Self-anchoring transcatheter aortic valve prosthesis

Abstract

Self-anchoring transcatheter aortic valve prosthesis comprising a collapsible stent structure with anchoring elements and a valve component located within said stent structure; characterized by the fact that the stent structure is configured to be positioned within a resection profile obtained after partial resection of the native valve leaflets (1); the said stent structure comprising a sub-annular anchoring element (13), a supra-annular anchoring element (12), and wherein said sub- and supra-annular anchoring elements (13,12) are configured to cinch ridges (9) that are formed by the valve commissures (2) and the resection profile (2,5) after the partial resection of said native valve leaflets (1), the said stent structure furthermore comprising at least one stabilization structure which is configured to be located downstream of the sinotubular junction level (11).

Description

[0001] SELF-ANCHORING TRANSCATHETER AORTIC VALVE PROSTHESIS

[0002] Field of invention

[0003] This invention relates to self-anchoring transcatheter aortic valve prostheses suitable to be implanted within a partially resected annulus of the native valve, obtained with a circular resection device.

[0004] Background

[0005] The replacement of stenotic native aortic valve has been surgically performed in the last 50 years. This replacement procedure requires open-heart access with an extracorporeal circulatory bypass. The calcific aortic valve is fully manually resected and replaced by a prosthetic valve that is anchored to the aortic root by stitches.

[0006] In alternative to stitched prosthetic valves, sutureless aortic valves were introduced in the early 2000s as an innovative solution to address limitations in traditional surgical aortic valve replacement (SAVR) , simplifying the implantation of aortic valves in high-risk patients or those with complex anatomies. The first sutureless valve, the Perceval Valve (Corcym, formerly LivaNova) , was launched in 2004. This valve design was developed to reduce surgical time by eliminating the need for suturing the valve to the aortic annulus, and to enable less invasive surgical techniques, such as ministernotomy .

[0007] Sutureless aortic valves were developed to address limitations in traditional surgical aortic valve replacement (SAVR) , particularly for patients with high surgical risk or complex aortic anatomies. Drawing from advancements in transcatheter valve technologies, sutureless valves, such as the Perceval Valve (Corcym) , integrate self-expanding stent structures with bioprosthetic leaflets, enabling secure anchoring and enhanced hemodynamic performance. This design improves patient outcomes by reducing recovery time and offering a safer, more efficient alternative to conventional SAVR for patients with severe aortic stenosis. In the last years a new replacement procedure for the aortic valve has been introduced in clinical use . This procedure , called TAVI ( Trans catheter Aorti c Valve Implantation ) is based on a trans catheter approach without cardiopulmonary bypas s . These new aortic valve bioprostheses are collapsible and are loaded into a delivery catheter to be positioned into the heart over the diseased aortic valve . These bioprostheses are retained in place by the radial compres sion exerted on the calci fic native valve , therefore no stitches are required . These expandable aortic valves are currently manufactured by sel f-expandable materials such as Nitinol , compres sed into a valve deployment device and released on calci fied native valve . Other trans catheter aorti c valves are balloon expandable and manufactured using stainles s steel or nickel- cobalt-chromium stents .

[0008] Leaflets of TAVI are typically made from cros s-linked tis sues of animal origin, such as bovine or porcine pericardium, are stitched to the stent typically by means of stitching the functional biologic component ( leaflets ) onto the stent frame , normally along a pericardium or fabric s kirt , or by means of direct stitching to the stent frame in the case of xenograft valves . Polymeric leaflets have also been proposed which may be attached to the stent by means of stitching, gluing or other means .

[0009] In recent years , polymeric leaflets have been part of several research programs in the attempt to replace bovine and porcine pericardium leaflets . However, these new materials are not immune from potential drawbacks . Polymeric leaflet designs causing overly close coaptation of the leaflets may limit the wash-out of blood during hemodynamic function, particularly in the regions close to the stent pillars at the commis sures . These regions , also referred to as regions of blood stagnation, may encourage local thrombogenesis , tears and calcifications , and may lead to structural deterioration in the longer term.

[0010] In general terms , the sutureles s bioprosthesis and TAVI stent structures share the same fundamental concept regarding the anchoring system within the patient' s anatomy . Both valve designs , by eliminating the need for sutures , were conceptually developed with increas ed height to enhance surface contact with the aortic wall and provide anchorage at various levels of the aortic root , including the annular level and the sinus level ( upstream of the sinuses of Valsalva and the prosthetic valve ) . Specifically, embodiments of sutureless valves or TAVI emphasize that some valve contact may occur at the sinotubular junction, but this location is not ideal. The key reason is the potential risk of lateral movement of the prosthesis. Such instability arises because the sinotubular junction lacks the stabilizing structures found further downstream within the aorta. In contrast, beyond the sinotubular junction (positioned at the end of aortic sinuses with rounded shape) , the aortic vessel maintains a constant cross-section, providing a more secure and stable environment for the prosthesis, minimizing the risk of displacement.

[0011] The transcatheter procedures are growing fast and gradually replacing the surgical and suturless procedures but unfortunately the TAVI are not free from clinical complications that in part are due to the presence of the native stenotic valve.

[0012] On the contrary, the surgical replacement is free from this inconvenience since the native diseased valve is fully resected till the aortic wall, without leaving any remnants of the native valve, but, as discussed before, the procedure is highly invasive.

[0013] Since the first-in-human procedure in 2002, TAVI has become a well- established therapeutic option for severe aortic stenosis and is offered increasingly to patients at lower surgical risk, who are typically younger. Increasing lifespan carries concerns that "minor" complications that may have little impact on elderly patients could have a greater long-term impact on younger patients. Issues such as mild paravalvular regurgitation, hypo attenuated leaflet thickening, atrioventricular block with need for permanent pacemaker implantation or difficult access to treat coronary arteries may have a substantial cumulative undesirable impact. Additionally, as happens with surgical bioprosthetic valves, transcatheter bioprosthetic valves will eventually degenerate, and may require repeating the intervention.

