Stent device for prosthetic heart valve

Abstract

To provide a stent device, a prosthetic heart valve, a delivery system, and a corresponding method, in the field for replacing a defective atrioventricular heart valve, especially a tricuspid valve, and providing improved fixation without causing distortion in a native anatomy of the tricuspid valve.SOLUTION: A stent device (10) for a prosthetic heart valve comprises: a mesh-shaped body (12), the mesh-shaped body (12) extending in an axial direction, and defines an inner channel (15) for providing a passageway from a proximal end (16) to a distal end (17) of the body (12); and at least three outside support arms (18), the outside support arms (18) extending from the body (12) from the distal end (17) of the body (12) towards the proximal end (16), each support arm (18) having a first support region (20) at the distal end (17), and a second support region (22) at the proximal end (16), the second support region (22) extending radially outwards in the deployed state.SELECTED DRAWING: Figure 4A

Description

[Technical field]

[0001] The present invention relates to the field of replacing defective atrioventricular heart valves, in particular the tricuspid valve, including stent devices, prosthetic heart valves, and delivery systems, as well as methods of manufacturing such stent devices and methods of using such stent devices to replace the tricuspid or mitral valve. [Background technology]

[0002] Blood circulation in mammals is driven primarily by the pumping function of the heart. Such cardiac function is provided not only to ensure that tissues are adequately perfused, but also to provide decarbonation and reoxygenation of the outflowing blood after passing through the tissues. The human heart comprises two ventricles, the left ventricle and the right ventricle, which pump blood through the vascular system via the aorta and through the pulmonary system via the pulmonary artery, respectively, to provide respiratory function and oxygenate the blood. The filling of said ventricles is made possible by the corresponding left and right atria, which are connected to the pulmonary veins and vena cava, respectively.

[0003] To provide for the proper functioning of the atria and ventricles, the human heart has four heart valves. Two of these valves are called atrioventricular valves, i.e. located at the junction between the atria and the ventricles. The tricuspid valve is located between the right atrium and the right ventricle. The mitral valve, also known as the bicuspid valve, is located between the left atrium and the left ventricle. The other two valves are located between the ventricles and the vascular system and include a semicircular shape. The aortic valve separates the left ventricle from the aorta, and the pulmonary valve separates the right ventricle from the pulmonary artery.

[0004] The filling and emptying of the atria and ventricles continues in a highly synchronized schedule during diastole and systole. However, the efficiency of cardiac function depends not only on the complex innervation of the myocardial tissue, but also on the sealing efficiency of the atrioventricular valves. Such sealing efficiency can be impaired due to various pathological conditions, for example due to functional lesions of the tricuspid valve, which can be subtle, severe, and secondary to marked dilatation of the tricuspid annulus. More rarely, this pathology results from rheumatic or infectious valvular diseases, or from degeneration of stenotic or leaky bioprostheses.

[0005] A dysfunctional tricuspid valve can lead to tricuspid regurgitation, which is a common medical problem and associated with significant challenges. For example, patients suffering from tricuspid regurgitation generally suffer from chronic dysfunctional fluid retention and have low cardiac output. Furthermore, the diameter of the annulus may extend beyond 40 mm, such that the anatomical landmark between the right ventricle and the right atrium is gradually lost, thereby compromising and complicating tricuspid valve treatment, repair and replacement.

[0006] More generally, replacement techniques for defective heart valves are established, especially by percutaneous or minimally invasive routes. However, such systems and techniques are mainly aimed at replacing the mitral valve and are not directly applicable to replacing the tricuspid valve. Among other things, the right ventricle is equipped with a unique anatomical structure. The tricuspid annulus is slightly fibrous in nature. Its dimensions are more ovoid, although it generally has a thin structure compared to the mitral annulus. Moreover, the dimensions of the tricuspid valve are substantially larger than the mitral valve. These differences may be even more pronounced as a result of pathophysiological conditions that cause structural changes in the shape and dimensions of the right atrioventricular anatomy, accompanied by fluctuations in volume status and pulmonary pressure, such that the tricuspid annulus can expand to a diameter of more than 40 mm, for example up to 50 mm, whereas the dimensions of the mitral annulus are about 30 to 35 mm under pathological conditions. Said differences directly affect both the mechanical stability and the tendency to periprosthetic leakage, and contrary to the claims of the literature, mitral valve replacement techniques are typically not applicable to the tricuspid valve.

[0007] Clinical practice regarding the aortic valve has now progressed so much that the aortic valve is routinely replaced by a percutaneous valve. A bioprosthesis model for a percutaneous mitral valve is also currently in the process of clinical evaluation. In contrast, clinical treatments involving percutaneous orthotopic, i.e. in situ, bioprostheses for tricuspid valve replacement are in the very early stages of development. Tricuspid valve replacement is also complex, since that body site generally lacks the body tissue volume to hold the prosthetic device in place. Various techniques are based on prosthetic devices with a conical plug shape to facilitate fixation. They generally exert an outward radial force that may further distort the anatomical structure at the right atrioventricular site. Alternative fixation-based techniques using the leaflets of the tricuspid valve are only adapted to a limited portion of the tricuspid valve and at the same time require a profile height of more than 30 mm, which is bulky, increases the risk of prolapse, and may impair blood flow.

[0008] For example, a prosthetic valve for the tricuspid valve is known from WO 2016 / 098104, which includes a flexible body with rigid ventricular stabilizers that engage the native leaflets of the tricuspid valve. Such an arrangement provides limited support and compliance with the tricuspid valve anatomy and requires clamping of the native leaflets, which can be detrimental to the remaining anatomical landmarks.

[0009] Furthermore, WO 2017 / 089179 discloses an assembly for replacing a tricuspid atrioventricular valve, in which support arms or fixation elements extend from a central portion of a mesh body. Such an arrangement requires fixation at the central portion.

[0010] Therefore, there is a need for devices, systems, and methods specifically adapted for tricuspid valve replacement that reduce the above problems and provide improved fixation without distortion of the native anatomy of the tricuspid valve. Such devices or systems may also provide improved support for mitral valve replacement. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] International Publication No. 2016 / 098104 [Patent Document 2] International Publication No. 2017 / 089179 Summary of the Invention [Problem to be solved by the invention]

[0012] It is an object of the present invention to provide a stent device for prosthetic heart valves which avoids at least some of the above observations which are undesirable for clinical practice. [Means for solving the problem]

[0013] Thus, in a first aspect, a stent device for a prosthetic heart valve is proposed, comprising an axially extending mesh-shaped body, the body being configured to fit into an orifice and defining an inner channel for providing a passage from the proximal end to the distal end of the body. The stent device further comprises at least three outer support arms extending from the body, i.e. from the distal end of the mesh-shaped body towards the proximal end, each support arm comprising a first support region at the distal end and a second support region at the proximal end, with a flexible region therebetween. The flexible region of each support arm is formed as a tapered portion of the support arm in the axial direction, the second support region of each support arm extending radially outward in the deployed state.

[0014] Thus, the body of the stent device forms a support structure or core frame that can be received in the opening provided by, for example, the tricuspid or mitral valve annulus. It should be understood that the body is not elastic or does not allow for deflection, but is deformable so that the body and the entire stent device can transition between a collapsed state and an expanded or deployed state. For example, the stent device may be formed from a shape memory metal, for example braided Nitinol, whereby the shape of the body may be predefined, for example by thermoforming, and / or the stiffness of the body may preferably vary depending on the temperature and / or with a temperature interval, for example between 0° C. and body temperature, while the dimensions of the body may vary.

[0015] In contrast, a flexible region should be understood as being elastic or allowing deflection such that the second support region can, for example, bend, deflect, fold, or pivot relative to the first support region via the flexible region.

[0016] Furthermore, the mesh shape may be formed, for example, as a lattice or as a plurality of polygonal or elliptical cells connected to each other directly or via struts. For example, the mesh shape may be composed of a plurality of polygons arranged transversely to each other to form a closed structure, with a plurality of polygons in the axial direction, for example two, three or more polygons, to form an essentially honeycomb structure. The plurality of polygons or cells in the axial direction may be connected via corresponding struts, preferably having equal strut lengths. Preferably, the mesh shape of the body is formed by a lattice of a plurality of diamond-shaped cells connected to each other directly or via struts, the size and / or shape of the cells being essentially equal. The diamond shape has the advantage of providing substantially equal stress and strain resistance in the axial and circumferential directions, which may increase the stability of the body with a reduced amount of deformation and strain applied during manufacturing.

