Method for producing a stent and computer-readable storage medium

By analyzing vessel anatomy and adjusting braiding parameters, the method produces patient-specific stents that adapt to individual vessel anatomy, ensuring proper expansion and reducing thrombus risk, addressing the inefficiencies of standard stents.

DE102020133096B4Active Publication Date: 2025-10-16ACANDIS GMBH & CO KG
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Patent Information

Application Number
DE102020133096
Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Filing Date
2020-12-11
Publication Date
2025-10-16
Estimated Expiration
2040-12-11

AI Technical Summary

Technical Problem

Existing stents fail to accurately adapt to the unique anatomy of individual patients' blood vessels, leading to potential damage, inadequate expansion, and functional inefficiencies such as insufficient opening or increased turbulence, which can cause injuries and thrombus formation.

Method used

A method for producing patient-specific stents by analyzing blood vessel anatomy through image data to determine curvature and torsion profiles, adjusting braiding parameters like braid type, angle, and pattern to ensure proper expansion and adaptation to vessel anatomy, using a braiding tool designed from a virtual tool model.

Benefits of technology

The method enables stents to be accurately tailored to individual vessel anatomy, ensuring proper expansion, reducing vessel damage, and minimizing thrombus risk, thereby improving clinical handling and treatment outcomes.

✦ Generated by Eureka AI based on patent content.

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Abstract

Method for manufacturing a stent, comprising the following steps: a) Providing image data of a blood vessel section to be treated, b) Determination of the diameter of the blood vessel section, c) Determination of the curvature and / or torsion of the blood vessel segment, d) Analysis of the curvature and / or torsion profile and determination of profile segments in which a predetermined curvature and / or torsion limit value is exceeded, e) Creation of a tool model by transferring the diameter curve to a linear axis; f) Creation of a braiding tool in the shape of the tool model; g) braiding wires on the braiding tool to form the stent with a braiding machine, wherein at least one braiding parameter is adjusted in a section of the stent in which the curvature and / or torsion limit is exceeded.
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Description

[0001] The invention relates to a method for producing a stent and a computer-readable storage medium.

[0002] Stents are well known and commonly used to treat stenoses, aneurysms, or other diseases of the vascular system. Since the vascular system differs anatomically from person to person, there is a need to adapt the implants or stents used within it to this anatomy. A replication of the vascular anatomy as accurately as possible is desirable to achieve good anchoring of the stent and, in particular, to prevent slippage. Furthermore, a stent design adapted to the anatomy of the target vessel reduces the stress on the target vessel.

[0003] In the standardized implants used to date, a stent often forces the blood vessel into dilation, exerting varying degrees of force on the blood vessel walls. This can lead to injury to the blood vessel walls or at least alter the course of blood flow, causing subsequent damage. In particular, this can overstimulate the blood vessel walls, which in turn can lead to inflammatory and swelling reactions. In blood vessels with comparatively rigid vessel walls, however, there is a risk that the stent will not be able to adapt to the course of the blood vessel. As a result, the stent often does not open sufficiently and therefore does not fully adhere to the vessel walls.

[0004] Therefore, it is desirable to produce a stent that is as well adapted as possible to the course of the target vessel while simultaneously exhibiting the good functional properties required for the specific application. Such functional properties could, for example, include greater compaction in an area where the stent covers an aneurysm. Greater compaction can slow or prevent blood flow into the aneurysm, which is desirable for treating the aneurysm. Furthermore, for the treatment of stenosis, it may be desirable for certain areas of the stent to exhibit increased radial force in order to dilate the blood vessel in a targeted manner at the affected location.

[0005] DE 10 2014 113 836 A1 already discloses a method for producing patient-specific stents. The invention described below is based on this method and is intended to improve the functionality of the stent produced using the known method.

[0006] DE 10 2017 203 161 A1 describes a braiding machine whose control system is adapted to compensate for imbalances in the wire spools that occur during wire unwinding. However, this known braiding machine is not suitable for the production of patient-specific stents.

[0007] The object of the invention is therefore to provide a method for producing a stent that produces stents that are individually tailored to the patient. Furthermore, the object of the invention is to provide a computer-readable storage medium with instructions that cause at least one processor to implement method steps for producing a patient-specific stent.

