Valve prosthesis with pivotable retention member

Abstract

A valve prosthesis for a heart valve includes a prosthetic member (16) and a retaining member (18) to at least partially secure the prosthetic member (16) relative to a portion of heart tissue in an implanted state of the valve prosthesis (10). The retaining member (18) comprises at least one component (22) having a main portion (24) joined at its end (24a) to the at least one connecting element (26) via a pivotable connection (30) to connect the retaining member (18) to the prosthetic member (16). The connecting element (26) and the main part (24) are connected in such a way as to be pivotable relative to each other from a first position in which the connecting element and the main part have a minimum space requirement adapted to its passage in the catheter, to at least one second position which assumes at least in the implanted state of the prosthesis. A connecting member (34, 39; 54, 56) is provided to stably connect the main portion (24) and the connecting element (26) in the second position to limit the stress suffered by the flexible section in the operational state of the valve prosthesis.

Description

Technical Field

[0001] The present invention relates to the field of valve prostheses for cardiovascular valves.

[0002] The present invention has been developed in a non-exclusive manner particularly for valve prostheses for atrioventricular heart valves (ie, mitral or tricuspid valves) that allow blood to flow from the atria to the ventricles during diastole and prevent blood from flowing back in the opposite direction during systole.

[0003] More specifically, the present invention relates to valve prostheses that can be implanted using transcatheter percutaneous techniques.

[0004] The invention has been developed in particular for a valve prosthesis provided with a pivotable retaining member. Background Art

[0005] A prosthesis is an artificial device that is usually used to replace or at least integrate the function of a part of a component after being implanted in situ (that is, arranged in the natural seat of a missing or damaged part of the component). Heart valve prostheses are used to enable a unidirectional flow of blood in the heart. Valve prostheses for atrioventricular heart valves (i.e., for the mitral valve or tricuspid valve) are used to regulate the flow of blood from the atria to the ventricles of the heart during diastole and prevent the reverse flow of blood from the ventricles to the atria of the heart during systole.

[0006] Heart valves may develop malfunctions that inhibit their correct operation; typically, the main malfunctions of heart valves include valvular regurgitation due to incomplete closure of the valve (e.g., due to prolapse of the valve annulus, resulting in lack of coaptation between the leaflets) and stenosis that restricts the corresponding orifice (e.g., due to calcification of the valve annulus). These malfunctions may be caused by a variety of pathologies involving the same heart valve and / or the entire heart (e.g., degenerative diseases, ischemia, cardiomyopathy, congenital anomalies, etc.). In such cases, if it is not possible to cure the malfunction pharmacologically or by surgical repair of the heart valve, a corresponding replacement prosthesis is implanted in the heart.

[0007] The implantation of a heart valve prosthesis is a rather complex intervention. Instead of open-heart implantation procedures of cardiovascular prostheses, which are particularly invasive and usually require interruption of the heartbeat and extracorporeal blood circulation, percutaneous transcatheter techniques are preferred, where possible and desirable, in which the prosthesis is implanted into the heart via a less invasive peripheral access (e.g., starting from the femoral artery) via a transluminal approach. To this end, the prosthesis is initially radially compressed. A guidance system or delivery system, which usually includes one or more catheters, guides the prosthesis to the implantation site in the heart. Once the prosthesis is correctly positioned, the prosthesis is released by the guidance system and expanded, for example due to elastic return or insufflation of a balloon positioned in the prosthesis, so as to restore the operating size of the prosthesis.

[0008] Cardiovascular prostheses have been proposed which include a prosthetic component and a retaining component which supports the prosthetic leaflets and which at least partially surrounds the prosthetic component to secure the prosthesis to a portion of cardiac tissue. Some of these prostheses include a retaining component which cooperates with the prosthetic component to capture the native leaflets of the heart valve, thereby ensuring secure anchoring of the prosthesis. One of these prostheses is described in WO2012 / 063228 and WO2014 / 080339.

[0009] A valve prosthesis is known in which a retaining member is fixed to a prosthetic member when the prosthetic member is still in a radially compressed configuration before it expands to an operational configuration. Such a prosthesis is described in WO2015 / 118464. In one embodiment described in the document, the retaining member of the prosthesis is constructed by means of sub-components, each of which has an articulation mechanism that allows the sub-component to be elastically deformed until a configuration with minimal radial space requirements is presented. In this way, the introduction and deployment of the components of the retaining member at the implantation site can be achieved in a catheter with a small diameter, which makes the operation safer and involves minimal invasiveness. More specifically, each sub-component includes a central portion that is joined to two end portions by a transition zone that serves as a one-way hinge, thereby allowing these ends to be realigned in one direction in the same plane of the rest of the sub-component, but once the sub-component is reconnected to the prosthetic member, a deflection greater than a predetermined angle between the main plane of the sub-component and the axis of the prosthetic member is prevented in the opposite direction.

[0010] For example, a transseptal implantation procedure using such a prosthesis is described in WO2021 / 014400.

[0011] It has been found that the structure of the retaining member of the prosthesis described in WO2015 / 118464 is particularly effective because it avoids the risk of excessive deflection of the segments of the retaining member (or the housing portion) towards the inside of the ventricular chamber. In this way, the continuity of the contact of the retaining member on the annulus of the natural valve when the prosthesis is finally released and the correct mutual alignment between the retaining member and the central member of the prosthesis are ensured. However, when the prosthesis is implanted, the transition zone, which acts as an articulation or hinge between the central part and each of the two ends of the sub-component, is constantly loaded by a variable load, which is also associated with the heartbeat, thereby generating a cyclic stress state that requires the transition zone to meet specific requirements in terms of fatigue resistance of a large number of cycles applied in the years of expected operation of the prosthesis. Therefore, it is necessary to develop an improved solution relative to the solution described in WO2015 / 118464 to allow the same function of the retaining member and in particular its sub-components, but at the same time ensure greater resistance to fatigue stresses to improve its performance level and reliability. Summary of the invention

[0012] An object of the present invention is to overcome the disadvantages of the prior art by means of a valve prosthesis for a heart valve which is resistant and durable with respect to the cyclic stresses caused by cardiac activity.

[0013] Another object of the invention is to provide a valve prosthesis that has a high degree of durability and reliability over time.

[0014] Another object is to provide a heart valve with a retaining member that ensures effective anchoring and retention of the heart valve in a desired position.

[0015] Another object is to provide a heart valve with a retaining member that is simultaneously resistant, reliable and durable, in particular to fatigue stresses of high cycle times caused by heartbeats and thrusts exerted on the prosthesis by blood flow caused by the opening and closing of the prosthetic valve leaflets.

