Intraluminal vascular graft
The intraluminal artificial blood vessel with U-shaped or V-shaped fenestration notches addresses the challenge of accurately positioning fenestrations, ensuring blood supply to side branch vessels and reducing end leaks, while enabling standardized manufacturing and flexible implantation.
Patent Information
- Application Number
- JP2020501276
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2017-07-14
- Filing Date
- 2018-07-13
- Publication Date
- 2025-05-09
- Estimated Expiration
- 2038-07-13
AI Technical Summary
Existing intraluminal artificial blood vessels face challenges in accurately positioning fenestrations to accommodate side branch vessels, leading to potential blockage of blood supply and uncontrollable end leaks.
The development of an intraluminal artificial blood vessel with a stent skeleton and prosthetic material featuring U-shaped or V-shaped fenestration notches, which create flap-like entryways that open only when side branch vessels are nearby, reducing unnecessary end leaks and allowing for targeted occlusion.
This design ensures maintained blood supply to side branch vessels, reduces the risk of prosthetic material tearing, and minimizes endoleaks, while allowing for standardized manufacturing and flexible implantation without customization.
Smart Images

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Abstract
Description
[Technical field]
[0001] The present invention relates to an intraluminal vascular graft for implantation in a blood vessel comprising a stent framework and a prosthetic material secured to the stent framework, the vascular graft having a hollow cylindrical body having an inner lumen extending entirely therethrough and a covering circumferentially surrounding the lumen. [Background technology]
[0002] Intraluminal vascular grafts, also called intravascular stents or stent grafts, are commonly known in the art. Intraluminal vascular grafts are implanted into arteries to treat aneurysms. Such vascular grafts are commonly used to support unstable, weakened or thrombosed vessel walls. In treatment, the vascular graft is released at the diseased or damaged part of the vessel, allowing the vessel's original function to be restored or the remaining integrity of the vessel to be maintained.
[0003] In this specification and generally, an aneurysm is understood as an expansion or bulging of an arterial blood vessel resulting from a congenital or acquired vascular wall lesion. A vascular wall lesion can result, for example, from extremely rapid growth of the blood vessel. For example, the human aorta continues to grow throughout life, so that its diameter is 20-30% larger in a person in their 70s than in their 20s. 75% of aneurysms are found in the abdominal aorta. The bulging in this case can affect the entire vessel wall, and in conditions called pseudoaneurysm and dissection, blood flows from the lumen of the vessel into between the layers of the vessel wall, causing the layers to peel off. If an aneurysm is left untreated, the artery can rupture in the advanced stages, causing bleeding in the patient's body.
[0004] In addition, thoracic and thoracoabdominal aortic aneurysms may also be caused by arteriosclerosis, hypertension, and inflammatory processes in the vessel walls. In addition, chest injuries from major accidents may also lead to the development of acute or chronic aortic aneurysms.
[0005] Aneurysms are treated by implanting a stent or stent-graft into the affected artery in accordance with the prior art to stabilize it and prevent it from rupturing. Depending on the application, various artificial blood vessels are used. In general, artificial blood vessels are divided into balloon-expandable and self-expandable systems, and also into those with and without prosthetic material. Artificial blood vessels covered with prosthetic material are also called "covered" stents. The prosthetic material, which is often made of a fabric or a polymer film, prevents, among other things, the penetration and deposition of blood and blood components through the artificial blood vessel wall, and the ingress and ingress of tissue beyond the artificial blood vessel wall into the artificial blood vessel. This design reduces the stress on the vessel wall at the site of implantation of the stent-graft and also reduces the possibility of embolization at this site.
[0006] A hollow cylindrical body is obtained by forming a tubular metal frame, which is optionally coated on the sides with a fabric or a polymer film. Such a metal frame is usually composed of a wire mesh or a number of serpentine stent elements arranged side by side. The serpentine stent elements, also called stent springs, may be connected by connecting supports or simply through the prosthesis material. In the case of self-expanding vascular grafts, the wire mesh or stent elements are made of a shape memory material or a shape memory alloy such as Nitinol.
