Medical device, method for producing the medical device, and circular loom for carrying out the method

Abstract

The invention relates to a medical device (100) comprising at least one support structure (10), wherein the support structure (10) comprises or consists of a metal and / or a plastics material and a woven fabric (11), wherein the medical device (100) is substantially tubular. In order to minimise the insertion profile, to increase the flexibility, to ensure optimised adaptation to the vessel wall and, at the same time, to improve material efficiency and biocompatibility and to simplify production, it is proposed that the woven fabric (11) be interlockingly interwoven with the support structure (10), and that a thickness of the woven fabric (11) be less than 100 µm, preferably less than 80 µm, particularly preferably less than 60 µm.

Description

[0001] Aortex UG 13.03.2025

[0002] 1

[0003] Medical device, a method for manufacturing the medical device and a circular weaving machine for carrying out the method

[0004] The invention relates to a medical device comprising at least one support structure, wherein the support structure comprises or consists of a metal and / or a plastic, and a tissue, wherein the medical device is essentially tubular in shape.

[0005] Such a medical device is known from the prior art.

[0006] US patent 10,893,931 B2 relates to a device for manufacturing a woven, tubular nanotextile used in vascular transplantation. The woven nanotextile tube has a diameter of 0.1 to 50 mm and contains a multitude of hierarchically arranged nanofibers. These are made from bundled, low-strength nanothreads containing thousands of nanofibers with enhanced mechanical strength. The weaving machine interweaves the warp and weft threads in both longitudinal and transverse directions, resulting in a flexible yet strong woven product. The physical and biological properties of the woven nanotextile are significantly improved compared to non-woven nanofibers and conventional medical textiles.The nanotextile exhibited superhydrophilic behavior in an otherwise hydrophobic material and, after implantation as a vascular graft, was robust, sutureable, kink-resistant and non-thrombogenic, with complete endothelialization of the graft luminal area.

[0007] US Patent 2023248 506 A relates to a stent graft system comprising a main body stent graft, an outer branch, and at least one inner branch. The main body stent graft is a tubular structure with a covering membrane on one surface, forming a radially recessed concave section.

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[0010] The outer branch extends outside the main body stent graft, with one end attached to a lateral wall of the concave section. The inner branch is attached to the inner wall of the main body stent graft, with an outer opening on the lateral wall of the concave section, the outer opening being distal to the inner opening.

[0011] US 2015 0 018 933 A1 relates to an aortic stent graft capable of preventing displacement, comprising a coated stent body and an uncoated stent connected to a proximal end of the coated stent body. The uncoated stent body features barbs for anti-loosening fixation, located on each crest and trough of the uncoated stent and extending toward a distal end of the coated stent body. Once the aortic stent graft is secured by the anti-loosening fixation structures, the barbs located on each crest of the bare stent are not in the same plane as the barbs located on each trough of the bare stent.Therefore, there are no simultaneous relative movements of the two sets of barbs that could lead to a detachment or loosening of the anti-loosening fixation structures, so that the aortic stent graft can be more firmly attached to the blood vessel wall.

[0012] Stent grafts are medical devices used in endovascular therapy to treat vascular diseases such as aneurysms, vessel dissections, or stenoses. They consist of a combination of a support structure (stent) and a textile or synthetic covering (graft) that directs blood flow and prevents blood from leaking through damaged vessel walls. The stent graft can be implanted preventively before the blood vessel is damaged. Implantation is minimally invasive using a catheter, thus avoiding open surgical procedures. Stent grafts stabilize weakened vessels.

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[0015] or damaged vessel walls, they bridge cracks or constrictions and help restore the natural function of the vascular system. Adapting them to different anatomical conditions, especially in complex vascular regions, is a challenge.

[0016] The invention is based on the objective of minimizing the insertion profile, increasing flexibility, ensuring optimized adaptation to the vessel wall, and simultaneously improving material efficiency and biocompatibility and enabling simplified manufacturing in a medical device of the type mentioned above.

