Functional guide wire with active elements for calcified stenoses

Abstract

The present invention relates to a guidewire (1), particularly for a catheter, comprising: a distal end section (1a), a functional element (2), wherein the functional element (2) is arranged on the distal end section (1a) and is configured to be deployed in a radial direction (R) of the guidewire (1) from an initial state to an expanded state for expanding a calcified stenosis of a vessel (V).

Description

[0001] Functional guide wire with active elements for calcified stenoses

[0002] The present invention relates to a guidewire. Typically, such elongated flexible members are used to guide medical devices such as catheters towards a desired target with a body cavity, particularly a vessel.

[0003] However, in case the vessel comprises a calcified stenosis it is often difficult to advance the guidewire past the calcified lesion. Particularly, in order to expand e.g. a balloon within the calcified stenosis (e.g. during an angioplasty), the guidewire needs to pass the stenosis and thereby create a path for a balloon catheter. The latter needs to be expanded in a way to facilitate guiding the catheter into the stenosis of the vessel via the guidewire.

[0004] Known solutions often only allow for a subintimal passage. Furthermore, known systems regularly comprise larger diameters and greater rigidity. Further, systems are known that require an additional guidewire. Particularly, opening calcified stenoses is often associated with an increased risk of vascular injury.

[0005] Specifically, US2008 / 0097247 comprises a tubular member that can have a thread member disposed on a distal portion of the tubular member. If the medical device encounters an occlusion, the medical device can be rotated, which can allow the thread members to engage and penetrate the occlusion, in some cases forming a pathway through the occlusion.

[0006] Based on the foregoing, the problem to be solved by the present invention is to provide a means for opening a channel in a calcified stenosis such that the channel is large enough to allow passage of a balloon catheter or stent system through the stenosis.

[0007] This problem is solved by a guidewire having the features of claim 1. A further aspect disclosed herein relates to a catheter system and to a method. Preferred embodiments of the respective aspect of the present invention are stated in the corresponding dependent claims and are described below.

[0008] According to claim 1 a guidewire is disclosed, particularly for a catheter, comprising: a distal end section, and a functional element, wherein the functional element is arranged on the distal end section and configured to be moved in a radial direction of the guidewire from an initial state to an expanded state (which radial direction extends orthogonal to a longitudinal extension direction of the guidewire) for expanding a calcified stenosis of a vessel.

[0009] Thus, in other words, the present invention particularly proposes a functional element in a region of the distal end of a guidewire, which can be activated by radial positioning and then expands the calcified stenosis, e.g., by means of an axial and / or rotational movement. Particularly, the functional element can remove stenosis material to such an extent that the subsequent passage of a balloon catheter or stent system is made possible. The transmission of the functional element between the initial state to the expanded state can occur either by setting free a self-expandable member of the functional element or by the active manipulation of an inner core member and an outer shaft of the guidewire by an operator.

[0010] In a preferred embodiment, the functional element can be configured to remove and / or cut and / or abrade stenosis material. Particularly, the functional element can be a grating element. Such grating element may have a grid-like structure with radially outwardly protruding edges. Such edges can have sharp or blade-like, and be suitable to cut into the stenosis. Particularly, the functional element can comprise a helical cutting edge. Furthermore, in another preferred embodiment, the functional element can be a scoring element. The proximal portion of the guidewire leading up to the functional element can be designed as a conventional guidewire and can be used to advance other medical devices such as balloon catheters or stent systems.

[0011] In an embodiment of the invention, the guidewire is configured to guide a catheter or another medical device to a pre-defined site in a human or animal body cavity, particularly vessel. Particularly, the guidewire is configured to be advanced towards said site prior to guiding the catheter / medical device towards said site by means of the guidewire. The guidewire can be a multi-component device. Particularly, with the functional element expanded, the outer diameter of the guidewire in the vicinity of the functional element particularly lies within the range from 0.36 mm to 3.00 mm. When the functional element is retracted (i.e., not radially expanded), the outer diameter in the vicinity of the functional element particularly lies within the range from 0.30 mm to 1.50 mm.

[0012] According to an embodiment of the invention, the guidewire comprises an elongated outer shaft extending in the longitudinal extension direction and comprising a lumen, and wherein the guidewire comprises an elongated flexible core member arranged in said lumen. Particularly, both components in combination, i.e., outer shaft and core member, fulfill the function of a guidewire.

