Device comprising an active-substance-releasing system

Abstract

The invention relates to a device comprising an implant, in particular in the form of a stent, which can be expanded into an implanted state, wherein the device also has an active-substance-releasing system, which is or can be connected at least partially or in regions to the implant and can be introduced into the body of the patient separately or together with the implant in a compressed insertion state, in particular minimally invasively, and can be expanded at the implantation site into an implanted state. According to the invention, it is provided in particular that the active-substance-releasing system is designed in such a way that it is not subjected to any or at least substantially not to any non-linear elastic and / or plastic deformation during the expansion of the implant at the implantation site and / or during the expansion of the active-substance-releasing system at the implantation site and during the associated change in shape of the implant and / or of the active-substance-releasing system.

Description

[0001] November 17, 2025 devie medical GmbH A / FIG-023-PC

[0002] TR

[0003] DEVICE WITH AN ACTIVE INGREDIENT RELEASE SYSTEM

[0004] Description

[0005] The present invention is in the field of cardiac surgery and cardiology and relates to a device with a drug-free delivery system. The device is suitable, among other things, for the treatment and / or replacement of a heart valve affected by inflammation and / or infection.

[0006] The invention is particularly suitable for releasing active substances locally, i.e. at a specific location, a specific structure, in particular anatomical structure or into a compartment in order to treat this / this with the active substance or substances, for example in contrast to systemic treatment by oral or intravenous application.

[0007] In particular, the present invention relates generally to drug-release delivery systems for active substances, for example for the treatment of inflammation and especially bacterial infectious diseases.

[0008] According to embodiments of the present invention, it relates to an implant with a drug-releasing system, in particular for treating a heart valve of a patient that is diseased with inflammation and / or infection. However, the invention is not limited to such drug delivery systems for treating an inflamed and / or infected heart valve.

[0009] There are four valves in native hearts that serve to direct blood flow through the two sides of the heart in a forward direction. On the left (systemic) side of the heart are the mitral valve, located between the left atrium and the left ventricle, and the aortic valve, located between the left ventricle and the aorta. These two valves direct oxygen-rich blood coming from the lungs through the left side of the heart and into the aorta for distribution throughout the body. On the right (pulmonary) side... MEISSNER BOLTE A / FIG-023-PC

[0010] On the right side of the heart are the tricuspid valve, located between the right atrium and the right ventricle, and the pulmonary valve, located between the right ventricle and the pulmonary artery. These two valves direct deoxygenated blood, which comes from the body, through the right side of the heart and into the pulmonary artery for distribution to the lungs, where it is re-oxygenated to begin the cycle again.

[0011] All four of these heart valves are passive structures in that they do not expend any energy themselves and perform no active contractile function. They consist of movable "leaflets," sometimes also called "leaflets," which are designed to simply open and close in response to different pressures on each side of the valve. The mitral and tricuspid valves are called "atria-ventricular valves" because of their location between an atrium and a ventricle on each side of the heart. The mitral valve has two leaflets, and the tricuspid valve has three. The aortic and pulmonary valves are described as "crescent-shaped valves," which are appropriately called "leaflets." The aortic and pulmonary valves each have three leaflets.

[0012] Endocarditis is an inflammation of the inner lining of the heart (endocardium), which lines the heart chambers and the portions of the arteries and veins near the heart, and also forms the structure of the heart valve leaflets. Numerous microorganisms can cause endocarditis—especially gram-positive bacteria such as streptococci, enterococci, and staphylococci. When these bacteria colonize the endocardium during bacteremia, infectious endocarditis develops.

[0013] Depending on the type of trigger, a fatal consequence of endocarditis occurs in approximately 25% of cases.

[0014] One current treatment option for endocarditis is the surgical removal of the inflamed heart valve and the implantation of an artificial or replacement heart valve. This typically involves complex and costly operations that place a significant burden on the patient and carry considerable risks. Specifically, the patient's chest is opened, the heart is stopped using a cardioplegic solution, the patient's own heart valve is removed, and a MEISSNER BOLTE A / FIG-023-PC valve is implanted in its place.

[0015] 3. An artificial heart valve is sewn onto the body's own tissue. Newer methods, as described in WO 2006 / 076890 Al, involve transcatheter implantation of artificial heart valves using a stent as a support structure, but these are only suitable for degenerated aortic valve diseases.

[0016] For inflamed heart valves with bacterial growths, deposits, or growths in the form of larger vegetations, only surgical procedures are currently applicable. These procedures involve removing the infected, inflamed material in the surrounding tissue of the heart valve, as well as the heart valve itself, and then suturing in an artificial heart valve. Catheter-based valve implantations are contraindicated in cases of inflamed heart valves because, as mentioned above, the inflamed material cannot be removed using this method.

[0017] However, surgical procedures, which are used in 75% of cases of endocarditis (25% are not operated on because the patients are either no longer candidates for surgery or because the inflammation is mild), are particularly risky. This is because patients with endocarditis usually have significant comorbidities related to the inflammation of the heart valves, such as embolizations to the brain, kidneys, skin, and other organs. Furthermore, patients often undergo emergency surgery while septic, meaning they have high fever, inflammation-related complications, and a damaged valve that has led to heart failure.

[0018] To enable targeted, interventional therapy, for example for a heart suffering from endocarditis, it is known, for example from publication WO 2016 / 045 808 Al, to insert an implant consisting of a stent system with an expandable stent and a replacement heart valve attached to the stent into the patient's body and release it at the implantation site on the patient's heart.

[0019] Document WO 2016 / 045 808 Al proposes that the implant incorporates a drug-releasing system through which antimicrobial agents are released at the implantation site once the implant is in place. This drug-releasing system, known from the prior art, features a skirt area containing a substance-filled MEISSNER BOLTE A / FIG-023-PC

[0020] 4

[0021] The chamber is designed in such a way that the substance contained in the chamber can be released into the surrounding tissue when the implant is in its implanted state.

[0022] The drug-releasing system of the implant known from the prior art, designed as an apron area, has a basic shape that is rotationally symmetrical in the broadest sense.

[0023] Other implantable drug-free systems are also known from medical technology, which also generally have a rotationally symmetrical basic shape, such as cylindrical implant pins, ring-shaped implants, tubular, tube-shaped or mushroom-shaped stents, tubular shunts, disc-shaped, hemispherical, sphere-shaped or dumbbell-shaped occluders, ring-shaped or regularly polygonal prostheses, for example heart valve prostheses, tubular urethral catheters, etc.

[0024] To insert these implants or the corresponding drug-releasing systems, insertion systems or insertion aids are usually used that have a round or rotationally symmetrical cross-section.

[0025] Often, the implants with the drug-releasing systems must be shaped into a delivery form before or during insertion into a patient's body, for example to reduce the diameter or cross-section of the implant and the drug-releasing system, so that insertion, especially into a blood vessel or body orifice of the patient, is facilitated or even made possible.

[0026] Particularly in the fields of cardiac surgery and cardiology, it is common to use self-expanding or balloon-expandable stents or heart valve prostheses in this context. With these implants, the delivery shape is created by radial compression from a pre-mold, i.e., a mold created during manufacturing or a final shape. With non-self-expanding implants, the delivery shape is often transformed into the final implanted shape by radial expansion, for example, using a balloon catheter. MEISSNER BOLTE A / FIG-023-PC

[0027] 5

[0028] It is often necessary or advantageous to incorporate drug-releasing systems into such implants or implant-like structures, for example, other materials in the form of films, membranes, tiles, fabrics, knitted or felted structures, or plates, to impart different or additional properties to at least part of the implant. These can include, among other things, improved sealing to tissue, blood, or other bodily fluids; promoting implant integration or reducing / preventing rejection; separating compartments; reducing or increasing friction; releasing drugs; modulating the body's biological functions; or inhibiting or promoting microbial growth.

[0029] These materials can be applied to the implants using various methods, such as spray or dip coating, spinning processes such as solvent, melt or electrospinning, adhesive bonding, simple adhesion, mechanical connectors, welding, etc.

[0030] When the implant with the drug-releasing system is placed in a delivery mold and its cross-section changes, its circumference also changes, often accompanied by a change in the macroscopic and / or microscopic surface, particularly the geometric surface, i.e., the "geometric surface, especially the geometric surface," for example, through deformation or compression of struts, as well as the closure of cells or cell-like structures. The materials of a drug-releasing system that are attached or affixed to the implant, at least in certain areas, are part of the implant; that is, they are attached or affixed to its surface, particularly its geometric surface, by means of material, force, form, and / or frictional bonding, and are moved, compressed, or expanded during the transfer into the delivery mold with its different cross-section and circumference.

[0031] Unless the material is particularly thin, stretchable, or elastic, the larger surface area of ​​the base mold must be accommodated on a smaller surface area of ​​the feed mold. MEISSNER BOLTE A / FIG-023-PC

[0032] 6

[0033] This results in the formation of regular or irregular folds, creases, thickenings, bulges, deformations, especially plastic deformations, etc., during compression, and cracks, stretchings, taperings, deformations, especially plastic deformations, etc., during expansion. These can negatively affect the material properties or cause problems when transferring the feed mold back into the implanted shape.

[0034] Negative effects can include, in particular: altered release of applied or embedded active ingredients, undesired permeability due to the formation of cracks, wrinkles, pores or undesired impermeability due to the blockage of pores, a reduction or increase in frictional forces and other surface properties, etc.

[0035] In cases where the material used to attach or support a drug-releasing system is adversely affected due to its properties, geometric requirements, or other design constraints, there is currently no technical solution for attaching it to the implants or implant-like structures described above without altering the properties of the drug-releasing system. In such cases, it is necessary to use alternative materials, reduce layer thicknesses, or accept compromises or limitations regarding the desired properties.

