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    • 专利摘要:
    IMPLANT TO INFLUENCE THE BLOOD FLOW IN ARTERIOVENOUS DISABILITIES. The invention relates to an implant (1) for blood vessels, especially to influence blood flow in the region of arteriovenous deficiencies, with a wall of different filaments (2), which are joined to an essentially tubular braid, which extends in axial direction from proximal to distal, with the different filaments (2) crossing each other and forming intersection points (3), the implant (1) is so deformable that in an introduction catheter it takes a shape with a diameter reduced and expands at the implantation site under adaptation to the diameter of the blood vessel, at the proximal and / or distal end of the braid the ends of the filaments are brought together at least in pairs respectively and are permanently joined together, with the ends of filaments joined they are non-traumatic, and the filaments (2) that cross each other are directly or indirectly connected to each other at the crossing points (3), located distant from the ends of the filaments, at the proximal end (10) of the implant (1). In this way, it is guaranteed that the implant (1) after release also expands at the proximal end to the vessel walls and that the filaments do not protrude into the (...).
    公开号:BR112013005678B1
    申请号:R112013005678-9
    申请日:2011-09-07
    公开日:2021-01-05
    发明作者:Manuel Schneider；Stefan Rolla；Carsten Aporta；Ralf Hannes；Hermann Monstadt
    申请人:Phenox Gmbh；
    IPC主号:
    专利说明:

    [0001] The invention relates to an implant for blood vessels, especially to influence blood flow in the region of arteriovenous deficiencies, with a wall of different filaments, which are brought together for an essentially tubular braid, which extends in axial direction from proximal to distal, with the different filaments crossing each other and forming intersection points, the implant is so deformable that in an introduction catheter it takes on a shape with a reduced diameter and expands at the implantation site under adaptation to the diameter of the blood vessel, at the proximal and / or distal end of the braid, the ends of the filaments are brought together at least respectively in pairs and are permanently joined together, with the ends of filaments joined together are formed atraumatic. The implant is specially designed to influence blood flow in the region of arteriovenous malformations, such as fistulas and aneurysms. It can also be used to treat ischemic accidents, as well as to restore, increase or maintain blood flow. The implant can be designed recoverable.
    [0002] Arteriovenous malformations in a patient lead to considerable damage and risk even to death. This applies especially to fistulas and arteriovenous aneurysms, especially when they occur in the brain region. As a rule, attempts are made to seal these malformations by implants. These implants are usually placed endovascularly, with the aid of catheters.
    [0003] Especially in the case of aneurysms, the implantation of platinum spirals was proved, which more or less completely fill the aneurysm, largely block the blood flow and cause the formation of a local thrombus, which fills the aneurysm and finally closes it. This treatment method, however, is only appropriate for aneurysms that have relatively narrow access to the vascular system, so-called Beeren's aneurysms. In emptying blood vessels, which have ample access to the vessel, implanted spirals threaten to be excavated again and lead to damage in other regions of the vascular system.
    [0004] In these cases, it has already been proposed to employ a type of stent, which “creates a grid” at the opening of the aneurysm and, thus, prevents the excavation of the occlusion spirals. These stents, which have a relatively wide mesh wall, however, have a number of disadvantages.
    [0005] On the one hand, there is a wide mesh structure, which allows blood to access the aneurysm unimpeded. , if the aneurysm is not sufficiently filled with the occlusion medium, the pressure on the vessel wall remains not reduced. Further treatment, however, is hardly possible under these circumstances, as the stent impairs access to the aneurysm and prevents the introduction of other means of occlusion.
    [0006] Another disadvantage is the poor adaptability of the stent to its place of employment. For optimal functioning, the stent should rest tightly against the vessel wall, without, however, exerting excessive pressure on the wall. Unlike stents, which must produce a dilation of the vessel in the case of strictures, these stents must first be understood as a type of lining, which should influence as little as possible the vessel lumen and the vessel endothelium wall. Therefore, these stents, even when they were selected especially for the purpose of use, are only limited to the requirements made.
    [0007] Stents consisting of braided metallic wires, especially for use in the coronary area, have long been known. These stents are usually manufactured as a round braid, with the different filaments of metallic thread executed in layers in the form of a spiral or in the form of a helix in the opposite direction forming the wall of the stent. The result is a braided mesh, which is both supported in a radial direction and also allows the passage of blood.
    [0008] A problem with these stents performed as braided back is the loose ends, existing at the ends, which due to their small diameter can have a traumatic effect.
    [0009] According to US-A-4 655 771 (Wallsten), this stent executed as a round braid is configured atraumatic in its extreme regions by U-shaped joining elements between the loose ends. The U-shaped joining elements, however, lead to stresses that lead to deformation of the stent.
    [00010] According to US-A-061 275 (Wallsten et al.), The loose ends of these metallic wire stents are fused round by laser treatment, in order to counteract a trauma. The stent described there also consists of a round braid, in which the different metallic wires present in the region of the stamping nodes, to enable tension-free fixation within the wall.
    [00011] These stents consisting of filaments as braided back, when used to treat stenoses, are hydraulically expanded with the aid of a balloon at the point of use and fixed to the vessel wall. During the introduction, the balloon attached to a metallic introduction wire serves as a transport vehicle, on which the stent is stapled. This transport vehicle should not, however, be used for implants, which serve to influence or channel blood flow in the brain region; before, an implant is advantageous here, which adapts automatically to the diameter of the vessel and touches the vessel wall.
