![]() FLUID CONNECTION SYSTEM AND METHOD OF MANUFACTURE
专利摘要:
The present invention relates to a fluidic connection system comprising a sleeve, a pipe and a fluidic connector, said fluidic connector comprising at least one rigid body in a sterilizable biocompatible material, defining a first bore, the rigid body comprising a first nozzle portion. mechanical assembly, said pipe comprising a flexible connection portion in a sterilizable biocompatible material at least partially elastomeric, defining a second bore and an end, the flexible connection portion comprising a second mechanical assembly portion, the fluidic connector and the flexible portion connecting the pipe being assembled to each other by mechanical cooperation in an assembly region of the first nozzle portion and the second mechanical assembly portion, in an assembly configuration in which the flexible connection portion of the pipe surrounds the rigid body, and the first and second bores are in fluid communication with each other, said sleeve being retracted tight and free on the pipe and extending into a planned stiffening region extending over a portion of the assembly region. 公开号:FR3028915A1 申请号:FR1461311 申请日:2014-11-21 公开日:2016-05-27 发明作者:Florian Blake;Isabelle Gay 申请人:Sartorius Stedim FMT SAS; IPC主号:
专利说明:
[0001] FIELD OF THE INVENTION The present invention relates to fluidic connection systems for the sealed transfer of medical and biopharmaceutical fluids, and to their manufacturing processes. [0002] Fluidic connection systems for the leakproof transfer of medical and biopharmaceutical fluids using a collar for maintaining a tube on a plastic tip are already commonly known in application FR1356350. However, the installation of the collar requires its mechanical clamping on the pipe and the cutting of its end, which generates risks of particulate pollution. Moreover, there is the problem of tightening all the collars according to uniform tightening forces collar collar, due to the difficulty of automating this implementation. The use of such collars also poses the problem of maintaining a constant tightening torque throughout the life of the product (which is made difficult because of the creep of the plastic material constituting certain elements of the fluidic connection system in the weather). Finally, the design of these collars does not allow uniform clamping on the periphery of the fluidic connection. This method of assembly also penalizes productivity in clean room because the establishment of the collar, its clamping and cutting are done manually and the total technical time is particularly long. In addition, certain materials constituting the collar may constitute sources of pollution for very clean environments (clean room ...) in which they are used. And finally, despite the precautions taken, a collar could damage flexible bags or tubes disposed in its immediate vicinity by an aggressive portion of said clamp. Also commonly known is a fluidic connection system for the sealed transfer of medical and biopharmaceutical fluids using gripping rings. EP1998096, for example, discloses such connections. However, these connection systems have in particular a limited resistance to the fluidic pressure at the connection, and a sizing problem to adapt depending on the use. Also known is a fluidic connection system between a connector and a pipe using a heat-shrinkable sleeve, for example described in DE102005024621 This system provides for bonding the sleeve to the underlying pipe or connector to ensure the attachment and to prevent the entry of external particles at the hose / connector connection. The use of an adhesive may be unsuitable depending on the underlying materials, and is sensitive to temperature. In addition, the use of an adhesive presents a risk of contamination of the biopharmaceutical fluid in particular. There is also a risk of deterioration of the components in contact with the glue, and migration into the biopharmaceutical fluid of contaminants from this deterioration. We are therefore looking for an alternative solution to the pipe / connector assembly specially adapted to the biopharmaceutical field. [0003] For this purpose, according to the invention, a fluidic connection system comprises a sleeve, a pipe and a fluidic connector, said fluidic connector comprising at least one rigid body in a sterilizable biocompatible material, defining a first bore, the rigid body comprising a first mechanical assembly tip portion, said hose comprising a flexible connection portion in a biocompatible material which is sterilizable at least partially elastomeric, defining a second bore and an end, the flexible connection portion comprising a second mechanical assembly portion, the fluidic connector and the flexible connection portion of the pipe being assembled to each other by mechanical cooperation in an assembly region of the first nozzle portion and the second mechanical assembly portion, in