[0016] Another object of the present invention is to provide a retaining member for a prosthesis of a heart valve which is easy to install by transcatheter surgery, in particular with regard to the positioning of the retaining member at the atrioventricular valve, such as the mitral valve or the tricuspid valve.

[0017] Another object of the present invention is to provide a retaining member for a heart valve that is easy to manufacture and assemble and easy to use.

[0018] These objects as well as other objects and advantages are achieved by the invention as defined in the accompanying claims.

[0019] According to a first aspect, a valve prosthesis for a heart valve is described. The valve prosthesis comprises a prosthetic member supporting prosthetic leaflets, which are capable of reproducing the function of the valve leaflets of a natural heart valve. The valve prosthesis comprises a retaining member, which is intended to at least partially fix the prosthetic member relative to a portion of the heart tissue in an implanted state of the prosthesis. In this state, the prosthesis is subjected to continuous stresses generated by the heartbeat, in particular causing the valve leaflets to open and close to allow a unidirectional flow of blood.

[0020] The described retaining member may comprise one or more parts. Each part may have at least one connecting element. By means of one or more of these connecting elements, the retaining member may be connected to the prosthetic member at least in the implanted state of the valve prosthesis. Each part of the retaining member may have at least one main part, which is joined to at least one connecting element at one end thereof via a pivotable connection to connect the retaining member to the prosthetic member. It is also described how the pivotable connection between the connecting element and the main part of the part allows the connecting element to be oriented at an angle relative to the main part of the part of the retaining member.

[0021] More specifically, it is described how the pivotable connection defines an articulation or hinge between the connecting element and the main part of the component. The articulation can allow the connecting element to move, in particular by pivoting relative to the main part, to move from a first position to at least one second position. For example, the first position can be defined as a position in which the main part of the component and the connecting element present a configuration having a minimum space requirement that matches its passage through the catheter. The term "minimum space requirement" is generally intended to be understood as meaning the lateral space requirement relative to the sliding direction in the catheter or more generally in a delivery device used in a transcatheter implantation procedure. A particularly effective configuration with a minimum space requirement is a configuration in which the connecting element is substantially aligned with the corresponding end of the main part, i.e., in this configuration, the longitudinal axis of the connecting element substantially coincides with the longitudinal axis of the main part at its connecting end relative to the connecting element itself.

[0022] The second position may be a position presented by the retaining member in the implanted state of the prosthesis, or more generally a position close to the implanted state of the prosthesis. This second position may sometimes, but not necessarily, coincide with the maximum deflection position of the articulation, i.e., the limit angular position at which the connecting element can be deflected relative to the end of the main part and cannot be exceeded. In other words, the extent of movement of the articulation defined between the connecting element and the end of the main part from the initial position (preferably but not necessarily aligned) with the minimum space requirement locates the maximum limit, which is determined and predefined and is functional for the correct implantation of the prosthesis.

[0023] In the above-mentioned second position presented by the retaining member in the implanted state of the prosthesis, the connecting element is deflected relative to the corresponding end of the main part, for example but not limited to being oriented substantially transversely to the corresponding end of the main part. The hinge portion can be configured so that at least in this second position, the connecting element is substantially blocked relative to the main part, preferably by an integral connection portion, which in some cases can be a connection portion with a mechanical connection portion or an interlocking connection portion. In this regard, it is described how the components of the retaining member can include a connecting member so that the main part and the connecting element are stably connected at least in the above-mentioned second position, thereby limiting the stress to which the flexible section is subjected in the operating state of the valve prosthesis. The connecting member is used to produce an additional mechanical connection between the main part and the connecting element in the implanted position, which can be a position close to the maximum deflection position of the connecting element relative to the main part or a position substantially coinciding with the maximum deflection position. This solution achieves a significant improvement with respect to the prior art, since in this way the pivoting system of the connection element is reinforced to reduce the stresses on the flexible section of the pivot connection, which acts as a hinge and is therefore arranged to be relatively elastic or flexible in the position assumed by the components of the retaining member in the implanted configuration of the valvular prosthesis. Advantageously, this provides a structurally stable and secure configuration for the transition zone, which acts as a hinge or articulation of the retaining member in the implanted position, to ensure the requirements of the retaining member with regard to stability and resistance to cyclic stresses generated by cardiac activity, thereby significantly extending the duration of the retaining member and therefore the reliability of the entire valvular prosthesis over time.

[0024] The hinge can be configured so that, in the case where the connecting element is substantially blocked relative to the main part in the second position, for example by means of the above-mentioned integral connection (as mentioned, in some cases, the integral connection can be a connection with a mechanical connection or an interlocking connection), the blocking can be released by manipulation performed on the retaining member, on one or more parts of the retaining member, on one or more main parts of the parts and / or on one or more connecting elements, for example, after a rotation and / or a predetermined thrust applied to one or more connecting elements during a positioning operation of the retaining member or more generally during an implantation operation of the valve prosthesis. Additionally or alternatively, the hinge can be configured so that in order to block the connecting element, a rotation and / or a predetermined thrust needs to be applied to the retaining member, one or more parts of the retaining member, one or more main parts of the parts and / or one or more connecting elements. These characteristics leave a certain degree of freedom of manipulation for the correct positioning of the retaining member during the implantation operation, allowing the hinge to be blocked in the final implantation position only when the correct positioning of the retaining member has been confirmed.

[0025] According to a particular aspect, not necessarily subordinate to the above, it is also described that the pivotable connection defining the hinge between the connecting element and the main part may comprise at least one flexible section. The flexible section thereby maintains the physical continuity between the main part and the connecting element. According to a particular aspect, the flexible section is arranged at the arch back of the hinge, that is to say, in the area of ​​the part of the retaining member that presents a greater radius of curvature when the hinge is bent and the connecting element is deflected. In this way, the physical continuity between the main part and the connecting element is located in a zone that contributes most to the robustness of the hinge and therefore to the reliability and resistance over time.

[0026] According to a specific aspect, which is not necessarily subordinate to one or more of the above-mentioned aspects, the possibility of providing a retaining member in such a way that the flexible section of the hinge between the corresponding ends of the connecting element and the main part of the component is also described, which comprises a less resistant portion and a more resistant portion. The less resistant portion can provide a predetermined flexibility for the pivotable connection during the movement of the connecting element from a first position with minimal space requirements to a second implantation position and / or a position with maximum deflection. In this way, the hinge can be easily bent, for example to change the connecting element from a configuration in which it is arranged essentially continuously with the end of the main part to a configuration in which the connecting element is, for example, transverse to the end of the main part. The more resistant portion can alternatively define or contribute to defining the resistance of the joint to the stresses to which it is subjected in the implanted state of the valve prosthesis.