[0036] For example, in the case of implants (e.g., heart valve prostheses) for the treatment of existing native endocarditis, or prosthetic endocarditis, or also for the prophylaxis of endocarditis by implanting a drug-eluting heart valve, drug quantities may be necessary that do not allow for a very thin layer simply because of the required amount of substance, or that are not stretchable / elastic or only conditionally stretchable / elastic due to the release matrix-drug combination.

[0037] In this case, using the example of a heart valve prosthesis inserted via catheter, a drug-eluting layer attached to the prosthesis / holder would be necessary, covering a cylindrical area. A dip coating would be folded and / or crushed and damaged during transfer into a delivery mold (e.g., radial compression by crimping). The surface, especially the geometric surface, and possibly even MEISSNER BOLTE A / FIG-023-PC, would be affected.

[0038] 7. The bulk material would be altered or damaged, leading to poorer sealing, altered drug release, persistent deformations, different surface properties, etc.

[0039] The technical problem, therefore, lies in adapting / attaching and positioning the described materials of a drug-releasing system and processing methods for materials, especially those that are not or only slightly elastic (e.g., polymer-drug combinations) and have flat geometries (films, foils, nonwovens, membranes, layers, including laminated layers, plates, etc.) to rotationally symmetrical implants in such a way that a planar presentation of this material may be desirable or advantageous (e.g., planar release of an active ingredient), such that the materials can accommodate / follow / enable the changes in circumference or cross-section of the implant during its compression and / or expansion or re-expansion without suffering damage to their geometry and properties.

[0040] In particular, the drug-releasing layer systems do not necessarily have to be connected to the implant, which is designed as a stent or carrier material. Therefore, the drug-releasing layer systems must be adapted and / or positioned to the implants in such a way, for example, by frictional engagement, that the materials of the drug-releasing layer system accommodate / follow / enable the changes in circumference or cross-section of the implant during its compression and / or expansion or re-expansion without suffering damage to their geometry and properties. The invention also specifically includes embodiments in which the drug-releasing layer systems are not connected to the implant or a carrier system of the implant by force-fit and / or form-fit.

[0041] Based on the problem described above, the present invention aims to provide an optimized drug-release delivery system for active ingredients in which the drug release mechanism is not, or at least not substantially, affected by the fact that the system can be inserted into the patient's body in a compressed state and expanded there. In particular, the system should also be capable of, with reference to MEISSNER BOLTE A / FIG-023-PC

[0042] 8. Its size allows it to deliver the largest possible amount of active ingredient into the patient's body.

[0043] Therefore, there is a need for appropriate materials and processing methods for materials that are suitable as drug-releasing systems and that are not or only slightly elastic, such as polymer-drug combinations, and that have a flat geometry (films, foils, nonwovens, membranes, layers, laminated layers, sheets, etc.).

[0044] This problem is solved in particular by the subject matter of the independent patent claims, with advantageous further developments of the device according to the invention being specified in the dependent claims.

[0045] According to a first aspect of the invention, the problem underlying the invention is solved by a device which has an implant, in particular in the form of a stent, which can be inserted into the body of a patient in a compressed insertion state, particularly in a minimally invasive manner, and which can be expanded into an implanted state at the implantation site, wherein the device further has a drug-releasing system which is at least partially or partially connected or connectable to the implant and can be inserted into the body of the patient separately or together with the implant in a compressed insertion state, particularly in a minimally invasive manner, and which can be expanded into an implanted state at the implantation site.

[0046] According to the invention, it is particularly provided that the drug-releasing system is designed in such a way that, during the expansion of the implant at the implantation site and / or during the expansion of the drug-releasing system at the implantation site and during the associated change in shape of the implant and / or the drug-releasing system, it is not subjected to any or at least substantially no non-linear elastic and / or plastic deformation.

[0047] According to implementations of the device according to the invention, it is provided that the drug-releasing system, at least in the implanted state of the drug-releasing system and preferably both in the compressed insertion state and in the implanted state of the drug-releasing system, has a MEISSNER BOLTE A / FIG-023-PC

[0048] 9. Drug-releasing surface, in particular geometric surface, of at least 1.5 cm² 2, preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 2.5 cm² 2 , preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 3.5 cm² 2 , and even more preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 5 cm² 2 exhibits, and / or wherein the drug-releasing system has a drug-releasing surface, in particular a geometric surface, of up to approximately 50.0 cm² 2 exhibits.

[0049] This makes it possible in particular for the drug-releasing system to contain at least 0.5 mg of active ingredient, preferably at least 2 mg of active ingredient and even more preferably at least 5 mg of active ingredient, and / or wherein the drug-releasing system contains up to about 500 mg of active ingredient.

[0050] According to a second aspect of the invention, the problem underlying the invention is solved by a device which has an implant, in particular in the form of a stent, which can be inserted into the body of a patient in a compressed insertion state, particularly in a minimally invasive manner, and which can be expanded into an implanted state at the implantation site, wherein the device further has a drug-releasing system which is at least partially or partially connected or connectable to the implant and can be inserted into the body of the patient separately or together with the implant in a compressed insertion state, particularly in a minimally invasive manner, and which can be expanded into an implanted state at the implantation site.

[0051] In particular, it is provided that the active ingredient-releasing system has at least one layer system, in particular at least partially or in certain areas, and preferably several layer systems, in particular at least partially or in certain areas, wherein the layer system, in particular at least partially or in certain areas, and preferably each of the layer systems, in particular at least partially or in certain areas, is designed as an active ingredient-releasing layer system.

[0052] In particular, the device for sealing the implant at the implantation site and / or for connecting a replacement heart valve, especially in the form of MEISSNER BOLTE A / FIG-023-PC, features

[0053] 10 a percutaneous or surgical heart valve, on the implant or on a support structure associated with the implant, preferably a skirt structure connected to the implant and / or to the support structure associated with the drug-releasing system.

[0054] The skirt structure is essentially a seal or cuff made of biological tissue or a special plastic, such as a woven fabric, nonwoven fabric, or membrane. The purpose of the skirt structure is twofold: first, to prevent blood from leaking around the artificial heart valve by sealing the space between the stent and the patient's own heart valve leaflets; and second, to serve as a retention structure, for example, to ensure the tight fixation of the heart valve leaflets. This seal is crucial for the proper functioning of the new heart valve.

[0055] Furthermore, the skirt structure can serve, alone or together with other structures of a prosthesis, to compartmentalize or delimit a spatial part of tissue from the lumen (e.g., blood flow in blood vessels), whereby the delimited or compartmentalized volume or tissue is treated by the drug-release delivery system and the escape of drug through the skirt structure into the lumen (e.g., blood) is prevented or largely reduced.

[0056] During implantation, the stent, along with any attached replacement heart valve and drug delivery system, is inserted into the patient's body. The skirt structure is initially folded. After the stent expands at its intended location in the heart, the skirt structure unfolds and conforms to the wall of the blood vessel or the heart valve structure.

[0057] The resulting seal prevents blood from flowing past the stent or any replacement heart valve connected to the stent, which could lead to leaks. This reduces the risk of complications such as paravalvular leaks, blood clots, and bacterial colonization.

[0058] According to preferred implementations of the device according to the invention, it is provided that the layer system of the drug-releasing system is at least in the MEISSNER BOLTE A / FIG-023-PC

[0059] 11. implanted state of the drug-releasing system and preferably both in the compressed insertion state and in the implanted state of the drug-releasing system a drug-releasing surface, in particular a geometric surface, of at least 1.5 cm² 2 , preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 2.5 cm² 2, preferably a surface that does not require the application of any active ingredient, in particular a geometric surface, of at least 3.5 cm² 2 , and even more preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 5 cm² 2 has, and / or wherein the drug-releasing system has a drug-releasing surface, in particular a geometric surface, of up to approximately 50.0 cm² 2 exhibits.

[0060] In particular, in embodiments of the invention, the layer system of the drug-releasing system comprises a drug-containing layer, in particular a polymer layer, and / or a drug-containing matrix.

[0061] It is advantageous for the active ingredient-containing layer, in particular the polymer layer, and / or the active ingredient-containing matrix of the layer system to have a particularly average thickness of at least 20 pm, preferably at least 30 pm and particularly preferably at least 50 pm, and in particular about 100 pm.

[0062] Alternatively or additionally, it is possible that the active ingredient-containing layer, in particular the polymer layer, and / or the active ingredient-containing matrix of the layer system contains at least 0.5 mg of active ingredient, preferably at least 2 mg of active ingredient and even more preferably at least 5 mg of active ingredient, and / or wherein the active ingredient-containing layer, in particular the polymer layer, and / or the active ingredient-containing matrix of the layer system contains up to about 500 mg of active ingredient.

[0063] In realizations of the device according to the invention, it is provided that the drug-releasing surface, in particular the geometric surface, of the layer system is continuous both in the compressed insertion state and in the implanted state of the drug-releasing system.

[0064] According to embodiments of the invention, it is provided that the layer system, which is particularly at least partially or partially planar, and preferably each of the particularly several, particularly at least partially or MEISSNER BOLTE A / FIG-023-PC

[0065] 12 layer systems, each with a surface area, are attached or can be attached to the implant or to a support structure of the device associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped, via the skirt structure.

[0066] Alternatively, it is provided that the layer system, which is at least partially or partially designed to cover a surface, and preferably each of the layer systems, which are at least partially or partially designed to cover a surface, is or can be attached to the implant or to a support structure of the device associated with the drug-releasing system via at least one attachment area, in particular in a point-like or line-like manner.

