Method of manufacturing a catheter or stent assembly and device therefor

Abstract

The invention relates to a simple and cost-effective method of manufacturing a catheter assembly (10, 110) or stent assembly by joining a first tubular component (11, 111) and at least a second component (12, 112), wherein the joining is provided in a joining section (15) of the first tubular component (11, 111), wherein the method comprises the following steps: - Providing the first tubular component (11, 111) and the at least one second component (12, 112), - Arranging at least a portion of the at least one second component (12, 112) adjacent the first tubular component (11, 111) in its joining section (15), - Arranging the catheter assembly (10, 110) or the stent assembly within a stretchable tube (20), - Stretching the tube (20) axially such that the diameter of the tube (20) is reduced thereby providing a joining pressure to the catheter assembly (10, 110) or stent assembly at the joining section (15) in this stretched condition, - Arranging the catheter assembly (10, 110) or stent assembly and the tube (20) within and / or at a heating unit (22, 28), - Heating the catheter assembly (10, 110) or stent assembly at and / or near the joining section (15) by the heating unit (22, 28) thereby creating a substance-to-substance bond between the first tubular component (11, 111) and the at least one second component (12, 112) at the joining section (15) while the tube (20) is in its stretched condition, - Subsequently, transferring the tube (20) from its stretched condition to a released condition and removing the catheter assembly (10, 110) or stent assembly from the tube (20) and the heating unit (22, 28). The invention further relates to a respective manufacturing device as well as to a respective catheter assembly, stent assembly and implant.

Description

[0001] Applicant: BIOTRONIK AG

[0002] Date: 30.10.2025

[0003] Our Reference: 242077WO

[0004] Method of manufacturing a catheter or stent assembly and device therefor

[0005] The disclosure relates to a method of manufacturing a catheter assembly or stent assembly by joining a first tubular component and at least a second component. The invention further relates to a device which is used to realize such method.

[0006] Catheters are medical devices that can be inserted into the patient’s body to treat diseases and / or to perform a surgical procedure. Additionally, catheters are used to insert implants such as stents or stent grafts into the patient’s body. Many catheters and implants to be inserted are tubular, at least over a large proportion of their length. However, for some applications, a catheter (section) has a more complicated form which is usually manufactured by joining a first catheter component and at least a second catheter component.

[0007] For joining tubular catheter components heat shrink tubing is usually used to create a joining pressure when generating a melt connection between a first tubular component and a second tubular component. The heat shrink tubing is usually heated from the outside, so that it begins to shrink and presses the components to be joined together. Energy continues to be added until the encased thermoplastics melt and thus the components weld together. The shrink tubing is not reusable and thereby expensive and can only be removed by hand which can be a cumbersome process. A heat shrink tube cannot guarantee uniform wall thickness after joining for asymmetric joint components. Furthermore, removing heat shrink tubes is not reliable and poses a risk of damaging the joint components, especially in cases of non-linear cracks.

[0008] Document WO 2024 / 046865 Al discloses a method of joining catheter components using an elastic component and a clamping tool. The catheter components to be joined are arranged within an elastic component opening or recess, wherein the elastic component is located within the clamping tool. When pressing the clamping tool against the elastic component a joining pressure is applied to the catheter components. The catheter components are heated while applying the joining pressure to the catheter components for joining. However, a major drawback of the manufacturing method using the elastic component is its difficult and time-consuming handling thereby compromising the process capability. When inserting the catheter components to be joined, the catheter components are moved out of position relatively to each other. This is because the inner diameter of the elastic component is rather small to ensure homogenous pressure application. Experiments with a larger inner diameter of the elastic component showed that handling was improved, but the joining result was compromised due to the uncontrolled deformation (collapsing) of the inner diameter.

[0009] It is therefore an object of the present invention to provide a cost-effective and simple method of manufacturing a catheter assembly or stent assembly having a pressure-resistant, tensile- strength joint of a first tubular component and at least a second component, that may be used for symmetrically and asymmetrically arranged catheter or stent assemblies and that is atraumatic (i.e. has a streamlined, smooth surface).

[0010] The above object is solved by a method having the features of claim 1, a device having the features of claim 11 as well as an assembly being a catheter assembly or stent assembly having the features of claim 14, a stent or stent graft having the features of claim 16 and a catheter having the features of claim 15. In the following, the stent assembly may be an assembly of a stent, e.g. a covered stent, or a stent graft.

[0011] In particular, the object is solved by a method of manufacturing a catheter assembly or stent assembly by joining a first tubular component and at least a second component, wherein the joining is provided in a joining section of the first tubular component and wherein at least one of the first tubular component and the at least one second component is a thermoplastic component or has a thermoplastic coating in at least one section of the respective component, wherein, e.g., the first tubular component being a first catheter component and the second component being a second catheter component, or, e.g., the first tubular component being a first tubular stent component such as a cover and the second component being a stent structure, wherein the method comprises the following steps:

[0012] - Providing the first catheter component and the at least one second component,

[0013] - Arranging at least a portion of the at least one second component adjacent the first tubular component in its joining section,

[0014] - Arranging the catheter assembly or stent assembly within a stretchable tube,

[0015] - Stretching the tube axially such that the diameter of the tube is reduced thereby providing a joining pressure to the catheter assembly or stent assembly at the joining section in this stretched condition,

[0016] 242077WO / 30.10.2025 - Arranging the catheter assembly or stent assembly and the tube within and / or at a heating unit,

[0017] - Heating the catheter assembly or stent assembly at and / or near the joining section by the heating unit thereby creating a substance-to-substance bond between the first tubular component and the at least one second component at the joining section while the tube is in its stretched condition,

[0018] - Subsequently, transferring the tube from its stretched condition to a released condition and removing the catheter assembly or stent assembly from the tube and the heating unit.

[0019] In the secondly mentioned step of the above method, the at least one second component and the first tubular component are arranged initially adjacently thereby forming an initial, unbonded catheter assembly or stent assembly. This initial catheter assembly or stent assembly is then arranged within the stretchable tube and within and / or at the heating unit. During heating of the initial catheter assembly or stent assembly, when the tube is in its stretched condition the substance-to-substance bond between the first tubular component and the at least one second component is created, if applicable via the thermoplastic coating, so that the catheter assembly or stent assembly transfers to a state in which the pre-defined connection / bond between the predefined components is provided. After sufficient heating and thereby creating a reliable substance-to-substance bond and thus completing the catheter assembly or stent assembly, the tube is transferred from its stretched condition to the released condition. Accordingly, the catheter assembly or stent assembly comprising the joined first tubular component and the at least one second component can be removed from the tube. Additionally, the catheter assembly or stent assembly is removed from the heating unit.