an assembly configuration in which the flexible connection portion of the pipe surrounds the rigid body, and the first and second bores are in fluid communication with each other, said sleeve being retracted tight and free on the pipe and extending into a planned stiffening region extending over at least a portion of the assembly region . [0004] In the case of such a connection system, no glue is needed between the elements to be assembled, which reduces the risk of contamination. With such a connection system, the tightening of the pipe and the connector on top of each other makes up for the manufacturing tolerances of the connector and the pipe, which improves the seal and the mechanical strength. In addition, the sleeve avoids the risk of disconnection between the connector and the pipe, related to the increase in the internal pressure of the pipe, which could cause leakage in the region of assembly between the pipe and the pipe. connector. In various embodiments of the connection system according to the invention, one or more of the following arrangements may also be used: the stiffening region extends from the end of the pipe , the first mechanical assembly end portion of the fluidic connector comprises at least one radially outward projecting notch, the second mechanical assembly portion of the pipe being placed above said at least one notch during assembly of the connector fluidic and the flexible connecting portion of the pipe, said notch being able to maintain the pipe around the rigid body, said notch is adapted to ensure good retention of the pipe in tension, the at least one notch is molded to the radially outer surface of the fluidic connector, the first mechanical assembly end portion of the fluidic connector comprises a stop, said abutment forming an axial abutment surface for the second port. In a mechanical assembly in the assembly configuration and a front surface opposite to the abutment surface, the sleeve includes the abutment, bearing on the front surface of said abutment. This allows a better maintenance of the sleeve. the sleeve extends from the end of the pipe and along a portion of the pipe beyond the assembly region, in the case of a long sleeve which would trap the entire assembly region it would prevent swelling of the hose near the assembly region, such swelling can cause leaks. the sleeve extends from the end of the pipe and along a portion of the included pipe 40 strictly in the assembly region, the sleeve extends between the end of the pipe and the notch, the components are symmetrical to revolution, the sleeve is made in one piece without preferred rupture zone, the sleeve is the only means of stiffening the pipe on the fluidic connector, 45 is placed a tight clamp at the assembly region on the 3028915 3 pipe, before placement of the sleeve. In addition, in the event of the use of a clamping collar at the joint between the pipe and the connector, to ensure a better maintenance of the assembly and a better seal, a sleeve provided around the The entire assembly and collar will protect the environment from possible contamination of the medium by the collar material and prevent collar geometry from damaging other elements of the medium. Further, the invention relates to a method of manufacturing a fluidic connection system between a pipe and a fluidic connector, said fluidic connector comprising at least one rigid body in a sterilizable biocompatible material, defining a first bore, the body rigid tube comprising a first mechanical assembly end portion, said tube comprising a flexible connection portion in a sterilizable biocompatible material at least partially elastomeric, defining a second bore and an end, the flexible connection portion comprising a second assembly portion mechanical, the method comprising the following two steps performed in any order: the fluidic connector and the flexible connection portion of the pipe are assembled to each other by mechanical cooperation in an assembly region of the first and second portions of the mechanical assembly, in an assembly configuration in wherein the flexible portion of the pipe surrounds the rigid body, on an assembly region, the first and second bores being in fluid communication with each other, a sleeve is positioned loosely around the pipe, said sleeve being of material heat-shrinkable sleeve, said sleeve extending in a planned stiffening region extending over at least a portion of the assembly region. The method then comprising the step of: said sleeve being retracted tight and free on the pipe, extending into a planned stiffening region extending over at least a portion of the assembly region. In one embodiment of the process according to the invention, the following arrangement may optionally be used: the sleeve is retracted by application of a temperature greater than 80 ° C. for a time greater than 3 seconds at the sleeve . The absence of collar cutting and sharp edge reduces