Scaffolds and replacement heart valve prostheses with single cell design

Abstract

The present invention relates to a new stent and to a replacement heart valve prosthesis.

Description

Technical Field

[0001] This invention relates to a novel stent and a replacement heart valve prosthesis. Background Technology

[0002] Over the past few decades, minimally invasive techniques and catheter-based implantation techniques have made progress and are now feasible in many medical fields.

[0003] In several medical fields, catheter-based technologies can now be used to treat patients who would otherwise not receive adequate care due to their physical condition or the risks associated with surgery. These catheter-based technologies are used in delivery systems, such as catheters and / or implantation sheaths, to implant medical devices at desired target sites via various pathways into the patient's body.

[0004] In particular, the treatment of valvular heart disease and insufficiency has become increasingly successful in recent years. Examples include transapical, transjugular, and transfemoral procedures for heart valve replacement therapy (such as aortic or mitral valve replacement).

[0005] In many cases, stent-based prostheses based on tissue replacement valves are used and implanted using a catheter delivery system to replace the native heart valve.

[0006] Heart valve replacement prostheses must be gripped and loaded onto a catheter. Proper positioning, durability, and good biocompatibility with the target site and its biological characteristics are important aspects of these prostheses.

[0007] Therefore, there is a need for a replacement heart valve prosthesis that can be accurately positioned, exhibits good durability, minimizes impact or interference with the target site, and maintains accurate positioning over a long period. Furthermore, the replacement heart valve prosthesis should exhibit good sealing properties to avoid, for example, paravalvular leakage.

[0008] Especially in soft endogenous tissues such as the mitral or tricuspid valve, and particularly in the case of the tricuspid valve (which presents various challenges to the design of replacement heart valves due to its soft tissue and the pressure requirements on the prosthesis), it is difficult to properly position the replacement heart valve prosthesis and provide sufficient fixation properties while avoiding unnecessary interference with the endogenous valve environment.

[0009] More specifically, the persistent positioning of replacement heart valves (e.g., in tricuspid or mitral valve replacement techniques, especially in the case of tricuspid valves) is a problem where the valve diameter is large and the valve annulus and the surrounding atrial and ventricular tissues are either sensitive or anatomically challenging for precise positioning and fixation.

[0010] Therefore, one object of this disclosure is to provide a replacement heart valve prosthesis, particularly a tricuspid valve replacement heart valve prosthesis, which has sufficient positioning and fixation features and / or exhibits reduced interference characteristics at the target site, or at least provides a prosthesis in which the disadvantages of the prior art are substantially avoided or exhibited reduced disadvantages relative to the prior art.

[0011] Therefore, another object of this disclosure is to provide a replacement heart valve prosthesis that can be used to replace the function of the tricuspid heart valve, and in particular to provide a tricuspid replacement heart valve that is advantageously adapted in terms of radial force, which affects the fixation and function of the replacement heart valve and advantageously affects compliance in tricuspid cases. Summary of the Invention

[0012] In one respect, this disclosure relates to a stent or replacement heart valve prosthesis that exhibits advantageous positioning characteristics and / or good durability characteristics and / or reduced interference characteristics, preferably in the case of a tricuspid valve.

[0013] In one aspect, this disclosure relates to a stent structure that can be used to replace a heart valve, the stent structure having a single-cell structure from the proximal end (atrial end) to the distal end (ventricular end), wherein the periphery of the stent structure has a plurality of single-cell structures, preferably 8 to 120, more preferably 10 to 20, and most preferably 12 or 18, wherein the single-cell structure consists of two atrial intermediate pillars (006), two ventricular intermediate pillars (008), and two longitudinal pillars (007).

[0014] In one aspect, this disclosure relates to a stent structure for replacing a heart valve as described above, wherein the dimensions of the strut are predefined, wherein the strut apex width (011), the strut waist width (012), and the strut radius (013) are predefined, preferably wherein the strut apex width (011) is 0.30 mm to 0.36 mm wide, the strut waist width (012) is 0.27 mm to 0.33 mm wide, and the strut radius (013) is 1150 mm to 2150 mm.

[0015] In one aspect, this disclosure relates to a stent structure having a single-cell structure from proximal (atrial end) to distal (ventricular end) for use in replacing heart valves, particularly in the case of tricuspid valves, wherein the periphery of the stent structure has a plurality of single-cell structures, preferably 8 to 120, more preferably 10 to 20, and most preferably 12 or 18, wherein the single-cell structure (005) comprises two atrial intermediate struts, two ventricular intermediate struts, and two longitudinal struts, wherein the dimensions of the struts are predefined, wherein the strut apex width, strut waist width, and strut radius are predefined, preferably wherein the strut apex width is 0.30 mm to 0.36 mm, the strut waist width is 0.27 mm to 0.33 mm, and the strut radius is 1150 mm to 2150 mm, and wherein the predefined intermediate struts can be used to substantially limit radial forces during expansion of the stent structure.