[0013] Particularly, in all embodiments described herein, the flexible core member can be an (inner) wire.

[0014] Further, according to yet another embodiment of the invention, the functional element is a self-expandable functional element and is arranged on the core member, and wherein the core member is arranged in the lumen such that the outer shaft can be retracted proximally with respect to the core member to allow the functional element to self-expand in the radial direction from the initial state to the expanded state.

[0015] According to a further embodiment of the invention, the functional element comprises a surface structure configured to remove (e.g. cut and / or abrade) material of the stenosis for expansion of the stenosis during an axial movement of the functional element along the longitudinal extension direction of the guidewire and / or during a rotational movement of the functional element.

[0016] Particularly, the surface structure can be a grid-structure. Particularly, the surface structure can comprise a plurality of through-openings having edges to facilitate stenosis material removal and allowing to transport removed material through the openings and proximally along the core member out of the body of the patient. Particularly, such axial movements of the (expanded) functional element can be realized by moving the core member (with the functional element attached to it) along the longitudinal extension direction, while rotational movements of the (expanded) functional element can be realized by rotating the core member (with the functional element attached to it) about said longitudinal extension direction.

[0017] According to an embodiment of the invention, the functional element is formed by an, e.g., circumferential portion of the outer shaft, wherein the core member is arranged in a lumen of the outer shaft such that the outer shaft can be retracted proximally with respect to the core member (or the core member can be retracted proximally with respect to the outer shaft), wherein the core member comprises a radial protrusion configured to press against a protrusion of an inner surface of said portion of the outer shaft when the outer shaft is retracted proximally with respect to the core member (or vice versa) such that the protrusion of the core member pushes the portion of the outer shaft radially outwards to bring the functional element to its expanded state.

[0018] Furthermore, according to an embodiment of the invention, the functional element is formed by a portion of the outer shaft, wherein the core member is arranged in a lumen of the outer shaft such that the outer shaft can be rotated about the core member, wherein upon said rotation, the core member is configured to press against an inner surface of the outer shaft such that the portion of the outer shaft is pushed radially outwards to bring the functional element to its expanded state.

[0019] According to an embodiment of the invention, said portion of the outer shaft is slotted to form a plurality of lamellae. Thus, the functional element comprises a plurality of lamellae extending along the longitudinal extension direction of the guidewire which facilitates outward movement of the functional element as a whole as the respective lamellae can bulge out radially while allowing separation of neighboring lamellae in the peripheral direction of the outer shaft.

[0020] Furthermore, according to an embodiment of the invention, the functional element comprises a plurality of lamellae formed by the outer shaft, wherein each two neighboring lamellae are separated by a slot of the outer shaft, wherein a distal end of the outer shaft is fixed to a distal end section of the core member, such that when the outer shaft is pushed from proximal towards its distal end relative to the core member, the lamellae bulge radially outwards to bring the functional element to its expanded state.

[0021] Particularly, in an embodiment, the inner wire comprises a constant outer diameter over its entire length.

[0022] Furthermore, in an embodiment of the invention, the functional element is formed by a portion of the outer shaft, which portion comprises a plurality of slots (extending in the longitudinal extension direction) and an internal thread, and wherein the core member comprises an external thread, the internal and external threads being configured to be screwed together such that said portion of the outer shaft is pushed radially outwards to bring the functional element to its expanded state.

[0023] According to yet another embodiment of the invention, the functional element is formed by a portion of the outer shaft, which portion comprises a plurality of slots, and wherein the core member comprises a plurality of, e.g., parallel and mechanically connected lamellae configured to be moved from a respective first position to a respective second position in which the lamellae push said portion of the outer shaft radially outwards to bring the functional element to its expanded state.

[0024] Furthermore, according to an embodiment of the invention, the lamellae are connected up to the proximal end of the guidewire by tension- and pressure-transmitting elements allowing to move the lamellae from the respective first position to the respective second position.

[0025] Further, in an embodiment of the invention, the functional element comprises a plurality of wings protruding from the core member, wherein the outer shaft is configured to be retracted relative to the core member to expose the wings, and wherein the wings are configured to be erected by a directed rotational movement on contact with a vessel wall once the outer shaft is retracted, to bring the functional element to its expanded state. Particularly, the respective wing can form a blade. Further, in one embodiment the wings are arranged in such a way that they do not expose a perpendicular angle in radial direction. Upon rotation around the longitudinal axis these wings exhibit cutting character when rotated in manner that the smaller angle is running in front during rotation.

