Heart valve prosthesis and method for placing said prosthesis in an implant device - Patents.com

Abstract

A heart valve prosthesis to be implanted by transcatheter surgery, comprising an expandable central body (16) and a housing (18) having one or more auxiliary parts (22), said central body being provided with at least one elastically flexible arm (19) to which a connection block (20a, 20b, 120a, 120b, 220, 320) is fixed for connecting each of the auxiliary parts of said housing (18) to said central body (16), said arms being formed such that each arm can assume an expanded configuration in which it returns without any constraint and a compact configuration which allows the prosthesis to be placed by transcatheter surgery, each connection block being provided with an interconnection mechanism (40a, 40b, 140a, 140b, 242, 340) capable of selectively maintaining the arm to which it is fixed in said compact configuration.

Description

[Technical field]

[0001] The present invention relates to the field of heart valve prostheses.

[0002] The present invention has been developed in particular, but not exclusively, with respect to a heart valve prosthesis intended to replace the physiological function of an incompetent heart valve, in particular an atrioventricular heart valve, which has been specially developed for use by a transcatheter implantation procedure.

[0003] The invention further relates to a method for deploying such a prosthesis for a heart valve within an implantation device that can be used in a transcatheter implantation procedure. [Background technology]

[0004] Heart valves are complex and delicate components that regulate the correct functioning of the human heart. Their main purpose is to allow one-way blood flow within the heart chambers, both during the filling phase (diastole) and the emptying phase (systole).

[0005] To optimize the efficiency of pumping blood, the heart is divided into two distinct compartments, the right and left compartments, each of which is divided into two chambers, the atrium and the ventricle. The right compartment of the heart, consisting of the right atrium and right ventricle, returns blood from the peripheral circulation and sends it to the pulmonary circulation for oxygenation. The left compartment, similarly divided into the left atrium and left ventricle, supplies blood to the peripheral circulation and returns oxygenated blood from the pulmonary circulation to the systemic circulation.

[0006] To ensure that blood flows in one direction within the heart, valves are located at the outlet of each ventricle and atrium. The valves located at the outlet of the atria are called atrioventricular valves, as they connect the atria and ventricles on each side of the heart. On the right side of the heart, this valve is also called the tricuspid valve, while on the left side it is usually called the mitral valve. Finally, the valve located at the outlet of the right ventricle is called the pulmonary valve, and the valve at the outlet of the left ventricle is called the aortic valve.

[0007] Conditions that alter the function of the heart valves are among the most serious in the cardiovascular field. Among them, mitral valve insufficiency, or the inability of the mitral valve to close completely, is a very debilitating valvular condition because it reduces the efficiency of the pumping action of the left side of the heart, which is responsible for circulating blood throughout the body.

[0008] With the current state of the art, the standard of care to treat severe valve insufficiency is to replace the valve with an implanted prosthesis. In other cases, mainly in the case of mitral valve insufficiency, valve repair is performed. In both cases, an open-heart surgery is performed that allows direct access to the insufficient valve. This operation requires the heart to be temporarily stopped and an artificial extracorporeal blood circulation to be generated using an appropriate pump and oxygen exchanger. Despite improvements in the techniques for managing cardiac arrest and improvements in extracorporeal circulation systems, open-heart treatments carry risks due to their invasiveness and the duration of the operation. In fact, both repair and replacement implanted prostheses typically used in conventional surgery usually require lengthy operations to be fixed at the implant site using specific suturing techniques. In some cases, the patient's overall condition, such as their advanced age or coexisting medical conditions, makes surgical treatment impossible.

[0009] To overcome these limitations, minimally invasive interventional procedures have been developed recently, the so-called transcatheter procedures. For this purpose, a radially foldable prosthesis is used that can self-fixate at the implantation site. This prosthesis can be implanted by a catheter that can be moved through the vascular system to reach the implantation site from a remote access made in a peripheral vessel, for example a vein or the femoral artery, and release the cardiac prosthesis. This allows the correction of valve insufficiency with limited use of surgery, while the heart is still beating. Currently, transcatheter techniques are only used clinically for the treatment of the aortic valve.