    [00012] Another problem with stents consisting of wire braiding or implants is manufacturing. It is advantageous to manufacture as a flexible braided endless tube, which is cut to the desired size. In the region of both ends of the elongated flexible tube there are loose ends of metallic wire, which must be carefully dismantled, for example by the connection elements mentioned above.
    [00013] In WO 2008/107172 A1 an implant is described, in which the braid presents an elongated shape with a reduced diameter in an introduction catheter and in the implantation site is expanded with adaptation to the diameter of the vessel and increased compression of the truss. with the filament ends protruding from the implant ends at least in pairs, gathered and joined together. In this way, an implant was made available, which is capable of adapting to the respective vessel diameter, with the filament ends being atraumatic.
    [00014] From DE 10 2009 006 180 A1 an implant is known, which also has atraumatic properties. The ends of the metallic threads are gathered for the first ends of the braid and these again for the second ends of the braid.
    [00015] However, in all these implants, the fact that the ends of filaments at the proximal end, when the implant is released, sometimes do not expand sufficiently with the vessel walls, was highlighted as a problem. This effect is also called in the literature partly the “fish mouth effect” and is due, among others, to the fact that the proximal end of the implant acts less radially than at the distal end. Upon release, the cover located on the implant is initially removed, so that the distal end can be dilated, while the proximal end remains in union with the detachment mechanism. Only after the release mechanism is released can the proximal end also expand. The forces, which press the proximal end radially outward, are, however, here smaller than the distal distance and in the central region, because the expansion must occur its additional aid.
    [00016] The effect of the fish mouth results in the fact that the filament ends at the proximal end protrude into the lumen of the vessel and are responsible for preventing the flow of blood. Thus, eventually, the implant is not atraumatic to a sufficient extent. Other interventions, in which, for example, a catheter must pass through the implant, are hindered or prevented.
    [00017] The invention aimed to provide an implant of the type mentioned at the beginning, in which the radial dilation of the implant at the proximal end is ensured.
    [00018] This objective is achieved, according to the invention, by an implant for blood vessels, especially to influence the blood flow in the region of arteriovenous deficiencies, with a wall of different filaments, which are brought together for a stranded braid. essentially tubular, extending in axial direction from proximal to distal, and the different filaments cross each other and form intersecting points, the implant is so deformable that in an introduction catheter it takes a shape with a diameter reduced and expands at the implantation site under adaptation to the blood vessel diameter, at the proximal and / or distal end of the braid the ends of the filaments are brought together at least in pairs respectively and are permanently joined together, that the ends of filaments joined together are formed atraumatic, and the intersecting filaments are connected directly or indirectly respectively between s i at the crossing points, located far from the ends of the filaments, at the proximal end of the implant.
    [00019] It has been proved that the mutual fixation of the filaments to each other in the region of the crossing points at the proximal end causes the implant also at that end to be radially dilated to a sufficient extent, so that the filament ends touch closely on each other. vase wall. The insufficient radial expansion of the filaments in the implants described in the current state of the art is due, among others, to the fact that at the crossing points between the filaments, friction results, which prevents dilation. This friction is imposed by the mutual fixation of the filaments in the region of the crossing points. The crossing points are, rather, kept in a certain axial position in relation to the proximal end of the implant, so that there is no longer a displacement of different crossing points associated with a mutual impediment of the filaments when dilating .
    [00020] By the crossing points at the proximal end of the implant, the crossing points are understood, in which the filaments actually cross, but not the filament ends themselves, to which the filaments are permanently attached. The proximal crossing points are thus located, seen from the end of the proximal filament, slightly in the distal direction. According to the invention, by crossing points at the proximal end of the implant, the crossing points are understood in the first three planes of crossing point located orthogonally to the longitudinal direction of the implant, that is, the crossing points located at the maximum close , the second crossing points located as close as possible and the third crossing points located as close as possible. Preferably, at least the filaments that intersect at the crossing points located as close as possible are joined together, but it may also be convenient to join the filaments that intersect at the crossing points located a little further apart. It is also possible to join filaments that cross at crossing points in the distal region of the implant.
    [00021] The joining of the filaments to each other at the crossing points located nearby can occur in different ways. One possibility is to guide the filaments by loops, which are formed by separate metallic threads. These metallic wires are attached to the implant, preferably at the proximal end of the implant. The filaments that intersect at the crossing point are guided by the loops, so that the crossing point is largely fixed in its axial position and the filaments cannot pass through each other. The friction between the filaments is thus prevented. On the other hand, the filaments still have a freedom of movement, albeit very limited, so that the expansion of the implant is not prevented.
    [00022] The metallic threads forming the loops can especially start from the points, where the filaments are joined at the proximal end. A union is possible for example by means of laser welding, brazing, gluing, among others. The different metallic wires extend from the proximal fixation point in the distal direction and are positioned around the proximal crossing points of the filaments.
    [00023] Alternatively, at least some of the filaments themselves may form at the crossing points located at the proximal end of the implant eyelets, through which other filaments that intersect with the respective filament at that crossing point extend. This other filament may, in turn, present an eyelet at this point, to guarantee mutual fixation. In this form of execution, a separate metal wire is not necessary for fixing the filaments.
    [00024] Other alternative possibilities of joining the filaments in the region of the proximal crossing points are viable. In particular, the filaments can be joined here by us, or glued, welded or joined by brazing. Other forms of positive union or form are also conceivable. However, the joint must have a measure of flexibility, so that it is still possible to vary the angle at which the filaments intersect at the crossing points.