[0027] According to a particular aspect, it is described how the flexible section capable of defining a hinge can be designed in the form of a flexible plate, wherein a first portion having a first cross section and a second portion having a second cross section greater than the first cross section define a less resistant portion and a more resistant portion, respectively. By making cutouts in the structure of the components of the retaining member, the different cross sections can be easily and precisely configured.

[0028] According to another particular aspect, it is described how the flexible section may be inextensible.In particular, the flexible section may be constructed integrally with a component of the retaining member to form a single piece with the main part and the connecting element.

[0029] According to a specific aspect, which is not necessarily subordinate to one or more of the above aspects, the connecting member may include a system of wings protruding laterally from the flexible section. The wings may be configured to engage in at least one corresponding cavity formed in the connecting element. The wings may be supported in the cavity to create an additional mechanical connection of the connecting element relative to the main part in the implant configuration, which protects and actually excludes the deformable and fragile parts of the pivotable connection (in particular the flexible section) from the exchange of cyclic loads between the elements of the annular structure.

[0030] According to another specific aspect, which is not necessarily subordinate to one or more of the above-mentioned aspects, it is described how the connecting element can be elastically pivoted. In particular, it is described how the connecting element can be elastically connected to the main part of the component of the retaining member. The elastic pivoting causes the retaining member to be elastically pushed toward the first position when the retaining member moves away from the first position. During the positioning of the valve prosthesis, the elastic pivoting provides specific feedback when the retaining member resists the surrounding cardiac tissue, for example in the area of ​​the valve ring. When the connecting member is between the main part and the connecting element, for example in the implantation position of the valve prosthesis, the elastic pivoting can be blocked, which blocks the connecting element so that it can no longer pivot relative to the main part.

[0031] According to another specific aspect, which is not necessarily subordinate to one or more of the above aspects, the pivotable connection of the retaining member can be constructed by means of cutouts and holes in the tubular element. In this way, structural continuity is advantageously maintained between the connecting element and the main part, also allowing the use of reliable processing techniques based on laser cutting and producing a generally simple and economical production process. Preferably, the tubular element can completely define the component, thereby achieving economy and ease of production. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Additional features and advantages will be appreciated from the following detailed description of preferred embodiments, with reference to the accompanying drawings, which are provided purely by way of non-limiting examples, and in which:

[0033] - Figure 1 is a schematic diagram of a valve prosthesis for a heart valve, the valve prosthesis being in a configuration that it may assume when implanted and in which native leaflets or other heart structures are not shown for simplicity of illustration, the valve prosthesis comprising a prosthetic member connected to a retaining member having two parts;

[0034] - Figure 2 is a method for incorporating aspects of the present invention Figure 1 A perspective view of components of a retaining member in a valve prosthesis;

[0035] - Figure 3 It is in the first position, limiting Figure 2 A detailed perspective view of the pivotable connection portion of the hinged portion of the component;

[0036] - Figure 4 is similar to Figure 3 a view of a view of the part wherein the hinged portion of the part is in a second position;

[0037] - Figure 5 yes Figure 3 A longitudinal section of the hinge portion;

[0038] - Figure 6It is in the third position, Figures 3 to 5 A plan view of the hinged portion;

[0039] - Figure 7 yes Figure 6 A side view of a hinged portion;

[0040] - Figure 8 yes Figure 6 A bottom view of the hinged portion;

[0041] - Fig. 9 is a plan view of a first variation of the hinged portion of the components of the retaining member;

[0042] - Fig.10 yes Fig. 9 A side view of a first variation of the hinge portion;

[0043] - Fig.11 is a plan view of a second variation of the hinged portion of the components of the retaining member;

[0044] - Fig.12 yes Fig.11 A side view of a second variation of the hinge portion;

[0045] - Fig.13 is a plan view of a third variation of a hinged portion of a component for retaining a member;

[0046] - Fig.14 yes Fig.13 A side view of a third variation of the hinge portion;

[0047] - Fig.15 is a perspective view of a fourth variation of the hinge portion of the component of the retaining member; and

[0048] - Fig.16 yes Fig.15 A side view of a third variant of the hinge portion. DETAILED DESCRIPTION

[0049] In the following embodiments, features that allow the implementation of the present invention are described. The features described can be combined with each other in various ways and are not necessarily limited to the precise embodiments referenced by the drawings and related descriptions. In other words, a person skilled in the art who reads the following description will know how to obtain useful information to understand the way in which one or more of the described features are implemented by combining one or more of the described features with one or more of the other described features, and the specific expression of the description, paragraph, phrase or drawing does not constitute a limitation on the possibility of isolating one or more of the described and shown features so as to combine them with one or more of any other described and shown features. In more detail, in this specification, it must be understood that any combination of any two explicitly described features is explicitly described, even if these features are taken alone from a specific context (where these features can be joined to other different features or combined with other different features), considering the ability and knowledge of a person skilled in the art, the person skilled in the art understands the possibility of combining features functionally without the need to apply other different features functionally. Unless otherwise specified, each and any element, component, device, system, part, object described and shown in this specification must be understood as being described separately and capable of being modified autonomously and separated and / or combined with each and any other element, component, device, system, part, object described and shown. The materials, forms, and functions described and illustrated are not limitations of the present invention, but are merely specified to enable those skilled in the art to understand and practice the present invention according to preferred but non-exclusive embodiments.

[0050] Now referring to the accompanying drawings, Figure 1 A valve prosthesis 10 for a heart valve is shown. The valve prosthesis 10 is preferably used to replace the function of an atrioventricular valve, such as a mitral valve or a tricuspid valve. This type of valve prosthesis and its implantation method are described, for example, in WO2021 / 014400, the entire contents of which are incorporated herein by reference.

[0051] The valve prosthesis 10 includes a prosthetic structure 12 for supporting and docking with a natural valve. A group of flexible prosthetic leaflets 14 are arranged in the prosthetic structure 12. A group of flexible prosthetic leaflets 14 are fixed to the prosthetic structure 12. The prosthetic structure 12 particularly includes a prosthetic member 16, which is preferably tubular and supports the prosthetic leaflets 14 arranged in a tubular cavity. A retaining member 18 surrounds the prosthetic member 16, which is intended to at least partially fix the prosthetic member 16 relative to the heart tissue portion in the implanted state of the valve prosthesis 10. In the exemplary embodiment of the accompanying drawings, the retaining member completely surrounds the prosthetic member 16 and forms a substantially closed ring, in which the prosthetic member 16 is located. In a variant not shown, the retaining member can partially surround the prosthetic member, thereby forming, for example, an open C-shaped ring, or the retaining member can form a plurality of turns, thereby forming a spiral winding around the prosthetic member.

