• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    process and device for sterile connection of flexible tubes. the invention relates to a process for sterile connection of flexible tubes with the steps: a) providing a first and a second flexible tube (1a, 1b); b) heating a region of separation of the first and second flexible tubes (1a, 1b) with the use of heating means; c) mechanical separation of both flexible tubes (1a, 1b) by applying a tensile and / or shear force on the flexible tubes, so that both flexible tubes (1a, 1b) are respectively separated in the separation region heated in a first and a second segment in the separation region heated in a first and a second segment in the separation region heated in a first and a second flexible pipe segment (100a, 100b, 101a, 101b); and d) after separation of the flexible tubes (1a, 1b) production of a mechanical contact of the end (1001a) of the first flexible tube segment (100a) of the first flexible tube (1a) formed by the separation of the first flexible tube with the end (1001b) ) of the first flexible tube segment (100b) of the second flexible tube (1b) formed by the separation of the second flexible tube (1b), e) the production of the mechanical contact occurs in such a way that the ends (1001a, 1001b) of the flexible pipe segments (100a, 100b) due to heating as per step b) still present such a temperature when they come into mechanical contact with each other, so that they establish a positive union connection with each other without additional heating after separation. the invention also relates to a device for sterile connection of flexible tubes.
    公开号:BR112013003765B1
    申请号:R112013003765-2
    申请日:2011-08-05
    公开日:2020-09-29
    发明作者:Michael Schwalm；Thomas Brückner
    申请人:Fresenius Kabi Deutschland Gmbh；
    IPC主号:
    专利说明:

    [0001] The invention relates to a process for connecting flexible tubes as well as a device for connecting flexible tubes.
    [0002] Especially in the medical field, there is a need to be able to sterilely connect flexible tubes to each other, which are used, for example, to transport blood or infusion fluids. In a process for sterile connection of flexible tubes known from EP 1 555 111 A1, for example, two flexible tubes of thermoplastic material are initially respectively separated from each other by means of a heated blade and respectively connected to each other two main segments of the separate flexible tubes , in such a way that they are moved towards each other along the heated blade and, after removing the blade, pressed against each other. After use, the blade must be disposed of as special waste.
    [0003] The problem to be solved by the present invention lies in making available a process, which allows the connection of flexible tubes as fast as possible and produces as little waste as possible. The present invention is also based on the problem of providing a corresponding device for connecting flexible pipes.
    [0004] A process for sterile connection of flexible tubes is thus made available with the steps: a) provision of a first and a second flexible tube; b) heating a separation region of the first and the second flexible pipe respectively with the use of heating means; c) mechanical separation of both flexible tubes by applying a tensile and / or shear force on the flexible tubes, so that both flexible tubes are respectively separated in the heated separation region in a first and a second segment flexible tube; and d) after separation of the flexible tubes producing a mechanical contact of the end of the first flexible tube segment of the first flexible tube formed by the separation of the first flexible tube with the end of the first flexible tube segment of the second flexible tube formed by the separation of the second tube flexible, e) the production of the mechanical contact occurs in such a way that the ends of the flexible pipe segments due to heating as per step b) still present such temperature when they come into mechanical contact with each other, so that they establish a positive union connection between without additional heating after separation.
    [0005] According to the process according to the invention, for the separation of both flexible tubes a cutting tool is not used, but the separation occurs due to the fact that a region (separation region) of the respective flexible tube is heated and a tensile and / or shear force is introduced in the separation region softened by heating. For the application of a tractive force, the flexible tubes are retracted especially at one end respectively and a force is produced along a longitudinal axis, along which the flexible tubes extend at least in the region of separation. At the same time or alternatively, a shear force can also be applied to the flexible tubes (acting especially in the respective separation area), for example, a shape is produced, which is generated perpendicularly or inclined to the longitudinal axis of the flexible tubes in the separation region.
    [0006] For example, the tensile and / or shear force for separating the flexible tubes is produced by a rotation and / or a translation of a part of the respective flexible tube.
    [0007] Possibilities for producing a tensile and / or shear force, which leads to the separation of the flexible tubes in the heated separation region, will be explained in more detail below.
    [0008] By the process according to the invention, preferably in addition to heating according to step b) there is no separate heating of the ends of the first flexible pipe segments, before they come into contact with each other. For example, the ends of the flexible pipe segments exhibit an extremely high temperature immediately after separating the flexible pipes and, until they come into contact with each other, cool to a lower temperature. But this lower temperature is still so high that the two ends connect in a positive way without further application of heat. In particular, the production of mechanical contact between the ends of the first flexible pipe segments is so rapid that, when they come into mechanical contact with each other, they still have a temperature, respectively, which is higher than the melting temperature of the material of the respective pipe segment. flexible tube. For example, the separation region of the flexible tubes heats up (for example, above 200 ° C), until the flexible tube material (thermoplastic) reaches the thermoplastic state. The temperature of the ends of the first flexible pipe segments after separating the flexible pipes until their connection is, for example, above 100 ° C.
    [0009] The ends of the first flexible pipe segments resulting from the separation of the flexible pipes can seal, so that especially a sterile closure results from the first flexible pipe segments. Due to the fact that the ends of the first flexible pipe segments have a temperature up to the connection of their ends with each other, above the melting point of the flexible pipe material, it is also guaranteed that this sealing remains until the first pipe segments are connected. flexible.
    [00010] The two flexible tubes are formed, as already mentioned above, especially of a thermoplastic material (for example, PVC or another plastic), the two ends of the first segments of the flexible tube being for example respectively still in their thermoplastic state when they come into contact with each other. But it is not necessarily necessary that the two flexible tubes consist of the same material, but can also be connected with the process according to the invention, of course also flexible tubes of different materials, for example, of different thermoplastic plastics.
    [00011] According to a configuration of the invention, the time distance between the separation of the first and the second flexible pipe and the moment of mechanical contact between the ends of the first flexible pipe segments matters in a maximum of 0.1 s, especially in the maximum in 0.05 s. The "moment of mechanical contact establishment" is especially the moment when a first contact occurs between the end of the first flexible pipe segment of the first flexible pipe and the end of the first flexible pipe segment of the second flexible pipe. Especially they present the ends to be connected to each other respectively front sides, which for the production of the mechanical contact are compressed mutually, so that as "moment of the establishment of the mechanical contact" the moment of the first contact of both sides can also be considered front.
    [00012] It should be noted that the invention is naturally not fixed in a certain time distance between the separation of the flexible tubes and the connection of the first segments of flexible tube. Time distances considerably longer than those described above are also conceivable, insofar as the production of the mechanical contact occurs quickly enough, to enable a positive connection connection of the ends of the first flexible pipe segments without another heating step. For example, the considered temporal distance can be clearly greater than 0.1 s, for example, import in up to 20 seconds.
    [00013] The production of mechanical contact between the ends of both first segments of flexible pipe comprises in particular a movement away from the respective first flexible pipe segment (for example, in the form of a main flexible pipe segment, which has a length greater than the second flexible pipe segment (for example, in the form of an end of the original flexible pipe) and an approach movement of both first flexible pipe segments, an alignment of its ends along a common axis and a mutual compression of both ends (especially their front sides).
    [00014] For example, the approach movement of both the first flexible pipe segments comprises a rotation of at least part of the first flexible pipe segment and / or a rotation of at least a part of the first flexible pipe segment of the second flexible tube. Here the first two flexible pipe segments (of the first and the flexible pipe segment) are, for example, so mounted respectively in a housing device that after separation of the first and the second flexible pipe by rotation, they can be moved in one direction to the other. These rotating housing devices will be dealt with in more detail below.
    [00015] The rotation of the first flexible pipe segment of the first flexible pipe and / or the first flexible pipe segment of the second flexible pipe occurs around an axis of rotation, which extends at least approximately perpendicular to a plane, along from which the first flexible pipe segment extends at least partially. For example, the first flexible pipe segment of the first flexible pipe is assembled in such a way that its end (which must be connected with the end of the first flexible pipe region of the second flexible pipe) extends at least approximately in a straight line (ie ie, along a longitudinal axis), and the axis of rotation is then oriented perpendicularly to that end extending in a straight line). Thus, in the formulation that the flexible pipe segment extends “along a plane” it does not necessarily mean that it extends curved or with segments angled between them. It is also possible that it extends at least in part essentially in a straight line.
    [00016] For example, a device is used to carry out the process described above, which comprises the following: - a first housing device for housing a first flexible tube; - a second housing device for housing a second flexible tube; - a heating means for heating a region of separation of the first and the second flexible tube; - means for producing a tensile and / or shearing force on the flexible tubes, to separate the two flexible tubes respectively in the heated separation region in a first and a second flexible tube segment; - contact producing means for producing a mechanical contact of the end of the first flexible pipe segment, formed by separating the first flexible pipe from the first flexible pipe segment of the first flexible pipe with the end formed by separating the second flexible pipe from the first flexible pipe flexible pipe segment of the second flexible pipe, where - the means of producing contact are carried out to bring the ends of the flexible pipe segments after the separation of the flexible pipes to mechanical contact with each other in such a way (quickly) that, due to the heating with the use of heating means, still present such a temperature, when they come into mechanical contact with each other, that they establish a positive union connection with each other without new heating.
