WO2011066962A1

WO2011066962A1 - Medical device

Info

Publication number: WO2011066962A1
Application number: PCT/EP2010/007304
Authority: WO
Inventors: Giorgio Cattaneo
Original assignee: Acandis Gmbh & Co. Kg
Priority date: 2009-12-01
Filing date: 2010-12-01
Publication date: 2011-06-09
Also published as: DE102009056449A1

Abstract

The invention relates to a medical device comprising a tube-shaped lattice braid (10) of wire elements (11, 12) which form terminal meshes (13, 14) on a longitudinal axial end of the lattice braid (10), wherein a first wire element (11) of a first terminal mesh (13) forms a loop (15) with a loop tip (15a) which is arranged together with other loop tips (15a) on a joint circumference line U that axially delimits the lattice braid (10). The invention is characterised in that at least a second wire element (12) of a second terminal mesh (14) forms an eyelet (16) that projects in the longitudinal axial direction over the circumference line U of the loop tips (15a), wherein a radiographically visible marker element (18) is arranged in the region of the eyelet (16).

Description

Medical device

description

The invention relates to a medical device according to the preamble of claim 1. Such a medical device is known for example from WO 2005/110286 AI.

The known medical device is formed as a stent comprising a mesh braid which is braided from a plurality of wires. The braid is created by the fact that the wires are spirally wound around a common longitudinal axis. The wires are partially wound in a clockwise direction and cross other wires, which are wound in a counterclockwise direction. This creates meshes that are bounded by four wires each. In the region of an axial end of the stent end meshes are formed, which are delimited by two wires, wherein a first wire is deflected at the axial end of the stent and forms a loop. The deflection point corresponds to the loop tip. About the circumference of the stent a plurality of loops are formed with loop tips at the axial end, wherein the loop tips are arranged substantially on a common circumferential line U.

In general, the need of the user, for example a physician, to continually monitor the position of the device, particularly a distal end of the device, during implantation of such a medical device. This need stems from the implantation procedure in which the medical device is first inserted into a catheter and advanced until the distal end of the device reaches the catheter tip. From this point on, the relative movement between the catheter and the medical device is reversed. This means that the device is held stationary and the catheter is retracted in the proximal direction. As a result, the need to visualize the distal end of the medical device under X-ray control to determine when the distal end leaves the catheter tip. The good radiopacity should also be ensured if the medical device is used, for example, for removing thrombi. In doing so, the medical see device moved within a body cavity. The movement of the medical device should be traceable under X-ray inspection.

WO 2005/110286 A1 describes a stent in which the radiopacity is achieved, on the one hand, in that the wires have a core of a radiopaque material. Due to the small dimensions of the stent, however, a relatively weak absorption of X-rays results in practice, which leads to a relatively inaccurate representation. Alternatively, it is provided to produce the welding spots, each connecting two wire elements, through a radiopaque material. However, the spot welds only provide sufficient radiopacity if the material application is relatively large. This has the disadvantage that the crimpability of the stent is reduced. In particular, the space requirement of the weld points within a catheter reduces the space for other components, such as wires, of the stent within the catheter. At least at the axial ends of the stent, where the welding points are arranged, the minimum cross-sectional diameter in the compressed state is comparatively large. The miniaturization of the stent and a corresponding delivery system is thus limited. In practice, therefore, a relatively large lumen catheter is required for implantation of the stent, whereby smaller blood vessels can not be achieved.

The invention has for its object to provide a medical device having at a distal end increased radiopacity and a relatively small cross-sectional diameter in the compressed state.

According to the invention, this object is achieved by the subject matter of patent claim 1.

The invention is based on the idea to provide a medical device with a tubular grid of wire elements, which form at one axial end of the mesh braid Endmaschen. In this case, a first wire element of a first end mesh forms a loop with a loop tip. The loop tip is arranged with further loop tips on a common, the grid mesh axially delimiting peripheral line U. At least one second wire element of a second end mesh forms an eyelet which extends in the longitudinal axial direction over the circumferential never project U of the loop tips. In the area of the eyelet, an X-ray-visible marker element is furthermore arranged.

With the invention, the idea is pursued to displace individual wire elements in the axial direction at the axial, in particular distal, end of the lattice structure, the staggered wire elements each receiving the radiopaque marker elements. In the invention, the marker elements are therefore not arranged inside the mesh but substantially axially outside. In this way, the influence of the marker elements on the crimpability of the braid is reduced. Thus, the marker elements can be made comparatively large, so that a sufficient X-ray visibility is ensured. Since the additional material in the form of the marker elements is arranged outside the grid, the grid is compressible to a relatively small cross-sectional diameter.