    [00025] The tubular braid according to the invention is, in general, a round braid and has a circular cross section considered from the proximal or distal end. Basically, however, deviations from the circular shape are also possible, for example an oval cross section.
    [00026] As for the filaments, which form the braid structure, it may be individual metallic threads; but it is also possible to envisage flexible strands, that is, several small diameter metallic wires, which together form a filament and are preferably twisted together.
    [00027] The implants according to the invention are able to influence the flow of blood in a vessel, in such a way that arteriovenous malformations are isolated as much as possible from the blood flow. This applies correspondingly to the obstruction of vessels, which must for example be isolated from the blood circuit, because for example they feed tumors. The implant must, with an optimal selection of implant diameter for vessel diameter, then be able to adapt to the respective vessel diameters. In the region of enlargements or excavations, it must assume a maximum of its nominal diameter.
    [00028] The implant can also be positioned non-traumatically, that is, without the aid of a balloon. A positioning device must reliably retain the implant until the catheter is finally released and in particular it also makes it possible to retract the implant into the catheter, as long as a complete release has not occurred.
    [00029] As material for the implant according to the invention, especially materials with a high recovery power or elastic effect are particularly important. They are especially materials with superelastic properties or with shape memory, for example nitinol. For the different filaments, metallic wires with a different diameter can also be used. Metal wires with a larger diameter provide sufficient radial strength, metal wires with a smaller diameter produce a sufficiently high mesh density. The advantages and disadvantages of metal wires with different cross sections can thus be combined or compensated. The cross section of metallic wires is round in most cases, but metallic wires with oval or rectangular cross sections or combinations of them are also possible.
    [00030] In the scope of the description, the term proximal end is understood to mean the end that faces the doctor performing the treatment, that is, the proximal end points towards the outside of the body. Conversely, the distal extremity is opposite to the physician, therefore departing towards the interior of the body. Correspondingly, proximal and distal must be understood facing or opposite to the metallic wire of introduction of the positioning system.
    [00031] The implants according to the invention will be described based on a braid for isolating an aneurysm. It is evident that these braids can be used for several purposes, especially for other forms of arteriovenous malformations.
    [00032] Implants according to the invention must not unconditionally perform a support function, as is the case with usual stents. Rather, they primarily serve to channel blood flow in the region of malformations. For example, they must also, in an occlusion medium positioned in an aneurysm, prevent them from being isolated into the path of the vessel. In addition, blood flow in and / or out of an aneurysm can be prevented. It is a kind of covering, interior trim or also “flow diverter”. Basically, however, it is also possible with implants according to the invention to carry out a support function in terms of conventional stents.
    [00033] The implants according to the invention are manufactured as a braid of a plurality of filaments, the braid forming in principle an endless flexible tube. The respective implant compliance required can then be cut from that endless flexible tube. The different filaments are therefore wound in the form of a spiral or helix, and the different filaments are introduced as a lattice, that is, crossed with each other and over each other. As a rule, the different filaments are then wound in two directions that intersect at a constant angle, which intersect, for example, at an angle of 90 o. According to the invention, angles of more than 90 o, especially from 90 to 160 o, in the normal stress-free state, are preferred, as they are open angles for the axial ends of the implant. This steep winding of the individual filaments can, when compact enough, lead to a braid with high surface compaction, which with axial extension for considerably smaller diameters can be expanded. With the elimination of the extension forces and sufficient recovery force of the filament material, the braid approaches the nominal diameter again, that is, the state originally without tension, and expands, which leads to a narrow amalgamation of the vessel wall. at the implant site and a compacting of the mesh structure on the wall. This is especially true in the area of vessel expansion. In addition, the surface compaction of the braid can also vary by the braiding technique applied. For example, in the central region, where the aneurysm typically covers, the implant can be braided more compactly than in the extreme regions, so that a wide coverage of the aneurysm neck is guaranteed. On the other hand, due to less surface compaction in extreme regions, sufficient flexibility is guaranteed.
    [00034] In the braid according to the invention, the filament ends protruding at the ends of the implant are brought together at least in pairs and permanently joined together. This can occur, for example, by welding, but also by mechanical tightening, twisting, welding or gluing. A joining of the filament ends can also take place by means of a seated housing. This enclosure can establish a positive union with the filament ends, for example welded or also clamped. An alternative resides in that the casing is so dimensioned that thickenings located at the ends of the filaments are prevented from slipping through the casing. The casing is thus movable with respect to the filaments in axial direction, but it cannot be completely extracted either. Furthermore, it is advantageous that the shells are mutually out of phase in an axial direction. In this way, it is achieved that the wrappers, when the implant is compressed, cannot lie directly above each other, so that the implant has a smaller diameter in total.
    [00035] It is also possible to combine the filaments for the first ends of the braid, which in turn are joined for the second ends of the braid, as described in DE 10 2009 006 180 A1.
    [00036] Another possibility is that loops are provided at the ends of the filaments, that is, the filament ends are joined at the proximal / distal end and curved back at 180 °. In this way, the ends of the filaments are atraumatic. They can be retained together by capsized casings or seated “coils”. The union occurs by contraction, bonding, among others.
    [00037] Then or in addition, the ends of joined filaments are deformed atraumatically. The ends of the filaments may show an atraumatic thickening, which is approximately spherical in shape, distal and proximal. The thickening can be deformed from the end of the filament or applied to the end of the filament by laser welding, brazing, gluing or clamping, among others.