[0067] According to embodiments of the invention, the device is a device, in particular for treating a heart valve of a patient that is diseased with inflammation and / or infection, wherein the device has an implant which, in a compressed state or insertion state, can be inserted into the patient's body, particularly minimally invasively, and can be expanded at the implantation site, preferably at a heart valve to be treated, and wherein the device further has a drug-releasing system which is at least partially or partially connected or connectable to the implant and can be inserted into the patient's body separately or together with the implant, particularly minimally invasively, and can be expanded at the implantation site.

[0068] The invention is characterized in particular by the fact that the drug-releasing system is designed in such a way that, during the expansion of the implant at the implantation site and / or during the expansion of the drug-releasing system at the implantation site and during the associated change in shape of the implant and / or the drug-releasing system, it is not subjected to any or at least substantially no non-linear elastic and / or plastic deformation.

[0069] According to implementations of the device according to the invention, the drug-releasing system comprises at least one layer system, in particular at least partially or in certain areas planar, and preferably several MEISSNER BOLTE A / FIG-023-PC

[0070] 13 in particular having layer systems that are at least partially or partially designed to form a surface, wherein the layer system that is at least partially or partially designed to form a surface and preferably each of the layer systems that are at least partially or partially designed to form a surface is or can be attached to the implant or to a support structure of the device associated with the drug-releasing system or to the skirt structure by means of a fastening area, in particular by points or lines, or by means of a material, force, form and / or friction fastening.

[0071] In this context, it is conceivable that the layer system, which is at least partially or partially designed to cover a surface, and preferably the several layer systems of the drug-releasing system, which are at least partially or partially designed to cover a surface, are attached or can be attached to the implant or to the support structure associated with the drug-releasing system or to the skirt structure via a fastening area, in particular point- or line-shaped, in such a way that the layer system of the drug-releasing system is movable relative to the implant or to the support structure.

[0072] The mobility of the layer system of the drug-releasing system relative to the implant or the support structure is preferably selected such that longitudinal elongation or shortening of the implant or the support structure during implantation at the implantation site is possible relative to the layer system of the drug-releasing system.

[0073] Alternatively or additionally, the layer system, which is at least partially or partially designed to cover a surface, and preferably the multiple layer systems of the drug-releasing system, which are at least partially or partially designed to cover a surface, can be attached or attachable to the implant or to the support structure associated with the drug-releasing system via a fastening area, in particular point- or line-shaped, in such a way that, after the attachment of the layer system(s) of the drug-releasing system, the layer systems are at least in the compressed state or insertion state of the drug-releasing system and preferably both in the MEISSNER BOLTE A / FIG-023-PC

[0074] 14. In the compressed or inserted state, as well as in the expanded or implanted state of the drug-releasing system, a scale-like or scale-like, sequin-like or sequin-like, feather-like or feather-like and / or lamellar or lamellar structure is formed.

[0075] In embodiments of the device according to the invention, it is provided that the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, are each attached or attachable to the implant or to the support structure associated with the drug-releasing system via a fastening area, in particular point- or line-shaped, in such a way that, after the fastening of the layer systems of the drug-releasing system, at least in the compressed state or insertion state of the drug-releasing system, and preferably both in the compressed state or insertion state, as well as in the expanded state or insertion state, are able to be attached or attached in such a way that, after the fastening of the layer systems of the drug-releasing system, at least in the compressed state or insertion state of the drug-releasing system, and preferably both in the compressed state or insertion state, and in the expanded state or insertion state, the drug-releasing system is able to be attached or attached in such a way that, after the fastening of the layer systems of the drug-releasing system, at least in the compressed state or insertion state, and preferably both in the expanded state or insertion state, the drug-releasing system is able to be attached or attached in such a way that, after the fastening of the layer systems of the drug-releasing system, the drug-releasing system is attached or attached in such a way that ...implanted state of the drug-releasing system, which in particular is at least partially or partially surface-shaped layer system and preferably overlaps at least two adjacent layer systems of the drug-releasing system at least partially or partially.

[0076] In this context, it is particularly advantageous that the layer system, which is at least partially or partially designed as a surface, and preferably the multiple layer systems of the drug-releasing system, which are at least partially or partially designed as surfaces, are attached or can be attached to the implant or to the support structure associated with the drug-releasing system or to the skirt structure via a fastening area, in particular point- or line-shaped, in such a way that, after the attachment of the layer system(s) of the drug-releasing system, at least in the compressed state or insertion state of the drug-releasing system, and preferably both in the compressed state or insertion state and in the expanded state or insertion state, the layer system(s) can be attached or secured in such a way that, after the attachment of the layer system(s) of the drug-releasing system, the drug-releasing system remains attached or secured in such a way that, after the attachment of the layer system(s) of the drug-releasing system, at least in the compressed state or insertion state, and preferably both in the compressed state or insertion state and in the expanded state or insertion state, the drug-releasing system remains attached or secured in such a way that, after the attachment of the layer system(s) of the drug-releasing system, the drug-releasing system remains attached or secured in such a way that, after the attachment of the layer system(s) of the drug-releasing system, the drug-releasing system remains attached or secured in such a way that the drug-releasing system is ...implanted state of the drug-releasing system, at least two adjacent layer systems of the drug-releasing MEISSNER BOLTE A / FIG-023-PC.

[0077] 15

[0078] The system is / are arranged in a fan-like or fan-shaped manner, at least partially or in certain areas.

[0079] In this context, "arranged in a fan shape or fan-like manner" means in particular an arrangement that is similar to roof tiles – i.e., in overlapping layers or rows, as is known from a roof covering with tiles, or in particular an arrangement that is similar to fish scales – i.e., individual scale-like structures are arranged in an overlapping manner relative to each other in a movable way on a non-rigid, movable surface.

[0080] Or, for example, the leaves of a tree are regularly arranged like roof tiles to better drain rainwater. Similarly, the armadillo's shell is also structured like roof tiles.

[0081] “Arranged in a fan shape or fan-like arrangement” thus also means “overlapping like scales” and / or “arranged in layers”.

[0082] Alternatively or additionally, the layer system, which is at least partially or partially designed to cover a surface, and preferably the multiple layer systems of the drug-releasing system, which are at least partially or partially designed to cover a surface, can be attached or attachable to the implant or to the support structure associated with the drug-releasing system or to the skirt structure via a fastening area, in particular point- or line-shaped, in such a way that, when the implant and / or the drug-releasing system is expanded and / or when the implant and / or the drug-releasing system is transferred from the respective expanded or implanted state to the compressed state or insertion state, the layer system or the individual layer systems of the drug-releasing system slide / slide over each other at least partially or partially.

[0083] In particular, it is provided that the layer system, which is at least partially or partially designed to cover an entire surface, and preferably the several layer systems, which are at least partially or partially designed to cover an entire surface, MEISSNER BOLTE A / FIG-023-PC

[0084] 16. The elements of the drug-releasing system are attached or can be attached to the implant or to the support structure associated with the drug-releasing system or to the skirt structure via a fastening area, in particular point- or line-shaped, in such a way that, when the implant and / or the drug-releasing system is expanded and / or when the implant and / or the drug-releasing system is transferred from the respective expanded or implanted state to the compressed state or insertion state, the layer system or the individual layer systems of the drug-releasing system are movable relative to each other.

[0085] According to implementations of the device according to the invention, the device has a support structure associated with the drug-releasing system, with which the layer system, particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, particularly at least partially or partially planar, are attached by material, force, form and / or friction, wherein the support structure is designed to be elastic in such a way that it can be transformed from a compressed state or insertion state, particularly when the drug-releasing system is inserted into the patient's body, into an expanded or implanted state, particularly at the implantation site of the patient's body, wherein the support structure with the layer system(s) of the drug-releasing system attached thereto is particularly in the expanded or implanted state.The implanted condition of the implant is connected or connectable to the implant.

[0086] The layer system, which is particularly at least partially or in certain areas designed to cover a surface, and preferably the several layer systems of the active ingredient-releasing system, which are particularly at least partially or in certain areas designed to cover a surface, is / are preferably designed as a foil, film, membrane or as a coated or laminated panel.

[0087] Alternatively, it is conceivable that the layer system, which is at least partially or partially designed to cover an entire surface, and preferably the several layer systems of the drug-releasing system, which are at least partially or partially designed to cover an entire surface, each comprise a foil, a film, a MEISSNER BOLTE A / FIG-023-PC

[0088] 17

[0089] membrane or a particularly coated or laminated panel.

[0090] According to preferred embodiments, the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, each have a layer thickness between 10 pm and 150 pm and preferably a layer thickness between 20 pm and 200 gm.

[0091] In particular, it is provided that the layer system, which is at least partially or partially designed to cover a surface, and preferably the several layer systems of the drug-releasing system, which are at least partially or partially designed to cover a surface, are each designed to release an active ingredient in a controlled manner in the implanted state of the drug-releasing system.

[0092] "Controlled release" refers to a system for the slow and delayed release of an active ingredient over an extended period. The aim is to ensure a consistent concentration of the active ingredient in the body (and, in the case of local release into a compartment, within the compartment), which increases efficacy and reduces side effects. The release is controlled by the formulation and occurs over a predefined period.

[0093] The drug-releasing system can be specifically designed to respond to certain environmental stimuli in the body, such as pH changes, temperature, or enzymatic activity, in order to release the drug in a targeted manner.

[0094] The release rate is determined in particular to achieve an optimal therapeutic concentration and to avoid fluctuations in the concentration at the target structure, for example in the treated compartment or in the systemic circulation in the case of systemic application.

[0095] Alternatively, according to embodiments of the invention, it is provided that the layer, which is at least partially or partially planar, MEISSNER BOLTE A / FIG-023-PC

[0096] 18 system and preferably the several layer systems of the drug-releasing system, which are at least partially or partially designed to be flat, are each designed to release an active ingredient over a longer period of time in the implanted state of the drug-releasing system (Extended Release, Delayed Release).

