CN210056361U

CN210056361U - Medical device for intravascular treatment

Info

Publication number: CN210056361U
Application number: CN201821256428.2U
Authority: CN
Inventors: 亚历山大·兰格; 弗兰克·纳格尔; 乔纳斯·克鲁舍尔; 大卫·克洛普
Original assignee: Arcadis Ltd
Current assignee: Arcadis Ltd; Acandis GmbH and Co KG
Priority date: 2018-03-29
Filing date: 2018-08-06
Publication date: 2020-02-14
Anticipated expiration: 2028-08-06
Also published as: DE102018107594B4; DE102018107594A1

Abstract

The utility model relates to a medical device for intravascular treatment, which comprises an at least partially tubular grid structure (10) formed by integrally connected ribs (11) which define cells (12), wherein four webs (11) are connected to one another by web connections (13), wherein at least one radio-opaque wire element (20, 20 ') is provided, which is guided along the at least one web (11) and forms a loop (21, 21') with a first leg (22a, 22a ') and a second leg (22b, 22 b') at an end section (10b) of the lattice structure (10), wherein the first leg (22a, 22a ') and the second leg (22b, 22 b') are arranged radially within the lattice structure (10) or the first leg (22a, 22a ') and the second leg (22b, 22 b') are arranged radially outside the lattice structure (10).

Description

Medical device for intravascular treatment

Technical Field

The utility model relates to a medical equipment for endovascular treatment.

Background

A medical device of this type is known, for example, from DE 102014115533 a 1.

Thrombectomy devices (Thrombektomie-devices), also known as Stent extractors (Stent Retriever), consist of a tubular lattice structure in which the ribs delimit individual cells. This type of lattice structure is typically laser cut from a shape memory material such as nitinol. The near end of the grid structure is connected to a transmission line. An example of such a thrombectomy device is known from WO 2012/106657A 2. To improve the radiopacity of the thrombectomy device, radiopaque wires are guided along the wire on the tendons of the lattice structure. The wire loosely surrounds the tendon. In this case, it must be prevented in a constructive manner that the wire may move or even loosen when the thrombectomy device is used. Particularly problematic is the positioning of the device, particularly if the thrombectomy device should be repositioned, re-retraction into the catheter is particularly problematic. Here, if the radiopaque wires inadvertently overlap the lattice structure, the wires may prevent compression of the lattice structure.

The above-mentioned medical device according to DE 102014115533 a1 solves this problem in that the wires at the proximal end of the lattice structure are formed into loops which surround the tendon connection arranged between the tendons, so that the wires are fixed longitudinally axially. This not only increases the safety during positioning, but also improves the fixing of the wire to the lattice structure. It has been shown that compression of such thrombectomy devices requires relatively large forces.

SUMMERY OF THE UTILITY MODEL

The object of the present invention is to improve a medical device of the type mentioned above in such a way that the lattice structure of the device can be compressed relatively easily without the functional safety of the device being impaired.

According to the invention, this task is solved by a medical device as described below. In particular, this object is achieved by a medical device for endovascular treatment, in particular for removing thrombi, having an at least partially tubular lattice structure with integrally connected webs (stem). These webs define cells, wherein three or four webs are connected to one another by web connections. At least one radio-opaque wire element is provided, which is guided along at least one rib and forms a loop with a first leg and a second leg in an end portion of the lattice structure.

According to the utility model discloses, it radially arranges first shank and second shank inside the grid structure to propose. Alternatively, the first leg and the second leg are arranged radially outside the lattice structure.

The loop is made up of two legs and a loop bend connecting the two legs. The portion of the wire immediately adjacent to the loop bend may be understood as a leg. The leg has a length extending at least to a first intersection with the tendon. In other words, the two legs are arranged on the same side of the lattice structure (radially inside or radially outside) at least until including the first intersection with the web. The two legs cross different webs in the region of the first intersection.

Thus, the legs are decoupled from the lattice structure such that the lattice structure is not obstructed by the wire elements upon compression. Obviously, the legs of the loops are arranged to continue after the first crossing at least over a certain distance or may be arranged on the same side (radially inside or radially outside) of the lattice structure.

In a further development of the lattice structure, the wire elements change the sides of the lattice structure, i.e. turn from radially inside to radially outside and vice versa. For example, the transformation may be performed in the proximal region of the end unit. The transformation may even further be performed proximally, e.g. in the region of other units proximally adjoining the end unit.

The wire element may then be transformed into a coil along the tendon.

The legs enclose an angle determined by the loop bend. The loops and legs are always arranged on the same radial side of the lattice structure.

By the present invention, a certain relative movement between the wire elements and the lattice structure is allowed, so that the movement of the cells is as undisturbed as possible when compressed or expanded in the circumferential and longitudinal direction of the lattice structure. The same applies to the foreshortening effect, wherein the total length of the lattice structure changes during compression or expansion. By arranging the two legs radially inside or radially outside the lattice structure, a mechanical decoupling of the wire elements from the lattice structure is achieved in the region of the distal end portion of the lattice structure. Thereby, there is a possibility of relative movement between the lattice structure and the wire elements in this area.

Furthermore, by the decoupled arrangement of the wire elements in a specific region of the lattice structure, i.e. in the region of the end portions, it is also achieved that the lattice structure and the remaining regions of the wire elements can be connected to each other relatively firmly, at least so firmly that the safety against sliding of the wire elements relative to the lattice structure is substantially maintained. In any case, there is the possibility of designing the connection between the wire elements and the lattice structure such that the function of the device is maintained without impairing the ease of handling of the device when compressed.

The decoupling is limited to the area of the loop. The loop may for example extend to the first intersection.

