Connector and system for aseptic fluid connection

Abstract

The present invention relates to a connector and a system for aseptic fluid connection comprising a hollow piercing needle (115) and a stopper (120) and a tubular connector (110) sliding in axial translation relative to said stopper (120), characterized in that said connector (110) has a shoulder (118) for exerting an axial force in translation on said tubular connector (110) and in that the sliding stroke of said stopper (110) is greater than the distance between the bottom (115) of said stopper (110) and the tip (114) of the needle (125) before connection. Abstract figure: figure 1

Description

Title of the invention: Connector and system for aseptic fluid connection Field of invention

[0001] The present invention relates to the field of personalized cellular immunotherapy and more particularly to the collection and automated processing of cellular subsets, in particular CAR-T (Chimeric Antigenic Receptor - T) cells in peripheral blood with the aim of locally reinjecting these cells to repair tissues.

[0002] Connector assemblies have been developed for handling fluids, keeping them free of contaminants. Attempts have been made to develop connector assemblies that isolate a fluid from the ambient environment of the connector, and from contaminants entrained in the environment.

[0003] Tube joining by welding typically involves using a sterile tube welding machine to weld the thermoplastic tube in a sterile manner. One type of tube welding machine sterilizes a cutting blade or wafer, then moves the blade through both ends of the tube to be joined. Once both ends of the tube are cut, the machine aligns the tube ends while maintaining a high temperature. After the thermoplastic tubes cool, a sterile weld is formed. State of the art

[0004] Patent FR3100984 relates to a connector for a flexible infusion bag intended to contain a medical liquid. The connector is made of at least one thermoplastic material, and comprises a welding zone and a connection zone, the welding zone comprising a first channel passing through said welding zone, the connection zone comprising a chamber sealed against microorganisms having a neck and a second channel separated by a sealed interface, the second channel being the extension in the connection zone of the first channel of the welding zone, the two channels defining a liquid flow channel.

[0005] Patent EP2038000 describes a method for joining together first and second thermoplastic tubes transversely to the axis of each tube, consisting of melting the thermoplastic ends of two thermoplastic tubes. The melted areas are then moved to form a joint between the two thermoplastic tubes.

[0006] Patent EP0975301 describes a sterile connector for connecting a hose to a container containing a medical liquid, with a connecting part provided of a channel-shaped recess, which is closed by a pierceable membrane, the pierceable membrane being designed as a film which covers the channel-shaped recess and which is fixed by welding to the underside of the connecting piece, the connecting piece being provided with a lower part which can be placed in the container wall and can be sealed with respect to the container wall and with a tubular-shaped upper part for receiving a piercing punch, to which the pipe is connected and a protective cap designed as a break-off part, which closes the tubular-shaped upper part of the connecting piece, being provided.The upper edge of the tubular upper part comprises an inwardly directed circular shoulder, which is followed by a connecting piece receiving the piercing punch and ensuring its sealing, the lower edge of the protective cap being connected with the circular shoulder and the cap being provided in the area of ​​its lower edge with a circular breaking zone.

[0007] Patent EP2152221 describes an attachment system for attaching a connector to an administration port of a fluid container, comprises a housing having a receiving chamber configured to receive the administration port, the receiving chamber having a wall and at least one flexible retainer attached to the wall of the receiving chamber, the at least one flexible retainer configured to non-removably engage the administration port when the administration port is inserted into the receiving chamber and to secure the administration port within the receiving chamber, and a needle at least partially within the receiving chamber and configured to pierce the administration port upon insertion of the administration port into the receiving chamber. Disadvantages of the prior art

[0008] The solutions of the prior art provide connection systems often using complementary male and female parts, arranged to ensure a sealed connection and designed to preserve the sterility of the circulating fluid.

[0009] These parts have different surfaces which are difficult to avoid contamination during handling. Furthermore, the manufacture of parts with sealed sliding surfaces and perfectly matched shoulders is complex and expensive. Solution provided by the invention

[0010] The present invention aims to overcome these drawbacks and proposes a connector for aseptic fluid connection comprising a hollow perforating needle and a stopper and a tubular connector sliding in axial translation relative to said plug characterized in that said connection has a shoulder to exert an axial force in translation on said tubular connection and in that the sliding stroke of said plug is greater than the distance between the bottom of said plug and the tip of the needle before connection.

[0011] Advantageously, said connection is constituted by a tubular conduit having a connecting collar with a membrane crossed by said conduit.