    [00038] The positioning of the implants according to the invention will occur in practice under X-ray control. For this reason, the implant must have a radiopaque marking material, insofar as it is not itself made of a radiopaque material. These radiopaque materials are especially tantalum, gold, tungsten or platinum metals, such as Pt-Ir alloys, the latter being preferred. These markers can, for example, be fixed in a known manner to the ends of the filaments, but also braided as marking filaments in the braided structure of the implant. It is also possible to coat different filaments with a helix or metallic thread made of a radiopaque material such as platinum. The helix or the metallic wire can be welded, glued, among others, with the filaments. Another possibility is to coat or fill the filaments with a radiopaque material.
    [00039] Another alternative is radiopaque markings in the form of envelopes, which enclose the assembled filaments. These sheaths may also be welded or clamped. The radiopaque wrappers can be identical to the wrappers mentioned for the retention of the ends of filaments and, thus, serve a dual function.
    [00040] Implants according to the invention, as a rule, are not hydraulically dilated or positioned with the aid of a balloon. It is also necessary to connect the implants with a metallic insertion wire in such a way that they can be reliably guided. This occurs, according to the invention, by joining elements, which cooperate with a retaining element of the metallic wire of introduction required for positioning. As these joining elements, the strand ends of the braid joined together.
    [00041] Vascular shunts (bifurcations) can be considered in implants according to the invention, for example by regions of a lower mesh density.
    [00042] The braiding can in principle be carried out in any known way. It can be single and / or multiple. A tight braid leads to a high demand from the different filaments in a compact truss. Therefore, the execution of a multiple braid is appropriate to absorb tension from the truss, however, a braid that is too high leads to a bad union in the braid. The braid indicates how many filaments intersect with the filament a given filament is passed on the same side before changing sides, and then passed through a corresponding number of filaments crossing on the other side. With an execution of two strands, for example, a filament is successively guided above two filaments crossing the filament, then successively below two filaments crossing.
    [00043] The filaments can, in particular, also be multiple. The number of threads indicates the number of individual filaments gathered, extending in parallel. A number of single or multiple strands is possible, where one or more filaments respectively extend in parallel. As, when the braid is manufactured, the filaments are added by coils, this means that from the corresponding coil one or more individual filaments are simultaneously added to the mandrel, in which the braid is made. Each individual filament may consist of an individual metallic thread or also of a strand of several individual metallic threads gathered together and preferably twisted together.
    [00044] Individual metallic wires can have the same diameter as well as different diameters. Metal wires can also consist of different materials (nitinol, cobalt-chromium alloys, platinum alloys). Metal wires of a radiopaque material provide, for example, the radiological visibility of the implant.
    [00045] According to the invention, the ends of the filament are joined together especially in pairs, with multiple filaments in pairs meaning that two bundles of several individual filaments are brought together respectively. This bundling can then take place in a compact manner, in such a way that all metallic wires are brought together into an essentially round bundle and the front sides of all metallic wires are fused together, so that uniform coupling results. Thus, a positive union of the metallic wires is produced with each other and the end of the bundle is implemented atraumatically.
    [00046] Alternatively, the metallic wires can be guided parallel to each other and fused together like chocks. The advantage of this execution is the relatively small diameter in the joining region compared to the bundling of the filaments.
    [00047] Finally, as another variant it is possible to scale the different filaments, that is, the metallic threads are cut to length out of phase. Each metallic wire is joined by its front area with the metallic wire located on the side. The longer metallic wire can then take on the function of the joint. Scaling can take place either with a compartmentalized or compact guide of the individual metal wires.
    [00048] As described above, with the arrangement of the individual strands without tension in the braid, it is important to configure the implant surface as compact as possible. As the flexibility of the braid must be maintained, 100% surface coverage by the filaments is possible in any case, however approximately. Depending on the application, however, smaller surface coverings or even smaller surface coverings may also prove to be sufficient.
    [00049] For better surface coverage, the braid can be coated with a sheet, for example of Teflon, silicone or another plastic compatible with the body. For greater flexibility and expandability, this plastic sheet can be split, with the slot arrangement being staggered and the longitudinal direction of the slot extending along the peripheral line of the implant. This sheet can be obtained, for example, by immersing the implant in a corresponding liquid sheet material (dispersion or solution) and subsequently inserting the slits, for example with a laser. For example, total or partial filling of the meshes can also be achieved by immersion.
    [00050] Alternatively, it is possible to coat the different filaments of the implant by immersing it in a plastic dispersion or solution with this plastic and, thus, increasing the cross section of the filament. In this case, open meshes remain, but the mesh size is markedly reduced.
    [00051] The implant according to the invention is produced from usual implant materials with replacement properties, preferably medical steel with elastic properties, cobalt-chromium alloys or a material with shape memory properties. In the latter case, especially nitinol. In any case, the important thing is that the implant on one side is able to assume a compressed form to pass through the introduction catheter, but it expands automatically when the external effort of the introduction catheter is released and it touches on the inner wall of the vessel at the implantation site. It is also possible to manufacture the implant from composite materials, for example, platinum wires coated with nitinol. In this way, nitinol's shape memory properties are combined with platinum radiological visibility.
    [00052] The implant may be coated in a manner known per se. As coating materials, they are especially important as they are described for stents, possibly with antiproliferative properties, ignition inhibitors, antithrombogens, growth promoters and / or precipitation inhibitors, hemocompatible. A coating is preferred, which promotes implant growth and neointima formation. It may be convenient to coat the implant externally and internally with a medium that reduces adhesion, possibly heparin or a derivative, ASS or oligosaccharides and chitin derivatives for this purpose. Here, layers of nano-particles are also suitable, such as ultra-thin layers of SiO2 polymers, which reduce adhesion.