In a preferred embodiment, the ring is substantially stress-free, i.e. free of residual stress, in the expanded rest state of the device by heat treatment.

The invention can be applied, for example, to a stent extractor produced by the applicant under the trade name APERIO, the basic structure of which is described in more detail in patent DE 102014115533B 1 to which the applicant is entitled. The utility model discloses specifically combine this equipment to disclose and claim. This known thrombectomy device is suitable for rapid recanalization and has a mixed unit design. Thereby, excellent adherence (Wandapposition) and thrombus fusion were achieved. It is possible to easily secure the radiopaque wire elements to the lattice structure of the stent extractor. The hybrid cell design includes closed small cells that result in excellent conformance to the vessel wall and safe thrombus uptake. A larger unit than this with integrated anchoring elements ensures effective grasping of the thrombus and safe, non-invasive removal.

The connection of four tendons by means of tendon connection does not exclude that the grid structure has tendon connections connecting less than four tendons, e.g. three tendons. In a hybrid braid with different cells, the standard cell can be formed by a web connection with four main webs and the sub-cells can be formed by a web connection with three webs.

The utility model can also be applied to other thrombectomy equipment.

In general, a medical device constructed in accordance with the present invention may constitute an implant (e.g., a stent) or a temporarily usable instrument (such as the thrombectomy device previously described).

Generally, it should be noted that medical devices have a tubular lattice structure that is radially expandable. The tubular lattice structure can be automatically transformed from the radially compressed state into the radially expanded state, for example by using the shape memory effect. In this respect, the medical device preferably has a self-expanding lattice structure.

For example, the lattice structure may be partially or completely constructed tubular.

Preferably, in a preferred embodiment of the medical device as a thrombectomy device, it may be provided that the lattice structure is partially configured in a tubular shape, wherein the tubular shape transitions into a funnel-shaped or conical portion at the proximal end of the lattice structure. The tapered portion forms a transition of the lattice structure into the conduit in which the device extends in use in a compressed state. The tapered portion has the function of enabling re-retraction. This advantage is shown in the compressed state of the device. By means of the wire elements or the legs arranged radially outside or radially inside the internally or externally arranged rings, there is a relative freedom of movement between the radiopaque wires and the lattice structure. Thereby, the stress in the catheter is reduced and less guiding force is required for reintroduction into the catheter. In particular in the axial direction, the relative mobility is advantageous, since it is assumed that the ring moves in this direction and its position changes during the pulling in or the removal.

The utility model is not limited to thrombectomy devices, but also includes other medical devices.

The term "distal" denotes the side of the device away from the user or the distal side of the lattice structure. The term "proximal" denotes the side of the medical device facing the user, i.e. the side closer to the user.

In a preferred embodiment, the end portion is a distal end portion. This has the advantage that a relative freedom of movement between the ring and the lattice structure is facilitated.

Thus, for example, the ring may be arranged between two adjacent distal end units of the lattice structure in the expanded state of the lattice structure in the circumferential direction. Alternatively, the ring may be arranged inside the distal end cell of the lattice structure in the expanded state of the lattice structure. In case of a plurality of wire elements, both alternatives can be combined. In this way, a distribution or pattern of the loops over the circumference of the lattice structure is achieved, even in the case of a plurality of wire elements with a corresponding plurality of loops, so that it is possible to compress or expand the lattice structure as unimpeded as possible.

In both variants (inside the distal end unit and between two adjacent distal end units), it is possible to arrange both legs radially inside the lattice structure or radially outside the lattice structure.

The invention does not exclude that a shift in the radial direction may result when using the device, so that the ring is shifted slightly inwards. In the rest state or generally in the expanded state, the two legs are arranged radially inside the lattice structure or radially outside the lattice structure. There may still be differences in the position of the legs or loops in the expanded state. However, particularly in the compressed state, the legs or loops cannot be accurately assigned to the cells.

In the above-described embodiment in which the ring is arranged between two adjacent distal end units in the circumferential direction, the first leg and the second leg may be implemented by one of the end units, respectively. In this way, the inner or outer loop is introduced over a relatively short path of the lattice structure, so that a good fixation of the wire element on the lattice structure is possible except for the distal end portion.

Preferably, the loops are spaced apart in the distal direction from the distal web connection of the lattice structure in the expanded state of the lattice structure, in particular at least one web width, preferably at least 25% of the web length, further preferably at least 50% of the web length. This embodiment supports a free mobility of the lattice structure in the region of the distal end portion, since the distance between the ring and the distal tendon connection enables a free path along which the lattice structure and the wire elements can move relative to each other.

Preferably, the loop divides the wire element into a first portion and a second portion. The first part and/or the second part are wound around a plurality of webs, which in each case form a web string (Stegreihe) in alignment with one another. The tendon string extends helically around the longitudinal axis of the lattice structure. In this way, a corresponding pattern or a corresponding course of the wire elements is achieved by the wire elements, which provides particularly good visibility or visibility.

In a preferred embodiment, the wire element is wound around the string of tendons such that a complete winding of the wire element is achieved, in particular a winding of 360 ° along the string of tendons after one tendon, in particular after 2 tendons, in particular after 3 tendons.

The wire elements may be constructed of wires that are completely radiopaque or composite wires with radiopaque cores. The latter is known, for example, in the term DFT wire and has the advantage of good biocompatibility of the wire element in relation to the function of radiopacity.

In order to increase the radiopacity, 2, 3 or 4 wire elements may be provided, which respectively constitute a loop in the distal end portion of the lattice structure. According to the invention, the rings are each constructed in such a way that the first leg and the second leg of the ring are arranged radially inside the lattice structure or radially outside the lattice structure.

