WO2011134663A2

WO2011134663A2 - Method for producing a medical device for endoluminal treatments, and starting product for producing a medical device

Info

Publication number: WO2011134663A2
Application number: PCT/EP2011/002138
Authority: WO
Inventors: Frank Nagl
Original assignee: Acandis Gmbh & Co. Kg
Priority date: 2010-04-28
Filing date: 2011-04-28
Publication date: 2011-11-03
Also published as: WO2011134663A3; DE102010018539A1

Abstract

The invention relates to a method for producing a medical device for endoluminal treatments, comprising the following successive steps: - making available a flat lattice structure (10) comprising interconnected webs (11) that delimit cell openings (12); then arranging a flexible cover (13) on at least part of the flat lattice structure (10), wherein the cover (13) comprises a plastic material; and then connecting the flexible cover (13) across the whole surface to the webs (11) of the lattice structure (10), in such a way that the cell openings (12) are at least partially covered; or comprising the following successive steps: - making available a flat lattice structure (10) comprising interconnected webs (11) that delimit cell openings (12); then at least partially coating the flat lattice structure (10) with a plastic material, in such a way that a flexible cover (13) forms that is connected across the whole surface to the webs (11) of the lattice structure (10) and that at least partially covers the cell openings (12). The invention also relates to a starting product for producing a medical device.

Description

A method of manufacturing a medical device for endoluminal treatments and starting product for the manufacture of a medical device

description

The invention relates to a method for producing a medical device for endoluminal treatments. Furthermore, the invention relates to a starting product for the production of a medical device.

For the treatment of aneurysms in blood vessels, it is known from practice to use cylindrical lattice structures, in particular stents. In doing so, the stent is positioned in the area of the aneurysm in the blood vessel in order to hinder the blood flow into the aneurysm.

For this purpose, stents are known on the one hand, which have a fine-meshed lattice structure.

Such stents have the disadvantage that required for anchoring in the vessel

Radial force is comparatively low. Alternatively, stents may be provided with a coarse mesh lattice structure having a metallic cover. The blood flow into the aneurysm is completely cut off or at least reduced so much that the blood in the aneurysm clots. In this way, a rupture of the aneurysm can be prevented and the adjacent blood vessel can be stabilized at the same time.

The disadvantage of stents which have a metallic coating is particularly evident during production. The application of the coating or cover to the lattice structure is comparatively complicated. In particular, a high technical effort is required to apply at least approximately a uniform, thin coating on the cylindrical lattice structure. Furthermore, with the known production method

Structuring of the coating, for example, to achieve special adhesion properties, difficult.

The object of the invention is to provide a method for producing a medical device for endoluminal treatments, which is simple and inexpensive to carry out and allows the application of a uniform, thin cover. It is also an object of the invention to provide a starting product for the production of a medical device. According to the invention, this object is achieved with regard to the manufacturing process by the

The subject matter of claims 1 and 2 and with regard to the starting material by the subject-matter of claim 13.

The invention is based on the idea of specifying a method for producing a medical device for endoluminal treatments, which comprises the following

successive steps includes:

Providing a flat grid structure comprising interconnected lands, the lands defining cell openings; subsequently

- Arrange a flexible cover on at least a portion of the flat

Grid structure, wherein the cover comprises a plastic material; and subsequently

- Full surface connecting the flexible cover with the webs of the grid structure such that the cell openings are at least partially covered.

According to a sidelined aspect, the invention is based on the idea of a

To provide a method of manufacturing a medical device for endoluminal treatments comprising the following sequential steps:

Providing a flat grid structure comprising interconnected lands, the lands defining cell openings; and subsequently

At least partially coating the flat lattice structure with a

Plastic material such that forms a flexible cover, which is connected to the webs of the lattice structure over the entire surface and the cell openings at least partially covered.