[0010] The situation is different when it comes to the treatment of atrioventricular valve dysfunction, and in particular mitral regurgitation: the complex anatomical configuration of the valve and its surrounding structures, the variety of pathologies that differ significantly from each other and that directly or indirectly affect the valve, make it extremely difficult to meet the requirements for a safe and effective implantation into the mitral valve via a transcatheter route.

[0011] In recent years, numerous transcatheter prostheses for atrioventricular valves have been developed, which can be implanted according to different accesses and procedures. The first implantation method, especially adapted for the mitral valve, creates an access to the native valve to be replaced via the apex of the left ventricle, a method already developed by the same applicant (WO2014 / 080338 and WO2014 / 080339). In this procedure, a chest incision is made to expose the apex of the left ventricle. Via the apex, direct access to the ventricle is surgically obtained, possibly by temporarily placing an apical port, i.e. limited to the duration of the procedure. Via the apical access, the catheters necessary to carry out the implantation procedure are then inserted at any time.

[0012] In another methodology developed by the same applicant (WO2021 / 014400), transseptal access is provided instead. The term "transseptal access" is intended to be understood as an access to the atrioventricular valve to be replaced, starting from the peripheral femoral vein and ascending up the inferior vena cava to the right atrium. In the case of the mitral valve, it is also necessary to reach the left atrium through an opening created in the septum between the two atria in an interventional procedure. The left atrium allows antegrade access to the native mitral valve. In this way, damage to the left ventricle, i.e. perforation, associated with a transapical procedure allowing access to the mitral valve from the ventricular side, i.e. retrogradely, is prevented.

[0013] Valve prostheses implanted via a transcatheter route have been specially studied so that they can assume a configuration of minimal radial dimensions, so that they can be inserted into a catheter for navigation within the patient's cardiovascular system. Patent application WO2015 / 118464 by the same applicant describes, for example, a transcatheter prosthesis particularly suitable for this purpose. This prosthesis has a support and connection structure with the native valve and a group of flexible prosthetic leaflets fixed therein. The prosthesis structure consists in particular of a central body of valve action, a receiving part formed by two or more arcuate segments, and a connecting block attached to the end of a connecting arm fixedly connected to the structure of the central body, providing mechanical continuity between the central body and the arcuate segments. The arms, like the entire structure of the central body, are made of a material with superelastic properties, so that when the prosthesis is attached to the distal end of a catheter, as described in WO2021 / 014400, they can be temporarily deformed into an insertion configuration that allows them to move within the human cardiovascular system, such as the femoral vein or the inferior vena cava. When the catheter carrying the prosthesis reaches the implantation site or the native valve to be treated, the arms are spring-loaded to the configuration required for implanting the prosthesis. As regards the release system of the transcatheter system described in patent application WO2021 / 014400, the solution adopted to keep the connecting arms in the deformed configuration is also to insert them into the distal capsule that already receives the compressed central body. Reorienting the connecting block is done by partially disengaging the catheter capsule, which allows both the connecting block and the connecting arms to be exposed and released.

[0014] In this known solution, the distal capsule of the catheter must be long enough to cover the deformed connecting arms and the connection block. Since the distal capsule is the stiffest part of the entire catheter, the longer its length, the less navigable the catheter itself is, since it is not suitable to overcome the tortuous anatomical features present to reach the implantation site from the peripheral access. Moreover, since the capsule's dimensions are determined by the diameter of the folded prosthesis inside the capsule, it is oversized relative to the connection block, so that, in the distal capsule, the connection block is not perfectly aligned with the axis of the catheter and therefore with the forward direction. This misalignment increases the friction between the connection block and the guidewire sliding in it, increasing the resistance to the forward movement of the catheter and increasing the risk of particulate release from the block itself or from the guidewire on which it slides. Summary of the Invention

[0015] One of the objectives of the present invention is to solve the problems of the prior art. In particular, it is intended to provide a heart valve prosthesis that is collapsible and safe and stable during the release procedure from the appropriate implantation catheter. Another objective is to allow easy and controlled navigation of the implantation catheter carrying the collapsible prosthesis in order to overcome in a controlled manner the tortuous anatomical features encountered during the advancement of the catheter itself from the peripheral vascular access to the native valve to be treated. Another objective is to provide a device that is economical, simple, reliable and safe to use.

