Dilator; treatment system with at least one dilator

Abstract

The invention relates to a dilator (10) for intravascular treatment, in particular for the treatment of stenoses (100), which is movably arranged in a catheter (40) during use and has at least one proximal longitudinal end (11), a distal longitudinal end (12) which is tapered in the distal direction, and a shaft (13) which extends between the proximal and distal longitudinal ends (11, 12), wherein the dilator (10) has an inner lumen (14) for receiving a guide wire (20) which opens into a proximal and a distal exit opening (15, 16) for the guide wire (20), wherein the distal exit opening (16) is arranged at the distal longitudinal end (12) of the dilator (10), characterized in that the proximal exit opening (15) is arranged on a proximal section (13a) of the dilator. (10) is arranged so that the guide wire (20) passes through the proximal exit opening (15) intracorporeally during use,wherein a transport wire (30) is connected to the proximal longitudinal end (11) of the dilator (10) such that the dilator (10) is movable through the transport wire (30) in the catheter (40).

Description

[0001] The invention relates to a dilator for intravascular treatment, in particular for the treatment of stenoses. A dilator according to the preamble of claim 1 is known, for example, from EP 3 322 470 A1 or WO 2023 / 017006 A1.

[0002] Dilators are commonly used to treat intravascular diseases, such as widening narrowed or stenotic blood vessels. To transport a dilator to the treatment site, a guidewire is typically first inserted into the affected vessel and advanced to the treatment site. After positioning the guidewire, the dilator is guided along it to the treatment site. The dilator can then be removed from the vessel, with the guidewire usually remaining in place. The guidewire can then be used to guide other treatment devices or a medical implant to the treatment site.

[0003] For example, dilators with an inner lumen for receiving a guidewire are known from the aforementioned EP 3 322 470 A1 and WO 2023 / 017006 A1. However, the treatment of intravascular diseases with these known dilators is complex and often leads to long operating times.

[0004] The invention is therefore based on the objective of providing a dilator that reduces the operating time. Furthermore, the invention is based on the objective of providing a treatment system with at least one such dilator.

[0005] According to the invention, this problem with respect to the dilator is solved by the subject matter of claim 1. With respect to the treatment system, the aforementioned problem is solved by the subject matter of claim 16.

[0006] Specifically, this task is accomplished by a dilator for intravascular treatment, particularly for the treatment of stenoses, which is movably positioned within a catheter during use and has at least a proximal longitudinal end, a distal longitudinal end that tapers distally, and a shaft extending between the proximal and distal longitudinal ends. The dilator has an inner lumen for receiving a guidewire, which opens into a proximal and a distal exit port for the guidewire. The distal exit port is located at the distal longitudinal end of the dilator. The proximal exit port is positioned on a proximal section of the dilator such that the guidewire passes through it intracorporeally during use. A transport wire is connected to the proximal longitudinal end of the dilator in such a way that the dilator is movable within the catheter via the transport wire.

[0007] The invention has several advantages.

[0008] The operating time can thus be reduced by the dilator according to the invention. For this purpose, the dilator preferably has a rapid exchange (RX) design. The dilator is preferably designed as a rapid exchange dilator.

[0009] The rapid exchange design of the dilator is achieved by providing the dilator with a proximal and a distal exit opening for a guidewire, the proximal exit opening being positioned such that the guidewire passes through it intracorporeally, i.e., inside the patient's body, during use. The guidewire is preferably guided from the distal exit opening through the inner lumen of the dilator to the proximal exit opening during treatment, such that it passes through the proximal exit opening intracorporeally. Specifically, the guidewire exits the inner lumen of the dilator through the proximal exit opening intracorporeally during use.

[0010] The distal exit opening is located at the distal longitudinal end, and the proximal exit opening is located on a proximal section of the dilator. The inner lumen for receiving the guide wire preferably extends from the distal longitudinal end to the proximal section of the dilator. The proximal section can be the proximal longitudinal end of the dilator. Alternatively, the proximal section can be a region of the dilator located distal to the proximal longitudinal end.

