DE102007034991A1 - Production of a stent, useful to treat stenosis and aneurism, comprises providing a catheter and a stent, coating the catheter on the surface with e.g. a polymer and positioning and crimping the stent on the surface of the catheter - Google Patents

Abstract

Production of a stent (2) crimped on a coated catheter, comprises (a) providing a catheter, (b) providing a stent, (c) coating the catheter on the surface, which is in contact with the luminal surface of the stent, with a polymer or with a mixture of polymer and one or more active substances and (d) positioning and crimping the stent on the surface of the catheter, which is partially coated with the polymer or the mixture of step (c). Independent claims are included for: (1) a medicine product containing a catheter, a polymer layer containing polymer or a mixture of polymer and one or more active substances, which are in contact with the surface of the catheter, and a stent, which is crimped on the coated catheter and contacted with the polymer or the mixture, produced by the above method; and (2) a kit comprising one or more catheters coated with a polymer or with a mixture of polymer and one or more active substances, where the layer is formed in such a way that it is contacted with the luminal surface of a stent crimped on the catheter and one or more stents.

Description

The The present invention relates to a process for producing a (active ingredient) crimped, coronary and peripheral stents on a balloon catheter, a medical device manufacturable after one inventive method, and a use a coating on the surface of a catheter for Improvement of the peel force of a crimped stent of the Catheter.

stents in general, endovascular prostheses or implants, which are used for example for the treatment of stenoses. Stents are also known for their treatment of aneurysms. Stents basically have a support structure on which is appropriate the wall of a vessel suitably support, so as to the vessel wide or aneurism to bridge.

stents be implanted in a human or animal Organism, preferably in cavities, more preferably in the vascular system, introduced. Because the implantation of the stent an invasive intervention in the human and animal Organism, there is a great desire to minimize the associated risks.

stents be in a compressed state for implantation, the so-called crimped state, introduced into the vessel and then widened at the place to be treated, especially against pressed the vessel wall. For this purpose, the Stent usually attached to a suitable catheter and then using standard parameters in a compressed Condition transferred (crimped), d. H. that the diameter of the stent is less than in the uncompressed state. hereby It is achieved that the crimped stent on the catheter in a certain position is fixed and fixed and a certain Peel-off force must be expended to the crimped stent to remove from this position.

This causes by means of the catheter the crimped on it Stent through the cavities of the organism, in particular the vessels, to the place of interest, for example stenosis or aneurysm, can be performed without that there is a risk that the stent is on the balloon catheter shifts or slips completely off the catheter.

There during implantation of the stent due to the cavity walls, especially vessel walls, frictional forces act on the crimped stent and this stent its position on the stent, in the worst case of the catheter can be subtracted, the peel force, which is necessary is to change the position of the crimped stent on the catheter, preferably greater than the friction forces occurring be.

in the Generally, most balloon expandable stents now exist Problems with adjusting the crimp parameters, e.g. Crimp force, temperature (Thermal embedding) and back pressure of the balloon to a sufficient Adhesive force of the stent to ensure the balloon.

Also there are stents that already have a drug coating, and then can only be crimped onto a profile, in which the adhesive force is smaller than the forces occurring is that occur during implantation. For example, this may be causing are characterized by a semi-ductile polymeric carrier matrix, the reduced the luminal diameter of the stent and the mural Diameter of the stent enlarged. alternative the stent coating can have improved sliding properties on the Own balloon material.

A The object of the present invention is, therefore, the risks minimize during stent implantation. In particular, an improved To provide medical device of catheter and stent, in which the crimped stent has a peel force in relation to the forces acting on the stent during implantation at least the same size or larger.

A Another object of the present invention is to provide an improved To provide medical device drug-coated catheter and / or stent.

• a) Bereitstellung eines Katheters,
• b) Bereitstellung eines Stents,
• c) Beschichtung des Katheters auf der Oberfläche, die mit der luminalen Oberfläche des Stents in Kontakt steht, mit einem Polymer oder mit einer Mischung aus Polymer und einem oder mehreren Wirkstoffen und
• d) Positionierung und Crimpung des Stents auf der Oberfläche des Katheters, die mit dem Polymer oder der Mischung aus Schritt c) zumindest teilweise beschichtet ist.

• Ein weiterer Gegenstand der vorliegenden Erfindung betrifft eine Medizinprodukt umfassend oder bestehend aus:
• a) einem Katheter,
• b) einer Polymerschicht umfassend Polymer oder eine Mischung aus Polymer und einem oder mehreren Wirkstoffen, die mit der Oberfläche des Katheters in Kontakt steht, und
• c) einem Stent, der auf dem gemäß Schritt b) beschichteten Katheter gecrimpt ist und mit dem Polymer oder der Mischung in Kontakt steht,

herstellbar nach einem vorstehend beschriebenen erfindungsgemäßen Verfahren sowie der nachfolgend beschriebenen bevorzugten Ausgestaltungen hiervon.At least one object is achieved according to the invention by a method for producing a crimped stent on a coated catheter comprising or consisting of the following steps:

• a) providing a catheter,
• b) providing a stent,
• c) coating the catheter on the surface, which is in contact with the luminal surface of the stent, with a polymer or with a mixture of polymer and one or more active substances and
• d) positioning and crimping the stent on the surface of the catheter which is at least partially coated with the polymer or mixture of step c).

• Another object of the present invention relates to a medical device comprising or consisting of:
• a) a catheter,
• b) a polymer layer comprising polymer or a mixture of polymer and one or more active ingredients, which is in contact with the surface of the catheter, and
• c) a stent which is crimped on the catheter coated according to step b) and which is in contact with the polymer or the mixture,

preparable by a method according to the invention described above and the preferred embodiments described below thereof.

One Another object of the present invention relates to the use one with polymer or with a mixture of polymer and a or more drug-coated catheter, characterized that the polymer layer is designed so that it luminal Surface of a stent crimped on the catheter in Contact will stand, to improve the peel force of the crimped Stents from the catheter.

• a) einem oder mehreren mit Polymer oder mit einer Mischung aus Polymer und einem oder mehreren Wirkstoffen beschichteten Kathetern, wobei die Schicht so ausgestal tet ist, dass sie mit der luminalen Oberfläche eines auf den Katheter gecrimpten Stents in Kontakt stehen wird und
• b) einem oder mehreren Stents.

Another object of the present invention relates to a kit comprising or consisting of:

• a) one or more catheters coated with polymer or with a mixture of polymer and one or more active ingredients, the layer being designed to contact the luminal surface of a stent crimped onto the catheter, and
• b) one or more stents.

Of the The present invention is based on the finding that a stent, which relates to a polymer-coated according to the invention Catheter is crimped, an increased peel force, in particular about 100%, compared to a stent that is on a non-polymer-coated Catheter is crimped. Thus, the advantage of the above described inventive objects in that the peel force of a crimped stent on a Catheter is increased to the extent that it forces in the vessels that are on the crimped stent during of the implantation process, exceeds.

