implant with a mesh structure for occlusion of aneurysms in the region of vascular branches

专利摘要:
IMPLANT. The present invention relates to an implant to be used to occlude aneurysms in the region of vascular ramifications, especially bifurcated aneurysms (A), with a mesh structure (3, 4), which - from a proximal to distal position - it has a fixation segment (b), with which the implant can be attached to a wall of the container, with a segment (c) permeable to the region of the vascular branch and a distal segment (d), in which the implant is radially extended in relation to segment (b), being expanded in a radial direction and which is intended for positioning in the aneurysm (A). In the region of segments (c) and (d) there is a separation zone (T1, T2) that closes - at least partially - the neck of the aneurysm, with the distal segment (d) presenting a variety of filaments and / or loops (12), joined with segment (c), and the filaments / loops (12) have - in the direction of the longitudinal axis of the implant (1) - an angle between - 45 ° and + 175 °, with a positive angle represents filaments / loops (12) that point radially outwards, and a negative angle represents filaments / loops (12) that point radially inwards. Alternatively, the distal segment (d) can also be expanded (...).
公开号:BR112015003624B1
申请号:R112015003624-4
申请日:2013-08-22
公开日:2021-03-02
发明作者:Hermann Monstadt；Ralf Hannes；Dennis Herklotz
申请人:Phenox Gmbh；
IPC主号:

专利说明:

[001] The present invention relates to an implant to be used in the occlusion of aneurysms in vascular branches, especially bifurcated aneurysms. An implant of this nature is applied with the aid of a catheter and a guidewire to the implantation site, where it will be implanted on a permanent basis. Correspondingly, the invention also encompasses an implant of this nature, coupled and ready for implantation in a guidewire. In addition, the invention encompasses a method for inserting the implant.
[002] Malformed arteriovenous formations can result in a patient in considerable restrictions and dangers, until death. This is especially true for aneurysms, especially when they are present in the brain area. Usually, attempts are made to close these malformed formations by means of implants. Usually, these implants are applied endovascularly with the aid of catheters.
[003] Especially in cerebral aneurysms, the implantation of platinum spirals that fill the aneurysms to a greater or lesser extent in complete form was approved, blocking, to a large extent, the blood flow and causing a local thrombus that fills the aneurysm and finally closes it. This treatment method, however, is only suitable for those aneurysms that have relatively narrow access to the vascular system, the so-called "berry aneurysms". This method of treatment, however, is only suitable for those aneurysms that have relatively narrow access to the vascular system, the so-called "berry aneurysms". In the lumps of blood vessels that have ample access to the vessel, the implanted spirals threaten to be expelled again. These can reach other regions of the vascular system, causing damage in those places.
[004] In these cases it has already been proposed to insert a kind of stent that forms a "grid" into the opening of the aneurysm, thus avoiding the expulsion of occlusive spirals. These stents, which have a relatively wide mesh wall, have already been used in some forms of aneurysms.
[005] Vascular ramifications, especially vascular bifurcations, are a relatively frequent phenomenon. The blood that passes through an artery in the area of a bifurcation, collides with the brain wall - in the case of a weakening of the vessel wall - leads to a rapid protuberance that will then widen at an accelerated rate. These bifurcated aneurysms have a wide neck that makes therapy with occlusive spirals impossible.
[006] Simultaneously, there is a lack of stent structures that are adequate to produce - in the region of a vascular branch - - - a "grid structure" of the aneurysm entrance. From this point of view, it is the task of the invention to provide an implant that is suitable to be inserted in the area especially of bifurcated aneurysms, forming a "grid" there at the entrance of an aneurysm. With spirals, occlusives applied in sequence, the aneurysm can then be stopped.
[007] A "railing" of this species is also imaginable in the sense of an influence of the bloodstream, in order to reduce the number of occlusive spirals or to represent an index equal to zero.
[008] This task will be solved with an implant with a mesh structure that - from a proximal to distal position - presents the segments (b) to (d):
[009] A fixing segment (b), with which the implant can be attached to a vascular wall,
[0010] a (c) permeable segment for the vascular branching region and
[0011] a distal segment (d), in which the implant, in relation to the segment (b), is radially enlarged and which is intended for insertion into the aneurysm,
[0012] and in the region of segments (c) or (d) there is a separation zone that closes - at least partially - the neck of the aneurysm, with the distal segment (d) a variety of filaments and / or loops, united with segment (c), configuring the filaments / loops, in the direction of the longitudinal axis of the implant, an angle between -45 ° and + 175 °, with a positive angle representing filaments / loops projecting radially outwards and a negative angle represents filaments / loops that project radially inwards.
[0013] The expressions "proximal" and "distal" must be understood in such a way that they designate parts of the implant that project in the direction of the guidewire and, therefore, in the direction of the catheter and the attending physician (proximal), that is, (distal) parts that protrude in the direction of the removal of the guidewire or the attending physician. Proximal therefore represents the side of the guidewire and the distal side is oriented in the direction of the guidewire. The expression "axial" refers to the longitudinal axis of the implant that projects from proximal to distal, and the notion "radial" designates related perpendicular planes.
[0014] In the implant according to the invention it is an implant with a mesh structure that can be constituted by a weave of individual wires, presenting a structure of sectioned meshes of a tube or being a combination of both. In this sense, it is - in relation to the implant - largely a stent or a structure similar to a stent that stands out for the special form of its insertion and structuring. In the case of braiding different wires, a number of 4 to 24 wires will be preferred for segments (b) and (c).
[0015] The implant according to the invention is divided into at least three, preferably four, segments, that is, segments (a) to (d), seen from proximal to distal, with segment (a) being optional. Segments (b) and (c) can also be of similar structure, differing only in relation to the position in the vessel after implantation.
[0016] Segment (a) is a proximal segment that narrows, in which the mesh structure is joined in one or more coupling elements. The coupling elements are preferably on the periphery, that is, in an implanted state, when the implant is planned in its expanded form, they begin to lean against the vessel wall, serving to join with an introducing aid, especially a wire -guide. A central arrangement is also not useful for technical application reasons, as the peripheral arrangement of one or more coupling elements facilitates - in the case of incorrect placement - the retraction of the implant in the delivery catheter. Embodiments with one or two coupling elements are preferred. Preferably, the coupling elements are coupling wires.
[0017] The coupling elements, especially the coupling wires, that is, the proximal end of the implant (without introducing aid), can configure - in the direction of the longitudinal axis of the implant - an angle between 0 ° and + 60 °, one positive angle represents a proximal end that protrudes outwards. A region between + 10 ° and + 30 ° is also preferred, the optimal angle depending on the configuration of the vessel. A positive angle of this nature facilitates the optimal expansion of the implant and the shoulder of the proximal end in the vehicle vessel; the projection of the proximal end into the lumen of the vessel that could affect blood flow or the insertion of another micro catheter, which is effectively avoided. Preferably, the proximal end of the implant is configured in an atraumatic way, in order to eliminate lesions in the vessel wall. The configuration of the angle, according to the invention, must be understood in such a way that the angle does not need to be present in the non-implanted state, but, on the contrary, it is important that the proximal end of the implant sets an angle in such a way after implantation. , that is, sufficient to apply a corresponding deformation to the implant after implantation. Here, in particular, the use of form memorization materials is indicated.
[0018] Segment (b) is a fixative segment, with which the implant leans against the wall of the blood feeding vessel. In this region, the vessel is undamaged and is suitable for being subjected to the wall of a stent. In self-expanding implants, segment (b), after the catheter is released, automatically leans against the container wall, and in the case of balloon positioning implants, the implant will be extended in this region by a balloon. positioning, being pressed against the vessel wall.
[0019] Segment (c) is a permeable segment that may have, in particular, a greater mesh width than segment (b) and that will be positioned in the region of the effective vascular bifurcation. A larger mesh width allows more or less uninhibited blood flow through the meshes into the vessel's outlet branches. However, it is not necessary to provide - in all cases - in segment (c) a larger mesh width; when this is not the case, segments (b) and (c) can also be largely or completely constituted in an identical way, differing only in relation to the position at insertion into the vascular system.
[0020] The distal segment (d), in front of segment (b) and generally also in front of segment (c), is widened radially outwards. It serves for positioning inside the aneurysm itself, on whose expanding wall it must fit.
[0021] In the region of segments (c) and (d), especially between segments (c) and (d), a separation zone is provided that seals the neck of the aneurysm. This separation zone serves especially for the retention of occlusive media, inserted in the bifurcated aneurysm. In the case of a sufficiently dense separation zone, which seals the neck of the aneurysm to a sufficient extent, however, one can also imagine dispensing with additional means of occlusion, such as spirals. It is important that, finally, in the aneurysm, blood clotting begins. In any case, the separation zone protrudes into the lumen of the implant in an orthogonal direction with respect to the longitudinal axis. The rate of coverage of the neck of the aneurysm is between 5 and 100%, with values between 30 and 60% being preferred. On one side, the surface coverage must be sufficiently extensive to prevent occlusive media, introduced into the aneurysm, from escaping from the aneurysm or, through sufficient material, creating a dense surface, and, on the other side, flexibility must be preserved. sufficiently large of the implant to be inserted in the region of the bifurcated aneurysm.
[0022] There are also imaginable ways of carrying out the implant that do not have a separation zone, but which, nonetheless, must be considered according to the invention. An implant of this nature can be used when more than one implant has to be inserted in the region of the bifurcated aneurysm, especially two implants. This can be advantageous when the aneurysm is of an irregular structure and when - in a partial area of the aneurysm - a closure must be produced, whereas in another partial area, in turn, the blood flow must be preserved because intersect the aneurysm and the overflow vessel. In this variant, an implant without a separation zone will be initially inserted, which, in the rest, fully corresponds to the implant already described. In a second step, crossing the first implant, another implant with a separation zone will be introduced, in order to ensure the closure of the aneurysm to the desired extent. By inserting two implants, reciprocally synchronized, the special requirements of the aneurysm can be taken into account, for example, when they present differentiated (d) distal segments or (c) permeable segments.