[0017] In the deployed state, the axial or longitudinal direction of the body is essentially oriented sagittally, and the radial direction is essentially oriented transversely. Thus, the terms proximal and distal should be understood in their anatomical sense, to refer to the direction of blood flow in the human heart. In other words, the proximal end may refer to the end of the stent device deployed in the atrium ("atrial portion"), while the distal end may refer to the end of the stent device deployed in the ventricles ("ventricular portion") of the tricuspid and mitral valves, respectively. Thus, the inner channel or passage is also oriented in the same direction, i.e., from the proximal end towards the distal end of the body, so that blood can flow from the atrium towards the ventricle through said passage along its axis that first passes through the "atrial portion" of the stent device.

[0018] Providing at least three support arms has the advantage that the stability of the fixation is improved compared to, for example, two support arms, so that the stent device can be properly supported during deployment. The support arms extend from the stent body at the distal end, i.e. from the "ventricular portion" of the body during deployment, and extend towards the proximal end, i.e. the "atrial portion". Thus, the extension from the body allows each of the support arms to start from the body at its distal end, and therefore to be attached to the body only at its distal end.

[0019] Thus, each of the support arms is supported only on one side of the free end of the body in the "ventricular portion". The concept not only ensures an improved support function, for example by providing an adaptable spring force extending through the entire support arm, but also allows the omission of any requirement for central fixation in the central portion of the body. Thereby, the support arms can exhibit an improved adaptation to the anatomical structure of the valve and annulus by providing an improved force distribution. Moreover, such an arrangement together with the flexible region ensures an improved flexibility, allowing the second support region to better adapt to the anatomical structure due to the bending in the radially outward direction. Thus, the support arm configuration and the provision of the flexible region provide an improved interrelationship or interaction between the first support region and the second support region.

[0020] Alternatively, or in addition to the flexible region, each support arm may be tapered towards its proximal end. In other words, the tapered portion of each support arm may be provided, for example, starting from the distal end of the stent body, from the flexible region, or at the proximal tip, i.e., the second support region of the respective support arm. The taper may be provided as an essentially triangular or conical shape, and may be continuous towards the proximal tip, or may be truncated by a rounded portion at the proximal tip. A continuous taper, for example starting after the first support region, has the advantage that less strain is applied during manufacture, thereby increasing stability while maintaining or providing some flexibility of the support arm. Furthermore, this feature may prevent entanglement during loading of the stent device in the delivery system, such that entanglement, interlocking, interlocking, twisting, and / or twisting of the support arms is effectively avoided. At the same time, a spring function is maintained between the second support region and the first support region such that the support arm conforms to the anatomy of the valve and annulus.

[0021] In addition, the extension of the support arms from the distal end only allows for improved stability since separate fixation at, for example, the central or mid-portion is no longer required. Furthermore, the insertion and positioning of the stent device in the desired anatomical location prior to deployment, i.e., before expanding the stent device, allows the distal portion to be positioned first, after which the stent device is expanded towards the proximal end, while facilitating withdrawal of the delivery system. By the same token, this arrangement allows for more adjustment during deployment that may be limited whenever the support arms are provided in the central or mid-region.

[0022] Although the stent device may be adapted to be deployed in various regions of the atrioventricular heart valve, the mesh-shaped body is preferably configured to fit into the annulus of the heart valve and the flexible region may be adapted to conform to the annulus. The first support region may be adapted to conform to a ventricular portion of the annulus and / or the second support region may be adapted to conform to an atrial portion of the annulus.

[0023] Thus, the stent device can fit into the tricuspid or mitral valve along the annulus of the respective valve. Preferably, the second support region, i.e. the proximal end, of each support arm is configured to be disposed in the atrial portion of the annulus such that the radially outwardly extending portion can be oriented to conform to the atrial portion of the annulus. This shape is facilitated by a flexible region that allows the proximal end of the support arm to flex so that the contact surface of the second support region to the atrial portion is increased. In the same sense, the first support region, i.e. the distal end, of each support arm is preferably configured to be disposed in the ventricular portion of the annulus such that the stent device is disposed in the radially innermost portion of the annulus by its flexible region and is supported at both ends of the annulus by the corresponding support region of the support arm. Thus, the flexible region is preferably configured to conform to the shape of the annulus, thus providing the necessary flexibility for the second support region, but also with flexibility to conform to the annulus anatomy.

[0024] Thereby, the stent device provides an optimal fit to the geometry or anatomical structure of the atrioventricular valve and the corresponding valve annulus. Moreover, by establishing two support regions for each single support arm, the body of the stent device is held securely in place without exerting clamping forces and without gripping the anatomical structure. No anchoring mechanism is required that allows puncturing tissue to fix the stent device. Thus, the pathophysiological annulus and the atrioventricular valve anatomical structure are not (further) distorted or further compromised, and the remaining cardiac function is not further impaired. The adaptation of the support arms to the anatomical structure also allows the mesh body of the stent device not to be flexible, but may be formed as an essentially rigid structure, thereby providing, for example, additional stability to the valve assembly. At the same time, the concept of the present invention allows the body of the stent device to assume smaller dimensions, since the stent device is not merely fixed by a force directed radially outward.

[0025] Conforming to the valve or annulus geometry or anatomy is particularly advantageous in view of the more complex anatomy of the tricuspid valve, however, any such configuration may also be applied as a mitral valve replacement stent device, as it also contributes advantageously to the functionality of the mitral valve stent device.

[0026] The body of the stent device may furthermore present an essentially tubular or cylindrical shape. Such a geometric shape has the advantage that a less complicated and / or more robust valve assembly can be implemented in the stent device. Nevertheless, the orientation or positioning of the body is facilitated and does not depend on the corresponding shape of the anatomical structure, thus ensuring a more versatile stent device. Furthermore, improved support is enabled in the region of the annulus with a smaller curvature, maximizing the volume of the inner channel for improving blood flow.

[0027] To increase the contact surface, reduce the amount of material and maintain the flexibility or adaptability of the support arms, each support arm may advantageously be formed as a closed loop. Although each support arm may generally be formed as a single extending element, for example with a thickness that varies in the axial direction and with a tapered or waisted portion, the closed loop allows for increased stability with an even larger contact area or surface provided by the first and second support regions. For example, the closed loop may have a larger width at the distal and / or proximal end compared to the flexible region. Similarly, the closed loop may typically be provided at a location distal to the flexible region, such that only the flexible region and the second support region are formed by the closed loop. Alternatively, the closed loop may be provided at a location distal to the first support region, but between the distal end of the body and the first support region of the support arm.

[0028] Preferably, the closed loop extends beyond the proximal end of the body. This may comprise a rounded (mostly) or tapered proximal end. Extension beyond the proximal end of the body has the advantage that the dimensions of the body can be kept to a minimum necessary size to reduce potentially bulky stent components protruding into the respective atrial or ventricular regions. This allows a larger contact area to be provided with the atrial portion of the annulus, thus further improving support.

[0029] In the same sense, a rounded or tapered proximal end avoids sharp surface edges or tips that could potentially puncture tissue, for example in the atrial region, while at the same time providing a larger contact area, as compared to, for example, a pointed or spiked proximal end. Furthermore, the rounded shape increases the stability of the closed loop and reduces the risk of separation or breakage of the loop elements. For example, the closed loop may typically have an essentially petal shape at the proximal end to ensure the necessary adaptability or conformability to the corresponding anatomical structure.

[0030] The closed loop may further define a profile in a longitudinal cross section of the support arm having a convex portion and a concave portion, the convex portion being defined by the first support region. Preferably, the concave portion is adjacent to the convex portion.

[0031] For example, the first support region located at the distal end may be formed as a rounded shape that can conform to the ventricular portion of the valve annulus, and the concave portion may be at least partially formed by the flexible region. The flexible region or tapered portion may be provided, for example, at the proximal portion of the convex portion, particularly starting from the inflection point of the convex portion, such that the concave portion at least partially coincides with the tapered portion. The concave portion may thereby include a degree of flexibility, which, for example, further facilitates conformance to the annular anatomical structure and interaction with the deflecting second support region at the proximal end.

