EP3694449A1

EP3694449A1 - Expandable vascular implant

Info

Publication number: EP3694449A1
Application number: EP18785354.4A
Authority: EP
Inventors: Christian Woerne
Original assignee: Jotec GmbH
Current assignee: Jotec GmbH
Priority date: 2017-10-10
Filing date: 2018-10-10
Publication date: 2020-08-19
Also published as: DE102017123461A1; WO2019072912A1; US11844680B2; US20200222215A1

Abstract

The invention relates to an expandable vascular implant (10, 22) for implantation into vessels of a patient, the vascular implant (10, 22) being changeable from a compressed state to an expanded state, and the vascular implant (10, 22) comprising the following: a hollow cylindrical main body (11) having a longitudinal direction (12) and a proximal end and a distal end (13, 14), and a main body lumen (15) which extends from the proximal to the distal end (13, 14). The hollow cylindrical main body (11) is formed by a tubular lattice structure (18), the tubular lattice structure (18) having at least one first and at least one second area (16, 17), the first area (16) being fixedly connected to the second area (17), the first area (16) being designed to be self-expandable, and the second area (17) is designed to be balloon-dilatable.

Description

Expandable vascular implant

The present invention relates to an expandable vascular implant for implantation in

Vessels of a patient, wherein the vascular graft is convertible from a compressed state to an expanded state.

Such vascular implants are known in the art and are generally for

Keeping open vessels, especially blood vessels, as well as for the treatment of aneurysms implanted in arteries. According to the prior art, such vascular implants are also known as vascular stents / stent grafts.

[0003] An aneurysm is understood to mean an expansion or outgrowth of an arterial blood vessel as a result of congenital or acquired wall changes. The Aussackung can thereby capture the vessel wall as a whole or, as in a so-called. Wrong aneurysm or the so-called. Dissection, it comes blood from the lumen of the vessel between the vessel wall layers and sheared them apart. Failure to treat an aneurysm at an advanced stage can result in rupture of the artery, with the result that the patient bleeds internally. For the treatment of aneurysms or of vessels threatening to occlude, therefore, the affected vessel is stabilized by implantation of a vascular stent / stent graft in order to avoid a rupture of the vessel or to generally ensure the open keeping of the vessel.

More serious blockage of the blood vessels of affected patients can also lead to hypertension, ischemic injury, stroke or myocardial infarction. Atherosclerotic lesions that limit or block coronary blood flow are the leading cause of ischemic heart disease.

The used for keeping open vessels or for the treatment of aneurysms

Vascular stents / stent grafts generally consist of a tube-shaped metal frame whose lateral surface may be covered with a textile or polymer film can, so that there is a hollow cylindrical body. For implantation, the stent can be radially compressed, for example by means of a surrounding and compressing sheath surrounding the stent, so that its cross-sectional area is significantly reduced. Alternatively, the stent can be applied for implantation on a dilation body, by means of which the stent can be expanded if necessary. The stent / stent graft is thus brought by means of an introducer into the area of the site to be treated or the aneurysm, where the stent is released. Due to the spring action of the metal frame or dilation of the dilation body, the stent expands, thereby tensing its lateral surface, which jams in the blood vessel proximally and distally of the aneurysm or open-site. In this way, the blood now flows through the stent / stent graft, preventing further stress on the effect and ensuring the vessel is kept open. Many of these expandable catheters are known in the art. Depending on the type of application, a wide variety of stents are used. Here, a distinction is made between balloon-dilatable and self-expandable systems. The self-expandable properties result from the use of self-expanding materials, such as Nitinol. Balloon-dilatable systems are expanded by an internal force when the system is mounted on a balloon, for example. When dilating balloon catheter, by means of a dilation body, the metal frame of the balloon catheter is dilated by the dilation of the dilation balloon, which is inserted from the inside into the metal frame. The balloon catheters are generally placed from the groin over a guide wire and guide catheter into the stenosis and inflated with pressure. This eliminates the bottleneck and avoids surgery. A disadvantage of a balloon-dilatable stent is that it must be protected against damage during insertion. Damage to the dilation body would mean that it can not be dilated at the desired location. Unlike self-expanding stents, balloon-deflatable stents are easy to handle and precise to place. A disadvantage of balloon-dilatable stents is the expansion of the vessel wall layers with a balloon, so that, for example, the destruction of the endothelial cell layer by the dilation of the balloon-dilatable stent can occur even at low deployment pressures (> 3 bar). This usually leads to a disadvantage Activation of coagulation. Balloon-sterilizable stents may be covered or uncovered. Another stent known in the art is the so-called covered