[0097] According to implementations of the device according to the invention, the drug-releasing system has at least one planar layer, in particular in the form of a foil, a film, a membrane or a coated or laminated plate.

[0098] In this context, it is advantageous that, at least in the compressed state or insertion state of the implant and especially in the compressed state or insertion state of the drug-releasing system, the at least one planar layer of the drug-releasing system is designed, at least partially or in certain areas, as a band wound in a spiral in a plane, at least partially or in certain areas.

[0099] For example, the at least one planar layer of the drug-releasing system can be designed in such a cylindrical shape, at least partially or in certain areas, as a band wound in a spiral in a plane, at least partially or in certain areas, that during the expansion of the implant and / or the drug-releasing system at the implantation site, the diameter of the cylindrical shape of the drug-releasing system increases and / or it unwinds at least partially or in certain areas during the expansion of the drug-releasing system.

[0100] Alternatively or additionally, the at least one planar layer of the drug-releasing system – viewed in cross-section – can be designed in a loop or loop shape and have a loop-shaped area whose diameter increases during the expansion of the drug-releasing system and / or which unfolds at least partially or in certain areas during the expansion of the drug-releasing system.

[0101] According to preferred embodiments, the layer system, which is at least partially or partially planar, or the at least one planar MEISSNER BOLTE A / FIG-023-PC

[0102] 19. The executed layer of the drug-releasing system is attached to the implant or to a carrier structure associated with the drug-releasing system in a material-bonded manner, in particular by adhesive bonding or ultrasonic welding, and / or force-bonded manner, in particular by a suture, in a material-bonded, force-bonded, form-bonded and / or friction-bonded manner.

[0103] Preferably, the drug-releasing system is self-expanding. Alternatively, the drug-releasing system can also be expandable via an externally manipulable mechanism.

[0104] According to preferred embodiments of the device according to the invention, it further comprises a replacement heart valve connected or connectable to the implant, in particular in the form of a percutaneous or surgical heart valve, which is attached or can be attached to the implant or to a support structure associated with the implant by means of material, force, form and / or friction.

[0105] In summary, the principle disclosed herein represents a technical solution to the problem described at the outset, by specifying a method for attaching the aforementioned (functional, function-imparting, property-modifying) materials to implants in order to tolerate and withstand radial movements, such as compression, expansion, and re-expansion of the entire implant, without damage. This enables certain functions or functionalizations of such implants and allows certain properties to be achieved (e.g., the introduction of a large quantity of active substances into a drug-eluting valve (DEV) or a drug-free stent).

[0106] An important aspect here is local drug release: The aim is to introduce the largest possible amount of the drug onto the rotationally symmetrical outer surface of a heart valve prosthesis. Uniform, even application is advantageous for uniform drug release and is therefore desirable. Drug release often requires not only the drug itself but also a suitable release matrix, such as a polymer or a MEISSNER BOLTE A / FIG-023-PC.

[0107] 20

[0108] It can consist of a polymer mixture, although a variety of other embedding / release matrices are also conceivable.

[0109] High drug concentrations in the release matrix, especially when the embedded solid is in a solid state at room / body temperature, can significantly influence the matrix's properties. For example, when using elastic polymers as the matrix, the elasticity of the matrix-drug combination decreases considerably due to high solid concentrations.

[0110] A matrix-drug combination attached as part of or separately to an implant that is rotationally symmetrical in the broadest sense can therefore no longer be transferred undamaged from the original shape to a delivery shape or from the delivery shape to an implantation shape, unlike a pure, drug-free matrix.

[0111] However, the invention is not limited to these applications, but also relates to other applications outside of heart valves and the cardiovascular field.

[0112] According to preferred embodiments of the invention, polymer-drug films are used as drug-releasing systems, which are not connected to the rest of the implant over a surface area, but are attached tangentially as individual pieces or in individual pieces (also adapted to the design and geometry of, for example, a rotationally symmetrical polymer or metal framework in the broadest sense) by material, force, form and / or friction.

[0113] In the case of a metal or polymer stent, or a heart valve prosthesis frame constructed from metal or polymer struts, the attachment can be made to the struts or to another part or layer of the implant. The individual component(s) are attached by material, force, form, and / or friction in such a way that each component covers the attachment point of at least one adjacent component, or, in the case of a single component, is placed circumferentially around the implant so that the end of the component covers its connection point to the rest of the implant, resulting in an overall scale-like or lamellar structure (e.g., with rotational symmetry like a paddle wheel). MEISSNER BOLTE A / FIG-023-PC

[0114] 21

[0115] The number of material parts to be attached is n > 1, (if n = 1 it would be a strip / film attached at one point, a scale).

[0116] Particularly in the case of heart valves with m leaflets / cusps, it can be advantageous if n = m or n is an integer multiple of m. When the cross-section / circumference of the implant changes, for example through radial compression, expansion or re-expansion, or even through longitudinal stretching or compression, which also leads to at least a partial decrease / increase in circumference, the material pieces can slide over each other in a scale-like / lamella-like manner without forming folds, cracks, or fractures.

[0117] To prevent butt joints and allow for largely free sliding, the end of each piece of material must overlap with the attachment area of ​​the next piece of material, or, in the case of n = 1, the end of one piece of material must overlap with its own connection / attachment area on the implant.

[0118] The adaptation and alignment of the material pieces as scales / lamellae / shovels, sequins, can also occur longitudinally, for example, when implant components are folded radially. This allows the material pieces to move with the prosthesis even during axial changes such as axial curvature, without adversely affecting their mechanical or release properties (see also FIG. 4, FIG. 13).

[0119] Numerous embodiments are conceivable, which can be used individually or in combination in their respective forms and configurations. These include oblique orientations, overlaps in one dimension such as circumferential or longitudinal, or oblique to it, as well as in multiple dimensions, creating a scale-like structure similar to reptile / fish skin or, analogously, sequins.

[0120] In other embodiments, the material pieces, in the form of films, membranes, or plates, are directly connected to the implant as part of it. MEISSNER BOLTE A / FIG-023-PC

[0121] 22

[0122] In other embodiments, the material pieces are connected to the implant indirectly via intermediate pieces, films, adhesive, welding or other connections, or purely mechanically, as part of the implant, in the form of films, membranes, or plates.

[0123] In other embodiments, the material pieces / the material piece are not directly or continuously connected to the implant as films, membranes, or plates, but are connected to the implant only at a later time.

[0124] In further embodiments, the material pieces / the material piece are applied as films, membranes, plates on a permeable or impermeable support structure, which is connected to the implant in a separate (partial) step (e.g. by pulling it over like a stocking or sliding it over like a piece of tubing).

[0125] In further embodiments, the material pieces / the material piece are designed as films, membranes, plates as thin layers of different geometries (round, oval, angular, beveled, or combinations thereof), of constant thickness or tapered or thickened at the edges.

[0126] In other embodiments, the material pieces / the material piece are rigidly connected to the rest of the implant, e.g. by gluing, welding, brackets, pins, etc.

[0127] In other embodiments, the material pieces / the material piece are flexibly connected to the rest of the implant, e.g. by sewing, loops, threads, bridges, hooking, gluing, etc.

[0128] In other embodiments, the material pieces / piece are rigidly connected to the rest of the implant, e.g., by gluing, welding, clamps, pins, etc. MEISSNER BOLTE A / FIG-023-PC

[0129] 23

[0130] In further embodiments, the material pieces / the material piece are arranged circumferentially in a scale-like / lamella-like manner with n > 1 scales / lamellae (attachment / connection point tangential).

[0131] In further embodiments, the material pieces / the material piece are arranged in a scale-like / lamella-like manner with n > 1 scales / lamellae axially and circumferentially (attachment / connection point tangential).

[0132] In further embodiments, the material pieces / the material piece are attached in a scale-like / lamella-like manner with n > 1 scales / lamellae arranged circumferentially, wherein the scales are arranged in one or more stacks in the feed form and are arranged largely evenly distributed around the circumference in the implantation form.

[0133] In further embodiments, the material pieces / the material piece are attached in a scale-like / lamella-like manner with n > 1 scales / lamellae arranged in a fan shape in order to compensate for non-uniform cross-sectional / circumference changes of the implant and to achieve a flat coverage with the material pieces.

[0134] In further embodiments, the material pieces / the material piece are arranged in a scale-like / lamella-like manner with n > 1 scales / lamellae connected via structures such as threads, rails, tapes, wires or other guide devices, so that the material pieces / the material piece can be moved (shifted, also rotated) with or via these devices (like drawing a lamella curtain).

[0135] In further embodiments, the material pieces / the material piece are arranged in a scale-like / lamella-like manner with n > 1 scales / lamellae, wherein the lamellae are oriented in different directions on different axial sections (direction of rotation right / left).

[0136] In further embodiments, the material pieces / the material piece are attached in a band-like manner, the band being a closed ring which, in the implantation form, has a similar circumference to the circumference of the underlying fastening structure / the implant part and which is shown in MEISSNER BOLTE A / FIG-023-PC

[0137] 24 of a different form of implant than a loop around the implant, forming two fold areas.

[0138] In further embodiments, the material pieces / the material piece are attached in a scale-like / lamella-like manner with n > 1 scales / lamellae / bands, which are placed around the implant in a feed mold and are attached with a structure (a pin / band / slider / pin etc.) in a material-, force-, form- and / or friction-fit manner, which prevents an uncontrolled release / detachment of the material piece(s) and allows controlled expansion.

