EP4164556A2

EP4164556A2 - Insertion system for implants for treatment of bifurcation aneurysms

Info

Publication number: EP4164556A2
Application number: EP21736976.8A
Authority: EP
Inventors: Hans Henkes; Hermann Monstadt; Ralf Hannes; Volker Trösken; Stefan Rolla
Original assignee: Phenox GmbH
Current assignee: Phenox GmbH
Priority date: 2020-06-12
Filing date: 2021-06-14
Publication date: 2023-04-19
Also published as: WO2021250282A3; CN116133621A; JP2023530101A; DE102020115614A1; WO2021250282A2; US20230233347A1

Abstract

The invention relates to an insertion system for an implant (1) for influencing the blood flow in the region of aneurysms (22) which are located at vascular bifurcations. The implant (1) has two distal tubular implant portions (2) which are intended to be placed in blood vessels (21) branching off from the stem blood vessel (20) and which are connected to one another at a branching point (4). The insertion system has two sleeves (5) which are each designed to hold a distal tubular implant portion (2). The two sleeves (5) each have a distal sleeve portion (6), and the distal sleeve portions (6) each have an opening zone (7) extending in the longitudinal direction. The distal sleeve portions (6) are each adjoined proximally by a proximal portion (8), by means of which the sleeves (5) can be retracted in the proximal direction so that the opening zones (7) open and the distal tubular implant portions (2) each pass through the opening zones (7) and are released into the branching blood vessels (21). Alternatively, it is also possible to use an individual sleeve which has an opening zone for gradual release of the implant (1) or an insertion system with the implant (1) releasably attached to the outside.

Description

Insertion system for implants for treating bifurcation aneurysms. The invention relates to an insertion system for an implant for influencing the blood flow in the area of aneurysms which are located at branching vessels. Such aneurysms are also referred to as bifurcation aneurysms.

Aneurysms are mostly sack-like or spindle-shaped (fusiform) extensions of the vascular wall, which arise primarily at structurally weakened areas of the vascular wall due to the constant pressure of the blood. The inner walls of the aneurysm are correspondingly sensitive and prone to injury. The rupture of an aneurysm usually leads to considerable health impairments, in the case of cerebral aneurysms to neurological failures up to and including death of the patient. In addition to surgical interventions in which the aneurysm is clamped off by means of a clip, for example, endovascular methods for treating aneurysms are known in particular, two approaches being pursued primarily. On the one hand, the aneurysm can be filled with occlusion means, in particular so-called coils (platinum spirals). The coils promote thrombus formation and thus ensure closure of the aneurysm. On the other hand, it is known to close the access to the aneurysm, for example the neck of a berry aneurysm, from the blood vessel side by means of stent-like implants and to decouple it from the blood flow. Both methods serve to reduce the blood flow into the aneurysm and thus the pressure on the aneurysm, ideally to eliminate it and thus to reduce the risk of the aneurysm rupturing. When filling an aneurysm with coils, it can happen that the filling of the aneurysm is insufficient, which allows the blood supply to the aneurysm and thus a continued pressure on its inner wall. The risk of constant expansion of the aneurysm and its eventual 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 protrude from a wide aneurysm neck into the blood vessel and thrombogenize there, which can lead to occlusions in the vessel. In the worst case, a coil will be completely washed out of the aneurysm and occlude vessels elsewhere. In order to keep the coils in place in the aneurysm sack, the aneurysm neck is often additionally covered with a special stent.

Another intravascular treatment approach relies on so-called flow diverters. These implants are similar in appearance to stents that are used to treat stenoses. Since the task of the flow diverters is not to keep a vessel open, but to close the aneurysm access on the blood vessel side, the mesh size is very narrow; alternatively, these implants are covered with a membrane. A disadvantage of these implants is the risk that branching branches in the immediate vicinity of the aneurysm to be treated are sometimes also covered and thus closed in the medium or long term.

Aneurysms in the area of vascular branches, particularly vascular bifurcations, are a relatively common phenomenon. The blood hitting the front wall through an artery in the area of a bifurcation quickly leads - in the case of a weakening of the vessel wall - to a bulge, which then quickly expands. Such bifurcation aneurysms often have a wide neck, which makes therapy difficult with only occlusion coils.

Vascular implants that are suitable for creating a “grating” of the aneurysm entrance in the area of a vascular branch are disclosed, for example, in the international patent applications WO 2012/113554 A1 or WO 2014/029835 A1. The aneurysm can then be shut down with occlusion spirals inserted after the implant has been placed. It is also possible for the implant itself to sufficiently decouple the aneurysm from the blood flow. Can do this For example, the implant may have a membrane that is placed in the area of the aneurysm neck or in front of the aneurysm neck. If necessary, the blood flow to the aneurysm can also be reduced with filaments, typically small-diameter wires, to such an extent that the additional introduction of occlusion spirals or other occlusion means into the aneurysm can be dispensed with.

A flow diverter system for treating bifurcation aneurysms is known from WO 2018/208662 A1, in which a stent-like flow diverter with a lateral opening is first introduced into the blood vessel. Then another stent-like flow diverter with a lateral opening is guided through the opening of the first flow diverter in such a way that overall a Y-shape results, with the branch in the Y lying in front of the bifurcation aneurysm. In this way, the aneurysm should be cut off from the blood flow, but the blood flow into the branching blood vessels should remain largely unaffected. A disadvantage of this prior art is that the two parts of the final flow diverter have to be introduced one after the other. For this purpose, the correct placement of the first flow diverter is first necessary before the second flow diverter has to be correctly positioned within the vascular system both relative to the aneurysm and relative to the first flow diverter. Since implants are usually inserted via the femoral artery in the treatment of bifurcation aneurysms in the intracranial area, the attending physician must therefore carry out very precise control over considerable distances precise alignment of the openings inside the body is difficult.

The task is therefore to provide an insertion system for implants for influencing the blood flow in the area of bifurcation aneurysms, with which the implant can be inserted in one step. These are implants that have at least two distal tubular implant sections which are placed in the blood vessels branching off from a blood vessel. In particular, it can be implants with a Y-shaped basic structure, which consists of two distal tubular implant sections for the branching blood vessels and a third, Assemble the proximal tubular implant section (stem section) for placement in the stem blood vessel.

According to a first embodiment, the object is achieved according to the invention by an insertion system for an implant for influencing the blood flow in the area of aneurysms that are located at branching vessels, the implant having two distal tubular implant sections which are intended to be placed in blood vessels branching off from the blood vessel and which are connected to one another at a branching point, the delivery system having two sleeves which are each configured to receive a distal tubular implant section, the two sleeves each having a distal sleeve section and the distal sleeve sections each having an opening zone running in the longitudinal direction have, proximally adjoining the distal sleeve portions in each case a proximal portion via which the sleeves can be withdrawn in the proximal direction so that the opening zones open and the distal tubes shaped implant sections each pass through the opening zones and are released in the branching blood vessels.

According to the invention, the insertion system provides a sleeve for each of the two distal tubular implant sections, which are to be placed in one of the blood vessels branching off from the blood vessel of the blood. The sleeve constrains the distal implant sections and prevents them from radial expansion. At least in the distal area, both sleeves have an opening zone running in the longitudinal direction, through which the distal implant sections can pass and are released when the sleeves are withdrawn in the proximal direction. Alternatively, the release can also take place in that the sleeves are held in place with the aid of the proximal sections, while the implant with the two distal implant sections is advanced in the distal direction. The relative movement between the sleeves and the implant is important for the release, the relative movement of the sleeves acting in the proximal direction, whereas the relative movement of the implant acts in the distal direction. In this context, an advancing device can be used to exert a force on the implant in the proximal direction, either in order to fix it while the sleeves are being pulled in the proximal direction, or in order to advance the implant in the distal direction. In this context, an opening zone is understood to mean a region of the distal sleeve sections which runs in the longitudinal direction from the distal end of the distal sleeve sections in the proximal direction, typically up to the start of the proximal sections. The opening zones should preferably point in the distal direction in order to facilitate the exit of the distal implant sections. The opening zones must extend in the proximal direction so that an at least sufficiently long section of the implant can be received by the sleeves and the implant is securely held by the insertion system during the insertion. On the other hand, at the proximal end of the distal sleeve sections, the distal implant sections emerge from the sleeves, while the sleeves have proximal sections that extend further in the proximal direction.

