Dilator tip design for enhanced force transfer

Abstract

A dilator comprises a shaft (110, 210) and a reinforcing element (120, 220), the reinforcing element (120, 220) comprising a generally cylindrical surface. The reinforcing element (120, 220) is connected to a distal end of the shaft (110, 210).

Description

Technical Field

[0001] The invention relates to a stent having a reinforcing element and to a method for producing such a stent. Background Art

[0002] Catheters have been used in a variety of ways to examine or treat blood vessels. Atherosclerosis is a vascular disease that manifests itself as an accumulation of degenerative material along the walls of blood vessels. Affected vessels can develop plaques / lesions, which can result in a progressive decrease in the diameter of the vessel lumen, thereby restricting blood flow. Chronic plaque accumulation (i.e., composed of a mixture of fatty, fibrous, and / or calcified tissue material) can lead to chronic total occlusions (CTOs).

[0003] However, catheters do not always provide optimal functionality for treating atherosclerosis. It would be desirable to provide an improved method for treating stenosis or lesions caused by atherosclerotic disease. Therefore, it would be desirable to improve known catheters for treating stenosis or lesions. Summary of the invention

[0004] Various aspects described herein satisfy this need.

[0005] According to a first aspect, a (medical) dilator (also called dilation catheter, dilator catheter or vascular dilator) for insertion into a blood vessel or the cardiovascular system is disclosed.

[0006] The expander has an expander shaft, a reinforcing element connected to the distal end of the expander shaft, and a connecting element. Thus, the reinforcing element contacts the distal end of the expander shaft and the connecting element. The connecting element at least partially surrounds the expander shaft and / or the reinforcing element. Preferably, the expander shaft is a braided expander shaft (i.e., an expander shaft comprising a reinforcing braid, for example, made of a polymer, metal, and / or a metal alloy).

[0007] Thus, for example, when the dilator shaft is moved towards a stenosis (e.g., a CTO), the reinforcing element may come into contact with the stenosis. Due to the increased resistance provided by the reinforcing element compared to the dilator shaft itself (e.g., a reduced tendency to bend, break and / or kink), higher forces may be transmitted to the stenosis by movement of the dilator shaft. The inventors have found that a particularly beneficial design is provided, in particular by separating the functionality between the dilator shaft and the reinforcing element. The reinforcing element provided selectively reinforces the distal end of the dilator shaft. Thus, the risk of force transmission to the reinforcing element and kinking is reduced (e.g., if there are asymmetric forces applied to the reinforcing element, e.g., by an asymmetric stenosis surface). In particular, direct force transmission from the dilator shaft to the reinforcing element and the stenosis may thereby be facilitated.

[0008] The reinforcing element may include a proximal portion and a distal portion located distal to the proximal portion. The proximal portion may have a (roughly) cylindrical shape. The (roughly) cylindrical proximal portion forms an outer proximal side and an inner proximal side. The proximal portion includes at least one notch, recess or through hole, preferably including several (i.e., two, three or more than three) through holes. The distal portion may taper distally. Preferably, the reinforcing element includes a cylindrical proximal portion and a conical distal portion located distal to the cylindrical proximal portion. The distal portion has an outer diameter (e.g., 0.9 to 1.3 mm). The outer diameter of the distal portion at its proximal end may be greater than the outer diameter of the (cylindrical) proximal portion. The outer diameter of the distal portion may taper distally. For example, at the distal end of the distal portion, its outer diameter may be similar to or greater than the outer diameter of the (roughly) cylindrical outer side. In one embodiment, the reinforcing element may have a distal opening and / or a cavity passing through its proximal and / or distal regions. In this case, a guide wire or another medical device may pass through the lumen. In another embodiment, the proximal portion and / or distal portion of the reinforcing element do not include a lumen and / or are solid. In this case, the reinforcing element can be used to dot into the stenosis. The distal end of the distal portion of the reinforcing element can be rounded and / or blunt. The distal end of the distal portion of the reinforcing element can form the farthest end of the dilator.

[0009] For example, the expander shaft and the reinforcement element may comprise different materials and / or may be manufactured separately and subsequently connected. This also allows complete design flexibility in terms of material selection and manufacturing methods for the individual components. For example, the reinforcement element may comprise a material with a higher hardness than the material (or any material) comprised by the expander shaft. With the aid of (roughly) cylindrical and / or conical metal or metal alloy reinforcement elements, a particularly strong connection may be feasible.

[0010] The expander according to the first aspect also allows,

[0011] The dilator can be used within a catheter system. For example, the dilator can be used with a multifunctional catheter system, preferably with a peripheral multifunctional catheter system.

[0012] The multifunctional catheter system comprises a retractable sheath which can accommodate successively different internal components, such as a dilator, a guidewire and / or a balloon catheter (e.g. a PTA or PTCA catheter). Therefore, a (peripheral) multifunctional catheter system is also disclosed, comprising a retractable sheath, preferably a support catheter, which is capable of successively accommodating more than one internal component, wherein the multifunctional catheter system also comprises a dilator according to the present invention as one of the internal components.

[0013] The peripheral multifunctional catheter system can be an intravascular balloon catheter system, which is provided with a retractable sheath (e.g., a support catheter), a flexible catheter (e.g., a dilator), and a percutaneous transluminal angioplasty balloon (PTA balloon). The support catheter and the dilator are used in series to facilitate lesion entry and lesion penetration. The peripheral multifunctional catheter system allows variable guidewire support and fluid injection, as well as an expandable balloon of adjustable length (e.g., up to 180 mm).

