Cardiac anchoring stent, valve system and a method for deploying same

Abstract

A prosthetic cardiac valve system comprises a stent with upstream, downstream, and intermediate mesh sections. The upstream and / or downstream sections may have tissue-engaging spikes made of shape memory material, configured to project radially outward at body temperature. An upstream elastic sleeve with an inflatable element can extend over the upstream mesh section. The system can accommodate a prosthetic cardiac valve in the native anatomy, securable after stent positioning and inflation of the upstream and downstream inflatable elements. The system offers versatility, allowing for use as a support structure for various valve types or as a fully functional valve with integrated leaflets. This design provides adaptability to different anatomies and clinical needs in cardiac valve replacement procedures.

Description

[0001] CARDIAC ANCHORING STENT, VALVE SYSTEM AND A METHOD FOR DEPLOYING SAME

[0002] TECHNOLOGICAL FIELD

[0003] The present disclosure is concerned with a cardiac valve, a personalized anchoring and sealing mechanism therefor, and a method for deploying and anchoring same.

[0004] BACKGROUND ART

[0005] Cardiac valve replacement may be necessary in cases where the valve is severely damaged or diseased. Replacement of a cardiac valve can often involve complications related with anatomic differences such as variable outlines and borders at the valve site.

[0006] References considered to be relevant as background to the presently disclosed subject matter: WO22201158; WO2017151566; US8,556,881; US2022241071; US2009088836;.

[0007] Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.

[0008] BACKGROUND

[0009] WO22201158 discloses a supporting structure for accommodating a prosthetic cardiac valve aimed at replacing valve, a prosthetic cardiac valve system, a method for sealing between a native tissue and a prosthetic implant, a kit for implanting a prosthetic cardiac valve and a medium to be used with a supporting structure. The technique provides an implant structure with high compatibility with various anatomies while allowing optimal sealing and tissue anchoring, thus implementing personalized valve replacement procedures. This technique provides an accurate fitting for optimal sealing and anchoring to various complex anatomies necessitating a prosthesis.

[0010] WO2017151566 discloses methods, devices, and systems for anchoring and / or sealing a heart valve prosthesis and, in particular, a mitral valve prosthesis, wherein inflatable elements are used to seal and anchor the mitral valve prosthesis and / or other elements associated with repairing a native mitral valve.

[0011] US2022104940 discloses prosthesis configured to grasp intraluminal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.

[0012] Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.

[0013] GENERAL DESCRIPTION

[0014] A first aspect of the disclosure is directed to a support structure for supporting a prosthetic cardiac valve. The support structure comprises a flexible tubular stent having an upstream mesh section and a downstream mesh section, with an intermediate mesh section extending therebetween.

[0015] The support structure offers versatile configurations to suit various clinical needs. It can include either a combination of upstream and downstream inflatable elements, or an upstream inflatable element paired with tissue engaging spikes, or all three features together. This flexibility allows for customized approaches to anchoring and sealing the prosthetic cardiac valve within the native valve site.

[0016] In some embodiments, the upstream mesh section is configured with a plurality of upstream tissue engaging spikes and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes. At an expanded position of the stent, these upstream tissue engaging spikes and downstream tissue engaging spikes project radially outwards from an outside surface of the stent. Alternatively, or in addition to the spikes, the support structure may include inflatable elements for anchoring and sealing. The support structure can be designed with upstream and downstream inflatable elements, or with an upstream inflatable element and tissue engaging spikes, or with all three features - upstream and downstream inflatable elements as well as tissue engaging spikes. This versatility allows for optimal adaptation to different anatomical and clinical scenarios.

[0017] The downstream mesh section of the stent can be designed to be deformable, allowing it to adapt to the specific anatomy of the sub-annular region and provide optimal anchoring.

[0018] The configuration of inflatable elements and tissue engaging spikes can be tailored to the specific requirements of each case. In some instances, both upstream and downstream inflatable elements may be used to provide comprehensive sealing and anchoring. In other cases, an upstream inflatable element may be combined with tissue engaging spikes on the downstream section, offering a balance of gentle sealing at the atrial side and secure anchoring on the ventricular side. The option to include all three features - upstream and downstream inflatable elements along with tissue engaging spikes - provides adaptability to complex anatomies.

[0019] The support structure further includes an upstream elastic sleeve extending over at least a portion of said upstream mesh section. This upstream elastic sleeve has an upstream inflatable element disposed axially upstream of said upstream mesh section.

[0020] In certain embodiments, the support structure may also include a downstream elastic sleeve extending over at least a portion of an inside face of the intermediate mesh section. This downstream elastic sleeve has a downstream inflatable element axially and radially disposed in overlap over at least an inside portion of the intermediate mesh section and the portion of the downstream mesh section.

[0021] It should be noted that in some configurations, the support structure may be designed without tissue engaging spikes, relying instead on the inflatable elements for anchoring and sealing within the native valve site.

[0022] The terms 'upstream' and 'downstream' as used herein in the specification and claims, correspond with normal hemodynamics flow directions, respectively. For example, when considering a mitral valve, blood flows from the upstream left atrium towards the downstream left ventricle. For a tricuspid valve, blood flows from the upstream right atrium towards the downstream right ventricle. In the case of the aortic valve, blood flows from the upstream left ventricle towards the downstream aorta, and for the pulmonary valve, blood flows from the upstream right ventricle towards the downstream pulmonary artery. The prosthetic cardiac valve, which is engageable within the elastic sleeve, is configurable as a one-way valve, facilitating blood flow in correspondence with hemodynamics flow directions. This valve can be secured within one or more of the mesh sections of the stent, either as an integral part of the support structure or as a separate component to be inserted during the procedure.

[0023] The support structure is configurable between a constricted, deploying position (closed position) and an expanded, open position. In the closed position, the tissue engaging spikes (when present) are coplanar. Herein the specification and claims, the terms ‘deployed’, ‘expanded’ and ‘nominal’ positions can be used interchangeably, all of which refer to the stent / support structure at a position at which it assumes a maximal diameter. Likewise, the terms "un-inflated’’ and "compressed" position refer to the stent at its position at rest, prior to manipulating into its deployed position.

[0024] A second aspect of the disclosure is directed to a stent member for supporting a prosthetic cardiac valve, the stent member being a flexible tubular element having an upstream mesh section and a downstream mesh section, with an intermediate section extending therebetween, and wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes, whereby radially outwardly deforming the upstream mesh portion entails radial outwards deformation of the of upstream tissue engaging spikes, and radially outward deformation of the intermediate section entails radially outwards deformation of the downstream mesh section and of the downstream tissue engaging spikes. The downstream mesh section can be designed to be deformable, allowing it to adapt to the sub-annular anatomy and provide optimal anchoring

[0025] The stent can be made of various biocompatible materials, such as metal (e.g. Nitinol -NiTi), polymeric materials, composite materials and others, however imparting the stent its unique property, namely the ability to be deformed from a closed position and return to its initial expanded shape upon exposure to heat or pressure, or upon cease of a restraint compacting force (in case of a self-expandable device). This allows the stent to be compressed for insertion through a small body incision, and then expand to the desired size and shape once manipulated in site. with an outside surface of the stent. However, once the stent is deployed and reaches body temperature (approximately 37°C), the tissue engaging spikes deform to their memory shape, projecting radially outwards from the outside surface of the stent.

[0026] A third aspect of the disclosure is directed to a prosthetic cardiac valve system, comprising: a support structure comprising a flexible tubular stent having an upstream mesh section and a downstream mesh section, with an intermediate mesh section extending therebetween, and wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes; wherein at an expanded position of the stent said upstream tissue engaging spikes and said downstream tissue engaging spikes project radially outwards from an outside surface of the stent; an upstream elastic sleeve extending over at least a portion of an inside face of said upstream mesh section; said upstream elastic sleeve having an upstream inflatable element disposed axially upstream of said upstream mesh section; and a prosthetic cardiac valve engageable within the upstream elastic sleeve and downstream of the upstream inflatable element, said valve configured to facilitate blood flow therethrough in direction from the upstream mesh section towards the downstream mesh section, corresponding with normal hemodynamics. The prosthetic cardiac valve can be configured to be secured within one or more of the mesh sections of the stent e.g., after the stent is positioned in situ and the upstream inflatable element of the upstream elastic sleeve and the downstream inflatable element of the downstream elastic sleeve are inflated.The stent is typically made of a shape memory material, such as Nitinol, allowing it to be compressed for insertion through a small body incision and then expand to the desired size and shape once manipulated in situ. Other suitable materials may include various biocompatible metals, polymers, or composite materials.

[0027] The upstream and downstream inflatable elements play a role in the functionality of the support structure. These elements can be independently inflated, allowing for customized anchoring and sealing within the native valve site. When inflated, the upstream inflatable element is designed to bear over the annulus of the native cardiac valve, thereby sealing the valve external vicinity and preventing blood flow external to the sleeve. Similarly, the downstream inflatable element, when present and inflated, applies radial force on the downstream mesh section, resulting in outward deformation and enhanced anchoring.

[0028] The inflatable elements are typically configured as fluid-tight annular portions of their respective sleeves, or as inflatable bladders received within pockets of the sleeves. Each inflatable element is associated with an inflation mechanism for inflating and pressure regulation. These mechanisms can include detachable tubing with suitable valves, allowing for precise control over the inflation process. The inflating agent can be a gas or liquid, and in some embodiments, may include a puncture sealing agent for added safety and durability.

[0029] The support structure can be adaptable for use with various types of cardiac valves, including mitral, aortic, tricuspid, and pulmonary valves. The configuration of the inflatable elements can be adjusted based on the specific valve type. For instance, in a mitral valve application, the upstream inflatable element is configurable for supra-annular positioning and inflating within the left atrium. In an aortic valve application, the upstream inflatable element may be configured for sub-annular positioning and inflation.

[0030] To facilitate the secure placement of a prosthetic cardiac valve, the support structure may include a receiving arrangement. This arrangement is designed to receive and facilitate the positioning and alignment of the prosthetic cardiac valve within the support structure. The receiving arrangement may comprise a base on which the prosthetic cardiac valve is to be mounted and a fixation element for securing the valve in position.

[0031] The base of the receiving arrangement can take various forms, such as one or more internal annular flanges securely connected to the intermediate section of the mesh, or an annular indentation in the intermediate mesh section. The fixation element may be designed as one or more directional resilient tongues, allowing the prosthetic cardiac valve to slide into position in one direction while preventing backward movement.

[0032] In some embodiments, the prosthetic cardiac valve itself may be fitted with a fixation arrangement designed to securely engage with the base of the receiving arrangement. This fixation arrangement could be in the form of an annular radially extendable skirt, which can be brought into its operational position in a contracted state and then triggered to extend once in place.

[0033] While the support structure is designed to accommodate various types of prosthetic cardiac valves, it can also function as a fully operational valve itself. In this configuration, permanent leaflets are directly integrated into the stent structure, creating a complete, self-contained prosthetic cardiac valve. These leaflets are positioned between the upstream and downstream mesh sections at a non-deformable section of the support structure. They are designed to regulate blood flow in the direction corresponding with normal hemodynamics during the positioning and deployment of the support structure.

[0034] For cases where immediate valve function is required during the deployment process, the leaflets may be temporary, i.e., they can be configured to be overridden by a permanent prosthetic cardiac valve when the latter is positioned and deployed within the support structure.

[0035] In some embodiments, the temporary leaflets and the

[0036] The deployment of the prosthetic cardiac valve system can be achieved through various methods, each tailored to specific clinical needs and valve configurations. These methods generally involve the use of a guide wire and a delivery system with a distal capsule containing the compressed prosthetic cardiac valve system.

[0037] In one method, the deployment process begins with introducing the guide wire and delivery system, visualized under imaging. The downstream inflatable element and mesh section are exposed at the sub-annular level of the native valve, distal to the native leaflets' coaptation line. The downstream inflatable element is then inflated while the upstream inflatable element remains crimped in the capsule. The capsule is retrieved towards the upstream portion of the valve, allowing the downstream spikes (if present) to engage downstream of the native valve. The upstream inflatable element is then unsheathed and inflated, followed by the withdrawal of the capsule.

[0038] In an alternative method, the deployment process begins with introducing the delivery system, visualized under imaging. The upstream inflatable element and mesh section are first exposed above the native valve, proximal to the native leaflets. The upstream inflatable element is then inflated while the downstream inflatable element remains crimped in the capsule. This initial inflation of the upstream element serves as a positioning aid, helping to center and stabilize the device, which improves initial positioning and enhances stability during deployment. It acts as a 'stop', helping to prevent over-insertion of the device. The capsule is then advanced distally, allowing the intermediate and downstream sections to pass through the native valve. This approach allows a high implant positioning, controlled, as well as atraumatic positioning and anchoring of the device, potentially reducing the risk of damage to surrounding structures. Once the downstream section is positioned sub-annularly, it is exposed and the downstream inflatable element is inflated. The inflated upstream element provides better visualization of the annulus and landing zone for the downstream portion, which is particularly useful in cases where the sub-annular anatomy is complex or calcified. Finally, the capsule is fully withdrawn, and any final adjustments to both inflatable elements can be made to ensure optimal sealing and anchoring. This method reduces the risk of valve dislodgement by securing the upstream portion first, and it offers the potential for repositioning if the initial position is not optimal, as it may be easier to adjust the device before the downstream element is deployed. These features make this approach particularly advantageous in transcatheter mitral valve replacement (TMVR) procedures, where precise positioning and anchoring are crucial due to the complex anatomy and high-pressure environment of the mitral position.