[0032] Further, the radial extension of the radially outermost point of the convex portion may be greater than the radially innermost point of the concave portion, and / or the radially outermost point of the convex portion may be radially disposed between the radially innermost point of the concave portion and the proximal tip of the second support region.

[0033] In other words, the proximal tip of the second support region can have the maximum radial extension of each support arm, and the first support region is arranged to extend beyond the concave portion directly adjacent to the convex portion. Thus, rather than a conical or frustoconical extension of the support arm, a shoulder may be formed by the convex portion and the adjacent concave portion, which improves the spring function of the support arm and improves its conformity to the annulus and ventricular anatomy. Furthermore, such a configuration allows the support region of each support arm to have a wider extension, thereby achieving a larger surface area for interacting with the annulus region in the deployed state, thus allowing the forces acting on the stent device to be better diffused through the support arms.

[0034] Alternatively, the flexible region may at least partially overlap the convex portion, e.g., begin at a proximal end of the convex portion and extend beyond the distal end of the concave portion. In other words, the flexible region may at least partially overlap the first support region and not extend beyond the radially outwardly extending portion of the second support region.

[0035] Preferably, the profile is formed as an axially and / or radially inverted S-shape, sinusoidal wave, N-shape, or M-shape. Such a shape allows a seamless transition between the changing regions and allows an optimal adaptation to the anatomical shape of the tricuspid or mitral valve, in particular to the corresponding annulus. Furthermore, such a shape may comprise a second convex portion that may be formed by a second support region. The stent device may be biased and thus positioned in the annulus and supported at both ends of the annulus by the corresponding convex portions formed by the support regions of the support arms, preferably without exerting a clamping or gripping force.

[0036] Furthermore, the convex and concave portions need not exhibit a symmetrical profile, but may have different curvatures, e.g., one or both convex portions may have an asymmetrical contour, and the curvature at the "ventricular portion" or distal end of the stent device may be less or steeper, e.g., compared to the curvature of the concave portion and / or the curvature at the "atrial portion" or proximal end of the stent device. Such a steeper curvature, e.g., resembling an N- or M-shaped curvature, may facilitate the stent device to be anchored in the ventricular portion of the annulus, e.g., even in the case of limited tissue volume, whereas a larger curvature, e.g., resembling an S-shape, at the "atrial portion" or proximal end may be predicted to cover a larger atrial region or portion to provide better distribution of support and / or improved sealing.

[0037] Although the particular shapes above are described with respect to configurations having support arms formed as closed loops, these shapes are not limited to closed loop configurations and may also be implemented in embodiments having support arms formed as a single extension element, for example having an axially varying thickness.

[0038] Each support arm may be connected to the mesh body via at least one, preferably two, connecting arms formed by a curved portion of the first support region. For example, such a curved portion may be formed by a convex portion originating from the distal end of the body of the stent device. However, it may also be formed as a curved portion independent of the presence of such a convex first support region. In other words, each connecting arm is provided as an extension of the body of the stent device and is typically formed integrally with the first support region of each support arm to form a continuous, e.g., single-piece structure. The curve has the advantage that sharp edges can be avoided, thereby improving the structural stability of the stent device and the connection between each arm and the body of the stent device. In addition, the curved portion ensures that the distal ends of both the body and the support arms extending into the ventricular portion can be dimensioned smaller so as to reduce the extension of the portion of the stent device into the ventricle.

[0039] Furthermore, the flexures can represent elastic elements such that a spring force biasing the support arms towards the atrioventricular valve anatomy, a less stiff support and a greater adaptability to the anatomy is provided. The flexures can be adapted to the required spring force.

[0040] Advantageously, each support arm is connected to the body via two connecting arms. While a single arm connection can reduce the amount of material and can be sufficient in terms of structural stability, the provision of two connecting arms increases the contact surface and force distribution of the first support area with, for example, the ventricular part of the annulus. Moreover, such a "two connecting arms" concept can prevent rotation or lateral deflection of the support arms by providing two fixing points or fixation points on the body of the stent device.

[0041] The curvature of the connecting arm may present an angle of more than 90° and / or define a rounded shoulder, said shoulder preferably having a distal or first radius, e.g. at the distal end of the stent body, and a second or proximal radius, e.g. at a proximal portion of the shoulder, which may be proximal to the distal radius and / or spaced radially and / or laterally from the distal radius, the distal radius of the shoulder being larger than the proximal radius of the shoulder. As outlined above, a wider shoulder, together with the angle of curvature, which may be formed, e.g. by a convex portion and optionally an adjacent concave portion, has the advantage that the support arm may better conform to the annular region and ventricular anatomy, and that forces acting on the stent device and the support arm may be better spread, e.g. by providing an improved spring function established by an improved interaction with the second support region. Additionally, the larger radius at the distal end of the rounded shoulder reduces the likelihood of fracture 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 annulus region.

[0042] Furthermore, the particular configuration of the curve or shoulder provides that the likelihood of entanglement with the native chordae tendineae present in the ventricular portion may be increased, such that improved fixation and therefore stability of the stent device may be achieved.

[0043] Thus, instead of extending axially or radially outward from the body, the bend may initially extend radially inward to form an additional rounded or initially concave portion. This has the advantage that an even softer support is provided so that even lower forces can be applied to the corresponding anatomical structure by the first support region. In addition, by avoiding sharp edges, the risk of breaking or cutting the support arm from the body of the stent device is further reduced and tissue damage is essentially prevented.

[0044] As mentioned above, the provision of at least three support arms can improve the stability of fixation compared to, for example, two support arms, so that the stent device can be properly supported during deployment. To further increase the support of the stent device to the opening or annulus and provide further adaptability to the anatomical structure, the stent device can include multiple or multiple two and / or three supports, for example, four, six or eight arms adapted to the tricuspid or mitral valve.

[0045] Alternatively, a non-uniform number of support arms may be provided, preferably 5, 7 or 9 support arms, to ensure improved conformance to the annulus region and / or anatomical structure of the valve assembly inserted within the body of the stent device.

[0046] Preferably, the stent device may include six support arms. Providing six support arms may provide a configuration for a tricuspid valve, which naturally has three cusps or leaflets, for example, with each pair of support arms corresponding to a region of the tricuspid valve with a respective leaflet. Thus, six support arms may increase both the stability and adaptability of the stent device to the tricuspid valve.

[0047] Six support arms may also be suitable for a mitral valve, also known as a bicuspid valve, which naturally has two leaflets. Three support arms may be positioned to correspond to regions of the mitral valve with each leaflet.

[0048] Alternatively, the stent device may also include, for example, four support arms, which are asymmetrically positioned to accommodate the shape of the tricuspid valve. In the same sense, four support arms may also facilitate configuration for mitral valve replacement, with each pair of support arms associated with a corresponding mitral valve region with a respective 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, for example, nine support arms for the tricuspid valve, with four and three support arms associated with each native leaflet, respectively.

[0049] The circumferential spacing between the support arms may be adapted to the tricuspid or mitral valve and / or may be asymmetric or symmetric.

[0050] As discussed above, for example, the three support arms may be positioned to be associated with each native leaflet of the tricuspid valve, e.g., by providing essentially equidistant spacing, but may also be positioned asymmetrically, e.g., in the case of a mitral valve configuration, e.g., with a single support arm associated with a first native leaflet and a pair of support arms associated with a second leaflet. Thus, the positioning may depend, for example, on the annular annulus anatomy and may further depend on the orientation of the valve assembly and / or stent device being used.

[0051] To provide additional structural stability of the stent device, the mesh shape of the body can be diamond-shaped, or drop-shaped, or essentially elliptical. Thus, the cells may also be provided with rounded shapes instead of polygonal or honeycomb shapes, which may facilitate the expansion and collapse of the body of the stent device. Furthermore, a more uniform or balanced distribution of biasing forces in the radially outward direction is enabled when the stent device is deployed. Thus, the stent body may be less susceptible to structural changes due to tensile or compressive forces acting axially on the stent device. The drop-shaped or essentially elliptical shape allows for a more seamless transition between the cells and / or struts, thus avoiding sharp edges.

[0052] To reduce the extension of the body of the stent device into the atrium, a portion of the proximal end of the stent body may extend radially outwardly, preferably at an angle of between 70° and 110° relative to the axis of the body.