[0011] Due to the rapid exchange design of the dilator, the distance between the distal and proximal exit openings in the axial direction of the dilator is advantageously so small, or the inner lumen for the guidewire is preferably so short, that during use the guidewire passes intracorporeally through the proximal exit opening. Such a short inner lumen results in easy handling of the dilator. In particular, the short inner lumen allows the dilator to be quickly threaded onto the guidewire, thus reducing operating time. This, in turn, reduces the patient's radiation exposure.

[0012] The dilator is advantageously delivered via a guidewire positioned within the vessel. Before the dilator is inserted into the vessel, it can be threaded onto the guidewire extracorporeally, preferably completely. The portion of the guidewire that protrudes from the patient's body in the implanted state, i.e., is located extracorporeally, is preferably used to thread the dilator onto the guidewire. The guidewire is advanced from the distal exit port through the inner lumen of the dilator to the proximal exit port.

[0013] The Rapid Exchange design, or rather the dilator's short inner lumen, allows the guidewire, especially the section that protrudes from the patient's body after implantation, to be kept correspondingly short. This makes threading the dilator onto such a short guidewire quick and easy.

[0014] Once the extracorporeal preparation of the dilator onto the guidewire is complete, the dilator can be advanced along the guidewire within a catheter to the treatment site. The dilator is positioned within the catheter to allow for movement during use. Advantageously, the dilator should be relatively mobile relative to the catheter during treatment. The dilator ensures that the catheter is guided to the treatment site in a way that protects the blood vessels. The catheter, along with the dilator, can be advanced to the treatment site without causing vascular injury.

[0015] In particular, the vessel-sparing guidance of the catheter is achieved by bridging the radial gap between the catheter and the guidewire with the dilator. Preferably, the outer circumference of the dilator rests at least partially against the inner circumference of the catheter. The dilator thus ensures optimal guidance of the catheter to the treatment site. Advantageously, the dilator guides the catheter through the vessel atraumatically, thereby preventing vascular injuries.

[0016] Particularly with large-bore catheters, such as 5F catheters with an inner diameter of approximately 1.35 mm, there is a large distance in the radial direction between the catheter and the guidewire. The dilator according to the invention makes it possible to bridge such a gap. Consequently, the dilator enables vessel-sparing guidance of large-bore catheters.

[0017] The distal longitudinal end of the dilator is tapered in the distal direction. The distal longitudinal end preferably has a substantially frustoconical shape. This allows the dilator to be guided atraumatically through a vascular constriction. The distal longitudinal end of the dilator is advantageously designed in such a way as to prevent injury to the stenosis.

[0018] The dilator is movable within the catheter via a transport wire. For this purpose, the proximal longitudinal end of the dilator is connected to the transport wire. By advancing the transport wire, the dilator can be guided to the treatment site. Furthermore, the transport wire advantageously allows the dilator to be retrieved. By pulling on the transport wire, the dilator can be removed from the vessel.

[0019] The transport wire preferably has a diameter between 0.3 mm and 1 mm, particularly at most 0.8 mm, particularly at most 0.6 mm, and particularly 0.4 mm. Other dimensions of the transport wire are possible. For example, the diameter can be 0.81 mm proximally and decrease to 0.25 mm distally.

[0020] The inner lumen of the dilator is preferably suitable for accommodating guide wires with a diameter of 0.014" (approx. 0.3556 mm). In this case, the diameter of the inner lumen is preferably approx. 0.4 mm. Other dimensions of the guide wire or the inner lumen are possible.

[0021] Preferred embodiments of the invention are specified in the dependent claims.

[0022] Preferably, the proximal exit opening is located a maximum of 35 cm, and particularly a maximum of 25 cm, axially from the distal longitudinal end of the dilator. This maximum distance ensures that the guide wire passes through the proximal exit opening intracorporeally during use. This arrangement of the proximal exit opening allows for quick and easy threading of the dilator onto the guide wire, resulting in reduced operating time. If the proximal exit opening is 35 cm axially from the distal longitudinal end of the dilator, the length of the guide wire protruding from the patient's body during use can be 35 cm plus a safety margin.