[0007] For implantation, the graft is radially compressed to significantly reduce its cross-sectional area. To achieve this, it is first introduced into a sleeve, also called a sleeve catheter. The sleeve catheter is part of a delivery system, and is used to advance the graft to the site of the aneurysm, where it is released. The position of the graft is usually monitored by an X-ray marker so that adjustments can be made as needed. The elasticity of the metal frame / scaffolding allows the graft to expand and return to its original shape, stretching the lateral / envelope surface of the graft, anchoring it in the vessel proximal and distal to the aneurysm. This allows blood to flow through the graft, avoiding further stress on the bulge. The graft is held fixed in the desired position in the vessel by its outward pressure. The metal frame can be expanded by using a self-expanding metal, such as Nitinol, or in the case of a balloon-expandable graft, an inflatable balloon is inserted into the metal frame from the inside, allowing the metal frame to expand upon inflation of the balloon.
[0008] A problem that often arises is that the blood vessel to be treated has side branches. If an artificial blood vessel is implanted in such a vessel, the blood-impermeable prosthesis material may cut off the blood supply to the side branches. This problem is solved by providing so-called "fenestrations" in the prosthesis material. Fenestrated artificial blood vessels have pre-drilled holes (fenestrations) that allow one or more blood vessel branches to branch off from the artificial blood vessel.
[0009] Vascular grafts are also known in which the fenestrations are introduced in situ, i.e. after the graft has been placed in the vessel. Such vascular grafts are known, for example, from WO 2009 / 064672 A2. According to this document, the stent graft trunk is penetrated in situ with a needle, which creates a needle hole in the graft material. A dilator assembly is then pushed through the needle hole, which is then expanded. A particular problem with such vascular grafts is that the prosthesis material tears or is damaged at the location where it is desired to create a fenestration. This can lead to further tears in the prosthesis material, leading to an uncontrolled expansion of the fenestration, which can also result in an uncontrolled outflow of blood from the vascular graft at this location. Another problem with known vascular grafts and methods is the inability to identify the location of side branch vessels with contrast agents.
[0010] A problem with the prior art vascular grafts is that they must be positioned with great precision relative to the branching vessels, otherwise the blood supply to the side branch vessels may be cut off and bulges may occur at the site of the hole. Also, positioning the vascular graft with great precision requires the physician to have a lot of experience.
[0011] In particular, for vascular grafts that bridge multiple side branch vessels, successful treatment usually requires the preparation of a vascular graft that is individually tailored to each patient, i.e., to each patient's vessels, which is particularly costly and time-consuming, since it is first necessary to carry out tests to accurately characterize the vessel to be treated.
[0012] Also known in the prior art are vascular grafts with lattice-like fenestrations in the prosthetic material into which side branches can be placed. In this prior art, endoleaks are temporarily induced using "small fenestrations" in the prosthetic material, allowing blood to leak through these "holes" in the tissue for a certain period of time, allowing examination of the tissue to which the branching occurs. In such models, a large number of small "holes" or fenestrations are distributed in some areas of the vascular graft. After fenestrations in situ, the remaining unused holes must be closed by blood clotting to stop the endoleaks.
[0013] However, such endoleaks are problematic in themselves, since blood will leak out of the graft in an uncontrolled manner through these fenestrations. Moreover, to avoid excessive endoleaks, the lattice / sieve-like fenestrations must not be too large, which would risk tearing the prosthesis material when larger side branches are placed. Summary of the Invention [Problem to be solved by the invention]
[0014] Therefore, the object of the present invention is to provide an intraluminal artificial blood vessel or stent graft that can overcome the above-mentioned problems, and to provide an artificial blood vessel that can be flexibly adapted without changing the dimensions of the fenestration, i.e., an artificial blood vessel that does not need to be custom-made. [Means for solving the problem]
[0015] According to the invention, this object is to provide an intraluminal vascular prosthesis for implantation in a blood vessel, comprising a stent framework and a prosthetic material fixed to said stent framework, said vascular prosthesis having a hollow cylindrical body with a lumen extending entirely therethrough and a jacket circumferentially surrounding said lumen, the prosthetic material of the artificial blood vessel is provided with at least one substantially U-shaped or V-shaped fenestration cut; and the fenestration cut is dimensioned to form a flap-like access hole for at least one side branch branching from the hollow cylindrical body and communicating with the lumen of the vascular graft; This is achieved by an intraluminal artificial blood vessel characterized by:
[0016] In this way the objects of the present invention are fully achieved.