[0039] For cases involving a prosthetic cardiac valve with a non-deformable portion, a modified approach may be used. In this method, the support structure is first introduced and positioned within the patient's body. The prosthetic cardiac valve, which cannot be compressed due to its non-deformable portion, is then separately introduced through a surgical procedure. Once both components are in place, the prosthetic cardiac valve is connected to the support structure inside the patient's body. This method allows for the use of standard surgical valves without requiring modifications to their structure.

[0040] Another deployment method involves connecting the prosthetic cardiac valve to the support structure outside the patient's body, creating an integrated system. Due to its non-deformable nature, this integrated system is then introduced into the patient's body in a surgical procedure.

[0041] According to an embodiment of the presently disclosed subject matter, for introduction of the integrated system, in cases where it involves downstream tissue engaging spikes, the downstream tissue engaging spikes are initially constrained by sutures or a protective cone. This prevents the sharp edges of the spikes from contacting tissue during insertion beyond the native valve annulus. Once the device is positioned, the sutures are cut or the cone is removed, allowing the spikes to 'pop out' to their preshaped form. Optionally, the downstream inflatable element is then inflated to ensure proper anchoring and engagement of the spikes with the surrounding tissue. It's important to note that in all these methods, the inflation of the upstream and downstream inflatable elements plays a crucial role in securing the support structure or integrated system in place and ensuring proper sealing against paravalvular leaks.

[0042] Further, the inflation mechanisms play a role in the deployment and functionality of the prosthetic cardiac valve system. When used in conjunction with surgical valve configurations, they not only fine-tune the positioning and sealing of the support structure, but also provide a robust anchoring mechanism. The inflation of both the upstream and downstream inflatable elements creates a 'sandwich effect', securely clamping the native valve tissue between them. This dual -balloon approach, combined with the grasping action of the tissue-engaging spikes, ensures proper anchoring of the support structure. This comprehensive anchoring strategy is effective even when accommodating valves with non-deformable components, as it adapts to various anatomical challenges and provides stability in high-pressure environments.

[0043] The support structure and associated deployment methods offer several advantages. They allow for a more personalized approach to valve replacement, accommodating various anatomies while providing sealing and tissue anchoring. The use of inflatable elements and, in some cases, tissue engaging spikes, ensures secure positioning and minimizes the risk of displacement. The ability to use standard surgical valves or specially designed prosthetic cardiac valves provides flexibility in treatment options rending the system compatible with a wide range of surgical and interventional approaches. It can be utilized in open heart surgery, minimally invasive robotic valve replacement procedures using surgical valves (such as mechanical and biological valves), and implantation via a transcatheter approach with balloon expandable and selfexpandable valves. This adaptability allows clinicians to choose the most appropriate method based on patient-specific factors and institutional capabilities. Importantly, it's worth noting that this device can also function as a fully operational valve on its own, capable of being implanted through any of the aforementioned methods. This feature further expands its utility, potentially simplifying procedures and reducing the need for additional valve components in certain cases.

[0044] The stent member of the support structure deserves special attention due to its unique properties and design. It can be in the form of a flexible tubular element with distinct upstream, downstream, and intermediate mesh sections. The support structure's design offers versatility and adaptability in valve replacement procedures. A feature allowing such is the intermediate section, which can be engineered as either non- deformable or deformable, depending on the intended application. When non-deformable, it provides a stable environment crucial for optimal leaflet function, whether these are leaflets integral to the device functioning as a fully operational valve, or leaflets of selfexpandable prosthetic cardiac valves that require additional support. Conversely, a deformable intermediate section is advantageous when used with stronger prosthetic cardiac valves, such as balloon-expandable or surgical valves. This deformability allows the support structure to accommodate various sizes of the same valve type, enhancing its flexibility in clinical use.

[0045] This dual-nature design of the intermediate section, combined with the use of inflatable elements and tissue engaging spikes, ensures secure positioning and minimizes displacement risk across different valve types. The system's adaptability extends to various surgical and interventional approaches, including open heart surgery, minimally invasive robotic procedures, and transcatheter implantation. Importantly, the device can serve either as a standalone, fully functional valve or as a host for different prosthetic cardiac valves, offering an unparalleled range of treatment options. This comprehensive flexibility allows clinicians to tailor the approach to individual patient needs, anatomical variations, and specific valve requirements, thereby optimizing outcomes in diverse clinical scenarios

[0046] In embodiments featuring tissue engaging spikes, these can be made of a memory shape material, typically the same material as the stent itself. At room temperature or when constrained within the delivery system, these spikes lie flat, coplanar with the outer surface of the stent. However, upon reaching body temperature (approximately 37°C) and being freed from constraint, they deform to their memorized shape, projecting radially outward from the stent surface.

[0047] When the intermediate section can be either non-deformable or deformable depending on the valve type, the downstream mesh section is designed to be deformable, enhancing the stent's ability to anchor securely and adapt to various anatomical configurations

[0048] The configuration of these spikes can vary. They may be equally distributed around the perimeter of the stent and can take various shapes such as triangular, teardrop, or elongated loops. The direction of these spikes is also noteworthy; typically, upstream spikes face towards the downstream side of the stent, while downstream spikes face towards the upstream side. This orientation helps to anchor the support structure securely in place, resisting movement in either direction.

[0049] At its initial, unstressed position, the stent may be cylindrical. However, once deployed and expanded, it can assume different shapes to best fit the anatomy of the specific valve site. For instance, in some applications, the stent may take on a frustoconical shape at its deployed, expanded position, with the narrow portion being the upstream section of the stent.

[0050] The elastic sleeve member of the support structure is another crucial component. It typically comprises an upstream portion and, in many embodiments, a downstream portion. These can be separate sleeves or a continuous sleeve member with an intermediate portion connecting the upstream and downstream sections. The sleeve is made of a stretchable, biocompatible material, which may include fabrics, polymeric sheets, braiding or even thin metal sheets.

[0051] The inflatable elements are incorporated into these elastic sleeves. In the upstream section, the inflatable element is typically positioned axially upstream of the mesh section, while in the downstream section, it often overlaps with the inside portion of the intermediate mesh section and part of the downstream mesh section.

[0052] An important feature of the support structure is its ability to accommodate various types of prosthetic cardiac valves. This includes valves that are integrated with the support structure during manufacturing, as well as those designed to be inserted separately during the medical procedure. The support structure can be configured to work with commercially available prosthetic cardiac valves, including those with non-deformable components like rigid rings.

[0053] To facilitate the use of such valves, the support structure may include specific adaptations. For instance, it might feature a receiving arrangement with a base designed to accept a standard valve size and a fixation mechanism to secure the valve in place once positioned. This could involve elements like annular flanges or indentations in the mesh structure, complemented by fixation elements such as directional resilient tongues or other locking mechanisms.

[0054] The prosthetic cardiac valve kit, as described in this disclosure, provides a comprehensive solution for valve replacement procedures. This kit typically includes the support structure as previously described, along with a prosthetic cardiac valve designed to be secured within the upstream elastic sleeve and downstream of the upstream inflatable element.

[0055] The kit may also include additional components to facilitate the deployment and operation of the system. These can include an inflating mechanism for inflating one or both of the upstream and downstream inflatable elements. This mechanism is crucial for achieving the desired shape and anchoring of the support structure once it's in place.

[0056] Furthermore, the kit might include a detachable inflation tube that can be articulated with each of the inflatable elements. This allows for precise control over the inflation process during deployment and can be detached once the desired inflation is achieved, leaving the support structure and valve in place without external connections.

[0057] One of the key advantages of this system is its versatility in deployment methods. The method can be adapted based on the specific type of prosthetic cardiac valve being used and the particular anatomical challenges of the patient.

[0058] For instance, in cases where a standard surgical valve with a non-deformable portion is to be used, the method allows for separate introduction of the support structure and the valve. The support structure can be introduced and positioned using minimally invasive techniques, while the valve itself can be introduced through a surgical approach. This method provides the benefit of using well-established, reliable valve designs while still leveraging the advantages of the support structure for optimal positioning and sealing.

[0059] Alternatively, for valves designed to work specifically with this support structure, a method of connecting the valve to the support structure outside the body can be employed. This creates an integrated unit that can then be introduced and deployed as a single piece. This method may be particularly useful when a very specific alignment between the valve and the support structure is required.

[0060] In all these methods, the use of inflatable elements provides a unique advantage. These elements can be precisely inflated to achieve optimal sealing and anchoring, adapting to the specific anatomy of each patient. This customizable approach can significantly reduce the risk of paravalvular leaks, a common complication in valve replacement procedures.

[0061] The support structure described in this disclosure is not limited to a single type of cardiac valve. It can be adapted for use in mitral, aortic, tricuspid, or pulmonary valve replacements. The positioning and configuration of the inflatable elements can be adjusted based on the specific requirements of each valve position.

[0062] For example, in a mitral valve application, the upstream inflatable element would be configured for supra-annular positioning and inflation within the left atrium. In contrast, for an aortic valve application, the upstream inflatable element might be configured for sub-annular positioning and inflation.

[0063] The versatility of this support structure extends to its ability to accommodate different valve designs and deployment strategies. For instance, in some embodiments, the support structure may include temporary valve leaflets. These are positioned between the upstream and downstream mesh sections and serve to regulate blood flow during the deployment process. Once the permanent prosthetic cardiac valve is in place, it overrides these temporary leaflets.

[0064] This feature is particularly valuable in scenarios where maintaining blood flow during the procedure is crucial, as it allows for a more controlled and potentially safer deployment process. The temporary leaflets ensure that there is no significant disruption to the heart's function while the permanent valve is being positioned and secured.

[0065] The design of the support structure also takes into account the need for future interventions. In some cases, it may be necessary to replace or adjust the prosthetic cardiac valve after initial implantation. The support structure is designed to facilitate such procedures, potentially allowing for valve -in- valve interventions or adjustments to the existing valve without needing to remove the entire support structure.

[0066] An important aspect of this system is its ability to provide a customized fit for each patient. The combination of the flexible mesh structure and the inflatable elements allows the support structure to conform to a wide range of anatomical variations. This is particularly important given the significant variability in valve anatomy between patients, especially in cases of valve disease.

[0067] The inflatable elements play a role in this customization. By allowing independent inflation, these elements can be adjusted to provide the optimal balance of sealing and anchoring for each specific patient. For example, in a patient with a particularly calcified valve annulus, the inflatable elements might be inflated to a higher pressure / volume to ensure proper sealing, while in a patient with more pliable tissue, a lower inflation pressure / volume might be sufficient. The material composition of the support structure and its components is another area of innovation. The stent portion is typically made of a shape-memory alloy, such as Nitinol, which allows it to be compressed for delivery and then expand to its predetermined shape once in position. However, other materials may also be used, including various biocompatible metals, polymers, or composite materials.

[0068] The elastic sleeve and inflatable elements are made of materials that are both biocompatible and capable of withstanding the pressures and movements they will be subjected to in the heart. These may include specially designed fabrics, polymeric materials, or even thin, flexible metal meshes.

[0069] In some embodiments, the materials used in the support structure, the elastic sleeves, or the prosthetic cardiac valve itself may be treated to be drug -eluting. This can be beneficial in reducing the risk of complications such as thrombosis or tissue overgrowth, potentially improving the long-term outcomes for patients.

[0070] The inflation mechanism for the inflatable elements is designed with both effectiveness and safety in mind. The inflation fluid can be a gas or a liquid, and in some embodiments, may include additives to enhance visibility under imaging or to promote sealing in case of small leaks. The inflation ports are designed to be easily accessible during the deployment process but secure against unintended deflation once the procedure is complete.

[0071] The deployment process for this prosthetic cardiac valve system has been carefully designed to be as efficient and controllable as possible. The use of a guide wire and a specialized delivery system allows for precise positioning of the support structure. The ability to deploy and inflate the downstream element before fully releasing the upstream portion provides a level of control that can be crucial in challenging anatomies.

[0072] Furthermore, the system is designed to be compatible with various imaging modalities, including fluoroscopy and echocardiography for transcatheter procedures and endoscopic camera for surgical procedures. This allows the medical team to have realtime visualization of the deployment process, ensuring optimal positioning and function of the valve.

[0073] One of the key advantages of this system is its potential to reduce procedural time and complexity compared to some existing valve replacement techniques. By providing a support structure that can accommodate various valve types and sizes, it may reduce the need for extensive pre-procedure measurements and custom valve fabrication. The system also addresses one of the significant challenges in transcatheter valve replacements: the risk of paravalvular leaks. The combination of the mesh structure, tissue engaging spikes (when present), and inflatable elements provides multiple mechanisms for ensuring a tight seal around the valve. This can potentially reduce the need for postprocedure interventions to address leaks. An important feature of this prosthetic cardiac valve system is its ability to control the shape and size of the device through inflation and deflation mechanisms. This allows for adjustment of the device's configuration during the implantation procedure. By manipulating the inflatable elements, clinicians can modify the device's shape to improve anchoring and address the paravalvular leaks. This level of control is useful in managing the variability of patient anatomies and challenges often encountered in valve replacement procedures. The ability to make these adjustments in real-time, without device removal or exchange, may help reduce procedure time and complications. Additionally, this adaptability could allow for post-operative adjustments if needed. The system's capacity to provide a more tailored approach to cardiac valve replacement addresses two key aspects of the procedure: anchoring and sealing against paravalvular leaks.

[0074] In addition to its use in replacing diseased native valves, this system may also have applications in valve -in-valve procedures, where a new valve needs to be placed within a previously implanted bioprosthetic cardiac valve that has degenerated. The support structure could potentially be designed to anchor within the existing bioprosthetic cardiac valve frame, providing a stable platform for the new valve.

[0075] The prosthetic cardiac valve system described in this disclosure represents a significant advancement in the field of cardiac valve replacement. By combining the benefits of both surgical and transcatheter approaches, it offers a flexible, customizable solution that can be adapted to a wide range of patient anatomies and clinical scenarios.

