Radiopaque coatings for intravascular devices - Patents.com

Abstract

The present invention relates to intravascular devices made from pseudoelastic alloys that include a selective coating of radiopaque material, the coating including only those regions or sections of the intravascular device that have an elongation of less than 5% in a maximum radially loaded state compared to the radially unloaded state of the device, such a coating allows for maximizing the x-ray visibility of the intravascular device while minimizing loss of mechanical properties.

Description

[Technical field]

[0001] The present invention relates to radiopaque coatings for intravascular devices, which are selectively applied to the device to minimize the effect of the coating on the mechanical properties of the device. [Background technology]

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

[0003] Therefore, intravascular devices are often equipped with markers made of radiopaque materials, such as gold or platinum, which allow the treating physician to better visualize the device under X-ray images during the intervention. However, such markers usually only mark certain areas of the device, such as the beginning or end of a stent.

[0004] However, it is fundamentally desirable to have as much of the device as possible visible in its entirety in the X-ray image, and not just to have certain regions of the device better visible: if only the edge regions of the device are visible, for example, little or no information is provided as to whether the intermediate region is also expanded as required.

[0005] To achieve improved X-ray visibility of the device, the entire device can also be coated with a corresponding radiolucent material. However, depending on the material and the radiopaque material used, the mechanical properties of the device also change.

[0006] Conventional materials, such as steel or gold, exhibit linear elastic behavior, i.e., the stress and strain of the material increase proportionally upon loading until the elastic limit is reached. In this range, the material under load returns to its original shape after the load is removed. If the load is increased and the stress or strain exceeds the elastic limit, irreversible plastic deformation occurs.

[0007] Pseudoelastic alloys, also known as shape memory alloys, are characterized by nonlinear elastic behavior: they have the ability to return to their original shape after large deformations when the load is removed.

[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 experiences stress-strain hysteresis with stress plateaus and stress relaxation plateaus.

[0009] In the case of intravascular devices whose basic structure is made from pseudoelastic alloys, a complete coating, which may include radiopaque materials, has at least one crucial drawback: the applied coating increasingly limits the pseudoelasticity of the material as the coating thickness increases. Important factors such as the radial and set-up forces of the device or the delivery forces in microcatheters are thereby affected.

[0010] Therefore, when coating intravascular devices, especially those made from shape memory alloys, a compromise must always be found between good visibility - via a higher coating thickness - and mechanical performance - via a lower coating thickness. Summary of the Invention [Problem to be solved by the invention]

[0011] It is therefore an object of the present invention to provide a coating and coating method for intravascular devices made from shape memory alloys that does not have the disadvantages of known coatings and that allows for improved X-ray visibility of the intravascular device without unduly compromising the mechanical properties of the intravascular device. [Means for solving the problem]

[0012] This problem is solved by the invention with the features of claims 1 and 16 and by the methods with the features of claims 6 and 9. Advantageous embodiments are the subject of the dependent claims. It should be noted that the features individually recited in the claims can also be combined with one another in any technically meaningful way and thus represent further embodiments of the invention.

[0013] The most important objective of the present invention is to find a compromise between a coating that is as completely radiopaque as possible, allowing almost perfect visibility of the device in X-ray images and at the same time affecting the mechanical properties of the device as little as possible.

[0014] The overriding idea of ​​the present invention is therefore based on coating only those areas of the device that have little effect on the mechanical properties of the device: tests have shown that these are the areas of the device that undergo only small elongations during use of the device.

[0015] The mechanical properties of intravascular devices that are important in this context include, on the one hand, the radial resistance force (RRF) against external influences, i.e. the force exerted by the device against external forces, and the chronic outward force (COF) that originates from the device itself and that the device exerts on the surrounding tissues, such as the vessel wall, during and after release.