• a) Bereitstellung eines Katheters,
• b) Bereitstellung eines Stents,
• c) Positionierung und Crimpung des Stents aus Schritt b) auf dem Katheter aus Schritt a) und anschließende
• d) Beschichtung der Oberfläche des gecrimpten Stents, die nicht mit dem Katheter in Kontakt steht, und/oder der Zwischenräumen zwischen gecrimpten Stent und Katheter mit einem oder mehreren Wirkstoffen oder mit einer Mischung aus Polymer und einem oder mehreren Wirkstoffen.

An alternative solution to the above object is provided by a method for producing a drug-containing crimped stent on a catheter, comprising or consisting of the following steps:

• a) providing a catheter,
• b) providing a stent,
• c) positioning and crimping the stent of step b) on the catheter of step a) and subsequent
• d) coating the surface of the crimped stent that is not in contact with the catheter and / or the spaces between the crimped stent and catheter with one or more active agents or with a mixture of polymer and one or more active agents.

• a) einem Katheter,
• b) einem Stent, der auf dem Katheter a) gecrimpt ist und
• c) einer Wirkstoffbeschichtung umfassend einen oder mehrere Wirkstoffe oder eine Mischung aus Polymer und einem oder mehreren Wirkstoffen auf der Oberfläche des gecrimpten Stents, die nicht mit dem Katheter in Kontakt steht, und/oder den Zwischenräumen zwischen gecrimpten Stent und Katheter

herstellbar nach einem vorstehenden erfindungsgemäßen Verfahren sowie dessen bevorzugten Ausgestaltungen.Another subject of the second invention alternative relates to a medical device comprising or consisting of:

• a) a catheter,
• b) a stent which is crimped on the catheter a) and
• c) a drug coating comprising one or more drugs or a mixture of polymer and one or more drugs on the surface of the crimped stent that is not in contact with the catheter and / or the spaces between the crimped stent and the catheter

preparable according to an above inventive method and its preferred embodiments.

The Items for the second alternative also contribute Solution of the above-mentioned problem, since by the active ingredient-containing coating according to the invention of the crimped stent or the active ingredients from step c) directly during implantation in the organism, in particular in the cavities, more preferably in the vessel, can be discharged and thus a beneficial effect can exert on the vascular system in the way that the forces acting on the crimped stent can be reduced. This ensures that at existing peel force of the crimped stent on the catheter, the Risk that changes the position of the stent on the catheter becomes, is humiliated.

For the objects of the invention present invention may conventional catheter materials and catheter shapes. It is preferred the catheter material selected from the group consisting out. From PA 12 (GRILAMID L25 from EMS GRIVURY), stents from PA 12 and PEBA (PEBAX 7033), which is suitable for softer blends are, and preferably mixtures of PA 12: PEBA in the ratio to 70: 30%.

additionally The catheter can be coated with thermoplastic polyurethane become adhesion forces to one or more To produce or increase active ingredients.

The Catheter shapes or types are preferably balloon catheters, in particular the type LektonMotion.

Conventional stent materials and stent geometries (stent designs) can be used for the articles according to the invention. In particular polymer materials and metal materials, each degradable or non-degradable. The preferred ones Embodiments are each described below in connection with further preferred embodiments of the invention.

As stent geometries, geometries known in the art (ProKinetics, Dynamic and Pheiron) can also be used. In particular, geometries which are balloon-dilatable and suitable for implantation in coronary or peripheral vessels are preferred. Particularly preferred geometries are, for example, in US 7,004,968 shown.

• – nichtresorbierbare (permanente) Polymere: Polypropylen; Polyethylen; Polyvinylchlorid; Polyacrylate, vorzugsweise Polyetyl- und Polymethylacrylate, Polymethylmetacrylat; Polymethyl-co-ethyl-acrylat, Ethylen/Ethylacrylat etc.; Polytetrafluorethylen, vorzugsweise Ethylen/Chlortrifluorethylen Copolymere, Ethylen/Tretrafluorethylen Copolymere; Polyamide, vorzugsweise Polyamidimid, PA-11, -12, -46, -66 etc.; Polyetherimid; Polyethersulfon; Poly(iso)butylen; Polyvinylchlorid; Polyvinylfluorid; Polyvinylalkohol; Polyurethan; Polybuthylenterephthalat; Silikone; Polyphosphazen; Polymerschäume, vorzugsweise aus Carbonaten, Styrolen etc.; sowie Copolymere und Elends der aufgezählten Klassen, bzw. der Klasse der Thermoplaste im Allgemeinen
• – (bio)resorbierbare (degradierbare) Polymere: Poly-dioxanon; Polyglycolid; Polycaprolacton; Polylactide, vorzugsweise Poly-L-Lactid, Poly-D,L-Lactid, und Copolymere sowie Elends wie Poly(L-Lactid-co-glycolid), Poly(D,L-lactid-co-glycolid), Poly(L-Lactid-co-D,L-Lactid), Poly(I-Lactid-co-trimethylen carbonat); Triblockcopolymere; Polyorhtoester; Polysaccharide, vorzugsweise Chitosan, Levan, Hyaluronsäure, Heparin, Dextran, Cellulose, Chondroitinsulfat etc.; Polyhydroxyvalerat; Ethylvinylacetat; Polyethylenoxid; Polyphosphorylcholin; Peptide, vorzugsweise Fibrin, Albumin, Polyhydroxybuttersäure, vorzugsweise ataktisch, isotaktisch, syndiotaktisch sowie deren Elends.

For the purposes of the present invention, the method according to the invention for producing a crimped stent on a coated catheter as the preferred polymer in step c) comprises one or more different polymers selected from the group consisting of:

• Non-resorbable (permanent) polymers: polypropylene; polyethylene; polyvinyl chloride; Polyacrylates, preferably polyethyl and polymethyl acrylates, polymethyl methacrylate; Polymethyl co-ethyl acrylate, ethylene / ethyl acrylate, etc .; Polytetrafluoroethylene, preferably ethylene / chlorotrifluoroethylene copolymers, ethylene / tetrafluoroethylene copolymers; Polyamides, preferably polyamide-imide, PA-11, -12, -46, -66, etc .; polyetherimide; polyether sulfone; butylene poly (iso); polyvinyl chloride; polyvinyl fluoride; polyvinyl alcohol; polyurethane; polybutylene terephthalate; silicones; polyphosphazene; Polymer foams, preferably from carbonates, styrenes, etc .; as well as copolymers and blends of the listed classes, or the class of thermoplastics in general
• - (bio) resorbable (degradable) polymers: poly-dioxanone; polyglycolide; polycaprolactone; Polylactides, preferably poly-L-lactide, poly-D, L-lactide, and copolymers as well as blends such as poly (L-lactide-co-glycolide), poly (D, L-lactide-co-glycolide), poly (L-lactide-co-glycolide) Lactide-co-D, L-lactide), poly (I-lactide-co-trimethylene carbonate); tri-block copolymers; Polyorhtoester; Polysaccharides, preferably chitosan, levan, hyaluronic acid, heparin, dextran, cellulose, chondroitin sulfate, etc .; polyhydroxyvalerate; ethyl vinyl acetate; polyethylene oxide; Polyphosphorylcholin; Peptides, preferably fibrin, albumin, polyhydroxybutyric acid, preferably atactic, isotactic, syndiotactic and their misery.

