Dilator shaft design allows for tip formability and deformable shaft flexibility

JP2024545401A5Pending Publication Date: 2025-10-09BIOTRONIK AG
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Patent Information

Application Number
JP2024528511
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-11-30
Filing Date
2022-11-30
Publication Date
2025-10-09

AI Technical Summary

Technical Problem

Existing endovascular treatment devices face challenges in maneuverability and pushability due to anatomical constraints, limiting their ability to reach and treat lesions such as chronic total occlusions (CTOs) effectively.

Method used

A dilator shaft with a braid-reinforced design featuring interwoven braided threads that vary in angle along its length, providing flexibility in some areas and stiffness in others, allowing for improved maneuverability and force transmission.

Benefits of technology

The dilator shaft enhances the ability to penetrate lesions by optimizing flexibility and stiffness, enabling effective treatment of both soft and hard CTOs, including those with fibrous caps.

✦ Generated by Eureka AI based on patent content.

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Abstract

A dilator (3) for intravascular treatment of a lesion in a patient's body comprises a dilator shaft (33) extending along a longitudinal axis (L), the dilator shaft (33) having a braid (31) comprising an arrangement of braiding threads (310, 311) braided to form a braid (31). A first group of braiding threads (310) and a second group of braiding threads (311) are interwoven with each other and arranged to cross each other at an angle (α, β, γ) therebetween, where in a first axial position of the dilator shaft (33), the first group of braiding threads (310) and the second group of braiding threads (311) are arranged to cross each other at a first angle therebetween, and in a second axial position of the dilator shaft (33), the first group of braiding threads (310) and the second group of braiding threads (311) are arranged to cross each other at a second angle different from the first angle therebetween.
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Description

[Technical field]

[0001] The present invention relates to a dilator, a catheter system, and a method for the endovascular treatment of a lesion within a patient's body. [Background technology]

[0002] A dilator is often understood as a medical device used to induce dilation, i.e. to dilate an opening or canal in the human or animal body, such as the cervix, urethra, esophagus, vaginal introitus, etc. However, the dilator of the present invention is not used for dilatation purposes and is therefore not adapted to induce dilation.

[0003] The dilator of the present invention comprises a dilator shaft extending along a longitudinal axis, the dilator shaft having a braid comprising an arrangement of braided threads braided to form a braid, the braided threads of the first group and the braided threads of the second group being interwoven with each other and arranged to cross each other at an angle therebetween. Over the past two decades, the number of intravascular devices, including balloons, stents, and stent grafts as well as auxiliary devices for removal of lesions and accurate re-entry into the lumen, has exploded as the industry has invested significant resources in their design and development. Furthermore, compared to previous generations, these newer devices are made with smaller and different delivery shaft lengths as well as varying guidewire platforms and delivery systems. The increase in device options has driven the growth of endovascular treatments. However, anatomical constraints are ever-present in the treatment of lesions. In other words, if you can't reach the lesion, you can't treat it. There has been a tremendous growth in guidewires, catheters, and sheaths as well, allowing you to reach lesions that were previously inaccessible.

[0004] US Pat. No. 5,399,433 discloses a functionally integrable catheter system CTO dilator having a reinforced shaft and dilator.

[0005] It is contemplated to use a catheter system in which a dilator is movably received and which includes a support catheter to treat an intravascular lesion such that the lesion can be treated by advancing a dilator towards the lesion, e.g., penetrating an obstruction to allow free passage through an intravascular lumen. As a fundamental principle, it is understood herein that only lesions that can be reached by an intravascular treatment device can be treated, and that anatomical constraints may prevent the advancement of a treatment device such as a dilator.

[0006] By using a dilator having a braid-reinforced dilator shaft, i.e., a dilator shaft having a braid consisting of an arrangement of braided threads woven to form a braid, the dilator shaft can be designed to have sufficient stiffness to allow for the penetration of a lesion such as a chronic total occlusion (CTO). The braided threads herein are braided and, for example, embedded in a surrounding matrix material to form a shaft that can be pushed towards the lesion and used to penetrate the lesion by the transmission of force through the dilator shaft.