[0016] To achieve these and other objects, the present application relates to a prosthesis as claimed in the accompanying claims 1 to 9 and to a method for deploying the prosthesis in an implantable device for transcatheter surgery as claimed in claim 10.

[0017] In particular, a prosthesis for transcatheter surgery is described, in which each connection block between the central body of the prosthesis and the receiving part is provided with an interconnection mechanism suitable for selectively maintaining the connection blocks themselves together with the connection arms to which they are fixed in a compact configuration. In this compact configuration, the connection blocks are preferably arranged to have an overall radial dimension smaller than that of the central body in the distal capsule. In this compact configuration, the connection blocks are preferably oriented substantially coaxially with respect to the implantation catheter. In this way, it is ensured that the connection blocks cannot in any way impede or interfere with the advancement of the catheter in the patient's circulatory system. Furthermore, since this interconnection mechanism keeps the compact configuration stable until the implanter intentionally releases the interconnection mechanism, the length of the distal capsule of the implantation catheter can be approximately equal to the length of the central body of the collapsed prosthesis, i.e. significantly shorter than in the prior art. In this way, the implantation catheter becomes more flexible and therefore more suitable to overcome tortuous anatomical features encountered when reaching the implantation site of the prosthesis. [Brief description of the drawings]

[0018] Further characteristics and advantages will become apparent from the following detailed description of preferred embodiments of the invention, given purely by way of non-limiting example with reference to the accompanying drawings, in which: FIG. 1 is an exploded view showing a schematic illustration of a heart valve prosthesis of the invention in an expanded implanted configuration according to a first embodiment; FIG. 2 shows the heart valve prosthesis of FIG. 1 with only the central body in the distal capsule and with the connecting blocks in a compact configuration with the interconnection mechanism, shown in a ready-to-implant configuration in dashed lines; 3a and 3b show two connection blocks each with a mutual coupling mechanism according to a first embodiment; FIG. 4 shows two connection blocks similar to those shown in FIG. 3a and FIG. 3b, which are connected together to achieve a compact configuration; 5a and 5b show two connection blocks each with a mutual coupling mechanism according to a second embodiment; FIG. 6 shows two connection blocks similar to those shown in FIG. 5a and FIG. 5b, which are connected together to achieve a compact configuration; FIG. 7 shows one of two connection blocks with a symmetrical interconnection mechanism according to a third embodiment; FIG. 8 shows one of two connection blocks with a symmetrical interconnection mechanism according to a fourth embodiment; FIG. 9 shows two connection blocks similar to the one shown in FIG. 8 connected together to achieve a compact configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Referring now to the drawings, FIG. 1 shows an implantable prosthesis 10 used to replace the function of the atrioventricular valve.

[0020] The prosthesis 10 comprises a prosthesis structure 12 for supporting and connecting with the native valve and fixed therein a group of flexible prosthesis valves 14. The prosthesis structure 12 comprises in particular a central body 16, a receiving portion 18 and connection blocks 20a, 20b for mechanically connecting the receiving portion 18 to the central body 16 via a series of connection arms 19 fixedly joined to the central body.

[0021] The prosthesis structure 12, as well as each of its components, is configured to be foldable without adversely affecting the safety and functionality of the cardiac prosthesis. Thus, it is possible to temporarily reduce the radial obstruction of the prosthesis 10 so that it can be introduced into the cardiac cavity through small vascular accesses compatible with minimally invasive surgical methods, in particular by transcatheter procedures for positioning and implanting the cardiac prosthesis, such as by transfemoral access, typical of the tricuspid valve, and by transseptal access. In other words, the cardiac prosthesis can be inserted into a catheter with a low radial profile that can carry the prosthesis from a minimally invasive peripheral vascular access to the inside of the cardiac cavity, near the implantation site, where it can be deployed and implanted to functionally replace the native valve.

[0022] More specifically, the central body 16 is part of the prosthetic structure that delimits a conduit for blood to pass through the device. A flexible prosthetic valve 14 that allows unidirectional blood flow in the conduit is fixed in the central body 16, as known for example from Italian patent no. 20140204 by the same applicant.

[0023] The central body 16 is a radially collapsible resilient structure that, as a result of springback, tends to expand to a diameter greater than that of the receiving portion 18 .