The arrangement of the marker elements takes place in the region of the eyelet, which protrudes in the longitudinal axial direction over the circumferential line U of the loop tips. The eyelet thus forms an axially projecting beyond the grid mesh element. This means that the eyelet is essentially no part of the lattice braid per se, but represents an extension over the lattice braid limiting circumferential line U. The eyelet, for example, on a braiding machine, easy to manufacture and thus provides an efficient and secure way to attach marker elements at the axial end of the grid structure.

Preferably, an eyelet between two loops is arranged in the circumferential direction of the grid structure, in particular arranged directly adjacent. This means that in each case at least one loop follows from the eyelet in both circumferential directions. This ensures that sufficient space in the circumferential direction is created for the marker element arranged in the region of the eyelet, so that the marker element does not impair the crimpability of the grid mesh. If several eyelets are provided with marker elements, at least one loop is provided in the circumferential direction between two eyelets. Between the eyelets several loops can be arranged. In general, it is therefore expedient for the eyelets to be spaced apart from one another, ie generally arranged in each case between two loops. In a preferred embodiment, the wire elements each have two wire sections, which are wound in opposite directions about a common center axis of the grid structure. Both the loop, as well as the eyelet are thus each formed from a single wire element, wherein the wire elements have two wire sections, which run in opposite directions in the lattice structure. Starting from the peripheral structure delimiting the grid structure U, in each case a first wire section runs spirally in the clockwise direction along the central axis and a second wire section runs counter-clockwise in the opposite direction. This configuration has the advantage that the mesh braid forms an atraumatic axial end. In particular, the axial end of the grid structure has no open ends of the wire elements, so that the risk of injury during implantation is reduced.

The wire sections of the second wire element may be merged at a circumferential location, which is arranged in the region of the circumferential line U. The connection point of the wire sections of the second wire element is thus arranged at the same axial height or in the same cross-sectional plane as the loop tips of the first wire element. This has the advantage that the wire sections of the first wire element and the wire sections of the second wire element within the grid mesh have the same length. In particular, the first

Wire element and the second wire element have the same or similar braid angle. This avoids that the grid structure is distorted during crimping or compressing. The structural stability of the medical device is improved in this way.

In this context, it should be noted that the grid mesh is limited by the circumferential line U. The eyelets projecting beyond the circumferential line U and formed by the second wire element are not considered as part of the grid in the context of this application. Rather, the eyelet formed by the second wire element is arranged outside of the grid mesh.

Preferably, a first wire portion of the second wire member is connected to a second wire portion of the second wire member to form a stabilizing portion of the eyelet. The first wire section may be twisted or welded or glued to the second wire section. Other connection types are possible. The stabilizing section increases the stability of the eyelet. Moreover, the attachment of marker elements is facilitated by the stabilization section. The stabilization section can be arranged axially outside the grid structure, in particular over the circumferential line U above. Specifically, it is provided in a preferred embodiment that the stabilizing portion between the second end mesh, in particular the joint, and an eye of the eyelet is arranged. The stabilizing section thus consolidates the part of the second wire element projecting beyond the grid structure or peripheral line U, which forms the eyelet. The stabilization section is part of the eyelet. The eyelet may further comprise an eye downstream of the stabilizing section. The eye may form a fictional subdivision of the second wire element into the first wire section and the second wire section. The first wire portion and the second wire portion extend in opposite directions within the mesh and are merged at the juncture of the second wire member and connected to each other, wherein the connected wire portions form the stabilizing portion that projects beyond the circumferential line U. The wire sections of the second wire element leave the stabilizing section separated and form the eye, wherein the first and the second wire section are integrally connected to one another in the region of the eye. The eyelet is thus formed overall by a single wire element, in particular the second wire element. In this way, a tapered section, namely the stabilizing section, is formed between the second end mesh and the eye. The tapered section or stabilization section provides an easy way to connect radiopaque marker elements to the eyelet. Moreover, a free space is formed within the eye, which also provides an easy way to arrange a radiopaque marker element in the eyelet.

The stabilizing portion may extend substantially parallel to the central axis of the grid mesh. This ensures that the eyelet arranges to save space when compressing the medical device. Furthermore, it is avoided by the parallel arrangement of the stabilizing section to the central axis of the grid mesh that the eyelet, for example, in the radial direction protrudes outward and thereby increases the risk of injury during implantation. Conveniently, the eyelet is aligned with a wall plane of the grid mesh. It can the

Stabilization section have an axial component which is arranged parallel to the central axis of the grid mesh. Moreover, the stabilizing portion may comprise a radial component which is arranged orthogonal to the central axis of the lattice braid. This means that the stabilizing section in the radial direction can be deflected the tubular grid mesh. The deflection can be directed both radially inward, and radially outward.

