WO2019174991A1

WO2019174991A1 - Temporary sealing of aneurysm necks

Info

Publication number: WO2019174991A1
Application number: PCT/EP2019/055548
Authority: WO
Inventors: Pervinder BHOGAL; Hans Henkes; Hermann Monstadt; Ralf Hannes
Original assignee: Phenox Gmbh
Priority date: 2018-03-12
Filing date: 2019-03-06
Publication date: 2019-09-19
Also published as: DE102018105679A1

Abstract

The invention relates to a kit for treating aneurysms, comprising a sealing device (1), which has an expanded state, in which it is temporarily released in the blood vessel, and a compressed state, in which it is inserted into and removed from the blood vessel, wherein: the sealing device (1) has a substantially cylindrical section (2) made of ribs (4) which form a plurality of openings (5) distributed over the lateral face of the cylindrical section (2); the sealing device (1) is connected to an insertion aid (7); the substantially cylindrical section (2) has a membrane (6) covering at least some of the lateral face; and the sealing device (1) forms a penetrable channel in the axial direction. Said kit also comprises occlusion means, which can be introduced into the aneurysm through a microcatheter, and a microcatheter, which is used to introduce the occlusion means into the aneurysm. The system according to the invention prevents the occlusion means from slipping out of the aneurysm and also cuts off the aneurysm from the blood flow while maintaining the blood flow in the main vessel.

Description

Temporary occlusion of aneurysmal necks The invention relates to a system and method for treating aneurysms, wherein occlusion agents are introduced into the aneurysm and prevented from escaping the aneurysm neck during insertion.

Aneurysms are usually bag-like or fusiform (fusiform) expansions of the vessel wall, which arise primarily at structurally weakened sites of the vessel wall by the constant pressure of the blood. Accordingly, the vessel inner walls of an aneurysm are correspondingly sensitive and prone to injury. The rupture of an aneurysm usually leads to significant health problems, in the case of cerebral aneurysms to neurological deficits to the death of the patient. In addition to surgical procedures in which, for example, the aneurysm is clamped by means of a clip, in particular endovascular methods for the treatment of aneurysms are known, with two approaches being pursued in the first place. On the one hand, the aneurysm can be filled with occlusion agents, in particular so-called coils (platinum spirals). The coils promote thrombus formation and thus provide closure of the aneurysm. Second, it is known to close the access to the aneurysm, such as the neck of a berry aneurysm, from the blood vessel side by stent-like implants and decouple the blood flow. Both methods serve to reduce blood flow into the aneurysm and thus pressure on the aneurysm, ideally to eliminate it and thus to reduce the risk of rupture of the aneurysm. When filling an aneurysm with coils, it may be the case that the filling of the aneurysm is insufficient, allowing the supply of blood into the aneurysm and thus a continuing pressure on the inner wall. The danger of a continuous enlargement of the aneurysm and finally its rupture persists, albeit in a weakened form. In addition, the treatment method is primarily suitable for aneurysms with a relatively narrow neck - so-called berry aneurysms - because otherwise there is a risk that the coils from a wide Aneurysmahals protrude into the blood vessel and thrombogenize there, which can lead to occlusions in the vessel. In the worst case, a coil is completely flushed out of the aneurysm and closes vessels elsewhere. Besides coils, other occlusion agents have also been described, for example in WO 2012/034135 A1 or WO 2017/089451 A1. In these, the occlusion means is composed of several subunits.