[0008] According to the invention, this object is achieved with regard to the method by the subject matter of patent claim 1 and with regard to the computer-readable storage medium by the subject matter of patent claim 10.

[0009] The invention is based on the idea of ​​providing a method for producing a stent in which the following steps are carried out, preferably in the specified chronological order: a) Providing image data of a blood vessel section to be treated, b) Determination of the diameter of the blood vessel section, c) Determination of the curvature and / or torsion of the blood vessel segment, d) Analysis of the curvature and / or torsion profile and determination of profile segments in which a predetermined curvature and / or torsion limit value is exceeded, e) Creation of a tool model by transferring the diameter curve to a linear axis; f) Creating a braiding tool in the shape of the tool model; g) braiding wires on the braiding tool to form the stent with a braiding machine, wherein at least one braiding parameter is adjusted in a section of the stent in which the curvature and / or torsion limit is exceeded.

[0010] The invention makes it possible to produce a stent that is particularly well adapted to the anatomy in a target blood vessel. The image data of the blood vessel section to be treated serves as the basis for the production of the stent. The image data preferably includes information on the length, width, and depth of the blood vessel section to be treated. In particular, the image data can include three-dimensional data of the blood vessel section to be treated.

[0011] The image data can be provided, for example, via an angiographic image acquisition system. The image data is used to determine the diameter profile of the blood vessel segment. In particular, a blood vessel diameter can be determined in regular, discrete sections. The combination of all determined diameters results in the diameter profile.

[0012] A particularly advantageous feature of the invention is that, in addition to the diameter profile of the blood vessel segment, a curvature and / or torsion profile of the blood vessel segment is also determined. This data enables a particularly precise adaptation of the stent to be manufactured to the profile of the blood vessel segment to be treated.

[0013] The manufacturing method according to the invention also provides for determining segments of the curvature and / or torsion curve in which a predetermined curvature and / or torsion limit value is exceeded. Such limit values ​​can be defined in advance and serve, in particular, to identify particularly narrow torsion sections and / or narrow curvature sections.

[0014] The information acquired in this way about the anatomy of the blood vessel section to be treated is used to manufacture the stent. In particular, the information about the diameter profile is used to create a virtual tool model, which in turn serves as the basis for manufacturing a braiding tool. The information about the curvature and / or torsion profile is taken into account when braiding the stent on this braiding tool. In particular, when braiding the wires on the braiding tool, an adjustment is made based on the previously performed analysis of the curvature and / or torsion profile. At least one braiding parameter is adjusted in a section of the stent in which the curvature and / or torsion limit is exceeded. This ensures that the stent to be manufactured fulfills the desired function, in particular that it expands well over its entire length in the blood vessel to be treated.

[0015] A stent made of braided wires has various properties that can become apparent during stent expansion. For example, a stent that is severely bent or twisted may collapse and thus no longer fulfill a desired recanalization function or adhere to a blood vessel wall. Moreover, if the stent wires do not fit tightly against the blood vessel wall, they can create turbulence in the blood flow, increasing the risk of thrombi formation. It has been shown that this undesirable behavior, i.e., insufficient expansion of the stent, occurs when certain curvature and / or torsion limits are exceeded. To avoid such behavior, the invention advantageously provides for a braiding parameter to be varied in a section of the stent in which the curvature and / or torsion limit is exceeded.The variation is preferably carried out in such a way that the function of the stent, in particular the correct expansion and opening behavior, is ensured. This allows the production of a stent that is highly adaptable to the specific blood vessel segment to be treated and that exhibits high functionality. The invention thus provides a manufacturing method that enables the production of stents that open well during implantation. This facilitates handling of the stent for the user.

[0016] In a preferred variant of the method according to the invention, the braiding parameter that is adjusted in a section of the stent in which the curvature and / or torsion limit is exceeded can be a braiding type. In particular, one of the following braiding types can be selected based on the curvature and / or torsion profile: 1-over-3 braiding, 1-over-2 braiding, and 1-over-1 braiding. It is also possible to combine the aforementioned braiding types.