Furthermore, the medical device in the expanded state at the axial end, preferably in the region of the axial end of the grid mesh, funnel-shaped (geflairt) be. This means that the grid mesh is widened in the direction of the axial end, so preferably a continuously increasing

Has cross-sectional diameter. The eyelet preferably extends from the funnel-shaped axial end in the wall plane or follows the course of the funnel-shaped widening. Preferably, the funnel-shaped widening is arranged at a distal end of the lattice braid. The distal end corresponds to the axial end of the lattice structure, which leaves the catheter or the catheter tip first upon release of the medical device from a catheter. The distal end is thus arranged away from the user, whereas a proximal end of the grid structure or the medical device faces the user. With the funnel-shaped flared distal end of the lattice structure, it is achieved that the expansion of the medical device upon release from a delivery system is facilitated. An expansion at the distal axial end of the medical device is particularly advantageous in recanalization systems or baskets, in particular thrombosis scavengers or filters, which distend themselves distally in the hollow organ. Alternatively, the proximal, ie in use close to the axial end of the mesh, have a funnel-shaped, in particular geflairte, structure. This embodiment is suitable for medical devices designed as thrombosis scavengers or baskets with a proximal

expandable axial end are formed. It is also possible that both the proximal and the distal axial end of the mesh have a funnel shape. This embodiment is advantageous for example in a

medical device which is designed as a permanent implant or stent, in particular a stenosis stent or aneurysm stent. In general, it is preferred if the funnel-shaped end forms an access to a cavity which is formed within the grid mesh. Another axial end of the medical device may be closed or also have a funnel shape.

The radiopaque marker element is preferably arranged in the region of the stabilization section or the eye of the eyelet. Such an arrangement is particularly simple and space-saving possible. The marker element may comprise a sleeve which surrounds the stabilization section. Alternatively, the marker element may comprise a disk-shaped element which is arranged in the eye of the eyelet. A combination of both types of marker elements, ie a sleeve in the stabilizing section and a disc-shaped element in the eye of the eye, is also possible. Moreover, the sleeve may have a C-shaped cross-sectional profile, so that the sleeve laterally over the

Pushed stabilization section and then can be connected by clamping with the stabilizing section. The clamping connection can be done for example by crimping. The C-shaped cross-sectional profile has the advantage that the radiopaque sleeve is subsequently connectable to the preformed eyelet. Threading the sleeve before the final production of the eyelet is thus avoided.

According to a secondary aspect, the invention is based on the idea to provide a medical device with a tubular grid of wire elements, which form end meshes at a longitudinal axial end of the mesh. The Endmaschen limit the grid mesh axially, wherein at least one

Wire element forms an aligned with a wall plane of the grid mesh eyelet. The eyelet projects beyond the end stitches and has an eye that divides the wire element into a first wire section and a second wire section. The first wire portion and the second wire portion are twisted between the end mesh and the eye to form a stabilizing portion of the eyelet. The stabilization section is for receiving a radiopaque

Adjusted marker element.

The aforesaid medical device has the advantage of being suitable for the

Recording of marker elements provided eyelets outside the grid are arranged. The grid mesh is limited by the end stitches. In this case, the end stitches may have nodes which are arranged on a common circumferential line. The nodes arranged on the circumferential line form an axial end edge of the grid mesh. At at least one of the nodes, the eyelet can connect, which is formed from the same wire element, which also forms the associated end stitch. In particular, the end stitch can form a loop which is twisted in the region of the node. The over the axial

The terminal edge or the node connecting peripheral line projecting, twisted portion of the loop forms the stabilizing portion. The top of the Loop is formed as eye of the eyelet, which adjoins the stabilizing section. The eyelet produced in this way offers a particularly simple possibility of radiopaque marker elements at one axial end of the

to arrange medical device. Since the eyelet over the axial end of

Lattice braid protrudes, it is avoided that the eyelet the crimpability of

medical device negatively affected. Moreover, the eyelet forms a blunt end of the medical device and therefore acts atraumatically. This is achieved in particular by the fact that the eyelet is formed by a single wire element. This avoids that at the axial end of the medical

Device or the grid mesh open wire ends are present. The risk of injury to the vessel wall is thus reduced.

Preferably, the radiopaque marker element comprises a sleeve which is arranged in the region of the stabilization section. The sleeve can with the

Stabilizing section firmly connected, in particular be crimped on the stabilizing section.

The embodiments, effects and advantages disclosed in connection with the medical device according to claim 1 apply equally to the claimed according to the independent aspect of the invention device.