    [00017] The invention also relates to a device for sterile connection of flexible tubes, especially for carrying out a process as described above, with - a first housing device for housing a first flexible tube; - a second housing device for housing a second flexible tube; - heating means for heating a region of separation of a first flexible tube disposed in the first housing device and a region of separation of a second flexible tube disposed in the second housing device; and - separation means for separating the first and second flexible tubes in the heated separation region respectively in a first and a second flexible tube segment, the first and second housing devices being respectively made to retain the first flexible pipe segment in such a way that it extends at least partially along a plane, and at least one of the two housing devices is mounted rotatable about an axis of rotation, which extends at least approximately perpendicular to the plane, and being - the device is so executed that after separation of the first and second flexible tube an end of the first flexible tube segment of the first flexible tube under rotation of the first and / or the second housing device around the axis of rotation can be brought into mechanical contact with one end of the first flexible pipe segment of the second flexible pipe.
    [00018] Especially the production of the contact between the ends of the first flexible pipe segments (and especially the rotation of the first and / or the second housing device) occurs so quickly that the ends, due to heating using the heating means, also after the separation of the flexible tubes (for example, also after the heating means have been switched off) they still show such a temperature, when they come into contact with each other, they establish a positive union connection with each other without further heating, as described above with respect to process according to the invention.
    [00019] This device requires for the separation of the flexible tubes and for the connection of the first flexible tube segments only a single heat source (heating medium), since a new heating, separate, from the flexible tube segments is not necessary before your connection. This makes possible a device that can be produced as compact as possible and at a cost as convenient as possible. The compact form of construction that is possible, in turn, can make possible short paths of the first flexible pipe segments, which must be covered when producing the mechanical contact of their ends. This can, for example, reduce or eliminate positioning problems and enables especially short “anchoring times”, that is, the separation of the flexible tubes and the connection of the first flexible tube segments occur in a relatively short time (for example, in less than 10 s, for example, in about 6 s). In addition, short flexible tubes (which have a maximum length of 3 cm for example) can also be connected together.
    [00020] Due to the fact that only one heating source needs to be provided, it is still possible, for example, to provide an especially simple and maximum effective mounting cover, which protects the device according to the invention against moisture penetration. In addition, the displacement of the first flexible pipe segments to put their ends in contact occurs essentially by rotating the housing devices. This rotation movement can be produced by a relatively simple and robust mechanism, so that for example, a device as safe in process and stable for as long as possible can be realized. An electrode is used to activate the housing devices. For example, a direct current motor, which has a special encoder, is used to determine the position of the motor and, therefore, the respective housing device.
    [00021] For example, the first flexible tube is connected with a first container (eg, blood bag) and the second flexible tube with a second container, which contains, for example, a blood additive. The process according to the invention can be used here to connect the two containers to each other, as from both flexible tubes an “free” flexible tube end (the “second flexible tube segments”) and the remaining main flexible tubes (the “first flexible tube segments”) are connected (“anchored”) to each other. Another application consists, for example, of connecting a flexible tube carrying blood with a leukocyte filter.
    [00022] Attention is drawn to the fact that the elements, which have already been described above with respect to the process according to the invention, naturally can also be realized in this device. For example, the interval from separation to contacting the ends of the first flexible pipe segments can matter in less than 0.1 s.
    [00023] As already mentioned above, it should also be noted that the formulation, according to which the first flexible pipe segments extend "along a plane", naturally can also include the case that the first flexible pipe segments are of so retained in the housing devices that extend (at least in part) essentially in a straight line (i.e., along a longitudinal axis).
    [00024] For example, each of the housing devices is associated with at least one clamping device for tightening the flexible tube arranged in the housing device, especially to compress the flexible tube in preparation for the separation and / or retain it ( for example, on a support, to which the clamping device is attached). In particular, this clamping device is so arranged that when the housing device is rotated it is not moved together. It is conceivable that the housing and clamping devices are arranged on a common support, but only the housing devices (or at least one of the housing devices) are rotatable relative to the support, but not the clamping devices.
    [00025] The clamping devices can respectively comprise two jaws, between which the first or second flexible tube is guided, and which can be moved respectively to each other, to tighten the flexible tube between the jaws. For example, the two jaws (or just one of the jaws) are rotated by means of an electric motor, which for example, can also have an encoder, respectively, in order to determine the position of the jaws.
    [00026] According to a device configuration according to the invention, the heating means comprise high frequency voltage generating means, which are electrically connected respectively with at least one of the two clamping devices and carried out to introduce a high frequency voltage. in the respective clamping device, to produce a high frequency electric field in the region of the clamping device. This high frequency field heats (especially by coupling the flexible pipe material to dipoles) a region (the separation region) of the flexible pipe tightened by means of the clamping device.
    [00027] For example, here also the clamping device has two jaws respectively, between which the flexible tube can be clamped, with at least one of the two jaws being supplied with high frequency tension. Especially the clamp, in which the high frequency voltage is fed, is made of metal (for example, brass). In other words, at least one of the jaws forms a high frequency electrode, which has, for example, unlike conventional high frequency electrodes, a flat side, with which it touches the clamping position in the flexible tube.
    [00028] The temperature of the flexible tubes in the separation region and the size of the heated flexible tube region can for example, be controlled (for example, regulated) by the duration and / or the intensity of the high frequency field produced. For example, the plasticity (hardness) of the heated flexible tubes can be considered as a measure for the temperature present in the flexible tube material, the plasticity of the flexible tubes being determined for example, based on a measure of the required force for the tightening of the flexible tubes by means of the clamping devices (for example, - when the clamping devices are activated by an electric motor - based on the current taken by the motor, which is required to carry the clamping device, especially its jaws, tightening position).
    [00029] Especially it is possible that the motor current (or the motor voltage) is predetermined and monitored with the aid of a motor encoder, the position of the driven jaw, and based on the motor current taken it can be checked when the jaw contact the flexible tube. After the jaw has touched the flexible tube, the high frequency voltage is switched on. Depending on the temperature (ie, softness) of the flexible tube, the clamp moves forward, for example, after a predeterminable value for the path traveled by the clamp after the high frequency tension is connected, that is, to a certain softness. of the flexible tube, the separation is initiated by rupture of the flexible tube (that is, for example, the movement production means described below are activated).
    [00030] The temperature of the flexible tube also influences the adaptation of a high frequency circuit of the high frequency voltage production means, required for supplying the high frequency, which can also be used for temperature regulation.
    [00031] It should be noted that the invention is not limited to heating by high frequency field. On the contrary, on the other hand, other heating means can also be used, especially those that make it possible to heat the flexible tube without contact (for example, a hot air generator or a laser).
    [00032] According to another embodiment of the invention, each of the housing devices is associated with at least one other clamping device for clamping a flexible tube arranged in the housing device, which is respectively arranged in such a way in the housing device that when the housing device is rotated it is rotated together. The second clamping device is especially used to hold the flexible tube in the respective housing and / or to compress the flexible tube before and after separation. For example, this other clamping device also comprises two jaws, which are connected with the housing device. At least one of the two jaws of the other clamping device can be formed of a plastic, to avoid as much as possible an influence of a high frequency field, if the heating means are based on high frequency field heating.
    [00033] For example, one of the two jaws of the other clamping device is fixedly connected with the housing device, while the other is connected with the mobile device (for example, by electric motor) relative to it, so that by movement (for example, rotation) from the movable jaw to the fixed jaw the flexible tube can be clamped between the two jaws.
    [00034] In particular, the device according to the invention comprises both a (first) non-rotating clamping device with the associated housing device and also a (second) clamping device rotating together (by housing device). For example, the first and the second clamping devices are so arranged that the flexible tube respectively by a relative movement of the clamping device with each other exerts a tensile and / or shear force on the respective flexible tube, which leads to the separation of the flexible tube in the heated separation region. For example, it is possible for the heating means to heat the flexible tube in the region of both clamping devices and / or in the region between the two clamping devices, so that the flexible tube is separated respectively between the first and the second clamping device. tightness due to their relative relative movement.
    [00035] For example, by the second clamping device respectively the inner sides of the end of the first flexible pipe segment are compressed with each other, with the result that, due to the high temperature of the pipe end, a particularly positive connection connection on the inner sides results. , so that the end of the first flexible pipe segments is respectively closed and the inside of the first flexible pipe segment remains thus sterile during the production of mechanical contact between the first flexible pipe segments. The first clamping device similarly closes the second flexible pipe segment.
    [00036] The separation of the first and second flexible tubes occurs, as indicated above, for example, due to the fact that a tensile and / or shear force is exerted on the tubes, that is, the separation means comprise means for applying a tensile and / or shear force, which leads to the separation of the flexible tubes in the heated separation region. For example, the separation means comprise means of producing movement for producing a movement of the first and / or the second housing device, the movement of the first and / or the second housing device being produced using the means of production of movement a pulling and / or shearing force is introduced in the first and / or the second housing device, which separates the first and / or the second flexible tube in the first and second segment of the flexible tube.
    [00037] The device according to the invention, however, is not restricted to separation means, which produce a tensile or shear force. The separation of the flexible tubes can be done in another way, for example, with the use of a laser or a cutting edge. It is also conceivable that different means of separation can be used in mutual combination, for example, one of the flexible tubes being able to be separated by applying a tensile force and the other flexible tube by applying a shearing force.
