Device for introducing an implant

By using devices with elongated axis and shape memory materials in the blood vessels, the difficulty of insertion of cylindrical implants and the problem of retention of connection points is solved, safe, rapid implantation and stable intravascular placement are achieved, and blood flow obstruction is avoided and blood vessel damage.

CN112165921BActive Publication Date: 2025-01-14PHENOX GMBH
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Patent Information

Application Number
CN201980035391.1
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2018-04-20
Filing Date
2019-04-16
Publication Date
2025-01-14
Estimated Expiration
2039-04-16

AI Technical Summary

Technical Problem

The prior art encounters difficulties in inserting cylindrical design intravascular implants into blood vessels, especially when the implants are prone to buckling or compressing during advancement, and may leave connection points after separation to block blood flow or damage the blood vessel walls. , and traditional insertion devices rely on microcatheters to limit the size and design of the implant.

Method used

Design a device where the implant is placed in a blood vessel in an extended state, and is introduced through an elongated shaft in a compressed state, with connection points that can be thermally separated, chemically separated or electrolytically separated, and the implant is compressed Fixed on the outside of the shaft in a state, the shape memory material and lattice structure are used to achieve self-expanding characteristics, avoid catheter restrictions, and ensure that the implant has no unnecessary connecting elements after separation.

Benefits of technology

The implant is safe and fast inserted without the use of micro catheters, avoiding the risk of buckling, stretching or kinking, ensuring the stability and functional integrity of the implant in the blood vessels, and reducing the retention of the connection points. blood flow obstruction and blood vessel damage.

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Abstract

The invention relates to a device (1) for introducing an intravascular implant (3) into a blood vessel, the implant (3) having an at least partially cylindrical design, wherein the implant (3) is provided in an expanded state, in which the implant is placed in the blood vessel, and in a compressed state, in which the implant can be introduced into the blood vessel, and the device (1) has an elongated shaft (2), the outer side of which is releasably fixed to the implant (3) in the compressed state, and through which the implant (3) is advanced. The implant (3) has at least one corresponding connection point (6) to the shaft (2) on the proximal and distal sides, and the connection point is heat-releasable, chemically releasable, or electrolytically releasable; or at least one wire (12) extends in the longitudinal direction on the implant (3), at least over most of the length of the implant (3), so that the implant (3) is fixed to the shaft (2) in a compressed state, and the wire (12) has at least one corresponding connection point (10, 11) to the shaft (2) on the proximal and distal sides, and at least one connection point (11) of the connection point is heat-releasable, chemically releasable, or electrolytically releasable.
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Description

Technical Field

[0001] The invention relates to a device for introducing an intravascular implant of at least partially cylindrical design into a blood vessel, wherein the implant is provided in an expanded state, in which the implant is placed in the blood vessel, and in a compressed state, in which the implant can be introduced into the blood vessel, wherein the device has an elongated shaft, on the outside of which the implant is fixed in the compressed state so that the implant is detachable, and the shaft extends through the implant. Background Art

[0002] It is well known prior art to place intravascular implants into blood vessels such as arteries, veins, aneurysms or other vascular malformations. In this regard, for example, stents are implanted in blood vessels to keep them permanently open. Other examples of such devices include occlusive coils or shunts, which are inserted into aneurysms to fill aneurysms and induce thrombosis, and shunts are placed in front of aneurysms to isolate aneurysms from blood flow. Typically, such implants are brought to the desired site and placed there by means of a catheter, which is inserted into the vascular system at a suitable position. The implant can, for example, be attached to the distal end of an insertion line, wherein a separation point is arranged between the insertion line and the implant, which, when an electric current is applied, is corroded and dissolved in any case to the extent that the implant is separated and unfolded. Other separation systems are based on the fact that a mechanical form closure provided between an implant and a device for inserting the implant is separated.

[0003] Especially for the stent, shunt and implants of similar design (these cylindrical structures of hollow interior have multiple openings present on the outer surface) with internal hollow cylindrical structure, the advancement of implant through conduit or blood vessel may be difficult. Specifically, it is necessary to exclude that implant is subjected to buckling or compression during advancement, so that it may be desirable to fix implant to proximal end and distal end before implant is released. However, at the same time, implant must be able to separate at target site safely, easily and quickly as far as possible. Therefore, the object of the invention is to further improve implant separation system known in the prior art.

