Intraluminal vascular prosthesis system

Description

[0001] The present invention relates to an intraluminal vascular prosthesis and an intraluminal vascular prosthesis system for implantation in the region of the aortic arch of a patient.

[0002] Such vascular implants are known in the prior art, for example from DE 103 37 739.5.

[0003] Intraluminal vascular prostheses, also known as endovascular stents / stent grafts, are commonly used to treat weakened, injured, ruptured, or aneurysmal vessels. A vascular prosthesis or stent graft is deployed at the diseased or injured site of the vessel, restoring the functionality of the original vessel or supporting the remaining vascular integrity.

[0004] An aneurysm is defined as a dilation or bulging of an arterial blood vessel resulting from congenital or acquired wall changes. The bulging can involve the entire vessel wall, or, as in a so-called false aneurysm or dissection, blood leaks from the lumen of the vessel between the layers of the vessel wall and shears them apart. If an aneurysm is left untreated, it can lead to a rupture of the artery in advanced stages, resulting in internal bleeding.

[0005] The self-expanding vascular implants used to treat such aneurysms generally consist of a hollow cylindrical metal frame or scaffold whose outer surface is covered with a textile or polymer film, resulting in a hollow cylindrical body. For implantation, the vascular prosthesis is compressed radially, significantly reducing its cross-sectional area. The vascular prosthesis is then guided into the area of ​​the aneurysm using a delivery system, where it is released. Due to the spring action of the metal frame / scaffold, the vascular prosthesis expands back to its original shape, stretching its outer surface, which clamps itself inside the blood vessel proximal and distal to the aneurysm. In this way, the blood now flows through the vascular prosthesis and further stress on the bulge is prevented.

[0006] The metal frame of such vascular prostheses typically consists of a wire mesh or of sequentially arranged, meandering, so-called stent springs, which may be connected to each other via wire connecting supports or simply via the prosthetic material. The wire mesh or stent springs are usually made of a shape-memory material, usually nitinol, which allows the stent springs to return to their expanded state after insertion into a vessel for release, thereby "stretching" the vascular implant.

[0007] In general, aneurysms often occur in the abdominal artery (aorta abdominal ) or mammary artery ( Thoracic aorta ). For the treatment of aneurysms in the abdominal or thoracic artery, it is already known to stabilize the artery by implanting a stent to such an extent that rupture of the vessel is prevented.

[0008] Aneurysms can also occur in the so-called ascending branch of the aorta ( Ascending aorta ). The ascending branch of the aorta is directly connected to the heart. Starting from the aortic root ( Aortic sinus ) the ascending branch runs upwards in a slightly curved shape away from the heart and then enters the aortic arch ( Aortic arch ) and leads into the descending branch of the aorta (aorta descending ). In the region of the aortic arch, the head vessels branch off, including the left and right carotid arteries. The aortic arch curves approximately 180° with a very narrow radius and connects the ascending branch of the aorta with the thoracic artery and, further on, with the abdominal artery.

[0009] Not only in the area of ​​the aortic arch is it important not to block side vessels branching off from the main vessel by positioning the vascular prosthesis, which is why many vascular prostheses have open zones or so-called fenestrations through which side branches branching off from the vascular implant, which protrude into the side vessels, can be introduced and fixed to the vascular implant.

[0010] Vascular diseases such as aneurysms or dissections in the aortic arch are still typically treated with invasive open surgery. Such an operation usually requires two major, separate procedures, and is a very extensive, complex, and therefore dangerous procedure, as not only the heart but also the patient's brain and abdominal organs must undergo hypothermic perfusion—that is, artificial, cold extracorporeal blood flow—or hypothermic perfusion arrest. However, only a few cardiac surgeons at experienced centers are familiar with such a procedure.

[0011] WO 2013 / 025727 A1 discloses a vascular prosthesis in which vascular prosthesis side branches can be anchored in the lumen of the vascular prosthesis via an opening provided in the prosthesis wall, which in turn is provided in a recess in the wall. Branching, double-lumen vascular prostheses are also known from WO 2013 / 155306 A.

[0012] Furthermore, stents and stent grafts, or combinations of stents, are currently known to be inserted minimally invasively. However, these are of limited use in many patients with diseased vessels.

[0013] There is therefore still a great need for stent / stent graft systems or vascular prostheses that can be used for implantation in the area of ​​the aortic arch and for the treatment of vascular diseases in the area of ​​the aortic arch.

[0014] The object of the present invention is therefore to provide a vascular prosthesis and a vascular prosthesis system with which the area of ​​the ascending aorta, the aortic arch and the descending aorta of a large number of different patients with different vascular properties can be treated quickly and easily, or which also enables the above-described interventions to be carried out by less experienced cardiac surgeons.