[0014] Although haemodynamic data for transcatheter aortic valves seem encouraging, long-term data on clinical durability are controversial. Redo TAVI (so called Valve-in-Valve or "V-i-V") has been shown to be feasible with acceptable outcomes in patients with failed TAVI, but in some patients, anatomical or device considerations may preclude a repeatable procedure because of the risk of coronary arteries obstruction and patient's mismatch sizing. Various strategies for lifetime management in this lower-risk and younger patient population have been proposed : Surgical Aortic Valve Replacement ( SAVR) first , followed by TAVI ; TAVI then SAVR; TAVI then TAVI , etc . A tailored approach may be considered according to patient co-morbidities , anatomy and the relative advantages and disadvantages of the two therapies and li fe expectancy . To answer in a safe and effective way this need for an early aortic valve replacement in patient populations younger and at lower operative ris k, a brand-new aortic bioprosthetic valve should be developed .

[0015] Under such circumstances , a good compromise should be found . Create a procedure with minimal invasivenes s j oined to the pos sibility of partially removing the native diseased aortic valve through a minimally invasive procedure such as a trans catheter intervention . This condition should be ideal for reducing ris ks related to a surgical operation and increasing li fe expectancy even in young patients with stenotic diseases .

[0016] There is , therefore , a need to improve existing trans catheter procedures for anchoring aortic valve prostheses .

[0017] Summary of the Invention

[0018] The present invention provides an improvement with respect to existing trans catheter procedures .

[0019] To this effect , the invention may advantageously be used in a trans catheter procedure where the native valve leaflets have been previously partially resected, leaving an anchoring circular rim of native valve tis sue .

[0020] More precisely, the invention consists of a sel f-anchoring trans catheter aortic valve prosthesis comprising a collapsible stent structure with two anchoring elements and a valve component located within said stent structure . The aorti c valve prosthesis according to the invention is provided with a stent structure which is configured to be positioned within an aortic valve annulus after partial resection of the native valve lea flets . The prosthesis is furthermore configured to permanently provide a two-level anchoring system at aortic valve annulus level and one stabili zation system downstream the sinotubular j unction level . The stent structure comprises a sub- annular anchoring element , a supraannular anchoring element configured to cinch ridges the area that is formed by the valve commis sures and the remnant resection profile after the partial resection of said native valve leaflets . Resection profile is defined as the leftover of native aortic valve tis sue following trans catheter aortic valve resection procedure . The aortic valve prosthesis according to the invention, may be efficiently anchored to the quasi-circular resection profile that is obtained after a partial resection of the native valve lea flets . This quasi-circular resection profile forms a circular rim that provides an optimal implant site for aortic valve prosthesis according to the invention . The aortic valve prosthesi s according to the invention, when compared to existing TAVI aortic valve prostheses , provides a larger ori fice area and a reduced number of drawback clinical complications observed after TAVI procedures .

[0021] Any suitable trans catheter device can be used for the resection of valve calci fied leaflets . To enable a safe and e ffective prosthetic valve deployment , after partial resection and removal of the calci fied valve leaflets , the trans catheter resection device , preferably also provides a temporary valve function .

[0022] The trans catheter aortic valve prosthesis may be advantageously deployed when the resection device , with a temporary valve function procedure is ongoing . The temporary valve function of the resection device should maintain a stable blood perfusion during the positioning and deployment of the present invention .

[0023] According to a preferred embodiment , the aortic valve prosthesis according to the invention is an aortic valve prosthesis . In this case the stent structure is configured to be positioned between the circular rim of the partially resected native valve at annulus level and the sinotubular stabili zer structure system positioned downstream of the sinus of Valsalva and prosthetic valve .

[0024] The aortic valve prosthesis according to the invention solves or mitigates at least the following important TAVI related clinical drawbacks :

[0025] Paravalvular regurgitation / leakages due to a sub-optimal ( irregular or incomplete ) coupling between the deployed TAVI and the stenotic leaflets leaving empty spaces leaking blood in systole and in diastole ;

[0026] Premature structural deterioration related to the non-circular deployment of the TAVI , inside the stenotic native valve , with altered functional opening / closure of the prosthetic leaflets ; Thrombotic clots , collagen and calcium emboli zation from the stenotic native valve during and after few years after TAVI deployment procedure ;

[0027] Reduction of the EGA ( Effective Ori fice Area ) with the condition of patient-prosthesis mismatch occurring when a TAVI is placed in degenerated surgical bioprostheses or TAVI s ;

[0028] Not negligible rate ( 20% ) of permanent pacemaker implantation due to atrio-ventricular conduction damages during TAVI procedures despite the improvements in procedural succes s ;

[0029] Di fficult acces s to coronary arteries , for angioplasty procedures , after TAVI due to the outward encumbrance of native leaflets and narrowing of Valsalva Sinuses .

[0030] The aortic valve prosthesis according to the invention is conceived with a dedicated anatomical anchoring system, designed to anchor the valve at native leaflets ' resected edges , valve annulus and, i f it is an aortic valve prosthesis , downstream of the sinotubular j unction level .

[0031] An anatomical anchoring system means a speci fic stent structure designed to perfectly match with the native valve annulus si ze and pos sibly ensure accurate alignment with native valve commis sures , fitting and sealing to the aortic root during the deployment of the prosthesis . Advantageously the prosthetic valve has di fferent si zes in diameter to allow the best fitting to di fferent patients ' native annuli .

[0032] In one speci fic embodiment of the present invention, the prosthetic valve used in the aortic position has a particular stent design that fits the anatomical features of the native aortic valve with partial resected leaflets ( e . g . , annulus si ze and diameter, coronary sinuses conformation, coronary ostia height from the annulus etc . ) . The prosthetic valve of the present invention may be dimensionally ( in diameter ) the s ame as the native valve due to the fact that native stenotic leaflets have been previously removed .

[0033] The partial resection of the stenotic native leaflets , leaving a resection profile , is demanding to design speci fic anchoring structures at the annulus level such as paddles and / or engagement arms and / or s kirts opened outward from the stent structure that are used to anchor the prosthesis , to prevent paravalvular leakages in the long-term and to ensure a perfect sealing at valve inflow. To anchor the valve at the valve annulus level, the stent could have "V" shape structures bent outward the frame of the stent or eventually "rhombus" shape ring structures with engagement arms bending outward the stent.

