DE102009056449A1 - Medical device - Google Patents

Abstract

The invention relates to a medical device having a tubular meshwork (10) of wire elements (11, 12) which form end meshes (13, 14) at a longitudinal axial end of the mesh mesh (10), wherein a first wire element (11) of a first mesh (11) 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. The invention is characterized in 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 ) a radiopaque marker element (18) is arranged.

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 A1 known.

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 device is displaced within a body cavity. The movement of the medical device should be traceable under X-ray inspection.

The WO 2005/110286 A1 describes a stent in which the radiopacity is on the one hand achieved 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 projects in the longitudinal axial direction over the circumferential line 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 respectively 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 radiopacity is ensured. Since the additional material in the form of marker elements outside of the grid mesh is arranged, the grid mesh 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 appropriate if the eyelets spaced from each other, d. H. generally between two loops, are arranged.

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 may have the same or similar braiding 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 and bonded together at the juncture of the second wire member, the connected wire portions forming the stabilizing portion projecting beyond the peripheral 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 so total through a single wire element, in particular the second wire element formed. 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 portion to the central axis of the grid mesh that the eyelet projecting, for example in the radial direction to the outside and thereby increases the risk of injury during implantation. Conveniently, the eyelet is aligned with a wall plane of the grid mesh. In this case, the stabilization section may have an axial component, which is arranged parallel to the central axis of the lattice braid. 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 stabilization section can be deflected in the radial direction of 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, thus having a preferably continuously increasing 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. 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 can have a C-shaped cross-sectional profile, so that the sleeve can be pushed laterally over the stabilizing section and then connected in a clamping manner to 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 section and the second wire section are between the end stitch and the eye twist and form a stabilizing portion of the eyelet. The stabilization section is adapted to receive a radiopaque marker element.

The aforementioned medical device has the advantage that the eyelets provided for the reception of marker elements are arranged outside the grid mesh. 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 twisted portion of the loop projecting beyond the axial end edge or nodes forms the stabilizing portion. The tip of the loop is formed as an eye of the eyelet, which adjoins the stabilizing section. The eyelet produced in this way offers a particularly simple possibility of arranging radiopaque marker elements on one axial end of the medical device. Since the eyelet protrudes beyond the axial end of the mesh braid, it is avoided that the eyelet adversely affects the crimpability of the medical device. 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 open wire ends are present at the axial end of the medical device or the mesh braid. 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 may be fixedly connected to the stabilizing section, in particular crimped onto 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:

1 FIG. 2 is an unfolded partial view of an axial end of the medical device according to the invention according to a preferred embodiment; FIG.

2 : A detailed view of an eyelet of the medical device according to 1 ;

3 a side view of an axial end of a medical device according to the invention according to a further preferred embodiment; and

4 u. 5 in each case a detailed view of an eyelet of a medical device according to the invention with differently arranged marker elements according to a preferred embodiment.

In 1 Fig. 3 shows a section of an axial end of a medical device, wherein the medical device comprises a tubular grid mesh 10 includes, consisting of wire elements 11 . 12 is formed. The tubular grid mesh is shown in the illustration 1 shown 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. Here are the wire elements 11 . 12 intertwined. This means that, for example, a first wire element 11 once over a second wire element 12 and in the further course under another wire element 12 is guided. 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 grid 10 has final stitches 13 . 14 on, at a longitudinal axial end of the lattice mesh 10 are arranged. The final stitches 13 . 14 form a ring or peripheral portion of the grid mesh 10 , The final stitches 13 . 14 are therefore arranged downstream of each other in the circumferential direction. The final stitches 13 . 14 are by wire elements 11 . 12 limited. In the embodiment according to 1 have the final stitches 13 . 14 a diamond-shaped geometric structure. Other geometries are possible. For example, the wire elements 11 . 12 have different braid angles. The braiding angles can be along the grid 10 vary. In particular, the braiding angles can be in the axial direction along the grid mesh 10 continuously or at least at discrete locations, such as at nodes. In other words, the wire elements 11 . 12 Spirals form, extending helically along the central axis of the lattice plexus 10 extend. The spirals can have different slopes. In particular, the slope of a single Spiral vary along the central axis. The spirals intersect, around the grid 10 to build. The final stitches 13 . 14 are by at least three different wire elements 11 . 12 limited. At the rhombic end stitches 13 . 14 according to 1 are the final stitches 13 . 14 through three different wire elements 11 . 12 limited, wherein a wire element 11 . 12 two sides of the end stitch arranged at an angle to each other 13 . 14 forms.