[0007] Chronic total occlusion (CTO) is the complete blockage of a coronary artery. A CTO that initially has a soft CTO cap can begin to age and become a hard, fibrous CTO cap over time. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] European Patent No. 3322470 Summary of the Invention [Problem to be solved by the invention]

[0009] It would be preferable to design a reinforced dilator shaft that can be reliably advanced towards the lesion while taking into account anatomical constraints.

[0010] It is an object of the present invention to provide a dilator, catheter system and method for endovascular treatment of a lesion within a patient's body that allows for improved maneuverability and pushability of a dilator toward a lesion within a patient's body to provide treatment for the lesion. [Means for solving the problem]

[0011] This object is achieved with a dilator having the features of claim 1, 15 or 29. The dilator comprises a dilator shaft having a distal dilator shaft end and a proximal dilator shaft end. The dilator shaft extends along a longitudinal axis.

[0012] In one embodiment, the dilator shaft has at least one braided section comprising an arrangement of braiding threads woven to form a braid, a first group of braiding threads and a second group of braiding threads woven together and arranged to cross each other at an angle therebetween, the angle varying between the distal and proximal dilator shaft ends. Optionally, the dilator shaft may further have at least one non-braided section that does not include any braiding threads. The non-braided section may be disposed between two braided sections.

[0013] At a first axial position of the dilator shaft, the braided threads of the first group and the braided threads of the second group are arranged to cross each other at a first angle therebetween, and at a second axial position of the dilator shaft, the braided threads of the first group and the braided threads of the second group are arranged to cross each other at a second angle therebetween that is different from the first angle.

[0014] The dilator shaft is reinforced by a braid formed by the arrangement of braiding threads woven to form a braid, where the braiding threads of the first group are woven together with the braiding threads of the second group such that the braiding threads of the first group and the braiding threads of the second group are arranged at an angle to each other to form the braided braid. Thus, the threads of the braiding threads of the first group and the braiding threads of the second group are interwoven to form the braided braid. In particular, the braiding threads may each extend in a circumferential direction around the longitudinal axis, and the braiding threads of the first group and the braiding threads of the second group are arranged at diagonal angles such that the braiding threads of the first group and the braiding threads of the second group cross and interweave with each other to form a braided mesh.

[0015] The braid may in particular extend longitudinally along the dilator shaft, i.e. not circumferentially, to form a tubular structure, the braid being formed by braiding threads extending circumferentially around the longitudinal axis at a given inclination angle, the braiding threads of the first group and the braiding threads of the second group having opposite inclination angles so as to cross each other in an interwoven shape to form a woven braid. Here, the braiding threads do not cross at a constant angle when viewed along the longitudinal axis of the dilator shaft. Rather, at different axial positions, the braiding threads of the first group and the braiding threads of the second group are arranged at different angles to each other. In particular, at a first axial position, the braiding threads of the first group and the braiding threads of the second group are arranged to cross each other at a first angle between them, and at a second axial position, the braiding threads of the first group and the braiding threads of the second group are arranged to cross each other at a second angle between them, different from the first angle.

[0016] Thus, one embodiment relates to a dilator for endovascular treatment of a lesion in a patient, the dilator shaft having a distal dilator shaft end and a proximal dilator shaft end, the dilator shaft extending along a longitudinal axis, the dilator shaft having an arrangement of braiding threads woven to form a braid, the braiding threads comprising a first group of braiding threads and a second group of braiding threads woven together and arranged to cross each other at an angle therebetween, where at a first axial position of the dilator shaft, the first group of braiding threads and the second group of braiding threads are arranged to cross each other at a first angle therebetween, and at a second axial position of the dilator shaft, the first angle can be greater than the second angle at a second axial position of the dilator shaft, e.g., the distal dilator shaft end.