[0017] To solve the problem underlying the invention, a medical device is proposed which comprises at least one support structure, wherein the support structure comprises or consists of a metal and / or a plastic. The medical device also comprises a fabric and is essentially tubular in shape. The fabric is interwoven with the support structure in an interlocking manner. The thickness of the fabric is less than 100 pm, preferably less than 80 pm, and particularly preferably less than 60 pm.

[0018] The medical device can be used, for example, as a stent graft, catheter, implant, and / or similar device. Essentially tubular means that the medical device has a predominantly cylindrical or tube-like shape, although slight deviations, such as branches, tapers, widenings, or asymmetrical areas, are not excluded. Interlocking woven refers to a structure in which two or more components are connected exclusively by a weaving process. Threads, fibers, or wires are systematically crossed or interwoven to form a textile structure that binds the components together.

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[0021] The support structure and fabric are integrated into an inseparable, stable, and functional unit. In particular, the support structure and fabric can be interwoven in such a way that the fabric is woven through and around the support structure. This ensures high stability and durability of the medical device and allows for flexibility in shape, porosity, and elasticity, as well as accelerated production time.

[0022] The thinness of the tissue allows the medical device to be designed with thin walls and flexibility, which is particularly advantageous in applications such as stent grafts, as these devices often need to be inserted through narrow and tortuous body channels. At the same time, the interlocking weave of the support structure and tissue ensures high stability of the medical device, allowing it to maintain its shape and function even under high stress. The thickness is measured by taking a cross-sectional image with a microscope. This method enables a precise and accurate measurement of the tissue thickness by generating a detailed image of the tissue cross-section. This image can then be analyzed, and the tissue thickness can be accurately determined. An alternative method for measuring tissue thickness is the use of a thickness gauge according to DIN EN ISO 5084 at a pressure of 1 kPa.

[0023] The support structure can consist of or comprise a biocompatible metal, such as, in particular, stainless steel, titanium, a nickel-titanium alloy (nitinol), or similar materials. Alternatively or additionally, the support structure comprises or consists of a plastic. Preferably, the plastic can also be a combination of a variety of plastics. For example, the plastic can be a thermoplastic, in particular a poly-L-lactide (PLLA), a polyetherketone (PEEK), and / or a polyurethane (PU). PLLA has the advantage that the medical device then exhibits at least partially bioresorbable properties. PEEK, on ​​the other hand, is not.

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[0026] It is biodegradable but exhibits very high, metal-like strength. PU is also non-biodegradable and possesses variable properties that allow for flexible design. The support structure can be woven in at the points where it is needed. By weaving in the support structure at the required locations, the flexibility of the medical device can be increased, which is particularly advantageous in applications such as stent grafts, as these need to be especially stable at the site of an aneurysm. This makes it possible to individually adapt the medical device to the specific requirements and needs of a patient while simultaneously ensuring high performance and reliability.

[0027] For example, the medical device for connecting the support structure to the tissue has no seams and / or adhesives. Preferably, the tissue is not applied to the support structure by heat shrinking.

[0028] For example, the fabric comprises or consists of synthetic fibers. Preferably, the synthetic fibers comprise or consist of polyethylene. Polyethylene exhibits high toughness, excellent chemical resistance, and the ability to withstand high temperatures. Furthermore, polyethylene is biocompatible and can therefore be safely used in medical devices that come into contact with the body. Polyethylene fibers can be produced by various processes, including melt spinning, solution spinning, and gel spinning. The resulting fibers can exhibit high strength and high elasticity, making them particularly suitable for use in medical devices.

[0029] The polyethylene used in the medical device can, for example, have a molecular mass of more than 500,000 g / mol, preferably more than 2,000,000 g / mol.

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[0032] g / mol. High molecular weight polyethylene exhibits increased strength and toughness, making it particularly suitable for use in medical devices that must withstand high loads.

