Radiopaque coatings for intravascular devices

Abstract

The present invention relates to an intravascular device made of a pseudo-elastic alloy, comprising a selective coating of radiopaque material wherein the coating comprises only a region or section of the intravascular device in a radially maximum load condition, the region or section having an elongation of less than 5% compared to in a radially unloaded condition of the device. This coating maximizes the radiopaque performance of the intravascular device, while minimising the impairment of mechanical properties.

Description

Technical Field

[0001] The present invention relates to a radiopaque coating for an intravascular device, wherein the coating is selectively applied to the device so as to minimize the coating's effect on the mechanical properties of the device. Prior art

[0002] Intravascular devices such as stents and other implants, filters, thrombectomy devices or flow diverters are often very delicate objects. For successful placement and application in the vascular system, it is important to identify their exact position in the X-ray images during interventional procedures. However, due to their low mass and the materials used, many intravascular devices show little contrast in the X-ray images themselves.

[0003] Therefore, intravascular devices usually include markers made of radiopaque materials such as gold or platinum, which allow the treating physician to better visualize the device during interventional treatment under X-ray imaging. However, these markers usually only mark certain areas of the device, such as the head or end of the stent.

[0004] However, in principle, it is desirable not only to visualize certain areas of the device better in the X-ray image, but also to visualize the entire device as much as possible. Visualizing only the end areas of the device provides little or no information, such as whether the device also expands as required between the end areas.

[0005] In order to achieve an improvement in the X-ray visibility of the device, the entire device may also be coated with a corresponding radiopaque material. However, the mechanical properties of the device may also vary depending on the material and radiopaque material used.

[0006] For example, conventional materials such as steel or gold exhibit linear elastic behavior, i.e., stress and strain in these materials increase proportionally under load until the elastic limit is reached. Within this range, the loaded material will also return to its original shape after the load is removed. If the load increases and the stress or strain exceeds the elastic limit, irreversible plastic deformation occurs.

[0007] Pseudoelastic alloys (also called shape memory alloys) are characterized by nonlinear elastic behavior. When the load is removed, they have the property of returning to their original shape (even after considerable deformation).

[0008] Pseudoelastic alloys such as Nitinol, NiTiCu, CuZn, CuZnAl or CuAlNi can be stretched up to 10 times longer than conventional spring steel without permanent deformation. The material exhibits stress-strain hysteresis when loaded and unloaded.

[0009] In the case of intravascular devices whose basic structure consists of pseudoelastic alloys, a complete coating (which may also include radiopaque materials) has at least one decisive disadvantage. The applied coating increasingly restricts the pseudoelasticity of the material as the coating thickness increases. Such factors as the radial force and setting force of the device Important factors such as the feeding force in the microcatheter are affected by this.

[0010] Therefore, especially when coating intravascular devices made of shape memory alloys, a compromise must always be found between good visibility (by increasing the coating thickness) and mechanical properties (by reducing the coating thickness). Summary of the invention

[0011] Therefore, the task of the present invention is to provide a coating and a coating method for an intravascular device made of a shape memory alloy, which coating and a coating method do not have the disadvantages of the known coatings and are able to improve the X-ray visibility of the intravascular device without excessively compromising the mechanical properties of the intravascular device.

[0012] This problem is solved by an invention having the features of claims 1 and 16 and a method having the features of claims 6 and 9. Advantageous embodiments are subject matter of the dependent claims. It should be pointed out that the features listed individually in the claims can also be combined with one another in any technically meaningful way, thereby presenting further embodiments of the invention.

[0013] The main object of the invention is to find a compromise between a coating that is as completely radiopaque as possible, which enables the device to be seen as completely as possible in an X-ray image, and which at the same time has as little influence as possible on the mechanical properties of the device.

[0014] The basic idea of ​​the invention is therefore based on coating only those areas of the device which are largely negligible for the mechanical properties of the device. Tests have shown that only slight elongation of these areas of the device occurs when the device is in use.

[0015] In this context, the mechanical properties of intravascular devices are important, including the radial resistance force (RRF) that counteracts external influences, that is, the force exerted by the device against external forces, and the chronic outward force (COF) generated by the device itself, that is, the force exerted by the device on the surrounding tissue (such as the vessel wall) during or after release.