[0016] In another aspect, this disclosure relates to a stent or replacement heart valve prosthesis, characterized in that an inner stent is combined with an outer stent, wherein a fixation device is connected to the inner stent or formed as part of the inner stent.

[0017] On the other hand, this disclosure relates to a replacement heart valve prosthesis comprising an inner stent and an outer stent, wherein a fixation device is connected to or formed as part of the inner stent, and at least one sealing device connected to the inner stent and / or the outer stent, and a valve connected to the inner stent.

[0018] In another aspect, this disclosure relates to a method for implanting or positioning a replacement heart valve prosthesis in a native tricuspid or mitral heart valve, wherein the prosthesis is delivered to the target site via a catheter-based delivery system.

[0019] On the other hand, this disclosure relates to a method for replacing a dysfunctional endogenous heart valve or implanting a replacement heart valve prosthesis in a human body experiencing impaired heart valve function. Attached Figure Description

[0020] Several embodiments of this disclosure are illustrated below with reference to the accompanying drawings: Figure 1 A side view of an example of a support (external support) according to this disclosure is shown.

[0021] Figure 2 A side view of an example of a stent (external stent) according to the present disclosure is shown, in which a unit is shown, demonstrating a single-cell (005) structure consisting of two atrial intermediate struts (006), two ventricular intermediate struts (008), and two longitudinal struts (007).

[0022] Figure 3A single cell (005) of a scaffold (external scaffold) according to the present disclosure is depicted, showing a single cell (005) structure consisting of two atrial intermediate pillars (006), two ventricular intermediate pillars (008), and two longitudinal pillars (007).

[0023] Figure 4 A side view of a laser-cut stent according to the present disclosure is depicted, wherein an atrial segment (001), a mid-section (V-shaped or U-shaped groove) (002), a ventricular segment (003), a connecting arm (strut) (004), a single cell (005), an atrial mid-strut (006), a longitudinal strut (007), and a ventricular mid-strut (008) are shown as examples.

[0024] Figure 5 Depicting Figure 4 A variant of it, which also includes ventricular reinforcement struts (009).

[0025] Figure 6 Depicting Figure 4 A variant of it, which also includes atrial reinforcement struts (010).

[0026] Figure 7 yes Figure 6 The enlarged detail view of the embodiment shown illustrates the details of the components (011, 012, 013).

[0027] Figure 8 Details of the heart and the right side of the heart are shown.

[0028] Figure 9 This is a graphical representation of the radial force on an outer support with a dimension of 45.

[0029] Figure 10 It is a graphical representation of the radial force of a support assembly (inner and outer supports) with a size of 45.

[0030] Figure 11 An oblique view of an example of a support assembly (inner support and outer support) according to this disclosure is shown.

[0031] Figure 12 A side view of an example of a scaffold assembly (inner scaffold and outer scaffold) according to the present disclosure is shown, in which a unit is shown, demonstrating a single cell (005). Detailed Implementation

[0032] In the following text, certain terms of this disclosure will be defined. Otherwise, the technical terms used in the context of this disclosure should be understood as would be understood by those skilled in the art.

[0033] In the sense of this disclosure, the terms "prosthesis," "medical device," or "implant" should be understood as any medical device capable of being delivered in a minimally invasive manner or via catheter-based surgery. These terms are used interchangeably. In the sense of this disclosure, a prosthesis can be, for example, a stent or a stent-based prosthesis or a stent-based replacement heart valve prosthesis, such as a mitral valve replacement or a tricuspid valve replacement.

[0034] In the sense of this disclosure, the terms "catheter" or "delivery device" should be understood as a device for deploying a prosthesis at a defined site within a patient's body, such as for replacing a native aortic valve, mitral valve, or tricuspid valve.

[0035] In the sense of this disclosure, a “laser-cut bracket” is a bracket that is laser-cut from, for example, a nitinol tube.

[0036] In the sense of this disclosure, “stent region” is a defined region of an external stent, mesh stent, or replacement heart valve prosthesis, and in particular, it is a longitudinal or external segment, defined as a proximal region, intermediate region, or distal region, or atrial region, annular region, or ventricular region.

[0037] In the sense of this disclosure, "proximal region," "intermediate region," and "distal region" refer to the regions of a stent or prosthesis relative to the operator who performs the implantation using a catheter, where proximal means closer to the operator and distal means farther from the operator. In the sense of this disclosure, "intermediate region" refers to the region between the distal and proximal regions of a stent or prosthesis. Regarding in situ (i.e., within the body) natural blood flow in an individual (person or patient), "proximal region" may also be referred to as the inflow end or inflow area, and "distal region" may also be referred to as the outflow end or outflow area; proximal may also be referred to as the atrium, intermediate as the annulus, and distal as the ventricle.

[0038] In the sense of this disclosure, "valve annulus region" is either the corresponding region of an intrinsic heart valve or the corresponding region in a replacement heart valve or stent that is to be positioned at the implantation site and aligned with the intrinsic valve annulus.

[0039] In the sense of this disclosure, the "subvalvular region" is the area of ​​the prosthesis located distal to the annulus of the intrinsic heart valve (or inflow or ventricular direction). The prosthesis may cover the "subvalvular region" with a U-shaped or V-shaped groove area and a distal area.

