUM> having a square, oval, polygonal or any other non-circular cross-section shape. Such a shape permits the adaptor <NUM> to slide along the mounting portion <NUM> without rotating around said mounting portion <NUM>.

With reference to <FIG> or <FIG>, the mounting portion <NUM> may further comprise blocking means for blocking the translational movement of the adaptor <NUM> relative to the tip <NUM>.

The blocking means may comprise a first abutment surface <NUM> for blocking the adaptor <NUM> respectively in the distal direction. The first abutment surface <NUM> further prevents the pull out of the adaptor <NUM>. In a distal-most position (<FIG>), the mounting ring <NUM> abuts against the first abutment surface <NUM>.

The first abutment surface <NUM> defines the distal end of the mounting portion <NUM>. The first abutment surface <NUM> may be arranged at the proximal side of a first orthoradial bump <NUM>. This first orthoradial bump <NUM> protrudes from an outer wall of the distal tip <NUM>. Having a first abutment surface <NUM>, that is defined by a bump <NUM> instead of being defined by a shoulder. The first orthoradial bump <NUM> may be in the form of a circumferential rib extending all around the tip <NUM>.

With reference to <FIG>, the first orthoradial bump <NUM> may have a ramp portion <NUM> provided on a distal side of said bump <NUM> in order to ease the passage of the mounting ring <NUM> of the adaptor <NUM> over said first orthorodial bump <NUM> in the proximal direction. This help the user mount the adaptor <NUM> onto the mounting portion <NUM> of the tip <NUM>.

The blocking means may comprise a second abutment surface <NUM> for blocking the adaptor <NUM> respectively in the proximal direction. In a proximal-most position (<FIG>), the mounting ring <NUM> abuts against the second abutment surface <NUM>.

The second abutment surface <NUM> defines the proximal end of the mounting portion <NUM>. The second abutment surface <NUM> may be arranged at the distal side of a second orthoradial bump <NUM>. This second orthoradial bump <NUM> protrudes from an outer wall of the distal tip <NUM>. Having a second abutment surface <NUM>, that is defined by a bump <NUM> instead of being defined by a shoulder. The second orthoradial bump <NUM> may be in the form of a circumferential rib extending all around the tip <NUM>.

The second abutment surface <NUM> may be located such that the distance d between the distal face of the tip <NUM> and the distal face <NUM> of the adaptor <NUM>, when said adaptor <NUM> is connected to the tip <NUM>, is no more than <NUM>. This allows the needle hub <NUM> to engage the adaptor <NUM>, even though the adaptor <NUM> is in the proximal-most position. Indeed, if the distance d becomes too high, the needle hub <NUM> would otherwise not be able to engage the adaptor <NUM>. More specifically, the maximum distance d of <NUM> allows the thread of the needle hub <NUM> to engage the thread <NUM> of the adaptor <NUM> when the distal tip <NUM> has a high external diameter.

The blocking means may define the length L of the mounting portion <NUM>. With reference to <FIG>, this length L may be defined by the distance between the first and the second abutment surfaces <NUM>, <NUM>.

<FIG> shows a needle hub <NUM> that is fitted to a distal tip <NUM> having a first diameter whereas <FIG> shows a needle hub <NUM> that is fitted to a distal tip <NUM> having a second diameter that is smaller than said first diameter. As can be seen on these Figures, the sliding movement of the adaptor <NUM> along the distal tip <NUM> permits that the needle hub <NUM> reaches a predetermined position relative to the distal tip <NUM> wherein said needle hub <NUM> properly fits onto the tip <NUM>. This predetermined position is advantageously defined as being the leakage limit of the needle hub <NUM> as defined in the ISO <NUM>-<NUM> (<NUM>) (paragraphs <NUM> and <NUM>). Whether the needle hub <NUM> is under connected and has not reach said position, a leakage may occur. The sliding movement allows the needle hub <NUM> to reach the leakage limit position despite the contact that may occur between the needle and the adaptor <NUM> distal face.

With reference to <FIG> and <FIG>, the invention also relates to an adaptor <NUM> configured to be connected to the mounting portion <NUM> of the tip <NUM>.

The adaptor <NUM> has a tubular wall <NUM> defining an inner cavity for receiving the needle hub <NUM>. The inner cavity is provided with connecting means, such as an inner thread <NUM>, for securing the needle hub <NUM> to the adaptor <NUM>.

The adaptor <NUM> further has a mounting ring <NUM> inwardly protruding from a proximal end of the adaptor <NUM>. The mounting ring <NUM> allows connecting the adaptor <NUM> onto the distal tip <NUM>.

The mounting ring <NUM> defines a through opening <NUM> for receiving the mounting portion <NUM> of the tip <NUM>. The through opening <NUM> may be shaped to complementarily engage the mounting portion <NUM> of the tip <NUM>. The thickness of the mounting ring <NUM> should be high enough to prevent the adaptor <NUM> pull out, but needs to be low enough to avoid increasing the length of the mounting portion <NUM> and thus the length of the distal tip <NUM>. For instance, said thickness may be approximately comprised between <NUM> and <NUM>.

The width or diameter of said through opening <NUM> may be at least equal to, preferably greater than, the outer width or diameter of the mounting portion <NUM>. As a result, a clearance is provided between the mounting ring <NUM> and the mounting portion <NUM>. This favors the sliding movement of the adaptor <NUM> relative to the tip <NUM>.