    [00038] A tensile and / or shear force can also be produced on the flexible tubes also by the fact that the first and / or the second housing device is rotated around its axis of rotation, which extends perpendicularly to the plane of the flexible pipe segment extending in the region of the housing device. In other words, the separation means only control the rotation of the housing devices, to produce a separation force (especially a shear force) in the separation region.
    [00039] According to one embodiment of the invention, the means of producing movement comprise a first arm connected with the first housing device and a second arm connected with the second housing device, the two arms being so connected between that are rotatable relative to each other in the manner of scissors around a common axis of rotation. For example, an extreme region of the first arm is coupled with the first housing device and an extreme region of the second arm with the second housing device. A region of the first arm away from the extreme region overlaps a region of the second arm away from the end of the second arm, and in this region of overlap, for example, coupling means (for example in the form of a pin) are provided, which couple the two arms rotating relatively to each other. By spreading both arms, the housing devices can be moved, namely, corresponding to the movement of the arms around the axis of rotation, around which the arms are rotated, that is, especially around an axis of rotation, which is located outside the housing devices. The means of producing movement thus allow additional movement of the housing devices (in addition to a possible rotation about the axis of rotation of the housing devices, which is oriented perpendicular to the plane, along which the first pipe segments extend. flexible).
    [00040] With corresponding length of the arms (that is, the radius of the orbit, in which the accommodation devices are moved), an almost linear movement of the accommodation devices can be produced.
    [00041] It is also conceivable that the separation means comprise means of producing translation for producing a translation (that is, a movement only in a straight line or at least essentially in a straight line) of the first and / or the second housing device , and by a translation caused by the means of translation production, a pulling and / or shearing force is produced on the first and / or the second flexible tube and, with this, the tubes are separated. Naturally it is also possible that the separation means have both rotational and translational production means, that is, at least one of both housing devices can perform both a rotation and a translational movement (especially simultaneously ).
    [00042] The device may also comprise a first clamping device (as already described above), which is associated with one of the housing devices, in which the flexible tube can be firmly clamped and which is not moved together when moving. rotation and / or translation of the housing device. The device further comprises (also as described above) for example, a second clamping device, which upon rotation and / or translation of the housing device is moved together, so that a tensile and / or shearing force can be applied. produced by translational and / or rotational movement of the housing device relative to the first clamping device (stationary). After separating the flexible tube, the first clamping device then squeezes the free end resulting from the second flexible tube segment and the second clamping device the free end of the first flexible tube segment.
    [00043] According to another embodiment of the invention, the first and / or the second housing device are respectively configured in the form of a disc, especially in the form of a disc (i.e., in the form of a disc shaped approximately in circular shape in seen from above). For example, the disc is rotatable about an axis of rotation, which extends through its central point.
    [00044] According to another embodiment of the invention, the first and / or the second housing device respectively comprises a housing body, which has on its side oriented parallel to the axis of rotation (which is associated with the respective housing device) a recess ( for example, in the form of a groove) for insertion of the first or second flexible tube. For example, the housing device is configured in the form of a disk, the housing body as a prism type body being arranged in one of the base areas of the disk. The recess mentioned is then found, for example, on one side of the prismatic body extending perpendicularly to the base area of the disc.
    [00045] The device described above serves especially to perform a process for the sterile connection of flexible tubes, which has the following steps: - provision of a first and a second flexible tube; - heating the first and second flexible tubes in a separation region; - separation of the first and second flexible tubes in the heated separation region in a first and a second flexible tube segment; and - production of a mechanical contact from one end of the first flexible tube segment of the first tube to an end of the first flexible tube segment of the second flexible tube, - the production of the mechanical contact occurs under rotation of the first and / or the second flexible pipe segment about an axis of rotation, which extends at least approximately perpendicular to a plane, along which the first flexible pipe segment extends at least partially respectively.
    [00046] The invention will be explained in detail below with the aid of execution examples with reference to the figures. They show: Figures 1A - 1D - schematically, process steps of a process according to an example of carrying out the invention; Figures 2A - 2H - the principle of operation of a device according to a first example of execution of the invention; Figures 3A -3F - the principle of operation of means of production of movement; Figures 4A - 4G - the principle of operation of a modification of the device of figures 2A - 2H; Figures 5A - 5E - steps when centering flexible tubes of different diameter arranged in a device housing according to the invention; Figures 6A - 6F - the positioning of the first flexible pipe segments; Figures 7A - 7F - a first configuration of device clamping devices according to the invention; Figures 8A - 8F - a second configuration of clamping devices of the device according to the invention; Figures 9 A - 9F - a third configuration of clamping devices of the device according to the invention with a flexible tube of a first diameter inserted; and Figures 10A - 10F - the third configuration of clamping devices of the device according to the invention with a flexible tube of a second diameter inserted.
    [00047] Figures 1A to 1D illustrate a process for sterile connection of flexible tubes according to an example of carrying out the invention. According to him, a first and a second tube 1a, 1b are provided, which are respectively formed of a thermoplastic material, which must be connected together. The flexible tubes 1, 1 b have a closed end respectively and are connected with their respective other end (not shown) for example, with a liquid reservoir (figure 1 A).
    [00048] Before connecting the flexible tubes 1a, 1b respectively, the flexible tubes are separated into a first flexible tube segment 100a, 100b and a second flexible tube segment 101a, 101b (which has the free end of the respective flexible tube) .
    [00049] For the preparation of the separation of the flexible tubes they are respectively clamped by means of a first clamping device 30a, 30b and a second clamping device 40a, 40b. With the use of heating means in the form of high frequency voltage generating means (not shown), a high frequency electrical voltage is conducted to the first clamping devices 30a, 30b, so that in the region of the first clamping devices 30a , 30b results in a high frequency electric field, which heats the flexible tubes 1a, 1b respectively in a planned separation region, that is, especially in the region of the first clamping devices 30a, 30b as well as in a region between the first and the first second clamping devices 30a, 30b or 40a, 40b (for example, at least 200 ° C). The tubes break especially in the region between the first and the second clamping devices 30a, 30b or 40a, 40b, which will be further explained below with reference to figures 2A to 2H. Thus, the process according to the invention and correspondingly the device according to the invention make it possible to separate the flexible tubes without contact.
    [00050] After the flexible pipe separation region 1a, 1b has been heated above the melting point of the flexible pipe material, that is, the flexible pipe material is located in the separation region in the thermoplastic state, respectively, is exerted a tensile force along its longitudinal axis on the flexible tubes 1a, 1b, so that in the region of softened separation they are separated by rupture (figure 1C). The pulling force is produced in the example of figures 1A to 1D by the fact that the clamping devices 30a, 30b are mounted stationary respectively and on the clamping devices 40a, 40b a force is applied away from the clamping device 30a or 30b (indicated in figure 1C by arrows A, B).
    [00051] For example, the heating means are switched off after separating the flexible tubes 1a, 1b (or shortly before), that is, the introduction of the high frequency voltage in the clamping devices 30a, 30b is terminated. But it is also conceivable that the heating means remain connected after the separation of the flexible tubes, for example, to safely close the remaining flexible tube segments 101a, 101b, in which fluid can be found. After separating the flexible tubes 1a, 1b, a mechanical contact is produced between the first end 1001 a of the first flexible tube segment 100a formed by the separation of the first flexible tube 1a and the end 1001 b of the first flexible tube segment 100b of the second flexible tube 1b formed by separating the second flexible tube 1b. For this purpose, especially the first flexible pipe segments 100a, 100b now separated initially are moved away from the second flexible pipe segments 101a, 101b and aligned along a common axis. Finally, the first flexible pipe segments 100a, 100b are moved towards each other (arrows C, D), until their two ends 1001 a, 1001 b come into mechanical contact with each other (figure 1D).
    [00052] It should be noted that the heating means can also remain connected for so long until the ends of flexible tube 1001 a, 1001 b are connected to each other. However, the ends 1001 a, 1001 b of the first flexible tube segments 100a, 100b after the separation of the flexible tubes are positioned at a distance from the heating means (especially the high frequency clamping devices 30a, 30b), so that it does not occur heating the ends 1001 a, 1001 b by the heating means.
    [00053] The production of the mechanical contact between the ends 1001 a, 1001 b after the separation of the flexible tubes 1a, 1b occurs so quickly that the two ends 1001 a, 1001 b respectively still have a temperature above the melting point of the material of flexible tube, when they come into contact with each other, so that they establish a positive union connection with each other (that is, they are welded together), without the need to reheat the ends 1001 a, 1001 b.
    [00054] Figures 2A to 2H show, respectively, several steps when producing a sterile connection between two flexible tubes using a device according to a first example of carrying out the invention. According to figure 2A, the device 10 has a first housing device in the form of a first disk 20a as well as a second housing device in the form of a second disk 20b. The disks 20a, 20 b are mounted rotatable respectively about an axis of rotation, which extends perpendicularly to their respective base areas and through its central point.
    [00055] A first flexible tube 1a is housed in the first disk 20a, a second flexible tube 1b in the second disk 20b. The flexible tubes 1a, 1b are guided respectively along a housing body 21a, 21b disposed on the respective disk 20a, 20 b, and the housing bodies 21a, 21b have a groove 211a, 211b for guide the flexible tube respectively ( cf. the cutout of the device 10 shown on the left below next to the main drawing in figure 2A in cross section), which extends over a part of the side of the housing body 21a, 21b prismatic facing the flexible tube 1a or 1b.