[0014] This multifunctional catheter system enables the guidance and support of a guidewire during access and passage through a lesion in the vasculature. It also allows for wire exchange and provides a catheter for delivery of saline solution or diagnostic contrast agents to facilitate wire passage.

[0015] Therefore, the present invention also discloses a catheter system, preferably a multifunctional catheter system, comprising a dilator as above. The catheter system may also include a support catheter. The support catheter has a support catheter shaft, which defines a support catheter lumen capable of receiving the dilator and an optional globe balloon catheter. The support catheter may have a metal ring at its distal portion. The metal ring may be spaced apart from the distal end of the support catheter. The dilator shaft may be reinforced, for example, with a metal braid. The support catheter shaft may be reinforced with a metal braid or a metal braid with staggered longitudinal wire pairs.

[0016] Also described herein is the use of such a catheter system for crossing a stenosis or chronic total occlusion.

[0017] Also described herein is the use of such a catheter system as a traversing catheter.

[0018] Further described herein is a method of treating a stenosis or chronic total occlusion using a dilator and / or catheter system as described above.

[0019] It should be noted that the first aspect may not only be helpful for treating stenosis, but may also be helpful for various further intravascular applications. The design according to the first aspect may be combined with any dilator technology, for example where the tip needs to be durable while transferring longitudinal forces. The distal dilator tip preferably comprises a polymer portion and a metal portion.

[0020] For example, the reinforcing element may extend at least partially distally relative to the distal end of the dilator shaft. The reinforcing element may be adapted to form the most distal portion of the dilator. Thus, the reinforcing element may be particularly present distally at the dilator, where the strongest forces typically occur.

[0021] The dilator may further comprise a connecting element which at least partially surrounds the dilator shaft and / or the reinforcing element. The connecting element may be adapted to connect the dilator shaft and the reinforcing element to each other. For example, the connecting element may form an atraumatic tip of the dilator. For example, the connecting element may comprise a material which is softer and / or more flexible than the material of the dilator shaft and / or the reinforcing element. Thus, when contacting a vessel wall, for example, the risk of penetration or stripping may be reduced.

[0022] In some examples, the shaft can be adapted to be relatively flexible in its distal-most portion (compared to a more proximal portion of the dilator shaft), for example, to allow manipulation of the distal tip away from the vessel wall.

[0023] The reinforcing element may extend distally at least partially relative to the distal end of the connecting element. Thus, the reinforcing element may form a reinforcing tip at the distal dilator end, for example, to support the treatment of stenosis, while the tip may be followed proximally by relatively soft material of the connecting element. Additionally or alternatively, the connecting element may have an extension to achieve a larger outer diameter than the outer diameter (or any diameter) of the reinforcing element. Thus, the fine reinforcing tip may be surrounded distally and / or radially by relatively soft material, thereby reducing the risk of damaging the vessel wall. The dilator may have an atraumatic tip (e.g., provided by the connecting element) having local reinforced strength (e.g., provided by the reinforcing element).

[0024] An exemplary longitudinal extension from the most distal portion of the reinforcing element to the most proximal portion of the connecting element is in the range of 1.0 mm to 20.0 mm, 2.0 mm to 10.0 mm, for example 6.0 mm to 7.0 mm. A relatively long extension may be beneficial in some respects, for example, for passing through an elongated lesion. However, a disadvantage is that a long extension will reduce operability and may be more traumatic and / or result in increased friction. In this respect, the specified value may represent an optimal compromise.

[0025] The portion of the reinforcing element that extends distally relative to the distal end of the connecting element may also be referred to as the distal portion of the reinforcing element.

[0026] In some examples, the reinforcing element may have a longitudinal extension of 0.1 to 5.0 mm, or 0.5 to 3.0 mm. For example, the distal portion of the reinforcing element may have a length (longitudinal extension) of 1.0 mm to 2.0 mm, such as 1.5 mm, and the proximal portion of the reinforcing element may have a length (longitudinal extension) of 1.0 mm to 2.0 mm, such as 1.5 mm.

[0027] For example, the distal portion of the reinforcement element can support anchoring of an atraumatic tip (eg, at a stenosis such as a CTO).

[0028] The connecting element may include a polymer. Polymer materials may be particularly suitable for providing a relatively soft connecting element that is durable, biocompatible and wear-resistant at the same time. In addition, polymer materials may allow for efficient manufacturing methods, such as injection molding. In some examples, the connecting element is injection molded.

[0029] The reinforcing element may include at least one notch, recess or through hole. For example, the (substantially) cylindrical proximal portion of the reinforcing element, such as the inner side and / or outer side of the reinforcing element, may include at least one notch. In some examples, at least one notch may include at least one through hole. In other examples, at least one notch may include at least one partial notch, such as a hole that only partially extends into the outer side of the reinforcing element, such as not penetrating the reinforcing element.

[0030] The connecting element may at least partially extend into at least one notch, recess or through hole of the reinforcing element. For example, at least one notch, for example at the (roughly) cylindrical proximal portion of the reinforcing element may be at least partially filled by the connecting element. This may ensure a particularly tight connection between the connecting element and the reinforcing element. In particular, this may provide a tight connection despite longitudinal forces acting on the connecting element and / or the reinforcing element.

[0031] Note that, additionally or alternatively, the expander shaft may comprise at least one recess, for example, in the (substantially) cylindrical outer side of the expander shaft. The at least one recess may be designed as described with reference to the at least one recess of the reinforcing element. The connecting element may extend at least partially into the at least one recess of the expander shaft, for example in order to make the connection between the connecting element and the expander shaft particularly strong.