[0015] According to the present invention, this object is achieved by an intraluminal vascular prosthesis system for implantation in the region of the aortic arch of a patient according to the appended claims, which has at least the following: a hollow cylindrical main vascular prosthesis, which has a lumen guided through the main vascular prosthesis, a first lumen end, a second lumen end, a hollow cylindrical stent framework, optionally with a prosthetic material attached thereto, a length L1 and a diameter D1, wherein the hollow cylindrical main vascular prosthesis is designed for implantation in the region of the aortic arch and the Descending aortaof the patient, and wherein the main vascular prosthesis has at least one hollow cylindrical anchoring vascular prosthesis which has a lumen guided through the anchoring vascular prosthesis, a first lumen end, a second lumen end, a hollow cylindrical stent framework, optionally with a prosthetic material attached thereto, a length L2 and a diameter D2, wherein the anchoring vascular prosthesis is firmly attached within the lumen of the main vascular prosthesis at least over part of the length L2 of the anchoring vascular prosthesis, and wherein the diameter D2 of the anchoring vascular prosthesis is at least 45% smaller than the diameter D1 of the main vascular prosthesis, and wherein the length L2 of the anchoring vascular prosthesis is smaller than the length L1 of the main vascular prosthesis.

[0016] The intraluminal vascular prosthesis system according to the invention for implantation in the region of the aortic arch further comprises at least one hollow cylindrical lateral vascular prosthesis, a lumen guided through the lateral vascular prosthesis, which has a first lumen end, a second lumen end, a hollow cylindrical stent framework, optionally with a prosthetic material attached thereto, a length L3 and a diameter D3, wherein the hollow cylindrical lateral vascular prosthesis is designed for implantation to bridge the origin of the Subclavian artery or the Carotid artery of the patient, such that the side vascular prosthesis with its first lumen end in the Subclavian artery or the Carotid artery can be positioned, and with its second lumen end for secure anchoring of the lateral vascular prosthesis, can be at least partially inserted into the lumen of the anchoring vascular prosthesis via the first lumen end of the anchoring vascular prosthesis and fixed therein.

[0017] Further disclosed herein is a method for implanting an intraluminal vascular prosthesis system into the aortic arch of a patient, comprising the following steps: Introduction and release of the main vascular prosthesis into the area of ​​the aortic arch and the Descending aorta, and introducing the side vascular prosthesis and releasing it with its first lumen end in the Subclavian artery or the Carotid artery and with its second lumen end over the first lumen end of the anchoring vascular prosthesis at least partially into its lumen.

[0018] The problem underlying the invention is thus completely solved.

[0019] The new vascular prosthesis or vascular prosthesis system enables a simple treatment of a weakened, injured, ruptured, or aneurysmal vessel, particularly in the aortic arch. According to the invention, a vascular prosthesis is thus provided that makes it possible to simplify surgical procedures and significantly shorten them, particularly in the aortic arch, or in the ascending aorta, the aortic arch, and the descending aorta.

[0020] In particular, the vascular prosthesis or vascular prosthesis system according to the invention can be used to treat vessels that have branching tributaries in the area to be treated. Due to the special design, the tributaries can continue to be supplied with blood via at least one tributary vascular prosthesis, while simultaneously supporting the injured affected vessels through the intraluminal vascular prosthesis. The introduction and placement of this system can be handled precisely and easily thanks to its at least two-part design, consisting of a hollow cylindrical main vascular prosthesis together with the anchoring vascular prosthesis and the tributary vascular prosthesis.

[0021] To introduce the vascular prosthesis system into a vessel of a patient to be treated, the intraluminal vascular prosthesis is first implanted at the desired location in the vessel, preferably the aortic arch. A lateral vascular prosthesis is then implanted into the lateral vessel. The first lumen end is positioned in the lateral vessel, while the second lumen end, for secure anchoring of the lateral vascular prosthesis, can be at least partially inserted into the lumen of the anchoring vascular prosthesis via the first lumen end of the anchoring vascular prosthesis and fixed therein.

[0022] Due to their special design, the vascular prosthesis and the lateral vascular prosthesis can be implanted separately. The vascular prosthesis and vascular prosthesis system according to the invention therefore offer the advantage that not only highly specialized cardiac surgeons, but also inexperienced specialists, can perform the aortic arch procedures described above. Furthermore, the invention offers the advantage that the vascular prosthesis and the vascular prosthesis system can be adapted to the specific anatomical conditions of the patient being treated.

[0023] Due to the design of the vascular prosthesis system according to the invention, in which the collateral vascular prosthesis is at least partially anchored or "plugged" into the anchoring vascular prosthesis, very anatomically different vessels can be treated with the same vascular prosthesis system. This can be achieved by varying the insertion / anchoring depth of the collateral vascular prosthesis into the anchoring vascular prosthesis. If the collateral vessels are located further away from the actual main vascular prosthesis, the insertion depth can be selected to be smaller, in contrast to a greater anchoring depth for nearby collateral vessels.

