Vascular prostheses

Abstract

This invention relates to a vascular prosthesis (10; 100) for a patient's blood vessel, comprising: a hollow cylindrical body (11) having a prosthetic material (12), a longitudinal axis (L), and a support frame (13), the body (11) including a proximal opening (14a) and a distal opening (15a) at a proximal end (14) and a distal opening (15a), respectively. The vascular prosthesis (10; 100) includes a first distal support ring (22) connected to the prosthetic material (12) at at least one end (14, 15). At least one filament element (30; 30a, 30b) is fastened to the vascular prosthesis (10; 100), the diameter of the corresponding distal or proximal opening decreasing when pulled.

Description

Technical Field

[0001] The present invention relates to a vascular prosthesis for a patient’s blood vessels, the vascular prosthesis comprising a hollow cylindrical body, the body including a support frame and prosthetic material attached thereto, the body having a longitudinal axis, an inner side and an outer side, and a proximal end having a proximal opening and a distal end having a distal opening. Background Technology

[0002] This type of vascular prosthesis is generally known in the art. Vascular prostheses, also known as endovascular stents / stent grafts, endovascular prostheses, or endovascular grafts, are commonly used to treat weakened, injured, ruptured, or aneurysmal vessels. The goal of endovascular treatment of aneurysms is to completely relieve pressure on the diseased segment of the vessel to reliably prevent rupture. This requires sealing the prosthesis against the failed lumen throughout the procedure, especially in the anchoring area. To this end, a vascular prosthesis or stent graft is released at the site of the lesion or injury of the vessel, restoring the function of the original vessel or supporting the integrity of the still-existing vessel. The implant thus causes correction or shielding of the lesion and / or redirection of blood flow. In this way, blood now flows through the vascular prosthesis, preventing further pressure on the bulge. The radial force of the vascular prosthesis is usually sufficient to anchor it in the vessel.

[0003] An aneurysm is a widening or dilation of an artery caused by congenital or acquired changes in the vessel wall. The bulge may involve the entire vessel wall, or in the case of a so-called pseudoaneurysm or dissection, blood may leak from the lumen between the layers of the vessel wall and tear the layers apart. Untreated aneurysms can lead to late-stage arterial rupture, causing the patient to bleed internally and die.

[0004] Self-expanding vascular prostheses used to treat aneurysms typically consist of a hollow cylindrical metal frame or stent made of stainless steel or a metal alloy (often a shape memory material; such as nitinol). The metal frame or stent is usually composed of a wire mesh or a series of zigzag ring-shaped stent springs arranged sequentially. The wire mesh or ring-shaped stent springs can be interconnected via wire connections or simply by means of the prosthesis material. The sheath covering the hollow cylindrical metal frame is typically covered with a fabric or polymer film, thus forming the hollow cylinder. The sheath is usually made of polyester or polytetrafluoroethylene (PTFE). The metal frame is typically sutured to the prosthesis material using a non-absorbable suture material.

[0005] Currently, vascular prostheses range in diameter from 18 to 46 mm, and sheath / cover length from 90 to 250 mm. These can be extended proximally or distally via additional prostheses. Custom-made vascular prostheses are also known. At the time of purchase, vascular prostheses are typically pre-assembled in an insertion system. The prosthesis is then inserted into the affected vessel via a rigid guide wire through this system.

[0006] Typically, vascular prostheses lack a sheath (“bare spring”) in their proximal region (10 to 20 mm). The “bare spring” ensures anchorage within the delivery system. Therefore, the “bare spring” is necessary during the implantation of the vascular prosthesis, during which the delivery system connects to the exposed stent ring of the vascular prosthesis, thereby ensuring targeted expansion of the vascular prosthesis at the desired location.

[0007] For implantation, the vascular prosthesis is radially compressed, significantly reducing its cross-sectional area. For this purpose, the vascular prosthesis is positioned distal to the sheathed catheter of the delivery system and can be released by slowly withdrawing the sheathed catheter.

[0008] During implantation, the vascular prosthesis is first guided into the aneurysm region with the assistance of an insertion / delivery system, where it can be released in the correct position. The delivery system includes a fixation device for the proximal stent graft spring for this purpose. For this purpose, the first stent spring, i.e., the proximal distal stent spring, is hooked into a closure mechanism. This is generally possible because the first stent spring protrudes proximally from the stent graft and there is no prosthetic material in that region. The fixation device holds the first stent spring together in the delivery system and can release it at any time by operating a release mechanism at the proximal end of the delivery system.

[0009] In this regard, the correct placement of the stent can be controlled by X-ray markings placed on the stent sheath (especially in the ostial region for supplying branch vessels or in the proximal and distal regions).

[0010] As mentioned above, the proximal fixation device of a vascular prosthesis is typically released via a stent spring protruding from the fabric sheath. This has been shown to lead to several disadvantages. For example, vascular injury frequently occurs due to the exposed, often pointed, stent spring, potentially leading to the development of new aneurysms in the worst-case scenario. Furthermore, there is a risk that the sheath catheter and guide wire may become entangled or "wrapped" around the free stent spring. The result will be dislocation and / or failure of the vascular prosthesis. Additionally, the exposed spring may damage any existing vascular prosthesis. Moreover, such a vascular prosthesis cannot be partially deployed, thus completely blocking blood flow during implantation.

[0011] Furthermore, a key issue when deploying self-dilatating vascular prostheses is that once deployed, the prosthesis cannot be rotated, moved, or displaced within the vessel for proper placement, potentially leading to vascular injury. This is a drawback of known insertion systems based on existing technology. This is particularly important in the case of vascular prostheses with collateral vessels, as these collateral vessels are designed to extend into branch vessels after deployment.

[0012] To avoid these drawbacks, vascular prostheses known in the prior art are designed such that, for example, a proximal stent spring is also sutured around / covered by the prosthesis material. The fixation of the vascular prosthesis on / at the delivery system (which is necessary for its insertion into the vessel to be treated) is ensured by a ring located within the hollow cylindrical body.

[0013] However, this type of vascular prosthesis results in unnecessary material buildup / fill density in the proximal loading area, thus requiring a larger catheter diameter. Therefore, it cannot treat patients with smaller vessels. Another drawback of these vascular prostheses is that the guide hook of the insertion system can get stuck in the ring, and the vascular prosthesis can move during release. Furthermore, it may increase the risk of thrombosis because blood components can adversely adhere to the exposed ring.

