Stent device for prosthetic heart valve

Abstract

The present invention relates to the field of replacing defective atrioventricular heart valves, in particular the tricuspid valve, comprising a stent device, a prosthetic heart valve, a delivery system and corresponding methods, providing for an improved fixation effect without distorting the native anatomy of the tricuspid valve. Thus, a stent device for a prosthetic heart valve is proposed, comprising a mesh-like main body extending in an axial direction, wherein the main body is configured to fit with an orifice and defines an inner passage for providing a passage from a proximal end to a distal end of the main body; and at least three outer support arms extending from the distal end of the main body towards the proximal end by the main body, wherein each support arm comprises a first support region at the distal end and a second support region at the proximal end, wherein the second support region extends radially outward in a deployed state. Each support arm comprises a flexible region between the first support region and the second support region, the flexible region being formed as a tapered section of the support arm in the axial direction, and / or each support arm tapers towards the proximal end.

Description

Technical Field

[0001] This invention relates to the field of replacing defective atrioventricular heart valves, particularly tricuspid valves, and includes stent devices, artificial heart valves and delivery systems, as well as methods for manufacturing such stent devices and methods for replacing tricuspid or mitral valves using such stent devices. Background Technology

[0002] In mammals, blood circulation is primarily driven by the pumping function of the heart. This cardiac function ensures adequate tissue perfusion and allows outflowing blood to be decarbonized and reoxygenated after passing through tissues. The human heart consists of two ventricles, the left and right ventricles, which pump blood through the vascular system via the aorta and through the pulmonary system via the pulmonary artery, respectively, thus providing respiratory function and oxygenating the blood. The filling of these ventricles is achieved through the corresponding left and right atria, which are connected to the pulmonary veins and the vena cava, respectively.

[0003] To provide normal function for the atria and ventricles, the human heart has four valves. Two of these are called atrioventricular valves, located at the junction between the atria and ventricles. The tricuspid valve is located between the right atrium and right ventricle. The mitral valve, also known as the bicuspid valve, is located between the left atrium and left ventricle. The remaining two valves are located between the ventricles and the vascular system and are crescent-shaped. The aortic valve separates the left ventricle from the aorta, while the pulmonary valve separates the right ventricle from the pulmonary artery.

[0004] During diastole and systole, the filling and ejection of blood from the atria and ventricles follow a highly synchronized system. However, the effectiveness of cardiac function depends not only on the complex neural innervation of the myocardial tissue but also on the sealing effect of the atrioventricular valves. This sealing effect can be impaired by various pathological conditions, such as functional pathology of the tricuspid valve, which can be elusive, severe, and secondary to significant dilation of the tricuspid annulus. More rarely, this pathology is due to rheumatic or infective valvular disease or deterioration of a stenotic or leaking prosthesis.

[0005] Tricuspid valve dysfunction can lead to tricuspid regurgitation, a common medical problem with significant associated challenges. For example, patients with tricuspid regurgitation often have chronic functional fluid retention and low cardiac output. Furthermore, the valve annulus diameter may extend beyond 40 mm, causing the anatomical landmarks between the right ventricle and right atrium to gradually disappear, thereby impairing and complicating the treatment, repair, and replacement of the tricuspid valve.

[0006] More generally, techniques for replacing defective heart valves, particularly via percutaneous or minimally invasive approaches, have been established. However, these systems and techniques are primarily designed for mitral valve replacement and are not directly applicable to tricuspid valve replacement. Among other differences, the right ventricle comprises a unique anatomy. The tricuspid annulus is essentially only slightly fibrous. Compared to the mitral annulus, the tricuspid annulus is more oval in size and typically has a thinner structure. Furthermore, the tricuspid valve is generally larger than the mitral valve. These differences can be exacerbated by pathophysiological conditions that cause structural changes in the shape and size of the right atrioventricular anatomy with fluctuations in volume and lung pressure, allowing the tricuspid annulus to expand to a diameter exceeding 40 mm, for example, up to 50 mm, while under pathological conditions, the mitral annulus is approximately 30 to 35 mm in size. These differences directly affect mechanical stability and the tendency for periprosthetic leakage, making—contrary to assertions in the literature—that mitral valve replacement techniques are generally not suitable for tricuspid valve replacement.

[0007] Currently, clinical practice regarding aortic valves is highly advanced, making percutaneous valve replacement routine. A percutaneous mitral valve bioprosthetic model is also under clinical evaluation. In contrast, clinical treatment involving percutaneous in-situ—i.e., in-situ—bioprosthetics for tricuspid valve replacement is still in its very early stages of development. Tricuspid valve replacement is also complex because this body site typically lacks the tissue volume to hold the prosthetic device in place. Various techniques are based on prosthetic devices with a conical plug shape for easy fixation. These prosthetic devices typically exert outward radial forces, which can further deform the anatomy of the right atrioventricular region. Alternative fixation techniques using tricuspid leaflets are only suitable for a limited portion of the tricuspid valve and require a profile height greater than 30 mm, which is cumbersome, may increase the risk of displacement, and may impair blood flow.

[0008] For example, according to WO 2016 / 098104 A2, an artificial valve for the tricuspid valve is known, comprising a flexible body with a rigid ventricular stabilizer having an autologous leaflet that engages with the tricuspid valve. Such an arrangement exhibits limited support and adaptation to the tricuspid valve anatomy and requires clamping of the autologous leaflet, which may be detrimental to the remaining anatomical landmarks.

[0009] Furthermore, WO 2017 / 089179 A1 discloses an assembly for replacing the atrioventricular valve of the tricuspid valve, wherein a support arm or fixing element extends from the central portion of the mesh body. Such an arrangement requires fixing at the central portion.

[0010] Therefore, there is a need for devices, systems, and methods specifically designed for tricuspid valve replacement that would reduce the aforementioned problems and provide improved fixation without distorting the tricuspid valve's own anatomy. Such devices or systems could also improve support for mitral valve replacement. Summary of the Invention

[0011] The object of the present invention is to provide a stent device for artificial heart valves, which at least eliminates some of the undesirable observations in the above-mentioned clinical practice.

[0012] Therefore, in a first aspect, a stent device for an artificial heart valve is proposed, comprising a mesh body extending in an axial direction, wherein the body is configured to mate with an orifice and define an internal channel for providing a passage from the proximal end to the distal end of the body. Furthermore, the stent device includes at least three external support arms extending from the body, i.e., from the distal end of the mesh body toward the proximal end, wherein each support arm includes a first support region at the distal end, a second support region at the proximal end, and a flexible region therebetween. The flexible region of each support arm is formed in the axial direction as a tapered section of the support arm, and the second support region of each support arm extends radially outward in the deployed state.

[0013] The main body of the stent device thus forms a supporting structure or core frame, which can be accommodated in an opening provided, for example, by the valve annulus of the tricuspid or mitral valve. The main body should be understood to be inelastic or not deflectable, but may be deformable, allowing the main body and stent device as a whole to change between a folded state and an unfolded or deployed state. For example, the stent device may be formed from, for example, a woven nitinol metal memory material, such that the shape of the main body can be predefined, for example, by heat forming, and / or the stiffness of the main body can be changed according to temperature and / or at certain temperature intervals, preferably between, for example, 0°C and body temperature, while the dimensions of the main body can be changed.

[0014] In contrast, the flexible region should be understood as having elasticity or allowing deflection, such that the second support region can be bent, deflected, folded or pivoted relative to the first support region, for example, via the flexible region.

[0015] Furthermore, the mesh shape can be formed, for example, as a grid or multiple polygonal or elliptical units, which are directly connected to each other or connected via struts. For example, the mesh shape can consist of multiple polygons arranged laterally to form a closed structure, and includes multiple polygons in the axial direction, such as two, three, or more polygons, thereby essentially forming a honeycomb structure. The multiple polygons or units in the axial direction can be connected via corresponding struts, preferably having equal strut lengths. Preferably, the mesh shape of the body is formed by a grid with multiple rhomboid units, which are directly connected to each other or connected via struts, wherein the units are preferably substantially equal in size and / or shape. The advantage of the rhomboid shape is that it provides substantially equal stress and strain resistance in the axial and circumferential directions, and can reduce deformation and strain applied during manufacturing, thereby increasing the stability of the body.