[0076] The system's ability to accommodate various valve types, including both specially designed valves and standard surgical valves, provides clinicians with a broader range of options for treating their patients. This flexibility, combined with the potential for reduced procedural complexity and improved outcomes, could make this system a valuable tool in the treatment of valvular heart disease.

[0077] The prosthetic cardiac valve system described here, with its innovative support structure, customizable deployment methods, and ability to accommodate various valve types, represents a promising approach to addressing the challenges of cardiac valve replacement. By providing a more personalized, adaptable solution, it has the potential to improve outcomes for a wide range of patients suffering from valvular heart disease.

[0078] A fourth aspect of the disclosure is directed to a prosthetic cardiac valve kit comprising: a support structure comprising a flexible tubular stent having an upstream mesh section and a downstream mesh section, with a radially deformable intermediate mesh section extending therebetween, and wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes and the downstream mesh section is configured with a plurality of downstream tissue engaging spikes; wherein at an expanded position of the stent said upstream tissue engaging spikes and said downstream tissue engaging spikes project radially outwards from an outside surface of the stent; upstream elastic sleeve extending over at least a portion of an inside face of said upstream mesh section; said upstream elastic sleeve having an upstream inflatable element disposed axially upstream of said upstream mesh section; a prosthetic cardiac valve engageable within the upstream elastic sleeve and downstream of the upstream inflatable element, said valve configured to facilitate blood flow therethrough in direction from the upstream mesh section towards the downstream mesh section, corresponding with normal hemodynamics; an introducing and deploying system comprising a catheter and a guide wire, said catheter encapsulating the prosthetic cardiac valve system at a collapsed position and configured for deploying the prosthetic cardiac valve system in situ; and an inflating mechanism for inflating the upstream inflatable element and the downstream inflatable element.

[0079] A fifth aspect of the disclosure is directed to a method of deploying a prosthetic cardiac valve system, or a fully functional prosthetic cardiac valve, (i.e., a prosthetic cardiac valve system), as disclosed herein above, the method comprising the following steps:

[0080] A. Introducing a guide wire with a distal capsule (Over The Wire Delivery system) containing the prosthetic cardiac valve support system ‘dock’), or the fully functional prosthetic cardiac valve (i.e. a prosthetic cardiac valve system), at a compressed position e.g., visualized under imaging; B. Exposing the downstream inflatable element with the downstream mesh section of the stent at the sub annular level of the native valve, distal to the native leaflets coaptation line;

[0081] C. Inflating the downstream inflatable element, while upstream inflatable element is still crimped in the capsule;

[0082] D. Retrieving the capsule towards the upstream portion of the valve, allowing the downstream spikes to engage downstream of the native valve;

[0083] E. Unsheathing the upstream inflatable element under imaging;

[0084] F. Inflating the upstream inflatable element;

[0085] G. Withdrawing the capsule, while the guide wire optionally remains in place;

[0086] In some embodiments the method further comprises: introducing and guiding a compressed prosthetic cardiac valve over the guide wire e.g., with a dedicated delivery system of the prosthetic cardiac valve into the prosthetic cardiac valve system; positioning the prosthetic cardiac valve within the inflated prosthetic cardiac valve system under imaging, between the upstream inflatable element and the downstream inflatable element; deploying the prosthetic cardiac valve; optionally, withdrawing the prosthetic cardiac valve’s capsule; optionally, adjusting inflation level of the upstream inflatable element and / or the downstream inflatable element for para-prosthetic leaks elimination and sub annular adjustments, performed under imaging; detaching the inflating mechanism of the upstream inflatable element and the downstream inflatable element; and removing the guide wire.

[0087] In yet another aspect there is provided a method of deploying a prosthetic cardiac valve system, or a prosthetic cardiac valve support system, the method comprising: introducing a guide wire with a distal splitable capsule containing the prosthetic cardiac valve system at a compressed position e.g., visualized under imaging; splitting the distal portion pf the capsule for exposing an upstream inflatable element above native leaflets of a native valve while maintaining downstream portions and a stent of the prosthetic cardiac valve in a splitted portion of the distal capsule distal to the upstream inflatable element; inflating the upstream inflatable element; distally advancing the inflated upstream inflatable element and the splitted portion of the capsule to place the inflated upstream inflatable element over an annulus of the native vale and introducing the splitted portion of the capsule below the native leaflets of the native valve; distally advancing the splitted portion of the capsule for unsheathing the downstream portions and the stent of the prosthetic cardiac valve e.g., under imaging; inflating the downstream inflatable element for anchoring the stent sub-annularly e.g., by upstream and / or downstream tissue engaging spikes of the stent; and withdrawing the capsule.

[0088] Any one or more of the following features, designs and configurations can be associated with any one or more of the aspects of the present disclosure, individually or in various combinations thereof:

[0089] • The upstream tissue engaging spikes and the downstream tissue engaging spikes face towards an upstream side of the stent;

[0090] • The intermediate mesh section can be configured as an undulating / serpentine-like section, axially extending between the upstream mesh section and the downstream mesh section;

[0091] • the intermediate section can be configured as axially extending posts or segments having a polygonal shape;

[0092] • The intermediate mesh section integrally extends with the upstream mesh section and the downstream mesh section:

[0093] • The upstream mesh section can extend in proximity below the downstream inflatable element;

[0094] • the upstream mesh section extends in proximity above the upstream inflatable element;

[0095] • The upstream inflatable element can extend opposite at least a portion of the intermediate mesh section and a portion of the downstream mesh section;

[0096] • The stent can be cylindrical and however is sufficiently elastic to assume a shape of the respective cardiac valve cavity into which it is applied;

[0097] • The upstream elastic sleeve and the downstream elastic sleeve can be a homogeneous sleeve or independent sleeves;

[0098] • The sleeve member can be a continuous sleeve member comprising an intermediate portion extending between the upstream elastic sleeve and the downstream elastic sleeve;

[0099] • At its deployed, expanded position, the stent can have a frustoconical shape wherein a narrow portion thereof is the upstream section of the stent;

[0100] • The projecting spikes can have a pointed end facing the upstream end of the stent; • The projecting spikes can be equally distributed about a perimeter of the stent;

[0101] • The projecting spikes can have a triangle / teardrop or elongated loop shape;

[0102] • The inflatable tubular upstream element can be disposed within an annular pouch of the sleeve;

[0103] • The support structure is configurable for use as a cardiac valve support for any one of the mitral valve, the aortic valve, the tricuspid valve and the pulmonary valve.

[0104] • The arrangement is such that at a deployed position, when the upstream inflatable element is inflated, it serves as an annular seal disposed upstream of the prosthetic cardiac valve, seal to restrict blood flow only through said prosthetic cardiac valve;

[0105] • The support structure is a valve support for a prosthetic mitral valve, wherein the upstream inflatable element is configurable for supra-annular positioning and inflating, within the left atrium;

[0106] • The support structure is a valve support for a prosthetic aortic valve, wherein the upstream inflatable element is configurable for sub-annular inflation;

[0107] • The support structure is configurable for use as a valve support for a prosthetic tricuspid valve, wherein the upstream inflatable element is configurable for supra-annular positioning and inflating, within the right atrium;

[0108] • The support structure is configurable for use as a valve support for a prosthetic pulmonary valve, wherein the upstream inflatable element is configurable for sub-annular inflation;

[0109] • At an initial, unstressed position, the stent be cylindric;

[0110] • The stent can be secured at an inside face of the flexible sleeve;

[0111] • The sleeve member can be made of any stretchable, biocompatible material, such as fabrics, polymeric sheets, metal sheet, etc.;

[0112] • The upstream inflatable element and the downstream inflatable element can each be configured as an annular pocket of the sleeve, accommodating an inflatable annular balloon; • Each of the upstream inflatable element and the downstream inflatable element can be configured with a one-way inflating valve, including a possibility to deflate as well by various methods, if needed;

[0113] • The prosthetic cardiac valve kit can further comprise a detachable inflation tube detachably articulated with each of the upstream inflatable element and the downstream inflatable element;

[0114] • Each of the upstream inflatable element and the downstream inflatable element can be configured with an inflation valve, to which an inflation tube is detachably attachable to;

[0115] • One or both of the stent and the elastic sleeve and the prosthetic cardiac valve can be drug-eluting;

[0116] • The prosthetic cardiac valve is anchorable to the upstream mesh section or to the upstream elastic sleeve;

[0117] • The upstream inflatable element and the downstream inflatable element can be received within an enveloping portion of the upstream elastic sleeve and the downstream elastic sleeve, respectively.

[0118] • Each of the upstream inflatable element and the downstream inflatable element can comprise an inflation / deflation valve;

[0119] • The inflation / deflation valve can be detachable;

[0120] • The inflation valve can be a silicon plug type valve;

[0121] • The upstream inflatable element and the downstream inflatable element can be inflated by a compressed inflation fluid;

[0122] • The compressed inflation fluid can be a gaseous substance;

[0123] • The compressed inflation fluid can be a liquid, such as isotonic, hypertonic, hypotonic, isosmotic, hyperosmotic, hypoosmotic with various degrees of viscosities

[0124] • The compressed inflation fluid can be a liquid comprising a puncture sealing agent;

[0125] • At an inflated state the upstream inflatable element extends radially beyond the free tips of the stent.

[0126] • The upstream elastic sleeve can be secured to an inside face of stent, or to an outside face thereof; • The downstream elastic sleeve can be secured to an inside face of stent, or to an outside face thereof;

[0127] • Each of the upstream inflatable element and the downstream inflatable element can be tubular.

[0128] BRIEF DESCRIPTION OF THE DRAWINGS

[0129] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0130] Fig. 1 A is perspective view of a stent used in conjunction with a prosthetic cardiac valve support structure, according to an aspect of the disclosure, the stent at an undeformed position;

[0131] Fig. IB is a side view of Fig. 1A;

[0132] Fig. 1C is a top view of Fig. IB;

[0133] Fig. ID is a flattened planar view of the deformable intermediate mesh section of the stent at a manufacturing position, before compressing;

[0134] Fig. IE is an enlarged view of the portion marked I in Fig. IB;

[0135] Fig. 2A is a perspective view of the stent of Fig. 1A, illustrated at a deployed / expanded position;

[0136] Fig. 2B is a side view of Fig. 2A;

[0137] Fig. 2C is a top view of Fig. 2B;

[0138] Fig. 2D is an enlarged view of the portion marked II in Fig. 2B;

[0139] Fig. 3A is a perspective view illustrating an embodiment of prosthetic cardiac valve support structure, comprising an upstream flexible sleeve, the support structure at a deployed position, however with the inflatable element deflated;

[0140] Fig. 3B illustrates the prosthetic cardiac valve support structure of Fig. 3A at a deployed / expanded position, upon inflating the upstream inflatable element;

[0141] Fig. 4A is a perspective view illustrating another embodiment of prosthetic cardiac valve support structure, comprising an upstream flexible sleeve and a separate, downstream flexible sleeve, the support structure at a closed position, however with the inflatable elements deflated; Fig. 4B illustrates the prosthetic cardiac valve support structure of Fig. 4A at a deployed / expanded position, upon inflating both the inflatable elements;

[0142] Fig. 5A is a perspective view illustrating an embodiment of prosthetic cardiac valve support structure, comprising an upstream flexible sleeve and an integrated, downstream flexible sleeve, the support illustrated prior to inflating the inflatable elements, however with the inflatable elements deflated;

[0143] Fig. 5B illustrates the prosthetic cardiac valve support structure of Fig. 5A at a deployed / expanded position, upon inflating both the inflatable elements;

[0144] Fig. 5C is a longitudinal section along line 5C - 5C in Fig. 5B;

[0145] Fig. 6A is a side view illustrating only the stent used in the embodiment of Fig. 5B;

[0146] Fig. 6B is a top view of the stent of Fig. 6A;

[0147] Fig. 7A is a top view of the prosthetic cardiac valve support structure of Fig. 5B;

[0148] Fig. 7B is a bottom view of the prosthetic cardiac valve support structure of Fig. 5B;

[0149] Fig. 7C is an exploded view of a support structure and a prosthetic cardiac valve for use in conjunction therewith, constituting together a prosthetic cardiac valve system;

[0150] Fig. 7D is a sectioned view through a prosthetic cardiac valve system at a deployed position;

[0151] Fig. 7E illustrates the prosthetic cardiac valve system deployed within a human heart as a mitral valve;

[0152] Fig. 8A illustrates a heart implanted with a mitral prosthetic cardiac valve system and a tricuspid prosthetic cardiac valve system, according to an example of the disclosure;

[0153] Fig. 8B illustrates a prosthetic cardiac valve system according to an example of the disclosure, configured as a pulmonary valve;

[0154] Fig. 8C illustrates a prosthetic cardiac valve system according to an example of the disclosure, configured as an aortic valve;

[0155] Fig. 8D is an enlarged view of the portion marked 8D in Fig. 8C;

[0156] Fig. 9 is a flowchart of a method for deploying a prosthetic cardiac valve support system according to an embodiment of the disclosure, referring to steps A to N of the disclosed method; Figs. 10A to 10E illustrate steps of deploying and positioning the dock or the prosthetic cardiac valve system according to some of the embodiments described in flow chart of Fig. 9, wherein;

[0157] Fig. 10A illustrates the prosthetic cardiac valve system at a crimped position, over the guide wire;

[0158] Fig. 10B illustrates the device of Fig. 10A upon exposing the downstream inflatable element;

[0159] Fig. IOC illustrates the device of Fig. 10A upon inflating the downstream inflatable element;