[0139] According to embodiments of the previously disclosed device according to the invention, the device further comprises at least one locking element, in particular in the form of a pin-shaped element, wherein the at least one locking element is designed to hold the implant, preferably together with the drug-releasing system, in a compressed state or insertion state, in which the implant, preferably together with the drug-releasing system, can be inserted into the patient's body, particularly in a minimally invasive manner, wherein the at least one locking element is manipulable, particularly externally, such that by manipulating the at least one locking element, the implant, preferably together with the drug-releasing system, expands, particularly at the implantation site.

[0140] In this context, it is conceivable that the device is designed to expand the implant, preferably together with the drug-releasing system, particularly at the implantation site, solely by manipulating the at least one locking element.

[0141] Alternatively or additionally, the at least one locking element may be designed to hold or fix the drug-releasing system in a fixed position relative to the implant, particularly in its compressed or inserted state, and to release the fixed position of the drug-releasing system on the implant after manipulation of the at least one locking element, so that the drug-releasing system is then movable relative to the implant. MEISSNER BOLTE A / FIG-023-PC

[0142] 25

[0143] For example, the entire stent / heart valve frame of the implant can also be held in a compressed or insertion state (delivery form) solely by means of one or more pins / pins through (a) a loop-shaped and (b) film-shaped (n> scale / s). Release then occurs by withdrawing at least one pin / pin, thereby releasing the drug-eluting system and allowing the expanding stent to unroll or unfold the film.

[0144] Preferably, the at least one locking element is further designed to hold or fix the implant in its compressed insertion state, and after manipulation of the at least one locking element, to release the holding or fixing of the compressed insertion state of the implant, so that the implant can then be transferred into an expanded state or transitions into an expanded state independently.

[0145] In embodiments of the device according to the invention, it is provided that, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device has a skirt structure connected to the implant and / or to the support structure associated with the drug-releasing system, which is arranged at least partially or in certain areas inside the implant and connected to the implant, wherein the layer system, which in particular is designed at least partially or in certain areas to cover a surface, and preferably the several layer systems of the drug-releasing system, which in particular are designed at least partially or in certain areas to cover a surface, are each attached to the skirt structure via at least one attachment area, in particular point-like or line-like.wherein the at least one attachment area extends at least partially or in sections through at least one window area or through at least one cell of the implant.

[0146] Alternatively, it may be provided that, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device MEISSNER BOLTE A / FIG-023-PC

[0147] 26. The skirt structure is connected to the implant and / or to the carrier structure associated with the drug-releasing system and is arranged at least partially or partially outside the implant and connected to the implant, wherein the layer system, which is particularly at least partially or partially designed to cover a surface, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially designed to cover a surface, are each attached to the skirt structure via at least one attachment area, in particular point- or line-shaped.

[0148] Alternatively or additionally to the aforementioned aspects, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device may have a skirt structure connected to the implant and / or to the support structure associated with the drug-eluting system, which has a first end region and an opposing second end region, wherein the first and second end regions of the skirt structure are connected to each other via a connection region, in particular a suture region, wherein the layer system, which in particular is at least partially or partially planar, and preferably the several layer systems of the drug-eluting system, which in particular are at least partially or partially planar, are each attached via at least one attachment region.in particular point- or line-shaped, attached to the skirt structure, wherein the at least one attachment area is located in or on the connection area of ​​the skirt structure.

[0149] It is advantageous in this case that the first and second end regions of the skirt structure are connected to each other via at least one axial connection region, in particular a suture region, with regard to a longitudinal extension direction of the implant, wherein the at least one axial connection region is at least partially or partially abluminally oriented.

[0150] In this context, it is particularly intended that the layer system of the drug-releasing system, which is at least partially or partially designed as a surface, is designed at least partially as a band or band section, wherein a first end area of ​​the band or MEISSNER BOLTE A / FIG-023-PC

[0151] 27

[0152] The layer system executed as a banderole or banderole section and a second end area of ​​the layer system executed as a banderole or banderole section opposite the first end area are each connected to the skirt structure in or at the connection area of ​​the skirt structure.

[0153] As an alternative to the aforementioned aspects, implementations of the device according to the invention provide that, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device has a skirt structure connected to the implant and / or to the support structure associated with the drug-releasing system, which is composed of several, in particular three, sections, in particular tissue sections, which are preferably designed separately from one another, and which are connected to each other at least partially or in certain areas via at least one connection area, in particular a suture area.wherein the layer system, which is at least partially or partially designed to be planar, and preferably the several layer systems of the drug-releasing system, which are at least partially or partially designed to be planar, are each attached to the skirt structure via at least one attachment area, in particular point- or line-shaped, wherein the at least one attachment area is arranged in or on the connection area of ​​the sections of the skirt structure.

[0154] It is advantageous for the layer system of the drug-releasing system, which is at least partially or partially designed as a surface, to be designed at least partially as a band or band section, wherein a first end region of the layer system designed as a band or band section is connected to the skirt structure at or on a first connection region of the skirt structure sections, and wherein a second end region of the layer system designed as a band or band section, opposite the first end region, is connected to the skirt structure at or on a second connection region of the skirt structure sections. MEISSNER BOLTE A / FIG-023-PC

[0155] 28

[0156] Alternatively or additionally, in realizations of the invention, it is provided that the several sections of the skirt structure are connected to each other at least partially or in certain areas via at least one axial connection area, in particular a seam area, with regard to a longitudinal extension direction of the implant, wherein the at least one axial connection area is at least partially or in certain areas abluminally oriented.

[0157] In further developments of this embodiment, it is provided that the layer system, which is at least partially or partially designed as a surface, and preferably the several layer systems of the active ingredient-releasing system, which are at least partially or partially designed as surfaces, are each attached to the at least one abluminally oriented axial connection area of ​​the skirt structure via at least one fastening area, in particular point- or line-shaped.

[0158] In this context, it is advantageous for at least one attachment area to extend at least partially or partially through at least one window area or through at least one cell of the implant.

[0159] Alternatively or additionally, in realizations of the invention, it is provided that the several sections of the skirt structure are connected to each other at least partially or in certain areas via at least one axial connection area, in particular a seam area, with regard to a longitudinal extension direction of the implant, wherein the at least one axial connection area is oriented at least partially or in certain areas luminally.

[0160] In this context, it is advantageous that the layer system, which is at least partially or partially designed to cover a surface, and preferably the several layer systems of the drug-releasing system, which are at least partially or partially designed to cover a surface, are each attached to the at least one luminally oriented axial connection area of ​​the skirt structure via at least one fastening area, in particular point- or line-shaped.

[0161] The aspects discussed above can be used to implement the drug-releasing system or the MEISSNER BOLTE A / FIG-023-PC in an easily achievable yet effective manner.

[0162] 29 drug-releasing film(s) are attached to the substantially cylindrical circumference of the heart valve prosthesis or stent of the device according to the invention, wherein the films are mechanically flexible but firmly attached to the heart valve prosthesis or stent until the intended dissolution / degradation of the films or the end of drug release. The connection is also mechanically stable to allow the complete prosthesis to be loaded onto a catheter system and released at the implantation site by means of the catheter system.

[0163] For this purpose, it is specifically provided that the (drug-containing) films are connected to a material other than the metallic stent of the device, wherein the films are joined as a film, scale, loop, ring, etc., to the material from the skirt structure of the device or a comparable structure (e.g., (im)permeable membrane, fabric, nonwoven, etc.). The skirt / skirt-like structure can be positioned essentially inside or outside the metallic (stent) structure or attached to it.

[0164] Traditionally, in aortic valve prostheses, this skirt structure lies largely within the metallic stent structure to which the valve leaflets are attached and to which a pressure-tight seal is achieved at the connection points. In this case, parts of the skirt / skirt-like structure can be guided through the cells of the (metal) stent framework from the inside out (abluminal). This results in a flexible (or even an elastic, if elastic materials are used) connection between the prosthesis and the (medicated) membranes.

[0165] This is also advantageous for adapting / wrapping the foils as a film, scales, etc., individually, in groups, or in loops around the (crimped) prosthesis. It is particularly advantageous to modify a method of attaching the skirt / skirt-like structure frequently used in aortic valves and adapt it specifically for use in the function according to the invention: In aortic valves (with n=3 heart valve leaflets / seatlets), the skirt is also frequently manufactured from three separate or partially joined pieces. These are either sewn together into a "kit" before being inserted into the metal framework and then sewn into the metal structure, or they are first individually attached to the metal framework and then MEISSNER BOLTE A / FIG-023-PC

[0166] The 30 sections are interconnected, creating a swirling skirt geometry, usually lying close to the metal frame. The protruding skirt material of the three essentially axially (vertically) oriented seams points luminally. If the seam orientation is deliberately reversed, the protruding areas of the seams point outwards (abluminally) and can be guided outwards between the struts or through the cells of the (metal) stent structure, thus serving as an anchor point for the (drug-containing) films, see attached schematic drawings.

[0167] The effort required for modifications in manufacturing is minimal, and any length of material can be routed to the outside. Due to their typically thin thickness, these sections can withstand the crimping, loading, and insertion processes of the stent without damage. This is further improved (in contrast to pure (drug-containing) films) because the skirt material / material of the skirt-like structure is usually not a solid film, but rather a woven, knitted, nonwoven fabric, etc. This means it is processed in a form with loops or gaps in the material, which inherently provide more mechanical freedom and thus greater flexibility. As a result, the original shape is returned much more easily after the crimping, loading, and insertion process.

[0168] In principle, joining methods that do not add any further material components (adhesives, adhesion promoters, etc.) but consist solely of the existing materials (film and skirt / skirt-like material) are advantageous. Ultrasonic welding is particularly suitable here, as it can be performed quickly, precisely, and with definable parameters (pressure, geometry, amplitude, frequency). This is advantageous because no solvents or other aggressive or reactive substances are required that could impair both the (active ingredient-containing) film and the skirt / skirt-like structure.