    [00053] According to the invention, the filament ends joined together can be formed as joining elements. This can happen, for example, due to the fact that these thickening elements with defined diameter are arranged in these joining elements, which can be produced by fusing with the aid of a laser. Thickenings can be spherical, oval, rectangular, square or other in shape and are designed to be retained in a positive union against detachment of the implant by a retention element in union with a metallic insertion wire.
    [00054] In the proximal and / or distal filament ends, joining elements can also be arranged, which also extend in a proximal / distal direction and whose ends are found to be thickened. The connecting element can, for example, be a metallic thread, which is arranged at the connection point of two or more filament ends and extends forward in an axial direction. Especially important are the thickening at the proximal end, where the thickening is expected to be retained in positive union by a retaining element. Through the retaining element, the implant is coupled to an insertion aid, especially a metallic insertion wire and guide. With detachment of the implant, the positive union between thickenings and the retaining element is suspended and the implant is released. But it is also possible to add an additional retaining element to the distal end of the implant.
    [00055] A configuration of the joining elements in a form other than the spherical one is also possible, for example in the form of anchors, rectangles or other molded parts. The connecting elements work on the key / lock principle, that is, they cooperate with a retaining element, which has correspondingly corresponding recesses or housings. As the retaining element with attached implant is conducted in a stretched form and reduced in diameter inside a catheter, both are forcibly held together by the catheter wall; after the exit of the retaining element from the catheter, the implant expands to its final diameter and thus loosens itself from the housing of the retaining element. Fixing and detaching fasteners from the retaining element are, however, also possible in another way. As a rule, the retaining element is symmetrical in rotation and can be produced, for example, from noble steel or nitinol.
    [00056] The fixation of the implant in the recesses or housings of the retaining element can also occur by a separate cover of the flexible tube type, which is threaded in positive union over the retaining element with joining elements or fixing devices. union set. The cover is pulled back after reaching the final position of the implant and thus releases the implant. Then, the retaining element with metallic insertion wire, cover and catheter can be pulled back. As for the cover, it can be a flexible plastic tube, a plastic or metal casing, a metal spiral volute or also combinations thereof. Fixing the cover to the insertion wire against inadvertent displacement is possible with a clamping device, for example with the aid of a torque generator. The cover must not cover the entire wire of the introduction, being sufficient an extension of the cover by the retaining element and the distal part of the wire of introduction. The extraction of the cover occurs in this case by a second metallic wire or wire, which runs parallel to the metallic wire of introduction of the cover in a proximal direction.
    [00057] The invention also relates to the combination of an implant of the type previously designated and an introduction metallic wire, to which the implant is coupled via the retaining element.
    [00058] As previously mentioned, the combination of retaining element and implant is guided by an endovascular catheter. For this purpose, the retaining element can be provided on its periphery of recesses for housing the implant joining elements. The diameter of the retaining element must then be so dimensioned that it can be immediately guided by a usual catheter, but the connecting elements must be retained by the internal wall of the catheter in the recesses. To this extent, a spherical execution of the joining elements is advantageous, since the contact area with the internal wall of a usual catheter and, thus, the friction and the guide resistance can be kept reduced.
    [00059] According to a preferred embodiment, at the proximal end of the implant there are thickenings, which are retained in a positive union by the retention element, being a segment of the retention element executed electrolytically corrosive, so that after electrolytic detachment of the segment to proximal end of the implant is released. In this case, the detachment of the implant is produced not only by displacing the catheter or removing a cover; instead, at least also electrolytic corrosion of a segment of the retaining element is necessary. The corrosive segment is then so arranged that it prevents the projected thickening from escaping into the retaining element. It may be, for example, a pin, which is placed between the thickening and keeps it separate, so that the implant diameter at the proximal end is too large for an exit from the retaining element. Fixing the implant to the retention element by positive union, which is controlled by the possibility of electrolytic detachment from a segment of the retention element, is especially advantageous with regard to the safe possibility of positioning control and eventually also to the repositioning or extraction implant. Of course, however, a possibility of merely electrolytic detachment from the implantation of the retention element is also viable, as is known in the current state of the art for stents and coils.
    [00060] Another possibility resides in employing as a segment of the element, made corrosible, a plate with an opening, the thickening located at the proximal end of the implant extending through the opening and the opening diameter being so adjusted to the thickening that a thickening pass through the opening with the plate intact is excluded. Only when the plate is loosened at least partially by applying tension does the implant thickening come out of the retaining element.
    [00061] For the electrolytically corrosive segment, various materials can be used, which guarantee a fast detachment capacity and, in addition, are medically compatible. Examples are noble steel, magnesium, magnesium alloys or cobalt-chromium alloys.
    [00062] The above described combination of fixation by positive union of the implant in the retention element with electrolytic detachment of a segment of the retention element, which leads to the release of the implant, is possible also independent of the invention described here of the union of the filaments that are they cross at the proximal crossing points, that is, in an implant according to the invention. This variant is also the subject of the order.
    [00063] The retaining element can consist of two fastening elements spaced apart, which hold the implant between them, tensioned. In this case, both fixation elements have the corresponding housings for the implant union elements and the implant corresponding union elements both in its proximal end as well as in its distal end.