The aforementioned methods according to the invention are based on the idea of applying the cover to a flat grid structure in order to ensure a uniform layer thickness over the entire grid structure. It has been found that by applying the cover to a flat grid structure in comparison to the coating of cylindrical grid structures, a uniform layer thickness can be achieved. This applies in particular to the use of plastic materials, which moreover have the advantage of increased flexibility or elasticity, so that the lattice structure can be used more flexibly in later use. In order to achieve a secure and reliable connection between the cover and the grid structure, it is further provided according to the first method variant (claim 1) to connect the cover over the entire surface with the lattice structure and according to the second process variant (claim 2) to coat the entire surface. In general, the cover is thus applied over the entire surface of the grid structure. The full-area connection means that all areas of the cover that are in contact with the grid structure are firmly connected to the grid structure. In particular, the cover is firmly connected to the webs of the lattice structure. The flexibility of the cover is therefore mainly in the area of the cell openings, which are covered by the cover levitating. The

Areas of the cover that touch the webs are firmly connected to the webs.

In particular, no regions of the cover are provided, which are arranged freely movable on the webs of the lattice structure. A relative movement of the cover with respect to the webs of the lattice structure is thus avoided.

Two variants are provided for the production process according to the invention. A first variant is based on the idea of a flat lattice structure and a prefabricated flexible

Provide cover to arrange the prefabricated flexible cover on the lattice structure and then to connect to the grid structure (claim 1). In this variant, it is particularly preferred that the flexible cover comprises a polymer film, which is connected to the flat grid structure by gluing or by a heat. The advantage of the polymer film is the good biocompatibility of the

Polymer, so that the medical device is well suited for permanent implantation.

The second variant of the manufacturing process, however, is based on the idea of a flat

To provide grid structure and a plastic material to coat the flat grid structure with the plastic material and thus to provide the grid structure with a cover of the plastic material (claim 2). In the second variant, the production of the cover thus takes place on the grid structure. In other words, the step of

Coating the steps of arranging and connecting the cover according to the first manufacturing variant in a single process step. In the manufacturing method according to the second variant, it is advantageously provided that the plastic material is sprayed onto the flat grid structure or the flat grid structure is immersed in the plastic material. To coat the lattice structure is therefore advantageous a spray or

Dip coating method used. The production or the application of the cover is thus particularly easy. The advantageous embodiments described below relate both to the

Production method according to the first variant, as well as the production method according to the second variant.

Advantageously, it is provided in the method according to the invention that the flat

Grid structure before applying the cover or coating with a

Plastic material is surface-treated such that a surface of the webs has an increased roughness. The surface treatment may include mechanical or electrochemical roughening of the surface of the lands. By the

Surface treatment, the connection between the cover and the grid structure can be improved.

The flat lattice structure may be after the step of full-surface bonding or the

Coating can be converted into a rotationally symmetrical shape. In this way, a rotationally symmetrical lattice structure can be provided by the comparatively simple production method, which is advantageous for the treatment of tubular

Hollow organs, such as blood vessels, can be used. By the cover is applied to the flat lattice structure before the transfer of the lattice structure in the rotationally symmetrical shape, a uniform and comparatively thin layer thickness of

Cover reached. The production of rotationally symmetrical lattice structures with a flexible cover is thus simplified.

In a further preferred embodiment of the method according to the invention is in the transfer of the flat lattice structure in a rotationally symmetrical shape

Connection area formed, comprising touching webs. In the

Connecting area contacting webs of the lattice structure can be used to form a

closed rotationally symmetrical shape are interconnected. In this way, a cylindrical or generally closed rotationally symmetrical shape of the lattice structure can be formed. In general, the lattice structure thus formed is expandable. This means that the lattice structure has a compressed state and an expanded state, wherein the lattice structure in the expanded state has a larger cross-sectional diameter than in the compressed state.

The cover may be patterned before or after the joining step, or during or after the coating step. With regard to the manufacturing process According to the first variant, it has proved to be particularly advantageous to provide the cover with a structuring prior to the joining step. Since the cover is arranged on the flat lattice structure in this process stage, the structuring can be set in a particularly simple and precise manner. A structuring of the cover directly after the step of connecting the cover to the grid structure is advantageous in order to provide as exact a structuring as possible, in particular in relation to the grid structure. Since the cover is already firmly connected to the flat grid structure, it is ensured that the structuring in the cover exactly maintains its position relative to the grid structure. A structuring of the cover during the coating of the lattice structure has the advantage that an additional process step is saved since the cover is structured directly during production or when applied to the flat lattice structure. The advantages of structuring the cover immediately after coating the grid structure to make the cover correspond to the advantages involved in structuring the cover

Cover after connecting the prefabricated cover with the grid structure occur.