[0169] Ultrasonic welding allows for real-time monitoring of process data and results in strong and durable joints. Ultrasonic welding offers high process stability and therefore minimal reject rates. Furthermore, an ultrasonic weld is significantly more reproducible than, for example, manually executed welds. MEISSNER BOLTE A / FIG-023-PC

[0170] 31

[0171] Furthermore, the materials are not penetrated by the needle and suture material, which can lead to tearing / slitting under the influence of force.

[0172] A further advantage of ultrasonic welding is that the overall material thickness at the joint does not increase, but can even decrease, because during the joining process, the materials are compressed under pressure, allowing, for example, material from the (active ingredient-containing) film to penetrate into the (e.g., air-filled) mesh of a skirt material made of woven or nonwoven fabric. This at least partial mechanical penetration of the material results in a very strong and therefore advantageous bond. However, the solution to this technical problem is by no means limited to ultrasonic welding, but can also be implemented using other joining techniques.

[0173] Ultrasonic welding processes, thanks to the individually customizable sonotrode geometry, can also be applied directly to heart valve prostheses that are finished except for the foils. The prosthesis can be either crimped or expanded.

[0174] The invention is described in more detail below with reference to the accompanying drawings.

[0175] They show:

[0176] FIG. 1 schematically shows an axial view of a first exemplary embodiment of the device according to the invention, wherein a scale-like layer system with polymer films is used;

[0177] FIG. 2 schematically shows a side view of a second exemplary embodiment of the invention, wherein a scale system in a vertical orientation is used as the active ingredient-releasing system;

[0178] FIG. 3 schematically shows a side view of a third exemplary embodiment of the present invention, wherein a scale system with an oblique arrangement is used as the drug-releasing system; MEISSNER BOLTE A / FIG-023-PC

[0179] FIG. 4 schematically shows a fourth exemplary embodiment of the device according to the invention, wherein a longitudinal-radial arrangement of scales is chosen for the active ingredient-free setting system;

[0180] FIG. 5 schematically shows an exemplary embodiment where the individual layers of the drug-release system can be connected to the implant or a stent of an implant;

[0181] FIG. 6 schematically shows another exemplary embodiment of the device according to the invention;

[0182] FIG. 7 schematically shows another exemplary embodiment of the present invention, wherein the drug-releasing system consists of lamellae / scales on the outside of a largely rotationally symmetrical implant;

[0183] FIG. 8 schematically shows another exemplary embodiment of the device according to the invention, wherein lamellae / scales are attached or adapted inside a largely rotationally symmetrical implant as the drug-releasing system;

[0184] FIGS. 9-14 each schematically show further exemplary embodiments of the device according to the invention, namely in the implantation form (left illustration) on the one hand and in the feeding form or compressed form (right illustration) on the other hand;

[0185] FIGS. 15-16 each schematically show further exemplary embodiments of the device according to the invention with locking element, namely in the implantation form (left illustration) on the one hand and in the feeding form or compressed form (right illustration) on the other hand;

[0186] FIG. 17 schematically and in an isometric view an embodiment of a skirt kit for a heart valve prosthesis with inwardly facing connection points, without a drug-eluting system; MEISSNER BOLTE A / FIG-023-PC

[0187] FIG. 18 schematically and in a sectional view the design of a skirt kit for a heart valve prosthesis according to FIG. 17;

[0188] FIG. 19 schematically and in an isometric view an embodiment of a skirt kit of a heart valve prosthesis with outward-facing connection points, without a drug-free setting system;

[0189] FIG. 20 schematically and in a sectional view the design of a skirt kit of a heart valve prosthesis according to FIG. 19 but with drug-releasing system (n=3);

[0190] FIG. 21 schematically and in a sectional view a variant of the device according to FIG. 19 also with the drug-releasing system;

[0191] FIG. 22 schematically and in an isometric view a variant of the device according to FIG. 19 with the drug-free setting system;

[0192] FIG. 23 schematically and in an isometric view a variant of the device according to FIG. 19 with the drug-free setting system;

[0193] FIG. 24 schematically and in an isometric view a variant of the device according to FIG. 19 with the drug-free setting system;

[0194] FIG. 25 schematically and in an isometric view shows another exemplary embodiment of the device according to the invention as shown in FIG. 19 with the drug-releasing system; and

[0195] FIG. 26 schematically and in a sectional view shows a further exemplary embodiment of the device according to the invention as shown in FIG. 25.

[0196] Different embodiments of the device according to the invention are shown schematically in the drawings. MEISSNER BOLTE A / FIG-023-PC

[0197] 34

[0198] Conventional transvascular implantable stents, especially valve stents, are sometimes coated with material, for example, to achieve a better seal against the vessel wall or between the heart chamber and the vessel. Drug-eluting stents contain the drug embedded in polymers in very thin layers directly on the stent struts. The stents are sometimes coated, dipped, or laminated with elastic materials to accelerate tissue ingrowth, seal areas, or protect the surrounding tissue from injury during stent insertion.

[0199] If larger quantities of drug are to be delivered over a surface area around an expandable stent or valve frame into a vessel or heart chamber, only highly elastic materials are suitable for embedding the drug, or processing methods in which non-elastomeric materials are processed, for example, within a tissue in such a way that the tissue itself is elastic or highly deformable. If non-elastic or only very weakly elastic materials were adapted to a stent or valve frame over a surface area, for example, as a film, they could be damaged during crimping of the (valve) stent or during re-expansion, for example, by plastic deformation or tearing / breaking / indentation.

[0200] The technical problem lies in adapting / attaching and positioning non-elastic or slightly elastic polymer-drug combinations in the form of films with layer thicknesses of approximately 20 pm to 500 pm in a novel way to or around a (flap) stent, whereby on the one hand a surface-wide release of the drug over the entire circumference of the stent should be achieved and on the other hand the polymer-drug films should not be damaged or impaired by the compression and re-expansion necessary for insertion.

[0201] The polymer drug foils are attached tangentially to the stent struts in individual pieces (also adapted to the design and geometry of the metal framework) using material, force, form, and / or friction bonding, so that each piece covers the attachment point of at least one adjacent piece, resulting in an overall scale-like structure (e.g., with rotational symmetry like a paddle wheel). The number of polymer drug pieces n > 1 (at n = 1 it would be one band, one scale; furthermore, due to the threefold MEISSNER BOLTE A / FIG-023-PC

[0202] 35

[0203] For aortic valves, symmetry makes a number of segments divisible by three advantageous. During radial compression or re-expansion, the foil segments can slide over each other like scales without forming creases, tears, or fractures (see videos). The adaptation and alignment of the leaflets or scales can also occur longitudinally, for example, during longitudinal-radial folding of stent segments / valve frame segments (gripper).

[0204] Furthermore, in addition to a linear fastening, a more point-based fastening is also possible as a solution to the technical problem, allowing movement of the scales in more than one direction. Both options were built in the model and work during crimping and re-expansion.

[0205] FIG. 1 shows an axial view of a stent / flap frame surrounded by scale-like polymer films and, in particular, the arrangement of the scales / blades along the circumference of the stent / flap frame. Reference numeral 1 denotes the corresponding attachment points. These are point or line attachment points of the scales / material pieces. Reference numeral 2 denotes the stent (metal, plastic). Reference numeral 3 denotes the scales (polymer-drug combination), while reference numeral 4 denotes radial orientation lines for 12-fold symmetry (not a structural element).

[0206] FIG. 2 is a tangential / frontal view with a vertical arrangement of the scales, which is particularly suitable for vertical fixing points 1a.

[0207] FIG. 3 shows a tangential / frontal view with oblique arrangement of the scales, particularly suitable for diamond-shaped / diagonal fixing struts lb.

[0208] FIG. 4 shows an example of an axial or longitudinal-radial arrangement of the scales or the arrangement of the scales in the longitudinal direction.

[0209] FIG. 5 shows an example of point-fixed scales with overlaps and multi-directional mobility. The fixing points can be selected according to the mobility requirements and mechanical parameters, e.g., on the MEISSNER BOLTE A / FIG-023-PC.

[0210] 36

[0211] be in the outer areas / corners (see reference numeral ld), central (see reference numeral lc) or other areas depending on the orientation of the stent or flap frame to the direction of advancement in the delivery catheter.

[0212] In FIG. 6, reference numeral 5 shows the struts of the stent (made of, for example, nickel-titanium, metal or plastic), while reference numeral 6 denotes antibiotic film scales (drug-release delivery system).

[0213] In FIG. 7 and FIG. 8, the lamellae / scales are designated by reference numeral 7.

[0214] Figures 9, 10, 11, and 12 show the implantation form (expanded form) on the left and the delivery form (compressed form) on the right. Figure 9 depicts a single-member (n = 1) embodiment, while Figure 10 depicts a three-member (n = 3) embodiment. Figure 11 shows the embodiment as a loop / ring with fold lines, with or without a connection point. The embodiment shown in Figure 12 represents the overlapping areas of the scale-like / fan-shaped drug-release delivery system on an internal structure.

[0215] FIG. 13 shows the longitudinal overlap of an axially aligned drug-release delivery system.

[0216] In FIG. 14, a thread / band pulling device is used to spread the drug-releasing system over the circumference.

[0217] In FIGS. 15 and 16, the implantation form (expanded form) is shown on the left and the delivery form (compressed form) on the right. In FIG. 15, the embodiment is designed as a loop / ring with fold-over points, with or without a connection point, and is held in place by pin(s) 8, 9.