Self-expanding stent. This is a vascular support or a medical implant in the form of a small lattice framework in tube form made of metal or plastic fibers. In a covered stent, the meshes of the lattice framework are predominantly covered by an implant material; This creates a tubular structure (a stent graft) made of an implant material carried by a (metal) framework, the stent part. The expansion of the metal frame is effected in particular by the use of self-expanding metal, such as Nitinol. Self-expanding stent grafts are very flexible and radially elastic. However, placement of such a stent requires much experience in implanting such a stent. The object of the present invention is therefore to provide an expandable vascular implant which can overcome the disadvantages described above. According to the invention, this object is achieved by an expandable vascular implant for implantation into vessels of a patient, wherein the vascular implant can be converted from a compressed state to an expanded state, wherein the vascular implant comprises: a hollow cylindrical body with a longitudinal direction and with a proximal and a distal end , and a body lumen extending from the proximal to the distal end, wherein the hollow cylindrical body is formed by a tubular lattice framework, characterized in that the tubular lattice framework has at least a first and at least a second region, wherein the first region with the second Area is firmly connected and wherein the first region is designed to be self-expandable and the second region is configured balloon-sterilizable. The object underlying the invention is further by an insertion system for

Release and expansion of an expandable vascular implant solved, the Insertion system comprises a retraction sheath for compressing at least the first portion of the vascular graft and a first catheter having a dilation body.

The object of the invention is further achieved by the use of an introducer system for introducing and releasing an expandable vascular graft into a patient's vessels for treating a vasoconstriction or rupture of a vessel.

In addition, the object underlying the invention is also achieved by a method for releasing an expandable vascular implant into vessels of a patient for treating a vasoconstriction or rupture of a vessel, the method comprising the steps of: a) providing an introducer system with a vascular graft for release and expanding a vascular graft for implantation in a patient's vessels; b) introducing the delivery system loaded with the expandable vascular graft to the site to be treated in the vessel; and c) releasing the expandable vascular graft by dilating the dilation body and retracting the retraction sheath.

The object underlying the invention is completely solved in this way.

With the expandable vascular implant according to the invention, a vascular implant is provided, which can be used to support labile, brittle or thrombic vessel walls and in particular for the treatment of aneurysmal vessels. This is achieved by the special construction of the vascular implant, which is based on a hollow cylindrical base body of a first self-expandable area and a second balloon-dilatable area, wherein the two areas are firmly connected to each other and together form the tubular lattice framework. In the present case, the term "expandable" is taken to mean both the self-expandable and balloon-dilatable properties of the vascular implant according to the invention in summary. The expandable vascular implant according to the invention has both self-expandable and balloon-dilatable regions; In summary, the term "expandable" vascular graft is thus used in this invention, since the two regions can self-expand or be dilated by means of a balloon. Furthermore, the term "expansion" is understood to mean both the self-expanding expansion and the balloon-dilating dilation. With the expandable vascular implant according to the invention, it is thus possible that, in particular, the expandable vascular implant to be used can be used for the treatment of those vessels in which both a self-expandable stent and a balloon-dendritic stent are necessarily to be used. It is particularly advantageous in this case that it is not necessary to use two stents directly one behind the other, in the form of two interventions, but only a vascular implant. Particularly advantageous results from the fact that only one intervention takes place. Basically, in vessel implants, the terms "distal" and "proximal" are used to refer to the respective ends, the term "distal" being the portion or end that is further downstream with respect to the bloodstream By contrast, "proximal", again with respect to the bloodstream, refers to a portion or end that is further upstream relative 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. In contrast, in the case of catheters or insertion systems, the term "distal" refers to the end of the catheter or insertion system introduced into the patient, or which is furthest from the user, and the term "proximal" to the end that faces the end User faces closer. By "hollow cylindrical body" herein is meant the main body of the expandable vascular graft having the tubular lattice framework. Furthermore, the hollow cylindrical body can optionally have prosthesis material. The "tubular lattice framework" is in turn made up of stent springs, either are held together via prosthesis material, or form a hollow cylindrical body due to their structure, for example. Because these reticulate or as