[0160] Fig. 10D illustrates the device of Fig. IOC from a proximal end;

[0161] Fig. 10E illustrates the device of Fig. IOC from a distal end;

[0162] Fig. 11A illustrates the transseptal approach to the mitral valve of a heart, with the prosthetic cardiac valve system over the guide wire (Fig. 10A), at a crimped, delivery position;

[0163] Fig. 11B illustrates positioning the delivery system tip sub annularly;

[0164] Fig. 11C illustrates the system upon exposing the downstream inflatable element (Fig. 10B);

[0165] Fig. HD illustrates the system upon inflating the downstream inflatable element (Fig. IOC - 10E);

[0166] Fig. HE illustrates the system with the inflated downstream balloon being pulled back towards the annulus for anchoring by via stent’s spikes grasping the native valve’s leaflets;

[0167] Fig. HF illustrates the upstream inflatable member deployed at its nominal size in location, prior to inflation;

[0168] Fig. 11G illustrates the upstream inflatable member positioned and while the inflation process ;

[0169] Fig. 11H illustrates the system at a deployed, operative position;

[0170] Figs. 12A to 12D exemplify a prosthetic cardiac valve according to possible embodiments a set of leaflets integrated therein, wherein Fig. 12A shows a top view, Fig. 12B shows a top-perspective view, Fig. 12C shows a bottom view, and Fig. 12D shows a front view of a leaflet band usable for integration in the prosthetic cardiac valve;

[0171] Figs. 13A to 13G demonstrates steps of placing a prosthetic cardiac valve according to possible embodiments; Figs. 14A to 14C schematically illustrate a stent according to other possible embodiments usable for a prosthetic cardiac valve and / or support structure thereof; wherein Fig. 14A shows the stent in a crimped state; Fig. 14B shows the stent in a deployed state, and Fig. 14C shows a flat view of the stent;

[0172] Figs. 15 schematically illustrate the stent of Figs. 14A to 14C implemented with single-wire spikes; and

[0173] Figs. 16A to 16C schematically illustrate different downstream (or upstream) spike configurations according to possible embodiments, wherein Figs. 16A shows a peglike spike configuration, Figs. 16B shows an elongated loop spike configuration, and Figs. 16A shows an elongated tapering loop spike configuration; and

[0174] Figs. 17A to 17D demonstrate a procedure for placing an insertable prosthetic cardiac valve in the prosthetic cardiac valve support structure according to possible embodiments;

[0175] Fig. 18 shows a new embodiment of the support structure configured to receive an unmodified surgical valve with a non-deformable ring surrounding it;

[0176] Figs. 19A to 19C show a sequence of introduction of a standard unmodified surgical valve with a non-deformable ring into the support structure of Fig. 18;

[0177] Fig. 20A shows another example of a surgical valve with a non-deformable ring surrounding it, modified to include a fixation arrangement;

[0178] Fig. 20B shows another example of a support structure configured to receive the valve of Fig. 20A; and

[0179] Figs. 21A to 21C show a sequence of introduction of the valve of Fig. 20A into the support structure of Fig. 18.

[0180] DETAILED DESCRIPTION OF EMBODIMENTS

[0181] Attention is now made to the drawings, for better understanding the disclosure. In Figs. 1A to IE there is illustrated a stent member generally designated 10, configured for supporting a prosthetic cardiac valve, as will be disclosed herein after in detail. In Figs. 1A - IE the stent member 10 is at an un-deformed position, i.e. after cutting. In other embodiments of the presently disclosed subject matter, the stent member can be able to support different types of prosthetic cardiac valves.

[0182] The stent member 10 is a tubular cylindrical wire / mesh-like element, which in the illustrated example is cut out of a cylindrical body, however, a stent can be made using different technologies, e.g. weaving a wire, welding, fine cutting techniques through a tubular element and other techniques used in the art of stent manufacturing, depending, among others, on final required mechanical properties. Optionally, but in some embodiments preferably, the stent undergoes thermal treatment, whereby it obtains memory shape, so that once introduced into the body it can be deformed into its operative, expanded position.

[0183] Accordingly, the stent can be configured to maintain said memory shape imparted thereto. The stent can be made of various biocompatible materials, such as metal (e.g. Nitinol -NiTi), polymeric materials, composite materials and others, or other suitable material for imparting the stent its unique property, namely the ability to be deformed from a closed / crimped position and return to / restore its initial expanded shape upon exposure to heat or pressure, or upon cease of a restraint compacting force (in case of a self-expandable device). This allows the stent to be compressed for insertion through a small body incision, and then expand to the desired size and shape once manipulated in situ.

[0184] The stent 10 is a flexible tubular element having an upstream mesh section 12 and a downstream mesh section 14, defining between them a flow path F in direction from the upstream mesh section 12 to the downstream mesh section 14, in correspondence with normal hemodynamics. The downstream mesh section is designed to be deformable, allowing it to adapt to the sub-annular anatomy and provide optimal anchoring. As the downstream mesh section is exposed, its deformable structure allows it to conform to the sub-annular region.

[0185] It is to be noted that the terms "upstream ’ and "downstream ’ as used herein in the specification and claims, correspond with normal hemodynamics flow directions, respectively. Accordingly, when considering a mitral valve blood flows in direction from the upstream left atrium towards the downstream left ventricle; when considering a tricuspid valve blood flows in direction from the upstream right atrium towards a downstream right ventricle; when discussing the aortic valve blood flows in direction from the upstream left ventricle towards the downstream aorta, and; and when discussing the pulmonary valve blood flows in direction from the upstream right ventricle towards the downstream pulmonary artery.

[0186] The stent 10 is further configured with an intermediate section 18 extending between the upstream mesh section 12 and the downstream mesh section 14, and wherein the upstream mesh section 12 is configured with a plurality of upstream tissue engaging spikes 20 facing upstream, and the downstream mesh section 14 is configured with a plurality of downstream tissue engaging spikes 22 also facing upstream. It is however noted that in possible variants the stent 10 can be configured only with the downstream tissue engaging spikes 22 (or only with the upstream tissue engaging spikes 20).

[0187] The upstream tissue engaging spikes 20 and the downstream tissue engaging spikes 22 are triangular / teardrop shaped having a pointed tip, wherein at an initial state (i.e. prior to exposure to predetermined temperature, optionally about 37°C) said spikes 20 and 22 extend coplanar with an outside surface of the stent, i.e. they do not radially project from an outside face 25 (see e.g., Fig. 1C) of the stent 10. However, once introduced in situ, and as the stent reaches the predetermined temperature (body temperature e.g., of about 37°C) - said upstream tissue engaging spikes 20 and downstream tissue engaging spikes 22 deform to their memory shape projecting radially outwards from the outside face of the stent.

[0188] The spikes 20, 22 are configured for projecting into the tissue of the native cardiac valve, for securing the stent 10 thereto, and in some embodiments also for securing a prosthetic cardiac valve system thereto, as will be discussed.

[0189] The free tips (ends) 26, 28 of the stent 10, at both respective axial ends thereof, are rounded, and said tips are also coplanar with the outside face 25 of the stent 10.

[0190] The intermediate section 18 of the stent 10 connects between the upstream mesh section 12 and the downstream mesh section 14, and has an undulating pattern 19, imparting it flexibility for radially deforming so as to bear against inside walls of the native valve (as will be discussed herein below).

[0191] However, it is appreciated that the undulating pattern of the intermediate section 18 is a mere example and other design options are possible (e.g., having a sinusoidal, rectangular, or triangular, wavy pattern). For example, the intermediate section 18 can be configured as axially extending posits or segments having a polygonal shape.

[0192] It should be noted that the support structure can be configured with various combinations of features to suit different clinical needs. These configurations may include two inflatable elements, tissue engaging spikes, or a combination of both. This flexibility allows for customized approaches to anchoring and sealing the prosthetic cardiac valve within the native valve site Further atention is directed also to Figs. 2A to 2D of the drawings, illustrating the stent 10 after it has been allowed to deform under thermal properties. Namely, predeploying the stent into the body (see Figs. 1A - IE), the tissue engaging spikes remain flush with an outside surface of the stent. However, once the stent is deployed and reaches body temperature (approx. 37C°) the upstream tissue engaging spikes and said downstream tissue engaging spikes project radially outwards from the outside surface of the stent, as per predesigned memory shape thereof.

[0193] It is noted that the axial length of the stent 10 decreases, as it radially expands, and significantly wherein the upstream tissue engaging spikes 20 and the downstream tissue engaging spikes 22 now project radially outwards, i.e. project from the outside face 25 of the stent 10 (see Fig. 2C).

[0194] With further atention being made now also to Figs. 3A and 3B, there is illustrated an example of a prosthetic cardiac valve system 50, according to an aspect of the disclosure.

[0195] The prosthetic cardiac valve system 50 comprises a stent 10 of the kind disclosed hereinbefore, and wherein an upstream elastic sleeve 54 having a tubular section 56 extends over at least a portion of an inside face 27 of said upstream mesh section 12, and secured thereto, e.g. by adhering, welding, stitching, etc. The sleeve member 54 can be made of any stretchable, biocompatible material, such as fabrics, polymeric sheets, metal sheet, etc.

[0196] The upstream elastic sleeve 54 comprises an upstream inflatable element 60 disposed axially beyond the free tips 26 of the stent, namely axially upstream of said upstream mesh section 12, wherein the upstream inflatable element 60 is a fluid-tight annular portion of the sleeve 54, or it can be an inflatable bladder received within a pocket of the sleeve. The upstream inflatable element 60 is configured with an inflating mechanism (e.g. tubing 64) for inflating and pressure regulating of the pressure within the upstream inflatable element 60. The tubing 64 can be detachable from the inflatable element with a suitable valve 66 (see Fig. 3A) provided. The inflatable element 60 can be inflated by any inflating agent (gas or liquids), and a puncture sealing agent can be applied to the inflating agent. It is noted that the diameter of the inflated upstream inflatable element 60 is greater than that of the prosthetic cardiac valve system 50 at its deployed position. In the example shown herein, both inflatable elements are tubular. As can be noted in Figs. 7A and 7B, the prosthetic cardiac valve system 50 comprises a unidirectional prosthetic cardiac valve V (secured within the upstream elastic sleeve however downstream of the upstream inflatable element 60). The valve V is configured to facilitate blood flow therethrough in direction of the flow path F (namely from the upstream mesh section 12 towards the downstream mesh section 14), corresponding with normal hemodynamics. It is appreciated that the prosthetic cardiac valve V can be a leaf-type valve as illustrated in the drawings, or any other type.

[0197] In Fig. 3A the upstream inflatable element 60 is deflated, whilst the upstream tissue engaging spikes 20 and the downstream tissue engaging spikes 22 are at their radially outwards deformed position, however with the stent 10 still at a cylindrical, undeformed state.

[0198] Once the upstream inflatable element 60 is inflated (see Fig. 3B), it assumes an overall radii greater than that of the stent and the associated sleeve, hence it will bear over the annulus of the native cardiac valve, thereby sealing the valve external vicinity, i.e. preventing blood flow external to the sleeve so that blood flow takes place through the flow path F (through the valve).

[0199] Figs. 4A and 4B illustrate a modification of the embodiment illustrated in Figs. 3A and 3B. A prosthetic cardiac valve system 70 (also usable as prosthetic cardiac valve support), according to an aspect of the disclosure comprises a stent 10 of the kind disclosed hereinbefore, and wherein an upstream elastic sleeve 74 having a tubular section 76 extends over at least a portion of an inside face 27 of said upstream mesh section 12, and secured thereto as discussed hereinabove. The sleeve member 74 can be made of any stretchable, biocompatible material, such as fabrics, polymeric sheets, metal sheet, etc.

[0200] Similar to the arrangement of Fig. 3A, the upstream elastic sleeve 74 comprises an upstream inflatable element 80 disposed axially beyond the free tips 26 of the stent, wherein the upstream inflatable element 80 is a fluid-tight annular portion of the sleeve 74 (or it can be an inflatable bladder received within a pocket of the sleeve, as discussed herein before). The upstream inflatable element 80 is configured with an inflating mechanism (e.g. tubing 84) for inflating and pressure regulating of the pressure within the upstream inflatable element 80. Tubing 84 can be detachable from the inflatable element with a suitable valve 86 (Fig. 4A) provided. The upstream inflatable element 80 can be inflated by any inflating agent (gas or liquids), and a puncture sealing agent can be applied to the inflating agent. Once inflated, the upstream inflatable element 80 radially expands to thereby assume a sealing position over the annulus of the native cardiac valve.

[0201] The prosthetic cardiac valve system 70 comprises a unidirectional prosthetic cardiac valve V (Figs. 7A and 7B), that can be sued or otherwise integrated with the prosthetic cardiac valve support of Figs. 3A and 3B.

[0202] Unlike the embodiment of Figs. 3A and 3B, the prosthetic cardiac valve system 70 exemplified in Figs. 4A and 4B further comprises a downstream elastic sleeve 94, made of any stretchable, biocompatible material, such as fabrics, polymeric sheets, metal sheet, etc. Downstream elastic sleeve 94 has a sleeve portion 96 secured (e.g. by adhering, welding, stitching, etc.) to an inside face 27' of the downstream mesh section 14. Downstream elastic sleeve 94 is further configured with a downstream inflatable element 100 disposed axially internally i.e. upstream of the free tips 28 of the stent 10.