[0023] The expansion of segment (d) is formed by filaments and / or loops joined with segment (c). The expansion normally has at least two filaments / loops, especially three filaments / loops or a larger number. Typically the number of filaments / loops is 1 to 24, preferably from 2 to 6. In the filaments or loops it can be wire elements of corresponding configuration, but also - provided that the implant is sectioned from a tube - they can be correspondingly produced by laser cutting the same tube. In the case of loops, these are preferably wire elements that extend from the segment (c), configuring a loop, and which project in the direction of the return, being that basically random complex shapes for the loops are imaginable. In particular, three-dimensional objects can be treated according to the projection of the loops. Ties are preferred because they are largely atraumatic, not damaging the sensitive wall of the aneurysm vessel. But the use of other filaments is also feasible, through which a radial expansion of segment (d) in relation to segment (c) is produced. the expansion may, for example, be in the form of a trumpet, in the form of a basket or in the form of a braid. In the case of filaments, it may be flaps that protrude radially towards the outside and that are preferably aligned towards the inside in a concentric direction. At the same time, the flaps can protrude distally. For example, two or more flaps can converge at a common joining point at the distal end of the segment (c).
[0024] The angle formed by the filaments / loops in the direction of the longitudinal axis of the implant, in the implanted state, is situated between -45 ° and + 175 °, with a positive angle representing filaments / loops projecting radially towards the outside and a negative angle represents filaments / loops that project radially inwards. In the case of relatively regular bifurcated aneurysms, the angle is preferably located at + 45 ° to + 90 °, however, partially aneurysms also appear that present an irregular shape, being, in a special way, markedly asymmetrical. In such cases, it may be useful to use sharply divergent angles of the filaments / loops. For example, it may be useful to select a large angle when the wall in a region of the aneurysm is sharply arched in the direction of the feeder vessel. In such cases, angles> 90 ° are useful. In other cases, it may be convenient to let a part of the filaments / loops point inwards, that is, choose negative angles to provide an adequacy in the aneurysm wall. The angles that are formed by the different filaments / loops can vary, for example, in the case of asymmetric aneurysms it may be useful to provide some loops with angles> 90 °, while other loops have conventional angles in the range between 45 ° and 90 °. It is important that the mentioned angles are configured after implantation, and it should also be considered, depending on the invention, an implant in which, before implantation, possibly due to external coercion, the mentioned angles have not yet formed.
[0025] Angles that form the filaments / loops in the direction of the long axis of the implant can, for example, be located between -45 ° and 90 °, -45 ° and 0 °, 90 ° and 135 ° or 135 and 175 °.
[0026] The filaments / loops in segment (d) can be extensions of the wires or fillets that make up the remaining body of the implant, but it can also be about separate wire filaments that are fixed - for example, by laser welding - in the distal area of the remaining part of the implant body, that is, at the distal end of the segment (c). In this case, each wire / loop filament in segment (d) may be joined at one or several points of connection with the remaining part of the implant, especially also only a single or two points of connection may be provided for each loop / thread of wire.
[0027] According to an alternative modality, an implant will be made available for use in the occlusion of aneurysms in the region of vascular ramifications, especially bifurcated aneurysms, with a mesh structure, which - from proximal to distal - presents the segments (b) to ( d):
[0028] a fixing segment (b), with which the implant can be attached to the wall of the container,
[0029] a segment (c) permeable to the vascular branching region, and
[0030] a distal segment (d), in which the implant is expanded in relation to segment (b) and which is intended for the positioning of the aneurysm, with a separation zone arranged in the region of segments (c) or (c) which closes - at least partially - the neck of the aneurysm and the distal segment (d) is of spherical, mushroom, anchor or ellipse shape. Preferably, the distal segments (d) are not centrally connected in segment (c), however, in the peripheral direction. However, the divergent configuration of the distal segment (d) will be valid for all other aspects of the implant that have been mentioned in relation to the embodiment according to the invention.
[0031] In the aforementioned forms, these are alternatives, in accordance with which a broad segment (d) in the radial direction may also be configured. A spherical segment (d) can fit, for example, in a good way, on the internal walls of the aneurysm, because a regular bifurcated aneurysm often has essentially the shape of a sphere. In this case, it should be mentioned that, as a spherical shape in the sense of the invention, one should not only understand exact spheres, corresponding to the geometric definition, but also those that are configured as spheres, in accordance with the invention, must also be configured. divergent round, three-dimensional shapes. In some cases, the shape of segment (d) also looks like an ellipsoid, and it is also valid here that the presence of an exact rotational ellipsoid is not required to be valid as an ellipsoid shape in the sense of the invention. Other possibilities are segments (d) in the shape of mushrooms or anchors that adapt especially in the case of irregular aneurysms, for example, when the wall in a region of the aneurysm is sharply arched in the direction of the feeder vessel. This is ensured by the fact that in the case of a mushroom or anchor shape, some regions of segment (d) extend in the proximal direction. At this point, it should be clarified that a segment in the form of a mushroom or anchor may, specifically, also be asymmetrical, for example, it may present, on only one side, regions that extend in the proximal direction. As long as the segment (d) has a sufficient surface density, this segment can even configure the separation zone, and in this way, separate devices can eventually be dispensed with. The distal segment (d) can be sectioned by laser or also braided, and, preferably, 8 to 128 wires have been used.
[0032] The implants according to the invention can be produced from conventional materials for stents, for example, steel for clinical purposes or from cobalt chromium alloys, but especially from shape memorizing material, possibly nitinol or ternary alloys of nickel-titanium.
[0033] As already mentioned, an implant according to the invention, preferably at least in part, is sectioned from a tube, especially from a tube of a shape memorization alloy. The separation zone can also be disconnected from the tube.
[0034] The separation zone, provided for in the implant according to the invention, extends especially between segments (c) and (d), in this context, it should be noted that segment (c) - at least at its end distal - may be expanded in relation to segment (b), which will be of assistance when the bifurcated aneurysm has already occupied parts of the extravasating blood vessels. In this case, the section of the aneurysm inlet will have to be kept released into the branched bloodstream, so that the separation zone extends within the aneurysm itself. The already expanded area of segment (c) will then eventually converge on segment (d) with further expansion. Here, too, the separation zone is located between segments (c) and (d). In the case of a very flat configuration of the segment (d), the separation zone can also coincide with the segment (d).
[0035] The separation zone can be configured, on the one hand, by the insertion of fibers, threads, thin wires, a membrane or similar separating elements, but it can also constitute an integral part of the implant, in the sense that it is not a separating element , cut out of the basic tube and correspondingly deformed, or of separating elements, constituted by a braid of wires, possibly loops or fillets. In the case of loops or fillets, these point radially towards the interior of the implant lumen, contrary to loops of the distal segment (d) that - at least in most parts - point outwards. So that the loops / fillets, which point inwards, do not create obstacles in a reciprocal sense, it may be useful for them to be configured asymmetrically. The number may vary depending on the implant structure and the number of hives.
[0036] The threads forming the separation zone can be produced from a polymer material, for example, a polyamide such as nylon (polyhexamethylene adipinic acid starch). Metal production is also possible, with shape memorizing alloys being preferred, especially nickel-titanium alloys, such as nitinol.
[0037] Another possibility lies in providing in the separation zone a membrane that, in a broad or complete way, is impermeable to blood, thus uncoupling the blood flow aneurysm. As long as a broadly complex decoupling of the blood flow is achieved, an insertion of occlusion means in the aneurysm may be dispensed with, that is, in this case, the separation zone is not used for the retention of occlusive media. The membrane can be prestressed over a strand of wires or wires, for example, wires or wires can form a structure, on which the membrane is protected. In addition, other projection wires / wires are conceivable, for example, in a cross shape, and which form a cross of wires. Wires or wires, however, are not absolutely necessary, and prestressing in the separation zone without additional wires / wires is also possible.
[0038] Also in cases where a membrane is provided in the separation zone, it may, however, be advantageous to insert, in addition, occlusive media in the aneurysm. For this reason, it may be useful to use a membrane with one or more indentations for the separation zone, so that through the indentation it is possible to introduce occlusion means, especially spirals. The cutout should be of a size that allows a catheter to be advanced through the cutout to the aneurysm region, and through the catheter the means of occlusion will be introduced. On the other hand, the cutout should cover the neck of the aneurysm to such an extent that the means of occlusion cannot abandon the aneurysm in an uncontrolled way, when, eventually, wires / wires that excessively protect the separation zone, are fulfilling a function additional retainer. Naturally, in this case, the wires, that is, the wires, can extend only with such density that it is still possible to transfix a catheter and insert an occlusion means.