[0034] In one embodiment, the bended stent structures at the level of valve annulus are coated to reduce possible anatomical damages granting prevention from paravalvular leakages and ensuring perfect sealing.

[0035] In another embodiment of the present invention all bended outward structures of the valve stent, (paddles, engagement arms, skirt etc. ) , used to enhance anchoring with the anatomy, could be coated. The coating used to cover bended stent structures could be made by biological tissues or polymeric fabrics or polymeric bulk materials / films .

[0036] Not only bended stent structures of the valve are coated. In one embodiment, specific areas of the stent valve are coated to enhance anatomical grip and sealing .

[0037] In one embodiment, the flared ventricular stent structures at inflow side of the present invention are asymmetrical to allow perfect anatomical conformation in the mitro-aortic continuity and preventing possible interference with the anterior mitral valve creating flow decompensation.

[0038] The valve could be self-expandable and realized in NiTinol or eventually balloon-expandable and realized by Chromium-Cobalt alloy or similar. In one embodiment, the balloon used to open the valve or specific part of the valve (e.g. bended stent structures) could be toroidal to expand the stent valve structure in a pre-defined shape.

[0039] In another embodiment, the valve could be expanded via another mechanical system.

[0040] In another embodiment, the balloon-expandable prosthetic valve could be deployed with two or three balloons inflated subsequently during the procedure (first the deployment at annulus level and second the deployment at downstream of the sinotubular junction level to stabilize the prosthesis) . These balloons can be mounted on the same delivery system's shaft.

[0041] Some of self-expandable TAVI systems, currently in clinical use, are causing ischemic compression of A-V node at mitro-aortic continuity. The mitro-aortic continuity compression is responsible for atrio- ventricular node conduction disturbances often requiring a pacemaker implantation. Therefore, the choice of a balloon-expandable design could be supported by the current TAVI studies in which, for this type of TAVI , electrical A-V conduction problems have a lower rate of occurrence . These A-V conduction is sues are pos sibly related to the dynamic continuing compres sion over the calci fic tis sue of the native aortic valve exerted by sel f-expandable prosthetic valves with the stent frames made by NiTinol alloy .

[0042] In synthesis the sel f-anchoring trans catheter aortic valve prosthesis , independently balloon- or sel f-expandable is designed with two levels of flanges or anchoring systems ( from inflow to outflow) : one on the ventricular side , the sub-annular anchor, one on the aortic side , the supra-annular anchor and a stabili zation system downstream of the sinotubular j unction level . The combination of the two levels of flanges or anchoring system and the stabili zation system guarantee perfect fit of the prosthesis within the aortic root anatomy . In particular, the first two are granting a cinching and sealing at level of the aortic resection profile after partial resection of the native stenotic valve . The stabili zation system is a flare of the outflow prostheti c pillars that can be shaped and extended with di fferent solutions of engagement at level , downstream of the sinotubular j unction level . The two levels of anchoring are providing sealing and preventing migration and paravalvular leakages while the stabili zation structures downstream of the sinotubular level are preventing the tilting movements . The anchoring system, in case of sel f-expandable prosthesis , should also allow the prosthesis to be recaptured for a pos sible repositioning .

[0043] The invention preferably comprises an as sembly representing the valve function that can be reali zed with one or more leaflets , preferably tri-leaflet , and is mounted inside the stent frame . The material used for the functional as sembly can be made of biologic tis sues such as swine or bovine pericardium or by polymeric films . A speci fic cros s- link or post-cros slink treatment on biological tis sue could be applied or polymeric material could be selected to grant the best biocompatibility, resistance to fatigue and to prevent longterm thrombotic ris k and stenosis due to dystrophic calcium formation .

[0044] The invention also preferably concerns a coated aortic valve as it is for TAVI s . The coating is made by biologi c tis sues such as swine or bovine pericardium or by polymeric films or fabrics used in a fashion of a s kirt to guarantee the sealing between the stent s tructure and the aortic root anatomy . The stent coating is required for two main functions : completely seal the annulus preventing paravalvular leakages and gain additional grip to maintain the valve stable and in the preferable deployed position . Depending on valve design, not all stent valve structures are coated . Coating is mainly adopted where it is neces sary to seal and increase grip , but it is not foreseen in areas where are located for example coronary arteries . The valve should always guarantee a perfect coronary perfusion and pos sible future acces ses for trans catheter coronary interventions .

[0045] Radio-opaque markers on stent valve structure are also used to facilitate positioning and deployment of the anchoring system and the rotational orientation whenever it is needed under Fluoros copy or Echo imaging . The present sel f-anchoring trans catheter aortic valve prosthesis , after its own trans catheter implant , is ensuring an optimal hemodynamic flow thanks to the tri-leaflets valve apparatus and also a perfect native valve commis sural alignement .

[0046] The sel f-anchoring trans catheter aortic valve prosthesis ' s delivery system i s reali zed adopting technical features speci fically adapted to this valve prosthesis . The sel f-anchoring trans catheter aortic valve prosthesis of the present invention is deployed with the help of a dedicated steerability of the outer catheter ( e . g . four degrees of freedom with multiple handles control ) able to drive the prosthesis in-situ, allowing axial rotation and longitudinal movements for the best positioning . In one embodiment , the delivery system axial rotation feature is neces sary to perfectly align the valve prosthesis structure with the native valve commis sural profiles .

[0047] Before prosthetic valve implantation, as for TAVI procedures , the valve prosthesis of the present invention is crimped down and loaded into a dedicated stent cover at the distal part of the delivery system. In one embodiment , with a sel f-expandable prosthetic valve , the stent cover can be single or in two parts to guarantee a more precise valve deployment . With two parts stent cover the sliding of distal part of stent cover is deploying the ventricular ( inflow) side of the valve , sliding of proximal part of the stent cover is deploying the aortic ( outflow) side of the valve prosthesis . The double stent cover option is also ensuring re-capturability of the valve when mispositioning may occur . In addition, the stent cover can be provided with radio-opaque markers to facilitate the procedure of valve deployment and alignment to the aortic root anatomy .