[0004] Another problem that may occur with the implant of the prior art is that the implant that is ultimately retained in the blood vessel still has a connection point provided for attaching the insertion device. For example, in the case of a mechanical separation system, the connecting element arranged on the implant so that an effective shape closure can be achieved can still remain on the implant. If the implant is inserted by means of an insertion line that can be separated by electrolysis, the implant is usually closely converged along the direction of the insertion line positioned proximally. In other words, after the electrolytic separation, the proximal portion is retained on the implant, which is not necessary for effective implant function. This proximal portion and the above-mentioned connecting element may all have a harmful effect after the implant has been placed, for example, by protruding into the lumen of the blood vessel and blocking blood flow, damaging the wall of the blood vessel or causing other problems.

[0005] Furthermore, in the case of conventionally inserted implants, in which the implant is pushed through a microcatheter, the size of the compressed implant is naturally limited due to the fact that only a certain amount of space is available and the diameter of the implant in the compressed state cannot exceed a certain limit related to the inner diameter of the microcatheter. In particular for neurovascular applications, microcatheters are only used up to a certain size. A device for inserting an implant that does not rely on the implant to be pushed through the microcatheter, but also allows insertion without the use of a microcatheter, will therefore open up additional degrees of freedom in the design of the implant. For example, the implant can then be made larger or heavier or have more or thicker struts. Summary of the invention

[0006] As proposed by the present invention, it is therefore an object of the present invention to provide a device for inserting an implant into a blood vessel that overcomes the above-mentioned problems.

[0007] According to the invention, the object is achieved by providing a device for introducing an intravascular implant of at least partially cylindrical design into a blood vessel, wherein the implant is provided in an expanded state, in which the implant is placed in the blood vessel, and in a compressed state, in which the implant can be introduced into the blood vessel, wherein the device has an elongated shaft, on the outside of which the implant is fixed in the compressed state so that the implant is detachable, and the shaft extends through the implant, wherein the implant has at least one connection point to the shaft on the proximal side and the distal side respectively, which connection point is thermally detachable, chemically detachable or electrolytically detachable.

[0008] The device of the present invention is characterized in that the elongated shaft, the implant is arranged on the outside of the elongated shaft in its compressed state. The implant is provided with at least one connection point to the shaft at the proximal and distal sides, and the connection point can be separated to make the implant free. Therefore, the device including the elongated shaft and the implant mounted on the elongated shaft can be advanced to the desired position. Preferably, the shaft is advanced distally without a catheter, that is, the shaft is usually advanced first through a guide catheter of a relatively large lumen, but it is undesirable to use a small lumen microcatheter to advance to a more distally positioned area. However, in principle, it is also conceivable to use a catheter for the entire advancement, in which case at least the portion of the shaft that carries the implant is pushed out of the catheter or the catheter is retracted to the extent that the implant is exposed.

[0009] The implant does initially separate due to the connection point that exists between the implant and the shaft. Conversely, if the attending physician determines that repositioning is necessary, the position of the implant can be changed at will by moving the shaft. If necessary, the shaft carrying the implant can also be retracted in the proximal direction, completely repositioned, or removed from the vascular system.

[0010] In the case where the treating physician has decided to separate the implant, the connection point between the shaft and the implant is separated. This can be done thermally, chemically or electrolytically. Once the connection point is disengaged, the inherent expansion tendency of the implant ensures that the implant is in its expanded state, in which the implant will be deposited in the blood vessel. After this, the shaft and (if applicable) the catheter can be retracted in the proximal direction and eventually removed from the vascular system while keeping the implant at its placement site.

[0011] The terms "proximal" and "distal" should be understood such that they refer to the proximal side of the portion pointing toward the attending physician and the distal side of the portion pointing away from the attending physician when the device is inserted. Typically, the device is thus pushed forward through the vessel or catheter in the distal direction. The term "axial" refers to the longitudinal axis of the device extending from the proximal side to the distal side, whereas the term "radial" refers to a horizontal / plane perpendicular to the extension of the device.

[0012] In order to ensure that the inherent expansion tendency of the implant is utilized, it is considered advantageous that the implant has self-expanding properties. For this purpose, the implant is preferably made of a shape memory material, since the manufacture of stents and similar components is basically known. Therefore, shape memory alloys are particularly suitable as materials for this application, such as binary nickel-titanium alloys (such as Nitinol) or ternary nickel-titanium-chromium and nickel-titanium-copper alloys. In particular, the use of Nitinol in self-expanding structures in the medical field is known. However, other shape memory materials such as other alloys or shape memory polymers are also conceivable.

[0013] Implants with at least partially and preferably completely cylindrical shapes are usually provided with openings distributed on the surface of the cylinder. In other words, a lattice structure or a mesh structure consisting of struts or struts is formed thereby, so that a plurality of openings or meshes are formed on the outer surface of the cylinder.