[0014] In other vascular prostheses known in the prior art, a metal ring protrudes from the encapsulated stent graft, and a guide wire can be attached to the stent graft. Another drawback of these prostheses is that the prosthesis may become stuck on the ring when the delivery system retracts, causing the vascular prosthesis to dislodge. There is also a risk of thrombosis and eventual embolism when using such vascular prostheses.

[0015] Therefore, there remains a great need for novel vascular prostheses that can be implanted into blood vessels and used to treat vascular diseases. In particular, vascular prostheses should enable simplified loading onto insertion catheters and easy insertion and delivery into the affected blood vessel. Summary of the Invention

[0016] In this context, one object of the present invention is to provide a vascular prosthesis and a suitable delivery system by which the vascular prosthesis can be easily loaded, compressed, introduced and released, thereby also ensuring the possibility of proper placement of the stent just before final release.

[0017] According to the present invention, this objective is achieved by a vascular prosthesis for a patient's blood vessels, the vascular prosthesis comprising: a hollow cylindrical body having a stent frame and prosthetic material attached to the stent frame, the body having a longitudinal axis (L), an inner side (Innenseite), and an outer side (Außenseite), and a proximal end having a proximal opening and a distal end having a distal opening, wherein a self-expanding first distal stent ring is provided at the proximal end and / or the distal end, the first distal stent ring being convertible from a compressed state to an expanded state, wherein the first distal stent ring is circumferentially curved and extends, and has a pointed arch (Spi). The vascular prosthesis consists of a first distal stent ring attached to the outer side of the body to the prosthesis material, such that the prosthesis without the first distal stent ring freely protrudes beyond the proximal and / or distal ends. Furthermore, at least one suture element is disposed on the first distal stent ring, the suture element having a first end and a second end, and wherein the suture element is securely fixed to the first distal stent ring at its first end and is at least partially circumferentially movable on the vascular prosthesis, such that the first distal stent ring can be converted from a radially compressed state to an expanded state by the pulling loading or pulling unloading of the at least one suture element.

[0018] This objective is also achieved by an insertion / delivery system for inserting a vascular prosthesis having at least one distal stent ring into a patient's blood vessel, the delivery system comprising: a catheter tubing to which the vascular prosthesis can be loaded for insertion into the blood vessel; a retractable sheath for compressing the vascular prosthesis in the loaded state; a fixation device capable of axial movement on the catheter tubing; and at least one suture element through which the distal stent ring of the vascular prosthesis can be compressed or expanded by pull loading or pull unloading / releasing.

[0019] The object of the present invention is further achieved by a method for inserting a vascular prosthesis into a patient's blood vessel using the insertion system according to the present invention, the method comprising the following steps:

[0020] - The vascular prosthesis according to the invention, which is loaded onto a catheter tube and kept compressed by a retractable sheath, is inserted into the patient's blood vessel;

[0021] - Remove the retractable sheath to release the main portion of the vascular prosthesis, keeping the proximal and / or distal ends of the vascular prosthesis fixed and compressed;

[0022] - To axially displace the fixing device to unload / relax the at least one linear element and thereby expand the distal and / or proximal ends; and

[0023] - Release the suture element from the fixation device of the delivery system to fully release the distal and / or proximal end of the vascular prosthesis.

[0024] This objective is further achieved by using a vascular prosthesis according to the invention and / or an insertion / delivery system according to the invention to implant into a patient's blood vessels to treat vascular diseases.

[0025] The purpose of this invention is fully achieved in this manner.

[0026] The vascular prosthesis according to the invention, or the insertion / delivery system according to the invention, can be placed easily and with extreme precision. This is possible because the suture element guidance allows the opening of the vascular prosthesis to be opened and closed again in a controlled manner if necessary. Therefore, uncontrolled immediate dilation of the vascular prosthesis after sheath catheter withdrawal is avoided. Instead, dilation is controlled so that the vascular prosthesis can be used to be partially dilated to full dilation in stages. In this case, dilation is controlled by the suture element guidance device and the pulling or releasing of the suture element. A particular advantage of this vascular prosthesis is that rotation is also possible after its placement, for example, to precisely place any lateral branch of the vascular prosthesis (which can be supplied to branch vessels).

[0027] The vascular prosthesis according to the present invention provides a novel vascular prosthesis that can be used to support unstable, fragile, or thrombotic vessel walls, and is particularly useful for treating aneurysms. The special design of the vascular prosthesis makes it easier for surgeons to correctly place the prosthesis within the injured vessel and to correct its position if necessary.

[0028] Specifically, the hollow cylindrical prosthesis has a proximal opening at the proximal end and a distal opening at the distal end, with the proximal and distal openings each having a diameter (d).

[0029] According to the invention, the angle or degree of opening of the proximal and / or distal openings of the vascular prosthesis can be controlled by at least one filament element, particularly after the retraction sheath, which previously held the remaining vascular prosthesis in a compressed state, is retracted. This allows the user to first precisely place the vascular prosthesis, compressed by the retraction sheath (e.g., along its longitudinal axis), into the vessel to be treated, and then retract the retraction sheath to allow the vascular prosthesis to expand, thereby controlling the opening or expansion of the proximal and / or distal openings of the vascular prosthesis by at least one filament element.

[0030] Furthermore, the vascular prosthesis according to the invention provides the advantage of a suture element that enables targeted dilation of the opening of the vascular prosthesis, and after dilation, anchoring it to the vascular prosthesis, so that the suture element does not hook into the delivery system, thereby preventing vascular prosthesis dislocation.

[0031] Furthermore, the advantage of the vascular prosthesis according to the invention is that it eliminates the need for the so-called "bare spring" discussed at the beginning, as the vascular prosthesis is designed such that the proximal opening can be substantially flush with the prosthesis material. According to a preferred embodiment, the vascular prosthesis according to the invention is used as a vascular prosthesis that is partially inserted into another vascular prosthesis at its proximal and / or distal end (i.e., the end where the suture element is located) for anchorage therein, thereby forming a "stent within a stent" or a so-called "secondary" stent. The vascular prosthesis according to the invention prevents damage that can occur with two vascular prostheses known in the prior art, which are guided into each other by their exposed stent rings / stent springs in the overlapping area.