[0048] In another embodiment with a balloon-expandable valve , the prosthetic valve is crimped down over a shaft carrying on one or more balloons placed sequentially . The deployment of the prosthetic valve , when the delivery system is in position, is occurring with on single inflation or with two sequential inflations ( the first one to deploy the annulus portion ( sub- and supra- annular ) and the second one to deploy the sinotubular portion . The double balloon expansion can be obtained with two single sequential balloons , independently controlled or with a single balloon having an internal partition in a way to act as a double balloon .

[0049] Detailed description of the invention

[0050] The invention will be better understood in the present chapter, with some nonlimiting illustrated examples that refer to an aortic valve prosthesis .

[0051] Brief description of the figures

[0052] Figure la Native aortic valve with calci fied leaflets .

[0053] Figure lb Native aortic valve after calci fied native leaflet partial resection .

[0054] Figure 2 Example of aortic root with the aortic leaflets .

[0055] Figure 3 TAVI deployed inside a calci fic aortic valve with leaflets .

[0056] Figure 4 Example of aortic root in which the native aortic valve leaflets have been partially resected .

[0057] Figure 5 Sel f-anchoring prosthetic valve with its two anchoring systems at aortic annulus level with remnant resection profile and a stabili zation system downstream of the sinotubular j unction level .

[0058] Figure 6 Flat design of a sel f-expandable stent with asymmetric sub- annular inflow structures .

[0059] Figure 7 3D configuration of a sel f-expandable stent represented in Figure 6 . Visible the flared supra-annular structures , asymmetric sub-annular structures a stabili zation system downstream of the sinotubular j unction level .

[0060] Figure 8 Sel f-expandable prosthetic valve as des cribed in Figure 6 and 7 deployed in an aortic annulus with remnant resection profile . Pericardial tis sue inside and cloth made of biologic or polymeric material .

[0061] Figure 9 In this embodiment a sel f-expandable stent in flat design is represented .

[0062] Figure 10 A sel f-expandable stent structure as per Figure 9 . The sub- and supra-annular anchoring is granted by a flaring of the stent structures . The stabilization of the stent is granted by upper structures bent outwards and placed downstream of the sinotubular junction level.

[0063] Figure 11 The assembled prosthetic valve as represented in Figures 9 and deployed in an aortic annulus with remnant resection profile. Pericardial tissue inside and cloth made of biologic or polymeric material. This prosthetic valve has an asymmetric sub-annular anchoring flare (variable angle of flare or length of the structures) . Stabilization structures are bent out to be in contact with the aortic wall and positioned downstream of the sinotubular junction level.

[0064] Figure 12 Flat design of a self-expandable stent. The bottom portion (inflow) can be flared out (sub-annular anchor) , the middle portion has structures that can be bent outwards ( supra-annular anchor) . The stabilization structures, positioned downstream of the sinotubular junction level, are obtained with the upper structures with elements that can be bent outwards to get in contact with the aorta's wall (downstream of the sinotubular junction level) .

[0065] Figure 13 3D configuration of the self-expandable stent represented in Figure 12. Visible the flared sub-annular structures and the bent supra-annular structures. The stabilization structures, positioned downstream of the sinotubular junction level, are granted by the bent out "V" shaped structures.

[0066] Figure 14 The assembled prosthetic valve as represented in Figures 12 and 13 deployed in an aortic annulus with remnant resection profile. Pericardial tissue outside and cloth made of biologic or polymeric material. This prosthetic valve has a symmetric sub-annular anchoring flare.

[0067] Figure 15 Flat design of a self-expandable stent. The bottom portion (inflow) can be flared out (sub-annular anchor) , the middle portion has structures that can be bent outwards (supra-annular anchor) . The stabilization structures, positioned downstream of the sinotubular junction level, are obtained with the upper structures with elements that can be bent outwards to get in contact with the aorta's wall.

[0068] Figure 16 3D configuration of the self-expandable stent represented in Figure 15. Visible the flared sub-annular structures and the bent supra-annular structures. The stabilization structures, positioned downstream of the sinotubular junction level, are granted by the bent out "V" shaped structures.

[0069] Figure 17 The assembled prosthetic valve as represented in Figures 16 deployed in an aortic annulus with remnant resection profile. Pericardial tissue outside and cloth made of biologic or polymeric material. This prosthetic valve has a symmetric sub-annular and supra-annular anchoring flare. The stabilization structures, positioned downstream of the sinotubular junction level, are not covered by tissue and helps valve stability thanks to "V" shaped structures bent out towards the aorta wall.

[0070] Figure 18 An alternative deployment of prosthetic valve, represented in Figures 16, in an aortic annulus with remnant resection profile. Pericardial tissue outside and cloth made of biologic or polymeric material. This prosthetic valve has a symmetric sub-annular and supra-annular anchoring flare. The supra- annular anchors are less opened and covered by a tissue skirt used to prevent paravalvular leaks. The stabilization structures, positioned downstream of the sinotubular junction level, are not covered by tissue and helps valve stability thanks to "V" shaped structures bent out towards the aorta wall.

[0071] Figure 19 An additional deployment of prosthetic valve, represented in Figures 16, in an aortic annulus with remnant resection profile. As per Figure 18, the sub-annular and supra-annular covered stent structures are less bended out.

[0072] Figure 20 Flat design of a balloon-expandable stent. The bottom portion (inflow) can be gently flared out (sub-annular anchor) , the middle portion has no bended out structures. The stabilization structures, positioned downstream of the sinotubular junction level, are obtained with the upper structures with elements that can be bent outwards to get in contact with the aorta' s wall to increase stability.

[0073] Figure 21 3D configuration of the balloon-expandable stent represented in Figure 20. Visible the flared sub-annular structures and the bent stabilization structures. Stabilization structures, positioned downstream of the sinotubular junction level, are granted by the bent out "V" shaped structures.