[0017] The appropriate braiding type is selected depending on the limit being exceeded and the degree to which this exceedance occurs. For example, a 1-over-3 braid may be selected if lower radial force and lower torsional stiffness are advantageous in the relevant section of the stent. A 1-over-1 braid offers comparatively high flexural stiffness, torsional stiffness, and radial force. A middle ground between the 1-over-3 braid and the 1-over-1 braid is the selection of a 1-over-2 braid.

[0018] The braiding style is preferably adjusted in the control system of a braiding machine. The control system can specify, for predetermined sections of the stent, how many wires a single wire crosses before transitioning from one side of the braided structure to the other. For example, in a 1-over-3 braid, the wire can first cross over three other, transverse wires and then change sides, crossing under the next three transverse wires.

[0019] The braiding parameter, which is adjusted in the section of the stent where the curvature and / or torsion limit is exceeded, can also be a braiding pattern. In particular, the following braiding patterns can be selected based on the curvature and / or torsion profile: radial, axial, and twist. With a radial braiding pattern, the braiding type is regularly repeated in the circumferential direction of the stent. This braiding type is useful when high torsional stiffness is to be achieved, especially in the event of a sudden change in torsion direction. With an axial braiding pattern, the braiding type is regularly repeated in the longitudinal direction of the stent. This is desirable when the blood vessel section has steep curvatures, thus creating a central line connecting all the centers of the diameters of the diameter profile (the so-called centerline) with small bending radii.In areas with small bending radii, an axial braid pattern is advantageous. Twisting involves twisting two wires that would otherwise cross at a certain point together. Twisting can be used in sections of the stent where, for example, the stent covers a branching vessel when deployed into the blood vessel to be treated. Twisting increases the mesh size of the stent in certain areas, thus providing good blood flow to branching blood vessels.

[0020] In a further embodiment of the manufacturing method according to the invention, the braiding parameter that is adjusted in a section of the stent in which the curvature and / or torsion limit is exceeded is a braiding angle. The braiding angle can be changed, in particular based on the curvature and / or torsion profile, by a maximum of 15°, in particular a maximum of 10°, in particular a maximum of 5°, in particular 5°, compared to immediately adjacent sections of the stent. The braiding angle varies with the speed at which the braiding tool is moved in a braiding machine. This speed of the braiding tool is freely adjustable.To form stent sections that are used in blood vessel sections where the curvature limit and / or the torsion limit has been exceeded, the control of the braiding machine is preferably adapted so that the speed of the braiding tool is changed during braiding so that the braiding angle in these stent sections changes.

[0021] The number of wires braided on the braiding tool to form the stent can be selected based on the smallest diameter of the tool model. By transferring the diameter profile of the blood vessel to be treated onto a linear axis, a diameter profile of the tool model is obtained. The diameter profile of the tool model has a diameter that is smaller than all other diameters. The wires to be used to braid the stent are preferably selected based on this diameter. For example, for diameters of less than 5 mm, between 28 and 48 wires, preferably exactly 48 wires, can be used to form the stent. If the smallest diameter of the diameter profile is at least 5 mm and less than 6.1 mm, for example, between 36 and 64 wires, preferably 52 wires, can be used.For a smallest diameter of the diameter profile of at least 6.1 mm and less than 8.1 mm, preferably between 48 and 96 wires, preferably 64 wires, are used. For a diameter profile whose smallest diameter is at least 8.1 mm and less than 10.1 mm, it is advantageous to use between 64 and 120 wires, preferably 72 wires. By varying the number of wires, the porosity, flexibility, especially bending flexibility, and / or torsional rigidity can be adjusted.

[0022] It is also possible, within the scope of a preferred embodiment of the manufacturing method, for X-ray markers to be embedded into the stent at at least one longitudinal end of the at least one section of the stent in which the curvature and / or torsion limit is exceeded, in particular at the transition to another section of the stent. In other words, individual sections of the stent that differ from one another in their arrangement, design, or function can be optically separated from one another by X-ray markers placed between these sections. This makes it easy for medical personnel to distinguish the individual sections of the stent from one another under X-ray control and, in particular, to check the placement of the individual sections in the desired blood vessel sections.Additionally or alternatively, the detectability of individual sections of the stent can also be achieved by appropriately positioned X-ray markers on a delivery element, in particular a delivery wire, for the stent.