[0016] For devices made of shape memory alloys, different considerations arise from the two quantities, RRF and COF, since the diameter of the target vessel into which the device is inserted is typically smaller than the diameter of the device in its freely deployed state.

[0017] When the initially compressed device is released from its delivery system (e.g., a delivery catheter), it expands until it contacts the vessel wall, which prevents it from further expansion. A low continuous force COF now acts on the vessel wall as the device attempts to return to its initial shape. The smaller the diameter of the device, i.e., the smaller the radial expansion of the device after release, the greater the COF acting on the vessel.

[0018] Another important quantity to mention is the RRF. The RRF describes the force required to compress the device back to a smaller diameter, for example by external pressure.

[0019] During storage or use of the device, various regions are currently stretched beyond the elastic limit of conventional coating materials, such as gold, which can be applied to the device as a radiopaque marker. Compared to the shape memory alloy of the device, the radiopaque layer of the conventional coating material is thereby permanently plastically deformed. As the layer thickness increases, this deformation weakens the pseudo-elasticity of the device's base structure, thereby weakening important performance characteristics of the device, such as RRF and COF.

[0020] For example, the desired COF can no longer be achieved or a high RRF has to be overcome in order to (re)insert the device into a delivery system or microcatheter.

[0021] In the selective coating according to the invention, only the areas or sections of the device that contribute little or nothing to the mechanical properties, such as COF and RRF, are coated accordingly. These areas are almost free of mechanical stress and deformation during storage, insertion into the patient and use. In this way, the X-ray visibility can be improved by increasing the layer thickness on the areas of the device that have little or no effect on the mechanical properties. Thus, the advantages of shape memory alloys do not have to be abandoned.

[0022] Therefore, the present invention relates to an intravascular device made of a pseudo-elastic alloy, which comprises a selective coating of a radiopaque material, wherein the coating comprises areas or sections of the intravascular device only in a radially maximum loaded state of the device, which areas or sections have an elongation in the corresponding area of ​​less than 5%, preferably less than 3%, even more preferably less than 1.5%, and in particular less than 1%, compared to the device in a radially unloaded state.

[0023] In other words, the selective coating does not include areas and segments of the intravascular device under the radial maximum load state of the device, which areas or segments have an elongation of at least 5% compared to the device under the radial unloaded state, and the elongation is preferably at least 3%, even more preferably at least 1.5% and specifically at least 1%.

[0024] It has been shown that by limiting the coating to those areas or sections of the device under the radial maximum load state, which areas or sections exhibit an elongation of less than 5% as defined, preferably less than 3%, even more preferably less than 1.5%, and in particular less than 1%, a sufficient improvement in the X-ray visibility of the device can be achieved while maintaining important mechanical properties.

[0025] Preferably, the coating also includes areas or segments of the intravascular device only under the device's maximum radial load state and under the radial nominal load state, and these areas or segments have an elongation of less than 5% in the corresponding areas compared to the device under the radial unloaded state, and the elongation is preferably less than 3%, more preferably less than 1.5%, and specifically less than 1%.

[0026] By definition, the elongation of the device should be understood as the relative change in length of a region of the device in a radially loaded state (e.g., a radially maximum loaded state or a radially nominal loaded state) relative to a radially unloaded state. The relative elongation of the device or regions of the device in a maximum loaded state or in a maximum loaded state and a nominal loaded state is essential to the concept of the present invention.

[0027] As described, the selective coating does not include those areas or sections having an elongation at least up to a defined limit value. Ideally, this means that the coating covers all areas below this limit value.

[0028] In practice, it has been shown that the desired improvement in the mechanical properties of the device is sufficient if sections of the device are not coated (including the region where the elongation reaches at least a defined limit value). For example, in the case of a stent, the corresponding sections of the respective struts are not coated.

[0029] When defining a section, it should be noted that it cannot be arbitrarily large and therefore include an unreasonable number of areas that are below the defined limit value of elongation. Therefore, a section should be defined as a portion of the device that includes precisely those areas that reach at least the defined limit value of elongation. The area that at least reaches the defined limit value should also be called an elongation area.

[0030] Using the example of a stent-like device (e.g. a stent, a thrombectomy device or a shunt), this means that at most a segment of the strut should be defined as a segment that completely encloses the elongated region (i.e. starting at the beginning of the elongated region and ending at the end of the elongated region) and is therefore not coated, where the terms beginning and end refer to the course of the elongated region along the device, i.e. for example along the strut.