Another intravascular treatment approach relies on so-called flow diverters. These implants are similar in appearance to stents used to treat stenosis. However, since the task of the flow diverter is not the keeping open of a vessel, but the occlusion of the aneurysm access on the side of the blood vessel, the mesh size is comparatively narrow. A disadvantage of these implants is the risk that outgoing side branches in the immediate vicinity of the aneurysm to be treated sometimes covered and thereby closed medium or long term. Another disadvantage is that the use of a flow diverter usually the permanent intake of platelet aggregation inhibitors is unavoidable. As already mentioned, the occlusion of an aneurysm through the introduction of occlusion means involves the risk that it will partly exit the aneurysm and bring about the occlusion of a blood vessel in other regions of the blood vessel system. This danger exists especially with relatively wide-necked aneurysms. For this reason, it is known from the prior art, after inserting a microcatheter into the aneurysm, through which the occlusion means are introduced, to temporarily insert a balloon into the blood vessel, place it in front of the aneurysm neck and expand it. In this way, the balloon effectively prevents the escape of occlusive agents from the aneurysm. If enough occlusive agents, in usually coils, were introduced into the aneurysm, these interlock and thus interfere with each other at the exit from the aneurysm, ie after complete backfilling of the aneurysm is usually no further coverage of the aneurysm neck by the balloon needed. The balloon can thus be deexpanded and removed. This technique is also referred to as jailing.

The problem with this method is that the balloon prevents blood flow to more distal regions. This is especially important in intracranial applications because u. U. important brain regions are temporarily cut off from the blood flow. In order to keep the effects as low as possible, the treating physician must introduce the occlusion agents as quickly as possible, d. H. he is under considerable time pressure. Alternatively, the balloon may at least partially be prematurely deexpanded, but this, in turn, involves the risk that coils or parts of coils may protrude from the aneurysm or even migrate into the main blood vessel. An alternative to the use of balloons is to place a stent in front of the aneurysm neck, in addition to inserting coils into the aneurysm, to prevent the coils from exiting the aneurysm. This has the advantage, compared to the use of a balloon on the one hand, that the blood flow in the main blood vessel is maintained and no (brain) regions are uncoupled from the blood flow. However, as long as no definitive occlusion of the aneurysm is established, blood continues to enter the aneurysm. Now, if the introduction of coils causes injury to the aneurysm wall or even rupture of the aneurysm, the continued blood flow will cause the blood to seep out of the aneurysm into the surrounding tissue. Again, this is particularly problematic in intracranial aneurysms because the infiltration of blood into the surrounding brain tissue can cause serious consequences. The only option left to the treating physician in such a case is to try to close the aneurysm as quickly as possible by introducing many coils and stopping the bleeding in this way. Again, however, this is associated with considerable time pressure for the doctor and uncertain outcome.

The described risk of seepage of blood into the surrounding tissue in case of perforation of the aneurysm wall or rupture of the aneurysm is Although this is not the case when using a balloon, since the balloon placed in front of the aneurysm neck decouples the aneurysm from the blood flow, using a balloon results in the disadvantages described above.

It is therefore the task of providing a system that combines the advantages of the methods described above with each other or avoids their disadvantages.

This object is achieved according to the invention by a system or kit for the treatment of aneurysms, which comprises: a closure device which is in an expanded state in which it is temporarily released in the blood vessel and in a compressed state in which it enters the blood vessel inserted and removed therefrom, the closure device having a substantially cylindrical portion of struts forming a plurality of openings distributed over the lateral surface of the cylindrical portion, and the closure device being coupled to an insertion aid having a substantially cylindrical portion on the Mantle surface at least partially has a cover through a membrane and the closure device in the axial direction forms a permeable channel;

- One or more occlusion means, which are introduced through a micro catheter into the aneurysm; and

- A microcatheter, which serves the introduction of occlusive agents in the aneurysm. By means of the closure device according to the invention, the advantages of using a balloon and a stent are combined, because on one side the blood flow in the main blood vessel is maintained, because the closure device has a lumen through which the blood can flow in the axial direction, on the other Side, however, the aneurysm of the Blood flow is decoupled because the area of the occlusive device placed in front of the aneurysm neck has a cover through a membrane. The membrane may be liquid impermeable, at least allowing only a small passage of liquid through the membrane. Even if a violation of the aneurysm wall should take place when introducing the occlusion means, the membrane ensures that no further blood flows into the aneurysm; the risk of infiltration of larger quantities of blood into the surrounding tissue of the aneurysm is prevented in this way. The running through the closure device channel, ie the lumen of the closure device should be as free as possible and allow undisturbed blood flow in the axial direction.