Especially preferred are polylactides, preferably poly-L-lactide, poly-D, L-lactide, and copolymers and blends such as poly (L-lactide-co-glycolide), poly (D, L-lactide-co-glycolide), Poly (L-lactide-co-D, L-lactide), poly (I-lactide-co-trimethylene carbonate), and polysaccharides, preferably chitosan, levan, hyaluronic acid, Heparin, dextran, cellulose, chondroitin sulfate, as well as polypeptides, preferably fibrin and albumin.

polymers selected from the group preferred above, allow in particular an increased increase the peel force of the crimped stent on the catheter and / or an incorporation of one or more active substances within these Polymer coating or subsequent coating this catheter coating with crimped stent with one or more Active substance mixtures or with a mixture of a polymer and one or more active substances.

Under Coating of the catheter is within the meaning of the present invention a complete or partial coating of the catheter material, in particular the proportion of catheter material to be understood with the luminal surface of a crimped stent in Contact will be. For subsequent coating the catheter coating with one or more active ingredients or with a mixture of one or more active ingredients can also a drug delivery on the murine stent side and thus on the the vessel wall facing stent side can be achieved.

in the Meaning of the present invention means "luminal surface" a stent that surface after implantation of the stent into a vessel with the vessel lumen and not in contact with the vascular tissue.

Provided the catheter represents a balloon catheter includes the coating with polymer also a coating of the balloon. In the coating process can the catheter material, especially the balloon, this slightly widened and / or folded before the catheter is coated with the polymer.

One such coating method, wherein the balloon is slightly is widened, is therefore preferred because in the convolutions of the Balloons also "polymer" and / or one or more active ingredients can reach, so a higher dosage of active ingredient can be achieved after the delation of the system, taking the entire surface of the balloon is unfolded to Available.

One Coating process wherein the balloon is coated in the folded state is then preferred when administered low drug doses should or should it be due to the present crimp profile not possible, the "folds" of the balloon to coat with.

As a coating method in the context of the present invention, all conventional coating methods can be used, preferably a dipping method (or dipping method), a spraying method, here preferably 2-nozzle or airbrush, a rotary atomizing method, an ultrasonic atomizing method, a method with rebound nozzle, or a method by means of roller application used, with which the catheter with the polymer according to step c) the process according to the invention is coated.

For The coating process may require that the polymer in step c) by conventional methods in addition is treated so that a suitable consistency can be set can. In particular, one or more of the polymers be dissolved. Preference will be this following adjuvants used, selected from the group consisting of water, methanol, ethanol, acetone, acetoacetone, Ethyl acetate, tetrahydrofuron (THF), dioxane, ethylene glycol, triethylene glycol, Propylene carbonate, chloroform, dichloromethane, acetonitrile, tert-butyl methyl ether, Dimethylsulfoxide (DMO) etc.

In a further preferred embodiment of the invention includes the polymer used in step c) additionally one or more active ingredients. This active ingredient-containing coating is particularly preferred for those drugs in which the On the one hand, the active ingredient is unstable per se or merely another delivered to the organism only for a short period of time may be, so to speak a "single dose" available got to.

Unstable For the purposes of the present invention means that the active ingredient on the one hand by degradation products of the stent material, especially in Magnesium stents, and / or used polymeric coating material so degraded that he is no longer his original Effect in the body can develop. As a result, one must increased concentration of the active substance or substances, so that the desired effect can be achieved.

"One Shot" in the sense of the present invention means that one or more Active ingredients due to their time (relatively low or narrow) therapeutic window only for a short time Period, preferably over the period in which the active ingredient-containing Catheter is present in the respective organism, ie of introduction of the catheter until removal of the catheter from the organism, may be delivered to the organism, preferably human or animal.

in the Meaning of the present invention is under the term "single dose" also to subsume an active ingredient coating with glucose, whereby there is a possibility that glucose and an or several active substances adhere to the vessel wall and so over a period of 2 to 30 minutes, so longer as the residence time of the balloon catheter in the organism, for provide a drug release.

To note also that in lipophilic drugs enrichment can take place in the vessel wall and this thus also beyond the period in which the catheter Being in an organism, being able to work in an organism.

Consequently can by the active ingredient according to the invention Coating a catheter the release of such drugs be made possible, which is a temporally low therapeutic Window, preferably from 0 to 30 minutes.

preferred Active ingredient groups are selected from the group consisting from the lipid regulators, immunosuppressants, vasodilators, calcium channel blockers, Calcineurin inhibitors, anti-inflammatory drugs, anti-inflammatory drugs, antiallergic drugs, Oligonucleotides, steroids, preferably estrogens, endothelium formers, proteins, Peptides, anticoagulants, analgesics, antirheumatics, angiogenesis inhibitors and cytostatics.

Under Cytostatic agents are usually to be subsumed: DNA alkylating Substances, in particular nitrogen-lost compounds and nitrosourea compounds; Platinum compounds; hydroxyurea compounds; Anti-metabolites, preferably folic acid antagonists, purine analogues and pyrimidine analogs; Microtubule inhibitors, preferably Winker alkaloids, taxanes, preferably paclataxel and dozetaxel; Topoisomerase inhibitors; antibiotics, preferably anthracyclines, particularly preferably danorobizine, doxorubicin, Epirubicin and idarubicin, anactinomycins, especially dactinomycin, Methoxanthrone, asarkrin and ansarkrin, mitomycin C and bleomycin; as well as various cytostatics from the group asparaginase, metefusin and imatinib; Hormones, preferably glucocorticoids, in particular prednisone, Sexual hormones, particularly preferably estrogens, progestagens, gonadoliberin (GnRH), fludamide, bizalutamide, tamoxifen and toremifene, aromatase inhibitors, such as Aminoglutetimide, formestane, eksemistan, retrozole and anastrozole; Antibodies, immunomodulators and cytokines, preferably trastuzumab, Cetiximab, rituximap, alemtuzumab, daklizumab, gemtuzumab, etratuzumab and Ibritumomap; Interleukin-II, interferon-α, tumor necrosis factor-α (TNF-α), hematopoietic growth factors such. G-CSF, GM-CSF.

Particularly preferred drugs are selected from the group consisting of: rapamycin, paclitaxel, fibrates (fenofibrate, clofibrate), decoy olide oxynucleotide (dODN), pimecrolimus, Inuk in, RGD peptide, preferably cyclic peptide and aptamer antibody, preferably CD 133.

Provided the active ingredient (s) does not have sufficient solubility in the polymer used for coating according to step c) of the method according to the invention, so are suitable solubilizers, usually are available, used to solubility the active ingredient (s) in the polymer used for coating to reach. Alternatively, the agent (s) may be cyclodextrin coupled into the polymer.

Prefers suitable solubilizers are selected from the group consisting of water, alcohols, preferably methanol, Ethanol and higher homologous thereof, dimethyl sulfoxide (DMSO), acetic anhydride, polyethylene glycol, are preferred in Molmassenbeich of 500-1800 g / mol, γ-butyrolactone, N-methyl-2-pyrrolidone, acetone, acetylacetone, ethyl acetate, tetrahydrofuran (THF), dioxane, ethylene glycol, triethylene glycol, propylene carbonate, Chloroform, dichloromethane, acetonitrile, tert-butyl methyl ether and Cyclodextrin, wherein the active ingredient (s) in a solvent be coupled to the cyclodextrin.