[0052] The retaining member 18 is stably fixed to the prosthetic member 16 via the connecting member 20. The retaining member 18 is configured to surround the natural leaflets of the heart valve and resist the expansion thrust of the prosthetic member 16 in the radial direction, so that in the final implantation structure, the natural heart valve remains trapped between the outer surface of the prosthetic member 16 and the retaining member 18 to stably anchor the valve prosthesis at a desired position within the heart.

[0053] The prosthetic structure 12 (in terms of each of its elements) is constructed to be foldable without any impact on the safety and functionality of the valve prosthesis. Therefore, the radial space requirement of the valve prosthesis 10 can be temporarily reduced to allow the valve prosthesis to be introduced into the heart cavity through an access port with a reduced opening, which is compatible with minimally invasive surgical techniques, transcatheter positioning and cardiac prosthesis implantation techniques, especially transcatheter techniques using transapical or transseptal approaches. Therefore, the valve prosthesis 10 can be inserted into a catheter that has a low radial profile and is capable of delivering the prosthesis to the heart cavity near the implantation site through a minimally invasive approach, and the deployment and implantation of the prosthesis are performed at this location, functionally replacing the natural valve.

[0054] More specifically, the prosthetic component 16 is the portion of the prosthetic structure 12 that defines the prosthetic conduit 13 for blood to pass through the device. A flexible prosthetic leaflet 14 is fixed inside the prosthetic component 16, which allows blood to flow unidirectionally inside the prosthetic conduit 13 in a direction parallel to the longitudinal axis ZZ of the prosthetic conduit 13. The prosthetic component 16 is preferably an elastic structure that is radially contractible relative to the axis ZZ and that tends to expand, for example, due to elastic recovery to a diameter greater than the maximum diameter of engagement (i.e., contact) between the free edges of the prosthetic leaflets 14 that maintain closure. The expansion of the prosthetic component 16 in the radial direction relative to the axis ZZ is limited by the retaining component 18, so that the natural leaflets of the heart valve are trapped between the outer surface of the prosthetic component 16 and the retaining component 18 as described above. In a variant, the prosthetic component 16 does not expand due to elastic recovery, but is forced to expand, for example, by inflating a balloon in the prosthetic component or using other techniques of a generally known type.

[0055] The connecting member 20 extends outwardly from the prosthetic component 16 and also secures the retaining member 18 to the prosthetic component 16 when the prosthetic component 16 is still in a radially retracted position relative to the axis ZZ within the heart cavity.

[0056] The retaining member 18 is a portion of the prosthetic structure 12 that resists and limits the free expansion of the prosthetic member 16, thereby preventing the prosthetic member from exceeding the maximum diameter that matches the engagement between the retaining prosthetic leaflets 14. In other words, the retaining member 18 defines the perimeter of the maximum expansion of the prosthetic member 16, and when the prosthetic member 16 reaches the perimeter, the retaining member applies a radially directed force and the force resists the surrounding retaining member, so that the natural leaflets of the heart valve remain trapped and clamped between the outer surface of the prosthetic member 16 and the retaining member 18. The retaining member 18 preferably has a substantially annular geometry and is substantially inextensible in the circumferential direction, that is, even when the prosthetic member 16 expands in the retaining member and applies radial forces to the retaining member, under the insertion of the natural leaflets, the retaining member 18 will not significantly change its circumferential expansion. The retaining member 18 can generally have any two-dimensional or three-dimensional form according to or not according to the anatomical structure of the natural atrioventricular valve. The retaining member 18 can have a closed annular configuration or can also have a partially open configuration. In this second case, the retaining member may again be resiliently closable, or may include a closure element, or may also maintain a partially open annular configuration in the implanted configuration of the valvular prosthesis 10 without re-establishing full annular integrity.

[0057] Retention member 18 is composed of one or more parts. Each part of retention member 18 can be provided separately from prosthetic member 16 and introduced into the heart chamber, so as to then be stably connected to the prosthetic member before expansion of the prosthetic member, which makes the valvular prosthesis stable in the final implantation configuration.

[0058] In various embodiments of the present invention, at least one component of the retaining member 18 can be pre-connected to the body of the prosthesis 16 at one end thereof via the connecting member 20, leaving the other end of the component free. In this way, at least one component of the retaining member is introduced into the heart cavity together with the prosthetic member 16. Since the retaining member is introduced in an open-ended configuration, at least one component of the retaining member can be positioned to surround the natural leaflet of the heart valve. Subsequently, the free end of the at least one component can be connected to the corresponding connecting member 20 to reconstruct the annular configuration of the implant.

[0059] exist Figure 1 In a non-limiting exemplary embodiment, the retaining member 18 is formed by two independent parts 2, which are provided with connecting members 26, which are engaged with the connecting members 20 extending from the prosthetic member 16 to fix the prosthetic member to the retaining member 18. The part 22 preferably has an elongated form, which has a corresponding main arcuate portion 24, which is basically in the form of two semi-rings, which are located in the same plane substantially perpendicular to the axis ZZ. However, it is not excluded that the retaining member can be formed by a single part, such as a closed ring, a spiral, a partially open ring, or a ring that is initially opened and can be closed again around the prosthetic member 16. Similarly, it is not excluded that the retaining member 18 is composed of three or more parts. If the retaining member 18 is formed by a plurality of parts, then for all or only some of the parts of the retaining member 18, the lengths, sizes (such as cross-sections and / or thicknesses) and / or configurations (such as curvatures and / or expansions in planes or spaces) of these parts are the same or completely different or partially different from each other.

[0060] exist Figure 1 In a non-limiting exemplary embodiment, each component 22 has two corresponding connecting elements 26 at its ends. Each connecting element 26 preferably comprises and even more preferably consists of a hollow structure, in particular but in a non-limiting manner, the hollow structure is essentially a hollow cylinder, even more preferably a hollow cylinder with a circular cross-section. The hollow structure of the connecting element 26 is configured to allow the free passage of a guide wire.

[0061] The connection element 26 has a shape and size that allows stable connection with the connection member 20. The connection members 20, which are preferably formed integrally with the prosthetic member 16 and protrude outward at the periphery, are each provided with a pair of pins 23. The pair of pins 23 are preferably parallel to each other and are sufficiently spaced apart from each other and are substantially aligned with the axis ZZ of the prosthesis itself to allow connection to the connection element 26, in particular by stable insertion into the hollow structure of the connection element 26. Each pin 23 is also preferably hollow to allow a guide wire to slide freely in the pin, preferably the same guide wire can also slide in the corresponding connection element 26.