Braided structure are configured. The structure of the expandable vascular implant according to the invention makes it possible to make individual vascular implants adapted to individual patients or vessels to be treated. In this case, it is particularly useful to be able to produce custom-made stent grafts with respect to the anatomy of the special vessel. Furthermore, the expandable vascular implant according to the invention can also be prefabricated as a vascular implant that can be used universally. The tubular grid structure according to the invention serves not only to the

expandable vascular implant to give the necessary structure, but in the implanted state, the expandable vascular graft also to the vessel wall to press and hold the vascular graft in position in the vessel. The material properties of the tubular lattice framework depend on the vessel to be treated, as well as on the first or second region. For example, in a very thin-walled vessel, it is advantageous to use materials that are less rigid. Furthermore, the tubular lattice framework of the first region is preferably made of a self-expandable material, while the tubular lattice framework of the second region is preferably made of a balloon-dilatable material which can deform by means of an applied force. In accordance with the present invention, the expandable vascular graft may be present as a fully "covered," partially "covered," or "uncovered" graft. When covered or partially covered vascular implant, the tubular lattice framework is covered with a textile or polymer film, so that there is a hollow cylindrical body. The tubular lattice framework is preferably configured as a wire mesh or arranged in succession, meandering, so-called stent springs, which are optionally interconnected via connecting posts made of wire, or which are interconnected only via the prosthesis material. The biocompatibility of the materials used causes the contact between the expanded vascular graft and the vessel wall to be free of complications. According to one embodiment of the vascular implant according to the invention, the tubular lattice framework of the first and / or the second region at least partially comprises a prosthesis material.

In this embodiment, therefore, it is a so-called "covered"

Vascular implant, which consists of the tubular lattice framework and an at least partially covering graft material. The lattice framework can according to this embodiment be present as individual springs which are introduced into the graft material or

sewn, or as a net-like or lichen-like lattice framework, which is connected to the prosthesis material. According to the invention, the lattice framework may be located inside the hollow-cylindrical basic body, so that the prosthesis material surrounds the hollow-cylindrical basic body; or the other way around.

This embodiment offers the advantage that the prosthesis material prevents a passage of blood or a passage of blood components or deposits through the wall of the stent graft, as well as ingrowth of tissue through the wall into the interior of the stent graft. Thus, the vessel wall at the implant site of the vascular graft is relieved and possible emboli at these sites are prevented.

Such vascular implants can be used, for example, in aneurysms. These seal the vessel in the area of the site to be treated and thus bridge the blood flow within the vessel.