In a further embodiment, the portions of the wire elements may regularly intersect along the lattice structure, wherein a string of at least two tendons, in particular at least three tendons and at most eight tendons, in particular at most six tendons, is arranged between two intersections, respectively. Thereby, the inclination of the wire elements along the lattice structure or along the central axis of the lattice structure may be influenced. In a preferred embodiment, exactly three tendon strings are arranged between two intersections.

In another preferred embodiment, in the distal end portion of the lattice structure, at most four rings with a first leg and a second leg, respectively, are arranged. In this case, the first leg and the second leg are arranged radially inside or outside the lattice structure.

The lattice structure can have at least one rib extension (stegfortsz) at the proximal end section, which rib extension is positively connected with the distal coupling piece of the transmission line. Preferably, two tendon extensions are provided. Thereby, a reliable connection of the grid structure to the transmission line is established. This embodiment is particularly suitable for use as a thrombectomy device.

The beam extension may have an engagement element which suitably engages into a recess of the coupling, the recess extending transversely to the longitudinal axis of the transmission line. In this way, axial forces occurring in the guide system during the movement of the device are reliably transmitted.

For further reliability, a crimp sleeve may be provided, which surrounds the web extension and the coupling piece.

By guiding the open ends of the wire elements through the crimping sleeve, a particularly good fixing of the wire elements on the lattice structure is achieved, so that the open ends of the wire elements ideally end approximately flush with the proximal end of the crimping sleeve or protrude just so far out of the proximal end that a complete bonding is still possible. Thus, it is ensured that the wire element is held firmly at the proximal end or at the area of the transmission line.

For example, the protruding wire end may be connected to the transmission line by an adhesive filled coil, wherein the coil surrounds the protruding wire end and the transmission line. Thereby, a further safety against unintentional loosening of the thrombectomy device from the transmission line is achieved.

Alternatively, the protruding wire ends may be glued directly together with the transmission line.

Furthermore, a method for producing a medical device according to the invention is also disclosed and claimed in the scope of the present invention. The method comprises heat treating at least one wire element such that the wire element is as stress free as possible in the expanded or partially expanded state. Thus, in particular, the loop of the wire element can be moved in the catheter with a low guiding force and can be retracted again. The wire element and the loop are about to transition to their expanded state after the transition temperature is reached. Below this temperature the lattice structure can be compressed stress-free by retracting into the catheter again.

The invention also provides a medical device for endovascular treatment, having an at least partially tubular lattice structure consisting of integral, mutually connected tendons, which define a unit, wherein four tendons are connected to each other by tendon connections, wherein at least one radiopaque wire element is provided, which is guided along the at least one tendon and constitutes in an end portion of the lattice structure a loop with a first leg and a second leg, wherein the first leg and the second leg are radially arranged inside the lattice structure, or the first leg and the second leg are radially arranged outside the lattice structure.

In some embodiments, the end portion is a distal end portion.

In some embodiments, the loop is arranged between two distal end cells of the lattice structure adjacent in the circumferential direction or inside one distal end cell of the lattice structure in the expanded state of the lattice structure.

In some embodiments, the first leg and the second leg are each guided through one of the two distal end units.

In some embodiments, the loop is distally spaced from a distal tendon connection of the lattice structure in the expanded state of the lattice structure.

In some embodiments, the loop is spaced apart from a distal tendon connection of the lattice structure in a distal direction by at least one tendon width in an expanded state of the lattice structure.

In some embodiments, the loops are arranged in an expanded state of the lattice structure at least 25% tendon length spacing in a distal direction from distal tendon connections of the lattice structure.

In some embodiments, the loops are arranged in an expanded state of the lattice structure at least 50% tendon length spacing in a distal direction from distal tendon connections of the lattice structure.

In some embodiments, the loop divides the wire element into a first portion and a second portion, wherein the first portion and/or the second portion is wound around a plurality of tendons respectively constituting a tendon string in alignment with each other, wherein the tendon string extends helically around a longitudinal axis of the lattice structure.

In some embodiments, the wire element is wound around a string of tendons such that the wire element achieves a complete winding.

In some embodiments, the wire element is wound 360 ° along the string of tendons behind one tendon or behind two tendons or behind three tendons.

In some embodiments, the wire element is comprised of a fully radiopaque wire or a composite wire with a radiopaque core.

In some embodiments, two, three or four wire elements are provided, which respectively constitute a loop in the distal end portion of the lattice structure.

In some embodiments, the first and second portions of the wire element regularly cross along the lattice structure, wherein a tendon string of at least two tendons and at most eight tendons is arranged between the two crossing points, respectively.

In some embodiments, a string of at least three and at most six tendons is arranged between the two intersections.

In some embodiments, a maximum of four loops having a first leg and a second leg, respectively, are disposed in the distal end portion of the lattice structure, wherein the first leg and the second leg are disposed radially inside the lattice structure or the first leg and the second leg are disposed radially outside the lattice structure.

In some embodiments, the lattice structure has at least one rib extension at the proximal end portion, which rib extension is form-fittingly connected with a distal coupling of the transmission line.

In some embodiments, the tendon extensions have engagement elements that suitably engage into recesses of the coupling that extend transverse to the longitudinal axis of the transmission line.

In some embodiments, a crimp sleeve is provided that surrounds the tendon extension and the coupling.

In some embodiments, the wire element is guided through the crimping sleeve with the wire end terminating substantially flush with the crimping sleeve and/or protruding proximally slightly beyond the crimping sleeve.

In some embodiments, the protruding wire end is connected to the transmission line by an adhesive filled coil, wherein the coil surrounds the protruding wire end and the transmission line.

In some embodiments, the crimp sleeve and the protruding wire end are bonded directly together with the transmission line.