[0014] The term "opening" refers to the lattice structure, whether or not the opening is separated from the environment by a membrane, which means that even openings covered by a membrane are referred to as openings. If desired, the membrane can be applied to the outside or inside of the grid / lattice structure. It is also possible to embed the grid / lattice structure in a membrane.

[0015] The lattice structure of the implant can be a braided structure, that is, it can be composed of a single wire or a bundle of wires forming a pillar, which are woven together and extend up and down each other at the intersection of the wire / bundle. Similarly, a cutting structure can be used, wherein the lattice structure is cut out from a tube with a suitable diameter by a laser. The material is usually composed of metal, but plastic materials can also be used. The material must have enough elasticity to allow contraction to the diameter of the shaft, and in addition, when released, it causes expansion to the required diameter. In addition, it is best to electropolish the lattice structure to make it smoother and rounder, and therefore make it less traumatic. This also reduces the risk of germs or other impurities that may adhere to the structure. The pillar or wire can have a circular, oval, square, rectangular or trapezoidal cross section, and in the case of a square, rectangular or trapezoidal cross section, the edge is advantageously rounded. Flat mesh / wire in the form of a thin strip can also be used, especially a metal strip.

[0016] For the implant provided as a component of the device proposed by the present invention, different implant types can be used, which are basically known from the prior art. However, as a prerequisite, the implant must have an inner cavity so that the elongated shaft can pass through the implant, and the implant is mounted on the shaft. Examples of such implants include stents, shunts or other implants, which will be placed in front of an aneurysm or other vascular malformation to affect the flow of blood. This also includes implants intended to be placed in the bifurcation aneurysm region, as described, for example, in the public document WO2014 / 029835A1.

[0017] Typically, the implant as part of the device of the present invention has a length ranging between 5 mm and 100 mm and a diameter between 1.5 mm and 7 mm, the size being determined by the size of the vessel segment. The indicated drawings relate to the free, non-compressed state of the implant, i.e., separated from the shaft and without any external force applied by the catheter. The struts forming the implant may, for example, have a width, respectively a diameter ranging between 20 μm and 60 μm.

[0018] The main advantage of the device of the present invention is that the implant can also be brought to its placement position without the use of a microcatheter, so that the implant is therefore less restricted in size. In addition, the implant remains fixed proximally and distally until it is separated, so there is no risk of buckling, stretching or kinking when the implant is advanced through a vessel or a catheter. In addition, another advantage is that essentially only the actual implant (whose components are required to achieve the desired effect) remains in the blood vessel, and after separation, no technically redundant elements are provided as connecting devices with an insertion wire or some other insertion device. This may be important, for example, if only a relatively short blood vessel portion is available, in which the implant can be placed without affecting or weakening any branch vessels.

[0019] The implant is provided with at least one connection point to the shaft proximally and distally. Preferably, the connection point can be located at the distal end and the proximal end of the implant respectively, but it is also conceivable to arrange the connection point in the proximal region and the distal region of the implant, however, the connection point is located at a slight distance from the respective end of the implant. Before separation occurs, the implant should preferably be fixed to the shaft substantially over its entire length.

[0020] In order to prevent the implant from being separated from the part of the shaft, if the implant has at least two connection points to the shaft at the proximal and distal sides, preferably at least two connection points are arranged at the proximal end and the distal end of the implant, then it is considered as an advantage. If necessary or considered to be useful, even more connection points can be provided to realize comprehensive fixing around the radial circumference of the implant on the shaft. In addition, the connection point also can be arranged between the proximal end and the distal end of the implant. However, because the implant is firmly positioned on the shaft with an elongated configuration and is maintained in the configuration by the connection point arranged at the proximal and distal sides, no additional connection is usually required between the proximal end and the distal end.

[0021] According to an alternative embodiment to which the considerations set out above also apply, in particular with regard to the structure and materials of the implant, a device for introducing an at least partially cylindrical implant into a blood vessel is provided, wherein the implant is in an expanded state and in a compressed state, in which the implant is placed in the blood vessel and in which the implant can be introduced into the blood vessel, wherein the device has a slender shaft, on the outside of which the implant is detachably fixed in the compressed state, and the shaft extends through the implant, wherein at least one wire extends over the implant in a longitudinal direction, at least over a majority of the length of the implant, so that the implant is fixed to the shaft in the compressed state, wherein the wire has at each proximal and distal side at least one connection point to the shaft, and at least one of the at least one connection points on the proximal and distal sides is thermally detachable, chemically detachable or electrolytically detachable.

