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 fitting (110) sliding axially relative to said stopper (120), characterized in that said fitting (110) has a shoulder (118) for exerting an axial force in translation on said tubular fitting (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 the invention

[0001] The present invention relates to the field of personalized cell immunotherapy and more particularly to the collection and automated processing of cell subsets, in particular CAR-T cells (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 while 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 carried into the environment.

[0003] Connecting the tube by welding generally involves using a sterile tube welding machine to weld the thermoplastic tube aseptically. One type of tube welding machine sterilizes a cutting blade or plate, then moves the blade across 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] French 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 having 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 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 displaced to form a joint between the two thermoplastic tubes.

[0006] Patent EP0975301 describes a sterile connector for connecting a tube to a container holding a medical liquid, with a connecting piece equipped of a channel-shaped recess, which is closed by a perforable membrane, the perforable membrane being made as a film which covers the channel-shaped recess and which is fixed by welding to the lower side of the connecting piece, the connecting piece being provided with a lower part which can be placed in the wall of the container and which can be made watertight with respect to the wall of the container and an upper tubular part to receive a piercing punch, to which the pipe is connected and a protective cap designed as a part which can be detached by breaking, which closes the upper tubular part of the connecting piece, being provided.The upper edge of the tubular upper part includes an inwardly directed circular shoulder, which is followed by a connecting piece receiving the drilling 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 a fastening system for attaching a connector to an administration port of a fluid container, comprising a housing having a receiving chamber configured to receive the administration port, the receiving chamber having a wall and at least one flexible retaining element attached to the wall of the receiving chamber, the at least one flexible retaining device configured to engage in a non-removable manner with the administration port when the administration port is inserted into the receiving chamber and to fix the administration port inside the receiving chamber, and a needle at least partially inside the receiving chamber and configured to pierce the administration port when the administration port is inserted into the receiving chamber. Disadvantages of prior art

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

[0009] These parts have different surfaces, making contamination difficult to avoid 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 overcome these drawbacks and proposes a connector for aseptic fluid connection comprising a hollow piercing needle and a stopper and a tubular fitting sliding in axial translation relative to said plug characterized in that said fitting has a shoulder to exert an axial force in translation on said tubular fitting 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 fitting consists of a tubular conduit having a connecting collar with a membrane through which said conduit passes.

[0012] According to alternative embodiments: • said fitting 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 stopper is elastically deformable to allow the tight passage of said annular shoulder • the tubular wall of said needle is pierced by at least one axial lumen opening into the tip on one side and into the base on the other • the section of said plug is connected to said tubular fitting by a flexible invagination zone • said plug has an outer cross-section smaller than the inner cross-section of said tubular fitting • said stopper has an inner cross-section corresponding to the outer cross-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 area, said connector comprising a hollow piercing needle and a cap surrounding a tubular fitting referred to above.

[0014] The base of the stopper, at least, is made of a material that can be heat-welded to the material of said flat connection zone. The material of said base of the stopper is a thermofusible material 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 is capable of being perforated by said needle by irreversible deformation. - said fitting has a shoulder to axially lock the needle in a position where its tip is recessed relative to the bottom of the stopper - the sliding stroke of said stopper is greater than the distance between the bottom of said stopper and the tip of the needle before connection.

[0015] Advantageously: • the bottom of the cap at least is made of a material that can be hot-welded to the material of said flat connection area. • the material of said base of said stopper is a thermofusible material 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 implementation

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

[0017] [Fig-1] [Fig. 1] shows a view of the connector and the tubing before connection

[0018] [Fig.2] [Fig.2] shows a view of the connector and the tubing after connection

[0019] [Fig. 3] [Fig. 3] shows a view of the connector and the tubular tube 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 fluidic component (200), which may be a bag, for example a blood bag or a tube. This fluidic component (200) has a flat connection area (210).

[0022] The connector (100) extends the end of a fluidic conduit or 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) forms a cap closed at the front by a perforated base (125). The other sleeve forms a tubular fitting (110) comprising a hollow needle (115) having a piercing point (114), fixed on the front face of said sleeve.

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

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

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

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

[0030] The tubular fitting (110) includes a hollow needle (115) having a piercing point (114).

[0031] When the plug (120) is pushed back, the point (114) pierces the bottom (125) of the plug (120) and the seal between the plug (120) and the fitting (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 fitting (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 fitting (110).

[0032] The base (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

[0033] The connection between the connector (100) and the component (200) is made by infrared irradiation thermal welding or hot-blade contact thermal welding, by applying a heated mold to the base (125) of the plug (120) on one side and to the flat surface (210) of the component (200) on the other. 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 plug (120) to contract and the base (125) of the plug (120) to be pierced by the tip (114) of the hollow needle (115). The welding temperature ensures sterilization and the destruction of any bacteria present. The tip (114) of the needle (115) is traversed by the channel (119) which opens into the cavity (215) located behind the flat area (210) of the component (200).

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

[0035] This variant of the embodiment provides for 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 in conjunction with the sleeve (110). The external cross-section of the hollow needle (115) corresponds substantially to the internal cross-section of the sleeve (120) closed by the perforable base (125).

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

Claims

Demands

1. A connector for aseptic fluid connection comprising a piercing hollow 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 stopper (120) closed frontally by a perforable base (125), the other of said sleeves constituting a tubular fitting (110) comprising a hollow needle (115) having a piercing point (114), fixed on the front face of said sleeve, the tubular fitting (110) being, in its rest position, offset from the stopper (120) and, when axially displaced by the application of an axial force, in a piercing position where the needle breaks the base (125) of the stopper (120) to penetrate a cavity (215) of a fluidic component (200), said fitting (110) having a shoulder (118) for exert an axial translational force on said tubular fitting (110),the sliding stroke of said plug (110) being greater than the distance between the base (125) of said plug (110) and the tip (114) of the needle (115) before connection.

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

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

4. Fluidic connector according to claim 1 characterized in that the tubular wall of said plug (120) is elastically deformable to allow the tight 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 light (119) opening into the tip on one side and into the base on the other.

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

7. Fluidic connector according to the preceding claim characterized in that said plug (120) has an outer section smaller than the inner section of said tubular fitting (110).

8. Fluidic connector according to claim 6 or 7 characterized in that said plug (120) has an inner section corresponding to the outer 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 by means of a hollow piercing needle (115) and a stopper (120) surrounding a tubular fitting (110) according to claim 1 - characterized in that the base (115) of the stopper (110) at least is made of a material that can be heat-welded to the material of said flat connection zone, the material of said base (115) of the stopper (110) is a material that is hot-meltable 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 irreversible deformation; said fitting (110) having a shoulder (118) to axially lock the needle in a position where its tip (114) is recessed relative to the bottom (115) of the plug (110); the sliding stroke 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 stopper (110) at least is made of a material that can be heat-welded to the material of said flat connection area.

11. Aseptic system according to claim 9 characterized in that the material of said base (115) of said stopper (110) is a material hot melt 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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