    [00056] The device 10 further comprises a guide body 22 associated together with both disks 20a, 20 b (but arranged separately from them), which has a first groove 221a facing the first flexible tube 1a and a second groove 221b facing the second flexible tube 1b, which serve to guide the respective flexible tube; cf. the aforementioned cross-sectional representation of a cutout of the device 10 in figure 2A.
    [00057] In addition, device 10 has two first clamping devices 30a, 30b, which are respectively associated with the first disk 20a or the second disk 20b. The first clamping devices 30a, 30b have respectively a first jaw 301a, 301b, which are rotatable about an axis of rotation, which extends perpendicularly to the base area of the disk 20a, 20 b (ie also perpendicular to a longitudinal plane or axis, along which the flexible tube 1a, 1b extends at least in the region of the housing bodies 21a, 21b). Between the jaws 301a, 302a or 301b, 302b the flexible tubes 1a, 1b are tightened by rotation of the first jaws 301a, 301b (cf. figure 2C explained in detail below).
    [00058] The device 10 further comprises two second clamping devices 40a, 40b, which are also respectively associated with one of the disks 20a, 20 b. The second clamping devices 40a, 40b respectively have a first jaw 401 a, 401b arranged respectively on the disc 20a, 20 b, but rotatable with respect to the respective disc 20a, 20 b, as well as a second jaw 402a, 402b fixed (non-rotatable) ) on disks 20a, 20 b. By rotating the first jaws 401a, 401b towards the second jaws 402a, 402b respectively, the flexible tube can be clamped above the first clamping device (that is, on one side of the first clamping device 30a, 30b opposite the free end of the tubes flexible 1a, 1b). For example, the jaws 401a, 401b are guided within a recess correspondingly made in the respective housing body 21a, 21b.
    [00059] After the insertion of the flexible tubes 1a, 1 b in the respective groove 211 a, 211 a or 211 b, 211 b of the housing bodies 21a, 21b and in the guide body 22 the discs 20a, 20 b are slightly rotated for the guide body 22, that is, the first disk 20a is rotated counterclockwise, the second disk 20b clockwise, so that the housing bodies 40a, 40b are moved towards the guide body 22 , whereby the flexible tube 1a, 1b is squeezed between the housing bodies 40a, 40b and the groove 221a, 221b of the guide body 22 associated with the respective flexible tube 1a, 1b.
    [00060] Thanks to the configuration of at least approximately V or U shape of at least one of the grooves 211 a, 211 b or 221a, 221b the flexible tube is centered, that is, moved a little (vertically) from its position after the insertion away from the disks 20a, 20 b, so that the central point of the flexible pipe segment 1a, 1b is tight between the housing bodies 40a, 40b and the guide body 22, regardless of the diameter of the flexible pipe on the upper side of disks 1a, 1b, that is, it is centered with respect to grooves 211a, 211b or 221a, 221b. This centering of the flexible tubes makes it possible especially to connect tube segments of different diameters, which will be dealt with in more detail below. The centering operation is shown especially in the left cross-sectional representations next to the main drawing of figure 2B, it should be noted that the housing body 211 a and the guide body 22 are arranged successively along the flexible tube 1a.
    [00061] After the initial rotation of the disks 20a, 20b according to figure 2B, the first jaw 301a, 301b of the first clamping devices 30a, 30b respectively for the respective flexible tube 1a, 1b, until the flexible tube 1a, 1b being tight between the two jaws 301a, 302a or 301b, 302b; cf. figure 2C. Then, the first jaws 401a, 401b of the second clamping device 40a, 40b are also activated, so that they also rotate towards the flexible tube and compress the flexible tube 1a, 1b against the second second jaws 402a, 402b and so on. , press; cf. 2D figure. The turning movement of the first stops 301a, 301b and 401a, 401b is produced especially by an electric motor, and an electric motor is associated especially with each jaw. For example, electric motors are arranged on a rear side (that is, a side opposite the flexible tubes 1a, 1b) of the jaws. The jaws are specially connected by arms 303a, 303b, 403a, 403b in a rotatable manner with an axis of the respective motor.
    [00062] Simultaneously or before the pivoting movement of the first jaws 401a, 401b there is a rotation of the disks 20a, 20 b at least approximately back to their starting position shown in figure 2A. The first devices 30a, 30b are activated before the second clamping devices 40a, 40b, especially to cope with a pressure increase in the remaining flexible pipe segments 101a, 101b, which could lead to a rupture or burst of the flexible pipe segments remaining. Of course, however, it is also conceivable that the second clamping devices 40a, 40b are activated before the first clamping devices 30a, 30b.
    [00063] The device 10 further comprises heating means for heating a flexible pipe separation region 1a, 1b, wherein respectively a first flexible pipe segment in the form of the main flexible pipe segment 100a, 100b and a second flexible pipe segment in the form of an extreme flexible pipe segment 101a, 101b are contiguous. The heating means are carried out in the form of high frequency voltage producing means (especially comprising a high frequency voltage source, which is not shown in figures 2A - 2H), which are electrically connected with the second metal jaws 302a, 302b (“heating electrodes”) of the first clamping devices 30a, 30b and which, after activation, introduce a high frequency voltage on the jaws 302a, 302b (indicated in figure 2E by lightning arrows).
    [00064] The first movable jaws 301a, 301b are found especially in mass potential. The high-frequency jaws 302a, 302b are arranged in a recess adjacent to the grooves 221a, 221b in the guide body 22, which, for example, can be made at least partially of an electrically insulating material. The high-frequency jaws 302a, 302b are furthermore positioned in such a way that respectively with a clamping side 3021a, 3021b essentially flat, with which they clamp in the clamping position 30a, 30b on the flexible tube and introduce the high tension frequency in the flexible tube, adjoin the groove 221a, 221b, that is, the clamping sides 3021a, 3021b form a bottom of the respective groove.
    [00065] The high frequency heating means produce by the jaws 301a, 302a, 301b, 302b a high frequency electric field in the separation region of the flexible tubes 1a, 1b (that is, in a region close to the jaws 301a, 301b ), which heats the flexible tubes in that separation region respectively. After heating the separation region or during heating, a movement of the discs 20a, 20 b is initiated away from the first clamping devices 30a, 30b (cf. figure 2F). For producing this movement, the device 10 has means of producing movement, which are explained, for example, based on figures 3A - 3F.
    [00066] By moving the disks 20a, 20 b away from the first clamping devices 30a, 30b, a tensile and shear force is applied on the flexible tubes 1a, 1b, so that they are extracted from each other in the separation region and finally separated by rupture, i.e., the flexible pipe segments 100a, 100b are separated from the extreme flexible pipe segments 101a, 101b. It should be noted that the movement of the disks 20a, 20 b represented in figure 2F is not necessarily necessary to produce the separation of the flexible tubes. Before, it is also conceivable that a separating force is produced by the fact that the disks 20a, 20 b are respectively placed only in rotation around their axis of rotation extending through their central point, without the disks 20a, 20 b moved away from the guide body 22.
    [00067] Among the flexible pipe segments 100a, 101a or 100b, 101b results in a particularly flat breaking edge above the first and second jaws 301a, 302a, 301b, 302b (ie, "hot" high-frequency electrodes) , which should be attributed in particular to the fact that the first jaws 301a, 301b formed of metal occur a better heat transport of the flexible tube 1a, 1b than in the region above the jaws 301a, 301b (that is, in the region between the jaws 301a, 301b and the first jaws 401a, 401b of the second clamping device 40a, 40b), with which in the flexible tube at the height of the upper side (ie, on one side facing the second clamping device 40a, 40b) of the first jaws 401a, 401b there is a temperature gradient, and under the action of the tensile or shearing force, the flexible tubes rupture, preferably in the region of this temperature gradient. Especially consists of the temperature gradient on the surface of the flexible tubes, it being possible that the surface of the flexible tubes between the clamping devices 30a, 30b and 40a, 40b has a higher temperature than the surface of the flexible tubes in the region of the first devices clamping 30a, 30b (that is, between jaws 301a, 302a or 301b, 302b).
    [00068] Especially the jaws serving as high frequency electrodes have a flat side, with which they touch in the clamping position on the flexible tube, so that on the one hand they produce a field as uniform as possible in the flexible tube and, on the other hand, perform a heat derivation as good as possible from the flexible pipe.
    [00069] After the separation of the flexible pipes 1a, 1b in the main flexible pipe segments 100a, 100b and in the extreme flexible pipe segments 101a, 101b the discs 20a, 20 b rotate in such a way that the resulting ends by separating the flexible tubes 1a, 1b and the ends of flexible tube segments 100a, 100b retained by the second clamping devices 40a, 40b are moved towards each other; cf. figure 2G. For this purpose, the first disk 20a is rotated against the clockwise direction around the axis of rotation oriented perpendicular to its base areas and, therefore, also perpendicular to a plane, along which a part (running in the region of the housing body 40a) of the main flexible pipe segment 100a. An analogous rotation movement executes the second plate 20 b, but clockwise.