[0022] According to this alternative embodiment as well, the implant is placed outside the shaft and is held on the shaft in its compressed form until separation occurs. However, the connection point does not connect the shaft to the implant, but is replaced by a shaft with one or more wires extending on the implant. Preferably, at least one wire extends spirally around the implant, that is, the wire is wound around the implant in a spiral pattern, thereby ensuring that the implant is fixed on the shaft and remains in its compressed state. In addition, the process for introducing the implant is similar to the first embodiment, which means that the shaft is navigated to the desired position together with the implant. In most cases, the shaft with the implant is not advanced to the placement position via a microcatheter but through the blood vessel itself. However, as in the first embodiment of the present invention, a relatively large lumen guide catheter is generally used to advance the shaft with the implant, and only the shaft of the small lumen microcatheter is omitted for further distal advancement. For example, in neurovascular applications, the device can be advanced from the groin to the carotid artery via a guide catheter, and then any further advancement is performed without a microcatheter.

[0023] However, it is of course also possible to navigate the shaft and the implant to the target position by means of a catheter. In this case, the shaft and the catheter are moved relative to each other so that the implant and at least the part of the shaft that carries the implant are no longer positioned inside the catheter.

[0024] Once the attending physician has decided on the final separation of the implant, at least one of the connection points between the shaft and the wire is disengaged. This causes the wire to become loose, so that it will no longer be able to hold the implant on the shaft in a compressed state. By taking advantage of the implant's inherent tendency to expand, the implant will now widen to assume its expanded shape and thus anchor itself in the vessel. The shaft, which now only extends loosely through the interior of the implant, can then be easily retracted proximally and removed from the vascular system.

[0025] In a second embodiment, in particular the distal connection point, or in the case of providing several wires, the distal connection point between the wire and the shaft is preferably designed to be detachable. However, the proximal connection point between the wire and the shaft preferably remains in place. The distal separation of the wire provides the following advantages: when the shaft is retracted after the implant has been deployed, the wire remains attached to the shaft at the proximal side, causing it to also retract and thus prevent its flipping. The flipping of the wire will cause the risk of the wire damaging the vessel wall or getting stuck on the implant.

[0026] Preferably, the connection points between the shaft and the wire are located at the proximal and distal ends of the wire, respectively, so that areas of the wire are prevented from protruding proximally or distally beyond the respective connection points. However, it is also conceivable to arrange the connection points at a distance from the proximal or distal ends of the wire, as long as it is ensured that the wire securely fixes the implant in its compressed state to the shaft. Conveniently, the wire extends over the entire length of the implant, preferably being arranged helically around the implant.

[0027] In a first and second embodiment of the invention, the connection point can be thermally designed, chemically designed or electrolytically designed, i.e., the connection point can be dissolved by thermal action, dissolved by chemical action (in particular by applying a solvent), or electrolyzed by applying a voltage at least to the extent of the implant, so that the wire becomes separated from the shaft, respectively. In the case where a hot connection point has been provided, a heat source must be applied to the connection point to be separated in order to disconnect the implant. The disconnection can be accomplished from the outside by running a heat source along the shaft to apply thermal energy to the connection point. However, preferably, the shaft has a hollow design, which also enables the heat source to be brought to the connection point to be separated through the interior of the shaft. Heating the interior of the shaft well at a position where the connection point is arranged on the outside ensures that the connection point is separated.

[0028] Alternatively, all or a portion of the shaft may also be heated to the point where the connection points become separated and the implant is released.

[0029] In the case of thermal separation, the connection point should be designed so that, on the one hand, separation does not occur at body temperature and the implant is firmly held on the shaft, but on the other hand, no excessively high temperatures have to be applied to achieve separation. Preferably, at least partial dissolution of the connection point occurs at a temperature ranging between 40° C. and 80° C., in particular between 50° C. and 70° C. Suitable materials for the connection point, such as polymers or low-melting-point metals, are known from the prior art.

[0030] As an alternative, the connection point can also have an adhesive design, wherein a polymer adhesive is preferably used. In this case, the implant or line is usually chemically separated by applying a solvent that at least partially dissolves the adhesive. For example, dimethyl sulfoxide (DMSO) can be used as a solvent.

[0031] In this case, the solvent can also be delivered to the connection point by different appliances. For example, a hose or similar appliance can extend along the outside of the shaft so that the solvent is applied to the connection point. However, also in the case of using an adhesive connection point, the solvent is preferably brought to the connection point via the inside of the shaft. This can be achieved by a hose or by a tube arranged in the shaft. Of course, a prerequisite for this is that, on the one hand, the shaft has an internal cavity, and in addition, the outer wall of the shaft has a certain permeability, so that the solvent applied inside is allowed to penetrate through the shaft, thereby causing the adhesive connection point to become separated. In addition, one or more solvent reservoirs can also be provided in the area of ​​the connection point, and the reservoir is controllable and open outside so that the solvent can have an impact on the connection point. In principle, a solvent reservoir of this nature can also be arranged on the outside of the shaft, providing the release of the solvent that can start from the outside.