[0031] If several elongation regions are assigned to one segment, for example because they are located on different sides of the strut but exactly in this segment, then at most this portion of the strut should be defined as a segment and not coated, which portion completely includes all elongation regions, i.e. starting at the beginning of the first elongation region and ending at the end of the last elongation region, whereby the beginning and the end can also be part of the same elongation region if they extend to all other elongation regions of the segment.

[0032] Similar definitions may apply to other intravascular devices.

[0033] How the intravascular device is manufactured from the shape memory alloy is irrelevant to the invention. The device can be produced, for example, by cutting (in particular laser cutting) or by weaving, for example, of a wire, whereby a stronger elongation is more likely to be expected for a cut device (for example laser cutting from a tube). However, in principle, other ways of manufacturing the device are also conceivable, for example additive processes by adding material to gradually build up the structure. One such additive method is in particular 3D printing.

[0034] By definition, the radial maximum load state is the state in which the device is subjected to its maximum radial compression. The device is subjected to the radial maximum load state, for example, in a delivery catheter, prior to or during an interventional procedure. For example, if the device is intended for use with a delivery catheter having an inner diameter of 0.53 mm, the device is subjected to its maximum radial load state when radially compressed to a diameter of 0.53 mm. The radial compression to a diameter of 0.53 mm is the maximum radial load state of the device.

[0035] If the device is intended for use with delivery catheters having different inner diameters, the maximum radial load state of the device should be the state that the device exhibits in the delivery catheter having the smallest inner diameter for the device.

[0036] If it is not appropriate to determine the radial maximum load state of the device based on the supply conduit, the radial maximum load state can alternatively be defined as the state where the device reaches its pseudo-elastic limit and, under radial load, there is no area of ​​permanent deformation, i.e., no longer reversibly deformable. This limit is typically reached if a device made of a shape memory alloy has an area that exhibits an elongation of 10% compared to the radial unloaded state under radial compression.

[0037] In certain cases, this alternative definition of the maximum radial load may be applicable to create another target reference value.

[0038] By definition, the radial nominal load state is the state in which the device is subjected to its nominal radial compression. The device is subjected to this state, for example, during use according to the instructions, such as during implantation or other use in a blood vessel, such as as a vascular support, filter or for thrombectomy. If the device is accordingly intended for use in a blood vessel with a diameter of 2 mm, the device is subjected to its nominal radial load state when radially compressed to a diameter of 2 mm. For the device, radial compression to a diameter of 2 mm is the radial nominal load state.

[0039] The radial load state of the device, whether it is the radial nominal load state or the radial maximum load state, should always be understood as a state with a uniformly distributed radial load on the device due to external forces, such as is achieved in a blood vessel or delivery catheter, or as a model in a uniformly compressed device within a uniform straight tube.

[0040] By definition, the radially unloaded state is a state in which the device is not subjected to any radial compression. The device is subjected to such a state, for example in a free expansion state outside a vessel or catheter without any external constraints. In the sense of the present invention, selective coating is achieved by all such coating methods that are able to provide a ready-to-use end product with only a partial coating. It is immaterial how the selective coating of the end product is achieved.

[0041] For example, the entire device may first be coated in a coating method, and then the coating may be partially removed again mechanically, chemically or electrochemically. In the coating method, the uncoated area may also be covered or covered in advance with various materials such as plastics, adhesives or covering lacquers. The corresponding mask may be removed or kept on the device again, for example, after coating. In addition, a plurality of auxiliary elements may be attached to the inside and / or outside of the device, which serve as templates during the coating method.

[0042] Last but not least, only the parts to be coated can be selectively coated. Various options for producing the desired selective coating are known to those skilled in the art.

[0043] The pseudo-elastic alloy or shape memory alloy may in particular be nitinol or nickel-titanium-copper. Other pseudo-elastic alloys are known to those skilled in the art.

[0044] The material of the radiopaque coating can be selected from platinum, palladium, platinum-iridium, tantalum, gold and tungsten. The radiopaque coating may also include a combination of two or more of these materials or their alloys. Therefore, the radiopaque coating includes at least one of the above materials. Those skilled in the art select additional radiopaque materials according to specific requirements and, if necessary, combine them with the above materials.

