IMPLANTABLE DEVICE FOR USE ON THE HUMAN AND/OR ANIMAL BODY TO REPLACE AN ORGAN VALVE.

专利摘要:
implantable device for use in the human and/or animal body to replace a valve in an organ. the invention relates to an implantable device (1) for use in the human and/or animal body (24) to replace a valve of an organ, comprising a main body (2) having a first end (3) and a second end. end (4), in which each of the first end (3) and the second end (4) has an opening for providing a fluid connection through the main body (2) between the first end (3) and the second end (4); a first membrane element (6) arranged within or at an end (3, 4) of the main body (2), in which the membrane element (6) is formed in such a way as to allow the connection of fluids through of the main body (2) in a first flow direction and locks it in a second flow direction opposite the first flow direction; wherein the main body (2) has a large ratio between length and transverse expansion along the longitudinal axis of the main body (2).
公开号:BR112015002933B1
申请号:R112015002933-7
申请日:2013-08-05
公开日:2021-07-13
发明作者:Franz Freudenthal
申请人:Pfm Medical Ag；
IPC主号:

专利说明:

[001] The present invention relates to an implantable device for use in the human and/or animal body to replace a valve of an organ consisting of a main body having a first end and a second end, each of which among the first end and the second end has an opening for providing a fluid connection through the main body between the first end and the second end; a first membrane element arranged within or at one end of the main body, where the membrane element is formed in such a way as to allow the connection of fluids through the main body in a first flow direction and block it in a second direction of flow. of flow (as opposed to the first flow direction); wherein the main body has a large length ratio for transverse expansion along the longitudinal axis of the main body in a first operational state (primary form), and a smaller length ratio for transverse expansion along the longitudinal axis of the main body at a second operational state (secondary form); and wherein the main body can be reversibly transferred from the secondary form to the primary form on account of elastic material forces through the application of a force.
[002] Such implantable devices to replace a valve of an organ in the human and/or animal body are known from prior technology. In the past it was customary to replace heart valves in particular with open-heart surgery, which is not a risk-free operation, especially for older patients. Thus, devices have been developed to replace a heart valve, which can be inserted without open-heart surgery through a catheter into the desired location in the heart. For example, it is known from EP 0 592 410 to provide a compressible resilient valve, which is mounted on a resilient stent, in which the commissural points of the elastic folding valve are mounted on the cylinder surface of the resilient stents. The compressible elastic valve is a three-lobed, biological valve. The stent is composed of a stainless steel wire bent in a number of turns and circularly bent together and welded together. The stent includes two or more closed rings that are connected together to form a cylindrical structure. Three of the loops in the outer ring are formed higher in height than the other loops to form points at which the commissural points of the biological valve are connected. The cylindrical surface of the stent can also be closed. Due to the tube or ring shape of the stent only relatively poor anchorage at the implant site, particularly in the aorta and heart, is possible.
[003] A more advanced anchorage for a replacement of cardiac valves is described in DE 101 21 210 A1. According to this document, an intraluminal anchoring element is molded in a shape other than a cylinder shape, so that at least partially it is attached in the position of use positively to the aorta. The intraluminal anchorage element of this document therefore has extensions that extend radially into the outlet of the heart (behind the original aortic valve). Furthermore, it is curved and adapted to the curved shape of the aorta. The anchoring element is, for example, composed of a grid type, loop-shaped or helical-shaped and is constructed of a segment structure or strands and may include various tortuous, ring-forming segment structures. The individual ring-forming structures are interconnected or joined together by gluing, welding, soldering, etc. This incorporation of a heart valve replacement has the disadvantage that the anchoring element is designed too long and therefore must be placed too deeply into a blood vessel or heart. Although openings are provided for connections to the different coronary arteries, it may be due to the length of the anchor element that they are partially covered by the anchor element, which can result in a blockage of blood flow or a blockage of connections to the coronary arteries .
[004] From EP 1057460 A1 or the abstract of JP 2001/000460A it is known to provide a heart valve replacement device comprising a stent, wherein the stent is expandable in the radial direction of the blood vessel and a valve biologic is attached to the stent. The stent valve arrangement is applied to the expanding portion of a balloon catheter and inserted into a human's body. The stent is made up of a plurality of sections, which are made of wire. The individual wire sections are soldered together. Through the balloon catheter, the stent is expanded to the desired diameter at the implant site, which is done in two steps. After expansion of the stent at the implantation site, the balloon catheter diameter is reduced and the catheter is removed. The pulmonary valve replacement device remains in the pulmonary artery, touching the artery wall. A disadvantage of this heart valve replacement device is that a balloon catheter must be used to expand the stent. Furthermore, the stent maintains its position only because of its expanded shape within the vessel or artery. In any case, it has been shown that this type of heart valve replacement device suffers from problems due to the alteration of the stent inside the vessel, especially because, in the case of inaccurate positioning, the connections with the coronary arteries can be blocked, causing an at least partial closure of these connections and thus can lead to stagnant blood flow. In addition, an incorrect placement is problematic because when using the balloon catheter, the stent can be expanded, however, it cannot be reduced again in diameter.
[005] As of U.S. 5,855,597 it is also known to cut star-shaped elements and mount them on a stent. An aortic valve of a flexible, biocompatible material is inserted into a central opening of the assembled star-shaped elements. Through a catheter system, the stent is delivered to the desired implant site. The star shape achieves a fixation within the aorta, but there is also a risk of injury, especially if the blood vessel is easily vulnerable, especially perforable, due to the patient's age or other health conditions.
[006] As of U.S. 6,482,228 B1, for example, an aortic valve replacement is known, with a stent and a displacement arising therefrom, but linked with it, a replacement of a rotor-shaped valve. This is placed over the original valve. The stent consists of several rings connected by a wire bent into a waveform. One disadvantage is the structure of a stent with a displacement rotor-shaped aortic valve replacement for placement behind the original aortic valve. The structure is, on the one hand, very complicated and, on the other hand, there is a risk that the rotor will disengage from the stent. In addition, the rotor is positioned in the aorta and essentially secured in the longitudinal direction, without additional fixation by the stent. Aortic valve replacement, for this reason, does not provide a stable and firm unit.
[007] As a replacement for state-of-the-art heart valves, ring-shaped devices are known which have post elements that protrude at three points outside the ring. These can either be rolled, as disclosed in WO 9746177, or consist of a solid material, as described in U.S. 4,816,029, DE 196 24 948 A1 and DE 35 41 478 A1. However, none of these ring-shaped valve replacement devices are implantable through a catheter because they cannot be collapsed to a correspondingly small size.
[008] From DE 103 34 868 another implantable device for use in a human and/or animal body to replace a valve of an organ is known. The implantable device disclosed is composed of a main body, having first and second ends with openings and a membrane element with at least one opening. The device has in a first operating state a large ratio of length to transverse extension along an axis and in a second operating state a smaller ratio of length to transverse extension along the axis, in which the device can be reversely transferred by applying a force against the forces of the elastic material from the secondary form to the primary form. Furthermore, the implantable device includes at least at one of the two ends of the main body an extended anchoring portion for anchoring the device to an organ and/or a vessel. The main body of the implantable device according to DE 103 34 868 A1 is integrally formed and, for example, cut and/or perforated and/or separated by another separation process from a single piece of material. This results in the disadvantage that the implantable device has a relatively high rigidity and must be chemically and/or mechanically treated in at least a partial region of the main body to generate different hardnesses and, in particular, engraved, electro-polished, micro-ground or treated otherwise. Furthermore, there is a risk of an excessive after-treatment of the main body, that the individual elements of the main body, in particular the supports formed therefrom, will be damaged by a transfer of the implantable device from the primary form to the secondary form.
[009] The objective of the present invention is to provide an implantable device to replace a valve of an organ, which has a high flexibility, without the risk that the individual elements of the implantable device may be damaged by a deformation. In particular, the invention has for its object the provision of an implantable device that has different hardness in different areas.
[0010] The objective is solved by an implantable device for use in the human and/or animal body to replace a valve of an organ, composed of a main body that has a first end and a second end, each of which among the first end and the second end has an opening for providing a fluid connection through the main body between the first end and the second end; a first membrane element arranged within or at one end of the main body, wherein the membrane element is formed in such a way as to allow the connection of fluids through the main body in a first direction and block it in a second direction. of flow opposite the first flow direction; wherein the main body has a large length ratio for transverse expansion along the longitudinal axis of the main body in a first operating state (primary shape) and a small length ratio for transverse expansion along the longitudinal axis of the body main in a second operating state (secondary form); and wherein the main body is reversibly transferable from the secondary shape to the primary shape against elastic material forces by applying a force; and wherein the main body is formed from a single yarn-like element, or from a plurality of yarn-like elements connected together by interlocking winding and/or twisting and/or weaving in the form of a fabric and/ or in layers of fabric and/or netting.
[0011] By forming the main body of a single yarn-like element or of a plurality of yarn-like elements connected to each other by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or in layers of tissue and/or mesh an implantable device is created, which has a high flexibility and at the same time guarantees a secure fit on the implantation side. In secondary form, the implantable device conforms, for example, to a vessel wall. Because of elastic material forces, a force acts in a radial direction, which holds the implantable device in place of the implant. Since the main body is reversibly transferable from a primary form to a secondary form, it can be transported to the implantation site via a catheter without any problems. Upon exit from the catheter the implantable device unfolds from the primary form to the secondary form, whereby the diameter of the main body is increased and the length is generally reduced. Due to the possibility of a reversibly transfer from the primary to the secondary form and vice versa from the secondary to the primary form, in contrast to the stent according to EP 1 057 460 A1, a recovery of the device within the catheter is possible. , if during implantation it is discovered that the implantation has not proceeded properly, particularly if the implantable device is not correctly positioned for connection with the coronary vessels and/or the native heart valve and/or the aorta as well as the ventricle of the heart. Due to the single yarn-like elements or the plurality of yarn-like elements connected to each other, which form the implantable device by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or layers of tissue and/or mesh, the advantage results, that the implantable device of the invention has a high flexibility, without the risk that the unique elements of the implantable device break during transfer from the main form to the secondary form or form. secondary to the main form. The single wire-type design of the implantable device, particularly of the main body, has the additional advantage that no connection points, eg solder points, between single elements of the main body are present, which could easily break. Especially a breakage of the unique elements of an implantable device can lead to protruding edges of the device, which could damage or perforate the vessel wall, particularly an aorta. The structure of the main body can be designed more evenly by an integral incorporation as is possible in the case of connecting separate ring-like elements as known from prior technology. An implantable device, constructed of a plurality of wire-like elements connected to each other, has the advantage that the implantable device can easily be manufactured automatically.
[0012] In a variant of the invention, the implantable device is formed as a stent, in which the first end and/or the second end is folded over each other for a double layer in the second operating state (secondary form). Because of the double layer the force acting in the radial direction during transfer from the primary form to the secondary form is increased, whereby the fixation of the implantable device at the implant site is improved, without a negative impact on the inner diameter (passage) of the implantable device.
[0013] According to an advantageous variant, the double layer of the first end and/or the second end is formed by a return fold inside the implantable device and/or externally to the implantable device.
[0014] According to a variant of the invention, the main body has in the second operating state (secondary form) at the first end and/or second end at least one anchoring member extending radially outward from the main body for anchoring of the device in an organ and/or in a vessel. In this way, an implantable device is created to replace a valve of an organ, which has, due to the use of at least one anchoring member extending radially outward at one end of the main body, a particularly good attachment to the organ and/ or in the vase. In the case of using the implantable device as a replacement heart valve, one end with the anchoring element extending radially outward may, for example, extend into the left ventricle and adhere there, and the other end of the main body can confirm with the aortic wall. In this way, the implantable device or main body can be constructed much shorter than possible, for example with a stent according to DE 101 21 210 A1.
[0015] Advantageously the at least anchoring member extending in a radial direction of the main body is in the second operating state (secondary form) at the first end and/or at the second end located and circumferentially provided on the circumference of the main body at the first end and/or at the second end. Alternatively, single radially extending anchoring members on the circumference of the main body can be provided. Depending on the implantation site one or the other variant may be preferred, whereby the choice depends mainly on space and a potential stenosis in a vessel caused by a calcium deposit or something similar.
[0016] In a variant of the invention the implantable device has areas of different rigidity. These areas of different stiffness can be formed, for example, by interlocking and/or twisting and/or weaving windings, differently from the single yarn-like element or by a yarn-like element with different cross sections, particularly round, oval and/or polygonal. An area of lesser stiffness between the areas of greater stiffness is particularly preferred. It is particularly preferred that the area with less rigidity is located in the main body outside the at least one anchoring member. Because areas with different stiffness that bend at the implant site can be replicated, for example, the bending of the aorta. To ensure a good fixation at the implantation site the area of the at least one anchoring member, therefore, the first and/or the second end of the main body preferably has a greater rigidity than one or more areas located between them. Along the length of the main body several areas with different stiffness factors can be provided, in the case of external conditions, particularly the aorta or ventricle of the heart, so require. The distribution of stiffness across the main body can be tailored to a specific patient and their heart or to the spatial conditions at the implant site.
[0017] Generally, it is possible for the implantable device according to the invention to be tailored for each patient and/or to provide a standard shape, which is substantially usable for most patients. Particularly in a basic form adaptable variable areas can be provided, which allows an adaptation in most exceptional cases. For this reason, implantable device production costs can be reduced because real custom implants are infrequent.
[0018] In a variant of the implantable device of the invention the main body has at least one opening in its circumferential wall, to provide a fluid connection between the interior of the main body and a vessel of the human and/or animal body. At the implant site the implantable device of the invention is in secondary form, for example located in such a way that at least one anchoring member extends into the heart's ventricle, where it is anchored, and the remaining part The main body, which is usually cylindrical, extends into a vessel, such as the aorta, where the remaining part of the main body is retained in the wall of the aorta. Through at least one opening in the circumferential wall of the main body a fluid connection to an outlet vessel, for example from the aorta of the human or animal body, can be provided, for example, a coronary artery. Advantageously at least one opening has a diameter corresponding to a coronary artery, such that blood flow in this area is not held back.
[0019] In a particularly advantageous variant of the implantable device of the invention, it has two openings in its circumferential wall, which in the state of the implanted device are arranged in such a way that the two openings overlap the coronary arteries.
[0020] According to a new variant of the invention at least one opening in the circumferential wall of the main body is located outside at least one anchoring member, so that the function of the anchoring member is ensured. The implantable device according to the invention is therefore advantageously situated within the human or animal body in such a way that the anchoring member does not block the exit vessels of the human or animal body.