[0017] The intraluminal vascular graft according to the invention provides a vascular graft that can be used to support unstable or weak or thrombosed vessel walls, in particular for the treatment of aneurysmal vessels. This is achieved by the special structure of the vascular graft according to the invention, in particular the flap-like port. The flap opens outward only when a side branch vessel is in close or direct contact with it. The rest of the flap remains closed since it is in contact with the vessel wall, thus reducing the risk of unwanted endoleaks.
[0018] Another advantage is that the flap openings can be made larger than the lattice / sieve-like fenestrations discussed above, thus reducing the risk of tearing the prosthetic material.
[0019] As applied throughout this specification, "substantially" means that with respect to U-shaped or V-shaped fenestration cuts, the shape need not be exactly in the shape of the letter U or V, but rather includes shapes that would be recognized and classified as approximately U-shaped or V-shaped by one of ordinary skill in the art.
[0020] The fenestration incisions, i.e. flap-like ports, allow the blood supply to be maintained to the side branch vessel. The artificial blood vessel of the present invention is released in the vessel so that at least one flap-like port faces the side branch vessel. It is particularly advantageous that the blood supply can be achieved by simply opening / unlocking the flap-like port. The prosthesis material in the area where the U-shaped or V-shaped fenestration incisions are present is pressed against the vessel wall of the side branch by the blood flow. It is also possible to release another artificial blood vessel via the flap-like port. This also ensures the blood supply to the side branch vessel.
[0021] Furthermore, the vascular prosthesis according to the present invention has the advantage that the number of fenestration incisions can be much greater than the number of side branch vessels of the target vessel. If the flap-like opening is in contact with the vessel wall in the implanted state, blood will not flow out of the opening. Therefore, the flap opens only when the side branch of the side branch vessel is behind or directly in contact with the flap. In other words, the flap can be easily pushed open at the desired location in the vessel, while remaining closed in areas without side branches. This special structure also allows targeted occlusion.
[0022] Furthermore, the special structure of the vascular graft according to the invention minimizes the risk of endoleaks, which refers to leakage between the implanted vascular graft and the aneurysmal sac. Endoleaks are the most common complication after endovascular treatment of aortic aneurysms, occurring in 15% of cases. If the occlusion of blood flow to the aneurysm is incomplete, blood flow in the aneurysmal sac will remain, leaving the aneurysm at risk of expanding and rupturing.
[0023] The artificial blood vessel according to the present invention as described above has the advantage that, on the one hand, it can be manufactured to suit the individual patient, i.e. with the same number of fenestration incisions as the target blood vessel has side branch vessels, and, on the other hand, it can also be manufactured in a standardized manner as an artificial blood vessel with a large number of fenestration incisions so that it can be used universally.
[0024] The stent framework according to the invention may consist of individual stent elements which can be connected to one another or may consist of a wire mesh. The stent framework serves on the one hand to fix the prosthesis material and on the other hand to provide the hollow cylindrical structure of the vascular graft of the invention. Furthermore, the stent framework serves to press the vascular graft against the vessel wall in the implanted state, thereby keeping the vascular graft in its proper position within the vessel.
[0025] In this case, "hollow cylindrical body" refers to the body of the vascular prosthesis of the invention, which has a structure comprising a stent framework and at least partly a prosthetic material. This stent framework may be composed of individual stent elements.
[0026] According to one embodiment, the intraluminal vascular artificial blood vessel of the present invention preferably has 1 to 9 fenestration notches on at least one outer periphery U.
[0027] Thus, according to the invention, 1, 2, 3, 4, 5, 6, 7, 8 or 9 fenestration incisions may be present distributed over at least one circumferential portion U of said artificial blood vessel. The presence of more fenestration incisions in a certain circumferential portion of the artificial blood vessel according to the invention has the advantage that the release of the artificial blood vessel does not require pinpointing of the circumferential position of the artificial blood vessel in the vessel. This is because the presence of more flaps increases the probability that one of these flaps or at least one of these flaps will be released at the location of a branching vessel. Due to the special flap-like structure of the fenestration incisions, the portal remains closed if the prosthesis material at the fenestration incision is released against or against the vessel wall. The more fenestration incisions present in the artificial blood vessel, the easier the implantation and, if necessary, the release of side branches.