[0203] The downstream inflatable element 100 is a fluid-tight annular portion of the sleeve 94, or it can be an inflatable bladder received within a pocket of the sleeve. The downstream inflatable element 100 is configured with an inflating mechanism (102) for inflating and pressure regulating of the pressure within the downstream inflatable element 100. The inflating arrangement can be common with the upstream inflatable element 80, for simultaneous inflation thereof, or each of the inflatable element 80 and 100 can be fitted with an individual inflating arrangement. As mentioned before, the inflating mechanism can be detachable from the inflatable element with a suitable valve 86 (Fig. 4A) provided and the inflation can take place by any inflating agent (gas or liquids), and a puncture sealing agent can be applied to the inflating agent.

[0204] These inflation mechanisms can be used to fine-tune the positioning and sealing of the support structure.

[0205] In Fig. 4A the prosthetic cardiac valve system 70 is illustrated at an un-inflated, nominal stent position, wherein the upstream inflatable element 80 and the downstream inflatable element 100 are deflated, however with the upstream tissue engaging spikes 20 and the downstream tissue engaging spikes 22 of the stent disposed into the radially outwardly projecting position. This is the position upon introducing the prosthetic cardiac valve system 70 and positioning same within the native cardiac valve.

[0206] The arrangement is such that radially outwardly deforming the upstream mesh portion (e.g., by inflating the upstream inflatable element 80) and the downstream mesh section (e.g., by inflating the downstream inflatable element 100) will increase respective engagement of the radial outwards projecting upstream tissue engaging spikes 20 and / or of the downstream tissue engaging spikes 22, wherein, as formerly explained, the tissue engaging spikes 20 and / or 22 deform to project radially outwards from the outside surface of the stent, upon reaching the predefined (e.g., body temperature of approximately 37°C), as per predesigned memory shape thereof. Accordingly, upon inflating the upstream inflatable element 80 and / or the downstream inflatable element 100 (shown in Fig. 4B), the prosthetic cardiac valve system 70 becomes arrested within the native cardiac valve, wherein the upstream inflatable element 80 will bear over the annulus of the native cardiac valve (as seen in Fig. 8A), thereby sealing the valve external vicinity, i.e. preventing blood flow external to the sleeve so that blood flow takes place through the flow path F (through the valve), and wherein the downstream inflatable element 100 applies radial force on the downstream mesh section 14, resulting in outward deformation of the downstream mesh section 14.

[0207] Yet an embodiment of the disclosure is disclosed with reference to Figs. 5A and 5B). In fact, the prosthetic cardiac valve system 120 illustrated in Figs. 5A and 5B is similar to the embodiment of Figs. 4A and 4B, in that it also comprises an upstream elastic sleeve 122 with an upstream inflatable element 124, and a downstream elastic sleeve 130 downstream inflatable element 132.

[0208] However, a distinguishing difference between the embodiments resides in that the upstream elastic sleeve 122 is integral (or integrated, e.g. by stitching, welding adhering, etc.) with the downstream elastic sleeve 130, through coextending tubular section 126 and sleeve portion 134.

[0209] The upstream inflatable element 124 and the downstream inflatable element 132 can be simultaneously inflated, or independently of one another, as mentioned hereinbefore.

[0210] The arrangement is such that deploying the system into the heart and upon reaching the nominal temperature (e.g., of 37C°) the upstream tissue engaging spikes 20, and / or the downstream tissue engaging spikes 22 deform into radial projection from the external face of the stent, and wherein inflation of the inflatable elements results in deformation of the downstream mesh portion 14, entailing outward deformation of the intermediate section 18, wherein the support structure securely bears against native heart tissue. Accordingly, upon inflating the upstream inflatable element 124 and the downstream inflatable element 132 (seen in Fig. 5B), the prosthetic cardiac valve system 120 becomes arrested within the native cardiac valve, wherein the upstream inflatable element 124 will bear over the annulus of the native cardiac valve (as shown in Fig. 8A), thereby sealing the valve external vicinity, i.e. preventing blood flow external to the sleeve so that blood flow takes place through the flow path F (through the valve), and wherein the downstream inflatable element 132 applies radial force on the downstream mesh section 14, resulting in outward deformation of the downstream mesh section 14.

[0211] In Figs. 6A and 6B the stent 10 is isolated from other elements of the prosthetic cardiac valve / support system, however after it has been deformed into its expanded position, having a frustoconical shape, as explained hereinabove, with the upstream tissue engaging spikes 20 and / or the downstream tissue engaging spikes 22 at their radially outwards deformed position. As indicated hereinabove, the stent may comprise only the downstream tissue engaging spikes 22 (or only the upstream tissue engaging spikes 20).

[0212] Figs 7C to 7E illustrate in further detail a prosthetic cardiac valve system according to the disclosure, generally designated 140. In Fig. 7C there is illustrated an insertable prosthetic cardiac valve generally designated 141 e.g., of known design, comprising a set of valve leaflets 142 secured within a stent cage 143. A nominal diameter Dnv of the insertable prosthetic cardiac valve 141 is slightly greater than a nominal diameter Dns of the support structure generally designated 145. The arrangement is such that once the insertable prosthetic cardiac valve 141 is deployed within the deployed support structure 145, the insertable prosthetic cardiac valve 141 is engaged there within (as shown in Fig. 7D). In the superimposed image of Fig. 7D the insertable prosthetic cardiac valve 141 is represented by thickened dashed lines. Fig. 7E illustrates a prosthetic cardiac valve system 140 deployed within a human heart H as a mitral valve.

[0213] Whilst hard to note in the drawings, it can be seen, best in Fig. 7D, that the support structure 145 is further configured in some embodiments with a set of temporary valve leaflets 148 positioned between the upstream and downstream mesh section at a non- deformable section of the support structure, said temporary valve leaflets 148 configured for temporarily regulating blood flow, in the flow direction F (corresponding with the normal hemodynamics), during a procedure of positioning and deploying the support structure 145 and until the insertable prosthetic cardiac valve 141 is positioned and anchored within the support structure 145, whereby upon positioning and deploying the insertable prosthetic cardiac valve 141, said temporary valve leaflets 148 are over-ridden by the stent cage 143 of the insertable prosthetic cardiac valve 141. In configurations designed for surgical valves with non-deformable rings, temporary leaflets may not be necessary as the valve itself provides immediate functionality upon deployment

[0214] Figs. 8A to 8C exemplify use of a prosthetic cardiac valve system / support structure with an insertable prosthetic cardiac valve according to the disclosure, at the different native valves in a human heart H.

[0215] In Fig. 8A a first prosthetic cardiac valve system / support structure 150 is fitted at the mitral valve of heart H, and wherein arrow F illustrates the flow path in a normal hemodynamics flow direction, from the upstream left atrium LA towards the downstream left ventricle LV, and wherein the upstream inflatable element 152 is inflated with the left atrium LA at a sealing position, and the downstream inflatable element 153 is inflated with the left ventricle LV at a sealing position.

[0216] Also seen in Fig. 8A, a second prosthetic cardiac valve system / support structure 160 is fitted at the tricuspid valve of heart H, and wherein arrow F illustrates the flow path in a normal hemodynamics flow direction, from the upstream right atrium RA towards the downstream right ventricle RV, and wherein the upstream inflatable element 162 is inflated with the right atrium RA at a sealing position, and the downstream inflatable element 163 is inflated with the right ventricle RV at a sealing position.

[0217] In Fig. 8B a prosthetic cardiac valve system / support structure 170 is fitted at the pulmonary valve of heart H, and wherein arrow F illustrates the flow path in a normal hemodynamics flow direction, from the upstream right ventricle RV towards the downstream pulmonary artery PA, and wherein the upstream inflatable element 172 is inflated sub annularly at a sealing position, and the downstream inflatable element 173 is inflated with the right ventricle RV at a sealing position.

[0218] In Figs. 8C and 8D a prosthetic cardiac valve system 180 is fitted at the aortic valve of the heart H, and wherein arrow F illustrates the flow path in a normal hemodynamics flow direction, from the upstream left ventricle LV towards the downstream aorta AO, and wherein the upstream inflatable element 182 is inflated sub annularly at a sealing position.

[0219] Turning now to Figs. 9, 10A to 10E and 11A to 11H of the drawings, there is described a method of deploying the prosthetic cardiac valve system / support structure 120 according to an example of the present disclosure, the method comprising the following steps (step numbering corresponding with levels / steps in Fig. 9): A. Introducing an assembly (delivery system - DS) 190 over a guide wire 191 received within a lumen (e.g., an insertion tube) 192 with a distal (full or splitable) capsule 194 (Over The Wire Delivery system) containing the prosthetic cardiac valve system 120 (‘dock’ / ’prosthetic cardiac system’) at a compressed position (see Figs. 10A, 11 A, 11B), visualized under imaging;

[0220] B. Distally advancing the guide wire 191 and the atraumatic tip 196 at the distal end of the DS 190, and exposing the downstream inflatable element 132 with the downstream mesh section 14 of the stent at the sub annular level of the native valve, distal to the native leaflets coaptation line (see Figs. 10B, 11C);

[0221] C. Inflating the downstream inflatable element 132 (see Figs. 10C - 10E and 11D), while upstream inflatable element 124 is still crimped in the capsule 194;

[0222] D. Retrieving the capsule 194 proximally (e.g., retrieving the delivery system 190) towards the upstream portion of the valve, allowing the downstream spikes 22 to engage the sub annular apparatus of the native valve (see Fig. HE);

[0223] E. Unsheathing the upstream inflatable element 124 under imaging (see Fig. HF);

[0224] F. Inflating the upstream inflatable element 124 (see Fig. 11G);

[0225] G. Retrieving the entire DS 190 towards the upstream portion of the valve, allowing the downstream spikes to attach to the sub annular apparatus of the native valve;

[0226] H. withdrawing entire DS 190 and the capsule 194 e.g., while the guide wire 191 remains in place (Fig. 11H);

[0227] L. Inflation level adjustment of the inflatable elements (upstream and downstream) for para valvular leaks elimination and sub annular adjustments performed under echo guidance;

[0228] M. Detaching the inflation tubes of the inflatable elements (upstream and downstream);

[0229] N. Removing the guide wire;

[0230] O. The fully inflated docking system with the prosthetic cardiac valve are functioning as a whole unit.

[0231] In case of a support system, introducing and guiding the compressed insertable prosthetic cardiac valve over the guide wire 191 with a dedicated delivery system of the insertable prosthetic cardiac valve into the prosthetic cardiac valve system 120; In case of a support system, positioning the insertable prosthetic cardiac valve within the inflated prosthetic cardiac valve system under imaging, between the upstream inflatable element and the downstream inflatable element;

[0232] In case of a support system, deploying the insertable prosthetic cardiac valve;

[0233] Withdrawing the prosthetic cardiac valve’s capsule;

[0234] Optionally, adjusting inflation level of the upstream inflatable element and / or of the downstream inflatable element for para-prosthetic leaks elimination and sub annular adjustments performed under echocardiographic guidance;

[0235] Detaching the inflating mechanism 64 of the upstream inflatable element and the downstream inflatable element; and

[0236] Removing the guide wire 191.

[0237] If the capsule is a splitable capsule, the following steps are carried out:

[0238] B'. Unsheathing proximal capsule for upstream inflatable element exposure above native leaflets and inflating the upstream inflatable element;

[0239] C . Distally advancing the inflated upstream inflatable element placing it supra annularly;

[0240] D'. Unsheathing distal capsule for downstream inflatable element exposure;

[0241] E'. Downstream inflatable element inflation for positioning and anchoring;

[0242] F'. Withdrawing the capsule;

[0243] And the above-described steps E, M N and O.

[0244] Inserting a prosthetic cardiac valve into a prosthetic cardiac valve support system of embodiments can be carried out as follows:

[0245] I. Positioning the prosthetic cardiac valve within the inflated docking system under fluoroscopic or echocardiography imaging, just between the upstream and downstream balloons;

[0246] J. Deploying the prosthetic cardiac valve (could be self-expandable or a balloon expandable prosthetic cardiac valve);

[0247] K. Withdrawing the prosthetic cardiac valve's DS;

[0248] L. Inflation level adjustment of the inflatable elements (upstream and downstream) for para valvular leaks elimination, performed under echo guidance; M. Detaching the inflation tubes of the inflatable elements (upstream and downstream);

[0249] N. Removing the guide wire;

[0250] Q. The fully inflated docking system with the prosthetic cardiac valve are functioning as a whole unit.

[0251] Figs. 12A to 12D exemplify a prosthetic cardiac valve 200 according to possible embodiments having a set of valve leaflets 148 integrated therein. Figs. 12A and Fig. 12B show the upstream inflatable element 80 of the prosthetic cardiac valve 200 in an inflated sate. As seen in the top views of Figs. 12A and Fig. 12B, in this non-limiting example the upstream inflatable element 80 located partially over the intermediate section (18) of the stent 10, downstream from the upstream mesh section (12). Fig. 12C shows a bottom view of the prosthetic cardiac valve 200 with its upstream inflatable element 80 and its downstream inflatable element 100 in their inflated states.

[0252] The prosthetic cardiac valve 200 is configured to allow normal hemodynamics from / to the heart (H) via the valve leaflets 148 configured to permit blood flow there through in one direction only.

[0253] Fig. 12D shows a front view of a leaflet band 149 comprising a tethered set of three valve leaflets 148. The valve leaflets 148 can be made from fabric, polymers, pericardium etc. ensuring optimal valve durability over time, and they can be attached to the stent 10 (or stent cage 143) by adhering, welding, stitching, etc.

[0254] Figs. 13A to 13G demonstrates a procedure of implanting a prosthetic cardiac valve according to possible embodiments by transseptal approach (i.e. , accessing the left atrium of the heart by puncturing the interatrial septum of the heart H). Of course, the procedure demonstrated in Figs. 13A to 13G is not limited to transseptal approach, and it may be similarly carried out mutatis mutandis using other approach techniques into other parts of the heart H for implanting prosthetic cardiac valve(s) of embodiments hereof in other valves of the heart H.

