WO2020038801A1

WO2020038801A1 - Device and method for threading a tubular preform into a cone of a balloon mold

Info

Publication number: WO2020038801A1
Application number: PCT/EP2019/071833
Authority: WO
Inventors: Amir Fargahi; Christoph Hoser; Matthias Wesselmann; Daniela Santos
Original assignee: Biotronik Ag
Priority date: 2018-08-24
Filing date: 2019-08-14
Publication date: 2020-02-27
Also published as: DE102018120729A1

Abstract

The application relates to a method and to a device (1) for threading a tubular preform (10) into at least one through-opening (20) of a cone (2) of a balloon mold (3) for producing a balloon for a balloon catheter. The method and the device prevent the buckling of a preform when introduced into the mold.

Description

Device and Method for Threading a Tubular Preform into a Cone of a Balloon Mold

The present invention relates to a method and to a device for threading a tubular preform or a tube into at least one cone of a balloon mold. Such preforms are used to form balloons that are utilized, for example, as balloons of balloon catheters (such as for use with angioplasty).

A method referred to as stretch blow molding can be used to form the balloon by means of the balloon mold. Stretch blow molding is preferably used to produce PTCA or PTA balloons made of thermoplastic material, such as PA12, Pebax, PUR, PET and the like, used in the medical technology field.

Changes in the chain mobility of the macro molecules under the influence of heat forms the basis for using the stretch blow molding technique. Under the action of heat, the macro molecules can be processed above the glass transition temperature, but below the melting temperature. The mobility of the macromolecules increases in the process, and they re-orient within the workpiece. The thin tubular preforms are used in the production of balloons using the stretch blow molding process (two-stage process). An operator threads a preform through a glass tube of the balloon mold into a first cone. Afterwards, the other end of the preform is threaded into a second cone. Different glass tube forms can be used, which, for example, correspond to different final diameters of the end product, that is, of the respective balloon. Next, one end of the preform is sealed by pressing. The open end is connected to a compressed air supply. Afterwards, two heating jaws close around the glass tube and the preform placed therein between the two cones.

Balloon forming is carried out by a (stretch) blow molding process in which heated thermoplastic tubes are biaxially stretched by applying internal pressure, while also being pulled. The goal is to mechanically orient the polymer chains by applying high stresses in such a way that they impart maximum strength, to withstand pressure loading, to the balloon, while maintaining a minimal wall thickness. The temperature and the pressure can vary, depending on the material and the balloon diameter. For example, Nylon 12 balloons are formed at a heated jaw temperature of 70°C to l00°C, and a 3 mm Nylon 12 balloon is formed at 30 to 35 bar, and then tempered at l20°C to l75°C.

Using stretch blow molding, the preform is blown under pressure using clean, dry air and under a controlled elevated temperature from the surrounding heating jaws while applying tensile stress.

Finally, the formed balloon is cooled using cold air or cold circulating water in a circumferential jacket, while maintaining a high internal pressure so as to set the dimensions. The biaxial blow molding process mainly orients the polymer chains in the direction in which loading of the balloon occurs, and thus enormously increase compressive strength. Typically, a stretch ratio (such as approximately 600% radial and 300% x axial for Nylon 12) is expected for a particular axis and a particular material. During balloon forming, a stepless balloon tube (for small balloons having a diameter < 2.0 mm) or a preform (for large balloons having a diameter > 2.5 mm) is placed into a mold.

According to the invention, a preform is a balloon tube in which the diameters of both ends were reduced by the pre-stretching process to such an extent that these can be pulled into tools having neck-type diameters which are smaller than the extruded tube diameter. In this way, profiles of balloon catheters can be kept smaller.

To thread a preform into the balloon mold, it is known in the prior art, for example, to remove the distal or proximal cone from the balloon mold, and to manually thread the preform into the glass tube and the cone remaining therein. Afterwards, the second end of the preform is inserted into the second cone. Finally, the two cones can be pushed over the preform into the glass tube. Furthermore, it is possible to use cones that can be separated so as to enable threading of the preform. The corresponding cone can be opened and closed mechanically, for example, using a modified chuck.