[0028] Depending on the characteristics of the blood vessel into which the intraluminal artificial blood vessel of the present invention is to be released, it may be necessary for the artificial blood vessel to have multiple outer peripheries, each having 1, 2, 3, 4, 5, 6, 7, 8 or 9 fenestration incisions.
[0029] It is possible for each fenestration incision to be made in a different size. The length of the fenestration incision, and therefore the diameter of the flap-like opening formed, is preferably adapted to the diameter of the side branch.
[0030] The "outer periphery" U of the artificial blood vessel according to the present invention is the outer periphery surface portion of the artificial blood vessel in which at least one fenestration is distributed, that is, the tubular portion.
[0031] According to one embodiment of the present invention, in the artificial blood vessel of the present invention comprising a plurality of serpentine-shaped annular stent rings arranged side by side and not connected to each other, and a prosthetic material to which the stent rings are fixed, the outer periphery is preferably defined as a prosthetic portion formed between two of the stent rings arranged side by side.
[0032] According to another embodiment, said outer periphery is preferably between 10 mm and 40 mm, preferably between 10 and 20 mm.
[0033] In accordance with the present invention and alternative embodiments, the vascular graft of the present invention has 1, 2, 3, 4, 5, 6, 7, 8, or 9 fenestration cuts on 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 circumferences.
[0034] According to one embodiment, the vascular graft of the invention has multiple, i.e. at least two, outer circumferences, which may have different or the same number of fenestration incisions. Also, the fenestration incisions of a first outer circumference may be the same or different in length as the fenestration incisions of another outer circumference, and similarly may be the same or different in length within the first and / or second outer circumference. It will also be understood that a circumference may have multiple, i.e. at least two, fenestration incisions of the same length, as well as at least one different fenestration incision.
[0035] According to another embodiment, the stent framework of the intraluminal vascular graft of the present invention is composed of a plurality of rings that are longitudinally arranged side-by-side, non-connected, serpentine-shaped annular supports.
[0036] "Serpentine" is understood herein to mean the looped linear shape of the stent elements. In this context, "stent", "stent element" or "stent ring" refers to any structure that provides expansive force and / or support to a vascular graft. Thus, a stent element is any element that has the properties of a stent.
[0037] In this case, a "stent spring" is understood to mean any continuous annular element that is compressible due to its material and can be re-expanded like a spring when the compressive pressure is removed. The stent spring has a wave-like shape, with alternating wave crests and wave troughs forming phases.
[0038] The circumferential amplitudes of the stent elements or stent springs may be the same or different, depending on whether the legs of the stent springs are the same or different lengths. Different amplitudes have the advantage that the stent graft can be adapted to individual vessels and individual situations (curvatures, branching vessels, stenosis, etc.).
[0039] According to the invention, the stent elements may also comprise braided, twisted or laser cut stent elements instead of individual stent springs.
[0040] In this embodiment, the individual serpentine annular supports are preferably connected via the prosthesis material. For this purpose, the serpentine annular supports may be fixed to the prosthesis material by stitches. The supports may be arranged on the prosthesis material in such a way that there are areas on the prosthesis material that are free of stents.
[0041] The preferred suture material is surgical thread, preferably made from polyester, polyurethane, polystyrene, polytetrafluoroethylene, ultra-high molecular weight polyethylene (UHMPE), or mixtures thereof.
[0042] According to a preferred embodiment, the stent framework extends the entire length of the vascular graft.
[0043] In some vessels, it may be necessary for the vascular graft of the present invention to have a stent framework over its entire length. This can be achieved, for example, by using a wire mesh that at least partially has prosthetic material. In the areas with prosthetic material, fenestration cuts may be present in the formed mesh.
[0044] Instead of a wire mesh, the vascular graft of the present invention may also comprise a number of stent elements connected together by connecting elements, which also form a continuous stent framework.