[0032] In other words, “free” (when referring to the protrusion of the first distal stent ring beyond the proximal and / or distal end) means that the prosthetic material is flush with the outermost tip of the protrusion, i.e., each region or segment of the first distal stent ring is covered by prosthetic material from inside or outside the vascular prosthesis.

[0033] According to the present invention, the first distal stent ring is a support element arranged perpendicular to the longitudinal direction at the proximal and / or distal end of the vascular prosthesis and looping and closing in a bend / winding manner. The first distal stent ring has a stent spring formed by a pointed arch and legs / strips connecting the pointed arch.

[0034] The term "mäanderförmig" is used herein to refer to any ring-shaped route of the stent ring. In this case, pointed arches or apexes are formed, which alternately point in the proximal and distal directions and are interconnected by straight strips or legs. According to a preferred embodiment, the stent ring has at least four pointed arches pointing in one direction (i.e., proximal or distal), particularly having at least or exactly four, five, six, seven, eight, or nine pointed arches.

[0035] As used herein, "stent" or "stent element," "stent spring" or "stent ring" refers to any structure that provides expansion force and / or support for a vascular prosthesis. Therefore, a stent element is any element that possesses the characteristics of a stent. In this document, the terms stent spring and stent ring are used interchangeably.

[0036] The support ring is defined as any one-piece ring element that, due to its material, can be compressed and, after the compression is removed, can expand again in a spring-like manner. The support spring / ring has a wavy loop, with crests and troughs forming a phase and alternating with each other.

[0037] According to the invention, at least one distal stent ring is not connected to the rest of the stent frame of the vascular prosthesis, but is only attached to the prosthesis material, preferably sutured to the prosthesis material. Preferably, the first distal stent ring is not attached to the entire surface of its material, but only to certain segments, such as only in the region of the pointed arch, so that the strips / legs connecting the pointed arches are not substantially directly connected to or sutured to the prosthesis material.

[0038] Stent rings can have equal or different circumferential amplitudes distributed around their circumference, due to the equal or different lengths of the legs of the stent springs. Varying amplitude lengths provide the advantage of allowing stent grafts to adapt to individual blood vessels and their respective characteristics (curvature, branching vessels, taper, etc.).

[0039] According to the present invention, the vascular prosthesis has a stent frame, which, according to a preferred embodiment, extends along the entire length of the vascular prosthesis and is connected to the prosthesis material along the entire length.

[0040] According to the present invention, the term "distal" is used to refer to the portion or end of the vascular prosthesis that is further downstream relative to blood flow. On the other hand, again relative to blood flow, the term "proximal" means the portion or end that is further upstream relative to blood flow. In other words, the term "distal" refers to being guided / provided in the direction of blood flow, while the term "proximal" refers to being guided / provided opposite to the direction of blood flow.

[0041] On the other hand, in the case of catheters or delivery systems containing catheters, the term "distal" refers to the end of the catheter or delivery system that is inserted into the patient or is furthest from the user, while the term "proximal" refers to the end that is closer to the user.

[0042] According to the present invention, a first distal stent ring may be provided at the proximal or distal end or both ends, the first distal stent ring being securely fixed to the prosthetic material of the vascular prosthesis. Conversely, therefore, unless specifically specified, "distal" refers to the proximal or distal end of the vascular prosthesis.

[0043] The attachment of the first suture element to the vascular prosthesis can be achieved, for example, by suturing, knotting and / or gluing the end of the first suture element to the vascular prosthesis, particularly the vascular prosthesis material and / or stent ring.

[0044] In this article, "linear element" should be understood as a line or rope of a certain length and having a first end and a second end, especially any flexible and inelastic structure made of twisted fibers, plastic or metal, which has a predominant one-dimensional elongation and uniformity in the longitudinal direction, thus having a first end, a second end and a certain length.

[0045] According to another preferred embodiment, a second distal stent ring is disposed at the proximal and / or distal ends, and the second distal stent ring can be switched from a compressed state to an expanded state by compression or expansion of the first distal stent ring. The second distal stent ring is circumferentially meandering and has a pointed arch and strip-shaped portions / legs connecting the pointed arch. The second distal stent ring is attached to the prosthetic material on the inside of the body in such a way that the pointed arch of the second distal stent ring does not freely protrude beyond the proximal and / or distal ends.

[0046] According to another preferred embodiment, the pointed arches of the first and second end support rings are arranged at the proximal and / or distal ends without overlapping on the inner and outer sides of the body, such that the first and second end support rings separated by the prosthetic material overlap only at the strip / leg portion and do not overlap at the pointed arch.

[0047] This embodiment provides the advantage that at least one end segment is additionally stabilized by a second end support ring.

[0048] According to one embodiment, preferably, at least one suture element is securely fixed to the vascular prosthesis at its first end in the region where the first end stent ring and / or the second end stent ring are attached to the prosthesis material.

[0049] Therefore, at least one suture element can also be securely fixed to the prosthesis material by the same sutures that secure the first end support ring and / or the second end support ring to the prosthesis material, such as by suturing, knotting and / or gluing to the first end support ring or the second end support ring.

[0050] According to a preferred embodiment of the vascular prosthesis of the present invention, the length of at least one suture element preferably corresponds to the length of an imaginary suture connecting at least two, preferably three, pointed arches pointing in the same (i.e., proximal or distal) direction.

[0051] The preferred length of the line element is between approximately 10 mm and 100 mm, particularly between 10 mm and 50 mm.

[0052] In a preferred embodiment, the diameter of the line element can be between approximately or exactly 0.05 mm and approximately or exactly 1 mm.

[0053] Advantageously, the degree of opening of the vascular prosthesis can be controlled by the length of at least one suture element.

[0054] At least one suture element is partially circumferentially present in the first distal stent ring of the vascular prosthesis, i.e., movably guided at its second free end, which is not fixedly attached to the vascular prosthesis. In this document, "circumferentially" means that the suture element is guided perpendicular to the longitudinal direction of the vascular prosthesis, and thus guided in the circumferential direction of the vascular prosthesis. Furthermore, "movably guided" or "movably attached" means that the suture element is fixed to the vascular prosthesis only at its first end and is not securely fixed to the prosthesis material and / or stent ring over its remaining length, particularly not at its second end, but is guided substantially freely (i.e., within a predetermined gap or path) such that the suture element can be compressed by pulling on it to close or reduce the vascular prosthesis opening, including the distal stent ring and the suture element, and can be expanded by unloading the distal stent ring to open or enlarge the vascular prosthesis opening.