[0016] In its deployed state, the axial or longitudinal direction of the body is substantially sagittal, while the radial direction is substantially transverse. Therefore, the terms proximal and distal should be understood anatomically to indicate the direction of blood flow within the human heart. In other words, for the tricuspid and mitral valves, respectively, proximal may refer to the end of the stent device in its deployed state located within the atrium (“atrial portion”), while distal may refer to the end of the stent device in its deployed state located within the ventricle (“ventricular portion”). Consequently, the internal passage or pathway is also oriented in the same direction, i.e., from proximal to distal, such that blood can flow from the atrium along the axis of the pathway, first through the “atrial portion” of the stent device, into the ventricle.

[0017] The advantage of providing at least three support arms is that, compared to, for example, two support arms, the stability of the fixation is improved, allowing the stent device to be properly supported during deployment. The support arms extend distally from the stent body, i.e., from the “ventricular portion” of the body after deployment, and proximally, i.e., towards the “atrial portion.” Thus, the extension originating from the body ensures that each support arm begins at the distal end of the body and is therefore attached to the body only at the distal end.

[0018] Therefore, each support arm is supported only on one side of the main body at the free end within the "ventricular portion". This concept not only ensures improved support function, for example, by providing an adaptive spring force extending throughout the support arm, but also eliminates the need for central fixation in the middle section of the main body. Thus, by providing an improved force distribution, the support arms exhibit an improved fit to the anatomy of the valve and valve annulus. Furthermore, this arrangement, together with the flexible region, ensures improved flexibility, allowing the second support region to better adapt to the anatomy due to radially outward deflection. Therefore, the arrangement of the support arms and the setting of the flexible region provide an improved interrelationship or interaction between the first and second support regions.

[0019] Alternatively, or in addition to the flexible region, each support arm may taper proximally. In other words, a tapered section may be provided for each support arm, starting, for example, from the distal end of the stent body, from the flexible region, or at the proximal tip, i.e., at the second support region of the respective support arm. The taper may be provided in a generally triangular or conical shape and may be continuous towards the proximal tip or truncated through a rounded portion at the proximal tip. For example, a continuous taper starting after the first support region has the advantage of allowing for the application of smaller strains during manufacturing, thereby increasing stability while maintaining or providing a degree of flexibility to the support arm. Furthermore, this feature prevents tangling during stent loading in the delivery system, effectively avoiding tangling, winding, interlocking, twisting, and / or warping of the support arms. Simultaneously, a spring function is maintained between the second and first support regions, allowing the support arms to adapt to the anatomy of the valve and valve annulus.

[0020] Furthermore, the extension of the support arm from the distal end only allows for improved stability, as separate fixation in, for example, the central or intermediate sections is no longer necessary. Additionally, it is advantageous to insert and position the stent device in the desired anatomical location before deployment, i.e., before unfolding the stent device, as this allows for initial positioning of the distal portion and subsequent proximal unfolding of the stent device while withdrawing the delivery system. Similarly, this arrangement allows for further adjustments during deployment, which might be limited if the support arm were provided in the central or intermediate region.

[0021] Although the stent device can be adapted for deployment in various regions of the atrioventricular heart valve, the mesh body is preferably configured to mate with the valvular annulus of the heart valve, wherein the flexible region is adapted to adapt to the valvular annulus. A first support region is adapted to adapt to the ventricular portion of the valvular annulus, and / or a second support region is adapted to adapt to the atrial portion of the valvular annulus.

[0022] Therefore, the stent device can be fitted to the tricuspid or mitral valve along the valve annulus of the corresponding valve. Preferably, the second support region of each support arm, i.e., at the proximal end, is configured to be disposed at the atrial portion of the valve annulus, such that the radially outwardly extending portion can be oriented to adapt to the atrial portion of the valve annulus. A flexible region facilitates this adaptation, allowing the proximal end of the support arm to deflect, thereby increasing the contact surface between the second support region and the atrial portion. Similarly, the first support region of each support arm, i.e., at the distal end, is preferably configured to be disposed at the ventricular portion of the valve annulus, such that the stent device is positioned at the radially inwardly positioned portion of the valve annulus by its flexible region and supported at either end of the valve annulus by the corresponding support region of the support arm. Therefore, the flexible region is preferably configured to adapt to the shape of the valve annulus, and thus not only provides the required flexibility for the second support region, but also includes flexibility to adapt to the anatomy of the valve annulus.

[0023] Thus, the stent device provides an optimal fit to the geometry or anatomy of the atrioventricular valve and the corresponding valvular annulus. Furthermore, by establishing two support regions for each support arm, the body of the stent device is securely held in place without applying clamping forces or gripping the anatomy. There is no need for anchoring features that would allow tissue puncture to secure the stent device. Therefore, the anatomy of the pathophysiological valvular annulus and atrioventricular valve is not further distorted or damaged, preventing further impairment of other cardiac functions. The fit between the support arms and the anatomy also allows the mesh body of the stent device to be formed as a fundamentally rigid structure, rather than flexible, thereby providing further stability for, for example, valvular assemblies. Simultaneously, the inventive concept allows for a smaller stent device body because the stent device is not fixed solely by radially outward directional forces.

[0024] Given the more complex anatomy of the tricuspid valve, adaptation to the geometry or anatomy of the valve or valve annulus is particularly advantageous. However, any such configuration can also be applied to mitral valve replacement stent devices, as such configurations also have a beneficial impact on the function of the mitral valve stent device.

[0025] Furthermore, the stent body can exhibit a basic tubular or cylindrical shape. The advantage of this geometry is that it allows for the implementation of less complex and / or more robust valve components within the stent. Additionally, it ensures a more versatile stent device because it facilitates the orientation or positioning of the body and is independent of corresponding anatomical shapes. Moreover, it enables improved support in valve annular regions with lower curvature, maximizing the volume of the internal channels used to improve blood flow.

[0026] To increase the contact surface area and reduce material usage while maintaining the flexibility or adaptability of the support arms, each support arm can be advantageously shaped as a closed loop. Although each support arm can typically be formed as a single extension element, which may have different thicknesses in the axial direction and have tapered or contracting sections, the closed loop allows for increased stability through even larger contact areas or surfaces provided by the first and second support regions. For example, the closed loop may have a greater width at the distal and / or proximal ends compared to the flexible region. Similarly, the closed loop can typically be provided at a location away from the flexible region, such that only the flexible region and the second support region are formed by the closed loop. Alternatively, the closed loop can be provided at a location away from the first support region, but between the distal end of the body and the first support region of the support arm.

[0027] Preferably, the closure ring extends beyond the proximal end of the body. The closure ring may include a rounded (maximum) or tapered proximal end. The advantage of extending beyond the proximal end of the body is that the size of the body can be kept to a minimum required size, thereby reducing the potential for large-volume stent components protruding into the corresponding areas of the atrium or ventricle. This allows for a larger contact area in the atrial portion of the valve ring, further improving support.

[0028] Similarly, compared to a pointed or acuminate proximal end, a rounded or tapered proximal end avoids any sharp surface edges or tips that could puncture tissue, such as in the atrial region, while providing a larger contact area. Furthermore, the rounded shape increases the stability of the closed loop and reduces the risk of ring element separation or breakage. For example, the closed loop may typically have a basic flap shape at the proximal end, thus ensuring the required fit or adaptation to the corresponding anatomy.

[0029] Furthermore, in the longitudinal section of the support arm, the closed loop may define a profile having a protruding portion and a recessed portion, wherein the protruding portion is defined by a first support region. Preferably, the recessed portion is adjacent to the protruding portion.

[0030] For example, the first support region located distally may be formed into a rounded shape adaptable to the ventricular portion of the valve annulus, while the recessed portion may be at least partially formed by a flexible region. The flexible region or tapering segment may, for example, be provided at the proximal portion of the protruding portion, specifically originating from the point of application of the protruding portion, such that the recessed portion at least partially coincides with the tapering segment. Thus, the recessed portion may include a degree of flexibility, which further facilitates adaptation to, for example, annular anatomy and interaction with the deflected second support region proximal to the ventricular portion.

[0031] Furthermore, the radial extension of the outermost point of the protruding portion may be greater than the radial innermost point of the concave portion, and / or the radial outermost point of the protruding portion may be located radially between the radial innermost point of the concave portion and the proximal tip of the second support region.

[0032] In other words, the proximal end of the second support region can have the maximum radial extension of each support arm, while the first support region is arranged to extend beyond the concave portion immediately adjacent to the protrusion. Therefore, instead of a conical or truncated conical extension of the support arm, a shoulder can be formed by the protrusion and the adjacent concave portion, which provides improved spring function of the support arms and improved adaptation to the valve annulus and ventricular anatomy. Furthermore, this configuration provides a wider extension of the support region for each support arm, enabling a large surface area for interaction with the valve annulus region in the deployed state, and thus allowing forces acting on the stent assembly to be better diffused via the support arms.