the particulate pollution and reduces the risk of damage to the pockets perforation by protruding areas. In addition, the necking of the sleeve 1 on the pipe 2 can be performed on automated machine possibly in parallel with other steps, the productivity is improved. [0005] Other features and advantages of the invention will become apparent from the following description of one of its embodiments, given by way of non-limiting example, with reference to the accompanying drawings. In the drawings: Fig. 1 is a representation of the fluidic connection system, Fig. 2 is a representation of the connector assembly between a pipe and a ladle, Figs. 3a-d are a representation of the fluidic connection system when the sleeve covers the entire assembly portion before and after necking, FIG. 4 shows an example of a manufacturing facility. FIGS. 5a-d are a representation of the fluidic connection system when the sleeve partially covers the joining portion before and after necking. FIGS. 6a-b are a representation of the fluidic connection system with sleeve retaining rib, FIG. is a representation of the fluidic connection system when a clamp is previously used for assembly, Figure 8 illustrates a plastic collar, Figure 9 illustrates a metal collar, Figures 10 ab are a representation of variants of the geometry of the sleeve. In the different figures, the same references designate identical or similar elements. [0006] FIG. 1 shows a fluidic connection system comprising a sleeve 1 which traps the connection between a pipe 2 and a connector 3 (shown partially). The fluidic connection system is for the transfer of biopharmaceutical fluid. In the context of the invention, the term "biopharmaceutical fluid" means a fluid derived from biotechnology - culture media, cell cultures, buffer solutions, artificial nutrition liquids, blood fractions and derivatives of blood products or a pharmaceutical fluid. or more generally a fluid for use in the medical field. Such fluids preferably have high purity requirements, and should not be contaminated by external particles, be they particles of the devices in contact with these fluids for their restraint, transport, or treatment, or particles from the atmosphere surrounding these devices. In this case, in the final configuration of the system, the sleeve 1 extends in the longitudinal direction X assembly around the pipe 2 and the connector 3. [0007] The sleeve 1 is positioned in an initial configuration around the joint between the pipe 2 and the connector 3, and then retracted to trap the assembly. The sleeve extends over a stiffening region 7. The retraction consists in reducing the inside diameter of the sleeve 1, which contributes, for example, to the decrease in the outside diameter of the latter. For example, heat shrinkage is applied, whereby the application of heat or cold to the sleeve 1 leads to this decrease. In particular, this application leads to a decrease in the inside diameter of the sleeve greater than that of the outer diameter of the underlying components. This reduction in the inside diameter of the sleeve 1 therefore takes place while the pipe 2 and the connector 3 remain assembled to one another. [0008] The sleeve 1 is retracted tight and free on the pipe 2. This free assembly is such that the sleeve 1 heat-shrunk remains movable on the pipe 2 underlying if the friction force between the sleeve 1 and the In practice, it is not otherwise fixed to the assembly by friction, but is not movable. Indeed, the frictional force between the sleeve and the pipe 2 will be greater than another disassembly force of the system, for example the disassembly force of the pipe 2 and the connector 3. The pressure allowed for use for this type connection assembly after tightening the sleeve can reach 3 bars inside the pipe 2. [0009] As illustrated in FIG. 1, the sleeve 1 is, for example, generally cylindrical along the axis X. The sleeve 1 comprises an elongated hollow body. As illustrated in FIG. 1, the fluidic connector 3 comprises at least one rigid body 4, the body defining a first bore 4 '. The body of the connector 3 comprises a first mechanical assembly end portion 10. As illustrated in FIG. 1, the pipe 2 comprises a flexible connection portion 12 defining a second bore 12 'and an end 6. The flexible connection portion comprises a second mechanical assembly portion 20. The rigid body 4 of the fluidic connector 3 is in a sterilizable biocompatible material. The rigid body is for example plastic, polyethylene (PET), polypropylene (PP), polycarbonate, polyethersulfone (PES) or other suitable material. [0010] The flexible connecting portion of the pipe 2 is deformable. The flexible portion is in a biocompatible sterilizable material, at least partially elastomeric, for example TPE or silicone. The pipe 2 can be made flexible, which facilitates, for example, the connection of two containers using the pipe. In addition, the flexible connection portion