WO1999001087A1 - Vascular support - Google Patents

Vascular support

Info

Publication number
WO1999001087A1
WO1999001087A1 PCT/EP1998/004081 EP9804081W WO9901087A1 WO 1999001087 A1 WO1999001087 A1 WO 1999001087A1 EP 9804081 W EP9804081 W EP 9804081W WO 9901087 A1 WO9901087 A1 WO 9901087A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
elements
stent
mesh
direction
element
Prior art date
Application number
PCT/EP1998/004081
Other languages
German (de)
French (fr)
Inventor
Wolfgang Ehrfeld
Martin Schmidt
Christoph Schulz
Gregor Feiertag
Original Assignee
INSTITUT FüR MIKROTECHNIK MAINZ GMBH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541Adjacent bands are arranged out of phase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91566Adjacent bands being connected to each other connected trough to trough
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91591Locking connectors, e.g. using male-female connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/005Rosette-shaped, e.g. star-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0078Quadric-shaped hyperboloidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal

Abstract

The invention pertains to a vascular support (1) adjustable in different diameters and capable of being stabilized when stretched. Said vascular support (1) presents a reticulate (3) meshed (8) tubular structure which gets tighter in the axial direction (12) when stretched towards the periphery (13). At least one series (17a-g, 18a-k) of meshes arranged in the peripheral direction (13) presents self-locking stop elements which interact when the mesh (8) shape changes. The stop elements (20) can consist of at least one plug-in element (21a, b) and one locating element (22a, b).

Description

Implantable endoprosthesis

description

The invention relates to an implantable endoprosthesis comprising a tubular structure that is stretchable in the circumferential direction.

The implantable vascular supports, so called stents, to be used in medical applications for maintaining the blood or fluid transport in containers. This is especially true in the treatment of stenoses by balloon in which the restenosis rates can be significantly reduced by the use of stents. Stents are usually applied in this case via a balloon, that is put forward in the application in a compressed state in the vessel and then expanded with the aid of the balloon. Upon removal of the balloon, the stent should maintain the expanded state as possible.

In certain applications in the field of pediatric surgery stents are needed beyond that also allow the unique setting of certain flow rates through the maintenance of a specified volume flow addition, that valve functions can take over with.

In WO 95/29728 a stent made of knit fiber material will be described. The net-like structure is stretched by means of a catheter, with the knitting to be stretched in both the axial and in Umtangsrichtung. No means are provided to stabilize the stent in the stretched state. This stent is longer than the stent used so far, which is a multiple introduction of shorter stents should be avoided. In order to avoid a uniform expansion, not on an elongated inflatable portion of the catheter is proposed, but a multiple applying a conventional inflatable catheter. The stent of this net-like structure is made of a biocompatible and corrosion-resistant material such as tantalum. The diameter may be 2 - 15 mm and the length be 10 - 30 cm. In WO 95/29728 a stent with a self-expanding structure is mentioned.

In the US 5,411,551 a stent is described from a rolled metal foil. The stent is introduced into the vessel in the rolled up state and is able to expand due to the spring force and thus bear against the inner wall of the vessel. An adaptation to irregular surfaces is not possible.

In WO 94/13268 a tubular, expandable stent is described in the structural threads are woven, which can release a drug. As the material of the stent tantalum, gold, titanium, tungsten and platinum, and polymers are known, inter alia, stainless steel. It will be described with plastic properties of materials that remain due to the performed during the expansion deformation in the expanded state. The use of material having elastic properties whereby a fixation of the stent in the expanded state is errreicht characterized in that the stent expands itself is mentioned. As the material for the active ingredient supporting yarns polymers are known, some of which, such as poly-lactide, are degradable in the body. As tubular structures perforated cylinder and wire structures are described.

For fixation of endoprostheses is proposed in EP 497 620 to provide a plurality of micromechanical barbs on the surface of the stent, which penetrate during expansion of the stent into the tissue and thus fix the stent at this point. Subsequent removal of the stent is inextricably linked to violations of the vessel.

In DE 42 22 380 Al an expandable elongate hollow body is described which is provided with a coating containing an active substance. The coating is flexible and degradable.