[0033] Alternatively, the flexible region may at least partially overlap with the protruding portion, for example, it may begin at the proximal end of the protruding portion and extend beyond the distal end of the recessed portion. In other words, the flexible region may at least partially overlap with the first support region and may not extend beyond the radially outward extension of the second support region.

[0034] Preferably, the profile is formed in an inverted S-shape, sinusoidal waveform, N-shape, or M-shape in the axial direction and / or radial direction. Such shapes allow for seamless transitions between different regions and allow for optimal adaptation to the anatomical shape of the tricuspid or mitral valve, particularly to the corresponding valve annulus. Furthermore, such shapes may include a second protrusion formed by a second support region. The stent assembly is biased within the valve annulus and thus can be positioned within the valve annulus, and can be supported at either end of the valve annulus by a corresponding protrusion formed by the support region of the support arm, preferably without the need for clamping or gripping forces.

[0035] Furthermore, the protruding and recessed portions do not need to exhibit symmetrical profiles and can have different curvatures. For example, one or both protruding portions can have asymmetrical profiles, wherein the curvature at the distal end of the "ventricular portion" or stent device can be, for example, smaller or steeper than the curvature of the recessed portion and / or the curvature of the "atrial portion" or the proximal end of the stent device. Such steeper curvatures, such as those resembling an N-shape or an M-shape, can, for example, facilitate the fixation of the stent device to the ventricular portion of the valve annulus even in cases of limited tissue volume, while larger curvatures at the "atrial portion" or proximal end, such as those resembling an S-shape, can be anticipated to cover a larger atrial area or portion to provide better support distribution and / or improved sealing.

[0036] Although the specific shapes described above have been given in view of the configuration of the support arm formed as a closed loop, these shapes are not limited to the closed loop configuration and can also be implemented in embodiments having the support arm formed as a single extension element, which, for example, has a varying thickness in the axial direction.

[0037] Each support arm can be connected to the mesh body via at least one, preferably two, connecting arms formed by a bend in the first support region. For example, such a bend can be formed by a protrusion originating at the distal end of the stent body. However, the bend can also be formed independently of the presence of such a protruding first support region. In other words, each connecting arm is provided as an extension of the stent body and is typically integrally formed with the first support region of each support arm, thus forming a continuous, for example, monolithic structure. The advantage of the bend is that it avoids sharp edges, thereby improving the structural stability of the stent and the connection between each arm of the stent and the body. Furthermore, the bend ensures that the distal ends of the body and support arms extending into the ventricle can be sized smaller, thereby reducing the amount of stent extending into the ventricle.

[0038] Furthermore, bending can represent an elastic element, thus providing a spring force that biases the support arm toward the anatomical structure of the atrioventricular valve, lower rigidity support, and greater adaptability to the anatomy. Bending can be adapted to the required spring force.

[0039] Advantageously, each support arm is connected to the body via two connecting arms. While a single-arm connection may reduce material usage and be sufficient in terms of structural stability, providing two connecting arms increases the contact surface and force distribution of the first support area, such as the ventricular portion with the valve annulus. Furthermore, this "dual-connecting-arm" concept prevents rotation or lateral deflection of the support arm by providing two anchoring or fixing points on the stent assembly body.

[0040] The bending of the connecting arm can exhibit an angle greater than 90° and / or define a rounded shoulder, wherein the shoulder preferably has, for example, a distal radius or a first radius at the distal end of the stent body, and a second radius or a proximal radius, for example, at the proximal portion of the shoulder, the proximal radius being spaced proximal to and / or radially and / or laterally from the distal radius, wherein the distal radius of the shoulder is larger than the proximal radius of the shoulder. As described above, the wider shoulder portion, together with the bending angle that can be formed, for example, by the protruding portion and optionally adjacent to the recessed portion, has the following advantages: the support arm can better adapt to the valve annulus region and ventricular anatomy, and the forces acting on the stent device and the support arm can be better diffused, for example, by providing improved spring function, which is established through improved interaction with the second support region. Furthermore, the larger radius at the distal end of the rounded shoulder reduces the likelihood of breakage between the support arm and the stent body, thereby increasing the stability and robustness of the stent device, while the smaller radius at the proximal end of the rounded shoulder maintains sufficient support for the valve annulus region.

[0041] Furthermore, the specific configuration of the curved or convex portion increases the likelihood of entanglement with autologous chordae tendineae present in the ventricular portion, enabling improved stent device fixation and thus stability.

[0042] Therefore, instead of extending from the body in an axial or radially outward direction, the bend can initially extend radially inward, thus forming an additional rounded portion or an initial concave portion. This has the advantages of providing even more flexible support, allowing even lower forces to be applied to the corresponding anatomical structures in the first support area. Additionally, by avoiding sharp edges, the risk of the support arm breaking or detaching from the support device body is further reduced, and tissue damage is essentially prevented.

[0043] As described above, the arrangement of at least three support arms allows for improved fixation stability compared to, for example, two support arms, ensuring proper support of the stent device during deployment. To further enhance support for the stent device entering the orifice or valve annulus and to provide further adaptation to anatomical structures, the stent device may include two and / or three, several times / more, of the support elements, such as four, six, or eight arms suitable for the tricuspid or mitral valve.

[0044] Alternatively, an odd number of support arms may be provided, preferably 5, 7, or 9. This ensures improved adaptability to the anatomy of the valve annulus region and / or the valve assembly to be inserted into the stent device body.

[0045] Preferably, the stent assembly may include six support arms. The arrangement of six support arms provides a configuration for, for example, a tricuspid valve that includes three tips or leaflets, such that each pair of support arms corresponds to a tricuspid valve region including the respective leaflet. Therefore, the six support arms increase the stability and adaptability of the tricuspid valve stent assembly.

[0046] Six support arms can also be adapted for mitral valves that themselves include two leaflets, also known as monk's hood valves. Three support arms can be arranged to correspond to the mitral valve regions that include the respective leaflets.

[0047] Alternatively, the stent device may also include, for example, four support arms, which are asymmetrically arranged to adapt to the shape of the tricuspid valve. Similarly, four support arms can also facilitate a configuration for mitral valve replacement, where each pair of support arms is associated with a corresponding mitral valve region including the corresponding leaflet. Instead of a single pair of support arms, the stent device may also include, for example, eight support arms for the mitral valve or nine support arms for the tricuspid valve, thereby associating four and three support arms with each autologous leaflet, respectively.

[0048] The circumferential spacing between the support arms may be adapted to the tricuspid or mitral valve, and / or may be asymmetrical or symmetrical.

[0049] As described above, for example, the three support arms can be arranged, for instance, by providing substantially equidistant intervals, to associate with the corresponding leaflets of the tricuspid valve, but they can also be arranged asymmetrically, such that, for example, in the case of a mitral valve configuration, a single support arm is associated with the first leaflet and a pair of support arms are associated with the second leaflet. Therefore, the arrangement can depend on, for example, the anatomy of the valve annulus, and also on the orientation of the valve assembly and / or stent device to be used.

[0050] To provide further structural stability to the support structure, the mesh shape of the main body can exhibit a rhomboid, teardrop, or substantially oval shape. Therefore, individual units can also include rounded shapes rather than polygonal or honeycomb shapes, which facilitates the unfolding and folding of the support structure's main body. Furthermore, when the support structure is deployed, a more uniform or balanced distribution of biasing forces in the radially outward direction is achieved. Therefore, the support structure may be less prone to structural changes due to the tensile or compressive forces acting on the support structure in the axial direction. Teardrop or substantially oval shapes allow for a more seamless transition between units and / or struts, thus avoiding sharp edges.

[0051] To reduce the extension of the stent body into the atrium, a portion of the proximal end of the stent body may extend radially outward. Preferably, this portion of the proximal end of the body extends between 70° and 110° relative to the axial direction of the body.

[0052] The volume of the proximal end of the body extending into the atrium is reduced. Furthermore, the fluid seal and support stability of the stent assembly are increased, for example, by anticipating that the proximal end of the body will be adjacent to or in contact with the proximal end of the second support region of the support arm. For example, the proximal end of the body can be deflected at an angle substantially perpendicular to the longitudinal axis of the stent assembly, such that the proximal end is substantially aligned with the atrial portion of the valve annulus. Furthermore, the insertion of the valve assembly is thus facilitated, for example, by providing a chamfer while presenting a reduced profile, so that blood flow is not, or at least not significantly, interrupted.