According to one embodiment of this invention, only one of the first and second regions may comprise the prosthesis material, while the other region may, for example, be configured as a reticulated lattice framework. In a further preferred embodiment of a covered vascular implant it is provided that the vascular implant is covered almost completely with the prosthesis material. In this case, therefore, both the first and the second region of the vascular implant have a prosthesis material attached to the lattice framework. It is understood that the respective resulting grid structure, ie the respective outermost proximal and distal end, for anchoring in Can have vessel-free grid ends. In a further embodiment, the two areas may only partially comprise a prosthesis material. According to a further embodiment, the tubular lattice framework of the first region is made of a self-expandable material, in particular nitinol, and the tubular lattice framework of the second region is made of a balloon-sterilizable material, in particular of a cobalt-chromium-containing alloy. The self-expanding material of the first area is

preferably a metal or a metal alloy, in particular a metallic shape memory alloy, for example. Nitinol (a nickel-titanium alloy), Elgiloy ^®, Phynox ^®, MP35N, stainless steel, cobalt alloy, or titanium alloy. Alternatively, the self-expandable material can also be designed as another biocompatible material, such as plastic or monofilament and / or multifilament and / or composite glass fibers. These materials can be converted from a compressed state to a relaxed state by themselves. The self-expandable material may also be formed from biodegradable materials. The balloon-dilatable material of the second region is preferably an elastic material which can be widened with the aid of an expandable dilation body. Possible materials are, for example, a polymeric or a metallic material such as metal alloys, steel, stainless steel, tantalum, nickel, titanium or cobalt or cobalt chromium alloys. These materials are deformable, so that the tubular lattice framework can be converted from a non-expanded state into a balloon-dilated state by an applied force. According to one embodiment of the present invention, at least two, three or four first regions and / or at least two, three or four second regions are provided, which are arranged one behind the other in the longitudinal direction and against each other alternately. This embodiment offers the advantage of providing a vascular graft that can be adapted to the individual needs of vessels. Depending on the vessel, it may be necessary for both self-expandable and balloon-dilatable vascular implants to be used in succession. According to the prior art, several vascular implants lying one behind the other would have to be introduced into the vessel, which in turn is accompanied by multiple interventions. A secure fixation of several consecutive vascular implants requires much experience and often leads to undesirable complications. According to the invention, this is achieved by a vascular implant having different areas. As a result, the introduction of multiple stents is replaced by only one vascular implant.

The specific number of the first region and the second region will be determined by those skilled in the art on the basis of the present teaching and taking into account the vascular implant to be used, as well as the particular vascular anatomy of a patient to be considered.

According to a further embodiment, the vascular implant has at least one branching side branch in the first and / or in the second region.

Depending on the vascular anatomy, it may be that in the area in which the vascular implant is to be introduced, a side arm of the vessel is discharged. This would be cut off from the restoration unless the vascular graft had any side branch in this position. Thus, a vascular graft is provided which also finds application in vessels having outgoing further vessels.

Advantageously, the vascular implant according to the invention is designed in such a way that branches branching off can also be bridged by the vascular implant. This advantageously has the effect that the area around the side branch, which is more sensitive due to its thinness than the portion of the side vessel which is located directly at the branch of a main vessel and is also thicker, can also be provided by a stent. This embodiment therefore offers the advantage that it can be adapted to the respective anatomical conditions of the patient to be treated. According to a further embodiment, a marker which contains a radiopaque material or consists entirely of radiopaque material is located on the vascular implant, the marker being located in particular at the ends and / or between the first and the second region. With the help of the markers, which are located on specific sites of the vascular implant, it is possible to determine particularly quickly the position of the vascular implant during and after the implantation. As specific points, the transitions between the first and second regions as well as the ends of the vascular implant are particularly suitable for this purpose. If the vascular graft has a branching lateral branch, the markers may serve to ensure proper positioning of the vascular graft relative to the lateral arm. According to another preferred embodiment of the vascular implant has the

Vascular implant diameter in the expanded state between 5 and 50 mm, in particular between 15 and 50 mm, in particular 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 1 1 mm, 12 mm, 13 mm, 14 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm or 50 mm. Depending on the vascular anatomy, many different suitable vascular grafts may be provided by this embodiment. Not only for small vessels, but also for larger vessels with a diameter of 15 mm, a vascular implant according to the invention can be provided.