Specifically, it is envisaged that a first final mesh 13 is bounded by two sides arranged at an angle to each other through the same first wire element 11 are formed. The first wire element 11 is at the axial end of the lattice mesh 10 diverted and into the grid 10 returned, leaving the first wire element 11 a loop 15 forms. The loop 15 thus forms two the first final mesh 13 limiting pages. Preferably, the axial end of the mesh braid 10 several loops 15 on, each one a loop tip 15a include. The loop tip 15a essentially corresponds to the deflection point of the first wire element 11 , About the circumference of the lattice mesh 10 are several loops 15 arranged, with 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 substantially perpendicular to the central axis of the grid mesh 10 is arranged. The grid 10 can thus have both a straight end and an oblique end. Preferably, the grid mesh 10 a straight axial end. It is also possible that the circumferential line U to the central axis of the grid mesh 10 is arranged obliquely. In this case, at least one eyelet 16 in the compressed or crimped state of the medical device in the region of the lattice mesh 10 be arranged. At least one more eyelet 16 is outside the grid 10 arranged so that the advantage, according to which the marker elements 18 or in general the eyelets 16 have a comparatively small influence on the crimpability of the medical device, is met. It is also possible that the eyelets 16 are adapted such that at an oblique axial end of the grid mesh 10 at least the eyes 16b the eyelets 16 regularly outside the crimped grid 10 are arranged. For example, the stabilizing sections 16a different eyelets 16 have different lengths, so that the eyes 16b the eyelets 16 in the same orthogonal to the central axis of the lattice braid 10 arranged cross-sectional plane are positioned.

The loop tip 15a divides the first wire element 11 in a first wire section 11a and a second wire section 11b , The first and second wire sections 11a . 11b together form, in particular in one piece, the first wire element 11 , The first and second wire sections 11a . 11b of the first wire element 11 differ in their winding direction within the grid mesh 10 , The first wire element 11 changes in the area of the loop tip 15a the winding direction. In particular, the first wire element changes 11 in the area of the loop tip 15a an axial component of the winding direction. That means that the first wire element 11 , in particular the first wire section 11a , For example, in the distal direction along the grid mesh 10 wound in a clockwise direction, in the area 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 11a and the second wire section 11b can be within the grid 10 cross.

By changing the axial component in the area of the loop tip 15a becomes the first wire element 11 So in two wire sections 11a . 11b divided in opposite directions about the central axis of the mesh 10 are tortuous.

The axial end of the mesh braid 10 further includes second end stitches 14 each having at least two sides arranged at an angle to each other and through the same second wire element 12 are formed. The angled sides of the second end stitch 14 cross or meet at a junction 17 , Starting from the connection point 17 runs the second wire element 12 in different, especially opposite, directions through the mesh 10 , The second wire element 12 So includes two wire sections 12a . 12b starting from the junction 17 in different winding directions through the grid mesh 10 run. The connection point 17 is arranged on the circumferential line U. The connection point 17 Aligns with the loop tips 15a the adjacent first end stitches 13 , This ensures that the first and second wire sections 11a . 12a . 11b . 12b of the first wire element 11 and the second wire element 12 each the same length within the grid 10 exhibit. In this way it is avoided that during expansion of the lattice structure 10 a distortion of the grid mesh 10 he follows.

The second wire element 12 , in particular the first and second wire section 12a . 12b of the second wire element 12 , runs from the junction 17 in different directions through the grid mesh 10 , The first and second wire section 12a . 12b can later on within the mesh 10 cross. From the perspective of the lattice structure 10 has the second wire element 12 two wire sections 12a . 12b on, in opposite directions around the central axis of the grid mesh 10 are tortuous. The wire sections 12a . 12b of the second wire element 12 are with first wire elements 11 intertwined 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 limit two sides of the second final mesh 14 and are at the junction 17 merged.