[0017] As the angle between the crossing groups of braided threads varies along the longitudinal axis of the dilator shaft, the flexibility and pushability of the dilator shaft varies along the longitudinal axis. By adjusting the angle between the crossing braided threads, the dilator shaft may be defined such that in some regions the flexibility of the dilator shaft is increased while in other regions the axial stiffness of the dilator shaft is increased and thus the pushability is improved. The larger the pitch angle of the braided threads, the more flexible the shaft is, and the smaller the pitch angle, the easier it is to push. For example, dilators closer to the distal end have more flexibility and dilators further from the distal end have more axial stiffness to facilitate the transmission of force by the dilator. The first (pitch) angle (hereinafter referred to as α) at ​​the distal dilator shaft end is greater than the second (pitch) angle (hereinafter referred to as β) at the proximal dilator shaft end. For example, the first pitch angle is 100° and the second pitch angle is 90°. The pitch angle is the angle between a first braided thread and a second braided thread that crosses the first braided thread. Such a dilator allows for optimal pushing and force transmission. In addition, the maneuverability and flexibility of the dilator shaft is enhanced, which allows the physician to individually support the guidewire during lesion access.

[0018] In one embodiment, the angle at which the braided thread groups cross one another may vary between a first axial location and a second axial location, and the angle may vary continuously or gradually, e.g., continuously increasing or decreasing or gradually increasing or decreasing, between a first axial location, e.g., the distal dilator shaft end, and a second axial location, e.g., the proximal dilator shaft end.

[0019] In another embodiment, the dilator shaft may comprise different sections, and within each section, different groups of braided threads are arranged to cross each other at a certain angle.

[0020] For example, in one embodiment, the dilator shaft comprises a first section having a first axial length and a second section having a second axial length, where in the first section the braided yarns of the first group and the braided yarns of the second group are arranged to cross each other at a first angle therebetween, and in the second section the braided yarns of the first group and the braided yarns of the second group are arranged to cross each other at a second angle therebetween, such that the braided yarns of the braids are arranged at different angles to each other in the different sections, resulting in different flexibility and stiffness (pushability) characteristics in the different sections.

[0021] The sections have a finite length greater than zero, where the sections, for example a first section formed at the distal end of the dilator shaft and a second section proximally adjacent to the first section, are advantageously joined to each other along the longitudinal axis. In one embodiment, the dilator shaft comprises a third section having a third axial length, in which the braided threads of the first group and the braided threads of the second group are arranged to cross each other at a third angle therebetween, the third angle being different from the first and second angles. Thus, in the third section, different braided threads may be arranged at a different third angle relative to each other to provide different flexibility and pushability characteristics compared to the first and second sections.

[0022] The braid may be formed from wire, for example, a metal wire or a metal alloy wire, such as a stainless steel wire or a Nitinol wire.

[0023] In one embodiment, the dilator shaft is composed of a matrix material with a braid embedded in it. The matrix material may be a polymeric material such as, for example, polypropylene, polyethylene, FEP, or ETFE.

[0024] In one embodiment, the dilator shaft includes an internal dilator lumen extending longitudinally along the dilator shaft. In the present application, one or more lumens may be provided within the dilator shaft, which may be used, for example, to flow contrast or another fluid through the dilator toward the lesion or to guide the dilator along a guidewire. To be effective, the dilator lumen is radially disposed within the braid such that the braid circumferentially surrounds the lumen.

[0025] In one embodiment, the dilator shaft comprises one or more longitudinal wires extending longitudinally along the dilator shaft, more preferably extending from the distal dilator shaft end to the proximal dilator shaft end. For example, multiple pairs of longitudinal wires may be provided and may extend longitudinally along the dilator shaft, advantageously interwoven with the braiding threads of the first group and the braiding threads of the second group, such that the longitudinal wires are woven into the threads formed by the braiding threads of the first group and the braiding threads of the second group.

[0026] When multiple pairs of longitudinal wires are provided, one of the pair of longitudinal wires may be located at a predetermined circumferential position close to the pair of longitudinal wires. The longitudinal wires of different pairs are then located equidistant from each other along the circumferential direction. Within a pair of longitudinal wires, the distance between two wires forming a pair is less than 50 um, preferably less than 30 um. Adding n pairs of longitudinal wires (n is 1-10, preferably 2-4) can improve the moldability of the dilator shaft. The dilator shaft may have a diameter less than 1 mm, preferably between 0.5 mm and 1 mm. The diameter of the dilator shaft is less than 1 mm, preferably between 0.5 mm and 1 mm.