[0026] During use and according to an embodiment of the invention, the wings are configured to abrade material of the stenosis when the guidewire rotates in a pre-determined direction, while the wings are configured to fold back to a smaller diameter and can be captured by the outer shaft when they are rotated in the opposite direction to said predetermined direction.

[0027] Furthermore, according to one embodiment of the invention the functional element comprises a brush with rigid hair-like components being configured to abrade material of the lesion. In one embodiment, the hair-like components are perpendicular to the plane of the catheter body and stand up-right. In a further embodiment the hair-like components are inclined leaning towards the proximal direction. In that an outer shaft member can be moved in distal direction to uncover and unsheathe the hair-like components. The outer shaft member of course could also be moved in proximal direction to uncover the hair-like components. Moving the outer shaft member in distal direction has the benefit with proximally inclined hair-like component that re-sheathing can be conducted before removing the guide wire from the patient in order to avoid unintentional hurting of the vessel system. When moved in proximal direction the hair-like components, in particular when inclined towards the proximal direction, can work against the lesion and abrade material from it.

[0028] According to a further aspect of the present invention, a catheter system is disclosed, the catheter system comprising a catheter and a guidewire according to one of the preceding claims, wherein the catheter comprises a guidewire lumen and wherein the guidewire is configured to slide in the guidewire lumen to allow the catheter to be guided by the guidewire.

[0029] According to a preferred embodiment, the catheter is a balloon catheter or an implant delivery catheter configured to deliver an implant to an implantation site, wherein particularly the implant is a stent. According to yet another aspect of the present invention, a method is disclosed, wherein the method particularly uses a guidewire according to the present invention, wherein the guidewire is advanced towards a stenosis of the vessel and the functional element is used to expand the stenosis to move a distal end section (particularly the functional element) of the guidewire past the stenosis, and wherein particularly a catheter is guided along the guidewire towards a target location.

[0030] In the following, embodiments as well as further features and advantages of the present invention shall be described with reference to the Figures, wherein

[0031] Fig. 1 shows an embodiment of a guidewire according to the invention, the guidewire comprising an outer shaft and a core member configured to bulge out a functional element of the guidewire radially into an expanded state by means of an axial movement of the core member, the functional element being formed by a portion of the outer shaft,

[0032] Fig. 2 shows a variation of the embodiment shown in Fig. 1, wherein here the functional element is bulged out radially into an expanded state by a rotation of the core member,

[0033] Fig. 3 shows a further embodiment of a guidewire according to the invention, wherein an outer shaft performs a compressing axial movement to bulge out the functional element radially into its expanded state,

[0034] Fig. 4 shows a further embodiment of a guidewire according to the invention, wherein the functional element is self-expanding and maintained in its initial state by an outer shaft of the guidewire,

[0035] Fig. 5 shows a further embodiment of a guidewire according to the invention, wherein the functional element is brought into its expanded state by screwing an inner thread of an outer shaft and an external thread of a core member into one another, Fig. 6 shows a further embodiment of a guidewire according to the invention, wherein the functional element is brought into its expanded state by means of mechanically interconnected lamellae; and

[0036] Fig. 7 shows a further embodiment of a guidewire according to the invention, wherein the functional element comprises wings that can be expanded by a rotating the functional element, and

[0037] Fig. 8a and b show a further embodiment of the guidewire according to the invention, wherein the functional elements are provided in the form of a brush.

[0038] Fig. 4 shows a preferred embodiment of a guidewire 1 according to the present invention, wherein the guidewire 1 can serve for guiding a catheter towards a desired target site and comprises a distal end section la, and a functional element 2, wherein the functional element 2 is arranged on the distal end section la and configured to be deployed in a radial direction R of the guidewire 1 from an initial state to an expanded state to expand a stenosis of a vessel V. Herein and in the following, distal refers to a location along the guidewire that is remote to a user along the guidewire, which user operates the guidewire, compared to a proximal location which is closer to the user along the guidewire.