[0053] Furthermore, the portion of the proximal region of the stent body is preferably defined by a plurality of second closed loops, which are preferably arranged in a circumferentially staggered manner relative to the support arm disposed at the distal end. This avoids overlap between the closed loops of the support arm and the second closed loops, and also increases the area or size of the atrial portion of the valve ring supported proximally. The second closed loops may extend radially outward together with a portion of the proximal end of the body, for example, reaching 1 / 4 to 1 / 2 or 1 / 3 of the length of the final proximal unit or strut line of the body.

[0054] For example, the second closing loop may typically be sized to be smaller than the closing loop of the support arm, thereby fitting into the distal ends of two adjacent second support regions of the two support arms, for example, fitting between the second support region and the flexible region. According to another example, the second closing loop may be sized to be substantially equal to or larger than the closing loop of the support arm. Alternatively, the second closing loop may be positioned between two adjacent second support regions of the two support arms. Even if one or more radially outwardly extending portions of the support arms do not perfectly adapt to the anatomy of, for example, the valve rings, such an interlacing configuration further ensures adequate support for the stent device at its "atrial portion." However, the second closing loop may also be arranged in a partially circumferentially interlaced or non-interlaced or substantially overlapping manner relative to the support arms positioned distally.

[0055] By defining the support arm as an extension at the far end of the main body, a high degree of structural and mechanical stability is ensured.

[0056] Furthermore, the radially outwardly extending portion of the body may include at least one eyelet for securing the support assembly to the delivery system. Preferably, the portion includes at least two eyelets, optionally arranged at opposite ends in the radial direction of the support body. Each eyelet is arranged at a corresponding second closed loop, preferably at every other second closed loop, and / or at the proximal end or the radially outermost end of the second closed loop. In other words, one or more eyelets may be arranged at the proximal tip of the support body, defined by a radially outwardly flared second loop. For ease of securing, each eyelet may include a substantially circular or rounded shape, thereby facilitating securing and deployment, and eliminating the need for a specific relative orientation between the eyelet and the delivery system.

[0057] Furthermore, the main body and multiple support arms can be formed as a single piece and / or a wire frame. Therefore, the main body and support arms of the support assembly can not only be formed from the same material, but can also be formed without any connecting parts, making the support assembly less prone to breakage, displacement, and / or manufacturing errors.

[0058] Through such embodiments, the different units of the support body, support arms, and mesh, as well as different areas of the support arms, can be connected by a continuous and seamless transition. Therefore, the body and support arms can be formed as an integral part of the support device, which can be formed as a single piece and manufactured using laser cutting technology, thereby significantly improving the structural integrity of the support device.

[0059] To further improve fixation with autologous tissue, particularly to improve retention of the component during translation and / or rotation, the stent device may include at least one fixation element, as disclosed in WO 2017 / 089179. In one embodiment, the fixation element has the form of a “taper,” “ring,” or “plate.” In one embodiment, the fixation element is made of nitinol. The height of the fixation element is approximately 8 to 10 mm, and the length is 10 to 12 mm. In one embodiment, one or more of these optional fixation elements are connected to one or more support arms, more specifically, in the flexible region of the support arm, and open only on the atrial side. In one embodiment of the invention, a single fixation element is used. In one embodiment of the invention, two fixation elements are symmetrically positioned.

[0060] To ensure the stent device is adapted to the anatomical dimensions of the pathological valve annulus region and to minimize harmful contact with other autologous tissue, the main body or the access defined by the main body preferably has an inner diameter between 29 mm and 36 mm, preferably about 30 mm or about 35 mm. Furthermore, this size facilitates deployment within the valve annulus region and any potential further medical applications.

[0061] In addition to the main body and support arms, the stent assembly may also include a clamp to prevent blood leakage and / or reflux. Therefore, at least the proximal end of the support arm—typically the second support region of the support arm—and / or the proximal end of the outer body may be covered with a foil of a liquid-impermeable or semi-impermeable material, thereby forming a clamp between the support arm and the main body and / or between the support arms. Alternatively, such a foil may at least cover the first support region of the support arm and / or the distal end of the outer body to form a clamp between the support arm and the main body and / or between the support arms.

[0062] Therefore, a foil of liquid-impermeable or semi-impermeable material can represent a covering material that typically—especially in the case of semi-permeable materials—restricts or at least substantially prevents blood from passing through or returning to the corresponding stent device element outside the central (tubular) pathway. Thus, the material seals the area or contact region between, for example, the anatomical structure of the valve annulus and the body or internal channel of the stent device. Such foils or coverings enhance the seal between the stent device and the environment at the deployment site. The foils or coverings can also enhance the migration resistance of the deployment device through appropriate foil characteristics, such as appropriate surface roughness.

[0063] The foil, for example, is made of a flexible sheet material and can be made of natural or synthetic materials. For example, the material may contain natural tissue, such as the pericardium of cattle, pigs, sheep, or horses, wherein the tissue is preferably chemically treated with glutaraldehyde, formaldehyde, triglycidylamine (TGA) solution, or other tissue crosslinking agents. Alternatively, the foil may include at least synthetic materials, such as fluoropolymers like polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE), polyesters like PET (polyethylene terephthalate), silicone, urethane, other biocompatible polymers, etc. Copolymers, or combinations thereof, and sub-combinations thereof. According to a preferred embodiment, the impermeable or semi-impermeable material is a low-porosity fabric, such as polyester, Fabric or PTFE.

[0064] Furthermore, foil materials can be modified through one or more chemical or physical processes to enhance certain physical properties. For example, a hydrophilic coating can be applied to the foil material to improve its wettability and echo translucency. Alternatively or additionally, the foil material can be modified with one or more chemical components that promote or inhibit endothelial cell adhesion, endothelial cell migration, endothelial cell proliferation, and antithrombosis. Additionally, the foil material can be modified with covalently linked heparin or impregnated with one or more in-situ released drugs, such as through a controlled-release mode, wherein, for example, a controlled-release formulation is coated on one or both sides of the foil.

[0065] The foil-based clamp offers the advantage of reduced, or even prevented, periprosthetic leakage at the contact area between the stent device and autologous tissue (e.g., valve annulus). Preferably, the foil is arranged to cover the height of the valve annulus and the proximal end of the main body or stent device on the "atrial portion," thereby typically also covering a second support area. The foil can be secured to the stent device by, for example, suturing, gluing, or heat forming.

[0066] Furthermore, the main body of the stent device preferably includes at least two or at least three fixing devices or windows or locations for receiving and securing the valve assembly within the tubular passage of the stent body. Such windows or locations may be formed, for example, between units of the mesh body or corresponding struts supporting said units, so that the stent device requires no additional components. The windows or locations are integrally formed with the stent device body. Alternatively, such windows may also be formed by corresponding portions of the units. Preferably, the windows are arranged circumferentially, with each window separated by a spacer. The windows correspond to the valve assembly, i.e., to a contemplated leaflet arrangement corresponding to a specific valve, such as the tricuspid or mitral valve.

[0067] Therefore, the fixation device or window can indicate the intended area of ​​the valve assembly, assisting the surgeon in placing the valve assembly. The fixation device or window can provide geometry that matches the valve assembly, thereby providing positive locking, for example in the case of synthetic valve assemblies, or allowing fixation of biological prostheses, such as tips or leaflets, for example by means of sutures or needles.

[0068] Alternatively, the units of the mesh body can be configured to receive and secure valve assemblies, allowing the valve assemblies to be directly attached or secured to one or more units of the mesh body. This offers greater flexibility in the attachment and securing of valve assemblies, and the body can be adapted to a wider variety of valve assemblies without requiring adjustments to the stent body configuration. Furthermore, this configuration reduces complexity and increases the stability of the stent body and stent assembly. Therefore, it facilitates the securing of valve assemblies and the manufacture and deployment of stent assemblies.

[0069] According to another aspect, an artificial heart valve is disclosed, comprising a stent assembly as described above and a valve assembly disposed within an inner channel and / or at a proximal or distal end of a body and secured to the stent body by means of a fixation device or window. For example, as described above, the artificial heart valve can be configured to replace a tricuspid or mitral valve, for example by means of the configuration of the corresponding valve assembly, the stent body, and / or the support arm.