[0021] In a particularly preferred variant of the implantable device of the invention the at least one opening in the circumferential wall of the main body is constructed by a further winding and/or twisting and/or weaving of the single wire-type element, wherein the winding and /or further twisting and/or weaving of the single yarn-like element of the main body in the area of the at least one opening in the circumferential wall of the main body a mesh of larger size is achieved compared to the remaining parts of the circumferential wall of the main body . Advantageously the larger mesh size is constructed in such a way that, in the areas of outlet vessels, no further coiled, twisted or woven main body elements are located.
[0022] According to a new variant of the invention, the implantable device is composed of at least one radiopaque marker, namely in the form of a marker label, marker or marker wire. The radiopaque marking is particularly located in the main body area. For this reason, it is possible to verify the positioning during implantation, namely with regard to the outflow coronary arteries, with the use of a monitor or something similar. Hence particularly an angiography or computed magnetic resonance tomography is suitable, which can exhibit an axially accurate positioning of the implantable device, which is preferably an aortic valve replacement. The markings can be provided at different positions of the main body or implantable device, particularly in the areas of the main body openings.
[0023] Advantageously, the implantable device according to the invention completely or partially consists of a shape memory material, in particular of nitinol or a plastic with shape memory effects.
[0024] A further variant of the invention provides that the implantable device consists completely or partially of an absorbable material.
[0025] In another variant of the invention, the first membrane element consists of a synthetic or biological material, in particular, of polyurethane.
[0026] According to a further preferred variant of the invention, the first membrane element has a coating for establishing a biostability. The coating for establishing biostability is preferably a titanium coating.
[0027] The main body and the first membrane element of the implantable device are, according to a variant, detachable or inseparably connected, or connectable to each other, particularly by gluing, welding, sewing, casting, dipping or other junction technology.
It is particularly advantageous that the first membrane element of the implantable device has a ring part and a valve part connected to the ring part. Preferably the valve part comprises three leaflet elements. In this way, particularly a natural valve can be reproduced. By providing a ring part a good anchorage to the main body of the implantable device is made possible. The main body is mainly composed of a biocompatible material, preferably of a metal or a metallic alloy, in particular stainless steel or plastic, such as polycarbonate, and particularly of a shape memory material such as nitinol. The first membrane element is preferably composed of a synthetic or biological material, particularly of polyurethane. The main body and the first membrane element can be detachable or inseparably connected or connectable to each other. A connection of the main body and the first membrane element can therefore be achieved by gluing, welding, stitching, casting, dip coating or other joining technology. The ring part of the first membrane element is preferably chosen with such a width that good anchoring to the main body is achievable. Since the first membrane element generally consists of a very thin material the ring part can, for example, be coupled to or inserted into the main body as a thin tube. In this connection particularly a dip coating of the main body or the application of a thin membrane inside or outside the main body are suitable. This provides protection against displacement of the first membrane element relative to the main body.
[0029] The implantable device according to the invention is particularly usable in adult cardiology, in which preferably in connection with the greater probability of aortic valve failure due to older age. The implantable device of the invention can also be used to replace a tricuspid valve, pulmonary valve or a bicuspid valve (mitral valve).
[0030] The first membrane element of the implantable device according to the invention is located in the second operating state (secondary form) at the first end of the main body, at the second end of the main body or between the first end and the second end of the body main body, preferably centered between the first end and the second end of the main body along the longitudinal axis of the main body. The implantable device according to the invention has, according to a variant of the invention in the second operating state (secondary form) at the first end and/or at the second end at least one second membrane element, for partially closing the opening for the fluids at the first end and/or at the second end. Advantageously, the first membrane element and the second membrane element are located adjacent to each other at the first end of the main body or at the second end of the main body. The second membrane element is used to close the fluid connection between the first membrane element and the main body, so that in this area of the connection between the first membrane element and the main body no fluid can pass.
[0031] Preferably the implantable device according to the invention is relocatable and/or expandable. Relocation or expansion is achieved in which the implantable device is reversibly transferable from the primary form to the secondary form and vice versa from the secondary form to the primary form. Thereby, the implantable device according to the invention can, for example, be retracted into the catheter during implantation in the case where it is recognized that implantation does not proceed correctly, in particular where the implantable device is not properly located in connection with the coronary vessels and/or the natural valve of the heart and aorta, as well as in the ventricle of the heart.
[0032] In a preferred variant of the implantable device of the invention the device is in a second operating state (secondary form) between the first end and the second end of the main body and at least partially, preferably completely, deformable in a radial direction , such that the main body can adapt to a vessel wall and/or a circumference of an opening and/or an edge of a defective organ valve. Due to the fact that the main body adapts during implantation to a vessel wall and/or to the circumference of an opening and/or to an edge of a defective organ valve this is achieved, that the implantable device does. invention, after implantation does not autonomously replace itself, for example, caused by the pumping action of the heart. Furthermore, it is achieved that the implantable device is centered on the opening of the human or animal body.
[0033] For example, the implantable device of the invention is inserted during implantation into the human and/or animal body in such an area of the heart valve, particularly the aortic valve, that the natural valve is pressed against the vessel wall during transfer of the implantable device from the first operating state (primary form) to the second operating state (secondary form) and thereby securing the implantable device. In general, it would be possible to place an implantable device in a previously implanted device, where the first membrane element of the previously implanted device is also pressed against the wall of the main body. Such implantation of an additional implantable device into a previously implanted device could be reasonable in the case, for example, of reduced stability or flexibility of the first membrane element. Furthermore, it is generally possible after removal of a natural valve, particularly by operation, to insert at this location an implantable device including a membrane element as a replacement for the valve. In particular, in the case of high calcification of the natural heart valve, complete removal of the heart valve may be advantageous, as it is generally mostly immobile. In such a case, it would be difficult to press the natural valve into the vessel wall. Furthermore, a narrowing would remain in this area, which is also not desired because of the reduction in the flow cross section and the resulting higher pressure, which would result in health problems for the patient. In case of a heart valve insufficiency, the implantable device of the invention can alternatively be implanted in the insufficient valve, for example in the aortic valve or mitral valve without first removing the natural valve.
[0034] For example, the implantable device of the invention can be introduced into the body via the carotid artery or the axillary artery, which results compared to an implantation through the patient's inguinal region at a reduced implantation distance.
[0035] The main body of the implantable device is preferably aligned so that the anchoring member protruding at the first end projects into the heart ventricle, e.g., the left ventricle of the heart, and the remaining part of the heart. main body locks to the vessel wall, for example, to the wall of the aorta. Thereby, a particularly good fixation and a stable arrangement are achievable. The dimensions of the at least one anchoring member and the main body can be individually tailored for a patient, depending on the anatomy of the particular patient. In addition, the dimension of the protrusion of the at least one anchoring member can be chosen individually. In general, a standardization is also possible, whereby the anchoring member protrudes in such a way that most patients with such a type of main body or implantable device can be attended to.
[0036] According to a variant of the invention the multiple to each of the other connected wire-like elements consist of a single wire, a strand of wires of at least two single wires and/or a multiple wire, particularly the implantable device consists of areas with different stiffness factors of different yarn-like elements, in particular of a single strand, a strand of yarn of at least two single strands and/or a multiple strand.
[0037] The single strand-like element of the implantable device of the invention consists of a variant of the invention of a single strand, of a strand of strands of at least two single strands, or a multiple strand. The cross section of the wire can be, for example, round, oval, a semicircle, quadratic or rectangular and also vary along the length of the wire-like elements, particularly in the area with different stiffness. The single wire type element can, if necessary, be wrapped with platinum or gold or tungsten, or provided with gold or platinum rings, to enhance the x-ray contrast. In the case of a strand of yarn, preferably single strands of platinum or gold can be added to the strand of yarn to enhance the x-ray contrast. Particularly the use of strand of yarn or a multiple strand has the advantage that the implantable device according to the invention is especially flexible with sufficient stability.
[0038] According to the invention the main body is formed by interlocking winding and/or twisting and/or weaving in the form of a fabric and/or fabric layers and/or a net. By means of interlocking winding and/or twisting and/or weaving of the single wire-like element a tube-like element in the first operating state (primary form) is constructed. Both ends of the single-wire type element are located at the first end or at the second end or on a side surface of the main body. In this way, on the one hand the risk of injury to the patient in whom the implantable device is implanted is reduced and on the other hand, the stability of the main body is enhanced.
[0039] According to a variant of the implantable device of the invention, the at least one anchoring member is in the second operating state (secondary form) in the form of a disk or in the form of an umbrella. Alternatively, the one or one additional anchoring member is of a domed and/or curved shape. After implantation of the device of the invention the disk-shaped or umbrella-shaped anchoring member rests, for example, against the inner wall of the heart and the remaining cylindrical part of the main body extends through the opening, which should be supplied with the valve device, to a vessel. The disk-shaped or umbrella-shaped anchoring member is partially deformable so that it can better conform to the inner wall of the heart.
[0040] In a further variant of the implantable device of the invention the main body has in the second operating state (secondary form) two anchoring members, each of which extends in a radial direction from the main body. For example, the first anchor member is located at the first end and the second anchor member is located at the second end of the main body in a second operating state (secondary shape). The main body has an intermediate member between the first anchor member and the second anchor member, which has a smaller diameter than the first anchor member and the second anchor member. The diameter of the two anchoring members is the same or different. An implantable device with a first anchoring member and a second anchoring member, wherein the anchoring members are sized differently, can be constructed for example such that the first anchoring member is located in the heart's ventricle and secures there in the second operating state (secondary form) on the inner wall of the heart and the second anchoring member is located in the second operating state (secondary shape) on the inner wall of a vessel, eg an aorta. The first anchoring member, for this reason, is larger than the second anchoring member, because within the heart's ventricle there is more space than in a vessel. An implantable device with two anchoring members, in which both anchoring members are equally sized can, for example, be used in an organ or vessel wall, where the opening is closed by the valve device in one direction. of flow and in the other direction of flow a fluid connection is provided. Such an embodiment, for example one in the form of a double umbrella, allows a firm seat in the opening of the organ or vessel.
[0041] In a particularly preferred variant of the invention at least one anchoring member in the second operating state (secondary form) of the main body has a first subpart and a second subpart, wherein the first subpart extends in a radial direction of the main body facing outwards, and the second subpart is folded back in a radial direction of the main body facing inwards or outwards, particularly in such a way that the first subpart and the second subpart are folded over each other to a double layer . As an alternative, the at least one anchoring member is wound in the second operating state (secondary shape) of the main body, in particular helically. Preferably, it is the backward bending or coiling of the at least one anchoring member directed towards the middle of the main body. The anchoring member therefore has a back bend or coil that is directed towards the middle of the main body. In this way a better fixation of the device of the invention is achieved. In addition, the anchoring member is in the area of backward bending or coiling and the resulting double layer design is at least partially deformable so that the anchoring member can better conform to an organ or vessel wall. .
[0042] In an advantageous variant of the implantable device the concentration of material and/or the thickness of material within the implantable device is differently in the sections. In a preferred variant the amount of material in the edge area of the implantable device and/or in the edge area of the at least one anchoring member is adapted to the desired mechanical properties, particularly a concentration of material in the edge area of the implantable device and /or in the edge area of the at least one anchoring member is provided as a partial reinforcement.
[0043] According to a variant of the implantable device the first end and/or the second end of the main body has one or more slings or loops interwoven with each other and/or located adjacent to each other and/or interwoven with one another. These slings or loops can form a regular edge or an irregular edge. A regular edge, for example, is constructed from slings or loops of equal sizes, and an irregular edge is constructed from slings or loops of different sizes, for example, with two different sizes. Advantageously, the arrangement of slings or loops with different sizes is normal, for example a large sling or loop after three small slings or loops. The implantable device, therefore, can be adapted to the implantation site for the patient. An irregular edge has the advantage that larger slings or loops can extend into the papillary muscle of the heart and remain there, whereby greater fixation of the implantable device of the invention is achieved.
[0044] Preferably the main body of the implantable device is in accordance with a variant in the first operating state (primary form) of the stent type. Thus, the implantable device of the invention can be easily implanted using a catheter.
[0045] In a preferred variant of the implantable device of the invention both ends of the wire-like element are connectable or connected to each other, in particular with the use of an additional element by twisting, gluing, welding, soldering or other joining technology. Because both ends of the wire-like element are connectable or connected to each other it is ensured that neither side will injure the surrounding vessel or organ after implantation of the implantable device according to the invention.
[0046] In a preferred variant of the implantable device of the invention the implantable device has around it an oval cross section in the first operating state (primary form). In the second operating state (secondary form) of the implantable device the implantable device has a round and oval cross section in areas where there are no anchoring members located, preferably additionally in areas of the at least one anchoring member a round or oval section, equally.
[0047] Preferably, the diameter of the implantable device in the second operating state (secondary form) is, in areas outside the anchoring members, about 35 mm. The length of the implantable device of the invention in the second operating state (secondary form) is maximum 50mm.
[0048] According to a variant of the implantable device of the invention, the main body has one or more layers. In this way, the stability or fluid tightness of the main body can be adapted.
[0049] According to a further variant of the implantable device of the invention, the main body and the first membrane element are integrally constructed. This can be achieved, for example, by means that the first end of the main body or the second end of the main body in the second operating state (secondary shape) extends inwardly, wherein the first end of the main body respectively the second end of the main body form a valve element at the first opening of the main body respectively at the second opening of the main body.
The invention further relates to a main body and a membrane element for an implantable device according to the invention.
[0051] In the following the invention will be explained with respect to the embodiments shown in the figures. She shows:
[0052] Figure 1: a perspective view of a 1st embodiment of an implantable device of the invention,
[0053] Figure 2: a sectional view of the 1st embodiment of the implantable device of the invention from Figure 1,
[0054] Figure 3: alternative embodiments of the deployable device from Figure 1,
[0055] Figure 4: a perspective view of a 2nd embodiment of an implantable device of the invention,
[0056] Figure 5: a top view of the first end of the implantable device of Figure 4,
[0057] Figure 6: a perspective view of a 3rd embodiment of an implantable device of the invention,
[0058] Figure 7: a top view of the first end of the implantable device of Figure 6,
[0059] Figure 8: a perspective view of a 4th embodiment of an implantable device of the invention,
[0060] Figure 9: a top view of the first end of the implantable device of Figure 8,
[0061] Figure 10: a perspective view of a 5th embodiment of an implantable device of the invention,
[0062] Figure 11: a perspective view of a 6th embodiment of an implantable device of the invention,
[0063] Figure 12: a perspective view of a 7th embodiment of an implantable device of the invention,
[0064] Figure 13: a perspective view of an 8th embodiment of an implantable device of the invention,