[0024] The implantation of the vascular prosthesis system is particularly simplified because the main vascular prosthesis does not need to be precisely aligned with the branching collateral vessels. The alignment can be corrected using the inventive "anchoring system" and the associated insertion / anchoring depth of the collateral vascular prosthesis in the anchoring vascular prosthesis. The alignment of a one-piece vascular prosthesis with branching collateral vessels, known from the prior art, complicates not only the implantation but also the manufacture of such implants.

[0025] According to the invention, both the main vascular prosthesis, the at least one anchoring vascular prosthesis, and the at least one side vascular prosthesis can be present as a covered or uncovered stent; thus, they can be at least partially coated with a prosthetic material, or they can have a prosthetic material attached to the stent. Depending on the injury to the vessel and the anatomical conditions, it may be expedient for at least one of the listed vascular prosthesis components to be free of any prosthetic material; for example, the side vascular prosthesis or the anchoring vascular prosthesis.

[0026] In particular, according to one embodiment, it is preferred if the main vascular prosthesis, if it comprises a prosthetic material, has a fenestration region, i.e., a region through which the lateral vascular prosthesis can be at least partially inserted and anchored into the lumen of the anchoring vascular prosthesis present in the lumen of the main vascular prosthesis. This fenestration region can, for example, be selected from fenestration regions in the prosthetic material, individual openings in the jacket region of the main vascular prosthesis, or an open region that extends circumferentially around the entire circumference of the main vascular prosthesis in this region.

[0027] Alternatively, the side vascular prosthesis can be at least partially introduced and anchored via the first lumen end of the main vascular prosthesis into the lumen of the anchoring vascular prosthesis present in the lumen of the main vascular prosthesis.

[0028] According to one embodiment, the main vascular prosthesis may further comprise at least two stent framework sections or consist of at least two stent framework sections that are connectable to one another, for example by partially inserting the second stent framework section into the second stent framework section.

[0029] According to one embodiment of the vascular prosthesis according to the invention, it comprises several anchoring vascular prostheses. The number of anchoring vascular prostheses depends primarily on the number of branching collateral vessels to be treated by the collateral vascular prostheses.

[0030] According to one embodiment of the present invention, the first lumen end of the main vascular prosthesis and the first lumen end of the anchoring vascular prosthesis are arranged flush.

[0031] "Flush" means that the anchoring vascular prosthesis is aligned with its first lumen end at the first lumen end of the main vascular prosthesis, so that both lumen ends are essentially at the same level. In this embodiment, the anchoring vascular prosthesis extends from the first lumen end of the main vascular prosthesis within the lumen of the main vascular prosthesis toward the second lumen end along the inner wall of the main vascular prosthesis. Access to the anchoring vascular prosthesis for a side vessel prosthesis is thus not via a side wall or a fenestration in the main vascular prosthesis, but via the first lumen end of the main vascular prosthesis.

[0032] Some terms used herein, although clear to those skilled in the art in themselves and in light of the present disclosure, are further defined below:

[0033] In general, the terms "distal" and "proximal" are used for stent grafts or endoluminal prostheses, as well as in this case, to refer to the respective ends. The term "distal" refers to the part or end that is further downstream in relation to the bloodstream. The term "proximal," on the other hand, refers to a part or end that is further upstream in relation to the bloodstream. In other words, the term "distal" means in the direction of the bloodstream, and the term "proximal" means opposite to the direction of the bloodstream. For catheters or delivery systems, however, the term "distal" refers to the end of the catheter or delivery system that is inserted into the patient, or the end that is furthest from the user's perspective, and the term "proximal" refers to the end closest to the user.

[0034] Accordingly, in this case, the "proximal" and "distal" openings of the vascular implant are the openings through which blood flow through the hollow cylindrical lumen of the vascular implant is ensured: When the vascular implant according to the invention is implanted in a blood vessel, such as the aorta, the blood coming from the heart flows through the proximal opening of the vascular implant and exits the vascular implant through its distal openings. The hollow cylindrical main vascular prosthesis or its anchoring vascular prosthesis, as well as the side vascular prosthesis, can have a uniform diameter or different diameters over their entire length.

[0035] According to the invention, the hollow-cylindrical stent framework is a metal frame, which is usually made of a wire mesh or of consecutively arranged, meandering, so-called stent springs, which may be connected to each other via wire connecting supports or simply via the prosthetic material. The wire mesh or stent springs are usually made of a shape-memory material, usually Nitinol, which allows the stent springs to return to their expanded state after implantation into a vessel for release, thus "stretching" the vascular prosthesis.