[0255] Fig. 13A shows introducing an insertion tube 192 over a guide wire 191 through the septum, into the left atrium of the heart H. The insertion tube 192 comprises a distal capsule 194 coupled to its distal end and accommodating the prosthetic cardiac valve crimped thereinside. As seen, a distal end potion of the guide wire 191 is introduced into the left ventricle through the mitral valve 195 and the distal capsule 194 is located above the valve 195 prepared to deploy the prosthetic cardiac valve crimped thereinside. In this specific and non-limiting example the capsule 194 comprises separable main (194b) and auxiliary (194a) capsules portions, configured for carrying out a two-stage stepped deployment procedure (e.g., as described in US Patent Publication No. 2021 / 0177593, the disclosure of which is incorporated herein by reference).

[0256] Next, as seen in Fig. 13B, the capsule is split to unsheathe the upstream inflatable element 80 of the prosthetic cardiac valve and part of its inflation tube(s) 198, that are distally discharged out of the auxiliary capsule portion 194a. The upstream inflatable element 80 is then inflated inside the atrium to assume its radially expanded stated, seen in Fig. 13C. The upstream inflatable element 80 and the distal / main capsule portion 194b are distally advanced to place the inflated tubular element 80 over the annulus of the native valve 195, as seen in Fig. 13D.

[0257] Thereafter, as seen in Fig. 13E, the distal / main capsule portion 194b is further advanced below the native valve leaflets to expose and inflate the downstream inflatable element. As the downstream inflatable element 100 is discharged out of the distal capsule portion 194b, the stent (10) radially expands to assume its memorized open state, and as the stent elements take the body temperature of their new environment their downstream tissue engaging spikes (22), and / or upstream tissue engaging spikes (20), radially project outwardly.

[0258] After the stent (10) assumes its expanded state, as shown in Fig. 13F, the downstream inflatable element 100 is inflated to assume its expanded state, thereby further expanding the downstream mesh section (14) of the stent (10) and anchoring the prosthetic cardiac valve to the native leaflets of the native valve 195, as the radially outwardly projecting downstream tissue engaging spikes 22 become embedded in the tissue of the natural valve 195. The insertion tube 192 is then removed over guidewire 191 out of the heart H, and the guidewire 191 can be then also removed, as shown in Fig. 13G.

[0259] As also seen in Fig. 13G, immediately after exposure and inflation of the downstream tubular element, the valve becomes fully functional thereby permitting blood flow in one direction only in accordance with the hemodynamics flow direction. Namely, in this specific and non-limiting example, the leaflets 148' permits blood flow from the left atrium into the left ventricle, and prevent blood from flowing in the reverse direction.

[0260] The leaflets 148' of the prosthetic cardiac valve can be either temporary valve leaflets, or a type of permanent biological leaflets (e.g., bovine or porcine pericardium) and / or polymeric leaflets, i.e., the prosthetic cardiac valve is configured as a fully functional valve. In possible embodiments, if the leaflets 148' are temporary valve leaflets, the guidewire 191 can be further used to deliver thereover an insertable prosthetic cardiac valve (141) for mounting in the prosthetic cardiac valve e.g., using a dedicated delivery system. The prosthetic cardiac valve (141) is then mounted over the temporary valve leaflets of the prosthetic cardiac valve, and the guidewire 191 can be then removed from the body of the treated subject.

[0261] While in the procedure demonstrated in Figs. 11A to 11H the downstream inflatable element is exposed and inflated first, and thereafter the upstream inflatable element is exposed and inflated, in the procedure demonstrated in Figs. 13A to 13G the upstream inflatable element is exposed and inflated first, and thereafter the downstream inflatable element is exposed and inflated.

[0262] Not illustrated but should be considered is a valve to be incorporated in the inflatable elements, e.g., a silicon plug type valve, that will prevent pressure leakage from the inflatable elements once inflated to the desired extent. According to an embodiment the valve is a one way valve, allowing fluid flow only into each inflatable element. According to another embodiment, the valve is a two way valve allowing also depressurizing of one or each of the inflatable elements.

[0263] Figs. 14A to 14C schematically illustrate a stent configuration 10' according to other possible embodiments usable for a prosthetic cardiac valve and / or support structures thereof. Fig. 14A shows the stent 10' in a crimped state, in which its upstream mesh section 12', comprised of a plurality elongated loop elements extending upwardly from the intermediate section 18', and its downstream mesh section 14', comprised of a plurality of triangular elements extending downwardly from the intermediate section 18', are axially stretched. The intermediate section 18' of the stent 10' has an undulating pattern 19 configured to provide elasticity quick shape restoration, as in other stent embodiments disclosed herein. As also exemplified, in some embodiments the stents disclosed herein may include only the downstream tissue engaging spikes 22.

[0264] Fig. 14B shows the stent 10' in a deployed state, with its downstream tissue engaging spikes 22 radially projecting outwardly. Fig. 14C shows the stent 10' in a flat (cut open) view. As seen, the downstream tissue engaging spikes 22 can be configured as elongated loop elements having a circular apertured base at the free tips 28. Fig. 15 schematically illustrates an embodiment of the stent 10" wherein the downstream tissue engaging spikes 22 are configured in a form of solid peg 22' . Figs. 16A to 16C schematically illustrate different downstream (or upstream) spike configurations according to possible embodiments. Fig. 16A shows a possible implementation of peg-like spikes 22' having solid bases 22b' at the free tips 28. Figs. 16B shows a possible implementation of elongated loop-shaped spikes 22 having an aperture 22b at the free tips 28, the aperture's diameter being proportional to, or about the size of, the width of the spike. Figs. 16C shows a possible implementation of elongated tapering loop spikes 22" having an aperture 22b" at the free tips 28, the aperture's diameter being proportional to, or about the size of, the width of the spike near the free tip 28.

[0265] Figs. 17A to 17D demonstrate a procedure for placing an insertable prosthetic cardiac valve 235 in the prosthetic cardiac valve support structure according to possible embodiments. Fig. 17A shows the delivery (e.g., transseptal approach) of the insertable prosthetic cardiac valve 235 into the support structure situated in the mitral valve position in the heart H by a delivery system 230. As seen, the insertable prosthetic cardiac valve 235 is advanced over the guidewire 191 into the prosthetic cardiac valve support system after it is placed in situ (e.g. , over a native cardiac valve of a treated subject) according to embodiments hereof.

[0266] Fig. 17B shows the deployment of the insertable prosthetic cardiac valve 235 inside the prosthetic cardiac valve support system, and Fig. 17C shows the insertable prosthetic cardiac valve 235 after it is fully deployed inside the prosthetic cardiac valve support system. The delivery system 230 and guidewire 191 are then removed, allowing and permit blood flow therethrough in one direction corresponding with the normal hemodynamics.

[0267] Turning now to Fig. 18, there is illustrated a new embodiment of the support structure, generally designated 300, which is similar in structure to the previous support structures discussed, however specifically configured to receive an unmodified surgical valve with a non-deformable ring surrounding it. Another visible difference relates to this support structure not having tissue engaging spikes. This configuration addresses the need to accommodate various types of prosthetic cardiac valves, including those with non-deformable components like rigid rings. The support structure 300 features a receiving arrangement in the form of a base comprising four or more radially arranged internal flanges 304. These flanges serve as a mounting platform for the surgical valve, providing a stable foundation within the flexible structure of the stent. Above each flange 304 is a securing element in the form of a radially arranged resilient tongue 306. These tongues 306 are designed to allow the surgical valve to slide into position and then prevent its backward movement, ensuring secure placement of the valve within the support structure.

[0268] Figs. 19A to 19C demonstrate the sequence of introducing a standard unmodified surgical valve 310 with a non-deformable ring 312 into the support structure 300. This sequence illustrates the practical application of the receiving arrangement and fixation mechanism. In Fig. 19A, we see the initial positioning of the valve 310 above the support structure 300. Fig. 19B shows the valve 310 being lowered into the support structure 300, with the non-deformable ring 312 aligning with the flanges 304. This step demonstrates how the receiving arrangement facilitates proper positioning and alignment of the valve within the support structure. Finally, Fig. 19C illustrates the valve 310 fully seated within the support structure 300, with the resilient tongues 306 engaging the upper surface of the non-deformable ring 312 to secure it in place. This final step showcases how the fixation element prevents backward movement of the valve once it's in position.

[0269] Fig. 20A presents another example of a surgical valve 320 with a non-deformable ring 322, but with an additional feature that enhances its adaptability to the support structure. This valve 320 is modified to include a fixation arrangement in the form of an expandable skirt 324. In its initial state, the skirt 324 is held in a crimped configuration by a surrounding wire mechanism 326. This wire mechanism is designed to be passable through a narrow tube, such as a catheter, allowing for minimally invasive deployment of the valve.

[0270] Complementing this valve design, Fig. 20B illustrates another example of a support structure 330 specifically configured to receive the valve 320. This support structure features a base in the form of an internal radial indentation 332, designed to receive the skirt 324 in its expanded state. This configuration demonstrates how the support structure can be adapted to work with specially designed valves, providing a customized fit for enhanced security and sealing.

[0271] Figs. 21A to 21C illustrate the sequence of introducing the valve 320 into the support structure 300. This sequence demonstrates the practical application of triggering the fixation arrangement into place after positioning. In Fig. 21A, we see the valve 320 being introduced with the skirt 324 in its crimped state. Fig. 21B shows the valve 320 positioned within the support structure 300, with the skirt 324 aligned with the indentation 332. Finally, Fig. 21C illustrates the skirt 324 expanded by releasing the surrounding wire mechanism 326, which is then removed from inside the support structure 300. This expansion of the skirt 324 into the indentation 332 provides an additional securing mechanism for the valve within the support structure.

[0272] Once the valve 320 is correctly positioned and the skirt 324 is aligned with the indentation 332, the wire mechanism 326 is carefully manipulated to release its hold on the skirt. This is typically achieved through a combination of rotation and axial movement of the wire, which disengages it from the skirt 324. The wire mechanism 326 is designed with a detachment point that allows it to be separated from the valve structure once its function is complete. After detachment, the wire is carefully withdrawn through the delivery catheter or surgical access point, ensuring no interference with the newly expanded skirt or the surrounding native tissue. This detachment and removal process is performed under imaging guidance to ensure precision and safety.

[0273] The receiving arrangement and fixation mechanisms described above provide additional support for securing various types of prosthetic cardiac valves, including those with non-deformable components. This adaptability enhances the versatility of the support structure, allowing it to accommodate a wide range of valve designs while maintaining optimal positioning and sealing within the native valve site.

[0274] The deployment of the prosthetic cardiac valve system can be achieved through various methods, each tailored to specific clinical needs and valve configurations. These methods generally involve the use of a guide wire and a delivery system with a distal capsule containing the compressed prosthetic cardiac valve system.

[0275] In one method, the deployment process begins with introducing the guide wire and delivery system, visualized under imaging until the downstream inflatable element and mesh section are exposed at the sub-annular level of the native valve, distal to the native leaflets' coaptation line. The downstream inflatable element is then inflated while the upstream inflatable element remains crimped in the capsule. The capsule is retrieved towards the upstream portion of the valve, allowing the downstream spikes (if present) to engage downstream of the native valve. The upstream inflatable element is then unsheathed and inflated, followed by the withdrawal of the capsule. Thereby bringing the support structure to a state where it is ready to receive a valve.

[0276] For cases involving a prosthetic cardiac valve with a non-deformable portion, such as those illustrated in Figs. 18-21C, The prosthetic cardiac valve, which cannot be compressed due to its non-deformable portion, is then separately introduced through a surgical procedure. Once both components are in place, the prosthetic cardiac valve is connected to the support structure inside the patient's body. This method can allow the use of standard surgical valves without requiring modifications to their structure, as demonstrated in the sequence shown in Figs. 19A-C.

[0277] In other cases the support structure and the valve can be both be introduced through a surgical operation, by hand operated or robotic operated means, separately and be connected once the support structure is fully deployed.

[0278] Another deployment method involves connecting the prosthetic cardiac valve to the support structure outside the patient's body, creating an integrated system, and introducing both as an integrated system into the body.

[0279] According to an embodiment of the presently disclosed subject matter, for introduction of the integrated system, in cases where it involves downstream tissue engaging spikes, the downstream tissue engaging spikes are initially constrained by sutures or a protective cone. This prevents the sharp edges of the spikes from contacting tissue during insertion beyond the native valve annulus . Once the device is positioned, the sutures are cut or the cone is removed, allowing the spikes to 'pop out' to their preshaped form. Optionally, the downstream inflatable element is then inflated to ensure proper anchoring and engagement of the spikes with the surrounding tissue.

[0280] These deployment methods can be adapted based on the specific type of prosthetic cardiac valve being used and the particular anatomical challenges of the patient. For example, when using the support structure with internal flanges as shown in Fig. 18, extra care is taken to align the non-deformable ring of the valve with these flanges during deployment.

[0281] The support structure's adaptability extends to accommodating surgical valves for different valve types. For mitral valve replacement, the receiving arrangement may be positioned to support an intra-annular valve placement. In aortic valve applications, the structure can be modified to support sub-annular valve positioning. Similar adaptations can be made for tricuspid and pulmonary valve replacements, ensuring that the system can be customized for each specific valve type and anatomical requirement.

[0282] The prosthetic cardiac valve system of the present disclosure offers flexibility in terms of integration and introduction methods. The support structure can be designed to be integral with a valve or separate from it, allowing for various deployment strategies. In some embodiments, the support structure can be introduced through a catheter in a minimally invasive procedure, while the valve is introduced separately through a surgical approach. This method is particularly useful for accommodating surgical valves with non- deformable components.