[0012] According to alternative embodiments: • said connection has an annular shoulder engaged, before sliding, in a complementary peripheral groove provided on the interior surface of said plug • the tubular wall of said plug is elastically deformable to allow the sealed passage of said annular shoulder • the tubular wall of said needle is pierced by at least one axial lumen opening into the tip on the one hand and into the base on the other hand • the section of said plug is connected to said tubular connector by a flexible invagination zone • said plug has an external section smaller than the internal section of said tubular connection • said plug has an inner section corresponding to the outer section of the rear part of said hollow needle

[0013] The invention also relates to an aseptic fluidic system comprising a connector and a fluidic component having a flat connection zone, said connector comprising a hollow perforating needle and a plug surrounding a tubular connection mentioned above.

[0014] At least the bottom of the plug is made of a material that can be heat-welded to the material of said flat connection zone, the material of said bottom of the plug is a material that can be hot-melted at a temperature higher than the melting temperature of said needle and higher than the temperature corresponding to the bacterial lethality rate for the minimum melting time, the material of said fluidic component being capable of being perforated by said needle by non-reversible deformation - said connector has a shoulder to axially lock the needle in a position where its point is set back from the bottom of the stopper - the sliding travel of said stopper is greater than the distance between the bottom of said stopper and the tip of the needle before connection.

[0015] Advantageously: • at least the bottom of the cap is made of a material which can be heat-welded to the material of said flat connection zone. • the material of said bottom of said cap is a heat-melting material with a temperature lower than the melting temperature of said needle and higher than the temperature corresponding to the bacterial lethality rate for the minimum melting time. Detailed description of a non-limiting example of embodiment

[0016] The present invention will be better understood on reading the following description, concerning a non-limiting example of embodiment illustrated by the appended drawings where:

[0017] [Fig-1] [Fig. 1] represents a view of the connector and the tubular before connection

[0018] [Fig.2] [Fig.2] represents a view of the connector and the tubular after connection

[0019] [Fig.3] [Fig.3] represents a view of the connector and the tubular before connection according to an alternative embodiment

[0020] [Fig.4] [Fig.4] represents a view of the connector and the tubular after connection according to an alternative embodiment. General principle of the invention

[0021] The invention relates to the connection of a connector (100) and a fluid component (200) which may be a bag, for example a blood bag or a tube. This fluid component (200) has a flat connection zone (210).

[0022] The connector (100) extends the end of a conduit or a fluidic accessory.

[0023] The connector (100) and the fluidic component (200) are made for example of po- sterile lyethylene.

[0024] The connector (100) is formed of two telescopic sleeves (110, 120), cooperating in a sealed manner. One of the sleeves (120) constitutes a plug closed at the front by a perforable bottom (125). The other sleeve constitutes a tubular connector (110) comprising a hollow needle (115) having a perforating point (114), fixed on the front face of said sleeve.

[0025] In the rest position, the tubular connector (110) is in a position spaced apart from the plug (120). By exerting an axial force, the tubular connector (110) is axially moved relative to the plug (120) into a perforation position where the needle breaks the bottom (125) of the plug (120) and penetrates into the cavity (215).

[0026] Presentation of a first variant embodiment of the connector according to the invention

[0027] The connector (100) comprises a tubular connection (110) closed by a plug (120) sliding axially relative to the tubular connection (110) between an initial position where the rear cylindrical end (116) of the plug (115) surrounds the front end (117) of said connection (110), and a retracted position for connection with a component (200). The inner section of the plug (120) corresponds to the outer section of the tubular connection (110) to preserve the seal regardless of the position of the plug (120) relative to the tubular connection (110).

[0028] The plug (120) is locked in the advanced position by the combination of an annular shoulder (111) and an annular groove (112) provided one on the rear cylindrical end (116) of the plug (115) and the other on the front end (117) of said connector (110). This combination ensures transient locking, preventing involuntary retraction of the plug (120). However, by exerting an axial force, the plug (120) can be released and then slides to a retracted position where its tubular skirt surrounds the tubular connector (110).

[0029] When the plug (120) is in the retracted position, its rear front face (113) comes into contact with the front surface of a shoulder (118) extending in a transverse plane on the tubular connection (110).

[0030] The tubular connector (110) comprises a hollow needle (115) having a piercing tip (114).

[0031] When the plug (120) is pushed back, the tip (114) pierces the bottom (125) of the plug (120) and the seal between the plug (120) and the connector (110) is ensured on the one hand by the conjugation between the inner tubular surfaces of the plug (120) and the outer tubular surfaces of the connector (110), and by the conjugation between the rear front surface (113) of the plug (120) with the front surface of the shoulder (118) of the connector (110).