[0045] Thus, the present invention includes a method of selectively coating an intravascular device made of a pseudo-elastic alloy, the method comprising the steps of:

[0046] (A) An intravascular device made of a pseudo-elastic alloy in a radially unloaded state is provided;

[0047] (D) compressing the intravascular device to a maximum radial load state by radially loading the device;

[0048] (E) determining a region of the intravascular device in a radially maximum loaded state that has an elongation of at least 5% compared to a radially unloaded, expanded state;

[0049] (F) Coating the intravascular device except for the area identified in step (E).

[0050] In a preferred embodiment, the method of selectively coating an intravascular device made of a pseudo-elastic alloy further comprises the steps of:

[0051] (B) compressing the intravascular device to a radial nominal load state by radially loading the device;

[0052] (C) determining a region of the intravascular device in a radially nominally loaded state that has an elongation of at least 5% compared to the device in a radially unloaded, expanded state;

[0053] According to their numbers, step (B) and step (C) are usually performed after step (A) and before step (D).

[0054] In this variant of the method, coating according to step (F) is performed by recessing the areas determined in steps (C) and (E).

[0055] Step (B) and step (C) can also be performed instead of step (D) and step (E). The coating according to step (F) is then performed accordingly, thereby omitting the area determined in step (C).

[0056] A method for selectively coating an intravascular device made of a pseudo-elastic alloy comprises the following steps:

[0057] (A') providing an intravascular device made of a pseudo-elastic alloy in a radially unloaded state;

[0058] (D') compressing the intravascular device to a maximum radial load state by radially loading the device;

[0059] (E') determining a region of the intravascular device in a radially maximum loaded state having an elongation of at least 5% compared to a radially unloaded expanded state, and then determining a section of the intravascular device including the corresponding region of defined elongation;

[0060] (F') Coating the intravascular device except for the segment identified in step (E').

[0061] In a preferred embodiment, the method of selectively coating an intravascular device made of a pseudo-elastic alloy further comprises the following steps:

[0062] (B') compressing the intravascular device to a radial nominal load state by radially loading the device;

[0063] (C') determining a region of the intravascular device in a radially nominally loaded state that has an elongation of at least 5% compared to the device in a radially unloaded, expanded state, and then determining a segment of the intravascular device that includes the corresponding region of defined elongation;

[0064] According to their numbering, steps (B') and (C') are usually performed after step (A') and before step (D').

[0065] In this variant of the method, coating according to step (F') is performed by recessing the sections determined in steps (C') and (E').

[0066] Step (B') and step (C') may also be performed instead of step (D') and step (E'). Coating according to step (F') is then performed by recessing the section determined in step (C').

[0067] It is clear to those skilled in the art that step (B) and step (C) as well as step (D) and step (E) can also be interchanged in order, i.e., after step (A), step (D) and step (E) are first performed, and then step (B) and step (C). The same applies to step (B') and step (C') as well as step (D') and step (E'). Step (B') and step (C') as well as step (D') and step (E') can also be interchanged in order, so that after step (A'), step (D') and step (E') are first performed, and then step (B') and step (C') are performed.

[0068] Compared to the radially unloaded state, the elongation according to step (C) and step (E) or according to step (C') and step (E') may preferably be at least 3%, more preferably at least 1.5%, and in particular at least 1%.

[0069] According to method step (B) or step (B'), the device can preferably be inserted into a straight tube with a corresponding inner diameter to be compressed into a radial nominal load state. The inner diameter of the tube should correspond to the outer diameter of the device in the radial nominal load state. The tube is advantageously rigid and does not yield when the device is expanded. This allows to obtain comparable results.

[0070] According to method step (D) or step (D'), the device can be inserted into a straight tube with a corresponding inner diameter to be compressed into a radially maximum loaded state. The inner diameter of the tube should correspond to the outer diameter of the device in the radially maximum loaded state. The tube is advantageously rigid and does not yield when the device is expanded. This allows to obtain comparable results.

[0071] In principle, it is also conceivable to carry out method steps (A) to (E) or steps (A′) to (E′) in a computer simulation, for example using a finite element method (FEM) which models the described real test setup.

[0072] Therefore, the present invention also comprises an intravascular device having a coating obtainable by the method of the present invention.

[0073] The present invention also includes a combination comprising an intravascular device coated according to the present invention and a delivery catheter for the device.