[0039] Particularly, the guidewire 1 comprises an elongated core member 12 arranged in a lumen 11 of an outer shaft 10 of the guidewire 1. Furthermore, the functional element 2 is a selfexpanding functional element 2. The self-expanding functional element 2 is arranged on the core member 12 (e.g. an inner wire 12 of the guidewire 1) proximal to a distal tip 12a of the core member 12, wherein particularly the distal and proximal ends 2a, 2b of the functional element 2 are firmly connected to the core member 12. Particularly, a section of the functional element 2 between the two ends 2a, 2b of the functional element 2 comprises a larger diameter in the relaxed state than its two ends 2a, 2b. Such larger diameter will then work against the lesion. It is preferred that at least the proximal end 2b is firmly connected to core member 12. In such way it is possible to re-sheath the functional element 2 into outer shaft 10. Particularly, the functional element 2 can be a grating element 2. Such grating element may have a grid-like structure with radially outwardly protruding edges. Such edges can have sharp or blade-like, and be suitable to cut into the stenosis. The removal of the stenosis material to widen the lumen of the stenosis can take place due to an, e.g., grid-like structure of the functional element 2 during axial and rotational movement of the core member 12 with the functional element 2 attached to it.

[0040] In addition, the functional element 2 can comprise struts 2c that can have a rough surface, i.e., a surface structure facilitating removal of stenosis material. For the passage of the guidewire 1 to the stenosis and back again, the outer shaft 10 is initially arranged over the entire core member 12 and the functional element 2 attached thereto, wherein the outer shaft 10 reduces the outer diameter of the functional element 2. To bring the functional element 2 from this initial state to its expanded state and thus activate the functional element 2, the outer shaft 10 can be retracted proximally relative to the core member 12, whereby the core member 12 with the functional element 2 remains in the desired position in the stenosis. The functional element 2 is designed in such a way that the outer shaft 10 can be moved back distally over the functional element 2 in order to reduce the diameter of the functional element 2 to its initial size and enable the guidewire 1 to be retracted.

[0041] Fig. 1 shows a further embodiment of a guidewire 1 according to the present invention. The guidewire 1 comprises a core member 12 (e.g. an inner wire 12) and an outer shaft 10 forming a lumen 11 in which the core member 12 is arranged. Both components 10, 12 in combination fulfill the function of a guidewire. Here, the functional element 2 is formed by a portion of the outer shaft 10. Particularly, the core member 12 can comprise a distal taper 121 in the vicinity of the functional element 2 as well as a radial protrusion 120 (e.g. thickening) relative to a reference diameter of the remaining core member section. In contrast, the wall thickness of the outer shaft 10 has an inwards protrusion 100 (e.g. thickening) distally and a taper 101 proximally, wherein the outer diameter of the outer shaft 10 particularly remains constant over the entire length. In addition, the outer shaft 10 can be slotted several times in the longitudinal extension direction x within the area of the functional element 2 and can also be provided with a rough surface, e.g., a surface structure that facilitates abrasion of stenosis material. If the outer shaft 10 is displaced proximally relative to the core member 12, the two protrusions 120, 100 lie on top of each other and thus force the functional element 2 formed by said portion 2 of the outer shaft radially outwards which corresponds to the expanded state of the functional element 2. Particularly, in the case the portion 2 of the outer shaft 10 is slotted, the outwards bulging lamellae of the outer shaft 10 formed between these slots then act as functional element 2 during axial movement or rotation of the guidewire 1.

[0042] Fig. 2 shows a variation of the embodiment of Fig. 1, wherein here a cross-section of the core member 12 (e.g. inner wire) in the vicinity of the functional element 2 is oval in shape and the lumen 11 of the outer shaft 10 is also oval, with its outer diameter being circular. This means that the outer shaft 10 has a different wall thickness offset by 90 degrees. In an initial position, the two components 12, 10 are oriented on top of each other in such a way that a relatively thin area of the outer shaft 10 lies over the long cross-sectional axis of the core member 12, so that the outer diameter of the outer shaft 10 in the vicinity of the functional element 2 corresponds to that of the overall system distally and proximally to the functional element 2. In case the outer shaft 10 is rotated by e.g. 90 degrees around the longitudinal extension direction x in relation to the core member 12, the relatively thick wall area of the outer shaft 10 lies above the long axis of the cross-section and the functional element 2 (i.e. a portion 2 of the outer shaft 10) bulges out radially which corresponds to the expanded state of the functional element 2. As before, the functional element / portion 2 of the outer shaft 10 can be slotted to form said lamellae (see above), which then bulge out and together act as the functional element 2. Similar to the embodiment described in conjunction with Fig. 1, the functional element 2 (e.g. said plurality of lamellae) can abrade stenosis material during an axial movement or rotation of the guidewire 1.