    [00070] The disks 20a, 20 b are rotated respectively by approximately 90 °, so that both ends of the main flexible pipe segments 100a, 100b are opposed after the disks 20a, 20 b are rotated along an axis common longitudinal. Then, both discs 20a, 20 b move towards each other, so that the front sides, mutually opposed along the common longitudinal axis, at the ends of the main flexible pipe segments 100a, 100b touch ( figure 2H). The rotation of the disks 20a, 20 b occurs especially around their respective axis of rotation and the movement of the disks towards each other so quickly that the ends of the main flexible pipe segments 100a, 100b due to heating according to figure 2E they also present, after switching off the heating means, still a temperature such that, when they come into mechanical contact with each other as shown in figure 2H, they establish a positive union connection, that is, they are welded together, without the need for that new heating.
    [00071] After a cooling phase (for example, at least 4 s), also the second jaws 401a, 401b of the second clamping device 40a, 40b can be released and the flexible pipe produced by connecting the flexible pipe segments main 100a, 100b taken from device 10. Naturally, the invention is not restricted to a certain cooling time; for example, depending on the composition of the flexible tube, shorter or longer cooling times may also be required. In particular, the flexible tube must have sufficient resistance after the cooling time, so that it can be removed from the container and used safely.
    [00072] Due to the high temperature of the ends of the main flexible pipe segments 100a, 100b a special film of material is formed, which closes the cross section of the main flexible pipe segments 100a, 100b (similarly also results in a closure of the flexible pipe segments extremes 101a, 101b). This is aided by the tightening of the flexible tube by means of the first and second clamping devices, with which a connection is especially established between the inner sides of the tight (and heated) flexible tube segments. Thus, the main flexible pipe segments during the production of the mechanical contact are closed especially sterile. After the connection of the main flexible pipe segments 100a, 100b, this closing can continue, but it can be opened by light pressure (especially manual) from outside on the connection point. By continuing to close even after connecting the first flexible pipe segments, it is possible to check initially whether the right flexible pipes (ie the right containers connected with these flexible pipes) have been connected. This can be verified, for example, by scanning the labels of the connected containers. Only when this check that the correct containers have been connected is confirmed that the closure between the flexible pipe segments is opened by pressing on the connection point.
    [00073] Figures 3A to 3F show an embodiment of a device 10, which presents means for producing movement for producing a movement of the disks 20a, 20 b, to, as shown in figure 2F, remove them from the first ones clamping devices 30a, 30b and, after aligning the ends of the main flexible pipe segments, move them towards each other, as shown in figure H.
    [00074] Thus, the device comprises means for producing movement 50, which generate a rotation of the disks 20a, 20b about an axis of rotation extending outside the disks. The movement producing means 50 has a first arm 51, which is connected by connection means 511 (for example, in the form of a screw) at least approximately with a central point of the first disk 20a, as well as a second arm 52, which is connected to the central point of the second disk 20b by analogous connection means 21. The two arms 51, 52 are coupled in such a way that they are rotatable relative to each other about a common axis of rotation 43. For this purpose, a pin extends through the aligned openings of the arms 51, 52. Thus, by means of the mutual opening of the ends 512, 513 of the arms 51, 52 opposite the disks 20a, 20 b, a movement of the ends 514, 515 of the arms 51, 52 connected with the disks 20a, 20b can be produced and, with that, a movement of the disks 20a, 20b.
    [00075] By rotating assembly around the point of rotation 53, a rotation movement of the disks 20a, 20 b (in spacing or approaching each other) is produced in an orbit around the axis of rotation 53. The mutual opening of the ends 512, 513 of the arms 51, 52 opposite the disks 20a, 20 b occurs by a rotating annular disk 55, which is connected by connecting elements (for example, executed approximately in the form of a bar) 56, 57 with the ends 512, 513 of the arms 51, 52. One end of the first connection element 57 is then pivotally connected with the end 513 of an arm 52, while the other end of the connection element 57 is pivoting and is eccentrically fixed to the annular disk 55. Similarly, the second connection element 56 is coupled with the arm 51 and the annular disk 55, the connection points (which are realized for example, by a pin-type connection of the annular disk 55 and the connection elements 56, 57 ) of the connecting elements with the annular disk are mutually opposed along a radius of the annular disk 55.
    [00076] The annular disk is driven, for example, by an electric motor, whose axis is connected especially in a central opening of the annular disk with it. The electric motor is located, for example, on one side of the annular disk, which is opposite the disks 20a, 20 b. Thus, especially all the elements, which are moved when producing the connection of the flexible tubes (the means 50, the discs 20a, 20 b as well as the movable jaws of the clamping devices 30a, 30b, 40a, 40b), are driven by electric motor. For example, all electric motors are equipped with an encoder, so that the position of the moved elements can be determined respectively. For example, disks 20a, 20b and clamping devices 30a, 30b, 40a, 40b are arranged (at least partially) on one side of a support (for example, in the form of a metal or plastic plate), while that, for example, the electric motors are arranged on one side of the opposite support, with a motor shaft respectively engaging through the support.
    [00077] Figure 3A corresponds to the initial position of device 10 (corresponding to figure 2A). Figure 3B shows the tightening of the flexible tube by means of the first clamping devices 30a, 30b analogously to figure 2C. The movement production means 50 are then still in their initial position. Only after activation of the second clamping devices 40a, 40b (similar to figure 2E) and heating of the flexible tubes 1a, 1b, the annular disk 55 is rotated to produce a gap in the upper ends 512, 513 of the arms 51 , 52 and, thus, a gaping of the ends 514, 515 of the arms 51, 52 connected with the disks 20a, 30b (figure 3D).
    [00078] Through this stripping of the lower ends 514, 515, the disks move in mutual spacing in an orbit around the point of rotation 53, with which a stripping of the flexible tubes in the heated separation region is produced (cf. figure 2F). Simultaneously or after the movement of the disks 20a, 20 b around the point of rotation 53, the disks 20a, 20 b are rotated themselves in turn of their axis of rotation extending through their respective central point, so that the ends of the main flexible pipe segments 100a, 100b, resulting from the opening of flexible pipes 1a, 1b, approach; see figure 3E.
    [00079] After the rotation of the disks 20a, 20 b around their respective central point (at about 90 °), the disks 20a, 20 b and, thus, also the ends to be connected of the main flexible pipe segments 100a , 100b, are mutually spaced due to the rotation around the point of rotation 53 produced by the means 50. Only by further rotation of the annular disk 55 do the lower ends 514, 515 of the arms 51, 52 be brought together again, so that the disks 20a, 20b are moved towards each other and the ends of the main flexible pipe segments 100a, 100b come into contact with each other; compare figure 3F.
    [00080] Figures 4A to 4G refer to a device according to another example of carrying out the invention. The device 10 of that embodiment corresponds in principle to the device structure of figures 2A to 2D. However, the housing bodies 40a, 40b are configured a little differently and especially in such a way that in the initial position (figure 4A) of the disks 20a, 20b are oriented in such a way that their sides, in which the groove is provided respectively flexible tube housing 1a, 1b, extend in mutual spacing.
    [00081] Especially, the housing sides of the housing bodies 40a, 40b are aligned so inclined to the vertical (for example, to a plane of symmetry of the device) that the flexible tubes 1a, 1b inserted in their grooves run towards each other, that is, flexible pipe segments in the vicinity of the first clamping device 30a, 30b have a small mutual distance in the initial position of the device 10 as flexible pipe segments, which are at a greater distance from the first device clamping This orientation of the housing bodies 21a, 21b makes it especially possible for the flexible tubes to be easily inserted into the device 10.
    [00082] In addition, the jaws 301a, 302a or 301b, 302b of the first clamping devices 30a, 30b compared to the example of figures 2A to 2H are mirrored, that is, the first jaw 301a of the clamping device 30a is rotated against the clockwise direction to bring the first jaw 301b of the clamping device 30b clockwise into the clamping position. The housing bodies 21a, 21b and the first clamping devices 30a, 30b are not shown in figures 4E to 4G for clarity.
    [00083] Figure 4G shows the release of the flexible tube, not shown in figures 2A to 2H, after the connection of the first segments of the flexible tube, the jaws 401a, 401b of the second clamping device being removed especially after a cooling time of the flexible tube, so that it can be removed from the device.
    [00084] Figures 5A to 5E show in detail the centering of the flexible tubes 1a, 1b produced by the shape of the grooves 211 a, 211 b in the housing bodies 40a, 40b, with the flexible tube 1a having a smaller diameter than the flexible tube 1 b.
    [00085] By centering both flexible tubes it is guaranteed that after separating the flexible tubes 1a, 1b and aligning the ends of the main flexible tube segments 100a, 100b (compare, for example, figure 2G above), the points central sections of the flexible pipe cross sections are at least approximately on the common longitudinal axis of the regions of the main flexible pipe segments 100a, 100b extending along that longitudinal axis. As a result, flexible pipes of different diameters can also be connected to each other with connection quality as good as possible. Another configuration of the grooves of the housing bodies 40a, 40b or of the guide body 22 is shown in figures 7A to 7F.
    [00086] Figures 6A to 6D show the situation after the production of mechanical contact (analogous to figure 2H) between the ends of the main flexible pipe segments 100a, 100b, the main flexible pipe segments 100a, 100b connected between each other being considered different diameters. itself. As shown in figure 6A, the two main flexible pipe segments 100a, 100b have the same diameter, so that their front sides, after producing the mechanical contact, rest almost completely on each other. Figure 6D considers a similar case, the two main flexible pipe segments 100a, 100b having, however, a greater wall thickness.