The invention can be used in principle for any aneurysms, however, the use in connection with intracranial aneurysms, d. H. Brain aneurysms. Especially in these cases, the treatment is particularly critical, because on the one hand, the interruption of blood flow in the main vessel can have negative effects on more distal brain regions, on the other hand, but also in the case of aneurysm rupture or injury to the aneurysm wall by the infiltration of blood into the surrounding brain tissue can have serious consequences. In addition, the kit according to the invention is particularly suitable for the treatment of wide-necked aneurysms, because in these the risk of leakage of the introduced occlusion agent is particularly large. Particularly useful is the use of the invention in sidewall aneurysms.

In principle, covered stents from the prior art are already known, for example from WO 2012/113581 A1, but these stents are implants that are to be permanently implanted in the blood vessel. Accordingly, they must have a detachment point at which, after insertion, a separation between the stent and the insertion wire takes place. In contrast, in the closure device according to the invention is a device that is only temporarily introduced into the blood vessel and removed after treatment. Accordingly, no release point between insertion and closing device is provided in the rule; if necessary, a release point provided here could be used in emergencies if an actually intended removal of the closure device by withdrawal into a catheter proves to be impossible during the treatment. According to the invention, the terms "proximal" and "distal" are to be understood as meaning that parts which point to the attending physician when introducing the closure device are referred to as distal, parts pointing away from the attending physician are referred to as distal. The occlusive device is thus typically advanced distally through a catheter. The term "axial" refers to the proximal to distal longitudinal axis of the closure device, the term "radially" on perpendicular thereto planes.

In addition to the system according to the invention, the invention also relates to a corresponding method with the following steps, in which the system according to the invention is used: a) insertion of the microcatheter into the aneurysm; b) placing the occlusive device in expanded form in front of the neck of the aneurysm in a manner such that the cover through the membrane lies in front of the neck of the aneurysm; c) introducing occlusion agents into the aneurysm through the

Microcatheter; and d) removing the microcatheter and occlusion device from the blood vessel.

During the treatment, the microcatheter, by which the occlusive means are to be introduced into the aneurysm, is thus first introduced into the aneurysm or the neck of the aneurysm. Then the closure device is brought by means of another catheter in a position in front of the neck of the aneurysm and released there from the catheter, so that the closure device assumes its expanded form. She remains, usually at the proximal end, connected to the insertion aid, usually a guide wire. The placement of the closure device in front of the neck of the aneurysm takes place in such a way that the radially outwardly applied membrane substantially or completely prevents blood flow into and out of the aneurysm. At the same time, the blood flow through the Main blood vessel, since the closure device is hollow inside and has a corresponding lumen.

Subsequently, the occlusion means are introduced through the microcatheter into the aneurysm. Since the occlusive device is placed with its membrane in front of the neck of the aneurysm, there is no risk that individual occlusion agents will pass out of the aneurysm neck or protrude into the main blood vessel. The introduction of occlusion means is carried out until the aneurysm is well filled with occlusive means which interlock with each other, so that, after complete filling of the aneurysm, the risk of leakage of occlusion agents from the aneurysm is minimized, regardless of the presence of the occlusive device. The occlusion of the aneurysm with occlusion means that the blood flow in and out of the aneurysm comes to a virtual standstill and in the aneurysm thrombosis occurs, ie the aneurysm is then no longer dangerous for the patient. Once the above steps are completed, the Microcatheter and the closure device withdrawn and removed from the blood vessel system. For this purpose, the occlusive device is typically withdrawn into the catheter from which it was previously released at the site of the aneurysm. Subsequently, this delivery catheter can be withdrawn. In the case of the closure device according to the invention, it is not always necessary that the entire cylindrical section has a membrane cover, but it is advantageous if at least the central region of the substantially cylindrical section has a cover on the lateral surface. Accordingly, the closure device can be placed approximately centrally in front of the Aneurysmahals, wherein the attachment of the membrane, a cover of the Aneurysmahalses is ensured. Significant to the invention is the presence of the membrane in the segment of the occlusive device which ultimately comes to rest in front of the aneurysm neck; other areas of the closure device need not necessarily have a membrane. On the other hand, it facilitates the placement of the closure device in front of the Aneurysmahals when at least a majority of the lateral surface has a membrane cover. It is particularly advantageous if the membrane is applied on the lateral surface radially over the entire circumference, so that the radial Orientation of the closure device when placing in front of the Aneurysmahals does not matter.