[0043] Furthermore, Fig. 3 shows yet another embodiment of a guidewire 1 according to the present invention, wherein the guidewire 1 comprises an outer shaft 10 and an elongated core member 12 accommodated in a lumen 11 of the outer shaft 10. Particularly, the core member 12 (e.g. an inner wire) may have a constant outer diameter over the entire length of the core member 12. Both components 10, 12 in combination fulfill the function of a guidewire. The functional element 2 is formed by a portion 2 of the outer shaft 10 proximal to the distal tip of the guidewire 1. The functional element / portion 2 can be provided with several slots and thus forms radially deployable lamellae. The distal end 10a of the outer shaft 10 is firmly connected proximal to the distal end 12a of the core member 12. If the outer shaft 10 is now pushed from proximal to distal relative to the core member 12, the functional element 2, i.e., portion 2 (particularly said lamellae), bulges radially outwards which corresponds to the expanded state of the functional element 2 that causes the stenosis to widen during axial and rotational movement of the entire guidewire 1. The outer diameter of the functional element 2 can be varied depending on the size of the relative advance of the outer shaft 10.

[0044] Fig. 5 shows a further embodiment of a guidewire according to the present invention, wherein the guidewire 1 comprises an elongated core member 12 and outer shaft 10 accommodating the core member 12 in a lumen 11 of the outer shaft 10. Particularly, the outer shaft 10 is provided with an internal thread 14 in the vicinity of the functional element 2, which preferably is an (e.g. slotted) portion 2 of the outer shaft, wherein the individual slots 13 extend in the longitudinal extension direction x of the shaft 10 / guidewire 1. The core member 12 can comprise a slightly larger diameter (i.e., thickening) in the vicinity of the functional element 2 and is provided with an external thread 15 in the area of said thickening. Due to the threads 14, 15, the core member 12 and outer shaft 10 can be screwed together due to the matching thread structures 14, 15. In the area of the screwed thread structure, the outer diameter of the functional element / portion 2 of the outer shaft 10 is increased which corresponds to the expanded state of the functional element 2 that allows opening of the stenosis. Particularly, the expanded state can be facilitated by the slotted structure of the portion 2.

[0045] Fig. 6 shows yet another embodiment of a guidewire 1 according to the present invention. Also, here, the guidewire 1 comprises an outer shaft 10 defining a lumen 11 that accommodates an elongated core member 12. The core member 12 comprises mechanically interconnected lamellae 16 extending in parallel. Particularly, these lamellae 16 are connected up to the proximal end of the guidewire 1 by means of tension-transmitting elements 17, and optionally pressure-transmitting elements 18 and can be set up vertically (i.e. perpendicular to the longitudinal extension direction x) by means of these elements 17, 18 as a result of the application of a tensile and compressive force at the proximal end of the guidewire 1. Due to the now vertically arranged lamellae 16, an outer diameter of the core member 12 is enlarged and an adjacent portion 2 of the outer shaft 10 forming the functional element 2 is bulged outwards which can be further facilitated by a slotted structure of the portion 2. This corresponds to the expanded state of the functional element and allows to open the area of the stenosis.

[0046] A variation of the embodiment shown in Fig. 6 includes only tension-transmitting elements 17, but no pressure-transmitting elements 18. The lamellae 16 are setup vertically to increase the diameter via tension at the tension-transmitting elements 17 and brought back to the lower diameter by releasing the tension at the tension-transmitting elements 17 and slightly pulling back the complete device.

[0047] Fig. 7 shows a further embodiment of a guidewire 1 according to the present invention, wherein the guidewire 1 comprises an outer shaft 10 forming a lumen 11 to accommodate an elongated core member 12. Particularly, the core member 12 comprises distal wings 23 (e.g. blades) that form a radially expandable functional element 2. The wings 23 are erected by a directed rotational movement on contact with the vessel wall. For this purpose, the wings 23 are exposed by retraction of the outer shaft 10 and can, for example, be erected and have an ablative effect when the guidewire 1 rotates in a predetermined direction DI, while they fold back to a smaller diameter and can be captured by the outer shaft 10 when they rotate in the opposite direction to this predetermined direction DI.