[0023] The proximal exit opening can be formed in a radially outward-facing surface of the proximal section of the shaft. Preferably, the proximal exit opening is arranged laterally on the proximal section of the shaft. This allows the guide wire to exit laterally from the inner lumen of the dilator during use, i.e., via the surface of the proximal section. In this way, the proximal exit opening is advantageously located distal to the transport wire, which is connected to the proximal longitudinal end of the dilator. The lateral arrangement of the proximal exit opening thus ensures that sufficient space is available at the proximal longitudinal end of the dilator for the transport wire.

[0024] Alternatively, the proximal exit opening can be formed in an end face of the proximal longitudinal end that points in the axial direction of the shaft. During use, the guide wire can exit the inner lumen of the dilator via this end face at the proximal longitudinal end of the proximal section. This ensures that the inner lumen for the guide wire and the transport wire preferably run parallel, at least partially, along the proximal section or at the proximal longitudinal end of the dilator.

[0025] Preferably, the proximal exit opening and / or the transport wire are arranged eccentrically on the end face of the proximal longitudinal end. If the proximal exit opening is formed in the end face of the proximal longitudinal end, then preferably both the transport wire and the proximal exit opening are arranged eccentrically on the end face of the proximal longitudinal end. If the proximal exit opening is formed in the outer surface of the proximal section of the shaft, then the transport wire is preferably arranged centrally on the end face of the proximal longitudinal end.

[0026] Preferably, the transport wire is embedded in the proximal longitudinal end of the dilator. The transport wire is preferably connected to the proximal longitudinal end of the dilator in such a way that its distal longitudinal end is completely surrounded by the dilator material. This ensures a secure connection between the dilator and the transport wire, allowing the surgeon to safely guide the dilator to the treatment site.

[0027] Alternatively, the transport wire can be bonded to the proximal longitudinal end of the dilator, particularly by adhesive bonding. The transport wire can also be bonded to the outer surface of the proximal longitudinal end of the dilator. Preferably, the transport wire is attached to the outer surface of the proximal longitudinal end, for example, by adhesive bonding. Other methods of connecting the transport wire to the proximal longitudinal end of the dilator are possible. For example, the transport wire can be connected to the proximal longitudinal end of the dilator by shrinking or extrusion.

[0028] The dilator is preferably made of plastic, in particular polyether block amide or polyamide. The transport wire is preferably made of metal or a metal alloy, in particular nitinol or stainless steel. The transport wire can be embedded in the plastic material of the dilator. Furthermore, the transport wire can be bonded to the plastic material of the dilator, in particular by adhesive bonding.

[0029] The transport wire can extend from the proximal longitudinal end of the dilator in a distal direction of at least 1 cm, and in particular at least 2 cm. Advantageously, the distal longitudinal end of the transport wire is embedded in the proximal longitudinal end of the dilator such that it projects at least 1 cm into the dilator. Alternatively, the distal longitudinal end of the transport wire is advantageously bonded to the outside of the proximal longitudinal end of the dilator in such a way that it extends along the dilator in a distal direction of at least 1 cm. This improves the security of the connection between the dilator and the transport wire.

[0030] In a preferred embodiment, the outer diameter of the shaft is adapted to the inner diameter of the catheter, at least in a distal section. In particular, the outer diameter of the shaft corresponds substantially to the inner diameter of the catheter, at least in the distal section. In use, the distal section of the dilator rests substantially against an inner lumen of the catheter. This ensures vessel-sparing guidance of the catheter. Specifically, this vessel-sparing guidance is achieved by bridging the radial gap between the catheter and the guidewire with the distal section of the dilator. The distal section ensures atraumatic guidance of the catheter to the treatment site, thus preventing vascular injuries.