    [00064] A correspondingly executed retaining element, with two fixing elements, can present the two fixing elements at a distance defined in the same metallic introduction wire, with which the implant suffers, with a given length, also a defined extension and tension. In this way, it is ensured that there is no excess dilation and that the replacement forces can act with full effectiveness after release into the vessel. Alternatively, however, it is also possible to fix the fixation elements in two separate metallic insertion wires, which allows an adjustment or extension of the implant by the doctor performing the treatment or by a corresponding fixation device. The second metallic insertion wire can also be made as a guide tube.
    [00065] According to another advantageous form of implementation, the introduction wire has a tip of a guide wire, which continues to extend from the distal end of the introduction wire in a distal direction into the internal compartment of the implant, especially until distal end of the implant or beyond. In this way, it is achieved that even after the implant is released initially, an object still extends inside the implant, insofar as the introduction wire is not removed. This makes it possible to re-probe the vessel or implant, for example as a catheter is guided by the insertion wire and then by the guide wire tip. The catheter is thus moved by the implanted and expanded implant. The tip of the guide wire is only removed by the definitive extraction of the introducing wire.
    [00066] The guide wire tip may have a rotating symmetrical design. The cross section can be round, oval, rectangular or basically any other shape. In addition, it is advisable to make the tip of the guide wire visible, eg as the tip of the guide wire itself is made at least partly from a radiologically visible material or as the tip of the guide wire The guide has a radiopaque marker at its distal end. The tip of the guide wire can be produced from noble steel, nitinol or other metals.
    [00067] The tip of the guide wire and the metallic wire of the proper introduction can be manufactured in one piece, that is, it is, after all, a continuous metallic wire. But it is also possible to manufacture the guide wire and the metallic introduction wire separately and to join them together only later. In general, the guide wire tip will have a smaller diameter than the guide wire, that is, the cross section is reduced from the introducing wire to the tip of the guide wire. In addition, it is advantageous that the tip of the guide wire is configured slightly conical, that is, its diameter decreases in the distal direction, so that the flexibility is increased in the distal direction.
    [00068] The variant described with a guide wire tip is also executable regardless of the invention described here of joining the filaments that cross at the proximal crossing points, that is, in an implant according to the invention. This variant is also the subject of the order.
    [00069] The invention will be explained in detail by the following representations. Show:
    [00070] Figure 1 - a typical example of a braid, as it is used according to the invention;
    [00071] Figure 2 - filaments with single and double shelves;
    [00072] Figure 3 - a single and double lattice braid;
    [00073] Figure 4 - the method of assembling the filament ends of a braid according to the invention;
    [00074] Figure 5a - an alternative embodiment for joining the filament ends;
    [00075] Figure 5b - Atraumatic execution of the filament ends;
    [00076] Figure 6 - another alternative form of execution for joining the filament ends;
    [00077] Figure 7 - the fixation according to the invention of the crossing points;
    [00078] Figure 8 - an execution form with additional joining elements;
    [00079] Figure 9 - an alternative form of execution for fixing the crossing points;
    [00080] Figure 10 - a form of execution with axially displaced shells;
    [00081] Figure 11 - the union of an implant in the retaining element as well as the detachment;
    [00082] Figure 12 - an alternative way of detaching the implant from the retaining element; and
    [00083] Figure 13 - Another alternative way of detaching the implant from the retaining element and
    [00084] Figure 14 - a form of execution with a guide wire tip extending through the implant.
    [00085] Figure 1 shows the braiding structure of an implant 1 according to the invention, which consists of filaments 2 intertwined with each other. The different filaments intersect in the case shown at an angle of around 120 o, with the open sides of the angle pointing to the open ends of the braid. The braid is represented in a slightly tensioned / elongated state, that is, with a reduced diameter.
    [00086] The Theta angle designates the braiding angle to the longitudinal axis, which in the extended state with nominal diameter can import up to 80 o. When stretching the strand on the catheter, the Theta angle may decrease to about 7 °.
    [00087] It is evident that the nominal diameter of the braid is adjusted to the lumen of the target vessel at the point to be treated.
    [00088] The braid is produced in a conventional lattice machine and presents itself as endless braiding. The braiding is done in a mandrel, whose outer dimensions correspond to the inner diameter of the posterior products.
    [00089] The braiding machine and its trim determine the structure of the braid, eg the number of threads, the course of the threads and the number of crossing points on the periphery and by length of throw. The number of wires is dependent on the number of tongues, with the tongues extending half and half in both directions around the core of the truss.
    [00090] The filaments usually consist of metal, for example steel wire, radiopaque metals or platinum alloys or nitinol. Plastic threads can also be used, which have the necessary flexibility. The thickness of the filaments matters, in the ideal case, in 0.01 to 0.2 mm, especially 0.02 to 1 mm. To obtain a high coverage of the wall area, instead of metal wire material, a flat strip material can also be used, for example with a width of 0.05 to 0.5 mm, preferably up to 0, 1 mm in the thickness indicated above.
    [00091] The braid according to the invention can be produced from individual strands (cala 1) or also from two or more filaments (cala 2).
    [00092] Figure 2 shows crossing points 3, in which respectively two filaments guided in parallel (shed 2) cross or only individual filaments 2 cross (shed 1). When two or more filaments are joined, they are added through the same coil.
    [00093] Figure 3 shows a pattern for structures of a truss and two trusses of filaments 2 of the shed 2. In the structure of a truss the pairs of filaments are alternately located above each other and below each other. In the double truss structure, the filament pairs, as shown, are guided respectively on two opposite filament pairs, before being guided on two opposite filament pairs.
