Heart valve replacement prosthesis with good sealing and loading characteristics

Abstract

The present invention is directed to replacement heart valve prostheses having advantageous sealing properties and advantageous properties for loading onto a delivery system, such as a catheter.

Description

Technical Field

[0001] The present invention relates to a heart valve prosthesis replacement having good sealing and good characteristics for delivery in a delivery system, such as a catheter. Background Art

[0002] Over the past few decades, minimally invasive techniques have been developed and are feasible in many areas of medicine.

[0003] In some areas of medicine, patients can now be treated with minimally invasive techniques, which make it possible to treat patients who cannot receive adequate care due to medical conditions and surgical risks. Many of these minimally invasive methods use delivery systems, such as catheters, to implant medical devices at the desired target location.

[0004] In recent years, heart valve diseases and defects have been treated with increasing success. Examples are transapical, transjugular and transfemoral procedures for heart valve replacement therapy, e.g., aortic or mitral heart valve treatment.

[0005] In many cases, a stent-based prosthesis with a tissue-based replacement valve is used and implanted to replace a native heart valve. The replacement heart valve is placed at the patient's target location in a controlled and coordinated manner via a catheter delivery system.

[0006] The replacement heart valve must be crimped and loaded onto a catheter system. The delivery system is then introduced into the patient's vasculature, for example transfemorally, and directed to the target site. The replacement heart valve prosthesis must be precisely placed at the target site and then finally released from the catheter in order to achieve correct deployment.

[0007] For a replacement heart valve prosthesis to function properly, it is equally important that the prosthesis is tight and does not develop paravalvular leak (PVL).

[0008] Therefore, there is a need for a replacement heart valve prosthesis that has good sealing characteristics to prevent blood backflow during function.

[0009] A known problem with replacement heart valves is the lack of an adequate seal on the implanted replacement heart valve resulting in PVL (paravalvular leakage) and causing the replacement heart valve prosthesis to malfunction.

[0010] In particular, replacement heart valve prostheses consisting of double-walled or stent-within-stent designs, wherein the replacement heart valve prosthesis consists of a first stent and a second stent connected to the second stent and attached to each other by suitable means, face greater challenges in providing adequate sealing features for the device.

[0011] In an aortic replacement heart valve prosthesis, the annulus and surrounding tissue are relatively strong. The radial force and simple sealing features of the prosthesis usually provide an adequate seal.

[0012] In contrast, the anatomical requirements of other heart valves, such as the mitral and tricuspid valves, make valve replacement heart valve surgery more complex and challenging.

[0013] The dimensions of the native annulus in these heart valves are relatively large. In addition, the native implant site may be additionally enlarged, which may cause problems in particular in the treatment of tricuspid regurgitation and pulmonary diseases. In addition, the larger annular diameter and valve diameter of the necessary replacement heart valve prosthesis result in a longer profile that may enter the ventricle or in the pulmonary outflow tract.

[0014] Additionally, large replacement heart valves consist of large leaflets with a certain resistance, which, however, must open and close properly, which is affected by intrinsic blood flow. PVL problems interfere with the correct opening and closing of the valve and, therefore, correct replacement heart valve function. Therefore, more energy is required during the opening and closing phases. Therefore, it is of utmost importance that the hemodynamic properties and on-site positioning of the replacement heart valve prosthesis are optimal.

[0015] Unfortunately, the native heart valve annuli of the above-mentioned heart valves are often non-circular in shape, especially the atrioventricular heart valve annuli of the mitral and tricuspid heart valves.

[0016] The implant site also does not provide an entire contact surface, but only a line of contact. The implant site is neither circular nor planar. The tricuspid valve annulus, for example, is saddle-shaped. Thus, the implant site may not provide adequate surface contact due to lack of mating with the tubular replacement heart valve stent. The lack of surface and contact makes it difficult to secure and seal the device by direct contact only with the cylindrical valve stent.

[0017] Finally, due to the extensive soft tissue surrounding the above-mentioned heart valves, such as the tricuspid valve and the mitral valve, sealing cannot be achieved by simply applying radial force and simple sealing.

[0018] In contrast to the calcified aortic valve / root, the pulmonary / tricuspid / mitral valves display different pathologies. Therefore, the implantation sites of mitral and tricuspid heart valves, for example, are not hardened by calcium and may not provide a strong and sustainable support for stent anchoring. As a result, the radial force is insufficient to anchor and seal the replacement device within the soft tissue of the target site.

[0019] Furthermore, the soft tissue surrounding the target site of a replacement heart valve is sensitive to surrounding pressure and motion, such as changes in blood pressure and muscle contraction. As a result, the implant site may experience large dimensional changes, especially during the cardiac cycle.

[0020] Furthermore, if a multi-part replacement heart valve system is used, the anchoring system (the outermost part) should conform to the soft tissue of the implantation site, its dynamics and its irregular anatomy.

[0021] Thus, the stent configuration changes during the cardiac cycle, which implies problems with proper sealing and avoiding PVL.

[0022] It is therefore an object of the present disclosure to provide a device that allows for better sealing of a replacement heart valve prosthesis or that at least reduces the disadvantages of the prior art or substantially avoids them.

[0023] Another object of the present disclosure is to provide a heart valve replacement prosthesis that provides a sealing device that supports favorable sealing characteristics and maintains adequate sealing after and after implantation, or at least reduces the disadvantages of the prior art or substantially avoids these disadvantages.

[0024] It is another object of the present disclosure to provide a heart valve replacement prosthesis that exhibits sealing properties for supporting favorable opening and closing of a replacement heart valve during heart beating and heart function. Summary of the invention

[0025] In one aspect, the present invention is directed to a sealing feature for improving the sealing characteristics of a replacement heart valve prosthesis.

[0026] In another aspect, the present invention relates to a replacement heart valve prosthesis that exhibits favorable sealing properties and / or blood flow properties and / or valve function.

[0027]

[0011] In another aspect, the present disclosure is directed to a replacement heart valve prosthesis including at least two sealing features.

[0028] In another aspect, the present invention relates to an advantageous sealing property or sealing solution which can be used in double-walled, e.g. two-part or multi-part stent prostheses, or / and replacement stent prostheses, which present a discontinuous stent design.

[0029] In another aspect, the present invention is directed to a heart valve replacement prosthesis exhibiting sealing properties for use in supporting the opening and closing of a favorable replacement heart valve during heart beating and heart function.

[0030] In another aspect, the present invention is directed to a replacement heart valve prosthesis having advantageous properties for loading into a delivery system, such as a catheter, combined with advantageous properties of replacement heart valve functionality and / or durability. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] FIG. 1 is a schematic diagram of atrioventricular heart valve annular irregularity. Figure 1a A top view of the heart is shown, which indicates the non-circular shape of the atrioventricular valve annulus. A perspective view of the mitral valve annulus shows Figure 1b Nonplanarity of the atrioventricular valve annulus in.

[0032] Figure 2 An embodiment according to the present disclosure is shown, namely a two-part stent consisting of an inner stent (e.g., laser cut nickel-titanium alloy) (2) with a replacement heart valve attached to an outer braided nickel-titanium alloy stent (1) including two sealing features, wherein one sealing feature is an inflow sealing cover (3) combined with an outflow sealing cover (4), and an inflow flange (11) is shown.

[0033] Figure 3 yes Figure 2 A top view of the inlet flange (11), the inner bracket (2) and the inlet sealing cover (3) is shown.

[0034] Figure 4 yes Figure 2 A side view of the inlet flange (11), the inner support (2), the inlet sealing cover (3) and the outlet sealing cover (4) and the outer support (e.g., braided nickel titanium alloy) (1) are shown.

[0035] Figure 5 An embodiment according to the present disclosure is shown in which a replacement heart valve prosthesis is loaded into a catheter sheet (9) with the inner stent (2) and outer stent (1) crimped to a crimped diameter (10).

[0036] Figure 6 One embodiment according to the present disclosure, a multi-part replacement heart valve prosthesis, is shown, wherein an outer stent (1) and an inner stent (2) are shown. The inner stent (2) will carry a replacement heart valve (not shown). On the left, the compliance of the stent to the cardiac cycle due to wall motion is indicated as "Co". The inward force is indicated by the arrow (Co), which effects the inward movement and compression of the outer stent (1). Multiple sealing features (not shown here) according to the disclosure of the present invention are designed to maintain a favorable seal during the systolic and diastolic heart cycles.

[0037] Figure 7 An embodiment of a multi-part replacement heart valve prosthesis according to the present disclosure is shown, wherein an outer support (1) with an inflow flange (11) and an inner support (2) are shown. Also shown are a stabilizer (7) and a ring (8) located at and coupled to the outer support (1). An inflow seal cap (atrium) (3) and an outflow seal cap (ventricle) (4) are shown connected to the outer support (1).

[0038] Figure 8 An embodiment according to the present disclosure is shown, namely another design of an outer support (1) which is not connected to the inner support (2) at the distal side. An inflow sealing cap (3) and an outflow sealing cap (4) are shown.

[0039] In the following Figures 9 to 15 In the drawings, the skilled artisan will understand that these drawings illustrate the general sealing concept and are intended to highlight the sealing function of the natural leaflets with the sealing cap, prosthesis, endogenous chordae tendineae, leaflets and heart wall, where, as in reality, these parts are closely adjacent but not completely attached together.

[0040] Fig. 9 An embodiment of a multi-part replacement heart valve prosthesis according to the present invention is shown, wherein an outer stent (1) and an inner stent (2) with a replacement valve (5) and an inflow flange (11) are shown. The prosthesis is implanted at a target site, with the outer stent (1) in contact with the heart wall (e.g., a tricuspid or mitral heart valve). The outer stent (1) pushes the native leaflets (NL) and chordae tendineae (Ch) in the direction of the heart wall (CW). During the cardiac cycle, the heart wall (CW) pushes inward according to the indication (Co). The deformation of the outer stent (1) means that there are certain sealing problems, which are solved by multiple sealing features (3, 4) not shown here. Advantageously, the multiple sealing features according to the present invention provide advantageous sealing properties of the disclosed prosthesis due to their specific design and fixation with the stent components of the prosthesis, which will be described in further detail below.

[0041] Fig.10 The problem of PVL in a replacement heart valve prosthesis is illustrated. The stent (1) is in contact with the heart wall (CW) and / or with the native leaflets (NL) and chordae tendineae (Ch) at surfaces (S-S1, S2). PVL occurs in the outer stent (1) when the replacement valve (5) is closed, and also occurs in the outer stent (1) when the replacement valve (5) is opened (not shown). Therefore, PVL is indicated by a double-headed arrow. Also shown is the deformation and elongation of the outer stent (1), which is represented by different widths and lengths on the left and right sides of the figure.

[0042] Fig.11 Blood flow during diastole (DBF) is shown. Due to diastolic hemodynamics and blood flow (SPD), the replacement valve (5) opens and the atrial cover (3) is pushed towards the inflow flange (11) and the inflow area of ​​the external stent (1). The contact surface (S1) represents the inflow area of ​​the external stent (1) being pushed towards the heart wall (CW) and PVL is avoided by the inflow cover (3). The main contact between the prosthesis and the heart wall is located at the surface and area S1. This results in proper opening of the replacement heart valve (5) attached to the internal stent (2) and favorable replacement heart valve prosthesis function.

[0043] Fig.12 Blood flow during systolic period (SBF) is shown and illustrates such a consequence of PVL occurring in a replacement heart valve prosthesis. The replacement heart valve (5) is closed. The inflow seal cap (3) provides a degree of systolic blood flow (SBF) seal. A certain amount of blood still passes through the replacement heart valve prosthesis between the prosthesis and the heart wall (CW).

[0044] Fig.13 An embodiment according to the present disclosure is shown, i.e., it shows the sealing ability of the outflow seal cap (4) relative to the systolic blood flow (SBF) pressure during systole. The SPS (sealing pressure during systole) is also shown. The seal cap design (4) of the present invention substantially prevents PVL during systole. In combination with the inflow seal cap (3) (not shown here), the present invention provides a combination of advantageous sealing functions during systole and diastole, and not only prevents PVL itself, but also further ensures that the replacement heart valve (5) functions appropriately and correctly, here the functions refer to opening and closing and correct engagement. The design of the special sealing connection point and multiple sealing features (3, 4) is combined to provide advantageous crimping and catheter loading functions in addition to the sealing function itself.

[0045] Fig.14 An embodiment according to the present disclosure is shown, i.e., how the outflow sealing feature, i.e., the sealing cover (4), behaves and provides a contraction seal and supports the function of a proper replacement heart valve (5). The replacement heart valve prosthesis (comprising 1, 2, 5, 11, 3, 4) and the heart wall (CW) are in contact at the surface (S2), and the systolic blood flow (SBF) exhibits a sealing pressure against the CW and / or native leaflets during the systolic phase (SPS). The outflow sealing cover (4) (sealing feature) is advantageously designed to have an attachment point at the external support (1) to prevent contraction PVL. The seal by (4) additionally supports a good fit of the leaflets of the replacement valve (5), thereby facilitating the function of the replacement heart valve prosthesis.

