Adaptor for Mounting onto a Medical Container, a Medical Container Comprising Said Adaptor, and a Method for Manufacturing Said Adaptor

An adaptor for mounting onto a medical container, the adaptor including a distal part configured to receive a connector, and a proximal part configured to be mounted onto the distal tip of the medical container. The proximal part includes an inner ring protruding from a lateral tubular wall of the adaptor, said inner ring having an inner edge that delimits an opening configured to receive the distal tip. The proximal part further includes a gripping member made of an elastomer material, said gripping member being connected to the inner edge of the inner ring in order to be in contact with an outer surface of the distal tip when the adaptor is mounted onto the medical container.

BACKGROUND OF THE DISCLOSURE

Field of the Disclosure

The present disclosure relates to an adaptor for mounting onto a medical container, a medical container comprising said adaptor, and a method for manufacturing said adaptor.

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 an adaptor or 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, are preferably 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 barrel. 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.

Description of Related Art

It is important that the connection between the medical container and the adaptor is strong enough to prevent accidental disengagement, either during connection of the connector onto the adaptor, or caused by the fluid pressures within the medical container and connector.

The document WO2015/007650 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. However, the incorporation of a groove to the longitudinal tip may cause the longitudinal tip to be sensitive to flaws and may potentially lead to tip breakage. Moreover, an adaptor connected around a longitudinal tip by snap-fitting or friction force may demonstrate both a limited torque and pull out force resistance. There is therefore a need for an adaptor that would improve the connection between the longitudinal tip of a medical container and said container. More specifically, there is a need for an adaptor that would improve the torque and the adaptor pull out force.

SUMMARY OF THE DISCLOSURE

An aspect of the disclosure is an adaptor for a medical container having a distal tip, said adaptor comprisinga distal part configured to receive a connector, anda proximal part configured to be mounted onto the distal tip of the medical container,

wherein the proximal part comprises an inner ring protruding from a lateral tubular wall of the adaptor, said inner ring having an inner edge that delimits an opening configured to receive the distal tip, and

wherein the proximal part further comprises a gripping member made of an elastomer material, said gripping member being connected to the inner edge of the inner ring in order to be in contact with an outer surface of the distal tip when the adaptor is mounted onto the medical container.

The adaptor of the disclosure thus provides a higher grip between said adaptor and the distal tip of the medical container. The increased friction force exerted by the elastomer gripping member onto the distal tip improves the torque and increases the adaptor pull out force. Because the adaptor pull out force is increased there is less risk that the adaptor disconnects from the distal tip of the medical container. The elastomer material of the gripping member further reduces the risk that the adaptor rotates around the distal tip.

In an embodiment, the inner ring comprises a distal and a proximal abutment surface abutting against the gripping member in order to secure said elastomer gripping member in a longitudinal direction A of the adaptor.

This limits the risks of an axial disassembly between the elastomer gripping member and the inner ring.

In an embodiment, the inner ring comprises a protrusion or a recess, preferably a protrusion, that engages a complementarily shaped recess or protrusion, preferably a recess, provided on the elastomer gripping member in order to secure said elastomer gripping member to the inner ring.

Preferably, said protrusion or recess has a dovetail shape.

This limits the risks of an axial disassembly of the gripping member and the protruding ring due to an increased pull out force exerted on the adaptor.

In an embodiment, the elastomer gripping member comprises a free distal lip.

This improves the pull out force of the adaptor.

In an embodiment, the gripping member is over-molded or co-injection molded.

In an embodiment, the elastomer material of the gripping member is rubber or thermoplastic elastomer (TPE).

The inner ring may be made of acrylonitrile butadiene styrene (ABS). This improves the attachment of the elastomer gripping member to the inner ring.

In an embodiment, the gripping member is in the form of a 360° extending sleeve.

This provides a 360° grip between the adaptor and the medical container distal tip, thereby improving the torque and increasing the adaptor pull out force.

In an embodiment, the adaptor comprises several gripping members, each of said gripping members being in the form of a partial sleeve, the adjacent gripping members thereby delimiting gaps allowing the inner edge of the inner ring to be in contact with the outer surface of the distal tip when the adaptor is mounted onto the medical container.

Therefore, the inner edge of the inner ring and the elastomer gripping members alternately contact the distal tip in a circumferential direction. This prevents a tilting movement of the adaptor relative to the distal tip. A tilting movement is a rotation of the adaptor relative to said distal tip around an axis orthogonal to the longitudinal axis of the adaptor and the distal tip.

The inner edge may comprise radial protrusions extending through said gaps in order to radially abut against the distal tip. The radial protrusions thus extend between adjacent gripping members.

Another aspect of disclosure is a medical container comprising a distal tip and an adaptor having the above features.

In an embodiment, the distal tip comprises bumps configured to abut against the inner edge of the inner ring at the gaps delimited by the adjacent gripping members.