[0032] The connecting element may be tapered in the distal and / or proximal direction. This may ensure a particularly tight connection between the connecting element and the dilator shaft and / or the reinforcing element, for example, because the thickness of the connecting element and thus the stability may be increased at the proximal end of the reinforcing element. At the same time, in particular, the distal tapering may improve the maneuverability of the dilator within the vessel.

[0033] For example, the distal and / or proximal portions of the connecting element may form a wedge shape having an angle between 3° and 30° or between 5° and 25° when viewed in longitudinal cross-section.

[0034] The connecting element may extend at least partially around the outer diameter of the expander shaft and, for example, the outer diameter of the reinforcing element (e.g., the (substantially) cylindrical outer side of the reinforcing element), in particular so as to form a step. For example, at the step, the inner diameter of the connecting element may change so that a transition zone is provided between a portion with a relatively larger inner diameter and a portion with a relatively smaller inner diameter. Thus, the expander shaft and / or the reinforcing element, for example, its (substantially) cylindrical proximal portion or outer side, may be provided with an additional anchor at the transition zone. For example, when the portion with a relatively larger inner diameter is arranged distally and the portion with a relatively smaller inner diameter is arranged proximally, the transition zone may provide additional support against relative longitudinal movement of the expander shaft and / or the reinforcing element relative to the connecting element.

[0035] The (substantially) cylindrical proximal portion of the reinforcing element, such as the (substantially) cylindrical inner side of the reinforcing element, can, for example, extend at least partially around the outer diameter of the expander shaft. For example, the (substantially) cylindrical proximal portion of the reinforcing element is at least partially glued, injection molded or otherwise connected to the outer surface of the shaft. In some examples, a connecting element can connect the (substantially) cylindrical proximal portion of the reinforcing element to the expander shaft.

[0036] If the (substantially) cylindrical proximal portion of the reinforcing element extends at least partially around the outer diameter of the dilator shaft, the lumen of the dilator shaft may be at least partially unaffected by the additional reinforcing element. For example, a guidewire may be moved within the lumen without being blocked by the reinforcing element. Furthermore, a low profile dilator may be provided which may be easily manufactured, for example by injection molding of the connecting element around the dilator shaft and the reinforcing element.

[0037] In some examples, the (substantially) cylindrical proximal portion of the reinforcing element extends at least partially along the inner diameter of the expander shaft. For example, the (substantially) cylindrical proximal portion of the reinforcing element, e.g., forming a (substantially) cylindrical outer side, can be glued or otherwise connected to the inner surface of the expander shaft. Also in these examples, injection molding of the connecting element around the expander shaft and the reinforcing element can be used.

[0038] The dilator shaft may include a distal region having an inner diameter that is the same as the inner diameter of the reinforcing element and a proximal region having an inner diameter that is the same as the inner diameter of the reinforcing element. This may allow for added functionality at the distal region, allowing more room to accommodate potential functionality.

[0039] The reinforcing element (e.g., which is generally cylindrical on the outer side) can terminate at or be adjacent to the transition zone (e.g., shoulder) between the distal region and the proximal region of the dilator shaft. Thus, the reinforcing element can be additionally anchored and the relative movement of the reinforcing element and the dilator shaft in the longitudinal direction can be particularly suppressed. For example, the dilator shaft can include, for example, in the transition zone, a portion that extends at least partially radially, which can absorb longitudinal forces (similar to what is described herein with reference to the steps of the connecting element). Thus, the direct force transmission from the dilator shaft to the reinforcing element and then to the stenosis can be further improved.

[0040] The connecting element may extend at least partially around the distal region and the proximal region of the dilator shaft so as to form a step. Thus, the step may further strengthen the anchoring of the dilator shaft, the reinforcing element and the connecting element, particularly in the longitudinal direction. The connecting element may have an olive shape. The olive shape means that the middle portion of the connecting element has a larger outer diameter and / or circumference than the distal portion and the proximal portion of the connecting element. The olive shape can be mathematically viewed as an ellipsoid (with the long sides oriented along the longitudinal dilator axis). The olive shape enables the injected contrast agent to be evenly dispersed over the lesion. Due to the improved fluid flow around the dilator tip, the olive shape also enables low volume contrast agent injection (aspiration) for optimal visualization.

[0041] The connecting element may have an outer diameter at its middle portion of 0.5 mm to 3.0 mm, for example 1.0 mm to 2.0 mm.

[0042] The reinforcing element may comprise or consist of a metal or a metal alloy. Thus, a particularly strong reinforcement may be provided. The metal or metal alloy reinforcing element increases the durability, visibility of the expander and withstands loads without deformation during clinical use.

[0043] For example, stainless steel, titanium and / or other biocompatible metals or metal alloys may be used. In addition, suitable alloys such as Nitinol, etc. may be used. The dilator shaft may, for example, include polyamide (eg, PA 12) or polyether-block-amide.

[0044] In other examples, the reinforcing element may include a polymer and / or a ceramic material. For example, the reinforcing element may include a polymer having a higher hardness, stiffness, and / or bending resistance than the material of the connecting element (e.g., the polymer of the connecting element) and / or the dilator shaft (e.g., the polymer of the dilator shaft).

[0045] The reinforcing element may include a distal opening. Thus, there may be functional communication between the exterior of the expander and the interior of the expander via the reinforcing element. For example, a guidewire may extend from the lumen of the expander to an area away from the expander. This may allow for specific compatibility with expanders that require the mentioned functional communication.

[0046] For example, the dilator (eg, the dilator shaft) may include a lumen for receiving a guidewire such that the guidewire may be moved distally through the lumen such that the guidewire extends out of the distal end of the dilator.