[0046] Fig.15 Blood flow through the replacement heart valve (5) and the inner stent (2) during diastole (DBF) is shown. Also depicted is the edge of the replacement heart valve prosthesis and the outer stent (1) between the heart wall (CW) and / or native leaflets, and flow through the edge of the outflow seal cap (4) because the outflow seal cap (4) is not pressed by the contraction flow toward the CW, and / or NL to create a tightly sealed surface. Fig.11 The inflow seal cap (3) shown prevents this type of PVL. The coordinated design of various sealing features, such as Fig.16 The outflow and inflow sealing covers (3, 4) are shown.

[0047] Fig.16 An embodiment of the invention, i.e., the design of the inflow cover (3) and the outflow cover (4) and the sealing cover (sealing feature) attachment points (I, J, K, E) and their positioning relative to the annulus (An), is shown. The replacement heart valve (5) is closed and closed. The sealing cover attachment points I and J are located in the superannular and subannular shapes, respectively. In addition, the leaflets of the replacement valve (5) are aligned with the outflow sealing cover (4) to guide the blood flow during heart contraction to support good contact between the external support (1) and the heart wall (CW) and / or between the native leaflets and the annulus (An), wherein the annulus also supports the sealing function of the outflow sealing cover (4). During diastole, the systolic blood flow (SBF) pushes the inflow sealing cover (3) against the heart wall (CW) and the annulus (An) to seal the PVL during systole and to guide substantially the entire blood flow through the internal support (2) and thereby support the proper opening of the replacement heart valve (5). Thus, the present disclosure provides a replacement heart valve prosthesis that not only exhibits coordinated function between multiple sealing features, but also substantially prevents PVL during cardiac systole and diastole. Furthermore, such coordinated function supports favorable opening and closing of the replacement heart valve during heart beating. Thus, good opening and closing operation of the replacement heart valve can be achieved even in replacement prostheses that exhibit unfavorable internal stent and replacement heart valve dimensions (prone to suboptimal function) when implanted to replace, for example, a mitral or tricuspid heart valve. Furthermore, the special design and positioning of the sealing cover attachment points and their positional positioning relative to each other provide advantageous characteristics that facilitate curling and avoid damage to the sealing cover tissue during curling and unfolding of the prosthesis at the target site.

[0048] Fig.17 The behavior of the stent during crimping is shown, which suggests issues regarding the tissue, and in particular the sealing tissue, of the stent attached to a replacement heart valve prosthesis.

[0049] Figures 18 to 21 The behavior of the sealing features during crimping of a replacement heart valve prosthesis and its sealing cover attachment point are shown.

[0050] Fig.18 The behavior of inflow into the sealing cap (3) during crimping at the sealing cap attachment points I and E is shown. The size of the sealing cap is governed by the size of the fully deployed prosthesis. The location of the attachment point I governs the relative longitudinal position of the two stent layers when the prosthesis is crimped without sealing cap tissue folding to relieve loading.

[0051] Fig.19The behavior of the outflow seal cap (4) during crimping of the seal cap attachment is shown, represented by points E and J. The dimensions of the seal cap are controlled by the dimensions of the fully deployed prosthesis. The location of the attachment point J governs the relative longitudinal position of the two stent layers when the prosthesis is crimped without the seal cap tissue folding to relieve loading.

[0052] Fig. 20 The behavior of flow into and out of the sealing cap (3) and (4) during crimping at the sealing cap attachment points, in this case represented by I, J, E and K, is shown. The dimensions of the sealing cap are governed by the dimensions of the fully deployed prosthesis. To prevent tissue stretching that could result in stent or tissue damage, the location of point K must be determined so that the crimped stent length IJ is equal to or less than the tissue length IKJ.

[0053] Preferably, the point K must be located so that the crimped stent length IJ is equal to the tissue length IKJ in order to prevent tissue folding and subsequent loading of the prosthesis.

[0054] Fig.21 The behavior of inflow into the sealing cover (3) and outflow from the sealing cover (4) during crimping is shown, wherein the attachment points are represented by I, J and E. This is an illustration of a prosthesis in a crimped configuration, wherein the sealing cover and the sealing cover size and / or the attachment points do not match, which can lead to tissue accumulation. In order to ensure the feasibility of loading the prosthesis within the minimally invasive device, the crimping size of the device must be minimized. Excessive tissue can cause the crimped structure to collapse, thereby increasing the crimping size of the device. In contrast, the prosthesis according to the present invention and advantageously achieves this purpose.

[0055] Fig. 22 An implanted replacement heart valve prosthesis according to the invention is shown in an asymmetric in vivo situation after implantation. It depicts the prosthesis, comprising an inner support (5) with a replacement valve (5) connected to an outer support (1) with an inflow flange (11), the prosthesis indicating the anterior (an) and posterior (po) directions. The atrioventricular node (AVN), the coronary sinus (CS) and the septum (S) are also depicted.

[0056] Fig.23 An embodiment according to the present disclosure is shown showing additional stent features for improving fixation of a prosthesis in a target site. An outer mesh stent (1) includes a Z-ring (13) connected thereto, and an inflow flange (11) is shown. A replacement heart valve (5) and sealing features (3, 4) are shown, as well as a portion of the prosthesis aligned with the annulus (An, 12) of the target site.

[0057] Fig.24An embodiment according to the present disclosure is shown, i.e., a multi-part stent, wherein both stent parts are made of a nickel-titanium alloy cut stent, wherein an inner stent and an outer stent are connected by a connecting device (14). Additional stent features for improving fixation of the prosthesis in the target site, i.e., the Z-ring (13), are also depicted. The prosthesis portion is also shown aligned with the annulus (An, 12) of the target site. A replacement heart valve (5) and sealing features (3, 4) are also shown.

[0058] In the following additional stent designs, drawings (designated as Figure B including reference numerals indicated by "B" in "Reference Number List B") that can be combined with advantageous sealing features of the present invention as described herein and in the above drawings and claims will be described.

[0059] Figure B1a and B1 b show an example of a prior art replacement heart valve prosthesis consisting of a laser cut tube inner stent (2) intended to carry the valve and a woven outer stent (1) (also indicated as an outer mesh stent), the outer stent (1) being combined with the inner stent (2) to place and secure the prosthesis at a target site (two-part stent).

[0060] Figure B2a and B2b One aspect of the present disclosure is shown, namely the two-part stent of Figure 1, including a stabilizer device (3) located at the distal end (also visible below) of the groove for supporting the fixation of the annulus position at the target site.

[0061] Figure B3a and B3b One aspect of the present disclosure is shown, namely Figure 2 A two-part stent comprises additional rings (4) for better fixation after implantation. In the embodiments (3a, 3b) shown, the rings (4) are located below the grooves of the external stent and are therefore located below the valve annulus in the distal or outflow direction after implantation. Thus, the external stent helps to fix the replacement heart valve prosthesis at the implantation site. These rings will contact the subvalvular and / or ventricular tissue and thereby increase the friction between the prosthesis and the implantation site, thereby better fixing the prosthesis at the implantation site. The rings of the prosthesis may exhibit further improved fixation and friction as the rings interfere with the chordae tendineae and thereby stabilize the prosthesis in the proper position. The rings may be at different angles to the external stent and therefore also present radial forces towards the heart tissue. Figure 3 b depicts the incision into the prosthesis so that the internal stent (2) is visible.

[0062] Figure B4 An aspect of the present disclosure is shown, namely rings of different types and shapes.

[0063] Figure B5aand B5b One aspect of the present disclosure is shown, namely, a ring (4) is located in the distal region of a woven external stent (mesh stent); the external stent is connected to the internal laser-cut stent in the middle region; the external stent is not connected to the internal stent in the distal region; the outer mesh (5) and the inner mesh (6) of the external mesh stent form a double layer in the middle or / and distal region, which provides stability and / or axial force, which can be designed according to the requirements of the specific situation; in some embodiments, there is no stabilizer feature (such as additional wires or / and twisted wires under the V-shaped groove), while in other embodiments according to the present disclosure, stabilizer features can be added to design the stent stability and stent axial force.

[0064] Figure B6a and B6b One aspect of the present disclosure is shown, namely a double-stent prosthesis, wherein the outer stent (2) is not connected to the inner stent (1) at the distal end. The inner mesh (6) and the outer mesh (5) are folded in the distal region and oriented close to each other. Moreover, the inner mesh (6) and the outer mesh (5) form an angle (for illustration, an "angle structure" is formed by two auxiliary lines being pulled into the outer stent), wherein the angle is marked as "α". "α" is the area between the two arrows, which are marked on the auxiliary lines in the figure in the direction of the axial center of the connection direction of the inner stent (2) connected to both the inner stent (2) and the inner stent (1). Therefore, the inner mesh (6) and the outer mesh (5) form an angle, which can be selected according to stability and size requirements. The close orientation of the inner mesh (6) and the outer mesh (5) combined with the "angle α" means that Figure 6 b) has many advantages, for example this means that there is a lack of connection between the inner support (2) and the outer support (1), so when the prosthesis is implanted, it can produce a spring or absorption effect and flexibility at the distal end. In addition, when the prosthesis is crimped into the catheter, the structure will produce an advantageous flexibility. The angle "α" can be varied, for example from 5° to 15°, which will contribute to or / and limit the stability and radial force of the outer support (1) related to the fixing characteristics of the prosthesis.

[0065] Figure B7 One aspect of the present disclosure is shown, namely, defining a prosthesis into three regions, namely, a proximal region (or inflow region), a middle region (or groove region, e.g., a V-shaped or U-shaped groove, which may also be referred to as a sub-groove region), and a distal region (or outflow region). The groove region and the distal region may also be referred to as sub-annular regions. The dimensions of these regions may be adjusted; thus, the stability / flexibility characteristics of the prosthesis may be designed and the prosthesis may be adapted to the specific geometry of the target site as well as the geometry and details of the patient.

[0066] Figure B8An aspect of the present disclosure is shown, namely, a prosthesis of the present disclosure is crimped into a loading portion of a catheter for delivery through the vasculature of a patient. It shows that the ring (4) is arranged in a manner that does not overlap with the outer mesh (5) and inner mesh (6) of the outer support (1), thereby providing a low profile of the crimped prosthesis. In one aspect of the present disclosure, the ring (4) can be designed to flip during the crimping / loading or reloading process to achieve optimal positioning and low profile in the catheter. Thus, the ring can, for example, flip substantially 180° or a maximum of 180°.

[0067] Figure B9 An aspect of the present disclosure is shown, wherein a laser cut inner stent (2) is depicted within a laser cut outer stent (11). The V-shaped groove (16) should be located in the endogenous annular region when implanted in the patient. In the distal region of the outer laser cut stent (11), an anchoring unit (15) is included to improve fixation at the target site. The laser cut inner stent (2) and the laser cut outer stent (11) are connected by a connecting strut (12), thereby directly (or through a connecting device) connecting the inner / outer stent (13). The connecting strut (12) can be connected by any useful method known in the art, such as welding, gluing, known connecting devices or specially designed connecting devices, such as clamping devices or mechanisms. The connecting strut (12) is located in the proximal and annular regions.

[0068] Figure B10 One aspect of the present disclosure is shown, in which a connecting strut (12) and a connecting device (19) for stable assembly of two laser cut stents are shown. The connecting strut (12) is located between the laser cut inner stent (2) and the laser cut outer stent (11), and in this way a double layer can be formed in the laser cut outer stent (11). When implanted, the double wall is in the valve annulus or the area below the valve annulus or essentially in the ventricular area. Therefore, the connecting device (19) is located (after implantation) in the annular area of ​​the implantation site, and during the beating of the heart, the impact on this area of ​​the replacement heart valve prosthesis is reduced. This implies the advantage that the connecting device (19) is subjected to less stress and impact due to the beating of the heart.