[0032] The bottom (125) of the stopper (120) is made of a thermofusible material, with a melting temperature lower than the melting temperature of the hollow needle (115), and higher than the temperature corresponding to the bacterial lethality rate for the minimum melting time. Functioning

[0033] The connection between the connector (100) and the component (200) is made by thermal welding with infrared irradiation or thermal contact type hot blade, by applying a heating mold on the bottom (125) of the plug (120) on the one hand and on the flat surface (210) of the component (200) on the other hand. The plug (120) is then applied against this flat surface (210) of the component to be connected, by applying axial pressure via the shoulder (118). This axial force causes the retraction of the plug (120) and the perforation of the bottom (125) of the plug (120) by the tip (114) of the hollow needle (115). The welding temperature ensures sterilization and destruction of any bacteria present. The tip (114) of the needle (115) is crossed by the channel (119) which opens into the cavity (215) located behind the flat zone (210) of the component (200).

[0034] Presentation of a second variant embodiment of the connector according to the invention

[0035] This variant embodiment provides two retractable sealed sleeves (110, 120) connected by a flexible zone (130) deformable by displacement of the winding point to allow retraction by invagination.

[0036] The sleeve (110) is provided with the coaxial hollow needle (115) which moves axially together with the sleeve (110). The outer section of the hollow needle (115) corresponds substantially to the inner section of the sleeve (120) closed by the perforable bottom (125).

[0037] The inner section of the sleeve (110) is greater than the outer section of the sleeve (110) to allow the flexible zone (130) to be turned back during deformation by invagination. The needle (115) is guided by the sleeve (120), which prevents buckling when axial pressure is exerted.

Claims

Claims

1. Connector for aseptic fluid connection comprising a hollow perforating needle (115) and a stopper (120) and a tubular connector (110) sliding in axial translation relative to said stopper (120), characterized in that said connector (110) has a shoulder (118) for exerting an axial force in translation on said tubular connector (110) and in that the sliding stroke of said stopper (110) is greater than the distance between the bottom (115) of said stopper (110) and the tip (114) of the needle (125) before connection.

2. Connector according to claim 1 characterized in that said connection (100) is constituted by a tubular conduit having a connecting collar with a membrane crossed by said conduit.

3. Fluid connector according to claim 1 characterized in that said connector (100) has an annular shoulder (111) engaged, before sliding, in a complementary peripheral groove (112) provided on the inner surface of said plug.

4. Fluid connector according to claim 1 characterized in that the tubular wall of said plug (120) is elastically deformable to allow the sealed passage of said annular shoulder (111).

5. Fluidic connector according to claim 1 characterized in that the tubular wall of said needle (114) is pierced by at least one axial lumen (119) opening into the tip on the one hand and into the base on the other hand.

6. Fluid connector according to claim 1 characterized in that the section of said plug (120) is connected to said tubular connector (110) by a flexible invagination zone (130).

7. Fluid connector according to the preceding claim characterized in that said plug (120) has an external section smaller than the internal section of said tubular connection (110).

8. Fluidic connector according to claim 6 or 7 characterized in that said plug (120) has an internal section corresponding to the external section of the rear part (135) of said hollow needle (115).

9. Aseptic fluidic system comprising a connector (100) and a fluidic component (200) having a flat connection zone (210), said connector (100) comprising a hollow perforating needle (115) and a plug (120) surrounding a tubular connection (110) according to claim 1 - characterized in that the bottom (115) of the plug (110) at least is made of a material which can be heat-welded to the material of said flat connection zone, the material of said bottom (115) of the plug (110) is a material which is hot-melt at a temperature lower than the melting temperature of said needle (115) and higher than the temperature corresponding to the bacterial lethality rate for the minimum melting time, the material of said fluidic component (200) being capable of being perforated by said needle (115) by non-reversible deformation • said connector (110) has a shoulder (118) for axially locking the needle in a position where its tip (114) is set back from the bottom (115) of the plug (110) • the sliding travel of said plug (110) is greater than the distance between the bottom (115) of said plug (110) and the tip (114) of the needle (125) before connection.

10. Aseptic system according to the preceding claim, characterized in that the bottom (115) of the cap (110) at least is made of a material which can be heat-welded onto the material of said flat connection zone.

11. Aseptic system according to claim 9 characterized in that the material of said bottom (115) of said cap (110) is a heat-melting material at a temperature higher than the melting temperature of said needle (115) and higher than the temperature corresponding to the bacterial lethality rate for the minimum melting time.

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