The substantially cylindrical portion of the closure device has a plurality of openings distributed over its lateral surface. In other words, it is a grid or mesh structure, constructed of struts, so that arise on the lateral surface of the cylindrical base structure, a plurality of openings or meshes. Further regions of the closure device, in particular a proximal section adjoining the cylindrical section proximally, can have a grid structure with openings constructed from struts, the diameter of the proximal section often decreasing proximally, ie the proximal section being non-cylindrical.

The term "aperture" refers to the lattice structure, regardless of whether the aperture is uncoupled from the environment by a membrane, i. H. an opening covered by a membrane is also referred to as an opening. Covering by a membrane is understood to mean any covering of a structure, irrespective of whether the membrane is applied externally or internally to the lattice structure or whether the lattice structure is embedded in a membrane.

The lattice structure of the closure device may be a braided structure, ie consisting of individual wires or strands of wire as struts, which are intertwined and extend at the intersection points of the wires / wire bundles and with each other. However, a cut structure is preferred in which the lattice structure is cut out of a tube of suitable diameter with the aid of a laser. The material is usually a metal, but can also be a plastic. It must have sufficient elasticity to permit contraction to the diameter of a conventional catheter and, on release from the catheter, expansion to the desired diameter. In addition, it makes sense to subject the grid structure to electropolishing to make it smoother and more rounded and thus less traumatic. In addition, the danger of attachment of germs or other contaminants decreases. The struts or wires may have a round, oval, square, rectangular or trapezoidal cross-section, wherein in the case of a square, rectangular or trapezoidal cross-section a Rounding the edges is beneficial. It is also possible to use flat webs / wires in the form of thin strips, in particular metal strips.

In addition to iron alloys (stainless steel, spring steel) and cobalt-chromium alloys, particularly suitable materials are shape memory alloys, for example binary nickel-titanium alloys (nitinol) and ternary nickel-titanium-chromium alloys (chromium-doped alloys). In particular, nitinol is known for use in self-expanding structures in the neurovascular area.

The number of openings that are adjacent to each other orthogonally to the longitudinal axis of the closure device on the lateral surface is at least 2, but preferably 3 to 5. With adjacent openings those openings are meant that in a cut-open and flat-spreading structure orthogonal to the longitudinal axis of the closure device side by side would lie. The correct selection of openings depends u. a. on the size of the blood vessel in which the closure device is to be used. The larger the diameter of the blood vessel, the larger will usually be the number of adjacent openings, since the closure device in the expanded state must cover a total of a larger peripheral surface. In addition, in principle, a smaller number of openings causes a more flexible device, which may be advantageous if the closure device must be moved within tightly wound blood vessels. On the other hand, the size of the openings should be chosen so that the struts bounding the openings can sufficiently support the membrane. Overall, it has been proven to use closure devices in which the number of openings which are adjacent to each other orthogonal to the longitudinal axis of the closure device along the circumference on the lateral surface, 3 to 5.

As already mentioned, insertion aid and closure device are normally firmly connected to one another. The connection usually does not provide for a detachment option. Herein, the closure device differs from prior art membrane-coated stents intended for permanent implantation. A corresponding closure device, which is placed only temporarily during the placement of occlusion devices in an aneurysm in front of the Aneurysmahals and removed after completion of the introduction of occlusion agents, has not been described in the prior art. It is meaningful that a proximal section adjoins the substantially cylindrical section in the proximal direction and this proximal section is coupled to the insertion aid. Due to the proximal connection, the

Closure device well controlled by the insertion, in particular moved back and forth, without the introducer itself in any way affects the actual function of the closure device in front of the aneurysm.