[0218] In FIG. 16, the embodiment is shown as a film with a loop, with or without a connection to the stent, and is held in place by pin(s) 8. MEISSNER BOLTE A / FIG-023-PC

[0219] 37

[0220] As can be seen in particular from the illustrations in FIGS. 17 to 19, the device according to the invention preferably has a skirt structure 10 connected to the stent of the device. The skirt structure 10 consists of three sections, which are at least partially or partially connected to one another via a connection area 11, in particular a seam area. In the embodiment shown in FIGS. 17 and 18, the seam areas 11 are internal seam areas with luminally projecting skirt material.

[0221] In the embodiment shown in FIG. 19, the seam areas 11 are external seams with abluminally projecting material for attaching drug-containing films 12 of the drug-free setting system. This is shown in particular in FIGS. 20 to 26.

[0222] In detail, both the embodiment shown in FIG. 20 and the embodiment shown in FIG. 21 provide that the drug-releasing system consists of three drug-releasing films 12. Each drug-releasing film 12 has an end region attached on one side to one or more tabs of the skirt structure 10, in particular by ultrasonic welding.

[0223] In the embodiment shown in FIG. 21, the respective end regions of the active ingredient-releasing films 12 are inserted centrally between the respective end regions of the sections of the skirt structure 10 (sandwich-like).

[0224] An alternative embodiment to the embodiment shown in FIG. 21 is shown in FIG. 20 and FIG. 22. In this embodiment, the drug-releasing system 12 is not located centrally between, but only on one side of, the connection area 11 of the skirt structure 10.

[0225] An embodiment of the variant shown in FIG. 21 is shown in FIG. 23. Here, only a single drug-releasing film in the form of a cuff 12 is shown as the drug-releasing system.

[0226] FIG. 24 shows an embodiment in which the end region of the drug-releasing film of the drug-releasing system is divided by a grid cell MEISSNER BOLTE A / FIG-023-PC

[0227] 38

[0228] 13 of the stent of the device is guided and then connected internally with an internal seam of the (outwardly guided) skirt structure 10.

[0229] Further embodiments of the invention are shown in FIG. 25 and FIG. 26.

[0230] In this case, the drug-releasing system is formed by a banderole-like / cuff-like drug-releasing film, wherein a first end region of the drug-releasing film is connected to an abluminal-facing seam region of the skirt structure 10 and a second end region of the drug-releasing film is preferably connected to the same abluminal-facing seam region.

[0231] The invention is not limited to the embodiments of the device according to the invention shown in the drawings, but results from a combination of all the features disclosed herein.

Claims

November 17, 2025 devie medical GmbH A / FIG-023-PC TR DEVICE WITH AN ACTIVE INGREDIENT RELEASE SYSTEM Patent claims 1. Device with an implant, in particular in the form of a stent, which can be inserted into a patient's body in a compressed insertion state, particularly minimally invasively, and can be expanded into an implanted state at the implantation site, wherein the device further comprises a drug-releasing system which is at least partially or partially connected or connectable to the implant and can be inserted into the patient's body separately or together with the implant in a compressed insertion state, particularly minimally invasively, and can be expanded into an implanted state at the implantation site, characterized in that the drug-releasing system is designed such thatthat during the expansion of the implant at the implantation site and / or during the expansion of the drug-releasing system at the implantation site and during the associated change in shape of the implant and / or the drug-releasing system, it is not subject to any or at least essentially no non-linear elastic and / or plastic deformation.

2. Device according to claim 1, wherein the drug-releasing system has a drug-releasing surface, in particular a geometric surface, of at least 1.5 cm² at least in the implanted state of the drug-releasing system and preferably both in the compressed insertion state and in the implanted state of the drug-releasing system. 2 , preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 2.5 cm² 2 , preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 3.5 MEISSNER BOLTE A / FIG-023-PC 2 cm 2 , and even more preferably an active ingredient-free setting surface, in particular a geometric surface, of at least 5 cm² 2 has, and / or wherein the drug-releasing system has a drug-releasing surface, in particular a geometric surface, of up to approximately 50.0 cm² 2 exhibits.

3. Device according to claim 2, wherein the drug-releasing system contains at least 0.5 mg of active ingredient, preferably at least 2 mg of active ingredient and more preferably at least 5 mg of active ingredient, and / or wherein the drug-releasing system contains up to about 500 mg of active ingredient.

4. Device according to one of claims 1 to 3 or according to the preamble of claim 1, wherein, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device preferably has a skirt structure connected to the implant and / or to the support structure associated with the drug-releasing system, characterized in that the drug-releasing system has at least one layer system, in particular at least partially or regionally designed, and preferably several layer systems, in particular at least partially or regionally designed.wherein the layer system, which is at least partially or partially designed to cover a surface, and preferably each of the layer systems, which are at least partially or partially designed to cover a surface, is designed as an active ingredient-releasing layer system.

5. Device according to claim 4, wherein the layer system of the drug-releasing system has a drug-releasing surface, in particular a geometric surface, of at least 1.5 mm², at least in the implanted state of the drug-releasing system and preferably both in the compressed insertion state and in the implanted state of the drug-releasing system. MEISSNER BOLTE A / FIG-023-PC 3 cm 2 , preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 2.5 cm² 2 , preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 3.5 cm²2 , and even more preferably an active ingredient-releasing surface, in particular a geometric surface, of at least 5 cm² 2 exhibits, and / or wherein the drug-releasing system has a drug-releasing surface, in particular a geometric surface, of up to approximately 50.0 cm² 2 exhibits.

6. Device according to claim 4 or 5, wherein the layer system of the drug-releasing system comprises at least one drug-containing layer, in particular a polymer layer, and / or a drug-containing matrix.

7. Device according to claim 6, wherein the at least one active ingredient-containing layer, in particular polymer layer, and / or the active ingredient-containing matrix of the layer system has a particularly mean thickness of at least 20 pm, preferably at least 30 pm and particularly preferably at least 50 pm, and in particular about 100 pm.

8. Device according to claim 6 or 7, wherein the at least one active ingredient-containing layer, in particular polymer layer, and / or the active ingredient-containing matrix of the layer system contains at least 0.5 mg of active ingredient, preferably at least 2 mg of active ingredient and more preferably at least 5 mg of active ingredient, and / or wherein the at least one active ingredient-containing layer, in particular polymer layer, and / or the active ingredient-containing matrix of the layer system contains up to about 500 mg of active ingredient.

9. Device according to one of claims 4 to 8, wherein the drug-releasing surface of the layer system is continuous both in the compressed insertion state and in the implanted state of the drug-releasing system. MEISSNER BOLTE A / FIG-023-PC 4 10.Device according to one of claims 4 to 9, wherein the layer system, which is in particular at least partially or partially planar, and preferably each of the layer systems, which are in particular at least partially or partially planar, is or can be attached to the implant or to a support structure of the device associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped, via the skirt structure; or wherein the layer system, which is in particular at least partially or partially planar, and preferably each of the layer systems, which are in particular at least partially or partially planar, is or can be attached to the implant or to a support structure of the device associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped.

11. Device according to one of claims 4 to 10, wherein the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, are each attached or attachable to the skirt structure, the implant, or the support structure associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped, such that after the attachment of the corresponding layer system of the drug-releasing system, it is movable relative to the implant or the support structure.

12. Device according to one of claims 4 to 11, wherein the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, are each attached or attachable to the skirt structure, the implant, or the support structure associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped, such that according to MEISSNER BOLTE A / FIG-023-PC 5. The layer system(s) of the drug-releasing system shall form a scale-like or scale-like, sequin-like or sequin-like, spring-like or spring-like and / or lamellar or lamellar structure at least in the insertion state of the drug-releasing system and preferably both in the insertion state and in the implanted state of the drug-releasing system.

13. Device according to one of claims 4 to 12, wherein the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, are each attached or attachable to the skirt structure, to the implant, or to the support structure associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped, such that after the attachment of the layer systems of the drug-releasing system, at least in the insertion state of the drug-releasing system and preferably both in the insertion state and in the implanted state of the drug-releasing system,The layer system, which is at least partially or partially applied to a surface, and preferably at least two adjacent layer systems of the active ingredient-releasing system overlap at least partially or partially.

14. Device according to one of claims 4 to 13 and in particular according to claim 13, wherein the layer system, which is in particular at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are in particular at least partially or partially planar, are each attached or attachable to the skirt structure, to the implant, or to the support structure associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped, such that after the attachment of the layer system or layer systems of the drug-releasing system, at least in the insertion state of the drug-releasing system and preferably both in the insertion state as MEISSNER BOLTE A / FIG-023-PC 6. Even in the implanted state of the drug-releasing system, at least two adjacent layer systems of the drug-releasing system are arranged at least partially or in areas in a fan-like or fan-shaped manner, in a scale-like or scale-like manner, and / or are arranged in layers overlapping each other in areas.

15. Device according to one of claims 4 to 14 and in particular according to claim 13 or 14, wherein the layer system, which in particular is at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which in particular are at least partially or partially planar, are attached or attachable to the skirt structure, to the implant, or to the support structure associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped, such that when the implant and / or the drug-releasing system is expanded and / or when the implant and / or the drug-releasing system is transferred from a respective expanded state to the insertion state, the layer system or the individual layer systems of the drug-releasing system slide / guide at least partially or partially over one another.