[0020] In one embodiment, the step of arranging the (initial) catheter assembly or stent assembly within the stretchable tube is performed prior to arranging the (initial) catheter assembly or stent assembly within and / or at the heating unit or these steps are performed in reverse order.

[0021] The above method of manufacturing a catheter assembly or stent assembly provides a joining pressure during heating by an axially stretched tube surrounding the initial catheter assembly or stent assembly. The initial catheter assembly or stent assembly consists of correctly arranged first tubular component and at least one second component prior joining. The stretched tube is arranged such that it applies the joining pressure to the catheter assembly or stent assembly externally and to the joining section. Consequently, the joining pressure is applied to all components located in the area of the joining section, i.e. the first tubular component section located in the joining section and the section of the at least one second component located within

[0022] 242077WO / 30.10.2025 the joining section. By using an axially stretched tube, the necessary pressure for joining has mainly radial components and provides a uniform and homogeneous pressure distribution along each circumference of the tube to the catheter assembly or stent assembly. Additionally, it is possible to join asymmetric arrangements of the catheter components. The advantage of the manufacturing method is that a reliable, pressure-resistant, tensile-strength catheter assembly or stent assembly is provided. Additionally, the joint is created using a device which consists of reusable device elements as the stretchable tube is reusable, as well. Furthermore, an atraumatic joint (i.e. streamlined, smooth surface) may be formed and insertion and removal of the catheter assembly or stent assembly from the manufacturing device is eased. Accordingly, streamlined heating / welding may be achieved in short time. This is also true, as there is no manual removal of the heat shrink required

[0023] In one embodiment the stretchable tube has an elasticity module of less than 1 GPa, for example less than 0.1 GPa. Additionally, the material of the stretchable tube may have a Shore hardness between 50 Shore A and 80 Shore A, further preferred between 60 Shore A and 70 Shore A. By providing a stretchable tube having such elasticity and / or Shore hardness, a sufficient stretching and suitable joining pressure is achieved. The stretchable tube may have an outer diameter between 0.5 mm and 10 mm. further preferred between 0.5 mm and 5 mm, a length (i.e. dimension in longitudinal / axial direction of the tube) between 1 mm and 50 mm, further preferred between 1 mm and 10 mm and / or a wall thickness between 0.7 mm and 1.2 mm, further preferred between 0.9 mm and 1.1 mm, each in the released condition. The axial stretching of the stretchable tube may be facilitated by clamping the tube between a first clamping member and a second clamping member as indicated below and subsequent moving of at least one of the first clamping member and the second clamping member apart from the other one of the first clamping member and the second clamping member in axial direction.

[0024] In one embodiment, the catheter assembly or stent assembly is arranged within the stretchable tube being in a released condition or a slightly stretched condition. Preferably, the tube is not bended but straight so that the catheter assembly or stent assembly may be easily arranged within the stretchable tube. Preferably, the diameter of the inner lumen of the stretchable tube is larger than the outer diameter of the catheter assembly or stent assembly so that the catheter assembly or stent assembly may be easily arranged within the stretchable tube.

[0025] In case of a slightly stretched condition, the axial stretching for the heating step is provided with a pulling force that is greater than the pulling force of tube stretching in the “slightly stretched

[0026] 242077WO 30.10.2025 condition” (see above). The full axial stretching of the tube to provide a joining pressure to the catheter assembly or stent assembly is then performed (e.g. shortly) prior to or during heating. Preferably, the stretchable tube is fully stretched prior heating.

[0027] The substance-to-substance bond between the first tubular component and the at least one second component at the joining section of the first tubular component is created by melting of at least one of the first tubular component, the at least one second component and, if applicable, the thermoplastic coating of the respective component and subsequent soldification. This process step is also referred to as welding in the following. The heating / welding requires that the temperature provided by heating is greater than the melting point or region of the respective one of the first tubular component and / or the at least one second component or the thermoplastic coating. In one embodiment, the at least one of the first component and the at least one second component or the thermoplastic coating is melted, for example partially, at an interface of two adjacent catheter components of the first tubular component and the at least one second component. In case a thermoplastic coating is used, this thermoplastic coating is located in at least one section of at least one of the first tubular component and the at least one second component such that during heating / welding it is located at the interface of the two adjacent catheter components in the joining section. In one embodiment, the heating time and intensity - depending on the used heating method explained below - is controlled or regulated aiming at a reliably fixed and / or fluid-tight connection at the joint. In one embodiment, the joined catheter assembly or stent assembly is cooled down after heating / welding prior to removal from the stretchable tube for soldification. The joining section may have a dimension in axial / longitudinal direction (i.e. a length) of the first tubular component of a catheter assembly or stent assembly of, for example, from 1 mm to 20 mm, for example from 1 mm to 15 mm, e.g. from 1 mm to 10 mm for a catheter assembly. With regard to a first tubular component of a stent assembly the joining section may have a dimension in axial / longitudinal direction (i.e. a length) of the first tubular component of 10 mm to 300 mm, e.g. 10 mm to 30 mm for coronary cover stents or e.g. 20 mm to 280 mm for peripheral cover stents.

[0028] In one embodiment, the one second component is a second tubular member of the catheter assembly or stent assembly. In one embodiment, the first tubular component is an outer catheter shaft and one second component is an inner catheter shaft. In one embodiment, the catheter assembly comprises a guide wire exit port, wherein the first tubular component is an outer catheter shaft and one second component is a catheter shaft for guiding a guide wire. This second component extends partially outside the first tubular component, through a through hole in the

[0029] 242077WO / 30.10.2025 wall of the first tubular component, and partially within the first tubular component in different sections of the guide wire exit port. In this embodiment, during the step of arranging at least a portion of the one second component in the joining section, the one second tubular component is inserted into the through hole formed in the wall of the first tubular component. This through hole is located in the joining section of the first tubular component. For such asymmetric arrangement, the stretched tube provides uniform joining pressure. Additionally, due to welding, an atraumatic structure of the guide wire exit port can be realized.

[0030] In one embodiment the first tubular component or the second component is a catheter balloon or a distal catheter tip assembly or a tubular stent structure (scaffold, stent, stent graft) or a catheter shaft or a tubular cover, for example an outer catheter shaft, an outer cover, an inner catheter shaft, an inner tubular cover turned outwards at one or both ends of the first / second (tubular) component to the outside of the first / second component such that the outwardly turned ends cover the first / second component from the outside. The stent assembly is, for example, an outer tubular cover as a first tubular component and a tubular stent structure as a second component. After joining they may form a covered stent, e.g. for vascular intervention, or a stent graft. For the above-mentioned embodiments, the material of the catheter shaft, the stent structure and / or the cover may be a thermoplastic material. Alternatively or additionally, the catheter shaft, the tubular cover and / or the stent structure may carry a thermoplastic coating in at least one section at the (outer or inner) side that is configured to be located adjacent the respective other component (first tubular component or at least one second component) for joining.