[0036] According to a first embodiment of the vascular prosthesis system according to the invention, the main vascular prosthesis and / or the anchoring vascular prosthesis and / or the side vascular prosthesis comprises / comprising a stent framework and a prosthetic material attached thereto.

[0037] In this context, "stent framework" refers to any metal framework that, by stretching or expanding the framework, imparts an expansion force to a vascular prosthesis to keep a vessel open, possibly in combination with a prosthetic material attached to the framework. The prosthetic material is preferably made of a biocompatible material, which ensures uncomplicated contact between the vascular implant and the vessel wall.

[0038] In this context, it is preferred if the prosthetic material comprises a material selected from a textile or a polymer. In particular, it is preferred if the prosthetic material comprises or is formed from a material selected from polyester, polyurethane, polystyrene, polytetrafluoroethylene, ultra-high molecular weight polyethylene (UHMPE), or mixtures thereof.

[0039] According to a further embodiment of the vascular prosthesis system according to the invention, the stent framework of the main vascular prosthesis and / or the stent framework of the anchoring vascular prosthesis and / or the stent framework of the side vascular prosthesis is selected from a laser-cut stent framework, individual stent springs or a braided stent framework.

[0040] The term "stent framework" refers to any stent configuration in which various wire strands are interwoven, intertwined, or otherwise linked to form a structure with zones, regions, or points where the strands overlap, and zones or regions that are free of the wire strands and therefore form openings, windows, or meshes. Accordingly, a laser-cut stent support framework also has meshes or openings. The openings, meshes, or windows are preferably diamond-shaped.

[0041] In this context, a "stent spring" is understood to mean any one-piece, ring-shaped element that can be compressed due to its material and can expand again in a spring-like manner after the compression pressure is removed.

[0042] According to one embodiment, the stent framework of the main vascular prosthesis and / or the stent framework of the anchoring vascular prosthesis and / or the stent framework of the side vascular prosthesis comprises meander-shaped circumferential stent rings arranged one behind the other and not connected to one another, as well as a prosthetic material firmly connected to the stent rings.

[0043] In this context, a "stent ring" is understood to mean any one-piece, annular element formed by a circumferential wire and having a substantially round circumference. The wire of the stent ring can be undulating, with alternating wave crests and troughs forming a phase or amplitude. "Meandering" is understood to mean any loop-like or loop-like course of the stent ring or stent wire.

[0044] The prosthetic material of the vascular prostheses to be used in the system according to the invention, which is optionally or necessarily used (in the case of the stent rings), preferably comprises a material which is selected from a textile or a polymer.

[0045] The prosthetic material of the main vascular prosthesis and / or the anchoring vascular prosthesis and / or the side vascular prosthesis, provided that each of them or only one or two of them has a prosthetic material, can be made of such a material or have such a material.

[0046] According to a further embodiment, the meandering orbit of at least one stent ring of the stent framework has a non-uniform amplitude.

[0047] According to this embodiment, a vascular prosthesis system is provided which can be used in particular in curved vessels, e.g. the aortic arch, since the uneven amplitudes do not lead to unnecessary accumulation of material in the vascular prosthesis in the region of the curvature.

[0048] According to one embodiment, the stent framework of the main vascular prosthesis and / or the stent framework of the anchoring vascular prosthesis and / or the stent framework of the side vascular prosthesis is self-expandable.

[0049] This means that the stent framework can be converted from a compressed state to an expanded state. The compressed state is achieved by a compressing and retractable element, e.g., a sheath, that compresses the stent framework—and any attached prosthetic material—and compresses it during insertion into a vessel. After correct placement, the element compressing the stent framework is removed, whereupon the stent framework expands, and its walls press against the vessel wall, securing the vascular prosthesis in the vessel.

[0050] In general, it is preferred if the stent framework consists of or comprises a self-expanding material. In this case, it is particularly preferred if the material is nitinol.

[0051] According to one embodiment, the diameter D1 of the main vascular prosthesis is from 24 mm to 42 mm, in particular 24 mm, 26 mm, 28 mm, 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, 40 mm or 42 mm.

[0052] According to a further embodiment, the diameter D2 of the anchoring vascular prosthesis is from 6 mm to 14 mm, in particular 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm or 14 mm.

[0053] According to a further embodiment, the diameter D3 of the lateral vascular prosthesis is from 6 mm to 16 mm, in particular 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm or 16 mm.

[0054] According to these embodiments, the diameters D1, D2 and D3 can be adapted to the respective vessel to be treated. These dimensions correspond in particular to the diameters within the aortic arch or the Brachiocephalic trunk artery, the Common carotid artery and the Left subclavian artery. According to the invention, the main vascular prosthesis, the anchoring vascular prosthesis, and the lateral vascular prosthesis can have a uniform diameter over their entire length, or they can have different diameters. If the respective vascular prosthesis components have different diameters, the diameters D1, D2, and D3 mentioned in these embodiments correspond to the largest or maximum diameters.