The opening zones can in particular be longitudinal slots through which implant sections can pass when the sleeves are withdrawn in the proximal direction. The edges of the longitudinal slots running in the longitudinal direction can abut one another or overlap to a certain extent, it being necessary in each case to ensure that the implant sections can still pass through. In this context, longitudinal direction means that the opening zone must run from the distal end of the distal sleeve sections in the proximal direction, a course with a certain radial component also being understood as “in the longitudinal direction”, for example a helical course.

Instead of providing a longitudinal slot, it is also possible to provide another opening zone in which the longitudinal slot is only created during the release process. For example, it can be a weakened zone in which a perforation is provided which opens when the sleeve sections are withdrawn. Another weakening zone based on a material thinning is also possible.

It is also sensible to provide the opening zone in such a way that the distal implant sections to be released are released from distal to proximal, i.e. first the two distal ends of the implant, until finally the most proximal areas of the distal implant sections that are located within the sleeve are located, emerge from the distal sleeve sections. This can e.g. B. can be achieved in that the exercise in the proximal direction Force for opening the opening zone increases from distal to proximal. For example, the resistance of a weakened zone can increase from distal to proximal by increasing the material thickness, using different materials or providing a perforation with intermediate segments increasing in strength in the proximal direction and / or openings increasing in the distal direction. In the case of a longitudinal slot, the overlap of the edges of the longitudinal slot can increase from distal to proximal, which also has the consequence that the distal ends of the implant are exposed first.

An insertion system for placing Y-shaped implants is also described in WO 2018/134097 A1. In this system, a Y-shaped insertion catheter is used which has a branch for receiving the distal implant sections. At the distal end of the insertion catheter there is a continuous longitudinal slot through which the implant can emerge and be released when the insertion catheter is withdrawn. One advantage of the solution according to the invention over the prior art is that parts of the implant can be released one after the other because two separate sleeves are provided for the distal implant sections placed in the branching blood vessels. The sleeves can be operated independently of one another and are usually present as separate parts of the delivery system. Accordingly, it is possible to first release the first distal implant section by pulling the corresponding sleeve back in the proximal direction, and then the second distal implant section. In addition, the delivery system is easier to manufacture with separate sleeves.

In order to facilitate the exit of the implant from the sleeves, the opening zones in the distal sleeve sections should be easy to open. For this purpose, it makes sense to manufacture the sleeves, at least in the area of the distal sleeve sections, from a flexible hose material that yields when the sleeves are withdrawn so that the implant sections can pass through.

The proximal sections of the sleeves can also be sleeve-shaped or tubular. In this case, the sleeve continues from the distal sleeve section to the proximal section, preferably basically unchanged, but with the The proximal section differs from the distal sleeve section in that it generally does not contain an opening zone, a longitudinal slot or the like. This is unnecessary in this area because the proximal section does not contain any components of the implant. The proximal sections extend so far proximally that the attending physician is able to either withdraw the sleeves while at the same time fixing the implant, so that the distal implant sections are released from the distal sleeve sections, or vice versa with the help of the proximal sections to close the distal sleeve sections fix in place and advance the implant in the distal direction. A sleeve or hose-shaped design of the proximal sections is also advantageous insofar as guide wires can be passed through the sleeves in this way, via which the sleeves can be advanced through the blood vessel system into the branching blood vessels. In principle, however, it is also conceivable to design the proximal sections in a different shape, for example wire, filament or strip shape. For example, narrow strips can be cut from the material of the tubing material that is used for the distal sections, which are used as proximal sections in order to pull back the sleeves. One advantage of providing the proximal sections with a small diameter and using a wire, for example, is that the outer diameter of the insertion system can be kept small in this way. This is particularly advantageous because the insertion system including the implant is usually advanced to the target position by a microcatheter.

At the proximal end of the proximal sections, for example, a hub can be provided, as is known from the prior art in the field of catheter technology. It is advisable to use a conventional Luer or Luer lock connection in the area of the hub. Aids, for example guide wires, can be introduced into the interior of the proximal section via such a connection. The connection element can, for. B. made of polycarbonate, polyamide, polypropylene or other polymers. As a rule, the material is stiffer than the material for the actual sleeve sections.

Advantageously, the insertion system also has a stem sleeve which is provided for receiving a tubular stem section of the implant is. The tubular stem section of the implant is placed in the stem blood vessel. The stem sleeve can be withdrawn in the proximal direction to release the stem section of the implant independently of the sleeves for the distal implant sections or the stem sleeve can be held in order to also release the stem section of the implant by advancing it in the distal direction. The stem sleeve must therefore continue in the proximal direction, the proximal area not necessarily having to be sleeve-shaped, but z. B. can also consist of a wire or the like. It is important, however, that control of the stem sleeve is possible for the attending physician. The stem sleeve can be pushed over one or more guide wires provided for this purpose. The sleeve shape of the stem sleeve can continue proximally to outside of the body, ie the stem sleeve corresponds to an over-the-wire (OTW) system, but the guide wire (s) can also exit further distally, similar to Rapid exchange (Rx) catheters is the case. In particular, guide wires can also be guided through the interior of the stem section of the implant into the two distal implant sections.

An insertion system with a stem sleeve for receiving the stem section is of course sensible if the implant not only has two distal tubular implant sections for the branching blood vessels, but also a proximal implant section for the stem blood vessel. The implant thus has a basic Y shape with a tubular proximal stem section for the stem blood vessel in the expanded state and two distal tubular implant sections branching off from this for the branching blood vessels. In contrast to the two sleeves for the distal implant sections, however, no opening zone is necessary for the stem sleeve. It is important that the individual implant sections are connected to one another in such a way that the blood can flow from the stem blood vessel into the two branching blood vessels.

In principle, however, embodiments of the insertion system for placing implants are also conceivable which have only two distal tubular implant sections for the branching blood vessels, but no additional implant section for the blood vessel. In this case, too, it is important to ensure the flow of blood from the main blood vessel into the two branching blood vessels, ie in the region of the branching of the implant into the two distal implant sections, the implant should have an opening in the proximal direction through which the blood can penetrate from the main blood vessel and flow further into the branching blood vessels.

If a stem sleeve is provided, the insertion system has three sleeves, namely two sleeves, each of which has a distal sleeve section with an opening zone, and a stem sleeve for the one further proximally

Implant section. The three sleeves can be operated separately to release the implant. For example, first the first distal implant section, then the second distal implant section and finally the proximally located stem section of the implant can be released. The stem sleeve can also be constructed from a flexible tube material, but a firmer sleeve material is basically also conceivable here, since the stem section of the implant does not have to pass through an opening zone or a slot, but is only released by pulling back the stem sleeve. The delivery system according to the invention with two sleeves for the distal

Implant sections and possibly a stem sleeve for the proximal implant section can be introduced into the blood vessel system through a microcatheter. The microcatheter is thus first brought to the desired location before the insertion system is advanced through the microcatheter in the distal direction. The insertion system can be advanced over two guide wires inserted into the two branching blood vessels. Then the microcatheter can first be withdrawn so far that the implant with the surrounding sleeves is exposed before the sleeves themselves are withdrawn in the proximal direction in order to release the implant. Finally, when the implant has been placed in the desired manner, the microcatheter including the insertion system can be pulled proximally out of the blood vessel system and removed.

If necessary, corrections can also be made in this context. For example, the implant with the sleeves can be withdrawn back into the microcatheter if it turns out that the position is not optimal or other problems arise. Such a withdrawal in the Microcatheter is still possible even after partial release of the implant at the distal end.