[0045] According to another embodiment, the stent framework does not extend the entire length of the vascular graft, such that at least one stent-free region is formed.
[0046] This embodiment offers the advantage that depending on the vessel in which the graft is to be implanted, a graft can be manufactured that is specifically adapted to that vessel, and thus the number and shape of the stent framework or individual stent elements, the amount of prosthesis material, the diameter of the graft, the materials used in the stent framework or prosthesis material, the number of fenestration cuts, etc. can be varied.
[0047] According to another embodiment, the artificial blood vessel of the present invention is provided with a stent ring at each of the first end and / or the second end, which may or may not be connected to the stent framework.
[0048] The first end or the second end according to the invention means the proximal end or the distal end of the vascular graft. As a rule, in the case of vascular grafts, the ends are usually designated by the terms "distal" and "proximal", respectively, the term "distal" meaning the part or end located downstream with respect to the blood flow. In contrast, the term "proximal" means the part or end located upstream with respect to the blood flow. In other words, the term "distal" means the direction of the blood flow, and the term "proximal" means the direction opposite to the blood flow. In contrast, in the case of a catheter or an insertion system, the term "distal" refers to the end of the catheter or insertion system that is inserted into the patient, i.e. the end farther from the user, and the term "proximal" refers to the end closer to the user.
[0049] According to another embodiment, the incision length of the at least one fenestration incision is between 2 mm and 10 mm, preferably between 5 mm and 7 mm.
[0050] This embodiment has the advantage that the dimensions of the opening formed by the fenestration cut match the typical dimensions of a side branch vessel.
[0051] According to another embodiment, when multiple fenestration incisions are present, the length of each incision is the same or different.
[0052] Different sized fenestration incisions are also required due to different characteristics of the side branch vessels. Even very small incisions can maintain blood supply, but too small an opening can have an unfavorable effect on blood pressure. This embodiment allows bridging of both large and small side branch vessels.
[0053] According to a further embodiment, the intraluminal artificial blood vessel of the present invention further comprises, in addition to the hollow cylindrical body, at least one hollow cylindrical side portion, which can be connected to the artificial blood vessel via the flap-like inlet / outlet.
[0054] "At least one hollow cylindrical side" preferably means one, two, three or four sides. Such vascular grafts have openings along with the sides, which ensure access to the side branch vessels through the sides of the vascular graft. This embodiment is particularly advantageous for vessels with a damaged or ruptured part near the side branch. It is therefore advantageous when the main vessel is supported by a first vascular graft and the side branch vessel is supported by a second vascular graft.
[0055] In the artificial blood vessel according to the present invention, when at least one side branch is connected to the artificial blood vessel via a flap-like entrance / exit communicating with the lumen of the artificial blood vessel, it is generally understood that the at least one side branch can branch outwardly relative to the artificial blood vessel and also inwardly toward the lumen of the artificial blood vessel.
[0056] The hollow cylindrical side may be a second vascular graft according to the invention. This second vascular graft may have the same properties as the vascular graft already described. It may therefore be a self-expanding vascular graft or a balloon-expandable vascular graft and may or may not have prosthetic material. In one embodiment, the hollow cylindrical side does not have prosthetic material.
[0057] This embodiment therefore has the advantage that the vascular prosthesis according to the invention can be adapted to the anatomical situation of each patient to be treated.
[0058] According to another embodiment, markers are disposed on the endoluminal vascular graft of the invention, the markers including or consisting of a radiopaque material, in particular at the end points and / or along at least one fenestration incision.
[0059] By using the markers placed at specific positions on the artificial blood vessel of the present invention, the artificial blood vessel can be accurately positioned very quickly during and after implantation. The markers placed around / along the fenestration incision are particularly useful, since this portion is particularly required for accurate positioning when positioning the artificial blood vessel.
[0060] When a radiopaque marker is used, it is preferred that the marker is made of one or more materials selected from, for example, gold, palladium, tantalum, chromium, silver, etc. The shape of the marker may be any shape, for example, circular, polygonal, etc., and / or may be in the shape of, for example, letters, numbers or figures that aid in the orientation of the stent graft within the vessel.