[0055] Advantageously, at least one suture element is thus guided from its fixed first end along one of the circumferential directions of the vascular prosthesis, i.e., to the right or to the left, wherein, according to another preferred embodiment, the at least one suture element is guided regularly or irregularly, alternately, above and below the strip / leg portion of the stent ring.

[0056] Therefore, according to a preferred embodiment, the suture element is guided at least partially and / or at one or more locations in the circumferential direction of the vascular prosthesis within the predetermined region.

[0057] According to a preferred embodiment, it is further preferred that at least one thread element has a second end guided by a deflection device. Hereinafter, "deflection device" refers to any element through which the thread element can be guided and / or pulled in a direction different from a predetermined circumferential direction starting from a fixed point at the first end of the thread element, for example, in the opposite direction and / or towards the longitudinal axis.

[0058] The predetermined area through which the suture element is partially guided, or the deflection device, can be limited or "predetermined," for example, by sutures and / or loops in the prosthetic material. In this way, the suture element is held within the predetermined area.

[0059] Therefore, according to a preferred embodiment, at least one suture element is guided at at least one point in the circumferential direction of the end support ring between two spaced-apart sutures, preferably through the two spaced-apart sutures / seams through which the end support ring is secured to the prosthesis material.

[0060] As described above, this embodiment has the advantage of deflecting the circumferentially guided suture element: the suture element is securely attached to the vascular prosthesis at its first end and guided in one circumferential direction (to the right or left) and at a fixation point below the strip of the first end stent ring and away from the first end of the suture element; by providing guidance through at least one suture element passing through two spaced-apart sutures / stitches, the suture element can then be deflected in another direction, thereby compressing the end stent rings respectively, thereby reducing the opening of the vascular prosthesis.

[0061] This guidance between the two sutures can be accomplished at one point or at several points in the circumferential direction. However, movement in the circumferential direction is always possible.

[0062] Therefore, at least one line element can be targeted and deflected in different directions if necessary.

[0063] At least one suture element can thus be further arranged in a mesh-like manner, partially circumferentially surrounding the vascular prosthesis. In this case, at least one suture element is "woven" or circumferentially wound between the first distal stent ring and the prosthetic material, such that the suture element is alternately guided above and below the strip / leg portion of the first distal stent ring. Again, the area in which at least one suture element is guided can be predetermined by attaching the prosthetic material to the suture of the first distal stent ring. The alternating guidance above and below the strip portion of the first distal stent ring can be regular, i.e., always alternating above and below consecutive strip portions, or the alternating guidance can be irregular, e.g., above two consecutive strip portions and then below one strip portion, etc.

[0064] According to another embodiment, preferably, the second end of the suture element has a loop through which the suture element can be releasably secured to the vascular prosthesis release system.

[0065] For example, a loop can be formed by knotting or gluing the second end of the yarn element in a loop-like manner. For this purpose, the second end of the yarn element can be configured as a loop and secured to the yarn element in the segment preceding the second end of the yarn element by knotting, gluing, welding, or other fastening methods. Advantageously, the yarn element can thus be detachably hooked into the fixing system.

[0066] The vascular prosthesis according to the invention typically has two (terminal) states: an expanded state and a compressed state. The compressed state can be achieved by compressing the vascular prosthesis about its longitudinal axis, for example, by holding the vascular prosthesis in a retracted sheath surrounding the guide catheter. The first distal stent ring is further and thus individually or additionally compressed by the pulling load of at least one suture element. With the removal of the retracted sheath, the vascular prosthesis expands (except for the first distal stent ring or the opening of the vascular prosthesis including the first distal stent ring), which can be individually opened by the pulling unload of the suture element.

[0067] Before the vascular prosthesis is loaded onto the delivery catheter (and in its expanded form within the blood vessel), at least one suture element is thus loosely and partially (e.g., over the length of two to four pointed bends) circumferentially guided onto the existing vascular prosthesis. The end of at least one suture element, not securely attached to the vascular prosthesis, is thus exposed. For example, this end may be formed as a loop. This facilitates pulling the suture element and securing it to the delivery catheter.

[0068] To compress the first distal stent ring of the vascular prosthesis, the loose, free second end of the suture element can be pulled / pulled. This reduces the diameter of the corresponding distal and / or proximal openings of the vascular prosthesis. This shortens the distance between the attachment end of the suture element and the free area of ​​the suture element, causing the first distal stent ring to contract / compress. The suture element can be detachably attached to the insertion system for the vascular prosthesis via the second free end, for example, by suspending the second end, formed as a ring, in a fixation system provided for the suture element. To open the vascular prosthesis or the first distal stent ring, the fixation system for the suture element can then be axially moved on the guide catheter, causing the ring to release again, thereby achieving pull-off unloading and allowing the first distal stent ring or opening to enlarge. "Releasable" fastening as used herein means that, in order to load the vascular prosthesis and compress at least one distal stent ring, the second end of the suture element can be fastened to the delivery catheter or the fixation system provided thereon, and the locking suture element can be released again from the fixation system, for example, by mechanically influencing / manipulating the delivery catheter or fixation system to open at least one distal stent ring.

[0069] Therefore, traction loading is understood as applying a pulling or tugging motion to the suture element, through which the suture element at least partially compresses the distal stent ring. On the other hand, traction unloading can be understood as the suture element being guided on the vascular prosthesis without traction.

[0070] If the sheathed catheter is withdrawn during implantation, the expansion of the distal stent ring of the vascular prosthesis, and therefore the expansion of the opening where the distal stent ring is located, can be controlled by selectively releasing the second end of the suture element or by “releasing” or releasing the suture element. Thus, the expansion of the distal stent ring of the vascular prosthesis within the vessel can be controlled by fixation and release within the delivery system. After releasing the suture element fixation device, the remaining portion of the vascular prosthesis can be pre-released for full expansion by retracting the sheathed tubing that compresses them. The suture element is circumferentially wound around the vascular prosthesis during release, thereby being guided below and / or above the strip of the distal stent ring, so that after the vascular prosthesis expands within the vessel, the suture element is also clamped between the vascular prosthesis and the vessel wall.