The introducer is preferably a guidewire as is well known in the art. The introducer may be coupled to the proximal portion of the closure device at one or more coupling points. Typically, the struts of the occlusive device converge in the direction of the introducer in the proximal portion. It is expedient if the one or more coupling points are arranged to the centrally extending longitudinal axis of the closure device in the direction of the lateral surface, d. H. radially outside. Such an eccentric arrangement of the coupling point has the advantage that the blood flow in the main blood vessel is disturbed as little as possible. In the discharged from the microcatheter state, the coupling point can thus lie on the vessel wall. The coupling points may be simple welding points at which

Insertion guide / guidewire and proximal portion of the closure device are brought together.

The guide wire can be made in one piece, ie it is ultimately a continuous wire. However, it is also possible to combine the advantageous properties of different materials with one another, for example the part of the guide wire made of stainless steel with good pushability, the distal part of the guide wire of a nickel-titanium alloy such as Nitinol with high flexibility to manufacture. A distal section made of a nickel-titanium alloy also has the advantage that the risk of kinking is minimized. On the other hand, for the proximal part of the guidewire, the use of a stiffer material such as stainless steel is advantageous because it allows the transmission of torques, which is advantageous for the ability to be advanced. The term insertion aid is to be understood broadly and does not necessarily mean a classic guidewire in each case. Also conceivable, for example, elongated insertion aids with an internal Flohlraum.

It makes sense for the closure device to have one or more radiopaque markings in order to enable the attending physician to visualize it. The radiopaque markers may, for. B. from platinum, palladium, platinum-iridium, tantalum, gold, tungsten or other radiopaque metals. They allow the attending physician to recognize whether the occlusive device is correctly placed relative to the thrombus to be removed and, if necessary, make corrections. It is also conceivable, at least some areas of

Closure device with a coating of a radiopaque material to provide, for example with a gold coating. This can, for. B. have a thickness of 1 to 6 pm. The coating with a radiopaque material need not cover the entire closure device. However, even when providing a radiopaque coating, it may be useful to additionally attach one or more radiopaque markers. Another possibility is to coat individual struts with a helix or a wire of a radiopaque material such as platinum.

Another way to make the closure device X-ray-visible, is in the membrane radiopaque substances, for example

To embed heavy metal salts such as barium sulfate. Such substances are for. B. known as a contrast agent in X-ray technology.

The occlusion means are usually occlusion coils or occlusion coils known from the prior art. These are short pieces of wire that take the form of a wire helix or assume such shape when released in the aneurysm. Together with other occlusion coils, they form a wire ball in the aneurysm and are accordingly able to close it and induce thrombus formation. Occlusion coils are mostly made of platinum. However, it is also conceivable to use alternative occlusion agents, such as those described in WO 2012/034135 A1 or WO 2017/089451 A1. In the context of the invention, one or more occlusive agents may be used in a treatment, ie Use of the plurals includes a single, appropriately shaped occlusive agent.

Expediently, an insertion aid designed as a guide wire can connect proximally to an occlusion device. The occlusive means may be in communication with the introducer via a release site prior to insertion. As soon as the occlusive agent has been introduced into the aneurysm and is to be detached there from the insertion aid, there is a separation between insertion aid and occlusion device. This can be z. B. electrolytically, mechanically or thermally. In particular, electrolytic detachment points are known from the prior art, in which by applying an electrical voltage, an electrolytic corrosion is induced, which causes an at least partial dissolution of the detachment point and thus destroys the firm connection between insertion aid and occlusive means.

At the locations where the closure device is covered by a membrane, it may be attached to the grid structure internally or externally, i. H. the membrane may be located on the inside and / or outside of the struts forming the openings. Preferably, however, the grid structure is embedded in the membrane. This can be achieved by initially introducing a grid structure which is subsequently braided or braided with fibers such that a membrane with embedded grid structure results. Corresponding methods are well known from the prior art, for example the so-called electrospinning.

It is also possible to first provide a mandrel on which a first membrane is applied. Subsequently, the grid structure itself is applied to the 1st membrane, before finally a second membrane is applied. The individual struts forming the closure device are thus enclosed by membranes. In those areas of the closure device in which a membrane is not necessary or undesirable, it can subsequently be removed.