[0031] The stent structure is comprised of interconnected struts and / or meandering struts having a generally net-like tubular shape with a plurality of open cells and consists of biocompatible metallic or polymer material.

[0032] In one embodiment the stretchable tube does not have any heat shrinking properties in the temperature range provided by the heating unit thereby allowing reuse of the stretchable tube.

[0033] In one embodiment, a pressure chamber is provided, wherein the catheter assembly or stent assembly and the tube are arranged within the pressure chamber prior to the heating step, wherein the heating of the catheter assembly or stent assembly is performed while the catheter assembly or stent assembly is located within the pressure chamber providing an overpressure. In one embodiment, the pressure chamber may comprise a pressure-tight housing during heating. In one embodiment, stretching the tube axially is provided by pressure increase within the pressure

[0034] 242077WO / 30.10.2025 chamber prior heating the catheter assembly or stent assembly. In one embodiment, the housing of the pressure chamber may partially consist of optically transparent material (e.g. an optically transparent tube) to allow permanent observation of the progress of the joining process. The pressure chamber may have a tubular form. The housing may at least partially consist of polymethyl methacrylate (PMMA). PMMA may be transparent and, thus, ease the arrangement of the catheter components. The additional external pressure component created by the pressure chamber at the initial catheter assembly or stent assembly during heating further increases the quality of the joint due to the greater compression force. Further, air bubbles are avoided. The pressure provided by the pressure chamber ensures that the stretchable tube fits snugly against the catheter assembly or stent assembly. The overpressure provided within the pressure chamber is transmitted via the tube to the catheter assembly or stent assembly prior, during and / or after joining / welding. A pressure equalization is provided within the pressure chamber relative to the ambient pressure after the heating / welding step and prior to removing the catheter assembly or stent assembly from the stretchable tube. In one embodiment, the pressure chamber has an adjustable air supply to ensure homogeneous compression of the stretchable tube. The applied pressure on the tube from the pressure chamber improves the repeatability and provides pressure adaptability independent from potential material changes of the stretchable tube due to fatigue or temperature.

[0035] In one embodiment, the pressure chamber provides an overpressure of a pressure value between 120 kPa and 2.000 kPa, for example between 150 kPa and 1.000 kPa.

[0036] In one embodiment, the first tubular component comprises a first lumen, wherein prior heating the first tubular component and the at least one second component are arranged such that at least a portion of the at least one second component is arranged within the first lumen of the first tubular component in its joining section. In this embodiment, a joint is created where a portion of the at least one second component is fixed to an inner surface of the first lumen of the first tubular component. For example, an end section of a tubular second component is connected with its outer surface to an inner surface of a tubular first tubular component.

[0037] In one embodiment, the thermal energy of the heating unit is provided by electromagnetic induction, electric conduction, laser heating, convection and / or radiation. I.e. heating the first tubular component and the at least one second component for joining said components comprises heating said components by means of one of: electromagnetic induction, heat conduction, heat

[0038] 242077WO / 30.10.2025 convection and / or electromagnetic radiation in the range of 690 nm to 15 cm, for example, infrared irradiation.

[0039] In one embodiment, the heating unit comprises an induction coil and an elongated electrically conductive member, wherein the method comprises the following additional steps:

[0040] - Arranging an elongated electrically conductive member at the first tubular component and / or at the at least one second component such that the electrically conductive member extends along the joining section of the first tubular component within the first lumen of the first tubular component and / or within a second lumen of the at least one second component,

[0041] - Arranging the catheter assembly or stent assembly within an induction coil such that the induction coil encompasses the catheter assembly or stent assembly at or near the joining section of the first tubular component,

[0042] - Induction welding the first tubular component to the at least one second component using the induction coil while the tube is in its stretched condition to create the substance-to-substance bond.

[0043] In this embodiment, heating is provided by electromagnetic induction which is also known as induction heating or induction welding. Induction welding uses the heat generated by electrically conductive material (i.e. the material of the elongated electrically conductive member) by electromagnetic induction. The thermal energy produced by the electrically conductive member is transferred to the first tubular component and / or to the at least one second component and / or the thermoplastic coating in such way that at least one of said components / coating is melted. The induction coil (inductor) creates a rapidly alternating electromagnetic field within the coil generated by high-frequency alternating current. This electromagnetic field causes eddy currents and / or, in case a ferromagnetic or ferromagnetic material is used, hysteresis losses within the electrically conductive member thereby heating the electrically conductive member. The elongated electrically conductive member, which may be a rod or a wire, is arranged at the first tubular component and / or at the at least one second component, e.g. within an internal space (first inner lumen) of the first catheter component and / or within an internal space (second inner lumen) of the at least one second component.

[0044] The induction coil is configured such that it encompasses the first tubular component and the at least one second component arranged within the stretchable tube. It contactlessly produces thermal energy within the electrically conductive member for heating the first tubular component and / or the at least one second component and / or the thermoplastic coating. In one embodiment,

[0045] 242077WO / 30.10.2025 in case the heating is provided within a pressure chamber, the induction coil may be accommodated outside the pressure chamber, e.g. encompassing the housing of the pressure chamber.

[0046] In one embodiment further parameters of the induction welding heating unit and method may be adapted to the specific needs for joining the components of the catheter assembly or stent assembly. For example, the material of the electrically conductive member, its surface structure and diameter as well as the material of the stretchable tube may be varied. Further, parameters such as the position of the joining section within the induction coil, the diameter of the induction coil as well as the number of windings of the induction coil may affect the properties of the weld. For effective positioning of the coil relative to the joining section it may be, for example, determined in advance in which area the field lines of the induced magnetic field have the highest energy transfer to the electrically conductive member. This may be provided using a thermocouple, the temperature sensor of which was able to measure the temperature increase.

[0047] The elongated electrically conductive member is removed after finishing the heating step, i.e. after joining. The elongated electrically conductive member may be used to provide or correct a pre-defined arrangement / alignment of the first tubular component and the second component prior to heating in a manner that resembles a handle. In one embodiment, the elongated electrically conductive member has a length that is greater than the length of the joining section (i.e. the dimension in longitudinal direction of the first tubular component / joining section). The elongated electrically conductive member is removed after finishing the heating step, i.e. after joining.

[0048] In one embodiment, the induction coil is arranged at a central position with regard to a longitudinal extension of the joining section of the first tubular component. This means that the joining section may be arranged such within the induction coil that the induction coil is located centrally relative to the joining section, wherein the longitudinal extension of the joining section is considered. In this embodiment, a reasonably uniform spatial distribution of the electromagnetic field is provided and hot spots are avoided so that a uniform joining of the first tubular component and the second component is achieved.

