Sterile connection device for a tube

Abstract

A sterile connection device for a tube, comprising: a tubular insert (20) defining a channel (21) and having an end section (20.1) provided with means for connecting it to a tube, the tubular insert being provided with a rod (25) axially extending in the channel in a cantilever manner; and an annular body (30) including a housing mounted on the end section of the insert and defining therewith for receiving an annular sealing element (40), the annular sealing element being deformable between a first state and a second state, in the first state, the annular sealing element defining a passage cross-section larger than the cross-section of the rod, in the second state, the annular sealing element tightly surrounds the rod, and the sealing element being designed to pass from its first state to its second state under the action of an axial compression exerted by the insert. A component for connecting two tubes includes two connection devices.

Description

Field of the Invention

[0001] The present invention relates to the field of conveying liquid or gaseous fluids, and more particularly to a sterile coupling device for joining two sterilization tubes together. Background Art

[0002] Known coupling assemblies are used to connect sterilization pipes together, which are connected to circuit elements in the pharmaceutical industry such as filters, centrifuges, pumps, storage tanks made of flexible plastic materials, or processing containers such as bioprocessors.

[0003] Such assemblies typically include two coupling devices that are joined together after each coupling device has been attached to the respective pipe end. Each device includes a tubular body that defines a passage arranged to receive the pipe end. The body has a front face that carries an annular sealing element firmly fastened thereto, and the pipe end makes a sealing contact therewith. The sealing element is covered in a protective film in the form of a strip, which is folded in half, with a part removably attached to the free flank of the sealing element and the other part forming a pull tab protruding from the first part.

[0004] After the pipe ends have been engaged in the body, the devices are placed facing each other on the same axis, and then they are moved towards each other until the protective film contacts and the sealing element is slightly compressed. By pulling the pull tab while removing the protective film, the flanks of the sealing element are brought into contact with each other, and thus a sterile passage is formed for the fluid to pass between the two pipes. The devices are moved closer together before locking the relative parts of the devices with a clamp.

[0005] At the end of the production process of a batch of pharmaceuticals, all the pipes and coupling devices are removed and incinerated. It has been found that repairing them (cleaning, disinfecting,...) is expensive and there is a risk of damaging the devices (wear, breakage, or even loss of a component).

[0006] However, it has been found that such a device with many components is particularly expensive for single use, especially when the usage time is very short.

[0007] It is also desirable to limit or even eliminate the flow of any fluid remaining in the pipes when disconnecting the devices. To do this, it has been proposed to equip the coupling device with a valve. Specifically, known washable and reusable coupling devices include a valve provided for this purpose. However, economically, it is not practical to equip disposable coupling devices with such a valve. Summary of the Invention

[0008] Object of the Invention

[0009] Accordingly, an object of the present invention is to provide a sterile connection device for a tube, which at least partially avoids the above problems. Summary of the Invention

[0011] To this end, the present invention provides a sterile connection device for a tube, the device comprising:

[0012] A tubular insert which defines a passage and has both a first end portion and a second end portion, the first end portion being provided with means for connecting it to a tube, the second end portion extending outside the tube, the tubular insert being provided with a cantilever rod which extends axially within the passage so as to have a free end portion which projects from the second end portion of the insert; and

[0013] An annular body which comprises both a first end portion mounted on the second end portion of the insert and a second end portion which projects axially from the second end portion of the insert so as to co-operate therewith to define a housing which is aligned with the free end portion of the rod for receiving an annular sealing element which is disposed between the front face of the second end portion of the insert and the inner lip of the second section of the annular body.

[0014] According to the present invention:

[0015] The annular sealing element is deformable between a first state and a second state, in which, in the first state, the sealing element defines a flow cross-section which is larger than the cross-section of the rod, and in the second state, the sealing element closely surrounds the rod, the sealing element being arranged to pass from its first state into its second state under the action of axial compression.

[0016] The sealing element has a front face which projects from the second section of the annular body, with a protective film removably fastened to the front face, the film having a pull tab which is folded down thereon, the pull tab having a first end connected to the edge of the protective film and a second end which projects from the edge of the film, opposite the first end of the pull tab; and

[0017] The first end portion of the body is mounted on the insert so as to be axially movable between a projecting position in which it projects axially from the insert and a flush position in which it is flush with the insert, in the projecting position the sealing element being in its first state and in the flush position the sealing element being axially fully compressed and in its second state.

[0018] Thus, the function of the sealing element is both to seal the connection of the tube and to completely close the passage, thereby limiting the number of components of the device while also preventing the flow of liquid remaining in the tube when the device is disconnected.