[0047] For example, the diameter of the distal opening may be smaller than the inner diameter of the (substantially) cylindrical outer surface. Thus, the reinforcing element may comprise a portion extending at least partially radially (e.g., extending from a relatively narrow opening to a relatively wide (substantially) cylindrical outer surface), which may improve force transmission in the longitudinal direction.

[0048] In other examples, for example, the distal opening may comprise a diameter substantially given by the inner diameter of the (substantially) cylindrical outer surface. For example, the reinforcing element may comprise a shape similar to an open cylinder at its distal side. This may facilitate anchoring, since, for example, the relatively narrow cylindrical wall may cut into a possible stenosis, thereby facilitating its removal.

[0049] In some examples, the reinforcing element includes a tapered distal end. This can increase maneuverability when moving through vessels and / or stenosis. The reinforcing element can also improve anchoring. For example, an opening can be provided at the distal end.

[0050] In some examples, the distal opening may be arranged in a tapered region of the reinforcing element, which tapered region may be arranged distally of the reinforcing element. The tapered region may be followed by, for example, a (substantially) cylindrical element on the proximal side. For example, the reinforcing element may thus have a (substantially) cylindrical inner side, which has, for example, a constant inner diameter. The (substantially) cylindrical element may also include a (substantially) cylindrical outer side, for example, with a constant outer diameter.

[0051] It should be noted that the dilator may also be adapted so that the reinforcing element does not comprise a distal opening, for example the reinforcing element may comprise a closed distal surface. In particular in this case, the dilator may be provided without a lumen and / or a guidewire function.

[0052] With respect to the term generally cylindrical proximal portion (e.g., surface) of a reinforcing element as outlined herein, it should be noted that reinforcing elements include not only cylindrical surfaces, but also, for example: a cylindrical surface with one or more openings, a surface that follows a generally cylindrical shape but includes local variations (e.g., a generally circular cross-section may be accommodated by small, e.g., sinusoidal, fluctuations, or a generally circular cross-section may be approximated by a polygon, etc.). It should be noted that an element described herein as having a generally cylindrical proximal portion may include a generally cylindrical inner surface and / or a generally cylindrical outer surface.

[0053] A method for manufacturing a dilator may include providing a dilator shaft and a reinforcing element having a (substantially) cylindrical proximal portion. The method may further include connecting the reinforcing element to a distal end of the dilator shaft.

[0054] In some examples, the method may include the step of injection molding the connecting element such that the connecting element at least partially surrounds the dilator shaft and / or the reinforcing element. This may allow for a particularly efficient method for manufacturing the dilators herein.

[0055] It should be noted that whenever it is mentioned in this document that A “comprises” B, it should be understood that the option of A (substantially) consisting of B is also included.

[0056] Furthermore, it should be noted that all steps described herein with respect to the method should be understood to also disclose the properties implied by the corresponding dilator and method. Similarly, all aspects described herein with respect to the dilator are understood to also include the corresponding method steps. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] Hereinafter, detailed exemplary embodiments will be described with reference to the following drawings, in which

[0058] Figure 1 A longitudinal cross-section of an exemplary dilator is shown;

[0059] Figure 2 shows a longitudinal cross-section of another exemplary dilator;

[0060] Figure 3A , 3B , 3C shows an exemplary reinforcement element;

[0061] Figure 4A , 4B Additional exemplary dilators are shown;

[0062] Figure 5 Aspects relating to the manufacture of an exemplary dilator are shown;

[0063] Figure 6 Another aspect regarding the manufacture of an exemplary dilator is shown;

[0064] Fig. 7A , 7B Another aspect regarding the manufacture of an exemplary dilator is shown;

[0065] Figure 8 Another aspect regarding the manufacture of an exemplary dilator is shown;

[0066] Fig. 9 Another aspect regarding the manufacture of an exemplary dilator is shown;

[0067] Fig.10 Another aspect of the manufacture of an exemplary dilator is shown.

[0068] Fig.11 An embodiment of a catheter system is shown,

[0069] Fig.12 An embodiment of a support conduit is shown,

[0070] Fig.13 An embodiment of a dilator is shown. DETAILED DESCRIPTION

[0071] Although not explicitly stated in all cases, the elements described below may generally include features as described above with respect to similarly designated elements, and vice versa. In addition, not every aspect is repeated with reference to every figure. Therefore, unless explicitly stated to the contrary, the embodiments summarized below may include features described with reference to other embodiments or more generally above.

[0072] Figure 1 A longitudinal cross-section of an exemplary dilator 100 is shown, which may include a dilator shaft 110 , a reinforcing element 120 , and a connecting element 130 .

[0073] The expander shaft 110 has a (substantially) cylindrical shape, in particular an elongated cylindrical shape, such as a tubular shape. In some examples, the expander shaft 110 may include a reinforcing material. For example, the expander shaft 110 may include a braided material, such as a braided metal. In some examples, the expander shaft 110 may be fiber-reinforced.

[0074] The reinforcing element 120 may include a (substantially) cylindrical element 121, which forms a (substantially) cylindrical surface in the form of an inner side and an outer side of the reinforcing element 120. The cylindrical element 121 may include a constant inner diameter and an outer diameter. In other examples, a variable inner diameter and / or outer diameter may be used. The reinforcing element 120 may also include a closed distal side 122. The thickness of the closed distal side 122 may be the same or substantially similar to the thickness of the (substantially) cylindrical element 121. The reinforcing element 120 may include a (substantially) cylindrical cap-like shape. As Figure 1As shown, the distal end of the dilator shaft 110 can contact the inner side of the closed distal side 122.