Metallic stents have basically the disadvantage that foreign matter must be implanted, the explant, such as during subsequent complications requiring surgical intervention which is connected in most cases with extreme risks, but often is impossible. A temporary stents application is not possible. Metallic Stents also have the disadvantage that a therapy supportive, local drug delivery is not possible.

and stents have been developed, therefore, that consist of biodegradable material.

From US 5,443,458 a stent in the form of a tube is known, which is placed in a rolled state in the vessel. In the expanded condition engage at the outside on the longitudinal edge arranged distributed hook into corresponding recesses of the overlapping tube section, whereby the expanded state of the stent is fixed. A disadvantage is that only a predetermined diameter is adjustable.

This stent is comprised of multiple layers of biodegradable material. The first layer provides the stent strength, while the second layer releases an active ingredient. As the material of the structure supporting layer of poly-lactide and poly-glycolic acid, and polyorthoesters, and polyanhydrides can be mentioned. The preparation takes place by extrusion and stretching. As a material of the second layer of poly-DL-lactide and poly-caprolactam can be mentioned. The interconnected layers are cut by stamping or laser cutting to the appropriate size.

In WO 93/06792 a biodegradable stent is described, containing the active ingredient-containing materials with different degradation rate, to allow controlled release of the active ingredients. The stent consists of a sleeve provided with a longitudinal slot cylinder having on its surface recesses and transverse fibers, which are tensioned so that they expand the cylinder. As the material is also proposed, inter alia, poly-lactide. The fibers are prepared by known techniques, such as melting and spinning.

The hitherto known solutions for the use of biodegradable materials in the fabrication of stents generally have the disadvantage that by the elastic properties of these materials, a permanent, plastic deformation from the compressed state to the expanded state is excluded. Site-stable, gentle, adapted to the surrounding tissue application is not possible in these stents. Also, the approach to replace plastic deformation by spirally rolled vascular structures with unstructured walls, in which the up stretched state is stabilized by suitable structures, as described in US 5, 443, 458 is feasible, as little as this stent only in a predetermined diameter can be fixed and thus can not adapt to the irregularly shaped surface of the surrounding tissue and therefore also can not be gentle but spatially stable implanted. All known stents made of biodegradable materials have in common that the resolution is carried out non-specific and therefore can not be ensured, at what time at what resolution size, parts of the stent solve, get into the bloodstream and lead to not kontrollbierbaren thromboembolic complications. All solutions proposed to date for the construction of stents provide no way to regulate the flow.

The object of the invention, a vascular support, which is adjustable to different diameters, wherein the stent in the expanded state is to be stabilized.

This object is solved by a stent according to the features of claim 1. Advantageous embodiments are the subject matter of the claims.

The tubular structure of the implantable endoprosthesis is formed by a net-like structure with meshes which are compressible when stretched in the circumferential direction at the same time in the axial direction. In at least one axial and / or at least one disposed in the circumferential direction of row of stitches has self-locking detent elements which cooperate with changes in shape of the meshes.

The stent is manufactured in a compressed state and inserted into the vessel. Upon expansion by a balloon catheter the stent is expanded in the radial direction and simultaneously compressed in the longitudinal direction. Thereby, the loops of a shape change, which is that each individual mesh is compressed in the axial direction and expanded in the circumferential direction subject. Due to this change in shape which are arranged in the mesh self-locking detent elements to be changed in its position and can cooperate in such a manner that in the expanded state the shape of the vascular support is stabilized and fixed.

The detachment of the fixation of the stent structure of the material used and the shift to special catch elements, enables the use of different materials for making the network structure. There come for the production of the stent, both non-biodegradable and biodegradable materials contemplated, such materials are preferred which can be used in direktlithographisch LIGA method or with the use of molding techniques. The non-biodegradable materials biocompatible plastics are preferred.

net meshes have the advantage that the tubular structure may be composed of recurring elements, each individual mesh may be provided with its own locking elements. There is thus the possibility to bring the locking elements in each individual stitch or pre-targeted distribution of locking elements over the whole network structure, to influence in this way, the elastic properties of the overall stent. Mesh without locking elements are more flexible in the expanded state depending on the type of material used and can customize in this way better irregular surfaces of the vessel wall without the entire stent is unstable.

By using different locking elements of different diameters in the expanded condition can be set at one and the same stent. It is thereby possible to provide, for example, stents with constrictions in order to adjust to this manner, a targeted flow rate within the vessel.