[0016] For devices made from shape memory alloys, the two quantities RRF and COF give rise to different considerations because 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 comes into contact with the vessel wall and is prevented from expanding further. At this point, a low, continuous force, COF, is exerted on the vessel wall as the device attempts to return to its original 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 is the RRF, which represents 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, the individual regions are stretched beyond the elastic limit of a conventional coating material, such as gold, which can be applied to the device as a radiopaque marker. In contrast to the shape memory alloy of the device, the radiopaque layer of the conventional coating material is permanently plastically deformed. As the layer thickness increases, this deformation compromises the pseudoelasticity of the device's basic structure and thus important performance characteristics of the device, such as RRF and COF.

[0020] For example, the desired COF may not be achievable, or a high RRF may have to be overcome in order to (re)insert the device into a delivery system or microcatheter.

[0021] In the selective coating according to the present invention, only the areas or sections of the device that do not or hardly contribute to mechanical performance such as COF and RRF are coated. These are the areas that show little mechanical stress and deformation during storage, insertion into the patient, and use. In this way, the X-ray visibility can be improved by a high layer thickness in the areas of the device that have little or no effect on mechanical performance. Therefore, the advantages of the shape memory alloy do not have to be sacrificed.

[0022] Thus, the present invention relates to an intravascular device made from a pseudoelastic alloy comprising a selective coating of radiopaque material, the coating comprising only areas or sections having an elongation of the corresponding area in the maximum radially loaded state of the device of less than 5%, preferably less than 3%, even more preferably less than 1.5%, especially less than 1%, compared to the device in the radially unloaded state.

[0023] In other words, the selective coating does not include areas and sections of the intravascular device that have an elongation at the maximum radial load of the device compared to the device in an unradially loaded state of at least 5%, preferably at least 3%, even more preferably at least 1.5%, and especially at least 1%.

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

[0025] Preferably, the coating further comprises only those areas or sections of the intravascular device that have an elongation in the corresponding areas of less than 5%, preferably less than 3%, even more preferably less than 1.5%, especially less than 1%, at both the maximum radially loaded state and the nominal radially loaded state of the device, compared to the device in an unradially loaded state.

[0026] By definition, elongation of a device is understood to be the relative change in length of a region of the device under radial load, e.g. under maximum radial load or under nominal radial load, with respect to the unloaded state. Of crucial importance to the idea of ​​the present invention is the relative elongation of the device or a region of the device under maximum radial load and under nominal radial load.

[0027] As mentioned above, the selective coating does not include areas or sections with elongation that reaches at least a specified limit. Ideally, this means that the coating covers all areas below this limit.

[0028] In practice, it has been shown that the desired improvement of the mechanical properties of the device is sufficient if the sections of the device that include at least the areas of elongation reaching a defined limit are not coated, in the case of a stent, for example, the corresponding sections of each strut are not coated.

[0029] It should be noted that when defining a section, it cannot be arbitrarily large and therefore include an unduly large area below the prescribed limit for elongation. Therefore, a section should be defined as a part of the device that includes exactly the area that at least reaches the prescribed limit for elongation. The range that at least reaches the prescribed limit is also referred to as the elongation area.

[0030] Using the example of a stent-like device such as a stent, thrombectomy device or flow diverter, this means that up to a section of a strut is defined as a section and therefore not coated, the section exactly surrounding the stretch region, i.e. starting at the beginning of the stretch region and ending at the end of the stretch region, the terms beginning and end referring to the path of the stretch region along the device, i.e. along, for example, a strut.

[0031] If multiple extension zones are assigned to a section, for example because these extension zones are on different sides of the strut but directly within this section, then at most that portion of the strut will not be defined and coated as a section that exactly includes all of these extension zones, i.e. starts at the beginning of the extension zone and ends at the end of the extension zone, and the beginning and end may be part of the same extension zone if it extends across all other extension zones of the section.

[0032] Similar definitions can be used for other intravascular devices.

[0033] It is not important for the invention how the intravascular device is manufactured from the shape memory alloy. The device can be manufactured, for example, by cutting, in particular laser cutting, or by braiding, for example braiding of wires, with stronger elongations being more likely to be expected by cutting devices, for example laser cutting from tubes. However, in principle, other manufacturing methods of the device are also conceivable, for example additive methods, where the structure is gradually built up by adding material. Such additive methods are in particular 3D printing.