    [00094] A configuration of two or even more drafts results in a higher surface density of the strand, with simultaneous reduction of the longitudinal extension during the strand compression. This higher surface density is achieved, however, at the expense of flexibility, also by increasing friction and tension. This can be remedied by an increase in interlacing, that is, a structure of two or more trusses leads to an increase in flexibility. According to the invention, an interlacing of 2 and a sheath of 2 are preferred.
    [00095] After separation into specific units for the product, the braid must be closed at the ends. This is necessary to ensure the stability of the lattice body shape and prevent injury to the vessels. For this, the order of the structure at the ends of the braid is necessary.
    [00096] Figure 4 shows the assembly of two 2.2 'filaments at the end of the strand for a pair of 4 filaments, 2 and 2' filaments in the opposite direction. For this purpose, the filaments are curved in an axial direction and welded together distally. The filaments overlapping at the crossing points on the edge are then joined together. These crossing points are found, for example, on line A-A.
    [00097] Figure 5a shows how the ends of filaments 2 are held together by a sheath 5. Sheath 5 can be welded or clamped with the filaments. In addition, the enclosure 5 can simultaneously serve the visualization of the implantation operation, when it is made of a radiopaque / radiovisible material.
    [00098] As shown in figure 5b, the filament ends show atraumatic thickening 6. They can be formed from filament 2 itself or be additionally arranged. When the thickenings 6 are of sufficient diameter, the casing 5 is only retained so as not to slip from the ends of the filament. But of course it is also possible to fix the casing 5 by clamping, welding, brazing, gluing, among others. Figures 5 a, b show the distal end of an implant, but similar filament fixation at the proximal end is also possible.
    [00099] Figure 6 also shows the fixation of ends of filaments 2 by a wrapper 5, especially at the distal end. But here, differently from the example presented above, the ends of the filaments are guided in such a way back to the casing 5 that a loop 7 is forced. In this way, an atraumatic end can be formed.
    [000100] In figure 7 the basic idea of the invention is represented, namely, the mutual fixation of the filaments 2 that cross at the proximal crossing point 3. This occurs to the extent that a loop 8 is positioned around the crossing point 3. Loop 8 is formed by metallic wire 9, which in turn is fixed at the end 10 near implant 1. In this way, when expansion of the implant 1, a displacement of the crossing points 3 positioned as close as possible is prevented, which guarantees complete dilation, without different filaments 2 protruding into the vessel lumen.
    [000101] In figure 8, the embodiment of figure 7 is complemented by an additional wrapper 5, in which case the wrappers 5 are arranged only at some ends of filament. The envelopes 5 serve here as marking envelopes and are made of a radiopaque material, to allow the introduction of implant 1 under radiographic control.
    [000102] Additionally, figure 8 shows joining elements 11 arranged at the proximal end of the implant 1, which in turn show thickening 6 at the proximal end. These thickenings 6 are suitable for engaging a retaining element 15, which serves to control the release of the implant 1.
    [000103] An alternative possibility for joining filaments 2 in the region of the proximal crossing points 3 is shown in figure 9. The filaments have eyelets 12 in the region of the 3 crossing points proximal. Filament 2, which crosses filament 2 with an eyelet 12 in that region, extends through eyelet 12, and filament 2 also has an eyelet 12 to avoid the possibility of longitudinal displacement at that point. The means for fixing the filaments 2 are thus, in this case, themselves part of the filaments 2.
    [000104] In figure 10, the proximal or distal end of an implant 1 is shown, with shells 5 being seated as radiopaque markers on the filament bundle. The shells are axially out of step to some extent. In this way, it is possible that the radial expansion of the implant 1 in the compressed state is kept small, that is, the profile height is less than when applying all the envelopes 5 in the same axial position.
    [000105] Figure 11 shows the fixation and detachment of implant 1, which is joined by a retaining element 15 with a metallic insertion wire 14. Retaining element 15 and metallic insertion wire 14 are surrounded by a cover 13 in the form of a flexible tube. The retaining element 15 has recesses in which the thickenings 6 engage at the proximal end of the implant 1. As the cover 13 surrounds the retaining element, the thickenings 6 do not protrude out of the retaining element 15 As soon as, however, the cover 13 is removed, the implant 1 can expand at the proximal end and the thickenings come out of the recesses in the retaining element 15.
    [000106] Next, the introducing metal wire 14 is also extracted, at whose distal end is the retaining element 15.
    [000107] In figure 12 is shown an alternative way of detaching implant 1 from the retaining element 15, in which in fact equally thickening 6 arranged in the joining elements 11 engages in corresponding recesses of the retaining element 15, but the release does not occur by removing a cover, but by the fact that the electrolytically corrosive segment 16 is dissolved by applying an electrolytic voltage, symbolized by lightning. This segment 16 protects the outlet 6 from the retaining element against dissolution. On the contrary, after dissolution, there is sufficient space available, so that implant 1 can loosen and expand. The combination of positive union fixation of implant 1 on the retaining element 15 with the possibility of electrolytic detachment makes it possible to dispense with an additional cover or housing of the retaining element 15.
    [000108] Another possibility of the possibility of electrolytic detachment is shown in figure 13. There, the thickenings 6 are retained by positive union in the retaining element 15, and a plate 17 with an opening in the middle prevents the exit of the thickenings 6 The opening then has a diameter, which in fact allows the passage of the joining elements 11, but not the passage of the thickening 6 at the proximal end of the joining elements 11. As soon as, however, the plate 17 is electrolytically dissolved , implant 1 can loosen and expand. Then, the insertion wire 14 with the retaining element 15 is removed.