[0033] For example, the polyethylene used in the medical device could also be UHMWPE (ultra-high-molecular-weight polyethylene). It is characterized by a number of properties that make it particularly suitable for use in this field. It is high-strength, meaning it has high tensile strength and high impact resistance. These properties allow the material to withstand high loads, which is crucial in medical applications where the devices may be subjected to high stress. Furthermore, UHMWPE is chemically resistant. This means it is resistant to a wide variety of chemical substances, including many acids, alkalis, and solvents.This chemical resistance makes it particularly suitable for use in medical devices that may come into contact with bodily fluids containing a variety of chemical substances. UHMWPE is smooth, which means it has low friction. This property can minimize friction between the medical device and surrounding tissues, potentially reducing irritation and increasing patient comfort. Additionally, the lower friction between the fabric or its fibers and the supporting structure of the medical device results in less wear and tear on the material, leading to increased device longevity. Furthermore, UHMWPE is hydrophobic, meaning it repels water.This property can help minimize moisture buildup and the associated potential for bacterial growth, thus reducing the likelihood of inflammation. UHMWPE is non-absorbable, meaning it is not broken down or absorbed by the body.

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[0036] This is an advantageous property for medical devices intended for long-term use in the body. Furthermore, UHMWPE has excellent biocompatibility because it is bio-inert. This means it does not cause any harmful or undesirable reactions in the body, making it particularly suitable for use in medical devices, especially implants.

[0037] For example, synthetic fibers include or consist of multifilament yarn. Multifilament yarn is made up of a multitude of individual threads and / or filaments that are twisted and / or spun together to form a yarn. Multifilament yarn can exhibit high strength, high elasticity, and high abrasion resistance, making it particularly suitable for use in medical devices that must withstand high stress. Furthermore, multifilament yarn can exhibit high dimensional stability and low moisture absorption, making it especially suitable for use in medical devices that may come into contact with bodily fluids.

[0038] For example, the multifilament yarn can consist of 2 to 10 individual filaments, preferably 4 to 8 individual filaments, and most preferably 5 to 7 individual filaments. The number of individual filaments in the multifilament yarn can influence the mechanical properties of the yarn and thus the properties of the medical device. For example, a yarn with a larger number of individual filaments can exhibit higher strength and elasticity than a yarn with a smaller number of individual filaments. Furthermore, a yarn with a larger number of individual filaments can exhibit greater dimensional stability and lower moisture absorption, making it particularly suitable for use in medical devices that come into contact with bodily fluids. The exact number of individual filaments

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[0041] The multifilament yarn can be selected according to the specific requirements of the medical device and the desired properties of the yarn, thus improving individual adaptability to the needs of the patient.

[0042] For example, the multifilament yarn may have a titer of less than 15 dtex, preferably less than 12.5 dtex, and most preferably less than 10 dtex. The titer of a yarn is a measure of its fineness and is expressed in decitex (dtex), where 1 dtex corresponds to the weight in grams of 10,000 meters of yarn.

[0043] For example, the tissue may have a microscopically and macroscopically highly smooth surface. A microscopically and macroscopically highly smooth surface, as understood by those skilled in the art, is one with a roughness (Ra value) of less than 1 pm, preferably less than 0.5 pm, particularly preferably less than 0.2 pm, and most preferably less than 0.1 pm. In a medical device used as a stent graft, a highly smooth surface can lead to laminar blood flow, which exhibits a lower tendency towards turbulent flow. Turbulent flow can trigger increased thrombus formation, which can pose a risk to the patient. Therefore, a membrane with a highly smooth surface can improve hemocompatibility by reducing the risk of turbulent flow and thus thrombus formation.