[0069] Figure B11An aspect of the present disclosure is shown in which a change in the position of a connecting device (19) is shown. The connecting device (19) can be located in the proximal region of the prosthesis. In addition, a connecting strut guide (17) is shown. The laser cut stent that makes up the replacement heart valve prosthesis can vary depending on the number of connecting devices. The prosthesis can be composed of two laser cut stents or three laser cut stent parts, wherein the laser cut inner stent (2) (with a valve commonly used in the art, the valve with three leaflets) is connected to the proximal laser cut outer stent part (11a) (ultimately placed in the atrium) by a connecting device (19) combined with a connecting strut guide (17). The distal part (11b) of the additional laser cut outer stent (ultimately placed in the ventricle) is connected to the other stent parts by the connecting strut guide (17). The connecting struts (12) (e.g., one by one) derived from the laser cut inner stent (2) are placed or moved through the connecting strut guide (17). The connecting strut guide (17) is derived from the laser cut distal portion (11b) of the outer stent, and by moving the connecting struts through the connecting strut guide (17), all three stent parts (11a, 11b and 2) are connected at least substantially in the annular region when implanted in an individual. The advantages of this three-part laser cut replacement heart valve prosthesis are improved flexibility and improved fixation of the prosthesis. Various design features according to the present disclosure work together to better fix at the target site and reduce longitudinal movement of the prosthesis and its components. As disclosed, the favorable flexibility and fixation of the prosthesis after implantation is characterized by the fact that the proximal prosthesis portion (11) of the outer stent (11) does not move substantially during heart beating. The distal prosthesis portion (11b) of the outer stent (11) has a favorable freedom of movement relative to the proximal outer stent portion (11a), supporting its functionality and facilitating conformity to the ventricular tissue of the heart. Therefore, the distal portion (11b) of the outer stent (11) can move with the ventricle in a coordinated manner during heart beating and heart function. One can assume that the increased flexibility of the grooves, or V-shaped grooves, allows for greater deformation of the prosthesis in the outer ventricular stent portion (11b), which helps to improve and properly secure the prosthesis in the implantation site (target site) over the long term.

[0070] Figure B12 An aspect of the present disclosure is shown wherein different longitudinal regions of a stent in a stent prosthesis are shown, namely a proximal region (20), a middle region (23) and a distal region (22). The distal region includes a ring or anchoring unit.

[0071] Figure B13is an enlarged view of an embodiment of a connection device (19) according to the present disclosure. It represents an aspect of the present disclosure, wherein a clamping device is shown: the connection strut (12) is connected by the clamping device. It represents a device or apparatus for releasably connecting the connection strut (12) of the laser cut inner bracket (2) and the laser cut outer bracket (11). The releasable connection is achieved by the interaction of the interlocking pin (9), the interlocking yoke (18) and the sleeve (10).

[0072] Figure B14a , b, c illustrate an aspect of the present disclosure, wherein the closing sequence of the clamping device (19) is shown.

[0073] Figure B14a ) shows an interlocking yoke (18) connected to a connecting strut (12, 12') of an inner or outer laser-cut stent and shown in its open state ready to receive an interlocking nail (9) of a connecting strut (12, 12') of another stent (representing the outer stent or the inner stent of the counter-connecting strut). The counter-connecting strut carries an interlocking nail (9) inserted through a cannula (10).

[0074] B14b) Insert the interlocking pins (9) of the connecting struts (12, 12') of the other stent into the interlocking yoke (18) to achieve a stable connection of the two laser cut stents. The stable connection of the two parts (9) and (18) is achieved by the specific geometry of their interlocking parts. The geometry can vary and is not limited to the geometry described here.

[0075] Figure B14c ) shows the final connection of the connecting struts (12, 12') of two laser cut stents. The sleeve (10) is pushed onto the interlocking parts (18) and (9), wherein the sleeve (10) is fixed by interaction with the distal part of the interlocking yoke (18). When the two distal parts of the interlocking yoke (18) are pushed together, the sleeve (10) can be released so that the sleeve (10) can be pushed onto one of the connecting struts (12') again. At the end of the part (18), a stop device prevents the sleeve (10) from moving too far on the interlocking device (18) and (9). The interlocking yoke end prevents the sleeve from moving along the connecting strut in at least one direction or in two directions.

[0076] Figure B15a ) and b) show variations of the clamping device (19). The interlocking yoke (18) is designed differently at its distal end. The interlocking yoke (18) is characterized by a different stop design and differences in the interaction with the sleeve (10) and its release mechanism. Fig.15 In one design as in a), the distal portions of (18) are pushed together to release the sleeve (10), while Fig.15 In b), the distal tip contains a spring that needs to be pushed inwards to release. Fig.15 In each of the figures a) and 15b), the interlocking pins (9) also have a specific design.

[0077] Figure B16 One aspect of the present disclosure is shown which relates to a particular design of struts used in a laser cut stent for a prosthesis. The S struts (8) are characterized by a wavy or S-shaped geometry. In specific areas of the laser cut stent, struts such as S struts (8) are introduced to achieve a certain flexibility or to block movement from one stent to another, such as movement caused by the beating heart received by the outer stent. However, these impacts are undesirably transmitted to the inner stent due to the beating heart. One goal is to isolate them from the inner stent carrying the valve and / or to isolate them from deformations of the inner stent that potentially impair proper valve engagement or / and to isolate them from function. Therefore, deformations visible in the outer stent should not be transmitted to the inner stent carrying the valve. The goal is to have the inner stent essentially maintain its circular geometry, which is beneficial to valve function and in particular to a good fit of the valve leaflets.

[0078] Figure B17 and B18 One aspect of the present disclosure is shown, namely, deformation of an outer laser cut stent during extracorporeal heart beating and retention and maintenance of the original circular geometry of a laser cut inner stent carrying a valve. The inventive design of two laser cut stents, preferably nitinol stents, connected at a predetermined position by a connecting device of the present invention advantageously achieves correct positioning of the prosthesis at the target site, good fixation characteristics and leak-free functionality of the valve fixed to the laser cut inner stent. The inventive design of two laser cut stents with two stents connected in a predetermined manner provides advantageous compression resistance, thereby allowing the replacement heart valve prosthesis to perform correct valve function.

[0079] Figure B17 is a photograph of a laser cut stent of the present invention in a stent prosthesis according to the present disclosure ( Fig.18 ). The dark line indicates Fig.12 The proximal region (20) is indicated by the light line. Fig.12 The middle and distal regions (22 / 23). Fig.17 It is shown in Figure 1 that even if stress affects the prosthesis, the internal stent is still not affected and the valve can function normally and maintain its function, which is very advantageous. Fig.17The behavior of a laser cut stent in a stent prosthesis according to the present disclosure is simulated: even if the laser cut stent in the stent prosthesis in the middle and distal regions is subjected to strong deformation stresses, such stress impacts will preferably be transmitted only to a minimum extent to the proximal region. Likewise, such stress impacts will not reach or impact the inner stent bearing the valve. This is partly or essentially due to the positioning of the connecting device in this area. When the heartbeat strikes the laser cut outer stent (11), one goal is to maintain the optimal geometry of the valve bearing part of the replacement heart valve prosthesis (inner stent (2)) while at the same time providing a favorable fixation of the prosthesis.

[0080] The inventors have discovered a design using two laser cut stents, characterized by a special connection device and design, which allows the inner stent (2) carrying the valve to substantially maintain its original geometry. At the same time, this design allows the replacement heart valve prosthesis to be advantageously fixed at the target site after implantation.

[0081] like Figure B17 and B18 As shown, the laser cut external stent (11) is flexible and therefore maintains contact with the surrounding tissue at the implantation site of the heart. Therefore, it has good compliance with the endogenous surrounding tissue. In addition, in this way, the external stent of the prosthesis maintains the maximum possible friction with the tissue, which, together with other aspects of the prosthesis, contributes to favorable fixation. At the same time, the laser cut internal stent (2) with the valve essentially maintains its circular shape and therefore maintains the optimal geometry to achieve optimal valve function. In particular, deformation and maintenance of contact with cardiac tissue can be seen in the middle and distal regions (22 / 23) of the laser cut external stent. The proximal region (20) is hardly deformed or not deformed at all. The connecting struts (12) and the connecting device (19) provide a stable connection between the laser cut internal and external stents. At the same time, these structures advantageously contribute to the vibration isolation of the internal laser cut stent from the external laser cut stent of the prosthesis. Moreover, the positioning of these elements (12)(19) provides favorable compression resistance, reducing the deformation of the laser cut internal stent. Furthermore, the S-struts (8) in combination with the attachment means (19) and their specific orientation and positioning within the replacement heart valve prosthesis provide positive compression resistance and maintain the laser cut inner stent in a generally circular shape and substantially retain optimal valve function geometry.

[0082] Figure B19 An aspect of the present disclosure is shown in which the outer stent is shown collapsing after release (28). Such collapsing should be avoided, and designs according to the disclosure herein support preventing such undesirable collapsing and malfunction of the replacement heart valve prosthesis.

[0083] Figure B20 andB21 One aspect of the present disclosure is shown in which specific positioning and orientation of laser cut inner and outer stents and connecting struts (12) and connecting devices (19) are described.

[0084] Figure B22 , B23, B24 illustrate an aspect of the present disclosure, wherein an anchoring unit (15) and a fixing ring are shown in different embodiments and designs.

[0085] Figure B25a One aspect of the present disclosure is shown, namely, a laser cut stent in a mesh stent of a replacement heart valve prosthesis according to the present disclosure is reloaded into a catheter. The advantage of the ring design according to the present disclosure is the flexibility of the ring (4) and its special design, which allows recoverable access to the catheter shaft by flipping during retrieval or reloading.

[0086] Figure B25b One aspect of the present disclosure is shown, namely, a laser cut stent connected to a mesh stent of a replacement heart valve prosthesis according to the present disclosure is shown being loaded into a catheter (7). A wire braided outer stent (1) having an inner mesh (6) and an outer mesh (5) connected to an inner stent (2) is shown, wherein a Z-ring (27) is connected to the outer mesh (5). Furthermore, it is apparent from this figure that the wire braided outer stent (1) elongates during loading, and the Z-ring (27) does not overlap the inner stent (2), but rather reaches a position away from the inner stent (2), which advantageously helps to reduce the catheter diameter.

[0087] Figure B26 One aspect of the present disclosure is shown, which is another variation of the connection device (19) (see also Fig.14 and 15 Another embodiment of the interlocking teeth (14) is covered by a sleeve (10) to connect the connecting struts (12, 12').

[0088] Figure B27An aspect of the present disclosure is shown, in which a laser-cut internal support (2) is connected to an external mesh support, which includes a Z-shaped ring (27) connected to a wire-braided external support (1) on an external mesh (5). The Z-shaped ring (27) is, for example, sutured to the outside of the external mesh (5) in a distal region, for example at its distal end. The Z-shaped ring (27) combines a stabilizer function and a loop function. In particular, the replacement heart valve prosthesis is advantageously better fixed in the implant or in the target site by interfering with the tendons (chordae tendineae) in the ventricle (hooking or being caught by one or more tendons). The Z-shaped ring can be attached to the external support in a manner known to those skilled in the art, for example, by suturing, clamping or other useful means. Advantageously, the Z-shaped ring becomes a zigzag line, wherein the tips formed by the zigzag geometry point substantially in the proximal and distal directions. The Z-ring is composed of struts; the struts are connected to an external support (e.g., an external mesh) substantially in their middle portion, so that the tips of the struts are substantially free and can interfere with the tendons to better fix the prosthesis to the target site of the heart. The Z-ring can also present other useful geometric shapes (still referred to herein as Z-rings), such as wavy or curved geometric shapes, but the prerequisite is that the tips are formed by the Z-rings within regular distances. The prosthesis can also include one, two, three or more Z-rings connected and / or not connected to each other, and / or an external support of the prosthesis. A groove (16) is also shown.

[0089] Figure B28 One aspect of the present disclosure is shown, wherein: Figure B27 The prosthesis is shown in a cross-sectional view. An inner support (2) and a braided mesh outer support (1) are shown, as well as a V-shaped or U-shaped groove (16), which also helps to fix the prosthesis to the target site. The Z-shaped ring (27) is located on the outside of the outer mesh (5) and is fixed to the outer mesh (5) by, for example, sutures. The sutures at each pillar of the Z-shaped ring can be different, each pillar has two or more sutures, or the sutures can start at one position and continue to extend around the support to reach the starting point again. The inner mesh (6) is aligned with the laser-cut inner support (2) and is connected to the laser-cut inner support (2), for example by suturing. On the left side of the figure, one tip of the Z-shaped ring (27) can be seen, which points outward and is not connected to the outer mesh (5). The other tips of the Z-shaped ring have the same characteristics.

[0090] Figure B29a to Figure 2 9f illustrates an aspect of the present disclosure showing a cut stent in a cut stent replacement heart valve prosthesis. Figure B29f Exploded details of the connection areas and connection means of the different bracket components are shown.

[0091] Figures B29a to B29cThree parts of the prosthesis according to the invention are shown, namely the proximal laser cut stent (11a); the distal laser cut stent (11b) comprising anchoring units (15) and connecting strut guides (17); and the inner stent (2) with connecting struts (12).

[0092] exist Figure B29d In the embodiment, the support components (2) and (11b) are assembled, wherein the connecting strut (12) passes through the connecting strut guide 17).