According to a further embodiment of the vascular implant, the vascular implant has a different diameter in the first and in the second region. It is possible not only to prepare individual vascular implants adapted to individual patients to be treated, but also to prefabricate universally applicable vascular implants.

According to a further preferred embodiment, the vascular implant has a length of 30 mm to 250 mm, in particular of 100 to 250, in particular 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 75 mm, 80 mm, 90 mm, 100 mm, 125 mm, 150 mm, 170 mm, 200 mm, 230 mm or 250 mm.

Due to this embodiment it can be ensured that vascular implants of different lengths can be produced. The first region may be the same length or a different length than the second region; depending on the nature of the vessel, the length can be adapted to the vessel. Thus, for example, the first region may account for 5 to 95% of the total vascular graft, with the second region being in the range of 5 to 95%, respectively. The percentages here refer to the total length of the vascular implant, which is designed from a first and a second area, so that the sum of the first and second area yields 100%.

As already mentioned, the present invention also relates to an introducer system for releasing and expanding an expandable vascular graft, the introducer system having a retraction sheath for compressing at least the first portion of the vascular graft, and a first catheter having a dilation body.

By means of this delivery system, the vascular implant described above can be safely introduced into a vessel and expanded at the desired location.

According to the invention, the dilation body and its dilation dilate the second area, which is designed to be balloon-airable. The dilation body or possibly existing balloon segments, which the dilation body may have, can be dilated, for example, by an introduced fluid or gas. The dilation body is in this case within the vascular implant, so that the vascular implant, in particular the second Area on which dilation body rests. The material from which the balloon segments of the catheter according to the invention consist or have one is preferably a polymer and, for example, selected from the group comprising polyurethane, polyetherpolyurethane, polyethylene etherophthalatepolybutyleneterephthalatepolyamide and copolymers and mixtures thereof.

Further, the delivery system has a retraction sheath that can compress at least the first portion of the vascular graft and retract at the desired location so that the first portion of the vascular graft can self expand. For this purpose, the retraction envelope has been slipped over at least over the first region of the vascular implant for compression.

According to a further embodiment of the invention, the dilation body of the

Delivery system dilatable by supplying a fluid.

According to this embodiment, the dilation body can be configured with balloon segments, into which a predetermined amount of fluid can be supplied. In the present case, the fluid may be a gas or a liquid; For example, saline or a radiopaque contrast medium and each used in this area usually for dilation of dilation bodies fluid.

According to a further embodiment of the invention, the first catheter is designed for carrying the vascular implant and dilating the second area.

The present invention further relates to a use of an introducer system for introducing and releasing an expandable vascular graft into a patient's vessels for treating a vasoconstriction or rupture of a vessel.

As already mentioned, the present invention also relates to the method for releasing an expandable vascular implant into vessels of a patient for treating a vasoconstriction or rupture of a vessel. The vessel is preferably a blood vessel or another hollow organ of a preferably human patient, such as, for example, the bile duct or the urethra. Further advantages and features will become apparent from the following description and the accompanying drawings. It is understood that the features mentioned above and those yet to be explained below can be used not only in the particular combination given, but also in other combinations or in isolation, without departing from the scope of the present invention. An embodiment of the invention is illustrated in the drawings and will be described in more detail below with respect to these. Show it:

Figure 1 is a schematic, not to scale representation of a first embodiment of the expandable vascular implant according to the invention in the expanded state.

FIG. 2 shows a schematic representation, not to scale, of a second embodiment of the expandable vascular implant according to the invention in the expanded state; FIG.