[0034] By definition, the most radially loaded condition is the condition of the device when it is undergoing its maximum radial compression. A device may undergo a most radially loaded condition, for example, in a delivery catheter pre- and during an intervention. For example, if a device is intended for use with a delivery catheter having an inner diameter of 0.53 mm, the device undergoes its most radially loaded condition when radially compressed to a diameter of 0.53 mm. Radial compression to a diameter of 0.53 mm is the most radially loaded condition for this device.

[0035] If the device is intended for use with delivery catheters of different inner diameters, the maximum radial load on the device should be the condition the device will assume in the smallest inner diameter delivery catheter for which the device is intended.

[0036] If it is appropriate not to determine the maximum radial load of the device as a function of the delivery catheter, the maximum radial load can alternatively be defined as the state where the device reaches its pseudoelastic limit and does not yet have any regions that are permanently deformed, i.e., no longer reversibly deformed, under radial load. Such a limit is typically reached in devices made from shape memory alloys when they have regions that exhibit 10% elongation under radial compression compared to the radially unloaded state.

[0037] In certain cases, such alternative definitions of maximum radial loading may be suitable to create a more objective criterion.

[0038] A nominal radial load condition is, by definition, the condition of a device when the device is undergoing its nominal radial compression. The device undergoes this condition during, for example, intravascular placement or other intravascular use, e.g., during use according to instructions, e.g., as a vascular support, as a filter, or for thrombus removal. If the device is intended for use in a vessel having a diameter of 2 mm, the device undergoes its nominal radial load condition upon radial compression to a diameter of 2 mm. Radial compression to a diameter of 2 mm is the nominal radial load condition for this device.

[0039] The radially loaded condition of a device, i.e., the nominal radially loaded condition or the maximum radially loaded condition, should always be understood as the condition in which the radial load is uniformly distributed on the device by an external force, as modeled in a vascular or delivery catheter, or in a uniform compression of the device in a uniform straight tube.

[0040] By definition, the radially unloaded state is the state of the device where the device is not under any radial compression. The device undergoes this state without any external constraint, for example outside a blood vessel or catheter. The selective coating in the present invention is achieved by all such coating methods that can provide a ready-to-use final product with only a partial coating. It is not important how the selective coating of the final product is achieved.

[0041] For example, in the coating method, the entire device can be coated first, and then the coating can be partially removed again mechanically, chemically or electrochemically.In the coating method, the areas that are not to be coated can also be pre-masked or covered with various materials, such as plastic, adhesive or cover lacquer.The corresponding mask can also be removed again after coating, or left on the device, for example.Furthermore, during the coating method, auxiliary elements that function as templates can be attached to the inside and / or outside of the device.

[0042] Lastly, but not without importance, only those parts that should be coated can be selectively coated. A variety of options are known to those skilled in the art to provide the desired selective coating.

[0043] The pseudoelastic or shape memory alloy may in particular be Nitinol (NiTi) or Nickel-Titanium-Copper (NiTiCu). Other pseudoelastic alloys are known to those skilled in the art.

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

[0045] [Figure 1] A comparison of the COF progression for a fully coated intravascular device made from a shape memory alloy (lower curve) and a fully uncoated intravascular device made from a shape memory alloy (upper curve) is shown. [Diagram 2] 1 shows a comparison of the COF evolution for a selectively coated device made from a shape memory alloy (lower curve) and a completely uncoated device made from a shape memory alloy (upper curve). [Diagram 3] A comparison of the increase in RRF for a fully coated intravascular device made from a shape memory alloy (right bar) and an uncoated intravascular device made from a shape memory alloy (left bar) is shown. [Figure 4] A comparison of the increase in RRF for a selectively coated intravascular device made from a shape memory alloy (right bar) and an uncoated intravascular device made from a shape memory alloy (left bar). [Diagram 5] 1 illustrates the identification in accordance with the present invention of regions of an intravascular device made from compressively stressed shape memory alloys. [Figure 6] 1 illustrates the identification according to the invention of regions 2 or struts 1 of an intravascular device made from a compressively stressed shape memory alloy. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] Accordingly, the present invention includes a method of selectively coating an intravascular device made from a pseudoelastic alloy, the method comprising the steps of: (A) providing an intravascular device fabricated from a pseudoelastic alloy in a radially unloaded state; (D) compressing the intravascular device to a maximum radially loaded state by radially loading the device; (E) identifying a region of the intravascular device that has an elongation of at least 5% under maximum radial load compared to a radially unloaded state; (F) Coating the intravascular device except for the areas identified in step (E).