[0065] Figure 14: a detailed view of a single wire for constructing a wire element of an implantable device of the invention,
[0066] Figure 15: a detailed view of a multiple wire for constructing a wire element of an implantable device of the invention,
[0067] Figure 16: detailed views of wire strands for the construction of a wire element of an implantable device of the invention,
[0068] Figure 17: a sectional view of a 9th embodiment of an implantable device of the invention,
[0069] Figure 18: a sectional view of a 10th embodiment of an implantable device of the invention,
[0070] Figure 19: a sectional view of an 11th embodiment of an implantable device of the invention,
[0071] Figure 20: a sectional view of a 12th embodiment of an implantable device of the invention in the implanted state,
[0072] Figure 21: a sectional view of a 13th embodiment of an implantable device of the invention,
[0073] Figure 22: a sectional view of a 14th embodiment of an implantable device of the invention,
[0074] Figure 23: a sectional view of a 15th embodiment of an implantable device of the invention,
[0075] Figure 24: a sectional view of a 16th embodiment of an implantable device of the invention,
[0076] Figure 25: a sectional view of a 17th embodiment of an implantable device of the invention,
[0077] Figure 26: a sectional view of an 18th embodiment of an implantable device of the invention,
[0078] Figure 27: a sectional view of a 19th embodiment of an implantable device of the invention,
[0079] Figure 28: a sectional view of a 20th embodiment of an implantable device of the invention,
[0080] Figure 29: a sectional view of a 21st embodiment of an implantable device of the invention,
[0081] Figure 30: a sectional view of a 22nd embodiment of an implantable device of the invention,
[0082] Figure 31: a detailed view of a main body of an implantable device of the invention with two layers,
[0083] Figure 32: a detailed view of a main body of an implantable device of the invention with three layers,
[0084] Figure 33: an exemplary process of implanting an implantable device of the invention,
[0085] Figure 34: a detailed view of a 1st embodiment of an edge area of an implantable device of the invention,
[0086] Figure 35: a detailed view of a 2nd embodiment of an edge area of an implantable device of the invention, and
[0087] Figure 36: a detailed view of a 3rd embodiment of an edge area of an implantable device of the invention.
[0088] In Figure 1 is shown a perspective view of the first embodiment of an implantable device of the invention 1 for use in the human and/or animal body 24 to replace a valve of an organ. The implantable device 1 is composed of a main body 2 having a first end 3 and a second end 4, the first end 3 and the second end 4 each having an opening 5 for providing a fluid connection through the main body. 2 between the first end 3 and the second end 4. The main body has, in a first operating state (primary form), a large ratio between the length for transverse expansion along the longitudinal axis of the main body 2 and in a second operating state (secondary shape) a smaller length ratio for the transverse expansion along the longitudinal axis of the main body 2, in which the implantable device 1 in Figure 1 is shown in the second operating state (secondary shape).
[0089] The main body 2 of the implantable device 1 is reversibly transferable from the secondary form to the primary form counteracting the forces of elastic material by applying a force.
[0090] In the center, between the first end 3 of the main body 2 and the second end 4 of the main body 2, the implantable device 1 of Figure 1 has a first membrane element 6, where the membrane element 6 is formed of such a a way that allows the connection of fluids through the main body 2 in a first flow direction and blocks the same in a second flow direction opposite to the first flow direction.
[0091] The main body 2 of the implantable device 1 of Figure 1 is formed from a single wire-like element 9 or a plurality of wire-like elements 9 connected to each other by means of interlocking and/or twisting winding and /or weaving in the form of a fabric and/or layers of fabric and/or netting.
[0092] The implantable device 1 of Figure 1 is, in the second operating state (secondary form), formed as a stent. The first end 3 of the main body 2 of the implantable device 1 of Figure 1 is, in the second operating state (secondary form), folded together into a double layer, wherein the double layer of the first end 3 is achieved by a backward folding inwards inside the implantable device 1.
[0093] In this way, an implantable device 1 to replace a valve of an organ is created, which due to the double layer at the first end 3 of the main body 2 offers a particularly good fixation in an organ and/or vessel. Because the main body 2 is reversibly transferable from the primary form to the secondary form it can be transported to the implantation site by means of a catheter 26 without problems. By pushing the implantable device 1 out of the catheter 26 the implantable device 1 unfolds from the primary form to the secondary form, whereby the diameter of the main body is increased and the overall length is reduced. Due to the possibility of reversibly transferring from the primary form to the secondary form and vice versa, from the secondary form to the primary form the implantable device 1 can be retracted into the catheter 26 in which case, during implantation , it is recognized that the implantation did not proceed correctly, particularly that the implantable device 1 was not properly placed with respect to the coronary arteries and/or the natural heart valve and/or the aorta, as well as the ventricle of the heart. By using a single thread-like element 9 constituting the implantable device 1 by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or fabric and/or mesh layers, it is achieved that the The implantable device of the invention 1 has a high flexibility without the risk that the single elements of the implantable device 1 break during transfer from the primary form to the secondary form or from the secondary form to the primary form. The design of the implantable device 1, in particular the main body 2, of a single wire type element, has the advantage that no connection points, for example solder points, between the single element of the main body are present, the which can break easily. Precisely such a breakdown of single elements of an implantable device 1 can result in sharp edge areas that protrude out of the device, which could injure or perforate a wall, in particular an aorta. The structure of the main body 2, moreover, can be constructed more evenly by means of a single wire, as is the case when connecting several ring elements, as is known from prior technology. The use of a plurality of thread-like elements 9 has the advantage that the implantable device of the invention 1 can be easily constructed by a machine.
[0094] The implantable device 1 of Figure 1 is composed of at least one radiopaque marker, namely in the form of a marker tag, marking or marker wire. The radiopaque marker, in particular, is located in the main body area 2, so it is possible to observe the positioning during implantation, particularly with regard to the connection with the coronary vessels using a monitor or something similar. Therefore, in particular an x-ray monitor or a magnetic resonance image is suitable, which can display an axial position of the implantable device 1 in the patient's body, in particular for an aortic valve replacement. The marking can be provided at different positions of the main body 2 or the implantable device 1, particularly in the area of the openings in the main body 2.
[0095] The implantable device 1 shown in Figure 1 is composed of a shape memory material, in particular of nitinol or a plastic with shape memory effect. According to the application, the implantable device 1 may consist entirely or partially of an absorbable material, in particular an absorbable plastic with a shape memory effect.
[0096] The first membrane element 6 of the implantable device 1 of Figure 1 is composed of a synthetic or biological material, particularly of polyurethane. The first membrane element 6 is further provided with a coating for establishing a biostability, in particular a titanium coating.
[0097] The main body 2 and the first membrane element 6 may be detachable or inseparably connected or connectable to each other, particularly by gluing, welding, sewing, casting, dip coating or another joining technology.
[0098] The first membrane element 6 is, in the second operating state (secondary form) of the implantable device 1, centrally located between the first end 3 of the main body 2 and the second end 4 of the main body 2.
[0099] Because the main body 2 is reversibly transferable from the secondary form to the primary form opposing the forces of elastic material through the application of a force, the implantable device 1 as shown in Figure 1 is relocatable and expandable.
[00100] The implantable device 1 is, in the second operating state (secondary form), as shown in Figure 1, between the first end 3 and the second end 4 of the main body 2, at least partially, preferably completely, deformable in a radial direction, such that the main body 2 can adapt to a wall of the vessel. Due to the main body resting against the vessel wall during implantation it is achieved that the implantable device of the invention, after implantation, does not relocate, for example, because of the pumping action of the heart. The implantable device of the invention 1 of Figure 1 can be introduced, for example, through the carotid artery or the axillary artery into the human or animal body 24, which results, compared to an implantation through the inguinal region of the patient, in a path shorter deployment.
[00101] In case the main body 2 is constructed of a single thread type element 9, for example, it is formed by a single thread 17, a strand of threads 18 of at least two single threads or a multiple thread 19. diameter can be, for example, round, oval, semicircular, quadratic or rectangular and also vary along the length of the single wire type element 9. Wire type element 9 can, if necessary, be wrapped with platinum or gold or tungsten or be supplied with gold or platinum rings to enhance x-ray contrast. In the case of a strand of yarn 18, for example, single strands of platinum or gold can be included in the strand of yarn 18 to enhance the x-ray contrast. In particular, the use of a strand of threads 18 or a multiple thread 19 has the advantage that the implantable device 1 according to the invention is particularly flexible with good stability.
[00102] According to the invention the main body 2 is formed by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or fabric layers and/or mesh. By interlocking winding and/or twisting and/or weaving of the single wire-like element 9 or the plurality of wire-like elements 9 connected to each other, a cylindrical or tube-like element is constructed in the first operating state ( primary form). Both ends of the single thread-like element 9 are, for example, located at the first end 3 or the second end 4 or on a side surface of the longitudinal main body 2 .
[00103] As can still be seen from Figure 1 the implantable device 1 has in the second operating state (secondary form) a round cross section.
[00104] In Figure 2 is shown a sectional view of the 1st embodiment of the implantable device 1 of Figure 1. In particular, Figure 2 shows that at the first end 3 of the main body 2 of the implantable device 1 a double layer is located, formed by a backward fold towards the interior of the implantable device. Due to the double layer at the first end 3 the anchoring of the implantable device 1 in the second operating state (secondary form) at the implantation site is reinforced.
[00105] In Figure 3a alternative embodiments of the implantable device 1 of Figure 1 are shown. The alternative embodiments shown differ with regard to the backward folding at the first end 3 and/or at the second end 4 of the main body 2 of the implantable device 1.
[00106] In Figure 3b, the first end 3 as well as the second end 4 of the main body 2 of the implantable device 1 is double-layered by means of a fold back towards the interior of the implantable device 1.
[00107] In Figure 3 the first end 3 of the main body 2 of the implantable device 1 is double-layered by means of a backward folding towards the outside of the main body 2 and the second end 4 of the main body 2 of the implantable device 1 is double-layered by folding back into the implantable device 1.
[00108] According to Figure 3c the first end 3 of the main body 2 of the implantable device 1 is folded back towards the inside of the implantable device 1 to build a double layer and the second end 4 is folded back towards the to the outside of the main body to build a double layer.
[00109] According to figure 3d the first end 3 and second end 4 of the main body 2 of the implantable device are folded back towards the outside of the main body 2 to create a double layer at the first end 3 and the second end 4 of the main body 2 of the implantable device 1.
[00110] In Figure 4 is shown a perspective view of the 2nd embodiment of an implantable device of the invention 1 for use in the human and/or animal body 24 to replace a valve of an organ. The implantable device 1 is composed of a main body 2 having a first end 3 and a second end 4, where each of the first end 3 and the second end 4 has an opening 5 to provide a fluid connection between the first end 3 and the second end 4 through the main body 2. The main body 2 has, in a first operating state (primary form), a large ratio between length and transverse expansion along the longitudinal axis of the main body 2 and in a second operating state (secondary shape) a minor relationship between length and transverse expansion along the longitudinal axis of the main body 2. The implantable device 1 of Figure 4 is shown in the second operating state (secondary shape).
[00111] The main body 2 of the implantable device 1 is reversibly transferable from the secondary form to the primary form by opposing the forces of elastic material through the application of a force.
[00112] At the first end 3 of the main body 2 of the implantable device 1 of Figure 4 a first membrane element 6 is located, in which the membrane element 6 is formed in such a way as to allow a fluid connection through the main body 2 in a first flow direction and locks it in a second flow direction opposite the first flow direction.
[00113] Furthermore, the main body 2 of the implantable device 1 of Figure 4 comprises, in the second operating state (secondary form), at the first end 3, an anchoring member 7 extending radially outwardly of the main body 2 to anchor device 1 in an organ and/or vessel.
[00114] The main body 2 of the implantable device 1 of Figure 4 is formed of a single wire type element 9 by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or layered fabric and/or networked.
[00115] Thereby, an implantable device 1 to replace a valve of an organ is created which has, because of the radially extending anchoring member 7 at the first end 3 of the main body 2, a particularly good anchorage in an organ and/or in a vase. When the implantable device 1 is used as in Figure 4 as a replacement of heart valves the first end 3 with the anchoring member 7 may, for example, extend into the left ventricle of the heart and anchor at this point, and the the second end 4 of the main body 2 can be placed against the wall of the aorta. Because the main body 2 is reversibly transferable from the primary form to the secondary form, it can be transported to the implantation site via a catheter 26. Upon leaving the catheter 26 the implantable device 1 deploys from the primary shape to secondary shape, in which the diameter of the main body 2 is increased and, therefore, the overall length is reduced. Due to the possibility of reversible transfer from the primary to the secondary form and vice versa from the secondary to the primary form a retraction of the implantable device 1 within the catheter 26 is possible. In the event that during implantation it is recognized that this has not proceeded correctly, in particular in the case where the implantable device 1 has not been neatly placed with respect to connections with coronary arteries and/or the natural heart valve and/or to the aorta as well as to the ventricle of the heart. Because of the use of a single-thread-like element 9 constituting the implantable device 1 by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or layered and/or mesh fabric the advantage is achieved that the implantable device of the invention 1 has a high flexibility without the risk that the unique elements of the implantable device 1 break by means of a transfer from the primary form to the secondary form or from the secondary form to the primary form. The formation of the implantable device 1, particularly of the main body 2, from a single wire-like element 9, has the additional advantage that no connection points, for example solder points, between the single elements of the main body 2 are present, which could break easily. Such a disruption of the unique elements of an implantable device 1 can result in sharp-edged areas that protrude out of the device, and can injure or perforate the wall, in particular the aorta. The structure of the main body 2 can be built more smoothly through an integral design, as is possible through the connection of single ring type elements, as known from prior technology.
[00116] The anchoring member 7 extending radially outwardly of the main body 2 is circumferentially provided on the periphery of the main body 2 at the first end 3 of the main body 2.
[00117] The implantable device 1 of Figure 4 is composed of at least one radiopaque marker, not shown, namely in the form of a marker tag, marker or marker wire. The radiopaque marker is located, in particular, in the main body area 2. In this way, it is possible to verify the positioning during implantation, particularly with regard to the connections with the coronary vessels, with the use of a monitor or something similar. . For that reason, in particular, the x-ray image or the magnetic resonance image is suitable, which can exhibit an axial positioning of the implantable device 1 in the patient's body, which is necessary for an aortic valve replacement. The marker can be provided in different areas of the main body 2 or the implantable device 1, particularly in the areas of openings in the main body 2.
[00118] The implantable device 1 shown in Figure 4 is composed of a shape memory material, particularly of nitinol or a plastic with shape memory effect. Depending on the application of the implantable device 1, it can be completely or partially made of an absorbable material, in particular an absorbable plastic with a shape memory effect.
[00119] The first membrane element 6 of the implantable device 1 of Figure 4 is composed of a synthetic or biological material, in particular of polyurethane. The first membrane element 6 is additionally provided with a coating for establishing a biostability, particularly with a titanium coating.
[00120] The main body 2 and the first membrane element 6 are detachable or inseparably connectable or connectable to each other, particularly by gluing, welding, sewing, casting, dip coating or by other joining technology.
[00121] The first membrane element 6 is, in the second operating state (secondary form) of the implantable device 1, located at the first end 3 of the main body 2.
[00122] The main body 2 is reversibly transferable from the secondary form to the primary form by opposing the forces of elastic material by applying a force, the implantable device 1 of Figure 4 is relocatable or expandable.
[00123] The implantable device 1 is, in the second operating state (secondary form) as shown in Figure 4, between the first end 3 and the second end 4 of the main body 2, at least partially, preferably completely, deformable into a radial direction, in such a way that the main body 2 can adapt to a vessel wall and/or to a circumference of an opening and/or to an edge of a defective organ valve. Because the main body 2 can adapt, during implantation to a vessel wall and/or a circumference of an opening and/or an edge of a defective organ valve, it is achieved that the implantable device of the invention 1 does not relocate, for example, caused by a pumping action of the heart.