The invention relates to the described insertion system with two sleeves, each of which has a distal sleeve section for receiving the distal implant sections, and optionally a stem sleeve. However, the invention also relates to a combination of insertion system and implant and / or microcatheter and other elements that are necessary or useful for placing the implant in front of a bifurcation aneurysm. This includes, for example, guide wires. The terms “proximal” and “distal” are to be understood as denoting parts of the implant that point towards the attending physician (proximal) or parts that point away from the attending physician (distal) when the implant is inserted. The term “axial” relates to the longitudinal axis of the implant running from proximal to distal, the term “radial” to planes perpendicular to this. According to a second embodiment, the invention provides an insertion system for an implant for influencing the blood flow in the area of aneurysms which are located at branching vessels, the implant having two distal tubular implant sections which are intended to be placed in blood vessels branching off from the blood vessel and which are connected to one another at a branching point, the delivery system having a sleeve with two distal sleeve arms which are each configured to receive a distal tubular implant section and are connected to one another, the sleeve having a continuous opening zone in the distal direction, the sleeve has a proximal section via which the sleeve can be withdrawn in the proximal direction so that the opening zone opens and the distal tubular implant sections each pass through the opening zone and into the branching blood vessel ßen are released, the opening zone being such that the sleeve opens sequentially from the distal ends of the distal sleeve arms in the proximal direction when the implant is released. The insertion system according to the second embodiment is based on an insertion system as described in WO 2018/134097 A1. Here's how As already described above, the Y-shaped implant is released with the aid of a likewise Y-shaped insertion catheter which has a continuous longitudinal slot at the distal end through which the implant emerges when the insertion catheter is withdrawn. A disadvantage of this insertion system is that the implant is released over the entire width at the same time. However, it may be desirable to first expose the distal ends of the implant and only gradually to expose the more proximal areas. Accordingly, an insertion system is advantageous in which the opening zone is designed in such a way that the sleeve opens gradually from the distal ends in the proximal direction when it is released. Correspondingly, the distal ends of the implant, ie the distal ends of the implant sections intended for the branching blood vessels, can first be released from the sleeve and expand before the rest of the distal implant sections also emerge step by step from the sleeve and lie against the inner wall of the vessel. Such a procedure is often advantageous for the attending physician in order to have the greatest possible control during the release process. Prior to release, the sleeve constrains the distal implant sections and prevents them from radial expansion.

In order to achieve this goal, the opening zone can be designed in different ways. In particular, the opening zone can have a continuous slot from the start, which points in the distal direction, but with the edges of the slot at least partially overlapping. This overlap should increase from the two distal ends of the sleeve arms in a proximal direction. In other words, the respective edges of the slots at the distal ends of the sleeve arms do not overlap or at most only slightly overlap where the sleeve arms meet and are connected to one another, whereas the two edges of the slot clearly overlap. Accordingly, the least amount of force is required to release the distal implant sections at the distal ends of the sleeve arms, while this force is relatively high where the sleeve arms meet. The slot thus initially opens at the distal ends of the sleeve arms and the opening continues in the proximal direction so that the implant in the center is later released. This center corresponds to the point that is typically placed in front of the neck of the aneurysm. According to another embodiment, the opening zone has a weakening zone pointing in the distal direction, the weakening zone being such that the force required for opening increases from distal to proximal. The weakened zone can be reached, for example, via a perforation in which the strength of the webs between the openings increases from distal to proximal and / or the size of the openings increases from proximal to distal. Another possibility is to provide a material thinning or a variation of the material in the area of the weakening zone so that the weakening zone at the distal ends of the sleeve arms first tears open when the sleeve is withdrawn in the proximal direction, and the opening of the weakened zone extends in the proximal direction, ie propagates to the branch point of the sleeve. The weakened zone is thus designed such that it tears open when the sleeve is withdrawn from the distal ends of the sleeve arms to the connection point of the sleeve arms. In this way, too, a sequential release of the distal implant sections is ensured, in which first the more distal areas are released and expand and only slightly later the more proximal areas.

The distal sleeve arms are connected to one another, the connection point being adjacent to the branch point of the distal implant sections when the implant is in the sleeve. The sleeve advantageously also has a proximal sleeve arm which forms the proximal section of the sleeve and is provided for receiving a tubular, proximal stem section of the implant. In other words, the sleeve overall has a Y-shape, the two distal sleeve arms accommodating the distal implant sections for the branching blood vessels, while the proximal sleeve arm is provided for the proximal stem section of the implant. The individual sleeve arms are connected to one another at a connection point and together form a cavity for the accommodation of the likewise Y-shaped implant. When the proximal sleeve arm is withdrawn in the proximal direction, the proximal implant section (stem section) is also released, so that the entire implant is released. The stem section of the implant expands accordingly after release and thus secures the implant in the stem blood vessel. In principle, however, embodiments of the insertion system for placing implants are also conceivable which have only two distal tubular implant sections for the branching blood vessels, but no additional implant section for the blood vessel. Also in In this case, however, it is important to ensure the blood flow from the stem blood vessel into the two branching blood vessels, i.e. in the area of the branching of the implant into the two distal implant sections, the implant should have an opening in the proximal direction through which the blood from the stem blood vessel can penetrate and into the branching blood vessels can continue to flow.

The sleeve shape of the proximal section does not have to extend to the outside of the body; it is sufficient if the sleeve shape extends so far that the proximal tubular implant section is completely received in the proximal sleeve section. This can also be followed by a wire or the like, which makes it possible to withdraw the sleeve in the proximal direction. At the proximal end of the proximal section, for example, a hub can be provided, as is known from the prior art in the field of catheter technology.

The sleeve including the implant can be brought to the target position via two guide wires and a microcatheter, one of the guide wires being guided through the first distal sleeve arm into the first branching blood vessel and the second guide wire being guided through the second distal sleeve arm into the second branching blood vessel. The guide wires can extend through the entire sleeve including a proximal sleeve arm to the outside of the body (OTW configuration) or exit the sleeve proximally of the implant through a port provided for this purpose (Rx configuration).

The delivery system with implant can be advanced to the target position via a micro-catheter. To release it is possible, for example, to apply a force to the implant by means of a feed device in the distal direction, so that the sleeve can be withdrawn in the proximal direction, whereupon the implant emerges through the opening zone. If necessary, the system comprising the delivery system and the implant can be withdrawn even after the implant has already been partially released into the microcatheter, in order to correct the placement of the implant or the whole

Cancel the implantation process. A feed device for applying a distally acting force to the implant can be used in all of the embodiments described in this patent application. The insertion system can be combined with further components, in particular with the implant itself, a microcatheter, guide wires, a feed device and the like .. Such combinations are also covered by the invention. According to a third embodiment of the invention, an introducer system for a

Implant for influencing the blood flow in the area of aneurysms, which are localized at vascular branches, made available, the implant having two distal tubular implant sections which are intended to be placed in blood vessels branching off from the blood vessels and which are connected to one another at a branching point are, wherein the two distal tubular implant sections are in an expanded state in which they are implanted in the branching blood vessels, and in a contracted state in which they are movable through the blood vessel system, the delivery system having two distal shaft sections which are passed through the run distal tubular implant sections and adjacent to the

Junction points are connected to one another, with a proximal section adjoining the connection of the distal shaft sections, via which the distal shaft sections can be retracted in the proximal direction, the distal tubular implant sections being detachably fixed on the distal shaft sections so that the distal tubular implant sections Loosen the fixing to take their expanded structure and be released in the branching blood vessels.

In contrast to the first two embodiments of the invention, in the third embodiment the implant is not brought to the desired location within a sleeve, but rather is fixed on the shaft sections of the insertion system. The at least two shaft sections run through the distal tubular implant sections, which are provided for placement in the blood vessels branching off from the stem blood vessel. Where the two distal implant sections are connected to one another, the inner shaft sections also have a corresponding connection, with a proximal section connecting proximally to this connection of the shaft sections, via which the shaft sections can be retracted in the proximal direction. The tubular implant sections are releasably attached to the shaft sections, so that the tubular implant sections assume their expanded structure after loosening the fixation and are released in the branching blood vessels.

In other words, the implant is brought to the desired location on the delivery system. As soon as the correct placement has taken place, the fixation of the implant on the shaft sections is released. The implant then expands and rests against the inner wall of the vessel, with the two distal tubular implant sections resting against the inner wall of the two branching blood vessels. In most cases, however, a further, proximal tubular implant section will be provided for the blood vessel. As a rule, the implant is designed to be self-expanding.

The attachment points between the distal tubular implant sections and the distal shaft sections are expediently arranged at least at the distal ends of the implant. As soon as the attachment points at the distal ends are loosened, the expansion of the implant begins. Further attachment points further proximally are also possible, but these are not absolutely necessary because the release further proximally can also be controlled via a microcatheter surrounding the implant including the insertion system.