[0074] The device according to the invention with the selective coating according to the invention has advantages over the prior art: due to the almost complete coating, the device is not only almost completely visible in the X-ray image, the coating also does not impair important mechanical properties such as RRF and COF to a relevant extent.

[0075] The following usage examples demonstrate the effectiveness of the proposed selective coating. DETAILED DESCRIPTION

[0076] In intravascular devices made of shape memory alloys, such as stent systems, the COF decreases continuously with increasing expansion and correspondingly larger stent diameters. In such devices made of shape memory alloys that are fully coated with radiopaque materials (e.g., gold), the COF degrades significantly, i.e., it decreases. This effect can be minimized by selectively coating areas that do not contribute significantly to the COF.

[0077] In this example, the selective coating is applied to a region or section of a device made of a shape memory alloy that, by definition, exhibits an elongation of less than 1.5% under radial maximum load or radial nominal load conditions.

[0078] Figure 1The course of COF of a fully coated intravascular device made of shape memory alloy (lower curve) and a fully uncoated intravascular device made of shape memory alloy (upper curve) is shown comparatively, the fully uncoated intravascular device expanding from its radially nominally loaded state (where the diameter of the device is 2 mm) to its radially unloaded state (where the diameter of the device is 5 mm). It is easy to see that the COF of the fully coated device is significantly lower than the COF of the uncoated device, with a loss of between 51% and 97%.

[0079] Figure 2 The course of COF of a selectively coated device made of shape memory alloy (lower curve) and a completely uncoated device made of shape memory alloy (upper curve) is shown comparatively, the completely uncoated device expanding from its radially nominally loaded state (where the diameter of the device is 2 mm) to its radially unloaded state (where the diameter of the device is 5 mm). It is easy to see that the COF of the selectively coated device (where the maximum loss of COF is only 26%) is significantly lower than the COF of the uncoated device.

[0080] Figure 3 The increase in RRF of a fully coated intravascular device made of a shape memory alloy (right column) and an uncoated intravascular device made of a shape memory alloy (left column) is shown comparatively, in each case, the diameter of the intravascular device being 2 mm under a radial nominal load state. It is easy to see that the RRF of the fully coated device (with a percentage increase of 35%) is significantly higher than the RRF of the uncoated device.

[0081] Figure 4 The increase in RRF of a selectively coated intravascular device made of a shape memory alloy (right column) and an uncoated intravascular device made of a shape memory alloy (left column) is shown comparatively, in each case with a diameter of 2 mm under radial nominal load conditions. It is easy to see that the RRF of the selectively coated device according to the present invention (with a percentage increase of only 2%) is only slightly higher than the RRF of the uncoated device.

[0082] Figure 5 The determination of the areas of an intravascular device made of a shape memory alloy that are subject to compressive stress according to the invention is shown. In the present case, data on the elongation of areas 2 of the device or struts 1 were determined in a computer simulation using the finite element method (FEM). The marked areas 2 represent areas of the device or struts 1 that elongate during compression in the microcatheter, i.e. in the radially maximum loaded state, by at least 1.5% compared to the radially unloaded state. These areas 2 are omitted in the coating according to the invention.

[0083] also, Figure 5Sections 3 of the struts 1 from regions 2 are shown, which regions may alternatively be omitted during the selective coating.

[0084] Figure 6 The determination of a compressively stressed region 2 or strut 1 of an intravascular device made of a shape memory alloy according to the invention is shown. In the present case, data on the elongation of a region 2 or strut 1 of the intravascular device were determined in a computer simulation using the finite element method (FEM). The marked regions 2 represent regions 2 or struts 1 of the intravascular device which elongate during compression in the vessel, i.e. in the radially nominally loaded state, by at least 1.5% compared to the radially unloaded state. These regions 2 are omitted in the coating according to the invention.

[0085] also, Figure 6 Sections 3 of the struts 1 from regions 2 are shown, which regions may alternatively be omitted during the selective coating.

[0086] Figures 1 to 6 Each refers to a laser cut intravascular device.

Claims

1. An intravascular device made of a pseudoelastic alloy including a selective coating of a radiopaque material, characterized in that The coating includes only regions or sections of the intravascular device in a radially maximum loaded state of the device, said regions or sections having an elongation of less than 5% compared to a radially unloaded state of the device.