[0039] To insert means of occlusion inside the aneurysm, the membrane that excessively protects the separation zone can also be configured partially transfixable, and for transfixing a microcatheter or guidewire is typically employed. Through the opening, thus created, a microcatheter will then be conducted, through which the occlusion means will be inserted. The membrane must be constituted in such a way that - also after transfixation - it remains partially preserved, so that, through the membrane, the occlusion means continue to be prevented in extroversion. For example, wires or wires provided in the separation zone, which can be prestressed in the form of a cross of wires, have taken care to ensure that only one segment of the membrane forms an opening at the time of its transfixation, whereas the other segments of the membrane remain covered, because the marginal areas of the membrane will be stabilized by the wires / wires, so they are protected against breakage. In the case of the prestressed membrane over the separation zone, it may be a single membrane that will only be partially transfixed or it may also be several small membranes.
[0040] Instead, or in addition to the prediction of a membrane in the area of the separation zone, it may be useful to provide membranes within the loops (of wire) that form the segment (d). When membranes are provided in the separation zone as well as inside the loops, this will facilitate the fixation of the membrane.
[0041] The membrane does not need to be restricted to the separation zone and to the inside of the loops, but it can, in all, go beyond the separation zone and the loops, being that the loops can serve to fix the membrane. For example, membranes may be provided at the interstices between the loops.
[0042] Also when segment (d) consists, in whole or in part, of other filaments that are not loops, it is possible to provide membranes here. For example, one or more flap membranes that protrude radially outwards can be applied. In this case, the constitution will be similar to that of an umbrella, that is, in the expansion of segment (d), the expanding flaps are protected in continuous form or containing several membranes between them. By predicting several flaps and a corresponding number of flap tips, it is possible that the surface covered by the membrane becomes larger and similar to a circle, presenting a smaller number of large interstices.
[0043] For the delimitation and reinforcement of the membrane, prestressed threads can also serve between the different loops / filaments, that is, the membranes are at least partially limited laterally by one or more threads that interconnect the loops / filaments. In this case, the limitation of the respective membrane does not need to be done in all directions through a wire, and, for that, they can also partially serve the loops / filaments themselves. For example, the outer edge of the membrane, which is often also in a more distal position, may be bordered by threads with the inner margin showing loops / filaments. Compared with a membrane without lateral delimitation, additional protection of the membrane against damage and rupture is achieved in particular. The threads will be produced, preferably, of a polyamide, such as nylon.
[0044] An advantage of using a membrane in the area of separation zone should be seen in the fact that this membrane, when placing the implant in the catheter, joins closely in a distal or proximal direction, so that it will be provided an implant with a widely dense separation zone in the expanded state, and which, in the contracted state, also allows it to be transfixed through narrow blood vessels. In the rest, the constitution of the implant will be largely unchanged compared to an implant without a separation zone.
[0045] The membrane may be produced from a polymeric material, such as polytetrafluoroethylene, polyester, polyamides, polyurethanes or polyolefins. Especially preferred are urethane-polycarbonates. An integral connection of the membrane with the wires or wires that form the separation zone is especially desirable. This can be produced by immersing or spraying the wires / wires.
[0046] Preferably, the membrane will be produced in an electrostatic deposition process. In this case, fibrils, that is, fibers, are precipitated with the aid of electric current - from a polymeric solution - on a substrate. In this precipitation, the fibrils start to stick together, constituting a fleece. Normally, fibrils have a diameter of 100 to 3000 nm. Membranes obtained through the electrostatic deposition process are configured in a very uniform way and can cover a basic structure of wires or wires. The membrane can be ordered in ductile and mechanical form and can be mechanically transfixed, without the opening becoming a starting point for further breaks. The thickness of the fibrils - as well as the degree of porosity - can be controlled by choosing the process parameters. In connection with the creation of the membrane and the materials for this purpose, reference is made in particular to WO 2008/049380, DE 28 06 030 A1 and the literature mentioned there.
[0047] An implant is also advantageous, in which the separation zone is formed by a membrane attached to the internal side of the implant, and this membrane is also firmly joined with other external segments of the membrane that fill the different loops. A membrane structure of this nature can be produced with the electrostatic deposition process. The inner and outer layers of the membrane are, in this case, partially joined; at the point where the inner layer of the membrane does not have a union with the outer layer of the membrane, it contracts like a nylon stocking and forms, in this way, a separation zone that allows passage.
[0048] Instead of the electrostatic deposition process, the membrane can also be produced through an immersion process.
[0049] The membrane does not need to extend, in all cases, in an orthogonal plane to the longitudinal axis of the implant, but it can also present an alignment in the proximal direction. In this case, the membrane will be fixed in its marginal area around the circumference of the implant, however the central area of the membrane extends in a proximal direction. In this way, it results in a conical or pyramidal shape, with the base of the cone / pyramid orientated in an orthogonal direction towards the longitudinal axis and the membrane, in the marginal area, is united with the implant, while the apex of the cone / pyramid continues to be positioned proximally. The blood flow to fall on the membrane will, in this way, be divided and diverted laterally, so that the blood flow will be stopped, largely, in the aneurysm.
[0050] Also in the case of a conical / pyramidal shape of the membrane that forms the separation zone, it may have one or more indentations, so that - after the implant insertion - the occlusion medium can continue to be inserted through the indentation, inside the aneurysm,
[0051] In order to permanently preserve the formatoconic / pyramidal shape of the membrane, the membrane should be fixed in a wire or wire structure, and, mainly, it can also be treated with fillets that are cut out of the implant's constituent structure, for example, with the aid of a laser. In this case, it should be noted that the wires / wires are sufficiently rigid to avoid a modification or protuberances of the membrane due to blood pressure. Eventually for this purpose it will be necessary to insert additional wires or wires.
[0052] One possibility resides in forming a cross of threads of relatively long individual two threads, and in this cross the membrane is fixed, however due to the length of the individual threads, the membrane is initially not prestressed. One or more wires can, in addition, be fixed in a distant loop in the most proximal direction of the implant, so that the cross of wires and, therefore, the membrane, will be prestressed in the proximal direction as soon as the implant is stretched. Of course, it does not have to be just two wires that form the cross of wires, one can also imagine, practically, other random strands of wires that configure a basic structure modeling to apply a structure to the membrane.
[0053] In general, it is essential for the invention that the separation zone fulfills its function, which is to retain occlusion means introduced into the aneurysm, possibly occlusive spirals, this retention being reliably, that is, to deflect the blood flow in such a way that other means of occlusion become unnecessary. The separation zone extends in an orthogonal direction to the longitudinal axis of the implant, and the fibers, wires, wires, etc., that configure the separation zone, can be essentially positioned in a plane.
[0054] If the separation zone consists of the insertion of fibers, threads or thin wires, it will be convenient to arrange eyelets in the area of the separation zone. For example, the meshes of segment (d) can be configured with corresponding eyelets, in which the threads will be looped in the form of a cross or a star. The eyelets themselves can be produced from a fiber material. The yarns / fibers consist, for example, of a suitable polymer such as a polyamide (nylon) or may be metallic fibers.
[0055] But the separation zone may also be formed by arcs cut out of a tubular material or loops (wire), with the meshes of segment (d) being deformed to the outside and the arcs / loops of the separation zone are bent into the implant body. At least one bow / loop is required. In the case of two to four arcs / loops, these constitute a stable separating element that reliably retains occlusive media inserted in an aneurysm.
[0056] The loops may have a beehive shape. Upon implantation, the loops will typically be stretched proximally and rest against the other filaments of the implant, so that the implant can be moved, without problems, through a catheter. The separation zone, formed by loops, may leave openings in the form of cracks between the loops, by which means of occlusion can be inserted into the aneurysm. Alternatively, it is also possible to predict the loops / or interstices between the loops with a membrane, in order to produce the most dense separation zone possible. It is also basically possible to use membranes that have one or more openings.
[0057] The distal segment (d) of the implant according to the invention is especially atraumatic, soft and elastic in its configuration. The walls of aneurysms are sensitive and, when requested, can break, which will have to be avoided anyway. Correspondingly, especially the distal segment (d) of the implant, according to the invention, must be configured in an atraumatic way. This will be achieved, for example, with the arrangement of loops, which, at the points where they establish contact with the aneurysm wall, fit smoothly against this wall. These ties, as well as other regions of the implant, can be generated by laser cutting a tube, being produced through fixed wires, being laser welded, for example, with segment (c), or they can be produced from a braid of uniform wire. This transition zone produces a cover especially with the separation zone, but it can also present an expanded area of the segment (c), with the separation zone arranged distally.