[0047] In a preferred embodiment, the method of selectively coating an intravascular device made from a pseudoelastic alloy further comprises the steps of: (B) compressing the intravascular device to a nominal radial load by radially loading the device; (C) Identifying a region of the intravascular device that has an elongation of at least 5% under a nominal radial load compared to the device under a radially unloaded condition.

[0048] Steps (B) and (C), according to their names, are usually carried out after step (A) and before step (D).

[0049] In this variation of the method, the coating according to step (F) is suitably carried out by recessing the areas identified in steps (C) and (E).

[0050] Steps (B) and (C) may also be carried out instead of steps (D) and (E). Coating according to step (F) is then carried out appropriately except for the areas specified in step (C).

[0051] An alternative method for selectively coating an intravascular device made from a pseudoelastic alloy includes the following steps: (A') providing an intravascular device fabricated from a pseudoelastic alloy in a radially unloaded state; (D') compressing the intravascular device to a maximum radially loaded state by radially loading the device; (E') identifying an area of ​​the intravascular device having an elongation of at least 5% under a maximum radially loaded condition as compared to a radially unloaded condition, and then identifying a section of the intravascular device that includes a corresponding area of ​​the defined elongation; (F') Coating the intravascular device, except for the section identified in step (E').

[0052] In a preferred embodiment, the method of selectively coating an intravascular device made from a pseudoelastic alloy further comprises the steps of: (B') compressing the intravascular device to a nominal radial load by radially loading the device; (C') Identifying an area of ​​the intravascular device having an elongation of at least 5% under a nominal radial load compared to the device in an unradially loaded state, and then identifying a section of the intravascular device that includes a corresponding area of ​​the defined elongation.

[0053] Steps (B') and (C') are usually carried out after step (A') and before step (D') according to their names.

[0054] In this variant of the method, the coating according to step (F') is carried out by recessing the sections identified in steps (C') and (E').

[0055] Steps (B') and (C') can also be carried out instead of steps (D') and (E'). The coating according to step (F') is then carried out by recessing the section identified in step (C').

[0056] As will be clear to those skilled in the art, steps (B) and (C) as well as steps (D) and (E) can also be interchanged, i.e., after step (A), steps (D) and (E) are performed first, and then steps (B) and (C). The same applies to steps (B') and (C') as well as steps (D') and (E'). These can also be interchanged, i.e., after step (A'), steps (D') and (E') are performed first, and then steps (B') and (C').

[0057] The elongation due to steps (C) and (E) or steps (C') and (E') may preferably be at least 3%, more preferably at least 1.5%, in particular at least 1%, compared to the radially unloaded state.

[0058] The device can preferably be inserted into a straight tube with a corresponding internal diameter for compression to a nominal radial load according to step (B) or (B') of the method. The internal diameter of the tube must correspond to the external diameter of the device at a nominal radial load. The tube is advantageously rigid and does not deform upon expansion of the device. This allows comparable results to be obtained.

[0059] The device can be inserted into a straight tube having a corresponding inner diameter for compressing it to the maximum radial load according to step (D) or (D') of the method. The inner diameter of the tube must correspond to the outer diameter of the device at the maximum radial load. The tube is advantageously rigid and does not deform when the device is expanded. This allows equivalent results to be obtained.

[0060] In principle, method steps (A)-(E) or (A')-(E') may also be performed by computer simulation, for example using a Finite Element Method (FEM) to model the production environment set-up described above.

[0061] Thus, the present invention also includes an intravascular device having a coating obtainable by the method of the present invention.

[0062] The invention further includes a combination comprising an intravascular device coated according to the invention and a delivery catheter for the device.