[0070] For example, the artificial heart valve may be configured as a tricuspid valve prosthesis, wherein the valve assembly consists of three tips or leaflets. For example, the tricuspid valve prosthesis may include a biological prosthesis, wherein the three tips are made of animal tissue, such as bovine or porcine pericardium, which has preferably been pretreated with, for example, glutaraldehyde, formaldehyde, triglycidylamine (TGA) solution, or other tissue cross-linking agents. The three tips or leaflets forming the valve assembly are configured to engage with each other and are connected to the proximal or distal end of a body or stent body within the inner channel by, for example, conventional suturing techniques. The biological prosthesis functions in the physiological direction of blood flow reaching the right atrium and filling the right ventricle during cardiac contraction.

[0071] Additionally, the artificial heart valve can be configured as a mitral valve prosthesis, wherein the valve assembly consists of two tips or leaflets.

[0072] Furthermore, the tip or leaflet of the valve assembly may also be made of synthetic fabric, in which fixation may be provided by, for example, welding, gluing, fixing links or springs and / or flexible or partially rotating contact points. An example of a synthetic leaflet is provided in US 9,301,837.

[0073] According to another aspect, a delivery system is proposed, which includes a support device in a folded state as described above.

[0074] For example, the delivery system may be configured as a catheter or sheath that enables percutaneous delivery and deployment to the atrioventricular region. The delivery system may define a lumen for receiving a stent device and may include a control string slidably engaged with the stent device such that tensioning the control string allows the stent device to retract, while dereliction of the control string allows the stent device to deploy. Therefore, the stent device can be reconfigured between a low-profile delivery configuration or a folded state housed within the lumen and an deployed or extended configuration.

[0075] The present invention also relates to a kit of parts comprising a delivery system (e.g., a catheter or sheath) for enabling percutaneous delivery and deployment to the compartment region, and a stent device as described above.

[0076] The present invention also relates to catheters or sheaths comprising foldable stent devices as described above.

[0077] According to another aspect, a method for replacing a tricuspid or mitral valve is disclosed, comprising the following steps:

[0078] - A folded support device, as described above, is provided in a delivery system preferably consisting of a catheter or sheath.

[0079] - The stent device is percutaneously introduced into the patient's tricuspid or mitral valve region via the delivery system, such that the distal end of the stent body is located in the ventricular portion and the proximal end of the stent body is located in the atrial portion, and the body and support arm span the valve annulus.

[0080] - The stent device is deployed by unfolding the stent device, such that the flexible region adapts to the valve annulus and the proximal end of the outer support arm or the second support region adapts to the atrial side.

[0081] To provide valve function, the method may further include securing the valve assembly to the proximal or distal end of the inner channel and / or the stent body, wherein the securing may preferably be performed before the stent device is folded, or may be performed using a delivery system after the stent device has been deployed and unfolded in the atrioventricular valve region.

[0082] According to another aspect, a method for manufacturing the support device as described above is disclosed, which includes the following steps:

[0083] - Laser-cut the main body and support arms from metallic memory material;

[0084] - Heating the body and support arm to form them, thereby providing a predefined shape for the body and support arm; and optionally...

[0085] - Fold the main body and support arm.

[0086] The metal memory material may be, for example, braided nitinol. Furthermore, folding of the body and support arms or the entire support assembly is optional and may be necessary, for example, for transport purposes or for assembly or encapsulation into delivery systems such as catheters or sheaths.

[0087] Preferably, the support assembly is made from a single piece. For example, a single piece of woven nitinol can be laser-cut so that the support arm forms an extension of the distal end of the body, thus providing high structural and mechanical stability. In other words, the body and support arm of the support assembly can not only be formed from a single material, but can also be formed as a single piece without any connecting parts, making the support assembly less prone to breakage, displacement, and / or errors, thus significantly improving the structural integrity of the support assembly, for example.

[0088] This invention design allows for overcoming any limitations on the adaptability of the fixing elements at opposite ends in the longitudinal direction of the assembly. Therefore, this invention design does not limit any adjustments to the positioning of the assembly after deployment (as observed in the prior art), where such limitations can be attributed to the opposite ends of the fixing elements, which may engage anatomical structures, thereby potentially preventing further adjustments. Thus, this invention design exhibits superior characteristics not yet addressed in prior art assemblies. Attached Figure Description

[0089] This disclosure will be more readily understood when considered in conjunction with the accompanying drawings, in which:

[0090] Figure 1 This is a graphical representation of a prior art embodiment of an artificial heart valve located in the ventricular portion of the tricuspid valve;

[0091] Figure 2 This is a graphic representation of a stent device deployed around the anatomical structures of the tricuspid valve according to the present invention;

[0092] Figures 3A-3D This is a schematic representation of the support device according to the invention after laser cutting and before heat forming;

[0093] Figure 4A and Figure 4B This is a perspective view of the support device in an unfolded state according to the present invention;

[0094] Figure 5 This is a schematic perspective view of an alternative proximal stent device with a main body according to the present invention;

[0095] Figure 6 It is based on Figure 5 A schematic side view of the support device;

[0096] Figure 7This is a schematic representation of an alternative proximal stent device according to the present invention, having a body including a second closed loop;

[0097] Figure 8 It is based on Figure 7 A schematic representation of the staggered form at the proximal end of the support device;

[0098] Figures 9A to 9C Depicting based on Figure 7 Different views of the staggered form with alternative second closed loops;

[0099] Figure 10 This is a schematic representation of a support device with perforations according to the invention, after laser cutting and before heat forming; and

[0100] Figure 11A and Figure 11B Different views of a support device with an alternative support arm configuration according to the present invention are depicted. Detailed Implementation

[0101] The invention will be explained in more detail below with reference to the accompanying drawings. In the drawings, corresponding elements are indicated by the same reference numerals, and repeated descriptions may be omitted to avoid redundancy.

[0102] exist Figure 1 The image shows a graphical representation of a prior art embodiment of an artificial heart valve located within the tricuspid valve. The artificial heart valve is thus positioned within the tricuspid valve by means of a delivery system 42, such as a catheter or sheath. The artificial heart valve is positioned such that the body 12 or frame of the artificial heart valve is oriented in a longitudinal direction from the proximal end 16 to the distal end 17 of the tricuspid valve. Therefore, after the artificial heart valve is deployed or extended, the support arm 18 of the artificial heart valve grasps the leaflet 27 of the tricuspid valve, thereby forming a ventricular stabilizer. Thus, the support arm 18 is arranged on the ventricular side 28 of the tricuspid valve and configured to provide stability to the leaflet 27. After the artificial heart valve is deployed, the body 12 or frame of the artificial heart valve extends toward the proximal end 16, wherein the body 12 is formed as a flexible mesh body to adapt to the anatomy of the leaflet 27 and apply a radially outward force toward the leaflet 27, so that the artificial heart valve is held by the leaflet 27, while neither the support arm 18 nor the body 12 actually contacts the ventricular portion 28 or the atrial portion 30 of the valve annulus.

[0103] According to an embodiment of the support device 10 of the present invention, Figure 2 The image is depicted graphically, showing the support device 10 deployed in accordance with... Figure 1The anatomical structures correspond to the tricuspid valve anatomy. The stent assembly 10 is depicted in an deployed or deployed state, wherein the longitudinal axes of the stent assembly 10 and the body 12 are oriented along the axis defined by the proximal end 16 and the distal end 17 of the tricuspid valve. The body 12 is composed of a mesh of nitinol and is formed into a basic tubular body 12 having a cylindrical or circular shape.

[0104] Multiple support arms 18 extend from the distal end 17 of the body 12. Although only two support arms 18 are depicted in the cross-sectional view, three or more, preferably six, nine, or twelve support arms 18 may be implemented along the periphery of the distal end 17 of the body 12, for example, at equal intervals, or formed to be arranged adjacent to each other. The support arms 18 extend along the outer surface of the body 12 toward the proximal end 16 of the body 12. The inner surface is defined by an inner channel (not shown) that establishes a pathway for blood flow from the proximal end 16 to the distal end 17, i.e., a pathway from the right atrium to the right ventricle of the heart during cardiac systole.

[0105] Furthermore, in the longitudinal section of the support assembly 10, the support arm 18 includes an S-shape or an inverse S-shape, thus extending radially outward and inward along the longitudinal axis. Thus, the support arm 18 defines a first support region at the distal end 17 and a second support region at the proximal end 16, wherein the second support region extends radially outward at the proximal end 16 due to deflection provided by a flexible region arranged between the first and second support regions.