[0019] According to a specific feature of the present invention, the device includes means for locking the body in the extended position and the flush position.

[0020] According to another specific feature of the present invention, the device includes pre - coupling and coupling means for engaging with another coupling device.

[0021] In a particular manner, the pre - coupling and coupling means includes at least one locking tab that projects axially from the front face of the body and includes at least two serrated portions at the free end for co - operating with the edge of another coupling device.

[0022] The present invention also provides a coupling assembly for joining two tubes together, the coupling assembly including two such coupling devices.

[0023] Advantageously, the two coupling devices are identical.

[0024] The present invention also provides a method of joining two tubes together by means of such a coupling assembly, the method comprising the steps of:

[0025] Placing the devices axially facing each other;

[0026] Moving the devices towards each other until the pull tabs contact each other and the protective film bears against the front face of the body;

[0027] Removing the protective film by simultaneously pulling the pull tabs; and

[0028] Moving the devices towards each other again until the bodies bear against each other. Description of the Drawings

[0029] The present invention can be better understood from the following description, which is purely illustrative and non - restrictive and should be read with reference to the drawings, in which:

[0030] Figure 1 is an axial cross - sectional view of a coupling device in a particular embodiment of the present invention;

[0031] Figure 2 is Figure 1 a cross - sectional view of the coupling device shown;

[0032] Figure 3 is Figure 1 a end view of the coupling device shown in ;

[0033] Figure 4A is an axial cross - sectional view of a coupling assembly before connection in a particular embodiment of the present invention;

[0034] Figure 4B is similar to Figure 4AView before removing the protective film during connection;

[0035] Figure 4C is similar to Figure 4A View after removing the protective film during connection;

[0036] Figure 4D is similar to Figure 4A View after connection;

[0037] Figure 5A is similar to Figure 4D View before disconnection;

[0038] Figure 5B is similar to Figure 5B View during disconnection; and

[0039] Figure 5C is similar to Figure 5A View after disconnection. Detailed implementation

[0040] The application of the present invention is described below. The first sterilized pipe 100 forming the first fluid delivery pipe is connected to the second fluid delivery pipe formed by the second sterilized pipe 200.

[0041] Referring to Figures 4A to 4D , in the first specific embodiment of the present invention, the fluid coupling assembly given the general reference numeral 1 includes two coupling devices 10 that cooperate to provide a sterile connection between the first pipe 100 and the second pipe 200. These two devices 10 are identical and are distinguished in the drawings by adding the letters A or B.

[0042] As Figure 1 shown, each device 10 includes a tubular end piece or insert 20 that defines a channel 21 through which fluid passes.

[0043] The insert 20 has a first end section 20.1 that defines a first hole 22.1 that forms part of the channel 21. The first section 20.1 has a tapered outer projection 23 and a collar 24 that form a spigot for anchoring this first section in the pipe 100 or 200, and a seat for preventing insertion into the pipe 100 or 200, respectively.

[0044] The insert 20 has a second end section 20.2 which defines a second hole 22.2 having the same axis as the first hole 22.1 and forming part of the passage 21. Inside the second section 20.2 there is provided a cylindrical cantilever rod 25 which extends axially within the passage 21 such that the free end portion 25.1 of the rod projects out of the second section 20.2 of the insert 20. As Figure 2 shown, the rod 25 is connected to the second hole 22.2 via four vanes 26 which are evenly distributed around the rod 25. In this example, the diameter of the rod 25 is such that the fluid flow cross-sectional area of the passage 21 is substantially the same in the first section 20.1 and the second section 20.2.

[0045] The second section 20.2 of the insert 20 is also provided externally both with a ferrule 27 disposed at the free end of the second section 20.2 and with three detents 28.1, 28.2 and 28.3 having substantially the same outer diameter around the axis. The ferrule 27 defines the front face of the second section 20.2 of the insert 20 and it forms a first centering means for centering the tubular body 30 mounted on the insert 20. The detents 28.1, 28.2 and 28.3 form both a second centering means for centering the body 30 on the insert 20 and a locking means for locking the body 30 in place on the insert 20, as described below.

[0046] The body 30 has both a first end section 30.1 mounted on the second section 20.2 of the insert 20 and a second end section 30.2 which projects axially from the second section 20.2 of the insert 20.