Furthermore, a "pick and place" method for threading the preforms into the balloon mold or into the cones of the balloon mold is known.

Furthermore, magnets, pneumatic grippers or other mechanical devices (such as twin rollers or twin belts with straps) are used for threading the preforms.

Proceeding from this, it is the object of the invention to create an improved method and an improved device for threading a preform into at least one cone of a balloon mold, in which, in particular, the risk of the preform being blocked by a gap between the at least one cone and the glass tube of the blow mold is significantly reduced.

This object is achieved by a method having the features of claim 1 and by a device having the features of claim 9.

Advantageous embodiments of these aspects of the invention are provided in the corresponding dependent claims and are described hereafter.

According to claim 1 , a method for threading a tubular preform into at least one through- opening of a cone of a balloon mold for blow molding the preform to yield a balloon is disclosed, wherein the balloon mold furthermore comprises a tube element extending along a longitudinal axis for receiving the preform, wherein the cone can be inserted (for example, via an opening of the tube element) into an interior of the tube element, and wherein the method comprises at least the following steps: inserting the preform into the interior of the tube element, and threading the preform into the through-opening of the cone arranged in the interior of the tube element, the through-opening extending along a longitudinal axis, wherein

- the cone is rotated around the through-opening while the preform is being threaded or - the preform is inserted into the interior of the tube element and threaded into the through-opening in that the tube element is fixed, and the preform is clamped between a plurality of flexible lamellae and is moved, with one end of the preform first, together with the lamellae toward an opening of the tube element (which, in particular, is located opposite the through-opening of the cone in the direction of the longitudinal axis), so that the preform is inserted via the opening into the interior of the tube element and is threaded into the through-opening of the cone.

According to one embodiment of the method, it is provided that the tube element or the balloon mold is fixed by way of a mount. The clamping lamellae can be displaced together with the preform by means of an actuator, for example, along the longitudinal axis with respect to the tube element.

According to one embodiment of the method, the tube element can be a glass tube.

According to one embodiment of the method, it is further provided that the through- opening of the cone is conically tapered in a tapering direction, wherein the preform is threaded into the through-opening of the cone in the tapering direction.

According to one embodiment of the method, it is further provided that the cone is rotated by means of an actuator.

According to an alternative embodiment of the method, it is further provided that the plurality of flexible lamellae is formed by a plurality of upper flexible lamellae and a corresponding plurality of lower flexible lamellae, wherein the preform is clamped between the upper lamellae and the lower lamellae, and wherein the upper lamellae are secured on at least one upper clamping jaw, and wherein the lower lamellae are secured on at least one lower clamping jaw.

According to one embodiment of the method, it is further provided in this regard that the two clamping jaws can be displaced toward one another (as well as away from one another) in a clamping direction perpendicularly to the longitudinal axis of the tube element so as to clamp the preform.

According to one embodiment of the method, it is further provided that each upper lamella is located opposite a lower lamella perpendicularly to the longitudinal axis of the tube element or in the clamping direction, wherein the preform is clamped between a lower edge of the respective upper lamella and an upper edge of the respective assigned lower lamella. The clamping direction extends, in particular, perpendicularly to the longitudinal axis of the tube element when the tube element is fixed by means of the mount. Furthermore, the lamellae or the upper and lower lamellae each extend perpendicularly to the longitudinal axis of the tube element when the tube element is fixed by means of the mount. Likewise, it is preferably provided that the preform extends perpendicularly to the lamellae when the preform is clamped therebetween, wherein the preform or the free end thereof is preferably centered with respect to the opening of the tube element.