[0032] Another possibility is the electrolytic separation of the connection point. In this case, at least partial dissolution of the connection point occurs by applying a voltage. In most cases, direct current is used for this, where low current strengths (<3 mA) are sufficient. Usually, the connection point consists of a metal and forms an anode when a voltage is applied, at which oxidation of the metal and thus dissolution occurs.

[0033] Electrolytic separation is achieved by applying a voltage to the connection point using a power source. Electrolytic separation of implants is a well-known practice in the prior art, such as for occlusive coils for the purpose of blocking aneurysms. See, for example, WO 2011 / 147567A1. Although the connection point is used as an anode, for example, the cathode can be located on the surface of the body. Alternatively, another area of ​​the device can also form a cathode. It should be understood that the connection point must be connected to the power source in an electrically conductive manner. The shaft itself can be used as a conductor; alternatively, the conductor can run through the inside of the shaft or extend along the outside of the shaft. Since the corrosion current generated is controlled by the surface area of ​​the cathode when the cathode is located on the surface of the body, the area of ​​the cathode should be selected to be significantly larger than the area of ​​the anode. To some extent, the speed of dissolution of the connection point can be controlled by appropriately adjusting the size of the cathode surface relative to the anode surface. Therefore, the device proposed by the present invention can also include a voltage source and (if applicable or appropriate) an electrode that can be placed on the surface of the body. Suitable materials for the connection point for electrolytic dissolution include, for example, stainless steel, magnesium, a magnesium alloy, or a cobalt-chromium alloy.

[0034] Regardless of the precise design of these connection points, it is preferred that the shaft has an inner cavity extending in the longitudinal direction of the shaft, in other words, an internal lumen is displayed. On the one hand and as already mentioned, this can be used for the separation of the connection points, on the other hand, the lumen is also advantageous because a guide wire can be provided to extend through the lumen. Therefore, the guide wire can initially be pushed forward to the desired placement position, and then the shaft and the implant are slid on the guide wire. Once the shaft has been placed in place, the guide wire can be retracted in the proximal direction. The lumen of the shaft must have a diameter that enables the shaft to advance on the guide wire. The inner cavity or hollow space of the shaft can extend from the proximal end of the shaft to the distal end. Therefore, the present invention also relates to a combination of a device proposed by the present invention and a guide wire.

[0035] If the lumen of the shaft extends from the proximal end to the distal end and the guidewire also extends through the entire shaft, this is called an over the wire (OTW) system. Alternatively, a rapid exchange (Rx) system can also be thought of. In this system, the guidewire extends only through the distal section of the shaft, wherein the distal section typically has a length of about 20 cm to 40 cm. In this context, the shaft has an opening or through hole located from the proximal section to the distal section, through which the guidewire passes and leaves the lumen of the shaft. Such an opening or through hole is also referred to as a port. For example, OTW and Rx systems are familiar to technicians in the field of balloon catheters. Even in the presence of an opening or through hole, the shaft can be provided with a lumen extending from the proximal side to the distal side, in which case the lumen is primarily used for the introduction or delivery of an electrolytically dissolved, thermally dissolved or chemically dissolved reagent for a connection point, as described above.

[0036] In the case where the adhesive connection point requires the introduction of a solvent through the lumen of the shaft, the shaft should be permeable to the solvent at least in the section where the detachable adhesive connection point is located, so that the solvent can penetrate through the wall of the shaft to the outside and release the adhesive connection point. Therefore, the present invention also relates to a device having a solvent delivery system, wherein the delivery system at least temporarily extends through the lumen of the shaft, so that the solvent can be delivered to a position on the inside of the shaft, which corresponds to a position on the outside of the shaft, at which the shaft has an adhesive connection point, which must be separated to deploy the implant. The delivery system can have different designs; it can include a hose or tube extending through the internal tubular cavity of the shaft, so that the solvent is delivered from the proximal side to the distal side through the entire shaft or a portion of the shaft. Alternatively, there is no need to provide a separate tube; instead, the solvent passes through the lumen of the shaft.