[0053] The bulkiness of the proximal end of the body extending into the atrium is reduced. Also, the fluid-tightness and support stability of the stent device is enhanced, for example, by projecting the proximal end of the body to 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 may be deflected at an angle essentially perpendicular to the longitudinal axis of the stent device, such that said proximal end is essentially aligned with the atrial portion of the valve annulus. Furthermore, for example, the insertion of the valve assembly is thus facilitated by providing a chamfer, while a reduced profile is presented and blood flow is not impeded, or at least not significantly impeded.

[0054] Said part of the proximal region of the stent body is further preferably defined by a plurality of second closed loops arranged circumferentially in a staggered manner with respect to the support arms, preferably arranged at the distal end. Thus, for example, an overlap of the closed loops of the support arms with the second closed loops is avoided on the one hand, and on the other hand, the area or size of the atrial part of the annulus supported by the proximal end is increased. The second closed loops can extend radially outward with a part of the proximal end of the body, for example by ¼ to ½ or ⅓ of the length of the final cell or strut line at the proximal end of the body.

[0055] For example, the second closed loops may typically be dimensioned to be smaller than the closed loops of the support arms, so as to fit into the distal ends of two adjacent second support regions of the two support arms, for example between the second support region and the flexible region. According to another example, the second closed loops may be dimensioned so that they are essentially equal to or larger than the closed loops of the support arms. Alternatively, the second closed loops may be disposed between two adjacent second support regions of the two support arms. Such a staggered configuration may further ensure sufficient support for the stent device in the "atrial portion" of the stent device, even if one or more of the radially outwardly extending portions of the support arms do not completely conform to the anatomical structure of, for example, the valve annulus. However, the second closed loops may also be partially circumferentially staggered, non-staggered, or essentially overlapping with respect to the distally disposed support arms.

[0056] By defining the support arm as an extension of the distal end of the body, a high degree of structural and mechanical stability is ensured.

[0057] The radially outwardly extending portion of the proximal end of the body may further comprise at least one eyelet for fixing the stent device to a delivery system. Preferably, said portion comprises at least two eyelets, the two eyelets being optionally arranged at radially opposite ends of the stent body. Each of the eyelets is arranged in a respective second closed loop, preferably in every second or third second closed loop, and / or at the proximal or radially outermost end of the second closed loop. In other words, one or more eyelets may be arranged at the proximal tip of the stent body defined by the radially outwardly extending second loop. To facilitate fixation, each of the eyelets may comprise an essentially circular or rounded shape such that fixation and deployment are facilitated and do not require a specific relative orientation between the eyelet and the delivery system.

[0058] Additionally, the body and support arms may be formed as a single piece and / or as a wire frame, such that not only may the body and support arms of the stent device be formed from the same material, but also without connecting parts such that the stent device is less susceptible to breakage, dislodgement, and / or manufacturing errors.

[0059] With such an embodiment, the stent body, the support arms, the different cells of the mesh, and the different regions of the support arms may be connected with a continuous and seamless transition. Thus, the body arms and the support arms may be formed as an integral part of the stent device, and the stent device is formed as a single piece that may be manufactured by laser cutting techniques, thereby greatly improving the structural integrity of the stent device.

[0060] To further improve the fixation in the native tissue, in particular to improve the retention of the assembly in translation and / or rotation, the stent device may comprise at least one fixation element as disclosed in WO 2017 / 089179. In one embodiment, the fixation element has the form of a "racket" or a "loop" or a "tab". In one embodiment, the fixation element is made of Nitinol. The fixation element has a height of the order of 8-10 mm and a length of 10-12 mm. In one embodiment, one or more of these optional fixation elements are joined to one or more support arms, more particularly to their flexible regions, and are only open 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 arranged symmetrically.

[0061] In order to allow the stent device to conform to the anatomical dimensions of the diseased annular region and to avoid, as much as possible, deleterious engagement with remaining native tissue, the body or the passageway defined by the body preferably has an inner diameter of between 29 mm and 36 mm, preferably about 30 mm or about 35 mm. Such dimensions have the further advantage that deployment in the annular region and any potential further medical applications are facilitated.

[0062] In addition to the body and the support arms, the stent device may comprise a cuff to prevent blood leakage and / or backflow. Thus, 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 by a foil of liquid impermeable or semi-impermeable material to form a cuff between the support arm and the body and / or between the support arms. Alternatively, such a foil may cover at least the first support region of the support arm and / or the distal end of the outer body to form a cuff between the support arm and the body and / or between the support arms.

[0063] Thus, a foil of liquid-impermeable or semi-impermeable material can typically represent a covering material that limits, especially in the case of semi-permeable materials, or at least essentially prevents the passage or backflow of blood through the respective elements of the stent device outside the central (tubular) passage. It therefore seals the zone or contact area between, for example, the annular anatomical structure and the body or inner channel of the stent device. Such a foil or cover can strengthen the seal between the stent device and the surroundings at the deployment site. Also, by suitable foil characteristics, for example a suitable surface roughness, the migration resistance of the deployed device can be increased.

[0064] The foil, for example made of a flexible sheet-like material, may be made of natural or synthetic materials. For example, the material may comprise natural tissues such as bovine, porcine, ovine or equine pericardium, the tissues being preferably chemically treated using glutaraldehyde or formaldehyde or triglycidylamine (TGA) solutions or other tissue cross-linking agents. Alternatively, the foil may comprise at least synthetic materials such as fluoropolymers, for example polymers of polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE), polyesters such as PET (polyethylene terephthalate), silicones, urethanes, other biocompatible polymers, Dacron®, copolymers, or combinations and partial combinations thereof. According to a preferred embodiment, the impermeable or semi-impermeable material is a low-porosity fabric such as polyester, Dacron® fabric, or PTFE.

[0065] Additionally, the foil material may be modified by one or more chemical or physical processes that enhance certain physical properties of the foil material. For example, a hydrophilic coating may be applied to the foil material to improve the wettability and echolucency of the foil material. Alternatively or additionally, the foil material may be modified with chemical moieties that promote or inhibit one or more of endothelial cell attachment, endothelial cell migration, endothelial cell proliferation, and resistance to thrombosis. The foil material may also be modified by covalently bound heparin or impregnated with one or more active pharmaceutical ingredients that are released in situ, e.g., by a controlled release mode, e.g., a controlled release formulation is coated on one or both sides of the foil.

[0066] The cuff established by the foil has the advantage that periprosthetic leakage in the contact area between the stent device and the native tissue (e.g., the annulus) may be reduced or prevented. Preferably, the foil is arranged to cover the "atrial portion" or the annulus level on the proximal end of the stent device and the proximal end of the body, typically also covering the second support area. The foil may be fixed to the stent device, for example, by sewing, gluing or thermoforming.

[0067] The body of the stent device further preferably comprises at least two or at least three fixing means or windows or sites for receiving and fixing the valve assembly in the tubular passage of the stent body. Such windows or sites may be formed, for example, by corresponding struts between the cells or supporting cells of the mesh-shaped body, such that the stent device does not require additional components. Said windows or sites are integrally formed with the body of the stent device. Alternatively, such windows may also be formed by corresponding portions of the cells.

[0068] The fenestrations are preferably circumferentially spaced with intervals separating each of them that correspond to the valve assembly, i.e., the anticipated leaflet arrangement of a particular valve, e.g., the tricuspid or mitral valve.

[0069] Said fixation means or fenestrations may thus indicate the intended area of ​​the valve assembly so as to aid the surgeon in positioning the valve assembly. The fixation means or fenestrations may provide a matching geometry with the valve assembly, for example in the case of a synthetic valve assembly, to provide a positive lock, or may allow fixation of a bioprosthesis, for example a cusp or leaflet, for example by suturing or sutures.

[0070] Alternatively, the cells of the mesh-shaped body may be configured to receive and secure the valve assembly such that the valve assembly may be directly attached or secured to one or more cells of the mesh-shaped body. This has the advantage that greater flexibility is provided for the attachment and securing of the valve assembly, and the body is adapted to a greater variety of valve assemblies without the need to adapt the configuration of the stent body. Furthermore, such a configuration can reduce the complexity and increase the stability of the stent body and the stent device. Thus, the securing of the valve assembly as well as the manufacturing and deployment of the stent device can be facilitated.