As far as according to the invention of a membrane is mentioned, it should be made clear that this can also be understood as more than one membrane. It may therefore be a continuous membrane, the larger areas of the lateral surface covering the cylindrical portion of the closure device, but it is also possible to use a plurality of individual membranes that cover areas of the lateral surface. These individual membranes may be contiguous to form a unitary surface, but it is also possible for gaps to remain between the membranes as long as the goal associated with the closure device of achieving temporary coverage of the aneurysm neck is ensured. A membrane may have multiple layers. If a plurality of membranes or membrane layers are arranged one above the other, this too is to be understood as a membrane in the sense of the invention as a whole. In the case of preferably used electrospinning, fibrils or fibers from a polymer solution are deposited on a substrate by means of electric current. During deposition, the fibrils stick together to form a fleece. As a rule, the fibrils have a diameter of 100 to 3,000 nm. Electrospinning membranes are very uniform. The membrane is tough and mechanically strong and can be pierced mechanically, without the opening becomes the starting point for further cracks. The thickness of the fibrils as well as the degree of porosity can be controlled by selecting the process parameters. In connection with the creation of the membrane and the materials suitable therefor, particular attention is drawn to WO 2008/049386 A1, DE 28 06 030 A1 and the literature cited therein.

Instead of electrospinning, the membrane can also be made via a dipping or spraying process, such as spraycoats. The membrane can be constructed in one or more layers. The total layer thickness of the membrane is preferably 10 to 400 μm, in particular 10 to 100 μm. The membrane may be made of a polymeric material such as polytetrafluoroethylene, polyesters, polyamides, polyurethanes or polyolefins. Particularly preferred are polycarbonate urethanes (PCU), which can be applied, for example, in a solvent such as chloroform. In particular, an integral connection of the membrane to the lattice structure is desirable. The membrane (s) should be fixed to the struts so that no free edges of the membrane remain. Such loose edges of the membrane could otherwise cause a so-called. Endoleak, which is understood as an endoleak, ie a leak between the aneurysm and temporarily introduced closure device. The liability of Membrane on the struts forming the lattice structure can be further improved by silanizing the struts.

The membrane used is advantageously substantially liquid-impermeable or has only a low permeability to liquids, in particular blood. Accordingly, the membrane is able to cut off the aneurysm completely or at least to a large extent from the blood flow. Some permeability of the membrane may be acceptable in this regard as long as the goal of extensive cutting of the aneurysm from blood flow is maintained. The closure device according to the invention usually has a length (without insertion aid) between 5 mm and 40 mm and a diameter between 1, 5 mm and 7 mm, wherein the dimensions of the dimension of the diseased vessel segment on the one hand and the nature of the aneurysm result. The figures relate to the free, relaxed state of the closure device, d. H. without exerting an external constraint through the catheter. The struts forming the closure device can, for. B. have a width or a diameter between 20 and 60 pm.

The invention will be explained in more detail by way of example with reference to the exemplary embodiments illustrated in the figures. It should be noted that the figures show preferred embodiments of the invention, but the invention is not limited thereto. In general, the invention includes, as far as is technically feasible, any combination of the technical features listed in the claims or described in the description. All designs that have been made to the closure device or the kit, apply in the same way for the inventive method and vice versa.

Show it:

1 shows the closure device in rolled-out form;

Fig. 2 a, the closure device in a side view and Fig. 2 b, the closure device in one

Frontal view.

In Figure 1, the closure device 1 according to the invention is shown in an unrolled form. The illustration is merely illustrative, of course, the closure device 1 is actually in a rolled-up and generally radially closed shape, which has a cylindrical shape over a majority of the length. The dotted lines indicate how the closure device 1 continues on the opposite side.

The closure device 1 is composed essentially of a cylindrical portion 2 and a proximal portion 3. The proximal portion 3 narrows proximally and is connected to an insertion aid at its proximal end. The cylindrical portion 2 is composed of a plurality of struts 4, between which openings 5 result. Furthermore, the cylindrical portion 2 has a cover by a membrane 6, d. H. the cylindrical portion 2 is radially substantially liquid impermeable.