[0049] In one embodiment, the electrically conductive member is a ferromagnetic wire or ferromagnetic rod-like member. The ferromagnetic wire or rod-like member may comprise or consist of a

[0050] 242077WO / 30.10.2025 material of the group comprising iron, an iron alloy, ferromagnetic steel, austenitic steel, e.g.

[0051] V2A steel.

[0052] In one embodiment, the stretchable tube consists of or comprises a material of the group comprising silicone rubbers, e.g. fluorosilicones, high-temperature silicones, fluoroelastomers, e.g. perfluoroelastomers, natural rubbers, synthetic rubbers, e.g. styrene-butadiene rubbers, butyl rubbers, nitrile rubbers, polyurethanes, ethylene propylene diene monomers (EPDMs), thermoplastic elastomers (TPEs) or hydrogels. Furthermore, the material of the tube is a material which does not adhere to the material of the first tubular component and / or to the material of the at least one second component when the material of these components is melted and solidified in contact with the elastic material during cooling. In one embodiment, a melting point, a decomposition temperature or a glass transition temperature of the tube material is above a melting point, a decomposition temperature or a glass transition temperature of the material of the first catheter component and / or of the material of the at least one second component. Particularly, according to one embodiment, the melting point (or decomposition temperature or glass transition temperature) of the material of the stretchable tube is above 200°C, for example above 250°C. A tube material for a long-term use above 200°C is, for example, EPDM, and for a long-term use above 250°C, for example, perfluoroelastomer, fluorosilicone, and high- temperature silicone. In one embodiment, the stretchable tube may be stretched to a length in the stretched condition that is at least 150%, e.g. at least 175%, of its length in the released condition.

[0053] In one embodiment, an elongated welding profile is provided and introduced into the first lumen of the first tubular component and / or into the second lumen of the at least one second component prior to the heating step such that it extends along the joining section during the heating step. The welding profile may be, for example, formed as a rod or wire. The welding profile is removed after the heating / welding step and keeps open and / or creates a lumen or open space within or at the first tubular component and / or the at least one second component in an easy way. The material of the welding profile does not form any substance-to-substance bond with, i.e. does not adhere to, the first tubular component and / or the at least one second component during the heating step. Accordingly, the outer dimensions of the welding profile may be configured such that they correspond to the dimensions of the lumen or open space to be created. The welding profile may consist of or comprise at least one material of the group comprising Nitinol, polytetrafluorethylene (PTFE). In one embodiment, a melting point, a decomposition temperature or a glass transition temperature of the welding profile material is above a melting

[0054] 242077WO / 30.10.2025 point, a decomposition temperature or a glass transition temperature of the material of the first catheter component and / or of the material of the at least one second component.

[0055] In one embodiment, the material of the first tubular component and / or the material of the at least one second component and / or the material of the thermoplastic coating and / or the tube material and / or the welding profile material is a medical grade material, wherein the requirement of a medical grade material is defined in EU Regulation 2017 / 745 (MDR) or ISO 10993.

[0056] In one embodiment, the first tubular component and / or the at least one second component and / or the thermoplastic coating comprises at least one material of the group comprising a polymer, a polymer blend, a biostable polymer, a biodegradable polymer, a silicone-based elastomer and a polymer mixture, in particular polyamides, polyether block amides or thermoplastic polyurethanes, thermoplastic silicone polycarbonate elastomers, preferably comprising 5 wt% silicone, polycarbonate aliphatic thermoplastic polyurethane elastomers, thermoplastic polycarbonate polyurethane polymers, aliphatic and aromatic polycarbonate-based thermoplastic polyurethanes, thermoplastic silicone polycarbonate polyurethane copolymers, aromatic polyether-based thermoplastic polyurethanes, silicone-polyurethane co-polymers or mixtures thereof. The thermoplastic component of the first tubular component and / or of the at least one second component and / or of the coating of the first tubular component and / or the at least one second component may comprise or consist of at least one material of the group comprising thermoplastic elastomers, thermoplastic polyurethanes, fluorinated ethylene propylene (FEP), thermoplastic silicone polycarbonate elastomers, preferably comprising 5 wt% silicone, polycarbonate aliphatic thermoplastic polyurethane elastomers, thermoplastic polycarbonate polyurethane polymers, aliphatic and aromatic polycarbonate-based thermoplastic polyurethanes, thermoplastic silicone polycarbonate polyurethane copolymers, aromatic polyether-based thermoplastic polyurethanes, silicone-polyurethane co-polymers or mixtures thereof. In one embodiment, the first tubular component and / or the at least one second component may comprise or consist of a biocompatible material.

[0057] Further, in a preferred embodiment of the method, the first tubular component and / or the at least one second component comprises a lumen configured to receive at least one electrical conductor and / or thermal conductor and / or a guide wire of the catheter assembly.

[0058] The above object is further solved by a device for manufacturing of a catheter assembly or stent assembly by joining a first tubular component and at least a second component, wherein the

[0059] 242077WO / 30.10.2025 joining is provided in a joining section of the first tubular component, wherein the device comprises:

[0060] - A stretchable tube extending in a longitudinal direction and having a first end and a second end.

[0061] - A heating unit.

[0062] - A first clamping member arranged at and attached to the first end of the stretchable tube and a second clamping member arranged at and attached to the second end of the stretchable tube.

[0063] - In a released condition an inner lumen of the stretchable tube is configured to accommodate the first tubular component and the at least one second component to be joined, wherein at least a portion of the at least one second component is accommodated adjacent the first tubular component in its joining section.

[0064] - The stretchable tube is further configured to be transferred into a stretched condition in which the tube is axially stretched by axial movement of at least one of the first clamping member and the second clamping member such that the diameter of the tube is reduced thereby providing a joining pressure to the catheter assembly or stent assembly at the joining section.

[0065] - The heating unit is configured such that the catheter assembly or stent assembly and the tube can be arranged within and / or at the heating unit and such that the catheter assembly or stent assembly is heated at and / or near the joining section by the heating unit while the tube is in its stretched condition to create a substance-to-substance bond between the first tubular component and the at least one second component at the joining section.

[0066] The above device is a cost-effective device that can provide a reliable and fluid-tight connection between the first tubular component and the at least one second component as indicated above.

[0067] As explained above, an even more reliable connection of the first tubular component and the at least one second component is achieved if the device further comprises a pressure chamber, wherein the pressure chamber is configured such that the catheter assembly or stent assembly and the tube can be arranged within the pressure chamber prior the heating step, wherein the heating of the catheter assembly or stent assembly is performed within the pressure chamber providing an overpressure. In some embodiments, the pressure chamber provides an overpressure of a pressure value between 120 kPa and 2.000 kPa, for example between 150 kPa and 1.000 kPa. In some embodiments, the first and / or the second clamping member are arranged within the pressure chamber.