Starting from the connection point 17 form the merged wire sections 12a . 12b of the second wire element 12 a stabilization section 16a an eyelet 16 , The connection point 17 separates the grid mesh 10 from the eyelet 16 , The eyelet 16 is thus outside the grid 10 arranged. In particular, the eyelet is 16 over the circumference U before.

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

The eyelet 16 serves to accommodate one or more radiopaque marker elements 18 , In this case, the marker element 18 both in the area of the stabilization section 16a , as well as in the area of the eye 16b be arranged. In the 1 and 2 is for reasons of clarity and to better illustrate the structure of the eyelet 16 on the representation of a marker element 18 waived.

In 2 is the eyelet 16 shown in detail. It is easy to see that the stabilization section 16a and the eye 16b So the whole eyelet 16 , from the same second wire element 12 is formed. The second wire element 12 includes a first wire section 12a and a second wire section 12b wherein the first and second wire sections 12a . 12b in the area of the stabilization section 16a interconnected, in particular twisted, are.

Twisting the first wire section 12a with the second wire section 12b to form the stabilization section 16a is particularly advantageous because the cross-sectional profile of the twisted by the first and second wire section 12a . 12b formed stabilization section 16a essentially forms a round outer contour or a substantially round cross-sectional profile. The sleeve 18a or in general the radiopaque marker element 18 can be easily and easily fixed in this way. The sleeve 18a can on the twisted stabilization section 16a be crimped. Through the twisted first and second wire sections 12a . 12b will reach that sleeve 18a the originally round cross-sectional profile in the crimped state largely retains. This is a particularly strong and stable connection of the sleeve 18a with the stabilization section 16a possible. Alternatively, the first wire section 12a and the second wire section 12b in the area of the stabilization section 16a parallel to each other. The cross-sectional profile of the stabilization section 16a in this case corresponds essentially to an oval contour. The crimped sleeve 18a therefore takes 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 section 12a . 12b with the wall of the grid mesh 10 run in alignment parallel to each other. The crimped sleeve 18a has in this case two flat or flattened sides, which are substantially parallel to the wall of the grid mesh 10 run.

3 shows an axial end of a medical device with a grid mesh 10 made of wire elements 11 . 12 is formed. The wire elements 11 . 12 form final stitches 13 . 14 , wherein the first end stitches 13 loops 15 each comprising a single first wire element 11 are formed. The loops 15 have loop tips 15a on, which are arranged on a common circumferential line U. Further, second end stitches 14 provided on at least two sides by a single, second wire element 12 are limited. The second wire element 12 includes a first wire section 12a and a second wire section 12b , wherein the wire sections 12a . 12b of the second wire element 12 at a junction 17 are merged and together over the circumferential line U of the mesh 10 protrude. The projecting part of the second wire element 12 forms the eyelet 16 , The eyelet 16 also has a stabilization section 16a and an eye 16b on, wherein the first and second wire section 12a . 12b of the second wire element 12 in the area of the stabilization section 16a interconnected, in particular twisted, is.

In the area of the stabilization section 16a is according to 3 a radiopaque marker element 18 arranged. The marker element 18 is as a sleeve 18a formed, the stabilization section 16a embraces. The sleeve 18a is through the eye 16b and the second final mesh 14 fixed in the axial direction. This means that the second final mesh 14 and the eye 16b in which the first and second wire sections 12a . 12b of the second wire element 12 with respect to the stabilization section 16a each diverge, in the axial direction a positive connection for attachment of the marker element 18 form. Alternatively or additionally, the marker element 18 or the sleeve 18a on the stabilization section 16a be crimped, so form a positive connection. The frictional connection or the crimp connection fixes the marker element 18 also in the axial direction. When using soft, radiopaque materials, such as platinum or gold, is the crimping or generally a cold forming process for fixation on the stabilizing section 16a prefers.

The crimping of the sleeve 18a on parallel 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 can be combined with a relatively small delivery system, in particular catheter, and on the other hand facilitates the repositioning of the medical device because of the flat structure of the marker element 18 retracting the medical device into a catheter is simplified. Furthermore, the marker element 18 or the sleeve 18a with the stabilizing section, in particular the second wire element 12 welded or soldered. Instead of a sleeve 18a can be the marker element 18 also have a coil or a helical spring-like structure. Alternatively or additionally, a separate X-ray-visible wire piece may be provided which is connected to the stabilization section 16a connected, in particular welded.