[00124] For example, the implantable device of the invention 1 is introduced during implantation into the human and/or animal body 24 as deeply as the location of the heart valve, particularly the aortic valve, such that the natural valve during device transfer implantable device of the invention 1 from the first operating state (primary form) to the second operating state (secondary form) is pushed against the vessel wall and fixed at this point by means of the implantable device 1. In general, it is possible to introduce a an additional implantable device 1 in an already implanted device 1, wherein the first membrane element 6 of the first implanted device 1 is also pushed against the wall of the main body 2. Such an insertion of an additional implantable device 1 in an already implanted device 1 it may, for example, be necessary in case of reduced stability and flexibility of the first membrane element 6. In general, it is also It is possible to introduce an implantable device 1 as in Figure 4, with a membrane element 6 as a valve replacement where prior to implantation the old natural valve has been removed, in particular by means of surgery. Particularly in the case of strong calcification of the natural heart valve, its complete removal may be advantageous because it becomes, in general, inflexible. In such a case, it would be nearly impossible to push the natural valve onto the vessel wall. In addition, a constriction would remain in this area, which is undesirable as this would result in a reduced flow cross section and lead to an increase in pressure and therefore disadvantages for patients. In case of heart valve insufficiency, the implantable device 1 may alternatively be implanted in the insufficient valve, in particular in the aortic valve or mitral valve, without prior removal of the natural valve.
[00125] The implantable device of the invention 1 of Figure 4 is introduced, for example, through the carotid aorta or the axillaris artery into the human or animal body 24, which results, compared to an implantation through the inguinal region of the patient, to a reduced deployment path.
[00126] The main body 2 of the implantable device 1 of Figure 4 is particularly organized such that the protruding anchoring member 7 at the first end 3 projects into the heart ventricle, for example into the left ventricle of the heart , and the remaining area of the main body 2 anchors to a vessel wall, for example, the wall of the aorta. In this way, a particularly good anchorage and a firm fit is achieved. The dimensions of the anchoring member 7 and the main body 2 can be individually tailored for a patient in accordance with the anatomy of the particular patient. Also, the projection dimension of the anchoring member 7 can be chosen individually. In any case, in general, a standardization is possible, whereby the anchoring member 7 protrudes in such a shape and in such dimensions that most patients can be provided with this type of main body 2 or implantable device 1.
[00127] The single strand type element 9 of the implantable device of the invention 1 consists of a single strand 17, a strand of strands 18 of at least two single strands, or of a multiple strand 19. The cross section can be, for example , round, oval, semicircular, quadratic or rectangular and also varies along the length of the single wire type element 9. The single wire type element 9 can be, if necessary, wrapped in platinum or gold or wolfram or be supplied with rings gold or platinum, to enhance x-ray contrast. In the case of a strand of strands 18 in particular single strands of platinum or gold can be integrated into the strand of strands 18 to enhance the x-ray contrast. In particular, the use of a strand of threads 18 or a multiple thread 19 has the advantage that the implantable device 1 according to the invention is particularly flexible with sufficient stability.
[00128] According to the invention the main body 2 is formed by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or fabric in layers and/or in net. By means of interlocking winding and/or twisting and/or weaving of the single wire-like element 9 in the first operating state (primary form) an element generally of the tubular or cylindrical type is achieved. Both ends of the single wire-like element 9 are located at the first end 3 or the second end 4 or on a side wall of the longitudinal main body 2 . In this way, on the one hand, the risk of injury to the patient in whom the implantable device 1 is implanted is reduced and, on the other hand, the stability of the main body 2 is enhanced.
[00129] The anchoring member 7 of the implantable device 1 is, in the second operating state (secondary form), disc-shaped, as shown in Figure 4. After the implantation of the implantable device of the invention 1 the anchoring member is shaped. disk 7 rests, for example, against the inner wall of the heart and the remaining cylindrical part of the main body 2 extends through an opening, which is to be provided with a valve device by the implantable device 1, within a vessel, so that the disc-shaped anchoring member 7 can conform to the inner wall of the heart, it is partially deformably constructed.
[00130] The anchoring member 7 has in the second operating state (secondary form) of the main body 2 a first subpart 22 and a second subpart 23, where the first subpart 22 extends in a radial direction from the main body 2 in the direction to the outside and the second subpart 23 is folded back in a radial direction of the main body 2 towards the inside, particularly in such a way that the first subpart 22 and the second subpart 23 are folded over each other forming a double layer. . The backward bending of the anchoring member 7 lies towards the middle of the main body 2. The anchoring member 7 is, due to the backward bending and the resulting double layer in this area, at least partially deformable, such that the member anchor 7 may better conform to the wall of an organ or vessel.
The first end 3 and the second end 4 of the main body 2 have one or more slings or multiple loops interwoven with each other and/or located adjacent to each other and/or interwoven with each other. These slings or loops 21 form a regular edge 28. The regular edge 28 is, for example, formed by slings or loops 21 of the same size.
[00132] Both ends of wire-like elements 9 are connectable or connected to each other, particularly through the use of an additional element, by twisting, gluing, welding, bending or other joining technology. In this way, it is guaranteed that neither of the two ends can injure a neighboring vessel or organ after implantation of the implantable device 1.
[00133] As can still be seen from Figure 4 the implantable device 1 has in the second operating state (secondary form) at least in the area where no anchoring member 7 is located a round cross section. The implantable device 1 of Figure 4 also has in the area of the anchoring member 7 a round cross section.
[00134] In Figure 5 a top view of the first end 3 of the implantable device 1 of Figure 1 is shown. Particularly it can be seen from Figure 5 that the first membrane element 6 has a ring part 13 and a ring part. valve 14 connected to ring part 13. Valve part 14 is provided with three leaflet elements 15.
[00135] The first membrane element 6 is, in the second operating state (secondary form), located at the first end 3 of the main body 2. The first membrane element 6 is, for example, in the area of the connected ring portion 13 to the first end 3 of the main body 2, for example by means of stitching. The valve part 14 is dimensioned such that a fluid connection through the main body 2 is allowed in a first flow direction and in a second flow direction opposite the first flow direction it is blocked, in particular in such a way that the cross section of the valve part 14 in cross section corresponds to the cross section of the valve arrangement to be replaced.
[00136] Figure 6 shows a perspective view of a third embodiment of an implantable device of the invention 1. The implantable device 1 for use in the human and/or animal body 24 to replace a valve of an organ according to Figure 6 is composed of a main body 2 having a first end 3 and a second end 4, each of the first end 3 and the second end 4 each having an opening 5 for providing a fluid connection between the first end 3 and the second end. 4 through the main body 2 and a first membrane element 6 arranged at the second end 4 of the main body 2, in which the membrane element 6 is formed in such a way as to allow the connection of fluids through the main body 2 in a first flow direction and blocks the same flow in a second flow direction opposite the first flow direction. The main body 2 has, in a first operating state (primary shape), a large relationship between length and transverse expansion along the longitudinal axis of the main body 2, and in a second operating state (secondary shape) a relationship the smallest between the length and the transverse expansion along the longitudinal axis of the main body 2. The main body 2 is reversibly transferable from the secondary shape to the primary shape by opposing the forces of elastic material through the application of a strength. The implantable device 1 in Figure 6 is shown in the second operating state (secondary form).
[00137] The main body 2 has, in the second operating state (secondary form), at the first end 3, an anchoring member 7 that projects radially towards the outside of the main body 2 to anchor the device in an organ and/ or in a vase.
[00138] The main body 2 of the implantable device 1 of Figure 6 is formed from a single wire-like element 9 or from a plurality of wire-like elements 9 connected to each other by means of interlocking winding and/ or twisting and/or weaving in the form of a fabric and/or layered and/or netted fabric.
[00139] The embodiment according to Figure 6 differs from the embodiments according to Figure 5, in this way, in that the first membrane element is located at the second end 4 of the main body 2. Furthermore, the first membrane element 6 according to the embodiment of Figure 6 differs from the embodiment of Figure 5 by means of that it consists of three leaflet elements 15 and has no ring portion 13 as the first membrane element 6 of Figure 5.
[00140] In Figure 7 a top view of the first end 3 of the implantable device 1 of Figure 6 is shown. The first membrane element 6 of the embodiment of Figure 7 is located at the end of the implantable device 1 extending to the plane of projection and visible by the fluid connection in the longitudinal direction through the main body 2. The remaining design of the embodiment according to Figures 6 and 7 corresponds to the embodiment according to Figures 4 and 5.
[00141] In Figure 8 is shown a perspective view of a 4th embodiment of an implantable device of the invention. The implantable device 1 is composed of a main body 2 having a first end 3 and a second end 4, each of the first end 3 and the second end 4 each having an opening 5 for providing a fluid connection between the first end 3 and the second end 4 through the main body 2 and a first membrane element arranged within the main body 2, in which the membrane element 6 is formed in such a way as to allow the connection of fluids through the main body 2 in a first flow direction and blocks it in a second flow direction opposite to the first flow direction. The main body 2 has, in a first operating state (primary shape), a large relationship between length and transverse expansion along the longitudinal axis of the main body 2, and in a second operating state (secondary shape) a relationship smaller between the length and the transverse expansion along the longitudinal axis of the main body 2, wherein the main body 2 of the implantable device 1 in Figure 8 is shown in the second operating state (secondary form). The main body 2 is reversibly transferable from the secondary shape to the primary shape by opposing the forces of elastic material by applying a force.
[00142] The main body 2 has in the second operating state (secondary form) at the first end 3 and at the second end 4, anchoring members 7, 8 that extend radially towards the outside of the main body 2 to anchor the device in a organ and/or in a vessel.
[00143] The main body 2 is formed from a single yarn-like element 9 or a plurality of yarn-like elements 9 connected to each other by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or layered and/or netted fabric.
[00144] The two anchoring members 7,8 which extend radially towards the outside of the main body 2 are provided circumferentially on the circumference of the main body 2 at the first end 3 and at the second end 4 of the main body 2.
[00145] Furthermore, the implantable device 1 of Figure 8 is composed of at least one radiopaque marker, namely in the form of a marker tag, marker or marker wire.
[00146] The implantable device 1 of Figure 8 consists completely or partially of a shape memory material, in particular of nitinol or a plastic with shape memory effect. Particularly when a shape memory plastic is used, the implantable device 1 can be completely or partially constructed in an absorbable manner.
[00147] Because the main body 2 of the implantable device 1 as shown in Figure 8 is reversibly transferable from the secondary form to the primary form opposing the forces of elastic material by applying a force, the implantable device 1 it is relocatable and/or expandable.
[00148] Furthermore, the implantable device 1 is, in the second operating state (secondary form) between the first end 3 and the second end 4 of the main body 2, at least partially, preferably completely, deformable in a radial direction, such that the main body 2 can adapt to a vessel wall and/or to a circumference of an opening and/or to a valve edge of the defective organ.
[00149] The single-strand element 9 of the implantable device 1 of Figure 8 consists of a single strand 17, a strand of strands 18 of at least two single strands, or a multiple strand 19. Both ends of the strand-type element 9 are located at the first end 3 or the second end 4 or on a side surface of the main body 2.
The first anchoring member 7 is located at the first end 3 of the main body 2 and the second anchoring member 8 is located at the second end 4 of the main body 2. The first anchoring member 7 is the second anchoring member. 8 anchors are disk-shaped in the second operating state (secondary shape). The first anchoring member 7 is flat and the second anchoring member 8 is domed. Between the first anchoring member 7 and the second anchoring member 8 the main body 2 of the implantable device 1 comprises an intermediate member 20, which has a smaller diameter than the first anchoring member 7 and the second anchoring member 8 The diameters of the two anchoring members 7, 8, are different. As can be seen from Figure 8 the diameter of the first anchoring member 7 is larger than the diameter of the second anchoring member 8.
[00151] The two anchoring members 7, 8, have in the second operating state (secondary shape) of the main body each a first subpart 22 and a second subpart 23, wherein the first subpart 22 extends in a radial direction of the main body 2 towards the outside, and the second subpart is folded back in a radial direction of the main body 2 towards the inside, particularly in such a way that the first subpart 22 and the second subpart 23 are folded one on top of the other to form a double layer. The dished design of the second anchor member 8 as shown in Figure 8 also forms a double-layer bent anchor member 8 in the sense of the invention.
[00152] The first end 3 and the second end 4 of the main body 2 of the implantable device 1 as shown in Figure 8 each have one or more slings or loops 21 intertwined with each other and/or located adjacent to each other and /or intertwined with each other. The slings or loops 21 form a regular edge 28.
[00153] Both ends of wire-like elements 9 are connectable or connected to each other, particularly through the use of an additional element, by twisting, gluing, welding, soldering, or other joining technology.
[00154] The cross section of the implantable device 1 of Figure 8 is, in the first operating state (primary shape), round or oval. In the second operating state (secondary form), the implantable device 1 has a cross section in areas where no anchoring member 7, 8, is located that is round or oval. In the areas of the anchoring members 7, 8, the implantable device 1 of Figure 8 also has a round or oval cross-section.
[00155] The diameter of the implantable device 1 of Figure 8 in the second operating state (secondary form) in areas outside the anchoring members 7, 8, particularly in the area of the intermediate member 20 is about 35 mm. The length of the implantable device 1 in the second operating state (secondary form) is a maximum of 50 mm.
[00156] The main body 2 of the implantable device 1 may have one or more layers.
[00157] Figure 9 shows a top view of the first end of the implantable device of Figure 8. As can be seen from Figure 9 at the first end 3 of the main body 2 of the implantable device 1 the first membrane element 6 is located . The first membrane element 6 consists of a synthetic or biological material, particularly of polyurethane. Furthermore, the first membrane element 6 comprises a coating for establishing biostability, particularly a titanium coating.
[00158] The main body 2 of the implantable device 1 and the first membrane element 6 are detachable or inseparably connected or connectable to each other, particularly by gluing, welding, sewing, casting, dip coating or by another technology of junction.
[00159] The first membrane element 6 has a ring part 13 and, connected thereto, a valve part 14. The valve part 14 of the first membrane element 6 comprises, according to Figure 9, three elements of leaflet 15.
[00160] The 4th embodiment of the implantable device of the invention 1 shown in Figures 8 and 9 with a first anchoring member 7, the second anchoring member 8 and the intermediate member 20 located therebetween is particularly suitable for replacing a bicuspid valve or a tricuspid valve. The implantable device 1 according to the 4th embodiment of Figures 8 and 9 is located in such a way in the human or animal body 24, that parts of the heart papillary muscle are located in the area of the intermediate member 20 and the first anchoring member 7 and the second anchoring member 8 are located on different sides of the papillary muscle and lean against the papillary muscle, whereby the implantable device 1 is fixed to the heart of the human or animal body 24. In the case of a stenosis of the natural valve, the old natural valve must be removed, in particular by surgery, and in this place the implantable device 1 with the first membrane element 6 must be implanted as a replacement for the valve. Particularly in the case of strong calcification of the natural heart valve it is advantageous to completely remove the natural heart valve, as it generally becomes substantially inflexible. In that case, it would be almost impossible to push the natural valve into the vessel wall. Furthermore, a narrowing would remain in this area, which is also not desired because it results in a reduction in the cross-section of the flow, and results in a higher pressure that causes health disadvantages for the patient. In case of a heart valve insufficiency, the implantable device of the invention 1 may be implanted in the insufficient valve, for example in the bicuspid valve (mitral valve) without prior removal of the natural valve.
[00161] In Figure 10, there is shown a perspective view of a 5th embodiment of an implantable device of the invention 1. The implantable device 1 for use in the human and/or animal body 24 to replace a valve of an organ is composed of a main body 2 having a first end 3 and a second end 4, where each of the first end 3 and the second end 4 has an opening 5 for providing a fluid connection through the main body 2 between the first end 3 and the second end 4, and a first membrane element 6 arranged within or at one of the ends of the main body 2, wherein the membrane element 6 is constituted in such a way as to allow the connection of fluids through the main body 2 in a first direction. of flow and blocks it in a second flow direction opposite to the first flow direction. The main body 2 has in a first operating state (primary shape) a large ratio between length and transverse expansion along the longitudinal axis of main body 2, and in a second operating state (secondary shape) a smaller ratio between the length and the transverse expansion along the longitudinal axis of the main body 2. The main body 2 of the implantable device 1 in Figure 1 is shown in the first operating state (primary form).