[0061] The objects of the present invention are also achieved by the use of an intraluminal vascular graft for implantation into a patient's blood vessel to treat a vascular disease.
[0062] The object of the present invention is also to provide a method for inserting an intraluminal vascular prosthesis into a blood vessel of a patient, comprising the steps of: inserting and releasing the first intraluminal vascular artificial blood vessel described above into a blood vessel of a patient; inserting at least one second vascular graft through a flap-like portal formed by at least one fenestration cut in a hollow cylindrical body of a first endoluminal vascular graft to form at least one side branch of the endoluminal vascular graft into a side branch vessel extending from the first vessel; This is achieved by a method comprising:
[0063] The object of the present invention is also to provide a method for expanding an intraluminal vascular graft, comprising the steps of: Providing an intraluminal vessel; guiding a second vascular graft through a flap-like portal formed by at least one fenestration cut in the hollow cylindrical body of the intraluminal vascular graft to form a side branch vascular graft; This is achieved by a method comprising:
[0064] The objects of the invention are also achieved by a method for producing an intraluminal vascular graft, in which the fenestration cuts in the prosthetic material are formed by heat treatment of the prosthetic material.
[0065] According to a preferred embodiment of the method, the fenestration incision is made using a laser instrument or device.
[0066] This embodiment has the advantage that a particularly precise incision can be made with a laser device, and furthermore, the heating during cutting melts the edges of the incision in the prosthetic material, thus avoiding unnecessary fraying of the tissue at this location or the formation of sharp edges that could damage the vessel wall.
[0067] It will be understood that the features mentioned above and those to be described below are not limited to the combinations listed individually, but can be used in other combinations or alone without departing from the scope of the invention. [Brief description of the drawings]
[0068] Exemplary embodiments of the invention are explained in more detail below and shown in the drawings. [Figure 1] FIG. 1 is a first schematic diagram showing details of an intraluminal vascular prosthesis according to the present invention. [Diagram 2] FIG. 2 is a second schematic diagram of an intraluminal vascular prosthesis according to the present invention. [Diagram 3] FIG. 2 is a schematic diagram showing a detail of an intraluminal vascular prosthesis according to the invention with a hollow cylindrical side section inserted therein. [Figure 4] FIG. 2 is another schematic diagram showing details of an endoluminal vascular prosthesis according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0069] 1 is a first schematic diagram showing a detailed embodiment of an intraluminal vascular prosthesis 10 according to the invention, comprising a stent framework 11. The stent framework is formed from individual stent springs or stent rings 12, which have a plurality of rings of serpentine-shaped annular supports. In this figure, five stent springs / stent rings 12, 12 I , 12 II , 12 III , 12 IV The stent springs 12 are secured to the prosthetic material 13 by stitches 14. The prosthetic material 13 in this figure extends throughout the entire vascular graft 10. In this embodiment, the stent springs 12 are arranged side by side, but are not connected to each other, only via the prosthetic material 13. The stent springs 12 are preferably made of or have a self-expanding material. Such a stent spring 12 can change from a compressed state to a relaxed, expanded state. This characteristic is preferred to allow the endoluminal vascular graft 10 to be implanted in a blood vessel.
[0070] The prosthetic material 13 is formed as a hollow cylindrical body 15 having a lumen extending therethrough, and the prosthetic material 13 forms a sheath circumferentially surrounding the lumen. The hollow cylindrical structure of the body 15 is mainly formed by the stent framework 11. The stent framework 11 may preferably extend over the entire length of the artificial blood vessel 10, which determines the structural strength of the artificial blood vessel 10. The stent framework 11 may not extend over the entire length of the artificial blood vessel 10. In that case, the stent framework 11 is divided by the prosthetic material 13. In this embodiment, both ends of the prosthetic material 13 are preferably supported by the stent framework 11 to give the artificial blood vessel 10 a hollow cylindrical structure.
[0071] In this figure, the prosthesis material 13 has three fenestration incisions 16, which are U-shaped or V-shaped, each with a different incision length. The incision length is preferably a function of the diameter of the side branch of the main vessel. In the case where the vascular graft 10 has a second vascular graft, which is released through a flap-like portal to form a side branch vascular graft, the incision length is determined by the diameter of the corresponding second vascular graft. If the diameter of the second vascular graft is smaller, the incision length of the fenestration incisions 16 will be correspondingly shorter.