According to one embodiment of the method according to the invention, it is further provided that the respective upper lamella is tapered toward the lower edge thereof, wherein the respective upper lamella comprises a trapezoidal section forming the lower edge thereof, and wherein the respective lower lamella is tapered toward the upper edge thereof, wherein the respective lower lamella comprises a trapezoidal section forming the upper edge thereof. In a preferred embodiment, the respective lamella can have a thickness of 0.2 to 3.5 mm, more preferably 0.5 to 2 mm, and most preferably 0.8 to 1.2 mm. The material of the lamella is preferably a silicone, more preferably a silicone having a Shore A hardness between 45 and 75, and preferably between 50 and 70. In particular, the combination of a thickness of 0.5 to 2 mm, more preferably 0.8 to 1.2 mm, and a material selection of a silicone having a Shore A hardness between 50 and 70 is preferred, since a particularly advantageous behavior of a lamella pair is observed with this combination, provided that the preform is held firmly and, furthermore, is released with sufficient ease as a result of a collision with the glass tube.

According to one embodiment of the method, it is further provided that the two clamping jaws are displaced together with the preform clamped between the upper and the lower lamellae along the longitudinal axis of the tube element, so as to move said end of the preform, together with the lamellae, in the direction of said opening of the tube element, and thereby insert the preform into the interior of the tube element and thread it into the through-opening of the cone.

According to one embodiment of the method, it is further provided that, during the displacement of the clamping jaws and of the preform (or during insertion of the preform into the interior of the tube element and, in particular, during threading of the preform into the through-opening of the cone), an end face of the tube element delimiting the opening of the tube element pushes the respective upper lamella arranged in front of the end face and the respective lower lamella arranged in front of the end face to the side, the two lamellae releasing the preform.

With respect to the above-described method, the threading of the preform into a cone of the balloon mold was described. The method according to the invention can, of course, also be used to thread the perform into the further cone of the balloon mold. This also applies to the device described hereafter.

According to a further aspect of the present invention, a device is disclosed which, in particular, is suitable or used for carrying out the method according to the invention.

Accordingly, a device for threading a tubular preform into at least one through-opening of a cone of balloon mold is proposed, comprising a balloon mold, which includes a tube element extending along a longitudinal axis for receiving the preform, and a cone, which can be inserted into an interior of the tube element, and wherein

- the device comprises an actuator, which is configured to rotate the cone around the through-opening, or

- the device comprises a mount, which is configured to fix the tube element, wherein the device further comprises a plurality of flexible lamellae, which are configured to clamp the preform and can be displaced along the longitudinal axis of the tube element when the tube element is fixed by means of the mount, so that the preform clamped between the lamellae can be moved, with one end of the preform first, together with the lamellae toward an opening of the tube element, so as to insert the preform into the interior of the tube element via the opening of the tube element and to thread it into the through-opening of the cone arranged in the interior of the tube element.

The balloon mold or the preform is, in particular, designed for blow molding a balloon for a balloon catheter. In a specific embodiment, the device, together with the actuator, is configured such that, when the cone is arranged in the interior of the tube element, the rotational axis extends parallel to the longitudinal axis of the tube element when the cone is inserted into the interior of the tube element. According to one embodiment of the device, it is further provided that the tube element is designed as a glass tube. According to one embodiment of the device, it is further provided that the through-opening of the cone is conically tapered in a tapering direction (see also above). According to one variant of the device according to the invention, it is provided that the cone is rotated by means of an actuator.

According to an alternative embodiment of the device, it is further provided that the plurality of flexible lamellae is formed by a plurality of upper flexible lamellae and a corresponding plurality of lower flexible lamellae, so that the preform can be clamped between the upper lamellae and the lower lamellae, and wherein the upper lamellae are secured on at least one upper clamping jaw of the device, and wherein the lower lamellae are secured on at least one lower clamping jaw of the device.

According to one embodiment of the device, it is further provided that the two clamping jaws are configured to be displaced toward one another (as well as away from one another) in a clamping direction so as to clamp the preform.

According to one embodiment of the device, it is further provided that each upper lamella is located opposite a lower lamella in the clamping direction, wherein the preform in each case can be clamped between a lower edge of the respective upper lamella and an upper edge of the respective assigned lower lamella.