To Work-up (for example, freeze-drying) of the active ingredients can for example, a lipophilic active ingredient in a hydrophilic solvent be solved.

• e) Beschichtung des Stents in der gecrimpten Form auf dem Katheter mit einem oder mehreren Wirkstoffen oder mit einer Mischung aus Polymer und einem oder mehreren Wirkstoffen (so genannte „Topcoat").

In a further preferred embodiment, the method according to the invention for producing a crimped stent on a coated catheter described above further comprises or consists of the following step:

• e) coating the stent in the crimped form on the catheter with one or more active substances or with a mixture of polymer and one or more active substances (so-called "top coat").

In In such a case, the structure of an inventive Medical device so that there is a polymer-coated balloon, wherein the polymer layer optionally one or more active ingredients on which the stent is crimped and subsequently the overall system with one or more active substances or with a mixture of one Polymer and one or more active ingredients coated.

One Advantage of this preferred embodiment of the invention Procedure is that the active substance (s) produced by the subsequent coating on the balloon surface between the crimped stents, from abrasion during the implantation are protected.

A Such additional coating is especially for those active ingredients which are unstable in the sense of the present invention Invention are thus in an increased concentration must be present. This preferred embodiment is based on the knowledge that in an inventive Coating a crimped stent on a catheter of the or the active ingredients both on the surface of the crimped Stents coated as well as in between spaces crimped stent and catheter are present or stored.

in the Embodiment of the experimental part of the present invention Registration is presented after trackability exam the available amount of drug in a stent, which is coated on the catheter after crimping, increased by 400% is opposite to a drug coating of a stent before crimping on the catheter. Thus, this coating is particular for such active ingredients of advantage, which in an increased Concentration must be present. This increased Concentration may be required because of the active substance (s) for example, by degradation products of the stent material and / or the Polymeric coating material can be degraded and especially unstable in alkaline medium.

Especially in the case of active substances which are unstable in an alkaline medium and at the same time Use of a degradable metal stent, in particular one Magnesium stents, which degrades already at implantation and thereby especially in the immediate vicinity of the jetties and struts an increase in pH, this is additional Amount of active ingredient advantageous, since this the degradation of the unstable Active ingredient can be compensated.

Prefers are the active ingredients in step e) as a solution, Suspension, emulsion or melt. This allows the improved Blend with the polymer used for coating.

Provided the active substance or substances in step e) are incorporated in a polymer matrix are then preferably a rapidly degradable polymer layer. Preferably suitable fast-degradable polymers are selected from the group of degradable polymers, as described above, with glucose being particularly preferred.

Alternatively, the coating of the stent with one or more active agents in step e) is polymer-free, ie no polymer is used during the coating of the active substance (s) in step e), and thus the active agent (s) coated on the crimped stent, or in the interstices between the crimped stent and the catheter on or were stored, without Elution process from a polymer matrix can be delivered directly to the organism. The rate-determining step thus represents only the solubility coefficient of the coated active substance (s) in the medium of the organism, in particular the vessel. This coating is thus of particular advantage for those active substances which are impaired by degradation products of the stent material and / or the polymer coating material in their effectiveness can.

The preferred active ingredient groups and active ingredients for the coating in step e) correspond to those described above for step c) Active ingredient groups and active ingredients.

The individual coating steps may optionally include a drying step or further chemical and / or physical processing steps consequences. A preferred drying step includes vacuum annealing, pure removal in vacuo, pure heating, storage in a desiccator and freeze-drying.

The above-described method according to the invention in particular for producing a crimped stent on a catheter then preferred when the stent is selected from a degradable or a non-degradable metal stent.

One degradable or non-degradable metal stent is preferred because of these stents, the peel force especially with respect to the preferred polymers for the coating according to step c) is increased.

Degradable metal stent:

Preferably the degradable metallic material is a biocorrodible Alloy selected from the group magnesium, iron and Tungsten; In particular, the degradable metallic material a magnesium alloy.

The Alloy, in particular comprising magnesium, iron and tungsten, is to be chosen in its composition so that it is biocorrodible. As biocorrodible in the context of the present invention are alloys in which takes place in physiological environment degradation, the Ultimately, this causes the entire stent or the part of the stent formed from the material its mechanical integrity loses.

Under In the present case alloy is understood as a metallic structure, whose main component is magnesium, iron or tungsten. main component is the alloy component, its weight fraction of the alloy is highest. A proportion of the main component is preferably more than 50% by weight, more preferably more than 70% by weight.

is the material is a magnesium alloy, this contains preferably yttrium and other rare earth metals, since you have one Such alloy due to their physicochemical properties and high biocompatibilities, especially its degradation products, distinguished.

Especially preferred are magnesium alloy of the WE series, preferably WE43 etc., or magnesium alloys of the composition of rare earth metals 5.5-9.9% by weight, of which yttrium 0.0-5.5% by weight and Remainder <1% by weight Zirconium, wherein magnesium to 100 wt.% Missing share of takes the alloy. These magnesium alloys confirmed already experimentally and in their first clinical trials their special Aptitudes, d. H. they show a high biocompatibility, favorable processing properties, good mechanical characteristics and an adequate corrosion behavior for the purposes. The term "rare earth metals" is used herein to mean scandium (21), Yttrium (39), Lanthanum (57) and the 14 following on Lanthanum (57) Elements, namely cerium (58), praseodymium (59), neodymium (60), Promethium (61), Samarium (62), Europium (63), Gadolinium (64), Terbium (65), dysprosium (66), holmium (67), erbium (68), thulium (69), ytterbium (70) and lutetium (71).

Non-degradable metal stent:

Of the Basic body of a non-degradable metal stent exists preferably of a metallic material of one or more Metals selected from the group iron, magnesium, nickel, Tungsten, titanium, zirconium, niobium, tantalum, zinc or silicon and optionally a second component of one or more Metals from the group lithium, sodium, potassium, calcium, manganese, iron or tungsten, preferably of a zinc-calcium alloy. In In another embodiment, the base body consists one of the memory material of one or more materials from the group consisting of nickel-titanium alloys and copper-zinc-aluminum alloys, preferably from nitinol. In a further preferred embodiment the main body of the non-degradable metal stent Stainless steel, preferably made of a Cr-Ni-Fi steel - here prefers the alloy 316L - or a Co-Cr steel. Furthermore, the main body of the non-degradable metal stent at least partially made of plastic and / or a ceramic.

• a) einen Katheter
• b) einer Polymerschicht umfassend Polymer oder eine Mischung aus Polymer und einem oder mehreren Wirkstoffe, die mit der Oberfläche des Katheters in Kontakt steht und
• c) einem Stent, der auf dem gemäß Schritt b) beschichteten Katheter gecrimpt ist und mit dem Polymer oder der Mischung in Kontakt steht, und herstellbar nach einem vorstehenden erfindungsgemäßen Verfahren ist, anzuwenden.

The preferred embodiments of the method according to the invention for the preparation of a ge crimped stents on a coated catheter are also included in the medical device according to the invention or consisting of

• a) a catheter
• b) a polymer layer comprising polymer or a mixture of polymer and one or more active ingredients, which is in contact with the surface of the catheter and
• c) a stent which is crimped on the catheter coated according to step b) and which is in contact with the polymer or the mixture and can be prepared by an above method according to the invention.