[0283] It should be appreciated that the integration of the valve and support structure can occur at different stages:

[0284] 1. Inside the body: The support structure is first positioned in the target location, and then the valve is introduced and secured within it during the procedure, as illustrated in Figs. 19A-C.

[0285] 2. On the preparation table: The valve and support structure are combined immediately before the procedure, allowing for final adjustments and checks before introduction as a single unit.

[0286] 3. In the factory: The valve and support structure are pre-integrated during manufacturing, creating a single-piece prosthetic cardiac valve system that's ready for implantation.

[0287] Each of these methods offers unique advantages, allowing clinicians to choose the most appropriate approach based on the specific patient anatomy, valve type, and procedural requirements. The variety of deployment and integration options, combined with the adaptable design of the support structure, provides a comprehensive solution for a wide range of cardiac valve replacement scenarios.

[0288] To further illustrate the versatility of the prosthetic cardiac valve system, we will now describe in detail the methods for integrating and deploying the system, each tailored to specific clinical scenarios and valve types. These methods can be broadly categorized into three approaches based on the stage at which the valve is integrated with the support structure:

[0289] 1. Integration inside the body: This method comprises the steps of: a) Introducing the support structure into the patient's body using a delivery system; b) Positioning the support structure at the target location within the heart; c) Expanding the support structure to engage with the native valve tissue; d) Separately introducing the prosthetic cardiac valve into the patient's body through a surgical approach; e) Guiding the prosthetic cardiac valve to the deployed support structure; f) Aligning the prosthetic cardiac valve with the receiving arrangement of the support structure; g) Securing the prosthetic cardiac valve within the support structure using the fixation mechanism. This method is particularly useful for accommodating surgical valves with non-deformable components, as illustrated in Figs. 19A-C.

[0290] 2. Integration on the preparation table: This method comprises the steps of: a) Preparing the support structure and the prosthetic cardiac valve separately; b) Combining the support structure and the prosthetic cardiac valve on the preparation table immediately before the procedure; c) Making any necessary adjustments to ensure proper fit and function; d) Introducing the combined prosthetic cardiac valve system into the patient's body as a single unit; e) Positioning the prosthetic cardiac valve system at the target location within the heart; f) Deploying and securing the prosthetic cardiac valve system in place. This method allows for final checks and adjustments before implantation, ensuring optimal integration of the valve and support structure.

[0291] 3. Integration in the factory: This method utilizes a pre-integrated prosthetic cardiac valve system and comprises the steps of: a) Selecting a pre -integrated prosthetic cardiac valve system based on patient-specific requirements; b) Introducing the pre-integrated system into the patient's body using a suitable delivery method (either minimally invasive or surgical); c) Positioning the system at the target location within the heart; d) Deploying the system, which may involve expanding the support structure and / or releasing any constraints on the valve; e) Securing the system in place, which may involve inflation of inflatable elements and / or engagement of tissue-engaging spikes. This method simplifies the implantation procedure by eliminating the need for intraoperative integration of components. Each of these integration and deployment methods offers distinct advantages and can be selected based on the specific requirements of the patient, the type of valve being used, and the preferred surgical approach. For instance, the in-body integration method provides maximum flexibility for using standard surgical valves, while the factory integration method offers a streamlined implantation process.

[0292] The ability to choose between these methods further enhances the adaptability of the prosthetic cardiac valve system. It allows clinicians to tailor their approach not only to the patient's anatomical needs but also to the logistical and practical considerations of the medical facility and the surgical team's expertise. Moreover, these varied integration and deployment strategies complement the earlier described features of the support structure, such as the inflatable elements, tissueengaging spikes, and receiving arrangements. Together, they form a comprehensive system that can address a wide spectrum of challenges in cardiac valve replacement procedures, from anatomical variations to procedural preferences.

[0293] As described hereinabove and shown in the associated figures the present application provides prosthetic cardiac valve configuration and related methods. While particular embodiments of the invention have been described, it will be understood, however, that the subject disclosed herein is not limited thereto, since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. As will be appreciated by the skilled person, the disclosed embodiments can be carried out in a great variety of ways, employing more than one technique from those described above, all without exceeding the scope of the claims.

Claims

CLAIMS:

1. A prosthetic cardiac valve system, comprising: a stent comprising a flexible tubular element having an upstream mesh section, a downstream mesh section, and an intermediate section extending therebetween, an upstream elastic sleeve extending over at least a portion of said upstream mesh section, said upstream elastic sleeve having an upstream inflatable element disposed axially upstream of said upstream mesh section; a downstream elastic sleeve extending over at least a portion of an inside face of the intermediate mesh section, said downstream elastic sleeve having a downstream inflatable element axially and radially disposed in overlap over at least an inside portion of the intermediate mesh section and the portion of the downstream mesh section; and a prosthetic cardiac valve configured to be secured within one or more of the mesh sections of said stent.

2. The prosthetic cardiac valve system of claim 1, wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes, and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes, adapted to engage and cling on the tissue surrounding them thereby anchoring the stent thereto.

3. The prosthetic cardiac valve system of claim 1 or claim 2, wherein the prosthetic cardiac valve is integrated with the stent.

4. The prosthetic cardiac valve system of any one of claims 1 to 3, wherein said upstream tissue engaging spikes and said downstream tissue engaging spikes are made of memory shape material and are configured, at a closed position to be coplanar with an outside surface of the stent, and at an expanded deployed position of the stent, after being introduced in situ and reaching a predefined temperature, to deform to their memory shape to project radially outwards from an outside surface of the stent to their radially outwards deformed position.

5. The prosthetic cardiac valve system of any one of the preceding claims, wherein said upstream inflatable element and said downstream inflatable element are tubular.

6. The prosthetic cardiac valve system of claim 5, wherein a maximal diameter of said upstream inflatable element, when inflated, is substantially identical to a maximal diameter of said downstream inflatable element, when inflated.

7. The prosthetic cardiac valve system of any one of the preceding claims, wherein said stent comprises a receiving arrangement configured to receive and facilitate positioning and alignment of said prosthetic cardiac valve therein.

8. The prosthetic cardiac valve system of claim 7, wherein said receiving arrangement comprises a base on which the prosthetic cardiac valve is to be mounted and a fixation element for securing the prosthetic cardiac valve in position.

9. The prosthetic cardiac valve system of claim 8, wherein the base is in the form of one or more internal annular flanges securely connected to the intermediate section of the mesh.

10. The prosthetic cardiac valve system of claim 8, wherein the base is in the form of an annular indentation in the intermediate mesh section.

11. The prosthetic cardiac valve system of any one of claims 8 to 10, wherein said prosthetic cardiac valve comprises a fixation arrangement adapted to securely engage said base.

12. The prosthetic cardiac valve system of claim 11, wherein said fixation arrangement is configured to be triggered into fixation after or during it has been brought into proper positioning and alignment within the stent.

13. The prosthetic cardiac valve system of claim 11 or claim 12, wherein the fixation arrangement is in the form of an annular radially extendable skirt, adapted to be brought into its operational position in a contracted state thereof and be triggered into extension once in the operational position.

14. The prosthetic cardiac valve system of any one of claims 8 to 13, wherein said receiving arrangement comprises a fixation element for keeping the prosthetic cardiac valve in its operational position on the base.

15. The prosthetic cardiac valve system of claim 14, wherein the fixation element is in the form of one or more directional resilient tongues allowing sliding thereupon of the prosthetic cardiac valve with its non-deformable component in one direction, while preventing back sliding in the opposite direction once the prosthetic cardiac valve slides therebeyond.

16. The prosthetic cardiac valve system of any one of the preceding claims, comprising temporary valve leaflets attached to the upstream elastic sleeve and / or one or more of the mesh sections, and wherein the prosthetic cardiac valve system is configured for attachment of the prosthetic cardiac valve over said temporary valve leaflets.

17. The prosthetic cardiac valve system of any one of the preceding claims, wherein the stent is configured for positioning and securing within a cardiac valve cavity, wherein at its deployed, expanded position the upstream inflatable element is configured for bearing over the annulus of a native cardiac valve, to thereby seal and prevent blood flow external to the upstream elastic sleeve.

18. The prosthetic cardiac valve system of any one of the preceding claims, wherein the stent is configurable for positioning and securing within a cardiac valve cavity, and wherein when the stent assumes its expanded shape and bears against the native annulus, the inflated upstream inflatable element bears over the annulus of a native cardiac valve, and functions as a seal to prevent blood flow external to the upstream elastic sleeve.

19. The prosthetic cardiac valve system of claim 5, wherein at the deployed position, when the upstream inflatable element is inflated, it serves as an annular seal disposed radially, surrounding the prosthetic cardiac valve, to restrict blood flow only through said prosthetic cardiac valve.

20. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream mesh section and the downstream mesh section define between them a flow path in direction from the upstream mesh section to the downstream mesh section, in correspondence with normal hemodynamics.

21. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the prosthetic cardiac valve is secured within the upstream mesh section of the stent, said prosthetic cardiac valve being configured and operable for blood flow administration along the flow path, in direction from the upstream mesh section to the downstream mesh section in direction corresponding with normal hemodynamics.

22. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream elastic sleeve and the downstream elastic sleeve are a homogeneous sleeve or independent sleeves.

23. The prosthetic cardiac valve system according to any one of the preceding claims, wherein each of the upstream elastic sleeve and the downstream elastic sleeve are secured to either an inside face of the stent, or to an outside face thereof.

24. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream elastic sleeve and the downstream elastic sleeve form a continuous sleeve member comprising an intermediate portion extending between the upstream elastic sleeve and the downstream elastic sleeve.

25. The prosthetic cardiac valve system according to any one of the preceding claims, wherein each of the upstream inflatable element and the downstream inflatable element is configured with an inflating mechanism for inflating and pressure regulating of the volume and pressure within the respective inflatable element.

26. The prosthetic cardiac valve system according to any one of the preceding claims, wherein each of the upstream inflatable element and the downstream inflatable element is associated with an inflation / deflation port.

27. The prosthetic cardiac valve system according to any one of the preceding claims, wherein each of the upstream inflatable element and the downstream inflatable element is disposed within an annular pouch of their respective elastic sleeve.

28. The prosthetic cardiac valve system according to any one of the preceding claims, wherein each of the upstream inflatable element and the downstream inflatable element is inflatable with a fluid comprising a puncture sealing agent.

29. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the upstream tissue engaging spikes face towards a downstream side of the stent and the downstream tissue engaging spikes face towards an upstream side of the stent.

30. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the intermediate mesh section is configured and operable as an undulating section, axially extending between the upstream mesh section and the downstream mesh section.

31. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the intermediate mesh section integrally extends with the upstream mesh section and the downstream mesh section.

32. The prosthetic cardiac valve system according to any one of the preceding claims, having one of the following configurations: the upstream mesh section extends in proximity below the upstream inflatable element; the upstream mesh section extends in proximity above the upstream inflatable element.

33. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the downstream inflatable element extends opposite at least a portion of the intermediate mesh section and a portion of the downstream mesh section.

34. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the projecting downstream spikes have a pointed end facing an upstream end of the stent.

35. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the projecting spikes are equally distributed about a perimeter of the stent.

36. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the projecting spikes have a triangle, teardrop, or elongated loop shape.

37. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the stent, the elastic sleeves, and the prosthetic cardiac valve are configured and operable as drug -eluting.

38. The prosthetic cardiac valve system according to any one of the preceding claims, wherein a nominal diameter of the stent of the prosthetic cardiac valve, at its deployed position, is greater than a diameter of the stent at its closed position, hence once deployed, the prosthetic cardiac valve is engageable within the elastic sleeves.

39. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the prosthetic cardiac valve is secured to the upstream elastic sleeve.

40. The prosthetic cardiac valve system according to any one of the preceding claims, wherein the prosthetic cardiac valve is secured at an inside face of the upstream elastic sleeve.

41. The prosthetic cardiac valve system according to any one of the preceding claims, further comprising an inflating mechanism for inflating one or both of the upstream inflatable element and the downstream inflatable element.

42. The prosthetic cardiac valve system according to any one of the preceding claims, further comprising a detachable inflation tube detachably articulated with each of the upstream inflatable element and the downstream inflatable element.

43. A prosthetic cardiac valve system, comprising: a stent comprising a flexible tubular element having an upstream mesh section, a downstream mesh section, and an intermediate section extending therebetween, wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes, and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes, adapted to engage and cling on the tissue surrounding them thereby anchoring the stent thereto; an upstream elastic sleeve extending over at least a portion of said upstream mesh section, said upstream elastic sleeve having an upstream inflatable element disposed axially upstream of said upstream mesh section; anda prosthetic cardiac valve configured to be secured within one or more of the mesh sections of said stent.

44. The prosthetic cardiac valve system of claim 43, further comprising: a downstream elastic sleeve extending over at least a portion of an inside face of the intermediate mesh section, said downstream elastic sleeve having a downstream inflatable element axially and radially disposed in overlap over at least an inside portion of the intermediate mesh section and the portion of the downstream mesh section.

45. The prosthetic cardiac valve system of claim 43 or claim 44, wherein the prosthetic cardiac valve is integrated with the stent.

46. The prosthetic cardiac valve system of any one of claims 43 to 45, wherein said upstream tissue engaging spikes and said downstream tissue engaging spikes are made of memory shape material and are configured, at a closed position to be coplanar with an outside surface of the stent, and at an expanded deployed position of the stent, after being introduced in situ and reaching a predefined temperature, to deform to their memory shape to project radially outwards from an outside surface of the stent to their radially outwards deformed position.

47. The prosthetic cardiac valve system of any one of claims 43 to 46, wherein said upstream inflatable element is tubular.