[0055] According to a further embodiment, the anchoring vascular prosthesis is attached to an inner wall in the lumen of the main vascular prosthesis, preferably sewn, glued or welded.

[0056] Secure attachment of the anchoring vascular prosthesis in the lumen of the main vascular prosthesis is preferred, as it could otherwise become unintentionally detached from the main vascular prosthesis. This can be ensured by the design. Due to its construction, the anchoring vascular prosthesis is not anchored in the vessel itself, unlike, for example, the main vascular prosthesis or the lateral vascular prosthesis. Due to strong blood flow within the vascular prosthesis, the anchoring vascular prosthesis may therefore become detached and unintentionally displaced. This disadvantage is avoided by the described design.

[0057] According to the invention, the second lumen end of the lateral vascular prosthesis can be inserted via the first lumen end of the main vascular prosthesis into the first lumen end of the anchoring vascular prosthesis and at least partially into its lumen.

[0058] This simplifies the implantation of side vessels with a side vascular prosthesis. The anchoring system of the side vascular prosthesis into the anchoring vascular prosthesis allows even an inexperienced cardiac surgeon to perform such implantations, as the main vascular prosthesis does not necessarily have to be precisely aligned with the side vessels. Any error during implantation regarding the location of the main vascular prosthesis can be compensated for by the interlocking of the two.

[0059] According to a further embodiment, the main vascular prosthesis has a jacket surface and a fenestration provided in the jacket surface, via which the second lumen end of the side vascular prosthesis can be at least partially introduced into the lumen of the main vascular prosthesis and via the first lumen end of the anchoring vascular prosthesis into its lumen.

[0060] Fenestrated vascular prostheses are those that have preformed holes (fenestrations) to allow one or more vascular branches within the vascular prosthesis. This embodiment makes it possible to continue supplying blood to laterally branching blood vessels via a side vascular prosthesis while simultaneously supporting the main vessel with a main vascular prosthesis.

[0061] Alternatively, the fenestration can be in situ Fenestration can be designed. The fenestration is inserted only after the vascular graft has been positioned in the vessel. Here, the main vascular graft is penetrated in situ with a needle to create a needle hole in the surface of the graft material. A dilator assembly is then pushed through the needle hole to expand the needle hole.

[0062] The outer surface is preferably made of a prosthetic material which is connected to the stent framework of the main vascular prosthesis.

[0063] The intraluminal vascular prosthesis system according to the invention can be used to treat vascular diseases of a patient, in particular in the area of ​​the aortic arch and the Descending aorta be used.

[0064] In the method disclosed herein, the side vascular prosthesis can be inserted into the lumen of the anchoring vascular prosthesis via the first lumen end of the main vascular prosthesis.

[0065] In the method disclosed herein, the main vascular prosthesis may have a shell surface and a fenestration provided in the shell surface, and the side vascular prosthesis may be inserted into the lumen of the main vascular prosthesis via the fenestration in the main vascular prosthesis and into the lumen of the anchoring vascular prosthesis via the first lumen end of the anchoring vascular prosthesis, at least partially.

[0066] The features, properties and advantages described for the vascular prosthesis or the vascular prosthesis system according to the invention can be applied accordingly to the methods disclosed herein.

[0067] Further advantages emerge from the figures and the following description of preferred embodiments.

[0068] It is understood that the features mentioned above and those to be explained below can be used not only in the combination specified in each case, but also in other combinations or on their own, without departing from the scope of the present invention.

[0069] Embodiments of the invention are illustrated in the drawings and explained in more detail in the following description. They show: Fig. 1 a schematic representation of a first embodiment of a main vascular prosthesis of an intraluminal vascular prosthesis according to the invention; Fig. 2 a schematic representation of the embodiment from Fig. 1 , whereby the intraluminal main vascular prosthesis is placed in the aortic arch or the Descending aorta implanted; Fig. 3a a schematic representation of a first embodiment of the intraluminal vascular prosthesis system according to the invention, wherein the intraluminal vascular prosthesis system is in the aortic arch or the Descending aorta implanted; Fig. 3b a schematic representation of a first embodiment of the hollow cylindrical lateral vascular prosthesis; and Fig. 4 a schematic representation of a second embodiment of the intraluminal vascular prosthesis system according to the invention, wherein the intraluminal vascular prosthesis system is in the aortic arch or the Descending aorta implanted.

[0070] In the figures, identical features are provided with identical reference symbols, although for reasons of clarity not all reference symbols are always indicated in all figures.