[0031] The distal section can have at least one groove extending axially along its length. This prevents or at least reduces aspiration effects when the dilator is withdrawn. Aspiration generally refers to the drawing in of a substance, such as blood, due to negative pressure. Since the outer diameter of the distal section is preferably adapted to the inner diameter of the catheter such that, during use, the outer diameter of the distal section rests against the inner lumen of the catheter, aspiration effects can occur when the dilator is withdrawn. By providing at least one groove on the distal section, aspiration effects can be avoided, as the blood can flow through the grooves when the dilator is withdrawn.

[0032] The distal section can have several grooves that are arranged essentially uniformly around its circumference. By providing multiple grooves, especially those that are essentially uniformly distributed, it is possible to further reduce aspiration effects.

[0033] Preferably, the dilator, and in particular the distal section of the shaft, has a hydrophilic coating. This ensures low-friction guidance of the dilator within the catheter. Alternatively or additionally, at least the distal section of the shaft can be made of a hydrophilic material.

[0034] The dilator can have a receiving area for a medical implant on the proximal section of its shaft, allowing the implant to be delivered through the dilator. To deliver the implant, it can be positioned at the receiving area of ​​the dilator and loaded into a catheter, thereby radially compressing the implant. The receiving area advantageously gives the dilator a dual function. Firstly, it can be used to pre-dilate a stenosis. Secondly, the dilator can be used to deliver an implant. For this purpose, the distal section of the dilator can first be advanced through the stenosis to widen it. Then, the dilator can be advanced through the stenosis until the proximal section, which contains the receiving area, is positioned at the pre-dilated stenosis. The implant can then be deployed.

[0035] By combining the dilator with the receiving area for a medical implant, predilation of a stenosis and the delivery of the implant are advantageously possible with just one component. Consequently, it is avoided that a dilator must first be inserted, then removed after predilation of the stenosis, before a delivery system for the implant can be introduced into the vessel. This further reduces the operating time.

[0036] The medical implant preferably has a substantially tubular support body made of support elements, in particular a tubular wall made of support elements. The support body can, for example, be a monolithic lattice structure of struts forming cells. The lattice structure can be produced, for example, by laser cutting. Alternatively, the support body can be a mesh structure made of braided wires or a single braided wire. The wire or wires preferably form meshes.

[0037] The medical implant is preferably self-expanding. For this purpose, the support body can be made of a material with self-expanding properties, in particular nitinol.

[0038] The receiving area preferably has at least one engagement element for a positive-locking connection with the implant. The engagement element is preferably fixedly connected to the receiving area. In particular, the engagement element is arranged immovably on the transport wire or fixed in position on the transport wire. The engagement element can have at least one lug extending radially outwards. The lug can be adapted to the shape of a gap between support elements of the implant, in particular to at least one cell or mesh of the implant. The engagement element can be brought into engagement with the implant to transmit force. This ensures that the implant is securely connected to the receiving area in the compressed state.

[0039] The at least one engagement element can be metallurgically bonded to the transport wire, in particular by welding. For this purpose, the engagement element preferably has a recess for receiving the transport wire. The transport wire can be arranged in the recess and welded to the engagement element. This advantageously connects the transport wire directly to the engagement element.

[0040] If at least one of the intervention elements is directly connected to the transport wire, the intervention element and the transport wire can be positioned together on the dilator. To do this, the intervention element and transport wire can be slid onto the outer circumference of the dilator. The intervention element and the transport wire can then be glued to the dilator.

[0041] The receiving area can comprise at least one first and one second engagement element for a positive connection with the implant, each having at least one lug. The two engagement elements are preferably spaced apart from each other in the axial direction. The lug of the first engagement element can form a first stop for the implant or can engage with the implant to transmit force in the proximal direction. The lug of the second engagement element can form a second stop for the implant or engage with the implant to transmit force in the distal direction.

[0042] Furthermore, the receiving area can have at least one shear element that is slidable on the receiving area and movable relative to the engagement element. Preferably, the shear element is slidably arranged on the receiving area to enable relative movement to the engagement element. By moving the shear element, for example, in the direction of the engagement element, the implant can be released from engagement with the at least one engagement element and thus freed.