[0048] Fig. 8a and 8b show a further embodiment of a guidewire 1 according to the present invention, wherein the guidewire 1 comprises an outer shaft 10 forming a lumen 11 to accommodate an elongated core member 12. Particularly, the core member 12 comprises a plurality of hair-like components 24 that form a radially expandable functional element 2 in the form of a brush. The hair-like components 24 exhibit rigidity such that they are erected upon removal of the outer shaft. The hair-like components 24 can stand perpendicular to the longitudinal extension x (as shown in Fig. 8a) or be inclined towards the proximal direction and can strongly work against the lesion when the guide wire is moved in proximal direction (as shown in Fig. 8b). In one embodiment as shown in Fig. 8b outer shaft 10 can be moved in distal direction to release hair-like components 24 which allows re-sheathing even with proximally inclined components 24. Once the stenosis treatment has been completed, the entire guidewire can be pushed so far distally through the stenosis in all of the embodiments described herein that the functional element 2 is positioned behind the stenosis. The area of the guidewire 1 proximal to the functional element 2 then serves for guiding other medical devices, such as balloon catheters or stent systems and the like.

[0049] The present invention offers the advantages of an easy handling and allows to reduce the number of components of a catheter system as the guidewire acts simultaneously as a proper guidewire and a tool for expanding a stenoses. Furthermore, the device is cost-effective and comprises a low risk of vascular injury. Further, the guidewire allows to adjust the outer diameter of the functional element in a variable manner.

[0050] List of reference numbers

[0051] 1 guidewire la distal end section

[0052] 2 functional element

[0053] 2a, 2b distal or proximal ends

[0054] 2c struts

[0055] 10 outer shaft

[0056] 10a distal end of the outer shaft 10

[0057] 11 lumen

[0058] 12 core member(e.g. an inner wire 12)

[0059] 12a distal end of the core member 12

[0060] 13 slots

[0061] 14 internal thread

[0062] 15 external thread

[0063] 16 lamellae

[0064] 17 tension-transmitting elements

[0065] 18 pressure-transmitting elements

[0066] 23 distal wings

[0067] 24 hair-like components

[0068] 100 inwards protrusion

[0069] 101 taper

[0070] 120 radial protrusion

[0071] 121 distal taper

[0072] DI predetermined direction

Claims

Claims1. A guidewire (1), particularly for a catheter, comprising: a distal end section (la), a functional element (2), wherein the functional element (2) is arranged in the distal end section (la) and configured to be deployed in a radial direction (R) of the guidewire (1) from an initial state to an expanded state to expand a stenosis of a vessel (V), wherein the functional element is a grating element.

2. The guidewire according to claim 1, wherein the guidewire (1) comprises an outer shaft (10) defining a lumen (11), and wherein the guidewire (1) comprises a core member (12) arranged in said lumen (11).

3. The guidewire according to claim 2, wherein the functional element (2) is a selfexpandable functional element (2) and is arranged on the core member (12), and wherein the core member (12) is arranged in the lumen (11) such that the outer shaft(10) can be retracted proximally with respect to the core member (12) to allow the functional element (2) to self-expand in the radial direction (R) from the initial state to the expanded state.

4. The guidewire according to one of the preceding claims, wherein the functional element (2) comprises a surface structure (20) configured to remove material of the stenosis for expansion of the stenosis during an axial and / or rotational movement of the functional element (2).

5. The guidewire according to claim 2, wherein the functional element (2) is formed by a portion of the outer shaft (10), wherein the core member (12) is arranged in a lumen(11) of the outer shaft (10) such that the outer shaft (10) can be retracted proximally with respect to the core member (12), wherein the core member (12) comprises a radial protrusion (120) configured to press against an inwards protrusion (100) of an inner surface of the outer shaft (10) when the outer shaft (10) is retracted proximally with respect to the core member (12) such that the radial protrusion (120) of the coremember (12) pushes the portion of the outer shaft (10) radially outwards to bring the functional element (2) to its expanded state.

6. A catheter system, comprising a catheter and a guidewire (1) according to one of the preceding claims, wherein the catheter comprises a guidewire lumen and wherein the guidewire (1) is configured to slide in the guidewire lumen to allow the catheter to be guided by the guidewire (1).

Images