[0075] The (substantially) cylindrical element 121 may include an inner diameter so as to fit onto the outer diameter of the dilator shaft 110 at the distal portion of the dilator shaft 110. The (substantially) cylindrical element 121 may, for example, be clipped onto the outer diameter of the dilator shaft 110, the cylindrical element may be shrink fit, pressed onto the outer diameter of the dilator shaft 110 and / or connected via an adhesive or the like.

[0076] In some examples, distal side 122 may include a (central) opening ( Figure 1 100) to provide fluid communication between the lumen of the dilator shaft 110 and the exterior of the dilator 100. For example, a guide wire guided inside the (reinforced) dilator shaft 110 may then be used.

[0077] The connecting element 130 may extend around the proximal portion of the (substantially) cylindrical element 121 (or: its (substantially) cylindrical outer side). The distal portion 125 of the (substantially) cylindrical element 121 may be free of the connecting element 130. The connecting element 130 may include a variable outer diameter. For example, the outer diameter may decrease, for example in a symmetrical manner, towards the distal end (e.g., in the distal tapered portion) and the proximal end (e.g., in the proximal tapered portion) of the connecting element 130. The outer diameter may include a maximum value at a central portion of the connecting element 130. The connecting element may include a polymeric material or consist essentially of a polymeric material, for example injection molded on the reinforcing element 120 and the dilator shaft 110.

[0078] The connecting element 130 can extend along the outer diameter of the dilator shaft 110 and the reinforcing element 120. At the proximal end of the reinforcing element 120, the connecting element 130 can form a step 131.

[0079] The longitudinal extension of the reinforcing element 120 (or the (substantially) cylindrical element 121 or the inner and / or outer side thereof) may comprise a value of 1-10 times the inner radius of the dilator shaft 110, such as 2-8 times or 3-6 times.

[0080] The longitudinal extension of the connecting element 130 may comprise a value of 1-10 times, for example 1.5-8 times, or 2-5 times, the longitudinal extension of the (roughly) cylindrical element 121 (or its inner and / or outer sides). For example, the longitudinal extension of the distal tapered portion of the connecting element 130 may be about 0.5-5 times, for example 0.7+3 times, or 0.8-2 times, the longitudinal extension of the (roughly) cylindrical element 121 (and / or its inner and / or outer sides). The same dimensions may apply to the proximal tapered portion of the connecting element 130.

[0081] Despite Figure 1 As shown in FIG. 1 , the dilator shaft 110 does not necessarily include a lumen.

[0082] Figure 2 Another example of a dilator 200 including a dilator shaft 210, a stiffening element 220, and a connecting element 130 is shown.

[0083] The dilator shaft 210 may be (generally) similar to that described with reference to the dilator shaft 110. However, the dilator shaft 210 includes a distal region 211 having a relatively larger diameter and a proximal region 212 having a relatively smaller diameter. A transition region 213 (e.g., a shoulder) is provided between the distal region 211 and the proximal region 212.

[0084] The reinforcing element 220 consists essentially of a (substantially) cylindrical element 221, which provides a (substantially) cylindrical inner side and a (substantially) cylindrical outer side of the reinforcing element 220. The reinforcing element 220 comprises an opening 226, the inner diameter of which is substantially the same as the inner diameter of the (substantially) cylindrical element 221. In other examples, an opening with a smaller diameter may be provided or even no opening may be provided. The reinforcing element 120 may comprise a (substantially) annular shape.

[0085] The outer diameter of the cylindrical element 221 or its (substantially) cylindrical face or outer side abuts the inner diameter of the distal region 211. The distal region 211 may snap onto the cylindrical element 221, for example, the distal region 2011 may be shrink fit and / or attached by adhesive. The cylindrical element 221 extends distally from the distal end of the dilator shaft 110. For example, the distal extension may have a value in the range of 0.5-5 times or 1-3 times the inner radius of the cylindrical outer side 221.

[0086] The connecting element 230 may (approximately) comprise a longitudinal extension and an outer diameter, which may be the same as described with reference to the connecting element 130. The connecting element 230 may be injection molded around the dilator shaft 110 and the reinforcing element 120. Thus, the connecting element inner diameter may follow the contours of the dilator shaft 110 and the reinforcing element 120. Thus, the connecting element 230 may comprise a step 231 at the transition zone 213. Furthermore, the connecting element may comprise a step 232 at the distal end of the distal portion 211 of the dilator shaft 210. The reinforcing element 220 comprises a distal portion 225, where the connecting element 230 does not extend.

[0087] The longitudinal extension of the reinforcing element 210 (or the cylindrical element 221 or its cylindrical (inner or outer) face) may comprise the same value relative to the inner diameter of the proximal portion 212 of the dilator shaft 210 as outlined with reference to the reinforcing element 110 (or the cylindrical element 121) and the inner diameter of the dilator shaft 110. The longitudinal extension of the connecting element 230 may comprise the same value relative to the longitudinal extension of the reinforcing element 220 (or the cylindrical element 221), as outlined with reference to the longitudinal extension of the connecting element 130 relative to the reinforcing element 120 (or the (substantially) cylindrical element 121).

[0088] The longitudinal extension of the distal portion 211 of the dilator shaft 210 may comprise a value of 0.2-1, 0.2-0.9, or 0.3-0.8 of the longitudinal extension of the reinforcing element 220 (or cylindrical element 221 (or the inner and / or outer sides thereof)).