may be deformed to be joined to the rigid body 4. The outer diameter of the pipe 2 is, for example, at most 4 cm. As also illustrated in FIG. 1, the fluidic connector 3 and the flexible connecting portion of the pipe 2 are assembled to one another by mechanical cooperation (friction) in an assembly region 5 of the first 10 and second portions. mechanical assembly. In this assembly configuration, the flexible portion 12 of the pipe 2 surrounds the rigid body 4 and is in close contact therewith. The first and second bores 4 ', 12' are in fluid communication with each other. The assembly can be done for example by insertion force of the flexible portion 12 of the pipe 40 2 around the rigid body 4, the bore of the pipe 2 and the bore of the connector 3 being then placed in fluid communication. This only insertion in force may be sufficient to hold together the pipe 2 and the connector 3, at least when no flow takes place through the connector 3 and / or in the absence of significant mechanical stresses on the connector assembly. pipe. [0011] The connector 3 may for example be a hollow rigid body comprising two ends, one of the ends included in the first mechanical assembly tip portion 10 and a second opposite end. The two opposite ends are in fluid communication with each other. The connector 3 is for example made by molding in one piece. [0012] The connector 3 is for example assembled to a biopharmaceutical product container 30 allowing fluid communication with the interior thereof, as shown in FIG. 2. The container 30 is for example a flexible pouch. The connector 3 is for example welded to a pocket by its second end, for example by a portion 25 of the rigid body 4 other than the first mechanical assembly end portion 10, so that the inside of the pocket is in communication fluidic with the bore 4 '. The second end can also be integrated into a multiple connector of Y shape, T ... to provide a connection between pipes, or integrated into a "quick" connector clipped male or female 15 to ensure a connection hose with hose or pipe with hose . The connector 3 may also comprise a flange 23 (FIG. 3a). Said flange 23 is for example provided on the outer surface of the connector 3. It extends radially along the circumference of the connector 3. It has a face facing the pipe 2 and an opposite face 20 in the longitudinal direction X. It may constitute a support at its face opposite to the face facing the pipe, for the abutment insertion of another element on the connector 3 on the side opposite the assembly connector 3 / pipe 2 in the longitudinal direction X. The heat-shrinkable sleeve 1 may be, for example, polyethylene terephthalate (PET), polypropylene (PP), ethylene tetrafluoroethylene (ETFE). The assembly assembly described above is preferably symmetrical to revolution. In a first embodiment, illustrated in FIGS. 3a-d, the first 10 and second 30 mechanical assembly portions 20 are superimposed in the assembly region 5. The first mechanical assembly end portion 10 of the fluidic connector 3 comprises at least one notch 21. The notch 21 is for example provided on the surface of the first mechanical assembly tip portion 10 of the fluid connector 3, over the entire circumference of the connector for example, which makes it possible not to define zones at stress concentration. Notch 21 may also be provided on only part of the circumference. Several notches, for example (regularly) spaced in the axial direction, may for example be provided on the surface of the first mechanical assembly tip portion 10. [0013] During the assembly of the fluidic connector 3 and the flexible connection portion 12 of the pipe 2, the pipe 2 surrounds the rigid body 4 and the second mechanical assembly portion 20 of the pipe 2 is placed above said at least one a notch 21: the pipe 2 then has a holding inner diameter which is greater than the inner diameter of the pipe 2 not mounted. This deformation guarantees a certain tightening of the pipe 2 on the connector 3. This configuration is called "assembly configuration" of the pipe 2 and the connector 3. The notch 21 makes it possible to hold the pipe 2 when the pipe 2 is subjected. Tensile along its longitudinal axis X. Biocompatible coatings disposed on the radially outer surface of the first mechanical joining tip portion 10 may be used to increase the adhesion of the surface of the connector 3 to the hose 2 in tension. [0014] The connector 3 may for example also incorporate an abutment ring 22 which serves as a stop for the insertion of the pipe 2 on the rigid body 4, during the assembly of the fluidic connector 3 and the flexible portion 12 of the pipe 2. [0015] The abutment 22 may for example be provided on the surface of the rigid body 4. The sleeve 1 is then loosely positioned around the assembly region 5 as illustrated in FIGS. 3a and 3b. In this embodiment, said sleeve 1 extends in a stiffening region 7 provided from the end 6 of the pipe 2 and beyond