[0023] Furthermore, additional elements can be integrated into the stent as needed. For example, elements with a supporting function can be integrated into the stent's mesh. This can be useful, for example, to support vascular branches or stenotic blood vessel segments. Additional elements are also conceivable that stiffen the stent's mesh structure as a whole and prevent sliding movement between the stent wires. It is also possible to couple such additional elements to the stent in an additional process step. For example, the stent can be provided with a covering, at least in sections.

[0024] The determination of the diameter profile and the curvature and / or torsion profile, the analysis of the curvature and / or torsion profile, and / or the creation of the tool model can be performed in a common control unit. This eliminates the need for interfaces for data transfer between different control units.

[0025] In one variant of the method according to the invention, several tool sections from a modular system are connected to one another when creating the braiding tool. This variant is particularly suitable for quickly providing a patient-specific stent. The braiding tool can be created from predefined tool sections particularly quickly. For this purpose, tool sections are kept in stock, which are selected and connected to one another based on the previously determined data on the diameter profile. The braiding tool can thus be created very quickly and easily.

[0026] An alternative variant aims to achieve greater precision in the braiding tool. In this variant, the braiding tool is manufactured in one piece using a subtractive or additive manufacturing process. This ensures that the diameter profile is preferably transferred identically to the braiding tool. Such a braiding tool can be manufactured subtractively, for example, by turning or milling, or additively by 3D printing. While this process requires more time, this variant offers greater accuracy in mapping the diameter profile on the stent to be inserted later.

[0027] A further aspect of the invention relates to a computer-readable storage medium containing instructions that cause at least one processor to implement at least method steps a) to d) of the method described above when the instructions are executed by the processor. In other words, the method steps described above are preferably combined in a common control unit.

[0028] The instructions can also cause the processor to implement method step e) of the previously described method when the instructions are executed by the processor. Likewise, in a further variant, the instructions can also cause the processor to implement method steps f) and g) of the previously described method when the instructions are executed by the processor.

[0029] The instructions may cause the processor to implement all method steps of the aforementioned method when the instructions are executed by the processor.

[0030] The invention is explained in more detail below with reference to schematic drawings. They show: Fig. 1 a flowchart of the method according to the invention according to a preferred embodiment; Fig. 2 a representation of a 3D model of a blood vessel section to be treated; Fig. 3 an overview of sub-steps of the procedure according to Fig. 1; Fig. 4 an overview of further steps of the procedure according to Fig. 1; Fig. 5 a representation of a curvature of the blood vessel section according to Fig. 2; Fig. 6 a representation of the torsion course of the blood vessel section according to Fig. 2; Fig. 7 a representation of the cumulative torsion curve of the blood vessel section according to Fig. 2; Fig. 8 is a side view of a stent produced by the method according to the invention; and Fig. 9 a detail of a stent structure with twists, produced by the method according to the invention.

[0031] The sequence of a manufacturing method according to the invention according to a preferred embodiment is shown in Fig. 1. This shows Fig. 1 the overall process. In Fig. 3 and Fig. 4 shows detailed steps in more detail.

[0032] In the procedure, according to Fig. 1 First, image data of a specific patient is acquired. This image data contains, in particular, information about a blood vessel section to be treated. Such image data can be created, for example, from angiographic images, such as X-ray images and / or computed tomography images. It is also possible to use magnetic resonance imaging data as image data. The data is preferably available as digital data, particularly in DICOM format.

[0033] In the next step, the image data is segmented, preferably using software, and reconstructed as a three-dimensional surface. This preferably results in a CAD model of the blood vessel section to be treated. Such a model is available in Fig. 2 shown.

[0034] The digital model or digital twin of the blood vessel segment to be treated is analyzed in subsequent steps. First, the diameter profile along the vessel model is determined. Preferably, the diameters along the blood vessel model are determined at regular, discrete intervals.

[0035] Furthermore, a centerline is determined based on the blood vessel model, which identifies all the centers of the measured diameters. This corresponds to the centerline that extends through the blood vessel section to be treated.

[0036] The course of this midline, which is also called centerline, is, for example, in Fig. 2 shown.