[0093] Figure B29e A replacement heart valve prosthesis according to the present disclosure is depicted, wherein laser cut external stent components (11a, 11b), V-shaped grooves (16), anchoring units (15), connecting devices (19), connecting struts (12), and connecting strut guides (17) are shown. Laser cut external stent components (11a, 11b) are shown, namely, the proximal portion (11a) placed in the patient's atrium during implantation, and the distal portion (11b) placed in the patient's valve annulus / ventricle. Therefore, the prosthesis involves a three-part stent. The three stent portions (2, 11a, 11b) are connected by connecting devices (19) and connecting strut guides (17), respectively. Of particular interest in this figure is the area around the reference numeral (19) showing the interconnection of different stents or / and different stent portions. This area is depicted and further described in Figure 29f.

[0094] (Figure 29e) Figure B29f The enlarged view shows the connecting strut (12), the end of the connecting device (19) (the rest of the connecting device 19 is not shown) and the connecting strut guide 17. The connecting strut (12) is pushed into the connecting strut guide (17) and its end will eventually (not shown) be connected to its corresponding connecting strut (12') and connected by the connecting device (19) as described above (for example, Fig.14, 15, 26). The distal ends of the connecting struts (12, 19) are designed to be easily pushed into the openings or holes of the connecting strut guides (17). The connecting struts (12) extend from the laser cut inner stent (2) (not shown), and the connecting strut guides (17) extend from the distal end of the laser cut outer stent (11b). The corresponding connecting struts (12'-not shown) extend from the proximal end of the laser cut outer stent (11a) to be passed through the connecting device (19-all parts not shown here) to stably connect the laser cut inner stent (2-carrying valve-not shown), the laser cut proximal outer stent and the laser cut distal outer stent (11) through the connecting device (19) and the connecting strut guides (17). As described herein, the special connection design according to the present disclosure provides advantageous flexible characteristics of a replacement heart valve prosthesis and supports valve function as well as improved fixation and function of the prosthesis. Advantageously, the distal region of the prosthesis, in particular the distal region of the external support (11b), can therefore interact well with the ventricular tissue of the heart and better fix the prosthesis. The favorable compliance of the replacement heart valve prosthesis is achieved. On the other hand, the laser-cut internal support (2) with the valve (not shown) is also advantageously isolated from the external support. The impact of the movement or deformation caused by the heart beat on the external support part (11a, 11b) will not be transmitted to the internal support (2), so the internal support (2) maintains its good geometry and ensures correct valve function. In addition, the position of the support part responsible for connecting the different support parts (17, 19) under the implanted state is basically located in the valve ring area of ​​the target part, so compared with the atrium or ventricle area of ​​the heart (higher force in this area will have an impact on the connecting part of the prosthesis), the valve ring area of ​​the target part is less affected and less pressure caused by the heart beat. The design of the present invention as shown in Figures 29a to 29f also reduces or substantially prevents the undesirable longitudinal movement of the prosthesis at the target part. The prosthesis replaces the intrinsic heart valve function, and its replacement valve opens and closes during the heart beat. When the valve is closed, longitudinal stress will affect the replacement heart valve prosthesis in the proximal direction (towards the atrium), and the internal support (2) tends to move in the upward (proximal) direction. More importantly in this regard, the connection design of the present invention is designed to prevent the internal support carried in the replacement heart valve prosthesis from longitudinal movement. The connection of the three support parts (2, 11a, 11b) is advantageously located on the proximal side of the internal support (2). In addition, the connecting strut guide (17) is V-shaped, or as shown here, it is a ring or eyelet for carrying the connecting strut (12) from the internal support 2, thereby preventing the longitudinal movement of the internal support when the valve is closed and the proximal direction pressure acts. At the same time, the design of the present invention characterized by a limited number of connecting devices (19) and connecting struts (12) ensures that the pressure caused by the beating of the heart and pressing the prosthesis inward will not basically reach the internal support (2).Thus, the inner stent (2) maintains its substantially circular shape and advantageous geometry to enable a replacement valve attached to the inner stent (2) to function as a valve. The connecting strut guides (17) and their special interconnection with the other connecting struts (12) are an additional way to secure and hold the inner stent (2) in place to prevent the inner stent (2) from longitudinally moving in the outer stent (11 / 11a, 11b). Thus, the inner stent (2) is substantially prevented from entering the atrium.

[0095] Figure B30 A replacement heart valve prosthesis according to the present disclosure is depicted during implantation at a cardiac target site of an intrinsic tricuspid heart valve. The prosthesis is partially released from a catheter (7) to the target site, wherein during deployment, the intrinsic tricuspid valve (30), the annulus (31), the chordae tendineae (32) and the right ventricle (29), the partially released prosthesis (1), the V-shaped grooves (16) to be released, and the Z-shaped ring (27) are shown.

[0096] Reference numerals list

[0097] 1 Braided Nitinol stent (mesh stent)

[0098] 2 Laser-cut Nitinol stent

[0099] 3 Inflow sealing cap

[0100] 4 Outflow sealing cap

[0101] 5. Replacement valve

[0102] 6 Sutures holding the stent together

[0103] 7 Stabilizer

[0104] 8 rings

[0105] 9. Catheter sheet

[0106] 10 crimp diameter

[0107] 11 Inlet (near end) flange

[0108] 12 The part of the prosthesis that is aligned with the annulus

[0109] 13 Z-Ring

[0110] 14 Connecting device

[0111] A. Aortic valve

[0112] P Pulmonary valve

[0113] M Mitral valve

[0114] T tricuspid valve

[0115] AN annulus

[0116] MA Mitral annulus

[0117] AVN Atrioventricular node

[0118] S Diaphragm

[0119] CS Coronary sinus

[0120] Po rear side

[0121] an front side

[0122] Compliance of Co-woven stents to arm motion during the cardiac cycle

[0123] NL Natural Leaflet

[0124] Ch Chordae tendineae

[0125] PVL Paravalvular Leak

[0126] S The contact surface between the external stent (woven mesh stent) and the implant site

[0127] S1 Surface 1

[0128] S2 Surface 2

[0129] BF Blood Flow

[0130] SBF Systolic blood flow

[0131] DBF Diastolic blood flow

[0132] SPS Sealing Pressure During Contraction

[0133] SPD Diastolic sealing pressure

[0134] I, J, E Sealing cover attachment points with stent (external / braided stent)

[0135] K Sealing cover attachment point (possible if a cover is connected between I and J)

[0136] A,B,C,D,F defined support points

[0137] List of reference numerals for the drawings "B"

[0138] 1-Wire braided external stent (mesh stent)

[0139] 2-Laser cut internal bracket

[0140] 3- Stabilizer (e.g. additional wire below the V-groove and / or twisted wire)

[0141] 4-Ring

[0142] 5-External network

[0143] 6-Intranet

[0144] 7-Catheter

[0145] 8-S pillar

[0146] 9-Interlocking nails

[0147] 10-Sleeve

[0148] 11-Laser cutting external bracket

[0149] 11a-Proximal laser cutting of external stent (stent part)

[0150] 11b- Distal Borrowed Light Cutting External Stent (Stent Part)

[0151] 12,12'-Connecting pillar

[0152] 13-Connect the internal / external bracket

[0153] 14-Interlocking teeth

[0154] 15-Anchor unit

[0155] 16-V-groove

[0156] 17-Connect the pillar guide

[0157] 18-Interlocking yoke

[0158] 19-Connection device

[0159] 20-Proximal region

[0160] 21-Joint

[0161] 22- Distal Region

[0162] 23-Middle area

[0163] 24-valve leaflets

[0164] 25-Ring Pillar

[0165] 26-RF pillar

[0166] 27-Z-ring

[0167] 28-Fold

[0168] 29-Right ventricle

[0169] 30-tricuspid heart valve

[0170] 31-valve ring

[0171] 32- Chordae tendineae. DETAILED DESCRIPTION

[0172] Hereinafter, certain terms of the present disclosure will be defined. Otherwise, the technical terms in the context of the present disclosure should be understood by those skilled in the art.

[0173] In the sense of the present disclosure, the term "prosthesis" or "medical device" or "implant" is to be understood as any medical device that can be delivered in a minimally invasive manner. These terms can be used interchangeably. It can be a stent or a stent-based prosthesis or a stent-based replacement heart valve, such as an aortic heart valve, a mitral heart valve or a tricuspid heart valve.

[0174] In the sense of the present disclosure, the term "catheter" or "delivery device" is to be understood as a device for placing a prosthesis at a determined site in a patient to replace a heart valve such as the aortic valve, mitral valve or tricuspid valve.

[0175] In the sense of the present disclosure, a "mesh stent" or "woven mesh stent" or "woven stent" is a stent composed of metal wires, as opposed to, for example, a laser-cut Nitinol tube.

[0176] In the sense of the present disclosure, a "cut stent" or "laser cut stent" is a stent that has been laser cut from a nitinol tube.

[0177] In the sense of the present disclosure, "one or more stent regions" are defined areas of an outer stent, mesh stent or replacement heart valve prosthesis and are in particular defined as a longitudinal portion or outer portion of a proximal region, a middle region or a distal region.

[0178] In the sense of the present disclosure, "proximal region", "middle region", "distal region" refer to regions of a stent or prosthesis relative to an operator who implants the stent using a catheter, wherein the proximal end is close to the operator and the distal end is away from the operator. In the sense of the present disclosure, "middle region" refers to the region between the distal region and the proximal region in a stent or prosthesis. With respect to the natural blood flow in situ (i.e., in vivo) of an individual (human or patient), the "proximal region" may also be denoted as the inflow end or inflow region, and the "distal region" may also be denoted as the outflow end or outflow region.

[0179] In the sense of the present disclosure, a "valve annulus region" is a corresponding region of an intrinsic heart valve, or it defines a corresponding region in a replacement heart valve or stent to be located in an implantation site, and the valve annulus region is aligned with the intrinsic valve annulus.

[0180] In the sense of the present disclosure, the "annulus sub-region" is the region of the prosthesis in the distal direction (or outflow direction) of the annulus of the native heart valve. The prosthesis may cover the "annulus sub-region" with a groove region and a distal region.

[0181] In the sense of the present disclosure, a "groove" describes a region of a stent or prosthesis having a smaller diameter than other regions, and wherein other regions of the stent or prosthesis having larger diameters are near the distal and proximal ends of the groove; the groove may have a V-shape or a U-shape, or a combination thereof, or other useful geometric shapes.

[0182] A "two-part stent" in the sense of the present disclosure consists of an inner and an outer stent, wherein the inner stent carries a heart valve attached to the inner stent, and the inner and outer stents are connected by one or more sutures, a specific mechanism such as a click mechanism or any other suitable connection means forming a replacement heart valve prosthesis. In the sense of the present disclosure, such a prosthesis may be suitable or implanted to treat, i.e. replace, a faulty intrinsic heart valve, wherein the heart valve is a mitral valve or a tricuspid valve.

[0183] In the sense of the present disclosure, in a "multi-part stent", the outer stent consists of two, three or more parts, for example, made of a laser cut tube, wherein the parts are connected to a laser cut inner stent carrying the valve by connecting devices and connecting guides; a "multi-part stent" prosthesis may comprise at least three or more, for example 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 connecting devices and connecting guides. The connecting guide can advantageously be placed substantially proximal to the inner stent and prevent or limit the longitudinal movement of the inner stent. The definition of "two-part stent" above constitutes a part and belongs here to this definition.

[0184] In the sense of the present disclosure, a "target site" is a location or site where a replacement heart valve prosthesis is to be implanted and where a dysfunction or malfunction is desired to be corrected.

[0185] In the sense of the present disclosure, "connection" of stents is the manner in which two or more stents are secured to each other by suturing, by clamping or snap-fitting mechanisms, or by any other useful means or devices.

[0186] In the sense of the present disclosure, a "connection means" is a mechanical or physical connection of two struts or two parts in a mesh stent or a laser cut stent, wherein the two stents are connected to form a stable unit. The connection means may be, for example, welding, coupling, suturing, gluing or any other known process or method or means. The connection means may also be an attachment or clamping device of special design and geometry for releasable or non-releasable connection.

[0187] In the sense of the present disclosure, a "connecting strut" is a strut of two different stents or two different laser-cut stents, which serves to connect the two stents together.

[0188] It involves one or more struts of a laser cut stent, the function of which is to connect the laser cut inner stent and the outer stent. The connection can be releasable or non-releasable by a non-releasable connection or by a connecting device.

[0189] In the sense of the present disclosure, an "anchoring unit" is a combination of a ring and a stent unit of a laser cut stent, wherein the ring is radially movable and forms an atraumatic geometry. An "anchoring unit" may be formed as a single integral body, wherein the stent unit of a laser cut stent or part thereof forms a ring that is radially movable and forms an atraumatic geometry.