The invention is explained in more detail below on the basis of exemplary embodiments with reference to the accompanying schematic drawings. Show:

Fig. 1: an unfolded partial view of an axial end of

inventive medical device according to a preferred embodiment;

2 shows a detailed view of an eyelet of the medical device according to FIG

Fig. 1;

3 shows a side view of an axial end of a medical device according to the invention according to a further preferred embodiment; and Fig. 4 u. 5 shows a detailed view of an eyelet of a medical device according to the invention with differently arranged marker elements according to a preferred exemplary embodiment.

1 shows a section of an axial end of a medical device, wherein the medical device comprises a tubular grid mesh 10, which is formed from wire elements 11, 12. The tubular grid mesh is shown in the illustration of FIG. 1 in the unfolded state. The wire elements 11, 12 each form spirally wound wall elements of the tubular mesh, wherein the wire elements 11, 12 intersect selectively. The wire elements 11, 12 are intertwined with each other. This means that, for example, a first wire element 11 is guided once over a second wire element 12 and in the further course under another wire element 12. Such a braiding is called 1 over -1 braiding. Other braiding configurations are possible. For example, the grid may have a 1 over -2, 1 over -3, 2 over -2, 2 over -1, 3 over -1, or 3 over 3 braided structure.

The mesh 10 has end meshes 13, 14, which are arranged at a longitudinal axial end of the mesh 10. The Endmaschen 13, 14 form a ring or peripheral portion of the grid mesh 10. The Endmaschen 13, 14 are thus arranged downstream of each other in the circumferential direction. The Endmaschen 13, 14 are limited by wire elements 11, 12. In the embodiment according to FIG. 1, the end stitches 13, 14 have a diamond-shaped geometric structure. Other geometries are possible. For example, the wire elements 11, 12 may have different braiding angles. The braiding angles may vary along the grid 10. In particular, the braiding angles in the axial direction along the lattice braid 10 can change continuously or at least at discrete locations, for example at nodal points. In other words, the wire elements 11, 12 can form spirals that extend helically along the center axis of the mesh 10. The spirals can have different slopes.

In particular, the pitch of a single spiral may vary along the central axis. The spirals intersect to form the mesh 10. The

Endmaschen 13, 14 are limited by at least three different wire elements 11, 12. In the diamond-shaped Endmaschen 13, 14 of FIG. 1 are the

Endmaschen 13, 14 bounded by three different wire elements 11, 12, wherein a wire element 11, 12 forms two sides of the end mesh 13, 14 arranged at an angle to one another.

Specifically, it is provided that a first end mesh 13 is bounded by two sides arranged at an angle to one another, which are formed by the same first wire element 11. The first wire element 11 is deflected at the axial end of the mesh braid 10 and fed back into the mesh 10, so that the first wire element 11 forms a loop 15. The loop 15 thus forms two the first end mesh 13 limiting sides. Preferably, the axial end of the mesh 10 has a plurality of loops 15 each comprising a loop tip 15a. The loop tip 15a substantially corresponds to the deflection point of the first wire element 11. About the circumference of the grid mesh 10 are a plurality of loops

15, wherein the loop tips 15a are arranged substantially on a common circumferential line U. The circumferential line U may be part of a plane, in particular a cross-sectional plane, which is arranged substantially perpendicular to the central axis of the lattice braid 10. The mesh 10 may thus have both a straight end and an oblique end. Preferably, this has

Grid 10 on a straight axial end. It is also possible that the

Circumference U is arranged obliquely to the central axis of the mesh braid 10. In this case, at least one eyelet 16 may be arranged in the compressed or crimped state of the medical device in the region of the lattice braid 10. At least one further eyelet 16 is arranged outside of the lattice braid 10, so that the advantage that the marker elements 18 or generally the eyelets 16 have a comparatively small influence on the crimpability of the medical device is fulfilled. Moreover, it is also possible that the eyelets 16 are adapted such that at an oblique axial end of the mesh 10, at least the eyes 16b of the eyelets 16 are regularly arranged outside the crimped mesh 10. For example, the stabilizing portions 16a of different eyelets

16 have different lengths, so that the eyes 16b of the eyelets 16 are positioned in the same orthogonal to the central axis of the grid mesh 10 arranged cross-sectional plane.

The loop tip 15a divides the first wire element 11 into a first wire section IIa and a second wire section Ib. The first and second wire sections 11a, 11b jointly, in particular in one piece, form the first wire element 11. The first and second wire sections IIa, IIb of the first wire element 11 differ in their winding direction within the lattice braid 10. The first wire element 11 changes in the region of the loop tip 15a, the winding direction. In particular, the first wire element 11 changes an axial component of the winding direction in the region of the loop tip 15a. This means that the first wire element 11, in particular the first wire section I Ia, for example, in the distal direction along the lattice braid 10 wound clockwise, in the region of the loop tip 15a is deflected in the longitudinal axial direction and returned in the same direction in the proximal direction. The axial component thus changes direction from distal to proximal or vice versa. The first wire section I Ia and the second wire section I Ib can cross each other within the mesh 10.