[0037] According to a preferred embodiment, the shaft is at least partially composed of a coil, which is formed by a metal wire or plastic wire in a spiral configuration. This is especially true for the distal region of the shaft or the region that carries the implant. On the one hand, the spiral design ensures an increase in the flexibility of the shaft, which is particularly advantageous when the shaft passes through a highly tortuous blood vessel with a narrow lumen with a small bending radius, such as those found in the neurovascular area. In addition, the gaps between the individual windings of the coil can be designed so that they can penetrate solvents. Therefore, in the case where the connection point between the shaft and the implant and / or the shaft and the wire is chemically dissolved, the solvent is allowed to be released into the interior of the shaft, passing through the gaps present between the windings, and thus causing the connection point to separate. Therefore, additional incisions in the shaft can be omitted.

[0038] Various materials may be used for the coil, for example typical metals such as those used for intravascular devices etc. Relevant examples include stainless steel, cobalt-chromium alloys and nickel-titanium alloys. Plastic materials which are not objectionable from a medical point of view may also be used.

[0039] An alternative to using a coil in the distal part of the shaft could be to provide a hose / tube material that should also be sufficiently flexible. Depending on which detachable method is chosen for the connection point, additional cuts could be provided in the hose material that allow solvents or also electrical contact to be brought to the connection point to be detached.

[0040] While it is advantageous to design the distal portion of the shaft to have sufficient flexibility, the more distal portion of the shaft can be designed to have greater stiffness. Since the shaft must often be advanced over relatively long distances within the vascular system, it is advisable to design the proximal region to be stiffer, while it is advantageous to have greater flexibility in the distal region, such as when a neurovascular intervention is to be performed, where the distal region must reach fine branching vessels with narrow lumens.

[0041] The proximal end of the shaft can be, for example, made of a traditional hub. It is recommended to use a standard Luer fitting (luerfitting) or Luer lock (luer-lock) connector, which makes it possible to insert an accessory into the interior of the shaft, such as a guide wire or the required utensil for separating the connection point. These can be the required utensil for supplying solvents, causing heating or applying voltage in the region of the shaft. In most cases, the internal lumen of the connector becomes narrower in the distal direction, that is, towards the internal lumen of the shaft itself. When using a Luer lock connector, connection with other elements is carried out in addition by means of a threaded fitting provided for this purpose. The connecting element can be made of, for example, polycarbonate, polyamide, polypropylene or other polymers. Typically, the material is harder than the material used for the actual shaft.

[0042] The present invention is particularly applicable to the neurovascular field, but the device may also be applied to other areas of the vascular system, such as cardiovascular and peripheral vasculature.

[0043] Meaningfully, the device is provided with one or more radiopaque markers to allow the attending physician to visualize them. Radiopaque markers can be, for example, composed of platinum, palladium, platinum-iridium, tantalum, gold, tungsten or other metals that are opaque to radiation. They allow the attending physician to view the device, particularly whether the implant arranged on the shaft is correctly positioned, if necessary, so that corrections can be made. It is also conceivable that at least some regions of the shaft and / or implant are provided with a coating of radiopaque material, for example, provided with a gold coating. The coating can, for example, have a thickness between 1 micron and 6 microns. However, even if a radiopaque coating is provided, it may also be useful to additionally arrange one or more additional radiopaque markers. Another possibility is to coat the various pillars of the implant with a spiral or silk consisting of a radiopaque material (such as platinum, etc.).

[0044] In addition to the device proposed by the invention, the invention also relates to a method for inserting / placing an implant into a blood vessel. The method provides that the implant is fixed on a shaft and placed in the blood vessel. In a first embodiment, all connection points between the implant and the shaft are then separated to release the implant. The implant expands to assume the shape it has in the released state and anchors itself in the blood vessel. The shaft itself is no longer attached to the implant and can therefore be retracted proximally and removed from the vascular system.

[0045] In a second embodiment, it is provided that the implant is held on the shaft by means of a wire, a substantially similar method is adopted, but in this case, usually only one connection point between the wire and the shaft is separated, so that the wire no longer holds the implant on the shaft in a compressed state. It is also possible to separate several connection points between one or more wires and the shaft; however, it is important that after separation, one or more wires are no longer able to compress the implant and hold it on the shaft, and expansion of the implant is ensured. Now, the shaft is no longer firmly attached to the implant and can therefore be removed proximally from the vascular system. Any and all statements made about the device will also apply in the same way to the method described herein, and vice versa. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Now with reference to the accompanying drawings showing various embodiments, the present invention is described in detail by the following embodiments. It should be noted that the accompanying drawings show preferred embodiment variations of the present invention, but the present invention should not be considered to be limited thereto. To the extent that the technology is advantageous, the present invention generally includes any optional combination of the technical features described in the claims or the specification. All statements about the connecting point between the shaft and the implant about the first embodiment of the present invention apply in the same manner to the second embodiment about the connecting point between the shaft and the line, and vice versa, unless the context otherwise indicates.