[0040] In the sense of this disclosure, "groove" describes a region of a stent or prosthesis that exhibits a smaller diameter than other regions, wherein other regions of the stent or prosthesis with a larger diameter are adjacent to the groove at its distal and proximal ends; the groove may have a V-shape or a U-shape or a combination thereof or any other curved and useful geometry, or it may be characterized solely by having a smaller diameter compared to the atrial and ventricular stent regions.

[0041] In the sense of this disclosure, "target site" is the location or place where a replacement heart valve prosthesis is to be implanted and where functional impairment or failure is to be treated, such as at the annulus of the tricuspid or mitral heart valve.

[0042] In the sense of this disclosure, the “connection” of a bracket is the way in which two brackets are secured to each other by stitching, by clipping or snapping mechanisms or any other useful means or connecting device, so as to attach the bracket or bracket to the fixing device.

[0043] In the sense of this disclosure, a "connecting device" is a mechanical or physical connection between two parts of a bracket or laser-cut bracket. The connecting device can be achieved, for example, by welding, bonding, or any other known operation, process, or method. The connecting device can also be an attachment or clamping device with a specific design and geometry for releasable or non-releasable connections.

[0044] In the sense of this disclosure, a "fixation device" or "anchoring device" is a component connected to the inner support and providing substantially anchorage of the prosthesis at the target site, optionally working in conjunction with other additional devices. In one particular aspect, the fixation device comprises or includes the aforementioned components, such as an anchoring ring, an anchoring arm, a connecting arch, and an inner support anchoring member; preferably, a connecting device connects the inner support anchoring member of the fixation device to the inner support.

[0045] In the sense of this disclosure, an "anchoring ring" is part of a stent used to secure a stent or prosthesis and to help prevent movement of the stent or prosthesis at the target site. Typically, an anchoring ring in the sense of this disclosure is a device for improving stent or prosthesis fixation, wherein the ring is secured to or connected to an inner stent, or formed as part of or integral with an inner stent. The "ring" in the sense of this disclosure can have different shapes, such as circular, square, etc., and is located in a defined area with a defined pattern. The "ring" in the sense of this disclosure will exhibit a defined angle relative to the surface of the inner stent, and it can be designed to straighten or flip when the stent or prosthesis is initially and possibly partially deployed and retracted into the catheter.

[0046] In the sense of this disclosure, "angle structure" or "angle" is the angle between two auxiliary lines drawn at a specific region or support layer to define the specific geometry of the support portion or arch or layer relative to other support structures (such as internal supports).

[0047] In the sense of this disclosure, "radial force" refers to the force exhibited by the stent or prosthesis in the radially outward direction, and more particularly by the force exhibited by the outer stent of the prosthesis (which may be a laser-cut stent, such as a nitinol stent). The radial force depends on the specific mesh or cut stent design and is related to the material density (e.g., the wire density per square area in a mesh stent) or the number and size of cells circumferentially in a specific laser-cut stent layer or region (e.g., the proximal / atrial region, the intermediate / annular region, or the distal / ventricular region). The radial force in the replacement heart valve prosthesis according to this disclosure will be selected for the combination of the outer stent or inner stent and the fixation device, its size being able to provide good contact with surrounding tissues and support the fixation function of the stent or prosthesis, and optionally also as small as possible to avoid interfering with the endogenous environment and biological characteristics of the target site. Therefore, its size will be selected to avoid interference with the implantation site and endogenous tissues and function. Thus, the stents and prostheses according to this disclosure can be designed to achieve compliance favorable to the tricuspid valve environment. In the context of this disclosure, radial force is the radial force measured during expansion according to the method described herein. The radial force may be used to support its fixing function by means of other means, such as a ring for fixing.

[0048] In the sense of this disclosure, the “target region” is the three-dimensional space surrounding or within a native organ (such as a native heart valve, which may be, for example, a tricuspid or mitral heart valve).

[0049] In the sense of this disclosure, “non-invasive design” of a ring means that the ring or other device or component of a stent or prosthesis is designed to avoid any or substantially any damage to surrounding tissue or tissue in contact with the component, or at least to minimize damage to or / and harm to the tissue in contact with it.

[0050] In the sense of this disclosure, the “compliance” of a stent or replacement heart valve prosthesis (e.g., an internally laser-cut stent included within an external mesh stent, or a laser-cut internal stent within an externally laser-cut stent) involves a positive interaction with the target tissue. “Compliance” refers to a design in which the stent or prosthesis exhibits good geometric fit to the implantation site, and in which the stent or prosthesis exhibits favorable fixation properties, good valvular function, while minimizing interference with intrinsic cardiac structures and function.