[0071] According to one embodiment of the invention, at least one suture element may be formed of or comprise the same material as the prosthetic material of the vascular prosthesis, such as polyethylene terephthalate (PET), and / or made of the same material as the suture material used to attach at least the first end stent ring to the prosthetic material, such as UHMWPE (ultra-high molecular weight polyethylene), and / or made of a superelastic material, such as NiTi, and other common surgical suture materials.

[0072] In this paper, a hollow cylinder refers to the body of a vascular prosthesis, which consists of a stent frame and at least partially prosthetic material, with at least one end covered. The stent frame may consist of individual stent rings / springs that are not interconnected, or it may consist of a braided or laser-processed stent frame whose elements are interconnected.

[0073] According to one embodiment of the vascular prosthesis of the present invention, preferably, at least two, three, four, five, six, seven, or eight suture elements are provided on the first distal stent ring, each suture element being securely fixed to the vascular prosthesis via its first end. According to a preferred embodiment, the vascular prosthesis has five suture elements, particularly in the region of the first distal stent ring, each suture element being fixed to the vascular prosthesis via its first suture element end.

[0074] According to one embodiment of the vascular prosthesis of the present invention, the second, third, and possibly each other suture element can be securely fixed to the vascular prosthesis by means of a first end stent ring at its respective first end.

[0075] If the vascular prosthesis according to the invention has two or more suture elements, all of which are fixed to the vascular prosthesis in the region of the first distal stent ring, then each suture element preferably has the same length and is distributed on the circumference of the distal stent ring, so that in each case, a suture element spans a portion of the distal stent ring, for example, spanning two or three spires, or passing through two or three spires. By providing deflectors to the individual suture elements, the segments of the distal stent ring can then be compressed by the suture elements when they are subjected to tensile loading.

[0076] Therefore, according to a preferred embodiment of the vascular prosthesis, deflectors corresponding to the number of suture elements are provided, i.e., preferably 2, 3, 4, 5, 6, 7 or 8 deflectors.

[0077] As described above, each free second end of the line element is then detachably fastened, for example, via a ring formed at the second end, to a fixing system for compressing the first end support ring.

[0078] The preferred features listed above for at least one wire element naturally also apply to other wire elements.

[0079] In another embodiment of the vascular prosthesis according to the invention, the filament element can also be disposed in a region / stent ring directly adjacent to the first terminal stent ring in the direction of the other end of the vascular prosthesis. Therefore, the corresponding end of the vascular prosthesis having the filament element / wire element can be controlled over a longer portion and its opening can be selectively controlled. Advantageously, the vascular prosthesis can thus be repositioned over a longer period of time.

[0080] Advantageously, the length of the suture element can also be used to determine the number of suture elements: the longer the suture element, the fewer suture elements are needed to control the opening and compression of the vascular prosthesis.

[0081] According to another embodiment, the vascular prosthesis has a radiopaque marking.

[0082] The advantage of radiopaque markings is that the placement of the vascular prosthesis within the blood vessel can be monitored during implantation. In this regard, the markings are preferably located at the proximal and / or distal portions of the vascular prosthesis. In this regard, the X-ray markings are preferably sutured or adhered to the prosthesis material. According to the invention, the markings comprise or are composed entirely of radiopaque material.

[0083] By using markers located at specific points on the vascular prosthesis, the precise location of the vascular prosthesis can be determined particularly quickly during and after implantation. Preferably, the radiopaque markers are made of one or more of the following materials: gold, palladium, tantalum, chromium, silver, etc.; the shape of the markers can be arbitrary, such as circular, angular, and / or have shapes such as letters, numbers, or graphics that help orient the vascular prosthesis in the blood vessel.

[0084] According to a preferred embodiment, the first and / or second end support rings have strips of the same and / or different lengths.

[0085] According to a preferred embodiment, the second terminal stent ring has a pointed arch facing the vascular prosthesis opening and having a uniform height, and a pointed arch facing away from the vascular prosthesis opening and having a non-uniform height.

[0086] The advantage of this embodiment is that it allows for better compaction and thus less material buildup at various locations.

[0087] According to another embodiment, the vascular prosthesis has an outgoing side branch.

[0088] This embodiment is particularly preferred in that the blood vessel to be treated has outgoing collateral branches, and furthermore, the vascular prosthesis in this region prevents blood from flowing to the corresponding collateral branches. Therefore, the number of collateral branches of the vascular prosthesis depends on the number of corresponding outgoing blood vessels of the blood vessel to be treated.

[0089] Typically, it is preferable that the diameter of the vascular prosthesis is adapted to the corresponding blood vessel of the patient being treated, such that the diameter of the vascular prosthesis approximately corresponds to the diameter of the blood vessel. This is to ensure that the vascular prosthesis, due to its self-expanding properties, weds itself into the blood vessel and does not dislodge on its own. For example, if the diameter of the vascular prosthesis is chosen to be too small, the vascular prosthesis may accidentally move due to blood flow.

[0090] According to a further embodiment, the prosthetic material includes materials selected from textiles or polymers, particularly materials selected from polyester, polyurethane, polystyrene, polytetrafluoroethylene, ultra-high molecular weight polyethylene (UHMPE), or mixtures thereof.

[0091] According to another embodiment, the vascular prosthesis is self-expanding. Preferably, the stent frame and / or the first and / or second terminal stent rings are made of a self-expanding material, such as nitinol.

[0092] According to a preferred embodiment, the stent frame has non-terminal stent rings that are successively distributed on the hollow cylindrical body and attached to the prosthesis material on its inner and / or outer sides.

[0093] These non-terminal stent rings may not be interconnected, but rather represent individual stent rings (similar to at least one terminal stent ring) formed in a circumferentially bent manner and having pointed arches and strip-shaped portions connecting the pointed arches. The non-terminal stent rings can be securely fixed to the exterior and / or interior of the vascular prosthesis, for example by sutures or adhesives or other suitable fastening methods.

[0094] According to another embodiment, preferably, the support frame includes a laser-cut or woven support attached to the prosthesis material on the inside or outside of a hollow cylindrical main frame.