The mesh may have a square, round or oval shape. Preferably, a diamond shape is the mesh. There are also mesh possible with wavy shape.

In order to make the setting of different diameter with one and the same stent, the locking elements preferably comprise a plurality of detent positions. The locking elements may be designed in different ways, wherein one expansion blocking in their direction of movement and deformation-blocking locking elements is different. Among the stretching blocking locking elements is understood to mean those which are formed and arranged in the loop such that they prevent the elongation of the mesh in the axial direction in the expanded state of the stent so that the stent can not contract again.

The compression-blocking catch elements are configured and disposed within the mesh, that a compression of the loop is prevented in the circumferential direction in the expanded state of the stent so that the stent does not again allowed to contract.

Preferably, the latch elements comprise a male element and one on pickup element.

If it is stretch-blocking detent elements, these are preferably arranged opposite in the axial direction. In compression-blocking locking elements, the arrangement of the plug-in elements and receiving elements are preferably opposite one another in the circumferential direction.

According to a preferred embodiment, the male member and the female member each of ratchet teeth, which can, depending on whether it is expansion or compression of blocking catch elements have different shapes.

The ratchet teeth on the expansion blocking catch elements are formed such that they block during telescoping of plug element and receiving element. Accordingly, the locking teeth on the compression-blocking locking elements are shaped so that they block during mating of plug element and on pickup element. In the direction in which the detent teeth do not block in the motion of male member and female member, the locking teeth may slide over each other, so that any diameter can be adjusted during stretching of the stent. Only in the final position when the stent is eager to contract again, the blocking effect of the locking teeth begins by hooking or support.

In order to set predetermined possibly different diameter of the stent during expansion of the stent, all or only selected strain blocking detent elements may be provided with at least one stop element. The stop member is preferably disposed between the ratchet teeth and the fixed end of the male element. When nesting of male member and female member, the end position is thus determined by the stop member.

In order to be able to produce stents for flow regulation, preferably latching elements are arranged with stop elements in a middle portion of the stent such that the stretch-blocking catch elements can in this area does not slide into each other so far as the other locking elements, whereby a constriction of the stent is achieved.

Preferably, the latching elements are arranged at nodes of the network structure. This has the advantage that the power structure in these points is most stable, so that unintentional cancel of the locking elements can be avoided during implantation.

The regular structure of the vascular support of a plurality of stitches further offers the possibility to provide predetermined breaking points at regular intervals. These breaking points can be formed in the walls of the mesh or at the nodes of the network structure, which is preferably made of biodegradable material. Characterized the dissolution behavior and the size of the released stent sections may be controlled during the degradation process of the material in a simple manner.

have net meshes the further advantage that is within the mesh despite the provision of locking elements have sufficient space available to order medication reservoirs. Preferably at least one drug reservoir is provided at least at a mesh wall. The drug reservoir may for example be molded onto the mesh wall and consist of the same material as the mesh, when this biodegradable material is used. Preferably, the wall thickness of the drug reservoir is adapted to the degradation rate of the biodegradable wall material. This allows the time at which the drug is released into the vascular fluid, are previously determined. Preferably poly-lactide is used as a biodegradable material.

In the production of the stent, a mesh mat is preferably formed first, having on its longitudinal side fasteners. To prepare the mesh mat, the LIGA process is preferably used. In the first manufacturing step joined flat stitches are made with locking elements integrated into a mesh mat. After detachment of these flat structures from the substrate, the mesh mat is rolled and the two open edges connected together, the connection may also be fixed again by means of mechanical structures. It is also possible to weld the two longitudinal edges or sticking.

As another preferable method, the direct production of the round stent is to be mentioned, whereby the connecting step the mat is omitted to form a hollow cylinder. This preparation of the round piece stent can be effected for example by laser machining, embossing or injection molding of plastics.

Preferably, the network structure is made of at least two layers. Preferably, three layers are formed one above the other, wherein a bottom layer, a middle layer and a cover layer is discriminated. This structure is suitable particularly when drug reservoirs within the mesh to be located.