The shaft sections can in particular be constructed from a flexible hose material, which has the advantage that the implant rests well against the hose material and an additional frictional connection is established between the implant and the hose material. In principle, however, a metallic shaft, on which the implant is applied and fixed, is also conceivable, for example. The proximal section, which i.a. also serves that in the distal

Withdrawing distal shaft sections located in the implant sections proximally is advantageously itself a shaft section in the sense that the proximal, tubular implant section can be applied to this proximal shaft section. The proximal shaft section can also be constructed from a flexible hose material. In this case, the implant itself typically has the described Y-shape, whereby for all three arms of the Internal shaft sections corresponding to the implant are provided. Further proximally, however, the proximal section no longer necessarily has to have a shaft shape; for example, a wire or the like can be attached to a proximal shaft section on which the proximal implant section is located, and further proximally a wire or the like that enables the shaft sections to be actuated. At the proximal end of the proximal section, for example, a hub can be provided, as is known from the prior art in the field of catheter technology. It is advisable to use a conventional Luer or Luer lock connection in the area of the hub. Aids can be introduced into the interior of the proximal section via such a connection, for example guide wires or means for causing the connection points to detach. These can be means for supplying a solvent, for bringing about heating in a region of the shaft or for applying an electrical voltage. In the case of a Luer-Lock connection, the connection to other elements is also made by screwing with the thread provided for this purpose. The connection element can, for. B. made of polycarbonate, polyamide, polypropylene or other polymers. As a rule, the material is stiffer than the material for the actual shaft sections.

The shaft sections expediently have an inner cavity, because this enables one or more guide wires to be passed through, via which the insertion system can be brought to the desired location. In particular, several guide wires can also be used, one of which is guided into the first and the other into the second branching vessel, for example, in order to be able to advance the insertion system to the desired location. With regard to the implementation of the guide wire (s), the proximal section can overall be designed in the shape of a shaft with an inner cavity (over-the-wire = OTW technology). However, it is also possible for the guide wires to exit via a port proximal to the implant, similar to what is the case with Rx catheters (Rapid Exchange Catheters). The implant may have a Y-shape with a third proximal tubular implant section intended to be placed in the blood vessel of the parent. This third proximal implant section is connected to the two other tubular distal implant sections for the branching blood vessels at the branch point, so that the blood flow from the blood vessel of the parent into the branching blood vessels is ensured. The third tubular implant section is applied to the proximal shaft section, ie the proximal implant section surrounds the proximal shaft section.

The third tubular implant section can have one or more detachable connection points with the proximal shaft section, in particular chemically, thermally, electrolytically or mechanically detachable connection points being possible. Such release techniques are basically known from the prior art.

The attachment points between the tubular distal implant sections and the shaft sections can also be connection points at which a chemically, thermally, electrolytically or mechanically detachable connection is present. The loosening of the connection points can be controlled accordingly by setting the corresponding parameters.

Chemically, thermally or electrolytically detachable connection points are understood to be connection points which can be dissolved by chemical or thermal action or electrolytically by applying an electrical voltage at least to such an extent that the respective implant section detaches from the shaft section.

The connection points can be adhesive connection points, a polymer adhesive preferably being used. In this case, the implant is detached chemically, namely typically by applying a solvent which at least partially dissolves the adhesive. As a solvent, for. B. DMSO (dimethyl sulfoxide) can be used. Under a chemically soluble

Connection point is also understood to be a connection point which is released solely by the action of the surrounding blood.

There are several ways to get a solvent to the joint. For example, a tube or the like can be guided past the outside of the implant and the shaft sections in order to apply a solvent at the connection points. However, it is preferred to supply the solvent to the connection points through the interior of the shaft sections via a supply system bring, which runs at least temporarily through the inner cavities of the shaft sections. This can take place through a hose or also through a tube provided for this purpose in the interior of the shaft sections. A prerequisite for this is, of course, that the shaft sections on the one hand have an inner cavity and on the other hand a certain permeability of the outer wall so that the solvent applied on the inside can pass through the shaft sections and loosen the adhesive connection points. Finally, it is also possible to provide one or more solvent reservoirs in the area of the connection points, which can be controlled and opened externally in such a way that the solvent acts on the connection point. Such solvent reservoirs can in principle also be provided on the outside of the shaft sections, provided that the release of the solvent from outside the body is controlled.

Another possibility is the electrolytic detachment of the connection points. In this case, the connection point is at least partially dissolved by applying an electrical voltage. Mostly it is a direct current, whereby a low current strength (<3 mA) is sufficient. The connection point usually consists of metal and, when the electrical voltage is applied, forms the anode at which the oxidation and thus the dissolution of the metal takes place.

The electrolytic detachment takes place by applying an electrical voltage to the connection point with the aid of a voltage source. The electrolytic detachment of implants is well known from the prior art, for example for occlusion coils for closing aneurysms, cf. B. WO 2011/147567 A1. While the junction serves as an anode, the cathode can e.g. B. be positioned on the body surface. Alternatively, another area of the device can also form the cathode. Of course, the connection point must be connected to the voltage source in an electrically conductive manner. The shaft sections themselves can serve as conductors; alternatively, a conductor can run through the interior of the shaft sections or along the outside of the implant. Since, when the cathode is placed on the body surface, the resulting corrosion current is controlled by the area of the cathode, the area of the cathode should be chosen to be significantly larger than the area of the anode. To some extent, the speed at which the joint dissolves can be adjusted by adjusting the Control cathode area in relation to anode area. The device according to the invention can thus also comprise a voltage source and, if necessary, an electrode that can be placed on the body surface. For example, stainless steel, magnesium, magnesium alloys or cobalt-chromium alloys are suitable as materials for the connection point to be electrolytically dissolved. A particularly preferred alloy magnesium Resoloy ^®, which was developed by the company MeKo from Sarstedt / Germany (see. WO 2013/024125 A1). It is an alloy of magnesium and, among other things, lanthanoids, especially dysprosium. Another advantage of using magnesium and magnesium alloys is that magnesium residues remain in the body without physiological problems.

In the case of a thermally detachable connection point, a heat source can be brought to the connection points to be detached in order to detach the implant. This can be done from the outside by passing a heat source past the implant in order to apply thermal energy to the connection points. However, the shaft sections are preferably designed to be hollow on the inside, so that a heat source can also be brought to the connection points to be released through the interior of the shaft sections. The heating of the respective shaft section inside at the position at which there is a connection point on the outside ensures that the connection point is released. It is also possible to provide thermally detachable connection points that detach solely through the action of body temperature; however, in this case premature detachment must be prevented, for example by bringing the insertion system and implant to the target position using a microcatheter, with one inside the microcatheter the temperature is lower.

Finally, it is also possible to heat all or a section of the shaft sections to such an extent that the connection points loosen and the implant is released.

In the case of thermal detachability, the connection point should be designed in such a way that, on the one hand, the implant is securely held on the shaft sections, but on the other hand no excessively high temperatures have to be applied in order to achieve detachment. The at least partial dissolution of the connection point preferably takes place at a temperature between 40 and 80.degree. C., in particular between 50 and 70.degree. Appropriate materials for the Connection points, for example polymers or low-melting metals, are known from the prior art.

Another possibility of fixing the tubular implant sections provided for placement in the branching blood vessels on the shaft sections is to place caps on the distal ends of the distal tubular implant sections that prevent the implant sections from expanding radially. These caps can be removed from the distal ends in the distal direction, in particular they can be pushed off, in order in this way to release the implant. The caps can in particular have a cylindrical design, the distal end of the caps generally being largely closed, apart from a small opening for the passage of a wire, as described further below. The inner diameter of the caps must be such that expansion and exposure of the distal implant sections is prevented when the cap is in place. The detachment of the caps can in particular be brought about by guiding push wires at least temporarily through the inner flea spaces of the distal shaft sections. These push wires are designed in such a way that the advancement of the push wires in the distal direction causes the caps to be pushed off the distal ends of the distal implant sections. For this purpose, the push wires can, for example, have thickenings that are attached at or near the distal end.

Particularly preferred is the provision of push wires which run through openings provided for this purpose in the caps, the push wires having thickenings distal and proximal to the openings and the thickening of a push wire located further proximally ensuring that the thickening is attached to the distal when advancing in the distal direction On the inside of the cap and pushes it off the implant when further force is exerted, while the distal thickenings ensure that the push wires are held in their positions and do not slip out of the openings in the caps. The thickenings should have a diameter which is larger than the diameter of the openings in the caps provided for the push wires, otherwise the push wires will become detached from the caps would be possible. In particular, the thickenings can be spherical.