[0062] exist Figure 1 In the final implant configuration of the valvular prosthesis 10 shown, the connecting elements 26 of each component 22 are oriented substantially perpendicularly to the main plane in which the main portion 24 lies. In other words, the connecting elements 26 are parallel to the axis ZZ. In this way, without damaging the connecting elements 26, the retaining members 18 are generally located in the same plane substantially perpendicular to the axis of the catheter 13, and therefore when the structural unit of the valvular prosthesis 10 has been reconstructed, the retaining members are substantially parallel to the annular plane of the native valve (that is, the plane defined by the annulus). Both the connecting elements 26 and the pins 23 present on the connecting member 20 can be provided with mutually engaging members, such as plates or teeth or other surface discontinuities, which can increase friction or block the connection between the pin and the hollow structure of the connecting element in a snap-fit ​​manner, thereby improving the stability of the connection.

[0063] The structure of each part 22 of the retaining member 18 can have a channel for the passage of a guide wire along all or at least some, preferably a greater part of its length. In this way, the positioning of the part 22 in the ventricular cavity behind the natural valve leaflet is simpler. In fact, with the known interventional techniques currently applied in clinical use, it is sufficient to arrange the guide wire along a path defined by the desired positioning of the segment and introduce the member by sliding it on the guide wire itself.

[0064] Figure 2 A possible embodiment of the part 22 of the retaining member 18, which is preferably in the form of an elongated part, is shown on an enlarged scale. This embodiment is particularly suitable for implantation surgery using transcatheter technology. In particular, Figure 2 The embodiment of the part 22 shown in refers to the case where the holding member 18 is subdivided into two parts. In any case, the following description can be applied in the same way to the case where the holding member 18 includes a different number of parts 22 (eg, a single part or more than two parts).

[0065] To simplify the explanation, Figure 2A single structural portion of a component 22 forming a retaining member 18 of a valvular prosthesis 10 is shown. This structural portion is substantially obtained by a tubular element 27, in the wall of which holes 28 are formed, the size and position of which are formed so as to give the structure the desired elastic behavior, which may be anisotropic and variable from segment to segment according to the position along the deployment direction of the component 22. Figure 2 In the illustrated embodiment, the holes 28 in the tubular element 27 define two sets of opposing ribs or skeletons 29. One function of the skeleton 29 is to provide the component with structural properties of longitudinal inextensibility and rigidity to out-of-plane deformation, which may be advantageous in certain applications. Of course, different types of holes 28 than those shown may be formed. For example, holes 28 may be formed that have different geometries and / or different sizes and / or different locations relative to the holes shown, for example, to provide a particular elastic response characteristic to the component. In an exemplary variation not shown, a single set of ribs 29 may be formed.

[0066] The structure of the component 22 formed in this way can then be Figure 2 2, wherein the main part 24 and in particular the skeleton 29 are curved to assume the geometry selected for the retaining member 18. The connecting element 26 can be deflected at an angle relative to the main part 24. The most suitable materials for structural components of this type with the requirements for optimal mechanical performance levels and the accompanying requirements for behavior in the elastic range (including large deformations) are in the range of superelastic alloys, such as the atomic alloy of nickel and titanium, which is commercially known as Nitinol. During construction, the structure can be easily obtained, for example, by means of a tube made of the selected alloy (such as Nitinol), in which the holes 28 are formed by laser cutting. The final form (such as Figure 2 In the finished part 22, in order to reduce the risk of damage to the native leaflets in the connection zone relative to the valvular prosthesis, the structure can be completely or only partially covered with tissue of biological nature (for example animal pericardium), or tissue of artificial nature (for example PET fabric or PTFE fabric, or polymer material, such as polyurethane or silicone-containing elastomeric material), or a combination of both tissue of biological nature and tissue of artificial nature (for example polymer material covered with fabric inside).

[0067] Figure 2Clearly shown are two connection elements 26 of preferably cylindrical form, which are deflected out of the main plane in which the main part 24 of the component 22 is located. These connection elements 26 are elements of the component 22, which are included in the connection mechanism of the prosthetic structure 12 relative to the valve prosthesis and are in particular connected to the connection members 20, which are preferably formed integrally with the prosthetic member 16 and protrude outwardly relative to the periphery of the prosthetic member, as described above. The connection elements 26 are pivotably joined to the main part 24 of the structure of the component 22 by means of a pivotable connection, which is also referred to here as an articulation or hinge and is generally designated as 30. The articulation 30 defines a connection that allows mutual pivoting between the connection elements 26 and the corresponding end 24a of the main part 24. In the specific example of the drawings, each articulation 30 is defined in particular by a transition zone between the main part 24 and each connection element 26. In other words, in the preferred embodiment shown in the figures, there is material continuity between the end 24a of the main portion 24 of the component 22 and the corresponding connecting element 26, because the hinge 30 is integrally formed as one piece with the structural portion of the main portion 24 and the connecting element 26. The hinge 30 allows the connecting element 26 to be hinged from a position in which the longitudinal axis of the connecting element 26 is substantially in the same plane as the main portion 24 of the component 22 and preferably substantially aligned with the adjacent end 24a of the main portion 24, to a position in which the connecting element 26 is deflected out of the main plane, such as Figure 2 . The hinge 30 is formed so that the connecting element 26 can be realigned with the plane of the main part 24, but cannot be deflected relative to this plane by more than a predetermined angle, for example but not limited to about 90°. After the component 22 is reconnected to the prosthetic component 16 of the valvular prosthesis 10, this solution prevents a greater deflection between the main plane of the component 22 and the axis ZZ of the prosthesis relative to this predetermined angle. In this way, when the valvular prosthesis 10 is finally released, the continuity of the contact of the retaining member 18 on the annulus of the native valve and the correct mutual alignment between the retaining member 18 and the prosthetic component 16 are ensured.

[0068] Figures 3 to 8A first embodiment of the hinge 30 is shown in more detail, which is indicated in this particular case as the hinge 30a. This embodiment is given by way of example, without limiting the generality of the invention in any way. The hinge 30a is formed by means of cuts and holes in the tubular element 27, which maintain the structural continuity of the part 22 through a flexible plate 32, which is positioned on the arch back of the hinge 30a, that is, in the area of ​​the part 22 where the radius of curvature is large when the hinge 30a is bent. In other words, the flexible plate 32 is a part of the tubular element 27 that, for any deflection angle of the connecting element 26, creates physical continuity between the main part 24 and the connecting element 26 via the corresponding hinge 30a.