[0190] In the sense of the present disclosure, a "connecting strut guide" is used to support or assist the connection of a three-part stent. The connecting strut guide interacts with the connecting strut. Preferably, the connecting strut and the connecting strut guide are positioned in a groove (V-shaped groove or U-shaped groove) around the proximal region of the middle region and the distal region, for example. The connecting strut guide end can be formed as an eyelet or otherwise formed to allow the connecting strut to pass through and connect with its connecting strut counterpart. In this way, the proximal part of the stent (prosthesis), the distal part of the stent (prosthesis) and the inner stent are connected. Therefore, the middle and distal stent parts of the prosthesis can move freely and are easy to align with the ventricular tissue and its geometry; in this way, the inner stent carrying the valve is separated from the outer stent part of the prosthesis, and the deformation of the outer stent part of the prosthesis caused by the beating of the heart will not reach the inner stent. Therefore, the circular geometry of the inner stent is advantageously ensured, which is conducive to the proper fitting and functioning of the valve, i.e., the correct opening and closing of the valve leaflets.

[0191] In the sense of the present disclosure, an "S-strut" or "U or V-strut" is a stent strut of a laser cut stent (e.g., a nitinol stent) wherein the strut comprises or consists of a repeating number of S, U or V units and thereby forms a specific geometric shape that exhibits other properties compared to a straight strut. An exemplary S-strut is Figure B16 It can be used together with the connecting struts and / or connecting devices of the laser cut stent according to the present disclosure.

[0192] A "ring" in the sense of the present disclosure is a device for improving the fixation of a stent or prosthesis, wherein the ring is fixed to an external stent or is connected to an external stent or forms part of an external stent or is an integral part of an external stent. "One or more rings" in the sense of the present disclosure may have different shapes such as circular, square, etc. and be located in a defined area in a defined pattern. A "ring" in the sense of the present disclosure will present a defined angle relative to the external stent surface and may be designed so that the ring can be flipped when the stent or prosthesis is withdrawn into the catheter after initial and possible partial deployment. A ring in the sense of the present disclosure may be comprised in an anchoring unit.

[0193] In the sense of the present disclosure, a "stabilizer" is a structure that helps to better fix the stent or replacement heart valve prosthesis to the target site, where the target site is the endogenous heart valve to be replaced. A "stabilizer" can also be understood as a reinforcement means. In the sense of the present disclosure, a "stabilizer" can support certain features of the stent or prosthesis, such as flexibility or axial force, etc., completely or in a limited area. The stabilizer can be an additional wire or stent layer; the "stabilizer" is, for example, at least one nickel-titanium alloy ring, preferably attached to the inside or outside of the mesh stent, or combined with or introduced into the mesh of the mesh stent, preferably, wherein at least one nickel-titanium alloy ring has a wavy, V-shaped or U-shaped or zigzag geometry or the "stabilizer" can be designed as a Z-shaped ring.

[0194] In the sense of the present disclosure, a "Z-ring" provides a fixation function, or it combines a stabilizer and a ring function. In addition, the fixation or ring function advantageously provides interference with cardiac structures (e.g., chordae tendineae at the target site), thereby improving the fixation of the prosthesis at the target site. A prosthesis according to the present disclosure may include 1, 2 or 3 Z-rings. Such Z-rings may be interconnected to each other, or they may be independently connected to an external support, preferably an external mesh support. The Z-ring may consist of 10 to 30 units or 15 to 25 units, and / or the strut length of each unit may be in the range of 5 to 12 mm, preferably in the range of 8 to 10 mm. The Z-ring may be positioned in any intermediate or distal region or portion thereof, for example, it may be located in the distal region of the external mesh support, and preferably at the distal end. The Z-ring may be made of any material that may be combined with an external mesh support, for example, may be made of laser-cut nickel-titanium alloy, wire, nickel-titanium alloy wire. The Z-ring may also have any useful geometry, such as a Z, V, U or zigzag geometry. The Z-ring is preferably a laser cut component and is made of nickel titanium alloy. The Z-ring is placed outside the outer mesh support and can be connected to the outer mesh support by known means, such as suturing, welding, weaving, clamping or knitting into the mesh support.

[0195] The Z-ring may be placed circumferentially around the outer stent. It may also be feasible to design a Z-ring that does not represent a single ring disposed circumferentially along the outer stent, but rather is composed of a single unit or component placed around the outer stent. It is also feasible to place a single Z-ring unit or component in a defined area of ​​the outer stent so as to be placed in a preferred area relative to endogenous structures that are prone to interaction and improve fixation function. An important aspect of the Z-ring is that the ends that are substantially directed distally or proximally are free and not connected to the outer stent in order to perform its fixation function.

[0196] In the sense of the present disclosure, an "angle structure" or "angle" is the angle between two auxiliary lines drawn at a specific area or stent layer to define a certain geometry of the stent layer relative to other stent structures, such as an internal stent.

[0197] In the sense of the present disclosure, "angle α" is the angle of two auxiliary drawing lines surrounding the outer mesh support, each auxiliary drawing line being aligned with one outer or inner layer of the mesh support.

[0198] In the sense of the present disclosure, "spring" or "spring function" or "absorption" relates to the function of the outer mesh stent when folded into two layers and exhibiting a certain radial force and flexibility, wherein the radial force and flexibility will allow absorption of movements and vibrations generated by, for example, a beating heart, and which supports better fixation in a soft tissue environment, such as the tricuspid or mitral valve, etc. The same advantageous effects can be achieved when using a laser cut outer stent.

[0199] In the sense of the present disclosure, "radial forces" are forces exerted by a stent or prosthesis in a radially outward direction, more particularly by the outer stent of the prosthesis, which may be a mesh or laser-cut stent, such as a nitinol stent.

[0200] The radial force depends on the specific mesh or cut stent design and is related to the material density, for example, the density of wires per square area in a mesh stent, or the number of holes and the size of the holes along the circumference at a certain laser cut stent level or area (such as the proximal, middle or distal area). A certain size of radial force in a replacement heart valve prosthesis according to the present disclosure will be selected for each area to ensure good contact with and good contact with the surrounding tissue. On the other hand, the size is selected to avoid interfering with the implant site and endogenous tissue and function. The radial force can be supported by other means, such as a ring for fixation, to support its fixation function.

[0201] In the sense of the present disclosure, "improved fixation" describes better fixation in situ or in vivo compared to a stent or replacement heart valve where the prime stent or replacement heart valve does not have the respective design features, or generally refers to a stent or replacement heart valve that supports stable, long-term implantation at the desired implantation site.

[0202] In the sense of the present disclosure, the term "loading" is to be understood as a way of placing the prosthesis on the catheter so that the catheter is ready to begin the delivery and deployment process to the patient.

[0203] In the sense of the present disclosure, a "target region" is a three-dimensional space surrounding or within a native organ such as a native heart valve, which may be, for example, a tricuspid heart valve.

[0204] In the sense of the present disclosure, an "atraumatic design" of a ring is one in which the ring or other device or component of a stent or prosthesis is designed to avoid causing any damage or substantially no damage to surrounding tissue or tissue in contact with said component or at least a component, wherein said at least part refers to being manufactured to minimize damage and / or injury to the tissue in contact with it.

[0205] "Compliance" of a stent or replacement heart valve prosthesis, such as in the sense of the present disclosure, including an inner laser-cut stent within an outer mesh stent or a laser-cut inner stent within a laser-cut outer stent, involves positive interference with target tissue. "Compliance" involves exhibiting good geometric conformability of the stent or prosthesis to the implantation site, wherein the stent or prosthesis exhibits favorable fixation characteristics, good functionality with respect to valve function, and minimal interference with intrinsic heart structure and heart function.

[0206] In the sense of the present disclosure, the "compression resistance" of a stent or replacement heart valve prosthesis or prosthesis relates to the maintenance of the geometry of the internal stent or / and the maintenance of the functionality of the replacement valve function due to the design of the external stent, such as a mesh stent or a laser-cut nickel-titanium alloy stent, which can disconnect the internal stent and the external stent from the influence of the endogenous heart beating on the external stent of the prosthesis. The positive "compression resistance" of the prosthesis according to the present disclosure advantageously achieves the maintenance of the geometry of the internal stent and the substantially correct replacement heart valve function. Particularly advantageous is the radial force of the external stent to provide a fixation force to the target site and at the same time not interfere with the endogenous tissue and function. The prosthesis according to the present disclosure, for example, including an external mesh stent, will show point deformability, while still showing radial outward forces as a whole. At the same time, it can be deformed to provide favorable compliance to the ventricular heart tissue. Therefore, for example, the prosthesis according to the present disclosure including an external mesh stent shows circumferential outward forces and point deformability to provide strong compliance. Therefore, the compression resistance should be small, and the magnitude of the outward radial force should be able to provide support and fixation functions. The advantage of the compression resistance of the external support advantageously achieves the distribution and reduction of point stress impacts in the target area.

[0207] In the sense of the present disclosure, a "frame" or "stent" is a portion of a replacement heart valve prosthesis that can be crimped and delivered to a target site in an individual via a delivery system or catheter. Specific portions of the frame carry a valve and sealing features, wherein the valve replaces the function of the native heart valve and one or more sealing features are used to prevent PVL (paravalvular leak).

[0208] In the sense of the present disclosure, a "single frame" is a frame that is made from one component or assembled from one functional component prior to delivery to an individual.

[0209] In the sense of the present disclosure, a "multi-frame" or "stent-in-stent" design forms part of a replacement heart valve prosthesis, wherein two or more parts form a single frame that carries the valve and sealing features. A stent-in-stent design may include two or more stents, for example, one or two or three laser-cut Nitinol stents or a braided stent in combination with one, two or more laser-cut stents, wherein the laser-cut stents are made, for example, of Nitinol.

[0210] In the sense of the present disclosure, a "valve" or "replacement heart valve" is connected to the frame or stent portion of a replacement heart valve prosthesis and is used to allow blood to flow in a first direction and prevent blood from flowing in a second direction. The valve can be made of or include any material known to those skilled in the art. The material can be selected from, for example, pericardial tissue, bovine or porcine or polymer tissue.

[0211] In the sense of the present disclosure, a "sealing feature" is a means of preventing unwanted blood flow in a particular direction or region. A sealing feature can prevent blood flow in one or more directions, or can prevent blood flow in one direction and allow blood flow in another direction, and in particular acts in coordination with the valve of the replacement heart valve prosthesis disclosed herein. The sealing features can be one, two or more, and each sealing feature can have a specific function, and each sealing feature can have a function that is different from one another. Each sealing feature can be divided into different regions. One sealing feature can be located in the proximal or inflow region on the outside of the replacement heart valve prosthesis, another sealing feature can be located in the annular or middle region, and another sealing feature can be located in the distal or outflow region. The material can be selected from, for example, pericardial tissue, bovine or porcine or polymer tissue.

[0212] In coordinated function with a minimally invasive heart valve prosthesis, the sealing feature may be attached to two or more stent frames by various attachment means, such as suturing, gluing, encapsulation or any other known process or technique or means.

[0213] The stent and sealing features can be made of a variety of materials that are compatible with other replacement heart valve components and are preferably biocompatible. In the sense of the present disclosure, the stent or frame can be made of or include a nickel titanium alloy. It can also contain one or more polymer materials, such as PLLA or / and one or more metals, such as stainless steel or cobalt chromium, platinum chromium alloy, magnesium. The sealing feature can be made, for example, from bovine or porcine pericardium.

[0214] In the sense of the present disclosure, an "attachment point" defines the connection of a sealing feature to the frame of a replacement heart valve prosthesis; an "attachment point" is connected to a sealing feature and other features support or / or provide a replacement heart valve prosthesis with favorable sealing features and favorable curling features. "Attachment points" may be denoted, for example, I, E, J, K. Other reference points in this context may be further defined. An attachment point defines the distance between two attachment points and the ratio of two attachment points to two other attachment points. The defined distances and ratios, combined with the specific attachment point positions within the replacement heart valve prosthesis, in particular its position on the prosthesis frame, provide favorable functionality with respect to sealing properties or / and its ability to curl well. The distances I to K and K to J may be adapted to different stent designs and may depend on the stent size and stent design being curled, such as a nitinol cut tube stent in a mesh stent or a nitinol cut tube in a nitinol cut tube.

[0215] The distance from K to E can be adapted to different stent designs and may depend on the crimped stent size and stent design, such as a nitinol cut tube stent in a mesh stent or a nitinol cut tube in a nitinol cut tube. For sealing and crimping, on the one hand, the distance J to K and the distance K to J are equidistant.

[0216] In the sense of the present disclosure, an "attachment region" relates to the area of ​​the attachment point within the stent of a replacement heart valve prosthesis.

[0217] Hereinafter, additional stent designs will be described that can be combined with the advantageous sealing features of the present disclosure as described above and in the drawings and claims. The following description particularly refers to the "B" list of figures and the "B" figure. These features can be combined with each other and with the features described above, and such combinations will imply numerous advantages that will be appreciated by those skilled in the art.

[0218] In one aspect, another stent design can be a mesh stent, wherein the stent includes one or more reinforcement regions.

[0219] In one aspect, another stent design may be a mesh stent that includes one or more fixation rings.