Especially preferably has a medical device according to the invention additionally a topcoat can be produced according to step e) of the production process according to the invention on.

• – nichtresorbierbare (permanente) Polymere: Polypropylen; Polyethylen; Polyvinylchlorid; Polyacrylate, vorzugsweise Polyetyl- und Polymethylacrylate, Polymethylmetacrylat; Polymethyl-co-ethyl-acrylat, Ethylen/Ethylacrylat etc.; Polytetrafluorethylen, vorzugsweise Ethylen/Chlortrifluorethylen Copolymere, Ethylen/Tretrafluorethylen Copolymere; Polyamide, vorzugsweise Polyamidimid, PA-11, -12, -46, -66 etc.; Polyetherimid; Polyethersulfon; Poly(iso)butylen; Polyvinylchlorid; Polyvinylfluorid; Polyvinylalkohol; Polyurethan; Polybuthylenterephthalat; Silikone; Polyphosphazen; Polymerschäume, vorzugsweise aus Carbonaten, Styrolen etc.; sowie Copolymere und Elends der aufgezählten Klassen, bzw. der Klasse der Thermoplaste im Allgemeinen
• – (bio)resorbierbare (degradierbare) Polymere: Poly-dioxanon; Polyglycolid; Polycaprolacton; Polylactide, vorzugsweise Poly-L-Lactid, Poly-D,L-Lactid, und Copolymere sowie Elends wie Poly(L-Lactid-co-glycolid), Poly(D,L-lactid-co-glycolid), Poly(L-Lactid-co-D,L-Lactid), Poly(I-Lactid-co-trimethylen carbonat); Triblockcopolymere; Polyorhtoester; Polysaccharide, vorzugsweise Chitosan, Levan, Hyaluronsäure, Heparin, Dextran, Cellulose, Chondroitinsulfat etc.; Polyhydroxyvalerat; Ethylvinylacetat; Polyethylenoxid; Polyphosphorylcholin; Peptide, vorzugsweise Fibrin, Albumin, Polyhydroxybuttersäure, vorzugsweise ataktisch, isotaktisch, syndiotaktisch sowie deren Elends.

The same applies to the application of the preferred embodiments described above to the use according to the invention of a catheter with polymer layering. Thereafter, a use according to the invention is preferred which comprises a polymer layer of one or more different polymers selected from the group consisting of:

• Non-resorbable (permanent) polymers: polypropylene; polyethylene; polyvinyl chloride; Polyacrylates, preferably polyethyl and polymethyl acrylates, polymethyl methacrylate; Polymethyl co-ethyl acrylate, ethylene / ethyl acrylate, etc .; Polytetrafluoroethylene, preferably ethylene / chlorotrifluoroethylene copolymers, ethylene / tetrafluoroethylene copolymers; Polyamides, preferably polyamide-imide, PA-11, -12, -46, -66, etc .; polyetherimide; polyether sulfone; butylene poly (iso); polyvinyl chloride; polyvinyl fluoride; polyvinyl alcohol; polyurethane; polybutylene terephthalate; silicones; polyphosphazene; Polymer foams, preferably from carbonates, styrenes, etc .; as well as copolymers and blends of the listed classes, or the class of thermoplastics in general
• - (bio) resorbable (degradable) polymers: poly-dioxanone; polyglycolide; polycaprolactone; Polylactides, preferably poly-L-lactide, poly-D, L-lactide, and copolymers as well as blends such as poly (L-lactide-co-glycolide), poly (D, L-lactide-co-glycolide), poly (L-lactide-co-glycolide) Lactide-co-D, L-lactide), poly (I-lactide-co-trimethylene carbonate); tri-block copolymers; Polyorhtoester; Polysaccharides, preferably chitosan, levan, hyaluronic acid, heparin, dextran, cellulose, chondroitin sulfate, etc .; polyhydroxyvalerate; ethyl vinyl acetate; polyethylene oxide; Polyphosphorylcholin; Peptides, preferably fibrin, albumin, polyhydroxybutyric acid, preferably atactic, isotactic, syndiotactic and their misery.

Especially preferred are polylactides, preferably poly-L-lactide, poly-D, L-lactide, and copolymers and blends such as poly (L-lactide-co-glycolide), poly (D, L-lactide-co-glycolide), Poly (L-lactide-co-D, L-lactide), poly (I-lactide-co-trimethylene carbonate), and polysaccharides, preferably chitosan, levan, hyaluronic acid, Heparin, dextran, cellulose, chondroitin sulfate, as well as polypeptides, preferably fibrin and albumin.

moreover is, as already shown above, the use of an active ingredient Polymer layer is preferred, wherein the active substance (s) are selected from the group of active substances consisting of the group of lipid regulators, Immunosuppressants, vasodilators, calcium channel blockers, calcineurin inhibitors, Anti-inflammatory drugs, anti-inflammatory drugs, antiallergic drugs, oligonucleotides, Steroids, preferably estrogens, endothelium formers, proteins, peptides, Anticoagulants, analgesics, antirheumatics, angiogenesis inhibitors and cytostatics.

• a) einem oder mehreren mit Polymer oder mit einer Mischung aus Polymer und einem oder mehreren Wirkstoffen beschichteten Kathetern, wobei die Schicht so ausgestaltet ist, dass sie mit der luminalen Oberfläche eines auf den Katheter gecrimpten Stents in Kontakt stehen wird,
• b) einem oder mehreren Stents,

anzuwenden.The preferred embodiments of the method according to the invention for producing a crimped stent on a catheter are also included in the kit according to the invention or consisting of:

• a) one or more catheters coated with polymer or with a mixture of polymer and one or more active agents, the layer being designed to be in contact with the luminal surface of a stent crimped onto the catheter;
• b) one or more stents,

apply.

• a) Bereitstellung eines Katheters,
• b) Bereitstellung eines Stents,
• c) Positionierung und Crimpung des Stents auf dem Katheter und
• d) Beschichtung der Oberfläche des gecrimpten Stents, die nicht mehr mit dem Katheter in Kontakt steht, und/oder der Zwischenräumen zwischen gecrimpten Stent und Katheter mit einem oder mehreren Wirkstoffen,

können ebenfalls die bevorzugten Ausgestaltungen des beschriebenen erfindungsgemäßen Verfahrens auf die hier vorliegenden Merkmale des zweiten alternativen Verfahrens angewendet werden.With regard to the second alternative method according to the invention for producing a drug-containing crimped stent on a catheter comprising or consisting of the following steps:

• a) providing a catheter,
• b) providing a stent,
• c) positioning and crimping the stent on the catheter and
• d) coating the surface of the crimped stent that is no longer in contact with the catheter and / or the spaces between the crimped stent and catheter with one or more active agents,

For example, the preferred embodiments of the inventive method described can also be applied to the features of the second alternative method presented here.

Especially preferred is the second alternative invention Process, if the active substance (s) in step d) as a solution, Suspension, emulsion or melt.

Further preferred is the second alternative invention Procedure when coating the stent with one or more Active ingredients in step d) either together with rapidly degradable Polymers as described above, preferably glucose or in step d) no polymer is used.