[0074] Figure 22 The assembled prosthetic valve as represented in Figures 21 deployed in an aortic annulus with remnant resection profile. Pericardial tissue outside and cloth made of biologic or polymeric material. This prosthetic valve has a symmetric sub-annular and stabilization structures. The stabilization structures, positioned downstream of the sinotubular junction level, are not covered by tissue and helps valve stability thanks to "V" shaped structures bent out towards the aorta.

[0075] Figure 23 Flat design of a balloon-expandable stent. The bottom portion (inflow) can be flared out (sub-annular anchor) , the middle portion can be flared out too (supra-annular anchor) . In addition, the stabilization structures, positioned downstream of the sinotubular junction level, are obtained with the upper structures with elements that can be bent outwards to get in contact with the aortic wall to increase stability .

[0076] Figure 24 3D configuration of the balloon-expandable stent represented in Figure 23 . Visible the flared sub-annular and supra-annular structures to get in contact with the aortic annulus ( cinching grip ( C shape ) at annulus level ) . The stabili zation structures , positioned downstream of the sinotubular j unction level , are granted by the bent out shaped structures in contact with aortic wall .

[0077] Figure 25 The as sembled prosthetic valve as represented in Figures 24 deployed in the aortic root . Pericardial tis sue outside and cloth made of biologic or polymeric material . This prosthetic valve has a symmetric sub-annular, supra- annular and stabili zation structures . The stabili zation structures , positioned downstream of the sinotubular j unction level , are not covered by tis sue to prevent coronary obstructions and help valve stability .

[0078] Figure 26a Pre configuration of the balloon-expandable stent represented in Figure 24 . The trilobed shaped balloon is granting a perfect expansion of the stent between the aortic roots level and the aortic wall , downstream of sinotubular j unction level .

[0079] Figure 26b Post configuration of the balloon-expandable stent represented in Figure 24 . The trilobed shaped balloon is granting a perfect expansion of the stent between the aortic roots level and the aortic wall , downstream of sinotubular j unction level .

[0080] Figure 27a Pre configuration of the balloon-expandable stent represented in Figure 21 . The doubled shaped balloon is granting a perfect expansion of the stent at sub-annular level and at the downstream of sinotubular j unction level , where stabili zation structures are positioned .

[0081] Figure 27b Post configuration of the balloon-expandable stent represented in Figure 21 . The doubled shaped balloon is granting a perfect expansion of the stent at sub-annular level and at the downstream of the sinotubular j unction level , where stabili zation structures are positioned . Numerical references used in the figures

[0082] 1. Aortic valve leaflet

[0083] 2. Aortic valve commissure

[0084] 3. Right coronary artery

[0085] 4. Left coronary artery

[0086] 5. Aortic annulus remnant resection profile

[0087] 6. Aortic valve outflow

[0088] 7. Coronary sinuses

[0089] 8. Aortic valve inflow

[0090] 9. Aortic annulus (anatomical part composed by resected native valve commissures and the remnant resection profile of the native valve leaflets )

[0091] 10. Sinotubular junction (anatomy that links the Valsalva sinus with the ascending aorta wall)

[0092] 11. Stabilization structures (downstream of the sinotubular junction level)

[0093] 12. Supra-annular anchoring flare

[0094] 13. Sub-annular anchoring flare

[0095] 14. Pericardial or polymeric tissue leaflets

[0096] 15. External pericardial or polymeric tissue cover

[0097] 16. Radiopaque markers

[0098] 17. Stent structure to sustain leaflet commissure stitches

[0099] 18. Overall stent expansion balloon

[0100] 19. Sinotubular level expansion balloon (downstream of the sinus of Valsalva and prosthetic valve)

[0101] 20. Sub-annular level expansion balloon Detailed description of the figures

[0102] In Figure la is possible to observe the stenotic pattern of an aortic valve in which the calcification of the leaflet 1 is spread along the three valve leaflets. The calcification process starts in the low middle portion of each belly looking from the aortic valve outflow 6. Calcifications of the leaflets 1 are irregular, and gradually extend to valve commissures 2 in one side and up to the top of each belly in the other side. They assume, in each leaflet 1, the aspect of a semilunar shape with larger part in the belly of each leaflet 1.

[0103] Dystrophic fibrosis and calcifications of leaflets 1 are responsible for tissue stiffening with narrowing of the valve orifice 6 and high systolic pressures. In diastole the leaflets 1, due to the stiffening, are unable to perfectly coapt and a variable grade of regurgitation into the left ventricle is occurring .

[0104] The aortic prosthetic valve, presented in this patent, is conceived to be implanted in a partially resected aortic annulus orifice 5 where the leaflets 1 are not anymore present (Figure lb) . The resection can be conducted with a dedicated transcatheter system without damaging the aortic wall, the Valsalva coronary sinuses 7, the commissures 2 and occluding the right 3 or the left 4 coronary arteries. The resection of calcified leaflets 1 should be done saving a portion of valve commissures 2 able to guarantee a stable anchoring of the prosthetic aortic valve at valve annulus level 9. The aortic annulus resection profile 5 and commissures 2 will be the part of the remaining aortic annulus anatomy (insertion portion of the native leaflets 1 into the aorta's wall) in which the anchoring systems of the self-anchoring transcatheter valve prosthesis should be positioned.

[0105] In Figure 2 a longitudinal section of the aorta is represented. In the Figure the coronary sinuses 7 and coronary arteries 3,4 as well the aortic leaflets 1 are visible.

[0106] The positioning of a TAVI into a native stenotic aortic valve is described (Figure 3) . In this representation, as example, a self- expandable prosthetic valve, currently in clinical use, is deployed.

[0107] The anchoring of this valve prosthesis is mainly granted by the stenotic leaflets 1 of the native valve that are gripping on the stent structure at annulus level 9 and by the supra-annular anchoring flare 12 and the stabilization loops (stabilization structures positioned downstream of the sinotubular junction level 11) in contact with sinotubular junction 10. The supra-annular anchoring flare 12 are seating over the leaflets' 1 free margin with the scope preventing the ventricular migration of the prosthesis. On reverse, the stabilization structures, positioned downstream of the sinotubular junction level 11, in contact with sinotubular junction 10, reduce the prosthetic tilting movement that could favor its dislodgement into the aorta .