As a result of the change in the axial component in the region of the loop tip 15a, the first wire element 11 is thus subdivided into two wire sections 11a, 11b, which are wound in opposite directions about the center axis of the mesh braid 10.

The axial end of the mesh 10 further includes second end stitches 14 each having at least two sides which are disposed at an angle to each other and formed by the same second wire member 12. Starting at the connection point 17, the second wire element 12 extends in different, in particular opposite, directions through the grid mesh 10. The second wire element 12 thus comprises two wire sections 12a, 12b, which extend from the connection point 17 in different Windungsrichtungen through the mesh 10. The connection point 17 is arranged on the circumferential line U. The connection point 17 is in alignment with the loop tips 15a of the adjacent first end stitches 13. This ensures that the first and second wire sections IIa, 12a, IIb, 12b of the first wire element 11 and the second wire element 12 each have the same length within the mesh 10. In this way it is avoided that during the expansion of the lattice structure 10, a distortion of the lattice braid 10 takes place.

The second wire element 12, in particular the first and second wire section 12a, 12b of the second wire element 12, runs in different directions through the grid mesh 10 starting from the connection point 17. The first and second wire sections 12a, 12b can later on within the grid mesh 10 cross over. From the viewpoint of the lattice structure 10, the second wire element 12 has two wire sections 12a, 12b, which are wound in opposite directions about the central axis of the lattice braid 10. The wire sections 12a, 12b of the second wire element 12 are intertwined with first wire elements 11 and together form the wall of the grid mesh 10. The first wire section 12a and the second wire section 12b of the second wire element 12 define two sides of the second end mesh 14 and are at the connection point 17 merged.

Starting from the connection point 17, the merged wire sections 12a, 12b of the second wire element 12 form a stabilizing section 16a of an eyelet 16. The connection point 17 separates the grid mesh 10 from the eyelet 16. The eyelet 16 is thus arranged outside the grid mesh 10. In particular, the eyelet 16 projects beyond the circumferential line U.

The eyelet 16 includes the stabilizing portion 16a and an eye 16b, wherein the stabilizing portion 16a and the eye 16b are each formed by the same second wire member 12. Analogous to the function of the loop tip 15a, the eye 16b of the eyelet 16 forms a fictitious subdivision of the second wire element 12 into the first wire section 12a and the second wire section 12b. In the region of the stabilization section 16a, the first wire section 12a and the second wire section 12b of the second wire element 12 are twisted together. In general, the first and second wire sections 12a, 12b are connected together in the stabilizing section 16a. A twist of the first and second wire sections 12a, 12b is preferred. Other connection types are possible. For example, the first and second wire sections 12a, 12b of the second wire element 12 in the region of the stabilization section 16a can run parallel to one another and touch each other. The connection of the first and second wire sections 12a, 12b can be effected by a sleeve 18a. The sleeve 18a may comprise a radiopaque material and form a radiopaque marker element 18 accordingly. The sleeve 18a can crimp the first and second wire sections 12a, 12b. Alternatively or additionally, the first and second wire sections 12a, 12b may be welded or glued.

The eyelet 16 serves to receive one or more radiopaque marker elements 18. The marker element 18 can be arranged both in the region of the stabilization section 16a and in the region of the eye 16b. In Figs. 1 and 2 is omitted for reasons of clarity and to better illustrate the structure of the eyelet 16 on the representation of a marker element 18.

In Fig. 2, the eyelet 16 is shown in detail. It can clearly be seen that the stabilizing section 16a and the eye 16b, ie the entire eyelet 16, is formed from the same second wire element 12. In this case, the second wire element 12 comprises a first wire section 12a and a second wire section 12b, wherein the first and second wire sections 12a, 12b are interconnected, in particular twisted, in the region of the stabilization section 16a.