The structuring of the cover can be done by imprinting or stamping. The structuring of the cover on the flat grid structure is particularly easy and quick to implement by a stamping process. In this case, the structuring can be impressed on the cover, so that a continuous, in particular gapless, but structured cover is produced. Alternatively, the structuring can be done by stamping the cover, so that openings are introduced into the cover. The openings may, for example, comprise pores or slots. The pores may have different geometries, for example, circular or diamond-shaped pores may be provided.

The flexible cover may extend in the region of the cell openings substantially in the wall plane of the grid structure. It is advantageous that the cover does not increase the wall thickness of the grid structure in addition. Thus, a grid structure can be provided with a cover having a comparatively small wall thickness.

According to a further preferred embodiment of the method according to the invention, the lattice structure can be converted into a rotationally symmetrical shape, in particular rolled, such that the cover forms an outer peripheral surface and / or an inner circumferential surface of the lattice structure. Concretely, the cover can be arranged on one side on the flat grid structure, so that by the choice of rolling or Winding direction of the grid structure can be influenced, whether the cover a

Outside peripheral surface or an inner peripheral surface of the rotationally symmetrical lattice structure forms. The arrangement of the cover on an outer peripheral surface of the lattice structure has advantages in terms of loading a vessel wall of a hollow body organ, in which the rotationally symmetric lattice structure is expanded. An advantage of the arrangement of the cover on an inner circumferential surface of the lattice structure is the positive influence on the flow behavior of a body fluid within the hollow body organ. At the same time, an improved adhesion or anchoring of the medical device in the hollow body of the body or on the vessel wall of the hollow body of the body is achieved by the lattice structure, which is free or uncovered on the outer circumference. It is also possible that the lattice structure is provided on both sides with the cover, so that in the rotationally symmetrical shape of the lattice structure both on the outer peripheral surface and on the inner peripheral surface in each case shows a cover.

The webs of the lattice structure which come into contact in the connection region can be connected to one another by local coating with a plastic, in particular a polymer material, or by a sputtering process. The plastic, especially the

Polymer material can be applied by spraying or dip coating method on the contacting webs in the connection area. Alternatively, the contacting webs can be joined together by sputtering a metallic material. In general, by connecting the contacting webs of the lattice structure with such a coating-like technology, both

Inhomogeneities within the entire medical device, as well

Production difficulties are avoided. In particular, by the

coating-like technology, namely the spray or dip coating with a polymer or the sputtering of a metallic material, avoiding damage to the applied cover of a plastic material.

According to a further independent aspect, the invention is based on the idea of a starting product for the production of a medical device for endoluminal

To specify treatments with a flat grid structure comprising interconnected lands. The bars limit cell openings. The medical device further comprises a flexible cover, which is connected to the webs of the grid structure over the entire surface. The flexible cover comprises a plastic material, in particular a polymer. The advantageous embodiments, effects and advantages mentioned in connection with the production method apply analogously to the invention

Starting product and are also disclosed and claimed for the starting material. This also applies to the advantageous embodiment of the starting product, according to which the flexible cover has a structuring.

The invention will be explained in more detail below by means of embodiments with reference to the accompanying schematic drawings. These show in each case a plan view of a flat grid structure for a medical device in different phases of the production method according to the invention according to a preferred embodiment; a plan view of a grid structure for a medical device in different phases of the manufacturing method according to the invention according to a further preferred embodiment; each a plan view of a cover for a medical device for use in the manufacturing method according to the invention according to a preferred

Embodiment;

Representations of different elements for use in different phases of the invention

Manufacturing method according to a preferred

Embodiment; each a section of a grid structure for the medical device according to a preferred

Embodiment;

FIGS. 5a-5d, 6a-6d, 7, 8 each show a plan view of a flat lattice structure of a

Starting product for manufacturing the medical device according to a preferred embodiment; 9 shows a perspective view of a medical device produced by the method according to the invention according to a preferred embodiment;

10 is a detail view of a flat grid structure with a

Cover produced by a method according to the invention according to a preferred embodiment; and

Fig. IIa, IIb each show a detailed view of a connecting portion of

medical device in different phases of the manufacturing method according to the invention according to a preferred embodiment.