[0089] Figure 3A An exemplary reinforcing element 320 is shown. The reinforcing element 320 comprises a proximal portion 321 and a distal portion 329 located distal to the proximal portion 321. The proximal portion 321 has a (roughly) cylindrical shape. The (roughly) cylindrical proximal portion forms an outer proximal side and an inner proximal side. The proximal portion 321 comprises a plurality of through holes 323. The distal portion 329 is a conical distal portion 329, preferably, the distal portion tapers distally. The distal portion has an outer diameter. The outer diameter of the distal portion 329 at its proximal end may be greater than the outer diameter of the (cylindrical) proximal portion 321. The outer diameter of the distal portion 329 may taper distally. For example, at the distal end of the distal portion 329, its outer diameter may be similar to or slightly greater than the outer diameter of the (roughly) cylindrical outer side.

[0090] The distal portion 329 may include an opening 326. The inner diameter of the opening 326 may be the same as the inner diameter of the (substantially) cylindrical proximal portion 321. For example, the reinforcing element 320 may thus include a constant inner diameter (a lumen having a constant inner diameter). The distal end of the distal portion 329 may be rounded (and thus blunt).

[0091] For example, the reinforcing element 320 may be formed by a process similar to that described in reference Figure 1 and Figure 2 The described connecting element is attached to the dilator shaft. Such a connecting element may, for example, extend into the opening 323 and abut (substantially) the proximal portion 321. Such a connecting element may, for example, extend distally from the proximal direction and stop at the proximal end of the distal portion 329. The reinforcing element is made of metal or a metal alloy.

[0092] Figure 3B and Figure 3C Shows Figure 3A329, which is connected to the connecting element 330 and the dilator shaft 310. Here it can be seen that the distal portion 329 of the reinforcing element has an undercut 340 at its proximal end, which in addition to the through hole also provides an anchor point for the connecting element 330.

[0093] The longitudinal extension from the most distal portion of the reinforcing element to the most proximal portion of the connecting element is in the range of 6.0 mm to 7.0 mm. The reinforcing element may have a longitudinal extension of 2.5 to 3.5 mm. For example, the distal portion of the reinforcing element may have a length (longitudinal extension) of 1.0 mm to 2.0 mm and an outer diameter of 0.9 mm to 1.3 mm, and the proximal portion of the reinforcing element may have a length (longitudinal extension) of 1.0 mm to 2.0 mm and an outer diameter smaller than the distal portion.

[0094] The connecting element has an outer diameter of 1.0 mm to 2.0 mm at its middle portion, which is larger than the outer diameters of its distal portion and its proximal portion. The connecting element has an inner diameter of 0.4 to 0.6 mm. The dilator shaft has an inner diameter that is the same as the inner diameter of the reinforcing element.

[0095] exist Figure 3B In the figure, the injection point of the injection molding process of the connecting element can be seen, and Figure 3C The connecting element 330 in FIG. 3 has no injection points (eg, because the polymer is connected to the reinforcing element 320 in another manner other than by injection molding).

[0096] Figure 4A and 4B Two examples of expanders 400A and 400B are shown. Expanders 400A and 400B each include expander shafts 410A, 410B, reinforcing elements 420A, 420B, and connecting elements 430A, 430B, respectively. Reinforcing elements 420A and 420B each include distal portions 425A and 425B, respectively, and connecting elements 430A and 430B do not extend in distal portions 425A and 425B, respectively. The expander shafts 410A and 410B of expanders 400A and 400B can be braided.

[0097] The reinforcement element 420B of the expander 400B includes a recess 427B into which the connecting element 430B extends.

[0098] The reinforcement element 420A / 420B is preferably the reinforcement element shown in FIG. 3 and is made of metal or a metal alloy.

[0099] The connecting element 430A / 430B preferably has an olive shape. The olive shape enables the injected contrast agent to be evenly dispersed on the lesion. The connecting element is made of a polymer. The middle part of the olive shape has a smaller diameter than the distal support catheter end.

[0100] The expander can be used with Fig.11 The invention relates to a (multifunctional) catheter system for use with / arranged within the (multifunctional) catheter system described in . By pulling the dilator (in the proximal direction), the user has a tactile feeling once the dilator enters the supporting catheter due to the olive shape. This can eliminate the need to perform this pulling step under X-ray (which means less radiation for the patient).

[0101] Figure 5 A cross-sectional view of the upper half of the expander 500 including the expander shaft 510 and the reinforcing element 520 is shown. The reinforcing element 520 may include metal and / or may be manufactured by machining (such as turning). The reinforcing element 520 may include a shape similar to the shape outlined with reference to the reinforcing element 320 shown in Figure 3. The reinforcing element 520 may, for example, include a (substantially) cylindrical (outer) face 521 forming a proximal portion of the reinforcing element 520. The reinforcing element 520 may also include a distal portion 529 that tapers distally and a proximally tapered intermediate portion 528. By machining, such as turning, the reinforcing element 520 may be manufactured in a dimensionally accurate and low-cost manner.

[0102] There may be no connecting elements in the expander 500. Instead, the distal tip of the expander 500 may be formed completely in one piece, for example, based on a metal material (e.g., by machining, such as turning a metal workpiece). However, in other examples, the distal tip of the expander 500 and / or the reinforcing element 520 may also include other materials, such as ceramics or polymers.

[0103] The dilator shaft 510 may, for example, comprise a braided material as described herein.

[0104] The dilator shaft 510 can include a proximal portion 512 and a distal portion 511, wherein the proximal portion 512 includes a constant but smaller diameter and the distal portion 511 includes a constant but larger diameter. Between the proximal portion 512 and the distal portion 511, a transition zone 513 can be located.