the assembly region 5 on the pipe 2. In a variant, the region of FIG. rigidification 7 could extend continuously over a portion of the connector 3 upstream of the assembly region 5 and then into the assembly region 5 and then beyond the assembly region 5 on the pipe 2 in the longitudinal direction X (not shown) [0016] The heat-shrinkable sleeve 1 has an inside diameter greater than the outside diameter of the pipe 2 in assembly configuration to allow this mounting. The sleeve 1 has an ability to shrink under the effect of heat on the pipe to maintain the pipe on the connector as shown in Figures 3c and 3d. [0017] The sleeve can be heated by hot air. The heating can then be carried out for example via one or more insufflation nozzles (s) which projects (s) a flow of gas (for example air) hot around the sleeve 1. Figure 4 shows an illustrative example of an embodiment. A gripping system 26 is used to position the assembly region 5 at the adapted location in the manufacturing facility. This is for example a clamp holding the connector 3 and a clamp holding the pipe 2, and arranged so that the assembly region 5 is located centered around an axis X0 installation d 'assembly. A support 27 surrounds the axis X0 and carries a plurality of insufflation nozzles 28 arranged circumferentially around the axis Xo. The nozzles 28 are connected to a source 29 of hot gas via a pipe 31 adapted. Such a method can be implemented in short time scale times necessary for mounting such fluidic connection systems, for example for a period of less than 1 minute, in order to achieve a temperature of necking at sleeve greater than 80 ° C. Heating of the sleeve can also be done by bringing a hot element closer to the sleeve. The heating time can range from 3s to 30s for temperatures ranging from 80 ° C. to 350 ° C. depending on the distance between the hot element and the sleeve 1. For example, an annular hot element surrounding the heating element is used. Xo axis. The method allows for example a restraint on the pipe 2 in a few seconds. The diameter of the sleeve 1 would be, for example, reduced by 50% by the present method in the absence of underlying components. In another variant, the heat can be provided by thermal welding (without infrared contact type). In such a method, the radiation source may be arranged all around the sleeve 1 at a distance from it, or may be of limited axial extension and displaced axially in reciprocating movements along the sleeve (according to FIG. axis Xo). This also applies to the other methods described above. [0018] Alternatively, the heat may be provided by soaking in a hot liquid (eg, water). The sleeve 1 can also be stretched elastically to increase the diameter, prior to its assembly on the assembly, to increase the holding force. The sleeve 1 20 is for example stretched and placed on the pipe 2 at the assembly region 5. The pipe 2 and the connector 3 are then assembled, and the sleeve 1 released to elastically grip the pipe 2. The sleeve 1 accepts the increase in diameter of the pipe 2 due to the assembly on the connector. In the case of a symmetry of revolution system, the clamping of the pipe 2 over 360 ° catches the manufacturing tolerances of the connector 3 and the pipe 2, which improves the seal and the mechanical strength. The notch 21 also makes it possible to hold the sleeve 1 in position along the longitudinal direction X. [0019] Once tightened, the sleeve 1 applies a pressure radially and 360 ° on the pipe 2 in order to guarantee pressure tightness of the interface between the fluidic connector 3 and the pipe 2. During the passage of a biopharmaceutical fluid , possibly under pressure, between the hose and the connector, the sleeve rigidly holds the connection between the hose and the connector, thus limiting the risk of deformation of the hose at the interface with the connector and, consequently, the risk leakage loss. By proceeding in a controlled manner to the thermal activation of the sleeve 1, the pipe 2 is stiffened in the stiffening region 7 uniformly on the periphery thereof. [0020] The sleeve 1 matches the shape of the assembly that it covers where it covers it. In one embodiment, illustrated in Figures 5a-5d, the sleeve 1 is shorter than the assembly region 5. The sleeve 1 extends in a stiffening region 7 provided from the end of the pipe 2 and on a part of the assembly region 5 in the longitudinal direction X. [0021] Alternatively, in the case where the surface of the first mechanical assembly tip portion 10 comprises both a notch 21 and a stop 22, the sleeve 1 can be placed axially between the stop 22 and the notch 21. [0022] As a variant, the stiffening region 7 could extend continuously over a portion of the connector 3 upstream of the assembly region 5 and then a portion of the assembly region 5 in the longitudinal direction X (not shown). [0023] In another embodiment, illustrated in FIGS. 6a-6b, the sleeve 1 retires and clings to