Figure 3 is a schematic, non-scale representation of a first embodiment of the expandable vascular implant delivery and expansion delivery system along with the compressed vascular graft; and

Figure 4 is a schematic, non-scale representation of a second embodiment of the expandable vascular implant delivery and expansion delivery system along with the compressed vascular graft. Fig. 1 shows a schematic, not to scale true representation of a first

Embodiment of the expandable vascular implant 10 according to the invention for implantation in vessels of a patient in the expanded state. The vascular implant 10 is shown as a hollow cylindrical base 1 1 with a longitudinal direction 12 and a first and second end 13, 14, and a main body lumen 15, which extends from the first end 13 to the second end 14. The first and the second end 13, 14 corresponds to the proximal and the distal end 13 ', 14'; or the other way around. Further, the vascular graft 10 includes first and second regions 16, 17. The first region 16, which is self-expandable, extends from the first end 13 to the second region 17, which is fixedly connected to the first region 16. The second region 17, which is designed to be balloon-airable, extends from the first region 16 to the second end 14. As can be seen from FIG. 1, the hollow-cylindrical basic body 1 1 is formed by a tubular lattice structure 18, which is provided with a prosthesis material 19 is covered, or on which the grid frame 18 is attached, for example. Sewn or glued. In a further preferred embodiment, the vascular graft 10 only partially comprises a prosthesis material 19 or a prosthesis material 19 (not shown). In this case, the vascular implant 10 can be covered with approximately 30, 50 or 100% prosthesis material 19. The lattice framework 18 of the vascular implant 10 can be formed according to the invention from stent springs 20. These stent springs 20 may be configured from meandering circular arches, which are each formed from two legs with interposed crests or troughs, which are arranged one behind the other in the longitudinal direction 12. In FIG. 1, the first self-expandable region 16 has such stent springs 20. These can also be interconnected with each other, so that a net-like structure or braiding structure 21 is formed. In FIG. 1, the second balloon dilatable region 17 has such a structure 21. The braiding structure 21 results by cutting a plurality of thread-like elements in a plane perpendicular to the longitudinal direction 12 of the vascular graft 10 and at a braiding angle, and forming stitches. The mesh density is higher in the expanded state than in the compressed state. For the formation of covered vascular implants 10, the stent springs 20 or the netlike structure or braiding structure 21 on the outside or inside of the hollow cylindrical body 11 may be connected by a prosthesis material 19 fastened to the stent springs 20 or to the netlike structure or braiding structure 21 , Due to the different properties of the lattice framework 18 of the first and the second region 16, 17, these regions have a different material or are formed from different material. While the material of the first region 16 is self-expandable, the material of the second region 17 is balloon-dilatable. The first region 16 may, for example, be sewn or glued to the second region 17. In one embodiment, the two regions 16, 17 may be interconnected via the prosthesis material 19. In particular, such compounds are preferred in which the individual regions 16 and 17 are firmly connected to one another, so that there is no detachment of the two regions 16, 17 during implantation of the vascular implant 10. Fig. 2 shows a schematic, not to scale representation of a second

Embodiment of the expandable vascular graft 22 according to the invention in the expanded state, wherein the same features as those of the vascular graft 10 of FIG. 1 are provided with the same reference numerals. Correspondingly, the vascular graft 22 also has a hollow cylindrical basic body 1 1, as well as a longitudinal direction 12, first and second ends 13, 14, and a main body lumen 15, which extends from the first end 13 to the second end 14. Furthermore, the vascular implant 22 comprises two first regions 16 and a second region 17, wherein the second region 17 is surrounded by the two first regions 16. In this case, the first region 16 extends from the first end 13 to the second region 17 and the second first region 16 extends from the second region 17 to the second end 14.

As can be seen from Figure 2, the hollow cylindrical body 1 1 is formed by a tubular lattice structure 18, wherein this is configured of two first regions 16 and a second region 17. Both the first area 16 and the second area 17 are covered with a prosthesis material 19, or to which the grid frame 18 is attached, for example, sewn or glued. In a further preferred embodiment, the vascular graft 10 only partially comprises a prosthesis material 19 or a prosthesis material 19 (not shown). In this case, the vascular implant 22 can be covered with approximately 30, 50 or 100% prosthesis material 19. The vascular graft 22 further includes a side branch 23 in the first region 16. This embodiment allows the implantation of the vascular graft 22 into a vessel having outgoing vessels. For example. Thus, in addition to a main vessel, a secondary vessel can also be bridged by the vascular implant 22. In this case, for example, the blood flow is not blocked in the side vessel. In one embodiment, not shown, the side branch 23 may also be configured as a fenestration, through which a further vascular implant can be located, for the supply of branching vessels. In one embodiment, not shown, the vascular graft 22 may have further first or second regions 16, 17, the regions alternating with each other.