[0024] The central body 16 is provided with an arm 19 on which the connection blocks 20a, 20b are mounted. The connection blocks are stably and permanently fixed to the arm 19. The fixing is preferably mechanical and preferably reversible, although different fixing methods such as welding are not excluded. It is also not excluded that the connection blocks and the arms are one piece.

[0025] The receiving portion 18 is the portion of the prosthesis structure 10 that resists and limits the free expansion of the central body 16, preventing it from exceeding a maximum diameter compatible with maintaining coaptation between the prosthetic valves 14. The receiving portion 18 has a substantially annular shape and is longitudinally non-extensible, i.e., its peripheral expansion is not significantly altered even when the central body 16 is internally expanded by the application of an outward radial force.

[0026] The housing 18 is preferably divided into two mutually separate, substantially arcuate sub-components 22. Each sub-component 22 is selectively connectable to a connecting block 20a, 20b and is fixedly connected to the connecting block 20a, 20b in the final implanted configuration.

[0027] At each end 24 of each auxiliary part 22 there is provided a coupling part 26. The connecting blocks 20a, 20b are provided with pins 28 which are received in axial holes 27 in the coupling part 26. It is clear that the pin / hole connection can alternatively consist of a pin at the end of the auxiliary part 22 and a hole, preferably cylindrical, in the connecting block 20a, 20b. More generally, the pin / hole connection is not intended to be limiting with regard to the general nature of the solution but has merely exemplary purposes.

[0028] During use, the leaflets of the native valve remain trapped within the connection between the central body 16 and the housing 18 .

[0029] Referring now to FIG. 2, the arms 19 are flexible to allow for implantation via a transcatheter procedure. In particular, the arms are elastically deformable and can be moved from an expanded configuration (dashed lines in FIG. 2), which corresponds to a use configuration of the prosthesis, to a compact configuration (shown in solid lines) that allows the central body of the prosthesis attached to the distal end of an implantation catheter to be advanced into the patient's cardiovascular system. In the expanded configuration, each arm 19 is curved, which increases the overall radial encumbrance of the prosthesis. However, in the compact configuration, each arm 19 is disposed approximately parallel to the axis A of the prosthesis. The arms 19 are preferably made of a material with superelastic properties, such as Nitinol, which allows them to spring back into the expanded configuration when unconstrained.

[0030] FIG. 2 shows the prosthesis structure 12 compacted in a distal capsule 30 of the implanted catheter, which covers only the central body 16. The distal capsule 30 according to this embodiment is therefore shorter in length than the distal capsules of the prior art. The connecting arms 19 and the connection blocks 20a, 20b are kept in a compact configuration aligned with the axis of the catheter by an interconnection mechanism formed directly on the connection blocks themselves. This interconnection mechanism allows selectively maintaining the configuration of the connection blocks parallel to the axis of the catheter and therefore in an optimal configuration with minimal resistance to the advancement of the catheter. This solution also allows the length of the capsule to be reduced to a minimum dimension. Since this distal capsule is the stiffest part with respect to catheter deflection, especially with respect to its immediate proximal part, this results in a catheter that is generally more flexible than previously known catheters and therefore characterized by a higher level of navigability, especially in tortuous anatomical structures.

[0031] A suitable remotely operable mechanism maintains the connecting blocks in a joined state and allows them to be deliberately released to again assume the expanded configuration, which is required to perform the final step of implanting the prosthesis.

[0032] Some examples of interconnection mechanisms that may be provided on the connection blocks are described below with reference to Figures 3 to 8. The interconnection mechanisms allow the connection blocks 20a, 20b to be joined and fixed to one another, thus allowing the blocks themselves and the arms 19 to be kept in a compact configuration suitable for enabling the catheter to be navigated within the patient's cardiovascular system to reach the implantation site.