Exemplary embodiments are described with reference to the drawings. Show it:

Fig. 1 is a perspective view of a stent in the compressed state,

Fig. 2, the stent shown in Figure 1 in the expanded state,

Fig. 3 a section of a mesh mat for the manufacture of the stent shown in Figure 1,

FIGS. 4a u. 4b are perspective views of the stitch from the position shown in figure 3 in the compressed mat network and in the stretched state,

Fig. 5 is a perspective view of the mesh shown in Figure 4a with the drug reservoir,

Figure 6 is a mesh mat in a perspective view with plug-in elements according to another embodiment, Fig. 7 is a perspective view of a stent from the position shown in Figure 6 and network mat.

Fig. 8 is a perspective view of a mesh mat with latching elements according to another embodiment.

In the figure, 1 is a stent 1 in a perspective view in the compressed state, that is illustrated in the not yet inserted into a vessel and therefore not expanded state. The stent 1 has a network structure 3, consisting of a regular array of mesh 8 having a diamond shape in the embodiment shown here. The mesh 8 are arranged such that constitute the respective apexes of the diamonds, the nodes 10, opposite in the axial direction 12 and in the circumferential direction 13 of the stent. 1

Each mesh 8 forms a parallelogram, so that when the mesh to stretch to dilation of the stent 1 in the circumferential direction 13 and contract at the same time in the axial direction 12, as shown in FIG. 2 The radial expansion caused by an unillustrated balloon catheter is indicated in Figure 2 by the arrows. 11 Therefore, the expansion of the stent 1 is accompanied by a contraction in length.

In the figure, 1 8 latch elements 20 in the form of plug-in elements 21a and receiving elements 22a are disposed in a part of the mesh. Here, longitudinal rows of stitches switch 8 with locking elements 20 with rows of stitches from having no latching elements. The locking elements 20 are arranged in the axial direction 12 on opposite sides of the mesh, so that the plug member 21a and the receiving element 22a move toward each other during expansion of the stent 1 and the male member is inserted into the receiving member 22a. This means that in the expanded state, as shown in Figure 2, the locking elements are placed in a position 20 to interact and stabilize the expanded network structure. 3 The receiving element 22a in this case surrounds the plug element 21a, with both latch elements are provided with locking teeth 23a and 24a 20 that are formed in the form of barbs. The number of locking teeth 23a, 24a defines the number of possible locking positions. After mating of female member and male member 21a, these locking teeth intermesh and prevent expansion of the meshes 8 in the axial direction, and thus contraction of the entire stent 1. It is therefore in this embodiment to stretch blocking catch elements 20th

In the production of the stent 1, it is assumed that a mesh mat 2 as shown for example in Figures 3 and 6. FIG. At the respective longitudinal sides of the mesh mat 2 8 locking elements 6 and 7 are provided at the corners of the outer mesh. This is to cylindrical plug elements 6 and correspondingly shaped arcuate pickup elements 7, which then engage each other when the mat is rolled up network 2 to that shown in the Figure 1 stent. 1 Instead of these locking elements 6, 7 which mesh mat 2 can also be welded or rolled up state at the corner points of the outer mesh be glued.

In FIG. 3, it is seen that the later is arranged in the axial direction 12 stitch rows 17a, 17c, 17e, 17g alternate with rows of stitches 17b, 17d and 17f in which no latching elements 20 are provided.

Also, when viewed in transverse direction, ie in the circumferential direction 13 c, e, g, i, k of rows of stitches 18b, d, f, h, j may rows 18a, are distinguished, in which no latching elements are provided 20th In FIG. 4a is an outer loop 8 is shown enlarged. At one of the four corner points of the lock member 6 is molded. Since it is a diamond-shaped mesh 8, four meshed walls 9a, b, c and d are provided. At opposite corners of the plug member 21a and the receiving member 22a are fixed or formed in the shown embodiment. The plug element 21 has a substantially rectangular cross-section, being formed on opposite sides within the mesh 8 ratchet teeth 23a. The top and bottom of the male element 21a are unstructured.

The receiving element 22a is formed U-shaped and has a web 25, are arranged on the two legs 26a, 21a against stretch the plug element. At the free end of the legs 26a, 26b are spring tongues 27a, 27b secured, extending in the intermediate space between the two legs 26a and 26b. On the opposite sides of the spring tongues 27a, 27b are disposed to the ratchet teeth 23 a complementary ratchet teeth 24a.