[0058] In any case, it is important to configure in the segmentodistal (d) all the wire ends in an atraumatic way in order to avoid a perforation of the aneurysm wall.
[0059] In the distal segment (d), the meshes may end up as rounded arches, and especially at the distal end they may also show bumps (advances), which, of course, are also rounded and atraumatic. These projections have the effect that the implant, in its stretched form, can be moved inside the catheter in a simpler way, that is, with less use of force.
[0060] The implants according to the invention can - in all their extension - take the form of a laterally closed tube, formed from the mesh structure, however, they can also be split laterally, in partial or continuous direction. The slits can project in an axially parallel direction or in an oblique / helical direction. In such a case, in the cracked areas the mesh structure is wavy, corresponding to the shape of the vessel, possibly having the shape of a wavy segment of a mesh wire fence. When implanting a cleft implant in this way, this allows for a good fit to the lumen of the vessel, especially of the feeder vessel, and it is not usually problematic to reduce the lower or upper concealment of the lateral edges of the mesh structure.
[0061] It is possible, for example, a partial crack formation that determines in the distal segment (d). Crack formation in this way allows for a good fit to the vessel configuration, especially in the region of segments (a) to (c) and therefore results in a good fixation of the implant in the vessel. It has been surprisingly demonstrated that the formation of cracks does not need to have a negative influence on the radial force.
[0062] It is possible to provide at least some implant loops with interruptions, that is, the loops, in part, are not fully closed. An open cell design of this type has greater flexibility, which can be advantageous in the case of markedly undulating blood vessels. In addition, the absence of fillets / flaps produces an improved blood flow in the vascular branching region. Nevertheless, the advantage of greater flexibility results in that an implant of an open cell design can be retracted more deficiently in the microcatheter when this is necessary in the introduction. For this reason, in the case of a modality of this form, proximal coupling in an introduction aid on segment (a) may be dispensed with. An alternative introducer system, for example, can be configured in such a way that the implant radially compressed in the microcatheter, is positioned on a wire between two cams and when removing the micro catheter it expands automatically, thus separating itself from the system. introducer.
[0063] The implants according to the invention usually have dense elements of x-ray marks that facilitate visualization and positioning at the implantation site. These brand elements are, for example, arranged in the region of the distal end of the segment (d), and in the case of joined wires, they can deform the connection points in atraumatic form. These brand elements can also be present in the form of coiled wire, as linings and as slotted tubular segments that can be clipped onto the implant, for example, in the transition area of segment (c) and (d) or in the loops of wires of segment (d). For the elements of the marks are considered as materials especially platinum and platinum alloys, for example, an alloy of platinum and iridium as has been used widely in the state of the art for the purpose of providing marks or as material for occlusion spirals. Ideally, the distal segment and especially the loops / filaments, are partly or totally watertight at x-ray, that is, they are configured visible by x-ray.
[0064] It is also possible to insert substances visible on x-rays into the membranes. In this case, it is possible to deal with particles visible in the x-ray as they are commonly used in the x-ray technique, in the form of contrast. These X-ray-proof substances are, for example, heavy metal salts, such as barium sulfate or iodine compositions. The x-ray visibility of the membrane is an aid in the insertion and location of the implant and can be used as an additional feature or instead of brand elements.
[0065] Eventually, a part of the hives of the implant may be formed with fillets with a thinner cross section, in order to increase the flexibility of the implant. This area will be located, preferably, in segment (b) and should take into account an irregular path of the blood vessel in the fixation area.
[0066] The implants do not need to have a tubular structure, but they can also be present as rolled "mats" that expand against the vessel wall. Partial crack formation is also possible.
[0067] Finally, the invention covers an implant according to the previous description, which is coupled to a conventional guidewire. This coupling can be done, for example, through connector elements that dissolve electrolytically in the application of the electric current. These connecting elements and materials are described in many ways for the separation of occlusion spirals and stents. Mechanical separation of the coupling elements is also perfectly possible, the coupling elements cooperating with correspondingly suitable coupled parts of the guidewires. Under the external force of a catheter or an envelope, this connection remains intact; after the outward displacement (extroversion) of the implant and the point of coupling of the catheter or envelope, the connection separates, however, and releases the implant with the coupling elements belonging to the implant.
[0068] The invention also covers the positioning of the implants according to the invention in the blood vessel system. This can be done with the aid of a conventional catheter or a microcatheter; this technique, in general, has already been tested and has been widely used. If the separation zone, specifically, does not provide sufficient sealing of the aneurysm neck, then after the implant placement, occlusion means will be inserted into the aneurysm. For this, the distal end of a microcatheter is transfixed by the separation zone inside the aneurysm and the occlusion means, especially spirals, will be released. Then, the microcatheter will be retracted, but the means of occlusion will be inhibited by the leakage of the aneurysm implant. In addition to conventional occlusion means, such as spirals, bodies of a different configuration can also be applied for aneurysm occlusion, for example, spherical or otherwise shaped spherical bodies.
[0069] The invention will be explained in more detail by the attached Figures. The Figures show:
[0070] Figure 1 is a principle sketch showing an aneurysm bifurcated;
[0071] Figure 2 schematically, an implant according to the invention, implanted in the region of a vascular branch with a bifurcated aneurysm;
[0072] Figure 3 on the implant according to the invention with its sections, in a presentation of principle;
[0073] Figure 3 Another presentation of the implant principle according to the invention;
[0074] Figure 4 an implant according to the invention as it can be used according to the Figure. two;
[0075] Figure 5variables for segment (d) of an implant according to the invention;
[0076] Figure 6 a preferred embodiment of an implant according to the invention, expanded in a spatial sense;
[0077] Figure 7a an implant according to the invention with distal loops-shaped segments (d) in a view from the distal position;
[0078] Figure 7bo implant according to the invention, from Figure. 7a, in a side view;
[0079] Figure 7 of an implant according to the invention, with a membrane in the separation zone that extends in the proximal direction,
[0080] Figure 8Other variants of an implant according to the invention, with distal (d) loop-shaped segments;
[0081] Figure 9 bifurcated aneurysm with lateral vessels that seramify the aneurysm area and with an implanted implant, according to the invention;
[0082] Figure 10 in an expanded spatial form, implant variants according to the invention;
[0083] Figure 11 Another variant with arcs in segment (d) facing in and out;
[0084] Figure 12 Another variant with connectors articulated in the segment (c);
[0085] Figure 13 Another variant of an implant according to the invention, with increased flexibility;
[0086] Figure 14 alternative modalities of an implant according to the invention;
[0087] Figure 15 different variants of the implant according to the invention, in lateral view and in frontal view;
[0088] Figure 16 Another variant of the implant according to the invention, in lateral view and in frontal view;
[0089] Figure 17Other variants of the implants according to the invention, in an expanded spatial form and
[0090] Figure 18 Another variant of the implant according to the invention, in frontal view.
[0091] Figure 1 shows a bifurcated aneurysm with an adductor Z vessel, two overflow X and Y vessels, as well as an A aneurysm integrated in the bifurcation. The long arrows represent the blood flow that enters the side of the shock inside aneurysm A, where it exerts pressure to the outside, under which the aneurysm expands (small arrows).
[0092] Figure 2 shows a constellation of vessels with anneurism A, as described in figure 1, with an implant 1 disposed there, according to the invention. The implant has a proximal end 2 that contains the coupling element, converging, before separation, in the guidewire (not shown). Implant 1 is anchored through its meshes 3 in the wall of the adductor Z vessel and presents - in the region of the bifurcation - meshes 4 with a greater mesh width. A distal region 5 is shown on the neck of the aneurysm. Between the distal region 5 and the region with the expanded meshes 4, there is a separation zone for the retention of occlusion media, introduced in aneurysm A after the insertion of the implant.
[0093] The enlarged meshes 4 in the bifurcation region allow the blood flow, fed through the Z vessel, to flow through the X and Y branches without encountering major obstacles. After the application of occlusion means not shown here in aneurysm A, the flow of blood will encounter such difficulties in aneurysm A that there is the conformation of a stopper and, therefore, the paralysis of the aneurysm. Alternatively, occlusion occurs without means of occlusion, as long as the separation zone is sufficiently dense.
[0094] Figure 3a shows, schematically, an implant according to the invention and its subdivision into different segments.
[0095] Implant 1 has a segment (a) proximal, in which the implant is narrowed, ending in a coupling element, presented here as wire. This segment corresponds to region 2 in figure 2.
[0096] The segment (b), which serves to fix the implant on the wall of the adductor Z vessel, follows distally. This region has 3 meshes with a relatively narrow mesh width that produces good contact with the vessel wall.