    [00087] According to figure 6B, a flexible pipe segment 100a has a larger diameter than the other main flexible pipe segment 100b; in figure 6C it is the reverse. In both cases, however, due to the centering mechanism illustrated in figures 5A to 5E, there is no lag between the main flexible pipe segment ends, so that flexible pipes of different diameter can be safely connected to each other.
    [00088] Figures 6E and 6F refer to a possibility of bringing first segments of flexible pipe of different thickness, as reproducibly as possible, by rotating the disks 20a, 20 b, to a position where their ends are opposed, along a common longitudinal axis. According to her, the device 10 presents, analogously to figures 3A to 3F, means of producing movement 50 in the form of scissors, of which figures 6E and 6F show only a lower region, that is, especially a lower segment of the arms 51 , 52.
    [00089] The arms 51, 52 of the movement production means 50 respectively form a stop in the form of a projection 5001, 5002, which cooperate with the arms 403a, 403b, through which the jaws 401a, 401b can be rotated and which are arranged on the same side of the disks 20a, 20 b as the arms 51,52.
    [00090] The arms 403, 403b are connected by a recess in the respective disk 20a, 20 b with the jaws 401a, 401b.
    [00091] The arms 403a, 403b respectively form an abutment area 4031a, 4031b, the discs 20a, 20b being used to align the flexible pipe segments 100a, 100b along a common longitudinal axis. until the contact areas 4031a, 4031b touch the projections 5001, 5002. Through the projections 5001, 5002 a defined rotation of the discs 20a, 20 b is thus possible, so that the flexible pipe segments regardless of their diameter are respectively brought to a position where the axes of their ends align; cf. especially the increase in clipping of fig. 6F shown below the main representation, according to which two flexible pipe segments with different diameters are positioned in such a way that their central axes align. Fig. 6E refers to the case that the two flexible pipe segments have the same diameter.
    [00092] Figures 7A to 7F also refer to a configuration of clamping devices, with which the flexible tubes can be centered before separation. The centering principle has already been explained on the basis of figures 5A to 5E. Such clamping devices can, for example, be obtained from the execution example of figures 2A to 2H.
    [00093] Figures 7A and 7B show the basic configuration of the clamping devices, while figures 7C to 7E represent steps when tightening a flexible tube by means of the clamping devices.
    [00094] According to fig. 7A, analogously to fig. 2A, a first clamping device with a rotating jaw 301a and a second jaw 302a (which is simultaneously a "hot" high-frequency electrode, as described above) is provided, which is arranged in a guide body (22) especially insulating ). A housing body 21a with a groove 211a for guiding a flexible tube as well as a second clamping device are attached to a housing device (disc 20a), the second clamping device comprising a first rotating jaw 401a as well as a second jaw 402a disposed together with the housing body 21a on the disk 20a.
    [00095] FIG. 7A shows the clamping devices in the initial position, fig. 7B after rotation of the clamping jaws 301a and 401a. The clamping devices shown in figures 7A to 7F correspond especially to the left side of the device 10 in fig. 2A, that is, are respectively associated with disk 20a. The clamping devices on the right sides in fig. 2A (that is, of the second circular plate 20 b of the device 10) may, however, have similar clamping devices.
    [00096] For tightening a flexible tube, in the initial position of the clamping devices (fig. 7C, analogously to fig. 2A), it is positioned especially between the groove 211 a of the housing body 21a and the clamp 402a. Then, a rotation of the disk 20a occurs, so that the flexible tube 1a is pressed against the groove 211 a and the clamping side 3021a of the clamp 302a; cf. fig. 7D (corresponding to fig. 2B). Due to the V-shape of the groove 211 a and the clamping side 4021a of the clamp 402a configured in the form of either U or V, the flexible tube 1a is centered.
    [00097] Then a rotation of the jaw 301a occurs, so that the flexible tube 1a is compressed between the jaws 301a and 302a, as shown in fig. 7E (cf. fig. 2C). Then, the disk 20a rotates back to its initial position and pivot the jaw 401a, so that the flexible tube 1a is tightened between jaws 301a and 302a as well as jaws 401a, 402a (fig. 7F, corresponding to fig. 2D).
    [00098] Figures 8A to 8F show a modification of the clamping devices shown in Figures 7A to 7E, which can be carried out especially in a device according to the example of execution of Figures 4A to 4G.
    [00099] Similarly to figures 7A and 7B, figures 8A and 8B show the basic configuration of the clamping devices, while figures 8C to 8F represent steps when tightening a flexible tube by means of the clamping devices. Like figures 7A to 7F, figures 8A to 8F refer to clamping devices, which are associated with a disk 20a of the device. The clamping devices of the other disc 20 b can, however, be made analogously.
    [000100] Unlike figures 7A to 7F, the jaws 301a and 302a are “exchanged”, that is, they are respectively on the other side of the flexible tube to be tightened, which is why the guide body 22 is configured differently and grabs, for example, the flexible tube on one side; cf. fig. 8A. In addition, the groove 211 a in the housing body 21a is configured a little differently, namely, with a cross section at least approximately semicircular. At the same time, the clamping side 4021a of the clamp 402a extends more flat, for example, at least at the level of the groove 211a. The positions of the jaws and the disc 20a shown in figures 8C to 8F correspond to the positions of the jaws in figures 7C to 7E.
    [000101] Figures 9A to 9F and figures 10A to 10F show a third embodiment of clamping devices. Figures 9A to 9F show the clamping operation for a relatively large first diameter flexible pipe, figures 10A to 10F for a relatively small second diameter flexible pipe.
    [000102] In this form of execution, the jaws are so executed that flexible tubes with relatively large diameter are also captured in full volume. This is achieved by the fact that the first jaw 402a and the second jaw 302a are cut more deeply on the inner sides, to better accommodate the flexible tube. Also, large diameter flexible tubes are securely retained between the jaws, thereby minimizing or totally eliminating the risk that the flexible tubes are pressed out in the edge region when jointly clamped between the jaws.
    [000103] According to another form and execution, the device is so designed for sterile connection of flexible tubes, that, for the purpose of determining the welding parameters for the welding of the flexible tubes, it performs a pre-welding and, according to or the parameters determined, perform another welding. This makes it possible to weld flexible tubes with different properties, especially with different diameters or wall thicknesses, or to take into account different conditions or conditions in both clamping devices 30a, 30b, 40a, 40b.
    [000104] Initially, the flexible tubes 1a, 1b inserted, cf. fig. 4A, are tightened with a defined force. Thick flexible tubes are then clamped with greater force than thinner flexible tubes. It is advantageous here that when the ends of both flexible tubes are subsequently connected, they have the same or similar measures in the region of their tube ends, so that the ends of the flexible tube can be pressed with sufficient adjustment between them . Furthermore, the tightening of larger flexible tubes with greater force has the disadvantage that the oscillating circle producing the high frequency is no longer sufficiently compensated, with the consequence that the thicker flexible tube can no longer be so well heated.
    [000105] Next, high frequency is connected for both flexible tubes 1a, 1b. After the flexible tube has softened in the clamping segments by high frequency, the high frequency for the respective flexible tube is switched off. The time between the high frequency connection until the flexible tube softens is measured for the respective flexible tube 1a, 1b. The measurement of the softening degree of the flexible tube takes place here respectively by an encoder connected with the motor, with which an adjustment of the jaws 301a, 301b of the first clamping devices 30a, 30b driven by the motor can be measured. By softening, the jaws 301a, 301b can move further towards each other than as in the initial soft state. Having the jaws moved towards each other by a certain stretch (for example, a determined percentage, for example, a value in the range of 20% to 30%), a certain degree of softening can be concluded. By measuring the motor current, the force with which the clamps tighten the respective flexible tube 1a, 1b can also be considered.
    [000106] Next, the jaws 401a, 402a and 401b, 402b of the second clamping devices open at least partially, the second clamping devices, similar to fig. 4D, however without separating the respective flexible tube, are moved slightly away from the first clamping devices 302a, 301a and 301b, 302b, however, the respective flexible tube is retained by the first clamping devices 30a, 30b and neither separated. Then, the second clamping devices 40a, 40b grip the respective flexible tube again, the first clamping devices 30a, 30b open at least partially the second clamping devices 40a, 40b are movements for the first clamping devices 30a, 30b, so that the respective flexible tube is moved towards the first clamping devices 30a, 30b by a short stretch, usually a few millimeters, by the first clamping devices 30a, 30b, up to the welding points resulting from the first operation welding parts are moved out of the region of the first clamping devices 30a, 30b and a state similar to that in fig. 4C. Then, the welding process takes place with the learned parameters. In this case, the longest welding process is first started, so that both welding processes are closed at approximately the same time or preferably at the same time. The degree of softening of the flexible pipe ends required for the subsequent connection of both flexible pipe segments 100a and 100b is thus also obtained for different flexible pipes 1a, 1b with sufficient precision at the same time.
    [000107] Alternatively, it is also possible to adjust the welding operation for the respective flexible tubes 1a, 1b, so that sufficient softening is completed simultaneously or almost simultaneously. Regulation can occur due to the fact that the intensity of the high frequency is post-regulated depending on the adjustment of the jaws. With this adjustment, the “pre-welding” stage could be dispensed with as described above.
    [000108] Also the motors, which actuate the jaws 401a, 402a of the second clamping devices 40a, 40b, can be equipped with encoders. This makes it possible, for example, under consideration of the motor current, to identify whether the flexible tubes 1a, 1b have been correctly gripped by the second clamping device respectively.