[0043] Alternatively or additionally, the receiving area can have at least one elastically deformable spacer element arranged on the intervention element and at least partially compressible by the compressed implant during use. The spacer element preferably has a protective function, preventing the intervention element from engaging with an already implanted implant. When the dilator is moved out of the catheter, the spacer element advantageously shields the intervention element to such an extent that the intervention element cannot engage with the cells or mesh of the implant. The spacer element thus keeps the intervention element at a distance from the implant. To avoid impairing the positive locking function of the intervention element, the spacer element is advantageously elastically deformable. This allows a compressed implant to continue to be positively coupled to the intervention element.The distance element adjacent to the engagement element can therefore be compressed, at least section by section.

[0044] Alternatively or additionally, the dilator can have an expandable balloon on the proximal section of the shaft. The balloon preferably serves to dilate a stenosis. By expanding the balloon, it widens and can conform to the stenosis in such a way that the balloon's expansion force widens it. In the expanded state, the balloon is filled, preferably with a saline solution. The balloon preferably has a cylindrical outer surface. In the expanded state, the balloon preferably has a substantially cylindrical section that extends between or is arranged between two end sections. The end sections preferably have a substantially frustoconical shape. In other words, the balloon catheter preferably tapers at the end sections.

[0045] In its compressed state, the balloon is preferably folded. Essentially, the balloon can form several folded sections that overlap in the circumferential direction of the balloon. The balloon is preferably folded regularly. In other words, in its compressed state, the balloon preferably assumes a geometry similar to that of a folded umbrella. Several folded sections can be provided, which are folded in the circumferential direction of the balloon and thus partially overlap. In a preferred embodiment of the invention, the folded sections are oriented in the same circumferential direction. This ensures that the balloon has a particularly small cross-sectional diameter in its compressed state. This facilitates the insertion of the dilator with the balloon, especially into small and / or highly tortuous blood vessels.

[0046] The balloon is preferably connected to at least one fluid-filled inflation channel. This allows the balloon to be expanded. An expansion medium, preferably a fluid, for example a liquid such as a saline solution, can be introduced into the balloon via the inflation channel to change the balloon from a compressed or folded state to an expanded state. In other words, a fluid can be introduced into and removed from the balloon via the inflation channel. The balloon can therefore be filled or inflated and expanded or deflated via the inflation channel.

[0047] According to dependent claim 16, the invention relates to a treatment system, in particular for the treatment of stenoses, comprising at least one catheter and at least one dilator according to the invention. Reference is made to the advantages explained in connection with the dilator. Furthermore, the treatment system may alternatively or additionally have one or a combination of several of the features mentioned above with regard to the dilator.

[0048] The invention is explained in more detail below with reference to the accompanying drawings. The illustrated embodiments represent examples of how the dilator and treatment system according to the invention can be designed.

[0049] These show, Fig. 1. a state-of-the-art catheter during the treatment of a stenosis; Fig. 2 a treatment system with a dilator and a catheter according to an embodiment of the invention during the treatment of a stenosis; Fig. 3 a longitudinal section of a dilator according to a further embodiment of the invention; Fig. 4 a longitudinal section of a dilator according to a further embodiment of the invention, wherein the dilator has a receiving area for a medical implant; Fig. 5a an enlarged section of a distal section of a dilator according to a further embodiment according to the invention, wherein the distal section has several grooves; Fig. 5b a cross-section of the distal section of the dilator according to Fig. 5a. Fig. 6 a longitudinal section of the dilator according to Fig. 4, wherein an implant is arranged at the receiving area of ​​the dilator; Fig. 7 a longitudinal section of a dilator according to a further embodiment of the invention, wherein the transport wire is bonded to the dilator; Fig. 8 a longitudinal section of the dilator according to Fig. 7, wherein the dilator has a receiving area for a medical implant; and Fig. 9 a cross-section of an intervention element of the receiving area for a medical implant according to Fig. 8.