the abutment 22 of the first mechanical assembly tip portion 10, the sleeve including the abutment 22 to encapsulate better the assembly of the fluidic connector 3 with the flexible portion 12 of the connection of the pipe 2. In the example shown, the sleeve 1 is narrowed on the face of the abutment 22 opposite the face receiving the pipe 2. [0024] In another embodiment, illustrated in FIG. 7, a clamping collar 8 is previously mounted on the above-described assembly of the connector 3 and the pipe 2. The heat-shrinkable sleeve 1 is then positioned on the previous assembly including the assembly and the clamp 8, and shrink. The sleeve 1 then conforms to the shape of the clamping collar 8 at the assembly. For example, a plastic collar of the polyamide type, for example Rilsan®, can be used. This type of plastic collar, illustrated in FIG. 8 'comprises a system of notches 32 on a strip 33 which cooperate with a locking hook arranged in the head 34, so that the clamping is not reversible. In other words, once the band 33 has been engaged in the head 34 to form a loop, the band 33 is pulled to reduce the diameter of the loop and tighten the collar 8, the backtrack being prevented by the locking hook engaged in one of the notches 32 of the band 33. After tightening, to prevent the band from exceeding the diameter of the loop of the collar, the free band portion is cut off near the head of the collar. necklace. The remaining unattached portion of the web often has a sharp edge which may be sharp. Alternatively, it is also possible to use a metal collar such as a shrinking ring, illustrated in FIG. 9, which is in the form of a preformed ring 36 provided with one or two lugs 37a, 37b protruding towards the outside relative to the general shape of the collar ring, this type of collar marketed by Oetiker®. After insertion of the collar on the tube to be maintained, it is carried out by means of a tool to pinch the ear (or ears) of the collar which causes a remanent deformation and thus a narrowing of the main diameter of the ring and by therefore tightening the collar on the tube. This type of metal ring clamping is particularly robust and reliable. However, at the point of the ear pinched by the tool, there may be an asperity or a burr which forms a sharp edge which may be aggressive. The addition of the sleeve 1 on the assembly avoids that the possible protruding portion of the collar may pierce for example adjacent pockets during transport or even injure the user. The collar is thus wrapped in the sleeve 1 which smooths the projecting ends. In addition, a metal collar may advantageously be masked to avoid contamination of the clean medium in which it would be used, such as the clean room. The sleeve 1 is preferably symmetrical of revolution, as illustrated in FIG. 10a. As a variant, the sleeve 1 may also be in the form of two half-rings 101 and 102 assembled by their respective ends as illustrated in FIG. 10b. In the case of such a sleeve, the two half-rings 101 and 102 are for example fixed together by their respective free ends, then each junction between assembled free ends is flattened so that said junction between assembled free ends emerges radially towards the outside the sleeve 1. [0025] In a variant, the sleeve 1 is mounted on the pipe 2 before the pipe 2 is mounted on the first mechanical assembly end portion 10 of the connector 3. In another variant, the pipe 2 is mounted on the first end portion of the pipe. mechanical assembly 10 of the connector 3 and the sleeve is mounted on the pipe 2 by sliding for example 15 of the sleeve 1 on the previous assembly. Alternatively, the sleeve 1 has at least one incision along its entire length, along X, for placing the sleeve around the assembly after making the connection between the pipe 2 and the connector 3. 20
权利要求:
Claims (16) [0001] REVENDICATIONS1. A fluidic connection system comprising a sleeve (1), a pipe (2) and a fluidic connector (3), said fluidic connector (3) comprising at least one rigid body (4) in a sterilizable biocompatible material, defining a first bore ( 4 '), the rigid body (4) comprising a first mechanical assembly end portion (10), said pipe (2) comprising a flexible connection portion (12) in a sterilizable biocompatible material at least partially elastomeric, defining a second bore (12 ') and one end (6), the flexible connection portion comprising a second mechanical assembly portion (20), the fluidic connector (3) and the flexible connection portion (12) of the hose (2) being assembled to one another by mechanical cooperation in an assembly region (5) of the first nozzle portion (10) and second mechanical assembly portion (20), in an assembly configuration in which the flexible portion of connection ( 12) of the pipe (2) surrounds the rigid body (4), and the first and second bores (4 ', 12') are in fluid communication with each other, said sleeve (1) being retracted tight and free on the pipe (2) and