[0108] In Figure 4 a longitudinal section of the aorta is represented. In the Figure the coronary sinuses 7 and coronary arteries 3,4 are visible, while are not visible the aortic valve leaflets 1 because are partially resected.

[0109] In Figure 5 the positioning of a self-anchoring prosthetic valve, into an annulus 9 with partially resected aortic native valve leaflets 1, is described. In this representation, as example, a self-expandable prosthetic valve is deployed. The anchoring of this valve prosthesis is mainly granted by three symmetrical level of anchoring 11,12,13.

[0110] The sub-annular anchoring flare 13 and the supra-annular anchoring flare 12 of the stent structure are perfectly cinching the resection profile 9 preventing dislodgement and leakages.

[0111] The stabilization structures positioned downstream of the sinotubular junction leve 1 11 in contact with the aortic wall reduces the prosthetic tilting movement that could favor its dislodgement into the aorta. The stabilization structures include radiopaque markers 16 used during valve deployment. Additional radiopaque markers can be positioned at level of sub-annular anchoring flare 13, supra-annular anchoring flare 12 as well as at commissural level with the aim to obtain a safe and effective valve deployment and alignment with the coronary sinuses.

[0112] In Figure 6 is represented a flat design of a self-expandable stent structure. The bottom portion of the stent is conceived with a sub- annular asymmetrical anchoring flare 13 to prevent atrial-ventricular conduction blockage (on left side close to mitro-aortic continuity) .

[0113] The middle portion of the stent has a supra-annular anchoring flare 12 to prevent leakages and a stabilization structures, positioned downstream of the sinotubular junction level 11 used to reduce the prosthetic tilting movement. Radiopaque markers 16, present on stabilization structures, positioned downstream of the sinotubular junction level 11, are used during valve deployment to align it within the native valve commis sures .

[0114] In Figure 7 , a 3D configuration of the sel f-expandable stent represented in Figure 6 . Visible the asymmetrical flared sub-annular anchoring 13 , the supraannular anchoring flare 12 to get in contact with the remnant resection profile ( cinching ridges that are formed after the partial resection of said native valve leaflets ) and the stabili zation structures , positioned downstream of the sinotubular j unction level 11 with radiopaque markers 16 used during deployment .

[0115] In Figure 8 is represented the as sembled prosthetic valve as represented in Figures 7 deployed in the aortic root . Are perfectly visible the functional pericardial or polymeric tis sue leaflets 14 and the external pericardial or polymeric tis sue cover 15 used to prevent paravalvular leakages at annulus level 9 . The sel f-expandable prosthetic valve is ensuring three level anchoring with asymmetrical sub-annular anchoring flare 13 , supra-annular anchoring flare 12 and stabili zation structures , positioned downstream of the sinotubular j unction level 11 with radiopaque markers 16 .

[0116] In Figure 9 is represented a flat design of a sel f-expandable stent structure . The bottom portion of the stent is conceived with a sub- annular asymmetrical anchoring flare 13 . The middle portion of the stent has a supra-annular anchoring flare 12 to prevent leakages and a stabili zation structures , positioned downstream of the sinotubular j unction level 11 , used to reduce the prosthetic tilting movement . Radiopaque markers 16 are visible and used during deployment of the stent .

[0117] In Figure 10 , a 3D configuration of the sel f-expandable stent represented in Figure 9 . Visible the asymmetrical flared sub-annular anchoring flare 13 , the supra-annular anchoring flare 12 to get in contact with the resection profile ( cinching ridges that are formed after the partial resection of said native valve leaflets ) and the stabili zation structures , positioned downstream of the sinotubular j unction level 11 with radiopaque markers 16 used during deployment .

[0118] In Figure 11 is represented the as sembled prosthetic valve as represented in Figures 10 deployed in an aortic annulus with remnant resection profile . Are perfectly visible the functional pericardial or polymeric tis sue leaflets 14 and the external pericardial or polymeric tis sue cover 15 used to prevent paravalvular leakages at annulus level 9 . The sel f-expandable prosthetic valve is ensuring three level anchoring with asymmetrical sub-annular anchoring flare 13 , supra-annular anchoring flare 12 and stabili zation structures , positioned downstream of the sinotubular junction level 11 with radiopaque markers 16. While the bottom part of the prosthesis (sub-annular anchoring flare 13) is covered by pericardial or polymeric tissue 15 to prevent paravalvular leakages, the upper part of the prosthesis (stabilization structures positioned downstream of the sinotubular junction level 11) is not covered by any pericardial or polymeric tissue to minimize the risk of coronary arteries 3,4 obstruction.

[0119] In Figure 12 is represented another flat design of a self-expandable stent structure. The bottom portion of the stent is conceived with a sub-annular symmetrical anchoring flare 13. The middle portion of the stent has a supraannular anchoring flare 12 to prevent leakages and a stabilization structure positioned downstream of the sinotubular junction level 11 used to reduce the prosthetic tilting movement. Radiopaque markers 16 are visible and used during deployment of the stent.

[0120] In Figure 13 a 3D configuration of the self-expandable stent represented in Figure 12. Visible the symmetrical flared sub-annular anchoring flare 13, the supra-annular anchoring flare 12 to get in contact with the resection profile (cinching ridges that are formed after the partial resection of said native valve leaflets) and the stabilization structures positioned downstream of the sinotubular junction level 11 with radiopaque markers 16 used during deployment .