[0033] In a first embodiment, shown in detail in figures 3a, 3b and 4, the two connection blocks 20a, 20b are formed differently from each other. The connection block 20a is provided with a protrusion 38a on its face 36a, which faces the connection block 20b in the above-mentioned compact configuration. Similarly, the connection block 20b is provided with a protrusion 38b on its face 36b, which faces the connection block 20a in the compact configuration. Each block is provided with a respective through hole 40a, 40b, which is more specifically located on the respective protrusion 38a, 38b constituting the coupling mechanism. The two protrusions and the holes are formed in such a way that, when the two connection blocks are next to each other, the respective protrusions are adjacent to each other and the respective holes are coaxial with each other. In this way, it is possible to insert the same connection element, for example, as a non-limiting example, a guide wire 50, into both, thereby holding the blocks side by side. Each block is subjected to equal and opposite elastic forces by its respective arm 19, so that the blocks remain in the compact configuration of FIG. 2b. In this position, the axis of the hole is approximately coincident with the axis A of the prosthesis. In FIG. 4, the two connecting blocks 20a and 20b are shown joined by a guide wire 50, which is coaxial with the prosthesis itself and runs through the entire catheter. With the guide wire 50 in place, the connecting blocks remain joined. Removing the guide wire 50 releases the connecting blocks instead, allowing the arms to return to their original configuration. Naturally, instead of a guide wire, a wire of suitable diameter, preferably made of metal or other suitable material, or other elongated elements can also be used as connecting elements.

[0034] Now, referring to Figures 5a, 5b and 6, two connecting blocks 120a, 120b are formed in a manner substantially similar to the connecting blocks 20a, 20b described above, the only difference being that they have open eyelets instead of through holes. The connecting block 120a is provided with a projection 138a on its face 136a, which faces the connecting block 120b in the compact configuration. The connecting block 120b is provided with a projection 138b on its face 136b, which faces the connecting block 120a in the compact configuration. The projections 138a, 138b are shaped to have an open channel 140a, 140b, respectively, for the guidewire 50, each of which defines a longitudinal direction B and is formed such that the guidewire 50 can be inserted and removed from the channel only by sliding it in the longitudinal direction B. The width L of the opening 142 of the channel 140a, 140b is therefore smaller than the diameter of the guidewire. The two protrusions and their respective channels are formed such that the two protrusions are adjacent and the two adjacent connection blocks have their respective channels coaxial with each other. Thus, they constitute an interconnection mechanism. In FIG. 6, two connection blocks 120a, 120b are shown joined together by a wire 50.

[0035] This configuration has the advantage over the previous configuration that it can be more easily washed in the blood stream and prevents blood or biological deposits from accumulating in the through holes. This configuration also has the additional advantage that the connection block can be released without necessarily completely removing the connection elements. In a non-limiting exemplary manner, with reference to FIG. 6, the wire 50 can be depicted as having a middle portion having a cross-section with a diameter generally larger than the dimension L and smaller than the width L of the opening 142. Initially, the two connection blocks can be kept joined by inserting the wire 50 into the channels 140a and 140b in the portion with a cross-section with a diameter larger than L. If it is desired to release the connection block and again place it in an expanded configuration suitable for implantation, the wire 50 only needs to be axially slid so that the portion with a diameter smaller than L is aligned with the opening 142, without having to be completely removed from the implantation catheter. In this way, the wire 50 can continue to be used as a guide wire for the implantation catheter even after the connection block has been released. In another variant, the same result can be achieved by constructing at least a portion of the wire 50 in a rectangular or elliptical shape, or in any case by constructing a portion characterized by two diameters, one diameter larger than the dimension L of the opening 142 and the other diameter smaller than the dimension L of the opening 142. In this way, when the larger dimension of the wire 50 is positioned to interfere with the opening 142, the connection blocks are joined together. By rotating the wire 50 and directing the smaller diameter portion towards the opening 142, the connection blocks are released and the arms can return to their original configuration.

[0036] 7 shows a further variant in which two connecting blocks 220 of the same prosthesis are identical to each other. The connecting blocks 220 are provided with projections 238 and recesses 239 on their faces 236 facing the other connecting blocks 220 in a compact configuration. The projections 238 and recesses 239 are such that the projection of one block 220 fits completely into the recess of the other block 220 next to it. Two adjacent blocks together form a hole for the guide wire 50 with axis B'. This hole is defined by respective grooves 242 formed in the projections 238 and adjacent to each other.