In order to further improve the closure of the aneurysm, in addition to the decoupling of the aneurysm from the blood flow through the implant, occlusion means, for example coils as are known from the prior art, can also be introduced into the aneurysm. It is also possible to introduce viscous embolizates such as onyx, an ethylene-vinyl alcohol copolymer, or cellulose-acetate polymers.

The following statements on the implant apply regardless of the various embodiments of the delivery system that are described in this application.

The implant itself is composed of two, preferably three tubular implant sections, it being possible for the implant to be in an expanded state in which it is implanted in the blood vessel and in a contracted state in which it can be moved through the blood vessel. Two tubular implant sections for placement in the branching blood vessels are mandatory, and there is preferably a third, proximal implant section for placement in the blood vessel of the blood. The implant is placed in such a way that the distal side of the branching point comes to rest in front of the aneurysm in order to cut it off from the blood flow. This side of the branch point should therefore be as tight as possible. The inside of the implant, on the other hand, is free, so that the blood flow through the stem blood vessel and the two branching blood vessels is unhindered. The implant sections preferably have a circular cross section when viewed from the proximal or distal end. In principle, however, deviations from the circular shape are also possible, for example an oval cross-section. As far as tubular implant sections are spoken of according to the invention, this particularly refers to the expanded state of the implant, the corresponding implant sections generally also being tubular in the contracted state, albeit with a smaller cross-section. With regard to the basic structure of the implant, it is typically a flow diverter, as has long been known in the prior art as a simple tubular object for side wall aneurysms. However, the flow diverter is specially adapted to the treatment of bifurcation aneurysms, ie it is a bifurcation flow diverter. As a rule, it is a lattice structure made of wires, filaments or struts with openings between them. The lattice structure of the implant can be a braided structure, ie it can consist of individual wires or wire bundles as struts which are braided with one another and run above and below one another at the crossing points of the wires / wire bundles. It can also be a cut structure 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 it can also be a plastic. It must have sufficient elasticity to allow contraction and, on the other hand, expansion to the desired diameter when released. In addition, it makes sense to subject the grid structure to an electro-polish in order to make it smoother and more rounded and thus less traumatic. In addition, the risk of germs or other contaminants adhering is reduced. The struts or wires can have a round, oval, square, rectangular or trapezoidal cross-section, with rounding of the edges being advantageous in the case of a square, rectangular or trapezoidal cross-section. The use of flat webs / wires in the form of thin strips, in particular metal strips, is also possible.

The implant largely or completely decouples the bifurcation aneurysm from the blood flow, since at least some of the wires come to rest in front of the aneurysm neck. The blood flow through the blood vessel of the bloodstream into the branching blood vessels is, however, practically unaffected. As a result, the aneurysm becomes obliterated by the formation of a thrombus due to the lack of blood movement in the aneurysm, which closes the aneurysm. When providing a flow diverter for bifurcations or for the treatment of bifurcation aneurysms, for example, it is possible to attach a side branch for a branching blood vessel to a conventional flow diverter, whereby a passage into the side branch for the blood flow must of course be ensured at the branch. Alternatively, a additional branch for the blood vessel of the blood vessel can be set up, which has the advantage that there is no seam in the area of the aneurysm itself that could impair the blood flow into the aneurysm. Finally, only two-armed implants are conceivable in which the two distal tubular implant sections are placed in the branching blood vessels, but none in the blood vessel trunk. In this case, too, it must of course be ensured that the blood can flow from the blood vessel stem into the branching blood vessels, which is why the implant has an opening in the direction of the blood vessel stem. An advantage, just as when the section for the blood vessel is attached, is to be seen in the fact that in the area of the aneurysm itself there are no seams or other irregular mesh or mesh densities.

According to a preferred embodiment of the implant, this has a first braid structure which is tubular in the expanded state and the wall of which is made up of individual interwoven wires, the first braid structure branching into a second and a third braid structure at a branching point located at one branch end , wherein the second and the third braid structure are tubular in the expanded state and their walls are made up of individual interwoven wires and some of the wires that form the first braid structure merge into the second braid structure at the branch point, and a further part of the wires , which form the first braid structure, merges into the third braid structure at the branching point.

Such a bifurcation flow diverter has a braided Y-structure, ie the implant consists of wires which are braided with one another by being led above and below one another. Such a structure is particularly suitable for expanding in the blood vessel after it has been released and adapting to the vessel walls. The implant has three interconnected tubular braid structures, the second and the third braid structure starting from the first braid structure. The fact that the wires that form the first braid structure are at least partially converted into the second or third braid structure is important. In other words, some of the wires that form the first braid structure merge at the branch point into the second, and some into the third braid structure. Preferably the implant is like this constructed so that all the wires that are present at the end of the first braid structure where it meets the two other braid structures (branching end) are transferred into the second and third braid structure, one in the second, the other in the third braid structure. It has been found that in this way a particularly good adaptation of the implant to the blood vessels takes place and, in addition, a sufficiently high surface coverage in the area of the aneurysm neck is achieved, which serves to prevent the blood flow into the aneurysm and thus to obliterate and eliminate the aneurysm. The number of wires that form the first braid structure can, for. B. 24 to 96. For example, of two wires in each case which form a crossing point at the branching end of the first braid structure, one wire can merge into the second and one wire into the third braid structure. Alternatively, z. B. two wires at the branch end of the first

Braid structure form a first intersection point, merge into the second braid structure, and two wires each at the branch end of the first

Braid structure form a crossing point adjacent to the first crossing point, merge into the third braid structure.

Another possibility of providing a Y-shaped bifurcation flow diverter implant is to provide a first and a second braid section, which in the expanded state are tubular and the walls of which are made up of individual interwoven wires, the first and the second braid section each have an opening in the wall and at least the size of the opening in the second braid section is sufficient for the passage of the first braid section, the openings in the walls being produced by the fact that the wires forming the braid sections are located radially at the positions of the openings are displaced, and the first braid section is guided through the opening in the wall of the second braid section that the opening in the wall of the first braid section faces the opening in the wall of the second braid section. The openings in the braid sections are produced in that at the respective positions the wires forming the braid section are displaced laterally, ie radially over the circumference of the braid section. An opening is not created by cutting out wires, but the wires themselves are retained without an interruption being introduced into the wires. The wires are only shifted sideways. This is important insofar as it allows reliable transport of the implant in the compressed / contracted state to the target position. The advancement of interrupted wires, on the other hand, is often not possible without further ado. Furthermore, the design of the implant with uninterrupted wires allows the implant to expand easily at the target position in the blood vessel. Since, according to the invention, the wires are not interrupted, the expansion is unproblematic. Finally, the formation of disadvantageous loose wire ends which could injure the vessel walls is avoided. The number of wires that form the respective braid sections is advantageously 24 to 96, more preferably 36 to 64, which is to be understood as the number per braid section. The first and the second braid section can be attached to one another in the region of their openings, e.g. B. be sewn.

Such an implant can be produced by first producing two mesh sections, each with an opening in the side wall. The first braid section is then passed through the opening in the second braid section and partially pulled through the interior of the second braid section. Alignment takes place in such a way that the two openings of the braid sections face one another. In this way, a passage is created in the transition area so that the blood flowing in from the trunk blood vessel can flow into both branching blood vessels without any problems.

The first and second braid sections can be connected to one another at the outer end of the segment in the segment in which the two braid sections run together. In this case, the implant is typically produced differently, namely by first providing a braided structure which is tubular in the expanded state and the wall of which is made up of individual interwoven wires, the braid structure having a first and a second braid section extending in the longitudinal direction adjoin one another and are arranged one behind the other, both braid sections each having an opening in the wall and at least the size of the opening in the second braid section is sufficient for the passage of the braid structure, the two openings being arranged on opposite sides of the braid structure and the first braid section inward turned inside out, through the inside of the second Braid section and is guided through the opening in the second braid section from the inside to the outside, in such a way that the opening in the wall of the first braid section points to the opening in the wall of the second braid section. A braid structure with two braid sections is therefore assumed, the first braid section first being pulled through its own interior and then at least partially through the interior of the second braid section, similar to when a sock is turned inside out. By having the two

Sections of braid at the outer end of the segment in which the two

Mesh sections are connected to one another, that is to say run in two layers, there are no free wire ends at this point, which is advantageous in that the risk of damage to the vessel wall is reduced. It also prevents wire ends from protruding into the vessel lumen (so-called fish-mouth effect) and obstructing the blood flow.