The twisting of the first wire portion 12a with the second wire portion 12b to form the stabilizing portion 16a is particularly advantageous because the

Cross-sectional profile of the formed by the twisting of the first and second wire portion 12a, 12b stabilizing portion 16a is substantially a round

Forming outer contour or a substantially round cross-sectional profile. The sleeve 18a or generally the radiopaque marker element 18 can be easily and easily fixed in this way. The sleeve 18a can be twisted on the

Stabilization section 16a be crimped. The twisted first and second wire sections 12a, 12b ensure that the sleeve 18a largely retains the originally round cross-sectional profile in the crimped state. This is a particularly strong and stable connection of the sleeve 18 a with the

Stabilization section 16a possible. Alternatively, the first wire portion 12a and the second wire portion 12b may be parallel to each other in the region of the stabilizing portion 16a. The cross-sectional profile of the stabilizing portion 16a in this case substantially corresponds to an oval contour. The crimped sleeve 18a therefore assumes a flattened contour. This has the advantage that the wall thickness of the wall of the medical device is reduced. For this purpose, it is particularly advantageous if the first and second wire sections 12a, 12b are aligned with the wall of the grid mesh 10 parallel to each other. The crimped sleeve 18a has in this case two flat or flattened sides, which extend substantially parallel to the wall of the mesh 10.

Fig. 3 shows an axial end of a medical device with a mesh 10, which is formed from wire elements 11, 12. The wire elements 11, 12 form Endmaschen 13, 14, wherein the first Endmaschen 13 loops 15, each formed of a single first wire element 11. The loops 15 have loop tips 15a, which are arranged on a common circumferential line U. Furthermore, second end stitches 14 are provided, which are delimited on at least two sides by a single, second wire element 12. The second wire element 12 comprises a first wire section 12a and a second wire section 12b, wherein the wire sections 12a, 12b of the second wire element 12 are brought together at a connection point 17 and project together over the circumferential line U of the mesh braid 10. The protruding part of the second wire element 12 forms the eyelet 16. The eyelet 16 also has a stabilizing section 16a and an eye 16b, wherein the first and second wire sections 12a, 12b of the second wire element 12 are interconnected, in particular twisted, in the region of the stabilizing section 16a , is.

In the area of the stabilization section 16a, a radiopaque marker element 18 is also arranged according to FIG. The marker element 18 is formed as a sleeve 18a, which surrounds the stabilizing portion 16a. The sleeve 18a is fixed by the eye 16b and the second end mesh 14 in the axial direction. This means that the second end mesh 14 and the eye 16b, in which the first and second wire sections 12a, 12b of the second wire element 12 diverge relative to the stabilization section 16a, form a positive fit in the axial direction for attachment of the marker element 18. Alternatively or additionally, the

Marker element 18 and the sleeve 18a be crimped onto the stabilizing portion 16a, so form a positive connection. The frictional connection or the crimped connection fixes the marker element 18 also in the axial direction. When using soft, radiopaque materials, such as platinum or gold, the crimping or generally a cold forming method for fixing on the stabilizing portion 16a is preferred.

The crimping of the sleeve 18a on parallel extending first and second wire sections 12a, 12b has the advantage that the marker element 18 or the sleeve 18a forms a relatively flat shape. This reduces the space requirement of the axial end of the medical device, so that the device with a relatively small

On the other hand, facilitates the repositioning of the medical device, since the flat structure of the marker element 18 simplifies the retraction of the medical device into a catheter. Furthermore, the marker element 18 or the sleeve 18 a welded to the stabilizing portion, in particular the second wire element 12 or be soldered. Instead of a sleeve 18a, the marker element 18 may also have a coil or a helical spring-like structure. Alternatively or additionally, a separate radiopaque wire piece may be provided, which with the

Stabilization section 16a connected, in particular welded.

In general, the marker element 18 preferably comprises a radiopaque material comprising platinum, gold or tantalum. Other materials which meet the requirements for biocompatibility and radiopacity are known to those skilled in the art.

The arrangement of the marker element 18, in particular a sleeve 18a in the region of the eyelet 16 is shown in detail in FIG. 5 that, in addition, but also alternatively, to the marker element 18, which is arranged in the region of the stabilization section 16a, a marker element 18, in particular a disc-shaped element 18b, can be arranged in the region of the eye 16b of the eyelet 16 , The disk-shaped element 18b can be clamped in the eye 16b. For example, the disc-shaped member 18b may have a circumferential circumferential groove in which the second wire member 12 is disposed when the disc-shaped member 18b is inserted into the eye 16b. The disk-shaped element 18b can also comprise a rivet or be designed rivet-like, so that the disk-shaped element 18b can be positively connected to the eye 16b. The

disc-shaped element 18b may engage over the second wire element 12. The disc-shaped element 18b can therefore protrude at least partially over the eye 16b.