In Fig. 1a a flat lattice structure 10 is shown which serves as a starting material for the manufacture of the medical device for endoluminal treatments. Such medical devices may be, for example, stents, thrombus, catheters, stent grafts or the like. The flat lattice structure 10 serves, in particular, as a carrier structure for a cover 13. The lattice structure 10 may comprise a grid mesh, a woven fabric or a net. Preferably, the grid structure 10 is made by a laser cutting process of a metallic solid material. Alternatively, the lattice structure 10 may be metallic

Comprise wire elements interwoven with each other. In general, the includes

Lattice structure 10 webs 11 which are interconnected in cross or node points 18. The webs 11 define cell openings 12 or meshes of the lattice structure 10. The meshes or cell openings 12 can have a substantially diamond-shaped contour.

In particular, the lattice structure 10 has free cell openings 12a. The lattice structure 10 is provided as a flat lattice structure 10. This means that the webs 11 of the lattice structure 10 are arranged substantially in a same plane.

As part of the manufacturing process is provided, the grid structure 10 with a

Plastic material to coat to form a cover 13, as shown in Fig. Lb. The cover 13 is applied over the entire surface of the lattice structure 10. For example, a spray coating method or a dip coating method may be used. The full-surface connection ensures that the cover 13 is firmly connected to the webs 11 of the lattice structure 10. Between the steps of providing the grid structure 10 and coating the grid structure 10 with a plastic material can be provided to subject the grid structure 10, in particular the webs 11 of the grid structure 10, a surface treatment. In this case, the surface of the webs 11 can be roughened, so that an improved adhesion of the plastic material on the webs 11 of the lattice structure 10 is ensured. By coating the lattice structure 10 with the plastic material, a cover 13 is created which completely covers the cell openings 12 so that covered cell openings 12b are formed. It is also possible that the covered cell openings 12 b are only partially provided with the cover 13. The covered cell openings 12b can thus comprise both free and covered areas.

Another variant of the manufacturing process is shown in FIGS. 2a to 2c. Therein, FIG. 2 a shows a flat lattice structure, which is constructed analogously to the flat lattice structure according to FIG. 1 a. In contrast to the manufacturing method, which is shown in Figs. La and lb, is provided in the manufacturing method according to FIGS. 2a to 2c, a prefabricated

Plastic film or generally a prefabricated cover 13 to provide (Fig. 2b). The prefabricated cover 13 is preferably the contour of the provided flat

Grid structure 10 adapted. The cover 13 may comprise a polymer film. The

Cover 13 is applied to the flat lattice structure 10 in a next method step. In particular, the cover 13 is arranged congruently with the grid structure 10. In a further method step, the cover 13 is connected to the grid structure 10, in particular the webs 11 of the grid structure 10 (FIG. 2c). The connection of the cover 13 with the lattice structure 10, for example, by dissolving the

Plastic material of the cover 13 by a solvent and then gluing the cover 13 with the webs 11 of the grid structure 10 done. A direct bonding of the cover 13 with the grid structure 10 is also possible. Alternatively or additionally, the cover 13 may be connected to the grid structure 10 by thermal methods.

The provided cover 13 may have a structuring 15 as shown in Figs. 2d and 2e. The structuring 15 can thus be introduced into the cover 13 before arranging the cover 13 on the lattice structure 10. The structuring can be done for example by stamping. Thus, for example, pores 15a can be introduced into the cover 13, as shown in Fig. 2d. Alternatively, the

Structuring be designed 15 by imprinting a structure. In this way, a surface structuring 15b is formed, as shown in Fig. 2e. FIGS. 3a to 3d show an exemplary embodiment of the invention

Manufacturing method shown in which the applied cover 13 by means of

By stamping is structured. In the method, provision is initially made for a prefabricated cover 13, in particular a polymer film (FIG. 3 a). Furthermore, an embossing punch 20 is provided which comprises embossing heads 21 (FIG. 3b). The embossing heads 21 have a substantially cone-like shape. The embossing heads 21 may also be cylindrical. Other geometric shapes of the embossing heads 21 are possible. In particular, the design of the embossing heads 21 is based on the desired embossed structure for the polymer film or cover 13.