extending into a stiffening region (7) provided extending over at least a portion of the assembly region (5). [0002] 2. Fluidic connection system according to claim 1 wherein the stiffening region (7) extends from the end (6) of the pipe (2). [0003] 3. Fluidic connection system according to any one of claims 1 and 2, wherein the first mechanical assembly tip portion (10) of the fluid connector (3) comprises at least one notch (21) protruding radially outwardly (21), the second mechanical assembly portion (20) of the pipe (2) being placed above the at least one notch (21) during assembly of the fluidic connector (3) and the flexible connection portion (12) of the pipe (2), said notch (21) being adapted to maintain the pipe (2) around the rigid body (4). [0004] 4. Fluidic connection system according to claim 3, said notch (21) being adapted to ensure good retention of the pipe in tension. [0005] 5. Fluidic connection system according to any one of claims 3 and 4 wherein the at least one notch (21) is molded to the radially outer surface of the fluid connector (3). [0006] 6. Fluidic connection system according to any one of claims 1 to 5 wherein the first mechanical assembly end portion (10) of the fluid connector (3) comprises a stop (22), said stop (22) forming a surface axial abutment for the second mechanical assembly portion (20) in the assembly configuration and a front surface opposite to the abutment surface. [0007] 7. Fluidic connection system according to claim 6, wherein the sleeve (1) includes the stop (22), bearing on the front surface of said stop (22). [0008] 8. Fluidic connection system according to any one of claims 1 to 7 for which the sleeve (1) extends from the end (6) of the pipe (2) and along a portion of the pipe (2). beyond the assembly region (5). A long sleeve traps the entire assembly region, to prevent swelling of the flexible tube near the junction, such swelling can cause leaks. 5 [0009] 9. Fluidic connection system according to any one of claims 1 to 7 for which the sleeve (1) extends from the end (6) of the pipe (2) and along a portion of the pipe (2). strictly included in the assembly area (5). [0010] 10. Fluidic connection system according to any one of claims 3 to 7 and 9 wherein the sleeve (1) extends between the end (6) of the pipe (2) and the notch (21). [0011] 11. Fluidic connection system according to any one of claims 1 to 10, whose components are symmetrical of revolution. 15 [0012] 12. Fluidic connection system according to any one of claims 1 to 11, wherein the sleeve (1) is made in one piece without preferred breaking zone. [0013] 13. Fluidic connection system according to any one of claims 1 to 12, wherein the sleeve is the only means of stiffening the pipe (2) on the fluid connector (3). 20 [0014] Fluidic connection system according to one of Claims 1 to 13, for which a clamping collar (8) is clamped at the region of assembly (5) on the pipe (2) before the sleeve (1). The use of a hose clamp provides an even better seal and the molded sleeve from above protects the environment against possible contamination of the medium by the collar material and to prevent the collar geometry from occurring. damage other elements of the environment. [0015] 15. A method of manufacturing a fluidic connection system between a pipe (2) and a fluidic connector (3), said fluidic connector (3) comprising at least one rigid body (4) in a sterilizable biocompatible material, defining a first bore (4 '), the rigid body (4) comprising a first mechanical assembly end portion (10), said pipe (2) comprising a flexible connection portion (12) in a biocompatible material 35 sterilizable at least partially elastomer defining a second bore (12 ') and an end (6), the flexible connecting portion comprising a second mechanical assembly portion (20), the method comprising the following two steps performed in any order: the fluidic connector ( 3) and the flexible connecting portion (12) of the pipe (2) are assembled to one another by mechanical cooperation in an assembly region (5) of the first (10) 40 and second (20) portions of the assembly mechanical, in an assembly configuration in which the flexible portion (12) of the pipe (2) surrounds the rigid body (4), on an assembly region (5), the first and second bores (4 ', 12' ) being in fluid communication with each other, a sleeve (1) is positioned loosely around the pipe (2), said sleeve (1) being of heat-shrinkable material, said sleeve (1) extending into a stiffening region (7) provided 3028915 13 extending over at least a portion of the assembly region (5). the method then comprising the following step: said sleeve (1) is retracted tight and free on the pipe (2), extending into a stiffening region (7) provided extending over at least a portion of the region of assembly (5). [0016] 16. The manufacturing method according to claim 15 wherein the sleeve (1) is retracted by applying a temperature greater than 80 ° C for a time greater than 3s at the sleeve (1).