[0069] The plate 32 may have different thicknesses and / or forms in different parts of its length, which defines different functional objectives for each section or portion of the plate itself. Figures 3 to 8 In the embodiment shown, the flexible plate 32 has a constant thickness corresponding to the thickness of the tubular element 27 in which it is formed, the flexible plate having a narrower section 32a joined to the tubular section of the connecting element 26 and a wider section 32b joined to the tubular section of the main part 24. Two wings 34 extend transversely between the narrower section 32a and the wider section 32b of the flexible plate 32, the two wings having an arcuate edge 35 facing the wider section 32b. The narrower section 32a is the most deformable portion of the plate 32, that is to say, the portion that allows the hinge 30a to flex at an acceptable stress level of the material, so as to allow the connecting element 26 to transition from one of two extreme configurations to the other, namely, Figures 6 to 8 The extended configuration shown, which is coplanar with the main part 24 and preferably aligned with the end 24a of this main part, and the terminal deflection angle allowed by the geometry of the hinge 30a (more generally by any hinge 30 described), in the region of the hinge, the hinge cannot deflect further and becomes a hinge with substantially infinite angular stiffness. The purpose of the part with two wings 34 is to engage stably with the connecting element 26, so as to engage in a shaped recess 37 formed at the edge of the connecting element 26 itself, which allows the wings 34 to connect to the shoulder 39 delimiting this recess. To this end, the radius of the main part of the profile 35 of the wings 34 is similar to the internal radius of the tubular element 27. The part with two wings 34 is then connected in a secure manner to the main part 24 of the component 22 via the widest part 32b of the plate 32, which is characterized by a more resistant section, which is therefore more suitable for supporting and transmitting the cyclic stresses applied to the retaining member 18 during operation of the prosthesis 10.

[0070] In more detail, when the hinge portion 30a is in Figure 4 and Figure 5 In the deflected configuration that it can assume as shown (for example the configuration assumed when the valvular prosthesis 10 is definitively implanted), the arcuate edge 35 is intended to move in the intra-arch region of the hinge 30a into abutment and / or interlock against a corresponding inner wall 36 of the tubular element 27. In this position, the end lip 38 of the main portion 24 bears against a corresponding portion of a wall 40 of the connecting element 26, which is situated diametrically opposite the plate 32. In the same rear wall 40 or more generally on the connecting element 26, one or more tongues 42 may be formed for engagement with one of the pins 23 present on the connecting member 20, as described above. The axial positioning of the lip 38 relative to the plate 32 defines a mechanical lock that creates a bending limit to the hinge 30a, thus acting as an angular limit stop. The connection of the wing 34 with the shoulder 39 of the shaped recess 37 supported on the inner wall 36 of the tubular element 27 cooperates with the width of the section of the resistant maximum portion 32b of the plate 32, the soffit of which then moves against the upper end of the wall 40, so as to also provide a firm torsional stability to the hinge 30a. Thus, the portion of the hinge 30a constituted by the portion with the wing 34 and the resistant maximum portion 32b of the plate 32 defines a resistant structural connection element between the main portion 24 of the part 22 and the connection element 26.

[0071] Fig. 9 and Fig.10 A variant of the hinge 30b is shown, also given by way of non-limiting example. In the figures, the same reference numerals correspond to the same elements as those described above. In this case, the hinge 30b is also formed by means of cutouts and holes in the tubular element 27, which maintain the structural continuity of a flexible plate 44, which is positioned on the arch back of the hinge 30b, that is to say, in the area of ​​the part 22 that has the greatest radius of curvature when the hinge 30b is bent. In other words, the flexible plate 44 is the part of the tubular element 27 that integrally joins the main part 24 to the connecting element 26 of the corresponding hinge 30b.

[0072] In this variant, the flexible plate 44 preferably has the same width or thickness over its entire range from the end engaging with the tubular section of the connecting element 26 to the end engaging with the tubular section of the main part 24. In a variant not shown, the flexible plate 44 is formed into portions having different widths or thicknesses in order to impart a bending behavior having a non-uniform curvature thereon, according to the methods and features indicated above with respect to the hinge 30a.

[0073] At the side opposite to the flexible plate 44, the tubular section of the connecting element 26 and the tubular section of the main part 24 are cut in a mirrored manner in the manner of a flute mouthpiece (i.e. inclined relative to the axis of the tubular section) to define two opposite supporting edges 46, 47. These two supporting edges 46, 47 are joined to one another near the flexible plate 44 by a narrow flexible section 48 obtained by enlarging the longitudinal cuts with grooves 49, which define the flexible plate 44 and isolate it from the rest of the wall of the tubular element 27.

[0074] When the hinge portion 30b is Fig.10 When the extended configuration shown in solid lines in the figure is bent to the configuration assumed in the implanted prosthesis 10, in which the main part 24 is rotated according to arrow A so as to enter the dotted position 24', the two supporting edges 46, 47 move to abut each other, thereby defining a mechanical locking action that limits the bending of the hinge 30b, acting as an angle limiting stop. At the same time, the two flexible sections 48 spaced laterally relative to the connecting element 26 on the transverse rotation axis of the main part 24 provide the hinge 30b with robust torsional stability. The transverse dimensions of the section of the flexible plate 44 that at least partially resists the pivoting action between the main part 24 and the connecting element 26 also contribute to this.

[0075] Fig.11 and Fig.12 Another variant of the hinge 30c is shown, also given by way of non-limiting example. In the figures, the same reference numerals correspond to the same elements as those described above. In this case, the hinge 30c is also constituted by a cutout and a hole in the tubular element 27, which maintains structural continuity via a flexible plate 50, which is positioned on the arch back of the hinge 30c, that is to say, in the area of ​​the part 22 that has the maximum radius of curvature when the hinge 30c is bent. In other words, the flexible plate 50 is the part of the tubular element 27 that, for any angle of deflection of the connecting element 26, forms a physical continuity between the main part 24 and the connecting element 26 of the corresponding hinge 30c.

[0076] In this variant, the flexible sheet 50 may have the same width or thickness over its entire extent, or may be shaped into sections having different widths, thicknesses or in any case different resistances, to give it a bending behavior with a non-uniform curvature, thus having the behavior and characteristics described above with reference to the hinge 30a. The example of the figures shows that the flexible sheet 50 comprises a section 50a that is narrower and longer than a section 50b, which gives the sheet 50 a different bending behavior.