The cover 13 is connected to the grid structure 10, as already described in connection with the embodiment of FIGS. 2a to 2c. Subsequently, the structuring 15 is introduced by means of the stamping die 20 in the cover 13 by the die 20 is pressed onto the cover 13. In this case, the embossing heads 21 press through the cover 13 and thus form the structuring 15 (FIG. 3c). Alternatively it can be provided to arrange the cover 13 on the die 20 and then apply the flat lattice structure 10 on the cover 13. The connection between the cover 13 and the grid structure 10 can then simultaneously with the

By stamping the cover 13 done. In this case, for example, the embossing pressure of the embossing punch 20 contribute to the fixed connection between the cover 13 and the lattice structure 10. After removal of the embossing punch 20, there is a medical device comprising a flat lattice structure 10 with a structured cover 13 (FIG. 3d). In this case, the cover 13 on pores 15a, which were produced by the stamping. The pores 15 can each be centered in a covered cell opening 12d. Another arrangement is possible. Moreover, it can be provided to use an embossing punch 20 which imprints a surface structuring 15b on the cover 13. A combination of imprinting and stamping is possible. For example, areas of the cover 13 can be stamped through and further areas of the cover 13 can be provided with a surface structuring 15b.

In addition to the round pores 15a shown in FIG. 3d, further structurings 15 may be provided. The type of structuring 15 can be selected according to the intended use of the medical device, so that special therapy methods are supported. For example, axial slits, ie axially extending slots, in the cover 13 may be advantageous in order to guide a coil catheter through the cover 13. At the same time, axial slits prevent coils from slipping through the coils

Cover 13.

FIGS. 4a to 4f show different variants of the structuring 15. In this case, the illustration according to FIG. 4a corresponds to the embossed structuring 15 according to FIG. 3d. The embodiment according to FIG. 4b differs therefrom by the number of through-punched pores 15a. In particular, in the exemplary embodiment according to FIG. 4 b, four pores are arranged uniformly in each case in a cell opening 12

provided. The cell opening 12 is covered by the cover 13 and has four

Openings which are formed as pores 15a and are arranged in a regular arrangement. Another number of pores 15a is possible. For example, a plurality of pores 15 a may be provided, which are arranged distributed irregularly over the cover 13. Such an arrangement is shown for example in Fig. 4c.

In general, the cell openings 12 may be covered not only completely but also partially with the cover 13. In Fig. 4d an embodiment is shown, wherein the cover 13 has two diamond-shaped portions 13a, which by free spaces 12c

are separated from each other and from the webs 11 of the lattice structure 10. Within an inner diamond-shaped region 13a, a diamond-shaped free space 12c is further formed. The two diamond-shaped regions 13a are interconnected by cover strips 13b, which extend essentially diagonally through the cell opening 12. The cover strips 13b are interrupted in the region of the inner diamond-shaped free space 12c. Overall, the embodiment of FIG. 4d shows a cover 13, which in the

Essentially has a spider-web-like configuration.

In contrast, in the exemplary embodiment according to FIG. 4e, provision is made for the cover 13 to comprise cover strips 13b which extend parallel to the diagonal of the diamond-shaped cell opening 12. Concretely, three cover strips 13b are provided, with a central cover strip 13b extending diagonally through the cell opening 12. Two outer cover strips 13b are parallel to the central cover strips 13b. Furthermore, two corner regions 13c are provided, which are substantially triangular in shape and have an inner longitudinal edge which runs parallel to the cover strips 13b.

In the embodiment according to FIG. 4f, triangular corner regions 13c are likewise provided. The corner regions 13 c are formed by the cover 13. In contrast to the embodiment according to FIG. 4e, the cell opening 12 in the exemplary embodiment according to Fig. 4f no cover strip 13b. Rather, a free space 12c is formed between the corner regions 13c. The corner regions 13c are also formed larger than in the embodiment of FIG. 4e.

In general, with the manufacturing method according to the invention a medical

Device having a flat lattice structure 10, wherein the flat lattice structure 10 includes a plurality of cell openings 12 which are bounded by webs 11. A part of the cell openings 12 can form free cell openings 12a, whereas a further part of the cell openings 12 forms covered cell openings 12b. The covered cell openings 12b at least partially have a cover 13. The distribution of the

Covered cell openings 12b be different. Possible variants are shown in the following figures.