[0097] In distal form follows segment (c), which presents meshes 4 with a relatively large width. This region is intended to release blood in flow to the X and Y branches, as shown in figures 1 and 2.
[0098] The distal end of implant 1 is the segment (d) where structure 5 seals, in the case shown in the form of a trumpet. This region becomes located in aneurysm A. Segment (d) may be an integral component of the implant, that is, it may have been cut from a tube together with segments (a) to (c) or it may be braided from these wires. . But it is also possible to section the segments (a) to (c) of a tube, braiding the segment (d) and welding it with the segment (c).
[0099] Between segments (c) and (d) the separation zone T1 is shown, which presents one or more separating elements 6. With respect to these separating elements, it can be prestressed threads, wires or fibers, possibly polyamide , but also parts of a sectioned structure that have been deformed to the inside. This separation zone T1 with the separating elements 6 serves to retain, in an aneurysm, occlusion means positioned inside it.
[00100] Depending on the type of aneurysm, the separation zone may also be displaced in segment (d) or may even be located at the distal end of the segment (d). A T2 separation zone of this species will be especially useful when the bifurcation is so modified that the branched Z and Y vessels do not branch directly from the adductor Z vessel, but do branch from the aneurysm. In this case, the separation zone should be located immediately above the branches, in the expanded segment of the implant. Segment (d) is restricted to the distal end of implant 1 and converges at the separation zone T2.
[00101] Figure 3b is a presentation of the implant according to the invention that corresponds, essentially, to the presentation of figure 3a. In addition, it is recognized that the loops 12, here only schematically reproduced, can configure different angles in relation to the longitudinal axis of the implant 1. The longitudinal axis is shown with a dashed line. The angle β can be quite large (> 90 °, shown in dashed form), which is especially advantageous in aneurysms with strong arching, with the arching projecting at least partially in the proximal direction. In extreme cases the angle β can be almost 180 °. In this way, a good adjustment of the distal segment (d) in the aneurysm wall is achieved.
[00102] In other cases (also shown in dashed form) it may be advantageous if the β angle is negative, because a part of the aneurysm wall is curved inward. It is important that the angles for the different loops (12) / filaments can be different, which is of great advantage in aneurysms of irregular conformation.
[00103] In addition, it can also be seen in figure 3b that the proximal end 2 of the segment (a) where the implant ends in coupling wires, through which the implant is joined with the introducer aid, presents an angle α in relation to the longitudinal axis of the implant. This angle will eventually be formed only after implantation. In this way, an improved expansion of the implant and the shoulder on the wall of the blood vessel are encouraged. Unwanted penetration into the blood vessel will be avoided.
[00104] Figure 4 shows an implant 1 according to the invention as it can be used according to figure 2. The implant 1 is shown with a guide wire 9 and has, at its proximal end 2, a dense mark 7 spiral for X-ray. One or several coupling elements, through which the guidewire 9 is connected with the implant, are not shown, however, are located in the region of the spiral of mark 7.
[00105] The implant shown is a braided individualized wire that preferably consists of nitinol and in which the final shape of the implant is applied. Nitinol, as a shape memorization material, allows you to conduct the implant in a compressed form in a catheter without losing the profile. After the catheter is released, the implant takes the form that was applied to it, so that it can fulfill its purpose of use.
[00106] Implant 1 is subdivided into four segments (a) to (d), with segment (a) representing the proximal segment that narrows and converges at the proximal end 2, ending in one or more coupling elements. Segment (b) is a fixation segment that is positioned on the wall of the adductor Z vessel. Segment (c) is configured in a permeable form with 4 meshes, through which blood flow can overflow into the branched vessels X and Y. Segment (d) in relation to segment (b), and here also in relation to segment ( c), is expanded and starts to be positioned in aneurysm A. The ends of the different wires are atraumatically remodeled by spirals of marks 8 from dense material for x-ray, possibly platinum or platinum alloy. Between segment (c) and (d) there is a braid of fibers 6 which can be produced, for example, from nylon and which, simultaneously, represents the separation zone T1. Reference number 5 refers to meshes, that is, filaments, which expand to the outside, belonging to the implant in the distal area.
[00107] Figure 5 shows, as a basic outline, four variants of the configuration of the distal region 5 of implant 1, according to the invention. Figure 5a shows a distal end that expands in the shape of the trumpet of the implant, that is, the segment (d) expands in the form of a chalice. According to figure 5b, the distal end 5 is expanded in disc shape with a distal segment (d) limited in very narrow form. Figure 5c shows a combination of the design elements of figure 5a and 5b.
[00108] Figure 5d finally shows a distal area with distal ends curled from the different filaments of implant 1. For orientation, in figure 5a, that is, 5b, the segments (a), (b), (c) are drawn.
[00109] Figure 6 shows, in an expanded spatial form, a preferred embodiment of an implant 1 according to the invention, with segments (a) to (d). Implant 1 should be understood as having been sectioned, in a mesh structure, from a nitinol tube, with the presentation of the 11 fillets in dashed form corresponding to the fillets extended on the opposite side. One can clearly recognize the hives enlarged in the region of the segment (c) in the presentation of figure 6a, as well as the expansion in calyx or trumpet format in the basic outline of figure 6b. There, the separation zone T1 is also shown with separating elements in the form of a contracted plane of nylon threads 6.
[00110] Figure 7a shows an embodiment of the implant according to the invention, in the distal view. The distal segment (d) is formed by loops 12 which are radially expanded outwards. The separation zone 6 will be formed by a plane from polymer threads or metallic fibers that prevent occlusion means, introduced into the aneurysm, from being able to overflow. Circle 14 symbolizes the transition in the cylindrical part of the implant. In addition, the loops have dense x-ray mark 13 elements.
[00111] The separation zone 6, that is, the region presented in a frame framed in the chosen presentation, and / or loops 12, may, in addition, have a membrane that effectively blocks the flow of blood in the aneurysm. This membrane may be attached to the polymeric wires or metallic fibers, as well as to the wires of the loops 12, especially polymer wires or metallic fibers may also be embedded in the membrane. The membrane can consist, for example, of urethane-polycarbonate, being produced through electrostatic deposition.
[00112] In figure 7b, implant 1 of figure 7a is shown from the side. In the distal region, several loops 12 that have elements of marks 13 can be known. In addition, the entrance to the aneurysm is blocked by the separation zone 6, which may be polymeric threads, woven in an interlaced or reciprocal form. , or it may be metallic fibers that prevent the extravasation of occlusion media, inserted in the aneurysm. It is also possible to provide loops 12 and / or the separation zone 6 with a membrane that separates the aneurysm, to a large extent, from the blood flow. In this case, occlusion means may eventually be dispensed with in the aneurysm. Finally, at the proximal end, implant 1 has a dense x-ray mark 7 element.
[00113] Figure 7c shows, finally, another modality with a membrane 24 in the separation zone 6, with the membrane 24 showing a projection in the proximal direction. The membrane 24 can be especially conical or pyramidal, with the apex of the cone / pyramid positioned proximally. To reinforce a membrane of this type, it will be useful to reinforce the membrane 24 with threads, wires or threads of the implant that hold the membrane 24 in the desired position.
[00114] Figure 8 shows an implant 1, according to the invention, with a configuration closer to a plate in segment (d) which is essentially made up of wire ties 12. The wire ties follow the cylindrical part of the body of implant 1, this cylindrical part being formed by the segments (a) to (c). In the area of the transition to applied loops 12 there are elements of marks 8 that serve for safe positioning. In the region of this union of the cylindrical body of the implant and of the segment (d) with the loops 12, there is the segment (c) that allows the outflow of the inflowing blood to the overflow vessels laterally. The blood therefore penetrates between the fillets with elements of marks 8 in the overflowing vessels (X and Y, figure 2).
[00115] Different variants of the distal segment (d) are shown in top view in figure 8b to 8g, with some or several loops 12 having mark 13 spirals. Mark 13 spirals may involve the loops totally or partially. In the case shown, the loops project from four connecting threads 15 that also support the elements of marks 8, and in the presentations 9b to 9g, the inner circle 14 represents the passage to the cylindrical part of the implant. Any existing supports from a T1 or T2 separation zone are not shown.
[00116] The modalities according to Figures 8f and g - show with a ductile membrane 16 - different loops 12 that, in this case, simultaneously configure a separation zone T2, as shown in figure 3. Figure 8f presents, in addition, that loops 12 can be joined through only one connection point with the other regions of the implant; this is true regardless of whether loops 12 have a membrane 16.
[00117] It is understood that the separation zones T1 and T2 must separate the occlusive segment of the aneurysm A. According to the type of aneurysm, this separation zone will then be provided in the entrance area - in the case of branched vessels which protrude proximally to the entrance region - or also into the aneurysm - when two vessels branch directly from the area of the aneurysm - in the latter case, only the part of the aneurysm that is free of branched vessels may be obstructed. Especially in the case of segments (d) of the implants, according to the invention, distal and configured in the form of a plate, in particular in the case of a greater number of wire loops, an additional support or an arrangement of separating elements may be unnecessary, sectioned from the tube.