[0047] The first section 30.1 has four axial grooves extending from the free edge of the first section 30.1 so as to define two diametrically opposed blade portions 31 and 32 therebetween, each blade portion having one end fixed to the remainder of the first section 30.1 and an opposite end which carries internal teeth 31.1 or 31.2 which cooperate with the flanks of the first detent 28.1. The blade portions 31 and 32 are elastically deformable between a rest state and a deformed state, in the rest state the through-section left by the teeth 31.1 and 32.1 being less than the diameter of the detents 28.1, 28.2 and 28.3 of the insert 20, and in the deformed state the through-section left by the teeth 31.1 and 32.1 being greater than the diameter of the detents 28.1, 28.2 and 28.3. The blade portion 31 differs from the blade portion 32 in that it includes at its free end an extension 31.2 which is arranged to receive a lifting force which causes the blade portion 31 to enter its deformed state.

[0048] The retaining rings 28.1, 28.2 and 28.3 of the insert 20 have a chamfered outer periphery to prevent the body 30 from being mounted on the insert 20 and to prevent the body 30 from axially moving from the protruding position where the teeth 31.1 and 32.1 of the blade portions 31 and 32 co-operate with the side wings of the first retaining ring 28 ( Figure 1 and Figures 4A to 4D ) to the flush position of the insert 20, where the teeth 31.1 and 32.1 co-operate with the side wings of the third retaining ring 28.3 ( Figure 5B and Figure 5C ), but also to prevent the body 30 from axially moving from its flush position towards its protruding position. As can be seen from Figure 1 , only the periphery of the second retaining ring 28.2 is partially non-chamfered to prevent the body 30 from axially moving from its protruding position to its flush position, unless a lifting force sufficient to bring the blade portion 31 into its deformed state is applied.

[0049] As Figure 2 shown, the periphery of each of the retaining rings 28.1, 28.2 and 28.3 has two diametrically opposite projections 29, which are arranged to be received in two grooves formed in the body 30 in order to constrain the body 30 and the insert 20 together during rotation.

[0050] The second section 30.2 of the body 30 co-operates with the second section 20.2 of the insert 20 to define a housing aligned with the end 25.1 of the rod 25 for receiving an annular sealing element 40, which is placed between the front end face of the second section 20.2 formed by the ferrule 27 and an annular lip 33 formed on the second section 30.2 and protruding inwards at the free end of the second section 30.2.

[0051] The second section 30.2 of the body 30 is externally provided with three fins 34.1, 34.2 and 34.3, which form an implement for the gripping device 10. The fins 34.1, 34.2 and 34.3 are coaxial with respect to the axis and they have substantially the same outer diameter. The first gripping fin 34.1 protrudes radially in alignment with the lip 33, and they together define the front end face 35 of the body 30 for co-operation with the front end face of the body of another device 10.

[0052] It should be noted that when the body 30 is in the flush position, the front end face 35 of the body 30 and the free end of the end 25.1 of the rod 25 are substantially in the same plane in this example.

[0053] Two elastically deformable locking tabs 36 (which are substantially rectangular in this example) protrude axially from the front end face 35 of the body 30, near its periphery. As Figure 3As shown, the locking tab 36 is symmetric and extends parallel to Figure 1 the plane of Figure 1 . The locking tab 36 has a free end, and each locking tab has an outer surface which is provided with two serrated portions 36.1 and 36.2 for providing both pre - coupling and coupling for the device 10 and another device 10.

[0054] The first fin 34.1 and the second fin 34.2 of the body 30 are each provided with two first openings 37.1 and two second openings 37.2 which are substantially rectangular, and each opening is for receiving a part of the corresponding locking tab 36 of another device 10. The openings 37.1 in the first fin 34.1 are arranged near the periphery of the ferrule 37 and they are diametrically opposite to the locking tab 36. The openings 37.2 in the second fin 34.2 are aligned with the openings 37.1 in the first fin 34.1, and each opening has an edge for co - operating with the serrated portions 36.1 and 36.2 of the corresponding locking tab 36 of another device 10.

[0055] The sealing element 40 is in leak - free contact with the front end face of the second section 20.2 and with the inner wing of the lip 33 facing the front end face. The sealing element 40 is deformable from a first state and a second state. In the first state, the flow cross - section defined by the sealing element is larger than the cross - section of the rod 25 of the insert 20. In the second state, the sealing element tightly surrounds the rod 25, and it is arranged to move from its first state to its second state under the action of axial compression. Such a sealing element is known from document EP2569665.

[0056] When the body 30 is axially moved from its protruding position to its flush position, the insert 20 compresses the sealing element 40 forcefully enough against the lip 33 to cause the sealing element to move from its first state to its second state.

