Sterile connection

Abstract

A method for the sterile connection of a cut end (13) of a silicone tube (1) with a connection element (2), the method comprising sterilizing the cut end (13) using ultraviolet C (UVC) radiation (5) and then connecting the cut end (13) with the connection element (2), thereby providing an adhesive-free connection. A device for implementing the method, the device comprising an operating chamber within which are arranged: a tube support configured to receive a silicone tube (1), an additional support configured to receive a connecting element (2), a UVC radiation source (5) configured to sterilize the silicone tube, and a driver configured to move the supports relative to each other. The UVC radiation (5) may comprise VUV (vacuum ultraviolet) radiation. UVC radiation can also cause surface activation of the silicone tube (1). The connecting element (2) can be a second silicone tube.

Description

Technical Field

[0001] The present invention relates to a method for connecting the cut end of a silicone tube to a connecting element, and an apparatus for carrying out the method. Background Technology

[0002] Plastic tubing typically has a circular cross-section, allowing for the circulation, flow, and connection of fluids. Aseptic connections of plastic tubing are used in various fields, including biotechnology, chemistry, medicine, and pharmaceuticals, to facilitate the transport and discharge of fluids or to seal fluid pathways.

[0003] In most cases, the operations performed on such tubes—especially cutting them into segments—must be carried out aseptically, meaning the bacterial integrity of the tubes must be preserved.

[0004] In some cases, the conduit needs to be cut into sections. To do this, fluid circulation within a given section is shut off by clamping the section to stop the fluid flow, thus separating the conduit into two sections or segments. The cut sections are then sealed or connected to other sections (as described in document US8857485), optionally possessing specific functions such as storage or filtration.

[0005] The sealing and joining of cut pipe segments is typically performed in a non-sterile environment, and therefore usually involves heating a cutting component such as a cutting blade. The heated cutting blade then comes into contact with the pipe, causing it to partially melt, thereby enabling it to fuse or seal with a pipe plug or other pipe segment.

[0006] However, silicone tubing is more difficult to handle compared to commonly used thermoplastic tubing. Silicone is favored for its excellent and unique mechanical properties and inertness. While silicone is the material of choice for fluid circulation due to its advantageous flexibility and pumpability, it softens when heated, making it difficult to cut with heated cutting tools. Furthermore, silicone becomes sticky when heated, making it difficult to cleanly separate the two parts of a silicone tube.

[0007] Therefore, cutting silicone tubing to connect it to another fluid passage or sealing it in a sterile manner remains a challenge.

[0008] Therefore, the purpose of this application is to provide a method for achieving aseptic connection or sealing of silicone tubes. Summary of the Invention

[0009] Therefore, the present invention provides a method for aseptically connecting a cut end of a silicone tube to a connecting element, the method comprising: sterilizing the cut end using UVC radiation to obtain a sterile cut end; and connecting the cut end to a connecting element to provide an adhesive-free connecting assembly.

[0010] Other optional, non-restrictive features are as follows.

[0011] The method may also include sterilizing the connecting elements with UVC radiation prior to connection, thereby obtaining sterile connecting elements.

[0012] UVC radiation can be radiation with one or more wavelengths from 100 nm to 280 nm, and therefore can consist of or be entirely composed of VUV radiation.

[0013] VUV radiation can have one or more wavelengths between 100 nm and 200 nm, preferably between 150 nm and 190 nm, and more preferably about 172 nm.

[0014] The advantage of this method is that it can provide sterile connections in any environment, so a cleanroom environment is not required. This is especially important because it imposes fewer restrictions than a cleanroom environment.

[0015] This method is advantageously implemented in a device with controlled parameters selected from the following list: temperature, humidity.

[0016] The method may include sterilizing the environment of the silicone tubing and connecting elements.

[0017] The sterilization of the cut ends and the sterilization of the connecting elements can be performed using the same VUV wavelength or different VUV wavelengths.

[0018] This is particularly advantageous for silicone tubing made of silicone, because sterilization under VUV radiation further activates the silicone surface, thereby promoting adhesion between the cut ends of the silicone tubing and the connecting elements.

[0019] Activation of the silicone surface leads to surface modification. This modification may include structural changes and / or changes in material composition of the modified surface compared to unmodified silicone. This modification is particularly achieved through VUV radiation with wavelengths of 200 nm or lower.

[0020] When VUV radiation acts on the cross-section of the cut end of a silicone tube, it causes further structural modification, resulting in cracks.

[0021] It has been shown that modifying the surface of silica gel according to the present invention results in, at least in preferred cases, a slight increase in oxygen content and a slight decrease in carbon content compared to unmodified silica gel, as illustrated in WO 2015 / 075040. In this context, it is assumed that the decrease in carbon content is due to the degradation of carbon functional groups (here caused by radiation), accompanied by the introduction of oxygen functional groups, particularly the formation of silanol groups.

[0022] Therefore, the sterilized cut end presents an activated surface that is easy to connect with sterile connecting elements, thus providing a sterile adhesive-free connection without the need for any adhesive materials or additives.

[0023] Furthermore, also in the case of silicone, modification of the silicone surface can lead to the formation of crack structures with a depth of 2-50 μm, thereby creating rough areas, as shown in WO 2016 / 030183.

[0024] This method ensures a physically resistant, sterile, adhesive-free connection between the sterilized cut end of the silicone tube and the connecting element without the need for additional adhesive materials. In fact, the connection between the VUV-treated cut end and the connecting element is performed immediately or within a very short time after the sterilization step.

[0025] The mechanical durability of achievable welds exceeds that of the mechanical materials.

[0026] Silicone tubing can be UVC-free.

[0027] The connecting elements can be made of silicone.

[0028] Connection may include bringing the cut end into contact with the connecting element. In practice, connection may also include directly contacting the cut end of the silicone tube with the connecting element and simultaneously bonding them together, thereby providing a sterile, adhesive-free connection.

[0029] The method may further include a cutting step prior to sterilizing the cut ends and the connecting elements, wherein the cutting includes sterilizing the cutting member and using the cutting member to transversely cut the silicone tube, thereby providing two silicone tube portions, each having a cut end. Advantageously, the cutting member is at room temperature during cutting.

[0030] According to an alternative embodiment, the cutting component is at a temperature above room temperature, preferably below 150°C, during cutting.