[0037] The determined centerline forms the basis for analyzing the curvature and / or torsion of the blood vessel segment to be treated. For this purpose, the centerline is analyzed, preferably using differential geometry, and the curvature and torsion curves are calculated.

[0038] In the next step, the results of the curvature and / or torsion analysis are evaluated. The obtained data on the curvature and torsion profiles are compared with predetermined limit values. If limit values ​​regarding curvature and / or torsion are exceeded in sections along the centerline, the braiding parameters are adjusted. This is intended to ensure that the braided stent expands reliably in these areas as well and exhibits the desired functionality.

[0039] The diameter profile determined from the vessel model is used to manufacture a braiding tool. For this purpose, the diameter profile is transferred to a line along an axis. This creates a digital tool model. This digital tool model can be available as a CAD data set. A braiding tool can then be manufactured using the digital tool model. This can be done, for example, using 3D printing, whereby the CAD data of the tool model can be transmitted directly to the 3D printer. Alternatively, a modular system can be provided that features different tool sections of the braiding tool. The tool sections can differ from one another in their shape, length, and diameter.Using the digital tool model, software can determine which tool sections should be combined and in which way to replicate the diameter of the blood vessel to be treated as accurately as possible. The software can then create a list of the tool sections to be used and an overview of the assembly sequence.

[0040] Braiding parameters are determined by determining the centerline, analyzing it, and evaluating the analysis results. This data is used to control the braiding machine, allowing it to produce the patient-specific stent on the patient-specific braiding tool. For this purpose, stent design features are derived. These design features include the diameter profile, the number of wires to be used, the preferred braiding angle, the braiding type, and / or the braiding pattern. These braiding parameters can be varied in specific areas or sections, depending on the centerline profile and the diameter of the blood vessel to be treated.

[0041] Preferably, a CAD model of the stent to be manufactured is generated based on the derived design features. The CAD model can be viewed by medical personnel and preferably compared with the blood vessel model. This allows verification of whether the proposed stent design meets the desired requirements. Medical personnel also have the option of adjusting design parameters, for example, varying limits for curvature and / or torsion, thus triggering the specification step again. Once the verification of the digital stent model is complete, the corresponding data is transferred to a braiding machine, which then produces the customized stent on the patient-specific braiding tool.

[0042] Fig. Figure 2 shows a vascular model created from digital image data. Fig. 2 highlights the centerline, which was determined based on the analysis of the image data. Fig. The vessel model shown in Figure 2 serves as a basis for determining the centerline and the vessel diameter.

[0043] Fig. Figure 3 shows in detail the process steps for determining the braiding parameters. In general, the centerline is preferably determined, then analyzed using differential geometry, and the analysis results are subsequently evaluated. The centerline can be determined by generating a Voronoi diagram. The provided image data is divided into polygons to create a three-dimensional vessel model. The centerline is then calculated using differential geometry, specifically by solving the minimization problem for path generation.

[0044] The centerline can then be analyzed using further differential geometric calculations. For this purpose, a curvature analysis is performed. This can be achieved using Frenet's formulas. Likewise, the torsion of the centerline or the blood vessel segment can be determined using Frenet's formulas. Characteristic values ​​are also determined. The values ​​for curvature and / or torsion can be represented, for example, in diagrams. An example of such a curvature diagram is shown below. Fig. 5. The characteristic values ​​of the curvature are recorded. A change in the direction of the curvature is indicated by a change in sign. Fig. Figure 6 shows an example of the characteristic torsion values ​​along the centerline. Here, too, a change in the direction of the torsion is evident through a change in sign.

[0045] To evaluate the analysis results, it is determined whether characteristic values ​​of curvature and / or torsion exceed predetermined limits. The evaluation can be performed in various ways. On the one hand, a cumulative torsion can be determined. The torsion values ​​along the centerline are added together to determine the total amount by which the blood vessel segment has twisted along a specific section of the centerline. A representation of the cumulative torsion is shown in the diagram according to Fig. 7 can be seen.