The clamping direction extends, in particular, perpendicularly to the longitudinal axis of the tube element when the tube element is fixed by means of the mount. Furthermore, the lamellae or the upper and lower lamellae each extend perpendicularly to the longitudinal axis of the tube element when the tube element is fixed by means of the mount.

According to one embodiment of the device according to the invention, it is further provided that the respective upper lamella is tapered toward the lower edge thereof, wherein the respective upper lamella comprises a trapezoidal section forming the lower edge thereof, and wherein the respective lower lamella is tapered toward the upper edge thereof, wherein the respective lower lamella comprises a trapezoidal section forming the upper edge thereof. The respective lamella can have the above-described thickness and/or be made of the above-described material.

According to one embodiment of the device according to the invention, it is further provided that the two clamping jaws are configured to be displaced together with the preform clamped between the upper and the lower lamellae along the longitudinal axis of the tube element when the tube element is fixed by means of the mount, so as to move said end of the preform, together with the lamellae, toward said opening of the tube element, and thereby insert the preform into the interior of the tube element and thread it into the through-opening of the cone. According to one embodiment of the device according to the invention, it is further provided that the tube element includes an end face delimiting the opening of the tube element, wherein, during the displacement of the clamping jaws and of the preform (or during insertion of the preform into the interior of the tube element and, in particular, during threading of the preform into the through-opening of the cone), the respective upper and lower lamellae arranged in front of the end face are designed to be pushed to the side by the end face of the tube element when the tube element is fixed by means of the mount, so that the two lamellae release the preform.

Embodiments of the invention and further features and advantages of the invention will be described hereafter based on the figures. In the drawings:

FIG. 1 shows a preform for stretch blowing a balloon;

FIG. 2 shows a balloon mold comprising a glass tube and two cones arranged therein for shaping the balloon during blow molding;

FIG. 3 shows a schematic representation of the problem underlying the invention, according to which the preform can be blocked by a cone of the balloon mold (B) when the preform is threaded into the glass tube of the balloon mold (A);

FIG. 4 shows an embodiment of a device according to the invention or of a method according to the invention;

FIG. 5 shows the principle of a further embodiment of a device according to the invention or of a method according to the invention;

FIG. 6 shows a lamella of a device according to FIG. 5 (or according to FIGS. 6 and 7);

FIG. 7 shows a perspective view of a device according to the invention of the kind according to FIG. 5 prior to clamping the preform; and FIG. 8 shows a further perspective view of the device of FIG. 6 as the preform is being threaded into a glass tube and a (right) cone of the balloon mold. The invention relates to a device 1 and to a method for threading a tubular preform 10, for example a balloon tube, in which both ends are drawn in using a controlled process, according to FIG. 1 into a cone 20 of a balloon mold 3, which is shown in FIG. 2, for example. The balloon mold 3 comprises a tube element 4, preferably in the form of a glass tube 4, in the interior 40 of which two cones 20 can be arranged (for example, via the openings 41), into the sectionally conically shaped through-openings 20 of which the preform 10 is to be threaded, so that the two ends lOa of the preform 10 are led out of the balloon mold 3 via the through-openings 20 of the cones 2 when the preform 10 is seated in the interior 40 of the tube element, so as to the formed into a balloon during a stretch blow molding operation. For this purpose, the preform 10 is suitably heated in the tube element 4 and subjected to pressure via one end lOa. The cones 20 and the circumferential wall of the tube element 4 define the shape of the stretch blow-molded balloon.