[0031] According to an alternative embodiment, the cutting component is at a temperature below room temperature during cutting.

[0032] UVC radiation is preferred for sterilizing the cut components. However, heating can be used as an alternative.

[0033] UVC radiation is typically radiation below 280 nm (referred to as UVC).

[0034] UVC radiation may include at least some VUV radiation.

[0035] The method may further include a clamping step prior to cutting, wherein clamping includes clamping the silicone tube at its clamping point to obtain a sealing area within the tube, and subsequently making a transverse cut at a cutting point adjacent to the clamping point to provide a cut end. Clamping the silicone tube may also include clamping the silicone tube at another clamping point, wherein the cutting point is located between the clamping point and the other clamping point.

[0036] The silicone tube can be clamped and transversely cut at its cutting point simultaneously.

[0037] The method may also include a step of sterilizing the silicone tubing and / or connecting elements with UVC radiation prior to clamping and / or cutting.

[0038] The method may also include sterilizing the silicone tube and connecting elements simultaneously using UVC radiation before clamping or cutting the silicone tube.

[0039] The preferred distances between the clamping point and the cutting point, as well as between another clamping point and the cutting point, are selected to create a flat region between the clamping points. Therefore, the transverse cutting is performed within this flat region, as described in document US8857485.

[0040] Clamping the silicone tube may include clamping the silicone tube at a first clamping point and a second clamping point, wherein the second clamping point is located between the first clamping point and the cutting point, and the method may further include releasing the tube at the second clamping point to provide a released cutting end. Before lateral cutting, clamping the silicone tube may further include clamping the silicone tube at another first clamping point and another second clamping point, wherein the other second clamping point is located between the other first clamping point and the cutting point, and wherein the cutting point is located between the second clamping point and the other second clamping point. Preferably, the following distances are selected: - The distance between the first clamping point and the second clamping point; - The distance between the second clamping point and the cutting point; - The distance between the cutting point and another second clamping point; and - The distance between another second clamping point and another first clamping point; To obtain a flat region between the first clamping point and another first clamping point.

[0041] However, the following distances are preferred: - The distance between the first clamping point and the cutting point; and - The distance between the other first clamping point and the cutting point; So that when the second clamping point and another second clamping point are released after the transverse cut, the cut end is in the released open state.

[0042] As an alternative to clamping the tube at the second clamping point and another second clamping point, the tube cutting end can be released by moving the first clamping point and another first clamping point away from the tube cutting end.

[0043] Connecting the sterile cut end of the silicone tube to the connecting element may include loosening the silicone tube portion.

[0044] The method may also include sterilizing the adhesive-free connection assembly using UVC radiation after the silicone tube is loosened.

[0045] In the wavelength range of approximately 200 to approximately 280 nanometers (nm), which corresponds to the UVC region, nucleic acids in microorganisms are destroyed. This leads to bacterial death and viral inactivation.

[0046] UVC radiation at 280 nm or lower has excellent bactericidal properties, inactivating a variety of microbial pathogens, such as bacteria, fungi, yeasts, molds, and viruses. Specifically, within the range of approximately 200 nm to approximately 280 nm, the effective range of UV-C, nucleic acids in microorganisms are destroyed. This leads to bacterial death and viral inactivation.

[0047] In a sealing embodiment, the connecting element can be a sealing element, such as a stop or heat shrink tubing. The sealing element can be made of silicone.

[0048] The plug can be a sheet material with a cross-section that contacts and covers the cross-section of the cut end.

[0049] Alternatively, the plug can be a rod with a cross-section that contacts or covers the cross-section of the cut end.

[0050] In the latter case, the method may include: clamping the silicone tube at a clamping point and another clamping point, with the cutting point located between the clamping point and the other clamping point; using a cutting member to laterally cut the silicone tube at the cutting point between the clamping point and the other clamping point, thereby providing two tube portions, each having a cut end; removing the cutting member relative to the cutting point; using the cutting member to laterally cut a rod, thereby providing two rod portions, each having a rod cut end; and contacting each rod cut end with the corresponding tube cut end.

[0051] After contact, the cross-section of the cut end of the tube can remain clamped. Heat shrink tubing can also be added, as described below.

[0052] The transverse cutting tube and transverse cutting rod can be cut by a single relative motion of the cutting components.

[0053] The method may also include, prior to transversely cutting the tube, arranging the tube and rod so that their longitudinal axes are collinear with each other, thereby providing two sets of transverse cuts, each set having a tube section and a rod section; and rotating one set 180° relative to the other set about a rotation axis that is collinear with the longitudinal axes of the tube and rod sections.

[0054] A plane containing two longitudinal axes can have any orientation. In particular, the plane can be horizontal, vertical, or at an angle of, for example, 45° relative to a vertical line.

[0055] When the plug is a heat shrink tubing, the connection may include inserting a sterilized, cut end into the open end of the heat shrink tubing and heating the tubing to provide an adhesive-free seal at the cut end. Sterilization may be performed after or during the connection.

[0056] In the welding embodiment, the silicone tube can be welded to another second silicone tube. In this embodiment, the connecting element can be the second silicone tube itself. Heat shrink tubing can also be added, as described below.

[0057] When the connecting element is a second silicone tube, the method may include: clamping the silicone tube at a clamping point and another clamping point, with a cutting point located between the clamping point and the other clamping point; using a preferably unheated cutting member to laterally cut the silicone tube at a cutting point adjacent to the clamping point and the other clamping point, thereby providing two tube portions, each having a cut end; clamping the second silicone tube at the clamping point to obtain a sealing area within the second silicone tube; using the cutting member to laterally cut the second tube at a cutting point adjacent to the clamping point, thereby obtaining two tube portions, each having a cut end; and contacting each cut end of the silicone tube with a corresponding cut end of the second silicone tube portion.

[0058] The second silicone tube can be clamped at one clamping point and another clamping point, and the cutting point is located between the clamping point and the other clamping point.

[0059] Laterally cutting the silicone tube and the second silicone tube can be performed through a single relative motion of the cutting component.

[0060] The method may further include, prior to transversely cutting the silicone tube and the second silicone tube, arranging the silicone tube and the second silicone tube such that their longitudinal axes are collinear with each other, thereby providing two sets of transverse cuts, each set having a portion of the silicone tube and a portion of the second silicone tube; and rotating one set 180° relative to the other set about a rotation axis collinear with the longitudinal axis of the tube portion.