In order to ensure that the implant automatically expands after being released in the blood vessel and adapts to the inner walls of the blood vessels, it is preferred to manufacture the wires at least partially from a material with shape memory properties. Nickel-titanium alloys, for example nitinol, or also ternary nickel-titanium-chromium alloys or nickel-titanium-copper alloys are particularly preferred in this context. However, other shape memory materials, for example other alloys or also shape memory polymers, are also conceivable. Materials with shape memory properties make it possible to impress a secondary structure on an implant, which it automatically tries to adopt as soon as it is no longer hindered from expansion.

Also possible is the use of so-called. DFT ^® (Drawn Filled Tubing) wires, that is wires, in which the core of the wire made of a different material than the jacket surrounding the core. In particular, it is advisable to use wires with a core made of a X-ray visible material and a sheath made of a material with shape memory properties. The X-ray visible material can for example be platinum, a platinum-iridium alloy or tantalum, the material with shape memory properties is, as already mentioned, preferably a nickel-titanium alloy. Such DFT ^® from wires, for example, offered by Fort Wayne Metals. Corresponding wires combine the advantageous properties of two materials. The shell with shape memory properties ensures that the implant can expand and adapt to the vessel walls, the X-ray visible material ensures that the implant is visible in the X-ray image and can thus be observed by the attending physician and can be positioned accordingly.

The distal and proximal ends of the wires are preferably designed in such a way that damage to the vessel walls is excluded. For example, wires can be rounded at their ends and thus atraumatic. Corresponding reshaping can be carried out by remelting with the aid of a laser. It is also possible to bring one or more wires together at the respective ends and thereby create a closure that is as atraumatic as possible. In particular, it is useful to avoid pointed wire ends.

Advantageous coverage rates of the implant, in particular also at the branching point at which the aneurysm neck is implanted, are 45 to 75%, preferably 35 to 65%, for the implant in the expanded state.

Unless otherwise evident from the context, an expanded state is understood according to the invention to be a state which the implant assumes when it is not subject to any external restrictions. Depending on the diameter of the blood vessels in which the implant is implanted, the expanded state in the blood vessel system can deviate from the expanded state without any external restrictions, because the implant may not be able to assume its fully expanded state. In the fully expanded state, the implant sections advantageously have an outer diameter between 1.5 mm and 7 mm, which can be adapted to the respective location in the blood vessel system. The total length of the implant in the expanded state is usually between 5 mm and 100 mm, in particular between 10 and 50 mm, if the implant is placed in such a way that the two distal implant sections of the Y-shaped implant for the branching blood vessels are parallel and in the run in the same direction as the proximal implant section for the blood vessel. The wires or struts forming the implant can, for. B. have a diameter or a thickness between 20 and 60 pm. On the other hand, the implant can also be in a contracted or compressed state, the terms in the context of this invention being used synonymously in the sense that the implant or an implant section in the contracted / compressed state has a significantly smaller radial extent than in the expanded state. A contracted / compressed state is e.g. B. assumed when the implant is brought to the target position through a catheter and within the sleeves or on shaft sections.

The implant and / or the insertion system according to the invention in the form of the shaft sections or sleeves described generally have radiopaque / radiopaque marker elements that facilitate visualization and placement at the implantation site. Such marker elements can, for. B. in the form of wire windings, as sleeves and as slotted pipe sections, which are fixed on the implant and / or the delivery system. In particular, platinum and platinum alloys come into consideration as materials for the marker elements, for example an alloy of platinum and iridium, as is often used in the prior art for marker purposes and as a material for occlusion coils. Other radiopaque metals that can be used are tantalum, gold and tungsten. Another possibility is to fill the wires with an X-ray visible material, as mentioned above. It is also possible to provide the implant, in particular the wires, with a coating made of a radiopaque material, for example with a gold coating. This can e.g. B. have a thickness of 1 to 6 pm. The coating with a radiopaque material does not have to encompass the entire implant. Even if a radiopaque coating is provided, however, it can be useful to additionally apply one or more radiopaque markers to the implant, in particular to the distal end of the implant.

The implant can also have membranes which at least partially cover the implant sections, it being possible to use both a membrane which extends over larger areas of the implant sections and a plurality of small membranes. Such a membrane is particularly useful at the aneurysm neck in order to cut off the aneurysm from the blood flow, ie at the branch point in the distal direction. A cover by a membrane is understood to mean any type of cover, ie the membrane can be applied to the outside of the implant sections, attached to the inside of the implant sections, or the wires / struts of the implant sections are embedded in the membrane. If one or more membranes are used, it is also possible to introduce X-ray visible substances into the membranes. These can be X-ray-visible particles, such as are usually used as contrast media in X-ray technology. Such radiopaque substances are, for example, heavy metal salts such as barium sulfate or iodine compounds. The X-ray visibility of the membrane is helpful for the introduction and localization of the implant and can be used in addition to or instead of marker elements.

Membranes can also be designed in such a way that they have an antithrombogenic or endothelial-promoting effect. Such an effect is particularly desirable where the implant adjoins normal vessel walls because the blood flow through the vessels is not impaired and, moreover, the implant should be well anchored in the blood vessel system. The membranes can have the appropriate properties by themselves by appropriate selection of the material, but they can also be provided with coatings that produce these effects.

According to the invention, a membrane is understood to be a thin structure with a flat extension, regardless of whether it is permeable, impermeable or partially permeable to liquids. To fulfill the purpose of treating an aneurysm, however, membranes are preferred which are completely or at least largely impermeable to liquids such as blood. In addition, a membrane can also be provided with pores, particularly in the area of the aneurysm neck, through which occlusion means can be introduced into the aneurysm. Another possibility is to design the membrane in such a way that it can be pierced with a microcatheter for the introduction of occlusion means or with the occlusion means itself. The membranes can be constructed from polymer fibers or films. The membranes are preferably produced by electrospinning. The wires are usually embedded in the membrane. This can be achieved by spinning or braiding the wires with fibers. In electrospinning, fibrils or fibers are deposited on a substrate from a polymer solution with the aid of an electric current. During the deposition, the fibrils stick together to form a fleece. As a rule, the fibrils have a diameter of 100 to 3,000 nm. Membranes obtained by electrospinning are very uniform. The membrane is tough and mechanically resilient and can be pierced mechanically without the opening becoming a 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 for it, reference is made in particular to WO 2008/049386 A1, DE 28 06 030 A1 and the literature cited therein.

Instead of electrospinning, the membranes can also be produced using a dipping or spraying process such as spray coating. With regard to the material of the membranes, it is important that they are not damaged by the mechanical stress when they are introduced into the blood vessel system. The membranes should therefore have sufficient elasticity.

The membranes can be made from a polymer material such as polytetrafluoroethylene, polyester, polyamides, polyurethanes, polyolefins or polysulfones. Polycarbonate urethanes (PCU) are particularly preferred. In particular, an integral connection of the membranes to the wires is desirable. Such an integral connection can be achieved through covalent bonds between the membranes and the wires. The formation of covalent bonds is promoted by silanizing the wires, that is to say by chemically bonding silicon compounds, in particular silane compounds, to at least parts of the surface of the wires. Silicon and silane compounds bind to surfaces, for example to hydroxyl and carboxy groups. In addition to silanization, other methods of promoting adhesion between wires and membranes are also conceivable. Regardless of the embodiment, the invention can be used in particular in the neurovascular area, but applications of the devices in other areas of the blood vessel system, for example cardiovascular and peripheral, are also possible. Depending on the intended use, the dimensions of the components of the delivery system must be coordinated and adapted. For example, implants with tubular implant sections with a small cross section are used in particularly small blood vessels. The outer diameters and lumens of sleeves, sleeve sections and shaft sections should also be matched to the implants accordingly. The term guide wire is to be understood broadly in the context of the invention and can be solid in cross-section as well as equipped with an inner cavity.