[0047] The following drawings provide an illustration of the present invention, wherein

[0048] Figure 1 is a side view showing the shaft of the device of the present invention;

[0049] Figure 2 shows a side view of the device according to the invention according to a first embodiment, wherein the implant is fixed to the shaft;

[0050] Figure 3 shows a side view of the device according to the invention according to a first embodiment, wherein the implant is separated from the shaft;

[0051] Figure 4 shows a side view of the device according to the invention according to a second embodiment, wherein the implant is fixed to the shaft;

[0052] Figure 5 shows a side view of the device according to the invention according to a second embodiment, wherein the implant is separated from the shaft;

[0053] Figure 6 The implant is shown in a released state. DETAILED DESCRIPTION

[0054] exist Figure 1 In the figure, a shaft 2 as part of the device proposed by the invention is shown in a side view, wherein in the selected representative illustration, the left represents the proximal side and the right represents the distal side. On the shaft 2 there is a relatively high hardness proximal region 5 and a flexible coil 4 forming the distal region of the shaft 2, the proximal end of the shaft 2 being formed as a connecting element 9 in the form of a wire Luer lock connector.

[0055] Figure 2 A device 1 according to a first embodiment is shown. In this case, a shaft 2 carries an implant 3 consisting of a laser cut stent. The implant 3 is connected to the coil 4 of the shaft 2 by means of several connection points 6. The connection points 6 are of adhesive design and can be separated by applying a solvent. Since the gaps between the windings of the coil 4 are sufficiently permeable, the solvent can be brought to the connection points 6 through the interior of the shaft 2.

[0056] Once the connection point 6 has been separated, there is no longer a direct connection between the implant 3 and the coil 4, such as from Figure 3 As can be seen in FIG. 2 . Due to the self-expanding properties of the implant 3, it opens and thereby assumes its final position within the vessel. The shaft 2, respectively the distal region of the shaft, i.e. the coil 4, only extends loosely through the interior of the implant 3 and can therefore be easily retracted in the proximal direction. The implant 3 comprises struts 7, between which openings 8 are formed.

[0057] Figure 4An example of a second embodiment is shown. In this embodiment, the implant 3 is also arranged on the coil 4 forming the distal region of the shaft 2, however, in contrast to the first embodiment, the connection points do not directly connect the implant 3 and the coil 4, but instead, the wire 12 is arranged to fix the implant via the connection points 10, 11. The wire 12 is wound around the implant 3 and thus holds it in its compressed form on the coil 4 of the shaft 2. The implant 3 has a natural tendency to expand, but as long as the wire 12 is wound around the implant 3, its expansion is prevented.

[0058] exist Figure 5 , the deployment of the implant is shown as provided by the second embodiment. The distal connection point 11 has been disconnected, i.e. the wire 12 is no longer connected to the coil 4 at the distal end. The separation of the connection point 11 can again be carried out in the following way: a solvent acts on the connection point 11, wherein the solvent penetrates the coil from the inside through the gaps between the windings of the coil 4. The connection point 11 is designed as an adhesive anchoring location. In contrast, the connection point 10 at the proximal end of the wire 12 is retained.

[0059] Since the wire 12 is no longer tightly wound around the implant 3, the implant 3 is allowed to expand due to its shape memory properties and anchor itself in the blood vessel. The coil 4 of the shaft 2 now only extends through the lumen of the implant 3 without any connection with the implant 3, so that it can be retracted proximally and removed from the vascular system. At the same time, the wire 12, which is still firmly attached to the coil 4 at the proximal connection point 10, is also retracted in the proximal direction and removed in this way.

[0060] at last, Figure 6 An expanded implant 3 is shown placed in this form into a blood vessel. The implant 3 is a cut stent utilizing struts 7 to form various openings 8 between the struts.

Claims

1. A device for placing a neurovascular implant (3) of at least partially cylindrical design into a blood vessel, wherein the implant (3) is provided in an expanded state, in which the implant is placed in the blood vessel, and in a compressed state, in which the implant can be inserted into the blood vessel, wherein: The device (1) has an elongated shaft (2), the implant (3) being fixed on the outside of the elongated shaft (2) in the compressed state so that the implant (3) is detachable, and the elongated shaft extends through the implant (3), the implant (3) having at least one connection point (6) to the elongated shaft (2) on the proximal side and the distal side, respectively, Characterized in that at least one connection point (6) is a chemically separable adhesive connection point (6), wherein the slender shaft (2) has an inner cavity or hollow space extending in the longitudinal direction of the slender shaft (2), and wherein the slender shaft (2) can be penetrated by a solvent at least in the section where the adhesive connection point (6) is located, wherein the solvent is brought to the adhesive connection point (6) through the interior of the slender shaft (2) and at least partially dissolves the adhesive connection point, so that the implant (3) is separated from the slender shaft (2).