[0051] In the sense of this disclosure, a "scaffold" is a scaffold made of any suitable material (e.g., a nitinol laser-cut scaffold), which can be a single scaffold or a scaffold consisting of an outer scaffold and an inner scaffold, wherein the scaffolds are connected by suitable means; the connection of two scaffolds may also suitably include a connecting arm, and preferably includes a connecting means, which preferably releasably connects the inner scaffold and the outer scaffold. The scaffold is composed of single cells at its periphery, wherein the number of single cells can vary depending on the shape, size and other requirements of the scaffold, and may be, for example, 8 to 50, 10 to 20, 12 to 18, or any other suitable number of single cells. The scaffold struts can be laser-cut straight struts, or, for example, longitudinal struts (007) can be designed as S-shaped struts, or / and wherein the longitudinal struts (007) include outwardly pointing means, preferably hooks, preferably circular. Another possible design feature is that the atrial intermediate strut (006) forms a convex V shape, and / or the ventricular intermediate strut (008) forms a concave V shape, and / or the atrial intermediate strut (006) points inward in the scaffold cells, and / or the ventricular intermediate strut (008) points outward in the scaffold cells. It is also possible that the external scaffold, as another design feature, includes one or more small holes on the ventricular side and / or the atrial side.

[0052] In the sense of this disclosure, a “single-cell” or “single-cell design” or “one-cell” or “one-cell design” consists of two atrioventricular intermediate pillars, two ventricular intermediate pillars, and two longitudinal pillars, wherein the dimensions of the pillars are predefined.

[0053] In the sense of this disclosure, "strut apex width" is part of a single cell of the scaffold and defines the width of the strut at a specific location, preferably at the end of the strut used to define radial expansion force.

[0054] In the sense of this disclosure, "strut waist width" is part of a single cell of the scaffold and defines the width of the strut at a specific location, preferably at the narrowest point of the strut, for defining radial expansion force.

[0055] In the sense of this disclosure, "strut radius" is part of a single cell of the scaffold, defining a predefined radius over the strut length between two defining points for defining radial expansion force.

[0056] The support element's "support apex width," "support waist width," and "support radius" are, for example, as described in this disclosure. Figure 7 The example is shown. These three parameters can be used to design and limit the radial expansion force.

[0057] In the sense of this disclosure, an "atrial and / or ventricular reinforcing strut" (010, 009) is a device that can be used to influence the stability of a particular strut, preferably increasing the stability of the strut or region within the scaffold or / and single cell described herein, and / or reducing its flexibility. The reinforcing strut can be a strut located in the atrial and / or ventricular region of the scaffold or / and at a single cell of the scaffold; for example, additional struts can be arranged parallel to the atrial and / or ventricular struts of the single cell. One, two, or three additional struts may be provided.

[0058] In the sense of this disclosure, "radial force during expansion" is the radial force on the outer support that can be measured using the methods disclosed herein (according to ASTM standard F3067-14) from the gripping stage to the expansion stage. Preferably, a predefined intermediate support may be used to substantially define the radial force during the expansion of the support structure. It may be further influenced by various design features and support composition, i.e., characterized by a single support or by the support consisting of an outer support and an inner support, which will affect the radial force during expansion.

[0059] In one aspect of this disclosure, the problem on which this application is based is solved by claim 1, 13 or 15.

[0060] In one aspect of this disclosure, the problem on which this application is based is solved by a scaffold composed of single cells, wherein the single cell design consists of two atrial intermediate struts, two ventricular intermediate struts, and two longitudinal struts, wherein the dimensions of the struts are predefined, and wherein the strut apex width (011), strut waist width (012), and strut radius (013) are predefined, and wherein the predefined struts can be used to substantially limit the radial force during the expansion of the scaffold structure.

[0061] In one aspect, this disclosure relates to a stent structure for replacing heart valves, the stent structure having single-cell (005) structures from proximal (atrial) to distal (ventricular) end, wherein the periphery of the stent structure has a plurality of single-cell (005) structures, preferably 8 to 120, more preferably 10 to 20, and most preferably 12 or 18, wherein the single-cell (005) structure comprises two atrial intermediate struts (006), two ventricular intermediate struts (008), and two longitudinal struts (007), wherein the dimensions of the struts are predefined, wherein the strut apex width (011), strut waist width (012), and strut radius (013) are predefined, preferably wherein the strut apex width (011) is 0.30 mm to 0.36 mm, the strut waist width (012) is 0.27 mm to 0.33 mm, and the strut radius (013) is 1150 mm to 2150 mm. mm, and the predefined intermediate support can be used to substantially limit the radial force during the expansion of the support structure.

[0062] In one aspect, this disclosure relates to a replacement heart valve prosthesis that includes or is composed of the stent structure and sealing device described herein.

[0063] In one aspect, this disclosure relates to a method for treating tricuspid valve dysfunction or insufficiency by minimally invasive implantation of a replacement heart valve prosthesis as described herein, and / or a method for treating a person with impaired heart valve function using a replacement heart valve prosthesis as described herein.

[0064] Therefore, in one respect, the present invention provides advantageous anchoring characteristics and / or advantageous compliance with the heart and its structures and other valves implanted with the stent or / and prosthesis, particularly with advantageous compliance with tricuspid valve function.