When the preform 10 is threaded into a cone 2 arranged in the interior 40 of the tube element 4, as is shown in FIG. 3 A, the problem regularly arises that the free end lOa of the preform 10 strikes against the end face of the cone 2, in particular when a gap S exists between the cone 2 present in the interior 40 and the tube element 4, and is blocked, so that the perform 10 cannot be threaded into the through-opening 20 in the tapering direction V of the through-opening 20, but the situation shown in FIG. 3B arises. According to a first variant of the method according to the invention or the device 1 according to the invention, it is thus provided according to FIG. 4 to rotate the cone 2 about a rotational axis R, which extends parallel to the longitudinal axis x of the tube element 4, by means of an actuator 5 when the preform 10 is being threaded. Rotating the cone 2 about the rotational or longitudinal axis R thereof results in a slight lateral deviation of the end lOa of the preform 10. Initially, the orientation of the rotational axis remains unchanged (conservation of angular momentum). During the advancement of the preform 10, the glass tube or tube element 4 is fixed. The tubular preform 10 is held, for example, by way of a releasable gripper 7 and is displaced toward the cone 2.

The cone 2 is rotated by way of the actuator 5. The point of contact between the preform 10 and the cone 2 is designed to be in the axial direction, and the preform 10, after making contact with the cone, will overcome a potential gap S between the cone 2 and the glass tube/tube element 4 as a result of the two movements (axial and rotatory). The threading process of the preform 10 into the through-opening of the cone 2 can thus be carried out without blockage.

According to one example of the invention, a rotation of the cone 2 in the manner of FIG. 4 was carried out for a PTCA balloon. So as to determine the gap size between the tube element (for example, glass tube) 4 and the cone 2, a PTCA balloon having a diameter of 2.25 was assumed, wherein the preform (in the unstretched region) has a diameter in the range of 0.68 mm to 0.70 mm, and wherein the tube element inside diameter is in the range of 2.39 mm to 2.41 mm, and wherein the cone 2 has an outside diameter in the range of 2.33 mm to 2.37 mm.

These dimensions or tolerances result in a gap S between the cone 2 and the tube element/glass tube 4 in the range of 0.02 mm to 0.08 mm.

The diameter of the preform end must be smaller than the diameter of the cone neck, since otherwise threading is not possible. The diameter of the preform end lOa of today's PCTA balloons is in the range of 0.43 mm to 0.45 mm. The cone 2 further has a wall thickness at the opening into which threading takes place in the range of 0.01 mm to 0.05 mm.

For the aforementioned parameters, the preform 10 can, for example, be threaded into the cone 2 without being blocked with a rotation about the rotational axis R in the range of 1 rps to 10 rps and a displacement velocity in the range of 1 mm/s to 20 mm/s, for example. The above-described variant of the solution according to the invention advantageously allows the preform 10 to be threaded through the through-opening 20 of the cone 2 with optimal probability of success. The solution according to the invention can be easily applied to different balloon forms (such as metal pipes instead of glass tubes 4). Furthermore, the method according to the invention can be carried out autonomously by way of a robot, the advantage being that a lower risk of contamination exists because human contact can thus be avoided.

According to a further variant of the method according to the invention or of the device 1 according to the invention, which are shown in FIGS. 5 to 8, it is provided to use lamella pairs 50, 51 for threading preforms 10 into the balloon mold 3, which grip the workpiece 10 on the outer circumference by means of clamping jaws 60, 61 and continuously push it through a fixedly positioned balloon mold 3. In this regard, the device according to FIG. 5 comprises at least one upper and one lower clamping jaw 60, 61, which can be moved toward one another (and away from one another) in a clamping direction K perpendicularly to the longitudinal axis x of the tube element (for example, glass tube) 4, wherein the clamping jaws are shown in a closed position in FIG. 5, in which the lamellae 50, 51 hold the preform 10 during the movement to the right.

It is provided that the upper lamellae 50, with a respective lower edge 50a, and the lower lamellae 51, with a respective upper edge 5 la, press against the preform 10 and thus clamp the same. The upper lamellae 50 are secured on the at least one upper clamping jaw 60, whereas the lower lamellae 51 are secured on the at least one lower clamping jaw 61. As is furthermore apparent based on FIG. 5, the lamellae 50, 51 extend parallel to one another, wherein a respective upper lamella 50 is located in one plane with an assigned lower lamella 51, the plane extending perpendicularly to the longitudinal axis x of the tube element 4, which is fixed by means of a mount 6. Accordingly, the preform 10 likewise extends perpendicularly to the lamellae 50, 51 and is oriented on the longitudinal axis x of the tube element 4, so that the preform 10 can be inserted into the interior 40 of the tube element 4, and then into the through-opening 20 of the right cone 2 (see FIG. 2), during the movement to the right, via the opening 41 of the tube element 4.