[00118] The distal segments (d), shown in figure 8, in the form of loops, can, on the one hand - as well as the remaining part of the implant body - be sectioned from a tube with a suitable diameter. But, it is also possible to section the segments (a) to (c) of the implant body of a tube in the conventional way and shape, securing the segment (d) of wire filaments, for example, in a laser welding process .
[00119] Figure 9 presents the special case of an aneurysm A, in which the branched X and Y vessels depart from the aneurysm itself. For this hypothesis, the implants 1 described in figure 8 are especially adapted, in which the loops 12 simultaneously form the separation zone T2, integrated in the aneurysm itself in the distal direction of the branched vessels. The cylindrical body of implant 1 with segments (a) and (b) is located in the adductor vessel Z, segment (c), which allows blood to pass through the X and Y branches, is located in the region of this branch and, in the indirect distal direction of this segment (c), there is the segment (d) with the loops 12. The loops can be flexed with a membrane, and this membrane consists of a ductile material, for example, Teflon, or a fiber fleece. A fiber fleece of this type of urethane-polycarbonate became known in document DE 28 06 030 and stands out for the high elasticity that is favorable for the application of the implant through a catheter. The membrane can be split, folded or porous in its configuration, for example, also to save material and to facilitate transport through a catheter.
[00120] A membrane of this type can also be used as a separation element for the separation zone, as it is arranged between the segments (c) and (d).
[00121] Figure 10 shows, in an expanded spatial form, several preferred modalities of an implant 1 according to the invention, in which the hive structure is configured by essentially large hives of identical extension; being that only the distal loops have a larger hive face.
[00122] As shown in figure 6a, the fillets 11, shown in dashed form, correspond to the filled fillets on the opposite side. Implant 1 therefore corresponds to a tube with a grid or honeycomb structure.
[00123] The coupling element 10, arranged in a proximal direction, is followed by the proximal segment (a), and then by the fixing segment (b). The distal segment (d) begins in the region of the eyelets 17, which serve to receive and fix wire or nylon elements, with which the implant will be pulled into a separation zone. The distal loops in the segment (d) that expands to the outside, present, in the distal direction, projections that have proved to be advantageous in the introduction of the implant through a catheter at the place of use.
[00124] Figure 10b corresponds, in all essential points, to the presentation of figure 10a, except for a partial crack in the region of arrow 19, where the tubular structure of implant 1 is not closed. The slit extends in an axially parallel direction and ends before the distal segment (d), at the point where the permeable segment (c) is located.
[00125] Figure 10c shows a variant with a slit 19 of non-axially parallel projection, which coils around the longitudinal axis, but also ends in front of the distal segment (d).
[00126] These slits proved to be very advantageous for flexibility in the region of the fixation zone (b). The radial force of implant 1 will thus not be essentially impaired, however, the suitability for the vessel path and the vessel lumen will be improved.
[00127] Figure 10d also shows an implant, according to the invention, however, the slit does not extend to the edges of the implant.
[00128] Figure 10e shows another variant with a slit 19 that also wraps around a longitudinal axis, although there are, however, forms of adjacent hives. The shape of the hive has an influence on flexibility and can be chosen according to needs.
[00129] The loops, that is, the hives of the distal segment (d) are designated in figure 10 with the reference number 12.
[00130] Figure 11 shows another variant of an implant 1 according to the invention, with a single coupling element 10 and an essentially regular honeycomb structure, in which, as separator elements, additional loops are provided 20. The additional loops 20 , in the implanted product, are turned inwards and constitute the separation zone T1. These loops 20 also have shoulders 18 that facilitate transportation through a catheter.
[00131] Figure 11b shows, schematically, the implant of Figure. 11a with loops 20 facing inward and with the separation zone T1.
[00132] Figure 12 shows another variant of an implant 1, especially flexible, with articulated connectors 21 in the form of a zigzag projection of the corresponding fillets to improve the suitability of implant 1 in curved projection vessels in the bifurcation region.
[00133] Figure 13a shows another variant, in which, as before, the fillets 11, drawn in dashed form, correspond to the fillets in solid lines on the opposite side. This modality stands out for the fact that the hive structure is partially transfixed, that is, some hives show interruptions 23, that is, spans. It is possible to provide all hives with interruptions 23, however, in the present case, only a few hives have an interruption 23. In addition, it is possible to vary between segments. In the presentation chosen here, only the hives in the segment (c), however, not the hives in the segment (b), present interruptions 23. At the proximal end, the implant 1 is connected through a coupling element 10 in the introducer aid.
[00134] In view of the problem of a retraction in the catheter of an implant 1, provided with interruptions, it may also be possible to dispense with the junction of the implant in coupling elements at the proximal end. Such a modality is shown in figure 13b. Implant 1 can expand automatically when it is expelled from the microcatheter.
[00135] Figure 14a shows a modality of an implant 1 according to the invention, which stands out for a special configuration of the distal segment (d), which is configured as a sphere formed of different wires or filaments. From the proximal end 2 of implant 1, segments (a) through (c) are configured as described above. Between the segment (c) and (d) there is the separation zone T1 with locking elements as already described above. Instead of a closed sphere, an open basket in the distal direction may also be used for segment (d) for the sphere or for the basket, a braided structure is preferred.
[00136] Figures 14b and c show other alternative modalities for the distal segment (d) that can be designated as having a spherical or mushroom shape, the shape not having to be regular. Especially the shape according to figure 14b differs from a perfect circle, however, it is able to fit well on the inner wall of the vessel. The modality chosen in figure 14c is adapted, in particular, for aneurysms of unusual conformation, in which the side walls are markedly arched and partially extend in the proximal direction.
[00137] Figure 15 shows a complete series of different embodiments of implant 1 according to the invention, in side view, as well as in a distal view, in which membranes 16, 24 are provided. The membranes 16 fill the interior of the wire loops 2, the membrane 24 forms (partly) the separation zone 6, the different membranes 16, 24 may converging each other or it may be a membrane covering different wire loops 12, the separation zone 6 and eventually other regions. The region, provided with a membrane 16, 24, is shown in a dotted shape. As can be recognized, it is also possible for regions outside the wire loops 12 to be covered with the membrane.
[00138] It can be recognized that there are modalities according to the invention, in which only the wire loops 12 have a membrane, while the separation zone 6 is formed by interlocking wires / wires. In addition, the separation zone 6 may also have a membrane 24, this membrane being supported by a wire structure, but this is not absolutely necessary. The inner face of the wire loops 12 can be filled, totally or partially, with the membrane 16.
[00139] Especially, modalities are also viable, in which the membrane 24 that configures the separation zone 6, has openings 25, so that the membrane 24 is sufficiently dense to prevent the extravasation of occluding means, however, on the other hand, a microcatheter can be inserted into the aneurysm through opening 25 in order to position the occlusive media there. Provided that in the region of the separation zone 6 there are also wires / wires that intertwine, there must be a sufficient interstice to allow the passage of a catheter.
[00140] Figure 16 shows a similar form of an alternative embodiment of implant 1 according to the invention, in which the membrane 24, which configures the separation zone 6, is aligned in a pyramidal direction in the proximal direction. In this way, it can be achieved that the blood flow is removed laterally, that is, from the aneurysm that is in a centralized position. The membrane 24 is maintained by a wire structure that has a proximal fixation of the separation zone 6, in order to produce, in this way, the pyramidal shape. As soon as implant 1 is pulled into a catheter, membrane 24 will also be pulled more proximally and fold, which is accompanied by reduced cross-sectional stress. Notwithstanding a sufficiently dense separation zone 6 in an expanded state, an implant 1 will be created in this way that can be maneuvered smoothly through a suitable catheter.
[00141] Figure 17 finally presents a modality, in which - similar to figure 11 - the separation zone 6 is formed by wire loops 20 that protrude into the internal compartment. As a presentation, an open implant structure was selected, in side view. In the presentation two wire loops 20 are shown that project towards the interior, basically, however more wire loops 20 can also be provided. The wire loops 20, in the same way as the wire loops 12 that project in the direction distal to the outside, they have a membrane 16, 24 which in the region of the separation zone 6 contributes to additionally increase the tightness. In the variant in figure 17b, in addition, interstices between wire loops 12 are also provided, having a membrane 16.
[00142] In figure 18 a front view of another embodiment according to the invention is shown. The presentation is similar to the one chosen in figure 15, however, instead of loops, there are provided here flaps 26 that project in a radial direction to the outside and that conform the segment (d). The flaps 26 converge concentrically, with two flaps 26 always constituting a unit, having a common origin at the distal end of the segment (c). The flaps 26 also serve to protect a membrane 26, 24, shown in a dotted shape, which extends both over the internal area of the separation zone, as well as over the interstices between the flaps 26. An additional stabilization can be verified by a wire structure 6 in the separation zone, but which is not absolutely necessary. However, the wire structure 6 facilitates a transfixation of different segments of the inner membrane 24, while at the same time, other regions of the membrane 24 remain in an undamaged state, so that occlusive media can be inserted into the aneurysm.