[0065] In another advantageous aspect, the stent and prosthesis according to this disclosure provide a seal through the outer stent and the associated sealing material attached thereto, which serves the primary purpose of sealing and preventing paravalvular leakage. The seal on the outer stent is preferably located on the inner side of the outer stent. In another embodiment, the seal is located on the outer side of the outer stent. The prosthesis's special design advantageously decouples the outer stent from the basic anchoring function provided by the anchoring device, which is substantially decoupled from the outer stent. Therefore, the outer stent is essentially used for sealing, and the sealing function is decoupled from the anchoring function, which in turn produces improved sealing characteristics through better alignment of the external sealing stent. Furthermore, the inner stent, carrying the replacement heart valve attached to the inner stent and preferably including an additional seal, is connected to the outer stent and decoupled from the impact of the heartbeat on the outer stent through its special strut connection device, thus improving the functionality of the inner stent and its valve.

[0066] The advantageous sealing properties of the external stent and its advantageous alignment with the surrounding tissue of the target site can be further achieved not only through decoupling but also through the use of a single-cell design of the laser-cut external stent, which advantageously has reduced stiffness and / or increased flexibility compared to a laser-cut internal stent.

[0067] Preferred embodiments according to this disclosure are described in the dependent claims.

[0068] Preferred embodiments are described in the dependent claims.

[0069] In particular, preferred embodiments relate to stent structures as described herein, which further include atrial and / or ventricular reinforcing struts (010, 009). The stent structure as described herein is preferably characterized by three segments: an atrial segment (001), an intermediate segment (002), and a ventricular segment (003), wherein the intermediate segment (002) is a V-shaped or U-shaped groove. The stent structure as described herein is preferably characterized by a radial force of 2 to 6 N, preferably 2.5 to 4 N, measured according to ASTM standard F3067-14, during expansion of the stent structure at a target diameter of 35 mm to 55 mm. The stent structure as described herein is preferably characterized by a radial force of 2 to 6 N, preferably 2.5 to 4 N, measured according to ASTM standard F3067-14, during expansion of the stent structure at a target diameter of 35 to 45 mm, or a radial force of 2 to 6 N, preferably 2.5 to 4 N, during expansion of the stent structure at a target diameter of 45 to 55 mm. The stent structure described herein preferably features the following characteristics: it further includes an inner stent to which a replacement valve is attached, and wherein the inner stent is connected to an outer stent via a connecting arm (004) and preferably via a connecting device, preferably wherein the connecting device is located at the proximal end of the inner stent, preferably in the valve annulus or atrium. The stent structure described herein preferably features the following characteristics: the connecting arms (004), preferably 4, 5, 6, 7, 8, 9, 10, 11, or 12, connect the inner stent in its atrial region to the outer stent in its ventricular region, preferably at the outermost atrial end and / or the outermost ventricular end, preferably wherein the connecting arm (004) includes an S-shaped strut region, or wherein the connecting arm (004) is an S-shaped strut. The stent structure described herein preferably features the following characteristics: the radial force during expansion of the stent structure, measured on the outer stent in a target area with a diameter of 35 mm to 55 mm, as measured according to ASTM standard F3067-14, is 2 to 6 N, preferably 2.5 to 4 N. The support structure described herein is preferably characterized by the following: a radial force of 2 to 6 N, preferably 2.5 to 4 N, measured on the outer support in a target area with a diameter of 35 to 45 mm, as measured according to ASTM standard F3067-14, during the expansion of the support structure; or a radial force of 2 to 6 N, preferably 2.5 to 4 N, measured on the outer support in a target area with a diameter of 45 to 55 mm. The support structure described herein is preferably characterized by the following: one or more longitudinal struts (007) are S-shaped struts, and / or said longitudinal struts (007) include outwardly pointing devices, preferably hooks, preferably circular.The stent structure described herein is preferably characterized by the following features: wherein the atrial intermediate strut (006) forms a convex V-shape, and / or the ventricular intermediate strut (008) forms a concave V-shape, and / or the atrial intermediate strut (006) points inward within the stent cells, and / or the ventricular intermediate strut (008) points outward within the stent cells. The stent structure described herein may also be characterized by the following features: the external stent includes one or more small openings on the ventricular side and / or the atrial side.

[0070] The replacement heart valve described herein is preferably characterized as a prosthesis comprising a stent structure as described herein and a sealing device for treating tricuspid valve dysfunction or insufficiency, or consisting of a stent structure as described herein and a sealing device for treating tricuspid valve dysfunction or insufficiency.

[0071] According to one aspect of an embodiment of the present disclosure, there is a support comprising an inner support and an outer support, wherein the two supports are connected by at least one or more, preferably 4 to 20, more preferably 10 to 12 connecting struts and preferably a combination of connecting means derived from the connecting struts of the inner support and the outer support, respectively.

[0072] A more specific description of aspects of this disclosure is a replacement heart valve prosthesis, a method for implanting such a prosthesis, and a method for positioning such a prosthesis.