When as shown in Fig. 4b, the loop has been stretched in the circumferential direction 13 8 and the loop has thus shortened in the axial direction 12, the male member 23a pushes into the female member 22a, whereby the two spring tongues 27a and 27b to the outside be pressed, so that the locking teeth can slide over each other 23a and 24a. When the end position which is defined by the balloon catheter upon expansion of the stent is reached, and the loop endeavors due to their elastic material properties to stretch back in the axial direction 12, engage the locking teeth 23a, 24a with each other and thus block the axial elongation.

In FIG. 5, a further mesh 8 is shown that the shown in Figs. 4a has, locking elements 20 shown 4b. In addition to the mesh walls 9a, 9b, 9c and 9d arranged medication reservoirs 30a-d of different size. It is cylindrical drug reservoirs, the amount of the height of the mesh walls corresponding 9a-9d. The wall thickness of this drug reservoirs 30a-d is set to the rate of degradation of the wall material used, so that the timing of drug delivery can be predetermined.

The mesh 8 5 shown in Fig. Has a three-layer structure. To illustrate this structure, the two drugs are reservoirs 30c and 30d partially in section. On a bottom layer 40 which forms the bottom plate of the drug reservoirs and at the same time, a middle layer 41 is applied, which has corresponding recesses for receiving the drugs in the field of drug reservoirs. This is followed upward a cover layer 42, which closes the openings in the middle layer 41 in the area of ​​drug reservoirs. Since the walls 9a-9d Medikamentenrservoire 30a-30d, and the locking elements 20 all have the same thickness, the manufacture of the mesh by the layer configuration as shown in a simple manner is possible.

In FIG. 6 is a mesh mat 2 is shown in which the plug-in elements 21a, are provided in the section 35 with differently sized stop members 28a, b, c. These stop members 28a, b, c are positioned between the fastening point of the plug elements 21a and the ratchet teeth 23a. When assembling of male element and female element of the fitting-together travel is limited by the stop elements, by abutting the end face of the legs 26a, 26b on the end surfaces of the stop elements 28a, b and c. The length of the insertion path is determined by the thickness or by the arrangement of the stop members 28a-c. The stop elements 28a are further away from the free end of the male element 21a as the abutment members 28b or 28c, the stop elements. Accordingly, the corresponding plug elements have less 21a ratchet teeth 23a, so that a total of less detent positions are possible. The stepped arrangement of the stop members 28a-28c in the area 35 leads during expansion of the stent formed from this mesh mat 2 to a constriction, as shown in FIG. 7. Such a vessel support 1 is suitable for setting the vascular flow.

In FIG. 8 is a mesh mat 2 is illustrated with locking elements 20 according to another embodiment. Plug elements 21b and receiving elements 22b are arranged opposite one another in the circumferential direction, it is in the embodiment shown here by compression blocking catch elements 20th In the compressed state of the stent, the connector elements 21b and the pickup elements 22b are joined together and are moved apart due to the expansion of the stent in the circumferential direction. 13 Here, the ratchet teeth 23b and 24b slide over one another until the predetermined final condition of the stent is achieved. Due to the material properties of the mesh 8, they are anxious then to contract in the circumferential direction 13 again, after which engage the ratchet teeth 23b and 24b and are supported against each other in order to prevent in this way a further contraction in the circumferential direction. 13

reference numeral

Stent (stent)

mesh mat

network structure

long side

narrow side

connecting element

connecting element

Stitch a, b, c, d mesh wall 0 Node 1 radial direction 2 axial direction 3 circumferentially 4 breaking point 7a, b longitudinal row 8a, b transverse row 0 latching element 1a, b plug element 2a, b receiving element 3a, b ratchet teeth 4a, b detent tooth 5 web 6a b leg 7a, b spring tongue 8a, bc stop element 0a.b, c, d drug reservoir 5 0 constriction bottom layer 1 layer