[0046] It has been shown in practice that local changes in the direction of torsion can prevent or at least impede stent expansion. A change in the direction of torsion is indicated by a change in sign. Fig. 7, the gradient between the highest and lowest torsion values ​​is therefore indicated. The distance ΔS along the centerline is thus set in relation to the magnitude of the maximum torsion ΔT. The ratio between the magnitude of the maximum torsion ΔT and the corresponding section ΔS of the centerline (ΔT / ΔS) describes the gradient of the change of direction. As soon as the gradient reaches a value that exceeds the limit, difficulties in expanding the stent are to be expected. To avoid such expansion difficulties, braiding parameters are adjusted in this section. Therefore, by evaluating the curvature and / or torsion curves, it is determined whether additional customization is necessary, and this adjustment is then made.

[0047] Fig. Figure 4 shows the individual steps in deriving design features based on the previously performed analysis of the centerline or vessel diameter profile. Based on the vessel diameter profile, a tool model, specifically a digital CAD model, is first created. This essentially involves transferring the centerline to a linear axis. The determined diameter profile is then applied along the linear axis. This creates a straight braided model that essentially maps the diameter profile of the blood vessel to be treated.

[0048] Based on the data obtained regarding the diameter and centerline profile, as well as the curvature and torsion profiles, the basic design parameters of the stent are then determined. These parameters primarily concern the number of wires and the wire diameter. These values ​​preferably remain constant throughout the entire length of the stent.

[0049] Next, the braiding parameters to be adjusted to the patient's specific needs are determined. This includes, for example, the braiding type, the braiding pattern, and the braiding angle. These flexible braiding parameters can vary in sections of the stent. Especially in sections where a predetermined limit is exceeded, the braiding type, braiding pattern, and / or braiding angle are preferably adjusted to ensure a secure opening of the stent in the blood vessel.

[0050] It is preferably provided that a change in the flexible braiding parameters along the stent to be manufactured occurs only in sections. Within a section, the braiding parameters preferably remain constant. Such a section preferably has a length between 1 mm and 10 mm, in particular between 2.5 mm and 5 mm. In any case, it is provided that such a stent section is at least as long as the section of the centerline in which the limit value for curvature and / or torsion is exceeded.

[0051] Based on the desired function of the stent to be manufactured and the previously analyzed anatomical data, additional elements can also be specified that the stent to be manufactured should contain. Such additional elements can be, for example, X-ray markers integrated into the stent's mesh to distinguish different stent sections from one another. For example, X-ray markers can be provided between two stent sections to mark the transition from one stent section to the next. X-ray markers can also be arranged on a delivery wire so that the individual stent sections can be distinguished from one another. It is also possible to incorporate reinforcing structures into the stent structure. Fig. Figure 9 shows an example of a side view of a stent produced using the manufacturing method according to the invention. For clarity, only one half of the stent is shown, meaning that wires in the background are hidden.

[0052] The stent comprises several stent sections S1 to S6, which differ from one another in their design features. Thus, the first stent section S1 has a cross-sectional diameter that is smaller than the cross-sectional diameter of the sixth stent section S6. The second stent section S2 and the third stent section S5 preferably each have braiding angles that differ from the braiding angles of adjacent stent sections S1, S3, S4, S6. In the third stent section S3, the cross-sectional diameter is provided to change continuously. The third stent section S3 thus forms a transition section between the cross-sectional diameter of the second stent section S2 and the fourth stent section S4. In this respect, the third stent section S3 has a truncated cone shape.

[0053] The change in diameter that occurs in Fig. 8, is preferably created on the individually manufactured braiding tool, which reproduces these different cross-sectional diameters. Other design parameters of the stent, such as the braiding angle and braiding type, are influenced by the braiding process on the braiding machine. For example, the braiding angle can be varied by moving the braiding tool through the braiding machine at different speeds.

[0054] Fig. Figure 9 shows an example of a special design feature of a stent which is preferably used for treating a blood vessel section according to Fig. 2 was manufactured. As in Fig. As can be seen in Figure 2, the blood vessel section has at least one branching blood vessel, which will be spanned by a stent to be manufactured. To ensure that sufficient blood can flow from the main vessel into the branching vessel, it can be specified during the manufacture of the stent that an increased mesh size is provided in this area. This can be achieved, for example, by introducing a twist 12 into this section of the stent, as shown in Fig. 9. To produce the twist 12, two intersecting wires 11 are intertwined at a crossing point. Fig. 9 also shows that the braiding angle, ie the angle between a wire 11 and a longitudinal axis of the stent, is different in a section before the twisting 12 and in a section after the twisting 12. Thus, Fig.9 different design parameters that are determined based on patient-specific data and taken into account in the production of the patient-specific stent.