[0073] In particular, on the other hand, the problem on which this application is based is solved by a replacement heart valve prosthesis comprising an inner stent and an outer stent as described above, at least one sealing device located in the inner stent and / or the outer stent, and a valve connected to the inner stent, wherein the valve optionally has two or three leaflets.

[0074] On the other hand, the problem on which this application is based is solved by a method of implanting the replacement heart valve prosthesis as described above using a catheter-based delivery system.

[0075] On the other hand, the problem upon which this application is based is solved by a method for positioning a replacement heart valve prosthesis in a native tricuspid or mitral heart valve, wherein the prosthesis is delivered to a target site (e.g., the native mitral or tricuspid valve annulus) via a catheter-based delivery system, wherein the target site is the valve annulus, and the prosthesis is released from the delivery system into the right or left ventricle. A tricuspid valve prosthesis is preferred.

[0076] In the stent according to this disclosure, the inner stent exhibits relatively high stiffness, while the outer stent exhibits relatively low stiffness and relatively high flexibility to adapt to and align with target endogenous tissue. Therefore, it has been shown that it is advantageous for the outer stent to have higher flexibility compared to the inner stent. Consequently, the inner stent has higher stiffness compared to the outer stent. In the outer stent, flexibility and stiffness can be designed through its single-cell design and the selection of two atrial intermediate struts (006), two ventricular intermediate struts (008), and two longitudinal struts (007), wherein the dimensions of the struts are predefined, preferably with a strut apex width (011), strut waist width (012), and strut radius (013) predefined, and wherein the predefined dimensions of the aforementioned structures can limit the flexibility of the outer stent.

[0077] Specifically, the scaffold can be designed for single-cell designs such that it achieves a radial force during expansion at 35 to 45 mm, preferably at 45 mm, which can be designed to be between 6 N and 2 N, preferably between 4 N and 2.5 N, wherein the radial force is measured according to ASTM standard F3067-14. Alternatively, a specific strut for a single-cell design can be designed such that the scaffold achieves a radial force during expansion at 45 to 55 mm, preferably at 55 mm, such that the radial force during expansion is between 6 N and 2 N, preferably between 4 N and 2.5 N, wherein the radial force is measured according to ASTM standard F3067-14. Preferably, the radial force during expansion is 6 to 7 N at 15 mm expansion, and / or 2.8 N at 45 mm expansion.

[0078] Specifically, the scaffold can be designed for single-cell use such that the scaffold expands to 35 to 45 mm, preferably at 45 mm, and the radial force during expansion can be designed to be between 6 N and 2 N, preferably between 4 N and 2.5 N, wherein the radial force is measured according to ASTM standard F3067-14.

[0079] Therefore, the single-cell design in a stent or external stent, particularly the two atrial intermediate struts (006), two ventricular intermediate struts (008), and two longitudinal struts (007), preferably with respect to the strut apex width (011), strut waist width (012), and strut radius (013), can be used to define the radial forces of the stent structure and prosthesis. Specifically, the struts of the single-cell stent and their specific design, and preferably the dimensions regarding the strut apex width (011), strut waist width (012), and strut radius (013), can be used to define the radial forces of the stent structure and prosthesis during expansion. A preferred material in such a stent structure is nitinol.

[0080] The radial force during expansion can be further influenced by including atrial and / or ventricular reinforcing struts (010, 009). The radial force during expansion can be varied by including or / and changing the values ​​of the strut apex width (011), strut waist width (012), and strut radius (013).

[0081] By adding reinforcing struts, particularly in specific areas of the external stent (e.g., in the proximal and / or atrium and / or recessed areas), the radial force during expansion can be designed and set to a limited value over the length of the stent and thus the prosthesis.

[0082] If multiple reinforcing struts are used along the length of the stent or prosthesis, the radial force during expansion can be gradually changed by altering the parameters of strut apex width (011), strut waist width (012), and strut radius (013). Similarly, or alternatively, the length of the stent or prosthesis can also be a means of changing the radial force during expansion.

[0083] Furthermore, in a preferred embodiment of the stent structure according to this disclosure, the atrial end of the stent is designed to be wavy and / or zigzag, and / or has two longitudinal struts (007) designed as S-shaped supports, wherein the two atrial intermediate struts (006) are concave relative to the two longitudinal struts (007), and / or the two ventricular intermediate struts (008) are convex relative to the two longitudinal struts (007). Additionally, in a preferred embodiment, atrial and / or ventricular reinforcing struts (010, 009) may be included to increase the radial force of the stent. Variations in the distal portion of the stent, such as loops in the distal direction, are particularly useful. Similarly, additional struts in the proximal region of the stent can increase the radial force.

[0084] Specifically, the strut apex width (011), strut waist width (012), and strut radius (013) can be used to define and adjust the radial force during the expansion of the stent structure and prosthesis. The strut radius (013) is preferably concave.

[0085] The radial expansion force can be increased by modifying the width of the support apex (011), for example by increasing the width of the support apex (011).

[0086] The radial expansion force can be reduced by modifying the width of the support apex (011), for example by reducing the width of the support apex (011).