[0050] The same reference numbers are used below for identical or equivalent parts.

[0051] The Fig. 3 and Fig. Figure 4 shows a dilator 10 for intravascular treatment according to an embodiment of the invention. This involves the application of the dilator 10 for the treatment of vascular constrictions or stenoses 100, particularly in large-bore vessels such as the carotid artery. The dilator 10 serves, among other things, to widen stenoses 100 and to guide catheters 40 in a vessel-sparing manner. Other applications are conceivable. For example, the dilator 10 according to the invention is suitable for the treatment of intracranial lesions or sinus vein stenoses.

[0052] Fig. Figure 2 shows that the dilator 10 is movably arranged within a catheter 40 during use. The dilator 10 can be transported within the catheter 40 to the treatment site. The dilator 10 enables the catheter 40 to be guided to the treatment site in a manner that protects the blood vessels.

[0053] To introduce the dilator 10 with the catheter 40, a guidewire 20 is first positioned in the affected vessel. The dilator 10 and the catheter 40 are then advanced along the guidewire 20 to the treatment site.

[0054] Fig. Figure 1 shows a state-of-the-art 40-gauge catheter. It is in Fig. 1. It can be seen that in the radial direction there is a greater distance between the catheter 40 and the guide wire 20 than between the in Fig. 2 catheters shown 40 and the dilator 10.

[0055] Fig. Figure 2 shows that the gap between the guide wire 20 and the catheter 40 is bridged by the dilator 10. The outer circumference of the dilator 10 is adapted, at least in sections, to the inner circumference of the catheter 40. This ensures that the catheter 40 is guided in a way that protects the blood vessels.

[0056] The dilator 10 and the catheter 40 form a treatment system according to an embodiment of the invention.

[0057] The dilator 10 has a proximal longitudinal end 11 and a distal longitudinal end 12. The proximal longitudinal end 11 is the section of the dilator 10 that is connected to a delivery device for administering the dilator 10. The distal longitudinal end 12 is the section of the dilator 10 that exits the catheter 40 first during intravascular treatment (see figure). Fig. 2).

[0058] The distal longitudinal end 12 of the dilator 10 is tapered in the distal direction. It can be seen that the distal longitudinal end 12 is essentially conical or has a truncated cone shape.

[0059] A shaft 13 extends between the proximal and distal longitudinal ends 11, 12 of the dilator 10. The shaft 13 is cylindrical, at least in part.

[0060] In the Fig. 3 and Fig. Figure 4 shows that the dilator 10 has an inner lumen 14 for receiving a guide wire 20. During the insertion of the dilator 10, the guide wire 20 is positioned at least partially within the inner lumen 14. The dilator 10 is movable relative to the guide wire 20. The dilator 10 is transported along the guide wire 20 to the treatment site.

[0061] The inner lumen 14 of the dilator 10 opens into a proximal and a distal exit opening 15, 16 for the guide wire 20. The guide wire 20 is inserted into the inner lumen 14 of the dilator 10 via the distal exit opening 16 and exits the dilator 10 at the proximal exit opening 15.

[0062] The guidewire 20 is inserted into the dilator 10 extracorporeally. Once the extracorporeal insertion of the guidewire 20 into the inner lumen 14 of the dilator 10 is complete, the dilator 10 is inserted into the vessel along the guidewire 20.

[0063] The distal exit opening 16 is located at the distal longitudinal end 12 of the dilator 10. The guide wire 20 passes through the distal exit opening 16 at the distal longitudinal end 12 of the dilator 10.

[0064] The proximal exit opening 15 is arranged on a proximal section 13a of the shaft 13 such that the guide wire 20 passes through the proximal exit opening 15 intracorporeally during use. This gives the dilator 10 a rapid exchange design.