[0037] When the guidewire 50 is inserted between the grooves 242, it prevents separation of the blocks in a manner similar to that described for the coupling mechanism of the previous embodiment. However, a single groove 242 on a single block 220 is not sufficient to hold the block 220 in a compact position without additional adjacent blocks. This configuration also prevents the accumulation of sediment due to the lack of through holes.

[0038] FIG. 8 shows an additional variant of the block 320 similar to the previous variant. In this example, the two connecting blocks of the same prosthesis are again identical to each other and have a protrusion 338 and a recess 339 on the face 336 that faces the other connecting block 320 in a compact configuration. Two adjacent blocks 320 together form a hole 340 for accommodating a connecting element such as a wire 50, which is defined by respective grooves 342 formed in the protrusions 338 and adjacent to each other. The difference with the previous embodiment is that the protrusions 338 and the recesses 339 are formed in such a way that when the connecting element 50 is inserted into the hole 340, the profiles of the two blocks mechanically interfere, preventing separation between the two blocks and reducing the forces on the connecting element 50. The interference between the two blocks 320 can be seen in FIG. 9, which shows two connecting blocks 320 connected to each other by a wire 50.

[0039] This configuration, like the configuration shown in FIG. 6, has the added advantage that the wire connecting the connection blocks does not need to be completely removed when releasing the connection blocks, and the wire can still be used for other purposes, for example as a guide wire for an implanted catheter. In fact, it is sufficient for the wire 50 to have a section of small cross-sectional area that creates enough play in the hole 340 to disengage the projection 338 from the groove 342 and release the two connection blocks from each other. Moving the wire 50 from the section of large cross-sectional area to the section of small cross-sectional area releases the two connection blocks without the need to remove the wire 50 from the implanted catheter. Similarly, a wire 50 depicted with a rectangular cross-section featuring large and small dimensions can also keep the connection blocks connected when the section of the large dimension is oriented such that the projection 338 remains pressed against the corresponding recess 339. By rotating the wire 50, the two coupling profiles are disengaged and the two connection blocks are separated.

[0040] Moreover, other configurations allowing the block to be coupled to a guidewire or other similar elongate element should not be excluded. By way of example only, the connecting block can be provided with different types of eyelets, even constructed of threads such as sutures.

[0041] Prostheses with connecting blocks according to the various embodiments described and other variants that can be derived by analogy all require a similar method for placement in a device for implanting the prosthesis in a transcatheter procedure, for example as described in patent application WO2021 / 014400. This requires compressing the expandable central body, placing the arms in a compact configuration with the connecting blocks adjacent to each other, and coupling the connecting blocks to each other by inserting the guide wires 50 into the connecting blocks in suitable seats formed in different ways. When the prosthesis is at the implantation site and the connecting blocks need to be in the expanded configuration, it is only necessary to pull the guide wires 50 out far enough to disengage them from the connecting blocks. Due to the elasticity of the arms 19, the connecting blocks automatically go into the expanded configuration and can be connected to the auxiliary part 22 of the receiving part.

[0042] In the above-mentioned embodiments, in the configuration of the prosthesis in FIG. 1, there is always reference to the presence of two connection blocks, equal to the number of auxiliary parts 22 of the receiving part. Naturally, the prosthesis may comprise a different number of auxiliary parts 22 of the receiving part and therefore a different number of connection blocks. The described version with two auxiliary parts 22 is the preferred version, since it allows the use of two guide wires, which are easier to position correctly than one guide wire that may remain entangled in the chordae tendineae, as described in patent application WO2021 / 014400. However, it should not be excluded that the receiving part may be composed of one auxiliary part, i.e. formed like a cut ring. In this case, it is advantageous for the single connection block to have a configuration similar to that of FIGS. 1-6, as a result of which the longitudinal elements can be held in their respective holes 40, 140 even in the presence of a single connection block. Moreover, it is preferable to use a bar with a given distal stiffness instead of the guide wire 50, in order to be able to maintain the connection block in a position as coaxial as possible with respect to the prosthesis.

[0043] In the case of prostheses intended primarily for the replacement of the tricuspid valve, solutions with a third auxiliary part should not be excluded, even though this requires a higher complexity of the positioning operations. If more than two auxiliary parts, i.e. more than two connecting blocks, are provided, it is only necessary to modify their profiles so that they can be adjacent to each other in groups of three and to provide in each connecting block a through-hole or a seat for the guide wire, so that the coupling between the connecting blocks is realized by the presence of an elongated element which can slide in the seat of each adjacent connecting block.