[0044] For example, the tissue may exhibit tissue homogeneity. In other words, the tissue does not exhibit undulation heterogeneity. Undulation heterogeneity refers to variation in waveform and / or ripple within the tissue. A tissue is considered homogeneous if its characteristic properties

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[0047] - for example, structure, density, and / or functional parameters are nearly constant. Variations must be subject only to random, statistically insignificant fluctuations, and no systematic, regularly recurring patterns may be discernible. The fabric may exhibit at least one variation in fabric homogeneity in different sub-areas, for example, through the use of fibers and / or yarns with different properties and / or through the application of specific weaving techniques. For example, the fabric may have a first sub-area and a second sub-area. Further sub-areas with individual properties are also possible. However, the respective sub-areas are homogeneous within themselves. Variation in fabric homogeneity can contribute to improving the mechanical properties of the fabric by, for example, increasing its flexibility or its ability to withstand loads.Furthermore, varying properties in the first and second sub-areas can help modulate the interaction of the tissue with biological tissues or fluids, for example, by influencing the adhesion of cells or proteins to the tissue surface. This can be particularly advantageous in medical applications where the device comes into contact with biological tissues or fluids.

[0048] For example, at least the first section of the fabric can be woven more densely or more loosely than the second section. Preferably, the fabric is configured by alternating the first and second sections.

[0049] For example, the fabric can have a large number of weft threads, with at least some of the weft threads exhibiting increased elasticity compared to the synthetic fibers. Weft threads are the threads that run perpendicular to the lengthwise direction of a fabric, i.e., perpendicular to the warp threads. By using

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[0052] Weft threads with increased elasticity allow for more flexible fabric, which can be particularly advantageous for medical devices that need to be placed in body channels or cavities that are subject to deformation or movement. The precise elasticity of the weft threads can be selected according to the specific requirements of the medical device and the desired fabric properties. Increased elasticity can be achieved through the use of special materials, such as elastic polymers, or through special processing techniques, such as the use of pre-stretched threads or the application of specific weaving techniques. This allows the medical device to be designed to regulate systolic and diastolic blood pressure like a real artery.The special arrangement and selection of the weft threads allows the medical device to adapt to the dynamic conditions of blood flow, similar to a natural artery.

[0053] For example, the longitudinal extensibility of the medical device can be influenced by the selection and arrangement of the weft threads. The specific extensibility requirements in this direction may depend on the size of the artery and the condition of the tissue.

[0054] For example, the medical device can be radially symmetrical or at least partially radially asymmetrical. Preferably, the medical device has at least one radius gradient. The radius gradient refers to a change in the radius of the medical device along its length and / or circumference. This can be achieved by designing the medical device to have a larger or smaller radius at certain points. A radius gradient can help optimize the fit and function of the medical device, especially when it is used in

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[0057] The device is placed in body channels or cavities that may have an irregular shape or size. Furthermore, a radius gradient can help improve the mechanical properties of the medical device, such as its flexibility or its ability to withstand stress. The precise design of the radius gradient can be selected according to the specific requirements and desired properties of the medical device. For example, the radius gradient can be linear. Preferably, the medical device features a variety of radius gradients. This allows the medical device to be manufactured, for example, according to a 3D scan of an artery. This enables the creation of a near-identical replica of the patient's artery to optimize the fit and function of the medical device.

[0058] For example, the medical device can have at least one first and at least one second end. Preferably, radially outward-facing barbs are formed at the first and / or second end. The barbs serve to hold the medical device in position after it has been placed in a body canal or cavity. The barbs can be designed to penetrate the surrounding tissue, thus preventing the medical device from slipping or dislodging. Preferably, the barbs comprise or consist of the same material as the support structure of the medical device. For example, the barbs may be made of a metal, a plastic, a ceramic material, and / or a composite material.

[0059] For example, the medical device may include at least one fenestration and / or at least one branch. A fenestration is an opening or hole in a surface of the medical device, which, for example,

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[0062] A fenestration can serve to allow liquids or other substances to pass through the surface of the medical device. A branch is an additional channel or tube that extends from the main structure of the medical device and can, for example, serve to direct liquids or other substances into or out of a specific area of ​​the body. The precise design and arrangement of the fenestrations and / or branches can be selected according to the specific requirements and desired properties of the medical device.