Since the tube element or glass tube 4 is secured in the mount 6, the lamellae pairs 50, 51 open as a result colliding with the end face 42 of the opening 40 of the tube element 4, making room for the tube element, wherein, at the same time, the lamellae pairs successively release the preform 10.

FIG. 7 shows a device 1 in the manner of FIG. 5, wherein the lamellae 50, 51 are open. The preform 10 is centrally positioned.

FIG. 8 shows the device 1 according to FIG. 7, wherein the preform 10 is already threaded into the tube element 4 and the right cone 2 here. The preform 10 can be threaded into the left cone 2 analogously to the right cone 2.

The lamellae 50, 51 that are used according to the second variant of the invention preferably have the configuration shown in FIG. 6, according to which the lamellae 50, 51 in each case are tapered toward the clamping edge 50a, 5 la thereof, wherein the respective lamella 50, 51 comprises a trapezoidal section 50b, 5 lb, which forms the respective edge 50a, 5 la used for clamping. The respective lamella 50, 51 can have a thickness D of 1 mm, for example, and can be made of silicone, for example.

Furthermore, the device 1 according to FIGS. 5 to 8 can be made to vibrate when the preform is being threaded, which further simplifies or supports the threading process.

The second variant of the present invention also has considerable advantages. For example, presently used balloon forming processes do not need to be modified or adapted to the solution according to the invention in a complex process. It is possible to meet the existing balloon specifications, and furthermore it is possible to use known glass tubes and cones. The lamella variant of the invention moreover advantageously allows the process to be automated with good accuracy in terms of the success of threading the preform in the respective cone.

Claims

1. A method for threading a tubular preform (10) into at least one through-opening (20) of a cone (2) of a balloon mold (3), the balloon mold (3) further comprising a tube element (4) extending along a longitudinal axis (x) for receiving the preform (10), the cone (2) being insertable into an interior (40) of the tube element (4), and the method comprising at least the following steps: inserting the preform (10) into the interior (40) of the tube element (4), and threading the preform (10) into the through- opening (20) of the cone (2) arranged in the interior (40) of the tube element (4), the through-opening extending along the longitudinal axis (x), wherein

- the cone (2) is rotated around the through-opening (R) while the preform (10) is being threaded into the through-opening (20),

or

- the preform (10) is inserted into the interior (40) of the tube element (4) and threaded into the through-opening (20) in that the tube element (4) is fixed, and the preform (10) is clamped between a plurality of flexible lamellae (50, 51) and is moved, with one end (lOa) of the preform (10) first, together with the lamellae (50, 51) toward an opening (41) of the tube element (4), so that the preform (10) is inserted via the opening (41) into the interior (40) of the tube element (4) and is threaded into the through-opening (20) of the cone (2).

2. The method according to claim 1, wherein the tube element (4) is a glass tube.

3. The method according to claim 1 or 2, wherein the through-opening (20) of the cone (2) is conically tapered in a tapering direction (V), the preform being threaded into the through-opening (20) of the cone (2) in the tapering direction (V).

4. The method according to any one of the preceding claims, wherein the cone (2) is rotated by means of an actuator (5).

5. The method according to any one of claims 1 to 3, wherein the plurality of flexible lamellae (50, 51) is formed by a plurality of upper flexible lamellae (50) and a corresponding plurality of lower flexible lamellae (51), the preform (10) being clamped between the upper lamellae (50) and the lower lamellae (51), and the upper lamellae (50) being secured on at least one upper clamping jaw (60), and the lower lamellae (51) being secured on at least one lower clamping jaw (61).