In addition to the insertion systems themselves, the invention also relates to combinations of insertion systems, implants, microcatheters and / or other aids such as guide wires and feed devices. According to the invention, two guide wires in particular can be used for placing the implant in the two branching blood vessels. The invention also relates to the use of the insertion system for inserting implants for the treatment of arteriovenous malformations, in particular (bifurcation) aneurysms. The invention also relates to a corresponding method. All statements made about the delivery system itself also apply in a corresponding manner to the combination with other components, the use and the method.

The invention is explained in more detail by way of example with reference to the figures. It should be pointed out that the figures show preferred embodiment variants of the invention, but the invention is not restricted thereto. In particular, as far as it is technically sensible, the invention includes any combination of the technical features that are listed in the claims or described in the description as being relevant to the invention. All statements made in relation to an embodiment of the invention apply in the same way to the other embodiments of the invention, unless the context indicates otherwise. Show it:

1 shows a Y-shaped implant with two distal and one proximal tubular implant sections;

2 shows a further Y-shaped implant with two distal and one proximal tubular implant sections;

3 shows an implant with two distal tubular implant sections without a proximal implant section;

4 shows an insertion system according to the invention according to a first one

Embodiment;

5 shows an insertion system according to the invention according to a second

Embodiment;

6 shows a further variant of the second embodiment of the

Delivery system;

7a shows an insertion system according to the invention in accordance with a third

Embodiment;

FIG. 7b shows the insertion system according to FIG. 7a in a sectional illustration; FIG.

8 shows the insertion system according to FIGS. 7a, b with the implant placed in front of an aneurysm;

9 shows the insertion system with an applied implant according to FIG. 8 in a sectional illustration and FIG

10 shows a further variant of the third embodiment of the insertion system.

FIG. 1 shows an implant 1, ie a bifurcation flow diverter, as it can be introduced into the blood vessel system with the aid of the introduction system according to the invention and placed in front of a bifurcation aneurysm. The implant 1 has three tubular implant sections 2, 3, of which the two distal implant sections 2 are placed in the branching blood vessels, while the proximal stem section 3 is anchored in the stem blood vessel. The aneurysm is located distal to the branch point 4 between the two distal implant sections 2. The blood flow from the main blood vessel into the two branching blood vessels is shown with the arrows. The implant 1 shown here is essentially a round braid that merges from the proximal stem section 3 into one of the two distal implant sections 2, with a branching branch also being attached as a further distal implant section 2. Of course, the connection between the individual implant sections 2, 3 must be such that the blood flow is also guaranteed in the second, attached distal implant section 2. In addition, the aneurysm should be well covered by a dense network of wires or bars.

FIG. 2 shows an implant 1 which essentially corresponds to the implant from FIG. 1, but here a continuous tubular structure was assumed for the two branching blood vessels and a side branch was added as a proximal trunk section 3. Here too, of course, the permeability for the blood flow from the blood vessel trunk into the two branching blood vessels must be guaranteed in accordance with the direction of the arrow. A certain advantage over the variant from FIG. 1 can be seen in the fact that in the area distal to the branching point 4 there are no seams or irregular meshes or

Braid densities are to be expected, which under certain circumstances could cause excessive permeability in the direction of the aneurysm.

A further implant 1 is shown in FIG. 3, which manages without a proximal stem section, but only consists of two distal implant sections 2. In this case, too, it is important to cover the aneurysm distal to the branch point 4 Arrows symbolizes can flow. In Figure 4, the delivery system according to the invention is according to a first

Embodiment shown together with the implant 1 to be introduced. The The insertion system has two sleeves 5, in the distal sleeve sections 6 of which the distal implant sections 2 are accommodated. In the proximal direction, proximal sections 8 adjoin the distal sleeve sections 6, so that the sleeves 5 as a whole can be withdrawn in the proximal direction in order to release the implant 1. The proximal sections 8 can also be designed in the form of a sleeve or hose. A third sleeve is provided as a stem sleeve 9 and surrounds the proximal stem section 3 of the implant 1. The stem sleeve 9 can also be withdrawn in the proximal direction for the purpose of releasing the proximal stem section 3. So that the implant 1 or the distal implant sections 2 can emerge from the distal sleeve sections 6, these are equipped with opening zones 7. These are longitudinal slots which run over a certain area in the longitudinal direction along the sleeves 5. The opening zones 7 extend from the distal end of the distal sleeve sections 6 so far in the proximal direction that the distal implant sections 2 can pass through completely when the sleeves 5 are withdrawn in the proximal direction. On the other hand, proximal to the opening zones 7, the sleeves 5 can essentially be designed as a simple sleeve or tube, since the passage of the implant 1 is no longer important in this area. The insertion system can be brought into the intended position by a microcatheter 10. As soon as this position has been reached, the microcatheter 10 can initially be withdrawn at least so far in the proximal direction that the insertion system with the implant 1 located on the inside is exposed. The sleeves 5 can then be withdrawn simultaneously or one after the other in the proximal direction in order to release the two distal implant sections 2, whereupon these expand and lie against the inner wall of the branching blood vessels. As a rule, the proximal implant section 3 is released last, in that the stem sleeve 9 of the insertion system is withdrawn in the proximal direction. In FIG. 5, a first variant of an insertion system according to the second embodiment is shown without an implant. The delivery system has a sleeve 11 which has two distal sleeve arms 12. The distal sleeve arms 12 are provided for receiving the distal implant sections 2. With the two distal Sleeve arms 12 are connected to the proximal sleeve arm 13, in which the proximal implant stem section 3 is received.

The two distal sleeve arms 12 have a slot 14 which extends from the distal end of the first distal sleeve arm 12 to the distal end of the second distal sleeve arm 12. The slot 14 is designed so that the edges along the slot 14 do not overlap at the distal ends of the distal sleeve arms 12, whereas the slot edges overlap in the area of the branching from the proximal sleeve arm 13 into the two distal sleeve arms 12. This has the effect that when the sleeve 11 is withdrawn, the implant initially emerges from the slot 14 at the distal end of the distal implant sections 2 and begins to widen, while regions of the implant 1 located further proximally only emerge from the sleeve 11 at a somewhat later point in time. Correspondingly, the distal areas of the implant 1 first come into contact with the inner wall of the blood vessel and only at a slightly later point in time the more proximal areas, which is advantageous in the context of the controlled release of the implant 1.

In FIG. 6, an insertion system is shown which essentially corresponds to that from FIG. The size of the openings within the perforation 15 increases from proximal to distal; H. In the area of the branching between the two sleeve arms 12, the size of the openings is relatively small, but significantly larger at the distal ends of the distal sleeve arms 12. The perforation 15 thus tears when the sleeve 11 is withdrawn in the proximal direction, initially at the distal end of the distal sleeve arms 12, so that here too the implant emerges from the sleeve 11 first and can expand. Only slightly later is the implant released further proximally, because here tearing open the perforation 15 requires more force. The implant is thus released gradually from distal to proximal.

FIG. 7a shows the insertion system according to a third embodiment, in which the implant to be inserted is applied on the outside. The implant itself is not shown here. It is a Y-shaped inner shaft system with a proximal shaft section 17 which branches into two distal shaft sections 16. The delivery system is attached to the intended use via two guide wires 18 Positioned, with one of the guide wires 18 being inserted into the first and the other guide wire 18 into the second branching blood vessel in order to then be able to bring the insertion system over the guide wires 18 to the corresponding position, with the two distal shaft sections 16 simultaneously in the respective branching blood vessels.

FIG. 7b shows the insertion system from FIG. 7a, but in a sectional view, i.e. H. it can be seen how the guide wires 18 initially run parallel through the proximal shaft section 17 in order to then branch into the two distal shaft sections 16. FIG. 8 shows the system from FIG. 7 with the implant 1 applied in the blood vessel system. The delivery system was brought in front of an aneurysm 22, the two distal shaft sections 16 being placed in the branching blood vessels 21 and the proximal shaft section 17 being placed in the blood vessel 20. The implant 1 in turn has two distal implant sections 2 and the proximal implant stem section 3. At the two distal ends of the distal implant sections 2, the implant 1 is connected to the distal shaft sections 16 via attachment points 19. The fixing points 19 can be, for example, chemically or electrolytically dissolvable connection points, i. H. a detachment of the implant 1 from the distal shaft sections 16 leads to the implant 1 expanding and detaching from the shaft sections. The shaft sections 16, 17 belonging to the insertion system can then be withdrawn in the proximal direction, while the implant 1 remains at the desired location in the blood vessel system in front of the aneurysm neck.