The axial end of the medical device may include one or more marker elements 18. Preferably, the axial end of the medical device comprises a single marker element 18. For this purpose, a single over the circumferential line U projecting eyelet 16 is provided. This configuration is particularly advantageous when the circumferential line U is inclined with respect to the central axis of the tubular mesh 10. The eyelet 16 in this case is preferably located at the point of the mesh braid 10 which, when the medical device is placed in a catheter, is closest to the catheter tip or reaches the catheter tip first. This ensures that the eyelet 16 or a marker element arranged in this region does not collide with the wire elements 11, 12 within the lattice braid 10 in the compressed state of the medical device. Alternatively, the single eyelet 16 may be located at the proximal end of the medical device. In this case, when the medical device is arranged in a catheter, the eyelet 16 is farther from the catheter tip than a distal end of the medical device. The proximal end of the medical device may have a circumferential line U inclined with respect to the central axis. In this connection, reference is made to the patent application filed on the same day entitled "Apparatus for Intake Into a Hollow Organ", which is to the Applicant and incorporated by reference in its entirety.

It is possible that a first axial end, in particular the proximal end, of the medical device has a single eyelet 16 which forms the tip of an obliquely extending peripheral edge of the lattice structure. The proximal eyelet 16 may be equipped with or without a radiopaque marker element 18. In addition, at a second axial end, in particular at the distal end, the

medical device one or more eyelets 16 may be provided. The eyelets 16 may include marker elements 18. It is also possible that none or only part of the eyelets 16 comprise marker elements 18 at the second axial end. The second axial end may also have an oblique contour, analogous to the first axial end. In general, the oblique contour of the axial end, both at the distal end and at the proximal end of the lattice structure 10, may be atraumatic. For example, the wire elements 11, 12 at the axial ends of the lattice structure 10 may have a braid configuration that forms a smooth end edge. Such a braided configuration is detailed in the above

Patent application "Device for delivery into a hollow organ" described.

In principle, all combinations of differently shaped axial ends are possible. For example, both at the proximal axial end of the medical device, as well as at the distal end an oblique end edge may be provided, from each of which a single eyelet 16 emerges, which projects beyond the circumferential line U and the oblique end edge.

It is also possible for a plurality of marker elements 18, in particular the marker elements 18 receiving eyelets 16, to be arranged over the circumference of the medical device at the axial end. In each case, an eyelet 16 between two loops 15 is arranged. Between the eyelets 16 a plurality of loops 15 may be arranged. The eyelets 16 are thus provided at a distance from each other over the circumference of the medical device. Preferably, at least three marker elements 18 are on axial end of the medical device provided. This allows the opening or expansion of the axial end of the medical device to be observed under X-ray control. In this way, it is possible to react in the short term to a collapse or possible errors in the expansion of the axial end.

The ratio between the number of loops 15 and the number of loops 16 is preferably at least 2: 1, in particular at least 3: 1, in particular at least 4: 1, in particular at least 5: 1, in particular at least 6: 1, in particular at least 7: 1 , in particular at least 8: 1, in particular at least 9: 1, in particular at least 10: 1, in particular at least 12: 1, in particular at least 14: 1, in particular at least 16: 1, in particular at least 18: 1. Concretely, at the axial end of the medical Device, in particular at the axial end of the mesh 10, at least 6, in particular at least 8, in particular at least 12, in particular at least 16, in particular at least 18, loops be provided. Furthermore, at least 1, in particular at least 2, in particular at least 3 eyelets 16 with marker elements 18 may be provided at the axial end of the medical device.

The mesh 10 preferably comprises wire elements 11, 12 comprising a self-expanding material. The wire elements 11, 12 preferably have a nickel-titanium alloy or cobalt-chromium alloy. It is also possible that the wire elements 11, 12 have self-expanding plastics. The

Lattice braid 10 may have a cover which preferably extends over the outer periphery of the grid mesh or generally the medical device. The cover may comprise polyurethane, for example. In the axial direction of the medical device, the cover may extend in the region of the grid mesh or beyond the grid mesh. For example, the

Cover up to the circumferential line U and extend to the loop tips 15a. Alternatively, the cover may extend to the eyelet 16, in particular to the eye 16b. It is also possible that the eyelet 16 is coated with a plastic per se.

The production of the grid mesh or generally the medical device is preferably carried out on a commercially available braiding machine. The braiding machine is equipped with wire elements 11, 12 and adjusted so that when braiding the grid structure 10 first and second wire elements 11, 12 are formed, wherein the In the region of the axial end of the medical device, the second wire elements are twisted to form the eyelet 16, so that the length of the arranged inside the grid mesh 10 wire elements 11, 12 or portions of the wire elements 11, 12 is the same. The original length difference between the first wire elements 11 and the second wire elements 12 is thus compensated by the formation of the eyelet 16. In concrete terms, this means that the wire section of the second wire element 12, which projects beyond the length of the first wire element 11, completely forms the eyelet 16.