[0065] The guide wire 20 is guided from the distal exit opening 16 through the inner lumen 14 of the dilator 10 to the proximal exit opening 15 such that the guide wire 20 passes intracorporeally through the proximal exit opening 15. Specifically, the guide wire 20 exits the inner lumen 14 of the dilator 10 through the proximal exit opening 15 intracorporeally during use.

[0066] The distance between the distal and proximal exit openings 15, 16 in the axial direction of the dilator 10 is so small that, during use, the guide wire 20 emerges intracorporeally from the proximal exit opening 15. The inner lumen 14 is short enough to allow for easy handling of the dilator 10, for example, when inserting the guide wire 20 into the inner lumen 14 of the dilator 10.

[0067] Due to the small distance between the distal and proximal exit openings 15, 16, and the short inner lumen 14, the section of the guide wire 20 that protrudes from the patient's body in the implanted state and is used to thread the dilator 10 onto it is correspondingly short. Threading the dilator 10 onto the guide wire 20 is therefore quick and easy.

[0068] A transport wire 30 is connected to the proximal longitudinal end 11 of the dilator 10 in such a way that the dilator 10 can be moved within the catheter 40 by the transport wire 30. By advancing the transport wire 30, the dilator 10 can be guided to the treatment site. By pulling on the transport wire 30, the dilator 10 can be removed from the vessel.

[0069] The proximal exit opening 15 is located at most 30 cm axially from the distal longitudinal end 12 of the dilator 10. This ensures that the guide wire 20 passes intracorporeally through the proximal exit opening 15 during use.

[0070] Fig. Figure 3 shows that the proximal exit opening 15 is formed in a radially outwardly projecting outer surface 13c of the proximal section 13a of the shaft 13. It can be seen that the proximal exit opening 15 is arranged laterally on the proximal section 13a of the shaft 13. As a result, the guide wire 20 exits laterally, or via the outer surface 13c of the proximal section 13a, from the inner lumen 14 of the dilator 10 during use.

[0071] In the exemplary embodiment according to Fig. Figure 3 shows that the transport wire 30 is arranged centrally on the end face 11a of the proximal longitudinal end 11. The end face 11a is essentially circular. It can be seen that the transport wire 30 is located essentially in the center of the circular end face 11a.

[0072] Fig. Figure 4 shows that the proximal exit opening 15 is formed in an end face 11a of the proximal longitudinal end 11, which points in the axial direction of the shaft 13. During use, the guide wire 20 exits the inner lumen 14 of the dilator 10 via the end face 11a at the proximal longitudinal end 11.

[0073] Furthermore, it is assumed that Fig. Figure 4 shows that the proximal exit opening 15 and the transport wire 30 are arranged eccentrically on the end face 11a of the proximal longitudinal end 11. It can be seen that both the transport wire 30 and the proximal exit opening 15 are arranged off-center on the circular end face 11a.

[0074] The transport wire 30 is embedded in the proximal longitudinal end 11 of the dilator 10 (cf. Fig. 3, Fig. 4 and Fig. 6) The transport wire 30 is connected to the proximal longitudinal end 11 of the dilator 10 in such a way that its distal longitudinal end is completely surrounded by the material of the dilator 10. In the exemplary embodiment according to Fig. 4 The part of the transport wire 30 that is embedded in the proximal longitudinal end 11 of the dilator 10 runs essentially parallel to the inner lumen 14 for the guide wire 20.

[0075] In the exemplary embodiment according to Fig. 6 The part of the transport wire 30 that is embedded in the proximal longitudinal end 11 of the dilator 10 runs substantially obliquely to the inner lumen 14 for the guide wire 20. That part of the transport wire 30 that is embedded in the proximal longitudinal end 11 of the dilator 10 has an angle to the inner lumen 14 for the guide wire 20.

[0076] Furthermore, the inner lumen 14 for the guide wire 20 is in the embodiments according to the Fig. 4 and Fig. The inner lumen 14 is arranged eccentrically in the proximal section 13a of the dilator 10 and centrically in the distal section 13b. The inner lumen 14 transitions from a centric arrangement in the distal section 13b to an eccentric arrangement in the proximal section 13a. This provides sufficient space for the transport wire 30 in the proximal section 13a.