[0071] According to another aspect, a prosthetic heart valve is disclosed that includes the stent device described above, and further includes a valve assembly disposed within the inner channel and / or at the proximal or distal end of the body and secured to the stent body by a securing means or fenestration. For example, the prosthetic heart valve may be configured to replace a tricuspid or mitral valve, e.g., by the configuration of the corresponding valve assembly, stent body, and / or support arms, as described above.

[0072] For example, the artificial heart valve may be configured as a tricuspid valve prosthesis, where the valve assembly is composed of three cusps or leaflets. For example, the tricuspid valve prosthesis may include a bioprosthesis, where the three cusps are preferably made from animal tissue, e.g., bovine or porcine pericardium, pretreated, e.g., with glutaraldehyde or formaldehyde or triglycidylamine (TGA) solution or other tissue crosslinking agents. The three cusps or leaflets forming the valve assembly are configured to join with each other and are connected, e.g., by common suturing techniques, to the body in the inner channel or to the proximal or distal end of the stent body. The bioprosthesis functions in the physiological direction of blood flow, which reaches the right atrium and is injected into the filling chamber of the right ventricle during systole.

[0073] The artificial heart valve may also be configured as a mitral valve prosthesis, where the valve assembly is made up of two cusps or leaflets.

[0074] Additionally, the cusps or leaflets of the valve assembly may also be made of synthetic fabric and fixation may also be provided by, for example, welding, adhesives, fixed links or springs, and / or flexible or partially rotatable contact points. Examples of synthetic leaflets are provided in U.S. Patent No. 9,301,837.

[0075] According to another aspect, there is proposed a delivery system comprising a stent device as described above in a collapsed state.

[0076] For example, the delivery system may be configured as a catheter or sheath that allows for percutaneous delivery and deployment to the atrioventricular region. The delivery system may define a lumen for receiving the stent device and may include a control string that is slidably engaged with the stent device such that tension in the control string may contract the stent device and slack in the control string may expand the stent device. Thus, the stent device is reconfigurable between a low profile delivery configuration or collapsed state for containment within the lumen and an expanded or deployed configuration.

[0077] The present invention further relates to a kit of parts comprising a delivery system (eg, a catheter or sheath) allowing percutaneous delivery and deployment in the atrioventricular region, and the stent device described above.

[0078] The present invention further relates to a catheter or sheath comprising the above-described folded stent device.

[0079] According to another aspect, a method for replacing a tricuspid or mitral valve is disclosed, the method comprising: Providing the stent device as described above in a collapsed state within a delivery system, preferably a catheter or sheath; introducing a stent device percutaneously through said delivery system into the tricuspid or mitral valve region of the patient such that a distal end of the stent body is in the ventricular portion, a proximal end of the stent body is in the atrial portion, and the body and support arms span the valve annulus; deploying the stent device by expanding the stent device such that the flexible region conforms to the valve annulus and the proximal end of the outer support arm or the second support region conforms to the atrial side; Equipped with.

[0080] To provide a valve function, the method may further comprise securing a valve assembly to the inner channel and / or the proximal or distal end of the stent body, said securing preferably being performed prior to crimping of the stent device or after deployment and expansion of the stent device in the atrioventricular valve region using a delivery system.

[0081] According to another aspect, a method of manufacturing the above-described stent device is disclosed, the method comprising: laser cutting the body and support arms from a shape memory metal material; thermoforming the body and the support arms to provide a predetermined shape of the body and the support arms; and, optionally, folding the body and the support arm; Equipped with.

[0082] The shape memory metal material may be, for example, braided Nitinol. Additionally, folding of the body and support arms, or the entire stent device, is optional and may be required, for example, for shipping purposes, or for assembly or packaging into a delivery system, such as a catheter or sheath.

[0083] Preferably, the stent device is made from a single piece. For example, laser cutting may be performed on a single piece of braided Nitinol such that the support arms are formed as an extension of the distal end of the body, thus providing a high degree of structural and mechanical stability. In other words, the body and support arms of the stent device may be formed not only from a single material, but also without connecting parts as a single piece, such that the stent device is less susceptible to breakage, dislodgment, and / or manufacturing errors, thus, for example, significantly improving the structural integrity of the stent device.

[0084] The design of the present invention makes it possible to overcome any limitations of adaptability at the opposing ends of the fixation elements in the longitudinal direction of the assembly. Thus, the present design does not restrict any adjustment of the positioning during deployment of the assembly (as observed by the prior art) that may result from the opposing ends of the fixation elements being able to engage anatomical structures, thereby potentially preventing further adjustment. Thus, the design of the present invention shows superior properties that have not yet been addressed by the assemblies of the prior art.

[0085] The present disclosure will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings. [Brief description of the drawings]

[0086] [Figure 1] FIG. 1 shows a prior art embodiment of a prosthetic heart valve in the ventricular portion of the tricuspid valve. [Diagram 2]FIG. 1 illustrates a stent device according to the present invention deployed around the tricuspid valve anatomy. [Figure 3A] FIG. 2 is a schematic diagram of a stent device according to the present invention after laser cutting and before heat forming. [Figure 3B] FIG. 2 is a schematic diagram of a stent device according to the present invention after laser cutting and before heat forming. [Figure 3C] FIG. 2 is a schematic diagram of a stent device according to the present invention after laser cutting and before heat forming. [Figure 3D] FIG. 2 is a schematic diagram of a stent device according to the present invention after laser cutting and before heat forming. [Figure 4A] FIG. 1 is a perspective view of a stent device according to the present invention in an expanded state. [Figure 4B] FIG. 1 is a perspective view of a stent device according to the present invention in an expanded state. [Diagram 5] FIG. 2 is a schematic perspective view of a stent device according to the present invention having an alternative proximal end of the body. [Figure 6] FIG. 6 is a schematic side view of the stent device according to FIG. [Figure 7] 2 is a schematic diagram of a stent device according to the present invention having an alternative proximal end of the body with a second closed loop. [Figure 8] FIG. 8 is a schematic diagram of the staggered formation of the proximal end of the stent device according to FIG. 7. [Figure 9A] 8A-8C show different views of the staggered formation according to FIG. 7, with an alternative second closed loop. [Figure 9B] 8A-8C show different views of the staggered formation according to FIG. 7, with an alternative second closed loop. [Figure 9C] 8A-8C show different views of the staggered formation according to FIG. 7, with an alternative second closed loop. [Figure 10] FIG. 2 is a schematic diagram of a stent device according to the present invention after laser cutting and with eyelets, but before heat forming. [Figure 11A] 11A-11C show different views of a stent device according to the present invention having alternative support arm configurations. [Figure 11B]11A-11C show different views of a stent device according to the present invention having alternative support arm configurations. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0087] The present invention will now be described in more detail with reference to the accompanying drawings, in which like reference numerals are used to designate corresponding elements in the drawings, and duplicated descriptions may be omitted to avoid redundancy.

[0088] FIG. 1 illustrates a prior art embodiment of a prosthetic heart valve disposed within a tricuspid valve. Thus, the prosthetic heart valve is disposed within the tricuspid valve by a delivery system 42, e.g., a catheter or sheath. The prosthetic heart valve is disposed such that the body 12 or framework of the prosthetic heart valve is oriented longitudinally from the proximal end 16 to the distal end 17 of the tricuspid valve. Thus, upon deployment or expansion of the prosthetic heart valve, the support arms 18 of the prosthetic heart valve grip the leaflets 27 of the tricuspid valve, thereby forming ventricular stabilizers. Thus, the support arms 18 are disposed on the ventricular side 28 of the tricuspid valve and are configured to provide stabilization of the leaflets 27. After deployment of the prosthetic heart valve, the body 12 or framework of the prosthetic heart valve extends toward the proximal end 16, and the body 12 is formed as a flexible mesh body to conform to the anatomical structure of the valve leaflets 27 and exert a radially outward force toward the leaflets 27, such that the prosthetic heart valve is retained by the leaflets 27 and neither the support arms 18 nor the body 12 actually contact the ventricular portion 28 or atrial portion 30 of the valve annulus.