    [000109] An example of execution is shown in figure 14, in which a segment of guide wire, namely the guide wire tip 18 of distal connection to the introduction metallic wire 14, extends inside the implant 1 The guide wire tip 18 extends throughout the implant 1 and ends at the distal end with a marker 19 of radiopaque material, which is formed here as a marking coil. The guide wire tip 18 is thinner than the introduction metallic wire itself 14 and extends conically distally, so that, on the one hand, it is ensured that the internal compartment of the implant 1 in compressed form is also sufficiently large for the guide wire tip 18, and on the other hand, it increases flexibility in the distal direction.
    [000110] Upon extraction of the cover 13, as described in relation to figure 11, the implant 1 is released, so that the implant 1 expands. Also the tip of the guide wire 18 extends further into the interior of the implant 1, as the introduction metallic wire 14 is not extracted. Due to the expansion and shortening of the implant 1 associated therewith, the tip of the guide wire 18 after the release protrudes a little more than before by the distal end 1 outwards. Now, to the extent that it is necessary from the physician's point of view, a catheter can be displaced by the metallic introduction wire 14 and the guide wire tip 18 through implant 1, as indicated by the arrow.
    权利要求:
    Claims (12)
    [0001]
    1. Implant for blood vessels, especially to influence blood flow in the region of arteriovenous deficiencies, with a wall of distinct filaments (2), which are joined to an essentially tubular braid, which extends axially from proximal to distal , since the different filaments (2) cross each other and form intersection points (3), the implant (1) is so deformable that in a delivery catheter it takes on a shape with a reduced diameter and expands at the implantation site under adaptation to the diameter of the blood vessel, at the proximal and / or distal end of the braid the ends of the filaments are brought together at least in pairs respectively and are permanently joined together, with the ends of filaments joined together are atraumatic and the filaments (2) that cross each other are connected directly or indirectly to each other at crossing points (3), located far from the ends of the filaments, at the proximal end (10) of the implant (1), characterized by the fact that the filaments (2) at the crossing points (3) located at the proximal end (10) of the implant (1) are guided by loops (8), which are formed by threads (9) attached to the implant (1).
    [0002]
    2. Implant according to claim 1, characterized by the fact that the filaments (2) that intersect are connected respectively directly or indirectly to each other at the crossing points (3) distant from the ends of the filaments located at the - close next.
    [0003]
    3. Implant according to either of Claims 1 or 2, characterized by the fact that the threads (9) forming the loops (8) are attached to the proximal end (10) of the implant (1).
    [0004]
    4. Implant according to any one of claims 1 to 3, characterized by the fact that at the ends of the filaments (2) gathered at the proximal and / or distal end of the implant (1) there are radiopaque markings.
    [0005]
    5. Implant according to claim 4, characterized by the fact that the radiopaque markings are envelopes (5) that enclose the joined filaments (2).
    [0006]
    6. Implant according to claim 5, characterized by the fact that the sheaths (5), which enclose the filaments (2) gathered together, are displaced in an axial direction.
    [0007]
    7. Implant according to any one of claims 1 to 6, characterized in that the filaments (2) are individual metallic wires or cables.
    [0008]
    8. Implant according to any one of claims 1 to 7, characterized by the fact that at the ends of proximal and / or distal filaments are joined elements (11), which extend in a proximal or distal direction and in whose extremities are found thickening (6).
    [0009]
    9. Combination of an implant, as defined in any of claims 1 to 8, and an introduction wire (14), characterized by the fact that the implant (1) is coupled by a retaining element (15) to the introduction wire (14).
    [0010]
    10. Combination according to claim 9, characterized by the fact that at the proximal end of the implant (1) thickening (6) is found, which are retained by positive union by the retaining element (15), a segment (16) of the retaining element (15) is formed electrolytically corrosive, so that after electrolytic dissolution of the segment (16) the proximal end of the implant (1) is released.
    [0011]
    11. Combination according to claim 10, characterized by the fact that the segment (16) of the retaining element (15) made corrosible is a plate (17) with an opening, the thickening (6) located in the proximal end of the implant (1) extends through the opening and the diameter of the opening is so adjusted to the thickening (6) that a passage of the thickening (6) through the opening with the plate (17) intact is excluded.
    [0012]
    12. Combination according to any of claims 9 to 11, characterized by the fact that the introduction wire (14) has an introduction wire tip (18), which continues to extend from the distal end of the introduction wire (14) in a distal direction into the internal compartment of the implant (1), especially up to the distal end of the implant (1) or beyond.
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    CN110037839A|2019-05-28|2019-07-23|南京微创医学科技股份有限公司|A kind of intracavity stent and preparation method thereof|
    EP3827762A1|2019-11-28|2021-06-02|Acandis GmbH|Medical device for intravascular treatment and method of manufacturing the same|
    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-09-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-06-23| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|
    2020-11-03| B09A| Decision: intention to grant|
    2021-01-05| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/09/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DE102010044746A|DE102010044746A1|2010-09-08|2010-09-08|Implant for influencing the blood flow in arteriovenous malformations|
    DE102010044746.3|2010-09-08|
    PCT/EP2011/004498|WO2012031748A2|2010-09-08|2011-09-07|Implant for influencing the blood flow in arteriovenous defects|
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