[0077] At opposite sides of the flexible plate 50, the tubular sections of the connecting element 26 and the main part 24 are cut in a mirrored manner in the manner of a flute mouthpiece (i.e. inclined relative to the axis of the tubular sections) to define two opposite supporting edges 52, 53. The supporting edge 52 formed at the end of the main part 24 extends until connected to the edge of the cutout 54 defining the portion of the flexible plate 50 extending from the main part 24. The supporting edge 53 extends from the two parts of the connecting element 26 until connected to the two lateral recesses 54, forming two corresponding peaks 58. In the region of the recesses 54, two wings 56 extend from both sides of the flexible plate 50, which protrude towards the connecting element 26 and face each other in the direction of the recesses 54.

[0078] When the hinge portion 30c is Fig.12 When the extended configuration shown in solid lines is bent to reach the configuration presented in the implanted prosthesis 10, in which the main part 24 is rotated according to arrow A to enter the dotted position 24', the two supporting edges 52, 53 move to abut against each other, thereby defining a mechanical locking action that limits the bending of the hinge 30c, so as to act as an angle limiting stop. The design of the wings 56 is such that, during this rotation of the hinge 30c, these wings slide in the recess defined by the edges of the cutout 54, but in any case remain supported on the peak 58, thereby distributing the stresses transmitted from the main part 24 to the connecting element 26 of the part 22 during the operation of the implanted prosthesis 10 over a more resistant section. In this way, the wings 56 significantly contribute to the stability, fatigue resistance and stability (including torsional stability) of the hinge 30c. The flexible plate 50 also resists the pivoting action between the main part 24 and the connecting element 26, which also contributes to the overall stability of the hinge 30c.

[0079] In another variation of this embodiment of the present invention, the hinge can be designed so that Fig.12 In the extended position shown in solid lines in FIG. 1 , the ends of the wings 56 prevent the hinge 30 c from bending in the direction opposite to the arrow A by interfering with the corresponding peaks 58, thereby stabilizing the fixing action which prevents errors during the assembly or installation of the component 22 and therefore the assembly or installation of the retaining member 18 of the valve prosthesis 10, or prevents the application of excessive stress to the plate 50 itself so that the hinge is excessively bent in a direction without an angular mechanical locking device.

[0080] In another variation of this embodiment of the invention, the wings 56 and recesses 54 are designed so that, in the configuration presented by the hinge 30c in the implanted prosthesis 10, the wings 56 lock into the corresponding recesses 54 to block the hinge 30c in a bent position, thereby providing the hinge with equally increased stability and fatigue resistance, but also preventing the hinge 30c from re-expanding to an extended position.

[0081] Fig.13 and Fig.14 Another variant of the hinge 30d is shown, also given by way of non-limiting example. In the figures, the same reference numerals correspond to the same elements as those described above. In this case, the hinge 30d is also constructed by means of cutouts and holes in the tubular element 27, which maintain the structural continuity of a flexible plate 60 positioned on the arch back of the hinge 30d, as defined above. In this case, the flexible plate 60 is also a part of the tubular element 27 that forms a physical continuity between the main part 24 and the connecting element 26 corresponding to the hinge 30d for any deflection angle of the connecting element 26.

[0082] In this variant, the flexible plate 60 has the same width or thickness over its entire extent. Of course, in this case, the flexible plate 60 can also be shaped in sections with different widths or thicknesses to give it a bending behavior with a non-uniform curvature, thereby presenting the behavior and characteristics described above with reference to the hinge 30a. At the opposite side of the flexible plate 60, the tubular section of the connecting element 26 is shaped with two protrusions 61, each defining a hook 62 at each side of the flexible plate 60. The protrusions 61 define corresponding recesses 64, which are connected to the edge 66 of the connecting element 26. At a position radially opposite to the flexible plate 60, the edge 66 has a protruding support lip 68.

[0083] The end of the main part 24 is shaped with two protrusions 70, each provided with a hook 72, the profile of which is such that, in the position where the hinge 30d (not shown) is bent through about 90°, the hook engages with the corresponding hook 62, being introduced into its recess 64. In this bent position, the lip 68 moves to a state of being supported against a portion of the rear wall 74 of the main part 24, which is located radially opposite to the flexible plate 60. The support between the lip 68 and the rear wall 74 forms a mechanical lock that defines the bending limit of the hinge 30d, so as to act as an angular limit stop. The engagement of the protrusion 70 with the hook 62 provides the hinge 30d with a firm torsional stability and a better distribution of the loads transmitted from the main part 24 of the component 22 to the connecting element 26.

[0084] The design of the protrusions 61 and 70 and the profile of the recesses and hooks 62 and 72 may be modified to provide a different engagement between the two elements of the hinge 30d and / or to increase the support provided by the connection of the surfaces.

[0085] Fig.15 and Fig.16Another variant of the hinge 30e is shown, also given by way of non-limiting example. In the figures, the same reference numerals correspond to the same elements as those described above. In this case, the hinge 30e is also formed by means of cutouts and holes in the tubular element 27. In this embodiment, no flexible hinge plate is provided, and the structural continuity between the main part 24 and the connecting element 26 is provided by two opposite S-shaped wall segments 78, which are symmetrical with respect to a longitudinal plane orthogonal to the axis of rotation of the hinge 30e. Each S-shaped wall segment 78 is formed so as to form a first loop 80 on the connecting element 26. After forming the first loop 80, the S-shaped wall segment 78 is bent to form a second loop 82, at the end of which the S-shaped wall segment 78 is joined to the main part 24. An extension 84 extends from the main part 24, which forms two lateral fingers 86, which are shaped so that each lateral finger 86 is connected in one of the first loops 80 of the S-shaped wall section 78 in a position in which the hinge 30e (not shown) is bent through about 90°. In the bent position, the support lip 88 of the connecting element 26 is supported against a portion of the rear wall 90 of the main part 24 located on the side of the extension 84. The support between the lip 88 and the rear wall 90 forms a mechanical locking action that defines the bending limit of the hinge 30e, so as to act as an angular limit stop. The engagement of the fingers 86 in the first loop 80 provides a firm torsional stability to the hinge 30e and particularly significantly unloads the deformable part of the hinge in terms of fatigue loads transmitted from the main part 24 of the component 22 to the connecting element 26.

[0086] By appropriate design of the lateral fingers 86 and the profile of the ring 80, the hinge can be made irreversible, for example by a geometric discontinuity creating an undercut, so that a permanent mechanical connection between the two elements prevents the hinge from returning from the flexed position shown to the extended position shown.

[0087] However, despite Fig.15 and Fig.16 , the main part 24 provided with a finger-like portion 86 has conventionally been shown on the right side and the connecting element 26 formed with the first ring 80 has been shown on the left side, but the possibility of flipping the hinge 30e so that the finger-like portion 86 is formed on the connecting element 26 and the first ring 80 is formed on the main part 24 is not excluded.