[0044] Finally, the above embodiment can also be implemented without a separate connection block for the connection arms fixedly joined to the central body: the above-mentioned profiles and coupling mechanisms can simply be built directly onto the structure of the connection arms.

[0045] It should also be noted that, to ensure that the native leaflets remain properly trapped between the central body 16 and the housing 18, it is also possible to provide a central body that expands to a predetermined maximum diameter that allows for proper coaptation between the prosthetic leaflets surrounded by the housing that holds the leaflets. A prosthesis constructed in this way may also include a connection block between the central body and the auxiliary components of the housing, similar to that described above.

[0046] Naturally, the principles of the invention remain the same and the details of the form and construction of the embodiments may vary widely with respect to that described and illustrated without departing from the scope of the invention.

Claims

1. 1. A transcatheter implantable heart valve prosthesis, comprising: an expandable central body (16); a housing (18) having one or more auxiliary components (22); the central body is provided with at least one resiliently flexible arm (19) terminating in a connection block (20a, 20b, 120a, 120b, 220, 320) for connecting each auxiliary component of the housing (18) to the central body (16); the arms are shaped such that each arm can assume an expanded configuration in which it returns freely and a compact configuration suitable for deploying the prosthesis via a transcatheter procedure; and each connection block is provided with a coupling mechanism (40a, 40b, 140a, 140b, 242, 340) suitable for selectively maintaining the corresponding arm in the compact configuration.

2. 2. The heart valve prosthesis of claim 1, wherein each arm is curved in the expanded configuration and generally aligned along an axis (A) of the prosthesis in the compact configuration.

3. 2. The heart valve prosthesis of claim 1, wherein the coupling mechanism is adapted to connect each connecting block (20a, 20b, 120a, 120b, 220, 320) with an elongated element (50) that is selectively coaxially slidable or selectively angularly rotatable relative to the heart valve prosthesis.

4. 2. The heart valve prosthesis according to claim 1, wherein the receiving portion comprises at least two auxiliary parts (22), and the coupling mechanism of each connecting block (20a, 20b, 120a, 120b, 220, 320) is a mutual coupling mechanism suitable for keeping each block coupled to at least one other connecting block.

5. 5. The heart valve prosthesis of claim 4, wherein the interconnection mechanism of each connecting block (20a, 20b, 120a, 120b, 220, 320) comprises a housing seat (40a, 40b, 140a, 140b, 242, 342) for a slidable elongate element (50) formed on each connecting block, the presence of the slidable elongate element in the seat of each connecting block enabling the coupling between the connecting blocks and the arrangement of the arms (19) in the compact configuration.

6. 5. The heart valve prosthesis of claim 4, wherein the connecting blocks (220, 320) are identical to each other.

7. 6. A heart valve prosthesis according to claim 5, wherein the housing seat for the slidable elongate element (50) of each connecting block (20a, 20b) comprises a through-hole (40a, 40b).

8. 6. The heart valve prosthesis of claim 5, wherein the housing seat for the slidable elongated element (50) of each connecting block (120a, 120b) comprises a channel defining a longitudinal direction (B) and formed such that the slidable elongated element can be inserted into the channel of the respective connecting block only by sliding in the longitudinal direction (B).

9. 6. The heart valve prosthesis of claim 5, wherein the respective housing seats of the respective connection blocks (220, 320) are provided with grooves (242, 342), and the grooves of the two connection blocks are formed so as to form a channel for the slidable elongated element when the connection blocks are adjacent to each other, and the slidable elongated element can be inserted into the channel simply by sliding it in the longitudinal direction (B) of the channel itself.

10. 10. A method of deploying the prosthesis of claim 1 in a transcatheter implantable device, comprising: compressing the expandable central body (16); - placing said at least one resiliently flexible arm (19) in said compact configuration; - coupling each connecting block (20a, 20b, 120a, 120b, 220, 320) by said respective coupling mechanism to maintain said at least one resiliently flexible arm (19) in said compact configuration. A method comprising:

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