[0087] The radial expansion force can be increased by modifying the width of the support waist (012), for example by increasing the width of the support waist (012).

[0088] By modifying the width of the support waist (012), for example by reducing the width of the support waist (012), the radial expansion force can be reduced.

[0089] By modifying the support radius (013), for example by increasing the support radius (013), the width of the support waist (012) can be increased, thereby increasing the radial expansion force.

[0090] By modifying the support radius (013), for example by reducing the support radius (013), the width of the support waist (012) can be reduced, thereby increasing the radial expansion force.

[0091] In a preferred embodiment, the structure that contributes the most to the radial force during expansion and is therefore crucial for the fixation of the stent and / or prosthesis is the design of two atrial intermediate struts (006) and two ventricular intermediate struts (008).

[0092] In a preferred embodiment, the stent is positioned within the valve annulus by its groove, and the stent is anchored within the valve annulus by radial force during expansion as described above. Additional hooks or rings may be used to enhance the anchoring.

[0093] According to one embodiment of the present disclosure, the inner stent is a laser-cut stent, the outer stent is a laser-cut stent or a braided stent, and wherein the inner stent and / or the outer laser-cut stent comprises 6 to 48 cells circumferentially and 1 cell longitudinally, or the outer braided stent (1) comprises 6 to 72 meshes circumferentially or consists of 6 to 72 meshes and comprises 1 mesh longitudinally.

[0094] Furthermore, those skilled in the art will understand that he will select suitable materials for the support structure, which may be stainless steel, nickel-titanium, plastic, composite materials or other known materials.

[0095] The stents according to this disclosure will be connected in a suitable manner based on the overall design and functionality. One embodiment of the stent according to this disclosure is a stent in which the inner stent and the outer stent are connected to each other at the atrial region or atrial end.

[0096] In the stent according to this disclosure, the connecting struts and / or connecting devices may be connected to or positioned in the ventricular region or ventricular end of the inner stent, or in the atrial region or atrial end.

[0097] It has been shown that it is useful if the stent includes means for easier loading onto the catheter. In the stent according to this disclosure, the outer stent may include at least two loading rings and / or a groove, such as a V-shaped or U-shaped groove (5).

[0098] According to this disclosure, the stent can be defined as having three parts, such as the atrial region, the annular region, and the ventricular region.

[0099] The dimensions of the stents will be adapted to each other and to the dimensions of the target area and space. In one embodiment of the stent according to this disclosure, it may have the following dimensions: wherein the diameter of the atrial region is 20 to 90 mm and the length is 2 to 30 mm, the diameter of the annular region is 10 to 80 mm and the length is 2 to 20 mm, and the diameter of the ventricular region is 20 to 90 mm and the length is 5 to 40 mm.

[0100] The number of connecting devices can vary. In one embodiment of the support according to this disclosure, the number of connecting struts and connecting devices derived from each support (inner support and outer support) is from 2 to 36.

[0101] In a preferred embodiment, the anchoring rings support fixation at the target location. In one embodiment, the bracket or external support according to this disclosure comprises 1 to 54 anchoring rings.

[0102] A further feature of the method described above is that it involves a method for implanting a replacement heart valve prosthesis using a catheter-based implantation and delivery system.

[0103] The catheter will be introduced in an appropriate manner according to the target native heart valve, and the catheter system can be introduced via the femoral artery, through the atrium, through the jugular vein, or through the apex of the heart.

[0104] In another detail, this disclosure relates to a method for positioning a replacement heart valve prosthesis in a native tricuspid or mitral heart valve, wherein the prosthesis is delivered to a target site (e.g., the native mitral or tricuspid valve annulus) via a catheter-based delivery system, the prosthesis being released from the delivery system into the right or left ventricle, wherein the annulus and / or ventricular region includes anchoring rings, and these anchoring rings are substantially positioned within the ventricle or substantially within the annulus region.

[0105] In the event of suboptimal positioning or other problems during implantation surgery, the prosthesis disclosed in this article can also be retrieved. Example

[0106] The following examples are used to illustrate various embodiments of this disclosure. They should not be construed as limiting in any way.

[0107] 1. Radial expansion force measurement method: Radial force testing was performed using a radial expansion force tester (RX650) manufactured by Machine Solutions Inc. (MSI) with an integrated high-speed data acquisition system. The RX650 uses an encoder to ensure diameter accuracy, a linear actuator for drive, and a precision roller bearing system to provide a low-friction testing environment. The measuring head of the MSI RX650 uses 12 polished metal elements made of stainless steel, similar to iris apertures, to grip and / or expand the cylindrical support component.

[0108] Parameters / Feature Values / Specifications

[0109] Test temperature 37°C + / -2°C Measuring head length 120 mm Starting diameter 50 mm Grip diameter (outer support): 15 mm Press-grip diameter (assembly) 15 mm Diameter accuracy of 0.2% of full scale. Diameter resolution 0.01 mm Force repeatability 1.0% of full scale Force resolution of 0.06% of full scale Measurement speed: 0.1 mm / s Test loop count 3 Reference Symbol List 001 – Atrial segment 002 – Middle section (V-shaped or U-shaped groove) 003 – Ventricular segment 004 – Connecting Arm (Support) 005 – Single Cell 006 – Middle pillar of the atrium 007 – Longitudinal Support 008 – Interventricular support 009 – Ventricular reinforcement pillar 010 – Atrial Strengthening Pillar 011 – Width of pillar apex 012 – Column waist width 013 – Support radius.