[0071] Fig. 1shows a schematic representation of parts of a first embodiment of an intraluminal vascular prosthesis system according to the invention. The vascular prosthesis system 10 shown here has two separate vascular prostheses that are firmly connected to one another: on the one hand, the main vascular prosthesis 12 and, on the other hand, the anchoring vascular prosthesis 20. The anchoring vascular prosthesis 20 can be attached to the main vascular prosthesis 12, for example, by sewing, gluing, or welding. Both the main vascular prosthesis 12 and the anchoring vascular prosthesis 20 each have a lumen 13 and 21. This extends from the first lumen end 14 and 22 to the second lumen end 15 and 23, so that a length L1 and L2 is formed. The hollow cylindrical structure of the main vascular prosthesis 12 orthe anchoring vascular prosthesis 20, with the diameter D1 and D2, is achieved in particular by the respective hollow cylindrical stent framework 16 and 24 and the respective surrounding prosthetic material 17 and 25. In this representation, the stent framework 16 and 24 is each constructed from individual stent rings 18 and 26, which are only connected to one another via the prosthetic material 17 and 18.

[0072] The dimension of the hollow cylindrical main vascular prosthesis 12 corresponds approximately to the dimension of the aortic arch and the Descending aorta. This allows for easy implantation into the vessel. Depending on the vessel characteristics of each patient, the dimensions of the intraluminal vascular prosthesis system can be adapted. In particular, the diameter D1 of the main vascular prosthesis 12 is adapted to the diameter of the Descending aortaadapted such that it is pressed against the vessel wall in the expanded state. Under certain circumstances, it is preferable if the main vascular prosthesis 12 and / or the anchoring vascular prosthesis 20 have a different diameter D1 and D2 over the length L1 and L2, respectively.

[0073] The anchoring vascular prosthesis 20 is firmly attached within the lumen 13 of the main vascular prosthesis over at least a portion of the length L2, wherein the diameter D2 of the anchoring vascular prosthesis 20 is at least 45% smaller than the diameter D1 of the main vascular prosthesis 12. In addition, the length L2 of the anchoring vascular prosthesis 20 is smaller than the length L1 of the main vascular prosthesis 12.

[0074] This design of the vascular prosthesis system according to the invention makes it possible to treat a large number of patients with different vascular conditions in the area of ​​the ascending aorta, the aortic arch and the descending aorta.

[0075] The internal hollow cylindrical anchoring vascular prosthesis 20 serves in particular the purpose of allowing a further hollow cylindrical lateral vascular prosthesis 30 to be inserted into the lumen 21 with its second lumen end and to be fixed therein (not shown in this figure).

[0076] In Fig. 2 is a schematic representation of the first embodiment of the intraluminal vascular prosthesis system according to the invention, wherein the intraluminal main vascular prosthesis 12 in the aortic arch 50 or in the area of ​​the aorta descending 52 implanted.

[0077] The ascending branch, also Ascending aorta 56 is mentioned about the Fig. 2 not shown aortic root ( Aortic sinus ) is connected to the left ventricle of the heart, which is also not shown. Ascending aorta 56 is connected via the aortic arch 50 to the Descending aorta52. In the area of ​​the aortic arch 50, arterial head vessels branch off, namely the arterial trunk Brachiocephalic trunk 55, the Common carotid artery 54 and the Left subclavian artery 53.

[0078] The main vascular prosthesis 12 of the intraluminal vascular prosthesis system 10 bridges an aneurysm in the area of ​​the Descending aorta 52. The one from the Ascending aorta The blood flow coming from the aortic arch 56 enters the first lumen end 14 of the main vascular prosthesis 10 via the aortic arch 50 and exits it at the second lumen end 15. For this purpose, the main vascular prosthesis 10 has a hollow cylindrical body which forms a first lumen 13. This lumen 13 is formed by meandering stent rings 18, which together form the stent framework 16. The individual stent rings 18 are connected by a prosthetic material 17. The prosthetic material 17 is preferably made of a textile material or a film and is attached to the stent rings 18 by sewing, gluing, or melting.

[0079] The anchoring vascular prosthesis 20 can be surrounded by a prosthetic material 25. If it does not have a prosthetic material 25, the individual stent rings 26 are designed such that they form a coherent stent framework 24.

[0080] The main vascular prosthesis 10 is preferably implanted in the vessel in such a way that a side vascular prosthesis 30 can be inserted into the lumen 21 of the anchoring vascular prosthesis 20 in the most space-saving manner possible. This means that the side vascular prosthesis 30 is connected to the anchoring vascular prosthesis 20 in such a way that no material accumulation occurs.

[0081] In Fig. 3a is a schematic representation of a first embodiment of the intraluminal vascular prosthesis system 10 according to the invention, wherein the intraluminal vascular prosthesis system 10 is in the aortic arch 50 or the Descending aorta52 is implanted. The intraluminal vascular prosthesis system 10 comprises a main vascular prosthesis 10 and a side vascular prosthesis 30. The main vascular prosthesis 10 corresponds to the one already described in Fig.2 described main vascular prosthesis 10.