[0106] Therefore, the shape of the support arm 18—especially the support region—allows the support arm 18 to adapt to the ventricular portion 28 and the atrial portion 30 of the valve ring 26. Furthermore, the flexible region is adapted to adapt to the valve ring 26 of the tricuspid valve. Thus, the support arm 18 ensures that the stent assembly 10 is supported on opposite sides of the tricuspid valve and mates with the valve ring 26 of the tricuspid valve, such that the stent assembly 10 is biased into the tricuspid valve region, particularly into its valve ring 26.

[0107] Therefore, the configuration of the support arm 18 allows the stent assembly 10 to be preferably secured to the valve annulus 26 without the need for invasive techniques such as sutures or needles, without any clamping or gripping force, or without the application of radial outward forces that could damage other anatomical landmarks and tissues. In effect, this configuration separates the function of the body 12 of the stent assembly 10 from that of the support arm, allowing the body 12 to be rigid and thus providing a stable support structure or frame for, for example, valve assemblies.

[0108] Figure 3A For example, according to Figure 2The embodiment depicts a schematic representation of a stent device after laser cutting and before the thermoforming process. On the left side, i.e., at the proximal end 16 of the stent device, the body 12 is depicted as being shaped into a mesh. The mesh is depicted as including two connecting units 14 arranged adjacent to each other along the longitudinal axis of the stent device. Thus, the body 12 includes a plurality of units 14, which can be formed, for example, by thermoforming into tubular or oval structures, thereby forming a cylindrical shape that defines an internal channel configured as a blood flow path.

[0109] Furthermore, the body 12 includes three fixation devices or windows 40 disposed at its distal end 17, wherein each window 40 is formed by three corresponding struts 13 extending in the longitudinal direction. Thus, when the body 12 is formed into its predefined shape, the windows 40 are arranged circumferentially at substantially equal intervals. For example, the windows 40 can be used to attach valve assemblies, such as synthetic or treated autologous tips or leaflets, to provide the desired valve function suited to the patient.

[0110] Although the window 40 is depicted at the distal end 17 of the body 12, the window 40 may also be provided at the corresponding strut 13 at the proximal end 16, and the spacing between the windows 40 may be varied. Similarly, the support device preferably includes at least three windows 40, for example for securing at least three tips of, for example, the tricuspid valve, but may also include more than three windows 40, thus providing more fixation possibilities for the physician or surgeon.

[0111] according to Figure 3A In one embodiment, the support device further includes six support arms 18 extending from the distal end 17 of the body 12. After being heat-formed into a predefined shape, the support arms 18 extend toward the proximal end 16 on the outer surface of the body 12 and define two support regions and a flexible region, as described above. Figure 2 As described. Furthermore, the support arms 18 are provided as closed loops, each connected to the body 12 via two connecting arms, thereby increasing the structural and mechanical stability of the support arms 18. Additionally, the support arms 18 comprise a generally lobed shape and include a rounded proximal end after thermoforming. Thus, the support arms 18 provide improved support due to the increased contact area, while the rounded proximal end ensures avoidance of sharp edges and potential tissue damage, and reduces the risk of proximal breakage.

[0112] Figures 3B to 3D An alternative embodiment is depicted, wherein the proximal end 16 includes a second closing loop 38 arranged in a staggered manner relative to the support arm 18. The proximal end 16 of the second closing loop may include a reinforcement formed of a thicker region to increase the connection strength between the legs of the second closing loop 38, such as... Figure 3B and Figure 3DAs shown on the left. The second closed ring 38 can be heated and shaped, for example, into an open shape, such that the second closed ring 38 extends radially outward, as described below. Figure 5 See Figure 9 for a more detailed explanation.

[0113] Before heat forming, the support assembly comprises a generally flat shape extending in the longitudinal direction, such as Figure 3C The bracket assembly is depicted as being able to be wound along a longitudinal axis to form a basic cylindrical body 12, wherein a second closed loop 38 extends from the proximal end and a support arm 18 extends from the distal end, as shown. Figure 3D As shown. Thus, the main body 12 of the support device is given more structural stability and can be easily transformed into its final shape by heating and forming the support arm 18 and the second closed ring 38.

[0114] according to Figure 4A The embodiments are basically corresponding to those based on Figure 2 The embodiment shown in Figure 3 depicts a support assembly 10 in an unfolded state after heat forming. Therefore, the support assembly 10 also includes a total of six support arms 18 forming a closed loop, which extends from the distal end 17 of the body 12 via two connecting arms 36. Figure 2 The description describes the support arm 18 as having a profile in its longitudinal section, the profile comprising a substantially inverted S-shape or an S-shape, the shape being defined by a first support region 20 at the distal end 17, a second support region 22 at the proximal end 16, and a flexible region 24 therebetween. The flexible region 24 is formed as a tapering section, for example, by contraction along the longitudinal axis of the support assembly 10, thereby allowing the second support region 22 to deflect.

[0115] A first support region 20 of each support arm 18 is formed as a protrusion 32, which at least partially defines the bend forming each connecting arm 36. This bend ensures reduced extension of the ventricular portion into the valve, preventing interruption of blood flow and ensuring that the stent device 10 does not contact any myocardial region, which the implanted stent device 10 should not contact. A flexible region 24 is arranged around the application point of the protrusion 32 and is configured to extend into a recess 34 in a radially outwardly extending second support region 22.

[0116] Thus, the protruding portion 32, the recessed portion 34, and the radially outwardly extending second support region 22 are adapted to support the ventricular portion, the annular portion, and the atrial portion of the tricuspid valve, respectively, such that each region provides a substantially matching geometry. Therefore, the stent assembly 10 can be biased into the annular portion of the tricuspid valve without invasively engaging or compressing the corresponding anatomical structures. Thus, damage to the remaining anatomical structures can be effectively avoided.

[0117] In addition, according to Figure 4AThe embodiment depicts an inner channel 15 defined by a mesh body 12 of the support device 10. Therefore, both the body 12 and the inner channel 15 comprise generally tubular and cylindrical shapes, wherein the stiffness, size, and dimensional specification of the body 12 ensure maximum inner channel volume, thereby maximizing blood flow from the proximal end 16 to the distal end 17. Furthermore, the mesh body 12 is composed of a plurality of units 14 and corresponding struts 13, wherein the units 14 comprise droplet shapes without sharp edges between adjacent units 14, thereby further improving the structural integrity of the body 12.

[0118] When the support device is in its deployed state, a gap can be formed between the outer surface of the main body 12 and the support arm 18, such as Figure 4B A top view of the proximal end 16 is shown. Therefore, the body 12 preferably does not exert radially outward forces on the anatomical structure of the valve annulus and is held only on one side of the body 12 by a support arm 18, which is adaptable to both the ventricular and atrial portions, thereby biasing the stent assembly within the valve annulus. This clearance ensures maximum flexibility and adaptability of the support arm 18, while simultaneously ensuring that the body 12 of the stent assembly does not deteriorate or impair its anatomical shape.

[0119] The alternative configuration of the proximal end 16 of the main body 12 is based on Figure 5 The embodiment is depicted in a schematic perspective view, wherein the support device 10 includes a body 12 having an alternative proximal portion 38 extending in a radially outward direction, forming an open surface. Therefore, a support arm 18 extending from the distal end 17 of the body 12 toward the proximal end 16 of the body 12 can approach or contact the proximal portion 38 of the body 12.

[0120] For example, in addition to the first support region 20 at the distal end 17 and the adjacent flexible region 24, a support arm 18 including a second support region 22 at the proximal end 16 can be radially outwardly deflected at the second support region 22, thereby contacting the radially outwardly extending proximal portion 38. Thus, the proximal portion 38 not only improves the seal of the stent assembly 10, but also, for example, by defining a chamfer at an angle relative to the longitudinal axis of the stent assembly 12, can simultaneously facilitate blood flow and / or insertion into the internal channel of the body 12. Furthermore, such an arrangement can further increase support for the stent assembly 10 in cases where the second support region 22 does not have the desired effect, through an additional surface that can be aligned with the valve annulus or the corresponding atrial portion of the valve and provides additional support features.