48. The prosthetic cardiac valve system of claim 44 and claim 47, wherein said downstream inflatable element is tubular, and wherein a maximal diameter of said upstream inflatable element, when inflated, is substantially identical to a maximal diameter of said downstream inflatable element, when inflated.

49. The prosthetic cardiac valve system of any one of claims 43 to 48, wherein said stent comprises a receiving arrangement configured to receive and facilitate positioning and alignment of said prosthetic cardiac valve therein.

50. The prosthetic cardiac valve system of claim 49, wherein said receiving arrangement comprises a base on which the prosthetic cardiac valve is to be mounted and a fixation element for securing the prosthetic cardiac valve in position.

51. The prosthetic cardiac valve system of claim 50, wherein the base is in the form of one or more internal annular flanges securely connected to the intermediate section of the mesh.

52. The prosthetic cardiac valve system of claim 50, wherein the base is in the form of an annular indentation in the intermediate mesh section.

53. The prosthetic cardiac valve system of any one of claims 50 to 52, wherein said prosthetic cardiac valve comprises a fixation arrangement adapted to securely engage said base.

54. The prosthetic cardiac valve system of claim 53, wherein said fixation arrangement is configured to be triggered into fixation after or during it has been brought into proper positioning and alignment within the stent.

55. The prosthetic cardiac valve system of claim 53 or claim 54, wherein the fixation arrangement is in the form of an annular radially extendable skirt, adapted to be brought into its operational position in a contracted state thereof and be triggered into extension once in the operational position.

56. The prosthetic cardiac valve system of any one of claims 50 to 55, wherein said receiving arrangement comprises a fixation element for keeping the prosthetic cardiac valve in its operational position on the base.

57. The prosthetic cardiac valve system of claim 56, wherein the fixation element is in the form of one or more directional resilient tongues allowing sliding thereupon of the prosthetic cardiac valve with its non-deformable component in one direction, while preventing back sliding in the opposite direction once the prosthetic cardiac valve slides therebeyond.

58. A support structure for supporting a prosthetic cardiac valve, comprising: a flexible tubular stent having an upstream mesh section and a downstream mesh section, with a intermediate mesh section extending therebetween, wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes; wherein at an expanded position of the stent, said upstream tissue engaging spikes and said downstream tissue engaging spikes project radially outwards from an outside surface of the stent; and an upstream elastic sleeve extending over at least a portion of an inside / outside face of said upstream mesh section; said upstream elastic sleeve having an upstream inflatable element disposed axially and radially upstream of said upstream mesh section.

59. The support structure of claim 58, being configured and operable between a constricted, deploying position at which it is at a closed position, and an expanded, open position at which it assumes a radially expanded position, and wherein at the closedposition the upstream tissue engaging spikes and the downstream tissue engaging spikes are coplanar with an outside surface of the stent.

60. The support structure of claim 58 or 59, being configured and operable for use as a cardiac valve support for any one of the following: mitral valve, aortic valve, tricuspid valve and pulmonary valve.

61. The support structure of any one of claims 58 to 60, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic cardiac valve in the mitral position, and wherein the upstream inflatable element is configurable for supra-annular positioning and inflating within the left atrium.

62. The support structure of any one of claims 58 to 61, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic aortic valve, and wherein the upstream inflatable element is configurable for sub-annular positioning and inflation.

63. The support structure of any one of claims 58 to 62, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic tricuspid valve, wherein the upstream inflatable element is configured and operable for supra-annular positioning and inflating within the right atrium.

64. The support structure of any one of claims 58 to 63, for use in conjunction with a prosthetic cardiac valve system, wherein the support structure is a valve support for a prosthetic pulmonary valve, wherein the upstream inflatable element is configurable for sub-annular positioning and inflating within the right ventricle.

65. The support structure of any one of claims 58 to 64, further comprising a temporary valve positioned between the upstream and downstream mesh section at a non- deformable section of the support structure thereof, for temporarily regulating blood flow, in the direction corresponding with the normal hemodynamics, during a procedure of positioning and deploying the support structure, whereby upon positioning and deploying the prosthetic cardiac valve within the support structure, said temporary valve is overridden by the prosthetic cardiac valve.

66. A stent member for supporting a prosthetic cardiac valve, the stent member being a flexible tubular element having an upstream mesh section, a downstream mesh section and an intermediate section extending therebetween, wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes, and / or the downstream mesh section is configured with a plurality of downstream tissue engaging spikes,wherein said upstream tissue engaging spikes and said downstream tissue engaging spikes are made of memory shape material and are configured, at a closed position to be coplanar with an outside surface of the stent, and at an expanded deployed position of the stent, after being introduced in situ and reaching a predefined temperature to deform to their memory shape to project radially outwards from an outside surface of the stent to their radially outwards deformed position.

67. The stent member according to claim 66, wherein at its deployed, expanded position, the stent assumes a frustoconical shape wherein a narrow portion thereof is the upstream section of the stent.

68. The stent member according to claim 66 or 67, wherein the projecting spikes are equally distributed about a perimeter of the stent.

69. The stent member according to any one of claims 66 to 68, wherein the projecting spikes have a triangle, teardrop or elongated loop shape.

70. The stent member according to any one of claims 66 to 69, wherein at an initial, unstressed position, the stent is cylindric.

71. A support structure for supporting a prosthetic mitral valve, said support structure comprising: an elastic sleeve member comprising an inflatable supra annular member and an inflatable sub annular member defining therebetween a flow space; and a flexible tubular mesh structure articulated at an inside face of the sleeve, the mesh structure having an atrial section and a ventricular portion, with an section extending therebetween, and wherein the atrial portion is configured with a plurality of annular / supra annular tissue engaging spikes and / or the ventricular portion is configured with a plurality of annular / sub annular tissue engaging spikes, whereby inflating the supra annular member entails radial deformation of the annular / supra annular tissue engaging spikes, and inflating the sub annular member entails radially outwards deformation of the deformable section and the sub annular portion, and radial deformation of the annular / sub annular tissue engaging spikes, wherein a prosthetic mitral valve is secured within the elastic sleeve thereof.

72. A prosthetic cardiac valve kit comprising: a support structure comprising a flexible tubular stent having an upstream mesh section and a downstream mesh section, with an intermediate mesh section extending therebetween, and wherein the upstream mesh section is configured with a plurality of upstream tissue engaging spikes and / or the downstream mesh section is configured with a plurality of downstream tissue engagingspikes; wherein at an expanded position of the stent said upstream tissue engaging spikes and said downstream tissue engaging spikes project radially outwards from an outside surface of the stent; an upstream elastic sleeve extending over at least a portion of an inside / outside face of said upstream mesh section; said upstream elastic sleeve having an upstream inflatable element disposed axially and radially upstream of said upstream mesh section; a prosthetic cardiac valve secured within the upstream elastic sleeve and downstream of the upstream inflatable element.

73. The prosthetic cardiac valve kit of claim 72, further comprising an inflating mechanism for inflating one or both of an upstream inflatable element and a downstream inflatable element.

74. The prosthetic cardiac valve kit of claim 72 or 73, further comprising a detachable inflation tube detachably articulated with each of the upstream inflatable element and the downstream inflatable element.

75. A method of deploying a prosthetic cardiac valve support system, or a fully functional prosthetic cardiac valve, the method comprising the following steps: A. introducing a guide wire with a distal capsule containing the prosthetic cardiac valve system, or the fully functional prosthetic cardiac valve, at a compressed position, visualized under imaging; B. exposing the downstream inflatable element with the downstream mesh section of the stent at the sub annular level of the native valve, distal to the native leaflets coaptation line; C. inflating the downstream inflatable element, while an upstream inflatable element is still crimped in the capsule; D. retrieving the capsule towards the upstream portion of the valve, allowing the downstream spikes to engage downstream of the native valve; E. unsheathing the upstream inflatable element under imaging; F. inflating the upstream inflatable element; G. withdrawing the capsule.

76. The method of claim 75 further comprising: introducing and guiding a compressed prosthetic cardiac valve over the guide wire; positioning the prosthetic cardiac valve within the inflated prosthetic cardiac valve system, between the upstream inflatable element and the downstream inflatable element; deploying the prosthetic cardiac valve.

77. A method of deploying a prosthetic cardiac valve support system, the method comprising the following steps: introducing over a guide wire a distal capsule containing the prosthetic cardiac valve system at a compressed position; splitting said distal capsule for exposing an upstream inflatable element above native leaflets of a native valve whilemaintaining downstream portions and a stent of the prosthetic cardiac valve in a portion of said distal capsule distal to said upstream inflatable element; inflating the upstream inflatable element; distally advancing the inflated upstream inflatable element and said portion of the capsule to place said inflated upstream inflatable element over an annulus of said native valve and introducing said portion of the capsule below the native leaflets of said native valve; distally advancing said portion of the capsule for unsheathing said downstream portions of the prosthetic cardiac valve under imaging; inflating the downstream inflatable element for anchoring said stent inside said native valves by upstream and / or downstream tissue engaging spikes of said stent; withdrawing the capsule.

78. A method of deploying a prosthetic cardiac valve support system, the method comprising: introducing a support structure comprising a flexible tubular stent having an upstream mesh section, a downstream mesh section, and an intermediate mesh section extending therebetween, into a patient's body; positioning the support structure at a desired location within the patient's body; separately introducing a prosthetic cardiac valve having a non-deformable portion through a surgical procedure; positioning the prosthetic cardiac valve within the support structure; and connecting the prosthetic cardiac valve to the support structure inside the patient's body.

79. The method of claim 78, wherein the prosthetic cardiac valve includes a non- deformable ring.

80. The method of claim 79, wherein the support structure includes inflatable elements, and the method further comprises inflating the inflatable elements after positioning the integrated prosthetic cardiac valve system.

81. A method of deploying a prosthetic cardiac valve support system, the method comprising: providing a support structure comprising a flexible tubular stent having an upstream mesh section, a downstream mesh section, and an intermediate mesh section extending therebetween, wherein the downstream mesh section includes tissue engaging spikes; providing a prosthetic cardiac valve with a non-deformable circumferential rim; connecting the prosthetic cardiac valve to the support structure outside a patient's body to form an integrated prosthetic cardiac valve system; constraining the tissue engaging spikes of the downstream mesh section with sutures or a protective cone; introducing the integrated prosthetic cardiac valve system into the patient's body through a surgical approach; positioning the integrated prosthetic cardiac valve system at a desired locationrelative to the native valve; releasing the tissue engaging spikes by cutting the sutures or removing the protective cone, allowing the spikes to assume their pre-shaped form; aligning the non-deformable circumferential rim of the prosthetic cardiac valve with the receiving arrangement of the support structure, thereby expanding the support structure to a specific diameter; and inflating a downstream inflatable element associated with the downstream mesh section.

82. A method of deploying a prosthetic cardiac valve support system, the method comprising: providing a support structure comprising a flexible tubular stent having an upstream mesh section, a downstream mesh section, and an intermediate mesh section extending therebetween; providing a prosthetic cardiac valve; connecting the prosthetic cardiac valve to the support structure outside a patient's body to form an integrated prosthetic cardiac valve system; crimping the downstream mesh section of the stent to allow introduction beyond the annulus of a native valve; introducing the integrated prosthetic cardiac valve system into the patient's body with the downstream mesh section in a crimped state; positioning the upstream mesh section and the intermediate mesh section of the integrated prosthetic cardiac valve system at a desired location relative to the native valve; uncrimping the downstream mesh section once the integrated prosthetic cardiac valve system is in position; and expanding a downstream inflatable element associated with the downstream mesh section.

83. The method of claim 82, wherein the pre -integrated prosthetic cardiac valve system is introduced using a minimally invasive catheter-based approach.

84. A method of deploying a pre-integrated prosthetic cardiac valve system, comprising: a) selecting an appropriate pre-integrated prosthetic cardiac valve system based on patient-specific requirements, wherein the pre-integrated prosthetic cardiac valve system comprises a support structure and a prosthetic cardiac valve integrated in a factory; b) introducing the pre-integrated system into a patient's body using a delivery method; c) positioning the system at a target location within the heart; d) deploying the system by expanding the support structure and / or releasing any constraints on the valve; e) securing the system in place by inflation of inflatable elements and / or engagement of tissue-engaging spikes.

85. A support structure for supporting a prosthetic cardiac valve, comprising: a flexible tubular stent having an upstream mesh section, a downstream mesh section, and an intermediate section extending therebetween, an upstream elastic sleeve extendingover at least a portion of said upstream mesh section, said upstream elastic sleeve having an upstream inflatable element disposed axially upstream of said upstream mesh section; a downstream elastic sleeve extending over at least a portion of an inside face of the intermediate mesh section, said downstream elastic sleeve having a downstream inflatable element axially and radially disposed in overlap over at least an inside portion of the intermediate mesh section and the portion of the downstream mesh section.

86. A method of deploying a prosthetic cardiac valve system, the method comprising the following steps: A. introducing a guide wire with a distal capsule containing the prosthetic cardiac valve system at a compressed position, visualized under imaging; B. exposing an upstream inflatable element and an upstream mesh section of the stent above a native valve, proximal to native leaflets; C. inflating the upstream inflatable element while a downstream inflatable element remains crimped in the capsule; D. advancing the capsule distally to position an intermediate mesh section and a downstream mesh section through the native valve; E. exposing the downstream inflatable element with the downstream mesh section of the stent at a sub-annular level of the native valve, distal to the native leaflets' coaptation line; F. inflating the downstream inflatable element, allowing downstream tissue engaging spikes, if present, to engage sub-annular tissue; G. withdrawing the capsule fully; H. making final adjustments to both inflatable elements to ensure optimal sealing and anchoring.

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