[0057] The sealing element 40 has a front end face protruding from the second section 30.2 of the body 30, and the front end face has a protective film 50 removably fastened thereto. The protective film 50 has a pull tab 51 which is folded down onto the protective film so that the protective film 50 can be removed without being touched. The pull tab 51 has a first end connected to one edge of the protective film 50 and a second end protruding from the edge of the protective film 50 opposite to the first end of the pull tab 51. At its center, the second end of the pull tab 51 has a hole 51.1, and the shape of the hole is such as to allow a finger to pass through the hole 51.1 to make the tongue 51 easier to grip.

[0058] To avoid any deterioration or contamination of the sealing element 40 during storage and transportation of the device 10, a protective cover 60 is removably mounted on the second section 30.2 of the body 30. For example, the cover 60 can be arranged to elastically clip onto the third fin 34.3 and removed immediately prior to coupling the device 10 to other devices 10.

[0059] It should be noted that the entire device 10 is sterilized in the factory so as to be free from any contamination prior to storage.

[0060] The operation of the coupling assembly 1 will be described below with reference to Figures 4A to 5C the description of the coupling assembly 1 will be described below with reference to

[0061] The end section 20.1 of the first device 10A is initially engaged within the first tube 100 until the first tube abuts against the ferrule 24 of the first device 10A. Similarly, the end section 20.1 of the second device 10B is engaged within the second tube 200 until the second tube abuts against the ferrule 24 of the second device 10B, such that the first device 10A and the second device 10B are respectively anchored within the first tube 100 and the second tube 200.

[0062] The protective covers 60 of the first device 10A and the second device 10B are then removed from the body 30, thereby particularly revealing the locking tabs 36 and the openings 37.1 and 37.1 of the body 30.

[0063] Thereafter, the first device 10A and the second device 10B face each other along a common axis, and the first device 10A is rotated 180° about the axis relative to the second device 10B so that the locking tab 36 and the openings 37.1 and 37.2 of the first device 10A respectively face the openings 37.1 and 37.2 and the locking tab 36 of the second device 10B ( Figure 4A ).

[0064] In a first stage, the first device 10A and the second device 10B are moved towards each other until the tongues 51 of the first device 10A and the second device 10B come into contact. Each of the openings 37.1 and 37.2 in the first device 10A then receives a portion of the corresponding one of the locking tabs 36 of the second device 10B, and each of the openings 37.1 and 37.2 in the second device 10B then receives a portion of the corresponding one of the locking tabs 36 of the first device 10A.

[0065] As the first device 10A and the second device 10B continue to move towards each other, the protective film 50 is pressed against the front end face 35 of the body 30 formed by the lip 33 and the first fin 34.1, thereby gently pressing the end portion of the sealing element 40 protruding from the front end face, and also causing the first serrated portion 36.1 of the locking tab 36 of the first device 10A to cooperate with the edge of the second opening 37.2 of the second device 10B, and causing the first serrated portion 36.1 of the locking tab 36 of the second device 10B to cooperate with the edge of the second opening 37.2 of the first device 10A( Figure 4B ). This can be said to constitute the "pre-connection" of the first device 10A and the second device 10B.

[0066] Then, the protective film 50 is removed by passing the same finger through the hole 51.1 in the tongues 51 of the first device 10A and the second device 10B and simultaneously pulling the tongues 51, so that the end portions of the sealing elements are decompressed and they come into leak-free contact with each other( Figure 4C ).

[0067] Then, the first device 10A and the second device 10B move towards each other one last time so as to press the front end faces 35 of the bodies 30 against each other, thereby once again slightly compressing the end portions of the sealing element 40 and causing the second serrated portion 36.2 of the locking tab 36 to cooperate with the edge of the second opening 37.2( Figure 4D ). This can be said to constitute the "connection" of the first device 10A and the second device 10B, and then they together form a passage for transferring fluid between the first pipe 100 and the second pipe 200.

[0068] When it is appropriate to disconnect the first device 10A from the second device 10B, an upward force is initially applied to the extension portion 31.2 of the first blade portion 31 of the body 30 so as to cause the blade portion 15 to enter its deformed state, thereby allowing the body 30 to move axially towards the flush position( Figure 5A ).

[0069] Then, an axial force is applied to the insert 20, for example via the pipes 100 and 200, so as to cause the body 30 to enter the flush position, thereby fully compressing the sealing element 40 so that it tightly surrounds the rod 25 of the insert 20( Figure 5B ). Then, the free ends of the end portions 25.1 of the rod 25 are substantially in contact, and fluid can no longer flow between the first pipe 100 and the second pipe 200, and in particular between the first device 10A and the second device 10B.

[0070] Then, when the teeth 31.1 of the first blade portion have passed over the second retaining ring 28.2, the upward force applied to the first blade portion is stopped, and the teeth 31.1 no longer impede the movement of the body 30 towards the flush position.