[0121] In addition, according to Figure 6 The side view schematically depicts the situation according to... Figure 5In this embodiment, the radially outwardly extending proximal region of the body 12 is slightly inclined toward the outer surface of the body 12 and the support arm 18 at an angle between 70° and 90°, for example. Such an angle can be selected, for example, to accommodate the atrial portion of the valve annulus, and further ensures optimal sealing toward the proximal end 16 of the support arm 18. It should be understood that other angles are possible, and the shape of the proximal portion 38 is not limited to... Figure 5 and 7 The shapes depicted in the figure may also include, for example, shapes corresponding to the mesh shape of the body 12.

[0122] Therefore, in an exemplary embodiment, the stent device may include a proximal portion 38 of the body, the proximal portion including a plurality of second closed loops, such as... Figure 7 The diagram is schematically depicted. Thus, the second closed loop becomes an extension extending from the proximal end of the body, i.e., an extension extending from the mesh shape of the body, such that the second closed loop connects to two adjacent units 14 at the proximal end of the body. As indicated by the dashed lines, the radially outwardly extending—i.e., opening in a direction substantially perpendicular to the longitudinal axis of the support assembly—proximal portion 38 includes a portion of the last row of struts 13 of each last unit 14 at the proximal end of the body.

[0123] For example, the radially outward extension may include 1 / 4 to 1 / 2 of the last row of struts 13. According to Figure 7 In one embodiment, in the longitudinal direction of the support device, the portion includes approximately one-third of the length of the last or final row of struts 13. Therefore, depending on the anatomical structure corresponding to the patient's pathophysiological condition, the size of the second closed loop and the proximal portion 38 may be equal to or smaller than the second support area of ​​each support arm.

[0124] Given the proximal end of the second support region 22 of multiple support arms, the proximal portion 38 can also be arranged in a staggered pattern, such as according to... Figure 8 The embodiments are depicted schematically. Therefore, the proximal portion 38 may include, for example, considering... Figure 7 The described plurality of second closed loops extending from the proximal end of the body are radially outwardly deflected and arranged between the second support regions 22 of each pair of adjacent support arms. Thus, the support assembly may include a total of six support arms having corresponding second support regions 22 and a total of six second closed loops defined by the proximal portion 38, the support arms and closed loops alternating circumferentially with each other along the outer periphery of the body 12 of the support assembly. An inner channel 15 is also shown, which is therefore not obstructed by the second support regions 22 and the proximal portion 38. While the tips of the support regions 22 may be in the form of triangles forming acute angles in the end regions, rounded tips ( Figure 8 (Not described in the text) may be more preferred.

[0125] Alternatively, for example, when the number of second closed loops and the number of support arms do not match, the proximal portion 38 can provide an alternative staggered configuration. For instance, the proximal portion 38 may include only three second closed loops, such that the second closed loops are arranged only between every other pair of adjacent second support regions 22. Similarly, the proximal portion 38 may include a larger number of second closed loops, sized smaller than the second support regions 22 of the support arms, such that, for example, two second closed loops are arranged between each pair of adjacent second support regions 22. It will be apparent to those skilled in the art that the aforementioned number of second closed loops and second support regions 22 is for illustrative purposes only and is not limited to the described embodiment. In other words, other arrangements with a higher number of support arms or a number between three and six support arms are possible and within the scope of the embodiments.

[0126] exist Figures 9A to 9C In the embodiment depicted, an alternative staggered form of the second closed loop 38 and the support arm 18 is shown, wherein the second closed loop 38 is sized such that it is similar to the closed loop of the support arm 18. Thus, as for example... Figure 9A As shown in the schematic top view (left) and perspective top view (right), the second closed loop 38 extends radially outward and may include a cross-sectional surface region similar to that of the support arm 18. This remains unchanged even though the second support region 22 of the support arm 18 is also as shown in the side view and perspective view of the embodiment, respectively. Figure 9B and Figure 9C The same applies if it extends further radially outwards.

[0127] In addition, according to Figure 4B The implementation examples are similar, Figure 9B and Figure 9C The diagram shows a possible gap between the support arm 18 and the main body 12 of the bracket assembly. This ensures the tolerance between the support arm 18 and the main body 12. Therefore, the elasticity of the support arm 18 is increased. In other words, as... Figure 9B As shown, the S-shape of the support arm 18, i.e., the protruding and recessed areas in the longitudinal section, and the gap between it and the main body 12 of the stent device can be changed at least partially or segmentally, thereby accommodating the stent device in the valve annulus and thus adapting it to the anatomy of the valve annulus.

[0128] Additionally, the open second closed ring 38 ensures that direct contact between the body 12 and anatomical structures is avoided, preventing the body 12 from exerting radially outward directional forces on the valve annulus. This reduces or avoids potentially adverse forces that could harm other anatomical landmarks. However, the open arrangement ensures that fluid flow from proximal to distal is not significantly impaired. Furthermore, as... Figure 9C As indicated, the proximal end 16 and the distal end 17 are inverted. This opening of the second closure ring facilitates, for example, the insertion of a valve assembly into the body 12 by forming a chamfered surface.

[0129] exist Figure 10 In the middle, as Figure 3B An alternative embodiment depicted in the diagram illustrates a schematic representation of the stent device 10 according to the invention after laser cutting and before thermoforming. In this embodiment, an eyelet 44 is provided at the proximal end 16 or proximal tip of the second ring 38 of the stent body 12, allowing the stent device 10 to be secured to a delivery system for insertion into the anatomical region of interest. Therefore, the eyelet 44 can also be used for release and final deployment of the stent device 10 after insertion. In this embodiment, a total of two eyelets 44 are provided, arranged on the closing ring 38, thus positioned on opposite sides of the stent device 10 in the radial direction in the assembled state. However, the arrangement and number of eyelets 44 can be selected as needed. Furthermore, the eyelets 44 have a circular or rounded shape, thereby facilitating securing to and release from the delivery system. Alternatively, the eyelets may also include other shapes, preferably symmetrical designs, such as polygonal or elliptical shapes.

[0130] exist Figure 11A and 11B The diagram shows a schematic top view and a perspective side view of the support device 10 with an alternative support arm configuration.

[0131] In this configuration, as per [the agreement / regulation]... Figure 9A The best direct comparison of the embodiments does not provide a flexible region with tapered sections "located in between," wherein the contraction is schematically indicated by a sharp V-shaped notch. Instead, according to Figure 11A In one embodiment, each support arm 18 includes a tapered section that extends substantially from the recessed portion 34 toward the second support region 22—that is, toward the proximal tip of the support arm 18. The tapered section is provided as substantially triangular, conical, or elliptical in shape, and includes a rounded portion at the proximal tip of, for example, an end portion or a ring portion of the second support region 22, thereby reducing the risk of tissue damage.

[0132] Simultaneously, a spring function is maintained between the second support region 22 and the first support region 20. This spring function is enhanced by a protrusion 32, which, in conjunction with an adjacent recess 34, defines a shoulder or bend in the first support region 20 and connects to the distal end of the support body 12, as shown below. Figure 11B As shown in the perspective side view. The radius 46 at the distal end of the shoulder is greater than the radius 48 at the proximal end of the shoulder. Therefore, a wider angle is provided at the distal end of the support body 12, which, together with the radial extension of the protrusion 32, ensures that the possibility of breakage between the support arm and the support body 12 is reduced, and the forces acting on the support device 10 and the support arm 18 can be better distributed.

[0133] Furthermore, the smaller radius 48 at the proximal end of the shoulder, together with the adjacent recess 34, ensures an improved fit to the valve annulus region and ventricular anatomy. Additionally, the radial extension of the outermost point of the protrusion 32 lies between the innermost point of the recess 34 and the proximal tip of the second support region 22, such that the proximal tip of the second support region 22 has the greatest radial extension in all segments of each support arm 18. Thus, while providing an improved fit or adaptation to the anatomical valve annulus region, the contact surface is increased in the atrial portion, and wider support is provided without adversely affecting the remaining autosomal structures of the valve annulus region.

[0134] In other words, the wider extension of the support area of ​​each support arm provides a larger engagement or interaction surface, while the specific configuration of the protrusion 32 and the recess 34, as well as the radial extension of the second support area 22, ensures an improved spring function by improving the absorption and distribution of forces acting on the support assembly.

[0135] This embodiment also illustrates the mesh shape of the body, which is formed by a grid of multiple rhomboid units directly connected to each other and substantially identical in size and / or shape. As summarized above, the advantage of the rhomboid shape is that it provides substantially equal stress and strain resistance in both the axial and circumferential directions, and reduces deformation and strain applied during manufacturing, thereby increasing the stability of the body. Furthermore, the desired flexibility can be maintained, for example, by varying the thickness towards the proximal and / or distal ends.