[0088] Of course, the principle of the invention remaining unchanged, the forms and details of construction of the embodiments may vary widely with respect to those described and illustrated, without departing from the scope of the invention.

Claims

1. A valve prosthesis for a heart valve, comprising: a prosthetic component (16) supporting a prosthetic leaflet (14) capable of reproducing the function of a valve leaflet of a native heart valve; as well as a retaining member (18) intended to at least partially fix the prosthetic member (16) relative to a portion of cardiac tissue in an implanted state of the valvular prosthesis (10), wherein the retaining member (18) comprises at least one component (22) having a main portion (24), an end portion (24a) of the main portion being engaged to at least one connecting element (26) via a pivotable connection (30) to connect the retaining member (18) to the prosthetic member (16), The connecting element (26) and the main part (24) are connected in a pivotable manner relative to each other so as to pivot from a first position to a second position in which the connecting element (26) is deflected relative to the end (24a) of the main part (24), The component (22) also includes a connecting member (34, 39; 54, 56) to stably connect the main part (24) and the connecting element (26) in the second position, thereby limiting the stress to which the pivotable connection (30) is subjected in an operating state of the valve prosthesis.

2. The valve prosthesis according to claim 1, wherein: The pivotable connection (30) between the connecting element (26) and the main portion (24) includes at least one flexible section (32, 44, 50, 60, 78) that maintains physical continuity between the main portion (24) and the connecting element (26).

3. The valve prosthesis according to claim 2, wherein: The at least one flexible section (32, 44, 50, 60) is arranged on the arch back of the pivotable connection (30).

4. A valve prosthesis for a heart valve, comprising: a prosthetic component (16) supporting a prosthetic leaflet (14) capable of reproducing the function of a valve leaflet of a native heart valve, and a retaining member (18) intended to at least partially fix the prosthetic member (16) relative to a portion of cardiac tissue in an implanted state of the valvular prosthesis (10), wherein the retaining member comprises at least one component (22) having a main portion (24), one end (24a) of the main portion being engaged to at least one connecting element (26) via a pivotable connection (30) to connect the retaining member (18) to the prosthetic member (16), The connecting element (26) and the main part (24) are connected in such a way that they can be pivoted relative to each other from a first position to at least one second position, in which at least one second position the connecting element (26) is deflected relative to the end (24a) of the main part (24), And wherein the pivotable connection (30) between the connecting element (26) and the main part (24) includes a flexible section (32, 44, 50, 60) located in the arch back area of ​​the pivotable connection, which maintains physical continuity between the main part (24) and the connecting element (26).

5. The valve prosthesis according to any one of claims 2 to 4, wherein: The flexible section includes a smaller resistance portion (32a, 50a) and a larger resistance portion (32b, 50b), wherein the smaller resistance portion provides a predetermined flexibility to the pivotable connection (30) during movement from the first position to the second position, and the larger resistance portion limits the resistance of the pivotable connection (30) to the stress to which the pivotable connection is subjected when the valve prosthesis is implanted.

6. The valve prosthesis according to claim 5, wherein: The flexible section is a flexible plate (32, 50), the flexible plate having a first portion (32a, 50a) and a second portion (32b, 50b), the first portion having a first cross-section, the second portion having a second cross-section larger than the first cross-section, the first portion and the second portion defining a less resistant portion and a more resistant portion, respectively.

7. The valve prosthesis according to any one of claims 2 to 6, wherein: The flexible sections (32, 44, 50, 60) are inextensible.

8. The valve prosthesis according to any one of claims 2 to 7, wherein: The flexible section (32, 44, 50, 60) is integrally formed with the component (22), and the flexible section is formed in one piece with the main part (24) and the connecting element (26).

9. The valve prosthesis according to any one of claims 2 to 8, wherein: The flexible section (32, 44, 50, 60) is arranged in the region of the arch of the pivotable connection (30) between the connecting element (26) and the main part (24).

10. A valvular prosthesis according to any of the preceding claims and when dependent on claim 3, the component (22) further comprising a connecting member (34, 39; 54, 56) to stably connect the main portion (24) and the connecting element (26) in the second position, thereby limiting the stresses to which the pivotable connection (30) is subjected in an operating state of the valvular prosthesis, wherein The connecting member comprises a wing (34) which projects laterally from the flexible section and is configured to engage in at least one corresponding cavity (37) formed in the connecting element (26).

11. Valve prosthesis according to any one of the preceding claims, wherein: The at least one connecting element (26) is resiliently connected to the main portion (24) of the component (22) such that a thrust is applied to the component (22) in the direction of the first position.

12. A valve prosthesis according to any one of the preceding claims, wherein: The pivotable connection (30) is formed by means of cutouts and holes in a tubular element (27) which maintain structural continuity between the main portion (24) of the component (22) and the connecting element (26).

13. The valve prosthesis according to claim 12, wherein: The tubular element (27) integrally defines the component (22).

14. A valve prosthesis according to any one of the preceding claims, wherein: The second position corresponds to a maximum deflection position, which is present at least in the implanted state of the prosthesis, and in which the connecting element (26) is deflected by a maximum angle relative to the end (24a) of the main part (24), and the connecting element cannot be further deflected beyond the maximum angle.

15. A method for implanting a valve prosthesis for a heart valve, comprising the steps of: - providing a prosthetic component (16) which supports prosthetic leaflets (14) which are capable of reproducing the function of the valve leaflets of a natural heart valve, - providing a retaining member (18) intended to at least partially fix the prosthetic member (16) relative to a portion of cardiac tissue in an implanted state of the valvular prosthesis (10), wherein the retaining member (18) comprises at least one component (22) having a main portion (24), one end (24a) of which is joined to at least one connecting element (26) via a pivotable connection (30) in order to connect the retaining member (18) to the prosthetic member (16), - configuring the main portion (24) of the retaining member (18) and the connecting element (26) to be in a first position in which the main portion (24) of the component (22) and the connecting element (26) present a configuration having a minimum space requirement matching their passage in the conduit, - introducing the component (22) into the heart chamber by means of the channel in the catheter, - configuring the main portion (24) of the retaining member (18) and the connecting element (26) to be in a second position in which the connecting element (26) is deflected relative to the end (24a) of the main portion (24), - stably connecting the main part (24) and the connecting element (26) in the second position by means of connecting means (34, 39; 54, 56) in order to limit the stresses to which the pivotable connection (30) is subjected in the operating state of the valvular prosthesis, - introducing the prosthetic component (16) into the heart chamber, - at least partially fixing the prosthetic component (16) relative to a portion of cardiac tissue by means of the retaining component (18) to achieve an implanted state of the valvular prosthesis (10).

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