[0071] Once in the flush position, due to the force generated by the compression of the sealing element 40, the teeth 31.1 and 31.2 impede the axial movement of the body 30 towards the protruding position. Then, a pinching force is applied simultaneously to the locking tabs 36 of the first device 10A and the locking tabs 36 of the second device 10B so as to elastically deform the said locking tabs 36 and enable the bodies 30 to be separated from each other( Figure 5C ). Thus, the function of the sealing element 40 that closely surrounds the rod 25 is to prevent the flow of fluid remaining in the tubes 100 and 200 when the devices 10A and 10B are disconnected.

[0072] Of course, the present invention is not limited to the described embodiments, but covers any variant falling within the scope of the present invention as defined by the claims.

[0073] Although in the foregoing, the coupling assembly includes two identical devices 10A and 10B, it may equally well include two different devices. For example, the locking tabs 36 of the first device 10A may be replaced by openings, while the openings 37.1 and 37.2 of the second device may be replaced by locking tabs so as to form a male connector and a female connector.

[0074] Although in the foregoing, the devices 10A and 10B are fastened together by means of a clamp, they may equally well be coupled together by any other means, such as screwing a part of the device 10A onto the other device 10B.

[0075] Although in the foregoing, the tubes 100 and 200 are anchored to the devices 10A and 10B by means of plug-ended protrusions, they may equally well be anchored by any other means, such as snap rings, washers with external teeth or elastically deformable arms.

[0076] Although in the foregoing, the body 30 is locked in the protruding position and locked in that position by using a snap ring, it may equally well be locked in that position by any other means, such as by using a nail.

[0077] Although in the foregoing, the sealing element is symmetrical, it is not necessarily so.

[0078] The steps for disconnecting the devices 10A and 10B may be carried out simultaneously on both the devices 10A and 10B, or the said steps may be carried out on one of the devices and then on the other device.

Claims

1. A sterile connection device (10) for a tube, characterized in that, The aseptic coupling device comprises: a tubular insert (20) which defines a channel (21) and has both a first end portion (20.1) and a second end portion (20.2), the first end portion being provided with means for connecting it to a tube, the second end portion extending outside the tube, the tubular insert being provided with a cantilever rod (25) which extends axially within the channel so as to have a free end portion (25.1) protruding from the second end portion of the insert; and an annular body (30) which comprises both a first end portion (30.1) mounted on the second end portion of the insert and a second end portion (30.2), the second end portion of the annular body protruding axially from the second end portion of the insert so as to cooperate therewith to define a housing aligned with the free end portion of the rod for receiving an annular sealing element (40), the annular sealing element being placed between the front face of the second end portion of the insert and the inner lip of the second end portion of the annular body, and the annular sealing element being deformable between a first state and a second state, in the first state the sealing element defining a fluid flow cross-section greater than the cross-section of the rod, in the second state the sealing element tightly surrounding the rod, the sealing element being arranged to pass from its first state to its second state under the action of axial compression; and in that: the sealing element has a front face protruding from the second end portion of the annular body, with a protective film (50) removably fastened to the front face, the film having a pull tab (51) folded down thereon, the pull tab having a first end connected to the edge of the protective film and a second end protruding from the edge of the film, opposite the first end of the pull tab; and the first end portion of the body is mounted on the insert so as to be axially movable between a protruding position in which it protrudes axially from the insert and a flush position in which it is flush with the insert, in the protruding position the sealing element being in its first state, in the flush position the sealing element being axially fully compressed and in its second state.

2. The device according to claim 1, comprising means (28.1, 28.2, 28.3, 31, 32) for locking the body (30) in its protruding position and its flush position.

3. The device according to claim 1, comprising pre-connection and connection means (36, 37.1, 37.2) for engaging with another coupling device.

4. The device according to claim 3, wherein the pre-connection and connection means comprise at least one locking tab which protrudes axially from the front face of the body (30) and comprises at least two serrated portions (36.1, 36.2) at its free end for cooperating with the edge of another coupling device.

5. A coupling assembly (1) for coupling two tubes (100, 200) together, the coupling assembly comprising two coupling devices (10A, 10B) according to any one of the preceding claims.

6. The assembly (1) according to claim 5, wherein the two coupling devices (10A, 10B) are identical.

7. A method of connecting two tubes (100, 200) together by means of a coupling assembly according to claim 5 or 6, the method comprising the steps of: placing the devices axially facing each other; moving the devices towards each other until the pull tabs (51) contact each other and the protective film (50) bears against the front face of the body (30); removing the protective film by simultaneously pulling on the pull tabs; and again moving the devices towards each other until the bodies bear against each other.

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