[0082] The lateral vessel prosthesis 30, with a length L3, has a continuous lumen 31 extending from the first lumen end 32 to the second lumen end 33. The lumen 31 is formed in particular from the hollow cylindrical stent framework 34, which in turn is formed from individual stent rings 36. In this illustration, the individual stent rings 36 are interconnected and not surrounded by a prosthetic material. In this embodiment, the blood coming from the aortic arch can flow through the stent framework 34 into the outgoing lateral vessel 53. At the same time, the lateral vessel 53 is supported by the lateral vessel prosthesis 30.

[0083] In an embodiment not shown, the lateral vascular prosthesis 30 can also be only partially surrounded by a prosthetic material 35; preferably in the region of the second lumen end 33.

[0084] In Fig. 3a A schematic representation of a first embodiment of the hollow cylindrical lateral vascular prosthesis 30 is shown. The lateral vascular prosthesis 30 has a lumen 31, which extends from the first lumen end 32 to the second lumen end 33. This also defines the length L3 of the lateral vascular prosthesis 30. In this representation, the lateral vascular prosthesis 30 has stent rings 36, which are interconnected by a prosthetic material 35. The prosthetic material 35 and the individual stent rings 36 together form the hollow cylindrical stent framework 36.

[0085] In this embodiment, the lateral vessel prosthesis 30 tapers toward the second lumen end 33. In this illustration, the diameter D3 corresponds to the larger diameter at the first lumen end 32. In this embodiment, the diameter at the first lumen end 32 corresponds to the diameter of the lateral vessel into which the lateral vessel prosthesis 30 is to be implanted, and the diameter at the second lumen end 33 corresponds to the diameter of the anchoring vessel prosthesis 20 into which the lateral vessel prosthesis 30 is to be inserted.

[0086] In Fig. 4 is a schematic representation of a second embodiment of the intraluminal vascular prosthesis system 10 according to the invention, wherein the intraluminal vascular prosthesis system 10 is in the aortic arch 50 or the Descending aorta 52 implanted.

[0087] The vascular prosthesis system 10 in Fig. 4 differs from the vascular prosthesis system 10 in Fig. 3shown in the fenestration or fenestration area 19 in the lateral surface. Via this fenestration 19, the second lumen end 33 of the side vascular prosthesis 30 can be at least partially introduced into the lumen 13 of the main vascular prosthesis 12 and via the first lumen end 22 of the anchoring vascular prosthesis 20 into its lumen 13. A fenestration 19 can be designed as preformed holes or as in situ Fenestration. By means of the lateral vessel prosthesis 30, which is inserted through the fenestration 19, the lateral vessels can continue to be supplied with blood. This design offers the advantage that, in addition to the aortic arch 50 and the Descending aorta 52 also the Subclavian artery 53 is supported by the vascular prosthesis system 10.

[0088] According to a further embodiment, as in Fig. 4As shown, the main vascular prosthesis can also be composed of two interconnectable hollow cylindrical stent framework sections 16a, 16b, such that a first stent framework section 16a comprises the anchoring prosthesis 20, and the second stent framework section 16b can be connected to the first stent framework section 16a to extend it. The side vascular prosthesis 30 can then be introduced via the second stent framework section 16b into the common lumen and into the anchoring prosthesis 20 present in the first stent framework section 16a.

[0089] X-ray markers can be applied at specific positions (not shown) to assist in positioning during implantation and to verify the position of the individual components of the vascular prosthesis system 10. For example, such X-ray markers are applied in the area of ​​the lumen ends 14, 15, 22, 23, 32 and / or 33 or the fenestration 19.