[00162] The main body 2 of the implantable device 1 is reversibly transferable from the secondary form to the primary form by opposing the forces of elastic material by applying a force.
[00163] In the second operating state (secondary form) the main body 2 has at the first end 3 and/or at the second end 4 at least one anchoring member 7, 8, which extends radially towards the outside of the main body 2 to anchor device 1 to an organ and/or vessel.
[00164] The main body 2 of the implantable device 1 is formed of a single wire-like element 9 or of a plurality of wire-like elements 9 connected to each other by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or layered and/or netted fabric.
[00165] The implantable device 1 of Figure 10 has areas of different stiffness 10, 11. The areas of different stiffness 10, 11 are formed by means of different interlocking windings and/or twists and/or weaves. In the 5th embodiment of the implantable device of the invention 1 of Figure 10 an area of lesser rigidity 10 is located between the areas of greater rigidity 11. The area of lesser rigidity 10 is located in the main body 2 outside of at least one member of anchorage 7, 8. In the case where at least one anchoring member 7, 8 is located at the first end 3 and/or the second end 4 of the main body 2 the area with less rigidity 10 of the main body 2 is located in the intermediate zone of the main body 2.
[00166] The area with less rigidity 10 of the implantable device 1 according to the 5th embodiment of the implantable device of the invention 1 of Figure 10 is constructed by means of a different interweaving of the single wire-type element 9 of the main body or of the plurality of wire-like elements 9 of the main body 2 connected to each other. As can be seen from Figure 10, the mesh size in the area of least stiffness 10 of the fabric and/or the layered fabric and/or the mesh formed by interlocking winding and/or twisting and/or weaving is greater than in areas with greater rigidity 11.
[00167] Alternatively, the area of lesser stiffness 10 can be created, for example, by means of another interlocking winding and/or twisting of a single wire-like element 9 or a plurality of wire-like elements 9 connected to one another. to the others as can be seen, for example, from the 6th embodiment of the implantable device of the invention 1 of Figure 11.
[00168] The implantable device 1 according to the 5th embodiment of Figure 10 and according to the 6th embodiment of Figure 11 is, in the first operating state (primary form) formed as a stent. A cross section of the implantable device 1 in the first operating state (primary shape) is round or oval.
[00169] The areas of different stiffness 10, 11, disclosed with respect to the 5th and 6th embodiments of the implantable device 1 can be combined with the two to four embodiments of the implantable device 1 of Figure 4 to 9 and the embodiments disclosed therein Follow. For example the implantable device 1 according to the 5a and 6a embodiments of Figures 10 and 11 can be constructed in the second operating state (secondary form) according to one of the embodiments two to four of Figures 4 to 9.
[00170] Figure 12 shows a perspective view of a 7th embodiment of an implantable device of the invention 1. The 7th embodiment of the implantable device of the invention 1 differs from the second embodiment of the implantable device of the invention 1, in that the main body has hair. at least one opening 12 in its circumferential wall, to provide a fluid connection between the interior of the main body 2 and a human and/or animal body vessel 24. The at least one opening 12 has a diameter corresponding to a coronary artery. In the 7th embodiment according to Figure 12 the main body 2 has two openings in its circumferential wall, which in the implanted state of the device 1 are arranged in such a way that the two openings overlap the coronary arteries. The two openings 12 in the circumferential wall of the main body 2 are located outside the at least one anchoring member 7, 8.
[00171] In Figure 13 a perspective view of an 8th embodiment of the implantable device of the invention 1 is shown. The 8th embodiment of the implantable device of the invention 1 according to Figure 13 differs from the 7th embodiment of the implantable device of the invention 1 according to Figure 12, in that the at least one opening in the circumferential wall of the main body 2 is constructed by another interlocking winding and/or twisting and/or weaving of the single yarn-like element 9 of the main body 2 or a plurality of yarn-like elements 9 connected together, of the main body 2, wherein in the area of the at least one opening 12 in the wall circumferentially of the main body 2 a larger mesh size is achieved by further interlocking winding and/or twisting and/or weaving of the single yarn-like element 9 of the main body 2 or the plurality of yarn-like elements 9 connected together. others, of the main body 2, compared to the other areas of the circumferential wall of the main body 2. In the embodiment according to Figure 13 the at least one opening 12 in the circumferential wall. The differential of the main body 2 is constructed by further twisting the single thread-like element 9 of the main body 2 or of the plurality of thread-like elements 9 connected to each other of the main body 2.
[00172] Embodiments according to Figures 12 and 13 may also be combined with embodiments 3 to 6 of the implantable device of the invention 1 according to Figures 6 to 11 and the embodiments disclosed in the following.
[00173] According to a particularly preferred embodiment at least one radiopaque marker is located in the area of the at least one opening 12 in the circumferential wall of the main body 2, namely in the form of a marker label, marking or marker wire. In this way, the positioning of the implantable device 1 during implantation of the implantable device 1, for example, in relation to the coronary arteries, can be monitored.
[00174] In Figures 14 to 16 different designs of the single wire type element 9 of the main body 2 according to the implantable device of the invention 1 are shown. With the use of a single thread-like element 9 the main body 2 of the implantable device 1 is formed by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or fabric in layers and/or in network.
[00175] According to an embodiment the single wire type element 9 is formed by a single wire 17, as shown in Figure 14. In Figure 15, an embodiment is shown whereby the single wire type element 9 is formed by a multiple wire. In Figures 16a to 16c strands of strands are shown, which form the single strand like element 9 of the implantable device 1. The strand of strands 18 of Figure 16a is composed of two single strands, the strand of strands 18 of Figure 16b is composed of four single strands, and the strand of strands 18 in Figure 16c is composed of six single strands.
[00176] The difference between the multiple strand 19 according to Figure 15 and a strand of yarn 18 according to Figure 16 is that the single strands of the strands of yarn are twisted together, while the single strands of the yarn multiple run in parallel to each other.
Advantageously, the single strand of the multiple strand 19 according to Figure 15 or the strand of strands 18 according to Figure 16 is constructed as a marker wire, to provide a radiopaque marking within the implantable device 1.
The single strands according to Figures 14 to 16 consist completely or partially of a shape memory material, particularly of nitinol or a shape memory effect plastic. In particular, when a shape memory plastic is used, it can be completely or partially absorbable.
[00179] Both ends of the wire-like element 9, as for example shown in Figures 14 to 16, are located at the first end 3 or the second end 4 or on a side surface of the main body 2 of the implantable device 1.
[00180] Both ends of the element of type 9 are advantageously connectable or connected to each other, particularly through the use of an additional element, by twisting, gluing, welding, welding or by another joining technology.
[00181] In Figure 17 a sectional view of a 9th embodiment of an implantable device of the invention 1 for use in the human and/or animal body 24 to replace a valve of an organ is shown. The implantable device 1 is composed of a main body 2 having a first end 3 and a second end 4, where each of the first end 3 and the second end 4 has an opening 5 for providing a fluid connection through the main body 2 between the first end 3 and the second end 4 and a first membrane element 6 arranged at the second end 4 of the main body 2, in which the membrane element 6 is formed in such a way as to allow the connection of fluids through the main body 2 in a first flow direction and locks it in a second flow direction opposite the first flow direction. The main body 2 has in the first operating state (primary shape) a large ratio between length and transverse expansion along the longitudinal axis of the main body 2 and in a second operating state (secondary shape) a smaller ratio between the length and the transverse expansion along the longitudinal axis of the main body 2, in which the implantable device 1 of Figure 17 is shown in the second operating state (secondary shape) of the main body 2. The main body 2 is reversibly transferable from the secondary form to the primary form opposing the forces of elastic material through the application of a force.
[00182] In the second operating state (secondary form) the main body 2 has at the first end 3 and at the second end 4 an anchoring member 7, 8, for anchoring the device in an organ and/or in a vessel. According to the embodiment of Figure 17 the first anchoring member 7 is located at the first end 3 of the main body 2 and the second anchoring member 8 is located at the second end 4 of the main body 2.
[00183] The main body 2 is formed from a single yarn-like element 9 or a plurality of yarn-like elements 9 connected to each other by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or layered and/or netted fabric.
[00184] The anchoring members 7, 8, which extend evenly towards the outside of the main body 2 are circumferentially provided on the circumference of the main body 2 at the first end 3 and at the second end 4.
[00185] The implantable device 1 of Figure 17 may have areas of different stiffness 10, 11, particularly as disclosed in relation to Figures 10 and 11. The areas of different stiffness 10, 11, are for example formed by means of a different interlocking winding and/or twisting and/or weaving. Advantageously, an area with less rigidity 10 lies between the areas with greater rigidity 11, and the area with less rigidity 10 is located in the main body 2 outside of the anchoring members 7, 8.
[00186] As disclosed in relation to Figures 12 and 13, the main body 2 may have in its circumferential wall at least one opening 12 to provide a fluid connection between the interior of the main body 2 and a human body vessel and/or animal 24. The at least one opening 12 advantageously has a diameter corresponding to a coronary artery. In particular, the main body 2 has in its circumferential wall two openings 12, which in the implanted state of the implantable device 1 are arranged in such a way that the two openings 12 overlap the connections to the coronary arteries. Advantageously the at least one opening 12 in the circumferential wall of the main body 2 is located outside the anchoring member 7, 8.
[00187] The at least one opening 12 in the circumferential wall of the main body 2, for example, is constructed by an additional interlocking winding and/or twisting and/or weaving of the single wire-like element 9 of the main body 2 or of the plurality of thread-like elements 9 connected together, of the main body 2, wherein by means of the additional interlocking winding and/or twisting and/or weaving of the single thread-like element 9 of the main body 2 or the plurality of elements of the wire type 9 connected to each other, of main body 2, a larger mesh size is achieved as in the other areas of the circumferential wall of main body 2.
[00188] As already explained in relation to the previous embodiments, the implantable device 1 comprises at least one radiopaque marker, namely in the form of a marker tag, marking or a marker wire. Advantageously the at least one radiopaque marker is located in the area of the opening 12 in the circumferential wall of the main body 2, to check during implantation whether the opening 12 corresponds with a coronary artery.
[00189] The implantable device 1, in particular the main body 2, according to the 9th embodiment of figure 17 is constructed completely or partially of a shape memory material, particularly of nitinol or a plastic with shape memory effect. . Furthermore, the implantable device 1 can consist entirely or partially of an absorbable material.
[00190] The first membrane element 6 of the implantable device 1 is composed of a synthetic or biological material, in particular of polyurethane. In particular, the first membrane element 6 has a coating for establishing a biostability, in particular a titanium coating.
[00191] The main body 2 and the first membrane element 6 are detachable or inseparably connected or connectable to each other, in particular by gluing, welding, sewing, casting, dip coating or by another joining technology.
[00192] The first membrane element 6 may have a ring part 13 and a valve part 14 connected thereto, as for example in relation to the second embodiment of the implantable device of the invention 1 and shown in Figure 5. The part valve 14 is advantageously composed of three leaflet elements 15.
[00193] According to the embodiment of Figure 17, the first membrane element 6 is located in the second operating state (secondary form) at the second end 4 of the main body 2.
[00194] The implantable device according to the 9th embodiment of Figure 17 comprises a second membrane element 16 to partially close the openings 5, at the first end 3 and at the second end 4, to fluids. In the embodiment according to Figure 17 the second membrane element 16 is located in the second operating state (secondary shape) of the main body 2 at the first end 3.
[00195] The implantable device 1 of Figure 17 is relocatable and/or expandable.
[00196] The implantable device 1 shown is, in the second operating state (secondary form) between the first end 3 and the second end 4 of the main body 2, at least partially, preferably completely, deformable in a radial direction, of a such that the main body 2 can adapt to a vessel wall and/or to a circumference of an opening and/or to a valve edge of a defective organ. The implantable device 1 of Figure 17 is therefore deformable, particularly in the area of the intermediate member 20 between the first anchoring member 7 and the second anchoring member 8 in a radial direction.
[00197] As illustrated in relation to Figures 14 to 16, the single strand type element 9 may consist of a single strand 17, a strand of strands 18 of at least two single strands, or a multiple strand 19.
[00198] Both ends of the wire-like element 9 are preferably located at the first end 3 or the second end 4 or on a side surface of the main body 2. Advantageously both ends of the wire-like element 9 are connectable or connected to a to the other, in particular with the use of an additional element, by twisting, gluing, welding, soldering or by another joining technology.
[00199] The first anchoring member 7 and the second anchoring member 8 of the 8th embodiment according to figure 17 are, in the second operating state (secondary form), disc-shaped.
[00200] The diameter of the two anchoring members 7, 8, are equal.
[00201] The first anchoring member 7 and the second anchoring member 8 each have in the second operating state (secondary form) of the main body 2 a first subpart 22 and a second subpart 23, in which the first subpart 22 extends is in a radial direction of the main body 2 towards the outside, and the second subpart is folded back in a radial direction of the main body 2 towards the inside, in particular in such a way that the first subpart 22 and the second subpart 23 are folded over each other to form a double layer. The backward bending of the first anchoring member 7 of Figure 17 is directed towards the middle of the main body 2. The backward bending of the second anchoring member 8 of Figure 17 is located away from the middle of the main body 2.
[00202] The thickness of the material and/or the concentration of material in the implantable device 1 may be different in the sections, for example the amount of material in the edge area of the implantable device 1 is adapted to the desired mechanical properties. Particularly in the edge area a concentration of material 27 is located for partial reinforcement.
[00203] The first end 2 and/or the second end 4 of the main body 2 of the implantable device 1 of Figure 17 has one or more slings or loops 21 interwoven with each other and/or located adjacent to each other and/or interwoven with each other. The slings or loops 21 can form a regular edge 28 or an irregular edge 29. The irregular edge 29, for example, is formed by slings or loops 21 of different sizes, for example, of slings or loops 21 of two different sizes. Advantageously the arrangement of slings or loops 21 with different sizes is normal, for example a large sling or loop 21 after three small slings or loops 21.
[00204] The main body of the implantable device 1 is, in the first operating state (primary form), of the stent type. The cross section of the implantable device 1 is, in the first operating state (primary shape) particularly round or oval. In the second operating state (secondary form) of the implantable device 1 the cross section is, in areas where there are no anchoring members 7, 8 located, round or oval, and particularly also in areas where the anchoring members 7, 8 are located. .
[00205] For example, the diameter of the implantable device 1 is, in the second operating state (secondary form) in the area outside the anchoring members 7, 8, of about 35 mm and the length of the implantable device 1 is, in the second operating status (secondary shape) of maximum 50 mm.
[00206] The main body 2 of the implantable device 1 may have one or more layers.
[00207] The 10th embodiment of the implantable device of the invention 1 shown in the sectional view in Figure 18 differs from the 9th embodiment of the implantable device of the invention 1 of Figure 17 in that the first membrane element 6 is located within the main body 2 between the first end 3 and second end 4 of the main body. In particular, approximately in the middle of the longitudinal direction of the main body 2 between the first end 3 and the second end 4 of the main body 2. Furthermore, in the 10th embodiment according to Figure 18 the second membrane element 16 is located in the second end 4 of the implantable device 1 between the first subpart 22 and the second subpart 23 of the second anchoring member 8.
[00208] Figure 19 shows a sectional view of an 11th embodiment of an implantable device of the invention 1 in an implanted state in a human or animal body 24. The 11th embodiment according to Figure 19 differs from the 10th embodiment according to Figure 18, in which the second membrane element 16 is located at the first end 3 of the implantable device 1. The second membrane element 16 and the first membrane element 6 are, in the second operating state (secondary form) of the device. implantable 1, adjacent to each other whereby, particularly in the second flow direction, a close fluid connection is achieved.
The 12th embodiment of an implantable device of the invention 1 in the implanted state is shown in Figure 20. The 12th embodiment of Figure 20 differs from the 9th embodiment of Figure 17 in that the first membrane element is located in such a way that the the first flow direction and the second flow direction of the 12th embodiment are designed in opposition to the 8th embodiment of Figure 17.