[0063] For example, the branching can be configured as a bifurcation, trifurcation, or more. A bifurcation is a branching that divides into two separate tubes. A trifurcation is a branching that divides into three separate tubes. A branching that divides into four or more separate tubes can be called a quadrifurcation, quintifurcation, etc. The precise design and arrangement of the branching can be selected according to the specific requirements and desired characteristics of the medical device. For example, the medical device can be precisely adapted to the bifurcations of the abdominal aorta, the two common iliac arteries (right and left), and / or the carotid bifurcation, the division of the common carotid artery into the internal and external carotid arteries.For example, the trifurcation of the middle cerebral artery (Arteria cerebri media) in the brain, in which the middle cerebral artery (Arteria cerebri media) is divided into three main branches, and / or the trifurcation of the popliteal artery, divided into the anterior and posterior tibial artery (Arteria tibialis anterior and posterior) and the fibular artery (Arteria fibularis) can be adapted.

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[0066] For example, a fenestrated medical device can have its cut edges cauterized or reinforced with an eyelet. This improves the stability and longevity of the medical device.

[0067] For example, the medical device comprises a tissue in a tubular shape, the tubular shape being not produced by an extrusion process.

[0068] For example, the medical device can be manufactured in one piece. This means that, after the support structure is provided, the medical device is produced in a single manufacturing process without the need for additional joining or assembly steps. This has several advantages, including increased structural integrity and strength of the medical device, improved manufacturing efficiency, and a reduction in the likelihood of errors or defects in the device. Furthermore, one-piece manufacturing can help reduce the complexity of the manufacturing process and lower the cost of producing the device. It also allows for improved blood flow, resulting in reduced thrombus formation, due to a homogeneous, smooth inner wall.

[0069] For example, manufacturing can help reduce the complexity of the manufacturing process and lower the cost of producing the device.

[0070] For example, the pore size of the tissue can be between 1 and 750 pm, preferably between 5 and 600 pm, and most preferably between 10 and 500 pm. For example, a larger pore size can allow for higher permeability to liquids, gases, and tissues, which is advantageous in certain applications.

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[0073] In certain applications, a smaller pore size may be desirable. On the other hand, a smaller pore size can help increase the mechanical strength of the tissue and prevent the ingress and / or penetration of unwanted substances, especially blood or organisms. The precise pore size of the tissue can be selected according to the specific requirements of the medical device and the desired properties of the tissue. For example, the pore size can be continuously varied by changing the weaving method. This allows for efficient integration with the tissue at the inlet and outlet of the medical device. Simultaneously, the adjustable pore size can help ensure a blood-tight barrier at the site of the aneurysm.An appropriate pore size can help the graft tissue form an effective barrier against blood seepage, which is particularly important to minimize the risk of bleeding and complications. For example, the pore size at the first and / or second end of the medical device may be larger than in other areas.

[0074] For example, the permeability of the tissue can be between 40 and 80 mL / cm²*min, preferably between 50 and 70 mL / cm²*min. This is measured using a water column method, where the height of the water hose is 1.6 m (approx.

[0075] 120 mmHg) and the water that seeps through per minute is collected and weighed. The permeability of a fabric is a measure of its permeability to liquids and can be influenced by various factors, including the pore size of the fabric, the thickness of the fabric, and the type of material from which the fabric is made. A fabric with high permeability may have a high permeability to liquids, which may be desirable in certain applications. On the other hand, a fabric with low permeability may help prevent the penetration of unwanted substances or organisms. The exact permeability of the fabric can vary depending on the

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[0078] The selection is based on the specific requirements of the medical device and the desired properties of the tissue.