[0068] 242077WO / 30.10.2025 In one embodiment, the heating unit comprises an induction coil and an elongated electrically conductive member configured to join the first tubular component and the at least one second component by induction welding.

[0069] With regard to further embodiments of the device it is referred to the above explanation of the invention describing the manufacturing method.

[0070] The above object is further solved by a catheter assembly or stent assembly comprising a first tubular component and at least one second component manufactured using the above explained method. Accordingly, a catheter or stent (including stent grafts) comprising such catheter assembly or stent assembly, respectively, a solves the above object, as well. The stent assembly may comprise a stent structure (stent). The catheter assembly or stent assembly and catheter or stent or stent graft manufactured by the above method have the above properties and advantages. It is referred to the above explanation in this regard. The stent may be a covered coronary or peripheral stent, wherein the cover is the first tubular component.

[0071] The present invention will now be described in further detail with reference to the accompanying schematic drawing, wherein

[0072] Fig. 1 shows a longitudinal section of a first embodiment of a device configured for manufacturing of a catheter assembly in a first step of the manufacturing method and a respective longitudinal section of a first embodiment of a catheter assembly,

[0073] Fig. 2 to 4 depict longitudinal sections of the embodiment of the device of Fig. 1 in further steps of the manufacturing method and respective longitudinal sections of the catheter assembly of Fig. 1,

[0074] Fig. 5 illustrates a cross section of the device and the catheter assembly of Fig. 1 in the first step of the manufacturing method according to Fig. 1,

[0075] Fig. 6 shows a cross section of the device and the catheter assembly of Fig. 1 in a second step of the manufacturing method according to Fig. 2,

[0076] 242077WO / 30.10.2025 Fig. 7 depicts a cross section of the catheter assembly of Fig. 1 after finishing the manufacturing method,

[0077] Fig. 8 illustrates a longitudinal section of a second embodiment of a device configured for manufacturing of a catheter assembly in a first step of the manufacturing method and a respective longitudinal section of a second embodiment of a catheter assembly,

[0078] Fig. 9 to 12 depict longitudinal sections of the embodiment of the device of Fig. 1 in further steps of the manufacturing method and respective longitudinal sections of the catheter assembly of Fig. 8,

[0079] Fig. 13 shows a longitudinal section of a third embodiment of a catheter assembly during manufacturing,

[0080] Fig. 14 illustrates the longitudinal section of the catheter assembly of Fig. 13 after heating and removing from the device,

[0081] Fig. 1 to 4 depict a first embodiment of a manufacturing device and catheter assembly 10 at various steps of the method relating to joining a first tubular catheter component 11, e.g. an outer catheter shaft (or alternatively an inner or outer tubular cover of a stent) and a second tubular catheter component 12, e.g. an inner catheter shaft (or alternatively a tubular stent structure). Joining is provided in a joining section 15 of the first catheter component 11 extending in longitudinal direction of the catheter assembly 10. The longitudinal or axial direction is indicated by means of the longitudinal axis 10a of the catheter assembly (see Fig. 1).

[0082] The inner diameter of the first catheter component 11 is slightly greater than the outer diameter of the second catheter component 12. In the first step of the manufacturing method, the second catheter component 12 is arranged within the inner lumen (first lumen) 1 la of the first catheter component 11. The second catheter component 12 is inserted within the inner lumen 1 la of the first catheter component 11 such that it is located adjacent the inner surface of the first catheter component 11 in the joining section 15 as indicated in Fig. 1 and 5. Fig. 1 further shows that the catheter assembly (prior joining) 10 is arranged within a stretchable silicone tube 20 which is clamped at its first end to a first clamping member 24. The first clamping member 24 is fixed at

[0083] 242077WO / 30.10.2025 the device during the whole joining process. The first catheter component 11 and the second catheter component 12 is made of, for example, a polymer.

[0084] Further, the device comprises a rod-like electrically conductive member 22 arranged within the inner lumen (second lumen) 12a of the second catheter component such that it extends along the full length of the joining section 15 and beyond at both ends of the joining section 15.

[0085] For joining the first catheter component 11 and the second catheter component 12 the stretchable tube 20 is firmly but detachably attached to a second clamping member 26 at its second end opposite the first end (see Fig. 2). The second clamping member 26 may have, e.g., a tubular form. Then, the second clamping member 26 is moved in the longitudinal direction away from the first end of the tube 20 such that the tube 20 is axially stretched thereby reducing the inner diameter of the tube 20 until the inner wall of the tube touches the first and second components 11, 12 to be joined (refer to Fig. 2 and 6) at least within the joining section 15. Accordingly, a radial pressure is applied to the catheter component 10 by the axially stretched tube 20 (see arrows in Fig. 2).

[0086] While in the stretched condition of the tube 20, in the next step depicted in Fig. 3, thermal energy for creating the joint is provided by an induction coil 28 encompassing the catheter assembly 10 and the stretched tube 20 at the joining section 15. Eddy currents are induced by an alternating electromagnetic field provided by the induction coil 28 within the rod-like electrically conductive member 22 thereby producing heat which is transmitted via the second catheter component 12 to the interface of the first catheter component 11 and the second catheter component 12. Alternatively or additionally, other heat generating methods such as conduction, convection, laser welding or radiation may be used for thermal energy supply. The thermal energy effects melting at the interface of the first catheter component 11 and the second catheter component 12 of at least one of both materials and formation of a reliably fixed substance-to- substance bond in the joining section.

[0087] Afterwards, the induction coil is removed and the tube 20 is transferred into the released condition (see Fig. 4). Then, the catheter assembly 10 comprising the joined first catheter component 11 and second catheter component 12 in the joining section 15 can be removed from the device, in particular from the tube 20. The final configuration of the first catheter component 11 and the second catheter component is depicted in Fig. 7.

[0088] 242077WO / 30.10.2025 The second embodiment of a manufacturing device is shown in Fig. 8 to 11. This embodiment differs from the first embodiment of Fig. 1 to 7 in that a pressure chamber 30 having a pressure tight housing is provided. As depicted in Fig. 8 to 11, the catheter assembly comprising the first catheter component 11 and the second catheter component 12 as well as the stretchable tube 20 are arranged within the pressure chamber 30 with a pressure gauge 31 indicating the pressure in the pressure chamber 30. The rod-like electrically conductive member 22 may extend through the housing of the pressure chamber 30. Since the rod-like electrically conductive member 22 is accessible from the exterior of the pressure chamber 30 it may be used to properly position the catheter assembly 10 or the second catheter component 12 within the first catheter component 11 in a pre-defined position comparable to a handle. However, the rod-like electrically conductive member 22 is pressure-tightly sealed within the pressure chamber 30 housing when overpressure is provided in the pressure chamber 30 during the heating / welding step.