In Figure 2a, the closure device is shown in side view, as it corresponds to the closure device 1 in reality. Again, one recognizes the cylindrical section 2 and the proximal section 3, which is connected via a coupling point 9 with the insertion aid 7, usually a guide wire. The coupling point 9 is located at the periphery of the closure device 1, d. H. When inserted into a blood vessel closure device 1, the coupling point 9 is located at or near the vessel inner wall.

It can be seen again the structure of the closure device 1 of struts 4 located between the individual struts 4 openings 5. The cylindrical portion 2 has a cover by a membrane 6, wherein the struts 4 between two or more membrane layers 6 are embedded.

Finally, FIG. 2 b shows a view of the closure device 1 from the distal front. It can be seen that, due to the membrane 6, the cylindrical section 2 is substantially impermeable to liquids in the radial direction, but forms a permeable channel 8 in the axial direction.

Claims

claims

1. Kit for the treatment of aneurysms, comprising

- A closure device (1), which is in an expanded state in which it is temporarily released in the blood vessel, and in a compressed state in which it is inserted into and removed from the blood vessel, said

Closing device (1) has a substantially cylindrical portion (2) of struts (4) having a plurality of distributed over the lateral surface of the cylindrical portion (2)

Form openings (5), and the closure device (1) is coupled to an insertion aid (7), the substantially cylindrical portion (2) on the lateral surface at least partially has a cover by a membrane (6) and the closure device (1) in the axial direction a permeable

Channel (8) forms;

- A microcatheter, which serves the introduction of occlusive agents in the aneurysm.

2. Kit according to claim 1, characterized in that at least the central region of the substantially cylindrical portion (2) on the lateral surface over a cover by a membrane (6).

3. Kit according to claim 1 or 2, characterized in that the number of openings (5) which are orthogonal to the longitudinal axis of the closure device (1) on the lateral surface next to each other, at least 2, preferably 3 to 5.

4. Kit according to one of claims 1 to 3, characterized in that the insertion aid (7) and the closure device (1) are firmly connected to each other and the connection does not provide a detachment possibility.

5. Kit according to one of claims 1 to 4, characterized in that adjoining the substantially cylindrical portion (2) in the proximal direction, a proximal portion (3) which is coupled to the insertion aid (7).

6. Kit according to claim 5, characterized in that the insertion aid (7) at one or more coupling points (9) to the proximal portion (3) of the closure device (1) is coupled, wherein the coupling point (9) to the centrally extending longitudinal axis of Closing device (1) is arranged radially displaced in the direction of the lateral surface.

7. Kit according to one of claims 1 to 6, characterized in that at least some areas of the closure device (1) are provided with a radiopaque coating.

8. Kit according to one of claims 1 to 7, characterized in that the occlusion means are Okklusionscoils.

9. Kit according to one of claims 1 to 8, characterized in that the membrane (6) on the outside of the openings (5) forming

Struts (4) is located.

10. Kit according to one of claims 1 to 8, characterized in that the membrane (6) on the inside of the openings (5) forming struts (4).

11. Kit according to one of claims 1 to 8, characterized in that the openings (5) forming struts (4) are embedded in the membrane (6).

12. Kit according to any one of claims 1 to 11, characterized in that the membrane (6) is produced by electrospinning.

13. Kit according to one of claims 1 to 12, characterized in that the membrane (6) is constructed of a polycarbonate urethane.

14. Kit according to one of claims 1 to 13, characterized in that the membrane (6) has a layer thickness of 10 to 400 pm, in particular from 10 to 100 pm.

A method of filling an aneurysm with occlusive means using a kit according to any one of claims 1 to 14, comprising the steps of: a) inserting the microcatheter into the aneurysm; b) placing the occlusive device (1) in an expanded form in front of the neck of the aneurysm in a manner such that the cover through the membrane (6) lies in front of the neck of the aneurysm; c) introducing occlusion agents into the aneurysm through the

Microcatheter; and d) removing the microcatheter and the occlusive device (1) from the blood vessel.