[0095] As described above, the present invention also relates to an insertion system / delivery system for inserting / delivering the vascular prosthesis of the present invention into a patient's blood vessel, the insertion system / delivery system comprising: a catheter tubing to which the vascular prosthesis can be loaded for insertion into the blood vessel; a retractable sheath for compressing the vascular prosthesis in its loaded state; and a fixation device axially movable on the catheter tubing, at least one linear element of the vascular prosthesis being releasably attached to the catheter tubing.

[0096] According to one embodiment, preferably, the fixation device is designed such that, by means of its axial displacement on the catheter tubing, the first end support ring can be compressed or expanded by the pulling load or pulling unload of at least one linear element, and if necessary, the second end support ring can be compressed or expanded by the pulling load or pulling unload of at least one linear element.

[0097] It should be understood that the above features and the features to be explained below can be used not only in the corresponding combinations indicated, but also in other combinations or individually, without departing from the scope of the invention. Attached Figure Description

[0098] Examples of embodiments of the present invention are shown in the accompanying drawings and will be explained in more detail in the following description. Wherein:

[0099] Figure 1A A schematic diagram of a first embodiment of a vascular prosthesis according to the present invention is shown;

[0100] Figure 1B A schematic diagram of a second embodiment of the vascular prosthesis according to the present invention is shown;

[0101] Figure 1C Show Figure 1A and Figure 1B Enlarged view of the proximal region of the illustrated embodiment; and

[0102] Figure 2 A schematic diagram of a segment of a vascular prosthesis according to the invention is shown, wherein the vascular prosthesis opening is partially opened and the suture element remains attached to the insertion / delivery system. Detailed Implementation

[0103] Figure 1A and Figure 1B Two embodiments of exemplary vascular prostheses according to the present invention are shown, which differ in different distal regions as will be explained below. The reference numerals for corresponding features are the same in both figures, but for clarity, they are not... Figure 1A and Figure 1B All features are assigned figure labels.

[0104] exist Figure 1A and Figure 1B In the middle, use 10 ( Figure 1A ) and 100 ( Figure 1B The first embodiment of a vascular prosthesis for implantation in a patient's blood vessel according to the invention is shown generally and not to scale, wherein... Figure 1A and Figure 1B The vascular prostheses 10 and 100 shown are in an expanded state.

[0105] Vascular prostheses 10 and 100 have a hollow cylindrical base or body 11, the base or body 11 including prosthesis material 12 and a stent frame 13 attached thereto. Figure 1A and Figure 1B In the illustrated embodiment, the support frame 13 includes a plurality of non-terminal support rings 13a, 13b, 13c, 13d, and 13e arranged sequentially. It should be understood that, as further explained above, the support frame 13 may also be in the form of a laser-processed or woven support frame, in which case the support frame has cavities (Zellens) between the woven or laser-processed support material.

[0106] Figure 1A and Figure 1B The vascular prostheses 10 and 100 include a proximal end 14 and a distal end 15 having a proximal opening 14a and a distal opening 15a, a longitudinal axis L, an outer / lateral surface 20, and an inner / medial surface 21.

[0107] The proximal end 14 also includes a first distal stent ring 22 and a second distal stent ring 23, such as Figure 1A and Figure 1B As shown by the dashed lines in the diagram. Figure 1A and Figure 1B In the illustrated embodiment, a first terminal stent ring 22 is attached to the outer surface 20 of the vascular prosthesis 10, 100, and a second terminal stent ring 23 is attached to the inner surface 21 of the vascular prosthesis 10, 100.

[0108] exist Figure 1A and Figure 1BIn the illustrated embodiment, the non-terminal stent rings 13a to 13e, the first terminal stent ring 22, and the second terminal stent ring 23 have spitzbögens 24 that alternately point in the proximal direction p and the distal direction d, and they are connected to each other by strips / legs 25. The non-terminal stent rings 13a to 13b, the first terminal stent ring 22, and the second terminal stent ring 23 are secured to the prosthetic material by sutures 27, which are indicated by dashed lines in the figure.

[0109] from Figure 1A and Figure 1B As can be seen, the outermost ends of the proximal pointed arches 24 of the prosthetic material and the distal stent rings 22 and 23 are flush with each other, so that the pointed arches do not freely protrude beyond the prosthetic material 12, and the two distal stent rings 22 and 23 are completely covered by the prosthetic material 12.

[0110] The distal 15 of the vascular prosthesis 10, 100 is in Figure 1A and Figure 1B The difference is that Figure 1A The distal end 15 of the vascular prosthesis 10 shown has a distal stent ring 26, wherein a portion of the distal stent ring's pointed arch 24 and strip 25 protrude beyond the prosthesis material 12.

[0111] exist Figure 1B In the distal end 15 of the vascular prosthesis 100 shown, the distal end 15, like the proximal end 14, is formed by distal stent rings 22 and 23 completely covered by prosthesis material 12.

[0112] Figure 1B It shows Figure 1A The proximal end 14 of the vascular prosthesis 10 is an enlarged truncated section, although the distal end 15 may or alternatively have the same design according to the invention. The vascular prosthesis 10 has an outer / lateral surface 16 facing the vessel wall and an inner / medial surface 17 facing blood flow after implantation.

[0113] from Figure 1A and Figure 1B As can be seen, the vascular prosthesis 10 has two end stent rings 22 and 23 at its ends. The first end stent ring 22 is fixed to the outer side 16 of the vascular prosthesis 10, and the second end stent ring 23 is fixed to the inner side 17 of the vascular prosthesis 10. The two end stent rings 22 and 23 are thus fixed to the prosthesis material 12 by sutures 27. The sutures 27 are not distributed on the entire stent ring, but are spaced apart from each other at specific intervals and in specific positions.

[0114] Figure 1C An enlarged view of the proximal end 14 of the vascular prostheses 10 and 100 is shown.

[0115] It is provided with two suture elements 30a and 30b, each suture element having a first end 31a, 31b and a second end 32a (the second end of the second suture element 30b is not shown), and a length Q extending between them. In each case, the first ends 31a, 31b are securely fixed to the prosthesis material 12 by a second end support ring 23 (the second end support ring 23 is attached from the inside 24 to the proximal end 14).