In general, the marker element has 18 preferably 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 eyelet area 16 is detailed in 4 shown. In 5 It can also be seen that additionally, but also alternatively, to the marker element 18 in the area of the stabilization section 16a is arranged, a marker element 18 , in particular a disk-shaped element 18b in the area of the eye 16b the eyelet 16 can be arranged. The disk-shaped element 18b can in the eye 16b be trapped. For example, the disc-shaped element 18b have a circumferential circumferential groove, in which the second wire element 12 is arranged when the disc-shaped element 18b in the eye 16b is used. The disk-shaped element 18b may also include a rivet or rivet-like design, so that the disc-shaped element 18b with the eye 16b is positively connected. The disk-shaped element 18b may be the second wire element 12 spread. The disk-shaped element 18b So at least partially over the eye 16b protrude.

The axial end of the medical device may include one or more marker elements 18 include. 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 intended. This configuration is particularly advantageous when the circumferential line U with respect to the central axis of the tubular grid mesh 10 slants. The eyelet 16 is in this case preferably at the point of the grid mesh 10 which is closest to the catheter tip when the medical device is arranged in a catheter or reaches the catheter tip first. This will ensure that the eyelet 16 or a marker element arranged in this region in the compressed state of the medical device does not interact with the wire elements 11 . 12 within the grid 10 collided. Alternatively, the only eyelet 16 are arranged at the proximal end of the medical device. Here is the eyelet 16 upon placement of the medical device in a catheter further 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 a single eye 16 which forms the tip of a sloping peripheral edge of the lattice structure. The proximal eye 16 can with or without a radiopaque marker element 18 be equipped. In addition, at a second axial end, in particular at the distal end, of the medical device one or more eyelets 16 be provided. The eyelets 16 can be marker elements 18 exhibit. It is also possible that none or only part of the eyelets 16 at the second axial end marker elements 18 include. 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 may be at both the distal and proximal ends of the lattice structure 10 be formed atraumatic. For example, the wire elements 11 . 12 at the axial ends of the lattice structure 10 have a braid configuration that forms a smooth end edge. Such a braided configuration is described in detail in the above-mentioned patent application "Apparatus for Intake into a Hollow Organ". 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 terminal edge may be provided, from each of which a single eye 16 emerges, which projects beyond the circumferential line U and the oblique end edge.

It is also possible that over the circumference of the medical device at the axial end of several marker elements 18 , in particular the marker elements 18 receiving eyelets 16 , are arranged. There is one eyelet each 16 between two loops 15 arranged. Between the eyelets 16 can have several loops 15 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 provided at the axial end of the medical device. 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 eyelets 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. Specifically, at the axial end of the medical device, in particular at the axial end of the grid 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 can be provided at the axial end of the medical device 16 with marker elements 18 be provided.

The grid 10 preferably comprises wire elements 11 . 12 comprising a self-expanding material. Preferably, the wire elements 11 . 12 a nickel-titanium alloy or cobalt-chromium alloy on. It is also possible that the wire elements 11 . 12 Self-expanding plastics have. The grid 10 may comprise 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 can be up to the circumferential line U or up to the loop tips 15a extend. Alternatively, the cover can be up to the eyelet 16 , especially to the eye 16b extend. It is also possible that the eyelet 16 in itself coated with a plastic.

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 made with wire elements 11 . 12 equipped and adjusted so that when braiding the grid structure 10 first and second wire elements 11 . 12 are formed, wherein the second wire elements 12 are longer than the first wire elements 11 , In the region of the axial end of the medical device, the second wire elements for forming the eyelet 16 twisted so that the length of the inside of the grid mesh 10 arranged wire elements 11 . 12 or sections of the wire elements 11 . 12 is equal to. The original length difference between the first wire elements 11 and the second wire elements 12 So it is through the formation of the eyelet 16 compensated. In concrete terms, this means that the wire section of the second wire element 12 that is the length of the first wire element 11 towers over, completely the eyelet 16 forms.