[0061] A plane containing two longitudinal axes can have any orientation. In particular, the plane can be horizontal, vertical, or at an angle of, for example, 45° relative to a vertical line.

[0062] When the connecting element is heat shrink tubing, the connection may include: inserting a cut end into one end of the heat shrink tubing, inserting a cut end of a second silicone tube into the other end of the heat shrink tubing, and heating the heat shrink tubing to provide an adhesive-free seal at the cut ends of the silicone tubes and the second silicone tube. Sterilization may be performed after or during the connection.

[0063] In all embodiments, the method may include finally releasing all (remaining) clamping points. Attached Figure Description

[0064] This disclosure can be better understood by referring to the accompanying drawings, and its many features and advantages will become apparent to those skilled in the art.

[0065] Figure 1A-1C A schematic diagram illustrating an exemplary silicone tube that is cut, sterilized, and connected to a connecting element according to the present disclosure is shown.

[0066] Figure 2A-2C The diagram shows two clamped states of the cutting end and the open state of the cutting end.

[0067] Figure 3A-3G A sealing embodiment is shown.

[0068] Figure 4A-4G A sealing embodiment is shown.

[0069] Figures 5A-5H A welding embodiment is shown.

[0070] Figure 6A-6I A welding embodiment is shown.

[0071] Figures 7A-7C An apparatus according to one embodiment is shown. Detailed Implementation

[0072] The same reference symbols are used in different figures to denote similar or identical items.

[0073] The following will be referenced Figure 1A-1C Describes a method for providing a sterile area at the cut end of a silicone tube.

[0074] Silicone tubing can be any commercially available tube or custom-made to specific needs. Its cross-section is typically circular, but the method is not limited to this tube geometry. For example, the cross-section can have any other shape, such as rectangular (including square), triangular, pentagonal, hexagonal, octagonal, etc. The cross-section can also have more complex shapes and does not have to be polygonal; that is, it can contain curved sections or be completely curved.

[0075] The method includes sterilizing the cut end 13 of the silicone tube 1 using UVC radiation 5. Figure 1A ), and connect it to connecting element 2 ( Figure 1B ), thereby providing adhesive-free connection components 4 ( Figure 1C ).

[0076] The method can also be further refined by using VUV (vacuum ultraviolet) radiation to sterilize the cut ends and connecting elements, thereby obtaining sterile tube cut ends and sterile connecting elements.

[0077] In this method, the sterilization of the connecting components is performed using VUV radiation 5. The combination of VUV radiation, the silicone properties of the tube, and the properties of the connecting elements allows for sterilization not only of the outer surface of the tube and the connecting elements, but also of the space between the tube and the connecting elements, as well as the space inside the tube near the cut end (typically the outer surface of the VUV lamp is located within 1 mm to 2 cm from the cut end, preferably between 2 mm and 1 cm, or between 3 mm and 7 mm, for example, about 5 mm).

[0078] Sterilization of the cutting ends and sterilization of the connecting elements can be performed simultaneously.

[0079] Typically, silicone tubing is any commercially available tubing that is opaque to UV radiation. Silicone tubing 1 has a longitudinal axis and presents a central lumen 12 extending along its longitudinal axis. The central lumen 12 serves as a fluid passage for fluid flow.

[0080] The cut end 13 can be obtained previously by cutting a section of the silicone tube 1, for example, with a cutting blade.

[0081] Preferably, the connecting element is made of the same material as the silicone tube.

[0082] Silica gel is an elastomer comprising a silica gel matrix component. Exemplary silica gel matrix components include polyorganosiloxanes. Exemplary polyorganosiloxanes include polyalkylsiloxanes, polyarylsiloxanes, or combinations thereof. Any suitable polyalkylsiloxane is contemplated. Polyalkylsiloxanes include, for example, silicone polymers formed from precursors such as dimethylsiloxane, diethylsiloxane, dipropylsiloxane, methylethylsiloxane, methylpropylsiloxane, or combinations thereof. In one particular embodiment, the polyalkylsiloxane comprises a polydialkylsiloxane, such as polydimethylsiloxane (PDMS). In one particular embodiment, the polyalkylsiloxane is a silane-hydrogen bonded polyalkylsiloxane, such as a silane-hydrogen bonded polydimethylsiloxane. In another embodiment, the polyalkylsiloxane is a vinyl-containing polyalkylsiloxane, such as a vinyl-containing polydimethylsiloxane. The vinyl group can be an endblock of a polyalkylsiloxane, a side chain group on a polyalkylsiloxane, or any combination thereof. In another embodiment, the silica matrix component is a combination of a polyalkylsiloxane containing silicon-hydrogen bonds and a polyalkylsiloxane containing vinyl groups.

[0083] This method is advantageously implemented in a controlled environment. A controlled environment is a specially designed and regulated environment in which specific parameters are manipulated, monitored, and maintained to facilitate the implementation and execution of the method. This environment is carefully controlled to ensure the consistency, accuracy, and repeatability of the method's results. In such a controlled environment, various parameters, such as humidity, temperature, or any other relevant parameters, can be adjusted to optimize the results of the method. In particular, the method includes controlling the humidity of the environment. The method may also include controlling the temperature of the environment.

[0084] The connection may include bringing the cut end 13 into contact with the connecting element 2.

[0085] Before connecting the cutting end 13 to the connecting element 2, the method may include sterilizing the cutting member and using the cutting member to cut the silicone tube laterally, wherein the cutting member is at room temperature during the cutting.

[0086] A cutting component is a tool specifically designed for cutting or severing the material that makes up silicone tubing. It is typically a sharp object that exhibits a cutting edge or kerf capable of penetrating and slicing the silicone tubing through pressure and / or motion.

[0087] Any cutting method is conceivable. The aim is to be able to cut the tube from one side to the other. The tube is cut into segments by a single cutting element or two opposing cutting elements, as needed. Examples of cutting elements include blades, knives, scissors, shears, rotary cutters, scalpels, or any other tool or instrument designed to perform the cutting.

[0088] Prior to cutting, the method may include clamping the silicone tube at its clamping points to obtain a sealed area within the tube, wherein a transverse cut is made at a cutting point adjacent to the clamping points to provide silicone tube sections, each section having a cut end.