[0105] The outer side of the reinforcing element 520, more specifically the (substantially) cylindrical outer surface 511, may be attached to the inner side of the distal portion 511, for example by clamping, heat shrinking and / or adhesive. The (substantially) cylindrical outer surface 521 may terminate or abut at a transition zone 513.

[0106] The reinforcement element 520 can be at least partially radiopaque.The distal tip of the reinforcement element 520 can be rounded to support an atraumatic tip design and to prevent damage to the guidewire, for example, when inserting a dilator over the guidewire.

[0107] Figure 6 The manufacture of another example expander 600 is shown in a cross-sectional view of the upper half of the expander 600. A expander shaft 610 is provided, which can be modified as outlined herein, such as braided. A radiopaque (e.g., metallic) sleeve is placed on the expander shaft 610 to form a reinforcing element 620. A connecting element 630 is provided, such as by using a polymer covering, as described herein. The connecting element 630 can secure the sleeve to the expander shaft 610. The connecting element 630 can be provided, for example, by injection molding or welding a portion of a pipe.

[0108] The geometry of the distal end of the dilator 600 can then be formed by the mold 601, for example, to form a suitable counterpart. Among them, the connecting element 630 can help to form a rounded edge to form an atraumatic tip. By using the mold 601, dimensional accuracy, consistent shape on many samples and low cost can be achieved.

[0109] 7 shows in cross-sectional view the manufacture of another example of a dilator 700. In step 700A, a dilator shaft 710 is provided having a proximal portion 711 and a distal portion 712. By using a shaping element 701, the distal portion 712 is widened, for example, to form a distal tapered portion 714 (disposed distally) and a proximal tapered portion 713 (disposed proximally).

[0110] Once the shaping element is removed, in step 700B, a reinforcing element 720 is inserted into the expander shaft 710 so that the reinforcing element 720 includes a distal portion 725. The shaft 710 may not extend over the distal portion 725. The reinforcing element 720 may include metal. The reinforcing element 720 may be manufactured by turning. However, in other examples, the reinforcing element 720 may also include other materials, such as ceramics or polymers. The connection between the reinforcing element 720 and the expander shaft 710 may be provided, for example, by shrink fitting the expander shaft 710 onto the reinforcing element 720 and / or by heating the expander shaft 710.

[0111] Figure 8 Another aspect of making a dilator 800 as described herein is shown. Figure 8Specifically shown is a longitudinal cross section of the upper half of the expander 800. A expander shaft 810 may be provided. A reinforcing element 820 may be at least partially disposed on the outer diameter of the expander shaft 810. The reinforcing element 820 may be provided by molding or injection molding. The connecting element 801 may then be provided, for example, by molding or injection molding. Similarly as described with reference to Figure 6 As described above, a die, such as an end forming device, can be used to thermally form the desired end shape.

[0112] Fig. 9 Another aspect of manufacturing a reinforcing element 920 as described herein is shown. The reinforcing element 920 may include a shape that allows it to be used without a connecting element on the expander shaft of the expander. The reinforcing element can be manufactured by drilling, corroding, laser cutting, etc. 901 a cylindrical opening into the main body component. For example, the main body component can be manufactured by injection molding, casting, machining, etc. Subsequently, a cylindrical opening can be produced. For example, the opening can be in the form of a longitudinal through hole with a uniform inner diameter. However, varying diameters can also be used. For example, a first inner diameter can be provided distally by drilling, corroding, laser cutting, etc., and a second inner diameter can be similarly provided proximally. The reinforcing element 920 can be attached to the expander shaft of the expander as described herein, for example, by an adhesive, by pressing, etc.

[0113] Fig.10 Another example for manufacturing the expander 1000 is shown in a cross-sectional view of the upper half of the expander 1000. A preformed (e.g., molded) component 1030 can be assembled on the expander shaft 1010. A reinforcing element 1020, such as a (metal) band, which can be a radiopaque marker band, can be forged at the distal portion of the expander shaft 110 and partially overlap the preformed component 1030. Thus, the reinforcing element 1020 can fix the preformed component 1030 on the expander shaft 1010. The preformed component 1030 can provide the functions described herein with reference to the connecting element, and the preformed component 1030 can generally include the same outer diameter and longitudinal extension. However, in this example, the component 1030 may not have a connecting function. Instead, the component 1030 can also be connected to the expander shaft 1010 by forging the reinforcing element 1020 into the expander shaft 1010.

[0114] Fig.11A catheter system 1 is shown, preferably a multifunctional catheter system, which includes a support catheter or retractable sheath 2, a dilator 3 having a distal dilator end 32, and an optional (locking) handle 4. The support catheter shaft 23 defines a support catheter lumen 26 capable of receiving the dilator 3. Therefore, the dilator 3 is arranged in the support catheter lumen 26 of the support catheter 2. The dilator shaft and / or the support catheter shaft can be reinforced, for example, with a metal braid or a metal braid with staggered longitudinal wire pairs. The support catheter may have a straight-edged distal end (which achieves higher pushability and avoids flaring). The support catheter may have an opaque marker at its distal end, preferably in the form of a metal (alloy) ring or a metal (alloy) cover covering the distal support catheter end and having a distal opening and a rounded edge.

[0115] exist Fig.12 , a support catheter 2 is shown. The support catheter 2 has a distal support catheter end 21, a proximal support catheter end 24, and a support catheter shaft 23 extending between the support catheter distal end 21 and the support catheter proximal end 24. The proximal support catheter end 24 may include a locking handle 4 or may be connected to the locking handle 4. The locking handle may have a gripping surface and an ergonomic design. The support catheter may include a manifold connected to the locking handle 4. The support catheter 2 may include one or more support catheter ports 27, preferably one or more ports for fluid media, such as flushing ports, inflation and / or deflation ports. The distal support catheter end 21 is the end inserted into the human or animal body. The proximal outer catheter end 24 is the end operated by an operator (particularly a physician).