Further, the vascular graft 22 shown in Figure 2 has numerous markers 24; shown as a square box. The marker 24 contains a radiopaque material or consists entirely of a radiopaque material. These markers 24 allow the attending physician to place at a desired location in the vessel during implantation of the vascular graft 22. The markers 24 are located in particular at the first and second ends 13, 14, between the first and second regions 16, 17 and / or at the outgoing side branch 23. With the aid of markers 24, which are located at specific locations of the vascular graft 22 it is possible to determine the position of the vascular graft 22 during and after implantation very quickly. Preferably, the radiopaque markers 24 are made of one or more of the following materials, e.g., gold, palladium, tantalum, chromium, silver, etc .; The shape of the marker 24 may be arbitrary, for example. Round square, and / or for example. Have the form of letters, numbers or figures that are helpful for the orientation of the vascular graft 22 in the vessel. Figures 3 and 4 show a schematic, non-scale representation of first and second embodiments of the expandable vascular graft 10 delivery and expansion delivery system 10 together with the compressed vascular graft 10. The delivery system 25 includes a retraction sheath 26 and a first catheter 27 on. The first catheter 27 is located inside the delivery system 25. The catheter 27 is surrounded by the catheter 27 or placed on the catheter 27. The vascular implant 10 is located in the region of the catheter on which the second balloon-sterilizable region 17 of the vascular implant 10 is located The catheter 27 preferably has a dilation body which, for example, can be filled with a fluid in order to dilate the second area 17 of the vascular implant 10. The retraction sheath 26 of the delivery system 25 is located around at least the first region 16 of the vessel implant 10. The retraction sheath 26 is designed such that it compresses the first region 16 and, if the vessel implant 10 is located at the desired location in the vessel Retracting the retraction sleeve 26 can expand. In addition to the vascular implant 10, the delivery system 25 can also have markers 28 which consist of radiopaque material or contain radiopaque material. These markers 28 allow secure positioning of the vascular graft 10 within the vessel. The delivery systems 25 in Fig. 3 and in Fig. 4 differ only in the different orientation of the vascular graft 10 and thus the different configuration of the delivery system 25. During the second region 17 of the vascular graft 10 shown in Fig. 3, distally on the catheter 27, ie the end of the catheter 27 or insertion system 25 which is inserted into the patient or which is located farthest away by the user, is the second region 17 of the vascular implant 10 shown in FIG Catheter 27, ie the end of the catheter 27, which faces closer to the user. According to this embodiment, the retraction sheath 26, shown in Fig. 3, only partially over the vascular graft 10, while the retraction sheath 26, shown in Fig. 4, is wrapped over the entire vascular graft 10. For the use of the insertion system 25 according to the invention this is with a

Loading vascular graft 10, wherein the vascular graft 10 is in a compressed state. The delivery system 25 is advanced to the desired location in the vessel during implantation, preferably over a guidewire 29. The position may be determined, for example, by means of the markers 24 and 28. Once the vascular graft 10 is positioned at the desired location, the Retraction shell 26 withdrawn or dilated the balloon segment of Dialtionskörper. Once the vascular graft 10 is expanded, the balloon segments of the dialysis body are again dilated and the catheter 27, along with the retraction hull 26, are removed from the vessel, whereas the vascular graft 10 remains in the vessel.