    [000109] It should be noted that elements of the figures above can naturally be used in principle in any combination between them. For example, the means of producing movement of figures 3A to 3F can be used together with the execution of the device according to figures 4A to 4G. It is also conceivable that jaws of different configuration are used; for example, jaws 20a to 7F are associated with the first disc 20a, and jaws 8a to 8F of the second disc. Listing of reference numbers 1a, 1b flexible tube 20a, 20b rotating disc 21a, 21b housing body 22 guide body 30a, 30b first clamping device 40a, 40b second clamping device 50 means of movement 51 first arm 52 second arm 53 pivot point 55 annular disc 56, 57 connecting elements 100a, 100b, first flexible pipe segment 101a, 101b second flexible pipe segment 211a, 211b groove 221a, 221b groove 301a, 301b first clamp first clamping device 302a, 302b second jaw first clamping device 303a, 303b, 403a, 403 b arm 305a clamping surface first jaw 306a clamping surface second jaw 401a, 401b first jaw second clamping device 402a, 402b second jaw second clamping device 403a, 403b arm 511,521 connection means 512, 513 upper end 514, 515 lower end 1001a, 1001b end of first hose section 3021a, 3021b clamping side 4021a , clamping side 5001,5002 protrusions
    权利要求:
    Claims (9)
    [0001]
    1. Device for sterile connection of flexible tubes, showing: - a first housing device (20a) for housing a first flexible tube (1a); - a second housing device (20b) for housing a second flexible tube (1 b); - a heating means for heating a region of separation of a first flexible tube (1a) disposed in the first housing device (20a) and a region of separation of a second flexible tube (1b) disposed in the second housing device ( 20b); and - separation means for separating the first and the second flexible pipe (1a, 1b) in the heated separation region respectively in a first and a second flexible pipe segment (100a, 100b, 101a, 101b), being that - the first and the second housing device (20a, 20b) are respectively made to retain the first flexible pipe segment (100a, 100b) respectively in such a way that it extends at least partially along a plane, and - at least one of the two housing devices (20a, 20b) is mounted rotatable about an axis of rotation, which extends at least approximately perpendicular to the plane along which the first flexible pipe segment (100a, 100b) extends , and since, - the device (10) is so executed that after separation of the first and second flexible tubes (1a, 1b), an ex-tremity (1001a) of the first flexible tube segment (100a) of the first flexible tube (1a) can be brought into mechanical contact, the first and / or the second housing device (20a, 20b) being rotated about the axis of rotation in the process, with an end (1001b) of the first flexible pipe segment (100b) of the second flexible pipe (1b), characterized by the fact that the separation means comprise means of producing movement (50) for producing a movement of the first and / or the second housing device (20a, 20b), with a movement of the first and / or the second device housing (20a, 20b) causes the first and / or the second flexible tube to be subjected to a tensile and / or shearing force, and thus said tube is separated in the first and the second flexible tube segment in the region of heated separation.
    [0002]
    2. Device according to claim 1, characterized by the fact that each of the housing devices (20a, 20b) is associated with at least one clamping device (30a, 30b) for tightening the flexible tube (1a, 1b ) arranged in the housing device.
    [0003]
    Device according to claim 2, characterized in that the heating means comprise means of producing high frequency voltage, which are electrically connected respectively with at least one of the clamping devices (30a, 30b) and executed for introduce a high frequency voltage in the respective clamping device (30a, 30b), to produce a high frequency electric field in the region of the clamping device (30a, 30b), which heats the flexible tube separation region (1a, 1b ) tightened by means of the clamping device (30a, 30b).
    [0004]
    4. Device according to claim 2 or 3, characterized by the fact that each housing device (20a, 20b) is associated with at least one other clamping device (40a, 40b) for tightening a flexible tube ( 1a, 1b) arranged in the housing device (20a, 20b), which is so arranged in the respective housing device (20a, 20b) that when rotating the housing device it is rotated together.
    [0005]
    Device according to any one of claims 1 to 4, characterized in that the means for producing movement (50) comprise a first arm (51) connected with the first housing device (20a) and a second arm ( 52) connected with the second housing device (20b), the two arms (51, 52) being so connected that they can be rotated relative to each other in the manner of a scissors around a common axis of rotation (53), so that upon rotation of the arms (51, 52) a rotation of the housing devices (20a, 20b) is also produced around that axis of rotation (53).
    [0006]
    Device according to any one of claims 1 to 5, characterized in that the means for producing movement (50) are performed for producing a translation of the first and / or the second housing device (20a, 20b) .
    [0007]
    Device according to any one of claims 1 to 6, characterized in that the first and / or the second housing device (20a, 20b) are executed respectively in the form of a plate, especially in the form of a circular scoreboard.
    [0008]
    Device according to any one of claims 1 to 7, characterized by the fact that the first and / or the second housing device (20a, 20b) respectively comprises a housing body (21a, 21b), which presents in a side oriented parallel to the axis of rotation is a recess (211a, 211b) for insertion of the first or second flexible tube (1a, 1b).
    [0009]
    9. Process for sterile connection of flexible tubes using the device (10), as defined in any of claims 1 to 8, characterized by comprising the steps of: - providing a first and a second flexible tube (1a , 1b); - heating a separation region of the first and second flexible tubes (1a, 1b) respectively; - separation of the first and second flexible tube (1a, 1b) in the heated separation region by means of the device separation means (10) to form a first and a second flexible tube segment (100a, 100b, 101a, 101b); and - producing a mechanical contact between an end (1001a) of the first flexible tube segment (100a) of the first flexible tube (1a) with the end (1001b) of the first flexible tube segment (100b) of the second flexible tube (1 b), where - mechanical contact is established when the first and / or the second housing device (20a, 20b) of the device (10) is rotating around an axis of rotation that runs more or less perpendicular to a plane along which in each case the first pipe segment (100a, 100b) extends at least to some extent, and the movement of the first and / or second housing device (20a, 20b) is generated with the aid of the means of producing movement (50) of the separation means, as a result the first and / or the second flexible tube (1a, 1b) are subject to a tension and / or shear force, and are therefore separated in one first and second flexible pipe segments (100a, 100b, 101a, 101b) in the heated separation region.
    类似技术:
    公开号 | 公开日 | 专利标题
    BR112013003765B1|2020-09-29|DEVICE AND PROCESS FOR STERILE CONNECTION OF FLEXIBLE TUBES
    JP4185735B2|2008-11-26|Tube joining apparatus and tube joining method
    US4793880A|1988-12-27|Sterile welding of plastic tubes
    US10307582B2|2019-06-04|Fluid flow conduits and apparatus and methods for making and joining fluid conduits
    KR20050033555A|2005-04-12|Tube-joining apparatus and tube-joining method
    BRPI0916742B1|2017-05-09|laser welding tool with a fiber laser
    CN102667231B|2014-07-23|Rapid-release belt splicer and method of operation
    WO2005000564A1|2005-01-06|Tube clamp device and tube connection device
    US9440396B2|2016-09-13|Sterile connection device for making multiple connections
    CN110418654B|2022-02-08|Pipe joining device
    CA2164749A1|1996-07-19|Total containment connect/disconnect device
    US8066269B2|2011-11-29|Clamp locking mechanism in device for welding plastic tubes
    JPH11178891A|1999-07-06|Tube connecting device
    CN105006414B|2017-01-18|Clamping and sealing machine
    US20090199949A1|2009-08-13|Disposable Connector For Use With Endoscopic Apparatus
    JPH0751448Y2|1995-11-22|Welding device for tubes
    JP5736793B2|2015-06-17|Tube joining device
    JPH0691011A|1994-04-05|Aseptic connection device for flexible tube
    同族专利:
    公开号 | 公开日
    US20170276281A1|2017-09-28|
    AU2011290906B2|2014-10-02|
    US20130153048A1|2013-06-20|
    WO2012022635A3|2012-09-13|
    EP2605822A2|2013-06-26|
    KR20130138210A|2013-12-18|
    EP2605822B1|2018-05-30|
    US20190105849A1|2019-04-11|
    EP3381504B1|2019-07-24|
    EP3381504A1|2018-10-03|
    US20200130290A1|2020-04-30|