Another aspect of the disclosure is a method for manufacturing an adaptor as above-described, wherein the gripping member is overmolded or co-injection molded.

In an embodiment, the adaptor is formed in a two-shot injection molding.

DETAILED DESCRIPTION

With reference toFIG.1is shown an adaptor1according to an embodiment of the disclosure. With reference toFIG.2, the adaptor1is intended to be mounted onto a distal tip102of a medical container100, more precisely onto an outer surface of said distal tip102. The outer surface may be either cylindrical or distally tapered. The adaptor1permits to connect a connector, such as a needle hub or a syringe cap, to the medical container100.

The adaptor1comprises a distal part2and a proximal part4. The adaptor1comprises a tubular wall6defining an inner cavity around a central longitudinal axis A.

The distal part2is configured to receive the connector. As illustrated onFIG.1, the distal part2defines a distal opening leading inside the inner cavity so as to receive the connector inside the adaptor1. The distal part2includes connecting means, such as an internal thread60, configured to engage corresponding connecting means, such as the wings of a needle hub or an external thread provided on a connector, in order to secure the connector to the adaptor1and accordingly to the medical container100. The connecting means may alternatively comprise a bayonet element, a snapping element or a press-fit element.

The proximal part4is configured to secure the adaptor1to the distal tip102of the medical container100. The proximal part4defines a proximal opening leading into the inner cavity so as to receive the distal tip102of the medical container100inside the adaptor1. The proximal part4further comprises an inner ring40and at least one gripping member50. The inner ring40and the gripping member50are configured to secure the adaptor1onto the distal tip102of the medical container100.

The inner ring40inwardly and radially protrudes from the tubular wall6of the adaptor1. The inner ring40is configured to support the gripping member50. The gripping member50is thus connected to the rest of the adaptor1by means of inner ring40and preferably by means of this inner ring40only.

The inner ring40has an inner edge42defining the proximal opening. The inner edge42is configured to maintain said gripping member50against the outer surface of the distal tip102when the adaptor1is mounted onto the medical container100. The gripping member50may thus be compressed by the outer surface against the inner edge42by the distal tip102having a frustoconical shape. The inner edge42may have a cylindrical shape and may preferably extend parallel to the longitudinal axis A. The inner edge42continuously extends in a circumferential direction.

The inner ring40preferably extends in a transversal plane that is orthogonal to the longitudinal axis A. Accordingly the inner ring40extends orthogonally to the tubular wall6of the adaptor1. The inner ring40therefore better withstands deformation when the adaptor1is mounted onto the distal tip102and better maintains the gripping member50against the outer surface of the distal tip102.

The inner ring40, and more generally the rest of the adaptor1apart from the gripping member50, may be made 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. The rest of the adaptor1at least includes the inner ring40and may further include the proximal part4, the tubular wall6and/or the distal part2. Preferably, the adaptor1, more specifically the inner ring40, is made of acrylonitrile butadiene styrene (ABS). Furthermore, the adaptor1may preferably be made of a light-transmitting material.

The gripping member50is configured to secure the adaptor1to the distal tip102. The gripping member50is made of a softer material than the inner ring40and more generally than the rest of the adaptor1in order to enhance the adherence of the proximal part of the adaptor1onto the distal tip102. More specifically, the gripping member50is made of an elastomer material such as thermoplastic elastomer or rubber. The rubber may be either natural or synthetic rubber. The gripping member50thus forms an elastomer inner sleeve configured to secure the adaptor1to the medical container100.

The gripping member50is supported by the inner ring40. More specifically, the gripping member50covers the inner edge42of the inner ring40. therefore, the gripping member50is configured to extend between said inner edge42and the distal tip102of the medical container100. As shown onFIG.2, the gripping member50advantageously stands remote from the tubular wall6or the internal thread60of the adaptor1. The gripping member50may fully cover the inner edge42.

The gripping member50is fixedly attached to the inner edge42of the inner ring40. For example, the gripping member50may be over-molded or may be co-injection molded with the inner ring40and more generally with the rest of the adaptor1. The inner ring40and the gripping member50thus form a single-piece adaptor1made of two different materials. By single-piece adaptor1it is meant that the inner ring40and the gripping member50that are made of different materials form together a single piece that cannot be disassembled or separated without damaging the adaptor1. The gripping member50is thus fixed relative to the inner ring40.

In order to prevent any sliding movement of the gripping member50relative to the inner ring40, the inner ring40may comprise a proximal abutment surface44aand a distal abutment surface44b.The gripping member50is preferably secured to these proximal and distal abutment surfaces44a,44b.