[0089] As illustrated in Fig. 9 the tube 20 is axially stretched within the pressure chamber analogously to the first embodiment. In one embodiment, the second clamping member 26 may be moved along a rail for stretching the tube by mechanical means (e.g. a motor and, if applicable, a gear) until it or its carrier reaches a stopper 32 and / or may be moved by overpressure provided within the pressure chamber. The stopper 32 ensures that the tube 20 is not stretched to any length. Similar to the first embodiment, the stretching of the tube 20 reduces the inner diameter of the tube 20 thereby applying a radial pressure to the catheter assembly as indicated in Fig. 2 and 3 of the first embodiment.

[0090] The thermal energy for heating is provided by electromagnetic induction as explained in connection with Fig. 3 of the first embodiment. Similarly, an induction coil 28 is used for heating via the electrically conductive member 22, wherein the induction coil 28 may be located exterior of the pressure chamber 30 (see Fig. 11). Prior and during heating an overpressure is applied to the tube 20 and the catheter assembly 10 accommodated within the pressure chamber 30. This overpressure of, for example, 200 kPa is symbolized by the position of a pointer of the pressure gauge 31 changing from a left to a center position as shown in Fig. 10 and 11. The overpressure effects a more homogeneous pressure application to the whole joining section 15 or catheter assembly 10 via the tube 20 so that the tube 20 conforms the contours of the components to be heated / welded thereby joining the first catheter component 11 and the second catheter component 12 in the joining section 15. The overpressure application prior heating is depicted in Fig. 10, whereas the heating under overpressure is shown in Fig. 11. The heating by

[0091] 242077WO / 30.10.2025 electromagnetic induction under the overpressure within the pressure chamber 30 may take, for example, 2.5 seconds.

[0092] Afterwards, the tube 20 is transferred to the released condition and a pressure equalization with the ambient pressure is provided (see Fig. 12, pressure gauge 31, pointer returns to its left position). Subsequently, the joined catheter assembly may be removed from the tube 20 and the pressure chamber 30.

[0093] A first catheter component 111 and a second catheter component 112 may be joined to form a guide wire exit port by the methods and devices explained either with respect to Fig. 1 through 7 or with respect to Fig. 8 through 12. However, as the guide wire exit port is an asymmetric connection, the second embodiment (see Fig. 8 to 12) using an overpressure provides a more homogeneous pressure distribution along the joining section and, accordingly, a more reliably fixed connection.

[0094] 107 samples of similar catheter assemblies 110 comprising a guide wire exit port were manufactured using the method shown in Fig. 8 to 12. The initial position of the components of such catheter assembly 110 prior the heating step and without tube is depicted in Fig. 13. Fig. 14 shows the sample catheter assemblies 110 upon completion of the manufacturing procedure and removal the respective catheter assembly 110 from the pressure chamber 30.

[0095] For manufacturing of one of such catheter assembly 110 comprising the guide wire exit port the first catheter component 111 was provided as the outer shaft and the second catheter component 112 was provided as the shaft guiding the guide wire. Prior the heating / welding step the second catheter component 112 was inserted with its one end into the inner lumen I l la of the first catheter component 111 through a through hole 111b within the wall of the first catheter component 111. Further, a wire-like electrically conductive member 122 was inserted into the inner lumen 112a of the second catheter component 112 as indicated in Fig. 13. In addition, a welding profile 129 was inserted into the inner lumen I l la.

[0096] The sample comprises joining of 107 catheter assemblies with the first hollow cylindrical catheter component 111 made of polyamid 12 (PA12). The diameter of the inner lumen 11 la of the first catheter component was approximately equal to the outer diameter of the second catheter component 112. The wire-like electrically conductive member 122 had a diameter of 0.41 mm

[0097] 242077WO / 30.10.2025 ± 0.005 mm and was made of 1.4301 V2A steel having a length of 300 mm ± 5 mm. The second catheter component 112 was introduced in the inner lumen of the first catheter component 111 as shown in Fig. 13 such that it runs through the through hole 11 lb.

[0098] The tube 20 to be stretched was a silicone tube having an inner diameter of 1.2 mm and an outer diameter of 2 mm, 65 shore A ± 5, 100 mm length in its initial state (released condition). The tube 20 was stretched to a length of 192 mm, i.e. to 192% of its length at released condition. In an alternative embodiment, a stretching to a length of 180 mm, i.e. to 180% was found to be suitable, as well.

[0099] The overpressure within the pressure chamber 30 during the induction welding step was 200 kPa.

[0100] The catheter assembly 110 upon completion of the manufacturing process is depicted in Fig. 14. As can be seen from this figure, the second catheter component 112 forms a substance-to- substance bond to the first catheter component 111 not only in the region of the through hole 111b but also proximally and distally of this region either on the outer surface of the through hole 11 lb (see right side of Fig. 14) or on the inner surface of the inner lumen 11 la of the first catheter component 111 (see left side of Fig. 14) due to the aforementioned homogeneous heat and pressure distribution over this extended joining section.

[0101] The above method and device for manufacturing a catheter assembly or stent assembly is advantageous because asymmetric structures may be joined easily and in a time-saving manner. The catheter assemblies can be manufactured with a reproducible quality. In addition, the device is simple and therefore cost effective. A further advantage is that due to the stretchable tube a streamlined welding connection (rounded and smoothed edges and surfaces) was received. Further, no adaption in welding parameters is necessary when changing the tube, since the connecting force is defined by the pressure inside the pressure chamber. A variability of the tube can be compensated for by the used overpressure value in the pressure chamber or by the stretching length. Last but not least, it is advantageous that critical parameters can be controlled, such as time, energy input of the coil, pressure application by overpressure value within the pressure chamber and / or stretching length of the silicone tube.

[0102] The joining method and device as principally shown in Fig. 1 through 12 and explained above may be used similarly for joining an outer tubular cover or an inner cover with a cover section (e.g. at one or both longitudinal ends of the stent structure) turned outwards as the first tubular

[0103] 242077WO / 30.10.2025 component to a tubular stent structure (see above) being a net-like structure of struts as the second (tubular) component. In case an inner cover is turned outwards in one section, at this section the stent structure is covered inwards and outwards. For attachment of the tubular cover to the stent structure the stent structure may be arranged on a mandrel, i.e. the mandrel extends through an inner lumen of the net-like tubular stent structure and / or, if applicable, the inner cover. It is therefore referred to the Figs. 1 to 12 for manufacturing a covered stent or stent graft. Therein, the tubular cover may be made of a thermoplastic material and / or carry a thermoplastic coating, e.g. FEP, in the joining section at the interface to the stent structure. The stent structure may be a CoCr structure. The mandrel may be a steel mandrel. The tubular cover may carry a thermoplastic coating at one shell surface that is directly adjacent the stent structure during manfacturing. The resulting stent assembly that is usually inserted into a patient’s body using a catheter, is a covered stent or stent graft. Alternatively, also a balloon (section) may be joined similarly to a catheter shaft using this method and device.