[0077] According to the Fig. 7 and Fig. 8. The transport wire 30 is bonded to the proximal longitudinal end 11 of the dilator 10. Specifically, the transport wire 30 is bonded to the outer surface of the proximal longitudinal end 11 of the dilator 10. The transport wire 30 is attached to the outer surface of the proximal longitudinal end 11 by bonding.

[0078] Furthermore, the transport wire 30 extends from the proximal longitudinal end 11 of the dilator 10 in a distal direction at least 1 cm (cf. Fig. 4, 6-8).

[0079] The distal longitudinal end of the transport wire 30 is according to the Fig. 4 and Fig. 6 embedded in the proximal longitudinal end 11 of the dilator 10 such that it protrudes at least 1 cm into the dilator 10.

[0080] The distal longitudinal end of the transport wire 30 is according to the Fig. 7 and Fig. 8 connected to the outside of the proximal longitudinal end 11 of the dilator 10 in such a way that it extends along the dilator 10 in a distal direction at least 1 cm.

[0081] Fig. Figure 2 shows that the outer diameter of the shaft 13 is adapted to the inner diameter of the catheter 40, at least in the distal section 13b. Essentially, the outer diameter of the distal section 13b corresponds to the inner diameter of the catheter 40. This ensures that the catheter 40 is guided in a way that protects the blood vessels.

[0082] From the Fig. 5a and Fig. Figure 5b shows that the distal section 13b has several grooves 17 extending axially along the distal section 13b. The grooves 17 are arranged essentially uniformly around the circumference of the distal section 13b (see Figure 5b). Fig. 5b). The grooves 17 prevent aspiration effects when withdrawing the dilator 10 from the vessel.

[0083] The dilator 10, or the distal section 13b of the shaft 13, has a hydrophilic coating. This allows the dilator 10 to move with low friction within the catheter 40.

[0084] In the exemplary embodiment according to the Fig. 4, Fig. 6 and Fig. The dilator 10 has a receiving area 18 for a medical implant 50 on the proximal section 13a of the shaft 13. An implant 50 can be positioned on the receiving area 18 such that the implant 50 can be introduced into the vessel through the dilator 10.

[0085] The Fig. 4, Fig. 6 and Fig. Figure 8 shows that the receiving area 19 has two engagement elements 18a for a form-fitting connection with the implant 50. The engagement elements 18a each have several lugs that extend radially outwards. The lugs are adapted to the spaces between the support elements of the implant 50. The lugs of the engagement elements 18a engage with the implant 50 to transmit force and guide the implant 50 into position.

[0086] Fig. Figure 9 shows a cross-section of the engagement element 18a. It can be seen that the engagement element 18a has a recess 18a' for receiving the transport wire 30. This allows the engagement element 18a to be directly connected to the transport wire 30. For example, the engagement element 18a can be bonded to the transport wire 30, in particular by welding. In use, the transport wire 30 is arranged in the recess 18a' of the engagement element 18a and welded to it.

[0087] Furthermore, in the Fig. 4 and Fig. Figure 6 shows that the receiving area 18 has a sliding element 18b which is slidable on the receiving area 18 and is movable relative to the engagement element 18a. By sliding the sliding element 18b, the implant 50 can be released from the engagement with the engagement elements 18a. Reference symbol list 10 Dilator 11 proximal longitudinal end 11a End face of the proximal longitudinal end 12 distal longitudinal end 13 shaft 13a Proximal section of the shaft 13b Distal section of the shaft 13c Surface area of ​​the shaft 14 internal lumens 15 proximal exit orifice 16 distal exit orifices 17 Nut 18 Recording area 18a Intervention element 18a' Recess of the intervention element 18b Shear element 20 guide wire 30 Transport wire 40 catheters 50 implants 100 Stenosis QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] EP 3 322 470 A1 [0001, 0003] WO 2023 / 017006 A1 [0001, 0003]

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