Drawings

The invention will be described in more detail below with reference to exemplary drawings with additional details according to embodiments. In the drawings:

fig. 1 shows a medical device according to an embodiment of the invention, wherein a grid structure is shown in a planar expanded state;

fig. 2 shows a detailed view of a device according to an embodiment of the invention in the region of the distal end portion;

FIG. 3 shows a perspective view of a transmission line with a coupling;

fig. 4 shows a perspective view (intermediate assembled state) of the transmission line according to fig. 3 with an inserted web extension and a semi-transparently drawn crimp sleeve;

fig. 5 shows a transmission line according to fig. 3 with a wire element (intermediate assembly state);

fig. 6 shows the transmission line according to fig. 3 in a final assembled state;

fig. 7 shows an alternative embodiment of a transmission line.

Detailed Description

Fig. 1 shows a plan view of a medical device with a lattice structure 10 of cells 12, which are formed from a plurality of webs 11 connected to one another in one piece. For ease of presentation, an unfolded view is used in fig. 1, in which the lattice structure 10 is cut in the longitudinal direction and shown flat-unfolded. It is clear that the lattice structure 10 is constructed tubular in nature. The tube shape is obtained by cutting, in particular laser cutting, from a tube material to obtain the grid structure 10. Other geometries of the grid structure are always possible and are explicitly mentioned in the introduction to the description. Other manufacturing methods than laser cutting are possible.

In fig. 1 is shown a state of rest without any external force acting on the lattice structure 10. In the compressed state, the ribs 11 abut against one another, so that a smaller cross-sectional profile of the lattice structure 10 results. The tendons 11 define cells 12. In this case, it is provided that in each case every fourth rib 11 at least partially delimits a cell 12. The ribs 11 form diamond-shaped cells 12 or form cells 12 with a diamond-shaped basic structure (closed cell design).

The girders 11, which respectively define cells 12, are coupled to each other by means of a girder connection 13. Four webs emerge from each web connection 13. These web connections 13 are each integrated into the grid structure 10 integrally with the webs 11. Essentially, the tendon connection 13 constitutes the intersection of the tendons 11. Each beam 11 constitutes a direct connection between two beam connections 13. Preferably, the tendon connection elements 13 are distributed in a pattern on the lattice structure 10. The tendons 11 may have the same or different tendon widths.

In this case, it can be provided that every two opposite webs oriented parallel to one another can have the same web width. These parallel opposite webs 11 each form a web pair, wherein the web widths of the webs 11 of a web pair of one of the units 12 can be different. In other words, each cell 12 has a first and a second pair of webs, the webs 11 of the first pair having a different web width than the webs 11 of the second pair. Such a configuration of cells is referred to as an asymmetric cell. Constructing the mesh structure 10 from asymmetric cells increases the bending flexibility of the mesh structure so that the medical device can be well placed into a curved blood vessel.

The rib width varies between 30 μm and 60 μm, preferably between 36 μm and 54 μm. In the proximal end region 10a, the web 11 is as wide as 90 μm. The wall thickness is between 60 μm and 100 μm.

The present invention is not limited to a lattice structure with symmetrical cells, but can also be applied to a lattice structure with asymmetrical cells.

The lattice structure 10 includes a hybrid cell design having a plurality of closed small cells 12 and larger cells 12c than the small cells 12. The small cells 12 enable good placement of the lattice structure 10 on the vessel wall. The larger unit 12c has integrated anchoring elements 12d which, in use, effectively grip the thrombus to be removed and ensure safe, non-invasive removal of the thrombus. It is also conceivable that no mixed unit design is required and that the field of application of the anchoring element 12d can be omitted.

As can be clearly seen in fig. 1, the device has at least one wire element 20, in particular two wire elements 20, 20'. More than two wire elements may be provided, for example a total of 3 or 4 wire elements, which are distributed in a pattern over the circumference.

The wire elements or the wire elements are made of a radiopaque material. For example, the material may be a solid material made of a radiopaque material. Composite materials, such as so-called DFT wire elements, may also be used. Such wire elements have a core wire of radiopaque material (e.g., platinum, tantalum, or gold) and a sheath of shape memory material. An example of a DFT wire element has a platinum core of 40-60 μm diameter and a nitinol sheath with an outer diameter corresponding to the core diameter plus about 20 μm. Other materials and different sizes or no superelastic sheath having only radiopaque wire are also contemplated.

In general, all radiopaque materials commonly used for implants can be used.

As can be gathered from fig. 1, the wire elements 20 form a loop 21 which is arranged in the region of the distal end portion 10b of the lattice structure 10. The distal end section 10b forms the axial end of the tubular lattice structure 10 which comes out of the catheter first when the device is released.

In the region of the loop 21, the wire elements 20 change their direction, that is to say so that they are guided out of the lattice structure 10 and are guided in again. The loop 21 has a first leg 22a and a second leg 22b, which extend at an angle to each other. The wire member 20 forms a bent portion between the two

legs

22a, 22b, which connects the two

legs

22a, 22 b.

In the initial example according to fig. 1, two wire elements 20, 20' are provided, which are each configured to match. Thus, the second wire element 20 'has two legs 22a', 22b 'which together form the second loop 21'. The two rings 21, 21' are substantially identically constructed. Therefore, the following embodiments in relation to the first ring 21 are applicable to the second ring 21'.

The two

legs

22a, 22b of the first ring 21 are arranged radially inside the lattice structure 10. This means in the example according to fig. 1 that the two

legs

22a, 22b are arranged in the image plane behind the grid structure 10. The two

legs

22a, 22b may also be arranged radially outside the lattice structure. This corresponds to the embodiment shown in fig. 1 in which the

legs

22a, 22b are arranged in the image plane in front of the grid structure 10.