[0079] The invention further relates to a method for manufacturing a medical device, comprising the following steps:

[0080] a. Provision of a support structure;

[0081] b. Provision of a yarn, in particular a multifilament yarn; and c. Weaving the support structure with the multifilament yarn to obtain a fabric and the medical device.

[0082] For example, the weaving can be carried out in such a way that the yarn and the support structure are interwoven to form a fabric that exhibits high strength and durability. Preferably, the weaving can be carried out in such a way that the fabric has a desired pore size and / or permeability. Preferably, the weaving can be carried out in such a way that the fabric exhibits homogeneity.

[0083] For example, after weaving, the medical device may undergo further processing steps, such as heat treatment and / or hygiene maintenance, in particular washing with tempered water to fix the shape of the device, or chemical treatment to modify the surface of the device and / or to immobilize drugs or other therapeutic substances on the device.

[0084] Preferably, in a further step, at least one fenestration can be cut into the medical device and the resulting cut edge can be cauterized and / or reinforced with an eyelet.

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[0087] For example, the medical device can be manufactured using a circular loom. A circular loom is a type of loom specifically designed for producing tubular or cylindrical fabrics. This type of loom can be particularly suitable for manufacturing the medical device because it allows the fabric and support structure to be woven in a tubular shape that corresponds to the final shape of the medical device. This can help simplify and speed up the manufacturing process, as it eliminates the need to shape the fabric after weaving.Furthermore, a circular loom can help improve the quality and uniformity of the fabric, as it can maintain consistent tension on the yarn during the weaving process. Using a circular loom ensures fabric homogeneity in the medical device, preventing, for example, the occurrence of endoleaks caused by unwanted banding. This fabric homogeneity results in consistent mechanical properties, and the use of first and second sections allows for the individual configuration of various properties. This, for example, increases the lifespan of the medical device.

[0088] For example, the weaving of the support structure with the yarn can be carried out at more than 75, preferably more than 100, particularly preferably more than 150, very preferably more than 250, and most preferably more than 500 picks per minute. The term "pick" refers to the number of times the yarn is passed through the loom in one minute. The pick count also refers to the sum of the picks of all

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[0091] Weft bobbins. A higher weft count can help increase production speed and improve the efficiency of the manufacturing process. Furthermore, a higher weft count can contribute to increased fabric density and strength, as it results in the yarn being woven more densely and evenly into the fabric. This can help improve the mechanical properties of the medical device and optimize its performance.

[0092] Furthermore, the invention relates to a circular weaving machine for carrying out the above-described method for manufacturing a medical device.

[0093] The invention is explained in more detail below with reference to the accompanying figures. These show:

[0094] Fig. 1 shows a schematic representation of a medical device with a bifurcation, and

[0095] Fig. 2 shows a schematic process flow.

[0096] Figure 1 schematically shows a top view of a medical device 100. The medical device is designed here as a so-called stent graft. The medical device comprises a support structure 10, which consists of nitinol. The support structure is interwoven with a fabric 11. This means that the medical device 100 is woven in one piece from the fabric 11 and the support structure 10. The medical device 100 contains no seams or adhesives and is not manufactured by a heat-shrinking process.

[0097] Fabric 11 consists of a synthetic fiber, the synthetic fiber being polyethylene with a molecular weight of more than 500,000 g / mol. Specifically

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[0100] For example, a UHMWPE multifilament yarn such as Spectra (UF BIOIO from Honeywell Ltd.) or Ulteeva (DSM) is used, with a fiber fineness of 10 dtex. The other properties of the Spectra multifilament yarn are: Denier 9; Filament (dpf) 1.5; Tenacity (g / den) 45.0; Breaking Strength (lbs) 1.5; Modulus (g / den) 1,500; Elongation 3.2%; Twist (TPI) 10. The Spectra multifilament yarn consists of 6 individual filaments.