[0027] The longitudinal wires may be formed by metal or alloy wires, such as, for example, stainless steel or nitinol wires. Polymeric wires may also be substituted. Thus, the disclosed dilator for endovascular treatment of a lesion within a patient's body comprises a dilator shaft having a distal dilator shaft end and a proximal dilator shaft end, the dilator shaft extending along a longitudinal axis with or without a braided section, the dilator shaft comprising at least one longitudinal wire, preferably multiple pairs of longitudinal wires, the wires extending longitudinally along the dilator shaft, preferably configured to extend from the distal dilator shaft end to the proximal dilator shaft end.

[0028] In another aspect, a catheter system includes a support catheter defining a support catheter lumen and a dilator of the type described above, the dilator received within and movable within the support catheter lumen.

[0029] To treat the lesion, a dilator may be inserted into the support catheter lumen and advanced toward the lesion, for example to penetrate the chronic total occlusion; to penetrate the chronic total occlusion, the dilator may extend and move within the support catheter lumen so as to protrude from the distal end of the support catheter, or may be advanced along with the support catheter such that the dilator is used to penetrate the chronic total occlusion.

[0030] The dilator can be used to reach or access a lesion within the human or animal body that is to be treated.

[0031] The dilator may be used in a catheter system. The catheter system may be a multi-purpose catheter system or an interventional catheter system. A multi-purpose catheter system is one in which a support catheter is housed simultaneously or sequentially with various internal members such as a dilator and a guidewire and / or a balloon catheter (e.g., a balloon catheter for percutaneous transluminal angioplasty (PTA) or a balloon catheter for percutaneous transluminal coronary angioplasty (PTCA)). The multi-purpose catheter system comprises a support catheter and at least one, preferably one, support catheter lumen.

[0032] The support catheter includes a locking handle configured with a limited movement state for preventing axial movement of the expander relative to the support catheter such that the expander is movable relative to the support catheter, and an unrestricted movement state for allowing axial movement of the expander from the support catheter. The locking handle may include an axial movement limiting element having an actuation mechanism and a locking mechanism, the axial movement limiting element being capable of limiting axial movement of the expander in the limited movement state compared to axial movement in the unrestricted movement state. The locking handle may be located on the support catheter proximal end or on the support catheter shaft.

[0033] The dilator shaft extends between a distal dilator end and a proximal dilator end, the distal dilator end having a proximal segment, a distal segment, and optionally one or more intermediate segments disposed between the proximal and distal segments. The distal dilator end may be connected or connectable to the dilator shaft. The proximal segment may be connected or connectable to the dilator shaft. The distal segment may have a uniform radial circumference, and the proximal segment may have a uniform radial circumference, with the radial circumference of the distal segment being smaller than the radial circumference of the proximal segment. In yet another aspect, a method is provided for endovascular treatment of a lesion within a patient's body, the method including providing a support catheter of a catheter system, the support catheter defining a support catheter lumen, and inserting a dilator of the catheter system into the support catheter lumen, the dilator comprising a dilator shaft extending along a longitudinal axis, the dilator shaft having at least one braided section including an arrangement of braiding threads woven to form a braid, a first group of braiding threads and a second group of braiding threads interwoven with each other and arranged to cross each other at an angle therebetween, the first group of braiding threads and the second group of braiding threads being arranged to cross at a first angle at a first axial location of the dilator shaft, and the first group of braiding threads and the second group of braiding threads being arranged to cross at a second axial location of the dilator shaft, the second angle being different from the first angle.

[0034] The benefits and advantageous embodiments discussed above for the dilator and catheter system, as referenced above in this regard, apply equally to the method.