In particular, the first rings 21 are arranged in the region of the

end cells

12, 12a, 12b, i.e. in the cells of the outermost row of the grid structure 10 in the axial direction. In this case, the two

legs

22a, 22b of the first loop 21 are guided through the

end units

12, 12a, 12b in the same direction and both are located on the same side of the lattice structure 10 in the area of the end portion 10 b. Thereby, fixation of the wire element 10 by the loop is avoided in the area of the end portion 10 b. The loop 21 may be substantially free to move relative to the lattice structure 10. Thereby, the ring 21 is decoupled from the lattice structure 10.

In addition, the ring 21, and in particular the region in which the ring 21 changes direction, is spaced from the distal tendon connection 13 b. The distal web connection 13b is the web connection 13 arranged outermost in the axial direction.

The ring 21 projects slightly beyond the immediately

adjacent end unit

12a, 12b in the axial direction. It is sufficient that the loop 21 is arranged loosely before the distal tendon connection 13b, since decoupling of the loop 21 from the lattice structure 10 is achieved by arranging the two

legs

22a, 22b on the same side of the lattice structure 10. By the spacing of the ring 21 from the distal tendon connection 13b it is even better ensured that the ring 21 does not impede the movement of the lattice structure 10. The loose arrangement of the loop bends may extend slightly further into the lattice structure 10 in the proximal direction.

The distance between the distal tendon connection 13b and the ring 21 may be at least 25% of the tendon length, in particular at least 50% of the tendon length. The maximum distance of the ring 21 from the distal tendon connection 13b should not be more than the axial ends of the lattice structure 10. In other words, the ring 21 should not protrude beyond the grid structure 10 in the axial direction, in particular beyond the free ends of the

end units

12, 12a, 12 b.

In the example according to fig. 1, the ring 21 is arranged between two

distal end units

12a, 12b adjacent in the circumferential direction in the expanded state of the lattice structure 10. In other words, the loop 21 extends at least partially into the free space formed between two

adjacent end units

12a, 12 b. Alternatively or additionally, the loop 21 may be arranged inside the distal end unit (not shown), wherein it is also applicable here that both legs of the loop 21 are arranged on the same side of the lattice structure 10.

X-ray markers, for example three distal PtIr dot markers, may be arranged on several distal end units 12, 12b of the grid structure 10. In contrast to the prior art, the wire elements 21, 21' are not fixed by X-ray markers in the region of the distal end portion 10 b.

Normally, the loops 21, 21' constitute free wire portions which extend beyond the tendons 11 of the immediately

adjacent end units

12a, 12 b.

In the example according to fig. 1, the first leg 22a is guided through the distal end unit 12a on the left in fig. 1 and the second leg 22b is guided through the distal end unit 12b on the right in fig. 1, more precisely from the inside outwards in the same direction, so that the entire ring 21 is arranged completely outside the lattice structure, i.e. radially outside the lattice structure 10. It is also applicable here that the decoupling of the ring 21 can also be effected in the opposite direction, i.e. when the two

legs

22a, 22b are guided in opposite directions, i.e. from the outside in.

In the initial example according to fig. 1, the fixation of the wire element 20 outside the end portion 10b is effected, in particular, from a unit row directly connected to the

distal end unit

12, 12a, 12 b. In other words, the distal row of

end units

12, 12a, 12b is the area in which the wire elements 20 or loops 21 are loosely arranged on the lattice structure 10. The loosely arranged areas of the loops 21 may extend even further into the grid structure 10, for example up to the second row of cells 12. In order not to interfere with the function of the lattice structure, the loose arrangement of the loops 21 should be limited to the distal region. A larger area of the lattice structure 10 is used for fixing the wire elements 20.

The arrangement of the rings 21 arranged radially inside the lattice structure 10 can be seen particularly well in the detailed view of the lattice structure 10 shown in fig. 2. It can be seen here that the two

legs

22a, 22b are guided out of the lattice structure 10 over the webs 11 of the adjacent cells 12 and are immersed in the distal end cells 12, 12 a. Both

legs

22a, 22b are guided through the

distal end unit

12a, 12b in the same direction, so that both

legs

22a, 22b are arranged on the same side of the grid structure 10, in particular both on the inside. The ring 21 is arranged radially inside and axially inside, i.e. the lattice structure 10 extends axially beyond the ring ends.

For fixing, wire elements 20 are locally woven into the lattice structure 10 and/or wound around the individual ribs 11 of the lattice structure 10. A plurality of wire elements 20 may be woven together with the lattice structure 10 and/or wound around the individual ribs 11 of the lattice structure 10 independently of one another.

The wire elements 20 may extend substantially parallel or transversely along the tendon 11. In general, the wire elements 20 preferably extend along a tendon string 14, which tendon string 14 is composed of a plurality of tendons arranged one after the other. In fig. 1, an arrow with reference numeral 14 is shown in the direction of the tendon string 14. Preferably, the tendon string 14 extends helically around the longitudinal axis of the lattice structure 10. The other webs 11 emerge transversely from the web row 14, wherein the wire elements 20 can cross the transversely emerging webs 11 alternately from below or from above. In this way, the wire elements 20 are securely woven into the lattice structure 10. In addition, the wire element 20 can also be wound around the webs 11 of the web string 14.

The wire element 20 is divided into two

parts

23a, 23b by the distal ring 21. The two

portions

23a, 23b may be helically wound around the longitudinal axis of the lattice structure 10 in parallel with each other. It is also possible that the first portion 23a and the second portion 23b extend along different tendon strings 14, such that the first portion 23a and the second portion 23b cross one or more times in the longitudinal direction of the lattice structure 10. As can be clearly seen in fig. 1, the wire elements 20 guided from the proximal end 10a to the distal end 10b are deflected there on the distal loop 21 and guided back into the lattice structure 10, crossing themselves a number of times.