类似技术:
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同族专利:
公开号 | 公开日 US10883643B2|2021-01-05| WO2016079451A1|2016-05-26| FR3028915B1|2017-04-21| US20170314719A1|2017-11-02| EP3221628B1|2020-04-15| US20210080043A1|2021-03-18| EP3221628A1|2017-09-27| CN107002933A|2017-08-01|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题 GB808984A|1956-02-21|1959-02-18|Stewarts & Lloyds Ltd|Pipe joints| US5566988A|1993-04-30|1996-10-22|The Gates Rubber Company|Heat shrinkable hose clamp with indicator| DE19735261C1|1997-08-14|1998-12-24|Hewing Gmbh|Connector for plastics pipes| DE20116488U1|2001-10-09|2003-02-27|Dannewitz Gmbh & Co|Circlip secured to pipe by heat-shrink hose or sleeve| US20050287326A1|2004-06-29|2005-12-29|Crane Resistoflex|Smooth inner bore hose with continuous fluoropolymer liner| FR1356350A|1963-02-12|1964-03-27|Improvement in stoves, especially oil stoves| US3565116A|1968-09-12|1971-02-23|White Motor Corp|Safety hose and fitting assembly| US3975039A|1970-11-03|1976-08-17|Raychem Corporation|Heat-recoverable members| US4169477A|1977-07-07|1979-10-02|Carbomedics, Inc.|Anastomatic couplings| GB1604444A|1977-09-30|1981-12-09|Raychem Ltd|Heatrecoverable articles| US4650228A|1983-09-14|1987-03-17|Raychem Corporation|Heat-recoverable coupling assembly| EP0141675B1|1983-11-08|1988-05-04|Raychem Limited|Device and method for connecting elongate objects| US4641860A|1984-06-25|1987-02-10|Berkley And Company, Inc.|Coupling for flexible tubing| FR2596133B1|1986-03-20|1988-08-12|Caoutchouc Manuf Plastique|METHOD FOR MANUFACTURING A CONNECTION AND / OR CONNECTION DEVICE FOR FLEXIBLE PIPES AND CONNECTION AND / OR CONNECTION DEVICE CARRIED OUT ACCORDING TO THIS METHOD| US5338070A|1991-07-31|1994-08-16|Furukawa Electric Co., Ltd.|Diameter-reducing member joint device| US5340167A|1992-02-26|1994-08-23|The Gates Rubber Company|Heat shrinkable polymer hose and tubing clamp| US5411300A|1993-03-16|1995-05-02|Toyoda Gosei Co., Ltd.|Hose connecting assembly| US5531483A|1993-12-06|1996-07-02|The Gates Rubber Company|Heat shrinkable hose clamp with heating indicator| US5770139A|1996-03-27|1998-06-23|Medtronic, Inc.|Method and apparatus for connecting tubing to barbed connectors| US6206430B1|1999-07-07|2001-03-27|Inter-Med, Llc.|Connector and attachment mechanism for a lumen| DE102005024621A1|2005-05-30|2006-12-14|Fresenius Medical Care Deutschland Gmbh|Method for joining a tube to a hard part e.g. port comprises joining the tube to the hard part and shrinking a collar in the joining region of the tube and hard part| US20080284163A1|2007-05-15|2008-11-20|Millipore Corporation|Connector for flexible tubing| US20100254758A1|2009-04-06|2010-10-07|International Business Machines Corporation|Apparatus and method for forming a mechanical, fluid-tight connection| US9046200B2|2012-01-03|2015-06-02|Berry Plastics Corporation|Heat-shrinkable tube covering| US20140291982A1|2013-03-29|2014-10-02|Superior Fit, Llc|Pipe coupling| FR3007812B1|2013-06-28|2016-01-01|Sartorius Stedim Biotech|FLUIDIC CONNECTOR WITH COLLAR AND PROTECTION.|US20170281888A1|2016-03-29|2017-10-05|McMurray Medical Group, LLC|Oral medical apparatus| JP2018050964A|2016-09-29|2018-04-05|テルモ株式会社|Medical device and infusion set| EP3743648A4|2018-01-24|2021-08-25|Sartorius Stedim North America Inc.|Fluid transfer assembly| FR3087869B1|2018-10-26|2020-12-18|Sartorius Stedim Fmt Sas|CONNECTION DEVICE FOR BIOPHARMACEUTICAL FLUID AND IRREVERSIBLE FLUID CONNECTION METHOD| DE102019108664A1|2019-04-03|2020-10-08|Sartorius Stedim Biotech Gmbh|Sterile connector for the sterile transfer of a liquid medium| US20210353855A1|2020-05-12|2021-11-18|Carefusion 303, Inc.|Shaped memory polymer junctions|
法律状态:
2015-10-08| PLFP| Fee payment|Year of fee payment: 2 | 2016-05-27| PLSC| Search report ready|Effective date: 20160527 | 2016-10-14| PLFP| Fee payment|Year of fee payment: 3 | 2017-10-12| PLFP| Fee payment|Year of fee payment: 4 | 2018-10-11| PLFP| Fee payment|Year of fee payment: 5 | 2019-10-14| PLFP| Fee payment|Year of fee payment: 6 | 2020-11-19| PLFP| Fee payment|Year of fee payment: 7 |
优先权:
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申请号 | 申请日 | 专利标题 FR1461311A|FR3028915B1|2014-11-21|2014-11-21|FLUID CONNECTION SYSTEM AND METHOD OF MANUFACTURE|FR1461311A| FR3028915B1|2014-11-21|2014-11-21|FLUID CONNECTION SYSTEM AND METHOD OF MANUFACTURE| CN201580065799.5A| CN107002933A|2014-11-21|2015-11-20|Fluid connection system and manufacture method| US15/528,298| US10883643B2|2014-11-21|2015-11-20|Fluid connection system and production method| EP15804177.2A| EP3221628B1|2014-11-21|2015-11-20|Fluid connection system and production method| PCT/FR2015/053156| WO2016079451A1|2014-11-21|2015-11-20|Fluid connection system and production method| US17/247,154| US20210080043A1|2014-11-21|2020-12-02|Fluid connection system and production method| 相关专利
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