[0116] For clarity, Figure 1C Only two line elements 30a and 30b are shown in the image; Figures 1A to 1C In the illustrated embodiment, other suture elements are provided in principle to compress the first end stent ring 22 and the second end stent ring 23 as a whole, thereby enabling the closure of the proximal opening 14a of the vascular prosthesis 10, 100.

[0117] Fixation can be performed at the strip portion 25 and / or the pointed arch 24, for example by means of adhesive bonding and / or suturing on the end support ring 22 or 23 and / or the prosthesis material 12.

[0118] The second end 32a of the thread element 30a has a ring 33a. Starting from its fixing point 34a, the thread element 30a is alternately and movably guided above the first strip 25a and then movably guided below the second strip 25b in the circumferential direction U. Figure 1C It can be seen that the line element 30a spans approximately three pointed arches 24 with its length Q, two of which point towards the proximal end p and one pointed arch 24 points towards the distal end d.

[0119] As described above, other suture elements 30 (not shown) are arranged in the circumferential direction U to close and open the proximal opening 14a of the vascular prosthesis 10, 100. Each of these suture elements crosses a subsequent pointed arch or strip in the circumferential direction U.

[0120] Finally, the suture element 30a passes between two spaced-apart sutures 36, 37 in the circumferential direction U of the first end support ring 22 at position 35, thereby creating a deflection of the suture element 30a. The two spaced-apart seams / sutures 36, 37 may be the same as those sutures used to attach the first end support ring 22 to the prosthetic material 12.

[0121] The thread element 30a is guided on the first end support ring 22 in such a way that the thread element 30a can only move very limitedly toward the proximal end p and the distal end d at least at that point 35, i.e., within the area defined by the two seam / stitch lines 36, 37, while on the other hand, the thread element can be movably guided in the circumferential direction U.

[0122] When the suture element 30a is pulled at the second end 32a, the traction load compresses a portion of the first end stent ring 22 through which the suture element 30a passes due to the deflection formed by the two sutures / sutures 36, 37. Through proximal traction loading, the ring 33a or the second end 32a of the suture element 30a can extend beyond the proximal end 14 of the vascular prosthesis 10, 100, and when loaded onto an insertion / delivery system (discussed below), it can be releasably hooked / secured therein via the ring 33a.

[0123] In the same manner, the second line element 30b (and any other line element 30) can be guided and provided with a pulling load, such that the support ring segment spanned by the second line element 30b can be compressed, thereby achieving full compression.

[0124] It should be understood that the length of the suture elements 30a and 30b also determines their quantity: the longer the suture element, the fewer suture elements are needed to control the opening of the vascular prosthesis and to control compression.

[0125] exist Figure 1C The example shown provides 5 line elements.

[0126] Figure 2 It shows Figure 1A and Figure 1B The proximal end 14 of the vascular prosthesis shown is in a partially open or dilated state: the first distal stent ring 22 and the second distal stent ring 23 of the vascular prosthesis 10, 100 are partially dilated, while the remaining portion of the vascular prosthesis 10, 100 remains under the retraction sheath 40 of the delivery system 46 (which only... Figure 2 (Partially shown in the middle) Keep compressed.

[0127] Figure 2 Four suture elements 30a, 30b, 30c, and 30d are also shown, each suture element being detachably secured to a fixation device 42 of the catheter tubing 44 via its respective second ends 32a, 32b, 32c, and 32d. The opening or expansion of the vascular prostheses 10 and 100 can be controlled as a function of the suture element length Q. After the proximal fixation device of the suture elements 30a, 30b, 30c, and 30d on the delivery system 46 is released, for example by axially moving the fixation device 42 in the direction of arrow 45, the second ends 32a, 32b, 32c, and 32d of the suture elements 30a, 30b, 30c, and 30d are released, and the vascular prostheses 10 and 100 can self-expand. Here, the thread elements 30a, 30b, 30c, and 30d are guided again around the circumference of the vascular prostheses 10 and 100 by their respective deflections and are placed in the blood vessels between the vascular prostheses 10 and 100 and the blood vessel wall.

[0128] To load the vascular prostheses 10 and 100 onto the delivery system 46, the prostheses are compressed around their longitudinal axis by a retractable sheath 40 on the catheter tubing 44. The proximal end 14 (or distal end 15) or proximal opening 14a (distal opening 15a) of the vascular prostheses 10 and 100 is thereby additionally closed by traction loading via the vascular elements 30a, 30b, 30c, 30d by means of the second ends 32a, 32b, 32c, 32d of the suture elements 30a, 30b, 30c, 30d into the fixation device 42.

[0129] Figure 2 The fixing device shown is a system of several elongated fixing rods, preferably corresponding to the number of filament elements, which are axially movable / slidably guided within the conduit hose. Alternatively, multiple filament elements can be mounted by a single fixing rod. Details of an exemplary insertion system having the fixing device described herein are disclosed, for example, in EP 1 920 739, the contents of which are herein taken as the subject matter.

[0130] To insert the vascular prosthesis according to the invention into a patient's blood vessel with the assistance of the delivery system 46, the vascular prosthesis 10, 100 is loaded onto the catheter tubing 44 and inserted into the patient's blood vessel by compression retaining the retractable sheath 40. After proper placement, the retractable sheath is removed to release the main portion of the vascular prosthesis 10, 100, fixing and compressing the proximal (or distal) end, and thus closing the corresponding opening of the vascular prosthesis. This allows for easy repositioning of the vascular prosthesis if necessary without damaging the blood vessel at that location. Subsequently, the axial fixation device is displaced to reduce the pull on the suture elements 30a, 30b, 30c, 30d, thereby selectively and gradually reducing the pull on the suture elements 30a, 30b, 30c, 30d if necessary, so that the openings 14a, 15a of the vascular prosthesis 10, 100 can also be gradually opened. Assuming that the second ends of the suture elements 30a, 30b, 30c, and 30d are completely released from the fixation device, the proximal end 14 / distal end 15 of the vascular prostheses 10 and 100 are fully opened.