If a plurality of wire elements 20, 20', in particular two wire elements 20, 20' are provided, the respective first and

second portions

23a, 23a ', 23b' may overlap so that overall a diamond pattern of radiopaque wire elements is created (see fig. 1, a planar expanded lattice structure). Two wire elements 20, 20' are helically arranged on the circumference of the lattice structure 10.

In the example according to fig. 1, the wire element 20 achieves a complete winding, in particular a winding of 360 ° behind one web 11, wherein the winding comprises two adjacent webs 11. Other numbers of tendons, for example one tendon or three tendons, are possible in order to achieve a complete winding of the wire element 20. In other words, the more tendons are provided along the string 14 for complete winding of the wire elements 20, the number of windings is reduced.

The two

portions

23a, 23a ', 23b ' of the wire elements 20, 20' intersect in a regular pattern along the grid structure 10. In particular, the wire elements 20, 20' intersect at a plurality of intersection points 25, wherein in the example according to fig. 1, 3 tendons are arranged along the tendon string 14 between 2 intersection points 25. Other numbers of tendons, for example two tendons or more than three tendons, are possible.

At the proximal end portion 10a, the wire elements 20, 20 'terminate in free wire ends 24, 24', which are not led back into the lattice structure 10, but are fixed on the outer edge of the lattice structure 10. For this purpose, the grid structure 10 has a plurality of web extensions 16, in particular two web extensions 16, which constitute the outermost regions of the grid structure 10 in the proximal direction. The free wire ends 24, 24' are guided as far as the web extensions 16 and there connected to them in the following manner.

In fig. 3, the distal end of the transmission line 40 is shown with the coupling 41 located thereon. The coupling 41 has the function of securely connecting the lattice structure 10 to the transmission line 40 so that the lattice structure 10 can be released from the catheter for treatment and can be retracted again after thrombectomy. For this purpose, the coupling 41 has a recess 42 which extends transversely to the longitudinal axis of the transmission line 40.

As can be seen in the intermediate step of the installation according to fig. 4, the web extensions 16 of the lattice structure 10 have engagement elements 16a which engage appropriately into the recesses 42. A form-fitting connection is thereby established which is sufficiently strong for the forces generated by the transmission.

The crimping sleeve 30, which is shown semi-transparent in fig. 4, is pushed over the form-fitting connection in order to reinforce and achieve the form-fitting connection.

Fig. 5 shows a further assembled state of the connection, in which the free wire ends 24, 24' are guided through the crimp sleeve 30. The free wire ends 24, 24' are guided through an intermediate region which is formed between the crimp sleeve 30 and the web extensions 16 of the lattice structure 10. The web extensions 16 can be profiled in the longitudinal direction of the transmission line such that the wire ends 24, 24' are guided in a particular position, in particular parallel to one another, in the crimp sleeve 30. The crimp sleeve 30 holds the wire ends 24, 24 'in place in the region of the coupling 41 so that the wire ends 24, 24' can be secured in place using an adhesive.

The free wire ends 24, 24' are substantially flush with the crimp sleeve 30, but are allowed to protrude slightly in the proximal direction.

In the example according to fig. 6, the coil 50 is pushed over the free wire ends 24, 24'. The coil 50 is filled with an adhesive.

Alternatively to the coil 50, as shown in fig. 7, the free wire ends 24, 24' protruding beyond the crimp sleeve 30 in the proximal direction may be fixed between the crimp sleeve 30 and the coupling 41 and the transmission line 40 using only adhesive. In this case, a change in the flatness of the crimp sleeve 30 is to be detected in order to better produce a positive-locking connection. The adhesive portion 43 tapers in the proximal direction from the crimp sleeve 30 in the direction of the transmission line 40 and closes flush with the transmission line. The adhesive exits at the distal end of the crimp sleeve 30 where the wire ends 24, 24' are introduced. It can be seen that the wire ends 24, 24' are also bonded inside the crimp sleeve 30.

Claims

1. A medical device for intravascular treatment, having an at least partially tubular lattice structure of integrally connected webs (11), which webs (11) delimit cells (12), wherein four webs (11) are connected to one another by web connections (13), wherein at least one radio-opaque wire element (20, 20 ') is provided, which is guided along at least one web (11) and which forms a loop (21, 21') with a first leg (22a, 22a ') and a second leg (22b, 22 b') in an end portion of the lattice structure (10),

it is characterized in that the preparation method is characterized in that,

the first leg (22a, 22a ') and the second leg (22b, 22 b') are arranged radially inside the lattice structure (10) or the first leg (22a, 22a ') and the second leg (22b, 22 b') are arranged radially outside the lattice structure (10).

2. The medical device according to claim 1, wherein the end portion is a distal end portion (10 b).

3. The medical device according to claim 1 or 2, characterized in that the loop (21, 21') is arranged between two distal end cells (12a, 12b) of the mesh structure (10) adjacent in the circumferential direction or inside one distal end cell (12a, 12b) of the mesh structure (10) in the expanded state of the mesh structure (10).

4. The medical device according to claim 3, characterized in that the first leg (22a, 22a ') and the second leg (22b, 22 b') are each guided through one of the two distal end units (12a, 12 b).

5. The medical device according to any of claims 1-2 and 4, wherein the loop (21, 21') is spaced in a distal direction from a distal tendon connection (13b) of the lattice structure (10) in an expanded state of the lattice structure (10).