[0116] Fig.13 A dilator 3 is shown having a distal dilator end 32, a proximal dilator end 34, and a dilator shaft 33 extending between the distal dilator end 32 and the proximal dilator end 34. The proximal dilator end 34 may include a dilator manifold 35. The dilator manifold may have a shape that an operator (e.g., a physician) can easily use the dilator manifold to manipulate the dilator. The dilator may include one or more dilator lumens (not visible). Preferably, the dilator includes a first lumen for receiving a guide wire and a second lumen for receiving a fluid medium (e.g., a contrast agent). However, the dilator may have only one lumen, so that a guide wire and a contrast agent can be injected simultaneously. The dilator (preferably, the dilator manifold 35) can include a dilator port 36 for injecting a fluid medium (e.g., a contrast agent) into at least one of the dilator lumens.

[0117] Figures 11 to 13 The dilator shown in is a dilator as described herein, in particular Figures 1 to 4A , Figure 4B One of the expanders described in .

Claims

1. A dilator (100, 200), comprising or consisting of: Axis (110, 210); reinforcement elements (120, 220, 320); and A connecting element (130, 230), in, The reinforcing element (120, 220, 320) is connected to the distal end of the shaft (110, 210), and wherein the connecting element (130, 230) at least partially surrounds the shaft (110, 210) and / or the reinforcing element (120, 220, 320), and wherein the connecting element (130, 230) extends into at least one notch, recess or through hole of the reinforcing element (120, 220, 320), wherein the connecting element (130, 230, 320) is composed of a polymer, and wherein the reinforcing element (120, 220, 320) is composed of a metal or a metal alloy.

2. The dilator according to claim 1, wherein: The reinforcing element (120, 220, 320) comprises a proximal portion (321) and a conical distal portion (329) located distal to the proximal portion (321), preferably comprises a cylindrical proximal portion (321) and a conical distal portion (329) located distal to the cylindrical proximal portion (321).

3. The dilator (100, 200) according to claim 2, wherein: The reinforcing element (120, 220, 320) at least partially extends distally (125, 225) from a distal end of the connecting element (130, 230).

4. The dilator according to claim 2 or 3, wherein: The connecting element (130, 230, 320) has an olive shape.

5. The dilator according to any one of claims 2 to 4, wherein: The reinforcing element (120, 220, 320) includes a lumen.

6. The dilator according to any one of claims 2 to 5, wherein: The connecting element (130, 230) extends at least partially around the outer diameter of the shaft (110, 210) and the proximal portion (321) of the reinforcing element (110, 120, 320) and / or the distal portion (329) of the reinforcing element (110, 120, 320), in particular so as to form a step (131, 231).

7. The dilator according to any one of claims 1 to 6, wherein: The reinforcing element (120, 220, 320) extends at least partially around an outer diameter of the shaft (110).

8. The dilator according to any one of claims 1 to 6, wherein: The reinforcing element (120, 220, 320) extends at least partially along an inner diameter of the shaft (210).

9. The dilator according to any one of claims 1 to 8, wherein: The shaft (210) includes a distal region (211) and a proximal region (212), and wherein the distal region (211) has a larger diameter than the proximal region (212).

10. The dilator according to claims 8 and 9, wherein The proximal portion (321) of the reinforcing element (110, 120, 320) terminates at or adjoins a transition zone (213) between the distal region (211) and the proximal region (212).

11. The dilator according to any one of claims 1 or 3 to 10, wherein: The reinforcing element (120, 220, 320) comprises a proximal portion (321), and the proximal portion (321) comprises at least one notch, recess or through hole.

12. The dilator according to any one of claims 1 to 11, wherein: The reinforcing element (220, 320) includes a distal opening (226, 326).

13. The dilator according to any one of claims 1 to 12, wherein: The reinforcing element (320) includes a distal end (329) that tapers distally.

14. The dilator according to any one of claims 1 to 13, wherein: The shaft includes a reinforcing braid.

15. A catheter system, preferably a multifunctional catheter system, comprising a dilator according to any one of claims 1 to 14.

16. The catheter system of claim 15, wherein: The catheter system further comprises a support catheter having a support catheter shaft 23 defining a support catheter lumen 26 capable of receiving the dilator.

17. The catheter system of claim 15 or 16, wherein: The support catheter has a metal ring at a distal portion thereof.

18. The catheter system of any one of claims 15 to 17, wherein: The supporting catheter shaft is reinforced with a metal braid or a metal braid having interlaced pairs of longitudinal wires.

19. The catheter system of any one of claims 15 to 18 for use in crossing a stenosis or chronic total occlusion.

20. A method for manufacturing a dilator (100, 200), the dilator (100, 200) being preferably a dilator according to any one of the preceding claims, comprising: Providing a shaft (110, 210) and a reinforcing element (120, 220); The reinforcing element (120, 220) is connected to the distal end of the shaft (110, 210) by using injection molding or gluing, so that the connecting element (130, 230) at least partially surrounds the shaft (110, 210) and / or the reinforcing element (120, 220, 320), wherein the reinforcing element (120, 220, 320) includes a cylindrical proximal portion (321) and a conical distal portion (329), wherein the connecting element (130, 230, 320) is composed of a polymer and the reinforcing element (120, 220, 320) is composed of a metal or a metal alloy.

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