[0089] Figure 2A and 2B The state of the silicone tube cut end 13 when clamped is shown. Depending on the distance between the clamping point 31 and the cut end 13, the latter can be relatively closed and slightly open. Figure 2A ) or completely closed ( Figure 2B ). Figure 2C The cut end 13 is shown in the loosened state.

[0090] The crimper 3 ensures that the fluid circulating within the central lumen 12 stops at the formed flat or sealed area. The newly formed sealed area prevents the fluid from circulating, passing through, and communicating on both sides of that area.

[0091] After horizontal cutting, the cut end is in the position of... Figure 2A Or the clamping state shown in 2B; in this state, the total cross-section of the cut end is reduced, causing the relative portions of the tube wall to approach each other, and sometimes even come into contact.

[0092] When this method is performed while fluid flows through the silicone tube, clamping the silicone tube can be advantageous. The fluid can be any flowable material, including but not limited to liquids, gases, solid particles, or combinations thereof such as slurries. Clamping stops the fluid flow before the transverse cut. Therefore, the silicone tube is compressed and flattened under mechanical pressure at its clamping point, forming a sealing area. As a result, the fluid flowing through the silicone tube stops before the sealing area and cannot cross it. Thus, the fluid stops before the cutting step and cannot reach the cutting point. This also maintains the sterility of the inside of the silicone tube during cutting.

[0093] In this case, a cutting point is specified, and two adjacent clamping points are selected on either side of it. The cutting member cuts the silicone tube at the cutting point. This results in two tube sections, each with a cut end.

[0094] Clamping a silicone tube may include clamping the silicone tube at a first clamping point and a second clamping point, wherein the second clamping point is located between the first clamping point and the cutting point, and the method may further include releasing the tube at the second clamping point, thereby providing, as Figure 2C The loosened open cut end 13 shown presents a central lumen 12.

[0095] When it is desirable to connect the cut end of the tube to the connecting element in the loose state, while preventing the remaining part of the tube from coming into contact with the external environment, it is particularly advantageous to use two clamping points and loosen the second clamping point.

[0096] However, as an alternative to clamping the tube at the second clamping point, the cutting end can also be released again by moving the first clamping point further away from the cutting end. This can be achieved by using a compression roller with its longitudinal axis perpendicular to the tube axis.

[0097] The cut end of the silicone tube can be sterilized both before and after releasing the second clamping point.

[0098] If you wish to connect the cut end of the tube to the connector while it is in the loose state, then make direct contact between the sterilized silicone tube cut end and the silicone connector, so that the cross-section of the silicone tube cut end or the cross-section of the silicone connector covers and engages the other, thereby providing a sterile, adhesive-free connection.

[0099] Clamping can be performed using any crimping device 3, such as clamps, screws, cable ties, or combinations thereof. When the silicone tubing or connecting element contains multiple clamping points, clamping can be performed using at least one crimping device at each clamping point. When using clamping jaws, the clamping device can include multiple sub-clamps, each configured to seal the silicone tubing or connecting element at multiple clamping points, which can be adjacent to or spaced apart from each other.

[0100] Typically, a compressive force of 25 to 500 N is applied during clamping.

[0101] Sterilization of the cut ends can be performed using a UVC shield to confine radiation from the silicone tubing to the cut ends. UV shields are typically made of UV-blocking material and have slits to face the cut ends. Similarly, sterilization of connecting elements can also be performed using a UVC shield. In this case, the slits should face the connecting elements during sterilization.

[0102] This method will be referenced below. Figures 7A to 7C The device 50 described is implemented.

[0103] The device includes an operating chamber CH, and within the operating chamber CH, a UVC radiation source 5, tube supports TH1 and TH1', and additional supports TH2 and TH2' for connecting element 2. The tube supports TH1 and TH1' are configured to hold the silicone tube T, and the additional supports TH2 and TH2' are configured to hold the connecting element 2. The device 50 also includes an actuator D configured to move the tube supports TH1 and TH1' and the additional supports TH2 and TH2' relative to each other.

[0104] UVC radiation source 5 is configured to emit radiation comprising one or more wavelengths from 100 nm to 280 nm. Preferably, UVC radiation source 5 is configured to emit radiation that at least partially comprises VUV radiation, or is composed entirely of VUV radiation. Alternatively, both UVC radiation source 5' and VUV radiation source 5 are provided. An example of such VUV radiation source 5 is a stable excimer light source (e.g., using xenon). A continuous 172 nm light source is preferred.

[0105] The pipe supports TH1 and TH1' typically define a support direction corresponding to the longitudinal axis direction of the pipe T once it is placed on the pipe supports TH1 and TH1'. The pipe supports TH1 and TH1' may include a pipe flattener configured to clamp the pipe at clamping point 31 and another clamping point 31', and to provide a sealing area between clamping point 31 and the other clamping point 31'. The pipe flattener may be a set of clamps or jaws. The set of clamps or jaws may also be in the form of rollers, with their axis perpendicular to the pipe axis and movable along the pipe axis.

[0106] The set of clamps or jaws can alternatively be configured to clamp the tube sequentially at clamping point 31, second clamping point 32, another second clamping point 32', and another clamping point 31'. In the latter case, the set of clamps or jaws is preferably configured to clamp clamping point 31 and another clamping point 31' independently of second clamping point 32 and another second clamping point 32'.

[0107] Additional support members TH2 and TH2' can be configured to hold sheet material 21, rod R, second silicone tube T*, or heat shrink tubing 8.

[0108] When configured to hold rod R, the additional supports TH2, TH2' typically define the direction of the additional support, which corresponds to the longitudinal axis direction of rod R once it is placed on the additional supports TH2, TH2'. The additional supports TH2, TH2' may include a set of retainers configured to hold rod R in two positions.

[0109] When configured to hold the second silicone tube T*, the additional supports TH2 and TH2' typically define the direction of the additional support, which corresponds to the longitudinal axis direction once the second tube T* is placed on the additional supports TH2 and TH2'. The additional supports TH2 and TH2' can be configured in the same manner as the tube supports TH1 and TH1' described above.

[0110] Pipe supports TH1, TH1' and additional supports TH2, TH2' can be arranged adjacent to each other, especially so that the support direction and the additional support direction are collinear.