[0136] It will be apparent to those skilled in the art that these embodiments and components are merely examples of a variety of possibilities. Therefore, the embodiments shown herein should not be construed as limitations on the formation of these features and configurations. Any possible combination and configuration of the described features may be selected according to the scope of the invention.

[0137] List of reference numerals

[0138] 10 Support device

[0139] 12 main body

[0140] 13 struts

[0141] Unit 14

[0142] 15 Internal passages

[0143] 16 Proximal

[0144] 17. Remote

[0145] 18 Support arms

[0146] 20 First Support Area

[0147] 22 Second Support Area

[0148] 24 Flexible Areas

[0149] 26 Valve Rings

[0150] 27. Autologous tip or leaflet

[0151] 28. Ventricular portion

[0152] 30. Atrium

[0153] 32. Protruding part

[0154] 34. Recessed portion

[0155] 36 Connecting Arms

[0156] 38. Proximal portion or second closed loop

[0157] 40. Fixtures or windows

[0158] 42 Delivery System

[0159] 44 holes

[0160] 46 Distal radius

[0161] 48. Proximal radius.

Claims

1. A stent device (10) for an artificial heart valve, comprising: - A mesh body (12), comprising multiple units and configured to mate with the valve annulus (26) of the heart valve and extending in an axial direction, the body (12) being configured to mate with an orifice and defining an internal channel (15) for providing a passage from the proximal end (16) to the distal end (17) of the body (12), and - At least three external support arms (18) extending from the distal end (17) of the body (12) toward the proximal end (16) of the body (12) and separated from each other, each support arm (18) forming a closed loop with the body (12) by being connected to the body (12) via two connecting arms (36) and having a free end and a fixed end connected to the distal end of the body, the support arms (18) being respectively connected to the ends of two adjacent units of the body (12) at the distal end; in the longitudinal section of the support arm (18), the closed loop defines a profile having a protruding portion (32) and a recessed portion (34); each support arm (18) includes a first support region (20) defined by the protruding portion (32) at the distal end (17) and a second support region (22) at the proximal end (16), wherein the second support region (22) extends radially outward from the distal end (17) of the body (12) toward the proximal end (16) in the deployed state, The proximal end of the second support region (22) has the maximum radial extension of each support arm (18), while the first support region (20) is arranged to extend beyond the recess (34) of the adjacent protrusion (32). The second support region (22) of each support arm (18) is configured to be disposed at the atrial portion (30) of the valve ring (26), such that the radially outwardly extending portion is oriented to adapt to the atrial portion (30) of the valve ring (26); the first support region (20) of each support arm (18) is configured to be disposed at the ventricular portion (28) of the valve ring (26). Each support arm (18) tapers in lateral width along the recessed portion toward the proximal end (16). At least one of the second rings is connected to the proximal end of the body (12) via two second arms, forming a ring with the body (12) and extending radially outward. When the stent device (10) is in its deployed state, a gap is formed between the outer surface of the body (12) and the support arm (18), wherein the support arm (18) and the at least one second ring prevent the body (12) from directly contacting the anatomical structure of the valve annulus and prevent the body (12) from applying radial outward force to the anatomical structure of the valve annulus.

2. The stent device (10) according to claim 1, wherein the flexible region (24) is adapted to be adapted to the valve ring (26), the first support region (20) is adapted to be adapted to the ventricular portion (28) of the valve ring (26), and / or the second support region (22) is adapted to be adapted to the atrial portion (30) of the valve ring (26).

3. The support device (10) according to any one of the preceding claims, wherein the body (12) comprises a tubular or cylindrical shape.

4. The stent device (10) according to claim 1, wherein the closed loop extends beyond the proximal end (16) of the body (12) and / or includes a rounded proximal end and / or a tapered proximal end.

5. The support device (10) according to claim 1, wherein the recessed portion (34) is adjacent to the protruding portion (32).

6. The support device (10) according to claim 5, wherein the radial extension of the outermost point of the protruding portion (32) is greater than the radial innermost point of the recessed portion (34), and / or wherein the radial outermost point of the protruding portion (32) is located between the radial innermost point of the recessed portion (34) and the proximal tip of the second support region (22).

7. The support device (10) according to claim 5 or 6, wherein the profile is formed in the radial direction as an inverted S-shape, a sine wave, an N-shape, or an M-shape.

8. The support device (10) according to claim 1 or 2, wherein each support arm (18) is connected to the body (12) via at least one connecting arm (36) formed by bending through the first support region (20).

9. The support device (10) according to claim 8, wherein the bending includes an angle greater than 90° and / or a defined rounded shoulder.

10. The support device (10) according to claim 9, wherein the shoulder has a distal radius (46) and a proximal radius, wherein the distal radius (46) is greater than the proximal radius.

11. The stent device (10) according to claim 1 or 2, comprising an odd number of support arms (18), or two and / or three times / more than three times the number of support arms (18), said support arms (18) being adapted for the tricuspid or mitral valve.

12. The support device (10) according to claim 11, comprising 5, 7 or 9 support arms (18).

13. The stent device (10) according to claim 11, comprising six support arms (18) and configured for the tricuspid valve.

14. The support device (10) according to claim 1 or 2, wherein the circumferential spacing between the support arms (18) is asymmetrical or symmetrical, and / or suitable for the tricuspid or mitral valve.

15. The support device (10) according to claim 1 or 2, wherein the mesh shape of the body (12) includes a droplet shape, a rhombus shape or an oval shape.

16. The support device (10) according to claim 1 or 2, wherein the mesh shape of the main body (12) is formed by a mesh of a plurality of diamond-shaped units that are directly connected to each other or connected via struts (13).

17. The support device (10) according to claim 16, wherein the units are identical in size and / or shape.

18. The support device (10) according to claim 1 or 2, wherein a portion (38) of the proximal end (16) of the body (12) extends radially outward.

19. The support device (10) according to claim 18, wherein the portion (38) of the proximal end (16) of the body (12) extends between 70° and 110° relative to the axial direction of the body (12).

20. The support device (10) according to claim 18, wherein the portion (38) is defined by a plurality of second closed loops.

21. The support device (10) according to claim 20, wherein the plurality of second closed loops are arranged in a circumferentially staggered manner relative to the support arm (18) disposed at the distal end (17).

22. The support device (10) according to claim 20, wherein the portion (38) includes at least one eyelet (44) for securing the support device (10) to the delivery system, each of the at least one eyelet (44) being arranged at a corresponding second closed loop, and / or at the proximal end (16) or the radially outermost end of the second closed loop.

23. The support device (10) according to claim 22, wherein the portion (38) includes at least two eyelets (44).

24. The support device (10) according to claim 22, wherein each of the at least one eyelet (44) is arranged at every other second closed loop or every other two.

25. The support device (10) according to claim 1 or 2, wherein the main body (12) and the plurality of support arms (18) are formed as a single piece and / or wire frame.

26. The support device (10) according to claim 1 or 2, wherein the body (12) or the passage defined by the body (12) includes an inner diameter between 29 mm and 36 mm.

27. The support device (10) according to claim 26, wherein the body (12) or the passage defined by the body (12) includes an inner diameter of 30 mm or 35 mm.

28. The support device (10) according to claim 1 or 2, wherein at least the second support region (22) of the support arm (18) and / or the proximal end (16) of the outer body (12) are covered with a foil of liquid impermeable or semi-impermeable material, thereby forming a ferrule between the support arm (18) and the body (12) and / or between the support arm (18).

29. The stent device (10) according to claim 1 or 2, wherein the body (12) includes at least two or at least three fixation devices or windows (40) for receiving valve components, or wherein the units of the mesh body (12) are configured for receiving and fixing valve components.

30. An artificial heart valve comprising a stent device (10) according to any one of the preceding claims and a valve assembly disposed within the inner channel (15) and / or at the proximal (16) or distal (17) end of the body (12) and secured to the body (12) by means of a fixation device or window (40) or by direct fixation to one or more units of the mesh body (12).

31. The artificial heart valve of claim 30, configured for replacing a tricuspid or mitral valve.

32. A delivery system comprising a support device in a folded state according to any one of claims 1-29.

33. A method for manufacturing a support device according to any one of claims 1 to 29, comprising the following steps: - The main body and support arm are laser-cut from a metallic memory material; -Heating the body and support arm to form a predefined shape, thereby providing the body and support arm; as well as - Fold the main body and support arm.

34. The method of claim 33, wherein the support device is made from a single piece.

Images