As visible onFIG.2, the proximal and the distal abutment surfaces44a,44bmay be provided at the two lateral sides of a radial protrusion44, such as a circular rib, provided on the inner ring40. The gripping member50may define a complementarily shaped recess54, as illustrated onFIG.6, configured to receive the radial protrusion44. The proximal and/or distal abutment surfaces44a,44bmay be inclined relative to a transversal plane. Accordingly, and as visible onFIGS.2and5, the radial protrusion44and the complementarily shaped recess54preferably form a dovetail joint in order to reduce risks that the gripping member50be removed. In an alternative embodiment not shown, the recess54may be provided on the inner ring40, said recess being for example in the form of a circular groove, while said radial protrusion44may be provided on the gripping member50. In this case, the proximal and the distal abutment surfaces44a,44bmay be provided at the two lateral sides of the circular groove of the inner ring40.

The inner ring40may further comprise a radial bottom shoulder46aand/or a radial top shoulder46b.The bottom and top shoulders46a,46bare respectively arranged proximally and distally relative to the inner edge42. The gripping member50is advantageously also secured to the radial bottom shoulder46aand/or top shoulder46b.

It should also be noted that the gripping member50may have a bottom proximal face57athat does not go beyond a bottom proximal face47aof the inner ring40. The gripping member50may also have a top distal face57bthat does not go beyond a top distal face47bof the inner ring40. Preferably, the bottom proximal face57aof the gripping member50is flush with the bottom proximal face47aof the inner ring40, and/or the top distal face57bof the gripping member50is flush with the top distal face47bof the inner ring40.

As shown onFIG.2, the gripping member50advantageously comprises a free distal lip52that may extend parallel to the longitudinal axis A. The free distal lip52is configured to prevent any tilting movement of the adaptor1relative to the distal tip102, i.e. any rotation of the adaptor1around a transversal axis, when the adaptor1is mounted onto the distal tip102. A transversal axis is an axis that is othrogonal to the longitudinal axis A. The free distal lip52distally extends from a base portion58of the gripping member50, said base portion58being secured to the inner ring40. The free distal lip52may distally extend beyond a proximal end60aof the internal thread60. As visible onFIG.2, the free distal lip52is advantageously distally tapered.

According toFIGS.1and2, the adaptor1comprises a single gripping member50. The gripping member50may be in the form of a 360° sleeve. In this embodiment, only the gripping member50of the adaptor1contacts the distal tip102.

Alternatively, as shown onFIGS.3to6, the gripping member50may be in the form of a circumferentially discontinued sleeve. The adaptor1actually comprises a plurality of gripping members50, each in the form of a partial sleeve or cylinder. As illustrated onFIGS.3to6, the adaptor1may comprise at least three gripping members50that are remote from each other. These gripping members50may be regularly distributed in a circumferential direction. As visible onFIGS.3and4, the gripping members50are separated from each other by circumferential gaps48allowing the inner edge42of the inner ring40to contact the distal tip102of the medical container100when the adaptor1is mounted onto the distal tip102of said medical container100. As a result, the inner edge42contacts the distal tip102in alternation with the gripping members50along a circumferential direction. This helps prevent a tilting movement of the adaptor1relative to the distal tip102. Preferably, the gripping members50are longer than the gaps48in a circumferential direction. Although not shown onFIGS.3-6, the inner edge42may include radial protrusions extending in the gaps48, i.e. between adjacent gripping members50, in order to contact the outer surface of the distal tip102. Alternatively or complementarily, the distal tip102comprises radial bumps that are received in the gaps delimited by the gripping members50, these radial bumps contacting the inner edge42. This permits a rigid connection between the adaptor1and the distal tip102.

The disclosure also relates to a medical container100as shown for example onFIG.2or7. The medical container100may be a syringe, such as pre-fillable or prefilled syringe. The medical container100comprises a tubular barrel104that defines a reservoir for a medical product. The distal tip102may be cylindrical or distally tapered. The tubular barrel104and the distal tip102are preferably made of glass. The medical container100further comprises the above-described adaptor1that is secured onto the distal tip102by means of the gripping member50adhering to the outer surface of the distal tip102. In order to improve the interference fit between the adaptor1and the gripping member50the gripping member50may have an inner diameter that is equal to or lower than an outer diameter of the distal tip102.

As visible onFIG.7, the medical container100may comprise a cap106having an external thread108configured to engage the internal thread60of the adaptor1so as to secure the cap to the adaptor1. The cap106is configured to be secured to the adaptor1without its external thread abutting against the gripping member50, more specifically the free distal lip52of the gripping member50. Therefore, the cap106may include a connecting portion whose length is lower than a distance between the distal end of the adaptor1and the gripping member50. The connecting portion extends from a proximal abutment surface110configured to abut against the distal end of the adaptor1to the distal end of the cap external thread108. The cap106may include an inner cap112, which may be made of a softer material than the cap106, so as to sealingly close the distal tip102.

The disclosure also relates to a method for manufacturing the above-described adaptor1. This method may include overmolding or co-injection molding of the gripping member50with the rest of the adaptor1. Preferably, the adaptor1is formed in a two-shot injection molding process.