[0111] The driver D is configured to bring the held tube T and the connecting element 2 into contact with each other.

[0112] The device 50 may also include a movable cutting member 6. The movable cutting member 6 is configured to move from a rest position to a cutting position and along the cutting direction. The UVC radiation source 5 may be configured to emit UVC radiation toward the movable cutting member 6, particularly when it is in a rest position.

[0113] When the silicone tube T is received by the tube supports TH1 and TH1', the cutting direction is configured to pass through the silicone tube T, particularly between clamping point 31 and another clamping point 31', or between a second clamping point 32 and another second clamping point 32' when provided. The travel of the movable cutting member 6 is long enough that the movable cutting member 6 can cut the silicone tube T received by the tube supports TH1 and TH1' and the connecting element 2, such as the rod R or the second tube T*, received by the additional supports TH2 and TH2' in a single movement.

[0114] The cutting direction thus divides the operating chamber CH, tube supports TH1, TH1', and auxiliary supports TH2, TH2' into two halves. In this case, each side of the cutting direction has a set of components, each set comprising a portion of tube supports TH1, TH1' and a portion of auxiliary supports TH2, TH2'. The actuator D can be configured to rotate one set of components 180° relative to the other set about a rotation axis collinear with the support direction and the auxiliary support direction. In this configuration, portions of tube supports TH1, TH1' and auxiliary supports TH2, TH2' are interchangeable. This means that they can function as either tube supports TH1, TH1' or auxiliary supports TH2, TH2' depending on their position determined by the actuator D.

[0115] The device 50 may include a controller for controlling the environment (e.g., humidity and / or temperature) of the operating chamber CH.

[0116] The device 50 may include a housing C forming an operating chamber CH. Pipe supports TH1, TH1' and additional supports TH2, TH2' are housed within the housing C. The cutting member 6 may be configured such that both its rest position and cutting position are within the housing C, or only its cutting position is within the housing C. The rest position may also be configured such that the cutting member 6 is partially within the housing C and partially outside of it.

[0117] The housing C may include two opposing openings C1 and C1' for pipe sections to pass through, with openings C1 and C1' arranged along the support direction. The housing C may also include two additional opposing openings C2 and C2' for rods or pipe sections to pass through, with additional openings C2 and C2' arranged along an additional direction.

[0118] Method Example Example 1 The method in Example 1 will be referenced below. Figures 3A to 3F Description. Example 1 is a sealing embodiment designed to seal the cut end of a silicone tube to a connecting element. The connecting element is a plug in the form of a sheet material 21, the cross-section of which contacts and covers the cross-section of the cut end. This method can be performed while fluid flows through the silicone tube.

[0119] In this example, the silicone tube with a cut end can be provided as such, or the method can begin with a silicone tube T having a continuous wall T1 and an internal central lumen T2. ​​The central lumen T2 extends along the longitudinal axis and allows fluid to flow through it. (See...) Figure 3A The method then further includes providing a cut end 13 for the silicone tube T.

[0120] Providing the cutting end 13 may include cutting the silicone tube T to obtain two silicone tube portions 1, 1', each tube portion having its own cutting end 13, 13'.

[0121] Cutting the silicone tube T may include sterilizing the cutting member 6 (not shown) and using the cutting member 6 to make a transverse cut to the silicone tube T at the cutting point 61. Figure 3C The cutting component 6 is preferably at room temperature during cutting.

[0122] Before cutting the silicone tube T, the method may include clamping the silicone tube T at clamping point 31 and another clamping point 31', for example using two tube clamps 3, 3'; thereby providing a flat area, also known as a flat area or sealing area, between clamping point 31 and another clamping point 31'. Figure 3B ).

[0123] Select clamping point 31 and another clamping point 31' such that the cutting point 61 is located between them. Cutting point 61 is sufficiently close to clamping points 31 and 31' such that the cutting ends 13 and 13' are clamped (see...). Figure 2A Or 2B).

[0124] The following description focuses on a portion 1 of the silicone tube, which will be referred to simply as silicone tube 1 for ease of description.

[0125] The method includes sterilizing the cut end 13 of the silicone tube 1 and the sheet material 21 using UVC radiation 5. Figure 3D This process yields a sterile cutting end 13 and a sterile sheet material 21. The method also includes connecting the cutting end 13 of the silicone tube 1 to the sheet material 21. Figure 3E ), thereby providing adhesive-free connection components 4 (see Figure 3F ).

[0126] The cut end and sheet material are sterilized by UVC radiation 5 (preferably VUV radiation). The cut end 13 and the sheet material 21 can be sterilized by UVC radiation simultaneously.

[0127] The connection also includes bringing the sterile sheet material into contact with the sterile cutting end ( Figure 3E ), thereby obtaining adhesive-free connecting components 4 ( Figure 3F ).

[0128] Example 2 The method in Example 2 will be referenced below. Figure 3G Description. Example 2 is essentially the same as Example 1, except that the cut end is sterilized using a UVC protective screen 7 with a notch 71. The UVC protective screen 7 is positioned such that the notch 71 faces the cut end.

[0129] Example 3 The method in Example 3 will be referenced below. Figures 4A to 4FDescription. Example 3 is a sealing embodiment in which the connecting element is a plug in the form of a rod R, the cross-section of which contacts and covers the cross-section of the cut end. This method can be performed while fluid F flows through silicone tube T.

[0130] In this example, silicone tubes and rods with cut ends can be provided as such. Alternatively, they can be supplied via... Figures 4A to 4C The following steps are provided as shown.

[0131] Therefore, the method can begin with a silicone tube T having a continuous wall T1 and an internal central lumen T2, and a rod R. The central lumen T2 extends along the longitudinal axis and allows fluid to flow through it. (See...) Figure 4A The method then further includes providing a cut end 13 for the silicone tube T.

[0132] Providing the cutting end 13 may include arranging the silicone tube and rod R such that their longitudinal axes are collinear with each other. Figure 4A ).

[0133] Providing the cutting end 13 may also include clamping the silicone tube T at clamping point 31 and another clamping point 31', for example using tube clamps 3 and 3', thereby providing a flat area between clamping point 31 and another clamping point 31', also referred to as a flat area or sealing area. Figure 4B ).

[0134] The arrangement and clamping can be performed in any order.