[0220] In one aspect, additional stent designs may be a combination of stents including one or more reinforcement regions and one or more fixation rings. Specific external stent designs that advantageously exhibit alignment capabilities with native tissue of the implant site may additionally support improved fixation.

[0221] Additional stent designs as described above may be combined with the sealing features described herein.

[0222] Thus, in one aspect, additional stent designs may provide stents and / or replacement heart valve prostheses having advantageous fixation characteristics and improved sealing characteristics.

[0223] On the other hand, another stent design relates to a mesh stent as described above, wherein one or more fixing rings are characterized in that metal wires extending from the stent and returning to the stent form a ring extending outward from the stent, preferably in an annular sub-region of the stent (ventricular region), in the proximal direction (in the inflow direction), forming an angle of 30°-90°, preferably 50°-60°, preferably wherein multiple rings are at the same or different distances from each other in the circumferential direction of the stent, or / and multiple rings are arranged in several rows, or / and are located in different rows or at alternating positions.

[0224] The rings according to the present disclosure may be formed in any useful manner and geometry, preferably they are formed in elliptical, circular, open, closed or / and conical geometries. Advantageously, the length dimension of the ring is in the range of 2mm to 15mm, or / and the diameter of the ring is in the range of 2mm to 10mm.

[0225] Preferably, in the mesh stent according to the present disclosure, the ring is formed with an atraumatic design. Therefore, the ring is designed to avoid or substantially not cause damage to surrounding tissue, or at least is produced in a manner that minimizes damage and / or injury to the tissue it contacts.

[0226] The rings can be positioned to best help increase the fixation properties of the prosthesis. Thus, the rings can be angled relative to the mesh stent in the proximal or distal direction. In one aspect, the mesh stent according to the present disclosure has rings that are designed to flip in the distal direction (outflow direction) when the stent is reloaded into the catheter in situ.

[0227] In a preferred aspect, a mesh stent according to the present disclosure is characterized by a combination of inventive features of the present disclosure, wherein the reinforced region is supported by a stabilizer and / or one, two or more additional mesh layers.

[0228] The stabilizer may be one, two, three or more stabilizers attached to or combined with the mesh stent, and preferably, the stabilizer is at least one or two nitinol rings or wires, preferably attached to the inside or outside of the mesh stent, or combined with or introduced into the mesh of the mesh stent. The stabilizer may exhibit geometric shapes in different regions or circumferences of the mesh stent, preferably, wherein at least one nitinol ring has a wavy or V-shaped or U-shaped or zigzag geometry.

[0229] On the one hand, the present disclosure relates to an embodiment in which the outer support includes a Z-ring located outside the distal region of the outer support (e.g., a mesh support) and preferably located at the distal end of the outer support. The Z-ring will advantageously incorporate a reinforcement or stabilizer function, and its tip protrudes substantially in the proximal and distal directions, and it is also characterized by a ring function or a function for interfering with a cardiac structure (e.g., chordae tendineae), as disclosed herein, thereby contributing to improved fixation properties of a replacement heart valve prosthesis.

[0230] On the one hand, the present disclosure relates to a Z-ring or multiple Z-ring components, which are used to support or improve the stable fixation of a stent, a two-part stent, or a three-part stent of a replacement heart valve prosthesis including the stent at a target site, preferably in the heart. The Z-ring or Z-shaped component is characterized by at least two strips and at least one peak or tip in one direction, and at least two peaks or tips in the opposite direction. The number of strips, tips / peaks varies depending on the overall size of the prosthesis and the functional requirements regarding the fixation features. Such a Z-ring portion or Z-ring component is connected to an external stent, such as a replacement heart valve prosthesis, so that the tips or peaks are substantially not connected to the external stent and are allowed to interact with endogenous structures or tissues, thereby supporting the improved fixation of the prosthesis. The external stent can be a mesh stent connected or interwoven with the Z-ring or Z-ring component.

[0231] The Z-ring or Z-ring component may advantageously be positioned in the middle or distal region of the outer stent or a sub-region thereof.Preferred are all curved regions of the outer stent.

[0232] On the one hand, it is also advantageous if the Z-ring or Z-ring component is located in the distal region of the outer support of the replacement heart valve prosthesis, because this positioning also implies an advantage in favor of the catheter diameter, thanks to the favorable placement of replacement prosthesis components, such as the inner support, the Z-ring or Z-shaped component, and the remaining prosthesis components that are favorable for the prosthesis diameter of loading and curling in the catheter (see also Figure 25b). In this way, the Z-ring and the inner support will be placed adjacent to each other and do not overlap, resulting in an increase in diameter. This favorable loading positioning of the prosthesis components is achieved by advantageously utilizing the elongation of the outer mesh support in the longitudinal direction during the curling and positioning of the Z-ring or Z-ring component and the inner support, thereby achieving a side-by-side arrangement in the catheter.

[0233] On the one hand, the use of a Z-ring or Z-ring component will support the concept that the inner stent exhibits relatively high radial forces, while the outer stent exhibits relatively low radial forces and is very compliant with the target site, which provides improved or favorable fixation characteristics of the prosthesis including the component. The Z-ring or Z-ring component thus makes it possible to maintain relatively low radial forces in the outer stent while providing favorable fixation characteristics.

[0234] In an advantageous manner, the mesh stent according to the present disclosure exhibits a reinforcement region, wherein the one or more reinforcement regions are a combination of rings attached to an external stent or as an integral part of the external stent, and wherein the mesh stent is reinforced by two, three or four layers, and / or is not connected to an internal stent.

[0235] The above features can be combined with an external mesh stent design, wherein when the stent region is arranged at the target site, the stent region will be substantially compliant with the annular or annular sub-region or ventricular region of the target site. Therefore, the mesh stent will not only be well aligned with the endogenous cardiac tissue, but also the contact area of ​​the mesh stent with the endogenous tissue will be increased. In this way, since more surfaces of the stent or replacement heart valve are in contact with the endogenous surface of the endogenous valve of the surrounding tissue, the fixation of the mesh stent and prosthesis according to the present disclosure is improved due to the improvement of friction. The mesh stent according to the present disclosure can advantageously achieve the adaptation of the a priori circular mesh stent to the elliptical endogenous heart valve geometry, and therefore, the stent or replacement heart valve prosthesis will exhibit improved fixation characteristics in situ. If the stent or replacement heart valve prosthesis only achieves partial alignment with the endogenous tissue or endogenous ventricular tissue, improved fixation characteristics can also be achieved. In addition, the interference of the ring with the chordae tendineae can help to improve the fixation characteristics of the prosthesis.

[0236] In one aspect, a mesh stent according to the present disclosure exhibits one or more enhanced regions, preferably wherein the enhanced regions are located on a mesh stent region that, when deployed in a target site, preferably in the case of a replacement heart valve for a tricuspid or mitral heart valve, will be substantially aligned with a ventricular region of the target site. Or wherein the enhanced regions are located on a mesh stent region that, when deployed to a target site, preferably in the case of a replacement heart valve for an aortic or pulmonary heart valve, will be substantially aligned with an aortic or pulmonary region of the target site.

[0237] In one aspect, in a mesh stent according to the present disclosure, the reinforcement region is located on a mesh stent region in an outflow region of the mesh stent.

[0238] The mesh stent according to the present disclosure may exhibit one or more enhanced regions, wherein, in one aspect, the enhanced region is characterized by a mesh double or triple layer, preferably made of a single-part mesh, preferably with a loop. A loop is specially formed. During reloading, the ring will flip and can therefore be pulled back into the catheter and form an integral part of the mesh stent. A single-part mesh can be used, preferably in which the layers of the outer stent have the same three-dimensional geometry and form a superimposed layer structure; in this superimposed stent structure, the individual layers can contribute to the definition and design of radial forces in a specific stent area, thereby contributing to the generation of a positive and advantageous spring or absorption effect. The layers of the mesh stent can be connected to each other by useful means such as sutures.

[0239] On the one hand, the enhanced region is characterized by a mesh bi-layer or tri-layer, which is also characterized by the space between the mesh layers and / or the conical geometry of two or three mesh layers, preferably, wherein the conical geometry and / or the distance between the mesh layers increases in the proximal (inflow) direction.

[0240] The flexibility characteristics of the mesh stent according to the present disclosure can be designed and adjusted by a reinforcement feature or a combination of reinforcement features, wherein the reinforced area is characterized by reduced flexibility compared to the unreinforced mesh stent area, or / and is characterized by increased radial force compared to the unreinforced mesh stent area.

[0241] The mesh stent according to the present disclosure may be characterized by three regions, which are defined as a proximal region or atrial region or inflow region, a middle region or annular region (or sub-groove region), and a distal region or ventricular region or outflow region.

[0242] The present invention can advantageously achieve a specific behavior of the prosthesis by limiting and selecting the design features of the present disclosure as single features or combinations of features, thereby achieving a specific radial force distribution and thus better fixation of the prosthesis at the implantation site.

[0243] In the prior art, replacement heart valve prosthesis designs may exhibit radial force distributions in different areas (over the entire length of the prosthesis), which is detrimental to optimal fixation of the prosthesis, particularly in the case of mitral or tricuspid valve replacement treatments. Prostheses according to the prior art may exhibit excessive radial forces at the distal end. This may therefore lead in situ - after implantation and while the heart is beating - to a gradual push of the prosthesis in the proximal direction (i.e., in the inflow direction) and to misalignment of the prosthesis.

[0244] Now, the prosthesis according to the present disclosure can be achieved through its enhanced features, for example, reinforced areas or designs, where the distal portion of the mesh is not connected to the internal stent, as well as different and improved radial force distribution of the replacement heart valve prosthesis at the ideal implantation site, and improved fixation.

[0245] Additional design features such as rings and / or improved alignment of the outer mesh stent with native cardiac tissue in the ventricular region may contribute to this improved fixation.

[0246] The size of the mesh stent according to the present disclosure will be designed to fit a specific patient or patient group, and the sizes of the three prosthesis regions will be selected to be the most appropriate. On the one hand, the prosthesis according to the present disclosure will have a prosthesis size, wherein the longitudinal dimension of the proximal region is 1 to 25 mm, preferably 1 to 5 mm, the longitudinal dimension of the middle region is 1 to 25 mm, preferably 4 to 10, and the longitudinal dimension of the distal region is 1 to 25 mm, preferably 4 to 10 mm.

[0247] On the other hand, the present disclosure relates to a heart valve prosthesis, which includes a mesh stent as described above (which is a first stent) and a second stent, wherein the first stent is a mesh stent (external stent) and the second stent is an internal stent, including a valve preferably fixed thereto by one or more sutures.

[0248] In the heart valve prosthesis according to the present disclosure, the inner stent is a laser cut nickel titanium alloy tube, wherein the inner stent preferably has an inner diameter between 8 mm and 40 mm, or / and the inner stent has an outer diameter between 15 mm and 200 mm, or / and the inner stent has a longitudinal diameter between 8 mm and 35 mm in its deployed configuration. The inner stent may consist of two, three, four, five or six rows of units.

[0249] In the heart valve prosthesis according to the present disclosure, the two stents can be connected by a skilled person in an appropriate and generally known manner. The inner stent can preferably be connected to the outer stent by one or more sutures or by one or more connecting structures. Such a connecting structure can be a clip or another two-part device that will remain stable once connected to each other.

[0250] In the heart valve prosthesis according to the present disclosure, the inner stent and the outer stent may be connected and fixed to each other, as this is suitable and useful for the function of the prosthesis, and this may also be useful for the crimping step. In certain embodiments, the inner stent is preferably connected to the outer stent at its distal region (outflow region) and proximal region (inflow region) or substantially at its proximal region, or / and wherein the distal region of the outer stent is not connected to the inner stent.

[0251] On the one hand, a heart valve prosthesis according to the present disclosure is advantageous in which the distal region (outflow region) of the external mesh support is not connected to the internal support, and in which the angle of the external mesh support relative to the internal support is particularly selected. In addition, the angle α can be selected in a specific size. All three of these design features will help improve the fixation of the mesh support and the heart valve prosthesis at the implantation site. In a specific embodiment according to the present disclosure, the angle formed by the external support and the internal support is preferably 25 to 50°, more preferably 35 to 45°.

[0252] Heart valve prostheses according to the present disclosure may be deployed via a catheter system. It is generally desirable to achieve a low profile for a heart valve prosthesis that is loaded onto a catheter. Thus, in one embodiment, in a heart valve prosthesis according to the present disclosure in a crimped configuration, the ring is on the mesh stent in the ventricular region, thereby being located in an area where the mesh stent does not overlap itself and / or is located on the mesh stent in an area where the prosthesis has one less stent layer in the crimped configuration. See, e.g. Figure 8 .