[0089] An embodiment of a stent device 10 according to the present invention is shown in graphical representation in Figure 2, where the stent device 10 is deployed around a tricuspid valve anatomy corresponding to the anatomy according to Figure 1. The stent device 10 is shown in an expanded or deployed state, where the longitudinal axis of the stent device 10 and body 12 is oriented along an axis defined by the proximal and distal ends 16, 17 of the tricuspid valve. The body 12 is comprised of a mesh-like wiring made of Nitinol and is formed as an essentially tubular body 12 having a cylindrical or circular shape.

[0090] A plurality of support arms 18 extend from the distal end 17 of the body 12. Although the cross-sectional view shows only two support arms 18, three or more, preferably six, nine, or twelve support arms 18 can be realized or formed adjacent to one another, for example at equidistant intervals, around the circumference of the distal end 17 of the body 12. 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 passage for blood flow from the proximal end 16 to the distal end 17 of the heart, i.e., from the right atrium to the right ventricle, during systole of the heart.

[0091] The support arms 18 further comprise an S-shape or an inverted S-shape in a longitudinal cross-section of the stent device 10, and thus extend radially outward and inward along the longitudinal axis such that the support arms 18 define a first support region at the distal end 17 and a second support region at the proximal end 16, the second support region extending radially outward at the proximal end 16 due to flexure provided by a flexible region disposed between the first and second support regions.

[0092] As a result, the shape of the support arms 18, and in particular the support regions, allow the support arms 18 to conform to the ventricular and atrial portions 28, 30 of the valve annulus 26. Additionally, the flexible regions are adapted to conform to the tricuspid valve annulus 26. The support arms 18 thereby ensure that the stent device 10 is supported on both sides of the tricuspid valve and fitted to the tricuspid valve annulus 26, thereby urging the stent device 10 into the tricuspid valve region, and in particular into the annulus 26.

[0093] The configuration of the support arms 18 thus allows the stent device 10 to be preferably secured to the valve annulus 26 without the need for invasive techniques such as sewing or suturing, and without the need for any clamping or gripping forces, or the exertion of radially outward forces that would potentially disrupt remaining anatomical landmarks and tissue. Instead, such a configuration allows the function of the body 12 of the stent device 10 to be decoupled from that of the support arms, such that the body 12 can be rigid, thus providing a stable support structure or framework for, for example, a valve assembly.

[0094] 3A is a schematic illustration of a stent device, such as that shown in the embodiment according to FIG. 2, 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 shown formed as a mesh shape. The mesh is shown to comprise two connected cells 14 arranged adjacently along the longitudinal axis of the stent device. Thus, the body 12 comprises a plurality of cells 14, which can be formed by thermoforming into a tubular or elliptical structure, for example, to form a cylindrical shape defining an inner channel configured as a passage for blood flow.

[0095] Furthermore, the body 12 comprises three fastening means or windows 40 located at the distal end 17 of the body 12, said windows 40 being formed by three corresponding longitudinally extending struts 13. As a result, when the body 12 is formed into its predetermined shape, the windows 40 are circumferentially spaced substantially equally apart from one another. The windows 40 can be used to mount valve assemblies, such as synthetic or treated natural cusps or leaflets, for example, to provide the required valve function adapted to the patient.

[0096] Although the fenestrations 40 are shown at the distal end 17 of the body 12, said fenestrations 40 may also be provided at corresponding struts 13 at the proximal end 16, and the spacing between said fenestrations 40 may vary. In the same sense, the stent device preferably comprises at least three fenestrations 40 for at least three cusp fixation, for example for a tricuspid valve, but may comprise more than three fenestrations 40 to provide the physician or surgeon with more fixation possibilities.

[0097] According to the embodiment of FIG. 3A, the stent device further comprises six support arms 18 extending from the distal end 17 of the body 12. After being thermoformed into a predetermined shape, said support arms 18 extend on the outer surface of the body 12 towards the proximal end 16, defining two support and flexible regions as described above with reference to FIG. 2. The support arms 18 are further provided as closed loops, each of which is connected to the body 12 via two connecting arms, such that the structural and mechanical stability of the support arms 18 is increased. Furthermore, the support arms 18 are essentially petal shaped and have rounded proximal ends after thermoforming. Thereby, the support arms 18 provide an improved support function due to an increased contact area, while the rounded proximal ends ensure that sharp edges and potential tissue damage are avoided, reducing the risk of proximal end breakage.

[0098] 3B-3D show an alternative embodiment, where the proximal end 16 includes a second closed loop 38 that is staggered relative to the support arm 18. The proximal end 16 of the second closed loop may include reinforcements formed by thicker regions to increase the connection strength between the legs of the second closed loop 38, as shown on the left side of FIGS. 3B and 3D. The second closed loop 38 may be heat formed, for example, into a flared shape, such that the second closed loop 38 extends radially outward, as described in more detail below with reference to FIGS. 5-9.

[0099] Prior to thermoforming, the stent device has an essentially longitudinally extending flat shape, as shown in Figure 3C. The stent device may be coiled along the longitudinal axis to form an essentially cylindrical body 12 having a second closed loop 38 extending from a proximal end and a support arm 18 extending from a distal end, as shown in Figure 3D. The body 12 of the stent device is thereby given additional structural stability and can be readily brought to its final shape by thermoforming the support arms 18 and second closed loop 38.

[0100] The embodiment according to Fig. 4A essentially corresponds to the embodiment according to Fig. 2 and Fig. 3 and shows the stent device 10 in an expanded state after thermoforming. The stent device 10 thus also comprises a total of six support arms 18 formed as a closed loop extending from the distal end 17 of the body 12 via two connecting arms 36. As explained with reference to Fig. 2, the support arms 18 comprise a longitudinal cross-sectional profile that essentially comprises an inverted S-shape or S-shape, 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. Said flexible region 24 is formed as a tapered portion, for example formed by a constriction along the longitudinal axis of the stent device 10, so as to allow deflection of the second support region 22.

[0101] The first support region 20 of each support arm 18 is formed as a convex portion 32 that at least partially defines a curve that forms each connecting arm 36. The curve ensures that extension into the ventricular portion of the valve may be reduced so that blood flow is not impeded and the stent device 10 does not contact areas of the myocardium in which it is implanted that should not be contacted by the stent device 10. The flexible region 24 is configured as a concave portion 34 that is disposed about the inflection point of the convex portion 32 and extends into the radially outwardly extending second support region 22.

[0102] The convex portion 32, the concave portion 34, and the radially outwardly extending second support region 22 are thereby adapted to support the ventricular, annular, and atrial portions of the tricuspid valve, respectively, such that each region provides an essentially matching geometry. Thus, the stent device 10 can be biased into the tricuspid valve annulus without invasively engaging or compressing the respective anatomical structures. Thus, disruption of the remaining anatomical structures can be effectively avoided.

[0103] Further, the inner channel 15 shown in the embodiment according to Fig. 4A is defined by the mesh-shaped body 12 of the stent device 10. Thus, both the body 12 and the inner channel 15 comprise essentially tubular and cylindrical shapes, and the stiffness as well as the size and dimensions of the body 12 ensure that a maximum inner channel volume is provided to maximize blood flow from the proximal end 16 to the distal end 17. The mesh body 12 is further comprised of a plurality of cells 14 and corresponding struts 13, the cells 14 comprising a drop shape with no sharp edges between adjacent cells 14 to further improve the structural integrity of the body 12.

[0104] When the stent device is in its deployed state, a gap may be formed between the outer surface of the body 12 and the support arms 18, as shown in the top view of FIG. 4B at the proximal end 16. Thus, the body 12 is preferably held only on one side by the support arms 18, which do not exert a radially outward force on the annular anatomy and can conform to both the ventricular and atrial portions to bias the stent device within the annulus. The gap ensures maximum flexibility and adaptability for the support arms 18 while at the same time ensuring that the anatomic shape is not degraded or compromised by the body 12 of the stent device.

[0105] An alternative configuration of the proximal end 16 of the body 12 is shown in the schematic perspective view of an embodiment of Figure 5, in which the stent device 10 comprises a body 12 having an alternative proximal end portion 38 of the body 12 that extends in a radially outward direction, i.e., forms a flared surface. Thus, the support arms 18 extending from the distal end 17 of the body 12 towards the proximal end 16 of the body 12 may be adjacent to or in contact with the proximal end portion 38 of the body 12.