[0121] In Figure 14 is represented the assembled prosthetic valve as represented in Figures 13 deployed in the aortic root. Are perfectly visible the functional pericardial or polymeric tissue leaflets 14 and the external pericardial or polymeric tissue cover 15 used to prevent paravalvular leakages at annulus level 9. The self-expandable prosthetic valve is ensuring three level anchoring with symmetrical sub-annular anchoring flare 13, supra-annular anchoring flare 12 and stabilization structures positioned downstream of the sinotubular junction level 11 with radiopaque markers 16. While the bottom part of the prosthesis (sub-annular anchoring flare 13) is covered by pericardial or polymeric tissue 15 to prevent paravalvular leakages, the upper part of the prosthesis (stabilization structures positioned downstream of the sinotubular junction level 11) is not covered by any pericardial or polymeric tissue to prevent coronary arteries 3,4 obstruction. Stabilization structures positioned downstream of the sinotubular junction level 11 are going well in contact with the aorta wall at the level of sinotubular junction 10 reducing the prosthetic tilting movement that could favor its dislodgement into the aorta. In Figure 15 is represented the same flat design of a sel f-expandable stent structure of Figure 12 . The bottom portion of the stent is conceived with a sub-annular asymmetrical anchoring flare 13 . The middle portion of the stent has a supra-annular anchoring flare 12 to prevent leakages and a stabili zation structures , positioned downstream of the sinotubular j unction level 11 , used to reduce the prosthetic tilting movement . Radiopaque markers 16 are visible and used during deployment of the stent .

[0122] In Figure 16 another 3D configuration of the sel f-expandable stent represented in Figure 12 and 15 . Visible the symmetrical sub-annular anchoring flare 13 , the supra-annular anchoring flare 12 to get in contact with the resected profile ( cinching ridges that are formed after the partial resection of said native valve leaflets ) and the stabili zation structures , positioned downstream of the sinotubular j unction level 11 with radiopaque markers 16 used during deployment . Di fferently from 3D of configuration of Figure 13 , this stent has more pronounced bent out structures used to anchor the stent into the anatomy . Speci fically, regarding the supra-annular anchoring flare 12 is used another part of the stent structure while the stabili zation structures , positioned downstream of the sinotubular j unction level 11 , are more bent out to increas e coaptation within the aortic wall 10 .

[0123] In Figure 17 is represented the as sembled prosthetic valve as represented in Figures 16 deployed in remnant resection profile . Are perfectly visible the functional pericardial or polymeric tis sue leaflets 14 and the external pericardial or polymeric tis sue cover 15 used to prevent paravalvular leakages mainly at annulus level 9 . The sel f-expandable prosthetic valve is ensuring three level anchoring with symmetrical sub-annular anchoring flare 13 , supra- annular anchoring flare 12 and stabili zation structures positioned downstream of the sinotubular j unction level 11 with radiopaque markers 16 . While the bottom part of the prosthesis ( sub-annular anchoring flare 13 ) is covered by pericardial or polymeric tis sue 15 to prevent paravalvular leakages , the upper part of the prosthesis ( stabili zation structures positioned downstream of the sinotubular j unction level 11 ) is not covered by any pericardial or polymeri c tis sue to prevent coronaries 3 , 4 obstructions . Stabili zation structures , positioned downstream of the sinotubular j unction level 11 , are going well in contact with the aorta wall at the level of sinotubular j unction 10 reducing the prosthetic tilting movement that could favor its dislodgement into the aorta .

[0124] In Figure 18 is represented another embodiment of the as sembled prosthetic valve as represented in Figures 16 deployed in the aortic root. Are visible the functional pericardial or polymeric tissue leaflets 14 and the external pericardial or polymeric tissue cover 15 used to prevent paravalvular leakages mainly at annulus level 9. The self-expandable prosthetic valve is ensuring three symmetrical level anchoring. In this configuration, while the sub-annular anchoring flare 13 is similar to Figure 17, the supra-annular anchoring flare 12 and stabilization structures, positioned downstream of the sinotubular junction level 11 with radiopaque markers 16 are less bended out towards the aortic wall. While the bottom part of the prosthesis (sub-annular anchoring flare 13) is covered by pericardial or polymeric tissue 15 to prevent paravalvular leakages, the upper part of the prosthesis (stabilization structures positioned downstream of the sinotubular junction level 11) is not covered by any pericardial or polymeric tissue to prevent coronaries 3,4 obstructions. Stabilization structures, positioned downstream of the sinotubular junction level 11, are going well in contact with the aorta wall at the level of sinotubular junction 10 reducing the prosthetic tilting movement that could favor its dislodgement into the aorta.

[0125] In Figure 19 is represented another embodiment of the assembled prosthetic valve as represented in Figures 16 deployed in the aortic root. Are visible the functional pericardial or polymeric tissue leaflets 14 and the external pericardial or polymeric tissue cover 15 used to prevent paravalvular leakages mainly at annulus level 9. The self-expandable prosthetic valve is ensuring three symmetrical level anchoring. In this configuration the sub-annular anchoring flare 13 is less bended out respect Figure 18, while the supra- annular anchoring flare 12 and stabilization structures positioned downstream of the sinotubular junction level 11 with radiopaque markers 16 are more bended out towards the aortic wall. While the bottom part of the prosthesis (subannular anchoring flare 13 and supra-annular anchoring flare 12) are covered by pericardial or polymeric tissue 15 to prevent paravalvular leakages, the upper part of the prosthesis (stabilization structures positioned downstream of the sinotubular junction level 11) is not covered by any pericardial or polymeric tissue to prevent coronaries 3,4 obstructions. Stabilization structures, positioned downstream of the sinotubular junction level 11, are going well in contact with the aorta wall at the level of sinotubular junction 10 reducing the prosthetic tilting movement that could favor its dislodgement into the aorta.

[0126] In Figure 20 is represented the flat design of a balloon-expandable stent structure. The balloon-expandable prosthetic valve is ensuring only two symmetrical level anchoring . The bottom portion of the stent is conceived with a sub-annular symmetrical anchoring flare 13 while the stabili zation structures , postioned downstream of the sinotubular j unction level 11 . are also bended out and used to reduce the prosthetic tilting movement . No supraannular anchoring flare 12 is foreseen for the balloon-expandable stent .

[0127] In Figure 21 the 3D configuration of the balloon-expandable stent represented in Figure 20 . Visible the symmetrical sub-annular anchoring flare 13 and the stabili zation structures , positioned downstream of the sinotubular j unction level 11 . It is also visible the stent structure to sustain leaflet commis sure stitches 17 .