[0135] The cutting end 13 may also include cutting the silicone tube T and the rod R to obtain two silicone tube portions 1, 1', each tube portion having a cutting end 13, 13', and two rod portions 2, 2'. Figure 4C ).

[0136] The cutting may include sterilizing the cutting member 6, such as a cutting blade, and laterally cutting the silicone tube T and rod R at a cutting point 61 between clamping point 31 and another clamping point 31', thereby providing two sets of assemblies on each side of the cutting point. Each set of assemblies consists of silicone tube portions 1, 1' having cutting ends 13, 13' and rod portions 22, 22' also having cutting ends. The cutting point 61 is sufficiently close to clamping point 31 and another clamping point 31' such that the cutting ends 13, 13' of the silicone tube are clamped.

[0137] The method includes sterilizing the cut end 13 of the silicone tube 1 and the rod R using UVC radiation 5. Figure 4D ), and connect it to rod R to provide an adhesive-free connection assembly 4 (see Figure 4F As shown below, this method actually provides two connection components.

[0138] The sterilization of each cut end 13, 13' of the silicone tube section 1, 1' and the rod section 22, 22' is preferably performed using VUV radiation 5 to obtain sterile tube cut ends and sterile rod cut ends.

[0139] The connection may also include rotating one set of components 180° relative to the other set of components about a rotation axis, the rotation axis being collinear with the longitudinal axis of the tubes 1, 1' and the rods (22, 22'), thereby positioning the cut end of the UV-transparent silicone tube (13, 13') in one set facing the cut end of the rod in the other set. Figure 4E ).

[0140] Rotation and sterilization can be performed in any order.

[0141] The connection also includes contacting the cut ends 13, 13' of one set of sterile tubes with the cut ends of another set of sterile rods, thereby forming two connecting assemblies 4, 4' of the silicone tube 1 and the rod 22'.

[0142] Example 4 The method in Example 4 will be referenced below. Figure 4G Description. Example 4 is essentially the same as Example 3, except that the cut ends are sterilized using UVC protective screens 7 and 7' with notches 71 and 71'. The UVC protective screens 7 and 7' are positioned so that the notches face the cut ends.

[0143] Example 5 The method in Example 5 will be referenced below. Figures 5A to 5G Description. Example 5 is a welding embodiment in which the connecting element is another silicone tube T*. The method can be carried out through the central lumen (T2, T2*) of the silicone tubes (T, T*) as a fluid passage.

[0144] Silicone tubes T and T* are chosen to have the same cross-section.

[0145] In this example, two silicone tubes with cut ends can be provided as such. Alternatively, they can be supplied via... Figures 5A to 5C The following steps are provided as shown.

[0146] Therefore, the method can begin with two silicone tubes T, T*, each having continuous walls T1, T1* and an internal central lumen T2, T2*. The central lumens T2, T2* extend along the longitudinal axis and allow fluid to flow through them. (See...) Figure 5A The method then further includes providing cut ends 13, 13* for the silicone tubes T, T*.

[0147] Providing cutting ends 13, 13* may include arranging silicone tubes T, T* such that their longitudinal axes are collinear with each other. Figure 5A ).

[0148] Providing the cutting end 13 may also include clamping the silicone tube T at clamping point 31 and another clamping point 31', for example using crimpers 3 and 3', thereby providing a flat area, also referred to as a flat area or sealing area, between clamping point 31 and another clamping point 31'. Providing the cutting end 13* may also include clamping the silicone tube T* at clamping point 31* and another clamping point 31'*, for example using the same crimpers 3 and 3', thereby providing a flat area between clamping point 31* and another clamping point 31'*. (See...) Figure 5B 。 The arrangement and clamping can be performed in any order.

[0149] Providing cutting ends 13, 13* may also include cutting silicone tubes T, T* to obtain four silicone tube sections 1, 1', 1*, 1'*, each tube section having its own cutting end 13, 13', 13*, 13'*. Figure 5C ).

[0150] The cutting may include sterilizing the cutting member 6, such as a cutting blade, and laterally cutting the silicone tubes T and T* at a cutting point 61 between clamping points 31, 31* and another clamping point 31', 31'*, thereby providing two sets of assemblies on each side of the cutting point 61. Each set of assemblies consists of a tube portion 1, 1' of the silicone tube T having cutting ends 13, 13', and a tube portion 1*, 1'* of an additional silicone tube T* also having cutting ends 13*, 13'*. The cutting point 61 is sufficiently close to the clamping points 31, 31* and the other clamping points 31', 31'*, such that the cutting ends 13, 13', 13*, 13'* of the silicone tubes T and T* are clamped.

[0151] The method includes sterilizing the cut ends 13, 13' of the silicone tube T and the cut ends 13*, 13'* of the second silicone tube T* using UVC radiation 5. Figure 5D ); and connect the cut ends 13, 13' of one silicone tube to the cut ends 13*, 13'* of another silicone tube ( Figure 5F This provides an adhesive-free connection assembly. As shown below, the method actually provides two connection assemblies.

[0152] The sterilization of each cut end 13, 13', 13*, 13'* of the silicone tubes T and T* is preferably performed using VUV radiation 5 to obtain sterile tube cut ends.

[0153] The connection may also include rotating one set of components 180° relative to another set of components about a rotation axis, the rotation axis being collinear with the longitudinal axis of the tube, thereby positioning the cut end of the first silicone tube in one set facing the cut end of the second silicone tube in the other set. Figure 5E ).

[0154] Rotation and sterilization can be performed in any order.

[0155] The connection also includes contacting the cut end of one set of sterile tubing with the cut end of another set of sterile tubing, thereby forming a connection assembly for the two silicone tubing sections. Figure 5F ).

[0156] The method may also include releasing the clamping points 31, 31*, so that the cutting end reopens and returns to the released open state. Figure 5G Any fluid F that was previously blocked from passing through the lumen T2, T2* of the tube can now flow through it.

[0157] Example 6 The method in Example 6 will be referenced below. Figure 5H Description. Example 6 is essentially the same as Example 5, except that the cut ends 13, 13*, 13', 13'* of the silicone tube portions 1, 1*, 1', 1'* are sterilized using UVC protective screens 7, 7' with notches 71, 71'. The UVC protective screens 7, 7' are positioned such that the notches face the cut ends.