[0063] Devices according to the invention having selective coatings according to the invention have the advantage over the prior art in that the near perfect coating allows the device to be nearly perfectly visible in an X-ray image, but the coating does not significantly impair important mechanical properties such as RRF and COF.

[0064] The effectiveness of the proposed selective coating is illustrated below with the aid of examples.

[0065] Working Example For intravascular devices such as stent systems made from shape memory alloys, the COF decreases continuously with increasing expansion and correspondingly larger stent diameters. For such devices made from shape memory alloys that are completely coated with a radiopaque material such as gold, the COF is significantly reduced or decreased. This effect can be minimized by selectively coating areas that do not substantially contribute to the COF.

[0066] In this example, a selective coating was applied to an area or section of a device made from a shape memory alloy, which, as defined, exhibited an elongation of less than 1.5% at maximum radial load or nominal radial load.

[0067] Figure 1 compares the progression of COF for a fully coated intravascular device made from a shape memory alloy (lower curve) and a fully uncoated intravascular device made from a shape memory alloy (upper curve) expanded from a nominal radially loaded state where the device diameter is 2 mm to a radially unloaded state where the device diameter is 5 mm. It can be readily seen that the COF of the fully coated device is significantly lower than that of the uncoated device, with between 51% and 97% loss.

[0068] Figure 2 shows a comparison of the progression of COF for a selectively coated device made from a shape memory alloy (lower curve) and a completely uncoated device made from a shape memory alloy (upper curve) expanded from a nominal radially loaded condition where the device diameter is 2 mm to a radially unloaded condition where the device diameter is 5 mm. It can be readily seen that the COF of the selectively coated device is significantly lower than that of the uncoated device, with a maximum loss of COF of only 26%.

[0069] 3 shows a comparison of the increase in RRF for a fully coated intravascular device made from a shape memory alloy (right bar) and an uncoated intravascular device made from a shape memory alloy (left bar), in each case at a nominal radial load at a diameter of 2 mm. It can be readily seen that the RRF of the fully coated device is significantly higher than that of the uncoated device, increasing by 35%.

[0070] 4 shows a comparison of the increase in RRF for a selectively coated intravascular device made from a shape memory alloy (right bar) and an uncoated intravascular device made from a shape memory alloy (left bar), in each case at a nominal radial load at a diameter of 2 mm. It is readily apparent that the RRF of the selectively coated device according to the present invention is only slightly higher than that of the uncoated device, an increase of only 2%.

[0071] 5 shows the identification according to the invention of regions of an intravascular device made of compressively stressed shape memory alloy. In this case, data on the elongation of regions 2 or struts 1 of the device were determined in a computer simulation using the Finite Element Method (FEM). The marked regions 2 represent regions or struts 1 of the device that, when compressed in a microcatheter, i.e. in the state of maximum radial load, elongate by at least 1.5% compared to the state of no radial load. These regions 2 are excluded by the coating according to the invention.

[0072] Furthermore, FIG. 5 shows sections 3 of the struts 1 that emanate from the regions 2; these portions 3 can alternatively be omitted during selective coating.

[0073] Figure 6 shows the identification according to the invention of regions 2 or struts 1 of an intravascular device made of a compressively stressed shape memory alloy. In this case, data on the elongation of the regions 2 or struts 1 of the intravascular device were determined in a computer simulation using the Finite Element Method (FEM). The marked regions 2 represent the regions 2 or struts 1 of the intravascular device, whose elongation during compression in a blood vessel, i.e. under a nominal radial load, is at least 1.5% compared to the radially unloaded state. These regions 2 are excluded in the coating according to the invention.

[0074] Furthermore, FIG. 6 shows sections 3 of the struts 1 that emanate from the regions 2; these portions 3 can alternatively be omitted during selective coating.

[0075] Each of Figures 1-6 refers to a laser cut intravascular device.

Claims

1. An intravascular device made from a pseudo-elastic alloy including a selective coating of a radiopaque material, The coating includes only the region or section of the intravascular device that has less than 5% elongation when the device is under maximum radial load compared to when it is not under radial load. An intravascular device characterized by the following features.