[0128] In Figure 22 is represented the as sembled prosthetic valve as represented in Figures 21 deployed in the aortic root . Are visible the functional pericardial or polymeric tis sue leaflets 14 and the external pericardial or polymeric tis sue cover 15 used to prevent paravalvular leakages mainly at annulus level 9 . This balloon- expandable prosthetic valve is ensuring two levels anchoring with symmetrical sub-annular anchoring flare 13 and the stabili zation structures positioned downstream of the sinotubular j unction level 11 . While the bottom part of the prosthesis ( sub-annular anchoring flare 13 level ) is covered by pericardial or polymeric tis sue 15 to prevent paravalvular leakages , the upper part of the prosthesis ( s tabili zation structures positioned downstream of the sinotubular j unction level 11 ) is not covered by any pericardial or polymeric tis sue to prevent coronaries obstructions . Stabili zation structures , positioned downstream of the sinotubular j unction level 11 , are going well in contact with the aorta wall at the level o f sinotubular j unction 10 reducing the prosthetic tilting movement that could favor its dislodgement into the aorta .

[0129] In Figure 23 is represented the flat design of a balloon-expandable stent structure . The balloon-expandable prosthetic valve is ensuring three symmetrical levels of anchoring with a sub-annular symmetrical anchoring flare 13 , the supra-annular symmetrical anchoring flare 12 and the stabili zation structures , positioned downstream of the sinotubular j unction level 11 , are bended out and used to reduce the prosthetic tilting movement . To ensure a better grip of the valve within the anatomy, the balloon is mostly inflated at sinotubular j unction 10 level . It is also visible the stent structure to sustain leaflet commis sure stitches 17 .

[0130] In Figure 24 the 3D configuration of the balloon-expandable stent represented in Figure 23 . Visible the symmetrical sub-annular anchoring flare 13 , supra- annular anchoring flare 12 and the stabili zation structures positioned downstream of the sinotubular j unction level 11 . It is also visible the stent structure to sustain leaflet commis sure stitches 17 . Both sub-annular 13 and supra-annular anchoring flare 12 are used to cinch ridges that are formed after the partial resection of said native valve leaflets 1 .

[0131] In Figure 25 is represented the as sembled prosthetic valve as represented in Figures 24 deployed in the aortic root . Are visible the functional pericardial or polymeric tis sue leaflets 14 and the external pericardial or polymeric tis sue cover 15 used to prevent paravalvular leakages mainly at annulus level 9 . The balloon- expandable prosthetic valve is ensuring three level anchoring with symmetrical sub-annular anchoring flare 13 , symmetrical supra-annular anchoring flare 12 and stabili zation structures positioned downstream of the sinotubular j unction level 11 . While the bottom part of the prosthesis ( subannular anchoring flare level 13 and supra-annular anchoring flare level 12 ) is covered by pericardial or polymeric tis sue 15 to prevent paravalvular leakages , the upper part of the prosthesis ( stabili zation structures positioned downstream of the sinotubular j unction level 11 ) is not covered by any pericardial or polymeric tis sue to prevent coronaries 3 , 4 obstructions . Stabili zation structures , positioned downstream of the sinotubular j unction level 11 , are going well in contact with the coronary sinuses 7 below the sinotubular j unction level 10 . In this embodiment the outflow portion of the valve prosthesis is extended into the aorta above the sinotubular j unction 10 so that the stabili zation structures , positioned downstream of the sinotubular j unction level 11 , are avoiding the migration of the prosthesis into the ventricle while the upper row of rhomboids prevents the tilting movement .

[0132] In Figures 26a and 26b a special version of double balloon used for two step prosthetic valve ( Figures 23 , 24 , 25 ) deployment into the aortic root is represented . I s Figure 26a is visible the inflated stent expansion balloon 18 inside the valve that is granting a full valve opening and the deflated balloon 19 fo r the sinotubular stent level expansion . In Figure 26b is visible the second step of valve deployment , where the expansion balloon 19 for sinotubular stent structures is inflated . The three bulge design of the balloon is granting a perfect expansion of the stent at coronary sinuses level 7 .

[0133] In Figure 27a and 27b a special version of a triple balloon used for three steps prosthetic valve deployment ( Figures 20 , 21 , 22 ) into the aortic root is represented . In Figure 27a the inflated stent expansion balloon 18 inside the valve , that is granting a full valve deployment , is visible . The balloons 19 and 20 are still deflated . In Figure 26b the two special tubular design balloons 19 and 20 are inflated respectively granting a perfect expansion of the stabili zation structures , positioned downstream of the sinotubular j unction level 11 and the sub-annular anchoring flare 13 .

Claims

Claims1. Self-anchoring transcatheter aortic valve prosthesis comprising a collapsible stent structure with anchoring elements and a valve component located within said stent structure; characterized by the fact that the stent structure is configured to be positioned within a resection profile obtained after partial resection of the native valve leaflets (1) ; the said stent structure comprising a sub-annular anchoring element (13) , a supra-annular anchoring element (12) , and wherein said sub- and supraannular anchoring elements (13,12) are configured to cinch ridges (9) that are formed by the valve commissures (2) and the resection profile (2,5) after the partial resection of said native valve leaflets (1) , the said stent structure furthermore comprising at least one stabilization structure which is configured to be located downstream of the sinotubular junction level (11) .

2. Aortic valve prosthesis according to claim 1 configured to be self- expandable or balloon-expandable.

3. Aortic valve prosthesis according to claim 1 or 2 comprising an inflow or proximal ring and an outflow or distal ring joined by at least two vertical structures or commissural pillars devoted to sustaining the functional component of the prosthesis.

4. Aortic valve prosthesis according to anyone of the previous claims wherein the sub-annular anchoring element (13) and the supra- annular anchoring element (12) , when fixed against a resection profile, are oriented in the same direction.

5. Aortic valve prosthesis according to claim 4 wherein the smallest angle of the anchoring elements in respect to the stent wall is oriented towards the inflow side of the prosthesis, in a way that is allowing the recapturing of the prosthesis in case of incorrect deployment.Aortic valve prosthesis according to anyone of the previous claims wherein said anchoring (13,12) and stabilization structure located downstream of the sinotubular junction level, have a flange shape.

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