[0035] The support catheter and the dilator placed in the support catheter lumen are used as a crossing catheter system. In particular, the catheter system with the dilator allows for crossing of CTOs with soft CTO caps using only the dilator for crossing, but also crossing of stiff fibrous CTO caps using the support catheter together with the dilator for crossing the CTO. The support catheter works in conjunction with the dilator to increase the strength of the column and increase the stiffness (pushability) of the catheter system through the occlusion. [Brief description of the drawings]

[0036] The idea of ​​the invention will now be explained in more detail with reference to an embodiment shown in the drawing. [Figure 1] 1 illustrates one embodiment of a multi-purpose catheter system. [Diagram 2] 1 illustrates one embodiment of a support catheter. [Diagram 3] 1 shows one embodiment of an expander. [Figure 4A] 1 shows one embodiment of an expander. [Figure 4B] A close-up of a section of the expander is shown. [Figure 5A] 13A and 13B show views of yet another embodiment of an expander. [Figure 5B] A close-up of a section of the expander is shown. [Figure 6] 5A and 5B show schematic cross-sectional views of the dilator of FIG. 5B. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037] 1 shows a catheter system 1, also called a multi-purpose catheter system, comprising a support catheter 2 and a dilator 3 having a distal dilator end 32. The support catheter shaft 23 defines a support catheter lumen 26 capable of receiving the dilator 3. The dilator 3 is thus disposed within the support catheter lumen 26 of the support catheter 2. The dilator may be provided with a locking handle 4.

[0038] 2, the support catheter 2 includes a support catheter distal end 21, a support catheter proximal end 24, and a support catheter shaft 23 extending between the support catheter distal end 21 and the support catheter proximal end 24. Disposed at the support catheter proximal end 24 is a locking handle 4. The locking handle 4 may be operable by a user and, in a locked position, serves to lock the dilator 3 relative to the support catheter 2 and, in a released position, serves to unlock the dilator 3 relative to the support catheter 2 such that the dilator 3 can move relative to the support catheter 2.

[0039] The support catheter 2 includes one or more support catheter ports 27, preferably one or more ports for injecting or evacuating fluids, such as a flush port, an inflation port, and / or a deflation port.

[0040] The support catheter distal end 21 is designed for insertion into the human or animal body to perform an endovascular procedure, while the outer catheter proximal end 24 is designed to remain outside the patient's body during the procedure, allowing operation of the catheter system 1 from outside the patient's body.

[0041] 3, the dilator 3 comprises a dilator shaft 33, which here forms a distal dilator end 32, and may have, for example, a tapered shape to allow for penetration of the CTO at the lesion site. At the proximal dilator end 34, a dilator manifold 35 is disposed, which provides access to one or more dilator lumens.

[0042] For example, in one embodiment, the dilator 3 includes a first lumen for receiving a guidewire and a second lumen for injecting a fluid medium, e.g., a contrast agent. In another embodiment, the dilator 3 may have only one lumen that allows for the injection of a contrast agent as well as guidance of a guidewire. The dilator manifold 35 can include one or more dilator ports 36, e.g., for injecting a fluid medium (e.g., a contrast agent) into one or more dilator lumens.

[0043] 4A and 4B, the dilator shaft 33 may be reinforced by a braid 31, which may be formed of interwoven braided threads 310, 311 extending circumferentially along a longitudinal axis L along which the dilator shaft 33 extends. The braid 31 is embedded within a matrix material 39 (see schematic diagram in FIG. 6), which may be formed of a polymeric material such as, for example, polypropylene, polyethylene, FEP, or ETFE.

[0044] The braid 31 is formed by woven braid threads 310, 311, where two groups of braid threads are provided, the first group of braid threads 310 extending circumferentially around the longitudinal axis L at a first inclination angle and the second group of braid threads 311 extending circumferentially around the longitudinal axis L at a second inclination angle opposite to the first inclination angle of the first group of braid threads 310. The braid threads 310, 311 of the different groups are interwoven to form the woven braid 31, which has a tubular, circumferentially closed structure and extends longitudinally along the longitudinal axis L of the dilator shaft 33.

[0045] The first group of braided threads 310 may be formed by a single wire or by multiple wires wound around the longitudinal axis L. Similarly, the second group of braided threads 311 may be formed by a single wire or by multiple wires wound around the longitudinal axis L, where the braids 310, 311 are interwoven to form the knitted braid 31.