FIG. 5 a shows a variant according to which each second cell opening 12 is covered

Cell opening 12 b is formed. The covered cell openings 12b are completely covered with the cover 13. Essentially, the lattice structure 10 according to FIG. 5a has a karo-like pattern.

In the exemplary embodiment according to FIG. 5b, the grid structure has predominantly covered cell openings 12b. Furthermore, free cell openings 12a are provided which are arranged directly downstream of one another in the longitudinal direction of the lattice structure 10, ie horizontally in the plane of the drawing. In the transverse direction or circumferential direction of the lattice structure 10, that is vertically in the

Drawing plane, two free cell openings 12a are separated by a covered cell opening 12b.

The exemplary embodiment according to FIG. 5c shows a flat lattice structure 10 which comprises exclusively covered cell openings 12b. A part of the cell openings 12b also has a structuring 15, in particular in each case a pore 15a. The pores 15a form a regular pattern. In particular, the covered cell openings 12b, which have a pore 15a, are formed analogously to the embodiment according to FIG. 4a.

FIG. 5d shows an exemplary embodiment of the lattice structure 10, wherein the lattice structure 10 comprises exclusively covered cell openings 12b. Every second covered

Cell opening 12d has four pores 15a each. Thus, every other covered cell opening 12b according to the embodiment of FIG. 4b is formed. The remaining cell openings 12 have a complete cover 13. FIG. 6 a shows a flat lattice structure 10 a substantially karo-like pattern covered cell openings 12b. The covered cell openings 12 b are completely provided with the cover 13. In addition to the checkered pattern, two cell openings 12 arranged in an edge region in the transverse direction of the lattice structure 10 have a cover 13. In this way, 10 V-shaped cell opening groups are formed in the transverse direction of the lattice structure.

The embodiment according to FIG. 6b substantially corresponds to the exemplary embodiment according to FIG. 5c, the arrangement of the individual pores 15a, which are formed in each case in a covered cell opening 12b, being slightly varied. In particular, in the

Embodiment of FIG. 6b provided that covered between two

Cell openings 12 b, in which a pore 15 a is formed, in the transverse direction of the grid structure 10, a covered cell 12 is arranged, which is completely covered by the cover 13.

The exemplary embodiment according to FIG. 6c shows a lattice structure 10 which comprises free cell openings 12a and covered cell openings 12b. Overall, most of the cell openings 12 are provided with the cover 13. In the transverse direction of the lattice structure 10, two free cell openings 12 are arranged in a line. In the longitudinal direction of the lattice structure 10, the free cell openings 12a, however, each offset, in particular transversely offset, arranged to each other.

FIG. 6d shows a flat lattice structure 10 which comprises exclusively covered cells 12b. A series of covered cells 12b, each dividing a limiting web 11, has a structuring in the form of cover strips 13b. The cover strips 13b extend parallel to the webs 11. A lateral cover strip 13b extends along a web 11 and has a longitudinal edge which is fixedly connected to the web 11. On the other hand, a middle cover strip 13b has two free longitudinal edges. In particular, a clearance 12c is formed between the outer cover strip 13b and the middle cover strip 13b. Another clearance 12c is between the middle one

Cover strip 13b and formed a parallel web. A series of covered cell openings 12c comprising cover strips 13b are separated from another row of covered cell openings 12b, which also comprise cover strips 13b, by a series of covered cell openings 12b which are completely covered by the cover 13. In this case, a series of cell openings 12 denotes adjacent cell openings 12, which share a common web 11 as delimiting element. FIG. 7 shows a further variant of the medical device with a flat lattice structure 10, which comprises two outer sections 16a and one middle section 16b. The cell openings 12 in the central portion 16b are completely covered with the cover 13. The cell openings 12 in the middle area 16b thus form covered cell openings 12b. The cell openings 12 in the outer regions 16a, however, are formed as free cell openings 12a.

The embodiment according to FIG. 8 essentially corresponds to the exemplary embodiment according to FIG. 7, wherein the outer sections 16a likewise have covered cell openings 12b which, unlike the covered cell openings 12b in the middle section 16b, comprise a structuring 15. Specifically, the covered cell openings 12b in the outer portions 16a have pores 15a. The outer sections 16a are in particular formed by covered cell openings 12b, which are formed in accordance with the embodiment according to FIG. 4a.