The insertion system including the implant 1 is brought to the intended position via a microcatheter 10. The release of the implant 1 in the region of the proximal implant stem section 3 typically takes place by withdrawing the microcatheter 10 in the proximal direction.

FIG. 9 shows the insertion system with implant 1 from FIG. 8 in a sectional view, it being possible to see how the guide wires 18 run through the interior of the shaft sections 16, 17, while the distal implant sections 2 are on the two distal ones Shaft sections 16 are applied and the proximal implant stem section 3 is seated on the proximal shaft section 17.

Finally, FIG. 10 shows an alternative form for fixing the distal implant sections 2 on the insertion system, the distal shaft sections being largely omitted here. Caps 23 are pulled over the distal ends of the distal implant sections 2, which prevent the distal implant sections 2 from expanding as long as the caps 23 are on the distal implant sections 2. In order to remove these from the implant sections 2, push wires 24 are pushed in the distal direction. The push wires 24 run through small openings at the distal ends of the caps 23 and have thickenings 25, so that the more proximally located thickenings 25 take the caps 23 with them when the push wires 24 are advanced in the distal direction and remove them from the implant sections 2. The further distal thickenings 25 are provided to prevent the push wires 24 from loosening from the caps 23. In addition, radiopaque markings 26 are provided on the proximal shaft section 17, which allow the implantation process to be visualized.

Claims

1. Insertion system for an implant (1) for influencing the blood flow in the area of aneurysms (22) which are localized at branching vessels, the implant (1) having two distal tubular implant sections (2) which are intended to be drawn in from the blood vessel (20) branching blood vessels (21) to be placed, and which are connected to one another at a branching point (4), characterized in that the insertion system has two sleeves (5) which are each configured to receive a distal tubular implant section (2) , wherein the two sleeves (5) each have a distal sleeve section (6) and the distal sleeve sections (6) each have an opening zone (7) running in the longitudinal direction, with a proximal section (6) each adjoining the distal sleeve sections (6). 8), via which the sleeves (5) can be withdrawn in the proximal direction, so that the opening zones (7) open and the di stal tubular implant sections (2) each pass through the opening zones (7) and are released in the branching blood vessels (21).

2. Delivery system according to claim 1, characterized in that the opening zones (7) are longitudinal slots.

3. Delivery system according to claim 1 or 2, characterized in that the sleeves (5) are constructed from a flexible hose material at least in the region of the distal sleeve sections (6).

4. Delivery system according to one of claims 1 to 3, characterized in that the proximal sections (8) are sleeve-shaped or tubular.

5. Delivery system according to one of claims 1 to 3, characterized in that the proximal sections (8) are wire, filament or strip-shaped.

6. Delivery system according to one of claims 1 to 5, characterized in that the insertion system has a stem sleeve (9) for the

Receiving a tubular stem section (3) of the implant (1) is provided, wherein the stem sleeve (9) can be withdrawn in the proximal direction to release the stem section (3).

7. Insertion system according to claim 6, characterized in that the stem sleeve (9) is constructed from a flexible hose material.

8. Delivery system for an implant (1) for influencing the blood flow in the area of aneurysms (22) which are localized at branching vessels, the implant (1) having two distal tubular implant sections (2) which are intended to be drawn in from the blood vessel (20) branching blood vessels (21) to be placed, and which are connected to one another at a branch point (4), wherein the insertion system has a sleeve (11) with two distal sleeve arms (12), each for receiving a distal tubular implant section ( 2) are configured and connected to one another, the sleeve (11) having a continuous opening zone (14, 15) in the distal direction, the sleeve (11) having a proximal section (13) over which the sleeve (11) extends in can be withdrawn in the proximal direction so that the opening zone (14, 15) opens and the distal tubular implant sections (2) each pass through the opening zone (14, 15) and into the branching blood vessels (21) are released, characterized in that the opening zone (14, 15) is such that the sleeve (11) moves sequentially from the distal ends of the distal sleeve arms (12) when the implant (1) is released opens in the proximal direction.

9. Delivery system according to claim 8, characterized in that the opening zone (14, 15) comprises a distal facing continuous slot (14), the edges of the slot (14) at least partially overlap in such a way that the overlap of increases distal to proximal.

10. Delivery system according to claim 8, characterized in that the opening zone (14, 15) comprises a zone of weakness pointing in the distal direction, the zone of weakness being such that the force required for opening increases from distal to proximal.

11. Delivery system according to claim 10, characterized in that the

Zone of weakness is a perforation (15).

12. Delivery system according to one of claims 8 to 11, characterized in that the proximal section (13) is a proximal sleeve arm which is provided for receiving a tubular stem section (3) of the implant (1).

13. Insertion system for an implant (1) for influencing the blood flow in the area of aneurysms (22) which are located at branching vessels, the implant (1) having two distal tubular implant sections (2) which are intended to be drawn in from the blood vessel (20) branching blood vessels (21) to be placed, and which are connected to one another at a branching point (4), the two distal tubular implant sections (2) in an expanded state in which they are implanted in the branching blood vessels (21) , and are in a contracted state in which they are movable through the blood vessel system, characterized in that the delivery system has two distal shaft sections (16) which extend through the distal tubular implant sections (2) and which are adjacent to the branching point (4) are connected to one another, with a proximal Ab This is followed by a cut (17), via which the distal shaft sections (16) can be withdrawn in the proximal direction, the distal tubular implant sections (2) being detachably fixed on the distal shaft sections (16) so that the distal tubular implant sections (2) after loosening assume their expanded structure and are released in the branching blood vessels (21).

14. Delivery system according to claim 13, characterized in that

Attachment points (19) between the distal tubular Implant sections (2) and the distal shaft sections (16) are located at least at the distal ends of the implant (1).

15. Delivery system according to claim 13 or 14, characterized in that the distal shaft sections (16) are constructed from a flexible hose material.

16. Delivery system according to one of claims 13 to 15, characterized in that the proximal section (17) is a shaft section.

17. Delivery system according to claim 16, characterized in that the proximal shaft section (17) is constructed from a flexible hose material.

18. Delivery system according to claim 16 or 17, characterized in that the implant (1) has a third, proximal tubular implant section (3) which is intended to be placed in the blood vessel (20), the proximal tubular implant section (3 ) is connected to the two distal tubular implant sections (2) for the branching blood vessels (21) at the branch point (4) and wherein the proximal tubular implant section (3) is applied to the proximal shaft section (17).

19. Introduction system according to claim 18, characterized in that the proximal tubular implant section (3) has at least one chemically, thermally, electrolytically or mechanically detachable connection point with the proximal shaft section (17).

20. Delivery system according to one of claims 13 to 19, characterized in that the attachment points (19) between the distal tubular implant sections (3) and the distal shaft sections (16) are connection points at which a chemically, thermally, electrolytically or mechanically detachable connection is present.

21. Delivery system according to claim 19 or 20, characterized in that at least some of the connection points (19) are adhesive connection points.

22. Delivery system according to claim 21, characterized by a supply system for solvent, which at least temporarily runs through the inner cavities of the shaft sections (16, 17) and through which a solvent can be applied to the adhesive connection points (19).

23. Delivery system according to claim 19 or 20, characterized in that at least some of the connection points (19) are electrolytically detachable metallic connection points.

24. Delivery system according to claim 23, characterized in that the metallic connection points (19) are constructed from magnesium or a magnesium alloy.

25. Delivery system according to one of claims 13 to 20, characterized in that the two distal tubular implant sections (2) provided for placement in the branching blood vessels (21) are fixed on the distal shaft sections (16) in that the distal ends the distal tubular implant sections (2) are fitted with caps (23) which prevent radial expansion of the distal implant sections (16) and which can be pushed in the distal direction from the distal ends in order to release the implant (1).

26. Delivery system according to claim 25, characterized by at least two push wires (24) which at least temporarily through the inner cavities of the distal

Shaft sections (16) on which the distal tubular implant sections (2) for the branching blood vessels (21) are applied, the push wires (24) being designed in such a way that pushing the push wires (24) in the distal direction pushes them off of the caps (23) is made from the distal ends of the distal tubular implant sections (2).

27. Delivery system according to claim 26, characterized in that the push wires (24) run through openings provided for this purpose in the caps (23), the push wires (24) having thickenings (25) distal and proximal to the openings.