[0046] As can be seen in Figures 4B and 4A, the dilator shaft 33 includes different sections 330, 331, 332, and 333 adjacent to one another along a longitudinal axis L, where the first section 330 is disposed at or near the distal end 32 of the dilator shaft 33 and can have an axial length L1. The second section 331 is adjacent to the first section 330 and can have an axial length L2. The third section 332 is adjacent to the second section 331 and can have an axial length L3. The fourth section 333 is adjacent to the third section 332 and can have an axial length L4.

[0047] Here, different sections 332, 333 have different structures of the braid 31.

[0048] 4B, in the first section 330, the braided threads 310, 311 may be arranged to cross each other at an angle α. Thus, the braided threads 310, 311 have a pitch angle of ±α / 2 with respect to the longitudinal axis L, where the pitch angle indicates the inclination of each of the braided threads 310, 311 with respect to the longitudinal axis L.

[0049] 4B, in the second section 331, the braided threads 310, 311 cross each other at a different angle β, which in the illustrated example is smaller than the angle α in the first section 330. Thus, the braided threads 310, 311 have a pitch angle ±β / 2 with respect to the longitudinal axis L, where the pitch angle indicates the inclination of each of the braided threads 310, 311 with respect to the longitudinal axis L in the second section 331.

[0050] In general, a larger angle between the intersecting braided threads 310, 311, such as in section 330, can increase the flexibility of a particular section 330. Increasing flexibility can improve maneuverability and allow the dilator 3 to be flexibly adjusted to the delivery path and shaped by the operator, for example, by bending section 330 into a desired shape, prior to inserting the dilator 3 into the support catheter 2.

[0051] A smaller angle, such as in section 331, may increase the axial stiffness in a particular section 331 and therefore improve the pushability of the expander 3 in that section 331.

[0052] In the adjacent third section 332 , the angle may again be different, for example less than the angle β of the second section 331 .

[0053] For example, a fourth section 333 adjacent to the third section 332 is not provided with a braid 31 such that the dilator shaft 33 in the fourth section 333 is not reinforced with a braid.

[0054] The braid 31 in the illustrated example is formed by wires, e.g., metal or alloy wires, such as stainless steel wires or nitinol wires, woven together to form a braided mesh, where the first group of braiding threads 310 and the second group of braiding threads 311 are arranged at different inclination angles to form an intertwined mesh that crosses each other such that the dilator shaft 33 is reinforced by a tubular circumferentially closed wire mesh.

[0055] 5A and 5B, in another embodiment, in addition to the reinforcement provided by the braid 31, there may be an arrangement of (paired) longitudinal wires 37. The longitudinal wires 37 extend longitudinally along (but eccentrically relative to) the longitudinal axis L and are further intertwined with the braid threads 310, 311 of the braid 31.

[0056] In particular, as can be seen in FIG. 5B, with respect to the longitudinal wires 37 shown in the upper portion of FIG. 5B, or conversely, the longitudinal wires 37 shown in the lower portion of FIG. 5B, the longitudinal wires 37 may cross the braided yarns 310, 311, for example, such that a particular longitudinal wire 37 is positioned radially outside of the braided yarn 310 and radially inside of the braided yarn 311.

[0057] 6, the longitudinal wires 37 are arranged, for example, in pairs, such that the wires 37 of a particular pair are disposed at an associated circumferential position and are circumferentially, preferably equally offset, relative to the longitudinal wires 37 of other pairs. Here, the longitudinal wires 37 are interwoven with the braiding yarns 310, 311 forming the braid 31, such that the longitudinal wires 37 are disposed in an interwoven configuration within the layers of the braid 31.

[0058] The axial stiffness of the dilator shaft 33 can be increased by providing one or more (pair) longitudinal wires 37. Additionally, moldability can be further improved in that the dilator shaft 33 can be molded to assume a curved shape, for example at or near its distal end 32.

[0059] 6, a dilator lumen 38 may extend longitudinally within the dilator shaft 33, and preferably the dilator lumen 38 is formed radially within the braid 31. One or more lumens 38 may be formed within and extend longitudinally along the dilator shaft 33, for example, to receive a guidewire or for injecting a fluid such as a contrast agent.

[0060] The invention is not limited to the embodiments described above but may be practiced in entirely different ways.