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 used in body cavities, from a medical point of view X-ray inspection of the implantation is appropriate. Due to the special arrangement of the marker elements 18 outside the grid 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

wickerwork

11

first wire element

11a

first wire section

11b

second wire section

12

second wire element

12a

first wire section

12b

second wire section

13

first final stitch

14

second final mesh

15

loop

15a

loop tip

16

eyelet

16a

stabilizing section

16b

eye

17

junction

18

marker element

18a

shell

18b

disk-shaped element

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2005/110286 A1 [0001, 0004]

Claims (14)

Medical device with a tubular mesh ( 10 ) of wire elements ( 11 . 12 ), which at a longitudinal axial end of the grid mesh ( 10 ) End stitches ( 13 . 14 ), wherein a first wire element ( 11 ) of a first final mesh ( 13 ) a loop ( 15 ) with a loop tip ( 15a ) formed with further loop tips ( 15a ) on a common, the grid mesh ( 10 ) axially delimiting circumferential line U is arranged, characterized in that at least one second wire element ( 12 ) a second final mesh ( 14 ) an eyelet ( 16 ) formed in the longitudinal axial direction over the circumferential line U of the loop tips ( 15a ) protruding, wherein in the eyelet ( 16 ) a radiopaque marker element ( 18 ) is arranged. Medical device according to claim 1, characterized in that in the circumferential direction of the grid structure ( 10 ) an eyelet ( 16 ) between two loops ( 15 ) is arranged. Medical device according to claim 1 or 2, characterized in that the wire elements ( 11 . 12 ) two wire sections ( 11a . 11b . 12a . 12b ) in opposite directions about a common center axis of the mesh ( 10 ) are wound. Medical device according to at least one of claims 1 to 3, characterized in that the wire sections ( 12a . 12b ) of the second wire element ( 12 ) at a connection point ( 17 ), which is arranged in the region of the circumferential line U. Medical device according to at least one of claims 1 to 4, characterized in that a first wire section ( 12a ) of the second wire element ( 12 ) to form a stabilization section ( 16a ) the eyelet ( 16 ) with a second wire section ( 12b ) of the second wire element ( 12 ), in particular twisted or welded or glued, is. Medical device according to claim 5, characterized in that the stabilizing section ( 16a ) axially outside the grid ( 10 ), in particular over the circumferential line U above, is arranged. Medical device according to claim 5 or 6, characterized in that the stabilization section ( 16a ) between the second end mesh ( 14 ), in particular the connection point ( 17 ), and one eye ( 16b ) the eyelet ( 16 ) is arranged. Medical device according to at least one of claims 5 to 7, characterized in that the stabilization section ( 16a ) substantially parallel to the central axis of the grid ( 10 ). Medical device according to at least one of claims 5 to 8, characterized in that the radiopaque marker element ( 18 ) in the area of the stabilization section ( 16a ) or the eye ( 16b ) the eyelet ( 16 ) is arranged. Medical device according to at least one of claims 1 to 9, characterized in that the marker element ( 18 ) a sleeve ( 18a ) having the stabilization section ( 16a ) surrounds. Medical device according to at least one of claims 1 to 10, characterized in that the marker element ( 18 ) a disk-shaped element ( 18b ) in the eye ( 16b ) the eyelet ( 16 ) is arranged. Medical device with a tubular mesh ( 10 ) of wire elements ( 11 . 12 ), which at a longitudinal axial end of the grid mesh ( 10 ) End stitches ( 13 . 14 ) forming the grid mesh ( 10 ) axially, wherein at least one wire element ( 12 ) one with a wall plane of the mesh ( 10 ) aligned eyelet ( 16 ) formed over the end stitches ( 13 . 14 ) and one eye ( 16b ) comprising the wire element ( 12 ) into a first wire section ( 12a ) and a second wire section ( 12b ), wherein the first wire section ( 12a ) and the second wire section ( 12b ) between the final mesh ( 14 ) and the eye ( 16b ) are twisted and a stabilization section ( 16a ) the eyelet ( 16 ) for receiving a radiopaque marker element ( 18 ) is adjusted. Medical device according to one of the preceding claims, characterized in that the radiopaque marker element ( 18 ) a sleeve ( 18a ), which in the area of the stabilization section ( 16a ) is arranged. Medical device according to one of the preceding claims, characterized in that the sleeve ( 18a ) with the stabilization section ( 16a ), in particular the stabilization section ( 16a ) is crimped.

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