[0253] It is described above that in a mesh stent according to the present disclosure or a heart valve prosthesis according to the present disclosure, a size can be selected that will be most suitable for use and advantageous implantation and fixation. It is also described that the mesh region can be adapted in its longitudinal dimension. The diameter of the mesh stent or the heart valve prosthesis can also be adjusted to improve the fixation characteristics. Therefore, the three regions of the mesh stent or the heart valve prosthesis can have different outer diameters, preferably, in the expanded state of the stent, the three outer diameters are in the range of 40 to 90 mm or 20 to 90 mm. The outer diameters can be equal or different.

[0254] On the one hand, the mesh stent according to the present disclosure or the heart valve prosthesis according to the present disclosure is designed to have an outer diameter in the middle region that is significantly smaller than the other two regions, and preferably forms a groove. Such a groove can be formed as a substantially V-shaped or U-shaped groove or any combination of such geometric shapes to achieve improved alignment with endogenous heart tissue and geometry.

[0255] The overall mesh stent and heart valve prosthesis design according to the present disclosure will result in a specific radial force distribution in the longitudinal dimension. In a specific embodiment, the radial force in the annular sub-region is substantially equal or higher than the ventricle or outflow region of the mesh stent or prosthesis. The radial force on the prosthesis disclosed herein is preferably as follows: the proximal region (inflow region) to the middle region to the distal region (outflow region) is equal to 1-2 to 0.5-1 to 2-3.

[0256] In one aspect, the mesh stent or heart valve prosthesis according to the present disclosure has a radial force in the annulus region in the range of 2 to 20 N. In the region of the Z-ring, the radial force may be 15 to 40 N.

[0257] In another aspect, the present disclosure relates to a heart valve prosthesis as described above, wherein the outer stent is a laser cut stent, preferably a nitinol stent.

[0258] On the one hand, the present disclosure relates to a stent or replacement heart valve prosthesis, which includes or consists of two laser-cut nickel-titanium alloy stents, which are an inner stent and an outer stent. The inner stent and the outer stent are preferably connected by one or more connection methods or by physical methods such as welding, and the valve is preferably attached to the inner stent.

[0259] The laser cut inner stent connected to the laser cut outer stent according to the present disclosure advantageously achieves good long-term fixation at the target site and simultaneously provides good replacement heart valve function. Advantageously, longitudinal movement of the inner stent relative to the outer stent is avoided. In addition, longitudinal movement of the replacement heart valve prosthesis is substantially avoided, which helps the replacement heart valve prosthesis to function correctly.

[0260] The combination of two laser cut stents according to the present disclosure advantageously provides favorable compression resistance of the prosthesis and, therefore, excellent functionality of the replacement heart valve.

[0261] A problem with replacement heart valve prostheses is the folding of the stent components during deployment at the target site. The specific design of the replacement heart valve prosthesis according to the present disclosure is achieved to substantially avoid said problem.

[0262] The replacement heart valve prosthesis can be divided longitudinally into three regions: First, the proximal region or inflow region or atrial region. Second, the middle region or preferably the groove region or annular region. Third, the distal region or outflow region or annular subregion. The different regions will be designed to best fit the specific native heart valve geometry and its dimensions. The three regions may have the following dimensions:

[0263] Proximal region: 1mm-25mm, diameter 20-90mm, number of circumferential stent units 6-48, preferably 10-18;

[0264] Middle region: 1mm-25mm, diameter 10-80, number of circumferential stent units 6-48, preferably 10-18.

[0265] Distal region: 1mm to 35mm, diameter 20 to 90, number of circumferential stent units 6 to 48, preferably 10 to 18.

[0266] On the one hand, the present disclosure relates to a heart valve prosthesis as described above, wherein the laser cut external stent is characterized by at least 4 rings and / or anchoring unilaterals, preferably 6 to 18, 8 to 12 or 10 rings and / or anchoring units. The laser cut external stent is characterized in the circumferential direction by having a limited number of units in different stent regions. The laser cut external stent according to the present disclosure is characterized in that it has 14 to 22 or 16 to 18 units (also called support units) in the proximal region and 14 to 22 or 16 to 18 units in the distal region. The distal region may include or consist of one row, two rows, three rows, four rows or five rows of units. In an embodiment in which the distal region consists of two or more rows of units, the number of circumferential units is 16 to 34 or 18 to 28 of the units.

[0267] The laser cut internal stent may be characterized by two, three, four, five or six rows of cells. The stent may include or consist of 10 to 30, 14 to 20 or 16 to 18 cells in each row in the circumferential direction.

[0268] The laser cut outer stent may include eyelets at the proximal end of one or more or all of the cells which may be used to more easily load into a catheter for deployment.

[0269] A laser cut outer stent according to the present disclosure that is not distally connected to the inner stent also contributes to the advantageous compliant function of the prosthesis according to the present disclosure.

[0270] A replacement heart valve prosthesis according to the present disclosure will be characterized in situ by a favorable radial force distribution that results in favorable fixation in the implantation site. A prosthesis according to the present disclosure is characterized by substantially no or only minimal motion in the atrial region. In the ventricular region, it is characterized by favorable flexibility and / or compliance that contributes to improved fixation and long-term function.

[0271] The design according to the above disclosure also implies the advantage of avoiding areas of the stent that are prone to potential stent fracture and damage. For example, the distal outer portion or tip has an open geometry. Therefore, in a prosthesis according to the present disclosure, stent fracture will not occur compared to a closed design in which the outer distal stent is connected to the inner distal portion of the inner stent.

[0272] The replacement heart valve prosthesis as described above has advantageous fixation characteristics, wherein the external stent includes a ring on the unit in the outflow region, preferably at its outflow end (distal end). In one embodiment, the prosthesis is preferably characterized by having at least two anchoring units, such as 4 to 20 anchoring units. The prosthesis may also include a ring as an integral part of the laser cut stent or fixed to its laser cut stent in any useful manner.

[0273] In the replacement heart valve prosthesis as described above, the ring may be located in the most distal cell, and the ring may protrude outward and show flexibility in an inward direction.

[0274] exist Figures B22 to B24 An embodiment including anchoring according to the present disclosure is depicted in . Such anchoring units advantageously help to better secure a replacement heart valve prosthesis in a target site in an atraumatic manner. The ring located inside the support unit of the external stent has the following characteristics, namely, the ring provides friction and interference with the tissue, which allows the prosthesis to be more properly secured in the target site after implantation.

[0275] The integral nature of the anchoring unit and the ring contained therein has the advantage that no additional material or device needs to be added in an additional production step, and in terms of the durability of the prosthesis, its service life can be extended and the stent is less prone to fracture.

[0276] The ring according to the above disclosure may be formed in another way, ie the ring points outwards, thereby supporting its fixing purpose.

[0277] The outer stent may comprise, for example, 4 to 20, 8 to 16 or 10 to 12 anchoring units, wherein the anchoring units are arranged in a row circumferentially at the distal region or outflow end of the prosthesis. The anchoring units may also be arranged in an outer stent in a staggered manner, for example in two rows.

[0278] The diameter of an anchoring unit according to the above disclosure may be in the range of 3 to 5 mm.

[0279] A replacement heart valve prosthesis as described above may have an inner stent and an outer stent connected by a connecting device or directly connected using, for example, a physical method such as welding, by one or more sutures, one or more screws, or one or more clamping devices.

[0280] The external support may also include S-struts in defined areas or positions. The S-struts may be combined with a connecting device, and one or two S-struts may be located on each side of the connecting device. The positions of the S-struts and the connecting device are arranged so that the commissures of the replacement heart valve are not at the same level, but are displaced at an angle β. Two connecting devices and / or two or four S-struts are located at the commissures of the replacement heart valve. Therefore, they contribute to favorable compression resistance. Unfavorable folding of the stent may also be prevented thereby. Finally, the coaptation function of the valve leaflets of the replacement heart valve is also improved or maintained thereby.

[0281] The S-strut element offers various advantages. The S-strut can provide easier shape forming during production and also offers advantages during crimping when loading the prosthesis onto a catheter for delivery. Also, material tension within the prosthesis is reduced, point stresses are reduced, and fatigue performance is improved.

[0282] A heart valve prosthesis as described above, wherein the holding means features interconnection means and securing means such as a sleeve.

[0283] The connection of the inner and outer stents by the use of one or more clamping devices is not immediately apparent, nor is the advantage and particular positioning of said clamping devices in the atrial region.

[0284] The inventors have found that placing the clamping device in this area has the following advantages: During the heartbeat, and when exposing the implanted prosthesis to the environment in which the clamping device is located, this environment is subject to less stress than, for example, the environment of the ventricles of the heart. It can be achieved that the clamping device is subject to less stress, thus having a less positive impact on the service life and fatigue of the implanted prosthesis. In addition, the clamping device represents a relatively large and dense material, which helps to visualize the prosthesis area to be positioned in the annular region. Therefore, the prosthesis can be correctly guided and placed without the need for opaque markers such as gold, tantalum, platinum iridium.

[0285] In an advantageous embodiment, valve commissures (or valve-carrying or valve-connected posts) of a replacement heart valve prosthesis located in the inner stent are located between connecting struts and / or connecting means (eg, clamping means).

[0286] These prosthetic structures can advantageously be positioned at a distance or angle. Thus, an optimized fit of the prosthetic valve leaflets can advantageously be achieved and ineffective replacement heart valve prosthesis function can be avoided. Moreover, in this way, deformation of the internal stent carrying the valve due to heart beating and tissue movement is reduced and kept to the minimum possible. This also contributes to the correct replacement heart valve prosthesis function after implantation.

[0287] Therefore and through this structural design feature, there is a synergistic effect on the stability of the inner support, as well as the reduction of shape changes, which can support the correct opening and closing of the valve leaflets connected to the inner support.

[0288] The compression resistance of the intrinsic cardiac structure should be optimized and should be functionally related to the behavior of the implanted prosthesis.

[0289] One goal achieved by the prosthesis as disclosed herein is that the implanted prosthesis cooperates with endogenous tissue and / or exhibits favorable compliance to endogenous tissue and heartbeat requirements, so that the prosthesis as disclosed herein is safely positioned and secured for long-term correct functioning while disturbing the endogenous heart structure as little as possible.

[0290] The replacement heart valve prosthesis comprises two laser cut stents preferably connected to each other by a connecting device, advantageously achieving a combination of an inner stent with high pressure resistance and good valve function, and wherein the outer stent has low pressure resistance, especially in the outflow area, thus advantageously only disturbing the ventricular heart area only slightly. Thus, the prosthesis disclosed herein has high pressure resistance in the inner stent and low pressure resistance in the outer stent. In fact, by the inventive design of the prosthesis disclosed herein, the outer stent is adapted to the natural endogenous ventricular geometry without having a significant impact on the ventricular geometry.

[0291] This positive interaction with endogenous cardiac tissue and structure can even be improved by the above-mentioned elements (e.g., S-pillars), which can be used in combination with connecting pillars and clamping devices. These elements and the specific placement and orientation of the commissures provide advantageous functions. The inclusion of anchoring units in the distal region of the prosthesis and their atraumatic design can reduce or avoid tissue damage, while improving the fixation and long-term fixation of the prosthesis after implantation. The combination and positioning of the connecting devices will advantageously avoid or limit the longitudinal movement of the internal stent described herein.

[0292] In addition, the prosthesis disclosed herein will show advantageous fixation features and characteristics, and in a three-part stent, a specific combination of connecting struts and connecting strut guides will limit longitudinal movement during contraction of the heart. When the valve is closed, the three-way connection of the connecting struts to the connecting strut guides and the connecting device and their arrangement near the inner stent will substantially prevent or limit longitudinal movement of the inner stent. The connecting strut guides can have eyelet, V-row or U-shaped shapes, wherein the eyelet shape is preferred. The eyelet shape will advantageously keep all components in a predetermined position, thereby allowing only minimal movement and maintaining a predetermined geometry during replacement heart valve function.

[0293] An aspect of the present disclosure is also a replacement heart valve prosthesis as described above, wherein the inner stent and the outer stent are connected with 4 to 20 connection devices, preferably with 6 to 14, 8 to 18 or 8 to 12 connection devices.

[0294] In a replacement heart valve prosthesis as described above, the prosthesis may be crimped to a diameter of 16 to 35 French, or 20 to 35 French, or 25 to 35 French.

[0295] The replacement valve is connected to the internal support and is usually composed of three leaflets in one or three pieces produced according to the prior art and sutured into the internal support. The material can be selected from any known and useful materials, such as bovine or porcine pericardium, polymer materials, etc., and since the materials and preparation methods are well known in the art, they do not need to be described in detail here. The prosthesis may include a cover and a seal suitable for its function.

[0296] Advantageously, in any prosthesis size where the outer stent size may vary, the inner stent carrying the replacement valve may always have the same diameter and size, which facilitates production while also reducing production costs.

[0297] A common advantageous concept for all variations and embodiments disclosed herein is an outer stent with improved fixation characteristics which simultaneously decouples or isolates or protects the inner stent from deformation or impact of the inner stent and / or valve geometry, thereby combining improved fixation characteristics with improved replacement valve function.