[0072] In FIG. 1, the "U" represents two serpentine stent springs / stent rings 12 arranged side by side. II , 12 III Thus, one boundary of this outer periphery is the stent spring 12 II The other boundary is the stent spring 12 III It is formed by the line body.
[0073] Depending on the vessel into which the intraluminal vascular graft 10 is to be implanted, the vascular graft 10 may require multiple fenestration incisions 16. This is especially true when the vessel has multiple branch vessels. In a preferred embodiment, the intraluminal vascular graft 10 has at least as many fenestration incisions 16 as there are side-branch vessels, and these fenestration incisions 16 are provided at locations that bridge the side-branch vessels. By placing a second vascular graft through such fenestration incisions 16, or even by simply opening the flap, it becomes possible to supply the branched side-branch vessels. For this purpose, the vascular graft 10 is implanted into the vessel in such a way that the branched side-branch vessels are either directly adjacent to the flap-like ostium or behind the flap-like ostium.
[0074] FIG. 2 shows a second schematic diagram of an intraluminal vascular graft 10 according to the invention. Here, the entire vascular graft 10 is shown, as well as the details of the vascular graft 10 as in FIG. 1. The vascular graft 10 shown has four stent springs 12, each of which is at least partially fixed to the prosthesis material 13 by stitches 14. In this embodiment, the stent springs 12 have different amplitudes. The shape of the stent springs 12 depends in particular on the characteristics of the vessel in which the vascular graft 10 is to be implanted. In particular, a stiff vascular graft 10 preferably comprises a large number of stent springs 12, which are preferably connected to each other to form a network structure. A vascular graft with a low stiffness can also be applied, for example, to vessels with thin walls, and such vascular grafts preferably have stent springs 12 with a larger amplitude. Furthermore, in this embodiment, the individual stent springs 12 are attached to the prosthesis material 13 at intervals.
[0075] In this figure, the intraluminal vascular graft 10 has two fenestration cuts 16, which are arranged in a partial area of the prosthesis material 13, the area bounded by the two stent springs 12. Each fenestration cut 16 has a marker 17 at each end, which marker 17 comprises or consists entirely of a radiopaque material, so that the position of the vascular graft 10, and in particular the position of the fenestration cut 16, within the vessel can be determined during implantation of the vascular graft 10.
[0076] Figure 3 is a detailed schematic diagram of an intraluminal vascular graft 18 according to the present invention with a hollow cylindrical side section 19 inserted. The vascular graft 18 shown in Figure 3 is generally similar to the vascular graft 10 shown in Figure 1. The vascular graft 18 has two fenestration cuts 16, one flap-like port open outward, while the other flap-like port is further flanked by a second vascular graft 19 passing through it. Both the open flap-like port and the side section allow for feeding of branching side vessels.
[0077] In this figure, the side or second graft 19 is formed as a covered graft. Other hollow cylindrical grafts are possible, such as grafts without prosthetic material, self-expanding grafts, balloon-expandable grafts, etc.
[0078] Figure 4 is another schematic diagram showing details of an intraluminal vascular graft 20 according to the invention. The intraluminal vascular graft 20 comprises two stent frameworks 11, each of which has a mesh or net-like shape. The stent frameworks 11 are connected to a prosthesis material 13 by stitches 14. In this figure, the stent framework 11 is not covered with the prosthesis material 13 as in Figures 1-3. The stent framework 11 and the prosthesis material 13 together form a hollow cylindrical body 15.
[0079] The vascular graft 20 has a fenestration cut 16 in the prosthetic material 13 with markers 17 at each end of the cut.