[0104] The invention in particular refers to the following numbered embodiments concerning a method of manufacturing a catheter assembly and a device therefor.

[0105] 1. A method of manufacturing a catheter assembly (10, 110) by joining a first catheter component (11, 111) and at least a second catheter component (12, 112), wherein the joining is provided in a joining section (15) of the first catheter component (11, 111) and wherein at least one of the first catheter component (11, 111) and the at least one second catheter component (12, 112) is a thermoplastic component, wherein the method comprises the following steps:

[0106] - Providing the first catheter component (11, 111) and the at least one second catheter component (12, 112),

[0107] - Arranging at least a portion of the at least one second catheter component (12, 112) adjacent the first catheter component (11, 111) in its joining section (15),

[0108] - Arranging the catheter assembly (10, 110) within a stretchable tube (20),

[0109] - Stretching the tube (20) axially such that the diameter of the tube (20) is reduced thereby providing a joining pressure to the catheter assembly (10, 110) at the joining section (15) in this stretched condition,

[0110] - Arranging the catheter assembly (10, 110) and the tube (20) within and / or at a heating unit (22, 28),

[0111] - Heating the catheter assembly (10, 110) at and / or near the joining section (15) by the heating unit (22, 28) thereby creating a substance-to-substance bond between the first

[0112] 242077WO / 30.10.2025 catheter component (11, 111) and the at least one second catheter component (12, 112) at the joining section (15) while the tube (20) is in its stretched condition,

[0113] - Subsequently, transferring the tube (20) from its stretched condition to a released condition and removing the catheter assembly (10, 110) from the tube (20) and the heating unit (22, 28). The method of embodiment 1, wherein a pressure chamber (30) is provided, wherein the catheter assembly (10) and the tube (20) are arranged within the pressure chamber (30) prior to the heating step, wherein the heating of the catheter assembly (10) is performed while the catheter assembly (10) is located within the pressure chamber (30) providing an overpressure. The method of embodiment 2, wherein the pressure chamber (30) providing an overpressure of a pressure value between 120 kPa and 2.000 kPa, for example between 150 kPa and 1.000 kPa. The method of any one of the embodiments 1 to 3, wherein the first catheter component (11, 111) comprises a first lumen (I la, I l la), wherein prior heating the first catheter component (11, 111) and the at least one second catheter component (12, 112) are arranged such that at least a portion of the at least one second catheter component (12, 112) is arranged within the first lumen (I la, 11 la) of the first catheter component (11, 111) in its joining section (15). The method of any one of the embodiments 1 to 4, wherein the thermal energy of the heating unit (22, 28) is provided by electromagnetic induction, electric conduction, convection and / or radiation. The method of embodiment 5, wherein the heating unit comprises an induction coil (28) and an elongated electrically conductive member (22, 122), wherein the method comprises the following additional steps:

[0114] - Arranging an elongated electrically conductive member (22, 122) at the first catheter component and / or at the at least one second catheter component (12, 112) such that the electrically conductive member extends (22, 122) along the joining section (15) of the first catheter component (11, 111) within the first lumen (I la, 11 la) of the first catheter

[0115] 242077WO / 30.10.2025 component and / or within a second lumen (12a, 112a) of the at least one second catheter component (12, 112),

[0116] - Arranging the catheter assembly within an induction coil (28) such that the induction coil (28) encompasses the catheter assembly (10) at or near the joining section (15) of the first catheter component (11),

[0117] - Induction welding the first catheter component (11) to the at least one second catheter component (12) using the induction coil (28) while the tube (20) is in its stretched condition to create the substance-to-substance bond. The method of embodiment 6, wherein the electrically conductive member (22, 122) is a ferromagnetic wire or ferromagnetic rod-like member. The method of any one of the embodiments 5 to 6, wherein the induction coil (28) is arranged at a central position with regard to a longitudinal extension of the joining section (15) of the first catheter component (11). The method of any one of embodiments 1 to 8, wherein the tube (20) consists of or comprises a material of the group comprising silicone rubbers, e.g. fluorosilicones, high- temperature silicones, fluoroelastomers, e.g. perfluoroelastomers, natural rubbers, synthetic rubbers, e.g. styrene-butadiene rubbers, butyl rubbers, nitrile rubbers, polyurethanes, ethylene propylene diene monomers (EPDMs), thermoplastic elastomers (TPEs), hydrogels. The method of any one of the embodiments 1 to 9, wherein the first catheter component (11, 111) is a first tubular member of the catheter assembly and / or wherein one second catheter component (12, 112) is a second tubular member of the catheter assembly. A device for manufacturing of a catheter assembly (10) by joining a first catheter component (11) and at least a second catheter component (12), wherein the joining is provided in a joining section (15) of the first catheter component (11), wherein the device comprises:

[0118] - A stretchable tube (20) extending in a longitudinal direction and having a first end and a second end,

[0119] - A heating unit (22, 28),

[0120] 242077WO / 30.10.2025 - 1 -

[0121] - A first clamping member (24) arranged at and attached to the first end of the stretchable tube (20) and a second clamping member (26) arranged at and attached to the second end of the stretchable tube (20),

[0122] - In a released condition an inner lumen of the stretchable tube (20) is configured to accommodate the first catheter component (11) and the at least one second catheter component (12) to be joined, wherein at least a portion of the at least one second catheter component (12) is accommodated adjacent the first catheter component (11) in its joining section (15),

[0123] - The tube (20) is further configured to be transferred into a stretched condition in which the tube (20) is axially stretched such that the diameter of the tube (20) is reduced thereby providing a joining pressure to the catheter assembly at the joining section (15),

[0124] - The heating unit (22, 28) is configured such that the catheter assembly (10) and the tube (20) can be arranged within and / or at the heating unit (22, 28) and such that the catheter assembly (10) is heated at and / or near the joining section (15) by the heating unit (22, 28) while the tube (20) is in its stretched condition to create a substance-to- substance bond between the first catheter component (11) and the at least one second catheter component (12) at the joining section (15). The device of embodiment 11, further comprising a pressure chamber (30) configured such that the catheter assembly (10) and the tube (20) can be arranged within the pressure chamber (30) prior the heating step, wherein the heating of the catheter assembly (10) is performed within the pressure chamber (30) providing an overpressure. The device of any one of the embodiments 11 to 12, wherein the heating unit comprises an induction coil (28) and an elongated electrically conductive member (22, 122) configured to join the first catheter component (11, 111) and the at least one second catheter component (12, 112) by induction welding. A catheter assembly comprising (10, 110) a first catheter component (11, 111) and at least one second catheter component (12, 112) manufactured using the method of any one of the embodiments 1 to 10. A catheter comprising the catheter assembly (10, 110) of embodiment 14.