In general, it can be provided in the context of the manufacturing process, the cover 13 in addition to medicines or biologically active substances, in particular

antithrombogenic or thrombogenic substances, to coat. The coating of the cover 13 may be done prior to placing the prefabricated cover 13 on the grid structure 10. Coating with drugs or biologically active substances may also be done after bonding the cover 13 to the grid structure 10 or coating the grid structure 10 to form the cover 13. Preferably, the

Coating with biologically active substances or drugs prior to the transfer of the flat lattice structure 10 in the rotationally symmetric shape.

In Fig. 9, a medical device is shown, which is manufactured with the manufacturing method according to the invention according to a preferred embodiment. The medical device comprises a lattice structure 10, which after production has a rotationally symmetrical shape. The lattice structure 10 is provided with a cover 13 extending on an inner circumferential surface of the lattice structure 10. Alternatively, the cover 13 may extend on an outer circumferential surface of the lattice structure 10. The grid structure 10 may also be encapsulated between two covers 13 disposed on an inner circumferential surface and on an outer peripheral surface. In particular, when coating the lattice structure 10 with a plastic material to form the cover 13, a medical device may be formed which comprises a lattice structure 10 in whose cell openings 12 the cover 13 in the wall plane of the Grid structure 10 is arranged. In this case, the cover 13 can extend between the webs 11 through the cell openings 12. Thus, the cover 13 does not contribute in addition to the wall thickness of the medical device.

In Fig. 9, a connection region 14 is further recognizable. The connecting region 14 essentially comprises the transverse edges of the originally flat lattice structure 10, which come into contact with each other as a result of the rolling of the lattice structure 10 or the transfer into the rotationally symmetrical shape. In the connection region 14, the webs 11 touch the free transverse edges of the lattice structure 10. It is possible that the cover 13 is structured such that in the region of the transverse edges of the lattice structure 10, a higher number of free spaces 12c is formed. In this way, thermal joining methods, which can be used to connect the contacting webs 11 in the connection region 14, supported.

If the cover 13 during the manufacturing process on one side to the flat

Grid structure 10 is applied and connected to the grid structure 10, it can then be determined by the rolling direction for the grid structure 10, whether the cover 13 of the finished medical device on the inner peripheral surface of the grid structure 10 or on the outer peripheral surface of the grid structure 10 is arranged. FIG. 10 shows a section of a lattice structure 10 which has a cover 13 applied on one side.

It is possible that after the application of a prefabricated cover 13 and the

Connecting the cover 13 with the grid structure 10, so generally after the covering of the grid structure 10 with the cover 13, a further cover 13 is applied to the grid structure 10. The further lattice structure 13 can be applied to the lattice structure 10 or the already applied cover 13, for example, by covering, spraying, dipping or a similar method. As a result, the lattice structure 10 can be provided on both sides with a cover 13, for example. Alternatively, the

Grid structure 10 and / or the already clamped cover 13 are coated with a drug or other biologically active substances, for example

To promote or prevent cell growth or thrombogenesis. FIG. 10 shows a detail of such a medical device, wherein a cell opening 12 is additionally provided with a medically effective coating 19. Alternatively, all cell openings 12 may be provided with a medically effective coating 19. The webs 11 contacting each other in the connection region 14 after rolling the lattice structure 10 can be connected to one another by known joining methods, in particular welding or soldering, in order to close the rotationally symmetrical shape of the lattice structure 10. Additionally or alternatively, the joining of the webs 11 contacting in the connection region 14 can be effected by applying local joining coatings 17. The

Joining coating 17 may comprise, for example, a polymer coating.

Method steps for connecting the contacting webs 11 by a

Joining coating 17 are shown in Figs. IIa and IIb. Specifically, Fig. IIa shows the connection region 14 of a lattice structure 10, wherein between the contacting webs 11 for reasons of clarity, a graphic distance is shown. During rolling of the lattice structure 10, the webs 11 of the transverse edges of the lattice structure 10 become such

aligned, that in each case at least two webs 11 in the rolled state of the lattice structure 10 are aligned with each other.