[0080] According to another embodiment, not shown, the stent framework 11 of the vascular prosthesis according to the invention can have stent elements 12 of known form. The stent elements 12 can be self-expanding or balloon-expandable stent elements consisting of stent springs, stent rings, stent meshes, etc. If the individual stent elements 12 are not connected to one another, the stent framework 11 is provided with a prosthetic material 13 to form a hollow cylindrical body 15. In this case, the prosthetic material 13 serves as a connector connecting the individual stent elements 12. Such a vascular prosthesis according to the invention can at least partially have a prosthetic material 13, which is for example connected or sewn to the stent framework 11 as a whole, or at least partially have the individual stent elements 12 and connected or sewn to them.
Claims
1. An intraluminal vascular prosthesis (10, 18, 20) for implantation in a blood vessel, comprising a stent framework (11) and a prosthetic material (13) fixed to the stent framework (11), the prosthesis having a hollow cylindrical body (15) having a lumen extending entirely therethrough and a jacket circumferentially surrounding the lumen, the prosthetic material (13) of the artificial blood vessel (10, 18, 20) is provided with a plurality of substantially U-shaped or V-shaped fenestration incisions (16) for ensuring access to side branch vessels through the sides of the artificial blood vessel (10, 18, 20); In an intraluminal vascular graft (10, 18, 20), the fenestration cut (16) is dimensioned to form a flap-like access hole for at least one second vascular graft (19) branching off from the hollow cylindrical body (15) and communicating with the lumen of the vascular graft (10, 18, 20), the main blood vessel is supported by the artificial blood vessel (10, 18, 20), the side branch blood vessel is supported by the second artificial blood vessel (19), the second artificial blood vessel (19) is connected to the artificial blood vessel (10, 18, 20) so as to communicate with the inner cavity of the artificial blood vessel (10, 18, 20) via a part of the plurality of flap-like inlets and outlets, and the second artificial blood vessel (19) is capable of branching outwardly relative to the artificial blood vessel (10, 18, 20) and also capable of branching inwardly toward the inner cavity of the artificial blood vessel (10, 18, 20); The second artificial blood vessel (19) is a self-expanding type, and a plurality of stent springs (12) forming the stent framework (11) are connected to each other to have a large amplitude, forming a structure having different amplitudes.
2. 2. The intraluminal vascular graft (10, 18, 20) of claim 1, characterized in that the intraluminal vascular graft (10, 18, 20) has 1 to 9 fenestration cuts (16) on its outer peripheral surface.
3. 3. An intraluminal vascular graft (10, 18, 20) according to claim 1 or 2, characterized in that the stent framework (11) extends over the entire length of the vascular graft (10, 18, 20).
4. An intraluminal vascular graft (10, 18, 20) according to any one of claims 1 to 3, characterized in that the stent framework (11) does not extend over the entire length of the vascular graft (10, 18, 20) so as to form at least one stent-free area.
5. An intraluminal vascular graft (10, 18, 20) according to any one of claims 1 to 4, characterized in that the vascular graft (10, 18, 20) is provided at its first end and / or at its second end with stent rings, respectively, optionally connected to a stent framework (11).
6. An intraluminal vascular prosthesis (10, 18, 20) according to any one of claims 1 to 5, characterized in that the incision length of at least one fenestration incision (16) is between 2 mm and 10 mm.
7. An intraluminal vascular prosthesis (10, 18, 20) according to any one of claims 1 to 6, characterized in that the fenestration incisions (16) have the same or different lengths.
8. The intraluminal vascular prosthesis (10, 18, 20) according to any one of claims 1 to 7, characterized in that a marker (17) is arranged on the intraluminal vascular prosthesis, the marker (17) comprising or consisting only of a radiopaque material, the marker (17) being provided at the end point of at least one fenestration incision (16) and / or along the fenestration incision (16).
9. The intraluminal vascular graft (10, 18, 20) according to any one of claims 1 to 8, characterized in that the flap-like port can be formed for at least one second vascular graft (19) extending inwardly and / or outwardly with respect to the lumen of the vascular graft (10, 18, 20).
10. A method for producing an intraluminal artificial blood vessel (10, 18, 20) as described in any one of claims 1 to 9, characterized in that the fenestration incision (16) in the prosthesis material (13) is formed by heat treatment of the prosthesis material (13).
11. 11. A method for producing an intraluminal vascular graft (10, 18, 20) according to claim 10, characterized in that the fenestration incisions (16) are made by means of a laser instrument or device.
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