权利要求:
Claims (13)
[0001]
1. Implant with a mesh structure (3, 4) for occlusion of aneurysms in the region of vascular ramifications, particularly bifurcated aneurysms (A), and from a proximal to distal position, it presents the segments (b) to (d) , (b) a fixation segment, with which the implant can be attached to a vessel wall, (c) a permeable segment to the region of the vessel branch, and (d) a distal segment, in which the implant is radially widened in relation to segment (b) and which is intended for positioning in the aneurysm (A), and in the region of segment (c) or (d) a separation zone (T1, T2) is provided that closes, at least partially, the neck of the aneurysm, the distal segment (d) being provided with a variety of filaments and / or loops (12), joined with the segment (c), and the filaments / loops (12) form an angle between - 45 ° and + 175 ° in relation to the longitudinal axis of the implant (1), with a positive angle representing filaments / loops (12) that extend in the direction radial towards the outside, and a negative angle represents filaments / loops (12) that project in a radial direction towards the inside, and the separation zone (T1, T2) presents one or more membranes (24), characterized by the fact that that either the membranes (16) fill the inside of the loops (12) and are arranged in the spaces between the loops (12) or the membranes (16) extend between the filaments.
[0002]
2. Implant according to claim 1, characterized by the fact that, which is applied in an orthogonal direction to the longitudinal axis of the implant (1).
[0003]
3. Implant according to claim 2, characterized by the fact that the membrane (24) is attached to filaments (6) that are in the separation zone (T1, T2).
[0004]
4. Implant according to any one of claims 1 to 3, characterized by the fact that the membrane (24) extends in a proximal direction and, preferably, forms a spherical or pyramidal shape.
[0005]
Implant according to any one of claims 1 to 4, characterized in that the membrane (24) has one or more openings (25), or in the membrane (24) one or more openings can be produced through transfixation.
[0006]
6. Implant according to any one of claims 1 to 5, characterized in that the filaments / loops (12) form, in the direction of the longitudinal axis of the implant (1), an angle between + 45 ° and + 90 ° .
[0007]
7. Implant according to any one of claims 1 to 6, characterized by the fact that the filaments / loops (12) have eyelets (17) in the distal segment (d).
[0008]
8. Implant according to any one of claims 1 to 7, characterized by the fact that the filaments / loops (12) of the distal segment (d) have projections (18) at the distal end.
[0009]
9. Implant according to any one of claims 1 to 8, characterized by the fact that the filaments / loops (12) are fixed through connection points, especially one or two, in the segment (c).
[0010]
10. Implant according to any one of claims 1 to 9, characterized by the fact that the implant (1) proximal to segment (b) has a segment (a), with segment (a) being a proximal segment that narrows and within which the mesh structure (3, 4) is joined in the form of one or more coupling elements (10), preferably coupling wires.
[0011]
11. Implant according to claim 10, characterized by the fact that the coupling elements (10) are eccentrically joined in the circumference of the implant (1) in its expanded form.
[0012]
12. Implant according to claim 11, characterized by the fact that the coupling elements (10), preferably coupling wires, form, in the direction of the longitudinal axis of the implant (1), preferably between 0 ° and + 60 °, preferably + 10 ° to + 30 °, with a positive angle representing coupling elements (10) that project outwards.
[0013]
13. Implant according to any one of claims 1 to 12, characterized in that the separation zone (T1, T2) has filament separating elements (6) that extend in an orthogonal direction to the longitudinal axis of the implant ( 1), preferably, essentially, in a plane.

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同族专利:

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公开号 | 公开日

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AU2013304936B2|2017-11-30|

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EP2887887A1|2015-07-01|

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AR092203A1|2015-04-08|

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CA2882216A1|2014-02-27|

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CN104736071A|2015-06-24|

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CA2882216C|2021-05-04|

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KR20150048171A|2015-05-06|

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CN104736071B|2018-09-28|

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JP6533463B2|2019-06-19|

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EP2887887B1|2021-12-29|

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法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2019-11-19| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-03-02| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 22/08/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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DE102012016555.2|2012-08-22|

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DE102013006503.8|2013-04-16|

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