16. Device according to one of claims 4 to 15, wherein the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, are each attached or attachable to the skirt structure, the implant, or the support structure associated with the drug-releasing system via at least one attachment area, in particular point- or line-shaped, such that when the implant and / or the drug-releasing system is expanded and / or when the implant and / or the drug-releasing system is transferred from the respective expanded state to the insertion state, the layer system or the individual layer systems of the drug-releasing system are movable relative to each other. MEISSNER BOLTE A / FIG-023-PC 7 17. Device according to any one of claims 4 to 16, wherein, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device has a skirt structure connected to the implant and / or to the support structure associated with the drug-releasing system, which is arranged at least partially or in certain areas inside the implant and connected to the implant, wherein the layer system, in particular at least partially or in certain areas having a planar surface, and preferably the several layer systems of the drug-releasing system, in particular at least partially or in certain areas having a planar surface, are each attached to the skirt structure via at least one attachment area, in particular point-like or line-like.wherein the at least one attachment area extends at least partially or in sections through at least one window area or through at least one cell of the implant.

18. Device according to one of claims 4 to 16, wherein, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device has a skirt structure connected to the implant and / or to the support structure associated with the drug-releasing system, which is arranged at least partially or in certain areas outside the implant and is connected to the implant, wherein the layer system, in particular at least partially or in certain areas having a planar design, and preferably the several layer systems of the drug-releasing system, in particular at least partially or in certain areas having a planar design, are each attached to the skirt structure via at least one attachment area, in particular point-like or line-like. MEISSNER BOLTE A / FIG-023-PC 819. Device according to any one of claims 4 to 18, wherein, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device has a skirt structure connected to the implant and / or to the support structure associated with the drug-releasing system, the skirt structure having a first end region and an opposing second end region, wherein the first and second end regions of the skirt structure are connected to each other via a connection region, in particular a seam region, wherein the layer system, which in particular is at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which in particular are at least partially or partially planar, are each connected via at least one attachment region,in particular point- or line-shaped, attached to the skirt structure, wherein the at least one attachment area is arranged in or on the connection area of ​​the skirt structure.

20. Device according to claim 19, wherein the first and second end regions of the skirt structure are connected to each other via at least one axial connection region, in particular a seam region, with respect to a longitudinal extension direction of the implant, wherein the at least one axial connection region is at least partially or partially abluminally oriented.

21. Device according to claim 19 or 20, wherein the layer system of the drug-releasing system, which is in particular at least partially or in certain areas designed to be planar, is designed at least in certain areas as a banderole or banderole section, wherein a first end region of the layer system designed as a banderole or banderole section and a second end region of the layer system designed as a banderole or banderole section opposite the first end region are each connected in or at the connection area of ​​the skirt structure to the skirt structure. MEISSNER BOLTE A / FIG-023-PC 9 22. Device according to any one of claims 4 to 18, wherein, for sealing the implant at the implantation site and / or for connecting a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, to the implant or to a support structure associated with the implant, the device has a skirt structure connected to the implant and / or to the support structure associated with the drug-releasing system, which is composed of several, in particular three, sections, in particular tissue sections, which are preferably designed separately from one another, and which are connected to each other at least partially or in certain areas via at least one connection area, in particular a suture area.wherein the layer system, which is at least partially or partially designed as a surface, and preferably the several layer systems of the drug-releasing system, which are at least partially or partially designed as surfaces, are each attached to the skirt structure via at least one attachment area, in particular point- or line-shaped, wherein the at least one attachment area is arranged in, next to or on the connection area of ​​the sections of the skirt structure.

23. Device according to claim 22, wherein the layer system of the drug-releasing system, which is at least partially or partially designed as a planar surface, is designed at least partially as a band or band section, wherein a first end region of the layer system designed as a band or band section is connected to the skirt structure in or at a first connection region of the sections of the skirt structure, and wherein a second end region of the layer system designed as a band or band section, opposite the first end region, is connected to the skirt structure in, next to or at a second connection region of the sections of the skirt structure. MEISSNER BOLTE A / FIG-023-PC 10 24. Device according to claim 22 or 23, wherein the multiple sections of the skirt structure are connected to each other at least partially or partially via at least one axial connection area, in particular a seam area, with respect to a longitudinal extension direction of the implant, wherein the at least one axial connection area is at least partially or partially abluminally oriented.

25. Device according to claim 24, wherein the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, are each attached to the at least one abluminally oriented axial connection area of ​​the skirt structure via at least one fastening area, in particular point- or line-shaped.

26. Device according to claim 25, wherein the at least one fastening area extends at least partially or partially through at least one window area or through at least one cell of the implant.

27. Device according to claim 22 or 23, wherein the multiple sections of the skirt structure are connected to each other at least partially or partially via at least one axial connection area, in particular a seam area, with respect to a longitudinal extension direction of the implant, wherein the at least one axial connection area is oriented at least partially or partially luminally.

28. Device according to claim 27, wherein the layer system, which is in particular at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are in particular at least partially or partially planar, are each attached via at least one attachment area, in particular point- or line-shaped, to which at least MEISSNER BOLTE A / FIG-023-PC 11 a luminally aligned axial connection area of ​​the skirt structure is / are attached.

29. Device according to one of claims 4 to 28, wherein the device has a support structure associated with the drug-releasing system, with which the layer system, in particular at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, in particular at least partially or partially planar, are attached, wherein the support structure is designed to be elastic in such a way that it can be transformed from the compressed insertion state, in particular when the drug-releasing system is inserted into the patient's body, into an expanded and implanted state, in particular at the implantation site of the patient's body, wherein the support structure with the layer system attached thereto iswith the attached layer systems of the drug-releasing system, particularly in the expanded and implanted state of the implant, which is connected or connectable to the implant.

30. Device according to one of claims 4 to 29, wherein the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, are each designed as a foil, film, membrane or as a coated or laminated plate; or wherein the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, each comprise a coated or laminated foil, a coated or laminated film, a coated or laminated membrane or a coated or laminated plate. MEISSNER BOLTE A / FIG-023-PC 12 31. Device according to one of claims 4 to 30, wherein the layer system, which is particularly at least partially or partially planar, and preferably the several layer systems of the drug-releasing system, which are particularly at least partially or partially planar, each have a layer thickness between 10 pm and 1,000 pm and preferably a layer thickness between 20 pm and 500 pm.

32. Device according to one of claims 4 to 31, wherein the layer system, which is in particular at least partially or in certain areas designed to be planar, and preferably the several layer systems, which are in particular at least partially or in certain areas designed to be planar, are each configured to release an active ingredient in a controlled manner in the implanted state of the drug-releasing system.

33. Device according to any one of claims 1 to 32 and in particular according to claim 1, wherein the drug-releasing system comprises at least one planar layer, in particular in the form of a foil, a film, a membrane or a particularly coated or laminated plate.

34. Device according to claim 33, wherein at least in the compressed state of the implant and in particular in the compressed state of the drug-releasing system, the at least one planar layer of the drug-releasing system is designed at least partially or in certain areas as a band wound in a helical pattern in cross-section at least partially or in certain areas.

35. Device according to claim 34, wherein the at least one planar layer of the drug-releasing system is designed at least partially or in certain areas as a band wound in a helical pattern in cross-section, such that during the expansion of the implant and / or the drug-releasing system at the implantation site a MEISSNER BOLTE A / FIG-023-PC 13 The diameter of the cylindrical shape of the drug-releasing system increases.

36. Device according to claim 33, wherein the at least one planar layer of the drug-releasing system is loop- or helix-shaped in cross-section and has a helix-shaped area whose diameter increases during the expansion of the drug-releasing system and / or which unwinds at least partially or in certain areas during the expansion of the drug-releasing system; and / or wherein the at least one planar layer of the drug-releasing system has a closed loop, in particular in the form of an annular band in cross-section, whose diameter increases during the expansion of the drug-releasing system and / or which unwinds at least partially or in certain areas during the expansion of the drug-releasing system.

37. Device according to one of claims 1 to 36 and at least according to claim 4, wherein the layer system, which is particularly at least partially or partially designed as a surface, or the at least one surface-designed layer of the drug-release system, is attached to the implant or to a support structure associated with the drug-release system by means of a material bond, in particular by bonding and / or welding, in particular ultrasonic welding, and / or by friction bonding and / or force bonding, in particular by a seam, and / or by a form-fit bond.

38. Device according to any one of claims 1 to 37, wherein the drug-free setting system is self-expanding; or wherein the drug-free setting system is expandable via an externally manipulable mechanism. MEISSNER BOLTE A / FIG-023-PC 14 39. Device according to any one of claims 1 to 38, wherein the device further comprises a replacement heart valve, in particular in the form of a percutaneous or surgical heart valve, which is preferably attached or attachable to the implant or to a support structure associated with the implant via a skirt structure.

40. Device according to one of claims 1 to 39, wherein the device further comprises at least one locking element, in particular in the form of a pin-shaped element, wherein the at least one locking element is configured to hold the implant, preferably together with the drug-releasing system, in a compressed state in which the implant, preferably together with the drug-releasing system, can be inserted into the patient's body, particularly in a minimally invasive manner, wherein the at least one locking element is manipulable, particularly externally, such that by manipulating the at least one locking element, the implant, preferably together with the drug-releasing system, expands, particularly at the implantation site.

41. Device according to claim 40, wherein the device is configured to expand the implant, preferably together with the drug-release system, particularly at the implantation site, exclusively by manipulating the at least one locking element.

42. Device according to claim 40 or 41, wherein the at least one locking element is configured to hold or fix the drug-releasing system in a fixed position relative to the implant, particularly in its compressed state, and, after manipulation of the at least one locking element, to release the fixed holding or fixing of the drug-releasing system on the implant, so that the drug-releasing system is then movable relative to the implant; and / or wherein the at least one locking element is configured to hold or fix the implant in its compressed insertion state, and after MEISSNER BOLTE A / FIG-023-PC 15. By manipulating at least one locking element, the implant is to be released from the holding or fixing of the compressed insertion state, so that the implant can then be transferred into an expanded state or automatically transitions into an expanded state.

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