The medical device may be designed as a stent, flow diverter, filter, basket-type temporary implant or occlusion device. Particularly suitable is the medical device for use in blood vessels, for example as a stent or thrombus filter. Particularly preferred applications are in the area of the coronary vessels and the cerebral arteries. In general, the medical device can be inserted into body cavities, from an medical point of view, radiographic control of the implantation is appropriate. Due to the special arrangement of the marker elements 18 outside of the mesh 10, the medical device is particularly suitable for small body cavities, especially small blood vessels.

It should be noted that all features mentioned in the context of this application are disclosed on their own as well as in connection with any other features described in this application.

LIST OF REFERENCE NUMBERS

10 grid mesh

11 first wire element

I Ia first wire section

I Ib second wire section

12 second wire element

12a first wire section

12b second wire section

13 first final stitch second final mesh

loop

a loop tip

eyelet

a stabilization sectionb eye

junction

marker element

a sleeve

b disk-shaped element

Claims

claims

1. Medical device with a tubular grid mesh (10)

Wire elements (11, 12), the end meshes (13, 14) form at a longitudinal axial end of the grid mesh (10), wherein a first wire element (11) of a first end mesh (13) forms a loop (15) with a loop tip (15a) , which is arranged with further loop tips (15a) on a common, the grid mesh (10) axially delimiting peripheral line U, as you can tell n e ch n et that

at least a second wire element (12) of a second end mesh (14) forms an eyelet (16) projecting in the longitudinal axial direction over the circumferential line U of the loop tips (15a), wherein in the region of the eyelet (16)

radiopaque marker element (18) is arranged.

2. Medical device according to claim 1,

d a n d u rch e g e n s that net

in the circumferential direction of the grid structure (10) an eyelet (16) between two loops (15) is arranged.

3. Medical device according to claim 1 or 2,

d e a n c e s that net

the wire elements (11, 12) each have two wire sections (IIa, IIb, 12a, 12b) which run in opposite directions about a common central axis of the

Grid mesh (10) are wound.

4. Medical device according to at least one of claims 1 to 3,

It does not show that

the wire sections (12a, 12b) of the second wire element (12) are brought together at a connection point (17) which is arranged in the region of the circumferential line U.

5. Medical device according to at least one of claims 1 to 4,

there is no evidence that

a first wire portion (12a) of the second wire member (12) for forming a stabilizing portion (16a) of the eyelet (16) with a second one

Wire section (12b) of the second wire element (12) connected, in particular twisted or welded or glued, is.

6. Medical device according to claim 5,

d a d u rc h e n c e n c e n e s that

the stabilization section (16a) is arranged axially outside of the mesh braid (10), in particular over the circumferential line U above.

7. Medical device according to claim 5 or 6,

d a d u rc h e n c i n e s that

the stabilizing section (16a) is arranged between the second end mesh (14), in particular the connection point (17), and an eye (16b) of the eyelet (16).

8. Medical device according to at least one of claims 5 to 7,

d a d u rc h e n c e n c e n e s that

the stabilizing portion (16a) extends substantially parallel to the central axis of the mesh (10).

9. Medical device according to at least one of claims 5 to 8,

d a d u rc h e n c e n c e n e s that

the radiopaque marker element (18) in the region of

Stabilization portion (16 a) or the eye (16 b) of the eyelet (16) is arranged.

10. Medical device according to at least one of claims 1 to 9,

d a d u rc h e n c i n e s that

the marker element (18) has a sleeve (18a) which surrounds the

Stabilization section (16a) surrounds.

11. Medical device according to at least one of claims 1 to 10,

d a d u rc h e n c i n e s that

the marker element (18) comprises a disc-shaped element (18b) which is arranged in the eye (16b) of the eyelet (16).

12. Medical device with a tubular grid mesh (10)

Wire elements (11, 12), which at a longitudinal axial end of the grid mesh (10) form end stitches (13, 14) which delimit the grid mesh (10) axially, at least one wire element (12) forming an eyelet (16) aligned with a wall plane of the grid mesh (10) and passing over the end stitches (13, 13). 14) and having an eye (16b) dividing the wire member (12) into a first wire portion (12a) and a second wire portion (12b), the first wire portion (12a) and the second wire portion (12b) between the end mesh (14) and the eye (16b) are twisted and form a stabilizing portion (16a) of the eyelet (16) adapted to receive a radiopaque marker element (18).

13. Medical device according to one of the preceding claims,

d a d u r c h g e ke n ze i c h n e t that

the radiopaque marker element (18) has a sleeve (18a) which is arranged in the region of the stabilization section (16a).

14. Medical device according to one of the preceding claims,

d a d u r c h g e ke n ze i c h n e t that

the sleeve (18a) is connected to the stabilizing section (16a),

in particular crimped onto the stabilizing section (16a).