6. The medical device according to claim 3, wherein the loop (21, 21') is distally spaced from a distal tendon connection (13b) of the lattice structure (10) in the expanded state of the lattice structure (10).

7. The medical device according to claim 5, wherein the loop (21, 21') is arranged in the expanded state of the lattice structure (10) at least one lattice width spacing in the distal direction from a distal lattice connection (13b) of the lattice structure (10).

8. The medical device according to claim 6, wherein the loop (21, 21') is arranged in the expanded state of the lattice structure (10) at least one lattice width spacing in the distal direction from a distal lattice connection (13b) of the lattice structure (10).

9. The medical device according to claim 5, wherein the loops (21, 21') are arranged in the expanded state of the lattice structure (10) at a rib length spacing of at least 25% in the distal direction from the distal rib connectors (13b) of the lattice structure (10).

10. The medical device according to claim 6, wherein the loop (21, 21') is arranged in the expanded state of the lattice structure (10) at a rib length spacing of at least 25% in the distal direction from a distal rib connection (13b) of the lattice structure (10).

11. The medical device according to claim 9 or 10, wherein the loop (21, 21') is arranged in the expanded state of the lattice structure (10) at a tendon length spacing of at least 50% in the distal direction from a distal tendon connection (13b) of the lattice structure (10).

12. The medical device according to any of claims 1-2, 4 and 6-10, characterized in that the loop (21, 21 ') divides the wire element (20, 20') into a first portion (23a, 23a ') and a second portion (23b, 23 b'), wherein the first portion (23a, 23a ') and/or the second portion (23b, 23 b') are wound around a plurality of tendons (11) which respectively constitute a tendon string (14) in alignment with each other, wherein the tendon string (14) extends helically around a longitudinal axis of the lattice structure (10).

13. The medical device according to claim 3, wherein the loop (21, 21 ') divides the wire element (20, 20') into a first portion (23a, 23a ') and a second portion (23b, 23 b'), wherein the first portion (23a, 23a ') and/or the second portion (23b, 23 b') is wound around a plurality of tendons (11) which respectively constitute a tendon string (14) in alignment with each other, wherein the tendon string (14) extends helically around a longitudinal axis of the lattice structure (10).

14. The medical device according to claim 5, wherein the loop (21, 21 ') divides the wire element (20, 20') into a first portion (23a, 23a ') and a second portion (23b, 23 b'), wherein the first portion (23a, 23a ') and/or the second portion (23b, 23 b') is wound around a plurality of tendons (11) which respectively constitute a tendon string (14) in alignment with each other, wherein the tendon string (14) extends helically around a longitudinal axis of the lattice structure (10).

15. The medical device according to claim 11, wherein the loop (21, 21 ') divides the wire element (20, 20') into a first portion (23a, 23a ') and a second portion (23b, 23 b'), wherein the first portion (23a, 23a ') and/or the second portion (23b, 23 b') is wound around a plurality of tendons (11) which respectively constitute a tendon string (14) in alignment with each other, wherein the tendon string (14) extends helically around a longitudinal axis of the lattice structure (10).

16. The medical device according to claim 12, characterized in that the wire element (20, 20 ') is wound around a tendon string (14) such that the wire element (20, 20') achieves a complete winding.

17. The medical device according to any of claims 13-15, wherein the wire element (20, 20 ') is wound around a tendon string (14) such that the wire element (20, 20') achieves a complete winding.

18. The medical device according to claim 16, characterized in that the wire elements (20, 20') are wound 360 ° along the string of tendons (14) after one tendon (11) or after two tendons (11) or after three tendons (11).

19. The medical device according to claim 17, characterized in that the wire elements (20, 20') are wound 360 ° along the string of tendons (14) after one tendon (11) or after two tendons (11) or after three tendons (11).

20. The medical device according to any of claims 1-2, 4, 6-10, 13-16 and 18-19, wherein the wire element (20, 20') is constituted by a completely radiopaque wire or a composite wire with a radiopaque core.

21. The medical device according to claim 3, characterized in that the wire element (20, 20') is constituted by a completely radiopaque wire or a composite wire with a radiopaque core.

22. The medical device according to claim 5, characterized in that the wire element (20, 20') is constituted by a completely radiopaque wire or a composite wire with a radiopaque core.

23. The medical device according to claim 11, characterized in that the wire element (20, 20') is constituted by a completely radiopaque wire or a composite wire with a radiopaque core.

24. The medical device according to claim 12, characterized in that the wire element (20, 20') is constituted by a completely radiopaque wire or a composite wire with a radiopaque core.

25. The medical device according to claim 17, characterized in that the wire element (20, 20') is constituted by a completely radiopaque wire or a composite wire with a radiopaque core.

26. Medical device according to any of claims 1-2, 4, 6-10, 13-16, 18-19 and 21-25, characterized in that two, three or four wire elements (20, 20 ') are provided, which respectively constitute a loop (21, 21') in the distal end portion (10b) of the lattice structure (10).

27. A medical device according to claim 3, wherein two, three or four wire elements (20, 20 ') are provided, which respectively constitute a loop (21, 21') in the distal end portion (10b) of the lattice structure (10).

28. Medical device according to claim 5, characterized in that two, three or four wire elements (20, 20 ') are provided, which respectively constitute a loop (21, 21') in the distal end portion (10b) of the lattice structure (10).

29. Medical device according to claim 11, wherein two, three or four wire elements (20, 20 ') are provided, which respectively constitute a loop (21, 21') in the distal end portion (10b) of the lattice structure (10).

30. Medical device according to claim 12, wherein two, three or four wire elements (20, 20 ') are provided, which respectively constitute a loop (21, 21') in the distal end portion (10b) of the lattice structure (10).

