Connector and system for aseptic fluidic connection

Abstract

The present invention relates to a connector provided for aseptic fluidic connection and comprising a perforating hollow needle, characterized in that it is formed of two telescopic sleeves cooperating in a sealed manner, one of the sleeves constituting a stopper closed at the front by a perforable base, while the other of the sleeves, constituting a tubular connector piece, comprises a hollow needle having a perforating tip fixed to the front face of the sleeve, the tubular connector piece, in a rest position, being in a spaced-apart position with respect to the stopper and, when moved axially, by the application of an axial force, being in a perforating position in which the needle pierces the base of the stopper in order to penetrate into a cavity of a fluidic component, the connector piece having a shoulder allowing a translational axial force to be applied to the tubular connector piece, the sliding travel of the stopper being greater than the distance between the base of the stopper and the tip of the needle before connection.

Description

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 to handle fluids, keeping them free of contaminants. Attempts have been made to develop connector assemblies that isolate a fluid from the connector's ambient environment, 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 insert, 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] US6341802 describes an exemplary connector assembly comprising first and second fittings, and first and second membrane assemblies. Each fitting defines a respective opening. Each membrane assembly has a layer sealing the opening, and a removable contaminant-retaining layer overlying a respective sealing layer. The first and second fittings may be resiliently coupled and biased in opposition to provide positive contact between the first and second removable contaminant-retaining layers and / or the first and second sealing layers by urging them toward each other. In one embodiment, a connector assembly may define a fluid communication path to manipulate a liquid without allowing the level of contaminants in the liquid to increase.

[0005] US9951899 discloses an aseptic fluid connector, having a male connector and a female connector matable for aseptically transferring a fluid therethrough. The male connector includes a closure and a piercing member including a hollow stem for receiving a fluid therein, a tip, and at least one orifice in fluid communication with the interior of the hollow stem for passage of the fluid therethrough. The closure and / or the stem is movable between a first position in which the closure closes the at least one orifice, and a second position opening the at least one orifice. The female connector includes a pierceable septum. The male and female connectors are matable such that the piercing member pierces the pierceable septum.Only when the pierceable element has fully penetrated the pierceable septum can the closure and / or stem move from the first position to the second position to aseptically transfer a fluid therethrough.

[0006] Patent EP0975301 relates to a sterile connector for connecting a flexible pipe line to a container of liquid for medical use. The sterile connector has a fitting with a channel-like cavity, closed by a pierceable membrane designed as a covering film for the fitting. This film is welded to the underside of the fitting, and the welding can be carried out with a bag-like film. A protective cap designed as a stopper closes the channel-like cavity of the fitting.

[0007] Patent WO0160436 relates to a needleless access system adapted to be mounted on a vial, comprising a generally elongated tubular housing having an interior partition wall, flexible hooks projecting upwardly from the partition wall which are diametrically opposed, a pair of opposed flutes projecting upwardly from the interior partition wall, a sleeve insertion portion having a piercing point carried normally in an armed position by hook members, a series of outwardly projecting teeth which engage and are guided in the flutes during axial movement of the sleeve insertion portion relative to the fluted housing. Disadvantages of the prior art

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

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

[0010] The present invention aims to address these drawbacks and proposes a connector for aseptic fluid connection having the characteristics set out in claim 1 and optionally by the dependent claims. It comprises a hollow perforating needle and a stopper and a tubular connector sliding in axial translation relative to said stopper, characterized in that said connector has a shoulder for exerting an axial force in translation on said tubular connector and in that 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.

[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 connector has an annular shoulder engaged, before sliding, in a complementary peripheral groove provided on the inner 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 outer section smaller than the inner section of said tubular connector 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] The bottom of the plug at least 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 is heat-meltable 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 connection has a shoulder for axially locking the needle in a position where its tip is set back from the bottom of the plug, the sliding travel of said plug is greater than the distance between the bottom of said plug and the tip of the needle before connection.

[0015] Advantageously: the bottom of the plug at least is made of a material that can be heat-welded to the material of said flat connection zone. The material of said bottom of said plug is a material that can be hot-melted at 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 an 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] represents a view of the connector and the tubular before connection

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

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

[0020] 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 area (210).

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

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

[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 base (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] The sleeve (110) is a cylindrical part open at one of its front ends to allow communication with the plug (120), also formed by a cylindrical part whose front end opposite the sleeve (110) is closed by a perforable cover. These two sleeves (110, 120) can be constituted by two parts sliding relative to each other, or by a single part with a flexible envelope at the junction between the part forming the connection and the part forming the plug, this flexible junction zone forming a bellows which can be folded 180° by turning over, to pass from a longitudinal “S” section to an aligned section.

[0026] When the connector (100) is formed by a single piece, comprising two separate parts connected by a flexible junction zone, this flexible junction zone is designed in the form of a flexible bellows, allowing great mobility by unrolling while ensuring sealing and structural continuity between the two parts. The first part of the element forms a connection, intended to fit or connect to another component, thus ensuring the passage of a fluid. The second part forms a plug, closed at the front to prevent leakage or contamination of the fluid.

[0027] The soft junction area, located between these two parts, consists of a flexible envelope. This envelope is specifically designed to form a bellows that allows a 180° folding movement. The bellows is able to fold or turn over on itself, thus changing the shape of the element between two distinct configurations: A first configuration, where the element adopts an "S" shaped longitudinal section. This configuration is particularly useful when the element is in a rest position or when a certain flexibility is required to avoid excessive stress on the connection. A second configuration, where the element adopts an aligned section. This configuration is obtained when the bellows turns over, thus aligning the two parts to allow a direct connection or optimal insertion.

[0028] 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).

[0029] Presentation of a first variant embodiment of the connector according to the invention

[0030] 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 whatever the position of the plug (120) relative to the tubular connection (110).

[0031] The plug (120) is locked in the forward 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).

[0032] When the plug (120) is in the retracted position, its rear end face (113) comes into contact with the front surface of a shoulder (118) extending in a transverse plane on the tubular fitting (110).

[0033] The tubular connector (110) comprises a hollow needle (115) having a piercing tip (114).

[0034] 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).

[0035] The bottom (125) of the stopper (120) is made of a hot-melt 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

[0036] 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).

[0037] Presentation of a second variant embodiment of the connector according to the invention

[0038] 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.

[0039] 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).

[0040] The inner section of the sleeve (110) is greater than the outer section of the sleeve (110) to allow the flexible zone (130) to bend back during invagination deformation. The needle (115) is guided by the sleeve (120), which prevents buckling when axial pressure is exerted.

Claims

Connector for aseptic fluid connection comprising a hollow perforating needle (115), characterized in that it is formed of two telescopic sleeves (110, 120), cooperating in a sealed manner, one of said sleeves constituting a plug (120) closed at the front by a perforable bottom (125), the other of said sleeves constituting a tubular connector (110) comprises a hollow needle (115) having a perforating point (114), fixed on the front face of said sleeve, the tubular connector (110) being, in the rest position, in a position spaced apart from the plug (120) and, moved axially, by the exercise of an axial force, into a perforation position where the needle breaks the bottom (125) of the plug (120) to penetrate into a cavity (215) of a fluidic component (200), said connector (110) having a shoulder (118) to exert an axial force in translation on said tubular connection (110),the sliding travel of said plug (110) being greater than the distance between the bottom (125) of said plug (110) and the tip (114) of the needle (115) before connection., 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. 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 interior surface of said plug. 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). 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. 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). 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). Fluid 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). 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 connector (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., 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. Aseptic system according to claim 9 characterized in that the material of said bottom (115) of said stopper (110) is a material which melts 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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