42 outer layer

Claims

Patentanspr├╝che
1. An implantable Gefäßstütze (stent) with a rohrförmigen structure that is stretchable in the circumferential direction, characterized in that
daß rohrförmige the structure is a net-like structure (3) with loops (8), which at the same time when stretched in the circumferential direction (13) in the axial direction (12) are compressible, and
have daß at least one in the axial direction (12) and / or at least in the circumferential direction (13) arranged row (17a-g, 18a-k) of stitches (8) self-locking detent elements (20) (at Formveränderung the mesh cooperate 8).
2. Gefäßstütze according to claim 1, characterized in that the mesh (8) daß have an N-angular, round or oval shape.
3. Gefäßstütze according to claim 1 or 2, characterized in that the mesh (8) have a daß rautenförmige shape.
4. Gefäßstütze according to claim 1, characterized in that the mesh (8) have a daß wellenförmige shape.
5. Gefäßstütze according to one of Ansprüche 1 to 4, characterized in that daß the latching elements (20) have a plurality of detent positions.
6. Gefäßstütze according to one of Ansprüche 1 to 5, characterized in that the latching elements (20) in their direction of movement daß dehnungsblockierend or stauchungsblockierend are formed.
7. Gefäßstütze according to one of Ansprüche 1 to 6, characterized in that the latching elements (20) daß a plug element (21a, b) and on pickup element (22a, b) comprise.
8. Gefäßstütze according to claim 7, characterized in that daß the plug element (21a, b) gegenü and the receiving element (22a, b) in the axial direction (12) or in the circumferential direction (13) are arranged berliegend.
9. Gefäßstütze according to claim 7 or 8, characterized in that the daß
Plug-in element (21a, b) and the receiving element (22a, b) each having Rastzähne (23a, b, 24a, b).
10. Gefäßstütze according to claim 9, characterized in that the Rastzähne daß (23 a) to the expansion blocking catch elements (20) are formed such they daß during telescoping of plug-in element (21a) and receiving element (22a) block.
11. Gefäßstütze according to claim 9, characterized in that the daß
Rastzähne (23b, 24b) to the compression blocking catch elements (20) are formed such they daß block during mating of the plug element (21b) and receiving element (22b).
12. Gefäßstütze according to one of Ansprüche 6 to 10, characterized in that the strain-blocking catch elements (20) daß least one stop element (28a, b, c) have.
13. Gefäß stütze according to claim 12, characterized in that the stop element (28a-c) between the daß Rastzähnen (23 a) and the fixed end of the male element (21a) is arranged.
14. Gefäßstütze according to one of Ansprüche 12 or 13, characterized in that the latching elements (20) daß with stop elements (28a-c) in a central portion (35) of Gefä ßstütze (1) are arranged.
15. Gefäßstütze according to one of Ansprüche 1 to 14, characterized in that the latching elements (20) daß at nodes (10) of the net structure (3) are arranged.
16. Gefäßstütze according to one of Ansprüche 1 to 15, characterized in that daß the network structure (3) to the Wänden (9a-d) of the mesh (8) predetermined breaking points (14 ) having.
17. Gefäßstütze according to one of Ansprüche 1 to 16, characterized in that is predetermined breaking points (14) daß at the nodes (10) of the net structure (3) are located.
18. Gefäßstütze according to one of Ansprüche 1 to 17, characterized in that at least daß a mesh wall (9a-d) at least one drug reservoir (30a-d) is arranged.
19. Gefäßstütze according to claim 18, characterized in that the daß
Drug reservoir (30a-d) on the mesh wall (9a, b, c, d) is formed.
20. Gefäßstütze according to claim 18 or 19, characterized in that the wall thickness of daß drug reservoirs (30a-d) is angepaßt to the degradation rate of the biodegradable wall material.
21. Gefäßstütze according to one of Ansprüche 1 to 20, characterized in that daß the biodegradable material is polylactide.
22 Gefäßstütze according to one of Ansprüche 1 to 21, characterized in that daß the network structure (3) consists of at least two layers.
23 Gefäßstütze according to claim 22, characterized in that daß the network structure (3) of a bottom layer (40), a middle layer (41) and a cover layer (42).
24 is Gefäßstütze according to one of Ansprüche 1 to 23, characterized in that the Gefäßstütze (1) daß from a mesh mat (2) formed on their Längsseite (4) has connecting elements (6,7).
PCT/EP1998/004081 1997-07-03 1998-07-02 Vascular support WO1999001087A1 (en)

Priority Applications (2)

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DE1997128337 DE19728337A1 (en) 1997-07-03 1997-07-03 Implantable endoprosthesis
DE19728337.3 1997-07-03

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