6. The method according to claim 5, wherein the two clamping jaws (60, 61) can be displaced toward one another as well as away from one another in a clamping direction (K) perpendicularly to the longitudinal axis (x) of the tube element (4) so as to clamp the preform (10).

7. The method according to claim 5 or 6, wherein the two clamping jaws (60, 61) are displaced together with the preform (10) clamped between the upper and the lower lamellae (50, 51) along the longitudinal axis (x) of the tube element (4), so as to move said end (lOa) of the preform (10), together with the lamellae (50, 51), toward said opening (41) of the tube element (4), and thereby insert the preform (10) into the interior (40) of the tube element (4) and thread it into the through-opening (20) of the cone (2).

8. The method according to claim 7, wherein an end face (42) of the tube element (4) delimiting the opening (41) of the tube element (4), during the displacement of the clamping jaws (60, 61) and of the preform (10), pushes the respective upper lamella (50) arranged in front of the end face (42) and the respective lower lamella (51) arranged in front of the end face (42) to the side, whereby the two lamellae (50, 51) release the preform (10).

9. A device (1) for threading a tubular preform (10) into at least one through-opening (20) of a cone (2) of balloon mold (3), comprising a balloon mold (3), which includes a tube element (4) extending along a longitudinal axis (x) for receiving the preform (10), and a cone (2), which can be inserted into an interior (40) of the tube element (4), and wherein

- the device (1) comprises a mount (6) for fixing the tube element (4), and a plurality of flexible lamellae (50, 51), which are configured to clamp the preform (10) and can be displaced along the longitudinal axis (x) of the tube element (4) when the tube element (4) is fixed by means of the mount (6), so that the preform

(10) clamped between the lamellae (50, 51) can be moved, with one end (lOa) of the preform first (10), together with the lamellae (50, 51) toward an opening (41) of the tube element (4), so as to insert the preform (10) into the interior (40) of the tube element (4) via the opening (41) of the tube element (4) and to thread it into the through-opening (20) of the cone (2) arranged in the interior (40) of the tube element (4).

10. The device according to claim 9, wherein the device (1) comprises an actuator (5), which is configured to rotate the cone (2) about a rotational axis (R) when the cone (2) is arranged in the interior (40) of the tube element (4), the rotational axis (R) extending parallel to the longitudinal axis (x) of the tube element (4) when the cone (2) is inserted into the interior (40) of the tube element (4).

11. The device according to claim 9, wherein the plurality of flexible lamellae (50, 51) is formed by a plurality of upper flexible lamellae (50) and a corresponding plurality of lower flexible lamellae (51), so that the preform (10) can be clamped between the upper lamellae (50) and the lower lamellae (51), the upper lamellae (50) being secured on at least one upper clamping jaw (60), and the lower lamellae (51) being secured on at least one lower clamping jaw (61).

12. The device according to claim 11, wherein the two clamping jaws (60, 61) are configured to be displaced toward one another in a clamping direction (K) so as to clamp the preform (10).

13. The device according to claim 11 or 12, wherein the two clamping jaws (60, 61) are configured to be displaced together with the preform (10) clamped between the upper and the lower lamellae (50, 51) along the longitudinal axis (x) of the tube element (4) when the tube element (4) is fixed by means of the mount (6), so as to move said end (lOa) of the preform (10), together with the lamellae (50, 51), toward said opening (41) of the tube element (4), and thereby insert the preform (10) into the interior (40) of the tube element (4) and thread it into the through-opening (20) of the cone (2).

14. The device according to claim 13, wherein the tube element (4) comprises an end face (42) delimiting the opening (41) of the tube element (4) and, during the displacement of the clamping jaws (60, 61) and of the preform (10), the respective upper lamella (50) arranged in front of the end face (42) and the respective lower lamella (51) arranged in front of the end face (42) being designed to be pushed to the side by the end face (42) of the tube element when the tube element (4) is fixed by means of the mount (6).