[00210] In Figure 21 a 13th embodiment of an implantable device of the invention 1 for use in the human and/or animal body 24 to replace a valve of an organ is shown in a sectional view. The implantable device 1 is composed of a main body 2 having a first end 3 and a second end 4, where each of the first end 3 and the second end 4 has an opening 5 for providing a fluid connection through the main body 2 between the first end 3 and the second end 4 and a first membrane element 6 arranged within the main body 2, in which the membrane element 6 is formed in such a way as to allow the connection of fluids through the main body 2 in a first flow direction and locks it in a second flow direction as opposed to the first flow direction. The main body 2 has in a first operating state (primary shape) a large ratio between length and transverse expansion along the longitudinal axis of main body 2 and in a second operating state (secondary shape) a smaller ratio between the length and the transverse expansion along the longitudinal axis of the main body 2. The main body 2 is reversibly transferable from the secondary shape to the primary shape by opposing the forces of elastic material through the application of a force. In Figure 18, the implantable device 1 is shown in the second operating state (secondary form).
[00211] In the second operating state (secondary form) shown the main body 2 has at the first end 3 and at the second end 4 each anchoring members 7, 8, which extend radially towards the outside of the main body 2 to anchor device 1 in an organ and/or vessel.
[00212] The main body 2 of the implantable device 1 is formed from a single wire-like element 9 or a plurality of wire-like elements 9 connected to each other by means of interlocking winding and/or twisting and/or weaving in the form of a fabric and/or layered and/or netted fabric.
[00213] The anchoring members 7, 8, which extend evenly towards the outside of the main body are circumferentially provided on the circumference of the main body 2 at the first end 3 and at the second end 4.
[00214] According to the 5th and 6th embodiments of Figures 10 and 11 the 13th embodiment according to Figure 21 may also have areas of different stiffness 10, 11.
[00215] The main body 2 of the implantable device 1 of Figure 21 may have at least one opening 12 in its circumferential wall, to provide a fluid connection between the interior of the main body 2 and a human or animal body vessel 24, in particular, as disclosed in relation to the embodiments of Figures 12 and 13.
[00216] Advantageously the implantable device 1 of Figure 21 consists completely or partially of a shape memory material, in particular of nitinol or a plastic with shape memory effect, and is further composed of at least one radiopaque marker, namely in the form of a marker tag, marking or marker wire. The implantable device 1 can also be completely or partially constituted from an absorbable material.
[00217] The first membrane element 6 of the implantable device 1 of Figure 21 is composed of a synthetic or biological material and, in particular, is provided with a coating for establishing a biostability, particularly a titanium coating.
[00218] The main body 2 and the first membrane element 6 of the implantable device 1 are detachable or inseparably connected or connectable to each other, in particular by gluing, welding, sewing, casting, dip coating or by another technology of junction. The first membrane element 6 is, in the second operating state (secondary form), located between the first end 3 and the second 4 of the main body 2, in particular centrally in the longitudinal direction of the main body 2 between the first end 3 and the second end 4 of main body 2.
[00219] The main body 2 of the implantable device 1 comprises in the second operating state (secondary form) at the first end 3 a second membrane element 16, to partially close the opening 5 at the first end 3, to fluids.
[00220] The implantable device 1 as shown in Figure 1 is relocatable and expandable.
[00221] Furthermore, the implantable device 1 of Figure 21 is, in the second operating state (secondary form) between the first end 3 and the second end 4 of the main body 2, therefore particularly in the area of the intermediate member 20, at less partially, preferably completely, deformable in a radial direction, such that the main body 2 can adapt to a wall of a vessel and/or a circumference of an opening and/or an edge of a defective opening.
[00222] The single strand 9 element of the implantable device 1 is composed of a single strand 17, a strand of strands 18 of at least two single strands or a multiple strand 19, as particularly disclosed with respect to the embodiments of the Figures from 14 to 16.
[00223] Both ends of the wire-type element 9 are located at the first end 3 or the second end 4 or on a side surface of the main body 2. In addition, both ends of the wire-type element are connectable or connected to one another. another, in particular with the use of an additional element by twisting, gluing, welding, soldering or by some other joining technology.
[00224] The first anchoring member 7 of the implantable device 1 is, in the second operating state (secondary form), located at the first end 3 of the main body 2 and the second anchoring member 8 is located at the second end 4 of the body main 2. The second anchoring member 8 is, in the second operating state (secondary shape), umbrella-shaped, as shown in Figure 21. The second anchoring member 8 is, in the second operating state (secondary shape), ) of the main body, a first subpart 22 and a second subpart 23, wherein the first subpart 22 extends in a radial direction towards the outside of the main body 2 and the second subpart 23 is folded back in a radial direction at towards the interior of the main body 2, in particular in such a way that the first sub-part 22 and the second sub-part 23 are folded over each other to form a double layer.
[00225] As shown in Figure 21 the first anchoring member 7 is, in the second operating state (secondary form) of the main body 2, coiled, particularly helical. The coiling of the first anchoring member 7 is directed towards the middle of the main body 2.
[00226] As already disclosed in relation to the previous embodiments the concentration of material 27 and/or the thickness of material within the implantable device 1 may partially differ. Particularly the amount of material in the edge area of the implantable device 1 is adapted to the desired mechanical properties, in particular in the edge area of the implantable device 1 a concentration of material 27 is localized for a partial reinforcement.
[00227] The first end 3 or the second end 4 of the main body 2 of the implantable device 1 advantageously has one or more slings or loops 21 interwoven with each other and/or located adjacent to each other and/or interwoven with each other . The slings or loops 21 form a regular edge 28 or an irregular edge 29. An irregular edge 29 is formed by slings or loops 21 of different sizes, for example by slings or loops 21 of two different sizes. The arrangement of slings or loops 21 with different sizes can be regular, for example a large sling or loop 21 after three small slings or loops 21.
[00228] In the first operating state (primary form) not shown, the main body 2 of the implantable device 1 of Figure 21 is of the stent type and has a round or oval cross-section.
[00229] In the second operating state (secondary form), the implantable device 1 of Figure 21 has round or oval cross-sections in areas where there are no anchoring members. The implantable device 1 shown has, in the second operating state (secondary form), in areas outside the anchoring members 7, 8, a diameter of about 35 mm and a length of at most 50 mm.
[00230] The main body 2 of the implantable device 1 of Figure 21 can have one or more layers.
[00231] Figure 22 shows a sectional view of a 14th embodiment of an implantable device of the invention 1 for use in the human and/or animal body 24 to replace a valve of an organ. The 14th embodiment according to Figure 22 differs from the 13th embodiment according to Figure 21, on the one hand, in that the first membrane element 6 is located at the first end 3 of the implantable device 1 in the second operating state (secondary form ). On the other hand, the implantable device 1 according to Figure 22 is composed of a second membrane element 16, which in the second operating state (secondary form) is located at the first end 3 of the implantable device 1. The first membrane element 6 and the second membrane element 16 are located adjacent to each other at the first end 3 of the main body 2 in the second operating state (secondary shape). In this way, particularly the fluid narrowing of the implantable device 1 at the first end is improved.
[00232] Furthermore, the 14th embodiment according to Figure 22 differs from the 13th embodiment of Figure 21, in that the second anchoring member 8 is domed. In this way, it is achieved that the second anchoring member 8 is deformable and, for example, better conforms to a vessel wall or to the inner wall of a heart ventricle.
[00233] In Figure 23 a sectional view of a 15th embodiment of an implantable device of the invention 1 for use in a human or animal 24 to replace a valve of an organ is shown. The 15th embodiment according to Figure 23 differs from the 14th embodiment according to Figure 22, in that the second membrane element 16 is located at the first end 3 of the implantable device 1. Furthermore, the second anchoring member 8 in the second end 4 of main body 2 is bent in the second operating state (secondary shape). A curvature of the second anchoring member 8 is located away from the middle of the main body 2, such that the apex of the curvature is directed towards the intermediate member 20 of the main body 2.
[00234] Furthermore, the diameter of the second anchoring member 8 is greater than the diameter of the first anchoring member.
[00235] A 16th embodiment of an implantable device of the invention 1 for use in the human or animal body 24 to replace a valve of an organ is shown in Figure 24 in a sectional view. The 16th embodiment according to Figure 24 differs from the 13th embodiment of Figure 21, in that the second membrane element 16 is located within the backward fold of the second anchoring member 8. Because the second membrane element 16 is within the fold behind the second anchoring member 8 the fluid tightness in the area of the second end 4 of the main body 2 is improved.
[00236] Figure 25 shows a sectional view of a 17th embodiment of an implantable device of the invention 1 for use in the human or animal body 24 to replace a valve of an organ. The 17th embodiment according to Figure 25 differs from the 15th embodiment according to Figure 23, in that the second anchoring member 8 is also constructed by a coil 25 of the main body 2.
[00237] The sectional view of the 18th embodiment of an implantable device of the invention 1 for use in the human or animal body 24 to replace a valve of an organ, shown in Figure 26, differs from the 15th embodiment of an implantable device of the invention 1 of Figure 23 by the curvature of the second anchoring member 8, the second membrane element 16 located within the backward fold of the second anchoring member 8 and the dimension of the second anchoring member 8. The curvature of the second anchoring member 8 of the implantable device 1 as shown in Figure 26 lies towards the middle of the main body 2.
[00238] Figure 27 shows a sectional view of a 19th embodiment of an implantable device of the invention 1 for use in the human or animal body 24 to replace a valve of an organ. The 19th embodiment according to Figure 27 differs from the 13th embodiment according to Figure 21, in that the first membrane element 6 at the second end 4 of the main body 2 is formed integrally with the main body 2.
[00239] The sectional view of a 20th embodiment of an implantable device of the invention 1 for use in the human or animal body 24 to replace a valve of an organ, shown in Figure 28, differs from the 19th embodiment of an implantable device of the invention 1 as shown in Figure 27 by the domed design of the second anchor member 8.
[00240] The 21st embodiment of an implantable device of the invention 1 for use in the human or animal body 24 to replace a valve of an organ, which is shown in Figure 21 in a sectional view, differs from the 19th embodiment of an implantable device of the invention 1 as shown in Figure 27 by the curved design of the second anchoring member 8, wherein the curvature of the second anchoring member 8 is directed away from the middle of the main body 2. Furthermore, the diameter of the second anchoring member 8 is larger than the diameter of the first anchor member 7.
[00241] In Figure 30 a sectional view of a 22nd embodiment of an implantable device of the invention for use in the human or animal body 24 to replace a valve of an organ is shown in contrast to the 21st embodiment of the implantable device of the invention 1 of Figure 29, in which the curvature of the second anchoring member 8 is directed towards the middle of the main body 2. Furthermore, within the double layer anchoring member 8 a second membrane element 16 is located.
[00242] All of the previously described embodiments of implantable device 1 for use in the human or animal body 24 to replace an organ valve may have one or more layers. In Figure 31 a detailed view of a main body 2 of an implantable device of the invention 1 with two layers is shown. Figure 32 shows a detailed view of a main body 2 of an implantable device of the invention 1 with three layers.
[00243] In Figure 33 an exemplary implantation procedure of an implantable device of the invention 1 for use in the human or animal body 24 to replace a valve of an organ is shown. The implantable device 1 is, in a first operating state (primary form), stent-like and is located within a catheter 26. The catheter 26 is directed, for example, through the venous system of the human or animal body 24 to the region of the implant site. In Figure 33a it is shown how the end of the catheter 26 is located within an opening in the human or animal body 24 into which the implantable device 1 is to be implanted.
[00244] Thereafter the implantable device 1 is pushed out of the catheter 26. Because the implantable device 1 consists of a shape memory material and is reversibly transferred by means of a force against the forces of elastic material from the secondary shape to primary shape, implantable device 1 adapts after leaving catheter 26 to secondary shape. In Figure 33b it is shown how the first end 3 of the implantable device 1 leaves the catheter 26. The first end 3 of the implantable device 1, which first leaves the catheter 26, forms a first sub-part 22 of the first anchoring member 7.
[00245] In Figure 33c it is shown how the first subpart 22 of the first anchoring member 7 has completely left the catheter and extends approximately rectangular to the catheter 26 in a radial direction of the implantable device 1.
By pushing the implantable device 1 of the catheter 26 further the fold back of the first subpart 22 of the anchoring member 7 is formed and the second subpart 23 of the first anchoring member 7 exits the catheter 26, as shown in Figures 33d and 33e .
[00247] As soon as the first anchoring member 7 is completely formed the catheter is retracted from the implant site, until the first anchoring member 7 rests against the surface of the human or animal body, in particular the first subpart 22 of the first anchoring member. The first sub-part 22 and the second sub-part 23 form the first anchoring member 7 with a fold back such that the first anchoring member 7 is of two layers. Thereafter, the implantable device of the invention 1 is further pushed out of the catheter 26 as shown in Figure 33f. Furthermore, Figure 33f shows that in the intermediate member 20 between the first anchoring member 7 and the second anchoring member 8 a first membrane element is located, in which the membrane element 6 is formed in such a way as to allow the fluid connections through the main body 2 in a first flow direction and blocks it in a second flow direction opposite the first flow direction. The second anchoring member 8 of the implantable device 1 is also composed of a first sub-part 22 and a second sub-part 23.
[00248] By further pushing the implantable device 1 out of the catheter 26, the second anchoring member 8 adopts the secondary shape, in which the first subpart 22 and the second subpart 23 of the second anchoring member 8 are also folded over each other to form a double layer. The backward bending of the first anchoring member 7 is towards the opening of the human or animal body 24 and the backward bending of the second anchoring member 8 is located away from the opening of the human or animal body 24. Figure 33g shows a device implantable 1, during implantation, with a fully formed first anchoring member 7 and a partially formed second anchoring member 8.
[00249] In Figure 33h an implantable device 1 with the first and second anchor members 7, 8, fully formed is shown. The implantation of the implantable device 1 is carried out, for example, with the use of guide wires 30 which are connected through the catheter 26 with the implantable device 1. In Figure 33h it is shown how the guide wires 30 are still connected to the second end 4 of the main body 2 of the implantable device 1. By retracting the guidewire 30 into the catheter 26 the implantable device 1 can be collected within the catheter 26 and thus be relocated or expanded.
[00250] In case the implantable device 1 is placed within the opening of the human or animal body 24 as desired the guide wires are released from the implantable device 1 and the implantable device 1 remains within the human or animal body 24. The implantable device of the invention 1 replaces, for example, a valve of a defective organ in the human or animal body 24.
[00251] In Figure 34 a detailed view of a first embodiment of an edge area of an implantable device 1 is shown. The edge area of the implantable device 1, therefore, the first end 3 or the second end 4 of the main body 2 , is formed by several slings or loops 21 interwoven with one another and/or located adjacent to each other and/or interwoven with one another. In Figure 34 the slings or loops 21 form a regular edge 28.
[00252] In Figure 35 is shown a detailed view of a second embodiment of an edge area of an implantable device of the invention 1. The embodiment according to Figure 35 differs from the embodiment according to Figure 34, in which the device implantable 1 has sections with different material concentration and/or material thickness. According to Figure 35 the edge area of the implantable device 1 has a material concentration 26 for a partial reinforcement.
[00253] Figure 36 shows a detailed view of the 3rd embodiment of an edge area of an implantable device of the invention 1. The slings or turns 21 of the implantable device 1 according to Figure 36 form an irregular edge 29. The irregular edge 29 is formed by slings or loops 21 with two different sizes. The arrangement of the different slings or turns 21 is regular in Figure 36, namely a large turn or sling 21 after two small turns or slings 21. The incorporation according to Figure 36 is particularly advantageous in the case of a backward folding, because the large slings or protruding loops 21 can engage, for example, in the capillary muscles of the heart during the backward folding of the edge area and thereby securely attach the implantable device 1.
[00254] The previously closed embodiments of the implantable device of the invention 1 are only illustrative for the invention and can be combined by a qualified person during their usual activity.Reference list1 implantable device2 main body3 first end4 second end5 opening6 first membrane element7 first anchoring member8 second anchoring member9 wire-type element10 area with less rigidity11 area with greater rigidity12 circumferential wall opening13 ring part14 valve part15 leaflet element16 second membrane element17 single wire18 strand of wires19 multiple wire20 intermediate member 21 slings/turns22 first subpart23 second subpart24 human or animal body25 coiling26 catheter27 material concentration28 regular edge29 irregular edge30 guide wire