2. The device according to claim 1, characterized in that At least one connection point (6) is located at the proximal end of the implant (3), and at least one connection point (6) is arranged at the distal end of the implant (3).

3. The device according to claim 1 or 2, characterized in that: The implant (3) is provided with at least two connection points (6) to the elongated shaft (2), proximally and distally, respectively.

4. The device according to claim 1 or 2, characterized in that: The adhesive connection points include a polymeric adhesive.

5. The device according to claim 1 or 2, characterized in that: The lumen or the hollow space extends from the proximal end of the elongated shaft (2) to the distal end of the elongated shaft (2).

6. The device according to claim 1 or 2, characterized in that: At the distal portion to the proximal portion of the elongated shaft (2), an opening or through hole for a guide wire is arranged from the inner cavity or the hollow space to the outside.

7. The device according to claim 1 or 2, characterized in that: A delivery system for a solvent at least temporarily extends through the lumen or hollow space of the elongated shaft (2), and through the delivery system a solvent can be applied to the location of the elongated shaft (2) where the adhesive connection point is arranged, wherein the adhesive connection point is arranged on the outside of the elongated shaft (2).

8. The device according to claim 1 or 2, characterized in that: The elongated shaft (2) at least partially comprises a coil (4) formed by a helically arranged metal or plastic wire, wherein the gaps between the windings of the coil (4) are permeable to a solvent.

9. The device according to claim 8, characterized in that The coil (4) forms a distal region of the elongated shaft (2).

10. The device according to claim 9, characterized in that The coil (4) forming the distal region of the elongated shaft (2) is followed proximally by a region (5) of the elongated shaft (2) which has a greater stiffness than the coil (4).

11. A device for placing an at least partially cylindrical neurovascular implant (3) into a blood vessel, wherein: The implant (3) has a longitudinal direction, wherein the implant (3) is in an expanded state and in a compressed state, in which the implant (3) is placed in the blood vessel, and in which the implant (3) can be inserted into the blood vessel, wherein the device (1) has a slender shaft (2), the implant (3) being detachably fixed on the outside of the slender shaft (2) in the compressed state, and wherein the slender shaft extends through the implant (3), wherein at least one wire (12) extends on the implant (3) in the longitudinal direction, at least over a large part of the length of the implant (3), so that the implant (3) is fixed to the slender shaft (2) in the compressed state, wherein the at least one wire (12) has at least one connection point (10, 11) to the slender shaft (2) on the proximal side and the distal side respectively, It is characterized in that At least one connection point (10, 11) is a chemically separable adhesive connection point (10, 11), wherein the slender shaft (2) has an inner cavity or hollow space extending in the longitudinal direction of the slender shaft (2), and wherein the slender shaft (2) is capable of being penetrated by a solvent at least in the section where the adhesive connection point (6) is located, wherein the solvent is brought to the adhesive connection point (10, 11) through the interior of the slender shaft (2) and at least partially dissolves the adhesive connection point (10, 11), so that the thread (12) is separated from the slender shaft (2).

12. The device according to claim 11, characterized in that The at least one wire (12) extends helically around the implant (3) in the longitudinal direction.

13. The device according to claim 11 or 12, characterized in that The adhesive connection points include a polymeric adhesive.

14. The device according to claim 11 or 12, characterized in that The lumen or the hollow space extends from the proximal end of the elongated shaft (2) to the distal end of the elongated shaft (2).

15. The device according to claim 11 or 12, characterized in that At the distal portion to the proximal portion of the elongated shaft (2), an opening or through hole for a guide wire is arranged from the inner cavity or the hollow space to the outside.

16. The device according to claim 11 or 12, characterized in that A delivery system for a solvent at least temporarily extends through the lumen or hollow space of the elongated shaft (2), and through the delivery system a solvent can be applied to the location of the elongated shaft (2) where the adhesive connection point is arranged, wherein the adhesive connection point is arranged on the outside of the elongated shaft (2).

17. The device according to claim 11 or 12, characterized in that The elongated shaft (2) at least partially comprises a coil (4) formed by a helically arranged metal or plastic wire, wherein the gaps between the windings of the coil (4) are permeable to a solvent.

18. The device according to claim 17, characterized in that The coil (4) forms a distal region of the elongated shaft (2).

19. The device according to claim 18, characterized in that The coil (4) forming the distal region of the elongated shaft (2) is followed proximally by a region (5) of the elongated shaft (2) which has a greater stiffness than the coil (4).

Citation Information

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