2. The intravascular device of claim 1, wherein the intravascular device is made of a pseudoelastic alloy and includes a selective coating of a radiopaque material, wherein: The coating includes an area or segment of the intravascular device only in the radial maximum load state and the radial nominal load state of the device, and the area or segment has an elongation of less than 5% compared to the radial unloaded state of the device.

3. The intravascular device according to claim 1 or 2, characterized in that: The elongation in the radial maximum load state or in the radial nominal load state is lower than 3%, preferably lower than 1.5%, and in particular lower than 1% compared to the radial unloaded state.

4. An intravascular device according to any one of the preceding claims, characterized in that The coating includes at least one radiopaque material selected from the group consisting of platinum, palladium, platinum-iridium, tantalum, gold, and tungsten.

5. An intravascular device according to any one of the preceding claims, characterized in that The pseudo elastic material includes Nitinol or Nitinol-Copper.

6. A method for selectively coating an intravascular device made of a pseudoelastic alloy, comprising the steps of: (A) An intravascular device made of a pseudo-elastic alloy in a radially unloaded state is provided; (D) compressing the intravascular device to a radial maximum load state by radially loading the device; (E) determining a region of the intravascular device in a radially maximum loaded state, said region having an elongation of at least 5% compared to a radially unloaded, expanded state; (F) coating the intravascular device except for the area determined in step (E).

7. The method of selectively coating an intravascular device made of a pseudo-elastic alloy according to claim 6, further comprising the steps of: (B) compressing the intravascular device to the radial nominal load state by radially loading the device; (C) determining a region of the intravascular device in a radially nominally loaded state, said region having an elongation of at least 5% compared to the device in said radially unloaded, expanded state; wherein the coating according to step (F) is performed by recessing the areas determined in steps (C) and (E).

8. The method of selectively coating an intravascular device made of a pseudo-elastic alloy according to claim 7, wherein: Step (D) and step (E) are performed after step (A) and before step (B) and step (C).

9. A method for selectively coating an intravascular device made of a pseudo-elastic alloy, comprising the steps of: (A') providing an intravascular device made of a pseudo-elastic alloy in a radially unloaded state; (D') compressing the intravascular device to the radial maximum load state by radially loading the device; (E') determining a region of the intravascular device in the radially maximum loaded state having an elongation of at least 5% compared to the radially unloaded expanded state, and then determining a segment of the intravascular device including the corresponding region of defined elongation; (F') coating the intravascular device except for the segment determined in step (E').

10. The method of selectively coating an intravascular device made of a pseudo-elastic alloy according to claim 9, further comprising the steps of: (B') compressing the intravascular device to the radial nominal load state by radially loading the device; (C') determining a region of the intravascular device in a radially nominally loaded state having a defined elongation of at least 5% compared to the device in the radially unloaded, expanded state, and then determining a segment of the intravascular device that includes the corresponding region of defined elongation; Wherein, coating according to step (F') is performed by recessing the sections determined in steps (C') and (E').

11. The method of selectively coating an intravascular device made of a pseudo-elastic alloy according to claim 10, wherein: Step (D') and step (E') are performed after step (A') and before step (B') and step (C').

12. A method for selectively coating an intravascular device made of a pseudo-elastic alloy according to any one of claims 6 to 11, characterized in that According to method step (B) or step (B'), the device is placed in a straight tube with a corresponding inner diameter for compression to the radial nominal load state.

13. A method for selectively coating an intravascular device made of a pseudo-elastic alloy according to any one of claims 6 to 11, characterized in that According to method step (D) or step (D'), the device is inserted into a straight tube with a corresponding inner diameter for compression to the radial maximum load state.

14. A method for selectively coating an intravascular device made of a pseudo-elastic alloy according to any one of claims 6 to 11, characterized in that Compared to the radially unloaded state, the elongation according to step (C) and step (E) or step (C') and step (E') is at least 3%, preferably at least 1.5%, and in particular at least 1%.

15. A method for selectively coating an intravascular device made of a pseudo-elastic alloy according to any one of claims 6 to 14, characterized in that The method steps (A) to (E) or steps (A′) to (E′) are carried out in a computer simulation, for example by means of the finite element method (FEM).

16. An intravascular device having a coating obtainable by the method according to any one of claims 6 to 15.

17. A combination comprising an intravascular device according to any one of claims 1 to 5 or 16 and a delivery catheter.

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