[0061] By providing a dilator shaft with a braided reinforcement having varying angles between the braided threads, flexibility and stiffness can be varied along the dilator shaft, where the angles between the braided threads can be discretely different in different sections of the dilator shaft. Alternatively, in another embodiment, the angles can vary continuously between different axial positions of the dilator shaft. A combination of continuous and discrete, stepwise changes can be used, where in some sections the angles between the crossing braided threads are constant, while in other sections the angles vary continuously. By appropriately varying the angles between the braided threads of the braid, the flexibility versus stiffness of the dilator shaft can be optimized, such that in some regions the dilator shaft is more flexible, and in other regions the dilator shaft is more stiff for improved force transmission. [Explanation of symbols]

[0062] 1 Catheter system 2 Support Catheter 21 Support catheter distal end 23 Support catheter shaft 24 Support Catheter Proximal End 26 Support Catheter Lumen 27 Support Catheter Port 3. Expander 31 Braid 310 First group braided yarn 311 Braided yarn of the second group 32 Distal dilator end 33 Expander shaft 330-333 Shaft section 34 Proximal dilator end 35 Expander Manifold 36 Dilator Port 37 Longitudinal Wires 38 Dilator lumen 39 Matrix Materials 4 Handle α, β angles L Longitudinal axis L1-L4 shaft length

Claims

1. A dilator (3) for intravascular treatment of a lesion in a patient's body, the dilator (3) comprising a dilator shaft (33) having a distal dilator shaft end and a proximal dilator shaft end and extending along a longitudinal axis (L), the dilator shaft (33) comprising at least one braided section (31) in which braided threads (310, 311) are arranged to form a braid (31), a first group of braided threads (310) and a second group of braided threads (311) that are interwoven with each other and arranged to cross each other at an angle (α, β, γ) therebetween, and optionally any and at least one non-braided section that does not include any braided threads, wherein the angle varies between the distal dilator shaft end and the proximal dilator shaft end, and the dilator shaft (33) further comprises at least one longitudinal wire (37) extending longitudinally along the dilator shaft (33), preferably extending from the distal dilator shaft end to the proximal dilator shaft end, and wherein the at least one longitudinal wire (37) is interwoven with the braided threads (310) of the first group and the braided threads (311) of the second group.

2. 2. The dilator (3) of claim 1, wherein at the distal dilator shaft end, the first group of braided threads (310) and the second group of braided threads (311) are arranged to cross each other at a first angle (α) therebetween, and at the proximal dilator shaft end, the first group of braided threads (310) and the second group of braided threads (311) are arranged to cross each other at a second angle (β) therebetween, and the first angle (α) is greater than the second angle (β).

3. The dilator (3) of claim 1, wherein the dilator shaft (33) comprises at least one first section (330) having a first axial length (L1) and at least one second section (331) having a second axial length (L2), and in the first section (330), the braided threads (310) of the first group and the braided threads (311) of the second group are arranged to cross each other at the first angle (α) therebetween, and in the second section (331), the braided threads (310) of the first group and the braided threads (311) of the second group are arranged to cross each other at the second angle (β) therebetween.

4. The dilator (3) according to claim 3, wherein the second section (331) is adjacent to the first section (330) when viewed along the longitudinal axis (L).

5. The dilator (3) of claim 3, wherein the dilator shaft (33) has a third section (332) having a third axial length (L3), and in the third section (332), the braided threads (310) of the first group and the braided threads (311) of the second group are arranged to cross each other at a third angle (γ) therebetween, and the third angle (γ) is different from the first angle (α) and the second angle (β).

6. 2. The dilator (3) according to claim 1, wherein the braided threads (310, 311) are formed by wires or stripes and / or the braided threads (310, 311) and / or the at least one longitudinal wire (37) are made of a metal, a metal alloy or a polymer, preferably the braided threads (310, 311) are made of stainless steel or a nickel-titanium alloy and / or the at least one longitudinal wire (37) is made of stainless steel or a nickel-titanium alloy.

7. 2. The dilator (3) of claim 1, wherein the dilator shaft (33) comprises a matrix material (39) in which the braid (31) is embedded, preferably the matrix material (39) being a polymeric material.