权利要求:
Claims (13)
[0001]
1. Implantable device (1) for use on the human and/or animal body (24) to replace a valve of an organ, comprising: a main body (2) having a first end (3) and a second end (4), wherein each of the first end (3) and the second end (4) has an opening (5) for providing a fluid connection through the main body (2) between the first end (3) and the second end (4 ); a first membrane element (6) arranged within or at an end (3, 4) of the main body (2), in which the membrane element (6) is formed in such a way as to allow the connection of fluids through of the main body (2) in a first flow direction and locks it in a second flow direction opposite the first flow direction; wherein the main body (2) has a large ratio between length and transverse expansion along of the longitudinal axis of the main body (2) in a first operating state (primary shape) and a smaller ratio between length and transverse expansion along the longitudinal axis of the main body (2) in a second operating state (secondary shape); and wherein the main body (2) is reversibly transferable from the secondary shape to the primary shape by opposing the forces of elastic material by applying a force; where the main body (2) is formed from a single wire-like element (9) or from a plurality of wire-like elements (9) connected to each other by means of interlocking winding and/or twisting and /or weaving in the form of a fabric and/or layered and/or netted fabric; wherein the main body (2) has, in the second operating state (secondary shape) at the first end (3) and/or at the second end (4) at least one anchoring member (7, 8) which extends radially outwardly of the main body (2) to anchor the device (1) to an organ and/or a vessel. that the at least one anchoring member (7, 8) in the second operating state (secondary shape) of the main body (2) has a first sub-portion (22) and a second sub-portion (23), wherein the first sub-portion (22) extends in a radial direction of the main body (2) outwards and the second sub-portion (23) is folded back in a radial direction of the main body. ipal (2) inwardly, so that the first sub-portion (22) and the second sub-portion (23) are folded on top of each other for a double layer; the backward folding of the at least one anchoring member (7, 8 ) is directed towards the middle of the main body (2).
[0002]
2. Implantable device (1) according to claim 1, characterized in that the first membrane element (6) is composed of a synthetic or biological material, in particular of polyurethane, in which the first membrane element (6 ) preferably has a coating for establishing biostability, such as a titanium coating.
[0003]
3. Implantable device (1) according to claim 1 or 2, characterized in that the main body (2) and the first membrane element (6) are detachable or inseparably connected or connectable with each other, in particular by gluing, welding, sewing, casting, dipping or other joining technology.
[0004]
4. Implantable device (1) according to any one of claims 1 to 3, characterized in that the first membrane element (6) has a ring part (13) and/or a valve part (14) connected to the ring part (13), wherein the valve part (14) is preferably composed of three leaflet elements (15).
[0005]
5. Implantable device (1) according to any one of claims 1 to 4, characterized in that the first membrane element (6) is located, in the second operating state (secondary form), at the first end (3 ) of the main body (2), at the second end (4) of the main body (2), or between the first end (3) and the second end (4) of the main body (2), preferably centrally between the first end (3) and the second end (4) of the main body (2) along the longitudinal axis of the main body (2).
[0006]
6. Implantable device (1) according to any one of claims 1 to 5, characterized in that the implantable device (1) is, in the second operating state (secondary form) between the first end (3) and the second end (4) of the main body (2) at least partially, preferably completely, deformable in a radial direction, in such a way that the main body (2) can adapt to a vessel wall and/or a circumference from an opening and/or to an edge of a defective organ valve.
[0007]
7. Implantable device (1) according to any one of claims 1 to 6, characterized in that the multiple to each of the other wire-type elements (9) connected consists of a single wire (17), a cord of threads (18) of at least two single threads and/or a multiple thread (19), in particular the implantable device (1) in areas with different stiffness (10, 11) is composed of different thread-like elements (9) , particularly of a single strand (17), a strand of strands (18) of at least two single strands and/or a multiple strand (19).
[0008]
8. Implantable device (1) according to any one of claims 1 to 7, characterized in that the backward bending or coiling of the at least one anchoring member (7, 8) is directed towards the middle of the main body (2) or away from the middle of the main body (2).
[0009]
9. Implantable device (1) according to any one of claims 1 to 8, characterized in that the first end (3) and/or the second end (4) of the main body (2) has one or more slings or loops (21) interwoven with each other and/or located adjacent to each other and/or interwoven with each other.
[0010]
10. Implantable device (1) according to claim 9, characterized in that the slings or loops (21) form an irregular edge (29), wherein the irregular edge (29) is formed by slings or loops (21 ) of different sizes.
[0011]
11. Implantable device (1) according to claim 10, characterized in that the irregular edge (29) is formed by slings or loops (21) of two different sizes, in which the arrangement of slings or loops (21) with different sizes it is regular, for example, a large sling or loop (21) after three small slings or loops (21).
[0012]
12. Implantable device (1) according to any one of claims 1 to 11, characterized in that the main body (2) has one or more layers.
[0013]
13. Implantable device (1) according to any one of claims 1 to 12, characterized in that the main body (2) and the first membrane element (6) are integrally constructed.