[0106] For example, the support arms 18, which include a second support region 22 at the proximal end 16 in addition to a first support region 20 and adjacent flexible region 24 at the distal end 17, can be flexed radially outward at the second support region 22 to contact a radially outwardly extending proximal end portion 38. The proximal end portion 38 can thereby not only improve sealing of the stent device 10, but also simultaneously facilitate blood flow and / or insertion of the body 12 into an inner channel, for example, by selecting an angle relative to the longitudinal axis of the stent device 12 to define a chamfer. Additionally, such an arrangement can further increase support of the stent device 10 by additional surfaces that can be aligned with the annulus or corresponding atrial portion of the valve to provide additional support if the second support region 22 does not have the desired effect.

[0107] The embodiment according to Fig. 5 is further diagrammatically shown in a side view according to Fig. 6. Here, the radially outwardly extending proximal end region of the body 12 is slightly inclined towards the outer surface of the body 12 and the support arms 18, for example at an angle of 70°-90°. Such an angle can be selected, for example, to accommodate the atrial portion of the valve annulus and further ensure optimal sealing towards the proximal ends 16 of the support arms 18. It is understood that other angles are possible and that the shape of the proximal end portion 38 is not limited to the shapes shown in Figs. 5 and 7, but may, for example, comprise a shape corresponding to the mesh shape of the body 12.

[0108] As a result, in an exemplary embodiment, the stent device may comprise a body proximal end portion 38 comprising a plurality of second closed loops, as shown diagrammatically in Fig. 7. The second closed loops are thus formed as an extension from the proximal end of the body, i.e., from the mesh shape of the body, such that the second closed loops are connected to two adjacent cells 14 at the proximal end of the body. As indicated by the dashed lines, the radially outwardly extending proximal end portion 38, i.e., the proximal end portion extending in a direction essentially perpendicular to the longitudinal axis of the stent device, includes a portion of the last row of struts 13 of each of the last cells 14 at the proximal end of the body.

[0109] For example, the radially outwardly extending portion may comprise ¼ to ½ of the last row of struts 13. In the embodiment according to Figure 7, said portion comprises approximately ⅓ of the length of the last or final row of struts 13 in the longitudinal direction of the stent device. Thus, depending on the anatomy corresponding to the patient's pathophysiological condition, the second closed loop and proximal end portion 38 may be sized equal to or smaller than the second support area of ​​each support arm.

[0110] The proximal end portions 38 may further be arranged in a staggered configuration as seen from the proximal ends of the second support regions 22 of the plurality of support arms, as shown diagrammatically in the embodiment according to FIG. 8. As a result, the proximal end portions 38 may comprise a plurality of second closed loops extending from the proximal end of the body, as described, for example, with reference to FIG. 7, which are deflected radially outward and are disposed between the second support regions 22 of each pair of adjacent support arms. As a result, the stent device may comprise a total of six support arms with corresponding second support regions 22 and a total of six second closed loops defined by the proximal end portions 38 that are staggered in the circumferential direction along the circumference of the body 12 of the stent device. The inner channel 15 is also shown and is therefore unobstructed by the second support regions 22 and the proximal end portions 38. The tips of the support regions 22 may be in the form of a triangle forming an acute angle at the end region, although a rounded tip (not shown in FIG. 8) may be more preferred.

[0111] Alternatively, the proximal end portion 38 may be provided in an alternative staggered configuration, for example, where the number of second closed loops and the number of support arms do not match. For example, the proximal end portion 38 may include only three second closed loops, such that a second closed loop is disposed only between every second pair of adjacent second support regions 22. Similarly, the proximal end portion 38 may include more second closed loops of smaller dimensions than the second support regions 22 of the support arms, such that, for example, two second closed loops are disposed between each pair of adjacent second support regions 22. It will be apparent to one of ordinary skill in the art that the above numbers of second closed loops and second support regions 22 are for illustrative purposes only and are not limiting of the embodiments. In other words, other arrangements having a greater number of support arms or having between three and six support arms are possible and within the scope of the embodiments.

[0112] In the embodiment shown in Figures 9A to 9C, an alternative staggered formation of the second closed loop 38 and the support arm 18 is shown, with the second closed loop 38 being dimensioned such that they are similar to the closed loop of the support arm 18. As a result, for example, as shown in Figure 9A in a schematic top view (left) and a perspective top view (right), the second closed loop 38 can extend radially outward and have a cross-sectional area similar to that of the support arm 18. This is true for the second support region 22 of the support arm 18 which may also extend radially outward, as shown in Figures 9B and 9C, which respectively represent a side view and a perspective view of the embodiment.

[0113] 9B and 9C further show a gap that may occur between the support arm 18 and the body 12 of the stent device, similar to the embodiment according to FIG. 4B. This ensures a tolerance between the support arm 18 and the body 12. Thus, the elasticity of the support arm 18 is increased. In other words, as shown for example in FIG. 9B, the gap between the S-shape of the support arm 18, i.e., the convex and concave regions in the longitudinal cross section, and the body 12 of the stent device may be at least partially or partially changed to accommodate the stent device within the valve annulus, thereby adapting the stent device to its anatomical structure.

[0114] Additionally, the flared second closed loop 38 ensures that direct contact between the body 12 and anatomical structures may be avoided, such that the body 12 does not exert a radially outwardly directed force on the annulus. Potentially harmful forces on the remaining anatomical landscape are reduced or avoided. However, the flared arrangement ensures that fluid flow from the proximal end to the distal end is not significantly compromised. Additionally, the proximal end 16 and distal end 17 are inverted, as shown in FIG. 9C.

[0115] The flare of such second closed loop may, for example, facilitate insertion of the valve assembly into body 12 by forming a chamfered surface.

[0116] In FIG. 10, a schematic diagram of a stent device 10 according to the present invention after laser cutting and before thermoforming is shown as an alternative to the embodiment shown in FIG. 3B. In this embodiment, an eyelet 44 is provided at the proximal end 16 or proximal tip of the second loop 38 of the stent body 12, which allows the stent device 10 to be fixed to a delivery system for insertion into an anatomical target area. Thus, said eyelet 44 may also be used after insertion for release and final deployment of the stent device 10. In this embodiment, a total of two eyelets 44 are provided, which are arranged on the closed loop 38 so as to be on both radial sides of the stent device 10 in the assembled state. However, the arrangement and number of eyelets 44 may be selected as desired. Furthermore, the eyelets 44 have a circular or rounded shape to facilitate fixation to and release from the delivery system. Alternatively, the eyelets may also have other shapes, preferably symmetrical designs such as polygonal or elliptical.

[0117] 11A and 11B show schematic top and perspective side views, respectively, of a stent device 10 having an alternative support arm configuration.

[0118] In this configuration, as best shown by direct comparison with the embodiment according to Fig. 9A, no flexible region with a taper is provided "between" the constriction being indicated diagrammatically by a sharp V-shaped notch. Instead, according to the embodiment of Fig. 11A, each support arm 18 is provided with a taper that extends gradually from the essentially recessed portion 34 towards the second support region 22, i.e. towards the proximal tip of the support arm 18. The taper is provided as an essentially triangular or conical or elliptical shape, with a rounded portion at the proximal tip of the second support region 22, e.g. at the end portion or loop portion, in order to reduce the risk of tissue damage.

[0119] At the same time, a spring function is maintained between the second support region 22 and the first support region 20, which is improved by the convex portion 32 that defines a shoulder or curvature of the first support region 20 with an adjacent concave portion 34 and that is connected to the distal end of the stent body 12, as shown in the perspective side view of FIG. 11B. The shoulder has a radius 46 at its distal end that is greater than a radius 48 at its proximal end. Thus, a wider angle is provided at the distal end of the stent body 12, which, together with the radial extension of the convex portion 32, ensures that the likelihood of breakage occurring between the support arms and the stent body 12 is reduced and that forces acting on the stent device 10 and the support arms 18 can be better distributed.

[0120] The smaller radius 48 at the proximal end of the shoulder, together with the adjacent recessed portion 34, further ensures that improved adaptation to the annular region and ventricular anatomy is provided. Furthermore, the radial extension of the radially outermost point of the convex portion 32 is - in the radial direction - between the radially innermost point of the recessed portion 34 and the proximal tip of the second support region 22, which has the greatest radial extension of all portions of each support arm 18. Thereby, the contact surface is increased at the atrial portion, providing improved fit or conformity to the anatomical annular region, providing wider support without adversely affecting the remaining native structure of the annular region.