[0298] In the laser cut stent of the replacement heart valve prosthesis according to the present disclosure, one advantage of the laser cut stent is that there is a very advanced production technology, so such a prosthesis can be manufactured at a very low cost.

[0299] Likewise, when manufacturing laser cut stents, the production process is easy to control, so this is also an advantage from a cost and quality control perspective.

[0300] The present disclosure relates to various stent embodiments, wherein the stent may be a two-part stent, wherein the two-part stent is characterized by a laser cut inner stent connected to an outer mesh stent or a laser cut inner stent connected to a laser cut outer stent (a two-part or three-part stent). Where the outer stent may include other features. In all embodiments and variations described herein, a varying number of features or combinations of features are utilized to achieve the purpose of improved fixation at a target site.

[0301] Thus, the present disclosure provides different advantageous solution variants, preferably in the case of tricuspid or mitral heart valves, solving the same problem of improved fixation of replacement heart valves.In addition, the present disclosure is directed to providing a number of methods that can be used to better fix a replacement heart valve on its target site.

[0302] In another aspect, the present disclosure relates to the use of the described replacement heart valve in replacement heart valve therapy or a method of implanting the same. The replacement heart valve prosthesis as described herein can be delivered and implanted into a patient's desired target site, such as to replace the tricuspid valve, by known catheter techniques. The delivery and deployment path is, for example, transfemoral (percutaneous) catheter implantation.

[0303] In another aspect, the present disclosure relates to a method of implanting a heart valve prosthesis as described above, wherein the prosthesis is delivered using a catheter, such as transfemoral delivery, the method comprising the steps of loading the prosthesis onto the catheter, introducing the catheter into a subject, moving the catheter tip to a target site and deploying the prosthesis.

[0304] On the other hand, the present invention relates to a connecting device for a support, characterized by interlocking yokes, interlocking pins or teeth and sleeves, wherein the interlocking yokes, interlocking pins and / or teeth, preferably connecting strut guides, preferably connect two or three connecting struts in a releasable manner.

[0305] The additional stent design described above, combined with the sealing features described herein, provides the additional advantage of providing improved fixation as well as improved sealing characteristics for the prostheses described herein.

[0306] It should be understood that each individual feature described above herein is intended to be combined in any possible manner or combination, and that specific embodiments described in the drawings or above in combination of specific features should not be interpreted as being limited to only those combinations, and that the specific embodiments described herein are not meant to limit the scope of the present disclosure.

[0307] The basic concept of the present disclosure relates to a special sealing concept and design for a replacement heart valve (e.g., a tricuspid, mitral or pulmonary replacement heart valve). This novel sealing concept is characterized by two or more sealing features working in a coordinated manner and substantially preventing systolic and diastolic PVL (paravalvular leak). Specific attachment points I, J, E and / or K for one or more sealing features provide a favorable and coordinated seal during systolic and diastolic heart contraction while improving the function of the replacement valve.

[0308] This advantageous sealing concept can be applied to many stent designs outlined herein. With particular reference to the accompanying drawings and the stent designs described therein, and the accompanying drawings A, B, which provide alternative stent designs, which when combined with the sealing features described herein are also within the scope of the present invention.

[0309] Thus, the inventive concept achieves advantageous replacement valve function and durability of the replacement heart valve prosthesis.In addition, the novel sealing concept according to the present disclosure has advantageous crimping characteristics when loaded into a catheter for delivery.

[0310] The general concepts of sealing features according to the present disclosure may be combined with any of the stent designs described herein.

[0311] The object of the present application is solved by a heart valve prosthesis comprising a frame, a valve attached to the frame and a sealing device, wherein the sealing device comprises or consists of one or more sealing features.

[0312] In principle, the advantageous sealing features can be combined with different stent designs and types known in the art, where an advantageous sealing is desirable. The prosthesis according to the present disclosure may in particular comprise or consist of a frame, wherein the frame is a single frame, a double frame or a stent in a stent design.

[0313] The skilled person will appreciate that different materials, such as metals, nickel-titanium alloys, plastics, polymers, etc., can be applied and these different materials can be combined with advantageous seals according to the present disclosure. In one embodiment, the prosthesis according to the present disclosure has a frame, wherein the frame is made of or includes a polymer material, a metal, or a nitinol material. The prosthesis according to the present disclosure particularly has a frame material that is a cast, laser cut, or / and a woven mesh.

[0314] In the prosthesis according to the present disclosure, the frame can be composed of an internal frame and an external frame, which are preferably attached to each other by sutures, wherein the internal frame is a laser-cut nickel-titanium alloy tube and the external frame is a woven nickel-titanium alloy mesh, or the internal and external stents are laser-cut nickel-titanium alloy stents.

[0315] The valve of the prosthesis according to the present disclosure can be made of any useful material and material combined with other features and materials of the prosthesis, or the valve is any useful material and material combined with other features and materials of the prosthesis, for example, the valve is made of or includes pericardial tissue, and the pericardial tissue is preferably taken from cows or pigs.

[0316] Of particular importance are the multiple sealing features and their interaction with each other and the stent components and their positioning within the prosthesis frame. In one aspect, a prosthesis according to the present disclosure includes or comprises sealing features, wherein a first sealing feature is a sealing cap at an inflow region (e.g., an atrial region) of the prosthesis and a second sealing feature is a sealing cap at an outlet (e.g., a ventricular region of the prosthesis).

[0317] The inflow and outflow sealing features may be multiple separate components that may be connected to each other or made integrally.

[0318] A prosthesis according to the present disclosure has multiple sealing features, wherein the multiple sealing features feature specific attachment points or areas for attachment to the frame.

[0319] It has been shown to be advantageous if the prosthesis according to the present disclosure has a plurality of sealing components attached to the frame at specific attachment points or areas (eg indicated as I, E, J or / and K in the figures).

[0320] The interaction of multiple sealing features and their specific design and dimensions has proven to be advantageous for the function of the prosthesis, its sealing properties and ease of loading the function into the catheter and avoiding damage to the sealing features during introduction. On the one hand, the prosthesis according to the present disclosure is designed so that the distance of the attachment points I to K is in the range of 12 to 30 mm, such as between about 12 and 26 mm, and the distance of the attachment points K to J is in the range of 12 to 30 mm, such as between about 15 and 26 mm, and the distances IK and JK are preferably substantially the same.

[0321] In the prosthesis according to the present disclosure, the sealing characteristics are advantageous due to the combination and positioning of multiple sealing features within the frame of the prosthesis. This is advantageous and can be designed to have a ratio of the length of the sealing feature and a defined distance from one fixed point to another, for example, the ratio of distance I to K: the ratio of distance K to J is about 0.5 to 1.2, preferably 1.

[0322] The sealing features of the prosthesis according to the present disclosure may be applied to different valve types, wherein the prosthesis may be an aortic, mitral, pulmonary or tricuspid heart valve.

[0323] The prosthesis according to the present disclosure is also characterized by a favorable crimping behavior, so that the prosthesis can be crimped to a favorable diameter, wherein the outer diameter of the prosthesis in its crimped state can be 13 to 35, 15 to 30 French, preferably 16 to 15 French. It is advantageous if the outer diameter of the prosthesis in its crimped state is equal to or less than 35 French.

[0324] In prostheses according to the present disclosure, the sealing features substantially prevent PVL during both systole and diastole, which advantageously supports proper long-term valve function and prosthesis durability.

[0325] In another aspect, the present disclosure relates to a heart valve prosthesis as disclosed herein for use in treating a heart valve disease or disorder, such as heart valve insufficiency, heart valve stenosis or regurgitation.

[0326] In another aspect, the present disclosure relates to a method of minimally invasively implanting a prosthesis described herein, wherein the prosthesis is loaded onto a delivery system, and the delivery system is introduced into the patient's body percutaneously, femorally, transjugularly, or transatrially, and the prosthesis is deployed at a target site.

[0327] The present disclosure provides a replacement heart valve prosthesis with favorable sealing properties and favorable replacement valve function. In addition, it has the following advantages: due to better hemodynamics, there is a lower risk of thrombosis and better long-term functionality. The disclosed replacement heart valve prosthesis reduces possible swirl, turbulence, shear forces and shear stresses that occur in known devices due to suboptimal blood flow during cardiac function, which will have a positive impact on the occurrence of thrombosis. In addition, the impact of the prosthesis according to the present disclosure on the patient will also be observed due to better replacement function and substantial avoidance of PVL.

[0328] Improved overall replacement valve function and substantial avoidance of PVL by the replacement heart valve prosthesis disclosed herein will have a positive impact not only on the replacement heart valve prosthesis but also on overall heart condition and physiological parameters. Thus, the disclosed prosthesis provides improvements in, among other things, valve opening and closing, pressure gradients, overall valve function, overall heart condition, and replacement heart valve prosthesis durability.

[0329] It should be understood that each of the individual features described herein is intended to be combined in any possible manner or combination, and that specific embodiments described in the drawings or above description with specific feature combinations should not be construed as being limited to only said combinations, and that the specific embodiments described herein are not meant to limit the scope of the present disclosure.

Claims

1. A prosthesis comprising a frame, a valve attached to the frame and a sealing device, the sealing device comprising two or more sealing features; in, One sealing feature is a sealing cover at an inflow area of ​​the prosthesis and the other sealing feature is a sealing cover at an outflow area of ​​the prosthesis; wherein the sealing feature is used to attach to a specific attachment point or area of ​​the frame; wherein the sealing feature is attached to the frame at attachment points or areas I, E, J and / or K; wherein the location of the attachment points or areas I, E, J and / or K prevents stretching or folding of the sealing cover tissue during the crimping phase of the prosthesis; wherein the distance between the attachment points I and K is within the range of 12 to 30 mm, the distance between the attachment points J and K is within the range of 12 to 30 mm, and the distance between the attachment points K and E is within the range of 0 to 15 mm; The ratio of the distance from the attachment point I to K to the distance from the attachment point J to K is 0.5 to 1.

2.

2. The prosthesis according to claim 1, characterized in that The sealing device consists of two or more sealing features.

3. The prosthesis according to claim 1, characterized in that The frame is a single frame, or a plurality of partial frames.

4. The prosthesis according to claim 3, characterized in that The plurality of partial frames are two partial frames or three partial frames.

5. The prosthesis according to claim 3, characterized in that The frame comprises: polymer material and / or metal.

6. The prosthesis according to claim 5, characterized in that The frame is composed of polymer material and / or metal.

7. The prosthesis according to claim 5 or 6, characterized in that The metal includes: nickel-titanium alloy.

8. The prosthesis according to claim 5, characterized in that The frame is cast, laser cut, or / and woven mesh.

9. The prosthesis according to claim 1, characterized in that The frame consists of an inner frame and an outer frame, which are attached to each other by one or more sutures, one or more mechanical connectors or by welding.

10. The prosthesis according to claim 9, characterized in that The inner frame and the outer frame are made of laser cut Nitinol tubes, wire Nitinol mesh, or a combination of laser cut Nitinol tubes and wire Nitinol mesh.

11. The prosthesis according to claim 10, characterized in that The metal wire nickel titanium alloy mesh is a woven nickel titanium alloy mesh.

12. The prosthesis according to claim 1, characterized in that The valve and / or the sealing device are made of synthetic material or biological material.

13. The prosthesis according to claim 12, characterized in that The synthetic material is a polymer, or / and the biological material is pericardial tissue.

14. The prosthesis according to claim 13, characterized in that The pericardial tissue is from pig or cow.

15. The prosthesis according to claim 1, characterized in that The sealing features of the inflow region and the outflow region are two or more separate components that are attached to or made integrally with each other.

16. The prosthesis according to claim 1, characterized in that The sealing feature and its attachment point or area for attachment to the frame are not compromised or damaged by the difference in elongation between the sealing feature and the frame.

17. The prosthesis according to claim 1, characterized in that The distance between the attachment points I to K is between 15 and 26 mm, the distance between the attachment points J to K is between 15 and 26 mm, and the distance between the attachment points K to E is between 3 and 10 mm.

18. The prosthesis according to claim 17, characterized in that The ratio of the distance from the attachment point I to K to the distance from the attachment point J to K is 1.

19. The prosthesis according to claim 1, characterized in that The prosthesis is an aortic heart valve, a mitral heart valve, a pulmonary heart valve or a tricuspid heart valve.

20. The prosthesis according to claim 1, characterized in that The prosthesis can be crimped and, in its crimped state, have an outer diameter equal to or less than 335 French, and the sealing features on the inflow region and / or outflow region can prevent or reduce PVL during both systolic and diastolic periods.

21. The prosthesis according to claim 1, characterized in that The sealing feature is biocompatible, and / or non-toxic, and / or The sealing features are designed not to promote thrombosis or stasis.

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