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EP2884946A2|2015-06-24|

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DE102012107465A1|2014-05-22|

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RU2015108901A|2016-10-10|

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CA2881588A1|2014-02-20|

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引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

---

US4816029A|1981-05-07|1989-03-28|Medtronic, Inc.|Stent for aortic heart valve|

---

DE3541478A1|1985-11-23|1987-05-27|Beiersdorf Ag|HEART VALVE PROSTHESIS AND METHOD FOR THE PRODUCTION THEREOF|

---

DK124690D0|1990-05-18|1990-05-18|Henning Rud Andersen|FAT PROTECTION FOR IMPLEMENTATION IN THE BODY FOR REPLACEMENT OF NATURAL FLEET AND CATS FOR USE IN IMPLEMENTING A SUCH FAT PROTECTION|

---

CA2256491A1|1996-05-31|1997-12-11|Wan-Kei Wan|Expansible bioprosthetic valve stent|

---

DE19624948A1|1996-06-24|1998-01-02|Adiam Medizintechnik Gmbh & Co|Prosthetic heart valve|

---

US8663311B2|1997-01-24|2014-03-04|Celonova Stent, Inc.|Device comprising biodegradable bistable or multistable cells and methods of use|

---

US5855597A|1997-05-07|1999-01-05|Iowa-India Investments Co. Limited|Stent valve and stent graft for percutaneous surgery|

---

EP1057460A1|1999-06-01|2000-12-06|Numed, Inc.|Replacement valve assembly and method of implanting same|

---

US6482228B1|2000-11-14|2002-11-19|Troy R. Norred|Percutaneous aortic valve replacement|

---

DE10103000B4|2001-01-24|2007-08-30|Qualimed Innovative Medizinprodukte Gmbh|Radially re-expandable vascular support|

---

DE10121210B4|2001-04-30|2005-11-17|Universitätsklinikum Freiburg|Anchoring element for the intraluminal anchoring of a heart valve replacement and method for its production|

---

KR100393548B1|2001-06-05|2003-08-02|주식회사 엠아이텍|Stent|

---

CN1385142A|2001-12-21|2002-12-18|中国科学院上海微系统与信息技术研究所|Method for improving blood compatibility and use safety of artificial cardiac valve material|

---

DE10302447B4|2003-01-21|2007-12-06|pfm Produkte für die Medizin AG|Occlusion device, placement system, set of such a placement system and such occlusion device and method for producing an occlusion device|

---

DE10334868B4|2003-07-29|2013-10-17|Pfm Medical Ag|Implantable device as a replacement organ valve, its manufacturing process and basic body and membrane element for it|

---

US20050137686A1|2003-12-23|2005-06-23|Sadra Medical, A Delaware Corporation|Externally expandable heart valve anchor and method|

---

FR2874813B1|2004-09-07|2007-06-22|Perouse Soc Par Actions Simpli|VALVULAR PROSTHESIS|

---

US8663312B2|2005-05-27|2014-03-04|Hlt, Inc.|Intravascular cuff|

---

DE102005052628B4|2005-11-04|2014-06-05|Jenavalve Technology Inc.|Self-expanding, flexible wire mesh with integrated valvular prosthesis for the transvascular heart valve replacement and a system with such a device and a delivery catheter|

---

EP1849440A1|2006-04-28|2007-10-31|Younes Boudjemline|Vascular stents with varying diameter|

---

DE102006050385A1|2006-10-05|2008-04-10|pfm Produkte für die Medizin AG|Implantable mechanism for use in human and/or animal body for e.g. closing atrium septum defect, has partial piece that is folded back on another partial piece from primary form into secondary form of carrying structure|

---

FR2906998B1|2006-10-16|2009-04-10|Perouse Soc Par Actions Simpli|IMPLANT INTENDED TO BE PLACED IN A BLOOD CIRCULATION CONDUIT.|

---

US20080262593A1|2007-02-15|2008-10-23|Ryan Timothy R|Multi-layered stents and methods of implanting|

---

US20100121423A1|2007-03-22|2010-05-13|Carag Ag|Stent with Vessel Valve|

---

FR2916959B1|2007-06-08|2009-09-04|Perouse Soc Par Actions Simpli|NECESSARY TO BE IMPLANTED IN A BLOOD CIRCULATION CONDUIT|

---

US20090171456A1|2007-12-28|2009-07-02|Kveen Graig L|Percutaneous heart valve, system, and method|

---

US20110160836A1|2008-06-20|2011-06-30|Vysera Biomedical Limited|Valve device|

---

US20100268320A1|2009-04-17|2010-10-21|Medtronic Vascular, Inc.|Endovascular Implant Having an Integral Graft Component and Method of Manufacture|

---

FR2947716B1|2009-07-10|2011-09-02|Cormove|IMPLANT IMPLANT IMPROVED|

---

WO2011072084A2|2009-12-08|2011-06-16|Avalon Medical Ltd.|Device and system for transcatheter mitral valve replacement|

---

US20110208293A1|2010-02-23|2011-08-25|Medtronic, Inc.|Catheter-Based Heart Valve Therapy System with Sizing Balloon|

---

EP2569043A4|2010-05-10|2017-06-07|HLT, Inc.|Stentless support structure|

---

KR20120004677A|2010-07-07|2012-01-13| 태웅메디칼|Using two kinds of tissue heart valve prostheses and manufacturing methods|

---

WO2012018599A1|2010-08-03|2012-02-09|Cook Medical Technologies Llc|Two valve caval stent for functional replacement of incompetent tricuspid valve|

---

US8696737B2|2010-08-11|2014-04-15|Hlt, Inc.|Reinforced commissural support structure|

---

CN102626354A|2012-04-26|2012-08-08|姬尚义|Valved homograft conduit|

---

DE102012107465A1|2012-08-15|2014-05-22|Pfm Medical Ag|Implantable device for use in the human and / or animal body for replacement of an organ flap|DE102007043830A1|2007-09-13|2009-04-02|Lozonschi, Lucian, Madison|Heart valve stent|

---

WO2010037141A1|2008-09-29|2010-04-01|Cardiaq Valve Technologies, Inc.|Heart valve|

---

WO2011072084A2|2009-12-08|2011-06-16|Avalon Medical Ltd.|Device and system for transcatheter mitral valve replacement|

---

US8579964B2|2010-05-05|2013-11-12|Neovasc Inc.|Transcatheter mitral valve prosthesis|

---

US9554897B2|2011-04-28|2017-01-31|Neovasc Tiara Inc.|Methods and apparatus for engaging a valve prosthesis with tissue|

---

US9308087B2|2011-04-28|2016-04-12|Neovasc Tiara Inc.|Sequentially deployed transcatheter mitral valve prosthesis|

---

AU2012299311B2|2011-08-11|2016-03-03|Tendyne Holdings, Inc.|Improvements for prosthetic valves and related inventions|

---

US9827092B2|2011-12-16|2017-11-28|Tendyne Holdings, Inc.|Tethers for prosthetic mitral valve|

---

US9345573B2|2012-05-30|2016-05-24|Neovasc Tiara Inc.|Methods and apparatus for loading a prosthesis onto a delivery system|

---

WO2014022124A1|2012-07-28|2014-02-06|Tendyne Holdings, Inc.|Improved multi-component designs for heart valve retrieval device, sealing structures and stent assembly|

---

US9675454B2|2012-07-30|2017-06-13|Tendyne Holdings, Inc.|Delivery systems and methods for transcatheter prosthetic valves|

---

DE102012107465A1|2012-08-15|2014-05-22|Pfm Medical Ag|Implantable device for use in the human and / or animal body for replacement of an organ flap|

---

US10583002B2|2013-03-11|2020-03-10|Neovasc Tiara Inc.|Prosthetic valve with anti-pivoting mechanism|

---

US10463489B2|2013-04-02|2019-11-05|Tendyne Holdings, Inc.|Prosthetic heart valve and systems and methods for delivering the same|

---

US9486306B2|2013-04-02|2016-11-08|Tendyne Holdings, Inc.|Inflatable annular sealing device for prosthetic mitral valve|

---

US11224510B2|2013-04-02|2022-01-18|Tendyne Holdings, Inc.|Prosthetic heart valve and systems and methods for delivering the same|

---

US10478293B2|2013-04-04|2019-11-19|Tendyne Holdings, Inc.|Retrieval and repositioning system for prosthetic heart valve|

---

US9572665B2|2013-04-04|2017-02-21|Neovasc Tiara Inc.|Methods and apparatus for delivering a prosthetic valve to a beating heart|

---

CN105431108B|2013-05-01|2018-05-29|艾纽梅德公司|Personalized aorta petal prosthese|

---

US9610159B2|2013-05-30|2017-04-04|Tendyne Holdings, Inc.|Structural members for prosthetic mitral valves|

---

WO2014210124A1|2013-06-25|2014-12-31|Mark Christianson|Thrombus management and structural compliance features for prosthetic heart valves|

---

US9561103B2|2013-07-17|2017-02-07|Cephea Valve Technologies, Inc.|System and method for cardiac valve repair and replacement|

---

WO2015017689A1|2013-08-01|2015-02-05|Robert Vidlund|Epicardial anchor devices and methods|

---

WO2015058039A1|2013-10-17|2015-04-23|Robert Vidlund|Apparatus and methods for alignment and deployment of intracardiac devices|

---

JP6554094B2|2013-10-28|2019-07-31|テンダイン ホールディングス，インコーポレイテッド|Prosthetic heart valve and system and method for delivering an artificial heart valve|

---

US9526611B2|2013-10-29|2016-12-27|Tendyne Holdings, Inc.|Apparatus and methods for delivery of transcatheter prosthetic valves|

---

JP6826035B2|2015-01-07|2021-02-03|テンダイン ホールディングス，インコーポレイテッド|Artificial mitral valve, and devices and methods for its delivery|

---

CN107896484B|2015-02-05|2020-09-08|坦迪尼控股股份有限公司|Expandable epicardial pad and delivery devices and methods therefor|

---

WO2015120122A2|2014-02-05|2015-08-13|Robert Vidlund|Apparatus and methods for transfemoral delivery of prosthetic mitral valve|

---

US9986993B2|2014-02-11|2018-06-05|Tendyne Holdings, Inc.|Adjustable tether and epicardial pad system for prosthetic heart valve|

---

WO2015138306A2|2014-03-10|2015-09-17|Tendyne Holdings, Inc.|Devices and methods for positioning and monitoring tether load for prosthetic mitral valve|

---

DE102014003654A1|2014-03-13|2015-09-17|Nasib Dlaikan-Campos|Compressible self-expandable stent for splinting and / or holding open a cavity, an organ passage and / or a vessel in the human or animal body|

---

US9492273B2|2014-12-09|2016-11-15|Cephea Valve Technologies, Inc.|Replacement cardiac valves and methods of use and manufacture|

---

ES2818128T3|2015-04-16|2021-04-09|Tendyne Holdings Inc|Apparatus for the delivery and repositioning of transcatheter prosthetic valves|

---

US10849746B2|2015-05-14|2020-12-01|Cephea Valve Technologies, Inc.|Cardiac valve delivery devices and systems|

---

EP3294221A4|2015-05-14|2019-01-16|Cephea Valve Technologies, Inc.|Replacement mitral valves|

---

US10327894B2|2015-09-18|2019-06-25|Tendyne Holdings, Inc.|Methods for delivery of prosthetic mitral valves|

---

WO2017096157A1|2015-12-03|2017-06-08|Tendyne Holdings, Inc.|Frame features for prosthetic mitral valves|

---

CN108366859B|2015-12-28|2021-02-05|坦迪尼控股股份有限公司|Atrial capsular bag closure for prosthetic heart valves|

---

CN105769383B|2016-03-18|2019-12-10|杭州唯强医疗科技有限公司|Aorta bare stent and aorta interlayer stent|

---

US10470877B2|2016-05-03|2019-11-12|Tendyne Holdings, Inc.|Apparatus and methods for anterior valve leaflet management|

---

EP3468480A4|2016-06-13|2020-02-12|Tendyne Holdings, Inc.|Sequential delivery of two-part prosthetic mitral valve|

---

WO2018005779A1|2016-06-30|2018-01-04|Tegels Zachary J|Prosthetic heart valves and apparatus and methods for delivery of same|

---

US11065116B2|2016-07-12|2021-07-20|Tendyne Holdings, Inc.|Apparatus and methods for trans-septal retrieval of prosthetic heart valves|

---

AU2018203053B2|2017-01-23|2020-03-05|Cephea Valve Technologies, Inc.|Replacement mitral valves|

---

WO2018136959A1|2017-01-23|2018-07-26|Cephea Valve Technologies, Inc.|Replacement mitral valves|

---

EP3634528A4|2017-06-07|2021-03-10|Shifamed Holdings, LLC|Intravascular fluid movement devices, systems, and methods of use|

---

CA3068527A1|2017-07-13|2019-01-17|Tendyne Holdings, Inc.|Prosthetic heart valves and apparatus and methods for delivery of same|

---

CN111263622A|2017-08-25|2020-06-09|内奥瓦斯克迪亚拉公司|Sequentially deployed transcatheter mitral valve prosthesis|

---

AU2018323900A1|2017-08-28|2020-02-27|Tendyne Holdings, Inc.|Prosthetic heart valves with tether coupling features|

---

JP2021511894A|2018-02-01|2021-05-13|シファメド・ホールディングス・エルエルシー|Intravascular blood pump and method of use and manufacture|

---

KR102095834B1|2018-06-07|2020-04-01|퍼스트 메디컬 컴퍼니 리미티드|Medical Stent|

---

CN109646060A|2019-01-15|2019-04-19|西安交通大学|A kind of minimal invasion tumor of spine aspiration biopsy device|

---

WO2021158509A1|2020-02-06|2021-08-12|Laplace Interventional Inc.|Transcatheter heart valve prosthesis assembled inside heart chambers or blood vessels|

法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-03-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-06-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-07-13| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/08/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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DE102012107465.8A|DE102012107465A1|2012-08-15|2012-08-15|Implantable device for use in the human and / or animal body for replacement of an organ flap|

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DE102012107465.8|2012-08-15|

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PCT/EP2013/066385|WO2014026870A2|2012-08-15|2013-08-05|Implantable device for use in the human and/or animal body to replace an organ valve|

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