[0101] The medical device 100 is tubular and has a thickness of 55 pm. The thickness is measured either by taking a cross-sectional image with a microscope or with a thickness gauge (D-2020 thickness gauge from Schmidt Control Systems) according to DIN EN ISO 5084 at a pressure of 1 kPa.

[0102] The medical device 100 has, as required, a multitude of weft threads 12, wherein, depending on the requirements, at least some of the weft threads 12 exhibit increased extensibility compared to the other multifilament fibers. This makes the medical device 100 more flexible at the relevant points and allows it to adapt better to a patient's artery. To further stiffen the medical device 100, weft threads 12 with reduced extensibility can also be used, resulting in the opposite effect.

[0103] In an axial direction, the medical device 100 exhibits tissue homogeneity in a first sub-region 13 and a second sub-region 14. The first sub-region 13 and the second sub-region 14 have different extensibility, resulting in a desired and controlled striation in the tissue 11. This allows the medical device to adapt to systolic and diastolic blood pressure. The extensibility is continuously adjustable, typically depending on the size of the artery and / or the condition of the patient's tissue.

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[0106] The medical device 100 has a first branch 15 and a second branch 16. These branches 15 and 16 are configured as a bifurcation, reflecting the course of an artery in a patient. For example, prior to manufacturing, a 3D model of the artery to be stabilized is created, and the medical device is custom-made.

[0107] Although the medical device 100 can be radially symmetrical, an artery is rarely radially symmetrical, so at least parts of the medical device 100 are radially asymmetrical and exhibit a radius gradient. For example, in Figure 1, the first section 15 has a different radius gradient than the second section 16.

[0108] For fastening within the artery, the medical device 100 has a series of barbs 18 at a first end 17 which engage in the tissue of the artery and prevent the stent graft from slipping.

[0109] The pore size of tissue 11 is approximately 10 to 40 pm. Pore size determination is performed using microscopy images and the Leica Application Suite V3.8 software. The pore size ensures, particularly at the first end 17 and at one of the second ends 19, that the stent graft is blood-tight yet nutrient-permeable, thus enabling ingrowth with the patient's existing tissue.

[0110] The permeability of the medical device 100 is approximately 0.6 to 0.7 mL / cm². 2 *min. This is measured using a water column method. The height of the water hose is 1.6 m (approx. 120 mmHg) and the water seeping through per minute is collected and weighed.

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[0113] Figure 2 shows a process diagram for manufacturing a medical device 100. In step a., the support structure 10 is provided. In the subsequent step b., the multifilament yarn, in particular a multifilament yarn, is provided and in step c. interwoven with the support structure to form the fabric 11, or the medical device 100. A circular loom is used as the weaving machine. This allows the flexibility and strength of the medical device 100 to be influenced and customized.By using multiple weft bobbins, the medical device can be divided into several sections during the process, for example the first section 15 and the second section 16, whereby the medical device 100 remains a single piece and the first or second section 15, 16 does not need to be sewn on or otherwise connected to the rest of the medical device 100.

[0114] The support structure is woven with the multifilament yarn at a rate of over 500 wefts per minute. This process utilizes a weaving ring, largely eliminating friction and stress on the multifilament yarn. Furthermore, this method allows the multifilament yarn to be processed as a single thread, rather than in bundles of 10 threads, as is common with band looms, because the multifilament yarns are self-sorting.

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[0117] Reference symbol list

[0118] 10 Support structure

[0119] 11 tissues

[0120] 12 weft threads

[0121] 13 first sub-area

[0122] 14 second sub-area

[0123] 15 first section

[0124] 16 second section

[0125] 17 first end

[0126] 18 barbs

[0127] 19 second end

[0128] 100 medical devices

[0129] RGTH A23664DE09936PT

Claims

Aortex UG 13.03.2025 22 1. Medical device (100)7 comprising at least one support structure (10), wherein the support structure (10) comprises or consists of a metal and / or a plastic, and a tissue (11), wherein the medical device (100) is essentially tubular in shape, characterized in that the fabric (11) is interwoven with the supporting structure (10), wherein the thickness of the tissue (11) is less than 100 pm, preferably less than 80 pm, particularly preferably less than 60 pm.