[0125] 242077WO / 30.10.2025

Claims

Claims1. A method of manufacturing a catheter assembly (10, 110) or a stent assembly by joining a first tubular component (11, 111) and at least a second component (12, 112), wherein the joining is provided in a joining section (15) of the first tubular component (11, 111) and wherein at least one of the first tubular component (11, 111) and the at least one second component (12, 112) is a thermoplastic component or has a thermoplastic coating in at least one section of the respective component, wherein the method comprises the following steps:- Providing the first tubular component (11, 111) and the at least one second component (12, 112),- Arranging at least a portion of the at least one second component (12, 112) adjacent the first tubular component (11, 111) in its joining section (15),- Arranging the catheter assembly (10, 110) or stent assembly within a stretchable tube (20),- Stretching the tube (20) axially such that the diameter of the tube (20) is reduced thereby providing a joining pressure to the catheter assembly (10, 110) or stent assembly at the joining section (15) in this stretched condition,- Arranging the catheter assembly (10, 110) or stent assembly and the tube (20) within and / or at a heating unit (22, 28),- Heating the catheter assembly (10, 110) or stent assembly at and / or near the joining section (15) by the heating unit (22, 28) thereby creating a substance-to-substance bond between the first tubular component (11, 111) and the at least one second component (12, 112) at the joining section (15) while the tube (20) is in its stretched condition,- Subsequently, transferring the tube (20) from its stretched condition to a released condition and removing the catheter assembly (10, 110) or stent assembly from the tube (20) and the heating unit (22, 28).

2. The method of claim 1, wherein a pressure chamber (30) is provided, wherein the catheter assembly (10) or stent assembly and the tube (20) are arranged within the pressure chamber (30) prior to the heating step, wherein the heating of the catheter assembly (10) or stent assembly is performed while the catheter assembly (10) or stent assembly is located within the pressure chamber (30) providing an overpressure.242077WO / 30.10.20253. The method of claim 2, wherein the pressure chamber (30) providing an overpressure of a pressure value between 120 kPa and 2.000 kPa, for example between 150 kPa and 1.000 kPa.

4. The method of any one of the previous claims, wherein the first tubular component (11, 111) comprises a first lumen (11 a, 111 a), wherein prior heating the first tubular component (11, 111) and the at least one second component (12, 112) are arranged such that at least a portion of the at least one second component (12, 112) is arranged within the first lumen (I la, I l la) of the first tubular component (11, 111) in its joining section (15).

5. The method of any one of the previous claims, wherein the thermal energy of the heating unit (22, 28) is provided by electromagnetic induction, electric conduction, convection and / or radiation.

6. The method of claim 5, wherein the heating unit comprises an induction coil (28) and an elongated electrically conductive member (22, 122), wherein the method comprises the following additional steps:- Arranging an elongated electrically conductive member (22, 122) at the first tubular component and / or at the at least one second component (12, 112) such that the electrically conductive member extends (22, 122) along the joining section (15) of the first tubular component (11, 111) within the first lumen (I la, 11 la) of the first tubular component and / or, if applicable, within a second lumen (12a, 112a) of the at least one second component (12, 112),- Arranging the catheter assembly or stent assembly within an induction coil (28) such that the induction coil (28) encompasses the catheter assembly (10) or stent assembly at or near the joining section (15) of the first tubular component (11),- Induction welding the first tubular component (11) to the at least one second component (12) using the induction coil (28) while the tube (20) is in its stretched condition to create the substance-to-substance bond.

7. The method of claim 6, wherein the electrically conductive member (22, 122) is a ferromagnetic wire or ferromagnetic rod-like member.242077WO / 30.10.20258. The method of any one of the claims 5 to 6, wherein the induction coil (28) is arranged at a central position with regard to a longitudinal extension of the joining section (15) of the first tubular component (11).

9. The method of any one of previous claims, wherein the tube (20) consists of or comprises a material of the group comprising silicone rubbers, e.g. fluorosilicones, high-temperature silicones, fluoroelastomers, e.g. perfluoroelastomers, natural rubbers, synthetic rubbers, e.g. styrene-butadiene rubbers, butyl rubbers, nitrile rubbers, polyurethanes, ethylene propylene diene monomers (EPDMs), thermoplastic elastomers (TPEs), hydrogels.

10. The method of any one of the previous claims, wherein one second component (12, 112) is a second tubular member of the catheter assembly or stent assembly.

11. A device for manufacturing of a catheter assembly (10) or stent assembly by joining a first tubular component (11) and at least a second component (12), wherein the joining is provided in a joining section (15) of the first tubular component (11), wherein the device comprises:- A stretchable tube (20) extending in a longitudinal direction and having a first end and a second end,- A heating unit (22, 28),- A first clamping member (24) arranged at and attached to the first end of the stretchable tube (20) and a second clamping member (26) arranged at and attached to the second end of the stretchable tube (20),- In a released condition an inner lumen of the stretchable tube (20) is configured to accommodate the first tubular component (11) and the at least one second component (12) to be joined, wherein at least a portion of the at least one second component (12) is accommodated adjacent the first tubular component (11) in its joining section (15),- The tube (20) is further configured to be transferred into a stretched condition in which the tube (20) is axially stretched such that the diameter of the tube (20) is reduced thereby providing a joining pressure to the catheter assembly or stent assembly at the joining section (15),- The heating unit (22, 28) is configured such that the catheter assembly (10) or stent assembly and the tube (20) can be arranged within and / or at the heating unit (22, 28) and such that the catheter assembly (10) or stent assembly is heated at and / or near the joining section (15) by the heating unit (22, 28) while the tube (20) is in its stretched242077WO / 30.10.2025condition to create a substance-to-substance bond between the first tubular component (11) and the at least one second component (12) at the joining section (15).

12. The device of claim 11, further comprising a pressure chamber (30) configured such that the catheter assembly (10) or stent assembly and the tube (20) can be arranged within the pressure chamber (30) prior the heating step, wherein the heating of the catheter assembly (10) or stent assembly is performed within the pressure chamber (30) providing an overpressure.

13. The device of any one of the claims 11 to 12, wherein the heating unit comprises an induction coil (28) and an elongated electrically conductive member (22, 122) configured to join the first tubular component (11, 111) and the at least one second component (12, 112) by induction welding.

14. An assembly being a catheter assembly or a stent assembly comprising (10, 110) a first tubular component (11, 111) and at least one second component (12, 112) manufactured using the method of any one of the claims 1 to 10.

15. An implant being a catheter comprising the catheter assembly (10, 110) of claim 14 or being a stent comprising the stent assembly of claim 14.242077WO / 30.10.2025

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