Claims

1. A vascular prosthesis (10; 100) for use in a patient's blood vessels, comprising: - A hollow cylindrical body (11) having a support frame (13) and a prosthetic material (12) attached to the support frame, the body (11) having a longitudinal axis (L), an inner side (21) and an outer side (20), and a proximal end (14) having a proximal opening (14a) and a distal end (15) having a distal opening (15a). Its features are, - A self-expanding first end support ring (22) is provided at the proximal end (14) and / or the distal end (15), the first end support ring (22) being capable of transitioning from a compressed state to an expanded state, wherein the first end support ring (22) is circumferentially serrated and has a pointed arch (24) and a strip (25) connecting the pointed arch, and wherein the first end support ring (22) is attached to the prosthetic material (12) on the outer side (20) of the body (11), such that the pointed arch (24) without the first end support ring (22) freely protrudes beyond the proximal end (14) and / or the distal end (15), and - At least one suture element (30; 30a, 30b) is also provided on the first terminal stent ring (22), the at least one suture element (30; 30a, 30b) having a first end (31; 31a, 31b) and a free second end (32; 32a), wherein the at least one suture element (30; 30a, 30b) is fixed to the vascular prosthesis (10; 100) with its first end (31; 31a, 31b) and is guided to be at least partially circumferentially movable on the vascular prosthesis (10; 100) so that the first terminal stent ring (22) can be converted from a radially compressed state to an expanded state by the pulling loading or pulling unloading of the at least one suture element (30; 30a, 30b). Each of the at least one thread element alternately passes over and under the strip portion (25) of the first end support ring (22) and is guided away from the fixing point of the first end (31; 31a, 31b) of the thread element in the circumferential direction of the first end support ring. The at least one suture element is guided through its second end (32; 32a) at at least one point (35) in the circumferential direction of the first end support ring between two spaced-apart sutures (36, 37), which secure the first end support ring (22) to the prosthesis material. By providing guidance for at least one suture element that passes through two sutures spaced apart from each other, the at least one suture element then deflects in another direction different from the circumferential direction.

2. The vascular prosthesis (10; 100) according to claim 1, characterized in that, A second end support ring (23) is provided at the proximal end (14) and / or the distal end (15), wherein compression and / or expansion of the first end support ring (22) causes the second end support ring (23) to transition from a radially compressed state to an expanded state, wherein the second end support ring (23) is circumferentially serrated and has a pointed arch (24) and a strip (25) connecting the pointed arch, and wherein the second end support ring (23) is fixed to the prosthetic material (12) on the inner side (21) of the body (11), such that the pointed arch (24) without the second end support ring (23) freely protrudes beyond the proximal end (14) and / or the distal end (15).

3. The vascular prosthesis (10; 100) according to claim 1 or 2, characterized in that, The at least one suture element (30; 30a, 30b) is fixed at its first end (31; 31a, 31b) in a region of the vascular prosthesis (10; 100), in which the first end stent ring (22) or the second end stent ring (23) is fixed to the prosthesis material (12), and the at least one suture element (30; 30a, 30b) is firmly fixed at its first end (31; 31a, 31b) to the prosthesis material (12) and / or to the first end stent ring (22) or the second end stent ring (23).

4. The vascular prosthesis (10; 100) according to claim 1 or 2, characterized in that, The second end of the at least one suture element has a loop, through which the at least one suture element can be detachably fixed to the vascular prosthesis insertion system.

5. The vascular prosthesis (10; 100) according to claim 2, characterized in that, It has 2 to 8 wire components.

6. The vascular prosthesis (10; 100) according to claim 5, characterized in that, The pointed arches (24) of the first end support ring (22) and the second end support ring (23) are disposed on the outer (20) and inner (21) sides of the body (11) without overlapping at the proximal end (14) and / or the distal end (15), and the first end support ring (22) and the second end support ring (23) separated by the prosthetic material (12) intersect at the strip (25).

7. The vascular prosthesis (10; 100) according to claim 1 or 2, characterized in that, The first end support ring (22) has strip-shaped portions (25) of equal length.

8. The vascular prosthesis (10; 100) according to any one of claims 2, 5, and 6, characterized in that, The second end support ring (23) has strip-shaped portions (25) of different lengths.

9. The vascular prosthesis (10; 100) according to any one of claims 2, 5, and 6, characterized in that, The second terminal stent ring (23) is provided with a pointed arch (24) of uniform height pointing to the proximal opening (14a) or distal opening (15a) of the vascular prosthesis (10; 100), and is provided with a pointed arch (24) of non-uniform height pointing away from the proximal opening or distal opening of the vascular prosthesis (10; 100).

10. The vascular prosthesis (10; 100) according to claim 1 or 2, characterized in that, The vascular prosthesis (10; 100) has extended lateral branches.

11. The vascular prosthesis (10; 100) according to claim 1 or 2, characterized in that, The support frame (13) also includes non-terminal support rings (13a, 13b, 13c, 13d, 13e), which are distributed sequentially on the entire hollow cylindrical body (11) and attached to the prosthesis material (12) on the inner side (21) and / or outer side (20) of the body.

12. The vascular prosthesis (10; 100) according to claim 1 or 2, characterized in that, The support frame (13) also includes a laser-cut or woven support, which is attached to the prosthetic material (12) at the inner (21) and / or outer (20) side of the hollow cylindrical body (11).

13. A delivery system (46) for inserting a vascular prosthesis (10; 100) having at least a first distal stent ring (22) into a patient's blood vessel, characterized in that, The delivery system (46) includes, - A catheter tubing (44), onto which the vascular prosthesis (10; 100) can be loaded for insertion into a blood vessel. - A retractable sheath (40) for compressing the vascular prosthesis (10; 100) in its loaded state, and - Fixing device (42), which is axially movable on the catheter hose (44), and - At least one suture element (30; 30a, 30b), through which the first distal stent ring (22) of the vascular prosthesis (10; 100) can be compressed or expanded by pull loading or pull unloading. The delivery system is designed for inserting a vascular prosthesis (10; 100) according to any one of claims 1 to 12.

14. The delivery system (46) according to claim 13, characterized in that, The fixing device (42) is designed such that, by means of axial displacement of the fixing device on the catheter hose (44), the first end support ring (22) can be compressed or expanded by the pulling loading or pulling unloading of the at least one linear element (30; 30a, 30b).

15. The delivery system (46) according to claim 14, characterized in that, The second end support ring (23) can be compressed or expanded by the pulling loading or pulling unloading of the at least one linear element (30; 30a, 30b).

Images