8. The dilator (3) of claim 1, wherein the dilator shaft (33) comprises an internal dilator lumen (38) extending longitudinally along the dilator shaft (33), and preferably the internal dilator lumen (38) is radially disposed within the braid (31).

9. The dilator (3) of claim 1, wherein the dilator shaft (33) comprises a plurality of pairs of longitudinal wires (37) extending longitudinally along the dilator shaft (33), preferably extending from the distal dilator shaft end to the proximal dilator shaft end, and the pairs of longitudinal wires (37) are interwoven with the first group of braided threads (310) and the second group of braided threads (311).

10. The dilator (3) of claim 9, wherein the dilator shaft (33) has at least one non-braided section that does not include any braided threads.

11. A dilator (3) for intravascular treatment of a lesion in a patient's body, the dilator (3) comprising a dilator shaft (33) having a distal dilator shaft end and a proximal dilator shaft end and extending along a longitudinal axis (L), the dilator shaft (33) having at least one braided section (31) in which braided threads (310, 311) braided to form a braid (31) are arranged, a first group of braided threads (310) and a second group of braided threads (311) braided to each other and arranged to cross each other at a certain angle (α, β, γ) therebetween, and at least one non-braided section not including any braided threads, the angle varying between the distal dilator shaft end and the proximal dilator shaft end.

12. 12. The dilator (3) of claim 11, wherein at the distal dilator shaft end, the first group of braided threads (310) and the second group of braided threads (311) are arranged to cross each other at a first angle (α) therebetween, and at the proximal dilator shaft end, the first group of braided threads (310) and the second group of braided threads (311) are arranged to cross each other at a second angle (β) therebetween, and the first angle (α) is greater than the second angle (β).

13. The dilator (3) of claim 11, wherein the dilator shaft (33) comprises at least one first section (330) having a first axial length (L1) and at least one second section (331) having a second axial length (L2), and in the first section (330), the braided threads (310) of the first group and the braided threads (311) of the second group are arranged to cross each other at the first angle (α) therebetween, and in the second section (331), the braided threads (310) of the first group and the braided threads (311) of the second group are arranged to cross each other at the second angle (β) therebetween.

14. 14. The dilator (3) according to claim 13, wherein the second section (331) is adjacent to the first section (330) when viewed along the longitudinal axis (L).

15. The dilator (3) of claim 13, wherein the dilator shaft (33) has a third section (332) having a third axial length (L3), and in the third section (332), the braided threads (310) of the first group and the braided threads (311) of the second group are arranged to cross each other at a third angle (γ) therebetween, and the third angle (γ) is different from the first angle (α) and the second angle (β).

16. An expander (3) as described in claim 11, wherein the expander shaft (33) further comprises at least one longitudinal wire (37) extending longitudinally along the expander shaft (33), preferably extending from the distal expander shaft end to the proximal expander shaft end.

17. 13. The dilator (3) according to claim 12, wherein the braided threads (310, 311) are formed by wires or stripes and / or the braided threads (310, 311) and / or the at least one longitudinal wire (37) are made of a metal, a metal alloy or a polymer, preferably the braided threads (310, 311) are made of stainless steel or a nickel-titanium alloy and / or the at least one longitudinal wire (37) is made of stainless steel or a nickel-titanium alloy.

18. 13. The dilator (3) of claim 12, wherein the dilator shaft (33) comprises a matrix material (39) in which the braid (31) is embedded, preferably the matrix material (39) being a polymeric material.

19. The dilator (3) of claim 12, wherein the dilator shaft (33) comprises an internal dilator lumen (38) extending longitudinally along the dilator shaft (33), preferably the internal dilator lumen (38) being radially disposed within the braid (31).

20. 12. A multipurpose catheter system comprising a support catheter (2) and at least one, preferably one, support catheter lumen (26), wherein the support catheter (2) is configured to accommodate at least two internal members simultaneously or sequentially within the at least one support catheter lumen (26), one of the at least two internal members being a dilator (3) according to claim 1 or 11, and one of the at least two internal members being a guidewire or a balloon catheter, preferably a percutaneous transluminal angioplasty balloon catheter or a percutaneous coronary angioplasty balloon catheter.