[0158] Example 7 The method in Example 7 will be referenced below. Figures 6A to 6H Description. Example 7 is a welding embodiment in which the connecting element is a heat shrink tubing 8. The method can be performed while fluid flows through silicone tubing T, T*.

[0159] In this example, two silicone tubes T, T* and their cut ends 13, 13* can be provided as follows. Alternatively, they can be provided via... Figures 6A to 6C The following steps are provided as shown.

[0160] Therefore, the method can begin with two silicone tubes T, T*, each having continuous walls T1, T1* and an internal central lumen T2, T2*. The central lumens T2, T2* extend along the longitudinal axis and allow fluid to flow through them. (See...) Figure 6A The method then further includes providing cut ends 13, 13* for the silicone tubes T, T*.

[0161] Providing cutting ends 13, 13* may include arranging silicone tubes T, T* such that their longitudinal axes are collinear with each other. Figure 6A ).

[0162] Providing a cutting end 13 may also include clamping the silicone tube T in this order at clamping point 31, second clamping point 32, another second clamping point 32', and another clamping point 31', for example using crimpers 3 and 3', thereby providing a flat region through clamping point 31, second clamping point 32, another second clamping point 32', and another clamping point 31', also referred to as a flat region or sealing region. Providing a cutting end 13* may also include clamping the silicone tube T* in this order at clamping point 31*, second clamping point 32*, another second clamping point 32'*, and another clamping point 31'*, for example using the same crimpers 3* and 3'*, thereby providing a flat region through clamping point 31*, second clamping point 32*, another second clamping point 32'*, and another clamping point 31'*. (See...) Figure 6B 。 The arrangement and clamping can be performed in any order.

[0163] Providing cutting ends 13, 13* may also include cutting silicone tubes T, T* to obtain four silicone tube sections 1, 1', 1*, 1'*, each tube section having its own cutting end 13, 13', 13*, 13'*. Figure 6C ).

[0164] The cutting may include sterilizing the cutting member 6, such as a cutting blade, and laterally cutting the silicone tubes T, T* at a cutting point 61 between the second clamping points 32, 32* and another second clamping point 32', 32'*, thereby providing two sets of assemblies on each side of the cutting point 61. Each set of assemblies consists of tube portions 1, 1' of the silicone tube T having cutting ends 13, 13' and tube portions 1*, 1'* of an additional silicone tube T* also having cutting ends 13*, 13'*. The cutting point 61 is sufficiently close to the second clamping points 32, 32* and another second clamping point 32', 32'*, such that when clamped at these points, the cut ends 13, 13', 13*, 13'* of the silicone tubes T, T* are in a clamped state, but sufficiently far away from the clamping points 31, 31* and another clamping point 31', 31'*, such that when no longer clamped at the second clamping points 32, 32* and another second clamping point 32', 32'*, the cut ends 13, 13', 13*, 13'* of the silicone tubes T, T* are in a loosened state.

[0165] The method includes sterilizing the cut ends 13, 13', 13*, and 13'* using UVC radiation. Figure 6E ), and connect the cutting ends 13, 13', 13*, 13'* via heat shrink tubing 7, 7'. Figure 6G and 6H This provides adhesive-free connection components.

[0166] VUV radiation is preferably used to sterilize the cut ends 13, 13', 13*, and 13'*.

[0167] Sterilization may also include loosening the second clamping sites 32, 32* and another second clamping site 32', 32'*, especially before irradiating the cut end with UVC radiation. Figure 6D The cutting point is far enough from the first clamping point and the other clamping point that the cut ends 13, 13*, 13', and 13'* of the silicone tubes 1, 1*, 1', and 1'* are in a loose state after this operation, thus forming an open cut end.

[0168] The connection may include rotating one set of components about 180° relative to another set of components, with the axis of rotation collinear with the longitudinal axis of the tube, thereby positioning the cut end of the first silicone tube in one set to face the cut end of the second silicone tube in the other set. Figure 6F ).

[0169] Rotation and sterilization can be performed in any order.

[0170] The connection also includes inserting the cut end 13 of one tube portion 1 of the first silicone tube T in one set into one end of the first heat shrink tubing 8, inserting the cut end 13'* of one tube portion 1'* of the second silicone tube T* in another set into the other end of the first heat shrink tubing 8, inserting the cut end 13* of the other tube portion 1* of the second silicone tube T* in one set into one end of the second heat shrink tubing 8', and inserting the cut end 13' of the other tube portion 1' of the first silicone tube T in another set into the other end of the second heat shrink tubing 8'. Figure 6G ).

[0171] The connection also includes heating the first and second heat-shrink tubing 8, 8' to form an adhesive-free seal between the cut ends 13, 13'* of the silicone tubes T, T* to form a new sealing tube, and forming a second new sealing tube between the cut ends 13', 13* of the silicone tubes T, T*. Figure 6H ).

[0172] The method may include releasing the remaining clamping areas (31, 31*, 31', 31'*) to reopen the lumen of the new sealed tube. Fluid that was previously prevented from flowing through the silicone tube lumen can now flow through it.

[0173] Example 8 Example 8 is essentially the same as Example 7, except that it includes sterilization of the cut ends, and specifically sterilization of the cut ends by means of UVC protective screens 7 and 7' with notches 71 and 71'. Figure 6I The UV protection screen is positioned at 7' and 7' so that the cut faces the open cutting end.

[0174] Example 9 Example 9 (not shown) is essentially the same as Example 7, except that the silicone tubes T and T* are clamped only at clamping points 31, 31* and another clamping point 31', 31'*. Then, the loosened state of the cutting ends 13, 13', 13*, 13'* is achieved by further moving the clamping points 31, 31* and the other clamping point 31', 31'* away from the cutting ends 13, 13', 13*, 13'*, thereby restoring the latter to a loosened state. Example 9 is, of course, compatible with the features described in Example 8.

[0175] Device Example refer to Figure 7A The device 50 is configured to establish a connection between the tube portion of the silicone tube T and the tube portion of the second silicone tube T* via the cut ends of each. The device is shown as including a housing C forming an operating chamber CH and having openings C1, C1', C2, C2' for the passage of tubes T and T*; a VUV radiation source 5 within the housing C capable of sterilizing and activating the cut ends 13, 13', 13*, 13'*; a cutting member 6; and two sets of tube supports TH1, TH1' and TH2, TH2'.