[0055] Using the method described above, it is therefore possible to adapt a stent to the individual patient based on several parameters or design features. In particular, the mechanical properties of the stent can be adapted to the vascular anatomy to be treated. This improves the handling of the stent in clinical use. In particular, by adjusting braiding parameters in sections of the stent that exceed a predetermined curvature and / or torsion limit, good opening behavior of the stent or expansion behavior of the stent can be ensured even in difficult anatomical conditions. This ultimately improves the long-term success of the treatment because the stent adapts better to the blood vessel wall. This typically results in improved colonization of the stent with endothelial cells and a reduced risk of thromboembolic complications. Reference symbol 10 stents 11 wire 12 twisting S1 first stent section S2 second stent section S3 third stent section S4 fourth stent section S5 fifth stent section S6 sixth stent section

Claims

[1] Method for manufacturing a stent, comprising the following steps: a) Providing image data of a blood vessel segment to be treated, b) Determination of the diameter profile of the blood vessel segment, c) Determination of the curvature and / or torsion pattern of the blood vessel segment, d) Analysis of the curvature and / or torsion profile and determination of profile segments in which a predetermined curvature and / or torsion limit is exceeded, e) Formation of a tool model by transferring the diameter profile onto a linear axis; f) Creation of a braiding tool in the form of the tool model; g) Braiding of wires on the braiding tool to form the stent using a braiding machine, wherein at least one braiding parameter is adjusted in a section of the stent where the curvature and / or torsion limit is exceeded. [2] Method according to claim 1, characterized by , that the braiding parameter is a braiding type, whereby, based on the curvature and / or torsion profile, in particular one of the following braiding types is selected: 1-over-3 braiding, 1-over-2 braiding, 1-over-1 braiding. [3] Method according to claim 1 or 2, characterized by , that the braiding parameter is a braiding pattern, whereby the following braiding patterns are selected based on the curvature and / or torsion profile: radial, axial, twisting. [4] Method according to any one of the preceding claims, characterized by , that the braiding parameter is a braiding angle, in particular wherein the braiding angle is changed by at most 15°, in particular at most 10°, in particular 5°, relative to immediately adjacent sections of the stent based on the curvature and / or torsion profile. [5] Method according to any one of the preceding claims, characterized by, that the number of wires to be braided on the braiding tool is selected based on the smallest diameter of the tool model. [6] Method according to any one of the preceding claims, characterized by , that X-ray markers are embedded in the stent at at least one longitudinal end of at least one section of the stent, in particular at the transition to another section. [7] Method according to any one of the preceding claims, characterized by , that the determination of the diameter profile and the curvature and / or torsion profile, the analysis of the curvature and / or torsion profile and / or the formation of the tool model are carried out in a common control unit. [8] Method according to any one of the preceding claims, characterized by , that several tool sections from a modular system are joined together when creating the braiding tool. [9] Method according to any one of claims 1 to 8, characterized by that the braiding tool is manufactured in one piece using a subtractive or additive manufacturing process. [10] Computer-readable storage medium containing instructions that cause at least one processor to implement at least the process steps a)-d) of the method according to any of the preceding claims when the instructions are executed by the processor. [11] Computer-readable storage medium according to claim 10, characterized by that the instructions also cause the processor to implement process step e) of the method according to any one of claims 1 to 8 when the instructions are executed by the processor. [12] Computer-readable storage medium according to claim 10 or 11, characterized bythat the instructions also cause the processor to implement the process steps f) and g) of the method according to any one of claims 1 to 8 when the instructions are executed by the processor. [13] Computer-readable storage medium according to any of the preceding claims, characterized by that the instructions cause the processor to implement all process steps of the method according to any one of claims 1 to 9 when the instructions are executed by the processor.

Citation Information

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