31. Medical device according to claim 17, wherein two, three or four wire elements (20, 20 ') are provided, which respectively constitute a loop (21, 21') in the distal end portion (10b) of the lattice structure (10).

32. Medical device according to claim 20, wherein two, three or four wire elements (20, 20 ') are provided, which respectively constitute a loop (21, 21') in the distal end portion (10b) of the lattice structure (10).

33. Medical device according to claim 26, wherein the first portion (23a, 23a ') and the second portion (23b, 23b ') of the wire element (20, 20 ') regularly cross along the lattice structure (10), wherein a tendon string (14) of at least two tendons (11) and at most eight tendons, respectively, is arranged between two crossing points (25).

34. The medical device according to any of claims 27-32, wherein the first portion (23a, 23a ') and the second portion (23b, 23b ') of the wire element (20, 20 ') regularly cross along the lattice structure (10), wherein a string (14) of at least two and at most eight tendons (11, 25), respectively, is arranged between two crossing points (25).

35. Medical device according to claim 33, wherein a string (14) of at least three webs (11) and at most six webs is arranged between two intersections (25).

36. Medical device according to claim 34, wherein a string (14) of at least three webs (11) and at most six webs is arranged between two intersections (25).

37. The medical device according to any of claims 1-2, 4, 6-10, 13-16, 18-19, 21-25, 27-33 and 35-36, characterized in that in the distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

38. A medical device according to claim 3, characterized in that in the distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

39. The medical device according to claim 5, characterized in that in the distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

40. The medical device according to claim 11, characterized in that in the distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

41. The medical device according to claim 12, characterized in that in the distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

42. The medical device according to claim 17, characterized in that in the distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

43. The medical device according to claim 20, characterized in that in the distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

44. The medical device according to claim 26, wherein in a distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

45. The medical device according to claim 34, wherein in a distal end portion (10b) of the lattice structure (10) there are arranged at most four loops (21, 21 ') having a first leg (22a, 22a ') and a second leg (22b, 22b '), respectively, wherein the first leg (22a ') and the second leg (22b ') are arranged radially inside the lattice structure (10) or the first leg (22a ') and the second leg (22b ') are arranged radially outside the lattice structure (10).

46. The medical device according to any of claims 1-2, 4, 6-10, 13-16, 18-19, 21-25, 27-33, 35-36 and 38-45, wherein the lattice structure has at least one rib extension (16) at a proximal end portion (10a), which rib extension is form-fittingly connected with a distal coupling (41) of a transmission line (40).

47. The medical device according to claim 3, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is positively connected with a distal coupling (41) of a transmission line (40).

48. The medical device according to claim 5, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is positively connected with a distal coupling (41) of a transmission line (40).

49. The medical device according to claim 11, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is form-fittingly connected with a distal coupling (41) of a transmission line (40).

50. The medical device according to claim 12, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is form-fittingly connected with a distal coupling (41) of a transmission line (40).

51. The medical device according to claim 17, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is form-fittingly connected with a distal coupling (41) of a transmission line (40).

52. The medical device according to claim 20, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is form-fittingly connected with a distal coupling (41) of a transmission line (40).

53. The medical device according to claim 26, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is form-fittingly connected with a distal coupling (41) of a transmission line (40).

54. The medical device according to claim 34, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is form-fittingly connected with a distal coupling (41) of a transmission line (40).

55. The medical device according to claim 37, wherein the lattice structure has at a proximal end portion (10a) at least one rib extension (16) which is form-fittingly connected with a distal coupling (41) of a transmission line (40).

56. A medical device according to claim 46, wherein the tendon extension (16) has an engagement element (16a) adapted to engage into a recess (42) of the coupling (41), the recess extending transversely to the longitudinal axis of the transmission line (40).

57. A medical device according to any of claims 47-55, wherein the tendon extension (16) has an engagement element (16a) adapted to engage into a recess (42) of the coupling (41), the recess extending transversely to the longitudinal axis of the transmission line (40).

58. A medical device according to claim 46, wherein a crimp sleeve (30) is provided, which surrounds the tendon extension (16) and the coupling (41).

59. A medical device according to any of claims 47-56, wherein a crimp sleeve (30) is provided, which surrounds the tendon extension (16) and the coupling (41).

60. A medical device according to claim 57, wherein a crimp sleeve (30) is provided, which surrounds the tendon extension (16) and the coupling (41).

61. The medical device according to claim 58 or 60, characterized in that the wire element (20, 20 ') is guided through the crimping sleeve (30), wherein a wire end (24, 24') terminates substantially flush with the crimping sleeve and/or protrudes slightly proximally beyond the crimping sleeve (30).

62. The medical device according to claim 59, wherein the wire element (20, 20 ') is guided through the crimping sleeve (30), wherein a wire end (24, 24') terminates substantially flush with the crimping sleeve and/or protrudes slightly proximally beyond the crimping sleeve (30).

63. The medical device of claim 61, wherein the protruding wire end (24, 24 ') is connected to the transmission line (40) by an adhesive filled coil (50), wherein the coil (50) surrounds the protruding wire end (24, 24') and the transmission line (40).

64. The medical device of claim 62, wherein the protruding wire end (24, 24 ') is connected to the transmission line (40) by an adhesive filled coil (50), wherein the coil (50) surrounds the protruding wire end (24, 24') and the transmission line (40).

65. The medical device of claim 61, wherein the crimp sleeve (30) and the protruding wire ends (24, 24') are bonded directly together with the transmission line (40).

66. The medical device of claim 62, wherein the crimp sleeve (30) and protruding wire ends (24, 24') are bonded directly together with the transmission line (40).