Claims

1. A stent structure for replacing a heart valve having single-cell (005) structures from a proximal (atrial) end to a distal (ventricular) end, wherein the periphery of the stent structure has a plurality of single-cell (005) structures, preferably 8 to 120, more preferably 10 to 20, and most preferably 12 or 18, wherein the single-cell (005) structure comprises two atrial intermediate struts (006), two ventricular intermediate struts (008), and two longitudinal struts (007), wherein the dimensions of the struts are predefined, wherein the strut apex width (011), strut waist width (012), and strut radius (013) are predefined, preferably wherein the strut apex width (011) is 0.30 mm to 0.36 mm, the strut waist width (012) is 0.27 mm to 0.33 mm, and the strut radius (013) is 1150 mm to 2150 mm, and wherein the predefined intermediate struts can be used to substantially limit radial forces during expansion of the stent structure.

2. The stent structure according to claim 1, further comprising atrial and / or ventricular reinforcing struts (010, 009).

3. The support structure according to claim 1 or 2, characterized in that, The three segments are: the atrial segment (001), the intermediate segment (002), and the ventricular segment (003), wherein the intermediate segment (002) is a V-shaped or U-shaped groove.

4. The support structure according to any one of claims 1 to 3, characterized in that, According to ASTM standard F3067-14, the radial force during the expansion of the support structure, measured at a target diameter of 35 mm to 55 mm, is 2 to 6 N, preferably 2.5 to 4 N.

5. The support structure according to any one of claims 1 to 4, characterized in that, According to ASTM standard F3067-14, the radial force during the expansion of the support structure, measured at a target diameter of 35 to 45 mm, is 2 to 6 N, preferably 2.5 to 4 N, or the radial force during the expansion of the support structure, measured at a target diameter of 45 to 55 mm, is 2 to 6 N, preferably 2.5 to 4 N.

6. The stent structure according to any one of claims 1 to 5, further comprising an inner stent, wherein the replacement valve is attached to the inner stent, and wherein the inner stent is connected to the outer stent via a connecting arm (004) and preferably via a connecting device, preferably wherein the connecting device is located at the proximal end of the inner stent, preferably in the valve annulus or atrium.

7. The support structure according to claim 6, characterized in that, The connecting arms (004), preferably 4, 5, 6, 7, 8, 9, 10, 11 or 12, connect the inner stent in its atrial region to the outer stent in its ventricular region, preferably at the outermost atrial end and / or the outermost ventricular end, preferably wherein the connecting arm (004) includes an S-shaped support region, or wherein the connecting arm (004) is an S-shaped support.

8. The support structure according to claim 6 or 7, characterized in that, Measured according to ASTM standard F3067-14, the radial force during the expansion of the support structure, measured on the outer support in a target area with a diameter of 35 mm to 55 mm, is 2 to 6 N, preferably 2.5 to 4 N.

9. The support structure according to claim 6 or 7, characterized in that, According to ASTM standard F3067-14, the radial force during the expansion of the support structure measured on the outer support in a target area with a diameter of 35 to 45 mm is 2 to 6 N, preferably 2.5 to 4 N, or the radial force during the expansion of the support structure measured on the outer support in a target area with a diameter of 45 to 55 mm is 2 to 6 N, preferably 2.5 to 4 N.

10. The support structure according to any one of claims 1 to 9, characterized in that, One or more of the longitudinal struts (007) are S-shaped struts, and / or the longitudinal struts (007) include outwardly pointing devices, preferably hooks, and preferably circular.

11. The support structure according to any one of claims 1 to 9, characterized in that, The atrial intermediate support (006) forms a convex V shape, or / and the ventricular intermediate support (008) forms a concave V shape, or / and the atrial intermediate support (006) points inward in the scaffold cells, or / and the ventricular intermediate support (008) points outward in the scaffold cells.

12. The support structure according to any one of the preceding claims, characterized in that, The external stent includes one or more small holes on the ventricular side and / or the atrial side.

13. A replacement heart valve prosthesis comprising or consisting of a stent structure and sealing device according to any one of the preceding claims.

14. A replacement heart valve prosthesis comprising a stent structure according to any one of the preceding claims and a sealing device for treating tricuspid valve dysfunction or insufficiency, or consisting of a stent structure according to any one of the preceding claims and a sealing device for treating tricuspid valve dysfunction or insufficiency.

15. A method for treating tricuspid valve dysfunction or insufficiency by minimally invasive implantation of a replacement heart valve prosthesis according to claim 13, and / or a method for treating a person with impaired heart valve function using a replacement heart valve prosthesis according to claim 13.

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