2. Medical device (100) according to claim 1, characterized in that the fabric (11) comprises or consists of synthetic fibers.

3. Medical device (100) according to claim 2, characterized in that the synthetic fibers comprise or consist of polyethylene.

4. Medical device (100) according to claim 3, characterized in that polyethylene has a molecular mass of more than 500,000 g / mol, preferably more than 2,000,000 g / mol.

5. Medical device (100) according to claims 2 to 4, characterized in that the synthetic fibers comprise or consist of multifilament yarn.

6. Medical device (100) according to claim 5, characterized in that the multifilament yarn consists of 2 to 10 single filaments, preferably of 4 to 8 single filaments, particularly preferably of 5 to 7 single filaments. RGTH A23664DE09936PTAortex UG March 13, 2025 23 7. Medical device (100) according to claim 5 or 6, characterized in that the multifilament yarn has a titer of less than 15 dtex, preferably less than 12.5 dtex, particularly preferably less than 10 dtex.

8. Medical device (100) according to one of the preceding claims, characterized in that the tissue (11) has tissue homogeneity.

9. Medical device (100) according to one of claims 2 to 8, characterized in that the fabric (11) has a plurality of weft threads (12), wherein at least a part of the weft threads (12) have increased extensibility compared to the synthetic fibers.

10. Medical device (100) according to one of the preceding claims, characterized in that the medical device (100) is radially symmetrical or at least partially radially asymmetrical, wherein the medical device (100) has at least one radius gradient.

11. Medical device (100) according to one of the preceding claims, characterized in that the medical device (100) has at least one first end (17) and at least one second end (19), wherein radially outwardly pointing barbs (18) are formed on the first and / or the second end (17, 19). RGTH A23664DE09936PTAortex UG March 13, 2025 24 12. Medical device (100) according to one of the preceding claims, characterized in that the medical device (100) comprises at least one fenestration and / or at least one branch.

13. Medical device (100) according to claim 12, characterized in that the branch is designed as a bifurcation, trifurcation or higher.

14. Medical device (100) according to one of the preceding claims, characterized in that the tissue (11) has a tubular shape, wherein the tubular shape is not produced by an extrusion process.

15. Medical device (100) according to one of the preceding claims, characterized in that the medical device (100) is manufactured in one piece.

16. Medical device (100) according to one of the preceding claims, characterized in that the pore size of the tissue (11) is between 1 and 750 pm, preferably between 5 and 600 pm, particularly preferably between 10 and 500 pm.

17. Medical device (100) according to one of the preceding claims, characterized in that the permeability of the tissue (11) is between 40 and 80 mL / cm². 2 * min, preferably between 50 and 70 mL / cm² 2 * min lies.

18. Method for manufacturing a medical device (100) according to any one of the preceding claims, comprising the following steps: a. Provision of a support structure (10); RGTH A23664DE09936PTAortex UG March 13, 2025 25 b. Provision of a yarn, in particular a multifilament yarn; and c. Weaving the support structure with the multifilament yarn to obtain a fabric (11) and the medical device (100).

19. Method for manufacturing a medical device (100) according to claim 18, characterized in that a weaving machine for carrying out the method is a circular weaving machine.

20. Method for manufacturing a medical device (100) according to claim 18 or 19 characterized in that the weaving of the support structure (10) with the multifilament yarn is carried out at more than 75, preferably more than 250, particularly preferably more than 500 shots per minute.

21. Method for manufacturing a medical device (100) according to claim 18 or 20 characterized in that the multifilament yarn is processed as a single thread.

22. Circular weaving machine for carrying out a method according to one of claims 18 to 21. RGTH A23664DE09936PT

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