[0121] In other words, the wider extension of the support region of each support arm provides a larger engagement or interaction surface, while the particular configuration of the convex and concave portions 32, 34 as well as the radial extension of the second support region 22 ensures that an improved spring function is established with improved absorption and distribution of forces acting on the stent device.

[0122] This embodiment also shows a mesh shape of the body, here formed by a lattice of a plurality of diamond-shaped cells directly connected to each other and essentially equal in size and / or shape. As outlined above, the diamond shape has the advantage of providing substantially equal stress and strain resistance in the axial and circumferential directions, which can reduce the amount of deformation and strain applied during manufacturing and increase the stability of the body. Furthermore, the required flexibility can be maintained, for example by varying the thickness towards the proximal and / or distal ends.

[0123] It will be apparent to those skilled in the art that these embodiments and items are merely examples of multiple possibilities. Therefore, the embodiments shown herein should not be understood to form limitations on these features and configurations. Any possible combinations and configurations of the described features can be selected according to the scope of the present invention. [Explanation of symbols]

[0124] 10 Stent Devices 12 Main unit 13 Posts 14 Cells 15 Inner Channel 16 Proximal end 17 Distal end 18 Support Arm 20 First Support Region 22 Second Support Area 24 Flexible area 26 Valve Annulus 27 Natural cusp or leaflet 28 Ventricular part 30 Atrial part 32 Convex part 34 Concave part 36 Connecting Arm 38 Proximal end portion or second closed loop 40 Fixtures or windows 42 Delivery Systems 44 Eyelet 46 Distal Radius 48 Proximal Radius

Claims

1. A stent device (10) for a prosthetic heart valve, comprising: an axially extending mesh-shaped body (12) configured to fit into the orifice and defining an inner channel (15) for providing a passageway from a proximal end (16) to a distal end (17) of said body (12); at least three outer support arms (18) extending from the body (12) from a distal end (17) toward a proximal end (16) of the body (12), each support arm (18) having a first support region (20) at the distal end (17) and a second support region (22) at the proximal end (16), the second support region (22) extending radially outwardly from the outer support arms (18) in a deployed state; Equipped with Each support arm (18) comprises a flexible region (24) between the first support region (20) and the second support region (22) formed as a tapered portion of the support arm (18) in the axial direction; and / or A stent device (10), wherein each support arm (18) tapers towards a proximal end (16).

2. 2. The stent device of claim 1, wherein the body (12) is configured to conform to an annulus (26) of a heart valve, the flexible region (24) is configured to conform to the annulus (26), the first support region (20) is configured to conform to a ventricular portion (28) of the annulus (26), and / or the second support region (22) is configured to conform to an atrial portion (30) of the annulus (26).

3. The stent device (10) of claim 1 or 2, wherein the body (12) comprises an essentially tubular or cylindrical shape.

4. The stent device (10) of any one of claims 1 to 3, wherein each support arm (18) is formed as a closed loop.

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

6. 6. The stent device (10) of claim 4 or 5, wherein the closed loop defines a profile in a longitudinal cross-section of the support arm (18) having a convex portion (32) and a concave portion (34), the convex portion (32) defining the first support region (20) and the concave portion (34) preferably adjacent the convex portion (32).

7. 7. The stent device (10) of claim 6, wherein each support arm (18) comprises a flexible region (24) between the first support region (20) and the second support region (22), the recessed portion (34) defining the flexible region (34).

8. A stent device (10) as described in claim 6 or 7, wherein the radial extension of the radially outermost point of the convex portion (32) is greater than the radially innermost point of the concave portion (34) and / or the radially outermost point of the convex portion (32) is between the radially innermost point of the concave portion (34) and the proximal tip of the second support region (22).

9. The stent device (10) according to any one of claims 6 to 8, wherein the profile is formed axially and / or radially as an inverted S-shape, a sine wave, an N-shape or an M-shape.

10. The stent device (10) of any one of claims 1 to 9, wherein each support arm (18) is connected to the body (12) via at least one connecting arm (36) formed by a curved portion of the first support region (20).

11. The stent device (10) of claim 10, wherein each support arm (18) is connected to the body (10) via two connecting arms (36).

12. 12. The stent device (10) of claim 10 or 11, wherein the curved portion has an angle of greater than 90° and / or defines a rounded shoulder, the shoulder preferably having a distal radius (46) and a proximal radius, the distal radius (46) being greater than the proximal radius (48).

13. The stent device (10) of any one of claims 1 to 12, comprising an odd number of support arms (18), preferably 5, 7 or 9 support arms (18), or a multiple / multiple of two or multiple of three support arms (18), said support arms (18) adapted for a tricuspid or mitral valve.

14. 14. The stent device (10) of claim 13, comprising six support arms (18), the support arms configured for a tricuspid valve.

15. The stent device (10) of any one of claims 1 to 14, wherein the circumferential spacing between the support arms (18) is asymmetric or symmetric and / or adapted for the tricuspid or mitral valve.

16. The stent device (10) according to any one of claims 1 to 15, wherein the mesh shape of the body (12) comprises a drop shape, a diamond shape, or an essentially elliptical shape.

17. The stent device (10) according to any one of claims 1 to 16, wherein the mesh shape of the body (12) is formed by a lattice of a plurality of diamond-shaped cells (14) connected to each other directly or via struts (13), said cells (14) being preferably essentially equal in size and / or shape.

18. The stent device (10) of any one of claims 1 to 17, wherein a portion (38) of the proximal end (16) of the body (12) extends radially outwardly.

19. The stent device (10) of claim 18, wherein a portion (38) of the proximal end (16) of the body (12) extends at an angle between 70° and 110° relative to the axis of the body (12).

20. The stent device (10) of claim 18 or 19, wherein the portion (38) is defined by a plurality of second closed loops, the closed loops being circumferentially staggered with respect to the support arm (18), preferably located at the distal end (17).

21. The stent device (10) of claim 20, wherein the portion (38) comprises at least one eyelet (44), preferably at least two eyelets (44), for securing the stent device (10) to a delivery system, each of the at least one eyelet (44) being disposed in a respective second closed loop, preferably in every second or third second closed loop, and / or at a proximal end (16) or radially outermost end of the second closed loop.

22. The stent device (10) of any one of claims 1 to 21, wherein the body (12) and the plurality of support arms (18) are formed as a single piece and / or as a wire frame.

23. The stent device (10) according to any one of the preceding claims, wherein the body (12) or the passageway defined by the body (12) has an inner diameter of between 29mm and 36mm, preferably about 30mm or about 35mm.

24. The stent device (10) of any one of claims 1 to 23, 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 to form a cuff between the support arm (18) and the body (12) and / or between the support arms (18).

25. The stent device (10) according to any one of claims 1 to 24, wherein the body (12) comprises at least two or at least three fixing means or windows (40) for receiving a valve assembly, or the cells of the mesh-shaped body (12) are configured to receive and fix the valve assembly.

26. 26. A prosthetic heart valve comprising a stent device (10) according to any one of claims 1 to 25, and a valve assembly disposed within the inner channel (15) and / or at the proximal end (16) or the distal end (17) of the body (12) and fixed to the body (12) by a fixing means or window (40) or by direct fixation to one or more cells of the mesh-shaped body (12).

27. 27. The prosthetic heart valve of claim 26 configured to replace a tricuspid or mitral valve.

28. A delivery system comprising a stent device according to any one of claims 1 to 25 in a folded state.

29. 1. A method for replacing a tricuspid or mitral valve, comprising: Providing a stent device according to any one of claims 1 to 25 in a folded state in a delivery system; introducing a stent device percutaneously into the patient's tricuspid or mitral valve region via said delivery system such that a distal end of the body is in the ventricular portion, a proximal end of the body is in the atrial portion, and the body and support arms span the valve annulus; deploying the stent device by expanding the stent device such that the flexible region conforms to the valve annulus and the second support region of the outer support arm conforms to the atrial side; A method for providing the above.

30. A method of manufacturing a stent device according to any one of claims 1 to 25, comprising the steps of: laser cutting the body and support arms from a shape memory metal material; thermoforming the body and the support arm to provide a predetermined shape for the body and the support arm; folding the body and the support arm; A method for providing the above.

31. 31. The method of claim 30, wherein the stent device is fabricated from a single piece.

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