The preferably suitable active ingredient groups and active ingredients which are among the above objects of the invention can also be described to the alternative second Methods are preferably used.

Especially preferred is the second alternative invention Method if the stent is degradable or non-degradable Metal stent is. The above preferred embodiments for this are also apply here.

• a) einem Katheter
• b) einem Stent, der auf den Katheter gecrimpt ist und
• c) einer Wirkstoffbeschichtung umfassend einen oder mehrere Wirkstoffe oder eine Mischung aus Polymer und einem oder mehreren Wirkstoffen auf der Oberfläche des gecrimpten Stents, die nicht mehr mit dem Katheter in Kontakt steht, und/oder den Zwischenräumen zwischen gecrimptem Stent und Katheter, dass nach einem der vorstehenden erfindungsgemäßen Verfahren herstellbar ist,

können die zu dem ersten oben beschriebenen erfindungsgemäßen Verfahren die dort beschriebenen bevorzugten Ausgestaltungen auf die hier vorliegenden Merkmale angewendet werden.Also for the medical device according to the invention comprising or consisting of:

• a) a catheter
• b) a stent which is crimped onto the catheter and
• c) an active substance coating comprising one or more active substances or a mixture of polymer and one or more active substances on the surface of the crimped stent, which is no longer in contact with the catheter, and / or the spaces between crimped stent and catheter that after a the above method according to the invention can be produced,

For example, the preferred embodiments described above for the first method according to the invention described above can be applied to the features present here.

Brief Description:

The Figures show a cross-section of a coated according to the invention Balloon catheter and a guide catheter 6F, the trackability test is used.

The However, the present invention is not limited to those shown here limited to specific embodiments.

From the figures is:

1 Cross section of a balloon catheter with inventive polymer coating and crimped stent,

2 Cross section of a balloon catheter with polymer coating according to the invention, crimped stent and subsequent active ingredient coating according to the invention,

3 Cross section of a balloon catheter with crimped stent and inventive subsequent drug coating and

4 Guide catheter 6F for use in trackability testing.

1 shows a balloon catheter 1 in cross section. This is according to the invention with a polymer 3 coated. In a preferred embodiment, the polymer 3 According to the invention also comprise one or more active ingredients.

If the polymer 3 For the purposes of the present invention, the one or more active ingredients can be administered a "single dose." In this case, the active ingredient (s) may only be present for a short period of time, preferably over a short period of time, due to its relatively short or narrow therapeutic window the period in which the active substance-containing catheter is present in the respective organism, that is, from introduction of the catheter until removal of the catheter from the organism, to the organism, preferably human or animal.

in the Meaning of the present invention is under the term "single dose" also to subsume an active ingredient coating with glucose, whereby there is a possibility that glucose and an or several active substances adhere to the vessel wall and so over a period of 2 to 30 minutes, so longer as the residence time of the balloon catheter in the organism, for provide a drug release.

Further shows 1 a cross section of a stent 2 pointing to the balloon catheter 1 , in the area in which the polymer coating according to the invention 3 is present on the surface is crimped (medical device).

The advantage of such a medical device according to the invention is that due to the polymer layer according to the invention 3 the stent 2 an increased peel force on the balloon catheter compared to a non-coated catheter 1 has. The preferred embodiments are given above in the description.

2 shows an inventive medical device consisting of balloon catheter 1 , Polymer layer 3 and stent 2 , as in 1 described.

In addition, the medical device in 2 a subsequent drug coating 4 on. The active substance 4 is in the area on and between the stent struts 21 of the stent 2 arranged and stands if in contact with the polymer layer 3 on the balloon catheter 1 is coated. The active ingredient layer 4 may include one or more active agents. active ingredient layer 4 On the one hand, it can consist of pure active substance or comprise a polymer matrix into which the active substance (s) are incorporated, this polymer matrix then preferably degrading rapidly. The possible embodiments thereof are given above in the description.

One Advantage of the embodiment of the invention is in that in subsequent drug coating of a on a balloon catheter crimped stent increased Amount of drug compared to a stent coated with drug, before the stent is crimped onto the catheter.

3 shows a cross section of a balloon catheter 1 on the one stent 2 is crimped (medical device). In the cross-sectional representation are only the webs 21 of the stent 2 to see.

In contrast to the balloon catheters according to 1 and 2 points the balloon catheter in 3 no polymer coating 3 on.

However, that shows in 3 shown medical device further an active ingredient coating 4 on the stent 2 or between the bridges 21 and the balloon catheter 1 is arranged.

The preferred embodiments of the drug coating 4 are already in 2 or shown above in the description.

The advantage of the medical device 3 compared to medical devices of the prior art is that an increased amount of drug for "single dose" during and after implantation of the stent can be released and thus the vascular resistance of the released drugs can be reduced and thus the adhesive force of the crimped stent is sufficient not to Position on the balloon catheter to be changed.

4 shows a guide catheter 6F with the corresponding length dimensions. This guide catheter 6F is used in the trackability test according to Example 1 of the present specification.

The The present invention will now be described by way of example describes in particular features, details and Advantages of the invention result from this. The present invention however, is not limited to the embodiment.

Trackability exam

Materials:

• - Mg stent 3.0 / 13
• - Catheter: LektonMotion 3.0 / 15
• Methanol / rapamycin solution 5 g / l

Case A:

• - Spraying the stent by means of AirBrush method
• - Manual crimping / crimping tool

Case B:

• - Manual crimping / crimping tool
• Coating the catheter with crimped on it stent

General trackability test arrangement for a coating according to case A and B:

• 1) Verwendung der aufgebauten Trackstrecke (siehe 4; Führungskatheter 6F) und des beiliegenden Führungsdrahtes (Galeo Hydro HF014)
• 2) Lösungen: PBS (pH 7,4), dest. Wasser (Reinwasseranlage, Raum 1.053), dest. Wasser/Methanol (1/1) werden im 37°C Wärmeschrank gelagert (250 ml Schott Glasgefäße)
• 3) Spülen des Führungskatheters mit dest. Wasser/Methanol (1/1, 37°C, 1 Spritze á 12 ml) und anschließend mit dest. Wasser (37°C, 3 Spritzen á 12 ml) um Methanol restlos aus dem Führungskatheter zu entfernen.
• 4) Spülen und vollständiges Befüllen des Führungskatheters mit PBS (37°C, 2 Spritzen á 12 ml zum Spülen, 1 Spritze á 12 ml zum langsamen Befüllen)
• 5) Führungsdraht in den gereinigten und PBS-befüllten Führungskatheter einbringen
• 6) Protector vom Ballonkatheter entfernen
• 7) Einbringen des Führungsdrahtes in den Ballonkatheter
• 8) Durchführung der Trackability über gleichmäßiges und kontinuierliches Vorschieben des Ballonkatheters; Die Zeit zum Durchqueren der Trackstelle muss aufgenommen werden und sollte 1 min betragen. Für jeden Stent ist dies zu protokollieren
• 9) Vorschieben des Ballonkatheters etwa 10 cm aus dem Führungskatheter heraus
• 10) Zurückziehen des Führungsdrahtes aus dem Ballonkatheter
• 11) Umgehendes Trocknen des noch auf den Ballonkatheter gecrimpten Stents mit dem Heißluftgebläse „Steinel HL2305 LCD, thermo control electronic": Einstellung des Gebläses auf etwa 60°C–70°C, niedrigste Gebläsestufe, Abstand vom Stent etwa 10 cm–15 cm; Den Stent unter schwenken des Gebläses etwa 1 min von allen Seiten restlos trocknen.
• 12) Anschluss der Pumpe am Ballonkatheter und trockenes, gleichmäßiges Dilatieren des Stents bis Nominaldruck (abhängig vom Ballonkatheter), bis volle Öffnung des Stents erfolgt ist (für SEAMS: 8 bar)
• 13) Trockenes Glasgefäß No. 1 (4,5 ml Glasvial, spülmaschinensauber oder neu, Schraubverschluss mit Septum) mit der Beschriftung „Stentnummer/Wirkstoffname/Stent" (mit Tesafilm überkleben) unter den Ballon mit dem darauf gecrimpten Stent halten
• 14) Deflation des Ballons und vorsichtiges Abschieben des Stents vom Ballon und Aufbewahrung im trockenen Glasgefäß No. 1 (s. o.). Möglichst nicht den Ballon berühren. Bei Zuhilfenahme von „Abschiebhilfen" diese bitte im Protokoll vermerken. Zusätzlich sollte die Adhäsionskraft des Stents auf dem Ballon dokumentiert werden (Stent klebt/klebt nicht)
• 15) Ballon gründlich in 1 ml Methanol schwenken (4,5 ml Glasvial No. 2; 4,5 ml Glasvial, spülmaschinensauber oder neu, Schraubverschluss mit Septum) Beschriftung „Stentnummer/Wirkstoffname/Ballon" (mit Tesafilm überkleben)
• 16) Ballonkatheter vor dem Zurückziehen durch den Führungskatheter mit einem fusselfreien Labortuch sauber abreiben
• 17) Neue Trackability-Prüfung mit dem gleichen Wirkstoff: Weiter bei Punkt 4)
• 18) Neue Trackability-Prüfung mit anderem Wirkstoff: Weiter bei Punkt 3)
• 19) Letzte Trackability-Prüfung: Punkt 3) zum Reinigen durchführen und den Führungskatheter mit dest. Wasser befüllt belassen.

The trackability exam will be referred to below with reference to 4 described.

• 1) Use of the constructed track track (see 4 ; Guide catheter 6F) and the enclosed guidewire (Galeo Hydro HF014)
• 2) Solutions: PBS (pH 7.4), dist. Water (pure water system, room 1.053), dist. Water / methanol (1/1) are stored in a 37 ° C oven (250 ml Schott glass jars)
• 3) Rinse the guide catheter with dist. Water / methanol (1/1, 37 ° C, 1 syringe á 12 ml) and then with dist. Water (37 ° C, 3 syringes á 12 ml) to remove methanol completely from the guide catheter.
• 4) Rinse and completely fill the guide catheter with PBS (37 ° C, 2 syringes á 12 ml for rinsing, 1 syringe á 12 ml for slow filling)
• 5) Insert the guidewire into the cleaned and PBS-filled guide catheter
• 6) Remove the protector from the balloon catheter
• 7) Insert the guide wire into the balloon catheter
• 8) performing trackability on uniform and continuous advancement of the balloon catheter; The time to traverse the track point must be recorded and should be 1 min. This should be logged for each stent
• 9) Advance the balloon catheter about 10 cm out of the guide catheter
• 10) Retract the guidewire from the balloon catheter
• 11) Immediate drying of the stent crimped onto the balloon catheter with the hot air blower "Steinel HL2305 LCD, thermo control electronic": Setting the blower to about 60 ° C-70 ° C, lowest blower level, distance from the stent about 10 cm-15 cm; Allow the stent to completely dry for about 1 minute while panning the fan.
• 12) Connection of the pump to the balloon catheter and dry, even dilatation of the stent to nominal pressure (depending on the balloon catheter) until full opening of the stent has occurred (for SEAMS: 8 bar)
• 13) Dry glass jar no. 1 (4.5 ml glass vial, dishwasher-clean or new, screw cap with septum) labeled "stent number / drug name / stent" (pasting over with tesa film) under the balloon with the stent crimped onto it
• 14) Deflation of the balloon and careful removal of the stent from the balloon and storage in a dry glass jar. 1 (see above). If possible do not touch the balloon. When using "deportation aids", please note these in the protocol.In addition, the adhesive force of the stent should be documented on the balloon (stent does not stick / stick)
• 15) Swirl the balloon thoroughly in 1 ml of methanol (4.5 ml glass vial No. 2, 4.5 ml glass vial, dishwasher-clean or new, screw cap with septum) Labeling "Stent number / active ingredient name / balloon" (cover with Tesafilm)
• 16) Clean the balloon catheter thoroughly with a lint-free lab towel before retraction through the guide catheter
• 17) New trackability test with the same active substance: Go to point 4)
• 18) New trackability test with other active substance: continue with point 3)
• 19) Last trackability check: point 3) to clean and guide the guide catheter with dist. Leave water filled.

Trackability exam for the coating according to case A:

First the mass of the stent ml is weighed, then the mass of the coated stent m2 determined. The difference m2 - m1 becomes the active ingredient mass determined. If the coating in case A was the raw mass of the Stents m1 = 8.683 mg and the mass of the drug-only coated Stents m2 was 8.910 mg. This results in a drug mass of 22.698 μg.

For the present coating according to case A gives Accordingly, an amount of active ingredient in glass vessel 1 with 4.5395 μg and an amount of active ingredient in vessel 2 with 0.7860 μg. The total amount of active ingredient applied to the vessel is therefore 5.3255 μg.

Trackability exam for the coating according to case B:

For the present coating according to case B yields Accordingly, an amount of active ingredient in glass vessel 1 with 3.2895 μg and an amount of active ingredient in vessel 2 with 19.1725 μg. The applied in the vessel Total active substance amount is therefore 22.4620 μg.

in the direct comparison of the total active substance amounts of a coating in case B with an amount of active ingredient according to a Coating according to case A can thus be seen that the inventive Coating after Case B an approximately 400% increased amount of active ingredient achieved in the vessel.