    CN103140259B|2015-04-15|
    RU2572987C2|2016-01-20|
    US10040247B2|2018-08-07|
    US10549484B2|2020-02-04|
    US10569478B2|2020-02-25|
    CA2808266C|2018-05-01|
    EP2420286A1|2012-02-22|
    CN103140259A|2013-06-05|
    AU2011290906C1|2015-03-05|
    RU2013111798A|2014-09-27|
    MX2013001898A|2013-04-05|
    AU2011290906A1|2013-02-21|
    NZ606389A|2014-09-26|
    BR112013003765A2|2016-10-18|
    CA2808266A1|2012-02-23|
    KR101883510B1|2018-07-30|
    WO2012022635A2|2012-02-23|
    JP2013534162A|2013-09-02|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US4013860A|1976-04-09|1977-03-22|Engineering & Research Associates, Inc.|Hand held electro-mechanism sealer|
    JPS53128176A|1977-04-15|1978-11-08|Kazuo Tsumura|Medical tube|
    US4610670A|1983-06-13|1986-09-09|E. I. Du Pont De Nemours And Company|Sterile connection process, apparatus and system|
    US4596551A|1983-12-05|1986-06-24|Baxter Travenol Laboratories, Inc.|Tubing clamp|
    US4574173A|1984-05-04|1986-03-04|Warner-Lambert Company|Device for RF welding an IV tube to a catheter lumen|
    US4619642A|1985-03-12|1986-10-28|E. I. Du Pont De Nemours And Company|Sterile, cold cut connection process, apparatus and system|
    DE3564191D1|1985-07-05|1988-09-15|Npbi Bv|Sterile docking process and apparatus for plastic tube portions or the like|
    US4933036A|1987-09-22|1990-06-12|Denco, Inc.|Techniques for welding thermoplastic tubes|
    JPH064283B2|1988-07-14|1994-01-19|テルモ株式会社|Method and apparatus for high-frequency fusion of heat-fusible tube|
    SU1625618A1|1988-09-29|1991-02-07|Всесоюзный научно-исследовательский, проектно-конструкторский и технологический институт электросварочного оборудования|A method of pressure contact butt resistance welding|
    US5279685A|1990-08-20|1994-01-18|Denco, Inc.|Total containment device for connect/disconnect of plastic tubes|
    US5256229A|1992-10-23|1993-10-26|Denco, Inc.|Sterile containment welding device for plastic tubes|
    US5141592A|1990-08-20|1992-08-25|Denco, Inc.|Sterile entry/exit total containment process for closed systems using plastic tubes|
    US5221267A|1990-11-30|1993-06-22|Fresenius Usa, Inc.|Breakable tubing coupling|
    JP3096086B2|1991-04-05|2000-10-10|テルモ株式会社|Tube joining method and apparatus|
    CA2063169A1|1991-05-31|1992-12-01|John B. Shaposka|Sterile welding of plastic tubes|
    US5250041A|1992-01-16|1993-10-05|Fresenius Usa, Inc.|Tubing administration set for use in peritoneal dialysis|
    US5272304A|1992-08-28|1993-12-21|Npbi Nederlands Produktielaboratorium Voor Bloedtransfusieapparatuur En Infusievloeistoffen B.V.|High-frequency dielectric heating hand-operated sealer for medical tubing|
    US5270003A|1992-11-20|1993-12-14|Baxter International Inc.|Blood sampling system|
    US5836619A|1993-11-05|1998-11-17|Migada, Inc.|Manually-severable coupling device, and medical infusion assembly including same|
    IL107509A|1993-11-05|1998-02-22|Travenol Lab Israel Ltd|Coupling device|
    CA2164749A1|1995-01-18|1996-07-19|Ivars V. Ivansons|Total containment connect/disconnect device|
    JP3422452B2|1995-12-08|2003-06-30|テルモ株式会社|Tube connection device|
    JP2710038B2|1996-01-31|1998-02-10|昭蔵 有我|Tube aseptic connection method and device|
    KR100248600B1|1996-12-11|2000-03-15|아마노 시게루|Tube connection device|
    JP3863271B2|1997-12-22|2006-12-27|テルモ株式会社|Tube connection device|
    SE9801885L|1998-05-28|1999-05-17|Novaseptum Ab|Tool for mechanical sealing of hollow hoses of flexible material|
    US6485593B1|1998-10-26|2002-11-26|Kurt J. Christoffersen|Sterile docking apparatus and method of use|
    JP2000308686A|1999-04-27|2000-11-07|Terumo Corp|Tube connection device|
    JP3856981B2|1999-04-27|2006-12-13|テルモ株式会社|Tube connection device|
    US6322551B1|1999-07-09|2001-11-27|Gambro Inc.|Break-apart tubing connectors for use in dialysis blood tubing sets|
    DE19960226C1|1999-12-14|2001-05-10|Fresenius Ag|Connection system, for two or more sterile systems, comprises male and female connectors with threshold breakage points inside the fluid supply system.|
    FR2803010B1|1999-12-24|2002-02-01|Aventis Pasteur|METHOD AND APPARATUS FOR STERILE CONNECTION OF TWO FLEXIBLE TUBES|
    US6696018B2|2001-11-14|2004-02-24|Electron Process Company, Llc|System and method for sterilization of biological connections|
    US6913056B2|2002-01-31|2005-07-05|Baxter International Inc.|Apparatus and method for connecting and disconnecting flexible tubing|
    JP4185735B2|2002-08-30|2008-11-26|テルモ株式会社|Tube joining apparatus and tube joining method|
    JP4162973B2|2002-11-01|2008-10-08|テルモ株式会社|Tube joining device|
    JP4073371B2|2003-06-30|2008-04-09|テルモ株式会社|Tube clamping device and tube joining device|
    US7722733B2|2004-03-29|2010-05-25|Baxter International Inc.|Method for sterile connection of tubing|
    CN101398506B|2004-11-11|2012-05-09|日东电工株式会社|Combination optical film, laminated combination optical film, and image display|
    US7914841B2|2006-02-09|2011-03-29|Cook Medical Technologies Llc|Inline application of coatings|
    US7398813B2|2006-07-31|2008-07-15|Denco Inc.|Device for welding plastic tubes|
    US7766394B2|2006-10-30|2010-08-03|Medtronic, Inc.|Breakaway connectors and systems|
    US20090302033A1|2008-06-04|2009-12-10|Engineering & Research Associates, Inc.|Automated hand held sealer|
    CH700795A1|2009-04-14|2010-10-15|Reed Electronics Ag|Apparatus for welding thermoplastic hoses.|
    US20110144581A1|2009-12-10|2011-06-16|Irwin Nathaniel A|Method for bonding low-profile rapid exchange catheter|
    US9795769B2|2010-04-01|2017-10-24|Seidensha Electronics Co., Ltd.|Balloon catheter, balloon catheter manufacturing device, balloon catheter manufacturing method, catheter connection device, catheter connection method, and connected catheter|
    WO2011144561A1|2010-05-18|2011-11-24|Crucell Holland B.V.|Methods for welding ethylene vinyl acetate tubing, tubing obtained thereby and use of such tubing for sterile transfer of content into a bioreactor|
    EP2420286A1|2010-08-18|2012-02-22|Fresenius Kabi Deutschland GmbH|Method and device for sterile connection of hoses|
    DE102011106852B4|2011-07-05|2019-02-14|Sartorius Stedim Biotech Gmbh|Device for aseptically connecting and disconnecting connections between containers|
    WO2013048336A1|2011-09-30|2013-04-04|Jms Singapore Pte Ltd|Method and apparatus for sealing an object|
    WO2014128972A1|2013-02-25|2014-08-28|テルモ株式会社|Sterile connecting apparatus|
    CN105636640B|2013-10-24|2019-07-16|通用电气健康护理生物科学股份公司|The equipment of connection for thermoplasticity pipeline|
    US9533135B2|2014-06-19|2017-01-03|Fenwal, Inc.|Method for forming, opening and/or evaluating a connection site|EP2420286A1|2010-08-18|2012-02-22|Fresenius Kabi Deutschland GmbH|Method and device for sterile connection of hoses|
    US9861733B2|2012-03-23|2018-01-09|Nxstage Medical Inc.|Peritoneal dialysis systems, devices, and methods|
    EP3542840A1|2011-03-23|2019-09-25|NxStage Medical Inc.|Peritoneal dialysis systems, devices, and methods|
    EP2731667B1|2011-12-21|2018-08-01|Fenwal, Inc.|Method of joining fluid flow circuits|
    US9308709B2|2013-06-06|2016-04-12|Fenwal, Inc.|Bonding apparatus and method|
    US9533135B2|2014-06-19|2017-01-03|Fenwal, Inc.|Method for forming, opening and/or evaluating a connection site|
    US9440396B2|2014-06-19|2016-09-13|Fenwal, Inc.|Sterile connection device for making multiple connections|
    DE102014223103A1|2014-11-12|2016-05-12|Siemens Aktiengesellschaft|Tomographic device and method and computer program for model-based positioning|
    CN108025118B|2015-09-14|2021-03-26|汾沃有限公司|Apparatus, system and method for storing, processing and/or processing blood and blood components|
    US10919235B2|2017-06-07|2021-02-16|Fenwal, Inc.|Apparatus and method for mechanically opening a connection site|
    CN107519567B|2017-08-11|2020-06-05|王岩|Device for medical catheter shunting and confluence|
    CN107320843B|2017-08-11|2018-05-22|韩旭|A kind of medical catheter rapid shunting device|
    US20190262525A1|2018-02-28|2019-08-29|Nxstage Medical, Inc.|Fluid Preparation and Treatment Devices Methods and Systems|
    US20210001563A1|2019-07-01|2021-01-07|Saint-Gobain Performance Plastics Corporation|Profile connection|
    WO2021011721A1|2019-07-17|2021-01-21|Fenwal, Inc.|Automated splitting of a fluid|
    WO2021194824A1|2020-03-25|2021-09-30|Fenwal, Inc.|Configurable system to automate blood component manufacturing processes|
    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-09-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-05-26| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-09-29| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/08/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US37464010P| true| 2010-08-18|2010-08-18|
    EP10173187.5|2010-08-18|
    US61/374,640|2010-08-18|
    EP20100173187|EP2420286A1|2010-08-18|2010-08-18|Method and device for sterile connection of hoses|
    PCT/EP2011/063541|WO2012022635A2|2010-08-18|2011-08-05|Method and device for the sterile connection of pipes|
    [返回顶部]