With reference to <FIG>, the mounting ring <NUM> comprises at least one guiding window <NUM>. The at least one window <NUM> is configured to engage the at least one longitudinal bump <NUM> in order to guide the sliding movement of the adaptor <NUM> relative to the tip <NUM> and to block any rotation of the adaptor <NUM> relative to said tip <NUM>. To that end, the at least one guiding window <NUM> and the longitudinal bump <NUM> may be complementarily shaped, while allowing the free sliding movement of the adaptor <NUM> relative to the distal tip <NUM>. Preferably, the at least one guiding window <NUM> and the at least one longitudinal bump <NUM> are configured such that the adaptor <NUM> and the distal tip <NUM> are snap-fitted. For example, the at least one guiding window <NUM> may be slightly larger than the at least one longitudinal bump <NUM>. The adaptor <NUM> may comprise as many guiding windows <NUM> as longitudinal bumps <NUM>, for example three as illustrated on <FIG>.

As shown on <FIG>, the at least one guiding window <NUM> may open in the through opening <NUM> defined by said mounting ring <NUM>. The adaptor <NUM> may thus be clipped onto the mounting ring <NUM> and the at least one longitudinal bump <NUM>. The at least one window <NUM> has lateral edges <NUM> configured to engage the corresponding lateral edges <NUM> of the at least one longitudinal bump <NUM>. This improves the clipping of the mounting ring <NUM> onto the at least one longitudinal bump <NUM>. The lateral edges <NUM> may be part of snap-fitting means for connecting the adaptor <NUM> to the mounting portion <NUM>.

With reference to <FIG>, the mounting ring <NUM> of the adaptor <NUM> may be in the form of a resilient frustoconical disc. The frustoconical is inclined relative to the longitudinal axis A and points towards the distal direction. This increases the adaptor <NUM> pull out force. This further helps the passage of the adaptor <NUM> over the first orthoradial bump <NUM>. The inclined proximal side of the mounting ring <NUM> cooperates with the ramp portion <NUM> of said first orthoradial bump <NUM> to permit resilient deformation of the mounting ring <NUM>. A beveled edge <NUM> may further be provided at the proximal side of the mounting ring <NUM>.

The adaptor <NUM> may be made 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. To simplify its manufacturing, the adaptor <NUM> preferably consists of a single piece of material, preferably of a light-transmitting material. The adaptor <NUM> may be made by injection molding.

With reference to <FIG>, the invention further relates to a drug delivery device <NUM> comprising said medical container <NUM> and said adaptor <NUM> connected to the distal tip <NUM> of the medical container <NUM>. The drug delivery device <NUM> may be a syringe, such as prefilled or pre-fillable syringe.

The drug delivery device <NUM> may comprise a connector such as a needle hub <NUM> as shown on <FIG>. The needle hub <NUM> comprises a proximal end defining an inner conduit <NUM> for receiving the distal tip <NUM> of the medical container <NUM>. The distal end is provided with connecting means, such as two diametrically opposite outer wings <NUM>, configured to engage the connecting means of the adaptor <NUM>, such a the inner thread <NUM>, in order to secure the needle hub <NUM> to the adaptor <NUM>. The needle hub <NUM> further includes a distal end that may be provided with a mounting port <NUM> for mounting an injection needle and thereby establish a fluid path from the reservoir to the injection needle. A pivoting arm (not shown) may be connected at a pivot connection <NUM> in the form of a hook, said pivoting arm being configured to cover or unveil the injection needle. In order to help the user move the pivoting arm back towards the needle, the needle hub <NUM> may comprise a ramp <NUM> configured to guide a user's finger against the pivoting arm. For example, the needle hub <NUM> may be a BD Eclipse®.

Claim 1:
A medical container (<NUM>) forming a reservoir for containing a medical product and having a longitudinal distal tip (<NUM>) extending along a longitudinal axis (A), the distal tip (<NUM>) defining a passageway in fluid communication with said reservoir, wherein the distal tip (<NUM>) includes
- a fitting portion (<NUM>) configured to fit with a connector; and
- a mounting portion (<NUM>) proximally located relative to said fitting portion (<NUM>) and configured to slidably connect an adaptor (<NUM>) to said distal tip (<NUM>),
wherein said mounting portion (<NUM>) is configured to allow a free longitudinal movement of the adaptor (<NUM>) relative to the distal tip (<NUM>) when the adaptor (<NUM>) is connected to the distal tip (<NUM>),
wherein the mounting portion (<NUM>) comprises guiding means configured to guide a translational movement of the adaptor (<NUM>) relative to the distal tip (<NUM>) and to prevent a rotation of the adaptor (<NUM>) relative to the distal tip (<NUM>),
the guiding means comprising at least one longitudinal bump (<NUM>), preferably three longitudinal bumps (<NUM>), configured to engage at least one complementarily shaped guiding window (<NUM>) of a mounting ring (<NUM>) of the adaptor (<NUM>), and characterized in that
the least one longitudinal bump (<NUM>) has a rounded shape and defines recessed lateral edges (<NUM>) configured to receive lateral edges (<NUM>) of said at least one guiding window (<NUM>), thereby allowing a snap-fit connection between the adaptor (<NUM>) and the mounting portion (<NUM>) of the distal tip (<NUM>).