In the exemplary embodiment according to FIGS. 11a and 11b it is provided that in each case two webs 11 in the region of a transverse edge of the lattice structure 10 form half a node 18 which is connected to a further half node 18 in order to obtain a complete one

Form node 18, from the four webs 11 go out. As shown in Fig. IIb, a joining coating 17 is selectively and locally applied to the flush with each other arranged half nodes 18 and the mutually aligned webs 11. For example, the joining layer 17 may comprise a polymer that can be replaced by a

Spray coating method or a dip coating process locally in the region of the connecting portion 14 is applied to contacting webs 11. The joining layer 17 may alternatively comprise a metal, which is applied by sputtering specifically in the connection region 14 on the contacting webs 11.

LIST OF REFERENCE NUMBERS

10 grid structure

11 footbridge

12 cell opening

12a free cell opening

12b covered cell opening

12c free space

13 cover 13a diamond-shaped area

13b cover strips

13c corner area

14 connection area

15 structuring

15a pore

15b Surface structuring

16a outer section

16b middle section

17 joining coating

18 node

19 medically effective coating

20 embossed stamp

21 embossing heads

Claims

claims

1. A method of manufacturing a medical device for endoluminal

Treatments, comprising the following, sequential steps:

- providing a flat grid structure (10) comprising interconnected lands (11) defining cell openings (12); subsequently

Arranging a flexible cover (13) on at least part of the flat lattice structure (10), the cover (13) comprising a plastic material; and subsequently

- Solid surface connecting the flexible cover (13) with the webs (11) of the grid structure (10) such that the cell openings (12) are at least partially covered.

2. Method for manufacturing a medical device for endoluminal

Treatments, comprising the following, sequential steps:

- Providing a flat grid structure (10), the interconnected webs

(11) defining cell openings (12); subsequently

- At least partially coating the flat grid structure (10) with a

Plastic material such that a flexible cover (13) is formed, which is connected to the webs (11) of the lattice structure (10) over its entire surface and the cell openings

(12) at least partially covered.

3. The method according to claim 1,

characterized in that

the flexible cover (13) comprises a polymer film that matches the flat one

Grid structure (10) is connected by gluing or heat.

4. The method according to claim 2,

dad u rch net that net

the plastic material is sprayed onto the flat grid structure (10) or the flat grid structure (10) is dipped in the plastic material.

5. The method according to at least one of claims 1 to 3,

dadu rch net that net

the flat grid structure (10) is surface-treated prior to application of the cover (13) or coating with a plastic material such that a surface of the webs (11) has increased roughness.

6. The method according to at least one of claims 1 to 5,

characterized in that

the flat lattice structure (10) is converted into a rotationally symmetrical shape after the step of bonding all over or coating.

7. The method according to claim 6,

dad urch featured net that

formed during the transfer of the flat lattice structure (10) in a rotationally symmetrical shape, a connecting region (14), the touching webs (11), wherein in the connection region (14) contacting webs (11) of the lattice structure (10) for formation a closed rotationally symmetrical shape are interconnected.

8. The method according to at least one of claims 1 to 7,

characterized in that

the cover (13) is patterned before or immediately after the joining step or during or immediately after the coating step.

9. The method according to claim 8,

characterized in that net

the structuring (15) of the cover (13) is effected by stamping or stamping.

10. The method according to at least one of claims 1 to 9,

characterized in that

the flexible cover (13) extends in the region of the cell openings (12) essentially in the wall plane of the lattice structure (10).

11. The method according to at least one of claims 1 to 10,

characterized in that

the lattice structure (10) is converted into a rotationally symmetrical shape, in particular rolled, such that the cover (13) forms an outer peripheral surface and / or an inner circumferential surface of the lattice structure (10).

12. The method according to at least one of claims 1 to 11,

characterized in that

the webs (11) of the lattice structure (10) which come into contact in the connection region (14) are connected to one another by local coating with a plastic, in particular a polymer material, or by a sputtering process.

A starting product for the manufacture of a medical device for endoluminal treatments comprising a flat lattice structure (10) comprising interconnected lands (11) bounding cell openings (12) and a flexible cover (13) connected to said lands (11). the lattice structure (10) is connected over its entire surface, wherein the flexible cover (13) comprises a plastic material, in particular a polymer.

14. starting product according to claim 13,

characterized in that

the flexible cover (13) has a structuring (15).