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• US 7004968 [0022]

Claims (19)

Method of making a crimped stent on a coated catheter comprising or consisting of the following steps: a) providing a catheter, b) Provision a stent, c) coating the catheter on the surface, the is in contact with the luminal surface of the stent, with a polymer or with a mixture of polymer and a or more active substances and d) positioning and crimping of the stent on the surface of the catheter attached to the Polymer or the mixture of step c) at least partially coated is. Process according to claim 1, characterized in that the polymer is selected from step c) is made of one or more different polymers from the Group consisting of - non-absorbable (permanent) Polymers: polypropylene; polyethylene; polyvinyl chloride; polyacrylates, preferably polyethyl and polymethyl acrylates, polymethyl methacrylate; Polymethyl co-ethyl acrylate, ethylene / ethyl acrylate, etc .; polytetrafluoroethylene, preferably ethylene / chlorotrifluoroethylene copolymers, ethylene / tetrafluoroethylene copolymers; Polyamides, preferably polyamide-imide, PA-11, -12, -46, -66 etc .; polyetherimide; polyether sulfone; butylene poly (iso); polyvinyl chloride; polyvinyl fluoride; polyvinyl alcohol; polyurethane; polybutylene terephthalate; silicones; polyphosphazene; Polymer foams, preferably from carbonates, styrenes, etc .; as well as copolymers and blends of the enumerated Classes, or the class of thermoplastics in general and - (bio) absorbable (degradable) polymers: poly-dioxanone; polyglycolide; polycaprolactone; Polylactides, preferably poly-L-lactide, poly-D, L-lactide, and copolymers and blends such as poly (L-lactide-co-glycolide), poly (D, L-lactide-co-glycolide), Poly (L-lactide-co-D, L-lactide), poly (I-lactide-co-trimethylene carbonate); tri-block copolymers; Polyorhtoester; Polysaccharides, preferably Chitosan, levan, hyaluronic acid, heparin, dextran, cellulose, Chondroitin sulfate, etc .; polyhydroxyvalerate; ethyl vinyl acetate; polyethylene oxide; Polyphosphorylcholin; Peptides, preferably fibrin, albumin, polyhydroxybutyric acid, preferably atactic, isotactic, syndiotactic and their misery. A method according to claim 1 or 2, characterized in that the one or more active ingredients in step c) are selected from the group consisting of lipid regulators, Immunosuppressants, vasodilators, calcium channel blockers, calcineurin inhibitors, Anti-inflammatory drugs, anti-inflammatory drugs, antiallergic drugs, oligonucleotides, Estrogens, endothelium formers, steroids, proteins, peptides, anticoagulants, analgesics, Antirheumatics, angiogenesis inhibitors, cytostatic drugs. Method according to one of the preceding Claims further comprising or consisting of the following Step: e) coating the stent in the crimped form the catheter with one or more active substances or with a Mixture of polymer and one or more active ingredients. A method according to claim 4, characterized in that the active substance (s) in step e) is used as a solution, Suspension, emulsion or melt. A method according to claim 4 or 5, characterized in that for the coating of the stent in step e) no polymer or a rapidly degradable polymer is used. Method according to one of the claims 4 to 6, characterized in that the one or more active ingredients in Step e) are selected from the group consisting of Lipid regulators, immunosuppressants, vasodilators, calcium channel blockers, Calcineurin inhibitors, anti-inflammatory drugs, anti-inflammatory drugs, antiallergic drugs, Oligonucleotides, estrogens, endothelium formers, steroids, proteins, Peptides, anticoagulants, analgesics, antirheumatics, angiogenesis inhibitors, Cytostatics. Method according to one of the preceding Claims, characterized in that the stent is degradable or a non-degradable metal stent. Medical device comprising or consisting of a) a catheter, b) a polymer layer comprising polymer or a Mixture of polymer and one or more active ingredients with the surface of the catheter is in contact and c) a stent coated on the according to step b) Catheter is crimped and in contact with the polymer or the mixture stands, producible according to one of the methods according to claims 1 to 8. Use one with polymer or with a mixture polymer and one or more active agent coated catheters, characterized in that the polymer layer is configured is that with the luminal surface of one on the Catheter crimped stents will be in contact for improvement the peel force of the crimped stent from the catheter. Use according to claim 10, characterized in that the polymer is selected one or more different polymers from the polysaccharide group consisting of non-resorbable (permanent) polymers: polypropylene; polyethylene; polyvinyl chloride; Polyacrylates, preferably polyethyl and polymethyl acrylates, polymethyl methacrylate; Polymethyl co-ethyl acrylate, ethylene / ethyl acrylate, etc .; Polytetrafluoroethylene, preferably ethylene / chlorotrifluoroethylene copolymers, ethylene / tetrafluoroethylene copolymers; Polyamides, preferably polyamide-imide, PA-11, -12, -46, -66, etc .; polyetherimide; polyether sulfone; butylene poly (iso); polyvinyl chloride; polyvinyl fluoride; polyvinyl alcohol; polyurethane; polybutylene terephthalate; silicones; polyphosphazene; Polymer foams, preferably from carbonates, styrenes, etc .; as well as copolymers and blends of the enumerated classes, or the class of thermoplastics in general and (bio) absorbable (degradable) polymers: poly-dioxanone; polyglycolide; polycaprolactone; Polylactides, preferably poly-L-lactide, poly-D, L-lactide, and copolymers as well as blends such as poly (L-lactide-co-glycolide), poly (D, L-lactide-co-glycolide), poly (L-lactide-co-glycolide) Lactide-co-D, L-lactide), poly (I-lactide-co-trimethylene carbonate); tri-block copolymers; Polyorhtoester; Polysaccharides, preferably chitosan, levan, hyaluronic acid, heparin, dextran, cellulose, chondroitin sulfate, etc .; polyhydroxyvalerate; ethyl vinyl acetate; polyethylene oxide; Polyphosphorylcholin; Peptides, preferably fibrin, albumin, polyhydroxybutyric acid, preferably atactic, isotactic, syndiotactic and their misery. Use according to claim 10 or 11, characterized in that the one or more active ingredients selected are selected from the group consisting of lipid regulators, immunosuppressants, Vasodilators, calcium channel blockers, calcineurin inhibitors, antiphlogistics, Anti-inflammatory drugs, antiallergic drugs, oligonucleotides, estrogens, endothelial agents, Steroids, proteins, peptides, anticoagulants, analgesics, antirheumatics, Angiogenesis inhibitors, cytostatic agents. Kit comprising or consisting of: a) one or more with polymer or with a mixture of polymer and one or more drugs coated catheters, wherein the layer designed so that they are with the luminal surface a stent crimped onto the catheter will be in contact, b) one or more stents. Process for the preparation of an active substance-containing crimped stents on a catheter comprising or consisting of following steps: a) providing a catheter, b) Providing a stent, c) positioning and crimping of the stent on the catheter and d) coating the surface the crimped stent which is not in contact with the catheter, and / or the spaces between crimped stent and catheter with one or more active substances or with a mixture of Polymer and one or more active ingredients. A method according to claim 14, characterized in that the active substance (s) in step d) are used as a solution, Suspension, emulsion or melt. A method according to claim 14 or 15, characterized in that for the coating of Stents in step d) no polymer or a rapidly degradable Polymer is used. Method according to one of the claims 14 to 16, characterized in that the one or more active ingredients be selected from the group consisting of: Lipid regulators, Immunosuppressants, vasodilators, calcium channel blockers, calcineurin inhibitors, Anti-inflammatory drugs, anti-inflammatory drugs, antiallergic drugs, oligonucleotides, estrogens, Endothel producers, steroids, proteins, peptides, anticoagulants, Analgesics, antirheumatics, angiogenesis inhibitors, cytostatic drugs. Method according to one of the claims 14 to 17, characterized in that the stent is degradable or a non-degradable metal stent. Medical device comprising or consisting of a) a catheter, b) a stent crimped on the catheter is and c) an active substance coating comprising one or more Active ingredients or a mixture of polymer and one or more Active ingredients on the surface of the crimped stent, the not in contact with the catheter, and / or the interstices between crimped stent and catheter producible after one the method according to claims 14 to 18th