2. An intravascular device made from a pseudo-elastic alloy comprising a selective coating of a radiopaque material according to claim 1, characterized in that the coating includes only regions or sections of the intravascular device that have less than 5% elongation compared to the state in which the device is not radially loaded, both when the device is under maximum radial load and when it is under nominal radial load.

3. The intravascular device according to claim 1 or 2, characterized in that the elongation in the state where the radial load is maximum or where a nominal load is applied in the radial direction is less than 3% compared to the state where there is no load in the radial direction.

4. The intravascular device according to claim 1 or 2, characterized in that the coating comprises at least one radiopaque material selected from the group consisting of platinum, palladium, platinum-iridium, tantalum, gold, and tungsten.

5. The intravascular device according to claim 1 or 2, characterized in that the pseudo-elastic material includes NiTi or NiTiCu.

6. A method for selectively coating intravascular devices made from a pseudo-elastic alloy, (A) A process of providing an intravascular device made from a pseudo-elastic alloy in a state where no radial load is applied; (D) A step of compressing the intravascular device to a state in which the radial load is maximized by the radial load of the device; (E) A step of identifying the region of the intravascular device that has an elongation of at least 5% when the radial load is at its maximum compared to when there is no radial load; (F) A step of coating the intravascular device, excluding the area identified in step (E). Methods that include...

7. (B) A step of compressing the intravascular device to a state under a nominal load in the radial direction by the radial load of the device; (C) A step of identifying the region of the intravascular device that has at least 5% elongation when a nominal load is applied in the radial direction, compared to the device when no load is applied in the radial direction. It further includes, A method for selectively coating an intravascular device made from a pseudo-elastic alloy according to claim 6, characterized in that the coating by step (F) is carried out by recessing the region identified in steps (C) and (E).

8. A method for selectively coating an intravascular device made from a pseudo-elastic alloy according to claim 7, characterized in that steps (D) and (E) are performed after step (A) and before steps (B) and (C).

9. A method for selectively coating intravascular devices made from a pseudo-elastic alloy, (A') A step of providing an intravascular device made from a pseudo-elastic alloy in a state where no radial load is applied; (D') A step of compressing the intravascular device to a state in which the radial load is maximized by the radial load of the device; (E') Identifying a region of the intravascular device having at least 5% elongation when the radial load is at its maximum compared to a state where there is no radial load; and then identifying a section of the intravascular device containing the corresponding region of the defined elongation; (F') A step of coating the intravascular device, excluding the section identified in step (E'). Methods that include...

10. (B') A step of compressing the intravascular device to a state under a nominal load in the radial direction by the radial load of the device; (C') Identifying a region of the intravascular device having a defined elongation of at least 5% under a nominal load in the radial direction, compared to the device under no radial load; and then identifying a section of the intravascular device containing the corresponding region of the defined elongation. It further includes, A method for selectively coating an intravascular device made from a pseudo-elastic alloy according to claim 9, characterized in that the coating by step (F') is carried out by recessing the sections identified in steps (C') and (E').

11. A method for selectively coating an intravascular device made from a pseudo-elastic alloy according to claim 10, characterized in that steps (D') and (E') are performed after step (A') and before steps (B') and (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 the device is placed in a straight tube having a corresponding inner diameter to compress it to a radially nominal load state according to step (B) or (B') of the method.

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 the device is inserted into a straight tube having a corresponding inner diameter to compress it to a state in which the radial load is maximized according to step (D) or (D') of the method.

14. A method for selectively coating an intravascular device made from a pseudo-elastic alloy according to any one of claims 6 to 11, characterized in that the elongation due to steps (C) and (E) or steps (C') and (E') is at least 3% compared to the state in which no radial load is applied.

15. A method for selectively coating an intravascular device made from a pseudo-elastic alloy according to any one of claims 6 to 11, characterized in that steps (A) to (E) or (A') to (E') of the method are performed by computer simulation, for example, by the finite element method (FEM).

16. An intravascular device comprising a coating obtained by the method described in any one of claims 6 to 11.

17. A combination comprising the intravascular device and supply catheter according to claim 1 or 2.

Images