[0176] Cutting component 6 is controlled in a static position (e.g.) Figure 7A Between (shown) and the cutting position (not shown).

[0177] The device 50 also includes a UVC radiation source 5' capable of emitting UVC radiation to sterilize the cut component 6. In some cases, the power of the UVC radiation source 5' may be sufficient to sterilize all accessible surfaces.

[0178] Device 50 also includes a driver D, which allows the tube supports TH1, TH1', TH2, TH2' to move.

[0179] Figure 7B The lower part of the device 50 after cutting is schematically shown. Here, pipe segments 1, 1' and 1*, 1'* have been pulled apart by the actuator D, positioning them on either side of the VUV lamp 5. Furthermore, the actuator D has rotated the assembly consisting of pipe supports TH1 and TH2 180° about axis A, which is collinear with the longitudinal axis of pipe segments 1, 1', 1*, 1'*. Figure 7C The schematic diagram illustrates the result after pipe segments 1, 1', 1*, and 1'* are connected. Here, the actuator D has moved pipe support TH1 closer to pipe support TH2' and pipe support TH1' closer to pipe support TH2, so that the cut ends of the corresponding pipe segments come into contact with each other and can be joined.

[0180] In addition, such as Figure 7C As shown, the environment 55 inside the operating chamber CH can be controlled by the environment controller W.

Claims

1. A method for aseptically connecting a cut end (13, 13') of a silicone tube (T) to a connecting element (2, 21, R, T*), the method comprising: - Sterilize the cutting end using UVC radiation (5) to obtain a sterile cutting end; as well as - Connect the cut end to the connecting element to provide an adhesive-free connection assembly (4).

2. The method of claim 1, further comprising sterilizing at least one of the following: - Sterilize the connecting elements using UVC radiation to obtain sterile connecting elements; and - Sterilize the environment of silicone tubing and connecting components.

3. The method according to claim 1 or 2, characterized in that, UVC radiation includes at least some VUV radiation.

4. The method according to any one of claims 1 to 3, characterized in that, The method is implemented in a controlled environment.

5. The method according to any one of claims 1 to 4, further comprising sterilizing the cut end and the connecting element beforehand: Clamp the silicone tube at the clamping point (31, 31') to obtain a sealed area inside the tube; The silicone tube is transversely cut at the cutting point (61) adjacent to the clamping point to obtain the cut end.

6. The method according to any one of the preceding claims, characterized in that, The sterilization of the cutting ends and the sterilization of the connecting elements are carried out simultaneously.

7. The method according to any one of the preceding claims, characterized in that, The connecting element is a sheet material (21) with a cross-section that contacts and covers the cross-section of the sterile cut end to form a plug.

8. The method according to any one of claims 1 to 7, characterized in that, The cutting end has a cross-section, and the connecting element is a rod (R) with a cross-section, the cross-section of which contacts or covers the cross-section of the cutting end to form a plug.

9. The method of claim 8, further comprising: - Clamp the silicone tube at clamping point (31) and another clamping point (31'), the cutting point being located between the clamping point and the other clamping point; - Using the cutting member (6), the silicone tube is laterally cut at the cutting point between the clamping point and the other clamping point, thereby providing two tube sections (1, 1') each having a cut end (13, 13'). - The rod is cut laterally using a cutting member, thereby providing two rod sections (22, 22'), each with a rod-cut end; and - Make contact between each rod cutting end and the corresponding tube cutting end.

10. The method according to claim 9, characterized in that, The tube and the rod each have a longitudinal axis, and the method further includes: - Before transversely cutting the tube, the tube and rod are arranged so that their longitudinal axes are collinear with each other, thus providing two sets of transverse cuts, each set having a tube section and a rod section; and - Rotate one set 180° relative to the other set about a rotation axis, which is collinear with the longitudinal axis of the tube and the rod; The transverse cutting tube and transverse cutting rod are cut through a single relative motion of the cutting components.

11. The method according to any one of claims 1 to 6, characterized in that, The connecting element is a second silicone tube (T*); and the method further includes: - Clamp the silicone tube at clamping point (31) and another clamping point (31'), with the cutting point located between the clamping point and the other clamping point; - Using a preferred unheated cutting member (6), the silicone tube is laterally cut at a cutting point adjacent to the clamping point and the other clamping point, thereby providing two tube sections (1, 1') each having a cutting end (13, 13'). - Clamp the second silicone tube at the clamping point (31*) and another clamping point (31'*); - A second tube is transversely cut at the cutting point between the clamping point and the other clamping point to obtain two tube sections (1, 1'*) each with a cut end (13*, 13'*); and - Contact each cut end of the silicone tube with the corresponding cut end of the second silicone tube section.

12. The method according to claim 11, characterized in that, The silicone tube and the second silicone tube each have a longitudinal axis, and the method further includes: - Before transversely cutting the silicone tube and the second silicone tube, the silicone tube and the second silicone tube are arranged so that their longitudinal axes are collinear with each other, thereby providing two sets of transverse cuts, each set having a portion of the silicone tube and a portion of the second silicone tube; and - Rotate one set 180° relative to the other set about a rotation axis, which is collinear with the longitudinal axis of the tube; The transverse cutting of the silicone tube and the transverse cutting of the second silicone tube are performed by a single relative movement of the cutting component.

13. The method according to any one of claims 1 to 6, characterized in that, The connecting element is a heat shrink tubing (8, 8') with two open ends, wherein the connection includes: inserting a sterile cut end into one end of the heat shrink tubing, inserting a sterile cut end (13'*) of a second silicone tube (T*) into the other end of the heat shrink tubing, and heating the heat shrink tubing to provide an adhesive-free seal at the cut ends of the silicone tube and the second silicone tube.

14. An apparatus (50) comprising an operating chamber (CH), and comprising within the operating chamber: - Tube support (TH1, TH1'), configured to receive silicone tube (T); - Additional support members (TH2, TH2') configured to receive connection elements (2, 21, R, T*); - A UVC radiation source (5), configured to sterilize the silicone tube received on the tube support; and - A drive (R) configured to move the tube support and the additional support relative to each other.

15. The apparatus of claim 14 further includes a movable cutting member (6) configured to move from a rest position to a cutting position and along a cutting direction to cut the silicone tube received on the tube support.

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