Claims

1. An intraluminal vascular prosthesis system (10) for implantation in the region of the aortic arch (50) of a patient, comprising: - a hollow-cylindrical main vessel prosthesis (12), which has a lumen (13) routed through the main vessel prosthesis, a first lumen end (14), a second lumen end (15), a hollow-cylindrical stent frame (16), optionally with a prosthesis material (17) secured thereon, a length L1 and a diameter D1, wherein the hollow-cylindrical main vessel prosthesis (12) is configured and dimensioned for implantation in the region of the aortic arch (50) and the descending aorta (52) of the patient, and wherein the main vessel prosthesis (12) has - at least one hollow-cylindrical anchoring vessel prosthesis (20), which has a lumen (21) routed through the anchoring vessel prosthesis, a first lumen end (22), a second lumen end (23), a hollow-cylindrical stent frame (24), optionally with a prosthesis material (25) secured thereon, a length L2 and a diameter D2, wherein the anchoring vessel prosthesis (20) is securely attached within the lumen (13) of the main vessel prosthesis (12), at least over part of the length L2 of the anchoring vessel prosthesis (20), and wherein the diameter D2 of the anchoring vessel prosthesis (20) is at least 45% smaller than the diameter D1 of the main vessel prosthesis (12), and wherein the length L2 of the anchoring vessel prosthesis (20) is shorter than the length L1 of the main vessel prosthesis (12), wherein the vascular prosthesis system (10) moreover comprises - at least one hollow-cylindrical side vessel prosthesis (30), with a lumen (31) routed through the side vessel prosthesis (30), wherein the side vessel prosthesis (30) has a first lumen end (32), a second lumen end (33), a hollow-cylindrical stent frame (34), optionally with a prosthesis material (35) secured thereon, a length L3 and a diameter D3, and wherein the hollow-cylindrical side vessel prosthesis (30) for implantation is designed and dimensioned to bridge the outlet of the subclavian artery (53) and / or the carotid artery (54) of the patient, in such a way that the side vessel prosthesis (30) can be positioned with its first lumen end (32) in the subclavian artery (53) and / or the carotid artery (54), and, in order to securely anchor the side vessel prosthesis (30), its second lumen end (33) can be inserted at least partially into and fixed in the lumen (21) of the anchoring vessel prosthesis (20) via the first lumen end (22) of the anchoring vessel prosthesis (20), and wherein the second lumen end (33) of the side vessel prosthesis (30) is insertable, via the first lumen end (14) of the main vessel prosthesis (12), into the first lumen end (22) of the anchoring vessel prosthesis (20) and at least partially into the lumen (21) thereof.

2. The intraluminal vascular prosthesis system (10) as claimed in claim 1, characterized in that the main vessel prosthesis (12) and / or the anchoring vessel prosthesis (20) and / or the side vessel prosthesis (30) have / has a stent frame (16; 24; 34) and a prosthesis material (17; 25; 35) secured on the latter.

3. The intraluminal vascular prosthesis system (10) as claimed in claim 1 or 2, characterized in that the stent frame (16) of the main vessel prosthesis (12) and / or the stent frame (24) of the anchoring vessel prosthesis (20) and / or the stent frame (34) of the side vessel prosthesis (30) is chosen from a laser-cut stent frame, individual stent springs or a braided stent frame.

4. The intraluminal vascular prosthesis system (10) as claimed in one of claims 1 to 3, characterized in that the stent frame (16) of the main vessel prosthesis (12) and / or the stent frame (24) of the anchoring vessel prosthesis (20) and / or the stent frame (34) of the side vessel prosthesis (30) has non-interconnected stent rings (18; 26; 36), which are arranged in succession and extend circumferentially in a meandering formation, and a prosthesis material (17; 25; 35) firmly connected to the stent rings (18; 26; 36).

5. The intraluminal vascular prosthesis system (10) as claimed in claim 4, characterized in that the meandering circumferential course of at least one stent ring (18; 26; 36) of the stent frame (16; 24; 34) has a non-uniform amplitude.

6. The intraluminal vascular prosthesis system (10) as claimed in one of claims 1 to 5, characterized in that the stent frame (16) of the main vessel prosthesis (12) and / or the stent frame (24) of the anchoring vessel prosthesis (20) and / or the stent frame (34) of the side vessel prosthesis (30) is self-expandable.

7. The intraluminal vascular prosthesis system (10) as claimed in one of claims 1 to 6, characterized in that the diameter D1 of the main vessel prosthesis (12) is from 24 mm to 42 mm, in particular 24 mm, 26 mm, 28 mm, 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, 40 mm or 42 mm.

8. The intraluminal vascular prosthesis system (10) as claimed in one of claims 1 to 7, characterized in that the diameter D2 of the anchoring vessel prosthesis (20) is from 6 mm to 14 mm, in particular 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm or 14 mm.

9. The intraluminal vascular prosthesis system (10) as claimed in one of claims 1 to 8, characterized in that the diameter D3 of the side vessel prosthesis (30) is from 6 mm to 16 mm, in particular 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm or 16 mm.

10. The intraluminal vascular prosthesis system (10) as claimed in one of claims 1 to 9, characterized in that the anchoring vessel prosthesis (20) in the lumen (13) of the main vessel prosthesis (12) is mounted on an inner wall, preferably by sewing, adhesive bonding or welding.

11. The intraluminal vascular prosthesis system (10) as claimed in one of claims 1 to 10, characterized in that the main vessel prosthesis (12) has a jacket surface, and a fenestration (19) which is provided in the jacket surface and via which the second lumen end (33) of the side vessel prosthesis (30) is insertable into the lumen (13) of the main vessel prosthesis (12) and at least partially into the lumen (21) of the anchoring vessel prosthesis (20) via the first lumen end (22) of the latter.