Claims

claims

An expandable vascular graft (10, 22) for implantation in a patient's vasculature, wherein the vascular graft (10, 22) is convertible from a compressed state to an expanded state, the vascular graft (10, 22) comprising: a hollow cylindrical body (11; ) with a longitudinal direction (12) and with a proximal and a distal end (13, 14), and a main body lumen (15) which extends from the proximal to the distal end (13, 14), the hollow cylindrical basic body (11 ) is formed by a tubular lattice framework (18), characterized in that the tubular lattice framework (18) has at least one first and at least one second region (16, 17), the first region (16) being connected to the second region (17). is firmly connected and wherein the first region (16) is designed self-expandable and the second region (17) is configured balloon-sterilizable.

Vascular implant (10, 22) according to claim 1, characterized in that the tubular lattice framework (18) of the first and / or the second region (16, 17) at least partially a prosthesis material (19).

Vascular implant (10, 22) according to claims 1 or 2, characterized in that the tubular lattice framework (18) of the first region (16) is made of a self-expandable material, in particular nitinol, and the tubular lattice framework (18) of the second Region (17) is designed from a balloon-sterilizable material, in particular of a cobalt-chromium-containing alloy.

4. vascular implant (10, 22) according to one of claims 1 to 3, characterized in that at least two, three or four first regions (16) and / or at least two, three or four second regions (17) are provided which in Longitudinal direction (12) are arranged one behind the other and alternately.

5. vascular implant (10, 22) according to one of claims 1 to 4, characterized in that the vascular implant (10, 22) in the first and / or in the second region (16, 17) has at least one branching side branch (23).

6. Vascular implant (10, 22) according to any one of claims 1 to 5, characterized in that on the vascular implant (10, 22) is a marker (24) containing a radiopaque material or consists entirely of radiopaque material, wherein the marker (24) is located in particular at the ends (13, 14) and / or between the first and second regions (16, 17).

7. vascular implant (10, 22) according to one of claims 1 to 6, characterized in that the vascular implant (10, 22) has a diameter in the expanded state between 5 and 50 mm, in particular between 15 and 50 mm, in particular 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 1 1 mm, 12 mm, 13 mm, 14 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm or 50 mm.

8. vascular implant (10, 22) according to one of claims 1 to 7, characterized in that the vascular implant (10, 22) has a different diameter in the first and in the second region.

9. vascular implant (10, 22) according to one of claims 1 to 8, characterized in that the vascular implant (10, 22) has a length of 30 mm to 250 mm, in particular from 100 mm to 250 mm, in particular 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 75 mm, 80 mm, 90 mm, 100 mm, 125 mm, 150 mm, 170 mm, 200 mm, 230 mm or 250 mm.

10. An insertion system (25) for the release and expansion of an expandable vascular implant (10, 22) according to any one of claims 1 to 9, characterized in that the insertion system (25) comprises a retraction sleeve (26) for compressing at least the first region (16). the vascular implant (10, 22), and a first catheter (27) with a dilation body.

1 1. Insertion system (25) according to claim 10, characterized in that the dilation body can be dilated by supplying a fluid.

12. An introducer system (25) according to claim 10 or 1 1, characterized in that the first catheter (27) for carrying the vascular implant (10, 22) and dilating the second region (17) is formed.

Use of an introducer system (25) according to any one of claims 10 to 12 for introducing and releasing an expandable vascular graft (10, 22) into a patient's vessels for treating a vasoconstriction or rupture of a vessel.

14. A method of releasing an expandable vascular graft (10, 22) in

A patient's vasculature for vascular constriction or rupture of a vessel, the method comprising the steps of: a) providing an introducer system (25) with a vascular graft (10, 22) for delivery and expansion of a vascular graft (10, 22) for implantation into Vessels of a patient according to any one of claims 10 to 12; b) introducing the delivery system (25) loaded with the expandable vascular graft (10, 22) to the site to be treated in the vessel; and c) releasing the expandable vascular graft (10, 22) by dilating the dilation body and retracting the retraction sheath (26).